1367 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220236&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220236 03/11/2026 (a) The purpose of this subchapter is to establish the requirements for a patient with a severe chronic disease to access and use an investigational drug, biological product, or device, consistent with Texas Health and Safety Code Chapter 490 and the rules in this subchapter.(b) Texas Health and Safety Code Chapter 490 and the rules in this subchapter do not require a manufacturer to make available an investigational drug, biological product, or device to an eligible patient but a manufacturer choosing to do so must not receive compensation. Source Note: The provisions of this §1.1 adopted to be effective August 19, 2024, 49 TexReg 6215. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS A INVESTIGATIONAL TREATMENTS FOR PATIENTS WITH SEVERE CHRONIC DISEASES §1.1 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220237&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220237 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220237&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220237 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Commissioner--The commissioner of the Texas Department of State Health Services.(2) Department--The Texas Department of State Health Services.(3) Investigational drug, biological product, or device--These words are defined in Texas Health and Safety Code §490.001.(4) Severe chronic disease--A condition, injury, or illness that:(A) may be treated;(B) may not be cured or eliminated; and(C) entails significant functional impairment or severe pain. Source Note: The provisions of this §1.2 adopted to be effective August 19, 2024, 49 TexReg 6215. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS A INVESTIGATIONAL TREATMENTS FOR PATIENTS WITH SEVERE CHRONIC DISEASES §1.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220238&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220238 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220238&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220238 03/11/2026 (a) A patient is eligible to access and use an investigational drug, biological product, or device, consistent with Texas Health and Safety Code §490.001, if:(1) the patient's treating physician confirms, in writing, the patient has a diagnosis of a severe chronic disease; and(2) the patient signs a written informed consent as described in §1.4 of this subchapter (relating to Informed Consent).(b) A treating physician must maintain the written confirmation of a patient's severe chronic disease diagnosis in the medical record of the treating physician in accordance with the applicable records retention requirements. Source Note: The provisions of this §1.3 adopted to be effective August 19, 2024, 49 TexReg 6215. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS A INVESTIGATIONAL TREATMENTS FOR PATIENTS WITH SEVERE CHRONIC DISEASES §1.3 Patient Eligibility https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220239&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220239 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220239&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220239 03/11/2026 (a) Pursuant to Texas Health and Safety Code §490.052(b), the department adopts a written informed consent form for use by physicians and patients receiving an investigational drug, biological product, or device. A physician may use a different informed consent form if it contains, at a minimum, the same information as the department form. The written informed consent form is available on the department website at www.dshs.texas.gov/chronic/.(b) A patient eligible to access and use an investigational drug, biological product, or device must sign a written informed consent form. If the patient is a minor or lacks the mental capacity to provide written informed consent, a parent, guardian, or conservator may provide written informed consent on the patient's behalf.(c) A patient must provide a signed, written informed consent form to a manufacturer of an investigational drug, biological product, or device before the manufacturer may make the investigational drug, biological product, or device available to the patient.(d) The written informed consent form must be maintained in the medical record of the treating physician in accordance with the applicable records retention requirements. Source Note: The provisions of this §1.4 adopted to be effective August 19, 2024, 49 TexReg 6215. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS A INVESTIGATIONAL TREATMENTS FOR PATIENTS WITH SEVERE CHRONIC DISEASES §1.4 Informed Consent https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90200 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90200 03/11/2026 These rules cover the hearing procedures and practices that are available to persons or parties who request formal hearings from the department. The intended effect of these rules is to supplement the contested case provisions of the Texas Government Code, Chapter 2001, Administrative Procedure Act (APA), the hearing procedures of the State Office of Administrative Hearings (Texas Government Code, Chapter 2003 and Rules of Procedure, 1 Texas Administrative Code, Chapter 155), and to make the public aware of these procedures and practices. Source Note: The provisions of this §1.21 adopted to be effective November 15, 2001, 26 TexReg 9093. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS B FORMAL HEARING PROCEDURES §1.21 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90201&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90201 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90201&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90201 03/11/2026 (a) On the written motion of any party or the Administrative Law Judge (ALJ), the department shall issue a subpoena to the appropriate process server to require the attendance of witnesses or the production of documents or other tangible evidence at the hearing.(b) There must be a showing of good cause for the subpoena.(c) Motions for the issuance of a subpoena shall be submitted to the commissioner or a designee of the commissioner and simultaneously filed with the Office of General Counsel. The subpoena shall be issued upon a finding of good cause.(d) A party or witness may object to the subpoena or move for a protective order as provided by the Texas Rules of Civil Procedure. Motions regarding objections to the subpoena or for a protective order shall be filed with the ALJ, who shall rule on them in a timely manner.(e) Documents subpoenaed include books, papers, records, accounts, photographs, and similar materials or objects.(f) Witnesses subpoenaed shall be paid per diem and mileage in accordance with those amounts paid to state employees as set out in the current State General Appropriations Act, or a higher amount as set by the department. The party that requests the subpoena is responsible for paying all subpoena costs and fees. Source Note: The provisions of this §1.23 adopted to be effective November 15, 2001, 26 TexReg 9093. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS B FORMAL HEARING PROCEDURES §1.23 Subpoena https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90202&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90202 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90202&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90202 03/11/2026 (a) For purposes of this section, default means the failure of the respondent to appear in person or by legal representative on the day and at the time set for hearing in a contested case or the failure to appear by telephone in accordance with the notice of hearing.(b) Remedies available upon default. The Administrative Law Judge (ALJ) shall proceed in the party's absence and such failure to appear shall entitle the department to seek informal disposition as provided by the Texas Government Code, Chapter 2001. The ALJ shall grant any motion by the department to remove the case from the contested hearing docket and allow for informal disposition by the commissioner.(c) The commissioner may enter a default judgment by issuing an order against the defaulting party in which the factual allegations in the notice of hearing are deemed admitted as true without the requirement of submitting additional proof, upon the offer of proof that proper notice was provided to the defaulting party opponent. For purposes of this section, proper notice means notice sufficient to meet the provisions of the Texas Government Code, Chapter 2001 and the State Office of Administrative Hearings Rules of Procedure, 1 Texas Administrative Code, Chapter 155.(d) Motion to set aside and reopen. A timely motion by the respondent to set aside the default order and reopen the record may be granted if the respondent establishes that the failure to attend the hearing was neither intentional nor the result of conscious indifference, and that such failure was due to mistake, accident, or circumstances beyond the respondent's control.(1) A motion to set aside the default order and reopen the record shall be filed with the commissioner prior to the time that the order of the commissioner becomes final pursuant to the provisions of the Texas Government Code.(2) A motion to set aside the default order and reopen the record is not a motion for rehearing and is not to be considered a substitute for a motion for rehearing. The filing of a motion to set aside the default order and reopen has no effect on either the statutory time periods for the filing of a motion for rehearing or on the time period for ruling on a motion for rehearing, as provided in the Texas Government Code.(e) This subsection also applies to cases where service of the notice of hearing on a defaulting party is shown only by proof that the notice was sent to the party's last known address as shown on the department's records, with no showing of actual receipt by the defaulting party or the defaulting party's agent. In that situation, the default procedures described in subsection (c) of this section may be used if there is credible evidence that the notice of hearing was sent by certified or registered mail, return receipt requested, to the defaulting party's last known address. Source Note: The provisions of this §1.25 adopted to be effective November 15, 2001, 26 TexReg 9093. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS B FORMAL HEARING PROCEDURES §1.25 Default https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90203&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90203 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=90203&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 90203 03/11/2026 (a) Proposed findings of fact and conclusions of law. The ALJ may invite parties to file briefs. Such briefs, if solicited, may contain proposed findings of fact and conclusions of law. Findings of fact and conclusions of law submitted may be adopted by the ALJ in the proposal for decision. Neither the ALJ nor the final decision-maker need rule on any proposed findings of fact and conclusions of law.(b) Proposal for decision.(1) The ALJ shall prepare the proposal for decision and provide copies to all parties.(2) Each party having the right and desire to file exceptions and briefs shall file them with the ALJ and the commissioner within 20 days after the date of the proposal for decision.(3) Parties desiring to do so shall file written replies and briefs to these exceptions and briefs with the ALJ and the commissioner within 15 days after the date of the exceptions.(4) All exceptions and replies to them shall be succinctly stated.(5) Failure to reply or except may be construed as agreement with the proposal or exceptions.(c) Reopening of hearing for new evidence.(1) The commissioner may reopen a hearing where new evidence is offered which was unobtainable or unavailable at the time of the hearing.(2) The department shall reopen a hearing to include such new evidence as part of the record if the commissioner deems such evidence necessary for a proper and fair determination of the case. The reopened hearing will be limited to only such new evidence.(3) Notice of any reopened hearing shall be provided to all previously designated parties, by certified mail, return receipt requested.(d) Final orders or decisions.(1) The final order or decision of the department will be rendered by the commissioner or by the authorized designee of the commissioner.(2) All final orders or decisions shall be in writing and shall set forth the findings of fact and conclusions required by law, either in the body of the order, by attachment, or by reference to an ALJ's proposal for decision.(3) Unless otherwise permitted by statute or by these sections, all final orders shall be signed by the commissioner, or his designee; however, interim orders may be issued by the ALJ.(e) Motion for rehearing. A motion for rehearing shall be governed by the APA or other pertinent statute and shall be filed with the commissioner.(f) Appeals. All appeals from final department orders or decisions shall be governed by the APA or other pertinent statute and shall be addressed to the commissioner. Source Note: The provisions of this §1.27 adopted to be effective November 15, 2001, 26 TexReg 9093. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS B FORMAL HEARING PROCEDURES §1.27 Action After the Hearing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64965&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64965 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64965&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64965 03/11/2026 (a) Authority. The Texas Department of Health (department) adopts by reference rules regarding Medicaid fair hearings adopted by the Texas Health and Human Services Commission under 1 Texas Administrative Code (TAC), Chapter 357, §§357.1, 357.3, 357.5, 357.7, 357.9, 357.11, 357.13, 357.15, 357.17, 357.19, 357.21, 357.23, 357.25, 357.27, and 357.29.(b) Scope. These rules establish fair hearing procedures which the department will follow when the department is required to conduct a fair hearing for Medicaid funded services. Source Note: The provisions of this §1.41 adopted to be effective July 18, 1999, 24 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS C FAIR HEARING PROCEDURES §1.41 Medicaid Uniform Fair Hearing Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12749&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12749 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12749&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12749 03/11/2026 (a) Purpose. Various federal and state statutes or regulations require the Texas Department of Health (department) to establish procedures for conducting fair hearings in connection with various programs administered by the department. These hearings are not required to be conducted under the provisions of the Administrative Procedure Act, Government Code, Chapter 2001 (APA). Rather, the department shall conduct fair hearings in accordance with rules adopted by the Texas Board of Health. Where there is a conflict between these sections and the sections of a particular program, the more particular program sections will control.(b) Scope.(1) These sections establish fair hearing procedures which the department will follow when the department is required to conduct a fair hearing by federal or state statutes, rules or regulations, or when a statute or regulation does not specify that a contested case be heard under the APA. Specifically, the sections cover the opportunity for a hearing, the hearing notice, the hearing procedure and the decision-making process.(2) These procedures apply to fair hearings for:(A) the County Indigent Health Care Program;(B) the Chronically Ill and Disabled Children's Services Program;(C) the Waiver Program for Medically Dependent Children;(D) the Kidney Health Care;(E) the Lead-Based Paint Certification Program;(F) participation in the Women, Infant, and Children (WIC) Program;(G) client appeals in the medical assistance program administered by the department; and(H) any other program hearing not required to be a contested case hearing under the provisions of the APA. Source Note: The provisions of this §1.51 adopted to be effective June 23, 1986, 11 TexReg 2589; amended to be effective April 14, 1997, 22 TexReg 3294. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS C FAIR HEARING PROCEDURES §1.51 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12748&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12748 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12748&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12748 03/11/2026 (a) Department notice. Prior to making a final decision adverse to an affected person, the appropriate department program shall give the affected person written notice of an opportunity for a hearing on the proposed action. The notice shall contain:(1) a statement of the action the department intends to take;(2) an explanation of the reasons for the action the department intends to take;(3) a reference to the statutory and regulatory authority supporting the intended action;(4) an explanation of the affected person's right to request a hearing; and(5) the procedure by which an affected person may request a hearing.(b) Request for hearing. In the absence of a specific department program rule or federal regulation to the contrary, the affected person has 20 days after receiving the notice to request a hearing on the proposed action. It is a rebuttable presumption that a notice is received five days after the date of the notice. A request for a hearing shall be made in writing and mailed or hand-delivered to the appropriate department program, unless the notice letter specifies an alternative method. If a person who is offered the opportunity for a hearing does not request a hearing within the prescribed time for making such a request, the person is deemed to have waived the hearing and the action may be taken.(c) Representation. An affected person may represent himself or herself or may be represented by legal counsel, a relative, a friend, or another spokesperson. Source Note: The provisions of this §1.52 adopted to be effective June 23, 1986, 11 TexReg 2589; amended to be effective April 14, 1997, 22 TexReg 3294. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS C FAIR HEARING PROCEDURES §1.52 Notice https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12751&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12751 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12751&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12751 03/11/2026 (a) Assignment of hearing examiner. When a department program receives a timely request for a hearing, the program shall within ten days after receipt, forward such request, along with other pertinent documentation relating to such request, to the Office of General Counsel for the purpose of docketing, assignment of a representative of the program, and assignment of a hearing examiner to conduct the hearing. Neither the hearing examiner nor the program representative need be an attorney.(b) Notification of hearing. The hearing examiner shall, not less than ten days prior to the date of the hearing, send a written notification of the hearing to the affected person who has requested the hearing. The notification shall contain the basis of the proposed action; the time, date, and place of the hearing; and a statement that the affected person may request the fair hearing be conducted based on the taking of oral testimony or written information contained in the program file and any additional written information the person may wish to submit, without the necessity of taking oral testimony.(c) Discovery. The affected person shall be given the opportunity to examine the case file, claim file and any other documents or records the program intends to use at the fair hearing at a reasonable time before and during the hearing. There shall be no other discovery.(d) Location of hearing. Hearings will be held in Austin, unless the hearing examiner determines that circumstances exist which justify that the hearing be held in another location. A fair hearing may be conducted through telecommunications on order of the hearing examiner.(e) Privileges, evidence, and procedure. Only the rules contained in this undesignated head apply to fair hearings. Any party to a fair hearing is not required to disclose communications between a lawyer and client, a husband and wife, a clergy-person and a person seeking spiritual advice, or the name of an informant or other information protected by federal or state substantive law from being divulged. No decision may be based on undisclosed information.(f) Hearing based on written information. The hearing may be conducted based on the written information contained in the program files and additional written information submitted to the hearing examiner and the other party not less than three days prior to the hearing without the necessity of taking oral testimony.(g) Dismissal of hearing. The hearing examiner shall deny or dismiss a request for a fair hearing and the proposed action may be taken if the affected person withdraws the request in writing or fails to appear at the scheduled hearing without good cause. Source Note: The provisions of this §1.53 adopted to be effective June 23, 1986, 11 TexReg 2589; amended to be effective April 14, 1997, 22 TexReg 3294. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS C FAIR HEARING PROCEDURES §1.53 Preliminary Matters https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12750&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12750 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12750&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12750 03/11/2026 (a) Testimony. The affected person shall have the opportunity to refute the basis of the proposed action, to offer oral and written testimony in the person's behalf, and to question any witnesses or appropriate department program representatives about the proposed action. The affected person may bring witnesses.(b) Burden of proof. The department program bears the burden of proof in a fair hearing, unless otherwise specified in a department rule.(c) Recording. The hearing examiner will make a record of the proceeding, either through a tape recording or a court reporter. The cost of a court reporter will be borne by the person who requests that a court reporter be present. The affected person shall have the right to make an audio recording of the fair hearing. Any witness shall have the right to make an audio recording of his or her testimony. Source Note: The provisions of this §1.54 adopted to be effective June 23, 1986, 11 TexReg 2589; amended to be effective April 14, 1997, 22 TexReg 3294. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS C FAIR HEARING PROCEDURES §1.54 Conduct of the Hearing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12752&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12752 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12752&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12752 03/11/2026 (a) Basis for decision. A decision made following a fair hearing shall be based exclusively on the evidence introduced at the hearing from the documents submitted by the affected person and the department if no oral testimony is taken. Otherwise, a decision shall be based on the record of the hearing. The hearing examiner may have the delegated authority to make a final decision.(b) Record. The record of the hearing shall consist of the transcript or recording of the testimony; the exhibits, documents and requests filed in the proceeding; the recommendation of the hearing examiner, if applicable; and the decision.(c) The decision.(1) The hearing examiner may render a final decision if the commissioner of health has delegated such authority.(2) If a hearing examiner has not been delegated authority from the commissioner of health to render a final decision, the hearing examiner shall prepare a recommendation for decision and provide it to the parties to a hearing. The parties to a hearing may provide to the hearing examiner a response to the recommendation. The recommendation and any responses shall be submitted to the commissioner of health or commissioner's designee for final decision.(3) Each decision shall summarize the testimony and evidence, decide the facts, and identify evidence and regulations supporting the decision. The decision need not include separately stated findings of fact and conclusions of law.(d) Notification of decision. Unless otherwise specified in applicable regulations, the decision shall be made as soon as practicable, but no later than 60 days from the date of the close of hearing, unless such date is extended for good cause as determined by the hearing examiner. The affected person shall be sent the final decision by first class mail within ten days of the date the decision is rendered. Source Note: The provisions of this §1.55 adopted to be effective June 23, 1986, 11 TexReg 2589; amended to be effective April 14, 1997, 22 TexReg 3294. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS C FAIR HEARING PROCEDURES §1.55 The Hearing Decision https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226928&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226928 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226928&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226928 03/11/2026 (a) An incurable neurodegenerative disease is a condition, injury, or illness:(1) that occurs when nerve cells in the brain or peripheral nervous system lose function over time; and(2) for which there is no known cure.(b) A qualifying physician under Texas Occupations Code, Chapter 169, may prescribe low-THC cannabis to a patient with a documented diagnosis of one or more of the conditions listed under Texas Occupations Code §169.003, or one or more of the following incurable neurodegenerative diseases:(1) Incurable Neurodegenerative Diseases with Adult Onset:(A) Motor Neuron Disease:(i) Amyotrophic lateral sclerosis;(ii) Spinal-bulbar muscular atrophy; and(iii) Spinal Muscular Atrophy.(B) Muscular Dystrophies:(i) Duchenne Muscular Dystrophy;(ii) Central Core; and(iii) Facioscapulohumeral Muscular Dystrophy.(C) Freidreich's Ataxia.(D) Vascular dementia.(E) Charcot Marie Tooth and related hereditary neuropathies. (F) Spinocerebellar ataxia.(G) Familial Spastic Paraplegia.(H) Progressive dystonias DYT genes 1 through 20.(I) Progressive Choreas: Huntington's Disease.(J) Amyloidoses:(i) Alzheimer's Disease;(ii) Prion Diseases:(I) Creutzfeldt-Jakob Disease;(II) Gerstmann-Straussler-Scheinker Disease;(III) Familial or Sporadic Fatal Insomnia; and(IV) Kuru.(K) Tauopathies.(i) Chronic Traumatic Encephalopathy:(ii) Pick Disease;(iii) Globular Glial Tauopathy;(iv) Corticobasal Degeneration;(v) Progressive Supranuclear Palsy;(vi) Argyrophilic Grain Disease;(vii) Neurofibrillary Tangle dementia, also known as Primary Age-related Tauopathy; and(viii) Frontotemporal dementia and parkinsonism linked to chromosome 17 caused by mutations in MAPT gene.(L) Synucleinopathies:(i) Lewy Body Disorders:(I) Dementia with Lewy Bodies; and(II) Parkinson's Disease; and(ii) Multiple System Atrophy.(M) Transactive response DNA-binding protein-43 (TDP-43) Proteinopathies:(i) Frontotemporal Lobar Degeneration;(ii) Primary Lateral Sclerosis; and(iii) Progressive Muscular Atrophy.(2) Incurable Neurodegenerative Diseases with Pediatric Onset:(A) Mitochondrial Conditions:(i) Kearn Sayers Syndrome;(ii) Mitochondrial Encephalopathy Ragged Red Fiber;(iii) Mitochondrial Encephalopathy Lactic Acidosis Stroke;(iv) Neuropathy, Ataxia, and Retinitis Pigmentosa;(v) Mitochondrial neurogastrointestinal encephalopathy;(vi) Polymerase G Related Disorders:(I) Alpers-Huttenlocher syndrome;(II) Childhood Myocerebrohepatopathy spectrum;(III) Myoclonic epilepsy myopathy sensory ataxia; and(IV) Ataxia neuropathy spectrum;(vii) Subacute necrotizing encephalopathy, also known as Leigh syndrome;(viii) Respiratory chain disorders complex 1 through 4 defects: Co Q biosynthesis defects;(ix) Thymidine Kinase;(x) Mitochondrial Depletion syndromes types 1 through 14:(I) Deoxyguanisine kinase deficiency;(II) SUCLG1-related mitochondrial DNA depletion syndrome, encephalomyopathic form with methylmalonic aciduria; and(III) RRM2B-related mitochondrial disease.(B) Creatine Disorders:(i) Guanidinoacetate methytransferase deficiency;(ii) L-Arginine/glycine amidinotransferase deficiency; and(iii) Creatine Transporter Defect, also known as SLC 6A8.(C) Neurotransmitter defects:(i) Segawa Disease, also known as Dopamine Responsive Dystonia;(ii) Guanosine triphosphate cyclohydrolase deficiency;(iii) Aromatic L-amino acid decarboxylase deficiency;(iv) Monoamine oxidase deficiency;(v) Biopterin Defects:(I) Pyruvoyl-tetahydropterin synthase;(II) Sepiapterin reductase;(III) Dihydropteridine reductase; and(IV) Pterin-4-carbinolamine dehydratase.(D) Congenital Disorders of Glycosylation.(E) Lysosomal Storage Diseases:(i) Mucopolysaccaridosis:(I) Mucopolysaccharidosis Type I, also known as Hurler Syndrome or Scheie Syndrome;(II) Mucopolysaccharidosis Type II, also known as Hunter Syndrome;(III) Mucopolysaccharidosis Type III, also known as Sanfilippo A and B;(IV) Mucopolysaccharidosis Type IV, also known as Maroteaux-Lamy; and(V) Mucopolysaccharidosis Type VII, also known as Sly.(ii) Oligosaccharidoses:(I) Mannosidosis;(II) Alpha-fucosidosis;(III) Galactosialidosis;(IV) Asparylglucosaminuria;(V) Schindler; and(VI) Sialidosis;(iii) Mucolipidoses:(I) Mucolipidoses Type II, also known as Inclusion Cell disease; and(II) Mucolipidoses Type III, also known as pseudo-Hurler polydystrophy;(iv) Sphingolipidoses:(I) Gaucher Type 2 and Type 3;(II) Neimann Pick Type A and B;(III) Neimann Pick Type C;(IV) Krabbe;(V) GM1 gangliosidosis;(VI) GM2 gangliosidosis also known as Tay-sachs and Sandhoff Disease;(VII) Metachromatic leukodystrophy;(VIII) Neuronal ceroid lipofuscinosis types 1-10 including Batten Disease; and(IX) Farber Disease; and(v) Glycogen Storage-Lysosomal: Pompe Disease.(F) Peroxisomal Disorders:(i) X-linked adrenoleukodystrophy;(ii) Peroxisomal biosynthesis defects:(I) Zellweger syndrome:(II) Neonatal Adrenoleukodystrophy; and(iii) D Bidirectional enzyme deficiency.(G) Leukodystrophy:(i) Canavan disease;(ii) Pelizaeus-Merzbacher disease;(iii) Alexander disease;(iv) Multiple Sulfatase deficiency;(v) Polyol disorders;(vi) Glycine encephalopathy, also known as non-ketotic hyperglycinemia;(vii) Maple Syrup Urine Disease;(viii) Homocysteine re-methylation defects;(ix) Methylenetetrahydrofolate reductase deficiency severe variant;(x) L-2-hydroxyglutaric aciduria;(xi) Glutaric acidemia type 1;(xii) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency;(xiii) Galactosemia;(xiv) Manosidosis alpha and beta;(xv) Salidosis;(xvi) Peripheral neuropathy types 1 through 4;(xvii) Pyruvate Dehydrogenase Deficiency;(xviii) Pyruvate Carboxylase Deficiency;(xix) Refsum Disease; and(xx) Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy.(H) Fatty Acid Oxidation:(i) Trifunctional protein deficiency; and(ii) Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency. (I) Metal Metabolism:(i) Wilson Disease;(ii) Pantothenate Kinase Associated Neurodegeneration; and(iii) Neurodegeneration with brain iron accumulation.(J) Purine and Pyrimidine Defects:(i) Adenylosuccinate synthase Deficiency;(ii) 5-aminoimidazole-4-carboxamide ribonucleotide transformylase deficiency;(iii) Hypoxanthine-guanine phosophoribosyltransferase Deficiency also known as Lesch-Nyhan disease;(iv) Dihydropyrimidine dehydrogenase Deficiency; and(v) Dihydropirimidinase Deficiency.(c) A physician may submit a form to the Texas Department of State Health Services (DSHS) to request adding a condition to the list of medical conditions in subsection (b) of this section for which a physician may prescribe low-THC cannabis.(1) For forms that request addition of non-neurodegenerative diseases to the list of medical conditions, DSHS will provide those forms and any submitted peer reviewed evidence to the Department of Public Safety (DPS). DPS will then submit requests to the legislature for consideration.(2) For forms that request addition of neurodegenerative diseases to the list of medical conditions, DSHS will assess those requests for any neurodegenerative diseases not currently listed in subsection (b) of this section.(d) A request under subsection (c) of this section must be submitted using the form, Request to Add Medical Conditions for Which a Physician May Prescribe Low-THC Cannabis or Add Pulmonary Inhalation Devices for Low-THC Cannabis, located on the DSHS website.(e) DSHS may request additional information after review of the submitted form. Source Note: The provisions of this §1.61 adopted to be effective December 5, 2019, 44 TexReg 7392; amended to be effective November 30, 2025, 50 TexReg 7730. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS D LOW-THC CANNABIS FOR COMPASSIONATE USE §1.61 Medical Conditions for which a Physician May Prescribe Low-THC Cannabis https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226929 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226929 03/11/2026 (a) A pulmonary inhalation device is a device designed, marketed, and dispensed to allow a patient to inhale an aerosolized or vaporized substance.(b) A pulmonary inhalation device must not burn or ignite a substance for the purpose of inhaling smoke.(c) A qualifying physician under Texas Occupations Code Chapter 169 may, but is not required to, prescribe pulmonary inhalation as the means of administration for low-THC cannabis to a patient who is qualified to receive a low-THC cannabis prescription.(d) A licensed dispensing organization, as defined in Texas Health and Safety Code Chapter 487, may submit a form to DSHS to request approval of a pulmonary inhalation device that may be dispensed to a patient for the pulmonary inhalation of low-THC cannabis.(e) A request under subsection (d) of this section must be submitted using the form, Request to Add Medical Conditions for Which a Physician May Prescribe Low-THC Cannabis or Add Pulmonary Inhalation Devices for Low-THC Cannabis, located on the DSHS website.(f) A request under subsection (d) of this section must include an attestation from the requester that the proposed pulmonary inhalation device is safe and effective for the pulmonary inhalation of low-THC cannabis.(g) The Texas Department of State Health Services must review pulmonary inhalation devices every four months with stakeholders to determine potential changes to this section. Source Note: The provisions of this §1.63 adopted to be effective November 30, 2025, 50 TexReg 7730. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS D LOW-THC CANNABIS FOR COMPASSIONATE USE §1.63 Pulmonary Inhalation Devices for Low-THC Cannabis https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206732&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206732 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206732&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206732 03/11/2026 (a) One or more compassionate-use institutional review boards (CIRBs) may be established to evaluate and approve proposed research to study the medical use of low-THC cannabis, in accordance with Texas Health and Safety Code §487.253.(b) When seeking approval from a CIRB, the principal investigator of a proposed research program must clearly identify the medical condition for which a patient will be treated with low-THC cannabis.(c) A principal investigator shall only study the use of low-THC cannabis in treating the medical condition identified in the proposed research program application approved by a CIRB.(d) The CIRB shall specify an end date to any study it approves. A study may terminate earlier than the date specified by the CIRB if the principal investigator chooses to end the study early. However, a CIRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the CIRB's requirements or that has been associated with unexpected serious harm to subjects.(e) Approval of a research program by a CIRB is not transferable to another research program.(f) A medical condition may be treated with low-THC cannabis as part of an approved research program if:(1) treatment is overseen by a CIRB;(2) treatment is administered by a physician in accordance with Texas Occupations Code §169.002 and the physician is certified by a CIRB to participate in the program;(3) the patient is a resident of Texas; and(4) the patient or, if the patient is a minor or lacks capacity to consent, a parent, guardian, or conservator, signs a written informed consent form provided by the approved research program.(g) Reports.(1) Not later than October 1 of each year, each CIRB must submit a written report that describes and assesses the research findings of each approved research program to the Texas Department of State Health Services.(2) Not later than October 1 of each even-numbered year, each CIRB must submit a written report that describes and assesses the research findings of each approved research program to the Legislature. Source Note: The provisions of this §1.65 adopted to be effective November 17, 2021, 46 TexReg 7789. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS D LOW-THC CANNABIS FOR COMPASSIONATE USE §1.65 Compassionate-use Research and Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226848&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226848 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226848&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226848 03/11/2026 (a) This section uses the same definitions as found in Texas Occupations Code Chapter 55. The requirements and steps in this section follow what Texas Occupations Code Chapter 55 allows or requires. This section does not change or affect any rights given by federal law.(b) This section applies to all licenses to engage in a business or occupation which the Texas Department of State Health Services (DSHS) issues to an individual under authority granted by the laws of the State of Texas. A more specific rule concerning recognition of out-of-state licenses of military service members and military spouses may also apply but only to the extent the more specific rule does not conflict with this rule. Any conflicts between this rule and the more specific rule are resolved in favor of this rule.(c) A military service member or military spouse may engage in a business or occupation as if licensed in the State of Texas without obtaining the applicable license in Texas if the military service member or military spouse:(1) currently holds a license similar in scope of practice issued by the licensing authority of another state and is in good standing with that state's licensing authority;(2) submits an application to DSHS in the manner required by the DSHS rules governing that business or occupation. The department does not charge any application fees, but the applicant may still be responsible for paying costs to third-party vendors, such as costs for criminal background checks. The application must include:(A) a copy of the member's military orders showing relocation to Texas;(B) a copy of the military spouse's marriage license, if the applicant is a military spouse;(C) a notarized affidavit affirming under penalty of perjury that:(i) the applicant is the person described and identified in the application;(ii) all statements in the application are true, correct, and complete;(iii) the applicant understands the scope of practice for the applicable license in Texas and will not perform outside of that scope of practice; and(iv) the applicant is in good standing, as defined by subsection (d) of this section, in each state in which the applicant holds or has held an applicable license.(d) For purposes of this section, a person is in good standing with another state's licensing authority if the person:(1) holds a license that is current, has not been suspended or revoked, and has not been voluntarily surrendered during an investigation for unprofessional conduct;(2) has not been disciplined by the licensing authority with respect to the license or person's practice of the occupation for which the license is issued; and(3) is not currently under investigation by the licensing authority for unprofessional conduct related to the person's license or profession.(e) Not later than the 10th business day after DSHS receives an application under subsection (c)(2) of this section, DSHS notifies the applicant that:(1) DSHS recognizes the applicant's out-of-state license; or(2) the application is incomplete; or(3) DSHS is unable to recognize the applicant's out-of-state license because DSHS does not issue a license similar in scope of practice to the applicant's license.(f) On receipt of the information required by subsection (c)(2) of this section, DSHS issues a provisional license to the applicant. (g) A provisional license issued under subsection (f) of this section may not be renewed. The provisional license expires on the earlier of:(1) the date the agency issues or denies the recognition under subsection (e) of this section; or(2) the 180th day after the date DSHS issues the provisional license.(h) DSHS reviews and evaluates the following criteria, if relevant to a Texas license, when determining whether another state issues a license that is similar in scope of practice to a license DSHS issues:(1) the activities the person is authorized to perform under the out-of-state license;(2) whether the out-of-state license authorizes the person to work with a similar population and in a similar setting as a Texas license;(3) whether a similar level of supervision or oversight is required under the out-of-state license; and(4) any other relevant factor.(i) A military service member or military spouse may engage in the business or occupation under the authority of this section only for the period during which the military service member or, with respect to a military spouse, the military service member to whom the spouse is married is stationed at a military installation in Texas.(j) In the event of a divorce or similar event that affects a person's status as a military spouse, the former spouse may continue to engage in the business or occupation under the authority of this section until the third anniversary of the date the spouse submitted the application required by subsection (c)(2) of this section. A similar event includes the death of the military service member or the military service member's discharge from the military. If the former spouse decides to keep practicing in Texas, the former spouse must obtain a Texas license.(k) The military service member or military spouse shall comply with all applicable laws, rules, and standards of Texas, including applicable Texas Health and Safety Code chapters and all relevant Texas Administrative Code provisions. Source Note: The provisions of this §1.81 adopted to be effective December 1, 2025, 50 TexReg 7575. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS F LICENSURE EXEMPTIONS §1.81 Recognition of Out-of-State License of a Military Service Member or Military Spouse https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226849&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226849 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226849&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226849 03/11/2026 (a) This section uses the definitions in Texas Occupations Code (TOC) Chapter 55. This section makes rules based on TOC Chapter 55 and does not change or affect rights under federal law.(b) This section applies to all licenses to engage in a business or occupation which the Texas Department of State Health Services (DSHS) issues to an individual under authority granted by the laws of the State of Texas. A more specific rule concerning alternative licensing for military service members, military spouses, and military veterans may also apply but only to the extent the more specific rule does not conflict with this rule. Any conflicts between this rule and the more specific rule are resolved in favor of this rule.(c) Notwithstanding any other rule, DSHS may issue a license or provisional license to an applicant who is a military service member, military spouse, or military veteran if the military service member, military spouse, or military veteran:(1) holds a current license issued by another state that is similar in scope of practice to the license in Texas and is in good standing, as defined by subsection (d) of this section, with that state's licensing authority; or(2) has had the same Texas license within the preceding five years.(d) For purposes of this section, a person is in good standing with another state's licensing authority if the person:(1) holds a license that is current, has not been suspended or revoked, and has not been voluntarily surrendered during an investigation for unprofessional conduct;(2) has not been disciplined by the licensing authority with respect to the license or person's practice of the occupation for which the license is issued; and(3) is not currently under investigation by the licensing authority for unprofessional conduct related to the person's license or profession.(e) DSHS may waive any requirement to obtaining a license for an applicant described by subsection (c) of this section after reviewing the applicant's credentials.(f) If an applicant described by subsection (c) of this section must demonstrate competency to meet the requirements for obtaining the license, DSHS may accept alternate forms of competency, including:(1) proof of a passing score for any national exams required to obtain the occupational license;(2) proof of duration or hours that meet the professional experience requirement, if specific professional experience is required; and(3) proof of verified hours related to training experience, if specific training hours are required to obtain the license.(g) On receipt of a complete application for alternative licensing, DSHS issues a provisional license pending the issuance of a license. A provisional license may not be renewed.(h) A provisional license issued under subsection (g) of this section expires on the earlier of:(1) the date DSHS approves or denies the provisional license holder's license application; or(2) the 180th day after the date DSHS issues the provisional license.(i) DSHS has 10 business days from the date a military service member, military spouse, or military veteran submits an application for alternative licensing to process the application and issue a license to an applicant who qualifies for the license.(j) The department does not charge for the license. However, the applicant is responsible for any required costs paid to third-party vendors, such as costs for criminal background checks. Source Note: The provisions of this §1.91 adopted to be effective December 1, 2023, 48 TexReg 6915; amended to be effective December 1, 2025, 50 TexReg 7575. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS G ALTERNATIVE LICENSING FOR MILITARY §1.91 Alternative Licensing for Military Service Members, Military Spouses, and Military Veterans https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12755&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12755 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12755&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12755 03/11/2026 (a) The Texas Department of Health adopts by reference a memorandum of understanding entered into between the department, the Texas Department of Human Services, the Texas Rehabilitation Commission, and the Texas Department of Mental Health and Mental Retardation concerning the exchange and distribution of public awareness information.(b) Copies of the memorandum of understanding are filed in the Public Health Promotion Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, and may be reviewed during regular business hours. Source Note: The provisions of this §1.101 adopted to be effective September 2, 1988, 13 TexReg 4234. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS H PUBLIC HEALTH PROMOTION §1.101 Memorandum of Understanding https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122852&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122852 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122852&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122852 03/11/2026 (a) The Health and Safety Code, §161.081, requires that each person who sells tobacco products at retail or by vending machine shall post a sign in a location that is conspicuous to all employees and customers and that is close to the place at which the tobacco products may be purchased. Section 161.082 also requires the Board of Health to determine the design and size of the sign. To implement this provision, the Board of Health has approved a sign to be placed on vending machines and a sign to be placed close to a cash register or check-out stand. The design and minimum size of each sign are as follows.(1) The minimum size of the sign to be posted close to the cash register or check-out stand shall be 8 1/2 by 11 inches. The sign shall be printed black on goldenrod colored paper or stock. The design of the sign, including wording and minimum print size, shall be as shown in the replica published as follows.Attached Graphic(2) The minimum size of the sign to be posted close to the vending machine shall be three by seven inches. The sign shall be printed black on goldenrod colored paper or stock. The design of the sign, including wording and minimum print size, shall be as shown in the replica published as follows.Attached Graphic(b) The department on request shall provide the sign without charge to any person who sells tobacco products. The department will provide the sign without charge to distributors or wholesale dealers of tobacco products in this state for distribution to persons who sell tobacco products. (c) Requests for signs shall be made to the Texas Department of Health, Literature and Forms Division, Warehouse Facility, 1100 West 49th Street, Austin, Texas 78756-3199. A requestor shall indicate the warehouse stock number (#4-171 for vending machine signs, #4-171A for vending machine signs in Spanish, #4-172 for cash register or check-out area signs, and #4-172A for cash register or check-out area signs in Spanish), the number of signs desired, and the person and address to whom the signs are to be mailed. (d) Retailers and wholesalers may develop their own signs provided they meet the minimum size specifications and the designs (including wording and minimum print size) for the signs as described in subsection (a) of this section. A wholesaler or retailer may submit a sample of its proposed sign for review to the department's Office of Smoking and Health, 1100 West 49th Street, Austin, Texas 78756. Source Note: The provisions of this §1.104 adopted to be effective August 23, 1995, 20 TexReg 6017. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS H PUBLIC HEALTH PROMOTION §1.104 Signs Covering the Prohibition of the Sale or Provision of Tobacco Products to a Minor under 18 Years of Age https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12759&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12759 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12759&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12759 03/11/2026 (a) The Texas Department of Health adopts by reference a memorandum of understanding entered into between the Texas Department of Human Services, the Texas Department of Health, the Texas Department of Mental Health and Mental Retardation, the Texas Rehabilitation Commission, the Texas Commission for the Blind, the Texas Commission for the Deaf, and the Texas Education Agency, concerning the coordination of each agency's financial and service responsibilities in relation to delivery of services to disabled persons.(b) Copies of the memorandum of understanding are filed in the office of the Associate Commissioner for Personal Health Services, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, and may be reviewed during regular business hours. Source Note: The provisions of this §1.121 adopted to be effective February 28, 1989, 14 TexReg 845. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS J SERVICES TO DISABLED PERSONS §1.121 Memorandum of Understanding on the Coordination of Services to Disabled Persons https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12758&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12758 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12758&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12758 03/11/2026 The purpose of these sections is to provide a definition of the term "special waste from health care-related facilities (SWFHCRF)," approve methods for the treatment and disposition of the waste, identify the entities that are subject to the provisions of these sections, and provide for the orderly application of the sections to covered entities. Although these sections provide for the methods of treatment of SWFHCRF, they do not require sterilization of the waste as a measure of adequate treatment. Source Note: The provisions of this §1.131 adopted to be effective April 4, 1989, 14 TexReg 1457; amended to be effective December 21, 1994, 19 TexReg 9599. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS K DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES §1.131 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191014 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191014 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.(1) Anatomical remains--The remains of a human body donated for the purposes of teaching or research to a medical school, a teaching hospital, or a medical research facility, after the completion of the activities for which the body was donated.(2) Animal waste--Animal waste includes:(A) carcasses of animals intentionally exposed to pathogens; (B) body parts of animals intentionally exposed to pathogens;(C) whole bulk blood and blood products, serum, plasma, and other blood components from animals intentionally exposed to pathogens; and(D) bedding of animals intentionally exposed to pathogens. (3) Approved alternate treatment process--A process for waste treatment which has been approved by the department in accordance with §1.135 of this title (relating to Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities).(4) Biological indicators--Commercially-available microorganisms (e.g., United States Food and Drug Administration-approved strips or vials of Bacillus species endospores) which can be used to verify the performance of waste treatment equipment and/or processes.(5) Blood and blood products--All waste bulk human blood, serum, plasma, and other blood components.(6) Body fluids--Those free-flowing body substances other than blood, plasma, or serum identified under universal precautions as recommended by the United States Centers for Disease Control and Prevention, and includes, but are not limited to:(A) semen;(B) vaginal secretions;(C) any body fluid containing visible blood;(D) saliva in dental settings;(E) amniotic fluid;(F) cerebrospinal fluid;(G) peritoneal fluid;(H) pleural fluid;(I) pericardial fluid; and(J) synovial fluid.(7) Bulk--A containerized, aggregate volume of 100 milliliters (mL) or more.(8) Bulk human blood, bulk human blood products, and bulk human body fluids--All free-flowing waste: human blood; serum; plasma; other blood components; and body fluids; including disposable items saturated with blood or body fluids.(9) Burial--The act of depositing a pathological waste in a grave, a crypt, vault, or tomb, or at sea.(10) Burial park--A tract of land that is used or intended to be used for the interment of pathological waste in graves.(11) Cemetery--A tract of land that is used or intended to be used for the permanent interment of pathological waste, and includes:(A) a burial park for earth interments;(B) a mausoleum for crypt or vault interments;(C) a columbarium for cinerary interments; or(D) a combination of one or more thereof.(12) Challenge waste load--A surrogate waste load assembled for use during waste treatment protocols to evaluate the efficacy of microbial inactivation processes. The composition of the challenge waste load will vary depending on the technology being evaluated.(13) Chemical disinfection--The use of a chemical agent to reduce significantly the numbers of active microorganisms, but not necessarily their endospores, from the surfaces of inanimate objects. (14) Chlorine disinfection/maceration--The process of shredding waste in the presence of a chlorine solution under negative pressure.(15) Columbarium--A structure or room or other space in a building or structure of most durable and lasting fireproof construction; or a plot of earth, containing niches, used, or intended to be used, to contain cremated pathological waste.(16) Contagious--Capable of transmission from human or animal to human.(17) Contaminated--The presence or the reasonably anticipated presence of blood or those body fluids as defined elsewhere in this section.(18) Cremation--The irreversible process of reducing tissue or remains to ashes or bone fragments through extreme heat and evaporation. Under this subchapter, this term includes the process of incineration.(19) Crematory--A building or structure containing one or more furnaces used, or intended to be used, for the reduction (by burning) of pathological waste to cremated remains.(20) Crypt or vault--The chamber in a mausoleum of sufficient size to inter the uncremated pathological waste.(21) Department--The Texas Department of State Health Services.(22) Deposition in a sanitary landfill--Deposition in a sanitary landfill in accordance with 30 TAC Chapter 330.(23) Discharge to sanitary sewer system--A discharge or flushing of waste into a sanitary sewer system which is done in accordance with provisions of local sewage discharge ordinances.(24) Disinfection--A somewhat less lethal process compared to sterilization which destroys or inactivates viruses, fungi, and bacteria (but not necessarily their endospores) on inanimate surfaces.(25) Embryonic and Fetal Tissue Remains--An embryo, a fetus, body parts, or organs from a pregnancy that terminates in the death of the embryo or fetus and for which the issuance of a fetal death certificate is not required by state law. The term does not include the umbilical cord, placenta, gestational sac, blood, or body fluids.(26) Encapsulation--The treatment of waste using materials which, when fully reacted, will encase such waste in a solid protective matrix.(27) Entombment--The permanent interment of pathological waste in a crypt or vault.(28) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.(29) Grave--A space of ground in a burial park that is used, or intended to be used for the permanent interment in the ground of pathological waste.(30) Grinding--That physical process which pulverizes materials, thereby rendering them as unrecognizable, and for sharps, reduces the potential for the material to cause injuries such as puncture wounds.(31) Immersed--A process in which waste is submerged fully into a liquid chemical agent in a container, or that a sufficient volume of liquid chemical agent is poured over a containerized waste, such that the liquid completely surrounds and covers the waste item(s) in the container. (32) Incineration--That process of burning special waste from health care-related facilities in an incinerator as defined in 30 TAC Chapter 101 under conditions in conformance with standards prescribed in 30 TAC Chapter 111 by the Texas Commission on Environmental Quality.(33) Interment--The disposition of pathological waste using the process of cremation, entombment, burial, or placement in a niche or by using the process of cremation followed by placement of the ashes in a niche, grave, or scattering of ashes as authorized by law, unless prohibited by this subchapter.(34) Log10 --Logarithm to the base ten.(35) Log10 reduction--A mathematically defined unit used in reference to level or degree of microbial inactivation. A 4 log10 reduction represents a 99.99% reduction in the numbers of active microorganisms, while a 6 log10 reduction represents a 99.9999% reduction in the numbers of active microorganisms.(36) Mausoleum--A structure or building of most durable and lasting fireproof construction used, or intended to be used, for the entombment pathological waste.(37) Microbial inactivation--Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 log10 reduction or greater; and inactivation of Bacillus subtilis endospores or Bacillus stearothermophilus endospores at a 4 log10 reduction or greater.(38) Microbiological waste--Microbiological waste includes: (A) discarded cultures and stocks of infectious agents and associated biologicals;(B) discarded cultures of specimens from medical, pathological, pharmaceutical, research, clinical, commercial, and industrial laboratories; (C) discarded live and attenuated vaccines, but excluding the empty containers thereof;(D) discarded, used disposable culture dishes; and(E) discarded, used disposable devices used to transfer, inoculate or mix cultures.(39) Moist heat disinfection--The subjection of:(A) internally shredded waste to moist heat, assisted by microwave radiation under those conditions which effect disinfection; or(B) unshredded waste in sealed containers to moist heat, assisted by low-frequency radiowaves under those conditions which effect disinfection, followed by shredding of the waste to the extent that the identity of the waste is unrecognizable.(40) Niche--A recess or space in a columbarium used, or intended to be used, for the permanent interment of the cremated remains of pathological waste.(41) Parametric controls--Measurable standards of equipment operation appropriate to the treatment equipment including, but not limited to pressure, cycle time, temperature, irradiation dosage, pH, chemical concentrations, or feed rates. (42) Pathological waste--Pathological waste excludes embryonic and fetal tissue remains. Pathological waste includes but is not limited to:(A) human materials removed during surgery, labor and delivery, autopsy, embalming, or biopsy, including:(i) body parts;(ii) tissues;(iii) organs; and(iv) bulk blood and body fluids; (B) laboratory specimens of blood and tissue after completion of laboratory examination; and(C) anatomical remains.(43) Saturated--Thoroughly wet such that liquid or fluid flows freely from an item or surface without compression.(44) Sharps--Sharps include, but are not limited to the following materials:(A) when contaminated:(i) hypodermic needles;(ii) hypodermic syringes with attached needles;(iii) scalpel blades;(iv) razor blades, disposable razors, and disposable scissors used in surgery, labor and delivery, or other medical procedures; (v) intravenous stylets and rigid introducers (e.g., J wires);(vi) glass pasteur pipettes, glass pipettes, specimen tubes, blood culture bottles, and microscope slides;(vii) broken glass from laboratories; and(viii) tattoo needles, acupuncture needles, and electrolysis needles;(B) regardless of contamination:(i) hypodermic needles; and(ii) hypodermic syringes with attached needles.(45) Shredding--That physical process which cuts, slices, or tears materials into small pieces.(46) Special waste from health care-related facilities--A solid waste which if improperly treated or handled may serve to transmit an infectious disease(s) and which is comprised of the following:(A) animal waste;(B) bulk blood, bulk human blood products, and bulk human body fluids;(C) microbiological waste;(D) pathological waste; and(E) sharps.(47) Steam disinfection--The act of subjecting waste to steam under pressure under those conditions which effect disinfection. This was previously called steam sterilization.(48) Thermal inactivation--The act of subjecting waste to dry heat under those conditions which effect disinfection.(49) Unrecognizable--The original appearance of the waste item has been altered such that neither the waste nor its source can be identified. Source Note: The provisions of this §1.132 adopted to be effective April 4, 1989, 14 TexReg 1457; amended to be effective November 21, 1991, 16 TexReg 6482; amended to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TexReg 9709; amended to be effective May 24, 2018, 43 TexReg 3242. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS K DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES §1.132 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191015 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191015 03/11/2026 (a) Exemptions.(1) Unless an item is specifically exempted, all special waste from health care-related facilities must be treated as provided in these sections.(2) These sections do not apply to:(A) teeth;(B) human fetal tissue as defined in the Texas Health and Safety Code, Chapter 173, and donated in accordance with that chapter, and human tissue donated for research or teaching purposes, with the consent of the person authorized to consent as otherwise provided by law, to an institution of higher learning, medical school, a teaching hospital affiliated with a medical school, or to a research institution or individual investigator subject to the jurisdiction of an institutional review board required by 42 United States Code 289;(C) placentas designated for sale and obtained from a licensed hospital or a licensed birthing center;(D) in vitro tissue cultures that have not been intentionally exposed to pathogens;(E) any material included in the definition of special waste from health care-related facilities which has been sold, donated, or in any way transferred from one health care-related facility to a subsequent facility(s) and other entities specified in subparagraph (B) of this paragraph for research or teaching purposes until it is discarded;(F) human tissue that is expelled or removed from the human body once the person is outside of a healthcare facility;(G) the remains of an unintended, intrauterine fetal death required to be released to the parent of an unborn child pursuant to Texas Health and Safety Code, §241.010;(H) a placenta removed from a hospital or birthing center pursuant to Texas Health and Safety Code, Chapter 172; and(I) embryonic and fetal tissue remains subject to the Texas Health and Safety Code, Chapter 697.(b) Minimum parametric standards for waste treatment technologies previously approved by the department.(1) Chemical disinfection.(A) Waste treatment via direct contact with chemical agents only shall utilize a registered chemical agent or an approved unregistered chemical agent as follows.(i) Registered chemical agents.(I) The chemical agent used shall be registered with the United States Environmental Protection Agency and the Texas Department of Agriculture.(II) The chemical agent shall be used according to the manufacturer's instructions.(ii) Unregistered chemical agents.(I) Those unregistered chemical agents previously approved are:(-a-) a freshly prepared solution of household chlorine bleach diluted 1:10 (volume/volume) with water; or(-b-) a solution of 70% by volume 2-propanol (isopropyl alcohol).(II) The containerized waste items shall be totally immersed in either solution for a period of time not less than three minutes.(B) If a chemical agent has been included by a manufacturer of a commercially-available waste treatment technology as the principle step in the treatment process, then:(i) the chemical agent (or its precursor(s)) or the microbial inactivating process must be registered with the United States Environmental Protection Agency for the purpose of waste treatment; or(ii) the manufacturer must provide evidence that the technology utilizing said chemical agent (or its precursor(s)) or the microbial inactivating process has been approved for use in another state; or(iii) the manufacturer must obtain approval for the process in accordance with §1.135 of this title (relating to Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities).(C) Waste immersed in a liquid chemical agent must be thoroughly drained before disposal.(2) Chlorine disinfection/maceration.(A) The waste must be shredded prior to or during treatment and made unrecognizable as to source.(B) The chlorine solution must have a free available chlorine concentration of at least 1,100 parts per million (ppm) when applied to the waste.(C) The chlorine solution must be drained from the waste prior to disposal.(3) Moist heat disinfection. Moist heat disinfection shall utilize either of the following processes.(A) When subjecting internally shredded waste to moist heat assisted by microwave radiation, the temperature of the waste must reach at least 95 degrees Celsius under atmospheric pressure for at least 30 minutes.(B) When subjecting unshredded waste in sealed containers to moist heat assisted by low-frequency radiowaves, the temperature of the waste must reach at least 90 degrees Celsius under atmospheric pressure for at least two hours, followed by shredding of the waste to the extent that the identity of the waste is unrecognizable.(4) Steam disinfection. Steam disinfection shall meet all of the following requirements.(A) To allow for sufficient steam access to or penetration of the waste, the waste shall be:(i) packaged according to the recommendations provided by the manufacturer; and(ii) loaded into the chamber so as to not exceed the capacity limits as set by the manufacturer.(B) When subjecting waste to steam under pressure, the temperature in the chamber of the autoclave must reach at least 121 degrees Celsius and there must be at least 15 pounds per square inch gauge pressure for at least 30 minutes.(C) The autoclave must be operated according to the manufacturer's instructions.(5) Thermal inactivation. Thermal inactivation shall meet all of the following requirements.(A) To allow for sufficient dry heat access to or penetration of the waste, the waste shall be:(i) packaged according to the recommendations provided by the manufacturer; and(ii) loaded into the chamber so as to not exceed the capacity limits as set by the manufacturer.(B) Waste shall be subjected to dry heat of at least 160 degrees Celsius under atmospheric pressure for at least two hours.(C) Waste shall be subjected to dry heat according to the manufacturer's instructions. Source Note: The provisions of this §1.133 adopted to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TexReg 9709; amended to be effective May 24, 2018, 43 TexReg 3242. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS K DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES §1.133 Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191016 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191016 03/11/2026 (a) This subchapter does not apply to embryonic and fetal tissue remains subject to Texas Health and Safety Code, Chapter 697.(b) These sections apply to special waste from health care-related facilities generated by the operation of the following publicly or privately owned or operated health care-related facilities, including but not limited to:(1) ambulatory surgical centers;(2) abortion clinics;(3) birthing centers;(4) blood banks and blood drawing centers;(5) clinics, including but not limited to medical, dental, veterinary;(6) clinical, diagnostic, pathological or biomedical research laboratories;(7) educational institution health centers;(8) educational institution research laboratories;(9) electrolysis facilities;(10) emergency medical services;(11) end stage renal dialysis facilities;(12) freestanding emergency medical care facilities;(13) funeral establishments;(14) home and community support services agencies;(15) hospitals;(16) long term care facilities;(17) facilities providing mental health and intellectual disability services, including but not limited to hospitals, schools, and community centers;(18) minor emergency centers;(19) occupational health clinics and clinical laboratories;(20) pharmacies;(21) pharmaceutical manufacturing plants and research laboratories;(22) professional offices, including but not limited to the offices of physicians, dentists, and acupuncturists;(23) special residential care facilities;(24) tattoo studios; and(25) veterinary clinical and research laboratories. Source Note: The provisions of this §1.134 adopted to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TexReg 9709; amended to be effective May 24, 2018, 43 TexReg 3242. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS K DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES §1.134 Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181293&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181293 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181293&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181293 03/11/2026 All manufacturers of commercially-available alternate technologies, equipment, or processes designed or intended for the treatment of special waste from health care-related facilities, except those meeting the standards of §1.133(b) of this title (relating to Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services), shall apply to the department on forms prescribed by the department for approval of said technologies, equipment, or processes to ensure that established performance standards are met.(1) Levels of microbial inactivation.(A) All laboratory evidence submitted to the department for review shall be provided by a laboratory that meets the standards of either the NSF International, the American Association for Laboratory Accreditation, or other accrediting agencies or organizations as approved by the department.(B) All manufacturers of commercially-available alternate technologies, equipment, or processes designed and intended for the treatment of special waste from health care-related facilities shall provide specific laboratory evidence that demonstrates:(i) inactivation of representative samples of vegetative bacteria, mycobacteria, lipophilic/hydrophilic viruses, fungi, and parasites at a level of 6 log10 reduction or greater, as determined by the department; and(ii) inactivation of Bacillus stearothermophilus endospores or Bacillus subtilis endospores at a level of 4 log 10 reduction or greater, as determined by the department.(C) One or more representative surrogate microorganisms from each microbial group shall be used in treatment efficacy evaluation. The department shall determine the appropriate microorganisms to serve as representative surrogate microorganisms.(D) The department shall prescribe those categories (types) and percent composition of special waste from health care-related facilities that present the most challenge to said treatment effectiveness under normal operating conditions of the equipment or process.(E) Protocols developed for efficacy testing shall incorporate, as applicable, recognized, standard procedures. The protocols shall be congruent with the treatment method under review. The department shall determine the specific pieces of information to be provided by the manufacturer to assure a thorough evaluation of the alternate treatment technology. (2) Documentation requirements.(A) The manufacturer of the alternate treatment technology, equipment, or process shall provide to the department the following information:(i) a detailed description of the treatment equipment, equipment specifications, operating instructions, and parameters of normal operation, and information detailing the intended use and typical site for which the equipment is designed;(ii) complete documentation that the alternate treatment technology, equipment, or process meets microbial inactivation criteria for all required representative microorganisms for all department-specified challenge waste load compositions, including a description of the test methods used, and, upon request, the original data from test procedures conducted by the manufacturer;(iii) documentation on available parametric controls, and, where technically feasible, evidence that demonstrates the efficacy relationship between biological indicator data and data derived from real-time parametric monitoring equipment;(iv) details relating to waste residues including their potential hazards/toxicities and their specific mode of disposal or recycling;(v) documentation providing occupational health assurance, and the means of providing required training in equipment operations;(vi) evidence of United States Environmental Protection Agency registration and Texas Department of Agriculture registration for those treatment processes that employ a chemical agent to inactivate microorganisms, or evidence of approval of the treatment process by a state other than Texas;(vii) documentation that user verification testing protocols are workable and valid; and(viii) documentation of approval of the alternate treatment process or technology in other state(s) utilizing performance standard review, if applicable. (B) Documentation must be submitted to the department on forms provided by the department.(3) Alternate treatment technology approval conditions.(A) The alternate treatment technology approval is contingent upon the following conditions:(i) Alternate treatment technology approval is granted only for the conditions specified in the manufacturer's instructions, equipment specifications, and operating procedures and conditions, including but not limited to:(I) treatment time(s);(II) temperature(s);(III) pressures;(IV) chemical concentration(s);(V) irradiation dose(s);(VI) feed rate(s); and(VII) waste load composition(s).(ii) Any significant revision on the part of the manufacturer to either the operating conditions of the equipment's existing process or technology, or the fundamental principles of the process itself, i.e., the equipment now utilizes a different technology in part or altogether, will require re-application for approval to the department.(B) Prior approval granted by a state other than Texas that utilizes a performance standards approach to review alternate treatment technologies shall be considered as a basis for approval by the department if the department is provided with a valid and current approval, license, or permit issued by such state and substantial evidence to indicate that the performance standards upon which the approval, license, or permit was issued are equal to or more stringent than the performance standards included in this section.(C) Facilities are not obligated to petition the department for approval for previously approved waste treatment technology they have currently on site, but the following items will apply should current equipment be replaced, regardless of reason:(i) if the new equipment reflects a previously approved technology and is operated in accordance with §1.133(b) of this title, then purchase and installation can proceed without further action on the part of the department or the purchaser; or(ii) if the new equipment represents an alternate treatment technology subject to prior approval by the department, based on performance standards as outlined in this section, then it is the purchaser's responsibility to ensure that the manufacturer has obtained such approval prior to purchase.(4) Fees and annual listing.(A) Initial application fee.(i) The department shall charge an initial application fee for the evaluation of an alternate treatment technology pursuant to this section in the amount of $4,000.(ii) The initial application fee must be paid in full before the department undertakes its evaluation of the manufacturer's alternate treatment technology.(B) Annual listing.(i) Alternate treatment technologies must be listed at the time of the manufacturer's first sale of the product in Texas and prior to the product's purchase by a health care-related facility or any other person.(ii) Failure by the manufacturer to maintain the listing after purchase does not preclude use of the alternate treatment technology, its transfer or re-sale, so long as compliance with §1.136(c) of this title (relating to Approved Methods of Treatment and Disposition) is achieved.(iii) The department shall maintain a list of those approved alternate treatment technologies, including manufacturer, product name, model number, or other appropriate identifying information. The list shall be made available and distributed upon request by contacting the department. Source Note: The provisions of this §1.135 adopted to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TeReg 9709. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS K DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES §1.135 Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191017 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191017 03/11/2026 (a) Introduction. The following treatment and disposition methods for special waste from health care-related facilities are approved by the department for the waste specified. Where a special waste from a health care-related facility is also subject to the sections in Chapter 289 of this title (relating to Radiation Control), the sections in Chapter 289 shall prevail over the sections in this subchapter. Disposal of special waste from health care-related facilities in sanitary landfills or otherwise is under the jurisdiction of the Texas Commission on Environmental Quality and is governed by its rules found in 30 TAC Chapter 326 (relating to Medical Waste Management) and Chapter 330 (relating to Municipal Solid Waste).(1) Animal waste. Animal waste shall be subjected to one of the following methods of treatment and disposal.(A) Carcasses of animals intentionally exposed to pathogens shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) incineration followed by deposition of the residue in a sanitary landfill;(iii) carcasses of animals intentionally exposed to pathogens which are not contagious may be buried on site under the supervision of a veterinarian licensed to practice veterinary medicine in the State of Texas;(iv) carcasses of animals intentionally exposed to pathogens which are not contagious may be sent to a rendering plant;(v) moist heat disinfection followed by deposition in a sanitary landfill;(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vii) an approved alternate treatment process followed by deposition in a sanitary landfill.(B) Body parts of animals intentionally exposed to pathogens shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) steam disinfection followed by grinding and discharging into a sanitary sewer system;(iii) incineration followed by deposition of the residue in a sanitary landfill;(iv) body parts of animals intentionally exposed to pathogens which are not contagious may be buried on site under the supervision of a veterinarian licensed to practice veterinary medicine in the State of Texas;(v) moist heat disinfection followed by deposition in a sanitary landfill;(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vii) an approved alternate treatment process followed by deposition in a sanitary landfill.(C) Bulk whole blood, serum, plasma, and/or other blood components from animals intentionally exposed to pathogens shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) steam disinfection followed by grinding and discharging into a sanitary sewer system;(iii) incineration followed by deposition of the residue in a sanitary landfill;(iv) thermal inactivation followed by deposition in a sanitary landfill;(v) thermal inactivation followed by grinding and discharging into a sanitary sewer system;(vi) chemical disinfection followed by deposition in a sanitary landfill;(vii) chemical disinfection followed by grinding and discharging into a sanitary sewer system;(viii) bulk blood, serum, plasma, and/or other blood components of animals intentionally exposed to pathogens which are not contagious may be buried on site under the supervision of a veterinarian licensed to practice veterinary medicine in the State of Texas;(ix) moist heat disinfection followed by deposition in a sanitary landfill;(x) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(xi) an approved alternate treatment process followed by deposition in a sanitary landfill.(D) Bedding of animals intentionally exposed to pathogens shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) incineration followed by deposition of the residue in a sanitary landfill;(iii) bedding of animals intentionally exposed to pathogens which are not contagious may be buried on site under the supervision of a veterinarian licensed to practice veterinary medicine in the State of Texas;(iv) moist heat disinfection followed by deposition in a sanitary landfill;(v) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vi) an approved alternate treatment process followed by deposition in a sanitary landfill.(2) Bulk human blood, bulk human blood products, and bulk human body fluids. Bulk human blood, blood products, and body fluids shall be subjected to one of the following methods of treatment and disposal:(A) discharging into a sanitary sewer system;(B) steam disinfection followed by deposition in a sanitary landfill;(C) incineration followed by deposition of the residue in a sanitary landfill;(D) chemical disinfection followed by deposition in a sanitary landfill;(E) chemical disinfection followed by grinding and flushing into a sanitary sewer system;(F) thermal inactivation, followed by deposition in a sanitary landfill;(G) thermal inactivation, followed by grinding and discharging into a sanitary sewer system;(H) moist heat disinfection followed by deposition in a sanitary landfill;(I) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(J) an approved alternate treatment process followed by deposition in a sanitary landfill.(3) Microbiological waste. Microbiological waste shall be subjected to one of the following methods of treatment and disposal.(A) Discarded cultures and stocks of infectious agents and associated biologicals shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) incineration followed by deposition of the residue in a sanitary landfill;(iii) thermal inactivation followed by deposition in a sanitary landfill;(iv) chemical disinfection followed by deposition in a sanitary landfill;(v) moist heat disinfection followed by deposition in a sanitary landfill;(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vii) an approved alternate treatment process followed by deposition in a sanitary landfill.(B) Discarded cultures of specimens from medical, pathological, pharmaceutical, research, clinical, commercial, industrial and veterinary laboratories shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) incineration followed by deposition of the residue in a sanitary landfill;(iii) thermal inactivation followed by deposition in a sanitary landfill;(iv) chemical disinfection followed by deposition in a sanitary landfill;(v) moist heat disinfection followed by deposition in a sanitary landfill;(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vii) an approved alternate treatment process followed by deposition in a sanitary landfill.(C) Discarded live and attenuated vaccines, but excluding the empty containers thereof, shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) incineration followed by deposition of the residue in a sanitary landfill;(iii) thermal inactivation followed by deposition in a sanitary landfill;(iv) chemical disinfection followed by deposition in a sanitary landfill;(v) moist heat disinfection followed by deposition in a sanitary landfill;(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vii) an approved alternate treatment process followed by deposition in a sanitary landfill.(D) Discarded disposable culture dishes shall be subjected to one of the following methods of treatment and disposal.(i) All discarded, unused disposable culture dishes shall be disposed of in accordance with 30 TAC Chapters 326 and 330.(ii) Discarded, used disposable culture dishes shall be subjected to the following methods of treatment and disposal:(I) steam disinfection followed by deposition in a sanitary landfill;(II) incineration followed by deposition of the residue in a sanitary landfill;(III) thermal inactivation followed by deposition in a sanitary landfill;(IV) chemical disinfection followed by deposition in a sanitary landfill;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process followed by deposition in a sanitary landfill.(E) Discarded disposable devices used to transfer, inoculate or mix cultures shall be subjected to one of the following methods of treatment and disposal:(i) steam disinfection followed by deposition in a sanitary landfill;(ii) incineration followed by deposition of the residue in a sanitary landfill;(iii) thermal inactivation followed by deposition in a sanitary landfill;(iv) chemical disinfection followed by deposition in a sanitary landfill;(v) moist heat disinfection followed by deposition in a sanitary landfill;(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vii) an approved alternate treatment process followed by deposition in a sanitary landfill.(4) Pathological waste. Pathological waste shall be subjected to one of the following methods of treatment and disposal.(A) Human materials removed during surgery, labor and delivery, autopsy, embalming, or biopsy shall be subjected to one of the following methods of treatment and disposal:(i) body parts, other than embryonic and fetal tissue remains:(I) interment;(II) incineration followed by deposition of the residue in a sanitary landfill;(III) steam disinfection followed by interment;(IV) moist heat disinfection, provided that the grinding/shredding renders the item as unrecognizable, followed by deposition in a sanitary landfill;(V) chlorine disinfection/maceration, provided that the grinding/shredding renders the item as unrecognizable, followed by deposition in a sanitary landfill; or(VI) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;(ii) tissues, other than embryonic and fetal tissue remains:(I) incineration followed by deposition of the residue in a sanitary landfill;(II) grinding and discharging to a sanitary sewer system;(III) interment;(IV) steam disinfection followed by interment;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;(iii) organs, other than embryonic and fetal tissue remains:(I) incineration followed by deposition of the residue in a sanitary landfill;(II) grinding and discharging to a sanitary sewer system;(III) interment;(IV) steam disinfection followed by interment;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;(iv) bulk human blood and bulk human body fluids removed during surgery, labor and delivery, autopsy, embalming, or biopsy:(I) discharging into a sanitary sewer system;(II) steam disinfection followed by deposition in a sanitary landfill;(III) incineration followed by deposition of the residue in a sanitary landfill;(IV) thermal inactivation followed by deposition in a sanitary landfill;(V) thermal inactivation followed by grinding and discharging into a sanitary sewer system;(VI) chemical disinfection followed by deposition in a sanitary landfill;(VII) chemical disinfection followed by grinding and discharging into a sanitary sewer system;(VIII) moist heat disinfection followed by deposition in a sanitary landfill;(IX) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(X) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill.(B) The products of spontaneous or induced human abortion other than embryonic and fetal tissue remains, shall be subjected to one of the following methods of treatment and disposal:(i) blood and body fluids:(I) discharging into a sanitary sewer system;(II) steam disinfection followed by deposition in a sanitary landfill;(III) incineration followed by deposition of the residue in a sanitary landfill;(IV) thermal inactivation followed by deposition in a sanitary landfill;(V) thermal inactivation followed by grinding and discharging into a sanitary sewer system;(VI) chemical disinfection followed by deposition in a sanitary landfill;(VII) chemical disinfection followed by grinding and discharging into a sanitary sewer system;(VIII) moist heat disinfection followed by deposition in a sanitary landfill;(IX) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(X) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;(ii) any other tissues, including placenta, umbilical cord and gestational sac:(I) grinding and discharging to a sanitary sewer system;(II) incineration followed by deposition of the residue in a sanitary landfill;(III) steam disinfection followed by interment;(IV) interment;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill.(C) Discarded laboratory specimens of blood and/or tissues shall be subjected to one of the following methods of treatment and disposal:(i) grinding and discharging into a sanitary sewer system;(ii) steam disinfection followed by deposition in a sanitary landfill;(iii) steam disinfection followed by grinding and discharging into a sanitary sewer system;(iv) incineration followed by deposition of the residue in a sanitary landfill;(v) moist heat disinfection followed by deposition in a sanitary landfill;(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(vii) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill.(D) Anatomical remains shall be disposed of in a manner specified by §479.4 of this title (relating to Final Disposition of the Body and Disposition of Remains).(5) Sharps.(A) All discarded unused sharps shall be disposed of in accordance with 30 TAC Chapters 326 and 330.(B) Contaminated sharps shall be subjected to one of the following methods of treatment and disposal.(i) Hypodermic needles, and hypodermic syringes with attached needles, shall be subjected to one of the following methods of treatment and disposal:(I) chemical disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(II) steam disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant container followed by deposition in a sanitary landfill;(III) incineration, and if the item can cause puncture wounds, placement in a puncture-resistant container followed by deposition in a sanitary landfill;(IV) encapsulation in a matrix which will solidify and significantly reduce the possibility of puncture wounds followed by deposition in a sanitary landfill;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable and can no longer cause puncture wounds, followed by deposition in a sanitary landfill.(ii) Razor blades, disposable razors, and disposable scissors used in surgery, labor and delivery, or other medical procedures; and scalpel blades shall be subjected to one of the following methods of treatment and disposal:(I) chemical disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(II) steam disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant container followed by deposition in a sanitary landfill;(III) incineration, and if item can cause puncture wounds, placement in a puncture-resistant container followed by deposition in a sanitary landfill;(IV) encapsulation in a matrix which will solidify and significantly reduce the possibility of puncture wounds followed by deposition in a sanitary landfill;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable and can no longer cause puncture wounds, followed by deposition in a sanitary landfill.(iii) Intravenous stylets and rigid introducers (e.g., J wires) shall be subjected to one of the following methods of treatment and disposal:(I) chemical disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(II) steam disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(III) incineration, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(IV) encapsulation in a matrix which will solidify and significantly reduce the possibility of puncture wounds, followed by deposition in a sanitary landfill;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable and can no longer cause puncture wounds, followed by deposition in a sanitary landfill.(iv) Glass pasteur pipettes, glass pipettes, specimen tubes, blood culture bottles, and microscope slides, and broken glass from laboratories shall be subjected to one of the following methods of treatment and disposal:(I) chemical disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(II) steam disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant container followed by deposition in a sanitary landfill;(III) incineration, and if the item can cause puncture wounds, placement in a puncture-resistant container followed by deposition in a sanitary landfill;(IV) encapsulation in a matrix which will solidify and significantly reduce the possibility of puncture wounds followed by deposition in a sanitary landfill;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable and can no longer cause puncture wounds, followed by deposition in a sanitary landfill.(v) Tattoo needles, acupuncture needles, and electrolysis needles shall be subjected to one of the following methods of treatment and disposal:(I) chemical disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(II) steam disinfection, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(III) incineration, and if the item can cause puncture wounds, placement in a puncture-resistant, leak-proof container followed by deposition in a sanitary landfill;(IV) encapsulation in a matrix which will solidify and significantly reduce the possibility of puncture wounds, followed by deposition in a sanitary landfill;(V) moist heat disinfection followed by deposition in a sanitary landfill;(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable and can no longer cause puncture wounds, followed by deposition in a sanitary landfill.(b) Records. The facility treating the wastes shall maintain records to document the treatment of the special waste from health care-related facilities processed at the facility as to method and conditions of treatment in accordance with 30 TAC Chapter 326.(c) Facility responsibility. The facility treating the wastes shall be responsible for establishing the conditions necessary for operation of each method used at the facility to insure the reduction of microbial activity of any waste treated according to the manufacturer's specifications and according to any approval granted by the department. Source Note: The provisions of this §1.136 adopted to be effective April 4, 1989, 14 TexReg 1457; amended to be effective November 21, 1991, 16 TexReg 6482; amended to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TexReg 9709; amended to be effective May 24, 2018, 43 TexReg 3242. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS K DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES §1.136 Approved Methods of Treatment and Disposition https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181295 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181295 03/11/2026 The appropriate regulatory programs of the department shall incorporate the definition and methodology contained in these provisions into their respective general program rules and shall formulate and present for the Executive Commissioner's consideration such additional rules as are necessary for the internal collection, storage, handling, movement, and treatment of special waste from health care-related facilities generated within or by the following facilities or activities:(1) abortion clinics;(2) ambulatory surgical centers;(3) birthing centers;(4) emergency medical service providers;(5) end stage renal disease facilities;(6) freestanding emergency medical care facilities;(7) hospitals;(8) special residential care facilities; and(9) tattoo studios. Source Note: The provisions of this §1.137 adopted to be effective April 4, 1989, 14 TexReg 1457; amended to be effective November 21, 1991, 16 TexReg 6482; amended to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TexReg 9709. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS K DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES §1.137 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223867&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223867 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223867&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223867 03/11/2026 The following words and terms, when used in this section, have the following meanings, unless the text indicates otherwise.(1) Applicant--An individual referred by the Department of Public Safety to the Medical Advisory Board (MAB) for medical review to include applicants defined under Texas Health and Safety Code §12.092(2)(b)(1) and (2).(2) Bylaws--Bylaws of the Medical Advisory Board.(3) Commissioner--The commissioner of the Texas Department of State Health Services.(4) Department of Public Safety (DPS)--Agency responsible for MAB referrals established under authority of 37 Texas Administrative Code Subchapter C, §15.58.(5) Medical Advisory Board (MAB)--The body of physicians and optometrists licensed by the State of Texas and established by Texas Health and Safety Code §12.092. Each person on the MAB is a MAB member or "member." The MAB is administratively attached to the department.(6) Medical Advisory Board Panel--A body of at least three MAB members assigned to review applicants and provide recommendations at the request of DPS. Additional members may be added as necessary to reach a consensus opinion.(7) Medical Packet--Information provided to members on the MAB panel, including:(A) medical conditions under review;(B) other medical information or records provided by the applicant's health care providers about the medical conditions under review; and(C) information provided by DPS, including Supplemental Medical History form, Medical Information Request form, and accident reports or other information about the medical conditions under review.(8) Set--Group of medical packets prepared for a MAB panel to review.(9) Texas Department of State Health Services (department)--Agency responsible for administering MAB activities under Texas Health and Safety Code Chapter 12, Subchapter H, Medical Advisory Board, §§12.091 - 12.098. Source Note: The provisions of this §1.151 adopted to be effective February 10, 2025, 50 TexReg 770. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS L MEDICAL ADVISORY BOARD §1.151 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223868&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223868 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223868&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223868 03/11/2026 (a) MAB Membership.(1) The commissioner appoints MAB members from:(A) persons licensed to practice medicine in Texas, including physicians who are board-certified in internal medicine, psychiatry, neurology, physical medicine, or ophthalmology and are jointly recommended by the department and the Texas Medical Association; and(B) persons licensed to practice optometry in this state who are jointly recommended by the department and the Texas Optometric Association.(2) Members may be recommended for dismissal, as described in the bylaws, for failure to perform in a professional manner, failure to attend meetings regularly, failure to review the minimum required number of cases, or missing two consecutive MAB board meetings without advanced notice to the chair.(b) Function of the MAB.Upon a request for recommendation from DPS under 37 Texas Administrative Code §15.58, Medical Advisory Board Referrals; Texas Transportation Code Chapter 521, Subchapter N, General Provisions Relating To License Denial, Suspension, or Revocation; and Texas Government Code Chapter 411, Subchapter H, License to Carry A Handgun, the department must convene a MAB panel.(1) Each MAB panel member must review the set of medical packets provided by the department within the time frame specified by the department.(2) Upon completion of the applicant's packet review, each member must provide an independent opinion, in the form of a written recommendation, stating the member's opinion as to the ability of the applicant to safely operate a motor vehicle or to exercise sound judgment in the proper use and storage of a handgun, as appropriate. In the report the panel member may also make recommendations relating to DPS' subsequent action.(3) The MAB panel recommendations or opinions are provided to DPS. The final decision to issue, renew, restrict, or revoke a driver's license or license to carry rests entirely with DPS.(4) All members are expected to act in an impartial manner in their medical reviews. Any member unable to be impartial to any applicant before the MAB must declare this impartiality and may not participate in any MAB proceedings involving the applicant.(5) MAB members are compensated for the review of a set of completed medical packets, and for each scheduled board or committee meeting attended.(6) MAB members will convene at least every two years. The MAB complies with the requirements for open meetings under Texas Government Code Chapter 551.(c) Medical Packet Requirements.(1) The applicant must provide current medical information to the MAB pertinent to the medical conditions for which DPS requested the review and recommendation. Information must be provided within 90 days of the date MAB received the DPS request for recommendation by a licensed physician or, in the case of medical conditions impacting vision, by a licensed optometrist.(2) Any licensed health care provider or facility who treated the applicant may provide information regarding the applicant's fitness to operate a motor vehicle safely or the ability to exercise sound judgment with respect to the proper use and storage of a handgun. Information completed or provided by a midlevel provider or an optometrist must be completed in accordance with Texas Occupations Code Chapters 157 and 351.(3) The panel may require the applicant or license holder to undergo a medical or other examination at the applicant's or holder's expense. A person who conducts an examination under this subsection may be compelled to testify before the panel and in any subsequent proceedings under Texas Government Code Chapter 411, Subchapter , or Texas Transportation Code Chapter 521, Subchapter N, as applicable, concerning the person's observations and findings.(d) All records, reports, and testimony relating to the medical condition of an applicant:(1) are for the confidential use of the MAB, a MAB panel, or DPS;(2) are privileged information; and(3) may not be disclosed to any person or used as evidence in a trial except as provided in (e) of this section.(e) In a subsequent proceeding under Texas Government Code Chapter 411, Subchapter H, or Texas Transportation Code Chapter 521, Subchapter N, the department may provide a copy of the report of the MAB or MAB panel and the medical packet relating to an applicant to:(1) DPS;(2) the applicant; and(3) the presiding officer at the license to carry or driver's license hearing. Source Note: The provisions of this §1.152 adopted to be effective February 10, 2025, 50 TexReg 770. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS L MEDICAL ADVISORY BOARD §1.152 Operation of the Medical Advisory Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124576&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124576 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124576&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124576 03/11/2026 In accordance with the Government Code, §2161.003, the Department of State Health Services (department) adopts by reference the rules of the Texas Building and Procurement Commission (TBPC) found at Title 1 Texas Administrative Code §§111.11 - 111.28 concerning the Historically Underutilized Business (HUB) Program. For purposes of implementing the TBPC rules at the department, references to "state agency" or "agency" shall be considered to be a reference to the department. This rule applies to the department's HUB program and to other state agencies for which the department administers the HUB program. Source Note: The provisions of this §1.171 adopted to be effective February 7, 2001, 26 TexReg 1141; amended to be effective May 21, 2006, 31 TexReg 3875. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS N HISTORICALLY UNDERUTILIZED BUSINESSES §1.171 Historically Underutilized Business (HUB) Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12764&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12764 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12764&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12764 03/11/2026 (a) This section establishes the methods by which the public, consumers, and service recipients can be notified of the mailing addresses and telephone numbers of appropriate Texas Department of Health (department) divisions, programs, and offices for the purpose of directing complaints to the department.(b) The names, mailing addresses, and telephone numbers of the appropriate department divisions, programs, and offices to whom the public, consumers, and service recipients can direct complaints will be included on a sign prominently displayed in the place of business of each person or entity regulated by the department.(c) For those regulated persons or entities not having a place of business, written notification must be provided to the clients of those persons and entities. Source Note: The provisions of this §1.191 adopted to be effective December 1, 1993, 18 TexReg 8213. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS P COMPLAINTS §1.191 Complaints https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2096&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2096 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2096&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2096 03/11/2026 The purpose of these sections is to:(1) define abuse or neglect of a child and describe procedures for reporting and investigating in accordance with the Family Code, Chapter 261; and(2) define abuse, neglect or exploitation of an elderly or disabled person and describe procedures for reporting and investigating in accordance with the Human Resources Code, Chapter 48. Source Note: The provisions of this §1.201 adopted to be effective November 16, 1995, 20 TexReg 9161. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Q INVESTIGATIONS OF ABUSE, NEGLECT, OR EXPLOITATION OF CHILDREN OR ELDERLY OR DISABLED PERSONS §1.201 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12745&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12745 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12745&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12745 03/11/2026 The provisions of this undesignated head shall apply to the Texas Department of Health's investigation of abuse or neglect of a child or abuse, neglect or exploitation of an elderly or disabled person which occurs in any facility licensed, certified, registered, or operated by the Texas Department of Health. Source Note: The provisions of this §1.202 adopted to be effective November 16, 1995, 20 TexReg 9161. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Q INVESTIGATIONS OF ABUSE, NEGLECT, OR EXPLOITATION OF CHILDREN OR ELDERLY OR DISABLED PERSONS §1.202 Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64334&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64334 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64334&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64334 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Agent--An individual not employed by a facility but working under the auspices of the facility, such as a volunteer, student, or consultant.(2) Allegation--A report by a person believing or having knowledge that a child has been or may be abused or neglected in a facility or that an elderly or disabled person has been or may be abused, neglected or exploited in a facility.(3) Caretaker--An owner, operator, manager, employee, or agent of a facility in which a patient or client is located.(4) Child--A person under 18 years of age who is not and has not been married or who has not had the disabilities of minority removed for general purposes.(5) Client--A child, disabled person or elderly person receiving services in a facility.(6) Clinical issues--Issues relating to unsafe practice by a licensed health care professional or a violation of a state law or rule relating to the licensure or practice of a licensed health care professional.(7) Confirmed--A finding that an allegation of abuse, neglect, or exploitation is supported by the preponderance of the evidence.(8) Department--The Texas Department of Health.(9) Disabled person--A person with a mental, physical, or developmental disability that substantially impairs the person's ability to provide adequately for the person's care or protection and who is either 18 years of age or older or who is under 18 years of age and has the disabilities of minority removed.(10) Elderly person--A person 65 years of age or older.(11) Facility--A facility providing health care services which is operated, licensed, certified, or registered by the department. Such facilities include licensed general or special hospitals, licensed private psychiatric hospitals, licensed special care facilities, licensed abortion facilities, licensed ambulatory surgical centers, licensed birthing centers, licensed end stage renal disease facilities, the two hospitals operated by the department, youth camps, and public health clinics operated by the department. This term includes any owner, operator, manager, employee, or agent of a facility.(12) Guardian--Anyone named as "guardian of the person" of a child, elderly person, or disabled person by a probate court order.(13) Inconclusive--A finding that an allegation of abuse, neglect, or exploitation leads to no conclusion or definite result due to a lack of witnesses or other relevant evidence.(14) Nonserious physical injury--Any injury determined not to be serious by the examining physician. Examples of nonserious injury may include superficial laceration, contusion, or abrasion.(15) Observable and material impairment--Discernable and substantial damage or deterioration.(16) Patient--A child, disabled person, or elderly person receiving health care services in a facility.(17) Perpetrator--The person who has committed an act of abuse or neglect of a child or abuse, neglect, or exploitation of an elderly or disabled person.(18) Perpetrator unknown--The term used to describe an incidence in which abuse, neglect, or exploitation is confirmed but positive identification of the responsible person can not be made and in which self injury has been eliminated as the cause.(19) Preponderance of evidence--The greater weight of evidence or evidence which is more credible and convincing to the mind.(20) Reporter--The person filing a report of abuse, neglect, or exploitation, either the:(A) victim of alleged abuse, neglect, or exploitation;(B) a third party filing a report on behalf of the alleged victim; or(C) both.(21) Serious physical injury--An injury determined to be serious by the examining physician. Examples of serious injury may include fracture; dislocation of any joint; internal injury; any contusion larger than two and one-half inches in diameter; concussion; second or third degree burns; first degree scald burns greater than the percentage of the body involved or involving hands, feet, face or genitals; or multiple lacerations, contusions or abrasions.(22) Sexual abuse--Any sexual activity, including any involuntary or nonconsensual sexual conduct that would constitute an offense under the Penal Code, §21.08 (indecent exposure) or Chapter 22 (assaulting offenses), involving a facility and a patient or client. Sexual activity includes but is not limited to kissing, hugging, stroking, or fondling with sexual intent; oral sex or sexual intercourse; and request, suggestion or encouragement for the performance of sex.(23) Substantial harm--Real and significant physical injury or damage to a child that includes, but is not limited to, bruises, cuts, welts, skull or other bone fractures, brain damage, subdural hematoma, internal injuries, burns, scalds, wounds, poisoning, human bites, concussions, and dislocations and sprains.(24) Substantial risk--Real and significant possibility or likelihood.(25) Unconfirmed--A finding that an allegation of abuse, neglect or exploitation is not supported by the preponderance of the evidence.(26) Unfounded--A finding that an allegation of abuse, neglect, or exploitation is spurious or patently without factual basis. Source Note: The provisions of this §1.203 adopted to be effective November 16, 1995, 20 TexReg 9161; amended to be effective June 13, 1999, 24 TexReg 4230. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Q INVESTIGATIONS OF ABUSE, NEGLECT, OR EXPLOITATION OF CHILDREN OR ELDERLY OR DISABLED PERSONS §1.203 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64335&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64335 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64335&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64335 03/11/2026 (a) Abuse defined.(1) Abuse of a child includes the following acts or omissions by any person:(A) mental or emotional injury to a child that results in an observable and material impairment in the child's growth, development, or psychological functioning;(B) causing or permitting the child to be in a situation in which the child sustains a mental or emotional injury that results in an observable and material impairment in the child's growth, development, or psychological functioning;(C) physical injury that results in substantial harm to the child, or the genuine threat of substantial harm from physical injury to the child, including an injury that is at variance with the history or explanation given and excluding an accident (an unforeseen event that causes or threatens physical injury despite prudent efforts to avoid the risk of injury) or reasonable discipline (correction of behavior that does not result in or risk substantial harm from physical injury) by a parent, guardian, or managing or possessory conservator that does not expose the child to a substantial risk of harm;(D) failure to make a reasonable effort to prevent an action (effort that an ordinary and prudent person would take to stop an action from occurring) by another person that results in physical injury that results in substantial harm to the child;(E) sexual conduct harmful to a child's mental, emotional, or physical welfare;(F) failure to make a reasonable effort to prevent sexual conduct harmful to a child;(G) compelling or encouraging the child to engage in sexual conduct as defined by the Penal Code, §43.01 (This is met whether the child actually engages in sexual conduct or simply faces a substantial risk of doing so);(H) causing, permitting, encouraging, engaging in, or allowing the photographing, filming, or depicting of the child if the person knew or should have known that the resulting photograph, film, or depiction of the child is obscene (as defined by the Penal Code) or pornographic (this is met whether or not the child voluntarily participates);(I) the current use by a person of a controlled substance as defined by the Health and Safety Code, Chapter 481, in a manner or to the extent that the use results in physical, mental, or emotional injury to a child; or(J) causing, expressly permitting, or encouraging a child to use a controlled substance as defined by the Health and Safety Code, Chapter 481.(2) Abuse of an elderly or disabled person means:(A) the negligent or wilful infliction of injury, unreasonable confinement, intimidation, or cruel punishment with resulting physical or emotional harm or pain by the person's caretaker, family member, or other individual who has an ongoing relationship with the person; or(B) sexual abuse by the persons, caretaker, family member, or other individual who has an ongoing relationship with the person.(3) Abuse does not include:(A) the proper use of restraints or seclusion in accordance with federal or state laws or regulations or court order;(B) other actions taken in accordance with federal or state laws or regulations or court order;(C) actions an employee may reasonably believe to be immediately necessary to avoid imminent harm to self, patients or clients, or other individuals if such actions are limited only to those actions reasonably believed to be necessary under the existing circumstances. Such actions do not include acts of unnecessary force or the inappropriate use of restraints or seclusion; or(D) complaints related to the daily administrative operations of a facility (e.g., staffing ratios).(b) Neglect defined.(1) Neglect of a child includes:(A) the leaving of a child in a situation where the child would be exposed to a substantial risk of physical or mental harm, without arranging for necessary care for the child, and a demonstration of an intent not to return by a parent, guardian, or managing or possessory conservator of a child;(B) the following acts or omissions by any person:(i) placing the child in or failing to remove the child from a situation that a reasonable person would realize requires judgment or actions beyond the child's level of maturity, physical condition, or mental abilities and that results in bodily injury or a substantial risk of immediate harm to the child;(ii) the failure to seek, obtain, or follow through with medical care for the child, with the failure resulting in or presenting a substantial risk of death, disfigurement, or bodily injury or with the failure resulting in an observable and material impairment to the growth, development, or functioning of the child;(iii) the failure to provide the child with food, clothing, or shelter necessary to sustain the life or health of the child (if the failure results in an observable and material impairment to the child's growth, development or functioning or in a substantial risk of such an observable or material impairment), excluding failure caused primarily by financial inability unless relief services had been offered and refused; or(iv) placing a child in or failing to remove the child from a situation in which the child would be exposed to a substantial risk of sexual conduct harmful to the child; or(C) the failure by the person responsible for a child's care, custody, or welfare to permit the child to return to the child's home without arranging for the necessary care for the child after the child has been absent from the home for any reason, including having been in residential placement or having run away.(2) Neglect of an elderly or disabled person means the failure to provide for one's self the goods or services, including medical services, which are necessary to avoid physical or emotional harm or pain or the failure of a caretaker to provide such goods or services.(c) Exploitation defined. Exploitation of an elderly or disabled person means the illegal or improper act or process of a caretaker, family member or other individual who has an ongoing relationship with the elderly or disabled person using the resources of an elderly or disabled person for monetary or personal benefit, profit, or gain without the informed consent of the elderly or disabled person. Source Note: The provisions of this §1.204 adopted to be effective November 16, 1995, 20 TexReg 9161; amended to be effective June 13, 1999, 24 TexReg 4230. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Q INVESTIGATIONS OF ABUSE, NEGLECT, OR EXPLOITATION OF CHILDREN OR ELDERLY OR DISABLED PERSONS §1.204 Abuse, Neglect, and Exploitation Defined https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64336&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64336 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64336&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64336 03/11/2026 (a) The Texas Department of Health (department) shall investigate allegations received relating to the abuse or neglect of a child or the abuse, neglect, or exploitation of an elderly or disabled person in a facility.(b) The department will only investigate reports when:(1) the act is reported to have occurred in a facility and the victim was a patient or client of the facility;(2) the act occurred away from the facility but the facility was responsible for the supervision of the patient or client who was the victim at the time the act allegedly occurred;(3) the act is reported to have occurred in a facility and the alleged perpetrator was an owner, operator, manager, employee, or agent of the facility; or(4) the act occurred away from the facility but the facility was responsible for the supervision of the alleged perpetrator at the time the act occurred.(c) The department shall review each allegation and determine that it is appropriate for the department to investigate the allegation.(1) If there is reason to suspect that the patient or client was abused, neglected, or exploited prior to admission to the facility or during an unsupervised absence from the facility, the department shall refer the allegation to the Texas Department of Protective and Regulatory Services.(2) If the allegation involves the actions of a licensed health care professional, the department will determine whether the allegation involves clinical issues.(A) The department will pursue an investigation of the portion of an allegation which does not involve clinical issues.(B) If the allegation involves clinical issues, the allegation shall immediately be forwarded to the state agency which licenses the health care professional involved. The identity of a person reporting abuse or neglect must be blacked out or deidentified.(3) The department need not investigate an allegation that clearly does not involve abuse or neglect of a child in a facility or abuse, neglect or exploitation of an elderly or disabled person in a facility. The department may refer the reporter to other agencies for assistance.(4) Injuries of unknown origin shall be investigated if the attending physician, after examining the patient, suspects that the injury is the result of abuse or neglect.(5) If an allegation involves the daily administrative operations of a facility and has not resulted in a specific case of abuse, neglect, or exploitation, such as the failure to maintain an adequate number of staff, the department need not investigate the matter under this section but may investigate the matter as a complaint investigation involving regulatory issues.(d) Allegations which cannot be investigated by the department pursuant to the Family Code, Chapter 261, or the Human Resources Code, Chapter 48, shall be referred to the Texas Department of Protective and Regulatory Services for appropriate investigation or action consistent with existing law.(e) The department shall make a thorough investigation promptly after receiving an allegation.(1) The primary purpose shall be the protection of the child or elderly or disabled person.(2) If a facility is licensed by the department and another state agency, the department shall notify the other agency (if the other agency is unaware of the allegation) before initiating an investigation and make a reasonable effort to coordinate the investigation and avoid duplication of effort.(3) If a report of serious physical injury or sexual abuse of a child is received by the department from the Texas Department of Protective and Regulatory Services, the investigation shall be conducted jointly by the appropriate local law enforcement agency and the department, if possible. The department shall document any instance in which a law enforcement agency is unable or unwilling to conduct a joint investigation.(f) Anonymous allegations will be received and investigated following the same procedures that are used when the reporter is known.(g) An allegation relating to a patient or client who is in the facility where the act allegedly occurred at the time of the department's receipt of the allegation shall be given priority by the department in the scheduling of investigations. An allegation relating to a patient or client who is no longer in the facility shall be given secondary priority.(h) An investigation of abuse, neglect, or exploitation may occur in conjunction with other survey activities or complaint investigations relating to violations of federal or state laws or rules; however, the determination as to whether abuse, neglect, or exploitation has occurred or is likely to occur is a separate determination from regulatory matters and shall be made without regard as to whether law or rule violations or deficiencies are cited.(i) An investigation shall include:(1) an interview with the alleged victim, if appropriate. An interview with a child alleged to be a victim of physical abuse or sexual abuse shall be audiotaped or videotaped unless the department determines that good cause exists for not audiotaping or videotaping the interview. Good cause may include, but is not limited to, such considerations as the age of the child and the nature and seriousness of the allegations under investigation. Nothing in this paragraph shall be construed as prohibiting the department from audiotaping or videotaping an interview of a child on any case for which such audiotaping or videotaping is not required under this paragraph. The fact that the department failed to audiotape or videotape an interview is admissible at the trial of the offense that is the subject of the interview;(2) an interview with the alleged perpetrator unless the investigator has already determined that there was no abuse, neglect, or exploitation or the risk of the same does not exist; and(3) consultation with persons thought to have knowledge of the circumstances.(j) An investigation shall address the issues set forth in the:(1) Human Resources Code, §48.038(a), concerning elderly or disabled persons; or(2) Family Code, §261.401, concerning children.(k) If during the course of the investigation it becomes apparent that the allegation is frivolous or patently without factual basis, the investigation may be closed as unfounded with supervisory approval. The reason for this determination, based on specific evidence, will be included in the report.(l) If there is not a preponderance of the evidence to indicate that an allegation should or should not be confirmed, due to lack of witnesses or other available evidence, a finding of inconclusive may be used with supervisory approval.(m) If during the course of the investigation it becomes apparent that abuse, neglect or exploitation has not occurred or is not likely to occur, the investigation may be closed as unfounded with supervisory approval.(n) An investigative report shall indicate "perpetrator unknown" in those incidences where the preponderance of evidence exists to confirm abuse, neglect, or exploitation but positive identification of the person responsible cannot be determined and self injury has been eliminated as the cause. Evidence must exist that abuse, neglect, or exploitation has been committed for the term "perpetrator unknown" to be used.(o) The department shall make a reasonable effort to notify each parent and legal guardian, if one has been appointed, of the nature of the allegation, that the interview or examination was conducted, and of the disposition of the investigation.(1) When during an investigation of a report of suspected child abuse or neglect a representative of the department conducts an interview with or an examination of a child, the department shall make a reasonable effort before 24 hours after the time of the interview or examination to notify each parent of the child and the child's legal guardian of the nature of the allegation and of the fact that the interview or examination was conducted.(2) If a report of suspected child abuse or neglect is administratively closed by the department as a result of a preliminary investigation that did not include an interview or examination of the child, the department shall make a reasonable effort before the expiration of 24 hours after the time the investigation is closed to notify each parent and legal guardian of the disposition of the investigation.(3) The notice required by paragraphs (1) and (2) of this subsection is not required if the department determines that the notice is likely to endanger the safety of the child who is the subject of the report, the person who made the report, or any other person who participates in the investigation of the report.(4) The notice required by paragraphs (1) and (2) of this subsection may be delayed at the request of a law enforcement agency if notification during the required time would interfere with an ongoing criminal investigation. Source Note: The provisions of this §1.205 adopted to be effective November 16, 1995, 20 TexReg 9161; amended to be effective June 13, 1999, 24 TexReg 4230. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Q INVESTIGATIONS OF ABUSE, NEGLECT, OR EXPLOITATION OF CHILDREN OR ELDERLY OR DISABLED PERSONS §1.205 Reports and Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=30448&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 30448 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=30448&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 30448 03/11/2026 (a) After receiving an allegation which the Texas Department of Health (department) determines is appropriate for investigation, the department's investigator shall finish an investigation within:(1) 14 days if the child or elderly or disabled person is in the facility at the time the department receives the allegation;(2) 60 days for all other allegations; or(3) the time period set by an extension granted to the investigator by his or her supervisor.(b) Following the investigation, the investigator shall submit an investigative report, including:(1) a statement of the allegations;(2) a summary of the investigation;(3) an analysis of the evidence;(4) the investigator's determination as to whether or not abuse, neglect, or exploitation occurred;(5) designation of the perpetrator, if possible;(6) a determination as to how the incident should be classified in accordance with §1.204 of this title (relating to Abuse, Neglect, and Exploitation Defined); and(7) recommendations resulting from the investigation.(c) An investigation is not considered complete until review of the investigative report is completed by all appropriate department personnel.(d) If the department determines that the child or elderly or disabled person should be removed from the facility in order to protect the child or person from further abuse, neglect, or exploitation, the department shall inform the Texas Department of Protective and Regulatory Services within 24 hours of the determination.(e) If the investigation confirms abuse, neglect, or exploitation, the written report of the completed investigation by the department, along with the department's recommendations and related documents, shall be submitted to:(1) the appropriate district or county attorney or law enforcement agency if the report concerns abuse or neglect of a child;(2) the Texas Department of Protective and Regulatory Services if protective services are necessary;(3) the appropriate probate court if a guardian has been appointed for an elderly or disabled person; and(4) the appropriate state or local law enforcement agency if the report concerns abuse of an elderly or disabled person which could constitute a criminal offense under any law, including the Penal Code, §22.04.(f) In cases of abuse, neglect, or exploitation by a licensed, certified, or registered health care professional, the department may forward a copy of the completed investigative report to the state agency which licenses, certifies or registers the health care professional. Any information which might reveal the identity of the reporter or any other patients or clients of the facility must be blacked out or deidentified.(g) The department shall notify the reporter, if known, in writing of the outcome of the complete investigation.(h) The department shall notify the alleged victim, and his or her parent or guardian if a minor, in writing of the outcome of the completed investigation.(i) If the department receives a complaint about a department investigation of abuse, neglect, or exploitation in a facility, the department shall refer the complaint to the appropriate associate commissioner or office which oversees the investigations in that particular facility. Source Note: The provisions of this §1.206 adopted to be effective November 16, 1995, 20 TexReg 9161. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Q INVESTIGATIONS OF ABUSE, NEGLECT, OR EXPLOITATION OF CHILDREN OR ELDERLY OR DISABLED PERSONS §1.206 Completion of Investigation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64337&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64337 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64337&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64337 03/11/2026 (a) The allegation and the reports, records, communications and working papers used or developed in the investigative process, including the resulting final report regarding abuse, neglect, or exploitation, are confidential and may be disclosed only as provided in the Family Code, §261.201, or the Human Resources Code, §48.101 and §48.038(f) and (g), and pursuant to the sections under this undesignated head.(b) Information discussed during deliberations of abuse, neglect, and exploitation investigations may not be discussed outside the purview of those deliberations.(c) The completed investigative report and related documents may be released to governmental agencies as described in this undesignated head.(d) The completed investigative report and related documents may be released by court order.(e) The completed investigative report and related documents may be released to the victim or the victim's parent or guardian if the victim is a minor if there is no ongoing criminal investigation. Any information which might reveal the identity of the reporter, any other patients or clients of the facility or any other person whose life or safety might be endangered by the disclosure must be blacked out or deidentified.(f) The investigative report and related documents shall not be available to the public.(g) The completed investigative report and related documents shall be released to the adoptive parents or prospective adoptive parents of a child who was the subject of an investigation or an adult who was the subject of an investigation as a child. Any information which might reveal the identity of the reporter, the biological parents or any other person whose identity is confidential shall be blacked out or deidentified.(h) The completed investigative report regarding abuse, neglect, or exploitation of an elderly or disabled person shall be released to the subject of a report of abuse, neglect, or exploitation or to that person's legal representative upon request. Any information relating to the reporter's identity or any other individual whose safety or welfare may be endangered by the disclosure shall be blacked out or deidentified.(i) At the conclusion of an investigation in which the department determines that the person alleged to have abused or neglected a child did not commit abuse or neglect, the department shall notify the person of the person's right to request the department to remove information about the person's alleged role in the abuse or neglect report from the department's records.(j) On request under subsection (i) of this section by a person whom the department has determined did not commit abuse or neglect, the department shall remove information from the department's records concerning the person's alleged role in the abuse or neglect report. Source Note: The provisions of this §1.207 adopted to be effective November 16, 1995, 20 TexReg 9161; amended to be effective June 13, 1999, 24 TexReg 4230. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Q INVESTIGATIONS OF ABUSE, NEGLECT, OR EXPLOITATION OF CHILDREN OR ELDERLY OR DISABLED PERSONS §1.207 Confidentiality of Investigative Process and Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99469&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99469 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99469&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99469 03/11/2026 The purpose of these sections is to establish the rules governing the relationship between the department and its officers and employees with private donors and with private organizations which exist to further the duties and purposes of the department. Source Note: The provisions of this §1.221 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.221 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99470&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99470 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99470&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99470 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Commissioner--The commissioner of the Texas Department of Health.(2) Department--The Texas Department of Health.(3) Donation--A contribution of anything of value (financial or in-kind gifts such as goods or services) given to the department for public health purposes or to a private organization which exists to further the duties or functions of the department. The department may not accept donations of real property (real estate) without the express permission and authorization of the legislature.(4) Employee--A regular, acting, exempt, full-time or part-time employee of the department.(5) Private donor--One or more persons or private organizations which give a donation to the department for public health purposes or to a private organization which exists to further the duties and purposes of the department.(6) Private organization--A private organization which exists to further the purposes and duties of the department. Source Note: The provisions of this §1.222 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.222 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99471&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99471 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99471&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99471 03/11/2026 (a) A private donor may make donations to the department to be spent for specified or unspecified public health purposes, including the enforcement of public health laws. If the donor specifies the public health purpose, the department must expend the donation only for that purpose.(b) All donations shall be expended in accordance with the provisions of the state Appropriations Act and shall be deposited in the state treasury unless exempted by specific statutory authority. All donations of value of $500 or more shall be accepted in accordance with Government Code, Chapter 575.(c) All donations will be coordinated through the commissioner.(d) The department may not transfer a private donation to a foundation or private/public development fund without specific written permission from the donor and the written approval of the commissioner or his designee. Source Note: The provisions of this §1.223 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.223 Donations by Private Donors to the Texas Department of Health https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99472&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99472 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99472&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99472 03/11/2026 (a) A private donor may make donations to a private organization which exists to further the purposes and duties of the department.(b) The private organization shall administer and use the donation in accordance with the provisions in the memorandum of understanding between the private organization and the department, as described in §1.226(c) of this title (relating to the Relationship between a Private Organization and the Texas Department of Health). Source Note: The provisions of this §1.224 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.224 Donations by a Private Donor to a Private Organization Which Exists To Further the Purposes and Duties of the Texas Department of Health https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99473&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99473 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99473&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99473 03/11/2026 (a) The commissioner and the membership of a private organization covered by these sections may cooperatively appoint a board of directors for the organization. The commissioner may be a non-voting member. Department employees or their family members may hold office and vote provided there is no conflict of interest in accordance with all federal and state laws and department policies.(b) As an alternative to the method described in subsection (a) of this section, the private organization may decide not to have its board cooperatively appointed. Source Note: The provisions of this §1.225 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.225 Organizing a Private Organization Which Exists To Further the Duties and Purposes of the Texas Department of Health https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99474&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99474 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99474&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99474 03/11/2026 (a) The department may provide to a private organization covered by these sections:(1) fundraising and solicitation assistance;(2) staff services to coordinate activities;(3) administrative and clerical services;(4) office and meeting space;(5) training; and(6) other miscellaneous services as needed to further the duties and purposes of the organization in support of the department.(b) The private organization may provide:(1) postage;(2) printing, including letterhead and newsletters;(3) special event insurance;(4) recognition of donors;(5) bond and liability insurance for organization officers; and(6) other miscellaneous services as needed to further the duties and purposes of the department.(c) The private organization and the department shall enter into a memorandum of understanding (MOU) which contains specific provisions regarding:(1) the relationship between the private organization and the department, and a mechanism for solving any conflicts or disputes;(2) fundraising and solicitation;(3) the use of all funds and other donations from fundraising or solicitation, less legitimate expenses as described in the MOU, for the benefit of the department;(4) the maintenance by the private organization of receipts and documentation of all funds and other donations received, including furnishing such records to the department; and(5) the furnishing to the department of any audit of the private organization by the Internal Revenue Service or a private firm. Source Note: The provisions of this §1.226 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.226 Relationship between a Private Organization and the Texas Department of Health https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99475&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99475 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99475&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99475 03/11/2026 (a) A department officer or employee shall not accept or solicit any gift, favor, or service from a private donor that might reasonably tend to influence his/her official conduct.(b) An officer or employee shall not accept employment or engage in any business or professional activity with a private donor which the officer or employee might reasonably expect would require or induce him/her to disclose confidential information acquired by reason of his/her official position.(c) An officer or employee shall not accept other employment or compensation from a private donor which would reasonably be expected to impair the officer's or employee's independence of judgment in the performance of his/her official position.(d) An officer or employee shall not make personal investments in association with a private donor which could reasonably be expected to create a substantial conflict between the officer's or employee's private interest and the interest of the department.(e) An officer or employee shall not solicit, accept, or agree to accept any benefits for having exercised his/her official powers on behalf of a private donor or performed his official duties in favor of private donor.(f) An officer or employee who has policy direction over the department and who serves as an officer or director of a private donor shall not vote on any measure, proposal, or decision pending before the private donor if the department might reasonably be expected to have an interest in such measure, proposal, or decision.(g) An officer or employee shall not authorize a private donor to use property of the department unless the property is used in accordance with a contract or memorandum of understanding between the department and the private donor, or the department is otherwise compensated for the use of the property. Source Note: The provisions of this §1.227 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.227 Standards of Conduct between Texas Department of Health Employees and Private Donors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99476&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99476 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99476&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99476 03/11/2026 The relationship between a private donor and a private organization and the department, including fundraising and solicitation activities, is subject to all applicable federal and state laws, rules and regulations, and local ordinances governing each entity and its employees. Source Note: The provisions of this §1.228 adopted to be effective July 19, 1994, 19 TexReg 5169; amended to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS R STANDARDS FOR CONDUCT GOVERNING THE RELATIONSHIP BETWEEN THE TEXAS DEPARTMENT OF HEALTH AND PRIVATE DONORS AND PRIVATE ORGANIZATIONS §1.228 Miscellaneous https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122370&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122370 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122370&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122370 03/11/2026 (a) The department requires that all public information requests be in writing, to include fax and e-mail, unless there are special circumstances. Program staff may determine whether a verbal request may be accepted.(b) The program handling the request for public information will review the request and determine what records are requested; who is requesting the records; whether inspection or actual copies of the records are requested; and whether the requested records are open, confidential, or partially open and partially confidential. The Office of General Counsel is available to provide assistance in making these determinations.(c) To the extent possible the department will attempt to accommodate a requestor by providing information in the format requested. For example, if a requestor asks that information be provided on a diskette and the requested information is electronically stored, the department should provide the information on diskette. The department is not required to acquire software, hardware, or programming capabilities that it does not already possess to accommodate a particular kind of request except in accordance with the Public Information Act (Act), §552.231.(d) Provision of a copy of public information in the requested medium must not violate the terms of any copyright agreement between the department and a third party. Therefore, the department will not make copies nor allow use of state equipment for copying of materials copyrighted by a person other than the department. This limitation also will apply to material copyrighted by the department when the department copyright is restricted to certain uses. The requestor may bring a portable copier, camera, or other recording device to copy the copyright material.(e) The program handling the request for public information must have the records ready for inspection or copies duplicated promptly or within a reasonable time, but no later than 10 business days after the date the department received the request. If the program cannot produce the public information for inspection or duplication within 10 business days after the date the department received the request, the program will certify that fact in writing to the requestor and set a date and hour within a reasonable time when the information will be available for inspection or duplication.(1) Prior to the end of the 10 business days or the set date and hour, if applicable, the program will notify the requestor of the estimated costs if the costs will be over $40.(2) The program may require a cash deposit on requests for copies of public information which are estimated to exceed $100. The breakdown on deposit requirements are outlined in the department's operating procedures relating to charges for records under the Act.(3) All efforts should be made to process requests as efficiently as possible so that requested information will be provided at the lowest possible charge.(4) Full disclosure must be made to the requesting party as to how the charges were calculated.(5) All charges for public information in an amount of $100 or more must be paid to the department before the public information is actually provided to the requestor by inspection or duplication. On orders under $100, the program staff have the option to require prepayment before providing the information or they have the option to provide the information to the requestor along with a copy of the billing statement, which must be returned with the remittance.(6) If the department has previously provided public information to a requestor and billed the requestor for the information and if the billings exceed $100 and are unpaid, the department may require a deposit for payment of the unpaid amounts owed to the department before preparing to fulfill a new request for public information from the same requestor. The department may not seek payment of those unpaid amounts through any other means.(7) If a request for information requires programming or manipulation of data pursuant to the Act, §552.231 and the department's policy established under that section, the time frame in this subsection will not apply until the requestor files the written statement described in the Act, §552.231(d)(1) or (2). Once the written statement is filed, the program handling the request shall comply with this subsection.(8) When payment is required in advance of providing the public information, failure of the requestor to pay the costs of the copies within 30 days of notification of the estimated costs, or a longer period of time, if granted by the program, will be considered a withdrawal of the request for information.(f) The program, at its discretion, may provide public information without charge or at a reduced charge if the waiver or reduction of the charge is in the public interest, because providing the copies primarily benefits the general public, or if the cost for the collection of a charge will exceed the amount of the charge.(g) The department may set the price for publications it publishes for public dissemination or it may disseminate them free of charge. This rule and department policy do not limit the costs of departmental publications. Source Note: The provisions of this §1.251 adopted to be effective August 9, 1998, 23 TexReg 7801; amended to be effective November 7, 2002, 27 TexReg 10382; amended to be effective December 12, 2005, 30 TexReg 8291. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS S REQUESTS FOR PROVIDING PUBLIC INFORMATION §1.251 Procedures for Handling Requests for Public Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=105200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 105200 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=105200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 105200 03/11/2026 (a) This section implements the provisions of the Family Code, Chapter 232, Suspension of License for Failure to Pay Child Support, as added by Acts 1995, 74th Legislature, Chapter 751, §85 (House Bill 433). The term "order" refers only to an order issued by a court or Title IV-D agency under that law.(b) This section applies to any program within the Texas Department of Health (department) which issues licenses. A "license" means a license, certificate, registration, permit, or other authorization issued by the department that:(1) is subject before expiration to suspension, revocation, forfeiture, or termination by the department; and(2) a person must obtain to practice or engage in a particular business, occupation, or profession or to engage in any other regulated activity.(c) On receipt of a final court or Attorney General's order suspending a license due to failure to pay child support, the department shall immediately determine if the department has issued a license to the obligor named on the order and if a license has been issued:(1) record the suspension of the license in the department's records;(2) report the suspension as appropriate; and(3) demand surrender of the suspended license if required by law for other cases in which a license is suspended.(d) The department shall implement the terms of a final court or Attorney General's order suspending a license without additional review or hearing. The department may provide notice as appropriate to the license holder or to others concerned with the license.(e) The department may not modify, remand, reverse, vacate, or stay an order suspending a license under this section and may not review, vacate, or reconsider the terms of a final order suspending a license under this section.(f) An individual who is the subject of a final order suspending a license under this section is not entitled to a refund for any fee or deposit paid to the department.(g) An individual who continues to engage in the business, occupation, profession, or other licensed activity after the implementation of the order suspending the license by the department is liable for the same civil and criminal penalties provided for engaging in the licensed activity without a license or while a license is suspended that apply to any other license holder.(h) If a suspension overlaps a license renewal period, an individual with a license suspended under this section shall comply with the normal renewal procedures applicable to the license; however, the license will not actually be renewed until subsections (k) and (l) of this section are met.(i) The department is exempt from liability to a license holder for any act authorized and performed under the Family Code, Chapter 232, and this section.(j) An order suspending a license or dismissing a petition for the suspension of a license does not affect the power of the department to grant, deny, suspend, revoke, terminate, or renew a license as authorized by applicable law.(k) On receipt of an order vacating or staying an order suspending a license, the department shall promptly issue the affected license to the obligor if the obligor is otherwise qualified for the license. An order rendered under this subsection does not affect the power of the department to grant, deny, suspend, revoke, terminate, or renew a license as otherwise provided by applicable law.(l) An individual whose license is suspended under this section must pay a reinstatement fee of $40 at the time of issuance of the license under subsection (k) of this section. Source Note: The provisions of this §1.301 adopted to be effective December 29, 1995, 20 TexReg 10770; amended to be effective November 20, 2003, 28 TexReg 10220. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS T FAILURE TO PAY CHILD SUPPORT §1.301 Suspension of License for Failure to Pay Child Support https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=88209&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 88209 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=88209&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 88209 03/11/2026 The Texas Department of Health (department) adopts by reference the state statute, Texas Government Code, §2171.1045, concerning the assignment and use of agency vehicles. Source Note: The provisions of this §1.401 adopted to be effective August 5, 2001, 26 TexReg 5642. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS U ASSIGNMENT AND USE OF AGENCY VEHICLE IN THE STATE VEHICLE FLEET MANAGEMENT PLAN §1.401 The Assignment and Use of Agency Vehicles in the State Vehicle Fleet Management Plan https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191548&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191548 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191548&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191548 03/11/2026 (a) This section implements Title 12, Health and Safety Code, Chapter 1003.(b) Autologous Adult Stem Cells are cells taken from a person to be transplanted into that same person.(c) Autologous Adult Stem Cell Bank is any facility that stores autologous adult stem cells for use in treatment or research.(d) An entity should apply the following criteria when establishing or operating an autologous adult stem cell bank in this state.(e) The governing body:(1) shall be responsible for the organization, management, control, staffing, and operation of the facility;(2) shall be formally organized in accordance with a written constitution and bylaws, which clearly set forth the organizational structure and responsibilities; and(3) shall adopt, be responsible for, and ensure that operating and ethics policies and procedures are implemented and enforced.(f) The facility shall use current scientific standards for the collection, storage, manipulation and use of adult stem cells.(g) The facility shall ensure that services are provided in a safe and effective manner in compliance with all applicable state and federal laws and regulations.(h) The facility shall adopt and implement an effective, ongoing, quality assessment and performance improvement program to monitor and evaluate the collection, storage, manipulation and use of adult stem cells.(i) An autologous adult stem cell bank operating in this state shall file, on a department form, the following information:(1) the bank's physical and mailing address and other contact information as specified;(2) the owner, principle and/or supervising physician.(j) The information may appear on the department's public web site. The information is not an endorsement by the department and may not be used in advertising by the stem cell bank, its parent or agent. Source Note: The provisions of this §1.451 adopted to be effective December 3, 2012, 37 TexReg 9514. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS V ADULT STEM CELLS §1.451 Autologous Adult Stem Cell Banks https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191560&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191560 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191560&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191560 03/11/2026 (a) Medical conditions that may be eligible for investigational stem cell treatments pursuant to the Health and Safety Code, Chapter 1003 must affect one or more body system.(b) The medical condition identified by the patient's treating physician documented in the patient's medical record is a medical condition that is the subject of an investigational stem cell treatment approved and overseen by an institutional review board that is affiliated with:(1) a medical school as defined by the Education Code, §61.501; or(2) a hospital licensed under the Health and Safety Code, Chapter 241 that has at least 150 beds.(c) The medical condition is documented by the patient's treating physician in the patient's medical record as specifically meeting the definition of severe chronic disease as described in paragraph (1) of this subsection or specifically meeting the definition of terminal illness as described in paragraph (2) of this subsection.(1) Severe Chronic Disease. A condition, injury, or illness that:(A) may be treated;(B) is never cured or eliminated; and(C) entails significant functional impairment or severe pain.(2) Terminal Illness. An advanced state of a disease with an unfavorable prognosis that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely. Source Note: The provisions of this §1.461 adopted to be effective July 10, 2018, 43 TexReg 4986. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS V ADULT STEM CELLS §1.461 Investigational Stem Cell Treatments https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203329&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203329 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203329&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203329 03/11/2026 (a) Pursuant to Texas Health and Safety Code, §1003.054(c), the Department of State Health Services adopts a written informed consent form for use by physicians administering and patients receiving investigational stem cell treatment under Texas Health and Safety Code, Chapter 1003, Subchapter B. The informed consent form is available on the Department of State Health Services website at www.dshs.texas.gov/chronic/.(b) The physician shall obtain any additional written informed consent required to comply with other laws or rules established by Texas Health and Safety Code, Chapter 1003.(c) The informed consent form must be maintained in the patient's medical record. Source Note: The provisions of this §1.462 adopted to be effective July 10, 2018, 43 TexReg 4986; amended to be effective January 18, 2021, 46 TexReg 456. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS V ADULT STEM CELLS §1.462 Informed Consent for Investigational Stem Cell Treatment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154997&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154997 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154997&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154997 03/11/2026 (a) Purpose.(1) The purpose of this section is to inform individuals of the department's privacy practices and establish department procedures to allow individuals to exercise their rights under the federal Standards for Privacy of Individually Identifiable Health Information, 45 Code of Federal Regulations (C.F.R.) Parts 160 and 164, which were promulgated to implement the Health Insurance Portability and Accountability Act of 1996 (HIPAA).(2) The department is a hybrid entity as that term is defined in 45 C.F.R. §164.103. The department has designated its health care components in accordance with 45 C.F.R. §164.105(a)(2)(iii)(C). Unless otherwise specified, this section applies only to the designated health care components within the department.(b) Definitions. Unless otherwise specified, terms have the meaning assigned by 45 C.F.R. §160.103, §164.103, and §164.501, or their common use meaning.(1) Department--The Department of State Health Services.(2) Designated health care component--A program or office within the department that performs services or functions as a covered entity.(3) Designated record set--A group of records maintained by or for a designated health care component of the department that consists of:(A) the medical records and billing records about individuals maintained by or for the department when the department provides direct health care services;(B) the enrollment, payment, claims adjudication, and case or medical management records systems maintained by or for health plans within the department; or(C) records that contain protected health information used, in whole or in part, by or for the department to make decisions about individuals regarding eligibility, prior authorization, treatment, or payment.(4) Health and Human Services (HHS) System--Interchangeably known as the HHS Enterprise, the coordinating entity providing common direction for the five agencies that comprise it are as follows:(A) Health and Human Services Commission (HHSC);(B) Department of Aging and Disability Services (DADS);(C) Department of Assistive and Rehabilitative Services (DARS);(D) Department of Family and Protective Services (DFPS); and(E) Department of State Health Services (DSHS).(5) Protected health information (PHI)--Individually identifiable health information about an individual, including demographic information, which relates to the individual's past, present, or future physical or mental health condition, provision of health care, or payment for the provision of health care.(6) Record--Any item, collection, or grouping of information that includes PHI and is created, maintained, collected, used, or disseminated by or for a designated health care component of the department.(c) Right to notice of privacy practices.(1) An individual has the right to receive notice of how the department uses and discloses PHI and of the individual's rights and the department's duties with respect to PHI.(2) A designated health care component of the department where an individual receives services shall post the notice of privacy practices in a prominent location.(3) An individual may request a copy of the notice from:(A) the department clinic, hospital, or office where the individual received or receives services;(B) the department's Internet web site at www.dshs.state.tx.us/hipaa/privacynotices.shtm; or(C) the department's Privacy Officer by sending a request in writing to the department's Privacy Officer's e-mail address at hipaa.privacy@dshs.state.tx.us or by mail to the DSHS Privacy Officer, Mail Code 1915, P.O. Box 149347, Austin, Texas 78714-9347.(d) Right of access to protected health information.(1) An individual has the right to view or obtain a copy of PHI about the individual for as long as the PHI is maintained by the department.(2) An individual shall follow the Public Information Act, Government Code, Chapter 552, and the department's procedures in §1.251 of this title (relating to Procedures for Handling Requests for Public Information) to access and obtain copies of PHI about the individual held by the department. Requests that are submitted by entities or by persons authorized by state or federal law to obtain an individual's medical or behavioral health records, which were created within department mental health facilities, other state hospitals, clinics, or laboratories are excluded from following the requirements of the Public Information Act.(3) The department shall follow the time requirements and access procedures in the Public Information Act and in §1.251 of this title to provide access to and copies of records under this section.(4) The department shall charge the same amount for copies of records under this section as charged for copies under the Public Information Act and §1.251 of this title or as specified by other state or federal law.(5) The department may deny access to records in a designated record set. The department shall send a denial letter explaining why access has been denied. The individual has a right to request a review of the department's decision if the decision was based on any of the following reasons:(A) a licensed health care professional decided that giving the individual access to the information would likely put the individual or another person in danger;(B) the information refers to another person other than a health care provider, and a licensed health care professional decided that giving the individual access to the information would likely cause the other person substantial harm; or(C) the individual's personal representative asked for the information, and a licensed health care professional decided that giving the personal representative access to the information would likely cause the individual or another person substantial harm.(6) If the denial is reviewable, the department shall provide the individual with instructions in a denial letter about how to request a review of the decision.(e) Right to request an amendment to a designated record set.(1) An individual has the right to request an amendment to PHI about the individual in a designated record set.(2) An individual shall follow the procedures in §1.503 of this title (relating to an Individual's Right to Correction of Incorrect Information) to request an amendment to PHI in a designated record set.(3) The department shall follow the procedures in §1.504 of this title (relating to Correction Procedure) for amendments to designated record sets under this section.(4) The department may deny a request for amendment for any of the following reasons:(A) the department could deny access to the information under subsection (d) of this section;(B) the department did not create the information;(C) the information is not contained in a designated record set; or(D) the information is correct and complete.(5) If the request for amendment is denied, the department shall send a letter explaining the decision and include instructions on how the individual can submit a written statement of disagreement with the department's decision. The written statement must contain specific facts that explain the basis for the disagreement.(f) Right to receive an accounting of certain disclosures made by a designated health care component of the department.(1) An individual has the right to receive an accounting of certain disclosures of the individual's PHI made by a designated health care component of the department.(2) The types of disclosures that must be included in the accounting are described in 45 C.F.R. §164.528.(3) An individual may submit a written request for a list of the designated health care components of the department to the department's Privacy Officer at the Privacy Officer's electronic mail address at hipaa.privacy@dshs.state.tx.us or by mail to the DSHS Privacy Officer, Mail Code 1915, P.O. Box 149347, Austin, Texas 78714-9347.(4) An individual may submit a written request for an accounting of certain disclosures of the individual's PHI made by a designated health care component of the department to either:(A) the designated health care component of the department that is in possession of the individual's PHI; or(B) the department's Privacy Officer at the Privacy Officer's electronic mail address at hipaa.privacy@dshs.state.tx.us or by mail to the DSHS HIPAA Privacy Officer, Mail Code 1915, P.O. Box 149347, Austin, Texas 78714-9347.(5) A request for a report submitted to the department's Privacy Officer must include the name(s) of the designated health care component of the department from which a report is requested.(g) Right to request further limits on uses and disclosures of protected health information.(1) An individual has the right to request that the department restrict its uses and disclosures of PHI about the individual; however, the department is not required to agree to any restrictions that are not required by law, rule, or regulation.(2) An individual may submit a written request for restrictions of uses and disclosures to the department's Privacy Officer at the Privacy Officer's electronic mail address at hipaa.privacy@dshs.state.tx.us or by mail to the DSHS HIPAA Privacy Officer, Mail Code 1915, P.O. Box 149347, Austin, Texas 78714-9347.(h) Right to request confidential communication from a designated health care component of the department by different means or at different locations.(1) An individual has the right to submit a written request that the individual receive communications of PHI from a designated health care component of the department in a way and in a place that is most appropriate for the individual. The written request must specify the reasonable accommodations that are required and the designated health care component of the department to which the request relates.(2) An individual may submit a written request for accommodation to:(A) the designated health care component of the department that is in possession of the individual's PHI; or(B) the department's Privacy Officer at the Privacy Officer's electronic mail address at hipaa.privacy@dshs.state.tx.us or by mail to the DSHS Privacy Officer, Mail Code 1915, P.O. Box 149347, Austin, Texas 78714-9347.(3) The department shall provide a written approval or denial of the request for accommodation.(i) Complaints.(1) An individual has the right to complain about the department's privacy policies or how the department complies with its privacy policies related to PHI.(2) An individual may file a complaint by telephone to the number printed on the department's HIPAA Privacy Notice, or in writing to:(A) the department's Privacy Officer at the Privacy Officer's email address at hipaa.privacy@dshs.state.tx.us or by mail to DSHS Privacy Officer, Mail Code 1915, P.O. Box 149347, Austin, Texas 78714-9347; or(B) Region VI - Dallas Office for Civil Rights (OCR), U.S. Department of Health and Human Services, by mail to 1301 Young Street, Suite 1169, Dallas, Texas 75202, or by email to OCR at OCRcomplaint@hhs.gov, or by phone at: (214) 767-4056, (214) 767-8940 (TDD), or by fax at (214) 767-0432; or(C) the Texas Attorney General's Office, Consumer Protection Division, by mail at: P.O. Box 12548, Austin, Texas 78711 or at the Attorney General's Internet web site at http://www.oag.state.tx.us/consumer/complain.shtml.(3) An individual may download a copy of a complaint form and instructions on how to file it at:(A) the department's HIPAA Internet web site at http://www.dshs.state.tx.us/hipaa/privacycomplaints.shtm; or(B) the U.S. Department Health and Human Services, OCR's Internet web site at http://www.hhs.gov/ocr/privacy/hipaa/complaints/index.html.(j) Uses and disclosures of protected health information among HHS System agencies, and other state agencies.(1) As authorized or required by law, programs or offices among HHS System agencies, and other state agencies may share PHI as necessary to accomplish the public health, health care oversight, business, and other essential functions of the HHS System, and other state agencies.(2) The department shall use and disclose PHI within the department in accordance with the applicable requirements in 45 C.F.R. §164.504, and federal and state statutes that require the department to protect the confidentiality of PHI. Source Note: The provisions of this §1.501 adopted to be effective February 12, 2012, 37 TexReg 496. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS W PRIVACY POLICY §1.501 Privacy of Health Information under the Health Insurance Portability and Accountability Act of 1996 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154998&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154998 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154998&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154998 03/11/2026 (a) Applicability. This section applies to all programs and offices within the department which have been designated as health care components.(b) Other laws. The department may be authorized or required by certain state and federal laws to collect, use and disclose PHI. Each statute or rule that authorizes or requires the department to collect, use, and disclose PHI, makes this information confidential under certain circumstances. The department shall comply with all applicable confidentiality provisions and collect, use, and/or disclose PHI in accordance with applicable state and federal law.(c) Complaints. An individual who believes the department has failed to comply with a state or federal confidentiality law may file a complaint with the program or office within the department that the person alleges has violated the law or with the DSHS Privacy Officer using the contact information contained in §1.501(i)(2)(A) of this title (relating to Privacy of Health Information under the Health Insurance Portability and Accountability Act of 1996). Source Note: The provisions of this §1.502 adopted to be effective February 12, 2012, 37 TexReg 496. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS W PRIVACY POLICY §1.502 Protecting the Confidentiality of Protected Health Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154999&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154999 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154999&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154999 03/11/2026 (a) Right to correction. An individual who believes that the information collected by and in the possession of the department on a form or through electronic media is incorrect has a right to have the department correct the information. The individual has no right to change information that was correct when submitted, but is no longer correct. An individual cannot request a change on a form that is submitted by another individual, except when he or she has legal authority to act on behalf of the other individual.(b) Submittal of request. The individual must submit the correction request in writing to the program within the department that is in possession of the information. The program may be identified by correspondence received by the individual from the department, a request for public information from the individual, or the program to whom the form was submitted by the individual.(c) Requirements for correction requests. The correction request must:(1) specifically identify the program where the records are located and include the document name, and if known, the page and paragraph;(2) specifically identify the information which the individual believes is incorrect;(3) provide the department with sufficient information to establish that the information is incorrect and was incorrect at the time it was submitted by the individual; and(4) provide the correct information. Source Note: The provisions of this §1.503 adopted to be effective February 12, 2012, 37 TexReg 496. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS W PRIVACY POLICY §1.503 Individual's Right to Correction of Incorrect Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=155000&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 155000 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=155000&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 155000 03/11/2026 (a) Acknowledgement. The program within the department shall provide an acknowledgement of receipt of the correction request to the requesting individual within 10 days from the receipt of the request.(b) Review of request. The program with custody and control of the information shall review the information identified by the individual as incorrect and determine whether the information is in fact incorrect in the department's record.(1) If the department determines that the information is incorrect in an electronic record or form, an individual with authority to access the information shall enter the correction into the record by electronic media, at or near the place where the incorrect information appears with the date, reason for the correction, by whom the correction was requested, and by whom the correction was made.(2) If the department determines that the information is incorrect in a paper record or form, an individual with authority to access the information shall insert the information as submitted by the individual requesting the correction, along with an entry of the date, and the name of the individual inserting the correction.(3) If the department determines that the information is correct, no correction shall be made to the information, and no entry of the request for correction shall be made in the department's record.(c) Notification. The program or division within the department shall notify the individual that the record is already correct or has been corrected and provide the individual with a copy of the corrected information.(d) Charges. The department shall not charge or bill a requesting individual for correction of an incorrect record.(e) Records. The department shall not alter or destroy an original agency record or document in its possession except as required or authorized by law. Source Note: The provisions of this §1.504 adopted to be effective February 12, 2012, 37 TexReg 496. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS W PRIVACY POLICY §1.504 Correction Procedure https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99480&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99480 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99480&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99480 03/11/2026 (a) Scope of subchapter.(1) Each final enforcement action taken by the Texas Board of Health, the Commissioner of Health, or his designee, against a person or facility regulated by the Texas Department of Health (department) shall be published on the department Internet website in accordance with this subchapter.(2) Final enforcement actions include imposition of a reprimand, period of probation, monetary penalty, condition on a person's continued practice or a facility's continued operation, refusal to license, refusal to renew, suspension, probation, or revocation of a license.(3) Except to the extent that the information is specifically made confidential by state or federal law, regulatory programs will publish the name, including any trade name, of the person or facility against which an enforcement action was taken, the nature of the violation that the person or facility was found to have committed, or allegedly committed, and the sanction imposed.(4) The information shall be published so that a complainant cannot be identified.(b) Definitions. For purposes of this subchapter only, the following words and terms shall have the following meanings unless the context clearly indicates otherwise.(1) Complaint--A formal or informal allegation of a violation of a statute or rule against a regulated person filed with the department.(2) Condition on practice or operation--Restrictions or limits placed on a person's license or on the person's ability to practice or operate in a regulated activity.(3) Final enforcement action--Revocation, suspension, refusal to license or to renew a license, imposition of a reprimand, a period of probation, a monetary penalty, and/or a condition on a person's continued practice or a facility's continued operation, and a signed final order has been issued by the agency and the parties have been notified of the order:(A) the order has become final in accordance with the Government Code, Administrative Procedure Act, Chapter 2001, or the department's Fair Hearing Rules in Chapter 1., Texas Board of Health, Subchapter C of this title (relating to Fair Hearing Procedures); or(B) the order is an emergency order and is effective on the date it is signed.(4) License--A permit, certificate, registration, certification, accreditation, credential, approval, or other permission to engage in a regulated activity.(5) Name--The name of the person or entity listed on the license or the name of the person engaging in the regulated activity, as well as other identifying information, such as the names of the partners in a partnership, to clarify the person(s) subject to enforcement.(6) Penalty:(A) administrative penalty imposed by agency order;(B) civil penalty imposed by a court;(C) costs of investigation and/or enforcement imposed by the agency or a court order; or(D) any allowance towards administrative penalties for costs to comply with the statute and the rules.(7) Period of deferment--Same meaning as the definition of the word "Probation" in paragraph (8) of this subsection.(8) Probation--The temporary suspension of an enforcement action during which the person must comply with certain requirements. Successful completion of the requirements usually means certain terms and/or conditions of the probation will be waived, while failure to complete the probation requirements usually means the final enforcement action will be imposed.(9) Program--The area of the department with responsibility for oversight of the regulated activity.(10) Refusal to license or refusal to renew--The department has refused to issue or renew a license to an applicant for failure to meet regulatory requirements for the license or for past enforcement compliance history. These definitions do not include a refusal to license or renew for failure of the applicant to complete the application or failure to pay the required fees.(11) Regulated activity--Those activities that the legislature has decided should be regulated by statute and for which a person must have a license in which to engage.(12) Reprimand--A reproval or censure of a person through means of an order or a letter to the person for failure to meet statutory or regulatory requirements or standards of practice.(13) Revocation--Annulling or voiding a license to engage in a regulated activity for failure to comply with statutory or regulatory requirements.(14) Sanction--A punitive action applied to a person licensed or engaging in a regulated activity.(15) Suspension--The temporary removal of rights or privileges associated with having a license or permission to engage in a regulated activity.(16) Violation--A failure to follow prescribed statutes or rules to engage in a regulated activity. Source Note: The provisions of this §1.551 adopted to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS X POSTING OF FINAL ENFORCEMENT ACTIONS §1.551 Posting Final Enforcement Action Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99479&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99479 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99479&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99479 03/11/2026 (a) Purpose. In order to facilitate public access to public information, each final enforcement action shall be published on the department Internet website in accordance with this subchapter.(b) Posting.(1) All final enforcement actions shall be posted within 10 working days of the date the action is final on the web page of the appropriate program, in the format provided by department policy.(2) Assurances of voluntary compliance or orders signed by a court arising from referrals by the department regulatory programs shall be posted within 10 working days of the date of the order on the web page of the appropriate program, in the format provided by department policy.(3) Final enforcement actions and court orders shall continue to be posted for a minimum of one year or until the end of any probationary term or period of deferment, whichever is longer.(4) Final enforcement actions and court orders must be updated at least quarterly with the most current information.(c) Website Information.(1) Posting of final enforcement actions and court orders must be on an easily located web page within each program's website. A link to the enforcement web pages must be made from the main department website.(2) Posting on the program's website shall be in addition to any other law that may require public dissemination of final enforcement actions.(3) Each program's enforcement web page shall, at a minimum, contain the toll-free number of the program and the name and telephone number of the person to contact in the program for more information.(4) Information shall be published in clear language that can be readily understood by a person with a high school education.(d) Effect of other laws.(1) Public Information Act. This subchapter is not intended to restrict or enlarge the scope of public information as defined by the Government Code, Public Information Act, Chapter 552.(2) Records retention. This subchapter is not intended to affect the length of time records must be preserved under the Government Code, §441.094 (relating to Records Schedule and Implementation Plan).(3) Effect of federal law. Unless federal law is preemptive and specifically conflicts with this subchapter, this subchapter prevails.(e) Corrections.(1) The affected program may correct information that is incorrect at the time it is posted.(2) The program shall update the information posted if the regulated entity has changed names, but is not a new entity, after the final enforcement action, but prior to the end of the posting period.(3) A judicial order on an appeal of a final enforcement action which sets aside or modifies a final enforcement action shall cause the posting to be removed from the website or modified to conform to the judicial order. Source Note: The provisions of this §1.552 adopted to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS X POSTING OF FINAL ENFORCEMENT ACTIONS §1.552 Posting Final Enforcement Actions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99477&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99477 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=99477&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 99477 03/11/2026 (a) Analysis.(1) Each program shall publish an annual analysis of its final enforcement actions based on the information from the previous state fiscal year. The analysis shall be posted on the program's website by November 1 of each year.(2) The analysis shall, at a minimum, encompass each profession, industry, or type of facility regulated by that program.(b) Trends.(1) An analysis of the year-to-year trends in the number and type of enforcement actions taken shall be included with the posted annual analysis.(2) The year-to-year trends shall be posted for a five-year interval, as the information becomes available to the program.(3) The year-to-year trends shall be posted by December 1 of each year. Source Note: The provisions of this §1.553 adopted to be effective February 6, 2003, 28 TexReg 951. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS X POSTING OF FINAL ENFORCEMENT ACTIONS §1.553 Annual Analysis and Trends https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224521&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224521 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224521&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224521 03/11/2026 (a) Scope of subchapter. In accordance with Health and Safety Code, Chapter 531, this subchapter applies to the final licensing or registration decisions of the Department of State Health Services (department) that resulted in a final order that was not reversed on appeal, for the following persons or entities regulated under the Health and Safety Code: (1) a youth camp licensed under Chapter 141; (2) a hospital licensed under Chapter 241; (3) a special care facility licensed under Chapter 248; (4) a chemical dependency treatment facility licensed under Chapter 464; and (5) a mental hospital or mental health facility licensed under Chapter 577. (b) Record of final decision. In accordance with Texas Government Code §526.0454, the department shall maintain a record: (1) of each application for a license, including a renewal license or a registration that is denied by the department under the law authorizing the department to regulate the person or entity; (2) of each license or registration that is revoked, suspended, or terminated by the department under the applicable law; (3) until the 10th anniversary of the date of the denial, revocation, suspension, or termination; (4) that includes: (A) the name and address of the applicant for a license or registration that is denied by the department, and the name and address of each person named on the application for a license or registration that is denied; (B) the name of each controlling person of an entity for which an application, license or registration is denied, revoked, suspended, or terminated as described in paragraphs (1) and (2) of this subsection and the specific type of license or registration that was denied, revoked, suspended, or terminated by the department; (C) a summary of the terms of the denial, revocation, suspension, or termination; and (D) the period the denial, revocation, suspension, or termination was effective. (5) The department shall provide a copy of the records maintained under this section, in a form determined by the department, to the Department of Aging and Disability Services and the Department of Family and Protective Services (each Health and Human Services agency that regulates a person described by Texas Government Code Chapter 526) on a monthly basis. (c) Denial of application based on adverse agency decision. The department may deny an application for a license, including a renewal license or a registration of a person described in subsection (a) of this section if: (1) the applicant, a person named on the application, or a person determined by the regulating agency to be a controlling person of an entity for which the license, listing, or registration is sought is listed in a record maintained by a Health and Human Services agency under Texas Government Code §526.0454; and (2) the agency's action that resulted in the person being listed in a record maintained under Texas Government Code §526.0454, is based on: (A) an act or omission that resulted in physical or mental harm to an individual in the care of the applicant or person; (B) a threat to the health, safety, or well-being of an individual in the care of the applicant or person; (C) the physical, mental, or financial exploitation of an individual in the care of the applicant or person; or (D) a determination by the agency that the applicant or person has committed an act or omission that renders the applicant unqualified or unfit to fulfill the obligations of the license, listing, or registration. (d) Required application information. An applicant submitting an initial or renewal application for a license, including a renewal license or a registration described in subsection (a) of this section must include with the application a written statement of: (1) the name of any person who is or will be a controlling person of the entity for which the license or registration is sought; and (2) any other relevant information required by law, rule, or department policy. Source Note: The provisions of this §1.601 adopted to be effective July 22, 2012, 37 TexReg 5275; amended to be effective April 1, 2025, 50 TexReg 2202. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Y ADVERSE LICENSING, LISTING, OR REGISTRATION DECISIONS §1.601 Decisions Based on Interagency Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158943&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158943 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158943&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158943 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Covered individual--(A) an employee of the health care facility;(B) an individual providing direct patient care under a contract with a health care facility; or(C) an individual to whom a health care facility has granted privileges to provide direct patient care.(2) Department--Department of State Health Services.(3) Health care facility--(A) a hospital licensed under the Health and Safety Code, Chapter 241;(B) an ambulatory surgical center licensed under the Health and Safety Code, Chapter 243;(C) a birthing center licensed under the Health and Safety Code, Chapter 244;(D) an abortion facility licensed under the Health and Safety Code, Chapter 245;(E) a special care facility licensed under the Health and Safety Code, Chapter 248;(F) an end stage renal disease facility licensed under the Health and Safety Code, Chapter 251;(G) a freestanding emergency medical care facility licensed under the Health and Safety Code, Chapter 254; or(H) a hospital maintained or operated by this state.(4) Regulatory authority--Department of State Health Services.(5) Vaccine preventable diseases--Diseases included in the most current recommendations of the Advisory Committee on Immunization Practices of the federal Centers for Disease Control and Prevention. Source Note: The provisions of this §1.1701 adopted to be effective October 21, 2012, 37 TexReg 8199. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Z VACCINE PREVENTABLE DISEASE POLICY §1.701 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158944&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158944 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158944&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158944 03/11/2026 (a) Each health care facility shall develop, implement, and enforce a policy and procedures to protect its patients from vaccine preventable diseases.(b) The policy must:(1) require covered individuals to receive vaccines for the vaccine preventable diseases specified by the facility based on the level of risk the individual presents to patients by the individual's routine and direct exposure to patients;(2) specify the vaccines a covered individual is required to receive based on the level of risk the individual presents to patients by the individual's routine and direct exposure to patients;(3) include procedures for verifying whether a covered individual has complied with the policy;(4) include procedures for a covered individual to be exempt from the required vaccines for the medical conditions identified as contraindications or precautions by the federal Centers for Disease Control and Prevention;(5) for a covered individual who is exempt from the required vaccines, include procedures the individual must follow to protect facility patients from exposure to disease, such as the use of protective medical equipment, such as gloves and masks, based on the level of risk the individual presents to patients by the individual's routine and direct exposure to patients;(6) prohibit discrimination or retaliatory action against a covered individual who is exempt from the required vaccines for the medical conditions identified as contraindications or precautions by the federal Centers for Disease Control and Prevention, except that required use of protective medical equipment, such as gloves and masks, may not be considered retaliatory action for purposes of this section;(7) require the health care facility to maintain a written or electronic record of each covered individual's compliance with or exemption from the policy; and(8) include disciplinary actions the health care facility is authorized to take against a covered individual who fails to comply with the policy.(c) The policy may include procedures for a covered individual to be exempt from the required vaccines based on reasons of conscience, including a religious belief. Source Note: The provisions of this §1.1702 adopted to be effective October 21, 2012, 37 TexReg 8199. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Z VACCINE PREVENTABLE DISEASE POLICY §1.702 Vaccine Preventable Diseases Policy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158945&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158945 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158945&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158945 03/11/2026 (a) In this section, "public health disaster" has the meaning assigned by the Health and Safety Code, §81.003.(b) During a public health disaster, a health care facility may prohibit a covered individual who is exempt from the vaccines required in the policy developed by the facility under §1.702 of this title (relating to Vaccine Preventable Diseases Policy) from having contact with facility patients. Source Note: The provisions of this §1.1703 adopted to be effective October 21, 2012, 37 TexReg 8199. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Z VACCINE PREVENTABLE DISEASE POLICY §1.703 Disaster Exemption https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158946&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158946 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158946&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158946 03/11/2026 A health care facility that violates this subchapter is subject to enforcement action by the department, including but not limited to imposition of administrative penalties, in the same manner, to the same extent, and pursuant to the same procedures, as if the health care facility had violated a provision of the applicable chapter of the Health and Safety Code or department rules as follows:(1) for hospitals, Health and Safety Code, Chapter 241, and 25 Texas Administrative Code (TAC), Chapter 133;(2) for ambulatory surgical centers, Health and Safety Code, Chapter 243, and 25 TAC, Chapter 135;(3) for birthing centers, Health and Safety Code, Chapter 244, and 25 TAC, Chapter 137;(4) for abortion facilities, Health and Safety Code, Chapter 245, and 25 TAC, Chapter 139;(5) for special care facilities, Health and Safety Code, Chapter 248, and 25 TAC, Chapter 125;(6) for end stage renal disease facilities, Health and Safety Code, Chapter 251, and 25 TAC, Chapter 117; and(7) for freestanding emergency medical care facilities, Health and Safety Code, Chapter 254, and 25 TAC, Chapter 131. Source Note: The provisions of this §1.1704 adopted to be effective October 21, 2012, 37 TexReg 8199. 1 DEPARTMENT OF STATE HEALTH SERVICES 1 MISCELLANEOUS PROVISIONS Z VACCINE PREVENTABLE DISEASE POLICY §1.704 Disciplinary Action https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161763&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161763 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161763&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161763 03/11/2026 (a) The Preparedness Coordinating Council (PCC).(1) The PCC shall be appointed under and governed by this section.(2) The PCC is established under the Health and Safety Code, §11.016, which authorizes the Health and Human Services Commission (commission) to establish advisory committees and Title 42 United States Code §247d-3a (b) which requires an advisory committee (or similar mechanism) to obtain input on preparedness planning.(b) Applicable law. The PCC is subject to the Government Code, Chapter 2110, concerning state agency advisory councils.(c) Purpose. The purpose of the PCC is to advise and assist the Department of State Health Services (department) as a multidisciplinary strategic review forum concerning topics related to preparedness, response, recovery, and mitigation activities in Texas at the state-level as they pertain to Emergency Support Function (ESF)-8 (Public Health and Medical).(d) Tasks.(1) The PCC will assist the department by providing strategic guidance to promote better consensus and coordination of state and local efforts to improve public health and medical preparedness.(2) The PCC shall carry out any other tasks assigned by the department as part of department's strategic and operational planning processes.(e) Composition. The PCC shall be composed of no fewer than 18 external members and no more than six ad hoc internal department members, so long as total membership does not exceed 24 total members.(1) The composition of the external membership shall reflect a broad spectrum of key preparedness partners.(2) The external members of the PCC shall be appointed by the Executive Commissioner of the Health and Human Services Commission (commission).(f) Terms of office. The term of office of each member shall be six years. Members shall be appointed for staggered terms so that the terms of six members will expire on December 31 of each even-numbered year.(g) Officers. The PCC shall select from its members the presiding officer and an assistant presiding officer.(1) The presiding officer shall serve until December 31 of each even-numbered year. The assistant presiding officer shall serve until December 31 of each odd-numbered year. Both the presiding officer and the assistant presiding officer may holdover until his or her replacement is elected by the PCC.(2) The presiding officer shall preside at all PCC meetings which he or she attends, call meetings in accordance with this section, appoint subcommittees of the PCC as necessary, and cause proper reports to be made to the department. The presiding officer may serve as an ex-officio member of any subcommittee of the PCC.(3) If the office of presiding officer or assistant presiding officer becomes vacant, it may be filled by vote of the PCC.(4) A member shall serve no more than two consecutive terms as presiding officer or assistant presiding officer.(5) The PCC may reference its officers by other terms, such as chairperson and vice-chairperson.(h) Meetings. The PCC shall meet as necessary as determined by the department, but no less than quarterly, to conduct business.(1) A meeting may be called by agreement of department staff and either the presiding officer or at least three members of the PCC.(2) Meeting arrangements shall be made by department staff. Department staff shall contact PCC members to determine availability for a meeting date and place.(3) The PCC is not a "governmental body" as defined in the Open Meetings Act.(4) Each member of the PCC shall be informed of a PCC meeting at least five working days before the meeting.(5) A simple majority of the appointed external members of the PCC shall constitute a quorum for the purpose of transacting official business.(6) The PCC is authorized to transact official business only when in a legally constituted meeting with a quorum present.(7) The agenda for each PCC meeting shall include an opportunity for new business or for any member to address the PCC on matters relating to PCC business.(i) Attendance. Members shall attend PCC meetings as scheduled.(1) A member shall notify the appropriate department staff or presiding officer if he or she is unable to attend a scheduled meeting.(2) PCC members who anticipate the inability to attend or have the need to be represented by an alternate for more than half of the PCC and subcommittee meetings in a 12-month period, should notify their agency of the need to nominate a replacement representative for the duration of their term.(3) The validity of an action of the PCC is not affected by the fact that it is taken when a ground for removal of a member exists.(j) Staff. Staff support for the PCC shall be provided by the department or its contractors.(k) Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.(1) Any formal statement, recommendation, or agency level concern taken by the PCC must be approved by a majority vote of the external members present once a quorum is established.(2) Each external member shall have one vote. Ad hoc members and proxies may not vote.(3) The PCC shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status and shall strive to consider the needs of populations with functional and access needs in their deliberations.(4) Minutes of each PCC meeting shall be taken by department staff or its contractors.(A) A draft of the minutes approved by the presiding officer shall be provided to the department and each member of the PCC within 30 days of each meeting.(B) After approval by the PCC, the minutes shall be signed by the presiding officer.(l) Statement by members.(1) The commission, the department, and the PCC shall not be bound in any way by any statement, recommendation, or action on the part of any PCC member except when a statement or action is in pursuit of specific instructions from the commission, department, or PCC.(2) The PCC and its members may not participate in legislative activity in the name of the commission, the department, or the PCC except with approval through the department's legislative process. PCC members are not prohibited from representing themselves or other entities in the legislative process.(3) A PCC member should not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.(4) A PCC member should not disclose confidential information acquired through his or her membership.(5) A PCC member should not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.(6) A PCC member who has a personal or private interest in a matter pending before the department shall publicly disclose the fact in a council meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the member has a direct pecuniary interest in the matter but does not include the member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.(m) Reports to the department. The PCC shall file an annual written report with the department.(1) The report shall list the meeting dates of the PCC, the attendance records of its members, a brief description of actions taken by the PCC, a description of how the PCC has accomplished the tasks given to the PCC by the department, the status of any rules which were recommended by the PCC to the department, and anticipated activities of the PCC for the next year.(2) The report shall identify the costs related to the PCC's existence, including the cost of agency staff time spent in support of the PCC's activities and the source of funds used to support the PCC's activities.(3) The report shall cover the meetings and activities in the immediately preceding fiscal year and shall be filed with the department each January. The report shall be signed by the presiding officer.(n) Reimbursement for expenses. In accordance with the requirements set forth in the Government Code, Chapter 2110, a PCC member may receive reimbursement for the member's expenses incurred for each day the member engages in official PCC business if authorized by the General Appropriations Act or the budget execution process.(1) No compensatory per diem shall be paid to PCC members unless required by law.(2) A PCC member who is an employee of a state agency, other than the department, may not receive reimbursement for expenses from the department.(3) Each member who is to be reimbursed for expenses shall submit to department staff the member's receipts for expenses and any required official forms no later than 14 days after each PCC meeting.(4) Requests for reimbursement of expenses shall be made on official state travel vouchers prepared by department staff. Source Note: The provisions of this §2.1 adopted to be effective February 6, 2003, 28 TexReg 952; amended to be effective August 8, 2007, 32 TexReg 4765; amended to be effective May 19, 2013, 38 TexReg 2839. 1 DEPARTMENT OF STATE HEALTH SERVICES 2 EMERGENCY PREPAREDNESS §2.1 Preparedness Coordinating Council https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225723&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225723 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225723&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225723 03/11/2026 (a) Statutory authority. The Texas School Health Advisory Committee (committee) must be appointed under and governed by this section. The committee is subject to Texas Health and Safety Code §1001.0711, Texas Government Code §523.0201, and Texas Education Code §38.104(c). Texas Government Code §2110.008 does not apply to a committee created under this section. (b) Purpose. The committee advises the executive commissioner and provides assistance in establishing a leadership role for the Department of State Health Services (DSHS) in support for and delivery of coordinated school health programs and school health services.(c) Tasks. The committee performs the following tasks: (1) provides assistance in establishing a leadership role for DSHS in support for the delivery of coordinated school health programs and school health services;(2) reviews the analysis of the required student physical fitness assessment adopted by the Texas Education Agency (TEA);(3) develops recommendations as outlined in Texas Education Code §38.104(c); and(4) adopts bylaws to guide the operation of the committee. (d) Reporting requirements. The committee must file an annual written report of the committee's activities to the commissioner. The committee must post the meeting dates of the committee and any subcommittees, meeting agendas, and meeting minutes on DSHS website at dshs.texas.gov.(e) Meetings. (1) Open meetings. Meetings must be announced and conducted in accordance with the Open Meetings Act, Texas Government Code Chapter 551. A meeting may be called by DSHS, the presiding officer, or at least three members of the committee. DSHS must make meeting arrangements and must contact committee members to determine availability for a meeting date and place. Each member of the committee must be informed of a committee meeting at least ten business days before the meeting. The agenda for each committee meeting must include an agenda item for public comment allowing any person to address the committee on matters relating to committee business. The presiding officer may establish procedures for public comment, including a time limit on each comment.(2) Frequency. The committee must meet at least twice each year.(3) Quorum. A simple majority of the committee will constitute a quorum for the purpose of transacting official business. The committee is authorized to transact official business only when in a legally constituted meeting with a quorum present.(f) Membership.(1) The committee is composed of 20 voting members with 17 members appointed by the executive commissioner. The executive commissioner delegates the commissioner of state health services to appoint committee members. In selecting members to serve on the committee, DSHS considers the applicants' qualifications, background, interest in serving, and geographic location.(A) Three members representing the following categories.(i) At least one representative from the Texas Department of Agriculture, appointed by the Commissioner of Agriculture;(ii) at least one representative from the TEA, appointed by the Commissioner of Education; and(iii) the DSHS School Health Program Coordinator or other DSHS representative. (B) Seventeen members representing the following categories. (i) Two individuals representing school superintendents, school district board members, or other school administrators;(ii) one registered nurse working in a school as a school nurse or school nurse administrator;(iii) five consumer members who are parents of school-age children with at least one parent of a child with special needs;(iv) one physician, or physician's assistant, or nurse practitioner currently providing health services to school-aged children;(v) one representative working in a school as a school counselor with certification as a school counselor;(vi) four members representing a nonprofit or not-for-profit entity directly working with schools or school-aged children to support student learning, development, mental health, substance abuse, and health-related activities with no more than one member representing an institution of higher education;(vii) one representative working in a school as a physical educator or physical education administrator with certification as a physical educator;(viii) one representative working in a school as a health educator or health education administrator with certification as a health educator; and(ix) one representative working in the school setting as part of the district's school nutrition program.(2) In an effort to build a committee reflective of the current Texas population, special consideration will be given to:(A) urban, rural, and suburban diversity; and(B) a broad statewide geographic representation whenever possible.(3) Membership appointments must include one alternate member for each appointed position. The alternate will automatically be appointed as a member if the primary appointee is unable or unwilling to fulfill the position; or, whenever there is a vacancy. The alternate will perform the same duties and have the same privileges once appointed as a member to fulfill the unexpired term.(4) The term of office of each member is four years. Members must serve after expiration of their term until a replacement is appointed.(A) Members are appointed for staggered four-year terms so the terms of an equal or almost equal number of members expire on July 31 of each year.(B) A member whose term is expiring has the option to apply for appointment for one additional term.(C) This subsection does not apply to agency representative members, who do not have term durations or limits and serve while remaining in the agency position.(g) Officers. The committee elects a presiding officer and an assistant presiding officer from among its members to begin serving a two-year term on August 1 of their term.(1) Each officer must serve until July 31 of their two-year term.(2) The presiding officer must attend in-person at all committee meetings, call meetings in accordance with this section, and appoint subcommittees of the committee, as necessary. The presiding officer may serve as an ex-officio member of any subcommittee of the committee.(3) The assistant presiding officer must act for the presiding officer during the presiding officer's absence and must assume the duties of the presiding officer in the event of a vacancy.(4) If the assistant presiding officer position becomes vacant, it may be filled by a vote of the committee.(5) A member may serve no more than two terms as an officer.(6) The committee may reference its officers by other titles, such as chairperson and vice-chairperson.(h) Required training. Each member must complete training on relevant statutes and rules, including this section and Texas Government Code Chapters 551, 552, and 2110; the Health and Human Services (HHS) Ethics Policy; the Advisory Committee Member Code of Conduct; and other relevant HHS policies. Training will be provided by DSHS. (i) Travel reimbursement. To the extent permitted by the current General Appropriations Act, a member of the committee may be reimbursed for their travel to and from meetings if funds are appropriated and available and in accordance with the HHS Travel Policy. (1) No compensatory per diem will be paid to members unless required by law.(2) A committee member who is an employee of a state agency, other than DSHS, may not receive reimbursement for expenses from DSHS.(3) Each member who is eligible to be reimbursed for expenses must submit to DSHS staff the member's receipts for allowable expenses as determined by school health program guidelines, and any required official forms, no later than 14 days after each committee meeting.(4) Requests for reimbursement of expenses must be made on official state vouchers prepared by DSHS.(j) Date of abolition. The committee is required by statute and will continue as long as the state law that requires it remains in effect. Source Note: The provisions of this §3.1 adopted to be effective August 3, 2025, 50 TexReg 4934. 1 DEPARTMENT OF STATE HEALTH SERVICES 3 ADVISORY COMMITTEES, COUNCILS, AND BOARDS §3.1 Texas School Health Advisory Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227384&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227384 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227384&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227384 03/11/2026 (a) Statutory authority. The Youth Camp Advisory Committee (YCAC) is established under Texas Health and Safety Code §141.010.(b) Purpose. The YCAC advises the executive commissioner and Department of State Health Services (DSHS) on the development of youth camp standards and procedures.(c) Tasks. The YCAC performs the following tasks: (1) makes recommendations to the executive commissioner regarding the content of the rules adopted to implement Texas Health and Safety Code Chapter 141;(2) performs any other functions requested by the executive commissioner in the implementation and administration of Texas Health and Safety Code Chapter 141; and(3) may adopt rules for the conduct of its own activities. (d) Reporting requirements. The presiding officer must sign and file an annual written report with DSHS and the executive commissioner by January 15, covering the meetings and activities in the previous fiscal year. The report includes: (1) a list of the meeting dates of the YCAC and any subcommittees;(2) the members' attendance records;(3) a brief description of actions taken by the YCAC; (4) a description of how the YCAC accomplished its tasks; (5) a description of activities the YCAC anticipates undertaking in the next fiscal year; and (6) recommended amendments to this section.(e) Meetings.(1) Open meetings. The YCAC complies with the requirements for open meetings under Texas Government Code Chapter 551, as if it were a governmental body.(2) Frequency. The YCAC will meet at least annually and at the call of the DSHS commissioner or the DSHS commissioner's designee. (3) Quorum. A simple majority of the members of the YCAC who are appointed constitutes a quorum for the purpose of transacting official business. (f) Membership. (1) The YCAC is composed of nine voting members appointed by the executive commissioner or the executive commissioner's designee. In selecting voting members to serve on the YCAC, the executive commissioner considers the applicants' qualifications, background, interest in serving, and geographic location. The YCAC consists of: (A) one member from the general public;(B) one member from the general public with expertise in specialized program safety, such as archery, firearms, or challenge courses;(C) one parent of a child who was a camper in the past two years;(D) one day camp operator; (E) one camp operator with experience in wilderness or primitive activities;(F) one residential camp operator operating a youth camp that provides overnight accommodations for 500 or more campers per year;(G) one residential camp operator operating a youth camp that provides overnight accommodations for 499 or fewer campers per year;(H) one waterfront safety expert; and(I) one pediatric psychologist, psychiatrist, or child abuse expert.(2) Members are appointed for staggered six-year terms, with the terms of three members expiring on August 31 of each odd-numbered year. Regardless of the term limit, a member serves until his or her replacement is appointed. This ensures sufficient, appropriate representation. (A) If a vacancy occurs, the executive commissioner or the executive commissioner's designee will appoint a person to serve the unexpired portion of that term.(B) Except as may be necessary to stagger terms, the term of each member is six years. (g) Officers. The YCAC:(1) must annually elect a chairperson from among its members who will serve as the presiding officer and preside over the YCAC; and(2) may elect a vice-chairperson and a secretary from among its members.(h) Required training. Each member must complete training on relevant statutes and rules, including this section; Texas Government Code Chapters 551, 552, and 2110; the Health and Human Services (HHS) Ethics Policy; the Advisory Committee Member Code of Conduct; and other relevant HHS policies. Training will be provided by DSHS.(i) Travel reimbursement. To the extent permitted by the current General Appropriations Act, a member of the YCAC may be reimbursed for the member's travel to and from meetings if funds are appropriated and available and in accordance with the DSHS Travel Policy.(j) Abolishment date. The YCAC is abolished and this section expires December 31, 2030. Source Note: The provisions of this §3.8 adopted to be effective February 2, 2026, 51 TexReg 570. 1 DEPARTMENT OF STATE HEALTH SERVICES 3 ADVISORY COMMITTEES, COUNCILS, AND BOARDS §3.8 Youth Camp Advisory Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199014 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199014 03/11/2026 (a) Consistent with Health and Safety Code, §12.0127, the Texas Conrad 30 J-1 Visa Waiver Program (program) will identify priorities for waiver recommendations and post the priorities on the Department of State Health Services' website for the program by May 1 of each year.(b) The program will identify priorities based on the following criteria:(1) the physician specialty;(2) the type of shortage designation;(3) the degree of shortage relative to other areas in Texas;(4) the health needs of the area relative to other areas in Texas; and(5) the existence of an area described under Health and Safety Code, §12.0127(c)(1). Source Note: The provisions of this §13.1 adopted to be effective February 22, 2009, 34 TexReg 1063; amended to be effective November 19, 2013, 38 TexReg 8243; amended to be effective April 12, 2020, 45 TexReg 2419. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT A RECRUITMENT OF PHYSICIANS TO UNDERSERVED AREAS §13.1 Priorities for Waiver Recommendations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199015 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199015 03/11/2026 The Department of State Health Services (department) collects a fee of $2,500 to $5,000 for each application submitted to the Texas Conrad 30 J-1 Visa Waiver Program (program). The program assesses the fee based on its operating costs and posts the amount on the department's website for the program by May 1 of each year. The refund policy is as follows:(1) If the department recommends the waiver to the U.S. Department of State, the department does not refund the application fee.(2) If the applicant withdraws the application before the department recommends the waiver, the department refunds 50% of the application fee.(3) If the department does not recommend the waiver, the department refunds 100% of the application fee. Source Note: The provisions of this §13.2 adopted to be effective February 22, 2009, 34 TexReg 1063; amended to be effective November 19, 2013, 38 TexReg 8243; amended to be effective April 12, 2020, 45 TexReg 2419. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT A RECRUITMENT OF PHYSICIANS TO UNDERSERVED AREAS §13.2 Application Fee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133584&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133584 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133584&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133584 03/11/2026 The purpose of the sections in this subchapter is to implement Health and Safety Code, Chapter 104, Subchapter D, which requires the department to adopt rules covering the collection of data from health care facilities, such as hospitals, and the dissemination of data to facilitate health planning and resource development; Health and Safety Code, Chapter 311, Subchapters C and D concerning the collection and reporting of hospital financial and utilization data including data regarding the provision of levels of charity care by certain nonprofit hospitals, and the submission of an annual report of a community benefits plan by certain nonprofit hospitals. The scope of this subchapter is to describe the criteria and procedures which the department will use in implementing data collection, dissemination, and reporting requirements. This subchapter will cover the collection and dissemination of data from the public or private hospitals that are included in the definition of the term "health care facilities" in the Health and Safety Code, Chapter 104, Subchapter A. The remaining entities included in the definition of the term "health care facilities" are not covered by this subchapter. If data covered by this subchapter will be collected from a public or private hospital that is a general or special hospital licensed under the Health and Safety Code, Chapter 241; a private mental hospital licensed under the Health and Safety Code, Chapter 577; or a treatment facility licensed under the Health and Safety Code, Chapter 464, the data will be collected under authority of and in compliance with the requirements of the Health and Safety Code, Chapters 104 and 311. Source Note: The provisions of this §13.11 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective May 10, 1998, 23 TexReg 4269; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.11 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133585&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133585 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133585&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133585 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Chapter 104--Provisions relating to the data collection responsibilities of the Department of State Health Services as the state health planning and development agency found within the Health and Safety Code, Title 2.(2) Chapter 311--Provisions relating to the powers and duties of hospitals found within the Health and Safety Code, Title 4.(3) Charity care--The unreimbursed cost to a hospital of providing, funding, or otherwise financially supporting health care services on an inpatient or outpatient basis to a person classified by the hospital as financially or medically indigent and/or providing, funding or otherwise financially supporting health care services provided to financially indigent persons through other nonprofit or public outpatient clinics, hospitals or health care organizations.(4) Community benefits--The unreimbursed cost to a hospital of providing charity care, government-sponsored indigent health care, donations, education, government-sponsored program services, research, and subsidized health services. Community benefits do not include the cost to the hospital of paying any taxes or other governmental assessments.(5) Department--The Department of State Health Services.(6) Donations--The unreimbursed costs of providing cash and in-kind services and gifts, including facilities, equipment, personnel, and programs, to other nonprofit or public outpatient clinics, hospitals, or health care organizations.(7) Education-related cost--The unreimbursed cost to a hospital of providing, funding, or otherwise financially supporting educational benefits, services, and programs including education of medical professionals and health care providers; scholarships and funding to medical schools, colleges, and universities for health professions education; education of patients concerning diseases and home care in response to community needs; and community health education through informational programs, publications, and outreach activities in response to community needs.(8) Financially indigent--An uninsured or underinsured person who is accepted for care with no obligation or a discounted obligation to pay for the services rendered based on the hospital's eligibility system.(9) Government sponsored indigent health care--The unreimbursed cost to a hospital of providing health care services to recipients of Medicaid and other federal, state, or local indigent health care programs, eligibility for which is based on financial need.(10) Government-sponsored program unreimbursed costs--The unreimbursed cost to the hospital of providing health care services to the beneficiaries of Medicare, the Civilian Health and Medical Program of the Uniformed Services, and other federal, state, or local government health care programs.(11) Health care facility--Regardless of ownership, a public or private hospital, skilled nursing facility, intermediate care facility, ambulatory surgical facility, family planning clinic which performs ambulatory surgical procedures, rural health initiative clinic, urban health initiative clinic, kidney disease treatment facility, inpatient rehabilitation facility, and other facilities as defined by federal law, but does not include the office of physicians or practitioners of the healing arts singly or in groups in the conduct of their profession.(12) Health care organization--A nonprofit or public organization that provides, funds, or otherwise financially supports health care services provided to financially indigent persons.(13) Hospital--A general or special hospital licensed under the Health and Safety Code, Chapter 241; a private mental hospital licensed under the Health and Safety Code, Chapter 577; and a treatment facility licensed under the Health and Safety Code, Chapter 464.(14) Hospital eligibility system--The financial criteria and procedure used by a hospital to determine if a patient is eligible for charity care. The system shall include income levels and means testing indexed to the federal poverty guidelines; provided, however, that a hospital may not establish an eligibility system which sets the income level eligible for charity care lower than that required by counties under §61.023 or higher, in the case of the financially indigent, than 200% of the federal poverty guidelines. A hospital may determine that a person is financially or medically indigent pursuant to the hospital's eligibility system after health care services are provided.(15) Hospital system--A system of local nonprofit hospitals under the common governance of a single corporate parent that are located within a radius of not more than 125 linear miles of the corporate parent.(16) Medically indigent--A person whose medical or hospital bills after payment by third-party payors exceed a specified percentage of the patient's annual gross income, determined in accordance with the hospital's eligibility system, and the person is financially unable to pay the remaining bill.(17) Net patient revenue--An accounting term that shall be calculated in accordance with generally accepted accounting principles for hospitals.(18) Nonprofit hospital--(A) A hospital that is organized as a nonprofit corporation or a charitable trust under the laws of this state or any other state or country and is:(i) eligible for tax-exempt bond financing; or(ii) exempt from state franchise, sales, ad valorem, or other state or local taxes. For purposes of determining whether a hospital is "organized" as a nonprofit corporation or charitable trust, the department will look at the entity which holds the hospital license issued by the department; that is the entity which must be organized as a nonprofit corporation or charitable trust.(B) A "nonprofit hospital" shall not include a hospital that:(i) is exempt from state franchise, sales, ad valorem, or other state or local taxes;(ii) does not receive payment for providing health care services to any inpatients or outpatients from any source including, but not limited to, the patient or any person legally obligated to support the patient, third-party payers, Medicare, Medicaid, or any other federal, state, or local indigent care program; payment for providing health care services does not include charitable donations, legacies, bequests, or grants or payments for research; and(iii) does not discriminate on the basis of inability to pay, race, color, creed, religion, or gender in its provision of services.(C) A "nonprofit hospital" does not include a hospital that is located in a county with a population under 50,000 where the entire county or the population of the entire county has been designated as a health professional shortage area. A "nonprofit hospital" includes a hospital that is located in a county with a population under 50,000 population where only a subpopulation, partial geographic area or a facility is designated as a health professional shortage area.(19) Patient data--Information derived from individual, acute care, inpatient, and outpatient discharge abstract records.(20) Subsidized health services--Services provided by a hospital in response to community needs for which the reimbursement is less than the hospital's cost for providing the services and which must be subsidized by other hospital or nonprofit supporting entity revenue sources. Subsidized health services include, but are not limited to, emergency and trauma care, neonatal intensive care, freestanding community clinics, and collaborative efforts with local government or private agencies in preventive medicine.(21) Survey--The annual data collection effort conducted by the department to implement the provisions of Health and Safety Code, Chapters 104 and 311.(22) Tax exempt benefits--All of the following, calculated in accordance with standard accounting principles for hospitals for tax purposes using the applicable statutes, rules and regulations regarding the calculation of these taxes:(A) the dollar amount of federal, state, and local taxes foregone by a nonprofit hospital and its nonprofit supporting entities. For purposes of this definition federal, state, and local taxes include income, franchise, ad valorem, and sales taxes;(B) the dollar amount of contributions received by a nonprofit hospital and its nonprofit supporting entities; and(C) the value of tax-exempt bond financing received by a nonprofit hospital and its nonprofit supporting entities.(23) Unreimbursed costs--The costs a hospital incurs for providing services after subtracting payments received from any source for such services including but not limited to the following: third-party insurance payments; Medicare payments; Medicaid payments; Medicare education reimbursements; state reimbursements for education; payments from drug companies to pursue research; grant funds for research; and disproportionate share payments. For purposes of this definition, the term "costs" shall be calculated by applying the cost to charge ratios derived in accordance with generally accepted accounting principles for hospitals to billed charges. The calculation of the cost to charge ratios shall be based on the most recently completed and audited prior fiscal year of the hospital or hospital system. For purposes of this definition, charitable contributions and grants to a hospital, including transfers from endowment or other funds controlled by the hospital or its nonprofit supporting entities, shall not be subtracted from the costs of providing services for purposes of determining the unreimbursed costs of charity care and government-sponsored indigent health care. Source Note: The provisions of this §13.13 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective February 28, 1996, 21 TexReg 1282; amended to be effective May 10, 1998, 23 TexReg 4269; amended to be effective February 8, 2001, 26 TexReg 1141; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.13 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133586&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133586 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133586&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133586 03/11/2026 The types of ASH data which hospitals must submit to the Department of State Health Services (department) through the online survey form are as follows:(1) reporting period data reflecting the 12-month period covering the hospital's most recently completed fiscal year;(2) organizational structure data reflecting the organization that is responsible for establishing policy for the overall operation of the hospital; the organization that owns the hospital's physical plant; the organization's affiliation with the hospital and any hospital systems of which the hospital is a part; and the type of service provided to the majority of admissions;(3) financial data about a facility's revenues and expenses. Financial data is based on the American Institute of Certified Public Accountants Hospital Audit Guide and on generally accepted accounting principles for hospitals and is extracted from the hospital's most recent annual financial statements as follows:(A) total gross revenue, including Medicare and Medicaid gross revenue, other revenue from state programs, revenue from local government programs, local tax support, charitable contributions, other third party payments, gross inpatient revenue and gross outpatient revenue;(B) total deductions from gross revenue, including contractual allowances and any other deductions;(C) net patient revenue;(D) charity care;(E) bad debt expense; and(F) total assets and liabilities;(4) utilization data about the use of a facility and/or its services, including:(A) total admissions, including Medicare admissions and Medicaid admissions, admissions under a local government program, charity care admissions, and any other type of admission;(B) total discharges;(C) total patient days;(D) average length of stay; and(E) total outpatient visits; and(5) additional data as follows:(A) estimates of unreimbursed costs of subsidized health services reported separately as emergency and trauma care, neonatal intensive care, freestanding community clinics, collaborative efforts with local government or private agencies in preventive medicine, and other subsidized health services;(B) donations;(C) total cost of reimbursed and unreimbursed research; and(D) total cost of reimbursed and unreimbursed education separated into the following categories: education of physicians, nurses, technicians, and other medical professionals and health care providers; scholarships and funding to medical schools, colleges, and universities for health professions education; education of patients concerning diseases and home care in response to community needs; community health education through informational programs, publications, and outreach activities in response to community needs; and other educational services that satisfy the definition of "education-related costs" under Health and Safety Code, §311.031(6). Source Note: The provisions of this §13.14 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.14 Annual Survey of Hospitals (ASH)--Types of Data To Be Reported https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133587&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133587 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133587&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133587 03/11/2026 (a) The hospital shall use the online survey form specified by the Department of State Health Services (department) for reporting purposes. The department shall provide access to an electronic survey form, including instructions to each hospital on how to submit hospital data electronically on an annual basis.(b) The submitting of data for the Annual Survey of Hospitals (ASH) and the Annual Statement of Community Benefits Standard (ASCBS) will be collected by one online survey form; however, the ASCBS will be required only for nonprofit hospitals. In addition, nonprofit hospitals will be permitted to file the ASCBS at a separate date from filing of the ASH data since state law requires the ASCBS to be filed no later than 120 days after the hospital's fiscal year ends and that date may not coincide with the date for the ASH.(c) The hospitals shall complete all requested sections on the electronic survey form and submit it electronically to the department within 60 days of receipt unless the nonprofit hospital chooses to submit the ASCBS at a different date as allowed by Chapter 311. The hospitals shall submit data for the hospitals' most recently completed fiscal year. A copy of the hospital's eligibility system and any other information requested shall be sent to the department by regular mail.(d) The department may request missing or incomplete data by written or telephone request. Hospitals shall complete all requested follow-up in the time frame specified by the department.(e) A hospital may, but is not required to, provide the data for the ASH if the hospital:(1) is exempt from state franchise, sales, ad valorem, or other state or local taxes; and(2) does not seek or receive reimbursement for providing health care services to patients from any source, including:(A) the patient or any person legally obligated to support the patient;(B) a third party payor; or(C) Medicaid, Medicare, or any other federal, state, or local program for indigent health care. Source Note: The provisions of this §13.15 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective May 10, 1998, 23 TexReg 4269; amended to be effective February 8, 2001, 26 TexReg 1141; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.15 Survey Forms and Methods of Reporting Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133588&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133588 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133588&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133588 03/11/2026 The department shall send each reporting hospital a copy of its data verification report prior to the publication of the results of the Annual Survey of Hospitals. The hospital shall review the contents of the verification report provided by the department. If modifications to the report are necessary, the appropriate changes shall be made on the report, and the hospital administrator shall sign and return the report to the department within 31 days of receipt. If no changes are reported within 31 days, the department shall consider the hospital's report verified. Source Note: The provisions of this §13.16 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.16 Verification Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133589&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133589 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133589&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133589 03/11/2026 (a) Annual report of the Community Benefits Plan (CBP).(1) The annual CBP report may be filed with the department on a hospital or hospital system basis. A CBP developed by a hospital serves as a hospital's operational plan for serving the community's health care needs and sets out goals and objectives for providing community benefits that include charity care and government-sponsored indigent health care.(2) A nonprofit hospital or hospital system shall file an annual CBP report with the department no later than April 30 of the following year.(3) The nonprofit hospital's or hospital system's annual CBP report must include, at a minimum:(A) the hospital's or hospital system's mission statement;(B) a disclosure of the health care needs of the community that were considered in developing the CBP;(C) a disclosure of the amount and types of community benefits, including charity care, actually provided. Charity care shall be reported as a separate item from other community benefits;(D) a statement of its total operating expenses computed in accordance with generally accepted accounting principles for hospitals from the most recent completed and audited prior fiscal year of the hospital; and(E) a completed worksheet that computes the ratio of cost to charge for the fiscal year referred to in subparagraph (D) of this paragraph and that includes the same requirements as Worksheet 1-A adopted by the department in August 1994 for the 1994 "Annual Statement of Community Benefits Standard".(4) In addition to the annual CBP report, a nonprofit hospital or hospital system shall file a completed worksheet as required by paragraph (3)(E) of this subsection no later than ten working days after the date the hospital or hospital system files its Medicare cost report.(b) Annual statement of community benefits standard (ASCBS).(1) Each nonprofit hospital or hospital system shall also report the following information to the department as the ASCBS part of the online survey form:(A) the amount of charity care provided;(B) the amount of government-sponsored indigent health care provided;(C) the amount of community benefits provided;(D) the amount of net patient revenue and the amount constituting 4.0% of net patient revenue;(E) the dollar amount of the hospital's or hospital system's charity care and community benefits requirements met;(F) the amount of tax-exempt benefits provided, if the hospital is required to report tax-exempt benefits under subsection (b)(3)(A) or (B) of this section;(G) the amount of charity care expenses reported in the hospital's or hospital system's audited financial statement; and(H) a brief summary of the charity care policy and community benefits provided by each hospital unless the hospital is a public hospital or for-profit hospital participating in the Medicaid disproportionate share program.(2) The ASCBS shall be filed online with the department on a hospital or hospital system basis.(3) A nonprofit hospital or hospital system is required to file an annual statement with the department no later than 120 days after the hospital's or hospital system's fiscal year ends; however, the department will accept the ASCBS as partially fulfilling the requirement to submit an annual report of the hospital or hospital system CBP. The ASCBS filed under this subsection shall be based on the most recently completed and audited prior fiscal year of the hospital and shall state which of the standards for providing community benefits has been satisfied. A nonprofit hospital or hospital system may elect to provide community benefits according to any of the following standards:(A) charity care and government-sponsored indigent health care are provided at a level which is reasonable in relation to the community needs, as determined through the community needs assessment, the available resources of the hospital or hospital system, and the tax-exempt benefits received by the hospital or hospital system, and other factors that may be unique to the hospital or hospital system, such as the hospital's or hospital system's volume of Medicare and Medicaid patients;(B) charity care and government-sponsored indigent health care are provided in an amount equal to at least 100% of the hospital's or hospital system's tax-exempt benefits, excluding federal income tax; or(C) charity care and community benefits are provided in a combined amount equal to at least 5.0% of the hospital's or hospital system's net patient revenue, provided that charity care and government sponsored indigent health care are provided in an amount equal to at least 4.0% of net patient revenue.(4) For purposes of satisfying paragraph (3)(C) of this subsection, a hospital or hospital system may not change its existing fiscal year unless the hospital or hospital system changes its ownership or corporate structure as a result of a sale or merger.(5) A nonprofit hospital or hospital system shall use the ASCBS part of the online survey form and accompanying worksheets developed by the department for reporting under this section. Hospitals electing to report on a system basis shall consolidate the individual hospital information into a single ASCBS form for the online system. A separate set of worksheets shall be completed for each individual hospital included in the system.(6) The department will accept written revisions of the ASCBS for 30 days after the filing date.(7) The department may request missing or incomplete data by written or telephone request. Nonprofit hospitals or hospital systems shall answer all requests received from the department in the time frame specified by the department.(8) A nonprofit hospital that has been designated as a disproportionate share hospital under the state Medicaid program in the current fiscal year or in either of the previous two fiscal years shall be deemed in compliance with these standards.(9) A hospital that satisfies paragraph (3)(A) or (8) of this subsection shall be excluded in determining a hospital system's compliance with the standards provided in paragraphs (3)(B) and (C) of this subsection.(10) A nonprofit hospital or hospital system under contract with a local county to provide indigent health care services under Health and Safety Code, Chapter 61 may credit unreimbursed costs from direct care provided to an eligible county resident toward meeting the nonprofit hospital's or hospital system's charity care and government-sponsored indigent health care requirement.(c) Reporting.(1) The department shall notify nonprofit hospitals in writing that the annual report of the community benefits plan and the online ASCBS form that includes a brief summary of charity care policy and community benefits must be filed in accordance with these rules.(2) Nonprofit hospitals changing to a hospital system reporting basis shall report for a continuous period of time.(3) All hospitals or hospital systems shall report as required under this title if the hospital or hospital system, for the previous fiscal year, reported as a nonprofit hospital or hospital system under §13.15 of this title (relating to Survey Forms and Methods of Reporting Data).(4) All hospitals or hospital systems shall report any change of ownership which may affect the nonprofit status of the hospital or hospital system to the Center for Health Statistics, Hospital Survey Unit, at the department within 60 days of the effective date of the change.(d) Posting of sign. Nonprofit hospitals shall prepare a statement notifying the public that the annual report of the CBP is public information, that it is filed with the department, and that it is available on request from the Center for Health Statistics, Hospital Survey Unit, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756. The statement must indicate the report's availability date and be posted in prominent places throughout the hospital, including, but not limited to, the waiting areas of the emergency room and the admissions office. Nonprofit hospitals shall also print the statement in the patient guide or other materials that provide the patient with information about the hospital's admissions criteria.(e) Charity care notice. Each hospital shall provide, to each person who seeks any health care service at the hospital, notice, in appropriate languages, if possible, about the charity care program, including the charity care and eligibility policies of the program, and how to apply for charity care. Such notice shall also be conspicuously posted in the general waiting area, in the waiting area for emergency services, in the business office, and in such other locations as the hospital deems likely to give notice of the charity care program and policies. Each hospital shall annually publish notice of the hospital's charity care program and policies in a local newspaper of general circulation in the county. Each notice under this subsection must be written in language readily understandable to the average reader.(f) Exemptions. A nonprofit hospital is exempt from the reporting requirement in subsection (c) of this section if the hospital is located in a county with a population under 50,000 and in which the entire county or the population of the entire county has been designated as a "Federally designated Health Professional Shortage Area (HPSA)" during the current or any previous fiscal year and has continued to maintain that designation.(g) For purposes of this section only (excluding subsection (b)(1)(H) of this section), a nonprofit hospital shall include a nonprofit hospital as defined in §13.13 of this title and:(1) a Medicaid disproportionate share hospital; or(2) a public hospital that is owned or operated by a political subdivision of municipal corporation of the state, including a hospital district or authority. Source Note: The provisions of this §13.17 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective February 28, 1996, 21 TexReg 1282; amended to be effective May 10, 1998, 23 TexReg 4269; amended to be effective February 8, 2001, 26 TexReg 1141; amended to be effective April 14, 2002, 27 TexReg 2827; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.17 Duties of Nonprofit Hospitals under Health and Safety Code, Chapter 311 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133590&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133590 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133590&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133590 03/11/2026 (a) Reporting of data on the online survey form for the Annual Survey of Hospitals (ASH).(1) If a hospital does not submit the completed online survey form to the Department of State Health Services (department) within the 60-day reporting period and in accordance with §13.15 of this title (relating to Survey Forms and Methods of Reporting Data), the department may institute the following procedures.(A) The department will notify the entity in writing by certified mail, return receipt requested, that the entity is in noncompliance with department reporting requirements and may be in violation of the Health and Safety Code, Chapter 104. The written notification will also state that the commissioner may request that the attorney general institute and conduct a suit in the name of the state to recover civil penalties if the hospital fails to submit the requested data to the department within 30 days of the date the entity received the notification letter.(B) If the department does not receive the requested data from the non-responding hospital within the specified time frame, the commissioner may notify the attorney general in writing of the entity's noncompliance. The department will send a copy of the written notification to the hospital.(2) A hospital that does not timely submit requested data to the department according to the requirements and procedures established in these sections is subject to a civil penalty of not more than $500 for each day of noncompliance, under the provisions of Health and Safety Code, Chapter 104.(b) Report of the Community Benefit Plan (CBP) and the online Annual Statement of Community Benefits Standard (ASCBS).(1) A nonprofit hospital or hospital system that does not timely submit a CBP report to the Department of State Health Services (department) according to the requirements and procedures established in these sections is subject to a civil penalty of not more than $1,000 for each day of noncompliance, under the provisions of Health and Safety Code, Chapter 311.(2) If a nonprofit hospital or hospital system does not submit a CBP report to the department within the reporting period established in §13.17 of this title (relating to Duties of Nonprofit Hospitals under Health and Safety Code, Chapter 311), the department may institute the following procedures.(A) The department will notify the entity in writing by certified mail, return receipt requested, that the entity is in noncompliance with department reporting requirements and may be in violation of the Health and Safety Code, Chapter 311. The written notification will also state that the commissioner may request that the attorney general institute and conduct a suit in the name of the state to recover civil penalties if the hospital or hospital system fails to submit the report to the department within ten days after receipt of the written notification letter.(B) If the department does not receive the CBP report from the non-responding hospital or hospital system within the specified time frame, the commissioner may notify the attorney general in writing of the entity's noncompliance. The department will send a copy of the written notification to the hospital or hospital system. Source Note: The provisions of this §13.18 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective February 28, 1996, 21 TexReg 1282; amended to be effective May 10, 1998, 23 TexReg 4269; amended to be effective February 8, 2001, 26 TexReg 1141; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.18 Noncompliance with Reporting Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133591&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133591 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133591&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133591 03/11/2026 (a) The following data received by the Department of State Health Services (department) from a hospital is confidential under authority of the Health and Safety Code, Chapters 104 and 311:(1) information relating to a specific patient; and(2) financial information relating to a provider or hospital that was submitted prior to September 1, 1987. All financial data regarding a provider or facility submitted after September 1, 1987, are no longer confidential.(b) The department will establish appropriate internal controls to maintain confidentiality of patient level data.(c) The department will disclose confidential patient information to a third party only upon receipt of appropriate written consent of the patient. Source Note: The provisions of this §13.19 adopted to be effective February 23, 1994, 19 TexReg 921; amended to be effective May 10, 1998, 23 TexReg 4269; amended to be effective February 8, 2001, 26 TexReg 1141; amended to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT B DATA COLLECTION §13.19 Confidential Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191690&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191690 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191690&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191690 03/11/2026 (a) Purpose. The purpose of these sections is to implement the provisions in the Texas Occupations Code, §157.051(11)(F), by the establishment of program rules for the designation of practices serving medically underserved populations (Practice-MUPs).(b) Scope. The scope of these sections is to describe the criteria and procedures that the Department of State Health Services (department) will use in designating Practice-MUPs. The criteria will apply to practices not already qualified under the other definitions of eligible practices identified in the Texas Occupations Code, §157.051(11).(c) Administration. The department shall designate Practice-MUPs. Source Note: The provisions of this §13.31 adopted to be effective November 19, 1990, 15 TexReg 6296; amended to be effective June 10, 2001, 26 TexReg 3935; amended to be effective December 4, 2007, 32 TexReg 8827; amended to be effective August 15, 2018, 43 TexReg 5213. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT C DESIGNATION OF SITES SERVING MEDICALLY UNDERSERVED POPULATIONS §13.31 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191691&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191691 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191691&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191691 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Area--A county, census tract, group of census tracts, or other identifiable geographic area in which the majority of the practice's patients live.(2) Department--The Department of State Health Services.(3) Eligible client populations--Residents meeting the eligibility criteria for participation in any of the following programs:(A) federally funded health care programs, including, but not limited to: AIDS (health care delivery programs); community and migrant health centers (Public Health Service Act, §§329 and 330 grantees); family planning; homeless (including Public Health Service Act, §340 grantees); Medicaid; or Medicare;(B) state funded health care programs, including, but not limited to: AIDS (health care delivery programs); children with special health care needs (CSHCN); Medicaid; state primary health care; or student health centers (state funded colleges and universities); or(C) locally funded health care programs, including, but not limited to: locally supported nonprofit health care programs; programs funded by city or county governmental entities; or programs funded by hospital districts.(4) Primary care physicians--Physicians practicing in family/general practice, obstetrics/gynecology, internal medicine, geriatrics, or pediatrics.(5) Practice serving a medically underserved population (Practice-MUP)--An eligible practice designated by the department as a practice serving a medically underserved population in accordance with the Texas Occupations Code, §157.051(11)(F) and this subchapter. Source Note: The provisions of this §13.32 adopted to be effective November 19, 1990, 15 TexReg 6296; amended to be effective June 10, 2001, 26 TexReg 3935; amended to be effective December 4, 2007, 32 TexReg 8827; amended to be effective August 15, 2018, 43 TexReg 5213. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT C DESIGNATION OF SITES SERVING MEDICALLY UNDERSERVED POPULATIONS §13.32 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191692&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191692 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191692&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191692 03/11/2026 (a) The department will designate a practice located in an area that has an insufficient number of primary care physicians providing services to the eligible client populations if it is determined that:(1) the ratio of population-to-primary care physicians for the practice's service area is above 3,000:1; or(2) the ratio of population-to-primary care physicians is above 3,000:1 for the geographic area surrounding the practice. This applies to practices that draw patients from a broad geographic area, such as an entire city or county, where the practice's total service areas may not have a ratio above 3,000:1 as required under paragraph (1) of this subsection, but the practice may be located in an area with a shortage of primary care physicians.(b) The department will designate a practice serving a disproportionate number of clients within eligible client populations if it is determined that:(1) over 50% of the practice's patients are from eligible client populations; or(2) the proportion of the practice's patients representing eligible client populations is at least twice the proportion of persons in the practice's service area who are eligible client populations. Source Note: The provisions of this §13.33 adopted to be effective November 19, 1990, 15 TexReg 6296; amended to be effective June 10, 2001, 26 TexReg 3935; amended to be effective December 4, 2007, 32 TexReg 8827; amended to be effective August 15, 2018, 43 TexReg 5213. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT C DESIGNATION OF SITES SERVING MEDICALLY UNDERSERVED POPULATIONS §13.33 Criteria for Designating Practice-MUPs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191693&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191693 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191693&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191693 03/11/2026 (a) Applicants must submit an application form, provided by the department, which includes the following information:(1) identification of the geographic area and types of eligible client populations served by the practice;(2) a description of the types of services offered at the practice;(3) adequate demonstration that the practice meets criteria in §13.33(a) or (b) of this title (relating to Criteria for Designating Practice-MUPs); and(4) additional information, as determined necessary by the department.(b) After making a determination that a practice serves a medically underserved population, the department will notify the applicant in writing and publish notice of the designation in the Texas Register, providing opportunity for public comment. After the public comment period is over, the department will publish notice of any revision to the determination.(c) If a practice is determined ineligible based on the criteria defined in §13.33 of this title, the department will notify the applicant in writing.(d) Mail or email an application to the Health Professions Resource Center, Center for Health Statistics, Department of State Health Services. Source Note: The provisions of this §13.34 adopted to be effective November 19, 1990, 15 TexReg 6296; amended to be effective June 10, 2001, 26 TexReg 3935; amended to be effective December 4, 2007, 32 TexReg 8827; amended to be effective August 15, 2018, 43 TexReg 5213. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT C DESIGNATION OF SITES SERVING MEDICALLY UNDERSERVED POPULATIONS §13.34 Application Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191694&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191694 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191694&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191694 03/11/2026 (a) Certification of continued eligibility. The department shall verify a practice's continued eligibility for designation as a Practice-MUP under §13.33 of this title (relating to Criteria for Designating Practice-MUPs) no more than two years after its initial designation and within each two-year period thereafter.(b) Change in designation eligibility. If a Practice-MUP no longer serves an area or client population eligible under §13.33 of this title, that practice shall notify the department of its change in eligibility and the department shall withdraw that Practice-MUP's designation.(c) Change in location of a designated practice. If a Practice-MUP changes locations, the designation remains in effect if an applicant verifies that the new location:(1) remains in the original service area;(2) provides the same services; and(3) serves the same populations that were originally used to designate the practice under §13.34(a)(1) or (2) of this title (relating to Application Process).(d) Notification. Information concerning continued and changing eligibility and changes of address should be directed to the Health Professions Resource Center, Center for Health Statistics, Department of State Health Services via mail or email. Source Note: The provisions of this §13.35 adopted to be effective August 15, 2018, 43 TexReg 5213. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT C DESIGNATION OF SITES SERVING MEDICALLY UNDERSERVED POPULATIONS §13.35 Changes in Status of Practice-MUP Designation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133562&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133562 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133562&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133562 03/11/2026 (a) Purpose. This section provides the criteria and procedures the department uses to determine a nonprofit hospital's or hospital system's eligibility for limited liability certification by the department.(b) Authority. This section is authorized by Health and Safety Code, §311.0456 (§311.0456), which requires the department to receive, determine eligibility, and certify limited liability status for nonprofit hospitals or hospital systems that meet the requirements of these sections.(c) Definitions. Terms used in this subchapter have the following meanings, unless the context clearly indicates otherwise. Terms not defined have their common meanings.(1) Department--The Department of State Health Services.(2) Charity care--Is defined in Health and Safety Code, §311.031(2).(3) Net patient revenue--Is defined in Health and Safety Code, §311.042(8).(d) Eligible Entities. This section applies to a nonprofit hospital and hospital system that:(1) meets the definition of nonprofit hospital in the Health and Safety Code, §311.042(9)(A); or(2) is a corporation certified by the Texas Medical Board as a nonprofit organization under Occupations Code, §162.001, whose sole member is a qualifying hospital or hospital system.(e) Certification Criteria. A nonprofit hospital or hospital system that satisfies the eligibility criteria under this section must additionally meet the following certification criteria:(1) provide charity care in an amount equal to or at least 8% of net patient revenue during the most recent fiscal year of the hospital or system; and(2) provide at least 40% of the total charity care provided in the county in which the hospital is located.(A) Charity care for purposes of this section is determined by the department by checking the report submitted by the hospital or system under the Health and Safety Code, §311.033 and the statement of community benefits and charity care submitted by the nonprofit hospital or hospital system under Health and Safety Code, §311.045.(B) If a report under §311.033 is not available for all hospitals in a county in which a nonprofit hospital meeting the requirement in paragraph (1) of this subsection is requesting certification, the department shall determine the eligibility of the hospital or hospital system using other sources of verified charity care information available at the time of certification.(f) Mandatory Submission Deadline. Not later than May 31 of each year for which certification is sought, a nonprofit hospital or hospital system must submit a written request for certification stating that the hospital or system is eligible for certification. Reports submitted after May 31 of each reporting year will not be considered for certification, and exceptions to the deadline will not be granted.(g) Duties of the Department. The department will determine whether a hospital or hospital system is an eligible entity and meets the certification criteria not later than December 31 of the year in which the department receives the request.(h) Effective Date of Certification. A certification issued under this section to a nonprofit hospital or hospital system takes effect on December 31 of that year for which certification is issued and expires on the anniversary of that date.(i) Effect of Certification. Section 311.0456 describes the effect of certification on liability for noneconomic damages. Source Note: The provisions of this §13.41 adopted to be effective December 4, 2007, 32 TexReg 8827. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT D LIMITED LIABILITY CERTIFICATION §13.41 Limited Liability Certification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191695&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191695 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191695&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191695 03/11/2026 The purpose of the sections in this subchapter is to implement Texas Health and Safety Code, Chapters 104 and 105, that provides the department, through the executive commissioner of the Health and Human Services Commission, rulemaking authority covering the collection of data by the Statewide Health Coordinating Council and the Health Professions Resource Center. The scope of this subchapter is to describe the criteria and procedures which the department uses in implementing data collection requirements of the relevant members of the Health Professions Council. Source Note: The provisions of this §13.51 adopted to be effective August 15, 2018, 43 TexReg 5213. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT E DATA COLLECTION §13.51 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191696&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191696 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191696&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191696 03/11/2026 The department uses these procedures to collect data from the relevant members of the Health Professions Council described by Texas Health and Safety Code, §105.003.(1) To initiate data collection, the department submits a reasonably detailed request to a relevant member of the Health Professions Council. The request is submitted using the method prescribed by that member.(2) The relevant member of the Health Professions Council receiving the request fulfills the request within a reasonable period of time, excepting:(A) if that member is unable to fulfill the request as submitted, that member notifies the department of any necessary revisions to the initial request and the department submits a revised request; or(B) if that member is unable to fulfill the request within a reasonable period of time, that member notifies the department of the reason for delay and the date by which the request will be fulfilled.(3) The department provides a secure means of transmitting resultant data, or uses those means preferred and provided by the relevant member of the Health Professions Council. Source Note: The provisions of this §13.52 adopted to be effective August 15, 2018, 43 TexReg 5213. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT E DATA COLLECTION §13.52 Data Collection Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226651&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226651 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226651&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226651 03/11/2026 The purpose of this subchapter is to implement Texas Health and Safety Code §105.011. The Workplace Violence Against Nurses Prevention Grant Program authorizes the Department of State Health Services to award grant payments to fund innovative approaches to reduce verbal and physical violence against nurses in hospitals, freestanding emergency medical care facilities, nursing facilities, and home health agencies. Source Note: The provisions of this §13.81 adopted to be effective October 11, 2018, 43 TexReg 6645; amended to be effective November 10, 2025, 50 TexReg 7288. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT G WORKPLACE VIOLENCE AGAINST NURSES PREVENTION GRANT PROGRAM §13.81 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226652&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226652 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226652&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226652 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Administer--Includes the proposal, development, and implementation of a program, within the parameters of a solicitation. (2) Department--The Texas Department of State Health Services.(3) Health care facility--Includes the following, as defined in Texas Health and Safety Code (HSC) §105.001:(A) freestanding emergency medical care facility licensed under Texas HSC Chapter 254;(B) home health agency licensed under Texas HSC Chapter 142;(C) hospital:(i) a general or special hospital licensed under Texas HSC Chapter 241;(ii) a private mental hospital licensed under Texas HSC Chapter 577; or(iii) a hospital that is maintained or operated by this state or an agency of this state; or(D) nursing facility licensed under Texas HSC Chapter 242.(4) Solicitation--A type of notice in which the department announces:(A) the available grant funding;(B) the guidelines for the program;(C) the evaluation criteria; and(D) the instructions for submitting applications.(5) Workplace Violence Prevention Grant Program--A grant program supporting health care facilities to protect nurses from violence. Source Note: The provisions of this §13.82 adopted to be effective October 11, 2018, 43 TexReg 6645; amended to be effective November 10, 2025, 50 TexReg 7288. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT G WORKPLACE VIOLENCE AGAINST NURSES PREVENTION GRANT PROGRAM §13.82 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226653&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226653 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226653&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226653 03/11/2026 The department will publish solicitations on its grant's website. Each eligible applicant must submit an application to the department staff listed in the solicitation to qualify for funding. Each application must, as outlined in the solicitation:(1) be submitted electronically in the required format;(2) adhere to the grant program requirements and funding priorities; and(3) include proper authorization and be submitted no later than the date and time specified by the department in the solicitation. Source Note: The provisions of this §13.83 adopted to be effective October 11, 2018, 43 TexReg 6645; amended to be effective November 10, 2025, 50 TexReg 7288. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT G WORKPLACE VIOLENCE AGAINST NURSES PREVENTION GRANT PROGRAM §13.83 Grant Application Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226654&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226654 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226654&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226654 03/11/2026 The total funding available for the program depends on the amount of money transferred to the department from the Texas Board of Nursing to fund grants. Each solicitation will specify the maximum and minimum award amounts and the maximum number of awards. Source Note: The provisions of this §13.84 adopted to be effective October 11, 2018, 43 TexReg 6645; amended to be effective November 10, 2025, 50 TexReg 7288. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT G WORKPLACE VIOLENCE AGAINST NURSES PREVENTION GRANT PROGRAM §13.84 Program Funding and Award Amounts https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226655&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226655 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226655&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226655 03/11/2026 (a) The department will select applicants for funding on a competitive basis.(b) The department will only consider applicants that meet all requirements of the solicitation.(c) A taskforce assigned by the Nursing Advisory Committee, defined by Texas Health and Safety Code §104.0155, will review and score proposals. The taskforce will provide recommendations for grant awards to the department.(d) Each application must:(1) provide a detailed explanation of the applicant's workplace violence prevention program, including:(A) a development and implementation timeline;(B) a description of the population identified to participate in the program;(C) a detailed budget; and(D) a description of the program's administration and support;(2) describe how the workplace violence prevention program will reduce verbal and physical violence against nurses in the applicant's health care facility; and(3) propose performance metrics to measure program outcomes, including changes in the severity and frequency of verbal and physical violence against nurses.(e) Each solicitation will define the priority criteria for selection. Source Note: The provisions of this §13.85 adopted to be effective October 11, 2018, 43 TexReg 6645; amended to be effective November 10, 2025, 50 TexReg 7288. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT G WORKPLACE VIOLENCE AGAINST NURSES PREVENTION GRANT PROGRAM §13.85 Award Criteria and Selection for Funding https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226656 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226656 03/11/2026 (a) The department may cancel or suspend a grant solicitation at its discretion.(b) Successful applicants must sign a Notice of Grant Award issued by the department before receiving funds. Source Note: The provisions of this §13.86 adopted to be effective October 11, 2018, 43 TexReg 6645; amended to be effective November 10, 2025, 50 TexReg 7288. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT G WORKPLACE VIOLENCE AGAINST NURSES PREVENTION GRANT PROGRAM §13.86 General Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226657&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226657 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226657&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226657 03/11/2026 (a) Each grant recipient must submit reports to the department as required by the solicitation. The reports must:(1) describe activities funded through the grant;(2) report changes in the severity and frequency of verbal and physical violence against nurses;(3) evaluate program performance based on stated performance metrics; and(4) detail budget expenditures.(b) At least annually, the department's Nursing Resource Section will publish a report describing the grants awarded under this subchapter, including the amount of the grants, the purpose of the grants, and the outcome reported by the grant recipient. The department will publish the report on its website. Source Note: The provisions of this §13.87 adopted to be effective October 11, 2018, 43 TexReg 6645; amended to be effective November 10, 2025, 50 TexReg 7288. 1 DEPARTMENT OF STATE HEALTH SERVICES 13 HEALTH PLANNING AND RESOURCE DEVELOPMENT G WORKPLACE VIOLENCE AGAINST NURSES PREVENTION GRANT PROGRAM §13.87 Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=153786&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 153786 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=153786&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 153786 03/11/2026 (a) Definitions. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Mother-friendly business--A worksite that actively promotes and supports breastfeeding by its employees and that maintains a written worksite lactation support policy that is regularly communicated to employees.(2) Department--Department of State Health Services.(b) Minimum standards. To be designated mother-friendly, a worksite must:(1) adhere to the definition of a mother-friendly business;(2) provide work schedule and work pattern flexibility to, at a minimum, accommodate a reasonable break time for an employee to express breast milk for her nursing child or breastfeed each time such employee has need to express the milk or breastfeed for one year or longer after the child's birth;(3) provide employees a private, accessible area, other than a bathroom, that is shielded from view and free from intrusion from coworkers and the public, for either expressing breast milk or breastfeeding each time such employee has need to express breast milk or breastfeed;(4) provide access to a clean, safe water source and a sink; and(5) provide access to a hygienic place to store expressed breast milk.(c) Silver and gold standards. The department may recognize mother-friendly businesses that implement additional best practice policies and program activities to promote and support breastfeeding by their employees that exceed the minimum standards in subsection (b) of this section by silver or gold designation of those worksites.(1) To be eligible for silver designation, a worksite must meet the minimum standards in subsection (b) of this section as well as the following standards:(A) provide a break room space with a locking door that is dedicated for use only by employees who are breastfeeding or expressing breast milk;(B) provide at least one of the following items for use in the dedicated break room space:(i) a hospital-grade multi-user electric breast pump for which employees provide their own access kits;(ii) a sink with hot and cold running water and a supply of soap and paper towels; and(iii) a refrigerator or personal coolers for breast milk storage;(C) adopt a written policy authorizing employees to select one or more of the following options to facilitate breastfeeding and/or expression of breast milk:(i) part-time work or work for some hours at home;(ii) individualized scheduling of work hours (flex time);(iii) job-sharing;(iv) compressed work week;(v) telecommuting;(vi) payment for time taken for breastfeeding and/or breast milk expression as work time;(vii) on-site childcare; or(viii) care of her baby by the mother at or near her work station for the first several months after the mother's return to work from maternity leave;(D) provide information about the worksite's written breastfeeding support policy to all employees and supervisors within six months of employment and at least annually thereafter;(E) make three or more of the following resources available to expectant and parenting employees:(i) a lending library of breastfeeding pamphlets, books, and/or videos;(ii) contact information for local lactation consultants, support group meetings, and/or other community breastfeeding resources;(iii) a forum, blog, or other electronic networking opportunity for mother-to-mother support among employees;(iv) classes on pregnancy and breastfeeding offered at the worksite;(v) facilities for regular support group meetings at the worksite;(vi) access to an International Board Certified Lactation Consultant or other lactation expert as an employee benefit;(vii) coordination of the worksite breastfeeding support program by a skilled lactation expert hired by the worksite; or(viii) breastfeeding education or other supports offered to employees' partners who are expectant fathers.(2) To be eligible for gold designation, a worksite must meet the minimum standards in subsection (b) of this section as well as the following standards:(A) provide a break room space with a locking door that is dedicated for use only by employees who are breastfeeding or expressing breast milk;(B) provide all of the following items for use in the dedicated break room space:(i) a hospital-grade multi-user electric breast pump, or a personal portable electric breast pump for each breastfeeding employee purchased by the worksite or by the employee with partial support from the worksite;(ii) a sink with hot and cold running water and a supply of soap and paper towels;(iii) a refrigerator for breast milk storage;(iv) a bulletin board; and(v) a telephone;(C) adopt a written policy authorizing employees to select any or all of the following options to facilitate breastfeeding and/or expression of breast milk:(i) at least six weeks of paid maternity leave;(ii) telecommuting;(iii) on-site childcare;(iv) care of her baby by the mother at or near her work station for the first several months after the mother's return to work from maternity leave; and(v) payment for time taken for breastfeeding and/or breast milk expression as work time;(D) provide information about the worksite's written breastfeeding support policy to all employees and supervisors within six months of employment and at least annually thereafter;(E) make five or more of the following resources available to expectant and parenting employees:(i) a lending library of breastfeeding pamphlets, books, and/or videos;(ii) contact information for local lactation consultants, support group meetings, and/or other community breastfeeding resources;(iii) a forum, blog, or other electronic networking opportunity for mother-to-mother support among employees;(iv) classes on pregnancy and breastfeeding offered at the worksite;(v) facilities for regular support group meetings at the worksite;(vi) access to an International Board Certified Lactation Consultant or other lactation expert as an employee benefit;(vii) coordination of the worksite breastfeeding support program by a skilled lactation expert hired by the worksite; or(viii) breastfeeding education or other supports offered to employees' partners who are expectant fathers.(d) Application for designation as a mother-friendly business. To apply for designation as a mother-friendly business, a worksite must:(1) complete a mother-friendly application. Applications are available from the Mother-Friendly Worksite Program, Division of Family and Community Health Services, Department of State Health Services, Mail Code 1922, P.O. Box 149347, Austin, Texas 78714-9347 and through the department's website at http://www.dshs.state.tx.us/wichd/lactate/mother.shtm; and(2) submit the completed application and written worksite lactation support policy to the department for review. Completed applications will be reviewed by department staff for compliance with designation standards. The review process shall be completed within 45 working days following receipt of an application. Worksites that meet the applicable standards for designation will receive a letter from the department and a certificate suitable for framing and display. Worksites that do not meet the applicable standards for designation will be notified by letter and will be offered technical assistance to achieve compliance.(e) Maintaining designated status. A worksite designated as mother-friendly must:(1) be listed as such by the department. The list of mother-friendly worksites will be maintained by the department and made available for public inspection;(2) keep the department informed of any changes in the worksite's lactation support policies. If its lactation support policies change, a worksite must submit an amended application;(3) comply with designation standards at all times. If a worksite does not comply with the program's designation standards at all times, the department may suspend, revoke, or change the mother-friendly designation. A worksite may amend its nonconforming policies and may reapply for the mother-friendly designation. Employees and clients should direct complaints to the department about the activities of a worksite designated as mother-friendly; and(4) agree to be subject to monitoring by the department for compliance with rules and designation criteria biannually and on an as-needed basis. Source Note: The provisions of this §31.1 adopted to be effective August 5, 2001, 26 TexReg 5642; amended to be effective January 8, 2006, 30 TexReg 8883; amended to be effective December 4, 2011, 36 TexReg 8033. 1 DEPARTMENT OF STATE HEALTH SERVICES 31 NUTRITION SERVICES A REGISTER OF MOTHER-FRIENDLY BUSINESSES §31.1 Register of Mother-Friendly Businesses https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2139&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2139 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2139&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2139 03/11/2026 The Texas Department of Health adopts by reference 42 United States Code Chapter 7, Subchapter V, (Maternal and Child Health and Crippled Children's Services). Source Note: The provisions of this §37.1 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES A FEDERAL LAWS AND REGULATIONS GOVERNING MATERNAL AND CHILD HEALTH SERVICES PROGRAMS §37.1 Federal Laws Governing Maternal and Child Health and Crippled Children's Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2140&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2140 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2140&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2140 03/11/2026 The Texas Department of Health adopts by reference 42 Code of Federal Regulations Chapter 1, Part 51a, (Grants for Maternal and Child Health and Crippled Children's Services). Source Note: The provisions of this §37.2 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES A FEDERAL LAWS AND REGULATIONS GOVERNING MATERNAL AND CHILD HEALTH SERVICES PROGRAMS §37.2 Federal Regulations Governing Maternal and Child Health and Crippled Children's Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12977&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12977 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12977&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12977 03/11/2026 (a) The Texas Department of Health adopts by reference U.S. Department of Health, Education and Welfare regulations on intrauterine contraceptive devices published in 21 Code of Federal Regulations, Chapter I, Part 310, §310.502, "Intrauterine devices for human use for the purpose of contraception," and Part 801, §801.425, "Professional and patient labeling for intrauterine contraceptive devices." These regulations became effective November 7, 1977.(b) The purpose of these federal regulations is that the U.S. Food and Drug Administration is establishing uniform professional and patient labeling for intrauterine devices (IUDs). The labeling will assist professionals and patients in deciding whether to use an IUD for contraception; it includes requirements for instructions on insertion and usage, contraindications, warnings, adverse reactions, precautions, side effects, and information on IUD effectiveness.(c) Copies of the regulations referred in this section are indexed and filed in the Texas Department of Health, Maternal and Child Health Services Division, 1100 West 49th Street, Austin, Texas 78756. Source Note: The provisions of this §37.3 adopted to be effective December 13, 1977, 12 TexReg 4780. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES A FEDERAL LAWS AND REGULATIONS GOVERNING MATERNAL AND CHILD HEALTH SERVICES PROGRAMS §37.3 Intrauterine Contraceptive Devices https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12978&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12978 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12978&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12978 03/11/2026 The purpose of these rules is to establish procedures for the administration of contracts between the Texas Department of Health and providers of early childhood intervention services which are executed under authority of the Human Resources Code, §73.018. The Texas Department of Health is under a duty to execute such contracts at the request of the Interagency Council on early Childhood Intervention Services. Source Note: The provisions of this §37.11 adopted to be effective November 16, 1984, 9 TexReg 5710. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES B MARCH OF DIMES RULES ON HEALTH EDUCATION GRANTS §37.11 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12984 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12984 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:(1) Agency--The Texas Education Agency and/or the Texas Department of Mental Health and Mental Retardation.(2) Department--The Texas Department of Health.(3) Interagency Council--The Interagency Council on Early Childhood Intervention Services, established under authority of the Human Resources Code, §73.002. Source Note: The provisions of this §37.12 adopted to be effective November 16, 1984, 9 TexReg 5710. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES B MARCH OF DIMES RULES ON HEALTH EDUCATION GRANTS §37.12 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12620&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12620 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=12620&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 12620 03/11/2026 The department shall withhold funds to a provider as authorized by interagency council rule, §621.30 of this title (relating to Withholding of Funds to Provider). Source Note: The provisions of this §37.15 adopted to be effective November 16, 1984, 9 TexReg 5710. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES B MARCH OF DIMES RULES ON HEALTH EDUCATION GRANTS §37.15 Withholding of Funds to Providers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227516&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227516 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227516&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227516 03/11/2026 This subchapter implements Texas Health and Safety Code Chapter 36, concerning the early identification of individuals from birth through 20 years old who have special senses and communication disorders and need remedial vision, hearing, speech, or language services. Source Note: The provisions of this §37.21 adopted to be effective August 1, 2004, 29 TexReg 3791; amended to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.21 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227517&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227517 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227517&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227517 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) American Academy of Pediatrics (AAP)--A professional organization that makes health recommendations for children.(2) American Association for Pediatric Ophthalmology and Strabismus (AAPOS)--A professional organization that, along with the AAP, sets recommended vision screening standards. AAPOS works to improve children's eye care, supports the training of pediatric eye doctors, supports pediatric eye research, and helps adults with alignment issues.(3) American National Standards Institute, Inc. (ANSI)--A national organization that provides information about standards used in the United States and around the world.(4) Audiometer--A device used to evaluate hearing sensitivity. For the purposes of this subchapter, the term refers specifically to a screening pure-tone audiometer used to conduct hearing screenings at prescribed intensity levels to identify individuals who may require further evaluation. Diagnostic audiometers are reserved for use by licensed audiologists to conduct comprehensive hearing assessments and are not permitted for screening purposes.(5) Audiometric calibration equipment--Electronic devices used to adjust audiometers.(6) Automated vision screening device--A vision screening instrument that uses automation technology (like computer control systems, software, etc.,) to perform vision screening tasks with little or no direct human intervention for each individual sample or patient.(7) Biological calibration check--A method to check an audiometer's accuracy by evaluating the device on an individual with known hearing levels.(8) Calibration--The process of comparing an instrument or device to a standard and making adjustments to an acceptable level of accuracy.(9) Certificate--A qualification given to individuals who complete vision or hearing screener training provided by either the Department of State Health Services (DSHS) or a DSHS-certified instructor.(10) dB--The decibel is a unit for measuring the loudness of sounds. Decibels range from zero, which is the quietest sound an average person can hear, up to around 130, which is the average level of sound that causes pain.(11) Electronic eye chart--Any computerized or other electronic system, device, or method of displaying on an electronic screen medically accepted and properly sized optotypes, which may be letters, numbers, or symbols a health care practitioner or other person uses to assess an individual's visual acuity. The term does not include an automated computer program that assesses an individual's visual acuity through the individual's interaction with the program by playing a game. (12) Exhaustive calibration--An audiometer calibration that checks all settings for both earphones.(13) Extended recheck--A hearing screen used after a child has failed two sweep-check screens.(14) Facility--Includes public and private preschools and schools, defined as follows:(A) schools, as defined in Texas Health and Safety Code §36.003;(B) preschools, as defined in Texas Health and Safety Code §36.003;(C) child care centers licensed by the Health and Human Services Commission (HHSC); and(D) child care homes licensed by HHSC.(15) Hz--Hertz is a unit of frequency equal to one cycle per second.(16) Instrument-based vision screeners--A broad term for any vision screening tool used for precise measurement, monitoring, or recording of visual information. Automated devices like photoscreeners and autorefractors that estimate refractive errors and other factors that may cause vision problems in children are types of instrument-based vision screeners. (17) Optotype--A standardized figure or letter used to evaluate visual acuity. (18) Otoacoustic emissions (OAE) testing--A hearing screen that checks vibrations from the inner ear using sounds from a small device placed in the ear. OAE is an alternate screening method for children with intellectual or developmental disabilities. (19) Pass/Fail--Allowable documentation of results if photoscreening is used for vision screening, as outlined in this subchapter.(20) Photoscreener--A device that uses a special camera to check a child's vision using light reflexes to identify vision problem risk factors. (21) Professional examination--A diagnostic evaluation by a provider with expertise to address the diagnostic needs of an individual with possible vision or hearing issues. This examination meets the requirements of this subchapter and Texas Health and Safety Code Chapter 36.(22) Program--DSHS Vision and Hearing Screening Program.(23) Provider--A person who delivers remedial services to individuals who have special senses and communication disorders, including a physician, audiologist, speech pathologist, optometrist, or psychologist. The term provider used here also includes locations such as a hospital, clinic, rehabilitation center, university, or medical school.(24) Reporting year--A 12-month period beginning June 1 of each year and ending May 31 of the next year.(25) Screener--An individual conducting vision or hearing screenings. A screener is either a provider as defined in this subchapter or is trained and certified by DSHS or a DSHS-certified external vision or hearing instructor to conduct vision or hearing screenings, or both.(26) Screening--An evaluation to see if someone might need a professional examination.(27) Screening equipment--An instrument or device used to measure sensory abilities.(28) Sweep-check--A hearing screen using a pure-tone audiometer to check if an individual can hear tones at 1000 Hz, 2000 Hz, and 4000 Hz at 25 dB.(29) Telebinocular instrument--A device used to check for various eye defects and measure visual acuity.(30) Vision disorder--An impairment of the sense of vision.(31) Visual acuity--The ability to distinguish letters or symbols at 20 feet or with a chart that simulates 20 feet. In this subchapter, visual acuity specifically means how clearly an individual can see things far away, measured as a standard ratio like 20/20. Source Note: The provisions of this §37.22 adopted to be effective August 1, 2004, 29 TexReg 3791; amended to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.22 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227518&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227518 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227518&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227518 03/11/2026 (a) Once the individual's parent or guardian has given consent for screening, vision screening is required to find signs of potential vision disorders for individuals attending a facility. Vision screening as described in this subchapter must meet the following requirements.(1) Facilities and school districts may select subparagraph (A) or (B) of this paragraph for vision screening of all ages. Deciding factors may include student population, screener availability, and cost.(A) Facilities may screen for visual acuity using traditional wall charts or electronic eye charts that show approved optotypes at the correct distances. See the vision screening manual on the Department of State Health Services (DSHS) website for detailed instructions and a list of approved optotypes.(B) Facilities may screen using an automated screening device. Refer to the vision screening manual on the DSHS website for additional guidance.(C) Facilities must calibrate, operate, and maintain all screening devices or equipment according to the manufacturer's instructions. Any screening tool that is not in good working order must not be used. The screening tool must be repaired or replaced.(2) Facilities must refer children aged four years and younger for a professional examination in the following circumstances. (A) Either eye cannot correctly identify the majority of optotypes on the 20/40 acuity line or if there is a difference of two lines between passing acuities in either eye. For example, if a child has 20/40 vision in one eye and 20/20 in the other, the child must be referred. However, if a child has 20/40 vision in one eye and 20/30 in the other, the child passed the screening.(B) Either eye receives a failing result when screened with an automated screening device. DSHS recommends children who fail an automated screen receive a follow-up screen with a traditional or electronic eye chart and other optional screening methods described in the vision screening manual on the DSHS website.(3) Facilities must refer children aged five years and older for a professional examination in the following circumstances.(A) Either eye cannot correctly identify the majority of optotypes on the 20/30 line. The DSHS requirement differs from the AAPOS standard of 20/32.(B) Either eye receives a failing result when screened with an automated screening device. DSHS recommends children who fail an automated screen receive a follow-up screen with a traditional or electronic eye chart and other optional screening methods described in the vision screening manual on the DSHS website.(4) Facilities must refer to and comply with additional pass or fail criteria in the vision screening manual on the DSHS website. (5) Facilities must use instrument-based vision screening, when available, for children aged 42 months to five years, as recommended by AAPOS, and for individuals with disabilities who do not respond well to other screening methods. Refer a child for a professional examination if the child fails the photoscreening.(b) A screener who is not a provider and conducts vision screening in facilities must be trained and certified as described in §37.27 of this subchapter (relating to Standards and Requirements for Screening Certification and Instructor Training).(c) Facilities must give the child's parent, other legally responsible adult, or the individual in the scenarios described in Texas Family Code §32.003, a referral form if the child fails a second screening or if after failing the initial screening, the screener determines a second screening is unnecessary. The referral is for further evaluation by an appropriate provider. Facilities must not refer a child to a specific person.(d) Facilities, school districts, and screeners must follow all instructions in the vision screening manual available on the DSHS website. Source Note: The provisions of this §37.23 adopted to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.23 Vision Screening https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227519&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227519 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227519&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227519 03/11/2026 (a) Once the individual's parent or guardian has given consent for screening, hearing screenings to detect hearing disorders must be provided for individuals attending a facility. Hearing screening as described in this subchapter must meet the following requirements.(1) Use a pure-tone audiometer to perform a sweep-check screen.(2) Record the screening results for each ear at less than or equal to 25 dB for 1000 Hz, 2000 Hz, and 4000 Hz.(3) A screener must perform a second sweep-check screen if the results show that the child did not respond to any one of the three frequencies in either ear. If the child has a cold, congestion, fluid buildup in the ears, or any other condition impacting hearing, delay the second sweep-check screen. The screener must perform the rescreening no later than 31 calendar days after the initial screening.(4) A screener must either perform an optional extended recheck or refer the child for a professional examination if the child does not respond to any one of the three frequencies in either ear on the second sweep-check. The hearing screening manual lists the steps for conducting an extended recheck.(5) A screener must refer for a professional examination if the child does not respond to any one of the three frequencies in either ear at 25 dB or lower during an extended recheck. The hearing screening manual lists the steps for conducting an extended recheck.(b) Otoacoustic emissions (OAE) testing may replace pure-tone audiometry only if a child has a documented disability preventing audiometer screening. OAE testing is optional and dependent on the screener's access to OAE testing equipment. The screener must use the equipment according to the manufacturer's recommendations.(c) A screener who is not a provider and performs hearing screenings in facilities must be trained and certified as described in §37.27 of this subchapter (relating to Standards and Requirements for Screening Certification and Instructor Training).(d) Facilities must give the child's parent, other legally responsible adult, or the individual in the scenarios described in Texas Family Code §32.003, a referral form if the child fails a second sweep-check or extended recheck screening. The referral is for further evaluation by an appropriate provider. Facilities must not refer a child to a specific person.(e) Facilities, school districts, and screeners must follow all instructions in the hearing screening manual available on the Department of State Health Services (DSHS) website. Source Note: The provisions of this §37.24 adopted to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.24 Hearing Screening https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227520&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227520 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227520&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227520 03/11/2026 (a) The chief administrator must ensure that each individual admitted to the facility is screened according to these screening requirements, provided the individual's parent or guardian has given consent for screening.(1) Children ages four and older as of September 1 of the school year who are enrolled in any facility for the first time must have vision and hearing screens. The screens should occur within 120 calendar days of the first attendance day. If a child enrolls within 60 calendar days of the end of the school year, the child's vision and hearing must be screened the next school year and should occur within 120 calendar days of the first attendance day.(2) Children in pre-kindergarten and kindergarten must be screened each year. Screens should occur within 120 calendar days of the first attendance day.(3) Children in the first, third, fifth, and seventh grades must be screened for vision and hearing problems. Screens should occur within 120 calendar days of the first attendance day in each of those grades to allow for early intervention if a problem is found.(4) Children turning four years old after September 1 of the school year do not need to be screened until the next school year.(5) Children may be screened on an alternate schedule (i.e., pre-kindergarten, kindergarten, first, second, fourth, and sixth grades) if DSHS approves a written request. DSHS may set conditions so children receive necessary screenings during the transition.(b) The facility must verify the screener has a valid DSHS screening certificate before screening begins.(c) Volunteers must have a high school diploma or equivalent to help with vision and hearing screenings. The screener is responsible for deciding how a volunteer will assist with the screening process, consistent with all state and federal confidentiality requirements.(d) Facilities must follow DSHS rules, instructions, policies, and the vision and hearing screening manuals available on the DSHS website. Source Note: The provisions of this §37.25 adopted to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.25 Facility Requirements; Department of State Health Services (DSHS) Activities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227521&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227521 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227521&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227521 03/11/2026 (a) Screeners at facilities must follow the rules for keeping records and reporting information.(1) A screener must document in each child's screening record the specific screening performed, the date the screening was performed, observations made during the screening, and results. The screener must document the child's name, age or birthdate, and if the child is wearing corrective lenses during the vision screening. The screener must sign and date this information.(2) A screener must provide facilities a copy of the screener's Department of State Health Services (DSHS) screener certificate.(3) Screeners at a facility must submit the required documentation referenced in paragraph (1) of this subsection to the facility by the specified deadline or no later than three business days after the screening.(b) Facilities must follow the rules for keeping records and reporting information.(1) A facility must maintain vision and hearing screening records onsite for at least two years.(2) A facility must maintain records of screening exemptions found in this subchapter for at least two years.(3) A facility must maintain the records received from screeners for at least two years.(4) A child's screening records may be transferred between facilities without consent of the child's parent, managing conservator, or legal guardian, or the individual in the scenarios described in Texas Family Code §32.003, according to Texas Health and Safety Code §36.006(c).(5) Facilities must provide the required records to DSHS in a timely manner if requested. DSHS or its representatives may enter a facility and inspect vision and hearing screening records.(6) Facilities or school districts must submit a yearly report on the vision and hearing screening status of the aggregate population screened during the reporting year. The report must be submitted on or before June 30 of each year in the manner specified by DSHS at https://www.dshs.texas.gov/vision-hearing-screening. DSHS may require individual reports for each school or may accept a single report from the school district. DSHS will notify stakeholders of the reporting requirement on the program website. If individual reports are required, school districts will determine if either the district will submit individual facility reports or will have each facility submit a report.(A) Hearing screening--The total number of children screened, including the number who failed; the number screened by OAE testing; the number referred for professional examination; the number who left the facility before the facility received the professional examination results; professional examination results showing none of the screened disorders were present; professional examination results showing a disorder was present; and referrals for a professional examination where no professional examination was done.(B) Vision screening--The total number of children screened, including the number screened with glasses or contact lenses, the number screened with instrument-based vision screeners, and the number screened with a wall or electronic eye chart; the number who failed; the number referred for professional examination; the number who left the facility before the facility received the professional examination results; the number whose professional examination results indicated no issues; the number whose professional examination results indicated an issue; and the number referred for a professional examination where no examination was done. (c) Additional recordkeeping requirements for screeners who own or use audiometers and audiometric screening equipment are in §37.28(g) of this subchapter (relating to Hearing Screening Equipment Standards and Requirements).(d) Submit documents described in this subchapter as directed on the DSHS website.(e) Facilities, school districts, and screeners must follow all recordkeeping instructions in the vision and hearing screening manuals. Source Note: The provisions of this §37.26 adopted to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.26 Recordkeeping and Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227522&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227522 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227522&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227522 03/11/2026 (a) A screener working in a facility must be certified by the Department of State Health Services (DSHS) unless the screener is a provider. Training for screeners is provided either directly by DSHS or by instructors authorized by DSHS to issue certificates. There is no fee for taking the course in either case.(1) DSHS provides training and issues certificates when the course is completed. To join, participants must have a high school diploma or equivalent and sign a form at the start of the course. Individuals who finish the training and pass the tests will receive a certificate from DSHS to conduct screenings.(2) The training and certification described in this subchapter are not intended for staff in medical offices or students in medical, nursing, or other training programs. Individuals who do not screen children in facilities as defined in this subchapter are neither eligible nor required to be trained and certified by DSHS.(b) Holders of certificates issued as described in this section must follow these requirements.(1) Certificate holders may conduct the type of screening listed on the certificate. Certificate holders must follow all the rules in this subchapter, and failure to do so may lead to modifications, suspension, or cancellation of the certificate.(2) If a screener uses an instrument-based vision screening device, the screener must follow the manufacturer's instructions. The screener also requires a current DSHS screening certificate as described in subsection (a) of this section.(3) A DSHS screening certificate described in this section is valid for five years. Renewing a certificate is explained in paragraph (4) of this subsection.(4) To renew a screening certificate, an individual must attend a recertification course either offered directly by DSHS, or approved by DSHS and provided by an external instructor before the certificate expires. If an individual does not complete the recertification within five years, the individual must take the complete certification training course again.(5) DSHS may change, suspend, or cancel a certificate. DSHS will provide notice to the affected screener of any action being taken if DSHS receives information that the screener has not followed the rules in this subchapter.(6) If a screener receives a notice of action, the screener has 20 business days to request a hearing. DSHS assumes the notice is received five days after being postmarked. Unless the notice specifies another method, the hearing request must be in writing and mailed or hand-delivered to the program at Vision, Hearing, and Spinal Screening Program, Department of State Health Services, Mail Code 1818, P.O. Box 149347, Austin, TX 78714-9347. If the request is not received or postmarked within 25 business days from the notice date, the screener waives the right to a hearing and DSHS may proceed with the action.(7) Appeals and administrative hearings follow DSHS fair hearing rules in §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).(c) DSHS may train individuals to become DSHS-authorized external instructors. These external instructors may train and certify individuals who screen children in facilities. Instructors may not charge fees for these activities.(1) An individual who wants to become an external instructor must apply and meet the following requirements:(A) the applicant has a valid DSHS screening certificate and has experience performing screenings; and(B) the applicant has experience training groups of adults.(C) An individual who meets the qualifications in subsection (c)(1)(A) - (B) of this section may submit an external instructor application, available on the DSHS website. DSHS will grant or deny the request based on the qualifications described in subsection (c)(1)(A) - (B) of this section and the external instructor manual located on the DSHS website.(2) DSHS prioritizes applications from facilities and areas with a high training need.External instructors must hold at least one training session for each type of screening every year to stay certified. The training may be either basic training or recertification training. For example, an external instructor may meet the training requirement for the year by conducting a basic training for hearing screening and a recertification training for vision screening.(3) The DSHS external instructor certificate lasts for five years. To renew an external instructor certificate, an individual must complete an instructor recertification course before the current certificate expires. If an individual does not recertify within the required time period, the individual must take the complete training course again. DSHS may not renew an external instructor's certificate if DSHS confirms the individual did not fulfill all requirements during the previous certification period.(4) DSHS-authorized external instructors must use the approved training materials from DSHS and follow all requirements and expectations listed in the instructor training manual.(5) Instructors who have a valid certification may also teach courses for screener recertification. Instructors must make sure the individuals signing up for these recertification courses are eligible. Instructors must follow all the rules for these recertification courses.(6) External instructors must turn in all documentation listed in the external instructor training manual in the specified manner and timeframe. Instructors must keep a copy of all records for five years.(7) External instructors may certify or recertify screeners but cannot certify instructors.(8) External instructors must follow all DSHS guidelines in the external instructor training manual, including rules about class size and duration, course and instructor evaluations, and testing. The manual also explains what happens if external instructors do not follow these rules.(9) External instructors must follow all instructions given in the vision or hearing screening manuals, or both, which can be found on the DSHS website.(10) External instructors may be audited or observed by DSHS at any time for quality checks without notice or permission.(11) If DSHS gets any information that an external instructor has not followed the rules described in this subchapter, DSHS may modify, suspend, or cancel the certification. DSHS will notify the instructor about any proposed actions.(12) DSHS will inform facilities or school districts when an external instructor fails to follow all the rules, instructions, policies, and manuals in this subchapter. If the instructor continues to not follow the rules, the instructor's certificate may be canceled.(13) The instructor has 20 business days after receiving the notice to request a hearing about the proposed action. The notice is considered received five business days after being postmarked. Unless the notice states otherwise, the request for a hearing must be written and mailed or hand-delivered to the address described in subsection (b)(6) of this section. If the request for a hearing is not received or postmarked within 25 business days from the date the notice was sent, the instructor waives the right to a hearing and DSHS may take action.(14) Screeners trained by a former external instructor with a revoked certificate will not be certified by DSHS.(15) Appeals and administrative hearings follow DSHS fair hearing rules described in §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures). Source Note: The provisions of this §37.27 adopted to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.27 Standards and Requirements for Screening Certification and Instructor Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227523&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227523 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227523&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227523 03/11/2026 (a) Unless specified otherwise, all audiometers and other hearing equipment used for hearing screens in facilities must follow the rules described in this subchapter. The facility and the screener must make sure these requirements are met.(b) The equipment mentioned in subsection (a) of this section must meet the relevant current ANSI standards, or the manufacturer's specifications if there are no ANSI standards, and must follow all other applicable federal and state standards and regulations for such equipment.(c) Screeners in facilities must be certified by the Department of State Health Services (DSHS) in how to properly use the equipment, as explained in §37.27 of this subchapter (relating to Standards and Requirements for Screening Certification and Instructor Training).(d) Qualified technicians must perform annual electronic calibrations and complete exhaustive electronic calibrations on audiometers used for screenings in facilities. The technician must provide proof of calibration to the audiometer's owner. Proof of calibration may be shown with a decal or sticker attached to the audiometer or the screener may keep a paper copy of the latest calibration documentation with the audiometer.(e) The owner of the audiometer or the person in charge at the facility must complete biological calibration checks once a month on all audiometers used in facilities for screenings.(f) The screener should conduct a brief pre-screen operational check to make sure the headset is operating properly.(g) Every facility or screener for a facility that uses audiometric screening equipment must keep records of the equipment's calibration and monthly biological calibration checks. These records must be kept for three years and made available to DSHS if requested for inspection. Source Note: The provisions of this §37.28 adopted to be effective August 17, 2014, 39 TexReg 6055; amended to be effective February 9, 2026, 51 TexReg 732. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES C VISION AND HEARING SCREENING §37.28 Hearing Screening Equipment Standards and Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165130&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165130 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165130&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165130 03/11/2026 (a) Newborn screening is composed of screening performed on blood specimens ("blood spot-based newborn screening") as well as that performed at the point-of-care ("point-of-care newborn screening"). This subchapter covers blood spot-based newborn screening, with two exceptions:(1) program benefits (§37.60 of this title relating to Newborn Screening Program Benefits); §37.61(a)(1) of this title (relating to Eligibility Requirements for the Newborn Screening Program Benefits); §37.63(a)(1) of this title (relating to Denial of Application, and Modification, Suspension, or Termination of Newborn Screening Program Benefits); and(2) Newborn Screening Advisory Committee (§37.64 of this title (relating to Newborn Screening Advisory Committee)). Point-of-care newborn screening tests are structured to be covered in a separate rule subchapter under this chapter. For purposes of this subchapter, references to the "Newborn Screening Program" (program) means newborn screening that is blood spot-based. This subchapter implements Texas Health and Safety Code, Chapter 33, administered by the Texas Department of State Health Services (department), except for the requirements associated with conducting Critical Congenital Heart Disease (CCHD) screening, which will be implemented in a separate subchapter. Each newborn delivered in the state must be screened, which involves two blood draws collected on separate days, as described in this subchapter, followed by department laboratory screening tests on those blood specimens for phenylketonuria, other heritable diseases, hypothyroidism, and certain other disorders as detailed in §37.53 of this title (relating to Disorders for Which Blood Specimen Screening is Performed).(b) This subchapter also details legal requirements applicable to physicians (or other persons attending a newborn, if no physician is present).(c) Specimen collection kits are obtained from the department as referenced in this subchapter. Screening results are reported by the department as provided by law. A screen may produce false positive or false negative results, and should not be relied upon as diagnostic. For this reason, the department strongly recommends that the child be placed under the care of a licensed physician with appropriate expertise for diagnosis and treatment.(d) This subchapter also details follow-up, reporting, and record keeping on abnormal screening results and confirmed cases.(e) This subchapter also identifies program services which are available to individuals who have an abnormal screening result (pending confirmation of diagnosis), or a confirmed diagnosis of a disorder referenced in this subchapter. Additionally, this subchapter establishes eligibility criteria, financial participation requirements and procedures for the orderly provision of the identified services to eligible individuals, subject to §37.61 of this title (relating to Eligibility Requirements for the Newborn Screening Program Benefits). Source Note: The provisions of this §37.51 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.51 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165131&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165131 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165131&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165131 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Abnormal screening result(s)--An out-of-range laboratory test result.(2) Bona fide resident--A person who:(A) is physically present within the geographic boundaries of the state;(B) has an intent to remain within the state;(C) maintains an abode within the state (i.e., house or apartment, not merely a post office box);(D) has not come to Texas from another country for the purpose of obtaining medical care, with the intent to return to the person's native country;(E) does not claim residency in any other state or country; and(i) is a minor child residing in Texas whose parent, managing conservator, or legal guardian is a bona fide resident;(ii) is a person residing in Texas who is the legally dependent spouse of a bona fide resident; or(iii) is an adult residing in Texas, including an adult whose parent, managing conservator, or legal guardian is a bona fide resident or who is his/her own legal guardian.(3) Charity care newborn--A patient who is not insured or self-pay, and is not covered or eligible to be covered for newborn screening services by Medicaid, Children's Health Insurance Program (CHIP), or any other government program.(4) CHIP-eligible newborn--A patient who is eligible for CHIP coverage in accordance with Texas Health and Safety Code, Chapter 62.(5) Commissioner--The commissioner of the Department of State Health Services.(6) Critical Congenital Heart Disease--CCHD is an abnormality in the structure or function of the heart that exists at birth, that causes severe, life-threatening symptoms, and requires medical intervention within the first few hours, days, or months of life. CCHD is detected by point-of-care screening. Comprehensive rules for CCHD will be established under a separate subchapter under this chapter.(7) Department--The Department of State Health Services or its successor.(8) Health care practitioner--One of the following individuals who is currently licensed and in good standing as indicated:(A) an advanced practice registered nurse licensed by the Texas Board of Nursing pursuant to Texas Occupations Code, Chapter 301;(B) a physician assistant licensed by the Texas Physician Assistant Board pursuant to Texas Occupations Code, Chapter 204; or(C) a midwife licensed by the Texas Midwifery Board pursuant to Texas Occupations Code, Chapter 203.(9) Medicaid-eligible newborn--A patient whose mother is a Medicaid recipient or who is otherwise eligible for Medicaid coverage for the newborn-related services in accordance with Texas Human Resources Code, Chapter 32.(10) Newborn--A child through 30 days of age.(11) Newborn Screening--One or more laboratory test(s) that identify an increased risk for phenylketonuria, other heritable diseases, hypothyroidism, and certain other disorders.(12) Physician--A person licensed to practice medicine by the Texas Medical Board pursuant to Texas Occupations Code, Chapter 151.(13) Specimen--A laboratory sample used for testing. The specimen used for newborn screening is capillary blood dried on specialized filter paper.(14) Specimen collection kit--A department-approved, bar-coded, newborn screening specimen collection kit obtained from the department and consists of a parental information sheet; Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards form; customized specimen collection device; demographic information sheet; and specimen collection directions applicable to the collection and submission of a newborn's blood specimen for the first, second, or repeat newborn screening test. Source Note: The provisions of this §37.52 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.52 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165132&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165132 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165132&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165132 03/11/2026 Newborn screening in Texas includes the disorders found on the national Recommended Uniform Screening Panel for which funds are available and allocated for the screening. For a complete list of the disorders the State of Texas screens for at any given time, go to http://www.dshs.state.tx.us/newborn. Source Note: The provisions of this §37.53 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.53 Disorders for Which Blood Specimen Screening is Performed https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165133&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165133 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165133&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165133 03/11/2026 The newborn screening tests referenced in §37.53 of this title (relating to Disorders for Which Blood Specimen Screening is Performed) are not required for a newborn child whose parent, managing conservator, or legal guardian objects on the ground that the tests conflict with the religious tenets or practices of an organized church of which they are adherents. The objection of the parent, managing conservator, or legal guardian to the screening tests shall be entered into the medical record of the child by the physician (or other person attending a newborn, if no physician is present). The parent, managing conservator, or legal guardian must sign the entry in order for the exemption to be valid. Source Note: The provisions of this §37.54 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.54 Newborn Screening Exemption https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165134&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165134 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165134&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165134 03/11/2026 (a) Purpose. This section establishes procedures for the obtaining, and subsequent submission of, newborn screening specimen collection kits provided by the department.(b) Specimen collection kits.(1) The requestor will estimate and submit to the department a written order, using forms designated by the department, for newborn screening specimen collection kits. The estimate should be based on the requestor's previous usage. A requestor shall provide further information to the department, upon request, to verify the appropriateness of the number of specimen collection kits ordered.(A) The department will provide specimen collection kits for Medicaid-eligible, CHIP-eligible, or charity care newborns at no cost. The no-cost specimen collection kit should only be used for a Medicaid-eligible, CHIP-eligible or charity care newborn, and the submitter must affirm this on the specimen collection kit request form.(B) The department will provide specimen collection kits for all other newborns at a fee described in §73.54(a)(1)(A)(i) of this title (relating to Fee Schedule for Clinical Testing and Newborn Screening).(2) The department reserves the right to adjust the quantity of kits provided for an order based on factors such as the requestor's past orders, submission rates, and the availability of kits.(3) The department will bill the requestor for specimen collection kits. Payment is due within 90 days from the statement date.(4) The department will accept only its approved specimen collection kits for submission of specimens.(5) Each time newborn screening samples are collected from the child, the physician (or other person attending a newborn, if no physician is present) shall ensure that the parent, managing conservator, or legal guardian is given the department's information on newborn screening, including the Texas Newborn Screening Parent Information form, and the Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards form. The physician (or other person attending a newborn, if no physician is present) shall verify the information was distributed to the parent, managing conservator, or legal guardian by checking the appropriate box on the demographic information sheet, which must be included with the blood specimen when the kit is submitted to the department for testing. The physician (or other person attending a newborn, if no physician is present) must also include the signed Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards form, if the parent signs the form at that time. If the signed form is presented to the physician (or other person attending a newborn, if no physician is present) at any other time, it must be submitted to the department at that time. The physician attending a newborn child may delegate the responsibilities in this section to any qualified and properly trained person acting under the physician's supervision.(6) Returned specimen collection kits: if the purchaser believes a kit(s) is defective, purchaser should immediately contact the department's laboratory in Austin. Kit(s) which are verified to be defective by the department can be returned for credit for future kit orders, as directed by the department. Source Note: The provisions of this §37.55 adopted to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.55 Newborn Screening Specimen Collection Kits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165135&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165135 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165135&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165135 03/11/2026 (a) A physician (or other person attending a newborn, if no physician is present) shall obtain a capillary blood specimen from the newborn and submit those specimens, all in accordance with instructions in §37.55 of this title (relating to Newborn Screening Specimen Collection Kits) and further instructions provided on and with the specimen collection.(b) A capillary blood specimen shall be collected by absorbing the blood onto target circles on a specialized filter paper collection device. Other body fluids or blood from the placenta, umbilical cord, or mother are not acceptable.(c) The blood specimen is to be obtained by the physician (or other person attending the newborn, if no physician is present) after 24 hours of age and before 48 hours of age. If the newborn is discharged from the hospital or birthing facility before the above criteria are met, the blood specimen must be obtained immediately prior to discharge. A second blood specimen is to be collected between one and two weeks of age in accordance with this section.(1) If program data and/or other available information demonstrate to the department's satisfaction that the second screening is no longer necessary, the commissioner may remove the second screening from the Texas Newborn Screening Program.(2) The commissioner's decision would be announced through means deemed appropriate by the commissioner to notify physicians, other health care practitioners, and other interested persons. Prior to the effective date of the announced change, the department's newborn screening educational information will be revised to reflect this program change.(d) A repeat blood specimen shall be obtained as instructed by the program to verify results, or if the initial blood specimen was unsatisfactory.(e) Transfusions can cause invalid results. The first screening should be collected prior to the first transfusion, if possible.(1) If collected prior to the transfusion, specimen collection should proceed as described in subsection (c) of this section;(2) If not collected prior to transfusion, a total of three specimens should be obtained. The first and second screen should be obtained as referenced in subsection (c) of this section. The third specimen should be collected 90 days after the date of transfusion.(f) Blood specimens must air-dry on a flat surface for at least four hours and must be mailed to the department within 24 hours after collection. Directions for handling blood specimens must be strictly followed to avoid cross-contamination.(g) A physician (or other person attending a newborn, if no physician is present), shall ensure that:(1) the identifying and demographic information sheet is complete and accurate when submitted to the department;(2) identifying information shall include contact information for the newborn's physician or health care practitioner to ensure ability to contact the physician or health care practitioner in case of abnormal screening results;(3) parents receive the Texas Newborn Screening Parent Information form, and the Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards form;(4) the box on the patient demographic information form is checked, and verifying information and decision forms were provided to a parent, managing conservator, or legal guardian; and(5) the Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards form is promptly sent to the department upon being signed, and received from a parent, managing conservator, or legal guardian. Source Note: The provisions of this §37.56 adopted to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.56 Responsibilities of the Physician (or Other Person Attending a Newborn, if No Physician is Present) and Collection of First and Second Specimen https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165136&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165136 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165136&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165136 03/11/2026 Newborn screening laboratory analyses of blood specimens for the screenings must be performed by the department or the department's designee. The department or the department's designee is responsible for identifying and implementing proper laboratory procedures for the screening tests referenced in §37.53 of this title (relating to Disorders for Which Blood Specimen Screening is Performed).(1) The analyses of first and any subsequent blood specimens are included in these responsibilities.(2) Upon completion of the laboratory analyses, screening results shall be transmitted to the person who submitted the blood specimen. The laboratory results are also available to authorized persons by telephone and other electronic means. The department shall establish a written policy for communicating the laboratory results. Source Note: The provisions of this §37.57 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.57 Screening Procedures To Be Used https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165137&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165137 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165137&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165137 03/11/2026 (a) The department shall make notification of abnormal screening results as specified in Texas Health and Safety Code, §33.014(a). The department maintains an active system of follow-up for those cases. The department will provide recommendations for clinical confirmation following abnormal screening results.(b) The department may request local health authorities, and/or the designated staff in the department's health service regions to provide follow-up and other appropriate assistance for individuals at risk from the disorders referenced in §37.53 of this title (relating to Disorders for Which Blood Specimen Screening is Performed).(c) The person submitting the newborn screening specimen may assist the department with follow-up of individuals at risk for the disorders referenced in §37.53 of this title.(d) The department will identify pediatric specialists in the state who are available to provide consultation to physicians and other health care practitioners regarding the diagnosis and management of newborns with abnormal screening results. If a screening test indicates that a newborn child is at high risk, department program staff will provide the physician, or other health care practitioner if the infant does not have a physician, with the names of appropriate consultants in the infant's geographic area. The program may provide information about abnormal screening results to the pediatric specialists who cooperate with the department as part of the department's activities under this subchapter.(e) Each physician, local health authority, or other individual shall report to the department all confirmed cases of the disorders referenced in §37.53 of this title within 30 days of obtaining such information.(f) The department will collect and compile information it receives under this subchapter and from other sources to derive incidence/prevalence rates for the disorders referenced in §37.53 of this title. The data may enable the department to identify high-risk population groups, with the ultimate goal of preventing severe sequelae of the disorders.(g) The department may follow up with a confirmed case through periodic data collection from the physician and/or other health care practitioner and/or parent, managing conservator, or legal guardian.(h) The department shall maintain a registry of children born in Texas who have been diagnosed as having one of the disorders referenced in §37.53 of this title, as required by Texas Health and Safety Code, §33.015(c). Source Note: The provisions of this §37.58 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.58 Follow-up, Reporting, and Record Keeping on Abnormal Screening Results and Confirmed Cases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165138&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165138 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165138&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165138 03/11/2026 (a) All newborns and other individuals under the age of 21 years who have an abnormal screening may be referred, if financially eligible, to the department's Children with Special Health Care Needs (CSHCN) Services Program.(b) An individual who is determined to be eligible for the CSHCN Services Program will be given approved services through that program, including special dietary formula, unless access to CSHCN Services Program health care benefits is restricted according to §38.16 of this title (relating to Procedures to Address Program Budget Alignment). An individual who does not meet CSHCN Services Program's eligibility criteria will be referred to the department's Newborn Screening Program Benefits staff for a determination of eligibility for that program's benefits, as referenced in §37.60 of this title (relating to Newborn Screening Program Benefits). Source Note: The provisions of this §37.59 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.59 Coordination With Children With Special Health Care Needs Services Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165139&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165139 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165139&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165139 03/11/2026 In cooperation with the individual's physician or other health care practitioner and within the limits of funds budgeted by the department for this purpose, the program will provide benefits such as dietary supplements, medications, vitamins, low-protein foods, and follow-up care at no cost or reduced cost to individuals approved for program benefits who have a disorder detected through the program, and confirmed with appropriate diagnostic tests, that have been interpreted by a physician recognized by the department as a specialist in the applicable disorder(s) as referenced in §37.53 of this title (relating to Disorders for Which Blood Specimen Screening is Performed), and/or CCHD, once the department has established rules covering that subject matter in a separate subchapter under this chapter. Program benefits also include coverage for confirmatory testing of individuals who have a presumptive disorder, from the list of disorders referenced in §37.53 of this title. These program benefits will be prioritized among eligible individuals in the following order:(1) children 0-2 years of age;(2) children 3-5 years of age;(3) children 6-21 years of age;(4) pregnant women;(5) women of child bearing age; and(6) other adults. Source Note: The provisions of this §37.60 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.60 Newborn Screening Program Benefits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165343&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165343 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165343&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165343 03/11/2026 (a) Except as otherwise provided for in this subchapter, to be eligible to receive the benefits from the program referenced in §37.60 of this title (relating to Newborn Screening Program Benefits), an individual must:(1) have an abnormal screening result (pending confirmation of diagnosis), or a confirmed diagnosis of a disorder screened by the program as referenced in §37.53 of this title (relating to Disorders for Which Blood Specimen Screening is Performed) and/or CCHD, once the department has established rules covering that subject matter in a separate subchapter under this chapter;(2) be a bona fide resident of the state;(3) have a family income that is at or below 350% of the federal poverty income guidelines;(4) if required, make financial participation payments in a timely manner;(5) as directed by the program, provide current medical, financial, and residency information and/or documentation in a timely manner; and(6) have a parent, managing conservator, or legal guardian agree to abide by the requirements in this subchapter if the individual is a minor.(b) An individual is not eligible to receive the benefits described in §37.60 of this title if the individual or the parent, managing conservator, or legal guardian is eligible for some other benefit, such as Medicaid, CSHCN Services Program, CHIP, or private insurance, that would pay for all or part of the services in question. Source Note: The provisions of this §37.61 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.61 Eligibility Requirements for the Newborn Screening Program Benefits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165141&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165141 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165141&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165141 03/11/2026 (a) To be considered for program benefits described in §37.60 of this title (relating to Newborn Screening Program Benefits), a complete application must be filed annually (according to the deadlines provided by the department) with the program by mailing to the following address: Newborn Screening Unit, Mail Code 1918, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347.(b) The application must be signed by one of the following as appropriate:(1) an adult individual seeking services;(2) the parent, managing conservator, or legal guardian of a minor seeking services; or(3) the legal guardian of an adult seeking services under a temporary, limited or general guardianship.(c) An application signed with a mark must be attested to before a notary public.(d) A complete application shall consist of the following:(1) a properly completed and signed application form;(2) a statement from the individual or, if the individual is a minor, from the individual's parent, managing conservator, or legal guardian that the individual is a bona fide resident of the state. If requested by the program, the applicant must also submit documentation of residency status, and proof of income as established in the department's program benefits policy; and(3) information, as requested by the department, on any other benefit to which the applicant, recipient, or person with a legal obligation to support the applicant or recipient may be entitled.(e) An application shall be deemed incomplete for any one of the following reasons:(1) failure to provide all information requested in the application form;(2) lack of supporting documents;(3) failure to provide documentary evidence requested by the program, including documentation to verify residency or financial data; and/or(4) lack of, or improper, signatures.(f) Following review, an application will be:(1) denied if eligibility requirements are not met;(2) returned, if incomplete, with the deficiencies noted to the individual, or if the individual is a minor or a ward, to the individual's parent, managing conservator, or legal guardian as is appropriate, for completion and resubmission; or(3) approved if all criteria are met to the department's satisfaction.(g) An individual's eligibility date is the date on which the program determines that the application is complete. Source Note: The provisions of this §37.62 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.62 Application Process for the Newborn Screening Program Benefits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165142&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165142 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165142&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165142 03/11/2026 (a) An individual applying for or receiving benefits described in §37.60 of this title (relating to Newborn Screening Program Benefits) may have his/her application denied or his/her benefits modified, suspended, or terminated for any of the following reasons:(1) the individual does not have a confirmed diagnosis of a disorder screened by the program for which benefits are available (including confirmatory testing), as referenced in §37.61(a)(1) of this title (relating to Eligibility Requirements for the Newborn Screening Program Benefits);(2) the individual is not a bona fide resident of the state;(3) the individual fails or refuses to provide the information requested by the program (e.g., regarding residency, financial status, eligibility for other benefits);(4) the individual submits an application form, or any document required in support of the application or continued participation in the program, which contains an intentional misstatement of fact which is material to the program's determination that the individual is eligible for program benefits; or(5) exhaustion of budgeted program funds, prioritized as required under §37.60 of this title.(b) An individual applying for or receiving benefits under §37.60 of this title may not appeal or request an administrative hearing concerning adjustments made by the program regarding the type and amount of program benefits available when such adjustments are necessary to conform to budgetary limitations.(c) An individual applying for benefits will be notified in writing if the individual's application is denied. The notification will state the reasons for denial.(d) An individual receiving benefits will be notified by certified mail to the most recent address known to the program if the benefits are to be modified, suspended, or terminated. The program will state the reasons for the proposed action.(e) Prior to making a final decision adverse to an affected individual, the program shall give the affected individual written notice of an opportunity for a hearing on the proposed action. The notice shall contain:(1) a statement of the action the department intends to take;(2) an explanation of the reasons for the action the department intends to take;(3) a reference to the statutory and regulatory authority supporting the intended action;(4) an explanation of the affected person's right to request a hearing; and(5) the procedure by which an affected person may request a hearing.(f) The affected individual has 20 days after receiving the notice to request a hearing on the proposed action. It is a rebuttable presumption that a notice is received five days after the date of the notice. Unless the notice letter specifies an alternative method, a request for a hearing shall be made in writing, and mailed or hand-delivered to the program at the following address: Newborn Screening Unit, Mail Code 1918, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347. If an individual who is offered the opportunity for a hearing does not request a hearing within the prescribed time for making such a request, the individual is deemed to have waived the hearing and the action may be taken.(g) Appeals and administrative hearings will be conducted in accordance with the department's fair hearing rules at §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures). Source Note: The provisions of this §37.63 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.63 Denial of Application, and Modification, Suspension, or Termination of Newborn Screening Program Benefits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165143&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165143 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=165143&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 165143 03/11/2026 The scope of matters on which the Newborn Screening Advisory Committee may legally submit recommendations to the department is as follows:(1) potential additional newborn screening tests under Texas Health and Safety Code, §33.011(a-1) for other disorders or conditions listed under the Recommended Uniform Newborn Screening Panel, or another report determined by the department to provide more stringent newborn screening guidelines to protect the health and welfare of this state's newborns;(2) matters regarding strategic planning, policy, rules, and services related to newborn screening and additional newborn screening tests;(3) review the necessity of requiring additional screening tests, including an assessment of the test implementation costs to the department, birthing facilities, and other health care providers; and(4) the scope of the Newborn Screening Advisory Committee is limited under Texas Health and Safety Code, §33.017(c), to advising the department regarding strategic planning, policy, rules, and services related to newborn screening tests for each disorder that are included in the list described by Texas Health and Safety Code, §33.011(a-1). Source Note: The provisions of this §37.64 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES D NEWBORN SCREENING PROGRAM §37.64 Newborn Screening Advisory Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168258&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168258 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168258&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168258 03/11/2026 This subchapter implements Texas Health and Safety Code, Chapter 33, administered by the Department of State Health Services (department), associated with conducting point-of-care newborn screening for critical congenital heart disease (CCHD). Newborns delivered in the state must be screened at a birthing facility for CCHD as described in this subchapter. This subchapter also defines the test procedures and standards required by the department for each screening test and details reporting and record keeping requirements on confirmed cases. Source Note: The provisions of this §37.75 adopted to be effective August 7, 2014, 39 TexReg 5949. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES E NEWBORN SCREENING FOR CRITICAL CONGENITAL HEART DISEASE §37.75 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168259&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168259 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168259&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168259 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Birthing facility--An inpatient or ambulatory health care facility that offers obstetrical or newborn care services. The term includes:(A) a hospital licensed under Texas Health and Safety Code, Chapter 241, that offers obstetrical services;(B) a birthing center licensed under Texas Health and Safety Code, Chapter 244;(C) a children's hospital; or(D) a facility that provides obstetrical services and is maintained and operated by this state or an agency of this state.(2) Critical Congenital Heart Disease (CCHD)--An abnormality in the structure or function of the heart that exists at birth, that causes severe, life-threatening symptoms, and requires medical intervention within the first few hours, days, or months of life.(3) Department--The Department of State Health Services or its successor.(4) Echocardiogram--An ultrasound test that evaluates the structure and function of the heart.(5) Health care practitioner--One of the following individuals who is currently licensed and in good standing as indicated:(A) an advanced practice registered nurse licensed by the Texas Board of Nursing pursuant to Texas Occupations Code, Chapter 301;(B) a physician assistant licensed by the Texas Physician Assistant Board pursuant to Texas Occupations Code, Chapter 204; or(C) a midwife licensed by the Texas Midwifery Board pursuant to Texas Occupations Code, Chapter 203.(6) Neonatal intensive care unit (NICU)--An intensive care unit specializing in the care of ill or premature newborn infants.(7) Newborn--A child through 30 days of age.(8) Physician--A person licensed to practice medicine by the Texas Medical Board pursuant to Texas Occupations Code, Chapter 151.(9) Pulse Oximeter--A U.S. Food and Drug Administration approved instrument used to measure the percentage of hemoglobin in the blood that is saturated with oxygen in neonates.(10) Screening algorithm--A standardized process and methodology used to conduct newborn screening for CCHD. Source Note: The provisions of this §37.76 adopted to be effective August 7, 2014, 39 TexReg 5949. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES E NEWBORN SCREENING FOR CRITICAL CONGENITAL HEART DISEASE §37.76 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168260&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168260 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168260&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168260 03/11/2026 The newborn screening test for CCHD referenced in §37.78 of this title (relating to Test Procedures and Standards) is not required for a newborn under the following conditions:(1) the parent declines the screening;(2) the newborn is transferred to another facility before the screening test is performed;(3) the screening test has previously been completed after birth;(4) the newborn is discharged from the birthing facility not more than 10 hours after birth and a referral for the newborn was made to another birthing facility, physician, or health care provider;(5) the newborn has previously been diagnosed with CCHD; or(6) the newborn has had a post-natal echocardiogram. Source Note: The provisions of this §37.77 adopted to be effective August 7, 2014, 39 TexReg 5949. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES E NEWBORN SCREENING FOR CRITICAL CONGENITAL HEART DISEASE §37.77 Exemption from Screen https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168261&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168261 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168261&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168261 03/11/2026 (a) A screening test for CCHD using pulse oximetry must be performed at a birthing facility that provides care to newborn patients except as described in §37.77 of this title (relating to Exemption from Screen). If another U.S. Federal Drug Administration approved instrument is available, it will be posted as identified in subsection (b) of this section.(b) Testing procedures must be consistent with the most current published screening algorithm and any other protocol currently posted, linked, or referenced on the department's Newborn Screening website at http://www.dshs.state.tx.us/newborn/.(c) Pulse oximeters used to conduct CCHD newborn screening must meet the standards and accuracy as determined by the Food and Drug Administration for hospital use in newborns.(d) Newborns in the NICU must receive CCHD screening prior to discharge except as described in §37.77 of this title (relating to Exemption from Screen). Source Note: The provisions of this §37.78 adopted to be effective August 7, 2014, 39 TexReg 5949. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES E NEWBORN SCREENING FOR CRITICAL CONGENITAL HEART DISEASE §37.78 Test Procedures and Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168262&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168262 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168262&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168262 03/11/2026 (a) A physician, health care practitioner, health authority, birthing facility, or other individual who has the information of a confirmed case of a disorder for which a screening test is required, shall report a confirmed case to the department.(b) Confirmed case information must be submitted to the department's Newborn Screening Unit using the most current reporting method(s) located on the department's Newborn Screening website at http://www.dshs.state.tx.us/newborn/. Source Note: The provisions of this §37.79 adopted to be effective August 7, 2014, 39 TexReg 5949. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES E NEWBORN SCREENING FOR CRITICAL CONGENITAL HEART DISEASE §37.79 Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171165&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171165 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171165&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171165 03/11/2026 The purpose of this subchapter is to implement Texas Health and Safety Code, Chapter 37, concerning the detection of abnormal spinal curvature in children. Source Note: The provisions of this §37.141 adopted to be effective March 21, 1986, 11 TexReg 1145; amended to be effective August 1, 2002, 27 TexReg 3157; amended to be effective September 17, 2008, 33 TexReg 7747; amended to be effective January 12, 2015, 40 TexReg 238. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.141 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186904&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186904 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186904&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186904 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Abnormal spinal curvature--An anatomic, structural deviation from the normal spinal curve, such as scoliosis or kyphosis.(2) Certification--The process by which the Department of State Health Services (department) trains individuals to conduct spinal screening as well as to then provide training screening procedures.(3) Chief Administrator--The principal (or designee) of a school as defined by the Texas Education Agency, Title 19, Part 2, Chapter 149, Subchapter BB.(4) Department--The Department of State Health Services.(5) Licensed professional--An individual who is appropriately licensed under state law, including physicians, chiropractors, physical therapists, and registered nurses, and has completed a course of study in physical assessment.(6) Professional examination--A diagnostic evaluation performed by an appropriately licensed professional whose expertise addresses the diagnostic needs of the individual identified as having a possible abnormal spinal curvature. A professional examination is one that is performed according to the requirements of this subchapter and of Texas Health and Safety Code, Chapter 37.(7) School--An educational institution, public or private, that admits children who are five through twenty-one years of age, which includes an individual school campus.(8) Screening--A test or battery of tests for rapidly determining the need for a professional examination. Source Note: The provisions of this §37.142 adopted to be effective March 21, 1986, 11 TexReg 1145; amended to be effective August 1, 2002, 27 TexReg 3157; amended to be effective September 17, 2008, 33 TexReg 7747; amended to be effective January 12, 2015, 40 TexReg 238; amended to be effective January 1, 2018, 42 TexReg 6928. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.142 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186905&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186905 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186905&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186905 03/11/2026 (a) Spinal screening is required, for all children who attend public and private schools, to detect abnormal spinal curvature. Spinal screening, conducted under this subchapter by a person who is not a licensed professional, as the term is defined in this subchapter, must be conducted following the most recent, nationally accepted and peer-reviewed standards for spinal screening. The spinal screening requirements are established in policy located on the department's website at http://www.dshs.texas.gov/spinal.(b) A person who is not a licensed professional, as that term is defined in this subchapter, who conducts spinal screening must be trained and certified as described in §37.146(a) of this title (relating to Standards and Requirements for Screening Certification and Instructor Training).(c) The requirements of this section do not apply when the individual is already actively under medical care by an appropriate licensed professional for one or more of the spinal problems for which screening is performed under this section. In order to claim this exception, the individual under the scenarios described in Texas Family Code, §32.003 or, if the individual is a minor, the individual's parent, managing conservator or legal guardian, must submit documentation from the licensed professional to the school. The documentation must be signed and dated by the licensed professional, and must affirmatively state that the individual is under active, ongoing medical care from the licensed professional for specific spinal problems as referenced in this subsection. Source Note: The provisions of this §37.143 adopted to be effective January 12, 2015, 40 TexReg 238; amended to be effective January 1, 2018, 42 TexReg 6928. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.143 Spinal Screening Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186906&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186906 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186906&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186906 03/11/2026 (a) The chief administrator of each school is responsible for notifying a parent, managing conservator, or guardian of the requirement to conduct spinal screening, the purpose of and the reasons for spinal screening and potential risk to the child if declined, the method used to perform the screening based on §37.143 of this title (related to Spinal Screening Procedures), and the method to decline spinal screening based on subsection (e) of this section. For purposes of this section, the notification may be in electronic format.(b) The chief administrator of each school is responsible for the school maintaining a copy of the screening results and the mailing of a copy of the report to the parent, managing conservator, or guardian of the individual screened if an abnormal spinal curvature is suspected, based on §37.143(a) of this title (relating to Spinal Screening Procedures).(c) The chief administrator of each school shall ensure that each individual admitted to the school complies with the screening requirements of this subchapter, according to the following schedule:(1) All children enrolled in a public or private school, who meet the criteria outlined in department policy, shall be screened for abnormal spinal curvature before the end of the school year. The screening requirements may also be met by a professional examination as defined in §37.142 of this title (relating to Definitions).(2) If a child is enrolled within 60 days of the date a school closes for the summer, the child's spinal screening must be conducted within 120 days of the beginning of the following school year.(3) Schools may offer a student the opportunity for spinal screening if the student has no record of having been screened previously.(d) A child's parent, managing conservator, or legal guardian, or the individual under the scenarios described in Texas Family Code, §32.003, may execute an affidavit stating that a person, other than the individual secured by the school to conduct screenings at the school, shall conduct the screening as soon as is feasible. The school may admit the child on a provisional basis for up to 60 days, or may deny admission until the screening record(s) are provided to the school. The 60-day time period is from November 30 to January 30 of each school year.(e) A school shall not require a child to be screened if the child's parent, managing conservator, or legal guardian, or the individual under the scenarios described in Texas Family Code, §32.003, submits to the school, on or before the date spinal screening is scheduled, an affidavit in lieu of the screening record(s) stating that the spinal screening conflicts with the tenets and practices of a church or religious denomination of which the affiant is an adherent or member.(f) Only individuals who have completed high school may serve as volunteer assistants during spinal screenings. It is the responsibility of the certified screener to determine how any volunteer assistant(s) will be used during the screening process, consistent with all state and federal confidentiality requirements. Source Note: The provisions of this §37.144 adopted to be effective January 12, 2015, 40 TexReg 238; amended to be effective January 1, 2018, 42 TexReg 6928. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.144 School Requirements; Department Activities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186907&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186907 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=186907&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 186907 03/11/2026 (a) Individuals conducting screenings under this subchapter must comply with the following recordkeeping and reporting requirements:(1) Individuals conducting screenings at the school (and those other than licensed professionals conducting screenings outside of the school) shall document in each child's screening record the specific screening conducted, the date the screening was conducted, observations made during the screening, and the final results of the screening. The individual shall also ensure that the following are included in the documentation: the name of the child and age or birthdate of the child. The documentation required under this subsection must also be signed and dated by the person who conducted the screening. For the purposes of this subchapter, electronic signatures and dates are also acceptable.(2) Individuals conducting screenings at a school (and those other than licensed professionals conducting screening outside of the school) shall submit the documentation referenced in this subsection to the school at the time of that screening.(3) Individuals must submit documentation to the department related to certifications and refresher courses, as specified in §37.146 of this title (relating to Standards and Requirements for Screening Certification and Instructor Training).(b) Schools must comply with the following recordkeeping and reporting requirements:(1) Each school shall maintain spinal screening records under this section onsite for at least two years.(2) A school must maintain screening records regarding any individual claiming the exemptions found in §37.143(c) of this title (relating to Spinal Screening Procedures).(3) Spinal screening records are transferrable between schools without the consent of the individual or, if the individual is a minor, the minor's parent, managing conservator, or legal guardian.(4) The recordkeeping required in this section must be made available to the department in a timely manner upon request. The department may, directly or through its authorized representative, enter a school and inspect records maintained relating to spinal screening.(5) On or before June 30 of each year, each school shall submit to the department a complete and accurate annual report on the spinal screening status of its aggregate population screened during the reporting year. Schools shall report in the manner specified by the department (currently found at http://chrstx.dshs.state.tx.us). Schools are required to report on the following categories:(A) grade screened;(B) number screened under prior treatment;(C) total number screened;(D) total number rescreened;(E) total number abnormal findings;(F) number abnormal findings diagnosed by a physician as "normal;"(G) number abnormal findings diagnosed with scoliosis by a physician;(H) number abnormal findings diagnosed with kyphosis by a physician;(I) number abnormal findings diagnosed with another type of abnormal curvature by a physician;(J) number receiving a physician's treatment plan of observation;(K) number receiving a physician's treatment plan of orthosis bracing;(L) number receiving a physician's treatment plan of surgery;(M) number receiving a physician's treatment plan not indicated in subparagraphs (J) - (L) of this paragraph; and(N) number for whom a physician's treatment plan was unavailable.(c) All correspondence shall be submitted to the department under this subchapter, with the following contact information (unless otherwise specified): Vision, Hearing and Spinal Screening Program, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347. Source Note: The provisions of this §37.145 adopted to be effective January 12, 2015, 40 TexReg 238; amended to be effective January 1, 2018, 42 TexReg 6928. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.145 Recordkeeping and Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171170&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171170 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171170&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171170 03/11/2026 (a) Individuals who conduct spinal screening must be certified under this section unless the screening is conducted by a licensed professional. There are two options for obtaining this certification:(1) a certificate issued directly by the department; or(2) a certificate issued by an instructor who has been trained and authorized by the department to issue certificates.(b) The department offers certification courses, and issues certificates to those who successfully complete them. To be eligible to take the department's certification course, you must be a high school graduate and sign a written statement to that effect at the beginning of the course. Individuals who successfully complete the course, including passing the associated tests, will be issued a certificate by the department.(c) The department trains instructors who themselves give screener certification courses, as described in this section. The eligibility requirement to attend such a course is the same as is described in subsection (b) of this section. Individuals who successfully complete the course, including passing the associated tests, will be issued a certificate signed by the authorized instructor. It will have the same validity, and is subject to the same restrictions, as a certificate issued under subsection (b) of this section.(d) Screening certificates issued under this section are subject to the following requirements.(1) Individuals who receive a certificate are authorized to conduct spinal screening (as applicable to the course taken, and as listed on the certificate) in accordance with this subchapter. Certified screeners are required to comply with this subchapter, and failure to do so is grounds for the modification, suspension and/or revocation of the certification as provided in this section.(2) Screening certification under this section allows the individual to screen children for abnormal spinal curvature (as applicable to the course taken, and as listed on the certificate) under this subchapter for a period of five years, with renewals processed as described in paragraph (3) of this subsection.(3) Screening certification may be renewed by attending a department-approved refresher training course (either offered directly by the department or by an instructor authorized under this section). The refresher training course must be completed during the fifth year of certification from the date the preceding certificate was issued. Once a refresher training course is successfully completed, the five-year cycle begins again. If certification is not renewed within the required time period, the individual must attend the basic certification training course (i.e., a refresher course will not be sufficient).(4) When the department receives information from any source that indicates a screener has not been following the requirements of this subchapter, the department may modify, suspend, or revoke the certification. The department will send a notice to the affected individual as part of any such action being taken.(5) The affected individual has 20 days after receiving the notice, referenced in paragraph (4) of this subsection, to request a hearing on the proposed action. It is a rebuttable presumption that a notice is received five days after the date of the notice. Unless the notice letter specifies an alternative method, a request for a hearing shall be made in writing, and mailed or hand-delivered to the program at the address specified in §37.145(c) of this title (relating to Recordkeeping and Reporting). If an individual who is offered the opportunity for a hearing does not request a hearing within the prescribed time for making such a request, the individual is deemed to have waived the hearing and the action may be taken.(6) Appeals and administrative hearings will be conducted in accordance with the department's fair hearing rules in §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).(e) Individuals who successfully complete a department instructor training course are authorized to conduct screening trainings and issue screening certificates to individuals who successfully complete the screening training (including all associated testing), subject to the requirements of this section. Individuals wishing to take the instructor course must first meet the following qualifications:(1) have experience conducting trainings to groups of adults; and(2) be physicians, chiropractors, physical therapists, or registered nurses, and must have the applicable Texas license, current and in good standing under Texas law.(f) Department authorization for instructors to conduct trainings is valid until December 31st of the fifth year from the date certification was issued. The individual must successfully update their instructor status with the department by submitting an updated instructor application within 30 days of December 31st of the fifth year from the date the preceding certificate was issued. It is the responsibility of the individual to request an instructor application from the department. The department will issue a renewed certification following the receipt of a complete instructor application. Failure to comply with these requirements, by the deadline given, means that the individual must then attend the initial instructor training course. The department will notify spinal screening instructors of new or updated education required by the department and where it is available.(g) Once authorized by the department to conduct trainings, instructors must do so using training materials obtained from the department.(h) All proposed screening training sessions must be approved by the department at least 15 working days prior to the training session. The instructor must provide all information sought by the department, by the deadlines given.(i) Instructors in good standing under this section may teach screening refresher courses as described in subsection (d)(3) of this section. Such refresher courses are subject to the same requirements under this section as those pertaining to initial screening courses.(j) When a department-authorized instructor issues a certificate of spinal screening, the instructor has 14 days to submit the participant rosters and evaluations to the department. These original documents should be submitted to the program at the address found in §37.145(c) of this title. The instructor should maintain a copy.(k) When the department receives information from any source that indicates a screening instructor has not been following the requirements of this subchapter, the department may modify, suspend, or revoke the certification. The department will send a notice to the affected individual as part of any such action being taken.(l) The affected individual has 20 days after receiving the notice, referenced in subsection (k) of this section, to request a hearing on the proposed action. It is a rebuttable presumption that a notice is received five days after the date of the notice. Unless the notice letter specifies an alternative method, a request for a hearing shall be made in writing, and mailed or hand delivered to the program at the address specified in §37.145(c) of this title. If an individual who is offered the opportunity for a hearing does not request a hearing within the prescribed time for making such a request, the individual is deemed to have waived the hearing and the action may be taken.(m) Appeals and administrative hearings will be conducted in accordance with the department's fair hearing rules in §§1.51 - 1.55 of this title. Source Note: The provisions of this §37.146 adopted to be effective January 12, 2015, 40 TexReg 238. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.146 Standards and Requirements for Screening Certification and Instructor Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171171&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171171 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171171&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171171 03/11/2026 When spinal screening indicates possible abnormal spinal curvature, the child's parent, managing conservator, or guardian is responsible for securing the services of a qualified licensed professional to perform a professional examination to diagnose the problem. Source Note: The provisions of this §37.147 adopted to be effective January 12, 2015, 40 TexReg 238. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.147 Responsibilities of Parent, Managing Conservator, or Guardian https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171172&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171172 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171172&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171172 03/11/2026 No person shall be excluded from participation, be denied benefits, or be otherwise subjected to discrimination in the department's Spinal Screening Program on the grounds of race, color, national origin, sex, religion, disability, or age. Source Note: The provisions of this §37.148 adopted to be effective January 12, 2015, 40 TexReg 238. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES G SPINAL SCREENING PROGRAM §37.148 Nondiscrimination Statement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122571&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122571 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122571&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122571 03/11/2026 The purpose of these sections is to define sudden infant death syndrome (SIDS) and to establish a reimbursement mechanism for autopsies for children younger than 12 months of age who die unexpectedly and whose primary cause of death is SIDS. Source Note: The provisions of this §37.171 adopted to be effective April 23, 2000, 25 TexReg 3271; amended to be effective January 8, 2006, 30 TexReg 8883. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES H SUDDEN INFANT DEATH SYNDROME §37.171 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122569&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122569 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122569&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122569 03/11/2026 The following words and terms pertain explicitly to this subchapter and shall have the following meanings, unless the context clearly indicates otherwise.(1) Autopsy--A post mortem examination of the body of a person, including X-rays, toxicology screen, and an examination of the internal organs and structures after dissection, to determine the cause of death or the nature of any pathological changes that may have contributed to the death.(2) Infant--A child who is younger than 12 months of age.(3) Sudden infant death syndrome (SIDS)--Death of an infant which remains unexplained after all known causes have been ruled out through a complete autopsy, death scene investigation, and medical and social history including, but not limited to, a family history of the infant as designated by Child Protective Services. Source Note: The provisions of this §37.172 adopted to be effective April 23, 2000, 25 TexReg 3271; amended to be effective January 8, 2006, 30 TexReg 8883. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES H SUDDEN INFANT DEATH SYNDROME §37.172 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122570 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=122570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 122570 03/11/2026 (a) The department shall reimburse the county in which an infant dies for the cost of an autopsy performed as required by Health and Safety Code, §673.002, only if the primary cause of death is SIDS.(b) Reimbursement by the department of all costs associated with an autopsy performed by any person or entity shall not exceed $500.(c) The county judge for the county in which the infant died shall sign and submit to the Department of State Health Services a state purchase voucher (voucher) requesting reimbursement for costs of the autopsy. A county's claim for reimbursement shall be submitted within 90 days following the completion of the written autopsy report, and shall include a copy of the signed autopsy report.(d) The department shall process the voucher and shall request that a warrant be issued for not more than $500 payable to the county in which the infant died, if the primary cause of death stated on the autopsy report or the death certificate is SIDS.(e) The department shall process no more than one voucher requesting reimbursement of autopsy costs for an infant.(f) Reimbursements to counties under this section shall be limited by the availability of funds. Source Note: The provisions of this §37.173 adopted to be effective April 23, 2000, 25 TexReg 3271; amended to be effective January 8, 2006, 30 TexReg 8883. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES H SUDDEN INFANT DEATH SYNDROME §37.173 Reimbursement for Costs of Autopsy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13045&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13045 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13045&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13045 03/11/2026 (a) The Texas Department of Health adopts by reference a memorandum of understanding entered into between the department and the Texas Department of Human Services, concerning a coordinated statewide family planning program in Texas.(b) Copies of the memorandum of understanding are filed in the Bureau of Maternal and Child Health, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, and may be reviewed during regular business hours. Source Note: The provisions of this §37.191 adopted to be effective August 2, 1988, 13 TexReg 3577. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES I MEMORANDA OF UNDERSTANDING §37.191 Memorandum of Understanding Concerning a Coordinated Statewide Family Planning Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13046&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13046 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13046&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13046 03/11/2026 (a) The Texas Department of Health adopts by reference a memorandum of understanding (MOU) concerning community interagency staffing of services for multiproblem children and youth. The MOU is entered into between the Texas Department of Health, the Texas Department of Human Services, the Texas Department of Mental Health and Mental Retardation, the Texas Education Agency, the Texas Commission for the Blind, the Texas Juvenile Probation Commission, the Texas Rehabilitation Commission, and the Texas Youth Commission.(b) Copies of the MOU are filed in the Office of the Associate Commissioner for Personal Health Services, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756 and may be reviewed during regular business hours. Source Note: The provisions of this §37.192 adopted to be effective March 31, 1989, 14 TexReg 1411. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES I MEMORANDA OF UNDERSTANDING §37.192 Memorandum of Understanding on Multiproblem Children and Youth https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13049&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13049 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13049&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13049 03/11/2026 (a) The Texas Department of Health adopts by reference a memorandum of understanding (MOU) covering the delivery of services to persons who are deaf. The MOU is entered into between the Texas Department of Health and the Texas Commission for the Deaf.(b) Copies of the MOU are filed in the office of the Associate Commissioner for Personal Health Services, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and may be reviewed during regular business hours. Source Note: The provisions of this §37.193 adopted to be effective July 31, 1989, 14 TexReg 3464. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES I MEMORANDA OF UNDERSTANDING §37.193 Memorandum of Understanding Covering the Delivery of Services to Persons Who Are Deaf https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13052&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13052 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13052&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13052 03/11/2026 (a) Definitions. The following words and terms, when used in this section, shall have the following meaning unless the context clearly indicates otherwise:(1) Act-House Bill 893, 68th Legislature, 1983, covering transportation of an infant to a hospital's level III neonatal intensive care unit.(2) Department-Texas Department of Health.(3) Infant-For the purposes of this rule, infant means the neonatal period, i.e., through the first 28 days of life.(b) Hospitals which may participate. A hospital qualifies for possible reimbursement under the Act if it furnishes to the department's Bureau of Crippled Children's Services written documentation that the hospital has a level III neonatal intensive care unit which complies with current American Academy of Pediatrics' standards. This documentation must be furnished by the hospital to the department annually.(c) Reimbursement procedures.(1) All requests for payment from a qualifying hospital shall be sent to the Bureau of Crippled Children's Services, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.(2) A request for payment from a qualifying hospital must be accompanied by a statement signed by the administrator certifying that the cost, or portion thereof, for which the department is being billed cannot be borne by a member of the infant's immediate family or other person legally liable for the infant's support by personal means, through insurance or through any other benefit system that pays for medical transportation. The request for payment must identify the transported infant by name, date of birth, diagnosis, parent's name, address, and social security number and must provide a detailed list of billed charges and the date on which the transport occurred.(3) Charges submitted must be actual cost usually and customarily paid by the hospital to a provider of transportation or, if provided by the hospital, costs not greater than the facility's usual and customary charges for transportation services. Charges must be submitted within 60 days of the service provision. Charges received later than 60 days after the provision of the service will not be considered for payment.(4) Payment by the department is subject to the availability of funds designated to the department under provision of the Act. Charges will be processed for payment in order they are received, and if charges are received after designated available funds are depleted during a fiscal year, no payment will be made for these charges by the department. Further, the charges received by the department after funds for a fiscal year are depleted cannot be considered for payment from possible future funding. Source Note: The provisions of this §37.201 adopted to be effective December 31, 1983, 8 TexReg 4748. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES J NEONATAL CARE §37.201 Transportation of an Infant to a Hospital's Level III Neonatal Intensive Care Unit https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64966&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64966 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64966&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64966 03/11/2026 The purpose of these sections is to establish the procedures and standards for the implementation of a statewide system for perinatal health care that fosters:(1) safe, quality, risk-appropriate perinatal care for women and for their infants;(2) continuity and comprehensiveness of care;(3) optimal and cost-effective utilization of perinatal personnel and facilities; and(4) access for women to health promotion and health education from preconception through the postpartum period, and parenting information through the first year of their infants' lives. Source Note: The provisions of this §37.251 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.251 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64967&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64967 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64967&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64967 03/11/2026 The following words and terms pertain explicitly to this subchapter and shall have the following meanings, unless the context clearly indicates otherwise.(1) Basic perinatal facility--An inpatient facility providing care during the prenatal period for women and infants whose care is or is expected to be uncomplicated.(2) Department--Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.(3) Health education--Provision of health information and anticipatory guidance concerning nutrition, fitness, and the prevention and early recognition of perinatal risk conditions and/or illnesses.(4) Health promotion--Provision of information or activities which motivate individuals to adopt healthy behaviors, including the appropriate use of health resources.(5) Infant--An individual from birth through the first year of life.(6) Intrapartum--The period beginning at the onset of labor or childbirth and ending with delivery.(7) Neonate--An infant from birth through 28 completed days after birth.(8) Parenting information--Information provided to any person responsible for the care of a child about practices which promote the child's mental and physical health and quality of life.(9) Perinatal--The period which begins before conception in a woman of child-bearing age and ends on the infant's first birthday.(10) Postpartum--The six-week period following delivery.(11) Prenatal--The period beginning on the date of conception and ending with the commencement of labor or childbirth.(12) Provider--A person, facility, and/or organized entity that delivers or affects the delivery of perinatal care.(13) Specialty perinatal facility--An inpatient facility providing care during the prenatal period for women and infants whose care is or is expected to be uncomplicated as well as for the majority of those women and infants who are at high risk for or who require complicated care.(14) State--The State of Texas.(15) Subspecialty perinatal facility--An inpatient facility providing care during the prenatal period for all pregnant women and infants, including those with serious illnesses and abnormal health conditions. Source Note: The provisions of this §37.252 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.252 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64968&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64968 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64968&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64968 03/11/2026 (a) Activities of the department and providers pursuant to this subchapter will be conducted in accordance with guidelines and standards for perinatal care found in the following obstetric and pediatric professional publications: (1) Guidelines for Perinatal Care, Fourth Edition (American Academy of Pediatrics, American College of Obstetricians and Gynecologists, 1997). (A) Table 1-1: Ambulatory Prenatal Care Provider Capabilities and Expertise, page 3; (B) Table 1-2: Health Screening for Women of Reproductive Age, page 10; (C) Table 2-1: Recommended Nurse/Patient Ratios for Perinatal Care Services, page 19; (D) Table 4-2: Risk Factors Associated with Spontaneous Preterm Labor and Birth, page 89; (E) Appendix B: Early Pregnancy Risk Identification for Consultation, pages 299-300; (F) Appendix C: Ongoing Pregnancy Risk Identification for Consultation, pages 301-302; (G) Appendix D: Federal Requirements for Patient Screening and Transfer, pages 303-309; (H) In-Hospital Perinatal Care, pages 4-7; (I) Inpatient Perinatal Care Services, pages 13-50; (J) Interhospital Care of the Perinatal Patient, pages 51-61; (K) Patient Education, pages 68-70; (L) Risk Assessment and Management, page 76; (M) Intrapartum Care, pages 91-125; and (2) Toward Improving The Outcomes of Pregnancy, The 90s and Beyond (March of Dimes, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists, 1993); (A) Table 1: Content of Reproductive Health Screening, page 15; (B) Appendix 4a: Early Pregnancy Risk Identification, page 96; (C) Appendix 4b: Ongoing Pregnancy Risk Identification, page 97; (D) Appendix 6: Levels of Inpatient Perinatal Care, pages 102-115. (b) Copies of these publications may be viewed during normal business hours at the Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199 or they may be obtained from the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, or the March of Dimes publications office. Contact numbers for these organizations are available from the department at the address in this subsection. Source Note: The provisions of this §37.253 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.253 Professional Standards/Guidelines https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64969&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64969 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64969&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64969 03/11/2026 (a) The department shall develop and maintain a reporting and analysis system to monitor outcomes of the statewide perinatal care system.(b) The department shall request information as specific issues arise from persons with expertise in the provision of perinatal care, data analysis, and community networking/systems development, including, but not limited to, individuals from academic institutions, professional groups, advocacy groups, and other state agencies. The department shall also seek ongoing input from consumers or recipients of perinatal care and from representatives of their identified community-based social support systems (e.g. extended families, churches).(c) The department shall facilitate the organization and operations of the perinatal resource coordinating groups described in §37.256 of this title (relating to Perinatal Resource Coordinating Groups).(d) The department shall facilitate cooperation and coordination with perinatal care providers and systems in adjoining states. Source Note: The provisions of this §37.254 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.254 Statewide Oversight of the Perinatal Care System and Interstate Cooperation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64970&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64970 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64970&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64970 03/11/2026 (a) Eight perinatal planning areas (PPAs), encompassing every county in the state, shall be established for descriptive, planning, and continuous quality improvement purposes. The PPA boundaries shall be based upon the regional organization of the Texas Health and Human Services Commission (HHSC).(b) PPA boundaries are not intended to restrict decisions concerning client referral or transfer to other facilities or providers.(c) The perinatal planning areas shall include the following counties:(1) Area One (HHSC Region 1): Armstrong, Bailey, Briscoe, Carson, Castro, Childress, Cochran, Collingsworth, Crosby, Dallam, Deaf Smith, Dickens, Donley, Floyd, Garza, Gray, Hale, Hall, Hansford, Hartley, Hemphill, Hockley, Hutchinson, King, Lamb, Lipscomb, Lubbock, Lynn, Moore, Motley, Ochiltree, Oldham, Parmer, Potter, Randall, Roberts, Sherman, Swisher, Terry, Wheeler, and Yoakum;(2) Area Two (HHSC Region 2/3): Archer, Baylor, Brown, Callahan, Clay, Coleman, Collin, Comanche, Cooke, Cottle, Dallas, Denton, Eastland, Ellis, Erath, Fannin, Fisher, Foard, Grayson, Hardeman, Haskell, Hood, Hunt, Jack, Johnson, Jones, Kaufman, Kent, Knox, Mitchell, Montague, Navarro, Nolan, Palo Pinto, Parker, Rockwall, Runnels, Scurry, Shackelford, Somervell, Stephens, Stonewall, Tarrant, Taylor, Throckmorton, Wichita, Wilbarger, Wise, and Young;(3) Area Three (HHSC Region 4/5): Anderson, Angelina, Bowie, Camp, Cass, Cherokee, Delta, Franklin, Gregg, Harrison, Henderson, Hopkins, Houston, Jasper, Lamar, Marion, Morris, Nacogdoches, Newton, Panola, Polk, Rains, Red River, Rusk, Sabine, San Augustine, San Jacinto, Shelby, Smith, Titus, Trinity, Tyler, Upshur, Van Zandt, and Wood;(4) Area Four (HHSC Region 6/5): Austin, Brazoria, Chambers, Colorado, Fort Bend, Galveston, Hardin, Harris, Jefferson, Liberty, Matagorda, Montgomery, Orange, Walker, Waller, and Wharton;(5) Area Five (HHSC Region 7): Blanco, Bosque, Brazos, Burleson, Burnet, Caldwell, Coryell, Falls, Fayette, Freestone, Grimes, Hamilton, Hays, Hill, Lampasas, Lee, Leon, Limestone, Llano, McLennan, Madison, Milam, Mills, Robertson, San Saba, Travis, Washington, and Williamson;(6) Area Six (HHSC Region 8): Atascosa, Bandera, Bexar, Calhoun, Comal, De Witt, Dimmit, Edwards, Frio, Gillespie, Goliad, Gonzales, Guadalupe, Jackson, Karnes, Kendall, Kerr, Kinney, La Salle, Lavaca, Maverick, Medina, Real, Uvalde, Val Verde, Victoria, Wilson, and Zavala;(7) Area Seven (HHSC Region 9/10): Andrews, Borden, Brewster, Coke, Concho, Crane, Crockett, Culberson, Dawson, Ector, El Paso, Gaines, Glasscock, Howard, Hudspeth, Irion, Jeff Davis, Kimble, Loving, McCulloch, Martin, Mason, Menard, Midland, Pecos, Presidio, Reagan, Reeves, Schleicher, Sterling, Sutton, Terrell, Tom Green, Upton, Ward, and Winkler; and(8) Area Eight (HHSC Region 11): Aransas, Bee, Brooks, Cameron, Duval, Hidalgo, Jim Hogg, Jim Wells, Kenedy, Kleberg, Live Oak, McMullen, Nueces, Refugio, San Patricio, Starr, Webb, Willacy, and Zapata. Source Note: The provisions of this §37.255 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.255 Perinatal Planning Areas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64971&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64971 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64971&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64971 03/11/2026 (a) A perinatal resource coordinating group (PRCG) shall be established within each perinatal planning area (PPA) to examine outcomes, to develop community-based plans for continuous improvement of perinatal care services, to work with communities in order to foster perinatal networks, and to develop at-risk and emergency transfer/transport protocols, considering the standards/guidelines listed in §37.253 of this title (relating to Professional Standards/Guidelines).(b) A PRCG shall be established in each PPA within five years from the date this subchapter becomes effective.(c) PRCG members shall be initially recruited by the following department staff:(1) the Regional Medical Director or designee from the region in which most of the counties in the PPA are located;(2) a representative of the Emergency Medical Services Division; and(3) representatives from the Medicaid and maternal and child health programs.(d) PRCG membership shall include broad-based community representation from the counties in the PPA; perinatal providers, including basic, specialty, and subspecialty perinatal care facilities; advocacy groups; consumers; social support systems; and primary care residency programs. PRCG membership shall reflect the demographics of the population.(e) Each PRCG shall adopt bylaws describing the purpose; membership and member terms; officers and their terms of office; and periodicity of meetings.(f) The department shall provide data and technical assistance to the PRCGs.(g) Each PRCG shall be charged with:(1) analyzing perinatal data, including, but not limited to the following:(A) reports provided by the department concerning the perinatal vital statistics in the PPA; and(B) aggregated reports of problems identified by the maternal, neonatal, and infant mortality review committees of each participating facility and by communities in the PPA;(2) responding to consumer and/or provider complaints that pertain to perinatal care and that have been directed to the PRCG;(3) responding to complaints that pertain to perinatal care originally received by the Texas Department of Insurance and/or the department;(4) identifying and supporting health care delivery systems and social support infrastructures within the communities of the PPA that enhance the quality of perinatal health care;(5) providing technical assistance to communities to enhance coordination of perinatal service planning and delivery among perinatal network providers (including perinatal transport providers), consumers, and community-based support entities within the PPA;(6) identifying unmet community needs, such as gaps in perinatal care or breakdowns in communications; and(7) developing a community-based perinatal plan to coordinate existing services and address unmet needs that builds upon and bolsters community strengths, health care delivery systems, and social support infrastructures. The plan will address community-based, culturally competent health promotion activities, both consumer and provider health education, the development and support of perinatal networks, and referral/transport protocols for high-risk pregnant women and newborn infants. Source Note: The provisions of this §37.256 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.256 Perinatal Resource Coordinating Groups https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64972&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64972 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64972&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64972 03/11/2026 (a) The perinatal resource coordinating group (PRCG) in each perinatal planning area (PPA) shall submit for approval to the department an initial perinatal plan concerning the provision of perinatal care for women of child-bearing age and infants within the PPA. The plan shall be submitted in a format specified by the department.(b) Each PRCG shall submit an annual revised plan in a format specified by the department.(c) The initial plan and any revisions shall be subject to approval by the department, contingent upon documentation of the following:(1) individuals representing the geographic and demographic diversity of all counties within the PPA have been involved in the development and implementation of the plan;(2) individuals representing all perinatal care facilities have been given an opportunity to participate in the planning and implementation process, through participation in either the PRCG or the perinatal network(s);(3) mechanisms are in place for communication and coordination of services among the PPA perinatal network(s);(4) the plan includes:(A) a list of participants in the PRCG and the perinatal network(s);(B) a list of identified strengths and unmet needs of the PPA based on analysis of the PPA data, registered complaints, and discussions with consumers, community-based support entities, and perinatal providers;(C) a list of goals and objectives to improve the quality of perinatal care based upon the identified strengths and unmet needs in the PPA and the health outcomes measures referenced in §37.258 of this title (relating to Data Analysis and Progress Report);(D) mechanisms for completing referrals and returning reports of care provided among the perinatal care providers;(E) protocols for exchange of confidential patient records among participating providers in the perinatal planning area;(F) descriptions of emergency transport capability requirements and protocols;(G) protocols for at-risk and emergency maternal and neonatal transfer from one hospital to another for the purpose of receiving more intensive or specialized care;(H) protocols for return transfer of a pregnant woman and/or her infant from a referral center to the original referring hospital or to a local hospital for continuing care;(I) triage criteria for appropriate level referrals; and(J) mechanisms and protocols for:(i) conducting high-risk screening and counseling guidance;(ii) increasing community awareness of the existence of the perinatal plan(s) and the importance of early and preventive care for women of child-bearing age and infants;(iii) increasing consumer access to the perinatal network(s);(iv) continuing improvement of the quality of perinatal care; and(v) community-based and area-wide perinatal health education, health promotion, and dissemination of parenting information. Source Note: The provisions of this §37.257 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.257 Perinatal Plans https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64973&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64973 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64973&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64973 03/11/2026 (a) Annually the department shall provide each perinatal resource coordinating group (PRCG) with:(1) information pertaining to the population of women of child-bearing age and infants within its perinatal planning area (PPA), including:(A) neonatal mortality rate, postneonatal (beginning after 28 completed days after birth and extending through one completed year of life) mortality rate, infant mortality rate, and maternal mortality rate;(B) information collated from birth and death certificates, including but not limited to:(i) trimester of entry into prenatal care;(ii) number of prenatal visits related to time of entry into prenatal care;(iii) maternal use of tobacco, drugs, and alcohol;(iv) number of low birth weight infants;(v) number of pre-term infants;(vi) numbers and rates of low birth weight and very low birth weight infants by facility of birth;(vii) causes of infant deaths;(viii) causes of maternal deaths;(ix) maternal transports and infant transports; and(C) other information available from state reported data and registries upon request of the PRCG; and(2) information recorded by the department pertaining to the perinatal care facilities within the PPA, including licensure status and level designation as perinatal center.(b) Each PRCG shall file an annual report in a format approved by the department describing its activities and progress toward outcome objectives projected in the plan or in the revised plan, as described in §37.257 of this title (relating to Perinatal Plans). The report shall include:(1) evidence that the members of the PRCG and perinatal networks are involved in evaluation and management of the plan;(2) changes in the membership of the PRCG;(3) documentation of community-based consumer education, including topics concerning prevention of health risks; the importance of early and regular preventive health check-ups; and access to the perinatal care systems;(4) documentation of perinatal provider education concerning the availability of high risk screening tools, patient counseling, referral protocols, and population-based health needs assessment; and(5) documentation of progress toward the goals and objectives stated in their plan.(c) The department shall maintain the confidentiality of all information in these reports to the extent authorized by the Texas Open Records Act, Government Code, Chapter 552. Source Note: The provisions of this §37.258 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.258 Data Analysis and Progress Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64974&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64974 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=64974&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 64974 03/11/2026 (a) The department or its designee(s) shall request inpatient facilities to report to the department their self-designations as basic, specialty, or subspecialty perinatal care facilities. Designations shall be self-reported by facilities based upon the standards and guidelines in the publications listed in §37.253 of this title (relating to Professional Standards/Guidelines). Facilities shall select the designation category that most accurately describes their capacity to provide perinatal care.(b) Each facility providing inpatient perinatal care may voluntarily report to the department its self-designated category.(c) The department shall publish the designation categories of all participating perinatal facilities in each perinatal planning area annually.(d) The department or its designees may evaluate a facility to confirm the facility's self-declared designation category through a random review process or upon request by a perinatal resource coordinating group (PRCG), at the discretion of the department.(e) The review team for specialty and subspecialty perinatal facilities may include board certified/eligible specialists in obstetrics, maternal-fetal medicine, pediatrics, and neonatal-perinatal medicine, as appropriate for the facility to be reviewed, and one or more department representatives.(f) The review team for basic perinatal facilities may include one or more active perinatal care providers and one or more department representatives.(g) The department shall provide a copy of the review report and recommendations to the reviewed facility, the review team, and the PRCG.(h) Whenever a facility review is conducted, the department may confirm the self-declared designation or approve a different designation.(i) If a perinatal care facility disagrees with the department's designation decision, the facility may request an administrative hearing which shall be conducted according to §§1.51-1.55 of this title (relating to Fair Hearing Procedures).(j) A participating perinatal care facility shall notify the department and its PRCG within 30 days if it is unable or chooses not to continue providing perinatal care commensurate with its designation category. Source Note: The provisions of this §37.259 adopted to be effective July 18, 1999, 24 TexReg 5196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES M TEXAS PERINATAL CARE SYSTEM §37.259 Designation of Perinatal Care Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224196&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224196 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224196&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224196 03/11/2026 These sections implement the provisions of Health and Safety Code, Chapter 87, that provides the authority to adopt rules relating to the surveillance and control of birth defects. The legislation directs the Texas Department of Health to develop a statewide surveillance program. The Texas Department of Health and the Texas Board of Health were abolished by Chapter 198, §§1.18 and 1.26, 78th Legislature, Regular Session, 2003. Health and Safety Code, Chapter 1001, establishes the Department of State Health Services (department), which now administers these programs. Texas Government Code §524.0005, provides authority to the Executive Commissioner of the Health and Human Services Commission to adopt rules for the department. Source Note: The provisions of this §37.301 adopted to be effective October 20, 1994, 19 TexReg 8032; amended to be effective August 28, 2003, 28 TexReg 6854; amended to be effective December 12, 2005, 30 TexReg 8291; amended to be effective November 4, 2009, 34 TexReg 7649; amended to be effective April 1, 2025, 50 TexReg 994. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES P SURVEILLANCE AND CONTROL OF BIRTH DEFECTS §37.301 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143008&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143008 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143008&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143008 03/11/2026 (a) The department, recognizing the sensitive and confidential nature of information collected regarding birth defects and their possible causes, expects all staff to carry out all duties in a professional, compassionate, and culturally sensitive manner.(b) The department shall limit medical researcher contact with individuals and families identified by the central registry to only those studies with high scientific merit with no feasible alternate means of conducting the study.(c) The department shall protect patient information from disclosure through the legal process and Government Code, Chapter 552. Source Note: The provisions of this §37.302 adopted to be effective October 20, 1994, 19 TexReg 8032; amended to be effective August 28, 2003, 28 TexReg 6854; amended to be effective December 12, 2005, 30 TexReg 8291; amended to be effective November 4, 2009, 34 TexReg 7649. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES P SURVEILLANCE AND CONTROL OF BIRTH DEFECTS §37.302 Policy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143009&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143009 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143009&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143009 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Birth defect--A physical or mental functional deficit or impairment in a human embryo, fetus, or newborn resulting from one or more genetic or environmental causes.(2) Birthing center--A place, facility, or institution at which a woman is scheduled to give birth following a normal, uncomplicated pregnancy, but does not include a hospital or the residence of the woman giving birth.(3) Case finding--The process used to identify potential cases for inclusion in the central registry of the program. Potential cases are obtained through review of medical and health records, logs, indices, appointment rosters and other records.(4) Central registry--Cases of birth defects obtained through the surveillance activity of the program.(5) Commissioner--The Department of State Health Services Commissioner.(6) Communicable disease--An illness that occurs through the transmission of an infectious agent or its toxic products from a reservoir to a susceptible host, either directly, as from an infected person or animal, or indirectly through an intermediate plant or animal host, a vector, or the inanimate environment.(7) Department--The Department of State Health Services.(8) Environmental cause--The sum total of all the conditions and elements that make up the surroundings and influence the development of an individual.(9) Harmful physical agent--A physical phenomenon, other than a toxic substance, that has or may have carcinogenic, mutagenic, teratogenic, or other harmful effects on humans, and includes ionizing radiation, X-rays, gamma rays, ultraviolet light, or other electromagnetic radiation; and acoustical, thermal, or mechanical vibration.(10) Health facility--Any of the following types of facility:(A) a general or special hospital licensed by the department under Health and Safety Code, Chapter 241;(B) a physician-owned or physician-operated clinic;(C) a publicly or privately funded medical school;(D) a state hospital maintained and managed by the Department of State Health Services and a state mental retardation facility maintained and managed by the Department of Aging and Disability Services;(E) a genetic evaluation and counseling center;(F) a public health clinic conducted by a local health unit, health department, or public health district organized and recognized under Health and Safety Code, Chapter 121;(G) a physician peer review organization;(H) a birthing center; or(I) a clinical or medical laboratory.(11) Health professional--An individual whose:(A) vocation or profession is directly or indirectly related to the maintenance of health in another individual; and(B) duties require a specified amount of formal education or training and may require a special examination, certificate, license, or membership in a regional or national association.(12) Local health unit--A division of municipal or county government that provides public health services but does not provide each service required of a local health department under Health and Safety Code, §121.032(a), or of a public health district under Health and Safety Code, §121.043(a).(13) Midwife--A person who practices midwifery and has met the requirements of the standards of the midwifery board.(14) Surveillance--The systematic collection, analysis, interpretation, and dissemination of health data on an ongoing basis.(A) Active surveillance--program staff regularly contact or visit data sources, or use remote electronic access, to find and collect data on cases.(B) Passive surveillance--program receives case reports from data sources.(15) Toxic substance--A substance that has or may have toxic, carcinogenic, mutagenic, teratogenic, or other harmful effects on humans, and includes a product that contains a toxic substance that poses or may pose a substantial hazard to human health. Source Note: The provisions of this §37.303 adopted to be effective October 20, 1994, 19 TexReg 8032; amended to be effective August 28, 2003, 28 TexReg 6854; amended to be effective December 12, 2005, 30 TexReg 8291; amended to be effective November 4, 2009, 34 TexReg 7649. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES P SURVEILLANCE AND CONTROL OF BIRTH DEFECTS §37.303 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143010&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143010 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143010&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143010 03/11/2026 (a) Reports, records, and other information collected by, or provided to the department relating to persons known to have, or suspected of having a birth defect are confidential records and not public information and may not be released except as described in subsection (b) of this section. The confidential records include medical and other information obtained as part of epidemiologic or other investigations and the records and information gathered as part of the operation of the central registry.(b) The department may release demographic, medical, epidemiological, or toxicological information:(1) for statistical purposes, if released in a manner that prevents the identification of any person;(2) with the consent of each person identified in the information or, if the person is unable to consent or is a minor, the minor's parents, managing conservator, guardian, or other person who is legally authorized to consent;(3) to medical personnel, appropriate state agencies, health authorities, regional directors, and public officers of counties and municipalities relating to the identification, monitoring, and referral of children with birth defects;(4) to appropriate federal agencies such as the Centers for Disease Control and Prevention of the United States Public Health Service;(5) to medical personnel to the extent necessary to protect the health or life of the child identified in the information; or(6) to medical researchers conducting bona fide medical research under the conditions described in §37.306 of this title (relating to Access to Information in the Central Registry), and Health and Safety Code, §87.063. Source Note: The provisions of this §37.304 adopted to be effective October 20, 1994, 19 TexReg 8032; amended to be effective August 28, 2003, 28 TexReg 6854; amended to be effective December 12, 2005, 30 TexReg 8291; amended to be effective November 4, 2009, 34 TexReg 7649. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES P SURVEILLANCE AND CONTROL OF BIRTH DEFECTS §37.304 Confidentiality of Information Provided to the Department https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143011&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143011 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143011&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143011 03/11/2026 (a) The central registry shall use a birth defects coding scheme used by the Centers for Disease Control and Prevention (CDC) of the United States Public Health Service in their birth defects monitoring programs.(b) In order for information related to a child to be included in the central registry, the following conditions must be met.(1) The county of occurrence of birth or the mother's residence at the time of birth must have been in Texas.(2) The child must have a structural or genetic birth defect or other specified outcome that can adversely affect his or her health and development as defined in subsection (a) of this section.(3) The defect must be diagnosed prenatally or within one year after delivery. In certain circumstances (e.g., the diagnosis of fetal alcohol syndrome, special studies and childhood genetic disorders diagnosed after infancy), the upper age limit will be extended to age six.(4) In addition, reports of Fetal Alcohol Spectrum Disorders (FASD), regardless of the affected person's age, will be collected under Health and Safety Code, §87.021(f), of the statute providing for passive data collection.(c) A reportable defect as defined in subsection (a) of this section occurring in a fetal death or pregnancy termination shall be included in the central registry.(d) Interaction between department staff and health facility staff is detailed below:(1) The chief operating officer, administrator, manager, director, and/or person in charge of each facility or office or center shall appoint one staff member as the contact person for the central registry surveillance activities. That staff member will coordinate scheduled visits and/or remote electronic access by central registry staff to review logs, discharge indices and other case-finding sources, and will be responsible for arranging visits and/or remote electronic access for medical records review and providing the needed records at the time scheduled.(2) Potential cases are obtained by department staff through review of medical and health records, logs, indices, appointment rosters, and other records. Cases may also be obtained through passive reporting from health facilities and health professionals.(3) Central registry staff and the contact individual shall establish a general schedule of visits and/or remote electronic access for case-finding and record review. This schedule shall take into account the capabilities of the health care facility in responding to requests, as well as the expected needs of the central registry workload.(e) The medical records and other materials provided by the health care facility shall not be removed from that facility. If copies are made, registry staff must abide by procedures regarding copier use agreed upon with each health care facility. All information, either on paper or in electronic form, which is removed from the health care facility shall be transported by secure means at all times. Forms, notes, and other information will be carried in locked brief cases and will be stored in locked offices or locked file cabinets. Source Note: The provisions of this §37.305 adopted to be effective October 20, 1994, 19 TexReg 8032; amended to be effective August 28, 2003, 28 TexReg 6854; amended to be effective December 12, 2005, 30 TexReg 8291; amended to be effective November 4, 2009, 34 TexReg 7649. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES P SURVEILLANCE AND CONTROL OF BIRTH DEFECTS §37.305 Surveillance of Birth Defects: Central Registry https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143012 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=143012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 143012 03/11/2026 (a) An application for access to any confidential data elements for individual patients identified as part of the operation of the central registry must contain a protocol and be submitted to the program manager. The protocol shall explain the applicant's "valid scientific interest" by describing, at length:(1) the name and qualifications of the principal investigator, professional staff, and every person who will review, analyze, or access the data;(2) the background justification for the study;(3) the goals and aims of the proposed study;(4) the health outcomes of interest;(5) the methodology for measuring exposures;(6) the methodology for measuring and adjusting for confounding variables;(7) the precise statistical techniques to be used in the analysis of data, including power and methods to address biases inherent in the study design and data;(8) the time tables and feasibility for completion of the study;(9) the level and sources of funding for the study;(10) an explanation of the potential benefits and disadvantages involving human subjects;(11) the plans to maintain the confidentiality of the information provided by the department; and(12) a discussion of the project's pertinence to the fields of medical research, medical care, public health, epidemiology, biostatistics, or maternal and child health(b) After the program manager receives the completed request for information, the protocol will be reviewed by a program review panel. The panel shall consist of the program manager, the unit manager, and a departmental epidemiologist. Upon approval by the program panel, the protocol shall be evaluated and judged by the department's institutional review board. Final approval of the protocol shall require the approval of both the program panel and the institutional review board and shall be based on an evaluation of the criteria listed in subsection (c) of this section. The department's institutional review board shall evaluate the research based on federal regulations found in Title 45, Code of Federal Regulations, Chapter 46.(c) The evaluation criteria for approval by the program review panel shall include the following.(1) The key investigators shall have significant training and experience in biomedical research as demonstrated by a history of prior research and publication of results in peer-reviewed journals. For bona fide student proposals, faculty committee members should possess these qualifications.(2) The background reasons for conduct of the proposed study shall be compelling, as judged by the importance of the scientific question being asked, relative to the fields of epidemiology, medicine, public health or other medical research.(3) The goals and aims shall be clearly stated, consistent with the scientific question, and relevant to the field.(4) If appropriate, the methods for measuring or estimating exposure shall be scientifically valid.(5) The roles of other factors (that might be related to both the exposures and the birth defects studied) shall be considered, and the methods for measuring and adjusting for these factors shall be clear and scientifically valid.(6) If appropriate, power calculations shall indicate a reasonable chance of identifying expected differences between groups.(7) The statistical techniques to be used in data analysis, including methods to address biases in the study design shall be clear and appropriately used.(8) The potential benefits and disadvantages of working with human subjects must be clearly described.(9) Plans of how the investigators propose to maintain the confidentiality and integrity of the information provided by the department shall be clearly detailed.(10) The hypothesis or topic to be studied must not already be under investigation.(d) Modification to the protocol or other terms and conditions may be required before releasing any data.(e) If the applicant intends to contact individuals whose names were provided by the program, the protocol must contain strong methodologic support for the need for such contact.(f) If the protocol is approved by both the program panel and the institutional review board, then the researcher shall be considered to have established a valid scientific interest as required. The program manager shall so advise the Commissioner. The researcher will be required to comply with the conditions of subsections (g) and (h) of this section before any data will be released.(g) If permission is granted, the applicant shall be responsible for costs incurred by the program in making the data available in compliance with established procedures for handling requests for public information. The applicant shall incur the cost of the program to monitor all contact with human subjects. The date of delivery of data shall be determined by the program manager based on workload and the nature of the request.(h) Prior to release of any data, the program manager shall receive from all applicants, including the principal investigators, staff, and consultants who will receive access to any confidential central registry data, a signed written statement guaranteeing that:(1) the applicant shall not allow any person other than those identified in the protocol, to access, use, or otherwise review the data supplied by the program;(2) there shall be no deviation from the protocol without explicit advance review and approval by the program panel, the department's institutional review board, and the Commissioner;(3) information obtained in the course of activities undertaken or supported using the data from the program shall not be used for any purpose other than the exact purpose for which it was supplied;(4) all data, data tapes and disks, hard copy output, interview questionnaires or other materials provided by the program are considered the property of the department and shall be returned to the department at the completion of the study. Any confidential information which is copied or otherwise transferred, electronically or through other means, shall be destroyed at the completion of the research unless otherwise stated in the research protocol;(5) the program shall be acknowledged as a source of birth defects or other data in all written reports, data tabulations or publications that are produced by use of these data;(6) the applicant agrees to notify the program manager immediately upon receiving any request for access to data in the applicant's possession;(7) the applicant shall notify the program manager on receiving notice of any legal action that might affect disclosure of the data, either by subpoena, discovery, or other means; and(8) the applicant must agree to reimburse the program for reasonable costs it incurs in protecting patient information from legal disclosure.(i) While the program utilizes some vital records information, that information is the responsibility and property of the department's Vital Statistics Unit (unit). Investigators who request vital records information from the unit must obtain approval according to the policies of the unit. Source Note: The provisions of this §37.306 adopted to be effective October 20, 1994, 19 TexReg 8032; amended to be effective August 28, 2003, 28 TexReg 6854; amended to be effective December 12, 2005, 30 TexReg 8291; amended to be effective November 4, 2009, 34 TexReg 7649. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES P SURVEILLANCE AND CONTROL OF BIRTH DEFECTS §37.306 Access to Information in the Central Registry https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137546&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137546 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137546&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137546 03/11/2026 The purpose of these sections is to implement the provisions of Texas Health and Safety Code, Chapter 88 which provides the Executive Commissioner of the Health and Human Services Commission with the authority to adopt rules relating to the reporting of child blood lead levels and control of elevated blood lead levels in children through an understanding of the prevalence and nature of the problem of childhood lead poisoning in Texas. Source Note: The provisions of this §37.331 adopted to be effective December 27, 1995, 20 TexReg 10771; amended to be effective June 1, 2003, 28 TexReg 4149; amended to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.331 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137547&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137547 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137547&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137547 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Certified lead risk assessor--A person certified by the department to conduct lead risk assessments, inspections, and lead-hazard screens, as defined by Subchapter I, Texas Environmental Lead Reduction, in Chapter 295 of this title concerning Occupational Health.(2) Child care--A school, preschool, kindergarten, nursery school, or other similar activity that provides care or instruction for young children.(3) Child care facility--A public place or a residence in which a person furnishes child care.(4) Child-occupied facility--A building or part of a building, including a day-care center, preschool, or kindergarten classroom, that is visited regularly by the same child, six years of age or younger, at least two days in any calendar week if the visits are for at least:(A) three hours each day; and(B) 60 hours each year.(5) Coordination of care--Includes overseeing that needed care is provided, including medical follow-up as defined under the most recent criteria issued by the Centers for Disease Control and Prevention of the United States Public Health Service.(6) Department--The Department of State Health Services.(7) Environmental lead investigation--An investigation performed by a certified lead risk assessor of the home environment of, or other premises frequented by, a child who has a confirmed elevated blood lead level warranting such an investigation, under the most recent criteria issued by the Centers for Disease Control and Prevention of the United States Public Health Service.(8) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.(9) Follow-up care--Medical management includes follow-up blood lead testing at the suggested frequency under the most recent criteria issued by the Centers for Disease Control and Prevention of the United States Public Health Service.(10) Health authority--A physician appointed as such under Texas Health and Safety Code, Chapter 121.(11) Health professional--An individual whose:(A) vocation or profession is directly or indirectly related to the maintenance of health in another individual; and(B) duties require a specified amount of formal education and may require a special examination, certification or license, or membership in a regional or national association.(12) Lead hazard--An item, surface coating, or environmental media that contains or is contaminated with lead and, when ingested or inhaled, may cause exposures that contribute to elevated blood lead levels in children, including:(A) an accessible painted surface or coating;(B) an article for residential or consumer use;(C) accessible soil and dust, including attic dust; and(D) food, water, or remedies.(13) Lead--Metallic lead and materials containing metallic lead with a potential for release in sufficient concentrations to pose a threat to public health.(14) Lead poisoning--Presence of a confirmed venous blood level established by rule in the range specified for medical evaluation and possible pharmacologic treatment in the most recent criteria issued by the United States Public Health Service, Centers for Disease Control and Prevention (CDC).(15) Local health department--A department created under the Texas Health and Safety Code, Chapter 121.(16) Physician--A person licensed to practice medicine by the Texas Medical Board.(17) Regional director--A physician appointed as the chief administrative officer of a public health region under the Texas Health and Safety Code, Chapter 121. Source Note: The provisions of this §37.332 adopted to be effective December 27, 1995, 20 TexReg 10771; amended to be effective June 1, 2003, 28 TexReg 4149; amended to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.332 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137548&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137548 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137548&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137548 03/11/2026 (a) Pursuant to the Texas Health and Safety Code, Chapter 88, §88.002, all data obtained is for the confidential use of the department and the persons or public or private entities that the department determines are necessary to carry out the intent of the Texas Health and Safety Code, Chapter 88, §88.002. Reports, records, and other information collected by, or maintained by, or provided to the Department of State Health Services relating to children's reports of blood lead testing are not public information under open records law and may not be released or made public on subpoena or otherwise, except as described in subsection (b) of this section.(b) Medical, epidemiologic, or toxicologic information may be released:(1) for statistical purposes if released in a manner that prevents the identification of any person;(2) with the consent of each person identified in the information;(3) to medical personnel, appropriate state agencies, health authorities, regional directors, and public officers of counties and municipalities as necessary to comply with this chapter and related rules;(4) to appropriate federal agencies, such as the Centers for Disease Control and Prevention or the United States Public Health Service, except that the information must be limited to the information requested by the agency; or(5) to medical personnel to the extent necessary in a medical emergency to protect the health or life of the child identified in the information.(c) Limited release of the data is allowed by the Texas Health and Safety Code, §88.002.(d) Any requests for confidential or statistical data shall be made in accordance with Texas Health and Safety Code, §88.002. Source Note: The provisions of this §37.333 adopted to be effective December 27, 1995, 20 TexReg 10771; amended to be effective June 1, 2003, 28 TexReg 4149; amended to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.333 Confidentiality of Information Provided to the Department https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137549&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137549 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137549&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137549 03/11/2026 (a) All blood lead levels in children 14 years of age or younger shall be reportable to the Department of State Health Services (department). Elevated blood lead levels for individuals over 14 years of age shall be reported in accordance with Chapter 99 of this title (relating to Occupational Condition Reporting).(b) The department will maintain a registry of children's blood lead test results.(c) Reports shall include all information as required on the Texas Child Blood Lead Level Report Form, Publication #F09-11709, which can be found at http://www.dshs.state.tx.us/lead, or by calling 1-800-588-1248. Source Note: The provisions of this §37.334 adopted to be effective December 27, 1995, 20 TexReg 10771; amended to be effective June 1, 2003, 28 TexReg 4149; amended to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.334 Reportable Health Condition https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137550&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137550 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137550&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137550 03/11/2026 (a) The following persons are required to report all blood lead results:(1) a physician after the first examination of a child;(2) the person in charge of:(A) an independent clinical laboratory;(B) a hospital or clinic laboratory; or(C) any facility in which a laboratory conducts blood lead testing.(b) If a report is not made as required in subsection (a)(1) or (2) of this section, the following persons shall report all blood lead results:(1) the administrator of a hospital licensed under Texas Health and Safety Code, Chapter 241;(2) a professional registered nurse;(3) an administrator or director of a public or private child care facility;(4) an administrator of a home health agency;(5) an administrator or health official of a public or private institution of higher education;(6) a superintendent, manager, or health official of a public or private camp, home, or institution;(7) a parent, managing conservator, or guardian; or(8) a health professional. Source Note: The provisions of this §37.335 adopted to be effective December 27, 1995, 20 TexReg 10771; amended to be effective June 1, 2003, 28 TexReg 4149; amended to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.335 Persons Required to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137551&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137551 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137551&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137551 03/11/2026 (a) The reporting physician, laboratory director, or alternate person as set forth in §37.335(b) of this title (relating to Persons Required to Report) shall make the report of the child blood lead level results to the Department of State Health Services (department) immediately after receiving the blood lead test result. The department may authorize one or more employees to receive the report from the physician, laboratory director, or alternate person by telephone or fax. The department shall implement a method for verifying the identity of the telephone caller when that person is unfamiliar to the employee.(b) Transmission also may be made by mail, courier, or electronic transfer.(1) If by mail or courier, the reports shall be placed in a sealed envelope addressed to the attention of the Department of State Health Services, Childhood Lead Poisoning Prevention Program and marked "confidential medical records."(2) If by electronic transmission, including facsimile transmission by telephone, it shall be in a manner and form authorized by the commissioner or his or her designee in each instance. Any electronic transmission of the reports must provide at least the same degree of protection against unauthorized disclosure as those of mail or courier transmission.(c) Blood lead levels of 40 micrograms per deciliter or greater shall be reported immediately by fax or telephone to the department at (800) 588-1248 or fax to (512) 458-7699. Reports shall include all information as required on the Texas Child Blood Lead Level Report Form, Publication #F09-11709. The following information shall be reported:(1) the child's name, address, date of birth or age, sex, race and ethnicity;(2) the child's blood lead level concentration, test date, and name and telephone number of the testing laboratory;(3) whether the sample is capillary or venous blood; and(4) the name and city of the attending physician. Source Note: The provisions of this §37.336 adopted to be effective December 27, 1995, 20 TexReg 10771; amended to be effective June 1, 2003, 28 TexReg 4149; amended to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.336 Reporting Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137552&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137552 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137552&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137552 03/11/2026 (a) Health care providers should follow the department's Form Pb-109, Physician Reference on Follow-up Testing and Coordination of Care, which may be obtained from the department's website http://www.dshs.state.tx.us/lead or by calling 1-800-588-1248, and meets the federal requirements for the recommended schedule for:(1) obtaining a confirmatory diagnostic venous blood lead test sample; and(2) providing early and late follow-up care and other activities.(b) Environmental lead investigation, shall comply with the department's eligibility criteria for environmental lead investigation as prescribed in §37.339(a) of this title (relating to Environmental Lead Investigations Procedures).(c) The investigator shall provide guidance to parents, guardians, and consulting physicians from lead-risk assessment reports on how to eliminate or control lead exposures that may be contributing to the child's blood lead level. Source Note: The provisions of this §37.337 adopted to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.337 Department Rules for Follow-Up Care; Coordination of Care https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137553&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137553 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137553&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137553 03/11/2026 (a) To be eligible for an environmental lead investigation, the child's elevated blood lead level(s) must meet the most recent criteria for environmental investigation issued by the Centers for Disease Control and Prevention of the United States Public Health Service.(b) The request for an environmental lead investigation shall be on the department's most current form, Pb-101, Request for Environmental Lead Investigation or equivalent. A current version of form Pb-101 may be obtained from the department's website at http://www.dshs.state.tx.us/lead, or by calling 1-800-588-1248. The completed form should be sent by FAX, ATTENTION: Environmental Specialist, using the fax number on the form.(c) On receiving a report of a child with a confirmed blood lead level warranting an environmental lead investigation, the department or its authorized agent may conduct an environmental lead investigation, using Form Pb-103 (Elevated Blood Lead Level Investigation Questionnaire) or its equivalent, of:(1) the home environment in which the child resides, or other premises frequented by a child, if the department or the department's authorized agent obtains the written consent of an adult occupant;(2) any child-care facility with which the child has regular contact and that may be contributing to the child's blood lead level, if the department or the department's authorized agent obtains the written consent of the owner, operator, or principal of the facility; and(3) any child-occupied facility with which the child has regular contact and that may be contributing to the child's blood lead levels, if the department or the department's authorized agent obtains the written consent of:(A) the owner, operator, or principal of the facility; or(B) an adult occupant of the facility if the facility is subject to a lease agreement.(d) Written consent shall be on the department's form or equivalent meeting the requirements of the Texas Health and Safety Code, §161.011, §161.0211, and §161.0212.(e) The lead risk assessor shall provide documented evidence when applicable, of all attempts made to receive consent for environmental lead investigation as required by subsection (c) of this section.(f) If consent is denied, the investigator shall document the reason and circumstance for the denial, and measures that should be taken to protect the health of the child.(g) Written consent is not required for an investigation for a child with a blood lead level of at least 45 micrograms per deciliter if a good faith attempt to contact the person authorized to provide written consent under subsection (e) of this section has been unsuccessful. Source Note: The provisions of this §37.338 adopted to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.338 Environmental Lead Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137554&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137554 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137554&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137554 03/11/2026 (a) Eligibility Criteria for Environmental Lead Investigation.(1) The eligibility criteria for an environmental lead investigation shall be as stated on the department's Form Pb-101, Request for Environmental Lead Investigation or equivalent.(2) A city, health district, or local health department may conduct an environmental lead investigation using lower elevated blood lead results than those in paragraph (1) of this subsection.(3) Before conducting the investigation, city, health district, or local health department will:(A) inform the health care provider of the intent to conduct the investigation; and(B) submit to the department the most current Form Pb-101, Request for Environmental Lead Investigation or equivalent.(b) Requesting an Environmental Lead Investigation.(1) The request for an environmental lead investigation shall be, completed in its entirety, on the department's most current form Pb-101, Request for Environmental Lead Investigation or equivalent.(2) The following persons may request an environmental lead investigation for a child meeting criteria in subsection (a) of this section:(A) the child's attending healthcare provider;(B) a public health nurse;(C) local health department staff;(D) local Childhood Lead Poisoning Prevention Program staff; or(E) designated Texas Childhood Lead Poisoning Prevention Program staff.(3) An environmental lead investigation request may be denied by the department if the eligibility criteria is not met.(4) The department will notify the requestor of the reason for such denial.(c) Conducting and Reporting an Environmental Lead Investigation.(1) Only a person currently certified by the State of Texas as a lead risk assessor shall conduct an environmental lead investigation.(2) The lead risk assessor shall conduct the investigation in accordance with the conditions and requirements of the certification by the department.(3) The lead risk assessor shall provide a written report of each completed environmental lead investigation to the provider; parent or guardian; and homeowner or property owner.(A) The written report shall contain at least the following from the investigation:(i) date lead risk assessment was performed;(ii) address where lead risk assessment was performed;(iii) name and address of property owner;(iv) date structure or unit was built;(v) name of lead risk assessor, certification number, or business affiliation of the person that conducted the investigation;(vi) testing methods used (e.g. X-ray fluorescence (XRF), what samples were collected, and name of the accredited laboratory that analyzed samples);(vii) a general statement of the results;(viii) a description of recommended interim controls and/or abatement options for each identified lead-based paint hazard;(ix) a suggested prioritization for taking each action based on the immediacy and severity of the hazard; and(x) if the risk assessor is recommending use of an encapsulant or enclosure, the report shall include maintenance and monitoring schedule for the encapsulant or enclosure.(B) If the parent or guardian is not the owner of the property investigated, and the risk-assessor discovered lead-based paint hazards on the property; the lead risk assessor shall inform the property owner about the investigation findings, recommendations, and their legal obligation to disclose the same to all future tenants and buyers.(4) The lead risk assessor conducting the investigation shall send a complete copy of the environmental lead investigation report to the department's Texas Childhood Lead Poisoning Prevention Program. The report shall consist of the following:(A) a copy of the summary report letter sent to the healthcare provider, the parent, or guardian, and to the property owner, if applicable;(B) a completed form Pb-103 (Elevated Blood Lead Level Investigation Questionnaire) or its equivalent;(C ) signed consent forms or records of consent denials; and(D) results of all environmental sampling and testing performed.(5) Confidentiality. The report shall be confidential as provided by the Texas Health and Safety Code, §161.0213. Source Note: The provisions of this §37.339 adopted to be effective August 28, 2008, 33 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES Q REPORTING, TREATMENT AND INVESTIGATION OF CHILD BLOOD LEAD LEVELS §37.339 Environmental Lead Investigations Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223886&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223886 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223886&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223886 03/11/2026 (a) The committee. The Maternal Mortality and Morbidity Review Committee (MMMRC) is appointed under and governed by this subchapter. The MMMRC is established under Texas Health and Safety Code (THSC) §§34.001 - 34.018.(b) Purpose. The MMMRC studies cases of pregnancy-related deaths and trends in severe maternal morbidity and makes recommendations to reduce the incidence of pregnancy-related deaths and severe maternal morbidity in Texas.(c) Tasks. The MMMRC:(1) studies and reviews:(A) cases of pregnancy-related deaths;(B) trends, rates, or disparities in pregnancy-related deaths and severe maternal morbidity;(C) health conditions and factors that disproportionately affect the most at-risk populations as determined in the joint biennial report required under THSC §34.015; and(D) best practices and programs operating in states with reduced rates of pregnancy-related deaths;(2) compares rates of pregnancy-related deaths based on the socioeconomic status of the mother;(3) determines the feasibility of the MMMRC studying severe maternal morbidity cases;(4) in consultation with the Perinatal Advisory Council, makes recommendations reducing the incidence of pregnancy-related deaths and severe maternal morbidity in this state; and(5) adopts bylaws guiding MMMRC operations.(d) Reporting requirements. No later than September 1 of each even-numbered year, the MMMRC and the Texas Department of State Health Services (DSHS) must submit a joint biennial written report to the Governor, Lieutenant Governor, Speaker of the House of Representatives, and appropriate committees of the Texas Legislature.(1) The report must include:(A) MMMRC findings related to the study and review of cases and trends in pregnancy-related deaths and severe maternal morbidity in this state; and(B) policy recommendations made to the Texas Health and Human Services Commission (HHSC) Executive Commissioner reducing the incidence of pregnancy-related deaths and severe maternal morbidity.(2) DSHS must send the report to state professional associations and organizations listed in THSC §34.006(b).(e) Composition.(1) The MMMRC is composed of 23 members.(2) Twenty-one voting members appointed by the DSHS Commissioner include:(A) four physicians specializing in obstetrics, at least one of whom is a maternal fetal medicine specialist;(B) one certified nurse-midwife;(C) one registered nurse;(D) one nurse specializing in labor and delivery;(E) one physician specializing in family practice;(F) one physician specializing in psychiatry;(G) one physician specializing in pathology;(H) one epidemiologist, biostatistician, or researcher of pregnancy-related deaths;(I) one social worker or social service provider;(J) two community members with experience in a relevant health care field, including a field involving the analysis of health care data, one of whom must represent an urban area of this state and one of whom must represent a rural area of this state;(K) one medical examiner or coroner responsible for recording deaths;(L) one physician specializing in critical care;(M) one physician specializing in emergency care;(N) one physician specializing in cardiology;(O) one physician specializing in anesthesiology;(P) one physician specializing in oncology; and(Q) one representative of a managed care organization.(3) Two voting ex-officio members include:(A) a DSHS representative from the Community Health Improvement Division and(B) the state epidemiologist for DSHS or the epidemiologist's designee.(4) In appointing members to the MMMRC, the DSHS Commissioner:(A) includes members working in and representing diverse communities with regard to race, ethnicity, immigration status, and English proficiency;(B) includes members from differing geographic regions in the state, including both rural and urban areas;(C) endeavors to include members working in and representing communities affected by pregnancy-related deaths and severe maternal morbidity and a lack of access to relevant perinatal and intrapartum care services; and(D) ensures the composition of the MMMRC reflects the racial, ethnic, and linguistic diversity of Texas.(5) Terms of office.(A) MMMRC members are appointed for staggered six-year terms, with one-third or as near as possible to one-third of the MMMRC members' terms expiring February 1st of each odd-numbered year. Regardless of the term limit, an MMMRC member serves until a replacement has been appointed. This guarantees sufficient and appropriate MMMRC member representation.(B) Exceptions may be necessary to stagger terms so the term of each member is six years. An MMMRC member may apply to serve more than one term.(C) If a vacancy occurs, the DSHS Commissioner will appoint a person to serve the unexpired portion of a term.(f) Officers. The DSHS Commissioner appoints from among the MMMRC members a presiding officer.(1) The presiding officer presides at all MMMRC meetings at which he or she is in attendance, calls meetings in accordance with this section, appoints subcommittees of the MMMRC as necessary, and ensures proper reports to the HHSC Executive Commissioner. The presiding officer may serve as an ex officio member of any MMMRC subcommittee.(2) The MMMRC may reference the presiding officer by another term, such as chairperson.(g) Meetings. The MMMRC meets at least quarterly to conduct business, or at the call of the DSHS Commissioner.(1) Meeting arrangements are made by DSHS staff.(2) The MMMRC is subject to the Open Meetings Act, Texas Government Code Chapter 551, except when the MMMRC conducts a closed meeting to review cases under THSC §34.007. Meetings may be conducted in person, through teleconference call, or by means of other technology.(3) A simple majority of the appointed MMMRC members, identified in subsection (e)(2) and (3) of this section, constitutes a quorum for the purpose of transacting official business.(4) The MMMRC is authorized to conduct business only when in a legally constituted meeting with a quorum present.(5) The agenda for each MMMRC meeting must include an opportunity for new business or for any member to address the MMMRC on matters relating to MMMRC business.(6) The MMMRC must allow for public comment during at least one public meeting each year.(7) The MMMRC must present in open session recommendations made under THSC §34.005, reducing the incidence of pregnancy-related deaths and severe maternal morbidity in this state.(8) The MMMRC must post public notice for meetings conducted for the sole purpose of reviewing cases for selection under THSC §34.007.(h) Attendance. Members must attend MMMRC meetings as scheduled.(1) An MMMRC member must notify the presiding officer or appropriate DSHS staff if unable to attend a scheduled meeting.(2) It is grounds for removal from the MMMRC if an MMMRC member cannot conduct MMMRC member duties for a substantial part of the term for which the MMMRC member is appointed because of illness or disability, is absent from more than half of the MMMRC meetings during a calendar year, or is absent from at least three consecutive MMMRC meetings.(3) The validity of an action of the MMMRC is not affected by the fact that it is taken when grounds for removal of a member exists.(i) Staff. Staff support for the MMMRC is provided by DSHS staff.(j) Confidentiality.(1) Any information pertaining to a pregnancy-related death or severe maternal morbidity is confidential.(2) Confidential information acquired by DSHS, including identifying information of an individual or health care provider, is confidential and may not be disclosed to any person.(3) Information is not confidential under this section if the information is general information that cannot be connected with any specific individual, case, or health care provider.(4) The MMMRC may publish statistical studies and research reports based on confidential information under this section, provided the information:(A) is published in the aggregate;(B) does not identify a patient or the patient's family;(C) does not include any information that could be used to identify a patient or the patient's family; and(D) does not identify a health care provider.(5) DSHS will adopt and implement practices and procedures confirming confidential information is not disclosed in violation of state and federal confidentiality laws.(6) As required by THSC §34.009, information held by DSHS or the MMMRC pertaining to pregnancy-related death or severe maternal morbidity is confidential and not subject to disclosure under the Public Information Act, Texas Government Code Chapter 552.(7) The MMMRC and DSHS must comply with all state and federal laws and rules relating to the transmission of health information, including the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and rules adopted under that Act.(k) Statements by members.(1) HHSC, DSHS, and the MMMRC are not bound in any way by any statement, recommendation, or action on the part of any MMMRC member, except when a statement or action is in pursuit of specific instructions from HHSC, DSHS, or the MMMRC.(2) The MMMRC and MMMRC members may not participate in legislative activity in the name of HHSC, DSHS, or the MMMRC except with approval through the DSHS legislative process. MMMRC members are not prohibited from representing themselves or other entities in the legislative process.(3) An MMMRC member must not accept or solicit any benefit that might reasonably influence the member in the conduct of the member's official duties.(4) An MMMRC member must not disclose confidential information acquired through MMMRC membership.(5) An MMMRC member must not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.(6) An MMMRC member with a personal or private interest in a matter pending before the MMMRC must publicly disclose the fact in an MMMRC meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the MMMRC member has a direct monetary interest in the matter but does not include the MMMRC member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.(l) Required Training. Each MMMRC member must complete training on relevant statutes and rules; Texas Government Code Chapters 551, 552, and 2110; the Health and Human Services (HHS) Ethics Policy; the Advisory Committee Member Code of Conduct; and other relevant HHS policies. DSHS will provide the training.(m) Travel Reimbursement.(1) Unless permitted by the current General Appropriations Act, MMMRC members are not paid to participate in the MMMRC nor reimbursed for travel to and from meetings.(2) In carrying out duties, the MMMRC may use technology, including teleconferencing or videoconferencing, to eliminate travel expenses.(n) Sunset Provision. The MMMRC is subject to Texas Government Code Chapter 325 (Texas Sunset Act). Unless continued in existence as provided by that chapter, the MMMRC is abolished and this subchapter expires September 1, 2027. Source Note: The provisions of this §37.401 adopted to be effective June 30, 2016, 41 TexReg 4644; amended to be effective October 17, 2018, 43 TexReg 6844; amended to be effective February 10, 2025, 50 TexReg 771. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES R ADVISORY COMMITTEES §37.401 Maternal Mortality and Morbidity Review Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=195198&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 195198 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=195198&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 195198 03/11/2026 (a) The committee. The State Child Fatality Review Team Committee (committee) is appointed under and governed by this section. The committee is established under Texas Family Code, §§264.501 - 264.515.(b) Purpose. The purpose of the committee is to reduce the number of preventable deaths to children in the State of Texas.(c) Tasks.(1) The committee develops an understanding of the causes and incidences of child death in Texas.(2) The committee identifies procedures within the agencies represented on the committee to reduce the number of preventable child deaths.(3) The committee promotes public awareness and makes recommendations to the Governor and Texas Legislature for changes in law, policy, and practice to reduce the number of preventable child deaths.(d) Reports.(1) Not later than April 1 of each even-numbered year, the committee files a biennial written report with the Governor, Lieutenant Governor, Speaker of the House of Representatives, Texas Department of State Health Services (DSHS), and Texas Department of Family and Protective Services (DFPS) and makes the report available to the public.(2) The report contains aggregate child fatality data collected by local child fatality review teams, recommendations to prevent child fatalities and injuries, and recommendations to DFPS based on input from the child safety review subcommittee.(e) Composition.(1) The committee is composed of 25 members. Permanent members of the committee include:(A) a person appointed by and representing the State Registrar of Vital Statistics;(B) a person appointed by and representing the DFPS Commissioner;(C) a person appointed by and representing the DSHS Title V Director;(D) a person appointed by and representing the speaker of the house of representatives;(E) a person appointed by and representing the lieutenant governor; and(F) a person appointed by and representing the governor.(2) The permanent members of the committee who serve under paragraph (1) of this subsection, shall appoint the following committee members, who must be members of their local Child Fatality Review Team, unless the committee member is an appointed representative of a state agency:(A) a criminal prosecutor involved in prosecuting crimes against children;(B) a sheriff;(C) a justice of the peace;(D) a medical examiner;(E) a police chief;(F) a pediatrician experienced in diagnosing and treating child abuse and neglect;(G) a child educator;(H) a child mental health provider;(I) a public health professional;(J) a child protective services specialist;(K) a sudden infant death syndrome family service provider;(L) a neonatologist;(M) a child advocate;(N) a chief juvenile probation officer;(O) a child abuse prevention specialist;(P) a representative of the Texas Department of Public Safety;(Q) a representative of the Texas Department of Transportation;(R) an emergency medical services provider; and(S) a provider of services to, or an advocate for, victims of family violence.(f) Terms of office. Except as necessary to stagger terms, the term of office for members that are appointed under subsection (e)(2) of this section is three years.(1) Members may apply to serve up to two terms. Terms do not have to be consecutive.(2) An appointment to a vacancy on the committee is made in the same manner as the original appointment.(g) Officers. The committee selects from its members a chair and vice-chair.(1) The chair presides at all committee meetings at which he or she is in attendance and calls meetings of the committee.(2) The vice-chair presides at meetings if the chair is unable to attend.(h) Meetings.(1) The committee meets quarterly.(2) Meeting arrangements are made by DSHS staff.(3) Except as provided by Texas Family Code, §264.504 (b), (c), and (d), the committee is a "governmental body" as defined in the Open Meetings Act, Texas Government Code, Chapter 551. Meetings may be conducted in person, through teleconference call, or by means of other technology.(4) A simple majority of the appointed committee members constitutes a quorum for the purpose of transacting official business.(5) The committee is authorized to transact official business only when in a legally constituted meeting with quorum present.(6) The agenda for each committee meeting includes an item entitled public comment under which any person is allowed to address the committee on matters relating to business. The chair may establish procedures for public comment, including a time limit on each comment.(i) Attendance. Members must attend committee meetings as scheduled.(1) A member must notify the chair or appropriate DSHS staff if he or she is unable to attend a scheduled meeting.(2) It is grounds for removal from the committee if a member cannot discharge the member's duties for which the member is appointed because of illness or disability or is absent from more than one committee meeting per year.(3) A member may give another member voting proxy upon his or her absence.(j) Staff. Staff support for the committee is provided by DSHS.(k) Procedures. The committee shall adopt bylaws to outline meeting and operating procedures.(l) Statement by members.(1) HHSC, DSHS, and the committee are not bound in any way by any statement, recommendation, or action on the part of any committee member, except when a statement or action is in pursuit of specific instructions from HHSC, DSHS, or the committee.(2) The committee and its members may not participate in legislative activity in the name of the committee. Committee members are not prohibited from representing themselves or other entities in the legislative process.(3) A committee member may not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.(4) A committee member may not disclose confidential information acquired through his or her committee membership.(5) A committee member may not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.(6) A committee member who has a personal or private interest in a matter pending before the committee must publicly disclose the fact in a committee meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the committee member has a direct pecuniary interest in the matter but does not include the committee member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.(m) Reimbursement for expenses. A member of the committee is not entitled to compensation for serving on the committee but is entitled to reimbursement for the member's travel expenses as provided for in the General Appropriations Act.(1) Reimbursement for a person serving on the committee is paid from funds appropriated by DSHS.(2) Reimbursement for other persons serving on the committee shall be paid from funds appropriated to DSHS. Source Note: The provisions of this §37.410 adopted to be effective June 30, 2016, 41 TexReg 4644; amended to be effective April 22, 2019, 44 TexReg 2055. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES R ADVISORY COMMITTEES §37.410 State Child Fatality Review Team Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210207&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210207 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210207&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210207 03/11/2026 (a) Statutory authority. The Sickle Cell Task Force (Task Force) is established in accordance with Texas Health and Safety Code Chapter 52.(b) Purpose. The Task Force advises the Texas Department of State Health Services (DSHS) to raise awareness of sickle cell disease and sickle cell trait.(c) Duties. The Task Force performs duties outlined in Texas Health and Safety Code Chapter 52.(d) Reporting requirements. By December 1 of each year, the Task Force must submit a written report to the Governor and the Legislature. The report must summarize the Task Force's work and include any recommended actions or policy changes endorsed by the Task Force.(e) Membership.(1) The Task Force is composed of seven members appointed by the Texas Health and Human Services (HHS) Executive Commissioner. Membership shall consist of:(A) two members from community-based organizations with experience addressing the needs of individuals with sickle cell disease;(B) two physicians specializing in hematology;(C) two members of the public, each of whom either has sickle cell disease or is a parent of a person with sickle cell disease or trait; and(D) one representative of a health-related institution.(2) Members are appointed for staggered two-year terms so that the terms of an equal or almost equal number of members expire on August 31 of each year. Regardless of the term limit, a member serves until his or her replacement has been appointed. This ensures sufficient, appropriate representation.(3) If a vacancy occurs, the HHS Executive Commissioner appoints a person to serve the unexpired portion of that term.(f) Bylaws. The Task Force shall adopt bylaws governing Task Force operations.(g) Officers. The Task Force selects a chair and a vice chair of the Task Force from its members. The chair and vice chair serve a two-year term as an officer.(1) The chair serves until August 31 of each odd-numbered year. The vice chair serves until August 31 of each even-numbered year.(2) A member serves no more than two consecutive terms as chair or vice chair. A chair or vice chair may not serve beyond their membership term.(h) Required training. Each member shall complete all training on relevant statutes and rules, including this section and Chapters 551 and 552.(i) Travel reimbursement. To the extent permitted by the current General Appropriations Act, and if funds are appropriated and available, a member of the Task Force may be reimbursed for the member's travel to and from meetings in accordance with the HHS Travel Policy.(j) Date of abolishment. In accordance with Texas Government Code §2110.008(b), the Task Force shall be abolished August 31, 2025. Source Note: The provisions of this §37.420 adopted to be effective September 29, 2022, 47 TexReg 6196. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES R ADVISORY COMMITTEES §37.420 Sickle Cell Task Force https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202258&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202258 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202258&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202258 03/11/2026 The purpose of this subchapter is to describe the newborn hearing screening process administered by the Department of State Health Services pursuant to Texas Health and Safety Code Chapter 47 to ensure all babies born in Texas receive a hearing screening, proper intervention, and referrals to services if they are suspected or diagnosed as deaf or hard of hearing. Source Note: The provisions of this §37.501 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.501 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202259&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202259 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202259&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202259 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Birthing facility:(A) a hospital licensed under Texas Health and Safety Code Chapter 241 that offers obstetrical services;(B) a birthing center licensed under Texas Health and Safety Code Chapter 244;(C) a children's hospital licensed under Texas Health and Safety Code Chapter 241 that offers obstetrical or neonatal intensive care unit services or both; or(D) a facility maintained or operated by this state or an agency of this state that provides obstetrical services.(2) Consent--Permission related to the release of individually identifying information that may be disclosed to the department or resource center.(3) Consent form (form)--A form that contains required language prescribed by the department found at https://www.dshs.texas.gov/tehdi to capture consent, as defined in this subchapter.(4) Department--The Department of State Health Services.(5) ECI--Early Childhood Intervention. The early intervention services described in Part C Early Childhood Intervention, Individuals with Disabilities Education Act, 20 United States Code §§1431-1443.(6) Follow-up care--Additional screening, diagnostic audiological evaluation, or intervention services to include medical and therapeutic treatment services for newborns or infants who do not pass the initial hearing screening.(7) Healthcare provider--Any licensed professional along the hearing continuum, including:(A) a registered nurse recognized as an advanced practice registered nurse by the Texas Board of Nursing or a physician assistant licensed by the Texas Physician Assistant Board;(B) a midwife, as defined by Texas Occupations Code §203.002, including a nurse midwife described by Texas Occupations Code §301.152;(C) a physician who is licensed to practice medicine by the Texas Medical Board; or(D) a licensed audiologist, as defined by Texas Occupations Code Chapter 401.(8) Hearing loss--A hearing threshold greater than 15 dB hearing level in the frequency region important for speech recognition and comprehension in one or both ears that is confirmed by a diagnostic audiological evaluation.(9) Hearing screening--The initial physiologic measurement of hearing to identify an increased risk for hearing loss before birthing facility discharge.(10) Individually identifying information--Confidential information that identifies the parent or newborn.(11) Infant--A child who is at least 30 days old but who is younger than 24 months old.(12) Newborn--A child younger than 30 days old.(13) Parent--A natural parent, stepparent, adoptive parent, legal guardian, or other legal custodian of a child.(14) Protocols--Guidelines or procedures based on the latest Joint Committee on Infant Hearing position statement, found at http://www.jcih.org/posstatemts.htm, as updated, used by programs to conduct newborn hearing screening.(15) Resource center--Primary statewide resource center as defined by Texas Education Code §30.051.(16) TEHDI MIS--Texas Early Hearing Detection and Intervention Management Information System. The department's central information source of results and referrals related to newborn hearing screens, audiological evaluations, and any type of intervention for newborns or infants. Source Note: The provisions of this §37.502 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.502 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202260&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202260 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202260&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202260 03/11/2026 (a) The birthing facility shall inform the parents during admission that:(1) the facility is required by law to screen a newborn or infant for hearing loss; and(2) the parents may decline the screening.(b) The birthing facility is responsible for obtaining and documenting, during admission, on the form referenced in §37.502(3) of this subchapter (relating to Definitions), consent to release individually identifying information. Consent may be obtained and stored electronically and must be documented in the TEHDI MIS. The consent form may be found at https://dshs.texas.gov/tehdi.(1) If the birthing facility contracts for hearing screening services, the birthing facility is responsible for ensuring its contractor is in compliance with Texas Health and Safety Code Chapter 47 and this subchapter, as it relates to newborn hearing screening.(2) If the parent declines the consent to release individually identifying information during admission, the parent may later consent to release individually identifying information during subsequent follow-up screenings or diagnostic evaluations.(c) Healthcare providers shall document and maintain consent, if obtained, in the medical record, and the consent must be provided at the request of the department.(d) A healthcare provider is not criminally or civilly liable for furnishing information in good faith to the department or its designee in accordance with Texas Health and Safety Code §47.009.(e) At any time, a parent may request in writing to the department or resource center that individually identifying information concerning their child be removed from:(1) the department's TEHDI MIS;(2) the resource center's records; or(3) both. Source Note: The provisions of this §37.503 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.503 Screening and Consent to Release Individually Identifying Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202261&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202261 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202261&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202261 03/11/2026 (a) Any healthcare provider who performs initial hearing screening, follow-up screening, diagnostic evaluations, follow-up care, or interventions is required to report all patient encounters and outcomes, including pass and do not pass results, in the TEHDI MIS within five calendar days after the date of the patient encounter.(b) If a parent declines the hearing screening for the newborn, the hearing screening refusal must be documented in the medical record and the TEHDI MIS. Source Note: The provisions of this §37.504 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.504 Required Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202262&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202262 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202262&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202262 03/11/2026 (a) A birthing facility screening provider shall be a department-certified newborn hearing screening program. A provider that is not certified is required to refer the infant to a department-certified newborn hearing screening program.(b) A birthing facility screening provider shall:(1) perform the initial hearing screening, or document why the screening was not performed, in accordance with Texas Health and Safety Code §47.003;(2) provide screening results and educational materials to the parents;(3) provide screening results to the applicable healthcare providers; and(4) report results in accordance with §37.504 of this subchapter (relating to Required Reporting).(c) Infants who do not pass the initial hearing screening must be offered a follow-up screening or referral consistent with Joint Committee on Infant Hearing guidelines, found at http://www.jcih.org/posstatemts.htm, as updated. Source Note: The provisions of this §37.505 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.505 Birthing Facility Screening Provider Responsibilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202263&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202263 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202263&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202263 03/11/2026 (a) A follow-up screening provider shall:(1) perform a follow-up screening no later than 30 days after birth;(2) provide screening results to the applicable healthcare providers;(3) provide screening results and educational materials to the parents; and(4) report results in accordance with §37.504 of this subchapter (relating to Required Reporting).(b) If the infant does not pass, a follow-up screening provider shall:(1) refer to ECI due to suspected deaf or hard of hearing diagnosis;(2) provide follow-up screening results to the resource center; and(3) schedule or refer for diagnostic audiological evaluation consistent with Joint Committee on Infant Hearing guidelines, http://www.jcih.org/posstatemts.htm, as updated. Source Note: The provisions of this §37.506 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.506 Follow-up Screening Provider Responsibilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202264&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202264 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202264&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202264 03/11/2026 A diagnostic evaluation provider shall:(1) perform a diagnostic evaluation no later than three months after birth;(2) provide results to the parents, applicable healthcare providers, and the resource center;(3) refer children confirmed as deaf or hard of hearing to ECI within seven days of the encounter; and(4) report in accordance with §37.504 of this subchapter (relating to Required Reporting). Source Note: The provisions of this §37.507 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.507 Diagnostic Evaluation Provider Responsibilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202265&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202265 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202265&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202265 03/11/2026 (a) The department shall:(1) maintain the TEHDI MIS;(2) certify newborn hearing screening programs, as described by program protocol at https://www.dshs.texas.gov/tehdi/FacilityCertRequire.aspx; and(3) make available standardized educational resources.(b) The department may assist in coordination of follow-up care and diagnosis.(c) The department shall ensure ECI services are available to a child suspected or diagnosed as deaf or hard of hearing.(d) The department shall report de-identified, aggregate data to the Centers for Disease Control and Prevention and the Health Resources and Services Administration Maternal and Child Health Bureau annually. Source Note: The provisions of this §37.508 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.508 Department Responsibilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202266&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202266 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202266&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202266 03/11/2026 (a) A newborn hearing screening performed by a birthing facility and any related diagnostic follow-up care, provided in accordance with Texas Health and Safety Code Chapter 47 and the requirements of this subchapter, for a newborn who receives medical assistance or who is Medicaid-eligible, is a covered service of the Texas Medical Assistance (Medicaid) Program, in accordance with Texas Human Resources Code Chapter 32.(b) The reimbursement rates and methodology for covered services described in this section shall be established by the Texas Health and Human Services Commission.(c) Screening for hearing loss from birth through the date the infant is 30 days of age and any diagnostic follow-up care related to the screening from birth through the date the child is 24 months of age, as provided under this subchapter, shall be a covered benefit pursuant to Texas Insurance Code, §§1367.101 - 1367.103. Co-payments or co-insurance requirements are permitted; however, deductible requirements or dollar limits are prohibited. Source Note: The provisions of this §37.509 adopted to be effective December 23, 2020, 45 TexReg 9210. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES S NEWBORN HEARING SCREENING §37.509 Authorized Newborn Hearing Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150896&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150896 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150896&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150896 03/11/2026 The purpose of these sections is to establish procedures for awarding grants to assist applicants with the costs of establishing and operating school-based health centers and to establish standards for the funded centers. Source Note: The provisions of this §37.531 adopted to be effective August 16, 2000, 25 TexReg 7699; amended to be effective April 24, 2008, 33 TexReg 3278; amended to be effective March 6, 2011, 36 TexReg 1280. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES T SCHOOL-BASED HEALTH CENTERS §37.531 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150897&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150897 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150897&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150897 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:(1) Applicant--A school district, charter school, private school, local health department, hospital, health care system, university or non-profit organization applying for a grant from the Department of State Health Services to assist with the costs of establishing and operating a school-based health center.(2) Primary health services--Family and home support; health care, including immunizations; dental health care; health education; and preventive health strategies.(3) Department--Department of State Health Services.(4) Funded applicant--A school district, charter school, private school, local health department, hospital, health care system, university or non-profit organization with which the Department of State Health Services executes a contract to establish and operate a school-based health center.(5) Grant--A sum of money awarded to a selected applicant on the basis of a Request for Proposals that results in a contract.(6) Local School Health Advisory Council--Persons appointed by the board of trustees of a school district to make recommendations concerning the establishment and operation of school-based health centers and to assist the district in ensuring that local community values are reflected in the operation of each center. In addition to the majority of appointees who shall be parents of students enrolled in the district or districts, the board of trustees may also appoint at least one person from each of the following groups:(A) teachers;(B) school administrators;(C) licensed health care professionals;(D) the clergy;(E) law enforcement;(F) the business community;(G) senior citizens; and(H) students.(7) Low property wealth per student--As defined by the Texas Education Agency, wealth is defined as total taxable property value divided by the total number of students, and is used as an indicator of a district's ability to raise local funds on a per pupil basis.(8) Parent--The mother, a man presumed to be the biological father, a man legally determined to be the biological father, a man who has been adjudicated to be the biological father by a court of competent jurisdiction, an adoptive mother or father, a guardian, or other person having legal control of the student.(9) Reproductive services--Family planning services as defined by §56.2 of this title (relating to Definitions).(10) Rural area--A county with a population not greater than 50,000, or an area that has been designated under state or federal law as:(A) a health professional shortage area;(B) a medically underserved area; or(C) a medically underserved community.(11) School-based health center--An entity established by a school district or by community partners in conjunction with a school district or districts at one or more campuses within the district to deliver primary and preventative health care programs and services for students and their families and prevent emerging health threats that are specific to the district.(12) Family and home support--Case management or the coordination of health services such as assisting families with obtaining health insurance. Source Note: The provisions of this §37.532 adopted to be effective August 16, 2000, 25 TexReg 7699; amended to be effective April 24, 2008, 33 TexReg 3278; amended to be effective March 6, 2011, 36 TexReg 1280. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES T SCHOOL-BASED HEALTH CENTERS §37.532 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150898 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150898 03/11/2026 The department shall award grants according to Texas Education Code, §38.063. Source Note: The provisions of this §37.533 adopted to be effective August 16, 2000, 25 TexReg 7699; amended to be effective April 24, 2008, 33 TexReg 3278; amended to be effective March 6, 2011, 36 TexReg 1280. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES T SCHOOL-BASED HEALTH CENTERS §37.533 Number of Awards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150900&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150900 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150900&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150900 03/11/2026 Grants awarded by the department shall not exceed $250,000 per applicant per biennium as required by law. Source Note: The provisions of this §37.534 adopted to be effective August 16, 2000, 25 TexReg 7699; amended to be effective April 24, 2008, 33 TexReg 3278; amended to be effective March 6, 2011, 36 TexReg 1280. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES T SCHOOL-BASED HEALTH CENTERS §37.534 Dollar Amount of Awards Per Biennium https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150899&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150899 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150899&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150899 03/11/2026 Funded applicants shall assure the department that matching funds secured from nonfederal sources, including in-kind contributions, community or foundation grants, individual contributions, and operating funds from local government agencies, shall be available to the school-based health center project. Source Note: The provisions of this §37.535 adopted to be effective August 16, 2000, 25 TexReg 7699; amended to be effective April 24, 2008, 33 TexReg 3278; amended to be effective March 6, 2011, 36 TexReg 1280. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES T SCHOOL-BASED HEALTH CENTERS §37.535 Matching Funds https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150903&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150903 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150903&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150903 03/11/2026 (a) Funded applicants shall comply with the following standards for school-based health centers.(1) Community-based solutions. The funded applicant shall facilitate collaboration among families, schools, and members of the community to assess and meet the health needs of the community's children and families. The funded applicant shall utilize all the following strategies for facilitating community-based solutions:(A) Establish or utilize a local school health advisory council per Education Code, Title 2, Chapter 28, §28.004 to make recommendations on the establishment and operation of school-based health centers and to assist the district in ensuring that local community values are reflected in the operation of each center and in the provision of health education.(B) Establish and/or enhance links between school personnel, school-based health center personnel, other health/social services providers and agencies in the community, and other supportive community sectors.(C) Enable students and families to be responsible decision-makers in promoting their own health and well-being, making connections with community systems that help to prevent the social isolation and alienation of individuals and families, and using the health care system wisely.(D) Require parental involvement in and management of the health care of children receiving services from the center; encourage parental accompaniment of any child younger than 18 years of age at visits to the center; notify the child's parent at least one week in advance or as early as possible of the scheduled appointment; and encourage the parent to attend the appointment.(2) Administration. The funded applicant shall plan and administer a school-based health center that meets the health needs of the community's children and families by use of the following strategies:(A) Deliver primary and preventive health services to children and families in a school-based setting.(B) Establish efficient, client-friendly procedures for utilizing all available sources of funding to compensate for services provided by the school-based health center, including reimbursement from the state Medicaid program, a state children's health plan program, private health insurance or health benefit plans. Funds received through billing for services shall be used for operations of the school-based health center.(C) Contract for provision of services at the school-based health center if necessary and appropriate. A school-based health center shall operate under the guidance of a medical director who is licensed by the Texas Medical Board. The medical director shall direct medical services of the school-based health center and be available for consultation, to see referrals, and to review charts.(D) Develop and present a specific, detailed plan for funding the school-based health center.(E) Research, develop, and implement the forms and administrative procedures necessary to remain in compliance with all applicable and relevant legislation and regulations. Required procedures contained in applicable legislation for operation of school-based health centers include but are not limited to the following:(i) provision of services to a student only if the school-based health center has obtained written consent to the services from the student's parent within the one-year period preceding the date on which the services are provided, and the consent has not been revoked;(ii) joint identification by school-based health center staff and the student's parent of any health-related concerns of the student that may affect the student's health and/or success in school;(iii) provision of neither reproductive services, counseling, nor referrals through the school-based health center receiving grant funds awarded under this subchapter;(iv) provision of all services by only appropriately licensed, certified, or credentialed professionals as required by law;(v) referral of a student for mental health services only upon notification of and with the written consent of the student's parent, which must be followed by written consent by the student's parent for each treatment occasion(s) authorized by the provider, including informed consent when required for specific services;(vi) a good faith effort by staff of a school-based health center to identify and coordinate with existing health care providers;(vii) provision of notice by the staff of the school-based health center to the primary care physician of a student who has received services;(viii) coordination by the staff of the school-based health center with the primary care physician concerning the clinical treatment of any person who has a primary care physician under the state Medicaid program or another health plan and obtaining authorization before delivering a service;(ix) utilization of all available sources of funding to compensate for services provided by a school-based health center;(x) conduct client surveys in school-based health centers by funded applicants; and(xi) documentation in the student's medical record of the school-based health center's efforts to involve the student's parent in identification of the student's health-related concerns; notification of the student's parent of scheduled appointments and proposed services; coordination with the student's primary care physician; and maintenance of written consent for treatment by the student's parent, including informed consent when required for specific services.(3) Emphasis on prevention. A funded applicant shall provide for primary emphasis on the delivery of primary health services and secondary emphasis on the implementation of population-based models that prevent emerging health threats by use of the following strategies:(A) increasing substantially the number of children in the community with health-care (medical) homes;(B) facilitating access to appropriate primary and preventive care for children;(C) educating, enabling, and empowering individuals for healthier lifestyles;(D) involving the community in identifying priorities and developing health promotion strategies; and(E) relying on the evidence of effective prevention to develop interventions that can demonstrate impact.(4) Focus on outcomes. A funded applicant shall focus on the achievement of outcomes that can be documented, using the following strategies:(A) delivering primary health services and disease prevention of emerging health threats through access to appropriate primary and preventive care for children through a program designed to achieve the following goals:(i) a reduction in student absenteeism with an emphasis on students with chronic conditions that use the school-based health center and drop-out rates;(ii) an increase in each student's ability to meet his or her academic potential; and(iii) an increase in the health of students through preventive health measures including immunizations, and routine physical examinations including checkups conducted in accordance with the Texas Health Steps program.(B) A funded applicant shall research, document, analyze, and evaluate outcomes, including the goals listed in subparagraph (A) of this paragraph, by activities that include but are not limited to the following:(i) gathering data and statistics, monitoring outcomes, and producing data by use of quantitative measurement systems to report on project impact as required by the Request For Proposals;(ii) providing quarterly and annual reports as required by the department;(iii) conducting client surveys and other qualitative measures of client satisfaction; and(iv) producing an annual written report that includes but is not limited to a narrative description of goals accomplished, numbers of students served, summary and outcomes of performance measures, results from client satisfaction surveys, any available statistics related to increased academic success, at least one story from consumers describing the impact of the school-based health center, and plan for sustaining the center after the final year of grant funding.(b) Compliance. A funded applicant shall comply with standards required by Education Code, Chapter 38, Subchapter B, and provide to the department annually a statement signed by a representative of the school district and the local school health advisory council stating that the district and the local school health advisory council have made a good faith effort to meet all requirements of the department. Source Note: The provisions of this §37.538 adopted to be effective August 16, 2000, 25 TexReg 7699; amended to be effective April 24, 2008, 33 TexReg 3278; amended to be effective March 6, 2011, 36 TexReg 1280. 1 DEPARTMENT OF STATE HEALTH SERVICES 37 MATERNAL AND INFANT HEALTH SERVICES T SCHOOL-BASED HEALTH CENTERS §37.538 Standards for School-Based Health Centers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198832&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198832 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198832&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198832 03/11/2026 The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors for an institution of higher education that adopts unassigned epinephrine auto-injector policies. These standards are implemented under Texas Education Code, Chapter 51, Subchapter Y-1 and Texas Health and Safety Code, Chapter 773, Subchapter A. Source Note: The provisions of this §40.1 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198833&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198833 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198833&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198833 03/11/2026 An institution of higher education (institution) may adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each institution's campus. If a written policy is adopted under this subchapter, the policy must comply with Texas Education Code, §51.882 or Texas Health and Safety Code, §773.0145, and this subchapter. Source Note: The provisions of this §40.2 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.2 Voluntary Unassigned Epinephrine Auto-injector Policies for an Institution of Higher Education https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198834&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198834 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198834&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198834 03/11/2026 The following terms and phrases, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:(1) Anaphylaxis--As defined in Texas Education Code, §51.881.(2) Authorized healthcare provider--A physician, as defined in Texas Education Code, §51.881, or person who has been delegated prescriptive authority by a physician under Texas Occupations Code, Chapter 157 as described in Texas Health and Safety Code, §773.0145.(3) Campus--An educational unit under the management and control of an institution of higher education and may include, in addition to the main campus, off-campus and secondary locations, such as branch campuses, teaching locations, regional centers, and where students are housed.(4) Institution of Higher Education--As defined in Texas Education Code, §61.003(8) and (15).(5) Personnel--Employees of an institution of higher education who are authorized and trained to administer epinephrine auto-injectors.(6) Unassigned epinephrine auto-injector--An epinephrine auto-injector prescribed by an authorized healthcare provider in the name of the institution of higher education issued with a non-patient-specific standing delegation order for the administration of an epinephrine auto-injector, and issued by an authorized healthcare provider.(7) Volunteer--A person who is providing services for or on behalf of an institution of higher education on the premises of the institution's campus, at an institution of higher education-sponsored event or an institution of higher education-related activity on or off institution property, and who does not receive compensation in excess of reimbursement for expenses and is authorized and trained to administer an epinephrine auto-injector. Source Note: The provisions of this §40.3 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.3 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198835&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198835 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198835&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198835 03/11/2026 This subchapter applies to any institution of higher education (institution) that voluntarily chooses to adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors on each institution's campus. Source Note: The provisions of this §40.4 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.4 Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198836&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198836 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198836&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198836 03/11/2026 (a) An institution of higher education (institution) shall obtain a prescription from an authorized healthcare provider each year to stock, possess, and maintain at least one unassigned adult epinephrine auto-injector pack (two doses) on each institution's campus as described in Texas Education Code, §51.885 and Texas Health and Safety Code, §773.0145. The number of additional adult packs may be determined by an individual campus assessment led by an authorized health-care provider, based on available resources.(b) An institution performing an assessment may consider:(1) consultation with campus police, office of risk management, office of food services, office of housing, office of health services, or any department involved with student well-being;(2) campus geography, including high risk areas; and(3) student population size.(c) In development of an epinephrine auto-injector policy, an institution shall include:(1) a designated campus department to coordinate and manage policy implementation that includes:(A) conducting an assessment;(B) training of institution personnel;(C) acquiring or purchasing, storing, and using unassigned epinephrine auto-injectors; and(D) disposing of expired unassigned epinephrine auto-injectors;(2) personnel who can be trained to administer unassigned epinephrine auto-injectors;(3) locations of unassigned epinephrine auto-injectors;(4) procedures for notifying local emergency medical services when a person is suspected of experiencing anaphylaxis and when an epinephrine auto-injector is administered; and(5) a plan to replace, as soon as reasonably possible, any unassigned epinephrine auto-injector that is used or close to expiration.(d) The policy and the locations of the unassigned epinephrine auto-injector must be publicly available, and the unassigned epinephrine auto-injector must be stored in accordance with the manufacturer's guidelines.(e) Each public institution of higher education's policy must be submitted to the Department of State Health Services (DSHS) in accordance with the DSHS procedure. Source Note: The provisions of this §40.5 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.5 Maintenance, Administration, and Disposal of Unassigned Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198837&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198837 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198837&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198837 03/11/2026 (a) Each institution of higher education (institution) that adopts an unassigned epinephrine auto-injector written policy under this subchapter is responsible for training institution personnel and institution volunteers in the recognizing of anaphylaxis signs and symptoms and hands-on administration of an unassigned epinephrine auto-injector.(b) Training shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention.(c) Each institution shall maintain training records and each public institution shall make available upon request a list of those institution personnel or institution volunteers trained and authorized to administer the unassigned epinephrine auto-injector on the campus. Source Note: The provisions of this §40.6 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.6 Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198838&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198838 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198838&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198838 03/11/2026 (a) Records relating to implementing and administrating the institution of higher education (institution) unassigned epinephrine auto-injector policy shall be retained per the record retention schedule for records of institutions of higher education found in 13 TAC §6.10.(b) The institution shall submit a report no later than the 10th business day after the date institution personnel or an institution volunteer administers an epinephrine auto-injector in accordance with the unassigned epinephrine auto-injector policy adopted under this subchapter. The report shall be submitted to the institution and those identified in Texas Education Code, §51.883.(c) Notifications to the commissioner of the Department of State Health Services (DSHS) shall be submitted on the designated electronic form available on DSHS's School Health Program website found at dshs.texas.gov.(d) This section does not apply to a private or independent institution of higher education, as defined in Texas Education Code, §61.003(15). Source Note: The provisions of this §40.7 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.7 Report on Administering Unassigned Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198839&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198839 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198839&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198839 03/11/2026 A person who in good faith takes, or fails to take, any action under this subchapter or Texas Education Code, Chapter 51, Subchapter Y-1 or Texas Health and Safety Code, Chapter 773, Subchapter A, is immune from civil or criminal liability or disciplinary action resulting from that action or failure to act in accordance with the Texas Education Code, §51.888 or Texas Health and Safety Code, §773.0145. Source Note: The provisions of this §40.8 adopted to be effective March 25, 2020, 45 TexReg 1996. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES A EPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION §40.8 Immunity from Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203498&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203498 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203498&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203498 03/11/2026 The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors for a specified entity that adopts an unassigned epinephrine auto-injector policy. These standards are implemented under Texas Health and Safety Code, Chapter 773, Subchapter A. Source Note: The provisions of this §40.11 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.11 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203499&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203499 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203499&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203499 03/11/2026 Specified entities may adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each venue's property. The adopted policy must comply with the standards outlined in Texas Health and Safety Code §773.0145 and this subchapter. Source Note: The provisions of this §40.12 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.12 Voluntary Unassigned Epinephrine Auto-injector Policies for Certain Entities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203500&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203500 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203500&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203500 03/11/2026 The following terms and phrases, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:(1) Anaphylaxis--As defined in Texas Education Code §51.881.(2) Authorized healthcare provider--A physician or person who has been delegated prescriptive authority by a physician under Texas Occupations Code Chapter 157, as described in Texas Health and Safety Code §773.0145.(3) Personnel--Employees and volunteers of a venue.(4) Unassigned epinephrine auto-injector--An epinephrine auto-injector prescribed by an authorized healthcare provider in the name of the venue issued with a non-patient-specific standing order for the administration of an epinephrine auto-injector.(5) Venue--An entity offering a place of public gathering including:(A) an amusement park, as defined by Texas Penal Code §46.035;(B) a restaurant, as defined by Texas Business and Commerce Code §17.821; or(C) a sports venue, as defined by Texas Local Government Code §504.151.(6) Volunteer--A person who:(A) is providing services for or on behalf of a venue on the premises of the venue, or providing services for or on behalf of a venue at an offsite sponsored event or related activity; and(B) does not receive compensation in excess of reimbursement for expenses. Source Note: The provisions of this §40.13 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.13 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203501&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203501 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203501&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203501 03/11/2026 This subchapter applies to any venue that voluntarily adopts and implements a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each venue. Source Note: The provisions of this §40.14 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.14 Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203502&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203502 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203502&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203502 03/11/2026 (a) A venue shall obtain a prescription and standing order from an authorized healthcare provider each year to stock, possess, and maintain at least one unassigned adult epinephrine auto-injector pack (two doses) on each venue's property, as described in Texas Health and Safety Code §773.0145. The number of additional adult packs may be determined by an individual venue assessment led by an authorized health-care provider, based on available resources.(b) A venue performing such an assessment may consider:(1) consultation with office of risk management, office of food services, or any department involved with public well-being;(2) venue geography, including high risk areas; and(3) venue occupancy limit.(c) In developing an epinephrine auto-injector policy, a venue shall designate:(1) a department to coordinate and manage policy implementation, which shall include:(A) conducting an assessment;(B) training venue personnel;(C) purchasing (or otherwise acquiring), storing, and using unassigned epinephrine auto-injectors; and(D) disposing of used or expired unassigned epinephrine auto-injectors;(2) personnel who can be trained to administer unassigned epinephrine auto-injectors;(3) locations for unassigned epinephrine auto-injectors;(4) procedures for notifying local emergency medical services when a member of the venue or volunteer suspects a person is experiencing anaphylaxis and when an epinephrine auto-injector is administered; and(5) a plan to replace, as soon as reasonably possible, any unassigned epinephrine auto-injector that is used, and to replace any unused unassigned epinephrine auto-injector upon or prior to its expiration.(d) The policy and the locations of the unassigned epinephrine auto-injector must be publicly available, and the unassigned epinephrine auto-injector must be stored in accordance with the manufacturer's guidelines. Source Note: The provisions of this §40.15 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.15 Maintenance, Administration, and Disposal of Unassigned Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203503&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203503 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203503&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203503 03/11/2026 (a) Each venue that adopts an unassigned epinephrine auto-injector written policy under this subchapter is responsible for training venue personnel and venue volunteers in the recognizing of anaphylaxis signs and symptoms and hands-on administration of an unassigned epinephrine auto-injector.(b) Training shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention.(c) Each venue shall maintain training records and each venue shall make available upon request a list of those venue personnel or venue volunteers trained and authorized to administer the unassigned epinephrine auto-injector on the venue's property. Source Note: The provisions of this §40.16 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.16 Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203504&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203504 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203504&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203504 03/11/2026 (a) The venue that adopts a policy for administering unassigned epinephrine auto-injectors shall submit a report no later than the 10th business day after the date an epinephrine auto-injection is administered, in accordance with the unassigned epinephrine auto-injector policy adopted under this subchapter. The report shall be submitted to the prescribing authorized healthcare provider and the Department of State Health Services (DSHS).(b) Notifications to the commissioner of DSHS shall be submitted on the designated electronic form available on the DSHS School Health Program website, available at dshs.texas.gov. Source Note: The provisions of this §40.17 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.17 Report on Administering Unassigned Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203505&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203505 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203505&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203505 03/11/2026 A person who in good faith takes, or fails to take, any action under this subchapter or Texas Health and Safety Code, Chapter 773, Subchapter A, is immune from civil or criminal liability or disciplinary action resulting from that action or failure to act in accordance with the Texas Health and Safety Code §773.0145. Source Note: The provisions of this §40.18 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES B EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES §40.18 Immunity from Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203506&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203506 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203506&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203506 03/11/2026 The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors for a youth facility that adopts unassigned epinephrine auto-injector policies. These standards are implemented under Texas Health and Safety Code, Chapter 773, Subchapter A. Source Note: The provisions of this §40.21 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.21 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203507&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203507 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203507&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203507 03/11/2026 A youth facility may voluntarily adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each youth facility. If a written policy is adopted under this subchapter, the policy must comply with Texas Health and Safety Code, §773.0145, and this subchapter. Source Note: The provisions of this §40.22 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.22 Voluntary Unassigned Epinephrine Auto-injector Policies for Youth Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203508&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203508 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203508&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203508 03/11/2026 The following terms and phrases, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:(1) Anaphylaxis--As defined in Texas Human Resources Code, §42.067.(2) Authorized healthcare provider--A physician, or person who has been delegated prescriptive authority by a physician under Texas Occupations Code, Chapter 157 as described in Texas Health and Safety Code, §773.0145.(3) Personnel--Employees or volunteers of a youth facility.(4) Unassigned epinephrine auto-injector--An epinephrine auto-injector prescribed by an authorized healthcare provider in the name of the youth facility, issued with a non-patient-specific standing order for the administration of an epinephrine auto-injector.(5) Youth facility is:(A) a child-care facility, as defined by Texas Human Resources Code, §42.002;(B) a day camp or youth camp, as defined by Texas Health and Safety Code, §141.002;(C) a youth center, as defined by Texas Health and Safety Code, §481.134;(D) a small employer-based day-care facility, as defined by Texas Human Resources Code, §42.151;(E) a temporary shelter day-care facility, as defined by Texas Human Resources Code, §42.201;(F) a listed family home, as defined by Texas Human Resources Code, §42.052(c); or(G) any other private or public entity that would benefit from the possession and administration of epinephrine auto-injectors, that provide services for youth under the age of eighteen. Source Note: The provisions of this §40.23 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.23 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203509&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203509 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203509&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203509 03/11/2026 This subchapter applies to any youth facility that voluntarily chooses to adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors. Source Note: The provisions of this §40.24 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.24 Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203510&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203510 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203510&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203510 03/11/2026 (a) A youth facility (facility) shall stock at least one unassigned pediatric epinephrine auto-injector pack (two doses) and one adult epinephrine auto-injector pack (two doses). The number of additional pediatric and adult packs may be determined by a facility assessment led by an authorized health-care provider, based on available resources, in accordance with this subchapter.(b) A facility with greater than 100 youth and staff that voluntarily adopts an unassigned epinephrine auto-injector policy shall conduct an assessment to determine the minimum number of additional unassigned epinephrine auto-injectors and may consider as a part of an assessment:(1) consultation with administrators, office of risk management, food services management, or any department involved with public well-being;(2) facility geography, including high risk areas where food exposure or environmental trigger exposure may occur;(3) enrollment limit and number of personnel; and(4) the number of youth with an identified allergy.(c) An unassigned epinephrine auto-injector policy shall include:(1) a designated administrator to coordinate and manage policy implementation;(2) an assessment, if greater than 100 youth and staff;(3) a training policy for personnel that is consistent with §40.22 of this subchapter (relating to Training);(4) a requirement to obtain a prescription from an authorized healthcare provider each year to stock, possess, and maintain the minimum number of unassigned epinephrine auto-injectors, described in §40.20 of this subchapter (relating to Applicability), to be dispensed by an authorized pharmacy, as defined by Texas Occupations Code, Chapter 560, §560.001;(5) a requirement to obtain a standing order designating how and when to administer an unassigned epinephrine auto-injector;(6) the number of unassigned epinephrine auto-injectors at the facility;(7) a process to verify the inventory of unassigned epinephrine auto-injectors at regular intervals for expiration and replacement;(8) a plan to replace, as soon as reasonably possible, any unassigned epinephrine auto-injector when used or close to expiration;(9) a requirement that the unassigned epinephrine auto-injectors be stored according to manufacturer's instructions;(10) designation of one or more secure and easily-accessible locations to store unassigned epinephrine auto-injectors; and(11) procedures for notifying local emergency medical services when a person is suspected of experiencing anaphylaxis and when an epinephrine auto-injector is administered.(d) If a facility implements an unassigned epinephrine auto-injector policy under this subchapter, the facility must provide written or electronic notice to a parent or guardian of each youth enrolled within 15 calendar days.(e) If a facility changes or discontinues the policy adopted under this subchapter, the facility must provide a written or electronic notice detailing the change or discontinuation to a parent or guardian of each youth within 15 calendar days of the change or discontinuation. Source Note: The provisions of this §40.25 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.25 Maintenance, Administration, and Disposal of Unassigned Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203511&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203511 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203511&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203511 03/11/2026 (a) Each youth facility (facility) that adopts an unassigned epinephrine auto-injector written policy under this subchapter is responsible for annually training personnel to recognize the signs and symptoms of anaphylaxis and to perform hands-on administration of an unassigned epinephrine auto-injector.(b) Training shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention.(c) Each facility shall maintain and make available upon request:(1) a list of personnel trained and authorized to administer the unassigned epinephrine auto-injector; and(2) annual training records for such personnel. Source Note: The provisions of this §40.26 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.26 Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203512&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203512 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203512&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203512 03/11/2026 (a) The youth facility (facility) shall submit a report no later than the 10th business day after the date facility personnel administer an unassigned epinephrine auto-injector. The report shall be submitted to the owner of the facility, the prescribing authorized healthcare provider, and the Department of State Health Services (DSHS).(b) Notifications to DSHS shall be submitted on the designated electronic form available on DSHS's School Health Program website found at dshs.texas.gov. DSHS will submit a copy of the report to the Child Care Regulation Department of the Texas Health and Human Services Commission. Source Note: The provisions of this §40.27 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.27 Report on Administering Unassigned Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203513&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203513 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=203513&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 203513 03/11/2026 A person who in good faith takes, or fails to take, any action under this subchapter or Texas Health and Safety Code, Chapter 773, Subchapter A, is immune from civil or criminal liability or disciplinary action resulting from that action or failure to act in accordance with the Texas Health and Safety Code, §773.0145. Source Note: The provisions of this §40.28 adopted to be effective February 9, 2021, 46 TexReg 917. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES C EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES §40.28 Immunity from Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224079 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224079 03/11/2026 The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of unassigned medication for respiratory distress in school districts, open-enrollment charter schools, or private schools voluntarily adopting unassigned medication for respiratory distress policies. These standards are implemented under Texas Education Code (TEC) Chapter 38, Subchapter E. Source Note: The provisions of this §40.41 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.41 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224080&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224080 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224080&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224080 03/11/2026 The following terms and phrases, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Authorized healthcare provider--A physician, as defined in TEC §38.201, or a person delegated prescriptive authority by a physician under Texas Occupations Code Chapter 157.(2) Campus--A geographic unit of a school district, open-enrollment charter school, or private school that:(A) has an assigned administrator;(B) has enrolled students who are counted for average daily attendance;(C) has assigned instructional staff;(D) provides instructional services to students;(E) has one or more grades in the range from early childhood education through grade 12 or is ungraded; and(F) is subject to Texas laws.(3) Open-enrollment charter school--As defined in TEC §38.151. (4) Private school--As defined in TEC §38.201.(5) Regular school hours--At least 30 minutes before the first bell to 30 minutes after the last bell of the school day.(6) School district--Independent school districts established under TEC Chapter 11, Subchapters A - F; and open-enrollment charter schools established under TEC Chapter 12, Subchapter D.(7) School nurse--Registered nurse, as defined in 19 Texas Administrative Code (TAC) §153.1022 (relating to Minimum Salary Schedule for Certain Professional Staff), or licensed vocational nurse working under supervision as described in Texas Occupations Code §301.353.(8) School personnel--As defined in TEC §38.201.(9) School-sponsored event--A school-sponsored or school-related activity occurring on or off school property.(10) School volunteer--As defined in TEC §22.053.(11) TEC--Texas Education Code.(12) Unassigned medication for respiratory distress--Albuterol, levalbuterol, or another medication based on the best available medical evidence for the treatment of respiratory distress that is:(A) delivered by metered-dose inhaler (MDI) with a spacer (valved holding chamber) or by a nebulizer as a rescue medication; (B) prescribed by an authorized healthcare provider in the name of the school district, open-enrollment charter school, or private school;(C) issued with a non-patient-specific standing delegation order for the administration of a medication for respiratory distress; and(D) issued by an authorized healthcare provider. Source Note: The provisions of this §40.42 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.42 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224081&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224081 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224081&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224081 03/11/2026 The rules of this subchapter apply to any school district, open-enrollment charter school, or private school voluntarily choosing to adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned medication for respiratory distress at each campus. Source Note: The provisions of this §40.43 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.43 Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224082&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224082 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224082&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224082 03/11/2026 (a) A school district, open-enrollment charter school, or private school may voluntarily adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned medication for respiratory distress at each campus.(1) If a written policy is adopted under this subchapter, the:(A) unassigned medication for respiratory distress policy must comply with TEC §38.208;(B) campus must have at least one school personnel or school volunteer authorized and trained to administer unassigned medication for respiratory distress present during regular school hours;(C) policy must state school personnel or a school volunteer authorized and trained to administer unassigned medication for respiratory distress may administer medication for respiratory distress at a school-sponsored or school-related activity on or off school property; and(D) school personnel or school volunteer may not be subject to any penalty or disciplinary action for refusing to administer or receive training to administer unassigned medication for respiratory distress, as applicable.(2) Subject to the availability of funding, a school district, open-enrollment charter school, or private school choosing to voluntarily adopt such a policy must allow for treatment of multiple students and secure or obtain at least:(A) one MDI with appropriate spacers (valved holding chambers) to accommodate the developmental needs of the student population, or(B) at least five vials of nebulizer solution with appropriate nebulizer-required equipment to accommodate the developmental needs of the student population.(b) In the development of an unassigned medication for respiratory distress policy, a school district, open-enrollment charter school, or private school may consider performing a review to include:(1) consultation with school nurses, the local school health advisory committee, local healthcare providers, or any department or organization involved with student well-being;(2) campus geography; and(3) student population size.(c) If a school district, open-enrollment charter school, or private school voluntarily adopts an unassigned medication for respiratory distress policy, the policy must include:(1) the designated campus administrator to coordinate and manage policy implementation, which includes:(A) conducting a review at the campus to determine the need for additional doses;(B) training school personnel and school volunteers;(C) acquiring or purchasing, maintaining, storing, and using unassigned medication for respiratory distress, subject to available campus funding; and(D) disposing of expired unassigned medication for respiratory distress;(2) a list of trained and authorized school personnel and school volunteers available to administer unassigned medication for respiratory distress;(3) the locations of unassigned medication for respiratory distress in compliance with TEC §38.208;(4) the procedures for notifying a parent, prescribing authorized healthcare provider, and the student's primary healthcare provider when unassigned medication for respiratory distress is administered; (5) a plan to check inventory of unassigned medication for respiratory distress for expiration at least twice during the school year, to replace, as soon as reasonably possible, and to document the findings;(6) a referral process to the student's primary healthcare provider if the student's parent or guardian has not notified the school the student has been diagnosed with asthma, referral must include:(A) symptoms of respiratory distress observed;(B) name and dosage of the unassigned medication for respiratory distress administered to the student;(C) patient care instructions given to the student; and(D) information about the purpose and use of an asthma action plan and medical authorization for schools, including a blank copy of the plan and authorization the provider completes and returns to the school; and(7) the process for providing information to assist the parent or guardian in selecting a primary healthcare provider for the student if the student received unassigned medication for respiratory distress and does not have a primary healthcare provider or the parent or guardian of the student has not engaged a primary healthcare provider for the student.(d) An adopted unassigned medication for respiratory distress policy must be publicly available. Source Note: The provisions of this §40.44 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.44 Voluntary Unassigned Medication for Respiratory Distress Policies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224083&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224083 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224083&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224083 03/11/2026 (a) Once a school district, open-enrollment charter school, or private school voluntarily adopts an unassigned medication for respiratory distress policy, any campus that implements an unassigned medication for respiratory distress policy must stock unassigned medication for respiratory distress, subject to available funding, as defined by §40.44 of this subchapter (relating to Voluntary Unassigned Medication for Respiratory Distress Policies).(b) A campus must obtain a prescription from an authorized healthcare provider to stock, possess, and maintain unassigned medication for respiratory distress at each campus as described in TEC §38.208 and any equipment necessary to administer the medication.(1) The campus must renew this prescription or obtain a new prescription annually.(2) In addition to the minimum number of doses as defined by §40.44 of this subchapter, the number of additional doses may be determined by an individual campus review led by an authorized healthcare provider.(c) An authorized healthcare provider prescribing unassigned medication for respiratory distress under subsection (b) of this section must provide the campus with a standing order for the administration of unassigned medication for respiratory distress to a person experiencing respiratory distress.(d) The unassigned medication for respiratory distress must be stored in accordance with the manufacturer's guidelines and local policy of the school district, open-enrollment charter school, or private school. The location of medication for respiratory distress at each campus must be secure and easily accessible to authorized school personnel and school volunteers.(e) Expired unassigned medication for respiratory distress and other used or expired supplies must be disposed of in accordance with the manufacturer's guidelines and local policy of the school district, open-enrollment charter school, or private school. Source Note: The provisions of this §40.45 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.45 Prescription, Administration, and Disposal of Unassigned Medications for Respiratory Distress https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224084&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224084 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224084&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224084 03/11/2026 (a) A school district, open-enrollment charter school, or private school that chooses to adopt a written unassigned medication for respiratory distress policy is responsible for training school personnel or school volunteers in the administration of unassigned medication for respiratory distress. Each authorized school personnel or school volunteer must receive initial training and an annual refresher training. The training must:(1) meet the requirements found in TEC §38.210;(2) cover the authorized healthcare provider's standing order;(3) include processes to follow-up with the prescribing authorized healthcare provider and the student's primary healthcare provider;(4) provide information on the report required after administering unassigned medication for respiratory distress under §40.47 of this subchapter (relating to Report on Administering Unassigned Medication for Respiratory Distress);(5) include information on the adopted unassigned medication for respiratory distress policy;(6) incorporate hands-on training with unassigned medication for respiratory distress; and(7) inform school personnel or school volunteers of the purpose and use of asthma action plans.(b) Each campus must maintain training records and must make available upon request a list of school personnel and school volunteers trained and authorized to administer unassigned medication for respiratory distress at the campus or at a school-sponsored event. Source Note: The provisions of this §40.46 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.46 Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224085&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224085 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224085&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224085 03/11/2026 (a) Records relating to implementing and administering the school district, open-enrollment charter school, or private school's unassigned medication for respiratory distress policy must be retained per the campus record retention schedule.(b) The report required under this subsection must comply with TEC §38.2091.(c) The campus must submit a report no later than the 10th business day after the date a school personnel or school volunteer administered medication for respiratory distress in accordance with the unassigned medication for respiratory distress policy adopted under this subchapter. The report must be included in the student's permanent record, if applicable, and must be submitted to the individuals and entities identified in TEC §38.2091:(1) the school district, the charter holder if the school is an open-enrollment charter school, or the governing body of the school if the school is a private school;(2) the physician or other person prescribing the medication for respiratory distress; and(3) the Department of State Health Services (DSHS) commissioner.(d) Notifications to the DSHS commissioner must be submitted on the designated electronic form available on the DSHS School Health Program website found at dshs.texas.gov. Source Note: The provisions of this §40.47 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.47 Report on Administering Unassigned Medication for Respiratory Distress. https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224086&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224086 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224086&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224086 03/11/2026 (a) If a school district, open-enrollment charter school, or private school implements an unassigned medication for respiratory distress policy under this subchapter, the campus must provide written or electronic notice to a parent or guardian of each student in accordance with TEC §38.212.(b) If a school district, open-enrollment charter school, or private school changes or discontinues the unassigned medication for respiratory distress policy under this subchapter, the campus must provide written or electronic notice detailing the change or discontinuation of the policy to a parent or guardian of each student within 15 calendar days after the change or discontinuation. Source Note: The provisions of this §40.48 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.48 Notice to Parents Regarding Unassigned Medication for Respiratory Distress Policies in Schools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224087&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224087 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224087&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224087 03/11/2026 A person who in good faith takes, or fails to take, any action under this subchapter or TEC Chapter 38, Subchapter E is immune from civil or criminal liability or disciplinary action resulting from that action or a failure to act in accordance with TEC §38.215(a). Source Note: The provisions of this §40.49 adopted to be effective February 18, 2021, 46 TexReg 1064; amended to be effective February 19, 2025, 50 TexReg 859. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES D MAINTENANCE AND ADMINISTRATION OF MEDICATION FOR RESPIRATORY DISTRESS §40.49 Immunity from Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215510&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215510 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215510&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215510 03/11/2026 The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors in school districts, open-enrollment charter schools, and private schools adopting unassigned epinephrine auto-injector policies. These standards are implemented under Texas Education Code Chapter 38, Subchapter E. Source Note: The provisions of this §40.61 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.61 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215511&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215511 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215511&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215511 03/11/2026 (a) A school district, open-enrollment charter school, or private school may adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each school campus.(b) If a written policy is adopted under this subchapter, the policy must comply with Texas Education Code §38.208 and this subchapter.(c) A school district or open-enrollment charter school that chooses to adopt and implement a written unassigned epinephrine auto-injector policy under Texas Education Code Chapter 38, Subchapter E, and this subchapter, is not required to create an additional policy for care of certain students at risk for anaphylaxis under Texas Education Code §38.0151. Source Note: The provisions of this §40.62 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.62 Voluntary Unassigned Epinephrine Auto-Injector Policies for School Districts, Open-enrollment Charter Schools, and Private Schools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215508&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215508 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215508&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215508 03/11/2026 The following terms and phrases, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:(1) All hours the campus is open--At a minimum, during regular on-campus school hours, and when school personnel are physically on site for school-sponsored activities.(2) Anaphylaxis--As defined in Texas Education Code §38.201.(3) Authorized healthcare provider--A physician or person who has been delegated prescriptive authority under Texas Occupations Code Chapter 157.(4) Campus--A unit of a school district, open-enrollment charter school, or private school with an assigned administrator, has enrolled students who are counted for average daily attendance, has assigned instructional staff, provides instructional services to students, has one or more grades in the range from early childhood education through grade 12 or is ungraded, and complies with relevant Texas laws.(5) Open-enrollment charter school--As defined in Texas Education Code §38.151.(6) Physician--As defined in Texas Education Code §38.201.(7) Private school--As defined in Texas Education Code §38.201.(8) School nurse--As defined in 19 Texas Administrative Code §153.1022.(9) School personnel--As defined in Texas Education Code §38.201.(10) School volunteer--As defined in Texas Education Code §22.053.(11) Unassigned epinephrine auto-injector--An epinephrine auto-injector prescribed by an authorized healthcare provider in the name of the school issued with a non-patient-specific standing delegation order for the administration of an epinephrine auto-injector, issued by a physician or person who has been delegated prescriptive authority under Texas Occupations Code Chapter 157. Source Note: The provisions of this §40.63 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.63 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215509&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215509 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215509&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215509 03/11/2026 This subchapter applies to any school district, open-enrollment charter school, or private school voluntarily choosing to adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors on each school campus. Source Note: The provisions of this §40.64 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.64 Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215501&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215501 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215501&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215501 03/11/2026 (a) A school district, open-enrollment charter school, or private school shall obtain a prescription from an authorized healthcare provider each year, to stock, possess, and maintain at least one unassigned adult epinephrine auto-injector pack (two doses) on each school campus as described in Texas Education Code §38.211.(1) A school may choose to stock unassigned pediatric epinephrine auto-injector packs, based on the need of the school's population.(2) A school district or the governing body of an open-enrollment charter school or private school may develop, as part of the policy, provisions for additional doses to be stocked and utilized at off campus school events, or in transit to or from school events.(b) Each school district superintendent, open-enrollment charter school administrator, or private school administrator will designate appropriate school personnel to coordinate and manage policy implementation, including training of school personnel, and the acquisition or purchase, usage, expiration, and disposal of unassigned epinephrine auto-injectors. Throughout the school calendar year, the designated school personnel must coordinate with each campus to ensure the unassigned epinephrine auto-injectors are checked monthly for expiration and usage and the findings are documented.(c) At least one school personnel or one school volunteer who is authorized and trained to administer an unassigned epinephrine auto-injector must be present on campus during all hours the campus is open for school-sponsored activities.(d) School personnel or school volunteers who are trained and authorized may administer an unassigned epinephrine auto-injector to a person who is reasonably believed to be experiencing anaphylaxis on a school campus, or as indicated in the school's unassigned epinephrine auto-injector policy.(e) Local emergency medical services must be promptly notified by the school when an individual is suspected of experiencing anaphylaxis and when an epinephrine auto-injector is administered. If the trained school personnel or school volunteer is the only individual available to notify emergency medical services, the trained individual should administer the unassigned epinephrine auto-injector before notifying emergency medical services.(f) The parent, legal guardian, or emergency contact must be promptly notified by the school when an unassigned epinephrine auto-injector is utilized on their child as soon as feasible during the emergency response to suspected anaphylaxis. School records of the administration of the unassigned epinephrine auto-injector and suspected anaphylaxis must be provided to the parent or guardian of the recipient upon request.(g) Records relating to implementation and administration of the school's unassigned epinephrine auto-injector policy shall be retained per the record retention schedule for records of public school districts found in 13 Texas Administrative Code §7.125.(h) Unassigned epinephrine auto-injectors shall be stored in a secure, easily accessible area for an emergency, in accordance with the manufacturer's guidelines. It is recommended the school administrator develop a map to be placed in high traffic areas indicating the location of the unassigned epinephrine auto-injectors on each school campus. It is recommended the map also indicate the locations of the automated external defibrillator.(i) The school district, open-enrollment charter school, or private school shall develop a plan to replace, as soon as reasonably possible, any unassigned epinephrine auto-injector used or close to expiration.(j) Used unassigned epinephrine auto-injectors shall be considered infectious waste and shall be disposed of according to the school's bloodborne pathogen control policy.(k) Expired unassigned epinephrine auto-injectors shall be disposed of according to the school's medication disposal policy. Source Note: The provisions of this §40.65 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.65 Maintenance, Administration, and Disposal of Unassigned Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215502&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215502 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215502&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215502 03/11/2026 (a) At each school campus adopting an unassigned epinephrine auto-injector policy, the school principal may:(1) assign school personnel or school volunteers to be trained to administer unassigned epinephrine auto-injectors; or(2) seek school personnel or school volunteers who volunteer to be trained to administer unassigned epinephrine auto-injectors.(b) In order to increase the number of trained individuals in the administration of unassigned epinephrine auto-injectors, schools may distribute to school personnel and school volunteers in the school district, open-enrollment charter school, or private school, at least once per school year, a notice including:(1) a description of the request seeking volunteers to be trained to administer an epinephrine auto-injector to a person believed to be experiencing anaphylaxis; and(2) a description of the training the school personnel or school volunteers will receive in the administration of epinephrine with an auto-injector.(c) Trained school personnel or school volunteers who administer the unassigned epinephrine auto-injector must submit a signed statement indicating they agree to perform the service of administering an unassigned epinephrine auto-injector to a student or individual who may be experiencing anaphylaxis. Source Note: The provisions of this §40.66 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.66 Assignment and Recruitment of School Personnel and School Volunteers to be Trained to Administer Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215503&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215503 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215503&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215503 03/11/2026 Each school district, open-enrollment charter school, or private school that adopts an unassigned epinephrine auto-injector written policy under this subchapter is responsible for training school personnel and school volunteers in the recognition of anaphylaxis signs and symptoms and administration of an unassigned epinephrine auto-injector. Each assigned school personnel or school volunteer shall receive initial training and an annual refresher training. Training shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention.(1) Training may be provided in a formal face-to-face training session or through an online education course.(2) Training required under this subchapter must meet the requirements found in Texas Education Code §38.210 and include information on properly inspecting unassigned epinephrine auto-injectors for usage and expiration.(3) The initial training must include hands-on training with an epinephrine auto-injector trainer.(4) The annual refresher training must include a hands-on demonstration of administration skills.(5) The training must also include information about promptly notifying local emergency medical services.(6) Each school campus must maintain training records and make available upon request a list of those school personnel or school volunteers trained and authorized to administer the unassigned epinephrine auto-injector on the campus. Source Note: The provisions of this §40.67 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.67 Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215507&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215507 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215507&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215507 03/11/2026 (a) A report must be submitted by the school no later than the 10th business day after the date school personnel or a school volunteer administers an epinephrine auto-injector in accordance with the unassigned epinephrine auto-injector policy adopted under this subchapter. The report shall be submitted to the individuals and entities identified in Texas Education Code §38.209, including the commissioner of the Department of State Health Services (DSHS).(b) Notifications to the commissioner of DSHS shall be submitted on the designated electronic form available on the DSHS School Health Program website found at dshs.texas.gov. Source Note: The provisions of this §40.68 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.68 Report on Administering Epinephrine Auto-Injectors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215504&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215504 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215504&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215504 03/11/2026 (a) If a school district, open-enrollment charter school, or private school implements an unassigned epinephrine auto-injector policy under this subchapter, the district or school shall provide written or electronic notice to a parent or guardian of each student in accordance with Texas Education Code §38.212.(b) If a school district, open-enrollment charter school, or private school changes or discontinues the policy under this subchapter, written or electronic notice detailing the change or discontinuation must be provided to a parent or guardian of each student within 15 calendar days. Source Note: The provisions of this §40.69 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.69 Notice to Parents Regarding Unassigned Epinephrine Auto-Injector Policies in Schools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215505&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215505 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215505&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215505 03/11/2026 A school district, open-enrollment charter school, or private school may accept gifts, grants, donations, federal funds, and local funds to implement the unassigned epinephrine auto-injector policy in accordance with Texas Education Code §38.213. Source Note: The provisions of this §40.70 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.70 Gifts, Grants, and Donations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215506&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215506 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215506&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215506 03/11/2026 A person who in good faith takes, or fails to take, any action under this subchapter or Texas Education Code Chapter 38, Subchapter E is immune from civil or criminal liability or disciplinary action resulting from action or a failure to act in accordance with the Texas Education Code §38.215. Source Note: The provisions of this §40.71 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES E EPINEPHRINE AUTO-INJECTOR POLICIES IN SCHOOLS §40.71 Immunity from Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215356&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215356 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215356&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215356 03/11/2026 The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of opioid antagonist medication in school districts, open-enrollment charter schools, and private schools adopting opioid antagonist medicine policies. These standards are implemented under Texas Education Code Chapter 38, Subchapter E-1. Source Note: The provisions of this §40.81 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.81 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215357&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215357 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215357&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215357 03/11/2026 The following terms and phrases, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:(1) All hours the campus is open--At a minimum, during regular on-campus school hours, and when school personnel are physically on site for school-sponsored activities.(2) Authorized healthcare provider--A physician, as defined in Texas Education Code §38.201, or person who has been delegated prescriptive authority by a physician under Texas Occupations Code Chapter 157.(3) Campus--A unit of a school district, open-enrollment charter school, or private school with an assigned administrator, has enrolled students who are counted for average daily attendance, has assigned instructional staff, provides instructional services to students, has one or more grades in the range from early childhood education through grade 12 or is ungraded, and complies with relevant Texas laws.(4) Open-enrollment charter school--As defined in Texas Education Code §38.151.(5) Opioid antagonist--As defined in Texas Health and Safety Code §483.101, any drug that binds to opioid receptors and blocks or otherwise inhibits the effects of opioids acting on those receptors.(6) Opioid-related drug overdose--As defined in Texas Health and Safety Code §483.101, a condition, evidenced by symptoms of extreme physical illness, decreased level of consciousness, constriction of the pupils, respiratory depression, or coma, that a layperson would reasonably believe to be the result of the consumption or use of an opioid.(7) Private school--As defined in Texas Education Code §38.201.(8) School personnel--As defined in Texas Education Code §38.201.(9) School volunteer--As defined in Texas Education Code §22.053. Source Note: The provisions of this §40.82 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.82 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215358&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215358 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215358&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215358 03/11/2026 This subchapter applies to any school district, open-enrollment charter school, or private school adopting and implementing a written policy regarding the maintenance, administration, and disposal of opioid antagonist medication on a campus or campuses. Source Note: The provisions of this §40.83 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.83 Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215359&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215359 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215359&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215359 03/11/2026 (a) Each school district must adopt and implement a policy regarding the maintenance, administration, and disposal of opioid antagonists at each campus in the district serving students in grades 6 through 12 and may voluntarily adopt and implement such a policy at each campus in the district, including campuses serving students in a grade level below grade 6.(b) An open-enrollment charter school or private school may adopt and implement a policy regarding the maintenance, administration, and disposal of opioid antagonists. If an open-enrollment charter or private school adopts a policy under this subchapter, the opioid antagonist policy must comply with the Texas Education Code §38.222. The policy may apply:(1) only at campuses of the school serving students in grades 6 through 12; or(2) at each campus of the school, including campuses serving students in a grade level below grade 6.(c) A policy adopted under this subchapter must:(1) provide that school personnel and school volunteers who are authorized and trained may administer an opioid antagonist to a person who they reasonably believe is experiencing an opioid-related drug overdose;(2) require each school campus, subject to a policy adopted under this subchapter, have one or more school personnel members or school volunteers authorized and trained to administer an opioid antagonist present during regular school hours;(3) establish the number of opioid antagonists that must be available at each campus at any given time; and(4) require the supply of opioid antagonists at each school campus, subject to a policy adopted under this subchapter, be stored in a secure location and be easily accessible to school personnel and school volunteers authorized and trained to administer an opioid antagonist. Source Note: The provisions of this §40.84 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.84 Required and Voluntary Opioid Antagonist Policies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215360&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215360 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215360&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215360 03/11/2026 (a) Once a school district, open-enrollment charter school, or private school adopts an opioid antagonist medication policy, a campus implementing an opioid policy must stock opioid antagonist medication as defined by §40.84 of this subchapter (relating to Required and Voluntary Opioid Antagonist Policies).(b) A campus must obtain a prescription from a physician or a person who has been delegated prescriptive authority to stock, possess, and maintain the established number of doses of opioid antagonists as determined by a school district, on each campus as described in Texas Education Code §38.225.(1) The campus must renew this prescription or obtain a new prescription annually.(2) The number of additional doses may be determined by an individual campus review led by a physician or a person who has been delegated prescriptive authority.(c) A physician or other person who has been delegated prescriptive authority under Texas Occupations Code Chapter 157 and prescribes opioid antagonist medication under subsection (a) of this section, must provide the school district, open-enrollment charter school, or private school a standing order for administration of an opioid antagonist medication to a person who is reasonably believed to be experiencing an opioid-related drug overdose. The standing order must comply with the Texas Education Code §38.225.(d) The unassigned opioid antagonist medication must be stored in a secure location and be easily accessible, in accordance with the manufacturer's guidelines and local policy of the school district, open-enrollment charter school, or private school.(e) Used, unassigned opioid antagonists are considered infectious waste and must be disposed of according to the school's blood-borne pathogen control policy.(f) Expired, unassigned opioid antagonists must be disposed of in accordance with the Federal Drug Administration's disposal of unused medications guidelines and local policy of the school district, open-enrollment charter school, or private school. Source Note: The provisions of this §40.85 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.85 Maintenance, Administration, and Disposal of Opioid Antagonist Medication https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215361&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215361 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215361&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215361 03/11/2026 (a) Each school district, open-enrollment charter school, and private school adopting a written unassigned opioid antagonist policy under Texas Education Code §38.222, is responsible for training school personnel and school volunteers in the administration of an opioid antagonist.(b) Training under this subchapter must:(1) include information on:(A) recognizing the signs and symptoms of an opioid-related drug overdose;(B) responding to an opioid-related drug overdose and administering an opioid antagonist;(C) implementing emergency procedures, after administering an opioid antagonist;(D) understanding the medical purpose and misuse of opioids; and(E) properly disposing of used or expired opioid antagonists;(2) be provided annually in a formal training session or through online education, including practicing the administration of an opioid antagonist with an opioid antagonist trainer device; and(3) be provided in accordance with the policy adopted under Texas Education Code §21.4515.(c) Each campus must maintain training records and must make available upon request a list of school personnel and school volunteers who are trained and authorized to administer the unassigned opioid antagonist medication on the campus. Source Note: The provisions of this §40.86 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.86 Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215362&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215362 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215362&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215362 03/11/2026 (a) Records relating to implementing and administering the school district, open-enrollment charter school, or private school's unassigned opioid antagonist medication policy must be retained per the campus record retention schedule.(b) The campus must submit the report no later than the 10th business day after the date a school personnel member or school volunteer administers an opioid antagonist in accordance with the unassigned opioid antagonist medication policy adopted under this subchapter. The report shall be submitted to the individuals and entities identified in Texas Education Code §38.223:(1) the school district, the charter holder if the school is an open-enrollment charter school, or the governing body of the school if the school is a private school;(2) the physician or other person who prescribed the opioid antagonist; and(3) the commissioner of the Department of State Health Services (DSHS).(c) Notifications to the commissioner of DSHS must be submitted on the designated electronic form available on DSHS School Health Program website found at dshs.texas.gov. Source Note: The provisions of this §40.87 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.87 Report on Administering Unassigned Opioid Antagonist Medication https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215363&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215363 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215363&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215363 03/11/2026 A school district, open-enrollment charter school, or private school may accept gifts, grants, donations, federal funds, and local funds to implement this subchapter. Source Note: The provisions of this §40.88 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.88 Gifts, Grants, and Donations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215364&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215364 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215364&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215364 03/11/2026 A person who in good faith takes, or fails to take, any action under this subchapter, or Texas Education Code Chapter 38, Subchapter E-1, is immune from civil or criminal liability or disciplinary action resulting from action or a failure to act in accordance with Texas Education Code §38.227. Source Note: The provisions of this §40.89 adopted to be effective November 1, 2023, 48 TexReg 6207. 1 DEPARTMENT OF STATE HEALTH SERVICES 40 STOCK MEDICATION IN SCHOOLS AND OTHER ENTITIES F OPIOID ANTAGONIST MEDICATION REQUIREMENTS IN SCHOOLS §40.89 Immunity from Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199931&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199931 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199931&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199931 03/11/2026 The rules in this chapter implement the Texas Oral Health Improvement Act, Texas Health and Safety Code, Chapter 43 (Act). The Act authorizes the Department of State Health Services Oral Health Improvement Program to implement activities for eligible individuals to prevent oral disease and associated health risks through surveillance and oral health promotion and education. The program is led by the State Public Health Dental Director. Source Note: The provisions of this §49.1 adopted to be effective June 29, 2020, 45 TexReg 4339. 1 DEPARTMENT OF STATE HEALTH SERVICES 49 ORAL HEALTH IMPROVEMENT PROGRAM §49.1 Purpose and Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199932&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199932 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199932&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199932 03/11/2026 The following words and terms, where used in this chapter, have the following meanings, unless the context clearly indicates otherwise.(1) Dental hygienist--An individual licensed by the State Board of Dental Examiners to practice dental hygiene in the State of Texas.(2) Dental sealant--A thin, plastic coating painted on the chewing surfaces of teeth to prevent tooth decay.(3) Dentist--An individual licensed by the State Board of Dental Examiners to practice dentistry in the State of Texas.(4) Department--The Department of State Health Services.(5) Fluoride varnish--A highly concentrated form of fluoride applied to the surface of teeth to prevent tooth decay, remineralize weakened teeth, and treat hypersensitivity.(6) Health risk--Any attribute or factor that presents a danger or hazard to health.(7) Oral health--Health affecting the structures of the mouth, including the hard and soft tissues such as teeth, jaws, gums, vestibule, tongue, cheeks, lips, floor and roof of the mouth, and adjacent masticatory structure.(8) Oral health promotion--Activity that supports or provides active encouragement for the furtherance of oral hygiene, dental care, and conditions conducive to good oral health.(9) Program--The Oral Health Improvement Program at the department.(10) Public health--Protection and improvement of community health through organized community effort.(11) Screening--A non-comprehensive visual observation of the oral cavity to assess oral health status.(12) Silver diamine fluoride--Topical liquid applied to dental caries (cavities) to relieve sensitivity and prevent further progression of tooth decay.(13) State Public Health Dental Director--A Texas licensed dentist who leads the Oral Health Improvement Program at the department.(14) Surveillance--Observation of a population group, condition, or ongoing activity in order to gather information. Source Note: The provisions of this §49.2 adopted to be effective June 29, 2020, 45 TexReg 4339. 1 DEPARTMENT OF STATE HEALTH SERVICES 49 ORAL HEALTH IMPROVEMENT PROGRAM §49.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199928&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199928 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199928&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199928 03/11/2026 The department may perform public oral health screening and surveillance across the State of Texas.(1) Regional dental teams perform open mouth screening to assess the oral health of individuals.(2) Regional dentists issue written findings, which may include recommendation for a comprehensive exam.(3) The data collected from oral health surveillance may include:(A) demographic data;(B) dental history;(C) history of tooth decay;(D) presence of dental sealants; and(E) early and urgent dental needs. Source Note: The provisions of this §49.3 adopted to be effective June 29, 2020, 45 TexReg 4339. 1 DEPARTMENT OF STATE HEALTH SERVICES 49 ORAL HEALTH IMPROVEMENT PROGRAM §49.3 Oral Health Improvement Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199929 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199929 03/11/2026 The program contracts with schools and school districts through a memorandum of understanding and adheres to the Texas Education Code, §22.0834. Source Note: The provisions of this §49.4 adopted to be effective June 29, 2020, 45 TexReg 4339. 1 DEPARTMENT OF STATE HEALTH SERVICES 49 ORAL HEALTH IMPROVEMENT PROGRAM §49.4 Oral Health Improvement Program in Schools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199930&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199930 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199930&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199930 03/11/2026 Program priorities are determined based on data, research, public health principles, and other factors. Priorities may include:(1) oral health surveillance;(2) oral disease prevention;(3) oral health education and promotion;(4) oral health subject matter expertise for the department, other agencies, and other organizations; or(5) facilitation of access to oral health services. Source Note: The provisions of this §49.5 adopted to be effective June 29, 2020, 45 TexReg 4339. 1 DEPARTMENT OF STATE HEALTH SERVICES 49 ORAL HEALTH IMPROVEMENT PROGRAM §49.5 Oral Health Improvement Program Priorities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199933&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199933 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199933&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199933 03/11/2026 (a) The implementation of any and all program activities is subject to the availability of funds. The program identifies populations based on socioeconomic need, limited access to dental providers, and other risk factors.(b) Program conducts oral health surveillance activities based on priorities determined by the program and may include:(1) collecting data through visual, open-mouth screening, survey, or other means as defined in policy; and(2) preparing statistical or other public health reports based on surveillance data.(c) Oral disease prevention activities may include open-mouth screening, community water fluoridation, fluoride varnish applications, silver diamine fluoride applications, or dental sealants.(d) Oral health promotion and education topics may include the improvement of home care, the importance of dental check-ups, the relationship between oral health and general health, the prevention and detection of oral cancer, and the improvement of perinatal oral health. Activities may include:(1) public health education to promote the prevention of oral disease;(2) initiation and expansion of preschool, school, and adult education programs;(3) organization of continuing health education for health providers; and(4) preventive health education information for the public.(e) Oral health subject matter expertise includes providing information and guidance to the department and other agencies and organizations regarding oral health and oral disease prevention. Activities may include:(1) assisting in the development of oral health training materials;(2) providing feedback on policies or programs with an oral health component; and(3) ensuring public health policies and procedures include oral health components.(f) Program shall work to facilitate access to oral health services by informing the public of available services and promoting better distribution of dentists and other oral health professionals throughout the State of Texas.(g) Program activities must adhere to the Dental Practice Act, Texas Occupations Code, Chapters 251 - Chapter 267.(h) The department may implement activities through contracts or interagency agreements with entities that may include academic institutions, professional associations, or nonprofit organizations. Source Note: The provisions of this §49.6 adopted to be effective June 29, 2020, 45 TexReg 4339. 1 DEPARTMENT OF STATE HEALTH SERVICES 49 ORAL HEALTH IMPROVEMENT PROGRAM §49.6 Implementation of Oral Health Improvement Program Activities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168364&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168364 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168364&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168364 03/11/2026 (a) Specimens submitted to the Department of State Health Services (department) shall meet the requirements specified in the department's Laboratory Testing Services Manual (manual) and other written instructions established by the department. The manual is posted on the department's website (currently found at http://www.dshs.state.tx.us/lab).(b) Failure to submit a specimen as required will result in the department's refusal to perform the requested services.(c) The manual and other written instructions may be obtained upon request from the Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3199, (512) 776-7318. Source Note: The provisions of this §73.31 adopted to be effective November 10, 2002, 27 TexReg 10386; amended to be effective April 16, 2006, 31 TexReg 3034; amended to be effective October 10, 2012, 37 TexReg 8020; amended to be effective September 1, 2014, 39 TexReg 6479. 1 DEPARTMENT OF STATE HEALTH SERVICES 73 LABORATORIES §73.31 Specimen Submission https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=195212&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 195212 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=195212&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 195212 03/11/2026 (a) Purpose. This section details the procedures concerning the sale of laboratory services by the Department of State Health Services (department). Particular services, with specific charges for each listed service, are found on the Laboratory Services Section (LSS) website (www.dshs.texas.gov/lab). Provision of those listed services by the department may or may not involve a contract, at the department's discretion. Other services not found in the LSS Public Fee Schedule that the department elects to sell will be memorialized in a contract between the department and the purchaser of such services. Entities which the department may contract with for the sale of laboratory services are limited to those found at Health and Safety Code, §12.0122. At the department's discretion, tests designated to be performed at a particular department laboratory may be performed at any of the department laboratories.(b) Definition of laboratory services. Laboratory services include the sale of the following services: the evaluation and testing of samples, and the subsequent reporting of test or evaluation results for samples submitted to the laboratory; certification, accreditation or approval of milk and shellfish laboratories and milk analysts; and special projects. Laboratory Services, as limited by Health and Safety Code, §12.0122, do not include services related to tissue and cytology specimens.(c) Charges. Fees for the sale of laboratory services to the public found on the LSS website were calculated to recover the department's costs associated with such activities. When laboratory services outside of the LSS Public Fee Schedule are sold under this section, the contract executed for that sale shall include charges for the services in question which recover the department's costs associated with such activities.(d) Other contracts. This section does not affect department contracts that are not governed by Health and Safety Code, §12.0122.(e) Fees. The LSS Public Fee Schedule is available upon request from the Department of State Health Services, 1100 West 49th Street, Austin, TX 78756-3199, (512) 776-7318. It is also available online at http://www.dshs.texas.gov/lab.(f) Future updates for laboratory services and fees. Changes to the LSS Public Fee Schedule will be posted on the LSS website and made based on the business needs of the LSS and the public health needs of the department. Changes to available laboratory testing and related pricing may include implementing new testing methodologies in the LSS, updating fees to reflect the cost of testing, and eliminating certain low volume tests to make more efficient use of staff time and to reduce costs. Any change in fees will be posted on the LSS website for at least 90 days to allow for stakeholder input as well as LSS customer communication regarding all changes to the LSS Public Fee Schedule. After the period for stakeholder notification and input, changes and amendments affecting the LSS Public Fee Schedule will be added to the LSS Public Fee Schedule as soon as practicable. Changes may include the following:(1) the addition of new tests or deletion of low volume tests as needed;(2) an increase in fees for existing tests may be applied to a test individually or collectively, but an individual test fee would not be increased more than once per year;(3) a decrease in fees for existing tests as needed; or(4) a change to the LSS Public Fee Schedule in response to a declared public health emergency or outbreak situation. This change may not include a formal process to receive stakeholder input before implementing a new test in order to ensure a rapid public health action. In the event of a declared public health emergency or outbreak, the LSS may implement tests as required without contract provisions or posting in the LSS Public Fee Schedule.(g) Payment of charges.(1) The department will determine whether a charge must be paid with submission of the specimen or whether the department will bill later for the charge, unless otherwise stated in this section.(2) A charge paid is non-refundable.(3) Failure to pay a charge in a timely manner may result in the department's refusal to accept specimens or samples until all delinquent charges are paid. Source Note: The provisions of this §73.41 adopted to be effective November 10, 2002, 27 TexReg 10386; amended to be effective April 16, 2006, 31 TexReg 3034; amended to be effective October 10, 2012, 37 TexReg 8020; amended to be effective September 1, 2014, 39 TexReg 6479; amended to be effective May 2, 2019, 44 TexReg 2158. 1 DEPARTMENT OF STATE HEALTH SERVICES 73 LABORATORIES §73.41 Sale of Laboratory Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168366&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168366 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168366&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168366 03/11/2026 Technical definitions associated with the sale of laboratory services can be found in the Laboratory Testing Services Manual. This manual is available online (currently found at http://www.dshs.state.tx.us/lab), and may otherwise be obtained as described in §73.31 of this title (relating to Specimen Submission). Source Note: The provisions of this §73.51 adopted to be effective October 10, 2012, 37 TexReg 8020; amended to be effective September 1, 2014, 39 TexReg 6479. 1 DEPARTMENT OF STATE HEALTH SERVICES 73 LABORATORIES §73.51 Technical Definitions Associated with the Sale of Laboratory Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96143&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96143 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96143&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96143 03/11/2026 (a) As authorized by the Government Code, §403.1055, relating to the Permanent Fund for Children and Public Health, and the Health and Safety Code, §121.0065, relating to Grants for Essential Public Health Services, the department shall institute and administer grants under this subchapter.(b) The grants shall be known as a part of the "Public Health Improvement Grants."(c) This subchapter governs the administration of the grants, the submission and review of grant applications, and the award of the grants. Source Note: The provisions of this §83.1 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96153&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96153 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96153&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96153 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.(1) Closing date--Date specified in the request for proposals as the date on which applications must be received or postmarked.(2) Commissioner--Commissioner of Health or his or her designee.(3) Department--Texas Department of Health.(4) Essential public health services--As defined in the Health and Safety Code, §121.002, services to:(A) monitor the health status of individuals in the community to identify community health problems;(B) diagnose and investigate community health problems and community health hazards;(C) inform, educate, and empower the community with respect to health issues;(D) mobilize community partnerships in identifying and solving community health problems;(E) develop policies and plans that support individual and community efforts to improve health;(F) enforce laws and rules that protect the public health and ensure safety in accordance with those laws and rules;(G) link individuals who have a need for community and personal health services to appropriate community and private providers;(H) ensure a competent workforce for the provision of essential public health services;(I) research new insights and innovative solutions to community health problems; and(J) evaluate the effectiveness, accessibility, and quality of personal and population-based health services in a community.(5) Minority populations--African-Americans, American Indians, Asians or Hispanics in Texas or other population in Texas for which a health disparity can be demonstrated by the applicant.(6) Nonprofit organization--A private, nonprofit, tax-exempt corporation, association or organization under Internal Revenue Code of 1986, §501(c)(3) (26 United States Code §501(c)(3)).(7) Rural area--A county that had a population in the most recent decennial United States census of 150,000 or less, or that part of a county with a population of greater than 150,000 that is not delineated as urbanized by the United States Census Bureau.(8) Urban area--A county or part of a county that is not a rural area. Source Note: The provisions of this §83.2 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96151&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96151 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96151&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96151 03/11/2026 (a) The intent of the grants is to build capacity to address public health issues, and identify and/or develop improved intervention and prevention strategies.(b) In making these grants, the goal of the department is to improve public health outcomes at the community level and to strengthen the public health infrastructure through improved public health practice.(c) To the maximum extent possible, the grants are intended to bring about improvements in health status that are demonstrable or measurable.(d) Grant funds will not be used to fund direct health care services except when those services are incidental to an essential public health service being addressed. Source Note: The provisions of this §83.3 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.3 Philosophy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96152&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96152 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96152&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96152 03/11/2026 The grants shall consist of three parts:(1) Part I. Grants for developing and demonstrating cost-effective prevention and intervention strategies for improving health outcomes for children and the public (Part I grants);(2) Part II. Grants to local communities to address disparities in health status that can be demonstrated in minority populations, including sickle cell anemia, diabetes, high blood pressure, cancer, heart attack, stroke, keloid tissue and scarring, respiratory disease and other conditions or diseases relating to minority populations that demonstrate disparities in health status (Part II grants); and(3) Part III. Grants to local communities for essential public health services (Part III grants). Source Note: The provisions of this §83.4 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.4 The Grants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96154&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96154 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96154&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96154 03/11/2026 (a) Funds for the grants shall be provided in accordance with the Government Code, §403.1055, relating to the Permanent Fund for Children and Public Health. Funds for Part III grants are also governed by the Health and Safety Code, §121.0065, relating to Grants for Essential Public Health Services.(b) All grants shall be awarded competitively according to the provisions of this subchapter.(c) Grants shall be made only to the extent that funds are appropriated and available.(d) The department shall have the authority and discretion to:(1) determine the purpose(s) of the grants pursuant to law and this subchapter;(2) approve or deny grant applications;(3) determine the number, size and duration of grants; and(4) modify or terminate grants.(e) The department shall determine the proportion of available funds to be granted under each part, provided that the funds available for each part shall be not less than 25% of the total amount of funds available. Such proportion shall be published in the request(s) for proposals.(f) Grants made under Part III shall be allocated in such a way so that the total amount of funds available is equally divided between services for rural and urban areas of the state.(g) If the funds for a part are not completely expended or allocated, the department shall have the authority to redistribute funds among the other two parts based on unfunded responses to a previous or current request for proposals. The percentage in subsection (e) of this section shall not apply to the redistribution of funds.(h) The department shall not be liable, nor shall grant funds be used, for any costs incurred by applicants in the development, preparation, submission, or review of applications.(i) Funds appropriated from the Permanent Fund for Children and Public Health to the department may be used by the department for Part I purposes and will not be subject to the grant and request for proposal process described in this chapter. The funds used by the department shall not be more than 10% of the estimated appropriation from the Permanent Fund for Children and Public Health as reflected in the General Appropriations Act, Article XII, Tobacco Settlement Receipts or in subsequent General Appropriations Acts. The department will use these funds to build capacity for providing essential public health services in areas not served by a local health department. Source Note: The provisions of this §83.5 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.5 Sources and Allocation of Funds https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96156&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96156 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96156&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96156 03/11/2026 (a) The following persons shall be eligible for the grants:(1) Part I grants. Any person or other entity, public or private, except the department;(2) Part II grants. Any county, municipality, public health district, other political subdivision or nonprofit organization in Texas; and(3) Part III grants. Any county, municipality, public health district, or other political subdivision in Texas.(b) An applicant may submit multiple proposals and must designate under which part the proposal should be considered for funding. An applicant may not be funded under multiple parts for a single proposal. Source Note: The provisions of this §83.6 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.6 Eligibility for Grants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96157&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96157 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96157&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96157 03/11/2026 (a) The department shall specify reasonable requirements for grant applications.(b) Applicants for grants shall submit, as a part of their application, a preliminary plan that identifies a public health issue and outlines strategies to evaluate the effectiveness, accessibility, and quality of the essential public health services that are provided under the grant to address the public health issue, and to demonstrate how the project will build capacity within the community to continue to address the public health issue after the project has been completed. If the applicant is awarded a grant, the grant recipient will work with the department to finalize the preliminary plan required in this section. The plan must, at a minimum:(1) identify the outcomes that are intended to result from the use of the grant money and establish a mechanism to measure those outcomes; and(2) establish performance standards for the delivery of essential public health services and a mechanism to measure compliance with those standards.(c) Grant recipients shall make quarterly reports to the department, in a form and at a time determined by the department.(d) Grant recipients under Part III must assure that they have a local health authority, as defined under the Local Public Health Reorganization Act, Health and Safety Code, Chapter 121, prior to the grant funds being awarded. A department regional director cannot serve as the local health authority for Part III grant recipients. Source Note: The provisions of this §83.7 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.7 Requirements for Grants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=73295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 73295 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=73295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 73295 03/11/2026 (a) The department may specify any reasonable requirements for grant applications, including, but not limited to, length, format, authentication, and supporting documentation.(b) Applications that are incomplete or substantially inconsistent with the requirements of this subchapter may be rejected without further consideration at the discretion of the department.(c) Applications received after the closing date will not be considered, unless the closing date is extended by the department.(d) Applicants will be given a minimum of 60 calendar days to file applications after a request for proposals is published. Applications must be received by the department on or before the closing date specified in the request for proposal. Source Note: The provisions of this §83.9 adopted to be effective February 10, 2000, 25 TexReg 779. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.9 Procedures for Grant Applications https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96159&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96159 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96159&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96159 03/11/2026 (a) Each application shall be reviewed by the department for completeness, relevance to the published request for proposals, adherence to department policies, general quality, technical merit, and budget appropriateness.(b) The department may invite an advisor or advisors to provide review and make recommendations concerning the grant process. Such advisor(s) may include any number of members from inside or outside the department, at the discretion of the commissioner. Advisor(s) from outside the department shall receive no compensation or reimbursement for expenses. No such advisor(s) shall be a current applicant for a grant under any part on which the advisor(s) would be making recommendations. Source Note: The provisions of this §83.10 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.10 Competitive Review Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96160&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96160 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96160&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96160 03/11/2026 (a) No grant shall be approved unless, in the opinion of the department:(1) the application addresses one or more essential public health services;(2) the application includes a workable plan to bring about improvements in health status that are demonstrable or measurable, or the application identifies specific positive outcomes;(3) the applicant provides a plan and method for evaluating the effectiveness of the activities carried out under the grant; and(4) with regard to Part II grants, the application addresses disparities in morbidity, mortality, or health status in minority populations.(b) A grant application will be given funding preference, in a manner determined by the department and announced in the request for proposal, to the extent that it:(1) demonstrates how the project will build capacity within the community to address the public health issue identified in the application;(2) documents the intent and ability of the applicant to communicate and collaborate with elements of the community that deliver essential public health services, health care providers, consumers, businesses, educational institutions, governmental agencies, law enforcement agencies, or religious institutions and how community needs have been or will be determined and addressed;(3) demonstrates a strong financial commitment on the part of the applicant toward sustaining the proposed activities after the project has been completed including direct funding or significant in-kind contributions from the applicant, local entities, private donors, state agencies, federal grantors, or private foundations;(4) clearly describes an effective strategy for evaluating project activities and measuring project outcomes;(5) includes a plan to provide a cost analysis for sustaining the project or activities within the targeted community after the project has been completed or replicating the project in other areas of Texas;(6) includes a plan for the dissemination of methods, findings or conclusions;(7) with respect to Part III grants, clearly describes how the project will strengthen public health infrastructure;(8) with respect to Part III grants, demonstrates that the applicant has or will develop a local health board or other appropriate advisory group during the grant period; or(9) contains such other information or criteria that the commissioner may specify and include in the request for proposals. Source Note: The provisions of this §83.11 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.11 Selection Criteria https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=73298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 73298 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=73298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 73298 03/11/2026 (a) Grant recipients shall execute a contract with the department. The contract shall detail items such as budget, reporting requirements, general provisions for department grant contracts and any other specifics that might apply to the award.(b) Grant recipients shall cooperate with the department in preparing reports to the Legislature as required by the Government Code, §403.1069.(c) Grant recipients under Part III shall cooperate with the department in preparing reports to the Legislature as required by the Health and Safety Code, §121.0067. Source Note: The provisions of this §83.12 adopted to be effective February 10, 2000, 25 TexReg 779. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.12 Project Approval https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96161&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96161 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96161&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96161 03/11/2026 (a) Grant recipients may be eligible for continuation funding. The department will consider the grant recipient's accomplishments, progress toward or completion of stated goals and objectives, proposal to conduct additional data analysis or evaluation to enhance the impact of the project, compliance with contract requirements, progress toward building the capacity or development of alternative funding to continue to address the public health issue within the community. Applications shall be submitted in accordance with instructions of the department.(b) The department will award continuation grants after a review of applications in accordance with the instructions of the department. Source Note: The provisions of this §83.13 adopted to be effective February 10, 2000, 25 TexReg 779; amended to be effective August 29, 2002, 27 TexReg 7805. 1 DEPARTMENT OF STATE HEALTH SERVICES 83 PUBLIC HEALTH IMPROVEMENT GRANTS A PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH §83.13 Continuation Funding https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133338&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133338 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133338&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133338 03/11/2026 (a) The committee. An advisory committee shall be appointed under and governed by this section.(1) The name of the advisory committee shall be the State Preventive Health Advisory Committee (committee).(2) The committee is established under Health and Safety Code, §11.016, which authorizes the Executive Commissioner of the Health and Human Services Commission to establish advisory committees and is required by 42 USC §300w-4.(b) Applicable law. The committee is subject to the Government Code, Chapter 2110, concerning state agency advisory committees.(c) Purpose. The purpose of the committee is to carry out the tasks outlined in 42 USC §300w-4(d) regarding formulation of an annual state plan for the Preventive Health and Health Services Block Grant (PHHSBG).(d) Tasks.(1) The committee shall make recommendations to the Department of State Health Services (department) regarding the development and implementation of a state plan, including recommendations on:(A) the conduct of assessments of the public health;(B) which of the activities authorized in 42 USC §300w-3 should be carried out in the state;(C) the allocation of payments made to the state under 42 USC §300w-2;(D) the coordination of activities carried out under the state plan with relevant programs of other entities; and(E) the collection and reporting of data in accordance with 42 USC §300w-5(a).(2) The committee shall carry out any other tasks assigned by the board.(e) Committee abolished. The committee may not be abolished unless the department ceases to receive Preventive Health and Health Services Block Grant funds or federal law relating to the block grant is amended to no longer require a committee. The date on which the committee shall be abolished is the date of the occurrence of the earlier of these events.(f) Composition. The committee shall be composed of eight members.(1) The composition of the committee shall include three consumer representatives and five non-consumer representatives.(2) The members of the committee shall be appointed by the Executive Commissioner of the Health and Human Services Commission as follows:(A) three consumers representing the interests of the general public;(B) five non-consumer members, including the following:(i) the Commissioner of the department;(ii) the PHHSBG Coordinator;(iii) one department regional director;(iv) one official of a local health department; and(v) one representative from a Texas school of public health.(g) Terms of office. The term of office of each member shall be six years.(1) Members shall be appointed for staggered terms so that the terms of two members will expire on December 31 of each even-numbered year.(2) If a vacancy occurs, a person shall be appointed to serve the unexpired portion of that term.(h) Officers.(1) The Commissioner of the department serves as the presiding officer of the committee. The presiding officer shall preside at all committee meetings at which he or she is in attendance, call meetings in accordance with this section, and cause proper reports to be made to the federal funding agency.(2) The committee shall select from its members an assistant presiding officer. The assistant presiding officer shall perform the duties of the presiding officer in case of the absence of the presiding officer.(3) If the office of assistant presiding officer becomes vacant, it may be filled by vote of the committee.(4) The committee may reference its officers by other terms, such as chairperson and vice-chairperson.(i) Meetings. The committee shall meet not less than twice each federal fiscal year.(1) A meeting may be called by agreement of department staff and either the presiding officer or assistant presiding officer.(2) Meeting arrangements shall be made by department staff. Department staff shall contact committee members to determine availability for a meeting date and place.(3) The committee is not a "governmental body" as defined in the Open Meetings Act. However, in order to promote public participation, each meeting of the committee shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception that the provisions allowing executive sessions shall not apply.(4) Each member of the committee shall be informed of a committee meeting at least five working days before the meeting.(5) A simple majority of the members of the committee shall constitute a quorum for the purpose of transacting official business.(6) The committee is authorized to transact official business only when in a legally constituted meeting with a quorum present.(7) The agenda for each committee meeting shall include an opportunity for any person to address the committee on matters relating to committee business. The presiding officer may establish procedures for such public comment, including a time limit on each comment.(j) Attendance. Members shall attend committee meetings as scheduled.(1) A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting.(2) It is grounds for removal from the committee if a member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability or is absent from at least four consecutive committee meetings.(3) The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists.(k) Staff. Staff support for the committee shall be provided by the department.(l) Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.(1) Any action taken by the committee must be approved by a majority vote of the members present once quorum is established.(2) Each member shall have one vote.(3) A member may not authorize another individual to represent the member by proxy.(4) The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.(5) Minutes of each committee meeting shall be compiled by department staff.(A) A draft of the minutes approved by the presiding officer shall be provided to the board and each member of the committee within 30 days of each meeting.(B) After approval by the committee, the minutes shall be signed by the presiding officer.(m) Statement by members.(1) The department and the committee shall not be bound in any way by any statement or action on the part of any committee member except when a statement or action is in pursuit of specific instructions from the department or committee.(2) The committee and its members may not participate in legislative activity in the name of the department or the committee except with approval through the department's legislative process. Committee members are not prohibited from representing themselves or other entities in the legislative process.(3) A committee member should not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.(4) A committee member should not disclose confidential information acquired through his or her committee membership.(5) A committee member should not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.(6) A committee member who has a personal or private interest in a matter pending before the committee shall publicly disclose the fact in a committee meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the committee member has a direct pecuniary interest in the matter but does not include the committee member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.(n) Reports to the Center for Consumer and External Affairs (CCEA). The committee shall file an annual written report with the CCEA.(1) The report shall list the meeting dates of the committee, the attendance records of its members, a brief description of actions taken by the committee, a description of how the committee has accomplished the tasks given to the committee, the status of any rules which were recommended by the committee, and anticipated activities of the committee for the next year.(2) The report shall identify the costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities and the source of funds used to support the committee's activities.(3) The report shall cover the meetings and activities in the immediately preceding fiscal year and shall be filed with the CCEA each October. The report shall be signed by the commissioner.(o) Reimbursement for expenses. In accordance with the requirements set forth in the Government Code, Chapter 2110, a committee member may receive reimbursement for the member's expenses incurred for each day the member engages in official committee business if authorized by the General Appropriations Act or the budget execution process.(1) No compensatory per diem shall be paid to committee members unless required by law.(2) A committee member who is an employee of a state agency, other than the department, may not receive reimbursement for expenses from the department.(3) Each member who is to be reimbursed for expenses shall submit to staff the member's receipts for expenses and any required official forms no later than 14 days after each committee meeting.(4) Requests for reimbursement of expenses shall be made on official state travel vouchers prepared by department staff. Source Note: The provisions of this §84.1 adopted to be effective March 23, 2003, 28 TexReg 2333; amended to be effective November 29, 2007, 32 TexReg 8506. 1 DEPARTMENT OF STATE HEALTH SERVICES 84 PREVENTIVE HEALTH AND HEALTH SERVICES BLOCK GRANT §84.1 The State Preventive Health Advisory Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201941&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201941 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201941&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201941 03/11/2026 The following terms and phrases, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:(1) Department--Department of State Health Services.(2) Essential public health services--As defined by Texas Health and Safety Code, Chapter 121.(3) Health authority--A physician who administers state and local laws relating to public health, appointed under the Local Public Health Reorganization Act, Texas Health and Safety Code, Chapter 121, by the governing body of a city, county, or public health district.(4) Local public health entity--A local health unit, local health department, or public health district.(5) Public health data--Any data relating to:(A) the health status of people, living or dead;(B) health, including data on the extent and nature of the disease, illness, disability, injury, and other aspects of well-being;(C) environmental, behavioral, occupational, social, and other health hazards; and(D) determinants of health.(6) Region--A geographic area in the State of Texas designated by the department.(7) Regional Director--A physician who is employed by the department and serves as the chief administrative officer of a region. Source Note: The provisions of this §85.1 adopted to be effective February 1, 2021, 45 TexReg 8522. 1 DEPARTMENT OF STATE HEALTH SERVICES 85 LOCAL PUBLIC HEALTH §85.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201942&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201942 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201942&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201942 03/11/2026 (a) The committee.(1) The Public Health Funding and Policy Committee (committee) shall be appointed under and governed by this section.(2) The committee is established under the Health and Safety Code, Chapter 117, which requires the Commissioner of the Department of State Health Services (commissioner) to establish the Public Health Funding and Policy Committee.(b) Applicable law. The committee is subject to the Health and Safety Code, Chapter 117, and Government Code, Chapter 2110, concerning state agency advisory councils.(c) Purpose. The purpose of the committee is to provide policy level advice and assistance to the Department of State Health Services (department) in the organization and funding of local public health in Texas and the relationship between local public health entities and the department.(d) Tasks. As required by the Health and Safety Code, §117.101, the committee shall:(1) define the core public health services a local health entity should provide in a county or municipality;(2) evaluate public health in this state and identify initiatives for areas that need improvement;(3) identify all funding sources available for use by local health entities to perform core public health functions;(4) establish public health policy priorities for this state; and(5) at least annually, make formal recommendations to the department regarding:(A) the use and allocation of funds available exclusively to local health entities to perform core public health functions;(B) ways to improve the overall public health of citizens in this state;(C) methods for transitioning from a contractual relationship between the department and the local health entities to a cooperative-agreement relationship between the department and the local health entities; and(D) methods for fostering a continuous collaborative relationship between the department and the local health entities.(6) The committee shall carry out any other tasks assigned by the commissioner.(e) Committee abolished. As required by the Health and Safety Code, §117.002, the committee shall be subject to the Texas Sunset Act, Government Code, Chapter 325. Unless continued in existence as provided by the Government Code, Chapter 325, the committee is abolished and this section expires September 1, 2023.(f) Composition. As required by the Health and Safety Code, §117.052, the committee shall be composed of nine members, appointed by the commissioner to include:(1) two regional health directors, each of whom is serving as a health authority in a municipality or county;(2) one local health entity representative of a municipality or county with a population of 50,000 or less;(3) one local health entity representative from a municipality or county with a population greater than 50,000 but less than 250,000;(4) one local health entity representative from a municipality or county with a population of at least 250,000;(5) two local health entity representatives, each of whom serves in a municipality or county as the health authority; and(6) two representatives of schools of public health at institutions of higher education in this state.(g) Terms of Office. As required by the Health and Safety Code, §117.053, the term of office of each member shall be six years.(1) Committee members serve staggered six-year terms, with the terms of three members expiring on February 1 of each odd-numbered year.(2) If a vacancy occurs on the committee, a person shall be appointed to fill the vacancy for the unexpired term in the same manner as the original appointment.(h) Officers. As required by the Health and Safety Code, §117.055, the committee shall select from its members the presiding officer and an assistant presiding officer.(1) The presiding officer shall serve until December 31 of each even-numbered year. The assistant presiding officer shall serve until December 31 of each odd-numbered year. Both the presiding officer and the assistant presiding officer may holdover until his or her replacement is elected by the committee.(2) The presiding officer shall preside at all committee meetings which he or she attends, call meetings in accordance with this section, appoint subcommittees of the committee as necessary, and cause proper reports to be made to the council. The presiding officer may serve as an ex-officio member of any subcommittee of the committee.(3) If the office of presiding officer or assistant presiding officer becomes vacant, it may be filled by vote of the committee.(4) The committee may reference its officers by other terms, such as chairperson and vice-chairperson.(i) Meetings. As required by the Health and Safety Code, §117.056, the committee shall meet as necessary to conduct committee business.(1) The committee shall meet at least quarterly, or more frequently, at the call of the presiding officer.(2) To ensure appropriate representation from all areas of this state, the committee may meet by videoconference or telephone conference call. A meeting held by videoconference or telephone conference call under this subsection must comply with the requirements applicable to a telephone conference call under Government Code, §551.125(c), (d), (e), and (f). Government Code, §551.125(b) and §551.127 do not apply to the committee.(3) Each member of the committee shall be informed of a committee meeting at least five working days before the meeting.(4) A simple majority of the members of the committee shall constitute a quorum for the purpose of transacting official business.(5) The committee is authorized to transact official business only when in a legally constituted meeting with a quorum present.(6) The agenda for each committee meeting shall include an opportunity for any person to address the committee on matters relating to committee business. The presiding officer may establish procedures for such public comment, including a time limit on each comment.(j) Attendance. Members shall attend committee meetings as scheduled. Members and subcommittee members shall attend meetings of subcommittees to which the members and subcommittee members are assigned.(1) A member shall notify the presiding officer, or appropriate department staff, if he or she is unable to attend a scheduled meeting.(2) It shall be grounds for removal from the committee if a member or subcommittee member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability, absence from more than half of the committee and subcommittees meetings during a calendar year, or absence from at least three consecutive committee meetings.(3) The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists.(k) Staff. Staff support for the committee shall be provided by the department. In accordance with the Health and Safety Code, §117.104, using existing personnel and videoconferencing equipment, local health entities, or their designees, may assist the committee in the performance of its duties under this section.(l) Procedures. Roberts Rules of Order shall be the basis of parliamentary decisions except where otherwise provided by law or rule.(1) Any action taken by the committee must be approved by a majority vote of the members present once a quorum is established.(2) Each member shall have one vote.(3) A member may not authorize another individual to represent the member by proxy.(4) The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.(5) Minutes of each committee meeting shall be taken by department staff.(A) A draft of the minutes approved by the presiding officer shall be provided to the council and each member of the committee within 30 days of each meeting.(B) After approval by the committee, the minutes shall be signed by the presiding officer.(m) Subcommittees. The committee may establish subcommittees as necessary to assist the committee in carrying out its duties.(1) The presiding officer shall appoint members of the committee to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer also may appoint nonmembers of the committee to serve on subcommittees, subject to the approval of the commissioner.(2) Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the committee.(3) A subcommittee chairperson shall make regular reports to the committee at each committee meeting or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting.(n) Statement by members.(1) The Health and Human Services Commission (commission), the State Health Services Council (council), the department, and the committee shall not be bound in any way by any statement or action on the part of any committee member or subcommittee member except when a statement or action is in pursuit of specific instructions from the commission, council, department, or committee.(2) The committee and its members or subcommittee members may not participate in legislative activity in the name of the commission, the council, the department, or the committee except with approval through the department's legislative process. Committee members are not prohibited from representing themselves or other entities in the legislative process.(3) A committee member or subcommittee member should not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.(4) A committee member or subcommittee member should not disclose confidential information acquired through his or her committee membership.(5) A committee member or subcommittee member should not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.(6) A committee member or subcommittee member who has a personal or private interest in a matter pending before the committee shall publicly disclose the fact in a committee meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the committee member has a direct pecuniary interest in the matter, but does not include the committee member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.(o) Reports to department. The committee shall file an annual written report with the department.(1) The report shall list the meeting dates of the committee and any subcommittees, the attendance records of its members, a brief description of actions taken by the committee, a description of how the committee has accomplished the tasks given to the committee by the council, the status of any rules which were recommended by the committee to the council, and anticipated activities of the committee for the next year.(2) The report shall identify all costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities and the source of funds used to support the committee's activities.(3) The report shall cover the meetings and activities in the immediately preceding fiscal year and shall be filed with the council each January. The report shall be signed by the presiding officer.(p) In accordance with the Health and Safety Code, §117.1033, beginning in 2012, not later than November 30 of each year the committee shall file a report on the implementation of the Health and Safety Code, Chapter 117 with the governor, the lieutenant governor, and the speaker of the house of representatives.(q) Reimbursement for expenses. In accordance with the Health and Safety Code, §117.054, a committee member is not entitled to compensation for service on the committee and is not entitled to reimbursement for any travel expenses. Source Note: The provisions of this §85.2 adopted to be effective May 30, 2013, 38 TexReg 3353. 1 DEPARTMENT OF STATE HEALTH SERVICES 85 LOCAL PUBLIC HEALTH §85.2 Public Health Funding and Policy Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201939&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201939 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201939&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201939 03/11/2026 (a) A health authority must be appointed in a municipality or county that has established a local health department or public health district.(1) The director of a local health department or public health district, if the director is a physician, shall be the health authority within the jurisdiction of the local health department or public health district.(2) If a non-physician serves as the director of a local health department or public health district, the director shall appoint a physician to serve as the health authority within the jurisdiction of such local health department or public health district, subject to the approval of the governing body of the local health department or public health district. No action is required by the department to further approve the appointment.(b) A health authority may be appointed, but is not required to be appointed, in a municipality or county that has not established a local health department or public health district. The governing body of the municipality or the commissioners court of the county may appoint the health authority within its jurisdiction.(c) A health authority serves for a term of two years and may be appointed to successive terms.(d) A regional director of the department shall perform the duties of a health authority when there is no health authority for a municipality, county, public health district, or entity authorized to appoint a health authority in a jurisdiction in the regional director's region.(e) A regional director of the department may perform some or all of the duties of a health authority, if an appointed health authority fails to perform duties prescribed by the department in this section. At the request of the appointing authority, a regional director may serve as a health authority because of the absence or incapacity of the appointed health authority. No action by the department is necessary to further approve a regional director's performance or service.(f) A health authority shall perform each duty that is necessary to implement and enforce a law to protect the public health, as stated in the Texas Health and Safety Code, §121.024.(g) An appointed health authority shall take the official oath required by the Texas Constitution, Article 16, §1, including the statement of appointed officer, and file a copy of the oath and appointment with the appropriate regional office within 10 working days of the date of taking the oath.(h) If a health authority ceases to hold office for any reason, the appointing authority shall immediately notify the department and appropriate regional director. When a new health authority has been appointed, the person takes the action outlined in subsection (g) of this section and notifies the appropriate regional office of the change. Source Note: The provisions of this §85.3 adopted to be effective February 1, 2021, 45 TexReg 8522. 1 DEPARTMENT OF STATE HEALTH SERVICES 85 LOCAL PUBLIC HEALTH §85.3 Health Authorities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201940&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201940 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201940&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201940 03/11/2026 (a) For any public health data request not subject to an existing agreement with the department, the local public health entity submits a request to the department using procedures posted on the department's website.(b) The local public health entity must provide sufficient information in its data request for the department to determine if the data will be used in the provision of essential public health services.(c) The department evaluates all requests timely to ensure the requests are processed as expeditiously and consistently as department resources allow.(d) Requests are evaluated on the following criteria:(1) the public health benefit and purpose of the request;(2) the privacy of the individuals whose data is requested;(3) the management of the data by the requestor, including management of public health data released to the requestor in previous requests; and(4) other relevant state and federal laws regarding the confidentiality of data.(e) The department may require the local public health entity to enter into a written agreement before the release of data.(f) The department notifies a requesting local public health entity in writing of any denied request and the reason for the denial. Source Note: The provisions of this §85.4 adopted to be effective February 1, 2021, 45 TexReg 8522. 1 DEPARTMENT OF STATE HEALTH SERVICES 85 LOCAL PUBLIC HEALTH §85.4 Public Health Data Review Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152246&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152246 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152246&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152246 03/11/2026 This subchapter implements the Texas Cancer Incidence Reporting Act, Health and Safety Code, Chapter 82. This legislation concerns the reporting of cases of cancer for the recognition, prevention, cure or control of those diseases, and to facilitate participation in the national program of cancer registries established by 42 United States Code, §§280e - 280e-4. Nothing in this subchapter shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own cancer registries. Source Note: The provisions of this §91.1 adopted to be effective August 6, 1998, 23 TexReg 7801; amended to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183261&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183261 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183261&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183261 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Cancer Incidence Reporting Act, Texas Health and Safety Code, Chapter 82.(2) Cancer--Includes a large group of diseases characterized by uncontrolled growth and spread of abnormal cells; any condition of tumors having the properties of anaplasia, invasion, and metastasis; a cellular tumor the natural course of which is fatal, including intracranial and central nervous system malignant, borderline, and benign tumors as required by the national program of cancer registries; and malignant neoplasm, other than non-melanoma skin cancers such as basal and squamous cell carcinomas.(3) Cancer Reporting Handbook--The Texas Cancer Registry's manual for reporting entities that documents reporting procedures and format.(4) Clinical laboratory--An accredited facility in which tests are performed identifying findings of anatomical changes; specimens are interpreted and pathological diagnoses are made.(5) Confidential cancer data--Information that includes items that may identify an individual, and is subject to Health and Safety Code, §82.009.(6) Department--Department of State Health Services.(7) Health care facility--A general or special hospital as defined by the Health and Safety Code, Chapter 241; an ambulatory surgical center licensed under the Health and Safety Code, Chapter 243; an institution licensed under the Health and Safety Code, Chapter 242; or any other facility, including an outpatient clinic, that provides diagnostic or treatment services to patients with cancer.(8) Health care practitioner--A physician as defined by Occupations Code, §151.002 or a person who practices dentistry as described by the Occupations Code, §251.003.(9) Quality assurance--Operational procedures by which the accuracy, completeness, and timeliness of the information reported to the department can be determined and verified.(10) Report--Information provided to the department that notifies the appropriate authority of the occupancy of a specific cancer in a person, including all information required to be provided to the department.(11) Reporting Entity--A reporting entity may include a health care facility, clinical laboratory, health care practitioner, or a health information exchange as defined by Health and Safety Code, §182.151.(12) Research--A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.(13) Statistical cancer data--Aggregate presentation of individual records on cancer cases excluding patient identifying information.(14) Texas Cancer Registry--The cancer incidence reporting system administered by the Department of State Health Services. Source Note: The provisions of this §91.2 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963; amended to be effective April 2, 2017, 42 TexReg 1450. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152252&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152252 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152252&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152252 03/11/2026 (a) Each health care facility, clinical laboratory or health care practitioner shall report to the department, by methods specified in §§91.4 - 91.7 of this title (relating to Cancer Registry), required data from each medical record pertaining to a case of cancer in its custody or under its control except for cases to which subsection (d) of this section would apply.(b) A health care facility or clinical laboratory providing screening, diagnostic or therapeutic services to patients with cancer shall grant the department or its authorized representative access to but not removal of all medical records which would identify cases of cancer, establish characteristics or treatment of cancer, or determine the medical status of any identified cancer patient.(c) A health care practitioner providing diagnostic or treatment services to patients with cancer shall grant the department or its authorized representative access to but not removal of all medical records which would identify cases of cancer, establish characteristics or treatment of cancer, or determine the medical status of any identified cancer patient except for cases to which subsection (d) of this section would apply.(d) The department may not require a health care practitioner to furnish data or provide access to records if:(1) the data or records pertain to cases reported by a health care facility providing screening, diagnostic, or therapeutic services to cancer patients that involve patients referred directly to or previously admitted to the facility; and(2) the facility reported the same data the practitioner would be required to report.(e) Health care facilities, clinical laboratories, and health care practitioners are subject to federal law known as the Health Insurance Portability and Accountability Act of 1996 found at Title 42 United States Code §1320d et seq.; the federal privacy rules adopted in Title 45 Code of Federal Regulations (C.F.R.) Parts 160 and 164; and applicable state medical records privacy laws. Because state law requires reporting of cancer data, persons subject to this chapter are permitted to provide the data to the department without patient consent or authorization under 45 C.F.R. §164.512(a) relating to uses and disclosures required by law and §164.512(b)(1) relating to disclosures for public health activities. Both of these exceptions to patient consent or authorization are recognized in the state law. Source Note: The provisions of this §91.3 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.3 Who Reports, Access to Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183262&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183262 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183262&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183262 03/11/2026 (a) Reportable conditions.(1) The cases of cancer to be reported to the Texas Cancer Registry are as follows:(A) all neoplasms with a behavior code of two or three in the most current edition of the International Classification on Diseases for Oncology (ICD-O) of the World Health Organization with the exception of those designated by the Texas Cancer Registry as non-reportable in the Cancer Reporting Handbook; and(B) all benign and borderline intracranial and central nervous system neoplasms as required by the national program of cancer registries.(2) Codes and taxa of the most current edition of the International Classification of Diseases, Clinical Modification of the World Health Organization which correspond to the Texas Cancer Registry's reportable list are specified in the Cancer Reporting Handbook.(b) Reportable information.(1) Except as provided in paragraph (2) of this subsection and health care practitioners in §91.5(c) of this title (relating to When to Report), those data required to be reported for each cancer case shall include:(A) name, address, zip code, and county of residence;(B) social security number, date of birth, gender, race and ethnicity, marital status, birthplace, and primary payer at time of diagnosis, to the extent such information is available from the medical record;(C) information on industrial and occupational history, smoking status, height and weight to the extent such information is available from the medical record;(D) diagnostic information including the cancer site and laterality, cell type, tumor behavior, markers, grade and size, stage of disease, date of diagnosis, diagnostic confirmation method, sequence number, and other primary tumors;(E) first course of cancer-related treatment, including dates and types of procedures;(F) text information to support cancer diagnosis, stage and treatment codes;(G) health care facility or practitioner related information including reporting institution number, casefinding source, type of reporting source, medical record number, registry number, tumor record number, class of case, date of first contact, date of last contact, vital status, facility referred from, facility referred to, managing physician, follow-up physician, date abstracted, abstractor, and electronic record version; and(H) clinical laboratory related information including laboratory name and address, pathology case number, pathology report date, pathologist, and referring physician name and address.(2) The department or its authorized representative may exempt a reporting entity from providing specific reportable data items delineated in paragraph (1) of this subsection to the extent that those data to be exempted are not collected by the reporting entity.(3) Except as provided in §91.6(b) of this title (relating to How to Report), each report shall:(A) be electronically readable and contain all data items required in paragraph (1) of this subsection;(B) be fully coded and in a format prescribed by the Texas Cancer Registry;(C) meet all quality assurance standards utilized by the Texas Cancer Registry;(D) in the case of individuals who have more than one form of cancer, be submitted separately for each primary cancer diagnosed;(E) be submitted to the Texas Cancer Registry electronically; and(F) be transmitted by secure means at all times to protect the confidentiality of the data. Source Note: The provisions of this §91.4 adopted to be effective August 6, 1998, 23 TexReg 7801; amended to be effective November 7, 2002, 27 TexReg 10387; amended to be effective April 24, 2003, 28 TexReg 3332; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963; amended to be effective April 2, 2017, 42 TexReg 1450. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.4 What to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152248&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152248 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152248&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152248 03/11/2026 (a) All reports shall be submitted to the department within six months of the patient's admission, initial diagnosis, or treatment for cancer.(b) Data shall be submitted no less than quarterly by health care facilities with annual caseloads of 400 or less. Monthly submissions are required for all other health care facilities.(c) Data shall be submitted no less than quarterly by health care practitioners initially diagnosing a patient with cancer and performing the in-house pathological tests for that patient. Otherwise, data shall be submitted within 2 months of the request to a health care practitioner by the department or its authorized representative for a report or subset of a report on a patient diagnosed or treated elsewhere and for whom the same cancer data has not been reported.(d) Data shall be submitted no less than quarterly by clinical laboratories. Source Note: The provisions of this §91.5 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.5 When to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183263&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183263 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183263&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183263 03/11/2026 (a) Reports of cancer from health care facilities, clinical laboratories and health care practitioners shall be submitted to the Texas Cancer Registry electronically using a secure electronic process as defined by the department. At the request and with the authorization of the applicable health care facility, clinical laboratory, or health care practitioner, data may be furnished to the Texas Cancer Registry through a health information exchange.(b) The Texas Cancer Registry may accept the submission of paper copies of medical records from a health care facility, pathology reports from a clinical laboratory and reports or subsets of reports from a health care practitioner under the following conditions.(1) The department, or its authorized representative, shall determine that such paper submissions are more expedient than electronic reporting.(2) The acceptance of paper submissions from a health care facility, clinical laboratory or health care practitioner shall be approved by the department or its authorized representative.(3) The department, or its authorized representative, may approve acceptance of paper submissions from defined groups or types of health care facilities, clinical laboratories or health care practitioners.(4) All records and reports provided to the Texas Cancer Registry pursuant to this subsection must be transmitted by secure means at all times to protect the confidentiality of the data. Source Note: The provisions of this §91.6 adopted to be effective August 6, 1998, 23 TexReg 7801; amended to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963; amended to be effective April 2, 2017, 42 TexReg 1450. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.6 How to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183264&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183264 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183264&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183264 03/11/2026 Data reports should be submitted to the Texas Cancer Registry as specified in the Cancer Reporting Handbook. Source Note: The provisions of this §91.7 adopted to be effective August 6, 1998, 23 TexReg 7801; amended to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963; amended to be effective April 2, 2017, 42 TexReg 1450. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.7 Where to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152251&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152251 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152251&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152251 03/11/2026 (a) Each health care facility, clinical laboratory, or health care practitioner that reports to the department, by methods specified in §§91.4 - 91.7 of this title (relating to Cancer Registry), is considered compliant.(b) A person will be notified in writing if the person has not reported in compliance with this chapter within 30 days following the end of the required monthly or quarterly reporting timeframe and will be given an opportunity to take corrective action within 60 days from the date of the notification letter. A second notification letter will be sent 30 days after the date of the original notification letter if no corrective action has been taken.(c) If a person is non-compliant and takes no corrective action within 60 days of the original notification letter, the department or its authorized representative may access the information from the health care facility, clinical laboratory or health care practitioner as provided in §91.3 of this title (relating to Who Reports, Access to Records) and report it in the appropriate format.(1) The health care facility, clinical laboratory or health care practitioner shall be notified at least two weeks in advance before a scheduled arrival for collection of the information.(2) A health care facility, clinical laboratory or health care practitioner that knowingly or in bad faith fails to furnish data as required by this chapter shall reimburse the department or its authorized representative for its cost to access and report the information. The costs must be reasonable, based on the actual costs incurred by the department or by its authorized representative in the collection of the data and may include salary and travel expenses. It is presumed that a health care facility, clinical laboratory or health care practitioner acted knowingly or in bad faith if it failed to take corrective action within 60 days of the date of the original notification letter.(3) A health care facility, clinical laboratory or health care practitioner may request the department to conduct a hearing under the department's fair hearing rules to determine whether reimbursement to the department is appropriate.(d) Any health care facility, clinical laboratory or health care practitioner which is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subsection (c)(2) of this section shall provide payment to the department or its authorized representative within 60 days of the day this payment is demanded. In the event any health care facility, clinical laboratory or health care practitioner fails to make payment to the department or its authorized representative within 60 days of the day the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 1-1/2% per month of the outstanding balance. Source Note: The provisions of this §91.8 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.8 Compliance https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183265&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183265 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183265&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183265 03/11/2026 (a) Pursuant to the Act, Chapter 82, §82.009, all data obtained is for the confidential use of the department and the persons or entities, public or private, that the department determines are necessary to carry out the intent of the Act.(b) Limited release of the data is allowed by the Act, §82.008(h) and §82.009(b).(c) Any requests for confidential or statistical cancer data shall be made in accordance with §91.11 or §91.12 of this title (relating to Cancer Registry).(d) The Texas Cancer Registry is subject to state law that requires compliance with portions of the federal law and regulations cited in §91.3(e) of this title (relating to Who Reports, Access to Records). The department is authorized to use and disclose, for purposes described in the Act, cancer data without patient consent or authorization under 45 C.F.R §164.512(a) relating to uses and disclosures required by law, §164.512(b)(1) and (2) relating to uses and disclosures for public health activities, and §164.512(i) relating to uses and disclosures for research purposes. Source Note: The provisions of this §91.9 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963; amended to be effective April 2, 2017, 42 TexReg 1450. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.9 Confidentiality and Disclosure https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152255&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152255 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152255&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152255 03/11/2026 The department shall cooperate and consult with persons required to comply with this chapter so that such persons may provide timely, complete, and accurate data. The department will provide:(1) reporting training, technical assistance, on-site case-finding studies, and reabstracting studies;(2) quality assessment reports to ascertain that the computerized data utilized for statistical information and data compilation is accurate; and(3) educational information on cancer morbidity and mortality statistics available from the Texas Cancer Registry and the department. Source Note: The provisions of this §91.10 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.10 Quality Assurance https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213035 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213035 03/11/2026 (a) Statistical cancer data previously analyzed are available upon written or oral request to the Texas Cancer Registry. All other requests for statistical cancer data shall be in writing and directed to: CancerData@dshs.texas.gov or Texas Cancer Registry, Mail Code 1928, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347.(b) To ensure that the proper data are provided, the request shall include the following information:(1) name, address, and telephone number of the person requesting the information;(2) type of data needed and for what years (e.g., lung cancer incidence rates, Brewster County, 1998 - 2002); and(3) name and address of persons to whom data and billings are to be submitted (if applicable). Source Note: The provisions of this §91.11 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963; amended to be effective April 2, 2017, 42 TexReg 1450; amended to be effective March 20, 2023, 48 TexReg 1563. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.11 Requests for Statistical Cancer Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213036&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213036 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213036&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213036 03/11/2026 (a) Data requests for research.(1) Requests for confidential cancer data shall be in writing and directed to: CancerData@dshs.texas.gov or Texas Cancer Registry, Mail Code 1928, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347.(2) Written requests for confidential cancer data shall meet the submission requirements of the department or its designated Institutional Review Board (IRB) before release.(3) The Texas Cancer Registry may release confidential cancer data to state, federal, local, and other public agencies and organizations if approved by the department or its designated IRB.(4) The Texas Cancer Registry may release confidential cancer data to private agencies, organizations, and associations if approved by the department or its designated IRB.(5) The Texas Cancer Registry may release confidential cancer data to any other individual or entities for reasons deemed necessary by the department to carry out the intent of the Act if approved by the department or its designated IRB.(b) Data requests for non-research purposes.(1) The Texas Cancer Registry may provide reports containing confidential cancer data back to the respective reporting entity from records previously submitted to the Texas Cancer Registry from each respective reporting entity for the purposes of case management and administrative studies. These reports will not be released to any other entity.(2) The Texas Cancer Registry may release confidential cancer data to other areas of the department, provided that the disclosure is required or authorized by law. All communications of this nature shall be clearly labeled "Confidential" and will follow established departmental internal protocols and procedures.(3) The Texas Cancer Registry may release confidential cancer data to state, federal, local, and other public agencies and organizations in accordance with subsection (a) of this section.(4) The Texas Cancer Registry may release confidential cancer data to any other individual or entities for reasons deemed necessary to carry out the intent of the Act and in accordance with subsection (a) of this section.(5) An individual who submits a valid authorization for release of an individual cancer record shall have access to review or obtain copies of the information described in the authorization for release. Source Note: The provisions of this §91.12 adopted to be effective November 7, 2002, 27 TexReg 10387; amended to be effective July 9, 2006, 31 TexReg 5300; amended to be effective August 14, 2011, 36 TexReg 4963; amended to be effective April 2, 2017, 42 TexReg 1450; amended to be effective March 20, 2023, 48 TexReg 1563. 1 DEPARTMENT OF STATE HEALTH SERVICES 91 CANCER A CANCER REGISTRY §91.12 Requests and Release of Confidential Cancer Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187656 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187656 03/11/2026 The purpose of this chapter is to establish rules in accordance with the Health and Safety Code, Chapter 442, Donation of Prescription Drugs, which creates the Prescription Drug Donation Program. Under this Program, individuals may donate unused unit-dose prescription drugs to participating providers, who may redistribute eligible drugs to willing recipients. Source Note: The provisions of this §95.1 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187648&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187648 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187648&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187648 03/11/2026 The following words and terms, when used in this chapter, must have the following meanings, unless the context clearly indicates otherwise.(1) Adulterated Drug or Device--As defined in the Texas Food, Drug and Cosmetic Act, Health and Safety Code, §431.111.(2) Controlled Substance--As defined in the Health and Safety Code, §481.002.(3) Department--The Department of State Health Services.(4) Dispense--To prepare, package, compound, or label in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the user's agent under a practitioner's lawful order.(5) Donor--An individual who donates unused, unit-dose packaged prescription drugs under Health and Safety Code, Chapter 442 to a participating provider.(6) Health Care Facility--A facility that provides health care services to patients and maintains a pharmacy in the facility. The term includes the following facilities if a pharmacy is maintained in the facility:(A) a general or special hospital as defined by Health and Safety Code, Chapter 241;(B) an ambulatory surgical center licensed under Health and Safety Code, Chapter 243; and(C) an institution licensed under Health and Safety Code, Chapter 242.(7) Health Care Professional--An individual licensed, certified, or otherwise authorized to administer health care and prescribe prescription drugs, for profit or otherwise, in the ordinary course of business or professional practice. The term does not include a health care facility.(8) Manufacturer--A person who is a designer, formulator, constructor, rebuilder, fabricator, producer, compounder, processor, or assembler of any product or any component part thereof and who places the product or any component part thereof in the stream of commerce.(9) Participating Provider--A health care facility or pharmacy, or a pharmacist who is an employee of the facility or pharmacy that elects to participate in the collection and redistribution of donated prescription drugs under Health and Safety Code, Chapter 442.(10) Pharmacist--A person licensed under Occupations Code, Chapter 558.(11) Pharmacy--An entity licensed under Occupations Code, Chapter 560.(12) Prescription Drug--As defined under Occupations Code, §551.003.(13) Program--Prescription Drug Donation Program.(14) Recipient--An individual who voluntarily receives donated prescription drugs under Health and Safety Code Chapter 442.(15) Tamper-Evident--Packaging that allows for detection of unauthorized access to a prescription drug.(16) Unit-Dose--A dose of medicine prepared in an individual packet by a licensed facility for convenience, safety, or monitoring. Source Note: The provisions of this §95.2 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187649&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187649 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187649&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187649 03/11/2026 (a) Participation in the Prescription Drug Donation Program by a health care facility or pharmacy is voluntary.(b) To be eligible for participation in the Program, a participating provider must be in compliance with all applicable federal and state laws relating to the inspection, storage, labeling, and dispensing of prescription drugs and shall maintain appropriate active, non-restricted state-issued licenses or registrations.(c) A participating provider electing to participate in the Program shall complete and return a Participating Provider Form prescribed by the Department and available on the Program's website, http://www.dshs.texas.gov/pharmacy/default.shtm, designating a responsible contact and verifying it meets and will comply with the requirements of the Program.(d) A pharmacy or health care facility may withdraw from participation in the Program at any time by providing written notice to the Department on a Participating Provider Form prescribed by the Department, and available on the Program's website referenced in subsection (c) of this section.(e) The Department shall establish and maintain an electronic database that lists each participating provider. The Department shall post the database on Program's Internet website referenced in subsection (c) of this section. Source Note: The provisions of this §95.3 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.3 Participating Provider Eligibility https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187650&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187650 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187650&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187650 03/11/2026 (a) Donor Requirements.(1) No drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or United States Pharmacopoeia (USP) shall be donated or accepted as part of the Prescription Drug Donation Program. Drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or USP shall not be donated or accepted because of the increased potential for these drugs to become adulterated.(2) Controlled substances shall not be donated or accepted. Pursuant to federal and state laws, a controlled substance cannot be returned or reused once the drug has been dispensed to a patient.(3) Drugs previously purchased by Medicaid shall not be donated.(4) All donated drugs must:(A) be approved by the Food and Drug Administration (FDA) and not be required to have a risk evaluation or mitigation strategy;(B) be dispensed only by prescription;(C) bear the federal legend "Rx Only" or "Caution," Federal Law Prohibits Dispensing Without Prescription;"(D) be packaged into unit-dose packages; and(E) be intended for human use.(5) The donor must sign a Donor Form prescribed by the Department stating that:(A) the donor is the owner of the donated prescription drug;(B) the donated prescription drug has been properly stored and the tamper-evident packaging has not been opened or tampered with;(C) the donated prescription drug has not been adulterated or misbranded; and(D) the donor is voluntarily donating the prescription drug.(b) Participating Provider Requirements.(1) Upon the Department's confirmed receipt of the Participating Provider Form, a participating provider may accept legally obtained prescription drugs from a donor in the Program if the drugs meet the requirements of this rule, as determined by a pharmacist who is employed by or under contract with the participating provider and the donor has completed a Donor Form as prescribed by the Department.(2) The participating provider may accept a prescription drug only if all of the following requirements are met:(A) the drug is in its original sealed and tamper-evident unit-dose packaging. However, a drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit-dose packaging is undisturbed;(B) the drug has been stored according to manufacturer or USP storage requirements;(C) the packaging contains the expiration date of the drug;(D) the drug is not expired;(E) the drug and the packaging does not have any physical signs of tampering or adulteration, and there is no reason to believe that the drug is adulterated; and(F) all drugs shall be inventoried by the participating provider. The inventory shall include the name of the drug, strength of the drug, quantity of the drug, and the date of donation. Source Note: The provisions of this §95.4 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.4 Standards and Procedures for Donating or Accepting Prescription Drugs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187651&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187651 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187651&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187651 03/11/2026 (a) A licensed pharmacist employed by or under contract with the participating provider shall inspect donated prescription drugs to determine, to the extent reasonably possible in the judgement of the pharmacist, that the drugs are not adulterated or misbranded, are safe and suitable for dispensing, and are not ineligible drugs.(b) Donated drugs may not be stored with non-donated inventory. When donated drugs are not inspected immediately upon receipt, the participating provider shall quarantine the donated drugs separately from all dispensing stock until the donated drugs have been inspected and approved for dispensing.(c) The participating provider shall destroy donated non-controlled substances that are not suitable for dispensing and make a record of such destruction.(d) The pharmacist-in-charge shall develop and implement a written procedure for proper management of drug recalls by the manufacturer. Such procedures shall include, where appropriate, contacting patients to whom the recalled drug products have been dispensed.(e) The pharmacist-in-charge shall reasonably ensure that a recalled drug has been removed from inventory no more than 24 hours after receipt of the recall notice, and quarantined until proper disposal or destruction of the drug. Source Note: The provisions of this §95.5 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.5 Standards and Procedures for Inspecting and Storing Donated Prescription Drugs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187652&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187652 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187652&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187652 03/11/2026 (a) Donated drugs may be dispensed only if the drugs are prescribed by a health care professional for use by an eligible recipient and are dispensed by a licensed pharmacist who has determined that the drugs are of an acceptable integrity.(b) The recipient must sign a Recipient Form prescribed by the Department stating that the recipient:(1) understands that the drugs are donated;(2) accepts any risk associated with accidental mishandling of the drugs; and(3) acknowledges that the donor and the participating provider are acting in good faith and are therefore released from liability.(c) The participating provider shall dispense donated prescription drugs in compliance with applicable federal and state laws and regulations for dispensing prescription drugs, including all requirements relating to packaging, labeling, record keeping, drug utilization review and patient counseling.(d) The participating provider shall remove the original donor's identification and the name of the original dispensing pharmacy from the package prior to dispensing the drugs.(e) The participating provider shall be responsible for drug recalls and shall have an established mechanism to notify recipients in the event of a drug recall.(f) Prescription drugs donated under this Program shall not be resold.(g) All participating providers shall comply with the laws and rules pertaining to dispensing of prescription drugs as contained in the Occupations Code, Chapters 551-566, and 569 (relating to the Texas Pharmacy Act); and Title 22 Texas Administrative Code, Chapters 281, 283, 291, 295, 297, 303, 305, 309, and 311 (relating to the Texas State Board of Pharmacy). Source Note: The provisions of this §95.6 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.6 Standards and Procedures for Dispensing Donated Prescription Drugs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187653&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187653 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187653&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187653 03/11/2026 Donors and participating providers in the Prescription Drug Donation Program are not criminally liable and are not subject to professional disciplinary action if they act in good faith in donating, accepting, storing, labeling, distributing, and dispensing prescription drugs under Health and Safety Code, Chapter 442. Donors and participating providers are not civilly liable for damages for bodily injury, death, or property damage that arises from donating, accepting, storing, labeling, distributing, or dispensing prescription drugs under the Health and Safety Code, Chapter 442, unless the injury, death, or damage arises from the donor or participating provider's recklessness or intentional conduct. Source Note: The provisions of this §95.7 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.7 Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187654&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187654 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187654&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187654 03/11/2026 The participating provider may charge a handling fee not to exceed $20.00 to a recipient to cover the costs of inspecting, storing, labeling, and dispensing the donated prescription drug. Source Note: The provisions of this §95.8 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.8 Handling Fee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187655&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187655 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187655&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187655 03/11/2026 Records required as part of this Program shall be maintained pursuant to Occupations Code, Chapter 554. Source Note: The provisions of this §95.9 adopted to be effective March 1, 2018, 43 TexReg 872. 1 DEPARTMENT OF STATE HEALTH SERVICES 95 PRESCRIPTION DRUG DONATION PROGRAM §95.9 Recordkeeping Requirements for Participating Providers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184678&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184678 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184678&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184678 03/11/2026 The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.(1) Blood--Human blood, human blood components, and products made from human blood.(2) Bloodborne pathogens--Pathogenic microorganisms that are present in human blood and that can cause diseases in humans, and include:(A) hepatitis B virus (HBV);(B) hepatitis C virus (HCV); and(C) human immunodeficiency virus (HIV).(3) Contaminated--The presence or reasonably anticipated presence of blood or other potentially infectious material on an item or surface.(4) Contaminated equipment--Any equipment used in the workplace that has been soiled with blood or other potentially infectious materials on an item or surface.(5) Contaminated sharps injury--Any sharps injury that occurs with a sharp used or encountered in a health care setting that is contaminated with human blood or body fluids.(6) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory that is:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.(7) Employee--An individual who works for a governmental unit or on premises owned or operated by a governmental unit whether or not he or she is directly compensated by the governmental unit.(8) Employs--Engages the services of employees.(9) Engineered sharps injury protection--A physical attribute that:(A) is built into a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids and that effectively reduces the risk of an exposure incident by a mechanism, such as barrier creation, blunting, encapsulation, withdrawal, retraction, destruction, or another effective mechanism; or(B) is built into any other type of needle device, into a nonneedle sharp, or into a nonneedle infusion safety securement device that effectively reduces the risk of an exposure incident.(10) Exposure incident--Eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties.(11) Governmental unit--This state and any agency of the state, including a division, section, unit, branch, department, bureau, board, commission, or office and includes:(A) a political subdivision of this state, including any municipality, county, or special district; or(B) any other institution of government, including an institution of higher education.(12) Hepatitis B virus (HBV)--A virus that may be contracted through exposure to blood and/or body fluids and can result in chronic liver disease, cirrhosis, and hepatocellular (liver) cancer.(13) Hepatitis C virus (HCV)--A virus that may be contracted through exposure to blood and/or body fluids and may result in chronic liver disease, cirrhosis, and hepatocellular (liver) cancer.(14) Health care professional--A person whose legally permitted scope of practice allows him or her to independently evaluate an employee of a governmental unit and determine the appropriate interventions after an exposure incident; this would include hepatitis B vaccination and postexposure evaluation and follow up.(15) Human immunodeficiency virus (HIV)--HIV may be contracted through blood and/or body fluids and can result in Acquired Immune Deficiency Syndrome (AIDS), a condition in which the body is unable to fight infections.(16) Needleless system--A device that does not use a needle and that is used:(A) to withdraw body fluids after initial venous or arterial access is established;(B) to administer medication or fluids; or(C) for any other procedure involving the potential for an exposure incident.(17) Occupational exposure--A reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.(18) Other potentially infectious materials (OPIMs); include:(A) the following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;(B) any unfixed tissue or organ (other than intact skin) from a human, living or dead; and(C) HIV-, HBV-, or HCV-containing cell or tissue cultures, organ cultures, culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV, HBV or HCV.(19) Personal protective equipment (PPE)--Specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts, or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.(20) Regulated waste/special waste from health care-related facilities--Solid waste which if improperly treated or handled may serve to transmit an infectious disease(s) and which is composed of the following:(A) animal waste;(B) bulk blood, bulk human blood products, or bulk human body fluids;(C) microbiological waste;(D) pathological waste; or(E) sharps.(21) Sharp--An object used or encountered in a health care setting that can be reasonably anticipated to penetrate the skin or any other part of the body and to result in an exposure incident and includes but is not limited to:(A) needle devices;(B) scalpels;(C) lancets;(D) a piece of broken glass;(E) a broken capillary tube;(F) an exposed end of a dental wire; or(G) a dental knife, drill, or bur.(22) Sharps injury--Any injury caused by a sharp, including a cut, abrasion, or needlestick.(23) Universal precautions/standard precautions--Approaches to infection control as defined in Title 29 Code of Federal Regulation §1910.1030, Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard and the Healthcare Infection Control Practices Advisory Committee's 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. According to the concept of universal precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, HCV, and other bloodborne pathogens. Source Note: The provisions of this §96.101 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626; amended to be effective June 21, 2017, 42 TexReg 3147. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.101 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184679&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184679 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184679&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184679 03/11/2026 (a) These minimum standards apply to a governmental unit that employs employees who:(1) provide services in a public or private facility providing health care-related services, including home health care organizations; or(2) otherwise have a risk of exposure to blood or other potentially infectious material containing bloodborne pathogens in connection with exposure to sharps.(b) These governmental units would include, but not limited to, hospital district hospitals, city hospitals, county hospitals, city/county hospitals, hospital authority hospitals, local health departments, Department of State Health Services regions and hospitals, other state hospitals and state supported living centers, community mental health and intellectual disability centers, Texas Juvenile Justice Department, Texas Department of Criminal Justice, locally or state-funded university student infirmaries, public school district clinics, emergency medical services, locally or state-funded long term care facilities, and blood banks.(c) Employees who are directly compensated by a governmental unit are subject to all provisions of this chapter. Employees who are subject through their private employer to the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard and uncompensated employees are subject only to the log and reporting provisions of §96.401 of this title (relating to Sharps Injury Log), and §96.402 of this title (relating to Confidentiality Statement) unless otherwise required by contract. Source Note: The provisions of this §96.201 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626; amended to be effective June 21, 2017, 42 TexReg 3147. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.201 Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184680&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184680 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184680&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184680 03/11/2026 (a) The exposure control plan (plan) developed by the Department of State Health Services (department), is adopted as a model plan to achieve the minimum standard to implement Health and Safety Code, §81.304. The plan is designed to minimize exposure of employees as described in §96.201 of this title (relating to Applicability) and includes policies relating to occupational exposure to bloodborne pathogens, training and educational requirements for employees, measures to increase vaccination of employees, and increased use of personnel protective equipment by employees.(b) Copies of the plan are available on the Internet at http://www.dshs.state.tx.us/IDCU/health/infection_control/bloodborne_pathogens/Resources.doc or from the department's regional offices. Source Note: The provisions of this §96.202 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626; amended to be effective June 21, 2017, 42 TexReg 3147. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.202 Exposure Control Plan https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184681&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184681 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184681&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184681 03/11/2026 (a) This exposure control plan (plan) is provided by the Department of State Health Services (department) to be analogous with Title 29 Code of Federal Regulation §1910.1030, Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as specified in Health and Safety Code, §81.304.(b) Employers should review the plan for particular requirements as applicable to their specific situation. Governmental units may modify the plan appropriately to their respective practice settings. Employers will need to include provisions relevant to their particular facility or organization in order to develop an effective, comprehensive exposure control plan specific to their facility or organization.(c) Employers will annually review their exposure control plan, update when necessary, and document when accomplished. Source Note: The provisions of this §96.203 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626; amended to be effective June 21, 2017, 42 TexReg 3147. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.203 Minimum Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125542&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125542 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125542&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125542 03/11/2026 (a) The Department of State Health Services (department) recommends that governmental units implement needleless systems and sharps with engineered sharps injury protection for employees.(b) Waivers shall not be granted. The provisions in the legislation which allowed the department to grant waivers, has expired (Chapter 1411, 76th Legislature, §26.02).(c) The use of a prefilled syringe that is approved by the Federal Food and Drug Administration may not be prohibited.(d) Evaluation committee.(1) At least half of the members of an evaluation committee established by a governmental unit to implement subsection (b) of this section must be employees who are health care workers who have direct contact with patients or provide services on a regular basis.(2) Whenever possible, the governmental entity establishing the evaluation committee shall consider using committees with similar duties already in existence. Source Note: The provisions of this §96.301 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.301 Safety Recommendations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125543&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125543 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125543&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125543 03/11/2026 (a) The Department of State Health Services (department) shall compile and maintain a list of needleless system devices and sharps devices with engineered sharps injury protection that are available in the commercial marketplace and registered with the department to assist governmental units to comply with this chapter.(b) Each needleless system device or sharps device with engineered sharps injury protection that is the subject of the department's device registration application shall be in conformance with all applicable premarket notification or premarket approval requirements established by the U.S. Food and Drug Administration (FDA) unless otherwise exempted from such requirements.(c) Each device manufacturer who manufactures a needleless system device or sharps device with engineered sharps injury protection and who desires to register the device for the first time with the department shall apply for registration in accordance with the procedures found in §96.303 of this title (relating to Registration Procedures).(d) If a device manufacturer introduces more than one needleless system device or sharps device with engineered sharps injury protection into commerce, the manufacturer shall register each device separately in order for the device to be included on a list maintained by the department.(e) Each sharps device with engineered sharps injury protection that is the subject of the department's device registration application shall contain physical attributes consistent with those recognized as effective for engineered sharps injury protection, as defined in §96.101(9) of this title (relating to Definitions).(f) The department may accept reports from authorities in other jurisdictions, including the FDA, to determine the extent of compliance with these sections and with the provisions of Health and Safety Code, Chapter 81, Subchapter H.(g) The department shall register a needleless system device or sharps device with engineered sharps injury protection that meets the requirements of these sections.(h) Registration of a needleless system device or sharps device with engineered sharps injury protection by the department does not constitute an endorsement or recommendation of such device.(i) Registration certificates shall not be transferable from one device to another or from one device name to another. Any request for transfer of registration due to a change in ownership shall be made pursuant to the requirements in subsection (l) of this section.(j) All device registration certificates shall expire two years from the date of issuance.(k) Renewal of registration.(1) Upon expiration of a device registration, the registration may be renewed by filing an application for renewal on a form prescribed by the department, accompanied by the appropriate renewal fee.(2) The renewal registration certificate shall be valid for two years.(3) The appropriate registration renewal form and renewal fee for each device should be submitted to the department not later than 30 days following the expiration date of the current device registration in order to maintain the device on the department's list of existing needleless system devices and sharps devices with engineered sharps injury protection.(4) The department shall renew the registration of a needleless system device or sharps device with engineered sharps injury protection following receipt of the appropriate renewal form and renewal fee.(l) The device manufacturer shall notify the department in writing of any change that would render the information required in the initial registration application no longer accurate. Upon receipt of a written notification involving a change, the department may update the information contained in its list of needleless system devices and sharps devices with engineered sharps injury protection in order to reflect the change. Source Note: The provisions of this §96.302 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.302 Device Registration https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125544&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125544 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125544&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125544 03/11/2026 (a) Any device manufacturer desiring to register a needleless system device or sharps device with engineered sharps injury protection shall make written application for registration on forms provided by the Department of State Health Services (department). A separate completed application is required for each device to be registered. Registration application forms may be obtained from the Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756.(b) The initial application for device registration shall include the following information:(1) name, model, common name, and available sizes of the device;(2) premarket notification or approval number assigned by the U.S. Food and Drug Administration, unless otherwise exempted;(3) name, mailing address, and telephone number of the device manufacturer;(4) name of the contact person for the device manufacturer;(5) designation as either a needleless system device or sharps device with engineered sharps injury protection;(6) if a sharps device with engineered sharps injury protection, a description of the physical attribute(s) that effectively reduces the risk of sharps injury; and(7) name and signature of the person responsible for submitting the device registration application. Source Note: The provisions of this §96.303 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.303 Registration Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125545&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125545 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125545&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125545 03/11/2026 The Department of State Health Services (department) shall charge a fee to register a needleless system device or sharps device with engineered sharps injury protection.(1) An initial registration fee of $2,500 shall be required for each device registered for a two-year period.(2) A renewal fee of $2,000 shall be required for renewing the registration of each device for a two-year term.(3) Initial and renewal registration fees will be assessed to cover the costs associated with the review and processing of device registration applications and in the administration of these sections and are therefore nonrefundable. Source Note: The provisions of this §96.304 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.304 Registration Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184682&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184682 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184682&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184682 03/11/2026 (a) The chief administrative officer for each facility within a governmental unit shall report, as required by this section, each employee, as defined in §96.101(7) of this title (relating to Definitions), who sustains a contaminated sharps injury, as defined in §96.101(5) of this title. The chief administrative officer of the governmental unit may designate an employee for each facility within the governmental unit to serve as the reporting officer.(b) Information concerning each contaminated sharps injury shall be recorded in a written or electronic sharps injury log which shall be maintained by a governmental unit, in accordance with Health and Safety Code, Chapter 81, Subchapter H, and this chapter.(c) The following information must be recorded in the sharps injury log:(1) name and address of facility where injury occurred;(2) name and phone number of the chief administrative officer or reporting officer;(3) date and time of the injury;(4) age and sex of the injured employee;(5) type and brand of sharp involved;(6) original intended use of the sharp;(7) whether the injury occurred before, during, or after the sharp was used for its original intended purpose;(8) whether the exposure was during or after the sharp was used;(9) whether the device had engineered sharps injury protection, as defined in §96.101(9)(A) and (B) of this title (relating to Definitions), and if yes, was the protective mechanism activated and did the exposure incident occur before, during, or after activation of the protective mechanism;(10) whether the injured person was wearing gloves at the time of the injury;(11) whether the injured person had completed a hepatitis B vaccination series;(12) whether a sharps container was readily available for disposal of the sharp;(13) whether the injured person received training on the exposure control plan during the 12 months prior to the incident;(14) the involved body part;(15) the job classification of the injured person;(16) the employment status of the injured person;(17) the location/facility/agency and the work area where the sharps injury occurred; and(18) a listing of the implemented needleless systems and sharps with engineered sharps injury protection for employees available within the governmental entity.(d) Information contained in subsection (c)(1) - (17) of this section concerning each contaminated sharps injury shall be reported no later than 30 days after it occurred.(e) A chief administrative officer for each facility within a governmental unit or the designee shall report the contaminated sharps injury to the local health authority where the facility is located. The local health authority, acting as an agent for the Department of State Health Services (department), shall receive and review the report for completeness, and submit the report to the department. If no local health authority is appointed for the jurisdiction where the facility is located, the report shall be made to the regional director of the department's regional office in which the facility is located.(f) A contaminated sharps injury shall be reported on the department's Contaminated Sharps Injury Reporting Form or through an electronic means established by the department. Copies of the Contaminated Sharps Injury Reporting Form can be obtained on the Internet at http://www.dshs.state.tx.us/idcu/health/bloodborne_pathogens/reporting/ or from the department's regional offices. Source Note: The provisions of this §96.401 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626; amended to be effective June 21, 2017, 42 TexReg 3147. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.401 Sharps Injury Log https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125547&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125547 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125547&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125547 03/11/2026 (a) All information and materials obtained or compiled by the Department of State Health Services (department) or an agent of the department in connection with a report under this chapter are confidential and not subject to disclosure under Government Code, Chapter 552, and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release by the department or its agents. For the purposes of these rules, all local health authorities are agents for the department.(b) The department shall make available, in aggregate form, the information described in Health and Safety Code §81.305(b) and this chapter, provided that the name and other information identifying the facility is deleted and the information is provided according to public health regions established by the department.(c) All information and materials obtained or compiled by the department or an agent of the department in connection with this chapter, are considered information relating to cases or suspected cases of diseases or health conditions, and may be released only as allowed by Health and Safety Code §81.046. Source Note: The provisions of this §96.402 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.402 Confidentiality Statement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125548&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125548 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125548&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125548 03/11/2026 Waivers shall not be granted. The provisions in the legislation which allowed the department to grant waivers, has expired (Chapter 1411, 76th Legislature, §26.02). Source Note: The provisions of this §96.501 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626. 1 DEPARTMENT OF STATE HEALTH SERVICES 96 BLOODBORNE PATHOGEN CONTROL §96.501 Waiver for Rural Counties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=177144&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 177144 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=177144&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 177144 03/11/2026 This subchapter contains the general reporting and other control requirements related to communicable disease. Specific reporting and other control requirements applicable to sexually transmitted diseases (including AIDS and HIV) are found in Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)). The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise.(1) Act--Communicable Disease Prevention and Control Act, Health and Safety Code, Chapter 81.(2) Advanced practice nurse--A registered nurse authorized by the Board of Nurse Examiners to practice as an advanced practice nurse based on completing an advanced educational program. The term includes a nurse practitioner, nurse-midwife, nurse anesthetist, and clinical nurse specialist.(3) Carbapenem resistant Enterobacteriaceae (CRE)--CRE-E. coli or CRE-Klebsiella species as defined in the Centers for Disease Control and Prevention, Patient Safety Component, Protocol for Multidrug-Resistant Organism and Clostridium difficile Infection (MDRO/CDI) Module, or its successor. (4) Carrier--An infected person or animal that harbors a specific infectious agent in the absence of discernible clinical disease and serves as a potential source or reservoir of infection. (5) Case--As distinct from a carrier, the term "case" is used to mean a person or animal in whose tissues the etiological agent of a communicable disease is lodged and which usually produces signs or symptoms of disease. Evidence of the presence of a communicable disease may also be revealed by laboratory findings.(6) Commissioner--Commissioner of the Department of State Health Services.(7) Common carrier--Any vehicle or device available to the public for transportation of persons, goods, or messages. (8) Communicable disease--An illness due to an infectious agent or its toxic products which is transmitted directly to a well person from an infected person or animal, or indirectly through an intermediate plant or animal host, vector, or the inanimate environment. (9) Contact--A person or animal that has been in such association with an infected person or animal or a contaminated environment so as to have had opportunity to acquire the infection.(10) Department--Department of State Health Services. (11) Diarrhea--A watery or loose stool that takes the shape of the container that holds it.(12) Disinfection--Application of chemical or physical agents to destroy infectious agents outside the body.(13) Epidemic--The occurrence in a community or region of a group of illnesses of similar nature, clearly in excess of normal expectancy, and derived from a common or a propagated source.(14) Exposure--A situation or circumstance in which there is significant risk of becoming infected with the etiologic agent for the disease involved.(15) Fever--A temperature of 100 degrees Fahrenheit (37.8 degrees Celsius) or higher.(16) Health authority--A physician designated to administer state and local laws relating to public health under the Local Public Health Reorganization Act, Health and Safety Code, Chapter 121. The health authority, for purposes of this subchapter, may be: (A) a local health authority appointed by the local government jurisdiction; or(B) a regional director of the Department of State Health Services if no physician has been appointed by the local government. (17) Hepatitis B, perinatal infection--HBsAg positivity in any infant aged >1 through 24 months.(18) Hospital laboratory--Any laboratory that performs laboratory test procedures for a patient of a hospital either as a part of the hospital or through contract with the hospital.(19) Multidrug-resistant Acinetobacter (MDR-A)--MDR-Acinetobacter species as defined by the Centers for Disease Control and Prevention, Patient Safety Component, Protocol for Multidrug-Resistant Organism and Clostridium difficile Infection (MDRO/CDI) Module, or its successor.(20) Notifiable condition--Any disease or condition that is required to be reported under the Act or by this chapter. See §97.3 of this title (relating to What Condition to Report and What Isolates to Report or Submit). Any outbreak, exotic disease, or unusual group expression of illness which may be of public health concern, whether or not the disease involved is listed in §97.3 of this title, shall be considered a "notifiable condition." The term "notifiable condition" is the same as the term "reportable disease" as used in the Health and Safety Code, Chapter 81.(21) Outbreak--See definition of epidemic in this section. (22) Pandemic--A global disease epidemic or an epidemic that crosses international borders and affects an extremely large number of people.(23) Physician--A person licensed by the Texas Medical Board to practice medicine in Texas.(24) Physician assistant--A person licensed as a physician assistant by the Texas Physician Assistant Board.(25) Regional director--The physician who is the chief administrative officer of a region as designated by the department under the Local Public Health Reorganization Act, Health and Safety Code, Chapter 121.(26) Report--Information that is required to be provided to the department.(27) Report of a disease--The notification to the appropriate authority of the occurrence of a specific communicable disease in man or animals, including all information required by the procedures established by the department.(28) Research facility--A facility that is licensed by the United States Department of Agriculture to use vertebrate animals for research purposes and is in compliance with the federal Animal Welfare Act (7 U.S.C., Chapter 54).(29) School Administrator--The city or county superintendent of schools or the principal of any school not under the jurisdiction of a city or county board of education.(30) Significant risk--A determination relating to a human exposure to an etiologic agent for a particular disease, based on reasonable medical judgments given the state of medical knowledge, relating to the following:(A) nature of the risk (how the disease is transmitted); (B) duration of the risk (how long an infected person may be infectious); (C) severity of the risk (what is the potential harm to others); and(D) probability the disease will be transmitted and will cause varying degrees of harm.(31) Specimen Submission Form--A current Department of State Health Services laboratory specimen submission form available from the Department of State Health Services, Laboratory Services Section, 1100 West 49th Street, Austin, Texas, 78756-3199.(32) Vancomycin-intermediate Staphylococcus aureus (VISA)--Staphylococcus aureus with a vancomycin minimum inhibitory concentration (MIC) of 4 µg/mL through 8 µg/mL.(33) Vancomycin-resistant Staphylococcus aureus (VRSA)--Staphylococcus aureus with a vancomycin MIC of 16 µg/mL or greater.(34) Veterinarian--A person licensed by the Texas State Board of Veterinary Medical Examiners to practice veterinary medicine in Texas. Source Note: The provisions of this §97.1 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective July 26, 1996, 21 TexReg 6622; amended to be effective March 5, 1998, 23 TexReg 1954; amended to be effective January 1, 1999, 23 TexReg 12663; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective August 5, 2001, 26 TexReg 5658; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective April 20, 2014, 39 TexReg 2853; amended to be effective April 3, 2016, 41 TexReg 2317. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.1 Definitions and Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=177145&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 177145 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=177145&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 177145 03/11/2026 (a) A physician, dentist, veterinarian, chiropractor, advanced practice nurse, physician assistant, or person permitted by law to attend a pregnant woman during gestation or at the delivery of an infant shall report, as required by these sections, each patient (person or animal) he or she shall examine and who has or is suspected of having any notifiable condition, and shall report any outbreak, exotic disease, or unusual group expression of illness of any kind whether or not the disease is known to be communicable or reportable. An employee from the clinic or office staff may be designated to serve as the reporting officer. A physician, dentist, veterinarian, advanced practice nurse, physician assistant, or chiropractor who can assure that a designated or appointed person from the clinic or office is regularly reporting every occurrence of these diseases or health conditions in their clinic or office does not have to submit a duplicate report.(b) The chief administrative officer of a hospital shall appoint one reporting officer who shall be responsible for reporting each patient who is medically attended at the facility and who has or is suspected of having any notifiable condition. Hospital laboratories may report through the reporting officer or independently in accordance with the hospital's policies and procedures.(c) Except as provided in subsection (b) of this section, any person who is in charge of a clinical laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields microscopic, bacteriologic, virologic, parasitologic, serologic, or other evidence of a notifiable condition, shall report as required by this section.(d) School authorities, including a superintendent, principal, teacher, school health official, or counselor of a public or private school and the administrator or health official of a public or private institution of higher learning should report as required by these sections those students attending school who are suspected of having a notifiable condition. School administrators who are not medical directors meeting the criteria described in §97.132 of this title (relating to Who Shall Report Sexually Transmitted Diseases) are exempt from reporting sexually transmitted diseases.(e) Any person having knowledge that a person(s) or animal(s) is suspected of having a notifiable condition should notify the local health authority or the department and provide all information known to them concerning the illness and physical condition of such person(s) or animal(s).(f) Sexually transmitted diseases including HIV and AIDS shall be reported in accordance with Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)).(g) Failure to report a notifiable condition is a Class B misdemeanor under the Texas Health and Safety Code, §81.049.(h) The Health Insurance Portability and Accountability Act (HIPAA) allows reporting without authorization for public health purposes and where required by law. Title 45 Code of Federal Regulations §164.512(a) and (b). Source Note: The provisions of this §97.2 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective March 5, 1998, 23 TexReg 1954; amended to be effective January 1, 1999, 23 TexReg 12663; amended to be effective March 26, 2000, 25 TexReg 2343; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective August 5, 2001, 26 TexReg 5658; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective April 3, 2016, 41 TexReg 2317. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.2 Who Shall Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221983 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221983 03/11/2026 (a) Humans.(1) Identification of notifiable conditions.(A) A summary list of notifiable conditions and reporting time frames is published on the Department of State Health Services web site at https://www.dshs.texas.gov/idcu/investigation/conditions/. Copies are filed in the Emerging and Acute Infectious Disease Unit, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756.(B) Repetitive test results from the same patient do not need to be reported except those for mycobacterial infections.(2) Notifiable conditions or isolates.(A) Confirmed and suspected human cases of the following diseases and infections are reportable:(i) acquired immune deficiency syndrome (AIDS);(ii) amebic meningitis and encephalitis;(iii) anaplasmosis;(iv) ancylostomiasis;(v) anthrax;(vi) arboviral infections, including those caused by California serogroup virus, chikungunya virus, dengue virus, Eastern equine encephalitis (EEE) virus, St. Louis encephalitis (SLE) virus, Western equine encephalitis (WEE) virus, yellow fever virus, West Nile (WN) virus, and Zika virus;(vii) ascariasis;(viii) babesiosis;(ix) botulism, adult and infant;(x) brucellosis;(xi) campylobacteriosis;(xii) Candida auris ;(xiii) carbapenem resistant Enterobacteriaceae (CRE);(xiv) Chagas disease;(xv) chancroid;(xvi) chickenpox (varicella);(xvii) Chlamydia trachomatis infection; (xviii) Cronobacter spp. in infants, invasive;(xix) cryptosporidiosis;(xx) cyclosporiasis;(xxi) diphtheria;(xxii) echinococcosis;(xxiii) ehrlichiosis;(xxiv) fascioliasis;(xxv) gonorrhea;(xxvi) Haemophilus influenzae , invasive;(xxvii) Hansen's disease (leprosy);(xxviii) hantavirus infection;(xxix) hemolytic uremic syndrome (HUS);(xxx) hepatitis, including hepatitis A, acute hepatitis B infection, hepatitis B acquired perinatally (child), any hepatitis B infection identified prenatally or at delivery (mother), acute hepatitis C infection, and acute hepatitis E infection;(xxxi) human immunodeficiency virus (HIV) infection;(xxxii) influenza-associated pediatric mortality;(xxxiii) legionellosis;(xxxiv) leishmaniasis;(xxxv) listeriosis;(xxxvi) Lyme disease;(xxxvii) malaria;(xxxviii) measles (rubeola);(xxxix) melioidosis;(xl) meningococcal infection, invasive;(xli) mumps;(xlii) novel coronavirus;(xliii) novel influenza;(xliv) paragonimiasis;(xlv) pertussis;(xlvi) plague;(xlvii) poliomyelitis, acute paralytic;(xlviii) poliovirus infection, non-paralytic;(xlix) prion diseases, such as Creutzfeldt-Jakob disease (CJD);(l) Q fever;(li) rabies;(lii) rubella (including congenital);(liii) salmonellosis, including typhoid fever;(liv) Shiga toxin-producing Escherichia coli infection;(lv) shigellosis;(lvi) smallpox;(lvii) spotted fever group rickettsioses (such as Rocky Mountain spotted fever);(lviii) streptococcal disease: Streptococcus pneumoniae , invasive;(lix) syphilis;(lx) Taenia solium and undifferentiated Taenia infections, including cysticercosis;(lxi) tetanus;(lxii) tick-borne relapsing fever;(lxiii) trichinosis;(lxiv) trichuriasis;(lxv) tuberculosis (Mycobacterium tuberculosis complex);(lxvi) tuberculosis infection;(lxvii) tularemia;(lxviii) typhus;(lxix) vancomycin-intermediate Staphylococcus aureus (VISA);(lxx) vancomycin-resistant Staphylococcus aureus (VRSA);(lxxi) Vibrio infection, including cholera (specify species);(lxxii) viral hemorrhagic fever; and(lxxiii) yersiniosis.(B) In addition to individual case reports, any outbreak, exotic disease, or unusual group expression of disease that may be of public health concern should be reported by the most expeditious means.(3) Minimal reportable information requirements. The minimal information that must be reported for each disease is as follows. (A) AIDS, chancroid, Chlamydia trachomatis infection, gonorrhea, HIV infection, and syphilis must be reported in accordance with Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)).(B) For tuberculosis disease - complete name, date of birth, physical address and county of residence, country of origin, and information on which diagnosis was based or suspected. In addition, if known, radiographic or diagnostic imaging results and dates; all information necessary to complete the most recent versions of department reporting forms: Report of Case and Patient Services, Report of Follow-up and Treatment for Contacts to TB Cases and Suspects, and Report of Verified Case of Tuberculosis; laboratory results used to guide prescribing, monitoring, or modifying antibiotic treatment regimens for tuberculosis, including liver function studies, renal function studies, and serum drug levels; pathology reports related to diagnostic evaluations of tuberculosis; reports of imaging or radiographic studies; records of hospital or outpatient care, including histories and physical examinations, discharge summaries, and progress notes; records of medication administration, including directly observed therapy (DOT) records, and drug toxicity and monitoring records; a listing of other patient medications to evaluate the potential for drug-drug interactions; and copies of court documents related to court-ordered management of tuberculosis.(C) For contacts to a known case of tuberculosis - complete name, date of birth, physical address, county of residence, evaluation and disposition, and all information necessary to complete the most recent versions of department reporting forms: Report of Follow-up and Treatment for Contacts to TB Cases and Suspects and Report of Case and Patient Services.(D) For other persons identified with tuberculosis infection - complete name, date of birth, physical address and county of residence, country of origin, diagnostic information, treatment information, medical and population risks, and all information necessary to complete the most recent version of the department's reporting form, Report of Case and Patient Services.(E) For hepatitis B (chronic and acute) identified prenatally or at delivery - mother's name, address, telephone number, age, date of birth, sex, race and ethnicity, preferred language, hepatitis B laboratory test results; estimated delivery date or date and time of birth; name and phone number of delivery hospital or planned delivery hospital; name of infant; name, phone number, and address of medical provider for infant; date, time, formulation, dose, manufacturer, and lot number of hepatitis B vaccine and hepatitis B immune globulin administered to infant.(F) For hepatitis A, B, C, and E - name, address, telephone number, age, date of birth, sex, race and ethnicity, disease, diagnostic indicators (diagnostic lab results, including all positive and negative hepatitis panel results, liver function tests, and symptoms), date of onset, pregnancy status, and physician or practitioner name, address, and telephone number.(G) For hepatitis B, perinatal infection - name of infant; date of birth; sex; race and ethnicity; name, phone number, and address of medical provider for infant; date, time, formulation, dose, manufacturer, and lot number of hepatitis B vaccine and hepatitis B immune globulin administered to infant; and hepatitis B laboratory test results.(H) For chickenpox - name, date of birth, sex, race and ethnicity, address, date of onset, and varicella vaccination history. (I) For Hansen's disease - name; date of birth; sex; race and ethnicity; disease type; place of birth; address; telephone number; date entered Texas; date entered U.S.; education and employment; insurance status; location and inclusive dates of residence outside U.S.; date of onset and history prior to diagnosis; date of initial biopsy and result; disease type (i.e., tuberculoid, borderline, and lepromatous); date initial drugs prescribed and name of drugs; name, date of birth, and relationship of household contacts; and name, address, and telephone number of physician or practitioner.(J) For novel influenza investigations occurring during an influenza pandemic - minimal reportable information on individual cases, a subset of cases or aggregate data will be specified by the department.(K) For all other notifiable conditions listed in paragraph (2)(A) of this subsection - name, address, telephone number, age, date of birth, sex, race and ethnicity, disease, diagnostic indicators (diagnostic lab results, specimen source, test type, and clinical indicators), date of onset, and physician or practitioner name, address, and telephone number.(L) Other information may be required as part of an investigation in accordance with Texas Health and Safety Code §81.061. (4) Diseases requiring submission of cultures. Pure cultures, or specimens as indicated below, must be submitted and accompanied by a current department Specimen Submission Form for:(A) anthrax (Bacillus anthracis ); (B) botulism, adult and infant (Clostridium botulinum );(C) brucellosis (Brucella species); (D) Candida auris ;(E) diphtheria (Corynebacteria diphtheriae from any site);(F) all Haemophilus influenzae , invasive, in children under five years old (Haemophilus influenzae from normally sterile sites);(G) listeriosis (Listeria monocytogenes );(H) meningococcal infection, invasive (Neisseria meningitidis from normally sterile sites or purpuric lesions);(I) plague (Yersinia pestis ); (J) salmonellosis, including typhoid fever (Salmonella species);(K) Shiga toxin-producing Escherichia coli infection (E.coli O157:H7, isolates or specimens from cases where Shiga toxin activity is demonstrated); (L) Staphylococcus aureus with a vancomycin minimum inhibition concentration (MIC) greater than 2 micrograms per milliliter (µg/mL);(M) all Streptococcus pneumoniae , invasive, in children under five years old (Streptococcus pneumoniae from normally sterile sites);(N) tuberculosis (Mycobacterium tuberculosis complex);(O) tularemia (Francisella tularensis );(P) vibriosis (Vibrio species); and(Q) any outbreak, exotic disease, or unusual group expression of disease that may be of public health concern may require submission of cultures or specimens.(5) Laboratory reports. Reports from laboratories must include patient name, identification number, address, telephone number, age, date of birth, sex, race and ethnicity; specimen submitter name, address, and phone number; specimen type; date specimen collected; disease test and test result; normal test range; date of test report; and physician or practitioner name and telephone number.(b) Animals.(1) Clinically diagnosed or laboratory-confirmed animal cases of the following diseases are reportable: anthrax, arboviral encephalitis, tuberculosis (Mycobacterium tuberculosis complex) in animals other than those housed in research facilities, and plague. All non-negative rabies tests performed on animals from Texas at laboratories located outside of Texas must be reported. All non-negative rabies tests performed in Texas must be reported by the laboratory conducting the testing. In addition to individual case reports, any outbreak, exotic disease, or unusual group expression of disease which may be of public health concern should be reported by the most expeditious means.(2) The minimal information that must be reported for each disease includes species and number of animals affected, disease or condition, name and phone number of the veterinarian or other person in attendance, and the animal owner's name, address, and phone number. Other information may be required as part of an investigation in accordance with Texas Health and Safety Code §81.061. Source Note: The provisions of this §97.3 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective July 26, 1996, 21 TexReg 6622; amended to be effective March 5, 1998, 23 TexReg 1954; amended to be effective January 1, 1999, 23 TexReg 12663; amended to be effective March 26, 2000, 25 TexReg 2343; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective August 5, 2001, 26 TexReg 5658; amended to be effective December 12, 2002, 27 TexReg 11547; amended to be effective May 29, 2003, 28 TexReg 4151; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective April 20, 2014, 39 TexReg 2853; amended to be effective April 3, 2016, 41 TexReg 2317; amended to be effective April 2, 2017, 42 TexReg 1452; amended to be effective January 5, 2021, 46 TexReg 162; amended to be effective January 1, 2025, 49 TexReg 92226. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.3 What Condition to Report and What Isolates to Report or Submit https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221984 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221984 03/11/2026 (a) Humans.(1) The following notifiable conditions are public health emergencies and suspect cases must be reported immediately by telephone to the local health authority or the appropriate Department of State Health Services regional epidemiology office:(A) anthrax;(B) botulism;(C) diphtheria;(D) measles (rubeola);(E) melioidosis;(F) meningococcal infection, invasive;(G) novel coronavirus;(H) novel influenza;(I) poliomyelitis, acute paralytic;(J) plague;(K) rabies;(L) smallpox;(M) tularemia;(N) vancomycin-intermediate Staphylococcus aureus (VISA);(O) vancomycin-resistant Staphylococcus aureus (VRSA);(P) viral hemorrhagic fever;(Q) yellow fever; and(R) any outbreak, exotic disease, or unusual group expression of disease that may be of public health concern.(2) The following notifiable conditions must be reported by electronic data transmission or telephone within one working day of identification as a suspected case:(A) brucellosis;(B) Candida auris ;(C) carbapenem resistant Enterobacteriaceae (CRE);(D) hepatitis A, acute;(E) hepatitis B, perinatal infection;(F) influenza-associated pediatric mortality;(G) mumps;(H) pertussis;(I) poliovirus infection, non-paralytic;(J) Q fever;(K) rubella (including congenital);(L) syphilis infection in pregnant females;(M) tuberculosis (Mycobacterium tuberculosis complex); and(N) Vibrio infection (including cholera).(3) AIDS, chancroid, Chlamydia trachomatis infection, gonorrhea, HIV infection, and syphilis must be reported in accordance with Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)).(4) Tuberculosis antibiotic susceptibility results must be reported by laboratories no later than one week after they first become available.(5) For all other notifiable conditions not listed in paragraphs (1) - (4) of this subsection, reports of disease must be made no later than one week after a case or suspected case is identified. (A) The preferred option for reporting is electronic data transmission, but reports may be made by telephone or fax. Any electronic data transmission of the report must provide protection against unauthorized disclosure and utilize a format prescribed by the receiving agency.(B) A health information exchange (HIE) organization as defined by Texas Health and Safety Code §182.151, may transmit reports on behalf of providers required to report in §97.2(a) - (d) of this chapter (relating to Who Shall Report) in accordance with Texas Health and Safety Code Chapter 182, Subchapter D, Health Information Exchanges, and all other state and federal law as follows.(i) The receiving agency has published message standards.(ii) A method of secure transmission has been established between the HIE and the receiving agency, and transmissions have been tested with the receiving agency and established as meeting the data exchange standards and conveying information accurately.(iii) Reporting by the HIE has been requested and authorized by the appropriate health care provider, practitioner, physician, facility, clinical laboratory, or other person required to report health-related information.(iv) HIE reports may be made in addition to but do not replace reports listed in paragraphs (1) - (2) of this subsection.(6) All diseases requiring submission of cultures in §97.3(a)(4) of this chapter (relating to What Condition to Report and What Isolates to Report or Submit) must be submitted as they become available.(b) Animals. Reportable conditions affecting animals must be reported within one working day following the diagnosis. Source Note: The provisions of this §97.4 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective July 26, 1996, 21 TexReg 6622; amended to be effective March 5, 1998, 23 TexReg 1954; amended to be effective January 1, 1999, 23 TexReg 12663; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective August 5, 2001, 26 TexReg 5658; amended to be effective December 12, 2002, 27 TexReg 11547; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective April 20, 2014, 39 TexReg 2853; amended to be effective April 3,2016, 41 TexReg 2317; amended to be effective April 2, 2017, 42 TexReg 1452; amended to be effective January 5, 2021, 46 TexReg 162; amended to be effective January 1, 2025, 49 TexReg 9226. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.4 When and How to Report a Condition or Isolate https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=177140&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 177140 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=177140&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 177140 03/11/2026 (a) Humans.(1) A physician, dentist, veterinarian, chiropractor, reporting officer of a hospital, person in charge of a hospital laboratory (if the laboratory reports independently), person permitted by law to attend a pregnant woman during gestation or at the delivery of an infant, or school authority shall report to the local health authority where the office, clinic, hospital, or school is located. If there is no local health authority appointed for the jurisdiction where the office, clinic, hospital, or school is located, the report shall be made to the Department of State Health Services (department) regional director. Public health emergencies shall be reported to the department's central office if the local health authority or the department's regional director is not immediately accessible.(2) The administrative officer of a clinical laboratory, blood bank, mobile unit, or other facility shall report a condition or submit an isolate as follows:(A) If the laboratory examination was requested by a physician, notice shall be sent to the local health authority for the jurisdiction where the physician's office is located, to the department's regional director for the jurisdiction where the physician's office is located if no local health authority exists, or to the department's central office when the regional director or local health authority are unknown to the laboratory.(B) If the laboratory examination was not requested by a physician, notice shall be sent to the local health authority for the jurisdiction where the laboratory is located, to the department's regional director for the jurisdiction where the laboratory is located if no local health authority has been appointed, or to the department's central office when the regional director or local health authority are unknown to the laboratory.(C) All diseases requiring submission of cultures in §97.3(a)(4) of this title (relating to What Condition to Report and What Isolates to Report or Submit) shall be submitted to the Department of State Health Services, Laboratory Services Section, 1100 West 49th Street, Austin, Texas 78756-3199 or other public health laboratory as designated by the Department of State Health Services.(3) Sexually transmitted diseases including HIV and AIDS shall be reported in accordance with Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)).(b) Animals.(1) Reportable conditions in animals shall be reported to either the appropriate Department of State Health Services regional zoonosis control office or the Zoonosis Control Branch office in Austin.(2) Conditions in animals that are reportable to both the Department of State Health Services and the Texas Animal Health Commission can be reported to either one of the agencies, which will forward the information to the other agency. Source Note: The provisions of this §97.5 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective March 5, 1998, 23 TexReg 1954; amended to be effective March 26, 2000, 25 TexReg 2343; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective April 3, 2016, 41 TexReg 2317. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.5 Where To Report a Condition or Isolate; Where To Submit an Isolate https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221985&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221985 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221985&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221985 03/11/2026 (a) The purpose of this section is to provide procedures for local health authorities and regional directors to report a disease to the Department of State Health Services (department) central office.(b) Those notifiable conditions identified as public health emergencies in §97.4(a) of this chapter (relating to When and How to Report a Condition or Isolate) must be reported immediately to the department by telephone at (888) 963-7111.(c) AIDS, chancroid, Chlamydia trachomatis infection, gonorrhea, HIV infection, and syphilis must be reported in accordance with Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)).(d) For notifiable conditions not listed in subsections (b) and (c) of this section, the local health authority or the department's regional director collects reports of disease and transmits the information listed in §97.3(a)(3) of this chapter (relating to What Condition to Report and What Isolates to Report or Submit) at weekly intervals, as directed by the department.(e) The preferred option for reporting is electronic data transmission, but reports may be made by telephone or fax.(1) Any electronic data transmission of the report must provide protection against unauthorized disclosure, and utilize a format prescribed by the receiving agency.(2) For any notifiable condition reported by telephone, the person reporting must follow-up with an electronic data transmission through an approved electronic means within 24 hours of the original notification.(f) The health authority must notify health authorities in other jurisdictions of a case or outbreak of a communicable disease if the case resides in another jurisdiction or there is cause to believe transmission of a disease may have occurred in another jurisdiction. The department will assist the health authority in providing such notifications upon request. The health authority of the area where the case or outbreak is diagnosed must report the case or outbreak to the department on the same basis as other reports.(g) The health authority upon identification of a case or upon receipt of notification or report of disease, must take such action and measures as may be necessary to conform with the appropriate control measure standards. The health authority may, upon identification of a case or upon report of a communicable disease in a child attending a public or private child-care facility or a school, notify the owner or operator of the child-care facility or the school administrator. The commissioner is authorized to amend, revise, or revoke any control measure or action taken by the health authority, if necessary or desirable in the administration of a regional or statewide public health program or policy.(h) The health authority is empowered to close any public or private child-care facility, school, or other place of public or private assembly when in his or her opinion such closing is necessary to protect the public health; and such school or other place of public or private assembly must not reopen until permitted by the health authority who caused its closure.(i) Persons reporting notifiable conditions in animals must be referred to the central office or the appropriate regional office of the department's Zoonosis Control Branch. Source Note: The provisions of this §97.6 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective January 1, 1999, 23 TexReg 12663; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective August 5, 2001, 26 TexReg 5658; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective April 3, 2016, 41 TexReg 2317; amended to be effective January 1, 2025, 49 TexReg 9226. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.6 Reporting and Other Duties of Local Health Authorities and Regional Directors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207514&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207514 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207514&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207514 03/11/2026 (a) The school administrator shall exclude from attendance any child having or suspected of having a communicable condition. Exclusion shall continue until the readmission criteria for the conditions are met. The conditions and readmission criteria are as follows: (1) amebiasis--exclude until treatment is initiated; (2) campylobacteriosis--exclude until after diarrhea free for 24 hours without the use of diarrhea suppressing medications and fever free for 24 hours without the use of fever suppressing medications; (3) chickenpox--exclude until the lesions become dry or if lesions are not vesicular, until 24 hours have passed with no new lesions occurring; (4) common cold--exclude until fever free for 24 hours without the use of fever suppressing medications; (5) conjunctivitis, bacterial and/or viral--exclude until permission and/or permit is issued by a physician or local health authority or until symptom free; (6) coronavirus disease 2019--exclude and readmit based upon guidance from the Department of State Health Services on its website at https://dshs.texas.gov/covid19readmission;(7) fever--exclude until fever free for 24 hours without use of fever suppressing medications; (8) fifth disease (erythema infectiosum)--exclude until fever free for 24 hours without the use of fever suppressing medications; (9) gastroenteritis--exclude until diarrhea free for 24 hours without the use of diarrhea suppressing medications; (10) giardiasis--exclude until diarrhea free for 24 hours without the use of diarrhea suppressing medications; (11) hepatitis A--exclude until one week after onset of illness; (12) infections (wounds, skin, and soft tissue)--exclude until drainage from wounds or skin and soft tissue infections is contained and maintained in a clean dry bandage; restrict from situations that could result in the infected area becoming exposed, wet, soiled, or otherwise compromised; (13) infectious mononucleosis--exclude until physician decides or fever free for 24 hours without the use of fever suppressing medications; (14) influenza--exclude until fever free for 24 hours without the use of fever suppressing medications; (15) measles (rubeola)--exclude until four days after rash onset or in the case of an outbreak, exclude unimmunized child for at least 21 days after the last date the unimmunized child was exposed; (16) meningitis, bacterial--exclude until 24 hours after start of effective treatment and approval by health care provider; (17) meningitis, viral--exclude until fever free for 24 hours without the use of fever suppressing medications; (18) meningococcal infections (invasive disease)--exclude until 24 hours after start of effective treatment and approval by health care provider; (19) mumps--exclude until five days after the onset of swelling; (20) pertussis (whooping cough)--exclude until completion of five days of appropriate antibiotic therapy, or until 21 days have passed since cough onset, whichever is earlier; (21) ringworm--none, if infected area can be completely covered by clothing or a bandage, otherwise exclude until treatment has begun; (22) rubella (German measles)--exclude until seven days after rash onset or in the case of an outbreak, unimmunized children should be excluded until at least three weeks after the onset of the last rash; (23) salmonellosis--exclude until diarrhea free for 24 hours without the use of diarrhea suppressing medications and fever free for 24 hours without the use of fever suppressing medications; (24) scabies--exclude until treatment has begun; (25) shigellosis--exclude until diarrhea free for 24 hours without the use of diarrhea suppressing medications and fever free for 24 hours without the use of fever suppressing medications; (26) streptococcal sore throat and scarlet fever--exclude until 24 hours from time antibiotic treatment was begun and fever free for 24 hours without the use of fever suppressing medications; (27) tuberculosis disease (suspected or confirmed), pulmonary or laryngeal--exclude until antibiotic treatment has begun and a physician's certificate or health permit obtained; and (28) typhoid fever-exclude until diarrhea free for 24 hours without the use of diarrhea suppressing medications and fever free for 24 hours without the use of fever suppressing medications; and 3 consecutive stool specimens have tested negative for Salmonella Typhi. (b) The school administrator shall exclude from attendance any child having or suspected of having a communicable disease designated by the Commissioner of the Department of State Health Services (commissioner) as cause for exclusion until one of the criteria listed in subsection (c) of this section is fulfilled. (c) Any child excluded for reason of communicable disease may be readmitted, as determined by the health authority, by: (1) submitting a certificate of the attending physician, advanced practice nurse, or physician assistant attesting that the child does not currently have signs or symptoms of a communicable disease or to the disease's non-communicability in a school setting; (2) submitting a permit for readmission issued by a local health authority; or (3) meeting readmission criteria as established by the commissioner. Source Note: The provisions of this §97.7 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective November 3, 2009, 34 TexReg 7650; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective April 20, 2014, 39 TexReg 2853; amended to be effective April 3, 2016, 41 TexReg 2317; amended to be effective January 26, 2022, 47 TexReg 85. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.7 Diseases Requiring Exclusion from Schools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=130215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 130215 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=130215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 130215 03/11/2026 Except for diseases for which equivalent measures of investigation and control are specifically provided in other sections in this chapter, the Commissioner of Health (commissioner), a health authority, or a duly authorized representative of the commissioner or a health authority may proceed as follows.(1) Investigation shall be made, as the circumstances may require, for verifying the diagnosis, ascertaining the source of the causative agent, disclosing unreported cases, and finding contacts. On request, a person shall provide the Department of State Health Services (department) or health authority with records, data, and other information according to the written instruction of the department or health authority. The health authority and the department shall keep this information confidential.(2) Laboratory specimens of the body tissues, fluids, or discharges and of materials directly or indirectly associated with the case, as may be necessary or desirable in confirmation of the diagnosis or for ascertaining the source of the infection, shall be collected and submitted to a laboratory for examination.(3) Control techniques, including disinfection, environmental sanitation, immunization, chemoprophylaxis, isolation, preventive therapy, quarantine, education, prevention, and other accepted measures shall be instituted as necessary to reduce morbidity and mortality. In establishing quarantine or isolation, the health authority shall designate and define the limits of the areas in which the persons are quarantined or isolated.(4) Information concerning the disease and its prevention shall be given to the patient or a responsible member of the patient's household to prevent further spread of the disease.(5) Control measures implemented by the health authority shall be consistent with and at least as stringent as those control measure standards imposed by the department. Individual control measures implemented by the health authority are subject to review and modification or change by the commissioner. Source Note: The provisions of this §97.8 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective June 5, 2007, 32 TexReg 2997. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.8 General Control Measures for Notifiable Conditions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=130216&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 130216 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=130216&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 130216 03/11/2026 (a) A health authority may declare a house, building, apartment, room, or place within the health authority's jurisdiction to be a place of quarantine whenever a case of communicable disease occurs therein, and, in the health authority's opinion, it is necessary to do so in order to protect the public health. No person shall leave or enter the place during the period of quarantine except with specific permission of the health authority.(b) The department or health authority may investigate and apply control measures to private and common carriers and private conveyances as authorized in Disease Prevention and Control Act (Act), Health and Safety Code, §81.086, when they have reasonable cause to believe that:(1) it has departed from or traveled through an area infected or contaminated with a communicable disease;(2) it is or may be infected or contaminated with a communicable disease;(3) an individual on board has been exposed to or is the carrier of a communicable disease; or(4) it has cargo or an object on board that is or may be infected or contaminated with a communicable disease. Source Note: The provisions of this §97.9 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective June 5, 2007, 32 TexReg 2997. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.9 Quarantine of Specific Premises and Application of Control Measures to Private and Common Carriers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=130217&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 130217 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=130217&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 130217 03/11/2026 (a) All individual morbidity case reports received by the health authority or the Department of State Health Services (department) are confidential records and not public records.(b) To implement disease control measures authorized in these sections, it may be necessary for the health authority or the department to investigate public or private health records including patient medical records pertinent to the notifiable condition. On request, a person shall provide the department with records, data, and other information according to the written instruction of the department. The health authority and the department shall keep this information confidential.(c) The department may use information obtained from reports or health records for statistical and epidemiological studies which may be public information as long as the information does not permit the identification of an individual. Source Note: The provisions of this §97.10 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective June 5, 2007, 32 TexReg 2997. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.10 Confidential Nature of Case Reporting and Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178629 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178629 03/11/2026 (a) Purpose. The Communicable Disease Prevention and Control Act (Act), §81.048, requires a licensed hospital to notify a health authority and designated infection control officer in certain instances when an emergency response employee or volunteer may have been exposed to a reportable disease during the course of duty from a person delivered to the hospital under conditions that were favorable for transmission. A hospital that gives notice of a possible exposure under this section or a local health authority or designated infection control officer that receives notice of a possible exposure under this section may give notice of the possible exposure to a person other than an emergency response employee or volunteer if the person demonstrates that the person was exposed to the reportable disease while providing emergency care.(b) Definitions.(1) Designated infection control officer--The person serving as an entity's designated infection control officer under Health and Safety Code, §81.012, who has a health care professional license or specific training in infection control, acts as liaison between the entity and the destination hospital, and monitors all follow-up treatment provided to the affected emergency response employee or volunteer.(2) Emergency response employee or volunteer--An individual acting in the course and scope of employment or service as a volunteer as emergency medical service personnel, a peace officer, a detention officer, a county jailer, or a fire fighter, as defined under Health and Safety Code, §81.003.(c) Disease and criteria which constitute exposure. The following diseases and conditions constitute a possible exposure to the disease for the purposes of the Act, §81.048:(1) chickenpox; diphtheria; measles (rubeola); novel coronavirus causing severe acute respiratory disease; novel influenza; pertussis; pneumonic plague; smallpox; pulmonary or laryngeal tuberculosis; and any viral hemorrhagic fever, if the worker and the patient are in the same room, vehicle, ambulance, or other enclosed space;(2) Haemophilus influenzae, invasive; meningitis; meningococcal infections, invasive; mumps; poliomyelitis; Q fever (pneumonia); rabies; and rubella, if there has been an examination of the throat, oral or tracheal intubation or suctioning, or mouth-to-mouth resuscitation;(3) acquired immune deficiency syndrome (AIDS); anthrax; brucellosis; dengue; ehrlichiosis; hepatitis, viral; human immunodeficiency virus (HIV) infection; malaria; plague; syphilis; tularemia; typhus; any viral hemorrhagic fever; and yellow fever, if there has been a needlestick or other penetrating puncture of the skin with a used needle or other contaminated item; a splatter or aerosol into the eye, nose, or mouth; or any significant contamination of an open wound or non-intact skin with blood or body fluids; (4) amebiasis; campylobacteriosis; cholera; cryptosporidiosis; Escherichia coli O157:H7 or other Shiga toxin-producing E. coli infection; hepatitis A; poliomyelitis; salmonellosis, including typhoid fever; shigellosis; and Vibrio infections, if fecal material is ingested; (5) Methicillin-resistant Staphylococcus aureus (MRSA) wounds, skin infections or soft tissue infections, if there has been contact of non-intact skin to these infections or drainage from these infections; and (6) any other reportable disease or a disease caused by a select agent or toxin identified or listed under 42 C.F.R. §73.3, if there has been an exposure via the usual mode of transmission of that disease as determined by the department or the local health authority. (d) Notification processes. The entity that employs or uses the services of an emergency response employee or volunteer is responsible for notifying the local health authorities or local health care facilities that the entity has a designated infection control officer or alternate designated infection control officer. The following notification processes shall apply when possible exposures to notifiable conditions occur.(1) If the hospital has knowledge that, on admission to the hospital, the person transported has any of the notifiable conditions listed in subsection (c)(1) of this section, then notice of a possible exposure of an emergency response employee or volunteer to the disease shall be given to the health authority for the jurisdiction where the hospital is located and the designated infection control officer of the entity that employs or uses the services of the emergency response employee or volunteer.(2) For possible exposures to any of the diseases listed in subsection (c)(2) - (6) of this section, the emergency response employee or volunteer or the designated infection control officer of the employing entity shall provide a medical professional at the hospital with notice, preferably written, of the circumstances of the possible exposure. Once the hospital has knowledge of a possible exposure, then notice shall be given as follows.(A) The hospital shall report the following information to the health authority for the jurisdiction where the hospital is located and the designated infection control officer of the entity that employs or uses the services of the emergency response employee or volunteer:(i) the name of the emergency response employee or volunteer possibly exposed;(ii) the date of the exposure; (iii) the circumstances of the exposure; (iv) whether laboratory testing was performed for diseases potentially transmitted by such exposures; and (v) positive or negative test results for these diseases.(B) The health authority or designated infection control officer of the entity that employs or uses the services of the affected emergency response employee or volunteer shall determine whether or not significant risk of disease transmission exists and report his/her assessment of the possible exposure event to the emergency response employee or volunteer.(C) A person notified of a possible exposure under this section shall maintain the confidentiality of the information provided to him or her. (e) Obligation to test. This section does not create a duty for a hospital to perform a test that is not necessary for the medical management of the person delivered to the hospital. Source Note: The provisions of this §97.11 adopted to be effective July 26, 1996, 21 TexReg 6622; amended to be effective December 20, 2000, 25 TexReg 12426; amended to be effective June 5, 2007, 32 TexReg 2997; amended to be effective February 28, 2011, 36 TexReg 1281; amended to be effective December 20, 2012, 37 TexReg 9777; amended to be effective June 28, 2016, 41 TexReg 4645. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.11 Notification of Emergency Response Employees, Volunteers, or Other Persons Providing Emergency Care of Possible Exposure to a Disease https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178630 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178630 03/11/2026 (a) Purpose. The Communicable Disease Prevention and Control Act, Health and Safety Code, §81.050, provides a mechanism by which an emergency response employee or volunteer or correctional officer who receives a bona fide exposure that places him or her at risk of a notifiable condition in the course of employment or volunteer service may request the Department of State Health Services (department) or the department's designee to order testing of the person who may have exposed the worker.(b) Definitions. For the purposes of this section, the following words and/or terms will have the following meanings, unless the context clearly indicates otherwise.(1) Correctional officer--A worker whose normal duties and responsibilities include management or supervision of incarcerated or detained persons or an employee, contractor, or volunteer, other than a correctional officer, who performs a service in a correctional facility as defined by §1.07, Penal Code, or a secure correctional facility or secure detention facility as defined by §51.02, Family Code.(2) Emergency response employee or volunteer--An individual acting in the course and scope of employment or service as a volunteer as emergency medical service personnel, a peace officer, a detention officer, a county jailer, or a fire fighter, as defined under Health and Safety Code, §81.003.(3) Requestor--An emergency response employee or volunteer who presents a sworn affidavit to a health authority to request testing of a person who may have exposed him/her to a notifiable condition in the course of his/her duties.(4) Source--The person who may have exposed an emergency response employee or volunteer to a notifiable condition during the emergency response employee or volunteer's course of duties.(c) Diseases and criteria that constitute exposure. The notifiable conditions and the criteria that constitute exposure to such diseases are as outlined in §97.11(c)(1) - (6) of this title (relating to Notification of Emergency Response Employees, Volunteers, or Other Persons Providing Emergency Care of Possible Exposure to a Disease).(d) The department's designee. For the purposes of implementing the Health and Safety Code, §81.050(d), (e), and (h), the following physicians have been delegated by the department to be the department's designee who will determine if a risk of exposure to a notifiable condition has occurred:(1) the health authority for the jurisdiction in which the emergency response employee or volunteer is employed;(A) if the health authority does not choose to make a determination of the risk of exposure, a licensed physician employed by the local health department who has responsibility for the control of notifiable conditions in the jurisdiction served by the health department; or(B) if the health authority does not choose to make a determination of the risk of exposure and there is not a separate physician employed by the county or municipal health department with responsibility for the control of notifiable condition, or for counties which do not have an appointed health authority, the regional director of the department of which the county or municipality is a part; and(2) for the Texas Department of Criminal Justice (TDCJ), the TDCJ Deputy Director of Health Services (Institutional Division) shall serve as the designated health official in determining risk of exposure to correctional officers employed by the TDCJ.(e) Criteria under which a request for mandatory testing can be made. A request under this section may be made only if the emergency response employee or volunteer:(1) has experienced the exposure in the course of his or her employment or volunteer service;(2) believes that the exposure places him or her at risk of a notifiable condition; and(3) presents to the department's designee a sworn affidavit that delineates the reasons for the request.(f) Initial actions required of the department's designee. Upon receiving a request for mandatory testing in accordance with subsection (e) of this section, the department's designee shall:(1) review the emergency response employee or volunteer's request and inform him or her whether the request meets the criteria establishing risk of infection with a notifiable condition;(2) determine which diagnostic tests may be indicated to verify exposure to certain notifiable conditions;(3) give the source who is subject to the order prompt and confidential written notice of the order which must include the following items:(A) the grounds and provision of the order, and the factual basis for its issuance;(B) a referral to appropriate health care facilities where the source can be tested for certain notifiable conditions;(C) a notice to the source who is subject to the order of the right to refuse to be tested; and(D) a statement of the authority of the department's designee to ask for a court order requiring the test; and(4) request the prosecuting attorney who represents the state in district court to petition said court for a hearing on the order, in the event that the source who is subject to the order refuses to comply.(g) Source's right to an attorney. If the source who is subject to the order refuses to comply, and a hearing in district court ensues, then:(1) the source has a right for an attorney to be present at the hearing;(2) the court shall appoint an attorney for a source who cannot afford legal representation; and(3) the source may not waive the right to an attorney unless he/she has consulted with an attorney.(h) Court proceedings. The district court proceedings include:(1) a determination as to whether exposure occurred and whether the exposure presents a possible risk of infection as outlined in §97.11(c)(1) - (6) of this title;(2) consideration of evidence if introduced by either the attorney for the state and/or the attorney for the source;(3) at the conclusion of the hearing, taking appropriate action being either:(A) an order requiring counseling and testing of the person for certain notifiable conditions; or(B) a refusal to issue an order if the court has determined that the counseling and testing of the source is unnecessary; and(4) the option to assess court costs against the requestor if the court finds that there was not reasonable cause for the request.(i) Additional actions required of the department's designee. The department's designee shall be responsible for the following actions with respect to testing:(1) develop protocols for coding test specimens to ensure that any identifying information concerning the source will be destroyed as soon as the testing is complete;(2) inform the requestor of the test results;(3) inform both the requestor and the source of the need for medical follow-up and counseling services in the event that the source is found to have a notifiable condition; and(4) advise appropriate postexposure medical follow-up as recommended by the United States Public Health Service.(j) HIV counseling and testing. HIV counseling and testing conducted under this section must conform to the model protocol on HIV counseling and testing required under the Health and Safety Code, §85.081.(k) Workers' compensation issues. For the purposes of qualifying for workers' compensation or any other similar benefits for compensation, the following shall apply:(1) An emergency response employee or volunteer who claims a possible work-related exposure to a notifiable condition must provide the employer with a sworn affidavit of the date and circumstances of the exposure and document that, not later than the tenth day after the date of the exposure, the emergency response employee or volunteer had a test result that indicated an absence of the notifiable condition.(2) An emergency response employee or volunteer exposed to a notifiable condition during the course of employment shall be entitled to the benefits described in the Government Code, Chapter 607.(3) A state emergency response employee or volunteer claiming an exposure to HIV infection in the normal course of his/her duties must follow the postexposure procedure mandated by the Health and Safety Code, §85.116, and §97.140 of this title (relating to Counseling and Testing for State Employees Exposed to Human Immunodeficiency Virus (HIV) Infection on the Job).(4) For posting and notice requirements, refer to the rules of the Texas Department of Insurance, Division of Workers' Compensation in Title 28, Texas Administrative Code, Chapter 110 (Required Notices of Coverage).(5) For further clarification of workers' compensation issues, emergency response employees or volunteers and their employers should contact the Texas Department of Insurance, Division of Workers' Compensation at 1-800-252-7031.(l) Testing of the exposed person. An emergency response employee or volunteer who may have been exposed to a notifiable condition, may not be required to be tested. Source Note: The provisions of this §97.12 adopted to be effective June 5, 2007, 32 TexReg 2997; amended to be effective June 28, 2016, 41 TexReg 4645. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.12 Mandatory Testing of Persons Suspected of Exposing Certain Other Persons to Notifiable Conditions and Workers' Compensation Issues Relevant to Postexposure Management of Emergency Response Employees or Volunteers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183270&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183270 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183270&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183270 03/11/2026 (a) If a physician has knowledge that a person had, at the time of death, a communicable disease listed in subsection (c) of this section, then the hospital administrator, clinic administrator, nurse, or the physician shall affix or cause to be affixed a tag on the body, preferably the great toe.(b) The tag shall be on card stock paper and shall be no smaller than five centimeters by ten centimeters. The tag shall include the words "COMMUNICABLE DISEASE--BLOOD/BODY SUBSTANCE PRECAUTIONS REQUIRED" in letters no smaller than six millimeters in height. The name of the deceased person shall be written on the tag. The tag shall remain affixed to the body until the preparation of the body for burial has been completed. (c) Diseases that shall require tagging are acquired immune deficiency syndrome (AIDS); anthrax; brucellosis; cholera; Hantavirus pulmonary syndrome; hepatitis, viral; human immunodeficiency virus (HIV) infection; novel coronavirus; novel influenza; plague; prion diseases, such as Creutzfeldt-Jakob disease (CJD); Q fever; rabies; Rocky Mountain spotted fever; smallpox; syphilis; tuberculosis (Mycobacterium tuberculosis complex); tularemia; and viral hemorrhagic fever. (d) All persons should routinely practice standard infection control procedures when performing postmortem care on a deceased person who is known or suspected of having a communicable disease listed in subsection (c) of this section. Source Note: The provisions of this §97.13 adopted to be effective June 5, 2007, 32 TexReg 2997; amended to be effective April 3, 2016, 41 TexReg 2317; amended to be effective April 2, 2017, 42 TexReg 1452. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES A CONTROL OF COMMUNICABLE DISEASES §97.13 Death of a Person with Certain Communicable Diseases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179068&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179068 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179068&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179068 03/11/2026 (a) The vaccine requirements apply to all children and students entering, attending, enrolling in, and/or transferring to child-care facilities or public or private primary or secondary schools or institutions of higher education.(b) The vaccines required in this section are also required for all children in the State of Texas, including children admitted, detained, or committed in Texas Department of Criminal Justice, Department of State Health Services, and the Texas Juvenile Justice Department (TJJD) facilities.(c) The vaccine requirements are adopted as a statewide control measure for communicable disease as defined in Health and Safety Code, §81.081 and §81.082. Source Note: The provisions of this §97.61 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.61 Children and Students Included in Vaccine Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226325&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226325 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226325&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226325 03/11/2026 Exclusions from compliance are allowable on an individual basis for medical contraindications, reasons of conscience, including a religious belief, and active duty with the armed forces of the United States. Children and students seeking enrollment in schools, child-care facilities, or institutions of higher education, including students enrolled in health-related and veterinary courses, must submit evidence for exclusion from compliance as specified in the Health and Safety Code §161.004(d), Health and Safety Code §161.0041, Education Code Chapter 38, Education Code §51.933(d), Human Resources Code Chapter 42, and §97.64 of this subchapter (relating to Required Vaccinations and Exclusions for Students Enrolled in Health-related and Veterinary Courses in Institutions of Higher Education).(1) To claim an exclusion for medical reasons, the child or student must present an exemption statement to the school or child-care facility, dated and signed by a physician (M.D. or D.O.), properly licensed and in good standing in any state in the United States who has examined the child or student. The statement must state that, in the physician's opinion, the vaccine required is medically contraindicated or poses a significant risk to the health and well-being of the child or student or any member of the child's or student's household. Unless it is written in the statement that a lifelong condition exists, the exemption statement is valid for only one year from the date signed by the physician.(2) To claim an exclusion for reasons of conscience, including a religious belief, the child's parent, legal guardian, or a student 18 years of age or older must present to the school or child-care facility a completed, signed, and notarized affidavit on a form provided by the department stating that the child's parent, legal guardian, or the student declines vaccinations for reasons of conscience, including because of the person's religious beliefs. The affidavit will be valid for a two-year period from the date of notarization. A child or student, who has not received the required immunizations for reasons of conscience, including religious beliefs, may be excluded from school in times of emergency or epidemic declared by the commissioner of the department.(A) A person claiming exclusion for reasons of conscience, including a religious belief, from a required immunization may only obtain the affidavit form from the department by:(i) downloading the affidavit form from the department's internet website, or(ii) submitting a request (via online, fax, mail, or hand-delivery) to the department.(B) A request for a mailed affidavit submitted online, fax, mail, or hand-delivery must include the following information:(i) complete mailing address, including name, address, and telephone number; and(ii) number of requested affidavit forms.(C) Requests for mailed affidavit forms must be submitted to the department through one of the following methods:(i) written request through the United States Postal Service (or other commercial carrier) to the department at: DSHS Immunization Branch, Mail Code 1946, P.O. Box 149347, Austin, Texas 78714-9347;(ii) by fax to (512) 776-7544;(iii) by hand-delivery to the department's physical address at 1100 West 49th Street, Austin, Texas 78756; or(iv) via the department's Immunization program website (at www.ImmunizeTexas.com).(D) The department will mail the requested affidavit forms to the specified mailing address.(E) The department may not maintain a record of the personally identifiable information of individuals who request an affidavit and must return the original documents (when applicable) with the requested affidavit forms.(3) To claim an exclusion for armed forces, persons who can prove active duty service with the armed forces of the United States are exempted from the requirements in these sections. Source Note: The provisions of this §97.62 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective December 16, 2007, 32 TexReg 9125; amended to be effective July 28, 2016, 41 TexReg 5422; amended to be effective October 8, 2025, 50 TexReg 6493. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.62 Exclusions from Compliance https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179070 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179070 03/11/2026 Every child in the state shall be vaccinated against vaccine-preventable diseases caused by infectious agents, in accordance with the following immunization schedule. While the department recommends that providers immunize children according to the recommendations found on the department's website at www.ImmunizeTexas.com, this section sets out minimum immunization requirements for school entry for the child. The child must have the indicated vaccinations by the grade level indicated. The vaccination schedule also indicates the grade before which the child should not obtain the specific vaccination. A copy of the current recommended schedule is available at www.ImmunizeTexas.com, or by mail by writing the Department of State Health Services, Mail Code 1946, P.O. Box 149347, Austin, Texas 78714-9347. (1) For those vaccines where it is stated in this section that a certain dose must be received on or after a certain birthday, a vaccine administered up to four days prior to the birthday is considered compliant.(2) For diseases listed below, a child or student shall show acceptable evidence of vaccination prior to entry, attendance, or transfer to a child-care facility or public or private elementary or secondary school. (A) Children enrolled in child-care facilities, pre-kindergarten, or early childhood programs shall be immunized against: diphtheria, pertussis, tetanus, poliomyelitis, Haemophilus influenzae type b (Hib), measles, mumps, rubella, hepatitis B, hepatitis A, invasive pneumococcal, and varicella diseases. In recognition of the fact that immunization needs vary depending on the age of the child, the minimum number of doses required for each vaccine is indicated in the schedule below: Attached Graphic(B) Students in kindergarten through twelfth grade shall have the following vaccines, according to the schedule listed. (i) Poliomyelitis. (I) Kindergarten through twelfth grade. Students are required to have four doses of polio vaccine--one of which must have been received on or after the fourth birthday. Or, if the third dose was administered on or after the fourth birthday, only three doses are required. Four doses of oral polio vaccine (OPV) or inactivated poliovirus vaccine (IPV) in any combination by age four to six years old is considered a complete series, regardless of age at the time of the third dose.(II) Polio vaccine is not required for persons eighteen years of age or older.(ii) Diphtheria/Tetanus/Pertussis. (I) Kindergarten through sixth grade. Students are required to have five doses of a diphtheria/tetanus/pertussis-containing vaccine -- one of which must have been received on or after the fourth birthday. Or, if the fourth dose was administered on or after the fourth birthday, only four doses are required. (II) Students seven years of age or older. Students seven years of age or older are required to have at least three doses of a tetanus/diphtheria-containing vaccine, provided at least one dose was administered on or after the fourth birthday. Any combination of three doses of a tetanus/diphtheria-containing vaccine will meet this requirement. (III) Tdap. (-a-) Seventh grade. Students are required to have one booster dose of a tetanus/diphtheria/pertussis-containing vaccine for entry into the 7th grade, if at least five years have passed since the last dose of a tetanus-containing vaccine. If five years have not elapsed since the last dose of a tetanus-containing vaccine at entry into the 7th grade, then this dose will become due as soon as the five-year interval has passed. Td vaccine is an acceptable substitute, if Tdap vaccine is medically contraindicated.(-b-) Grades 8 - 12. Students who have not already received Tdap vaccine are required to receive one booster dose of Tdap when ten years have passed since the last dose of a tetanus-diphtheria-containing vaccine. (IV) Children who were enrolled in school, grades K - 12, prior to August 1, 2004, and who received a booster dose of DTaP or polio vaccine in the calendar month of (or prior to) their fourth birthday, shall be considered in compliance with clause (i)(I) (polio) and clause (ii)(I) (DTaP) of this subparagraph. (iii) MMR. Beginning SY 2016 - 2017, students enrolling in kindergarten through 12th grade are required to have two doses of MMR vaccine with the first dose received on or after the first birthday. Students vaccinated prior to 2009 with two doses of measles and one dose each of rubella and mumps satisfy this requirement. (iv) Hepatitis B. (I) Students enrolling in kindergarten through 12th grade are required to have three doses of hepatitis B vaccine. (II) In some circumstances, the United States Food and Drug Administration may officially approve in writing the use of an alternative dosage schedule for this vaccine. Such an alternative regimen may be used to meet the requirements under this section only when alternative regimens are fully documented. Such documentation must include vaccine manufacturer and dosage received for each dose of that vaccine. (v) Varicella. Beginning SY 2016 - 2017, students enrolling in kindergarten through 12th grade are required to have two doses of varicella vaccine received on or after the first birthday. (vi) Hepatitis A. For SY 2016 - 2017, students are required to have two doses of hepatitis A vaccine with the first dose received on or after the first birthday for the following grades and school years: (I) SY 2016 - 2017: K - 7; (II) SY 2017 - 2018: K - 8; (III) SY 2018 - 2019: K - 9; (IV) SY 2019 - 2020: K - 10; (V) SY 2020 - 2021: K - 11; and (VI) SY 2021 - 2022: K - 12. (VII) Effective SY 2022-2023, students enrolling in kindergarten through 12th grade are required to have two doses of hepatitis A vaccine with the first dose received on or after the first birthday.(vii) Meningococcal. Effective SY 2016 - 2017, students enrolling in 7th - 12th grades are required to have one dose of quadrivalent meningococcal conjugate vaccine (MCV4) on or after the student's 11th birthday. Source Note: The provisions of this §97.63 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective December 10, 2006, 31 TexReg 9835; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 20, 2011, 36 TexReg 4563; amended to be effective June 7, 2015, 40 TexReg 3170; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.63 Immunization Requirements in Child-care Facilities, Pre-Kindergarten, Early Childhood Programs, and Texas Elementary and Secondary Schools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226326&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226326 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226326&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226326 03/11/2026 (a) Students enrolled in (non-veterinary) health-related courses. This section applies to all students enrolled in health-related higher education courses which will involve direct patient contact with potential exposure to blood or bodily fluids in educational, medical, or dental care facilities.(b) Vaccines Required. Students must have all of the following vaccinations before they may engage in the course activities described in subsection (a) of this section:(1) Tetanus-Diphtheria Vaccine. Students must show receipt of one dose of tetanus-diphtheria-pertussis vaccine (Tdap). In addition, one dose of a tetanus-containing vaccine must have been received within the last ten years. Td vaccine is an acceptable substitute, if Tdap vaccine is medically contraindicated.(2) Measles, Mumps, and Rubella (MMR) Vaccines.(A) Students born on or after January 1, 1957, must show, prior to patient contact, acceptable evidence of vaccination of two doses of a measles-containing vaccine administered since January 1, 1968 (preferably MMR vaccine).(B) Students born on or after January 1, 1957, must show, prior to patient contact, acceptable evidence of vaccination of two doses of a mumps vaccine.(C) Students must show, prior to patient contact, acceptable evidence of one dose of rubella vaccine.(3) Hepatitis B Vaccine. Students are required to receive a complete series of hepatitis B vaccine prior to the start of direct patient care.(4) Varicella Vaccine. Students are required to have received two doses of varicella (chickenpox) vaccine.(c) Limited Exceptions:(1) Notwithstanding the other requirements in this section, a student may be provisionally enrolled in these courses if the student has received at least one dose of each specified vaccine prior to enrollment and goes on to complete each vaccination series as rapid as medically feasible in accordance with the Centers for Disease Control and Prevention's Recommended Adult Immunization Schedule as approved by the Advisory Committee on Immunization Practices (ACIP). However, the provisionally enrolled student may not participate in coursework activities involving the contact described in subsections (a) and/or (d) of this section until the full vaccination series has been administered.(2) Students, who claim to have had the complete series of a required vaccination, but have not properly documented them, cannot participate in coursework activities involving the contact described in subsections (a) and/or (d) of this section until such time as proper documentation has been submitted and accepted.(3) The immunization requirements in subsections (b) and (d) of this section are not applicable to individuals who can properly demonstrate proof of laboratory confirmation of immunity or laboratory confirmation of disease. Vaccines for which this may be potentially demonstrated, and acceptable methods for demonstration, are found in §97.65 of this subchapter (relating to Exceptions to Immunization Requirements (Verification of Immunity/History of Illness)). Such a student cannot participate in coursework activities involving the contact described in subsection (a) of this section until such time as proper documentation has been submitted and accepted.(d) Students enrolled in schools of veterinary medicine.(1) Rabies Vaccine. Students enrolled in schools of veterinary medicine whose coursework involves direct contact with animals or animal remains shall receive a complete primary series of rabies vaccine prior to such contact. Serum antibody levels must be checked every two years, with a booster dose of rabies vaccine administered if the rabies virus-neutralizing antibody response is inadequate according to current Centers for Disease Control and Prevention guidelines.(2) Hepatitis B Vaccine. Students enrolled in schools of veterinary medicine whose coursework involves potential exposure to human or animal blood or bodily fluids shall receive a complete series of hepatitis B vaccine prior to such contact.(3) Tetanus-Diphtheria Vaccine. One dose of a tetanus-diphtheria toxoid (Td) is required within the last ten years. The booster dose may be in the form of a tetanus-diphtheria-pertussis containing vaccine (Tdap).(e) Requirements regarding acceptable evidence of vaccination are found at §97.68 of this subchapter (relating to Acceptable Evidence of Vaccination(s)).(f) Exclusions from compliance are allowable for students in institutions of higher education, including students enrolled in health-related and veterinary courses, on an individual basis for medical contraindications, reasons of conscience, including a religious belief, and active duty with the armed forces of the United States. Students in these categories must submit evidence for exclusion from compliance as specified in the Health and Safety Code §161.0041, Education Code §51.933(d), and §97.62 of this subchapter (relating to Exclusions from Compliance). Source Note: The provisions of this §97.64 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective May 25, 2010, 35 TexReg 4178; amended to be effective July 28, 2016, 41 TexReg 5422; amended to be effective October 8, 2025, 50 TexReg 6493. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.64 Required Vaccinations and Exclusions for Students Enrolled in Health-related and Veterinary Courses in Institutions of Higher Education https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179072&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179072 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179072&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179072 03/11/2026 (a) Serologic confirmations of immunity to measles, rubella, mumps, hepatitis A, hepatitis B, or varicella, are acceptable. Evidence of measles, rubella, mumps, hepatitis A, or hepatitis B, or varicella illnesses must consist of a valid laboratory report that indicates confirmation of either immunity or infection.(b) A written statement from a parent (or legal guardian or managing conservator), school nurse, or physician attesting to a child's/student's positive history of varicella disease (chickenpox), or of varicella immunity, is acceptable in lieu of a vaccine record for that disease (see form at http://www.dshs.state.tx.us/immunize/docs/c-9.pdf). Source Note: The provisions of this §97.65 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.65 Exceptions to Immunization Requirements (Verification of Immunity/History of Illness) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179073&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179073 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179073&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179073 03/11/2026 (a) The law requires that children and students be fully vaccinated against the specified diseases. A child or student may be enrolled provisionally if the child or student has an immunization record that indicates the child or student has received at least one dose of each specified age-appropriate vaccine required by this rule. To remain enrolled, the child or student must complete the required subsequent doses in each vaccine series on schedule and as rapidly as is medically feasible and provide acceptable evidence of vaccination to the child-care facility or school. A child-care provider, school nurse, or school administrator shall review the immunization status of a provisionally enrolled child or student every 30 days to ensure continued compliance in completing the required doses of vaccination. If, at the end of the 30-day period, a child or student has not received a subsequent dose of vaccine, the child or student is not in compliance and the facility shall exclude the child or student from attendance until the required dose is administered.(b) A child or student who is homeless, as defined by §103 of the McKinney Act, 42 USC §11302, shall be admitted temporarily for 30 days if acceptable evidence of vaccination is not available. The facility shall promptly refer the student to an appropriate health provider to obtain the required vaccinations.(c) A child or student who is a "child in foster care" as defined by 45 C.F.R. §1355.20(a) shall be admitted temporarily for 30 days if acceptable evidence of vaccination is not available. The facility shall promptly refer the child or student to an appropriate health provider to obtain the required vaccinations. Source Note: The provisions of this §97.66 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.66 Provisional Enrollment for (Non-Higher Education; Non-Veterinary) Students and Children https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179074&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179074 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179074&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179074 03/11/2026 All schools and child-care facilities are required to maintain immunization records sufficient for a valid audit or other assessment to be completed by federal, state and/or local public health officials. Immunization records may be maintained in paper and/or electronic form. Source Note: The provisions of this §97.67 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.67 School Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179075&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179075 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179075&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179075 03/11/2026 (a) Vaccines administered after September 1, 1991, shall include the month, day, and year each vaccine was administered.(b) Documentation of vaccines administered that include the signature or stamp of the physician or physician's designee, or public health personnel, is acceptable. Immunization records generated from electronic health record systems must include clinic contact information and the provider's signature/stamp.(c) An official immunization record generated from a state or local health authority is acceptable.(d) An official record received from school officials, including a record from another state, is acceptable. Source Note: The provisions of this §97.68 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.68 Acceptable Evidence of Vaccination(s) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179076&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179076 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179076&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179076 03/11/2026 (a) A student can be enrolled provisionally for no more than 30 days if the student transfers from one Texas school to another, and is awaiting the transfer of the immunization record.(b) A dependent of a person who is on active duty with the armed forces of the United States can be enrolled provisionally for no more than 30 days if the student transfers from one school to another and is awaiting the transfer of the immunization record. Source Note: The provisions of this §97.69 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective December 30, 2004, 29 TexReg 11973; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.69 Transfer of Immunization Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179077&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179077 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179077&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179077 03/11/2026 Representatives of the department and local health authorities may advise and assist schools in meeting the requirements delineated in this subchapter. The department shall conduct periodic review of school immunization records in order to determine compliance with this subchapter. Source Note: The provisions of this §97.70 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.70 Review of Records and Providing Assistance https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179078&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179078 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179078&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179078 03/11/2026 All public school districts and accredited private schools shall submit annual reports of the immunization status of students, in a format prescribed by the department, to monitor compliance with the immunization requirements. Source Note: The provisions of this §97.71 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.71 Annual Report of Immunization Status of Students https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179079 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179079 03/11/2026 Under Texas Health and Safety Code, Chapter 81, Subchapter E, additional vaccinations may be required by the department and/or the local health authority in specific situations under the mechanism of a control order containing control measures to prevent the spread of disease. Source Note: The provisions of this §97.72 adopted to be effective April 1, 2004, 29 TexReg 3188; amended to be effective March 5, 2009, 34 TexReg 1433; amended to be effective July 28, 2016, 41 TexReg 5422. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION §97.72 Additional Vaccination Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133039 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=133039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 133039 03/11/2026 (a) Certain information must be obtained prior to immunizations of a minor when the parent/legal guardian is not present and another adult purports to have consent of that parent/legal guardian. (b) The information may be hand written or typed and should be completed on each minor for each clinic visit when an adult other than the parent/legal guardian is providing consent for the immunizations. (c) The delegation of authority to consent for immunization of a minor shall include the following information: (1) the signature of parent, managing conservator, legal guardian, or other person authorized to give consent; (2) the name and birthdate of minor; (3) the name of the adult giving consent for immunizations of the minor; and (4) the relationship of the adult to the minor for whom they are giving consent. (d) The delegation of authority statement must contain the information in subsection (c) of this section and could resemble the following. Attached Graphic(e) Immunizations may also be administered as provided in Family Code, §32.101. Source Note: The provisions of this §97.91 adopted to be effective February 17, 1992, 17 TexReg 942; amended to be effective December 15, 2002, 27 TexReg 11750; amended to be effective November 8, 2007, 32 TexReg 7931. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES C CONSENT FOR IMMUNIZATION §97.91 Delegation of Authority to Give Informed Consent for Immunizations of a Minor https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152157&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152157 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152157&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152157 03/11/2026 (a) All private and public hospitals in Texas that provide health care to children shall:(1) administer age-appropriate vaccines or refer newborns for immunizations to other health care providers at the time of the newborn screening test;(2) review the immunization history of every child admitted to the hospital, examined in the hospital's emergency room, or outpatient clinic; and(3) administer the needed vaccines or refer the child to another health care provider for immunizations.(b) All physicians and other health care providers who provide health care to children in Texas shall:(1) review the immunization history of every child examined; and(2) administer vaccine(s) or refer every child who needs immunizations to another health care provider.(c) Hospitals, all physicians, and other health care providers, who provide health care to children in Texas, must document in a newborn's or other child's hospital or medical record that the newborn or child has either received age-appropriate immunizations or has been referred for immunizations at the time of the newborn screening or upon a child's admission to the hospital, examination in a hospital emergency room or visit to an outpatient clinic. Hospitals, all physicians, and other health care providers who provide health care to children in Texas must document in a newborn's or other child's hospital or medical record that the:(1) newborn's or other child's immunization history has been reviewed; and(2) that the newborn or child has been age-appropriately immunized or that the newborn has been referred to another health care provider for immunizations. Source Note: The provisions of this §97.101 adopted to be effective April 14, 1995, 20 TexReg 2386; amended to be effective December 15, 2002, 27 TexReg 11750; amended to be effective December 22, 2005, 30 TexReg 8435; amended to be effective July 20, 2011, 36 TexReg 4563. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES D STATEWIDE IMMUNIZATION OF CHILDREN IN CERTAIN FACILITIES AND BY HOSPITALS, PHYSICIANS, AND OTHER HEALTH CARE PROVIDERS §97.101 Statewide Immunization of Children by Hospitals, Physicians, and Other Health Care Providers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152158&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152158 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152158&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152158 03/11/2026 (a) On admission of a child to a facility of the Department of Aging and Disability Services, Department of State Health Services, the Texas Department of Criminal Justice, or the Texas Youth Commission, the facility physician shall review the immunization history of the child, if available, and administer any needed immunization(s) or refer the child for immunization(s) to another health care provider. Required immunizations are those set out in §97.63 of this title (relating to Immunization Requirements in Child-care Facilities, Pre-Kindergarten, Early Childhood Programs, and Texas Elementary and Secondary Schools). Copies of Immunization Requirements in Texas Elementary and Secondary Schools and Institutions of Higher Education may be obtained from the Department of State Health Services, Mail Code 1946, P. O. Box 149347, 78714-9347, Austin, Texas 78714-9347, (512) 458-7284.(b) The provisions of §97.62 of this title (relating to Exclusions of Compliance) and §97.66 and §97.69 of this title (relating to Provisional Enrollment for (Non-Higher Education; Non-Veterinary) Students and relating to Transfer of Immunization Records) apply to this section.(c) The facility covered by this section shall keep an individual's immunization record during the child's period of admission, detention, or commitment in the facility. Representatives of the department and local health authorities may advise and assist these agencies in meeting these requirements. The department may conduct periodic review of these agencies' identified immunization records in order to allow public health officials to obtain information required for public health purposes. The information, if available, must include at least the name and date of birth of the child, the child's address, the name and telephone number of a parent or guardian, the month, day, and year of vaccine administration, the name or type of vaccines administered, the name and address of the provider that administered the vaccines; or other evidence of immunity to a vaccine-preventable disease. Source Note: The provisions of this §97.102 adopted to be effective April 14, 1995, 20 TexReg 2386; amended to be effective December 15, 2002, 27 TexReg 11750; amended to be effective December 22, 2005, 30 TexReg 8435; amended to be effective July 20, 2011, 36 TexReg 4563. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES D STATEWIDE IMMUNIZATION OF CHILDREN IN CERTAIN FACILITIES AND BY HOSPITALS, PHYSICIANS, AND OTHER HEALTH CARE PROVIDERS §97.102 Immunizations Required upon Admission of a Child to the Texas Department of Criminal Justice, Department of Aging and Disability Services, Department of State Health Services, or the Texas Youth Commission https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131685&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131685 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131685&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131685 03/11/2026 The purpose of these sections is to provide anti-rabies biologicals (vaccines and hyper-immune sera) in accordance with the recent "Human Rabies Prevention, United States, Recommendations of the Advisory Committee on Immunization Practices (ACIP)" of the U.S. Health Services. Source Note: The provisions of this §97.121 adopted to be effective March 5, 1982, 7 TexReg 743; amended to be effective February 5, 1998, 23 TexReg 756; amended to be effective August 28, 2003, 28 TexReg 6855; amended to be effective September 6, 2007, 32 TexReg 5700. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES E PROVISION OF ANTI-RABIES BIOLOGICALS §97.121 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131686&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131686 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131686&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131686 03/11/2026 (a) Stocking. Anti-rabies biologicals may be procured and distributed by the Department of State Health Services (department). The department may enroll off-site depots for the storage and distribution of department-owned anti-rabies biologicals. The depot will be licensed as defined by the Texas Board of Pharmacy that allows for the storage and distribution of anti-rabies biologicals to individuals presenting a signed order from a medical practitioner licensed to practice in Texas. The products in each depot will remain under the ownership of the department until issued.(b) Issuing.(1) Anti-rabies biologicals may only be issued upon receipt of a signed order from a medical practitioner licensed to practice in Texas.(2) The department has the right to refuse to provide anti-rabies biologicals if the incident in question does not warrant rabies post-exposure prophylaxis according to the recent ACIP's recommendations on human rabies prevention.(3) Partial issuance. Issues may be less than the full regimen of treatment when:(A) there is reason to believe that the treatment may be terminated before completion; or(B) in the event of a biological shortage.(4) For individuals who are declined anti-rabies biologicals, the department will provide a source from which biologicals may be purchased.(5) At the time of issuance.(A) A human rabies prophylaxis surveillance report will be completed by the person issuing the anti-rabies biologicals and forwarded to the appropriate health service region.(B) An information sheet about rabies and rabies biologicals will be provided by the department for use by the attending medical practitioner to inform the patient of the risks and benefits of the anti-rabies treatment.(C) The recent ACIP's recommendations on human rabies prevention will be provided to the attending medical practitioner.(D) An information sheet will be provided to the patient or the patient's agent on the proper transport of the biologicals.(E) The patient or patient's agent will receive and sign an information sheet pertaining to payment responsibilities.(F) Anti-rabies materials may be obtained from the Department of State Health Services, Immunization Branch, 1100 West 49th Street, Austin, Texas 78765-3199, or by request by phoning, 1-800-252-9152.(c) Return of anti-rabies biologicals. Once issued to a patient or patient's agent and removed from the depot storage area, no anti-rabies biologicals may be returned for credit or reimbursement. Source Note: The provisions of this §97.123 adopted to be effective March 5, 1982, 7 TexReg 743; amended to be effective February 5, 1998, 23 TexReg 756; amended to be effective August 28, 2003, 28 TexReg 6855; amended to be effective September 6, 2007, 32 TexReg 5700. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES E PROVISION OF ANTI-RABIES BIOLOGICALS §97.123 Stocking, Issuing, and Returns https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131687&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131687 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131687&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131687 03/11/2026 The department is specifically authorized by law to distribute anti-rabies biologicals and to receive reimbursement based on the department's current contract.(1) Options for reimbursement will be in accordance with policies set by the department, and are as follows:(A) The patient or patient's agent will provide the department proof of viable insurance coverage. If the insurance does not pay or does not pay the entire amount, the patient or patient's agent may be responsible for any outstanding balance.(B) Proof of inability to pay. If a patient is unable to pay, the patient will be required to sign a statement that he/she will provide the department with financial information to pursue a reduced amount charged.(2) Refusal to pay. The department shall have the right to seek reimbursement in the event of a refusal to pay by a patient, or by his or her third-party coverage or other legally obligated source. A county or district attorney or the Texas Attorney General, upon request of the department, may initiate suit or other proceeding in the county of the recipient's residence.(3) The issuance of anti-rabies biologicals will not be withheld due a patient's inability to pay. Source Note: The provisions of this §97.124 adopted to be effective March 5, 1982, 7 TexReg 743; amended to be effective February 5, 1998, 23 TexReg 756; amended to be effective August 28, 2003, 28 TexReg 6855; amended to be effective September 6, 2007, 32 TexReg 5700. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES E PROVISION OF ANTI-RABIES BIOLOGICALS §97.124 Payment for Anti-Rabies Biologicals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131688&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131688 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131688&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131688 03/11/2026 The department may enroll off-site depots for the storage and dispensing of department-owned anti-rabies biologicals.(1) The depots will be licensed as defined by the Texas Board of Pharmacy that allows for the storage and distribution of anti-rabies biological to individuals presenting a signed order from a medical practitioner licensed to practice in Texas.(2) The depot's designee will enroll as a depot with the department and comply with the department's policy regarding storage, distribution, and reporting requirements.(3) Anti-rabies biologicals will be dispensed at the price the department procures the vaccine under the current state contract.(4) Loss due to negligence.(A) The department will require a letter outlining the reason for the loss and the corrective action to prevent recurrence.(B) The department will review the letter and determine if billing is appropriate.(C) If found to be at fault and reimbursement does not occur, the department may pursue legal action.(D) Failure to reimburse the department within the specified time frame may result in revocation of the authority to dispense anti-rabies biologicals. Source Note: The provisions of this §97.125 adopted to be effective February 5, 1998, 23 TexReg 756; amended to be effective August 28, 2003, 28 TexReg 6855; amended to be effective September 6, 2007, 32 TexReg 5700. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES E PROVISION OF ANTI-RABIES BIOLOGICALS §97.125 Designation of Depots for Anti-Rabies Biologicals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174095&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174095 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174095&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174095 03/11/2026 The following words and terms when used in this subchapter shall have the following meanings unless the context clearly indicates otherwise.(1) Acute HIV Infection--The stage immediately following HIV infection, as identified by clinical symptoms, history of exposure, and/or specific laboratory results. This includes, but is not limited to, a case that has a documented negative or indeterminate HIV test result that occurred no more than 180 days prior to the initial positive HIV test result.(2) AIDS and HIV Infection--Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) infection are as defined by the Centers for Disease Control and Prevention (CDC) and in accordance with the Health and Safety Code, §81.101.(3) Contract Research Organization (CRO)--An organization that is contracted by pharmaceutical, biotechnology, or medical device industries to provide various aspects of the clinical research process. A CRO may provide such services as clinical trials management and laboratory testing.(4) Drug Resistance Testing--Genotypic testing that identifies the nucleotide sequence and uses the resulting sequence to identify strains resistant to specific types of drug therapies.(5) Health professional--An individual whose:(A) vocation or profession is directly or indirectly related to the maintenance of the health of another individual or of an animal; and(B) duties require a specified amount of formal education and may require a special examination, certificate or license, or membership in a regional or national association.(6) HIV-Exposed Infant--Any infant suspected of HIV exposure through mother to child transmission.(7) Nucleotide Sequence--The relative order of base pairs in a fragment of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), a gene, a chromosome, or an entire genome.(8) Point of Care Tests--Analytic tests performed at or near the site of patient care outside of a laboratory setting.(9) Screening Test--The initial analytical test used to preliminarily detect the presence of disease. Positive screening test results should be followed by a supplemental test to verify the presence of that disease.(10) Sexually transmitted disease (STD)--An infection, with or without symptoms or clinical manifestations, that is or may be transmitted from one person to another during or as a result of sexual relations, and that produces or might produce a disease in, or otherwise impair, the health of either person, or might cause an infection or disease in a fetus in utero or a newborn. For purposes of this subchapter, the term "STD" refers to the following reportable conditions: HIV (including AIDS); chancroid; Chlamydia trachomatis; Neisseria gonorrhea; and syphilis infections. Each of these conditions is as defined by CDC.(11) Stages of HIV Infection--For purposes of this subchapter, HIV infection is classified into four stages (stage 0, 1, 2, or 3). The CDC definition of each stage is incorporated here by reference (see http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm?s_cid=rr6303a1_).(12) Supplemental test--The subsequent test or tests in a diagnostic testing algorithm that are performed following a preliminary positive on the initial/screening test. Positive or reactive results on supplemental tests, when performed in a specific sequence as part of a diagnostic algorithm, confirm disease infection. However, supplemental tests, when run outside of a testing algorithm, are not necessarily sufficient to diagnose infection. Source Note: The provisions of this §97.131 adopted to be effective January 1, 1999, 23 TexReg 12668; amended to be effective August 5, 2001, 26 TexReg 5819; amended to be effective January 1, 2010, 34 TexReg 9445; amended to be effective October 14, 2015, 40 TexReg 7234. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.131 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174094&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174094 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174094&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174094 03/11/2026 (a) In addition to the reporting requirements for communicable diseases found in §97.1 of this title, the following shall report cases and suspected cases of STD(s), which includes HIV-exposed infants, in the manner described in §97.133 of this title (relating to Reporting Information for Sexually Transmitted Diseases):(1) A health professional, and any other person mandated to report under Texas Health and Safety Code §81.042;(2) Any person in charge of a clinical laboratory, hospital laboratory, blood bank, mobile unit, or other facility (such as a contract research organization laboratory) in which a laboratory examination of a blood specimen, or any specimen derived from a human body, yields microscopic, cultural, serological or any other evidence of a suspected STD;(3) The medical director or other physician responsible for the medical oversight of a testing program, as defined in Texas Health and Safety Code §85.002.(b) Failure to report as required under this subchapter is prohibited by law, as described in Texas Health and Safety Code, §81.049.(c) The Health Insurance Portability and Accountability Act (HIPAA) allows covered entities to disclose otherwise protected health information, without either obtaining the written authorization of the individual whose information is at issue or giving that individual the opportunity to agree or object, for purposes of public health communicable disease reporting requirements (see Title 45 Code of Federal Regulations §164.512(a) and (b)). Source Note: The provisions of this §97.132 adopted to be effective January 1, 1999, 23 TexReg 12669; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective January 1, 2010, 34 TexReg 9445; amended to be effective October 14, 2015, 40 TexReg 7234. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.132 Who Shall Report Sexually Transmitted Diseases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174096&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174096 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174096&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174096 03/11/2026 (a) Reporting entities described in §97.132 of this title (relating to Who Shall Report Sexually Transmitted Diseases) shall report all information required by the department for each person (which includes an HIV-exposed infant) who has or is suspected of having an STD, as well as for any specimen derived from a human body that yields microscopic, cultural, serological or any other evidence of a suspected STD.(b) The department has established the reporting procedures required under Texas Health and Safety Code, §81.044, including the designation of specific forms and methods of reporting. The required written reports, electronic reports, and telephone reports shall be made in a complete, accurate and timely manner, all in accordance with §97.134 of this title (relating to How to Report Sexually Transmitted Diseases).(c) All persons required to report under §97.132 of this title, must report the following (each report must either use the department's form specified in this subsection, or a substitute form which captures all the data elements of the specified department form):(1) All adult or adolescent (13 years of age or older) HIV infections and AIDS (stage 3 of HIV infection) diagnoses for individuals 13 years of age or older (see the most current version of the department's Texas HIV/AIDS Adult/Adolescent case report form (available as specified in §97.134 of this title.(2) All pediatric (less than 13 years of age) HIV infections and AIDS (stage 3 of HIV infection) diagnoses (see the most current version of the department's Texas HIV/AIDS pediatric case report form (available as specified in §97.134 of this title)).(3) All HIV-positive pregnant women. (see the most current version of the department's Texas HIV/AIDS Adult/Adolescent case report form (available as specified in §97.134 of this title)).(4) All HIV-exposed infants (see the most current version of the department's Texas HIV/AIDS Pediatric case report form (available as specified in §97.134 of this title)).(5) All chancroid, Chlamydia trachomatis, Neisseria gonorrhea, and syphilis infections (see the most current version of the department's Confidential Report of Sexually Transmitted Diseases form (STD-27) (available as specified in §97.134 of this title)).(6) All congenital syphilis infections (see the most current version of the CDC's Congenital Syphilis Case Investigation and Report form (available as specified in §97.134 of this title)).(7) All positive or reactive results from point of care testing for STDs (see the most current version of the department's Confidential Report of Sexually Transmitted Diseases form (STD-27) (available as specified in §97.134 of this title)).(d) Persons described in §97.132(a)(2) of this title must report the following regarding any specimen derived from a human body that yields microscopic, cultural, serological or any other evidence of a suspected STD (each report must either use the department's form specified in this subsection, or a substitute form which captures all the data elements of the specified department form):(1) All positive or reactive STD test results, including screening tests; all HIV viral loads (detectable and non-detectable); and all CD4+T-lymphocyte cell counts and percentages (see the most current version of the department's Notification of Laboratory Test Findings Indicating Presence of Chlamydia trachomatis, Gonorrhea, Syphilis, Chancroid, HIV Infections or CD4 Counts form (STD-28) (available as specified in §97.134 of this title)).(2) HIV DNA or RNA virologic tests on all infants suspected of HIV exposure from birth to three years of age, regardless of the test findings (e.g., negative or positive) (see the most current version of the department's STD-28 form (available as specified in §97.134 of this title)).(3) All supplemental tests for syphilis and HIV that result from an initial positive screening test, regardless of result (e.g., reactive or non-reactive) (see the most current version of the department's STD-28 form (available as specified in §97.134 of this title)).(4) All HIV nucleotide sequences that are resultant of genotypic testing, including HIV drug resistance testing (see the most current version of the department's STD-28 form (available as specified in §97.134 of this title)). Source Note: The provisions of this §97.133 adopted to be effective January 1, 1999, 23 TexReg 12669; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective January 1, 2010, 34 TexReg 9445; amended to be effective October 14, 2015, 40 TexReg 7234. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.133 Reporting Information for Sexually Transmitted Diseases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174097&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174097 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174097&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174097 03/11/2026 (a) All reportable information received by the health authority or the department is confidential as provided by law, including (but not limited to) Texas Health and Safety Code, §81.046 and §81.103.(b) Reporting forms and/or information from all entities required to report should be sent to the local health authority where the health professional's office, hospital, laboratory or medical facility is located or, if there is no local health authority in that jurisdiction, the reports should be forwarded to the regional director in the department's health service region office which covers the area where the health professional's office, hospital, laboratory, or medical facility is located. A department resource to help determine the proper reporting location can be found at http://www.dshs.state.tx.us/hivstd/healthcare/reporting/regions.shtm.(c) Reports of STD cases (including HIV) as well as HIV-exposed infants shall contain all of the information required on the reporting forms specified in §97.133(2) of this title (relating to Reporting Information for Sexually Transmitted Diseases). Forms can be obtained from local health departments and department health service regions; forms shall be provided without charge to individuals required to report. A list of local health departments and department health service region offices that can provide reporting forms is currently available at http://www.dshs.state.tx.us/hivstd/healthcare/reporting/regions.shtm.(d) Health professionals and other persons as specified by §97.132(a)(1) - (3) of this title must submit reports of suspected primary or secondary syphilis and acute HIV infection by telephone within one working day of a suspected diagnosis. All other reports of suspected STD cases and HIV-exposed infants from health professionals and other persons as specified by §97.132 of this title must be submitted within seven calendar days of that determination.(e) Any person in charge of a clinical laboratory or other entity as specified by §97.132(a)(2) of this title shall submit reportable syphilis test results within three working days of obtaining the test result and shall submit all other reportable STD (including HIV) test results within seven calendar days of obtaining the test results. In addition to required reporting, if, during any calendar quarter, tests for chancroid, Chlamydia trachomatis, Neisseria gonorrhea, HIV and/or syphilis are performed and all test results are non-reportable, the person in charge of reporting for the laboratory shall submit a statement to this effect on or before January 5, April 5, July 5, and October 5 following that calendar quarter.(f) A local health authority shall forward each week to the department all cases and STD test results, including HIV infection and AIDS (stage 3 of HIV infection) reported to that health authority during the previous week.(g) All reporting of personal health information to the department shall be submitted in accordance with department's security and confidentiality requirements, currently found at https://www.dshs.state.tx.us/hivstd/policy/security.shtm.(1) Information on how to submit electronic reports can be obtained from the Epidemiology and Surveillance Branch through an email request (current e-mail address is HIVSTDreporting@dshs.state.tx.us).(2) Paper reports should be mailed to the Texas Department of State Health Services, Epidemiology and Surveillance Branch, Mail Code 1873, P.O. Box 149347, Austin, Texas 78714-9347. Source Note: The provisions of this §97.134 adopted to be effective January 1, 1999, 23 TexReg 12669; amended to be effective August 5, 2001, 26 TexReg 5819; amended to be effective January 1, 2010, 34 TexReg 9445; amended to be effective October 14, 2015, 40 TexReg 7234. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.134 How to Report Sexually Transmitted Diseases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191182&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191182 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191182&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191182 03/11/2026 (a) A physician, nurse, midwife, or other person in attendance at childbirth shall apply, or cause to be applied, to the child's eyes a 0.5% ophthalmic erythromycin ointment in each eye within two hours after birth. If this ointment is not available due to a disruption in distribution or manufacturing, a physician, nurse, midwife, or other person subject to this section shall apply or cause to be applied to the child's eyes an alternative treatment included in guidance issued by the Department of State Health Services (department) or the Centers for Disease Control and Prevention.(b) Except as provided by subsection (c) of this section, a person commits an offense if the person is a physician, nurse, midwife, or other person in attendance with a pregnant woman either during pregnancy or at delivery and fails to perform a duty required by subsection (a) of this section. An offense under this section is a Class B misdemeanor under the Texas Health and Safety Code, §81.091(g).(c) A physician, nurse, midwife, or other person in attendance at childbirth who is unable to apply the prophylaxis as required by this section due to the objection of a parent, managing conservator, or guardian of the newborn infant does not commit an offense under this section and is not subject to criminal, civil, or administrative liability or any professional disciplinary action for failure to administer the prophylaxis. The physician, nurse, midwife, or person shall ensure that the objection of the parent, managing conservator, or guardian is entered into the medical record of the infant.(d) The department may provide an approved prophylaxis without charge to health-care providers if the newborn's financially responsible adult is unable to pay. The health-care provider shall not charge for the prophylaxis that is received free of charge from the department.(e) Midwives shall follow the additional requirements in Texas Health and Safety Code, §81.091. Source Note: The provisions of this §97.136 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective December 4, 2008, 33 TexReg 9693; amended to be effective March 28, 2010, 35 TexReg 2311; amended to be effective June 6, 2018, 43 TexReg 3594. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.136 Prophylaxis against Ophthalmia Neonatorum https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138856&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138856 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138856&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138856 03/11/2026 (a) Health-care personnel are at risk of exposure to HIV or AIDS if the personnel are in contact with blood or other body fluids (amniotic fluid, pericardial fluid, peritoneal fluid, pleural fluid, synovial fluid, cerebrospinal fluid, semen, and vaginal secretions) or any body fluid visibly contaminated with blood through percutaneous inoculation or contact with an open wound, nonintact skin or mucous membrane during the performance of normal job duties.(b) Health-care personnel are at risk of exposure to HIV or AIDS during a medical procedure if the personnel have their mucous membranes or skin in contact with any body fluid or tissue (other than patient's intact skin) and if the procedure to be performed is an invasive procedure that involves surgical entry into tissues, cavities, or organs or the repair of major traumatic injuries, including angiographic, bronchoscopic, endoscopic, and obstetrical procedures.(c) Health-care personnel should follow the most current exposure and risk guidance provided by the federal Centers for Disease Control and Prevention.(d) Publications related to the prevention of HIV or AIDS are available upon request from: HIV/STD Comprehensive Services Branch, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3199.(e) Texas Health and Safety Code, §§85.201 - 85.203 contain requirements and information for health care personnel regarding infection control standards and related issues under this section. Also, see §96.202 of this title (relating to Exposure Control Plan). Source Note: The provisions of this §97.137 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective August 5, 2001, 26 TexReg 5819; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.137 Exposure of Health-Care Personnel to Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) Infection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=146997&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 146997 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=146997&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 146997 03/11/2026 (a) A person indicted for, or who waives indictment for, an offense under the Texas Penal Code, §§21.02, 21.11(a)(1), 22.011, or 22.021, shall, at direction of the court on the court's own motion or on request of the victim of the alleged offense, undergo a standard diagnostic test for HIV and other sexually transmitted diseases. The standard diagnostic test shall be a type approved by the United States Food and Drug Administration for testing for those diseases. On request of the victim of the alleged offense, the court shall order the defendant to undergo the test not later than 48 hours after an indictment for the offense is presented against the defendant, or not later than 48 hours after the defendant waives indictment. The Texas Code of Criminal Procedure, Article 21.31, provides procedures for situations where the defendant cannot be located within that 48-hour period, as well as procedures for any subsequent testing after a conviction, or as otherwise necessary following an initial positive result.(b) A person indicted for, or who waives indictment for, an offense under the Texas Penal Code, §22.11, shall, at direction of the court on the court's own motion or on request of the victim of the alleged offense, undergo a diagnostic test for HIV, Hepatitis A, Hepatitis B, Tuberculosis, or any other disease listed as reportable under Texas Health and Safety Code, §81.048. On request of the victim of the alleged offense, the court shall order the defendant to undergo the test not later than 48 hours after an indictment for the offense is presented against the defendant, or not later than 48 hours after the defendant waives indictment. The Texas Code of Criminal Procedure, Article 21.31, provides procedures for situations where the defendant cannot be located within that 48-hour period, as well as procedures for any subsequent testing after a conviction, or as otherwise necessary following an initial positive result. The person charged with the offense shall pay the costs of testing under this subsection.(c) A hospital shall perform the medical procedure or test on a person if a court so orders, as required in Texas Health and Safety Code, §81.094. All aspects of testing, whether performed in a hospital or not, under this section must be conducted in accordance with the Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guidelines and with other applicable CDC and department testing guidelines and in accordance with state and federal confidentiality requirements (note that Texas Code of Criminal Procedure, Article 21.31, allows certain specific disclosures).(d) The person performing the procedure or test under this section shall timely submit the test results to the local health authority, following which that local health authority must timely notify the victim of the alleged offense, and the person charged with the offense, of the test result. Source Note: The provisions of this §97.138 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective December 4, 2008, 33 TexReg 9693; amended to be effective August 15, 2010, 35 TexReg 6829. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.138 Guidelines for Testing Certain Indicted Persons for Certain Diseases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174098&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174098 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=174098&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 174098 03/11/2026 An applicant for insurance must be given written notice of a positive HIV-related test result by a physician designated by the applicant, or in the absence of that designation, by the department. When the department is requested to make this notification:(1) the form designated by the department for this purpose must be used. Copies of the form and other information concerning notification by the department may be requested from: Texas Department of State Health Services, Epidemiology and Surveillance Branch, Mail Code 1873, P.O. Box 149347, Austin, Texas 78714-9347; and(2) the insurer shall pay the department a fee of $25 to cover the cost of the department providing the written notice to the applicant for insurance, pursuant to Texas Insurance Code, §545.055. Source Note: The provisions of this §97.139 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective January 1, 1999, 23 TexReg 12668; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective October 14, 2015, 40 TexReg 7234. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.139 Fee for Providing Written Notice of a Positive Human Immunodeficiency Virus (HIV)-Related Test Result to an Applicant for Insurance https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138857&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138857 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138857&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138857 03/11/2026 (a) Purpose. The purpose of this section is to implement the provisions of the Communicable Disease Prevention and Control Act, Texas Health and Safety Code, §85.116, which requires the Department of State Health Services (department) to adopt rules to implement the Act.(b) Counseling and testing.(1) The counseling for state employees exposed to HIV on the job should be performed in accordance with the most current guidelines developed by the department. Copies are available for review in the HIV/STD Comprehensive Services Branch, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3199. Copies also are available on request.(2) A state employee who may have been exposed to HIV while engaged in activities within the course and scope of state employment may not be required to be tested for HIV.(3) HIV counseling and testing will be performed on the state employee, when requested by that employee, at the expense of the state agency if:(A) the employee documents to the agency's satisfaction that he or she may have been exposed to HIV while engaged in activities within the course and scope of state employment; and(B) the exposure was a needlestick or other penetrating puncture of the skin with a used needle or other contaminated item; or either a splatter or aerosol into the eye, nose, or mouth or any significant contamination of an open wound or non-intact skin with blood or body fluids known to transmit HIV.(c) Workers' compensation. To qualify for workers' compensation or similar benefits or compensation, the employee must provide the state agency with a written statement of the date and circumstances of the exposure and document that, within ten days after the date of the exposure, the employee had a test result that indicated the absence of HIV infection. Further information can be obtained from "Risk Management for Texas State Agencies, Volume III, Workers' Compensation Exposures," which is available from the State Office of Risk Management, P.O. Box 13777, Austin, Texas 78711-3777. Source Note: The provisions of this §97.140 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective October 6, 1997, 22 TexReg 9677; amended to be effective August 5, 2001, 26 TexReg 5819; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.140 Counseling and Testing for State Employees Exposed to Human Immunodeficiency Virus (HIV) Infection on the Job https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138858&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138858 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138858&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138858 03/11/2026 (a) Purpose. The purpose of this section is to implement the provisions of the Health and Safety Code, §85.087 and §94.004, requiring the Department of State Health Services (department) to develop and offer a training course for persons providing HIV and/or hepatitis C counseling, and authorizes the department to charge a fee for the course.(b) Content. The training course includes information relating to risk reduction and the special needs of persons with positive test results for the diseases. General information on these diseases is sent to participants prior to the actual course.(c) Fee.(1) The course fee will be $300 for each participant, except that no fee is required from employees of an entity that receives state or federal funds for HIV or Hepatitis C counseling and testing through a current contract with the department. The HIV/STD Comprehensive Services Branch may waive the fee, at its sole discretion, according to its written internal procedures regarding compelling public health need.(2) Fees shall be made payable to the Department of State Health Services. All fees are non-refundable and must be received by the department prior to participation in the course. The accepted forms of payment are cashiers check or money order. No other form of payment will be accepted.(d) Notice. Notice of the training courses will be announced through the on-line training calendar located at http://www.dshs.state.tx.us/hivstd/training/schedule.shtm. Source Note: The provisions of this §97.141 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective October 6, 1997, 22 TexReg 9677; amended to be effective June 13, 2000, 25 TexReg 5636; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.141 Fee to Cover the Cost of Providing the Human Immunodeficiency Virus (HIV) and Hepatitis C Protocol-Based Counseling Course https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138859&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138859 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138859&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138859 03/11/2026 The documents referenced in Texas Health and Safety Code, §§85.004 - 85.007 and §§163.001 - 163.002 can be obtained from the Health Promotion Unit, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3199. Source Note: The provisions of this §97.142 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective October 6, 1997, 22 TexReg 9677; amended to be effective August 5, 2001, 26 TexReg 5819; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.142 Model Health Education Program/Resource Guide for HIV/AIDS Education of School-Age Children https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138860&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138860 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138860&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138860 03/11/2026 (a) The Department of State Health Services has prepared and maintains model workplace guidelines consistent with current public health information and with state and federal laws and regulations as required by the Texas Health and Safety Code, §85.012.(b) Interested individuals or entities may review the guidelines or obtain copies by contacting the HIV/STD Comprehensive Services Branch, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3199.(c) Employers are encouraged to adopt HIV-related workplace guidelines that incorporate, at a minimum, the department guidelines referenced in this section. Source Note: The provisions of this §97.143 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective October 6, 1997, 22 TexReg 9677; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.143 Model HIV/AIDS Workplace Guidelines https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138861&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138861 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138861&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138861 03/11/2026 (a) The Department of State Health Services has prepared the model policies concerning persons in custody required by the Texas Health and Safety Code, §85.141.(b) The model policies are available for review in the HIV/STD Comprehensive Services Branch, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3199. Copies are available upon request. Source Note: The provisions of this §97.144 adopted to be effective March 16, 1994, 19 TexReg 1453; amended to be effective August 5, 2001, 26 TexReg 5819; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.144 Model Policies for the Handling, Care, and Treatment of HIV/AIDS-infected Persons in the Custody of the Texas Department of Criminal Justice, Local Law Enforcement Agencies, Municipal and County Correctional Facilities, and District Probation Departments https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138862&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138862 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138862&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138862 03/11/2026 (a) State-funded primary health, women's reproductive health, and sexually transmitted disease clinics shall provide voluntary and affordable counseling and testing programs for HIV infection, or provide referrals to such programs. These entities shall offer both anonymous and confidential testing for HIV infection or provide referrals for anonymous and confidential testing.(b) All HIV testing sites funded by the Department of State Health Services shall offer confidential and anonymous HIV testing on site. Source Note: The provisions of this §97.145 adopted to be effective January 1, 1999, 23 TexReg 12669; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.145 Anonymous and Confidential HIV Testing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138863&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138863 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=138863&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 138863 03/11/2026 A test result under this subchapter is confidential. A person that possesses or has knowledge of a test result may not release or disclose the test result or allow the test result to become known except as provided by Health and Safety Code, §81.103 and other applicable state and federal law. Under Texas Health and Safety Code, §81.103(j), a person commits an offense if, with criminal negligence and in violation of this section, the person releases or discloses a test result or other information or allows a test result or other information to become known. An offense under this section is a Class A misdemeanor. Source Note: The provisions of this §97.146 adopted to be effective January 1, 1999, 23 TexReg 12669; amended to be effective March 20, 2003, 28 TexReg 2335; amended to be effective December 4, 2008, 33 TexReg 9693. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES F SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) §97.146 Confidentiality of Test Results https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187452&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187452 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187452&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187452 03/11/2026 The U.S. Public Health Service has designated the Department of State Health Services as the governmental entity in the State of Texas that is responsible for determining which physicians in the state are authorized to administer yellow fever vaccine for persons who travel outside the United States. The department provides this authorization by issuing Uniform Stamps to designated physicians. These sections cover the criteria by which the department issues the Uniform Stamp and the criteria for designating and operating a Vaccination Center. Source Note: The provisions of this §97.151 adopted to be effective March 13, 1986, 11 TexReg 1045; amended to be effective September 26, 2002, 27 TexReg 8932; amended to be effective November 8, 2007, 32 TexReg 7931; amended to be effective January 18, 2018, 43 TexReg 235. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES G VACCINATION STAMPS §97.151 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187453&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187453 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187453&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187453 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:(1) Department--The Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756.(2) Unit--The Immunization Unit, Infectious Disease Prevention Section, Department of State Health Services.(3) Physician--A physician (medical doctor or doctor of osteopathic medicine) licensed to practice medicine in the State of Texas.(4) Vaccination Center--The location where a physician is authorized to administer yellow fever vaccine.(5) Uniform Stamp--A stamp issued by the unit to a physician for use in validating certificates of yellow fever vaccination for persons who travel outside the United States. Source Note: The provisions of this §97.152 adopted to be effective March 13, 1986, 11 TexReg 1045; amended to be effective September 26, 2002, 27 TexReg 8932; amended to be effective November 8, 2007, 32 TexReg 7931; amended to be effective January 18, 2018, 43 TexReg 235. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES G VACCINATION STAMPS §97.152 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187454&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187454 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187454&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187454 03/11/2026 Uniform Stamps may be issued to physicians holding a current Texas medical license, for use only at the specific Vaccination Center designated on the Uniform Stamp Application Form. If a physician practices at more than one Vaccination Center, a separate Uniform Stamp Application Form and Uniform Stamp are required for each Vaccination Center.(1) Physicians may apply for the Uniform Stamp by sending the Uniform Stamp Application Form to the unit. The Uniform Stamp Application Form may be obtained from the unit or online at http://www.dshs.texas.gov/immunize/.(2) Physicians who move the location of their practice within the same county must report a change of address in writing to the unit. Physicians who move their practice to another county must submit a Uniform Stamp Replacement Form and a Uniform Stamp replacement fee.(3) Physicians are authorized to use the Uniform Stamp solely for the purpose of validating administration of yellow fever vaccine on vaccination certificates issued only at the approved Vaccination Center indicated on the Uniform Stamp Application Form.(4) Physicians are authorized to use only the Uniform Stamp assigned to them. Uniform Stamps may not be assigned, loaned, or given to another person or physician except those working under supervision of the physician holding the stamp. The physician will at all times be responsible for the Uniform Stamp.(5) A physician shall report immediately to the unit any loss or theft of the Uniform Stamp.(6) Physicians are encouraged to report adverse events potentially caused by yellow fever vaccination to the CDC/FDA Vaccine Adverse Events Reporting System (VAERS http://www.vaers.hhs.gov/).(7) U.S. Public Health Services (PHS) requirements. The PHS requirements are found, as follows:(A) Code of Federal Regulations, Title 42-Public Health, Part 71-Foreign Quarantine, §71.3, Designation of Yellow Fever Vaccination Centers; Validation Stamps; and(B) PHS publications entitled, Division of Quarantine Circular No. 106; Advisory Memorandum No. 66; and Advisory Memorandum No. 72.(C) The department adopts the PHS requirements listed in subparagraphs (A) and (B) of this paragraph by reference. Copies of the requirements are available upon request from the Immunization Unit, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347 or (800) 252-9152.(8) Fees for the Uniform Stamp.(A) New Applicant Fee. Each new applicant is required to submit a fee of $68 by personal check, cashier's check, or money order along with the completed Uniform Stamp Application Form. If the unit denies the Uniform Stamp Application Form, the unit will return the $68 to the physician.(B) Annual Renewal Fee. In January of each year, each physician holding a Uniform Stamp is required to pay an annual fee of $38. The physician shall submit the $38 by personal check, cashier's check, or money order to the unit with the Uniform Stamp Renewal Form. If the unit denies the Uniform Stamp Renewal Form, the unit will return the $38 to the physician.(C) Stamp Replacement Fee. A fee of $50 and submission of the Uniform Stamp Replacement Form will be required for issuing replacement Uniform Stamps in the event the original is lost or stolen, or if the physician moves their practice to another county.(D) Waived Fees. All fees will be waived for public health departments, public health districts, and health service regions. Source Note: The provisions of this §97.153 adopted to be effective March 13, 1986, 11 TexReg 1045; amended to be effective September 26, 2002, 27 TexReg 8932; amended to be effective November 8, 2007, 32 TexReg 7931; amended to be effective January 18, 2018, 43 TexReg 235. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES G VACCINATION STAMPS §97.153 Criteria for Issuing Uniform Stamps to Physicians https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187455&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187455 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187455&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187455 03/11/2026 Designation as a Vaccination Center is made upon completion and approval of a Uniform Stamp Application Form.(1) A physician shall use the Uniform Stamp only at the Vaccination Center where the yellow fever vaccine is delivered and the vaccine may not be redistributed. The physician to whom the Uniform Stamp has been issued is not authorized to administer yellow fever vaccine on board ship or aircraft.(2) Physicians shall administer and store yellow fever vaccine in accordance with the vaccine manufacturers' recommendations for safe and effective use of yellow fever vaccine.(3) Each physician holding a Uniform Stamp shall establish the need for continuing possession of the stamp by completing and returning the Uniform Stamp Renewal Form along with the annual renewal fee. The Uniform Stamp Renewal Form is available from the unit or online at http://www.dshs.texas.gov/immunize/.(A) If the Uniform Stamp Renewal Form is not received by the unit by the deadline stated on the Uniform Stamp Renewal Form, designation as an authorized Vaccination Center may be removed and the physician will be required to return the Uniform Stamp.(B) If the physician no longer wishes to retain the Uniform Stamp, the stamp must be returned to the unit.(4) Local health requirements. Local health departments and public health districts may choose to require additional measures for yellow fever vaccinations occurring within their jurisdictions. Source Note: The provisions of this §97.154 adopted to be effective November 8, 2007, 32 TexReg 7931 ; amended to be effective January 18, 2018, 43 TexReg 235. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES G VACCINATION STAMPS §97.154 Criteria for Operating as a Vaccination Center https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187456&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187456 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187456&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187456 03/11/2026 The format of the Uniform Stamps will be according to federal guidelines in the Division of Quarantine Circular No. 106, which is adopted by reference in §97.153 of this title (relating to Criteria for Issuing Uniform Stamps to Physicians). Source Note: The provisions of this §97.155 adopted to be effective March 13, 1986, 11 TexReg 1045; amended to be effective September 26, 2002, 27 TexReg 8932; amended to be effective November 8, 2007, 32 TexReg 7931; amended to be effective January 18, 2018, 43 TexReg 235. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES G VACCINATION STAMPS §97.155 Format of the Uniform Stamp https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187457&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187457 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187457&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187457 03/11/2026 (a) The unit may deny a Uniform Stamp Application Form for a Uniform Stamp or suspend or revoke an existing stamp or not renew a stamp if the applicant or holder fails to comply with the requirements of this subchapter (relating to Vaccination Stamps). The applicant or holder has the opportunity to request a hearing on any of these actions in accordance with department fair hearing rules, §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).(b) The unit will not suspend or revoke a Uniform Stamp without a prior hearing, except if the unit determines that immediate suspension or revocation is necessary because of imminent threat to public health. Source Note: The provisions of this §97.156 adopted to be effective March 13, 1986, 11 TexReg 1045; amended to be effective September 26, 2002, 27 TexReg 8932; amended to be effective November 8, 2007, 32 TexReg 7931; amended to be effective January 18, 2018, 43 TexReg 235. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES G VACCINATION STAMPS §97.156 Denial, Suspension, or Revocation of a Uniform Stamp https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108820&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108820 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108820&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108820 03/11/2026 These sections establish regulations for screening and treatment for tuberculosis and latent tuberculosis infection of employees, volunteers and inmates or detainees in county jails and other correctional facilities that have bed capacities of 100 or more, jails that house inmates transferred from a county that has a jail with a capacity of 100 or more beds, and jails that house inmates from another state or country. Source Note: The provisions of this §97.171 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective December 15, 1997, 22 TexReg 12056; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.171 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108821&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108821 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108821&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108821 03/11/2026 These sections cover the screening process (tests, administration of tests, interpretation of tests, vaccination, x-rays, frequency of screening tests, and exemption from testing); professional examinations, criteria for repeat testing and treatment of latent tuberculosis infection; diagnostic evaluations, isolation and disease prevention; treatment; reporting requirements; and recordkeeping for all employees, volunteers, and inmates of county jails and other correctional facilities in Texas. Source Note: The provisions of this §97.172 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.172 Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108822&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108822 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108822&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108822 03/11/2026 Screening for tuberculosis (TB) in institutional settings usually involves testing for latent tuberculosis infection (LTBI) and additional evaluation of those who are infected. In some correctional facilities, it may be more practical to screen with chest x-rays to identify individuals with lung abnormalities suggestive of pulmonary tuberculosis. While the chest x-ray method is more expensive, it can be an acceptable technique to identify and segregate tuberculosis suspects; however, use of the chest x-ray screening method on intake is to be followed by testing for latent TB infection within 14 days.(1) Tuberculin skin test. (A) The tuberculin skin test utilizing purified protein derivative (PPD) is the standard method of identifying persons infected with Mycobacterium tuberculosis, the causative agent of TB. The intradermal Mantoux PPD test, not a multiple puncture test, shall be used to detect latent tuberculosis infection. (B) The Mantoux PPD test is the only type of testing material that is supplied by the Texas Department of Health (department). (2) Administration of tests. (A) The Mantoux PPD test can be applied by anyone properly trained in tuberculin skin testing procedures including applying, reading, and interpretation. (B) Unlicensed personnel should be supervised by licensed health care workers according to the requirements of the Board of Medical Examiners and Board of Nurse Examiners in conformity with the Texas Medical Practice Act and the Nurse Practice Act, §218.11, and other applicable laws. (3) Interpretation of tests for latent tuberculosis infection. (A) The Mantoux PPD test shall be read 48 to 72 hours after injection. However, if the person is not available for the scheduled reading, positive reactions may still be measurable up to one week after testing. The reading shall be based on measurement of induration (palpable swelling), not erythema (redness). The diameter of induration shall be measured transversely to the long axis of the forearm and recorded in millimeters. (B) A reaction of 5 mm or greater shall be considered positive in persons who are human immunodeficiency virus (HIV) infected, who are recent contacts to TB cases, who have apical fibronodular infiltrates on chest x-rays consistent with prior tuberculosis, or persons with organ transplants and other immunosuppressed persons receiving the equivalent of 15 mg/d or greater of prednisone for 1 month or more. All other persons tested in a correctional facility will be considered positive if their skin test reaction is 10 mm or greater. (C) Absence of a reaction to the tuberculin test does not exclude the diagnosis of TB or latent TB infection. Persons who have symptoms consistent with active tuberculosis shall be evaluated for disease even if they have a negative skin test. (D) The PPD test can be read by anyone properly trained in tuberculin skin testing procedures including applying and reading. (E) Positive tuberculin reactions in Bacillus Calmette-Guerin (BCG)-vaccinated persons usually indicate infection with TB. Such persons shall be evaluated for treatment of latent TB infection. Skin tests shall be interpreted without regard to a history of BCG vaccination. (4) Scope. Skin test screening for tuberculosis shall be performed on employees and volunteers as well as inmates of county jails and correctional facilities as follows. (A) Employees. (i) Employees who share the same air with inmates shall be screened at time of employment and at least annually thereafter according to this section unless the employee or volunteer is exempt as described in clauses (ii), (iii), or (iv) of this subparagraph. A certificate or similar document may be used to record results. The recommended certificate is located in §97.179 of this title (relating to the Tuberculosis Record). (ii) Employees with a history of a positive tuberculin skin test shall provide documentation of the test and any appropriate medical follow-up or a certificate signed by a physician or registered nurse. The documentation shall be included in the certificate or a similar document. (iii) Employees are exempt from screening if the screening conflicts with the tenets of an organized religion to which they belong. (iv) Employees may be exempt from screening if medically contraindicated based on an examination signed by a physician. The only valid contraindication is a documented history of severe reaction to a tuberculin skin test. (v) Employees with a history of negative skin tests who are close contacts to a known or suspected case of TB shall be skin tested after exposure. If the test is still negative, they shall be retested 90 days after break in contact with the known or suspected case of TB occurs. (B) Volunteers. (i) All volunteers who share the same air space with inmates on a regular basis (more than 30 hours per month) shall be screened prior to becoming a volunteer and at least annually thereafter according to this section unless the volunteer is exempt as described in clauses (ii), (iii), or (iv) of this subparagraph. A certificate or similar document may be used to record results. The recommended certificate is located in §97.179 of this title. (ii) Volunteers with a history of a positive tuberculin skin test shall provide documentation of the test and any appropriate medical follow-up or a certificate signed by a physician or registered nurse. The documentation shall be included in the certificate or a similar document. (iii) Volunteers are exempt from screening if the screening conflicts with the tenets of an organized religion to which they belong. (iv) Volunteers may be exempt from screening if medically contraindicated based on an examination signed by a physician. The only valid contraindication is a documented history of severe reaction to a tuberculin skin test. (v) Volunteers with a history of negative skin tests who are close contacts to a known or suspected case of TB shall be skin tested after exposure. If the test is still negative, they shall be retested 90 days after break in contact with the known or suspected case of TB occurs. (C) Inmates. (i) With the exception of those inmates who meet the criteria in clauses (iii), (iv) or (v) of this subparagraph, all inmates who reside (or are expected to reside) in the facility for seven days or longer shall be screened according to this section. A certificate or similar document may be used to document results. The recommended certificate is located in §97.179 of this title (relating to Tuberculosis Record). (ii) Every inmate shall have a screening test on or before the seventh day of incarceration and at least annually thereafter if the inmate is not known to be a previous positive reactor. (iii) Every inmate must have a screening test unless the inmate has documented results of at least one screening test during the previous 12-month period or documented history of a positive tuberculin skin test. An inmate with a history of a positive tuberculin skin test shall provide documentation of the test and any appropriate medical follow-up. The documentation shall be included in the certificate or a similar document. (iv) Inmates are exempt from screening if the screening conflicts with the tenets of an organized religion to which they belong. (v) Inmates may be exempt from screening if medically contraindicated based on an examination signed by a physician. The only valid contraindication is a documented history of severe reaction to a tuberculin skin test. (vi) Inmates with a history of negative skin tests who are close contacts to a known or suspected case of TB shall be skin tested after exposure. If the test is still negative, they shall be retested 90 days after break in contact with the known or suspected case of TB occurs. (5) X-ray screening programs. (A) Correctional facilities may elect to perform chest x-rays on inmates on intake instead of a skin test screening program; however, use of the chest x-ray screening method on intake is to be followed by testing for latent TB infection within 14 days. (B) If inmate chest x-rays screening is done on inmates, the requirement for skin test screening of staff and volunteers will remain in effect. (6) Frequency of screening tests. (A) Frequency. Annual (or more frequent) tuberculosis (TB) screening of employees, volunteers, or inmates is required. When a specific situation indicates an increased risk of transmission, more frequent TB screening is recommended. (B) Repeat tests. Employees or volunteers who have a verified record of a previous positive test for TB do not have to have repeat tests. Source Note: The provisions of this §97.173 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective December 15, 1997, 22 TexReg 12056; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.173 Screening https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108823&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108823 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108823&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108823 03/11/2026 (a) Examination for active tuberculosis (TB).(1) Persons with positive tuberculin skin tests or with skin-test conversions on repeat testing or after exposure shall be clinically evaluated for active TB. Persons with symptoms suggestive of TB shall be evaluated regardless of skin-test results.(2) If TB is diagnosed, appropriate therapy shall be instituted according to accepted medical practice.(A) Persons diagnosed with active TB shall be offered counseling and human immunodeficiency virus (HIV)-antibody testing.(B) The need for counseling and HIV testing should be stressed in persons diagnosed with active TB.(b) Latent TB infection without disease.(1) Persons who have latent TB infection but do not have symptoms or radiologic findings suggestive of TB disease shall be evaluated for treatment of latent TB infection. Persons with positive skin tests shall be evaluated for risk of HIV infection. If HIV infection is considered a possibility, counseling and HIV-antibody testing shall be strongly encouraged.(2) All persons with a history of TB or latent TB infection are at risk for developing TB in the future. These persons shall be reminded at least annually and following their exposure to a known or suspected case of TB that they shall promptly report any pulmonary symptoms. If symptoms of TB develop, the person shall be evaluated immediately.(3) Routine chest films are not required for asymptomatic persons who have negative tests for latent TB infection. After the initial chest radiograph is taken, persons with positive tuberculin skin-test reactions do not need repeat chest radiographs, unless symptoms develop that may be due to TB. Source Note: The provisions of this §97.174 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.174 Scope of Professional Examinations/Evaluation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108824&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108824 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108824&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108824 03/11/2026 (a) The following flow chart shows the steps used in the diagnostic evaluation process.Attached Graphic(b) Bacteriologic examinations of specimens. (1) Persons with TB symptoms and/or chest x-ray suggestive of active TB will need bacteriologic evaluation of sputum or another specimen for "acid fast bacilli" (AFB) smear and culture. (2) Initially, a series of three sputum specimens shall be collected and examined by smear and culture. At least two of the sputum specimens shall be collected early in the morning of successive days. Supervision shall be used to ensure proper specimen collection. (3) The Texas Department of Health will supply appropriate sputum collection materials and perform the smear and culture tests. Source Note: The provisions of this §97.175 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.175 Diagnostic Evaluations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108825&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108825 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108825&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108825 03/11/2026 (a) Treatment of latent TB infection, no disease.(1) Treatment of latent TB infection is the administration of medicine to which a person's infecting organism is presumed to be susceptible. Treatment of latent TB infection substantially reduces the risk of developing active tuberculosis (TB) in infected persons.(2) All persons who have latent TB infection with no symptoms suggestive of TB disease or radiographic findings suggestive of TB disease shall be considered for treatment of latent TB infection in accordance with current recommendations of the Centers for Disease Control and Prevention and of the department.(b) Treatment of active TB disease.(1) When symptoms and/or results of skin test, chest x-ray, and sputum smear suggest active tuberculosis (TB), the suspect shall be placed on a TB treatment regimen consisting of four drugs until TB has been ruled out, unless another regimen is indicated due to contraindications to one or more of the preferred drugs.(2) Clinical response to treatment shall be monitored, since the development of drug resistance can be a problem. Persons with clinically active disease shall be monitored bacteriologically through the collection of at least one sputum sample taken monthly until conversion to negative is confirmed by all cultures being negative in two consecutive months. Persistence or reappearance of organisms in the sputum smear shall create a high index of suspicion for drug-resistant disease or noncompliance with therapy. When this occurs, evaluate compliance and perform drug susceptibility tests, in addition to those obtained from the initial positive cultures. The inmate shall also be evaluated for possible reintroduction of isolation.(3) Treatment of TB shall be in accordance with current Centers for Disease Control and Prevention (CDC)/American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) recommendations and the recommendations of the department. Source Note: The provisions of this §97.176 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.176 Treatment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108826&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108826 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108826&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108826 03/11/2026 (a) Respiratory isolation of inmates. (1) To prevent the spread of Mycobacterium tuberculosis in the facility, it is important to recognize and isolate inmates (in appropriate TB respiratory isolation facilities) who have symptoms suggestive of TB disease. Officers and health care staff shall suspect TB in inmates with a persistent cough (more than two weeks duration), especially in the presence of other symptoms or signs compatible with TB, such as weight loss, night sweats, bloody sputum, anorexia or fever. These inmates shall be evaluated for TB no later than 72 hours after observation or report of symptoms. The inmate shall not leave appropriate TB respiratory isolation until TB is excluded or the inmate is on therapy and documented to be noninfectious. (2) Inmates suspected of having TB shall be placed in respiratory isolation until they are no longer infectious. Inmates who are cases or suspects shall be released from isolation only after infectiousness has been ruled out. Three consecutive negative sputum smears must be obtained before an inmate who has had a positive smear can be considered noninfectious. At least two of the sputum specimens shall be collected early in the morning of consecutive days. (3) Cough-inducing procedures can place health staff and nearby inmates at special risk of acquiring TB infection. These procedures include sputum collection, bronchoscopy, and the administration of aerosolized pentamidine. It is very important to carry out such procedures in an individual room or booth with negative pressure relative to adjacent rooms and hallways, ideally with room or booth air exhausted directly to the outside and away from all windows and air intake ducts. Inmates should remain in the booth or treatment room and not return to common areas until coughing has subsided. (4) The installation of ultraviolet (UV) lights may be considered in some facilities, especially in high volume, high turnover holding facilities. However, UV lights shall be used only to supplement other control measures (such as good ventilation). Proper precautions and scheduled maintenance of the lights are essential. (b) Work restrictions for jail employees and volunteers. (1) Jail facility employees and volunteers with current pulmonary or laryngeal TB pose a risk to inmates and others while they are infectious; therefore, stringent work restrictions for these persons are necessary. They shall be excluded from work until adequate treatment is instituted, cough is resolved, sputum is free of bacilli on three consecutive smears (at least two of the sputum specimens shall be collected early in the morning of consecutive days), and they have received a release for work signed by their physician or the local health authority. Employees and volunteers with current TB at sites other than the lung or larynx usually do not need to be excluded from work if concurrent pulmonary TB has been ruled out. Employees and volunteers who discontinue treatment before the recommended course of therapy has been completed shall not be allowed to work until treatment is resumed, an adequate response to therapy is documented, they have three consecutive negative sputum smears (at least two of the sputum specimens shall be collected early in the morning of consecutive days), and they have received a release for work signed by their physician or the local health authority. (2) Employees and volunteers who are otherwise healthy and receiving treatment for latent TB infection shall be allowed to continue usual work activities. (3) Employees and volunteers who cannot take or do not accept or complete a full course of treatment for latent TB infection shall have their work situations evaluated to determine whether reassignment is indicated. Work restrictions may not be necessary for otherwise healthy persons who do not accept or complete treatment for latent TB infection. These persons shall be counseled about the risk of developing disease and shall be instructed to seek evaluation promptly if symptoms develop that may be due to TB, especially if they have contact with high-risk inmates (i.e., inmates at high risk for severe consequences if they become infected.) Source Note: The provisions of this §97.177 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective December 15, 1997, 22 TexReg 12056; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.177 Prevention of Disease https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108829&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108829 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108829&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108829 03/11/2026 (a) Cases.(1) All suspected or diagnosed cases of tuberculosis (TB) shall be reported within one working day to the local health authority or a Texas Department of Health regional office.(2) The following information shall be reported: complete name, date of birth, physical address and county of residence, information on which diagnosis was based or suspected. In addition, if known, radiographic or diagnostic imaging results and date(s); all information necessary to complete the most recent versions of forms TB 400 A & B (Report of Case and Patient Services), TB 340 (Report of Contacts) and TB 341 (Continuation of Report of Contacts); laboratory results used to guide prescribing, monitoring or modifying antibiotic treatment regimens for tuberculosis to include, but not limited to, liver function studies, renal function studies, and serum drug levels; pathology reports related to diagnostic evaluations of tuberculosis; reports of imaging or radiographic studies; records of hospital or outpatient care to include, but not limited to, histories and physical examinations, discharge summaries and progress notes; records of medication administration to include, but not limited to, directly observed therapy (DOT) records, and drug toxicity and monitoring records; a listing of other patient medications to evaluate the potential for drug-drug interactions; and copies of court documents related to court ordered management of tuberculosis. Reporting forms are available from local health departments, Texas Department of Health regional offices, or the TB Elimination Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756.(b) Latent TB infection.(1) All occurrences of latent TB infection shall be reported no later than one week after diagnosis to the local health authority or a Texas Department of Health regional office.(2) The following information shall be reported: complete name; date of birth; physical address, county of residence, tuberculin skin test result, and chest x-ray result.(3) For those with latent TB infection who are receiving treatment all information necessary to complete the most recent versions of forms TB 400 A & B (Report of Case and Patient Services) shall be reported.(c) Tuberculin tests. Aggregate numbers of positive tests, total tests administered, and total tests read shall be reported monthly to the local health authority that shall forward the reports to the TB Elimination Division of the Texas Department of Health.(d) Contacts. For contacts to a known case of tuberculosis--complete name; date of birth; physical address; county of residence; and all information necessary to complete the most recent versions of forms TB 400 A & B (Report of Case and Patient Services), TB 340 (Report of Contacts), and TB 341 (Continuation of Report of Contacts) shall be reported to the local health authority or a Texas Department of Health regional office. Source Note: The provisions of this §97.178 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective December 15, 1997, 22 TexReg 12056; amended to be effective May 29, 2003, 28 TexReg 4151; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.178 Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108830&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108830 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108830&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108830 03/11/2026 (a) Form and content of the certificate. The certificate is part of a multipurpose form, Tuberculosis Record, which shall be used for certification that an employee or volunteer does not have tuberculosis; a medical record of the screening, evaluation, and/or treatment of an employee or volunteer or an inmate; or as a medical transfer record for employees, volunteers, or inmates moving from one correctional facility to another. This form, or equivalent information, must accompany an inmate whenever he or she is transferred from one correctional facility to another. (b) Deadline for filing a certificate. The deadline for filing certificates is one month after the certificate is completed and signed by a physician. The certificate shall be filed with the local health authority. (c) Tuberculosis record. The Tuberculosis Record is a multipurpose report form that can be used for a Certificate, Record of Transfer, and/or a Tuberculosis History Record. The form shall be used to submit the reports pertaining to an employee, volunteer, or inmate of a jail or correctional facility. The form to be used is as follows and is available from the Texas Department of Health upon request.Attached Graphic Source Note: The provisions of this §97.179 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.179 Tuberculosis Record https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108831&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108831 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108831&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108831 03/11/2026 Under the terms of Chapter 786, §3, 73rd Legislature (Act), the costs of providing inmate screening, evaluation, and treatment is supported by a combination of individual counties and judicial districts, Texas Department of Health (department), and Texas Department of Criminal Justice (TDCJ) funds. The following terms govern this allocation.(1) Texas Department of Health. The Texas Department of Health (department) shall supply the materials, pharmaceuticals, and laboratory services to covered jails and community corrections facilities that are necessary to accomplish the screening required by the Act, and provide other services requested by individual counties and judicial districts, where such services can be reasonably provided. These materials, drugs, and services may be requested from the Texas Department of Health, Tuberculosis Elimination Division, 1100 West 49th Street, Austin, Texas 78756.(2) Texas Department of Criminal Justice.(A) The Texas Department of Criminal Justice (TDCJ) shall provide funds for administering screenings, evaluating inmates, and administering drugs to two classes of inmates suspected of having an active case of tuberculosis. The two classes are:(i) inmates whose paperwork and processing required under Code of Criminal Procedure, 8, Subsection (a), Article 42.09, has been completed; and(ii) inmates in a community corrections facility.(B) The TDCJ shall reimburse a county or judicial district in the same manner provided for reimbursements under Government Code, §499.123.(3) Counties and judicial districts. Counties and judicial districts shall provide funds for administering screenings, evaluating inmates, and administering drugs to inmates suspected of having an active case of tuberculosis:(A) for inmates who are pretrial, inmates whose paperwork and processing under Code of Criminal Procedure, §8, Subsection (a), Article 42.09, is not completed; and(B) for inmates who are not to be transferred to a TDCJ facility. Source Note: The provisions of this §97.180 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.180 Resource Allocation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108832&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108832 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108832&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108832 03/11/2026 (a) Counties, judicial districts, and private entities operating community corrections facilities shall adopt local standards for screening tests of employees, volunteers, and inmates.(b) The standards required in subsection (a) of this section shall, at minimum, be compatible with, and at least as stringent as, the standards set out in these sections. In addition the standards shall incorporate the requirements set out in the Texas Health and Safety Code, §§89.001-89.072.(c) Prior approval of the Texas Department of Health (department) shall be obtained before the adoption of local jail standards.(d) Prior to final adoption of local jail standards, the jail TB screening plan shall be submitted to the Texas Department of Health, Tuberculosis Elimination Division, 1100 West 49th Street, Austin, Texas 78756-3199. The department shall review the jail TB screening plans to determine their compliance with subsection (b) of this section and the Texas Health and Safety Code, §89.073. This approval shall be from the director of the Tuberculosis Elimination Division. If the approval is denied by the director of the Tuberculosis Elimination Division, the county, judicial district, or private entity may appeal the denial to the Bureau Chief, Bureau of Communicable Disease Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756. Source Note: The provisions of this §97.190 adopted to be effective May 16, 1994, 19 TexReg 3370; amended to be effective December 15, 1997, 22 TexReg 12056; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.190 Approval of Local Jail Screening Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108833&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108833 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108833&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108833 03/11/2026 A correctional facility regardless of size that houses adult or youth inmates, must assure continuity of care for those inmates receiving treatment for tuberculosis who are being released or transferred to another correctional facility. A facility must contact the department prior to the inmate being released or transferred, if possible. If that is not possible, the facility must make the contact immediately upon the inmate's release from custody or transfer to another correctional facility. Source Note: The provisions of this §97.191 adopted to be effective December 15, 1997, 22 TexReg 12056; amended to be effective April 1, 2004, 29 TexReg 3192. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES H TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES §97.191 Continuity of Care https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125079 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125079 03/11/2026 These requirements apply to nursing homes that are licensed institutions serving residents who are elderly persons as defined by the Health and Safety Code, §242.002. Source Note: The provisions of this §97.201 adopted to be effective March 26, 2000, 25 TexReg 2345; amended to be effective June 19, 2006, 31 TexReg 4863. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES I IMMUNIZATION REQUIREMENTS FOR RESIDENTS OF TEXAS NURSING HOMES §97.201 Facilities Included in Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125080&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125080 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125080&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125080 03/11/2026 (a) Nursing homes are required to offer immunizations in accordance with the most recent recommendations of the Advisory Committee on Immunization Practices (ACIP).(1) Pneumococcal vaccine for residents. The facility must offer pneumococcal vaccination to all residents 65 years of age or older who have not received this immunization and to residents younger than 65 years of age who have not received this vaccine but are candidates for vaccination because of chronic illness. Pneumococcal vaccine must be offered both to residents who currently reside in the facility and to new residents upon admission. Vaccination must be completed unless the vaccine is medically contraindicated by a physician or the resident refuses the vaccine. Vaccine administration must be in accordance with the recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention at the time of the vaccination.(2) Influenza vaccine for residents and employees. The facility must offer influenza vaccination to residents and employees in contact with residents. Vaccination must be completed unless the vaccine is medically contraindicated by a physician or unless the employee or resident has refused the vaccine.(A) Influenza vaccination for all residents and employees must be completed by November 30 of each year. Employees hired or residents admitted after this date and during the influenza season (through March of each year) must receive influenza vaccinations unless medically contraindicated by a physician or unless the employee or resident has refused the vaccine.(B) Vaccine administration must be in accordance with the recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention at the time of the most recent vaccination.(b) Documentation of receipt or refusal of vaccinations. Immunization records will be maintained for each employee in contact with residents and will show the date of the receipt or refusal of each annual influenza vaccination. The medical record for each resident will show the date of the receipt or refusal of the pneumococcal and the annual influenza vaccines. Source Note: The provisions of this §97.202 adopted to be effective March 26, 2000, 25 TexReg 2345; amended to be effective June 19, 2006, 31 TexReg 4863. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES I IMMUNIZATION REQUIREMENTS FOR RESIDENTS OF TEXAS NURSING HOMES §97.202 Required Immunizations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126279 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126279 03/11/2026 The following words and terms when used in this subchapter and Health and Safety Code, Chapter 96 ("Respiratory Syncytial Virus") shall have the following meanings unless the context clearly indicates otherwise.(1) Department--The Department of State Health Services.(2) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.(3) Health facility includes:(A) a general or special hospital licensed by the department under Health and Safety Code, Chapter 241;(B) a physician-owned or physician-operated clinic;(C) a publicly or privately funded medical school;(D) a state hospital or state school maintained and managed by the Department of State Health Services or the Department of Aging and Disability Services;(E) a public health clinic conducted by a local health unit, health department, or public health district organized and recognized under Health and Safety Code, Chapter 121; and(F) another facility specified by a rule adopted by the executive commissioner.(4) Local health unit--Defined in Health and Safety Code, §121.004.(5) RSV--Respiratory Syncytial Virus. Source Note: The provisions of this §97.251 adopted to be effective September 14, 2006, 31 TexReg 7351. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES K RESPIRATORY SYNCYTIAL VIRUS §97.251 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126280 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126280 03/11/2026 (a) Except as specifically authorized by this subchapter and Health and Safety Code, Chapter 96 ("Respiratory Syncytial Virus"), reports, records, and information furnished to a department employee or to an authorized agent of the department that relate to cases or suspected cases of a health condition are confidential and may be used only for the purposes of this subchapter.(b) Reports, records, and information relating to cases or suspected cases of health conditions are not public information under Government Code, Chapter 552, and may not be released or made public on subpoena or otherwise except as provided by this chapter.(c) The department may release medical, epidemiological, or toxicological information:(1) for statistical purposes, if released in a manner that prevents the identification of any person;(2) to medical personnel, appropriate state agencies, health authorities, regional directors, and public officers of counties and municipalities as necessary to comply with this subchapter and Health and Safety Code, Chapter 96 ("Respiratory Syncytial Virus") relating to the identification, monitoring, and referral of children with RSV; or(3) to appropriate federal agencies, such as the Centers for Disease Control and Prevention of the United States Public Health Service. Source Note: The provisions of this §97.252 adopted to be effective September 14, 2006, 31 TexReg 7351. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES K RESPIRATORY SYNCYTIAL VIRUS §97.252 Confidentiality https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126281&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126281 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126281&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126281 03/11/2026 A health professional, a health facility, or an administrator, officer, or employee of a health facility subject to this subchapter and Health and Safety Code, Chapter 96 ("Respiratory Syncytial Virus") is not civilly or criminally liable for divulging information required to be released under this subchapter and Health and Safety Code, Chapter 96 ("Respiratory Syncytial Virus"), except in a case of gross negligence or willful misconduct. Source Note: The provisions of this §97.253 adopted to be effective September 14, 2006, 31 TexReg 7351. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES K RESPIRATORY SYNCYTIAL VIRUS §97.253 Limitation of Liability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126282&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126282 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126282&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126282 03/11/2026 Another state board, commission, agency, or governmental entity capable of assisting the department in carrying out the intent of this subchapter and Health and Safety Code, Chapter 96 ("Respiratory Syncytial Virus") shall cooperate with the department and furnish expertise, services, and facilities to the sentinel surveillance program. Source Note: The provisions of this §97.254 adopted to be effective September 14, 2006, 31 TexReg 7351. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES K RESPIRATORY SYNCYTIAL VIRUS §97.254 Cooperation of Governmental Entities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=159761&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 159761 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=159761&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 159761 03/11/2026 The department shall establish and maintain a sentinel surveillance program for RSV infection in children. The program will:(1) maintain a central database of laboratory-confirmed cases of RSV that can be used to investigate the incidence, prevalence, and trends of RSV; and(2) recruit at least one health care facility or provider associated with a health care facility in each Health Service Region of the State to report RSV data. Source Note: The provisions of this §97.255 adopted to be effective September 14, 2006, 31 TexReg 7351; amended to be effective December 20, 2012, 37 TexReg 9777. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES K RESPIRATORY SYNCYTIAL VIRUS §97.255 Sentinel Surveillance Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126284&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126284 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126284&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126284 03/11/2026 (a) To ensure an accurate source of data, the department may require a health facility or health professional to make available for review by the department or by an authorized agent medical records or other information that is in the facility's or professional's custody or control and that relates to an occurrence of RSV.(b) The department shall request that data on RSV be reported weekly to the department through an existing surveillance program as specified by the department.(c) The data reported should include at minimum the total number of laboratory tests performed for RSV infection and the total number of positive tests for RSV infection collected during the week for which it is reported. Source Note: The provisions of this §97.256 adopted to be effective September 14, 2006, 31 TexReg 7351. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES K RESPIRATORY SYNCYTIAL VIRUS §97.256 Data Collection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=159762&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 159762 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=159762&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 159762 03/11/2026 The department may use the data to:(1) design and evaluate measures to prevent the occurrence of RSV and other health conditions; and(2) provide information and education to providers on the incidence of RSV infection. Source Note: The provisions of this §97.257 adopted to be effective September 14, 2006, 31 TexReg 7351; amended to be effective December 20, 2012, 37 TexReg 9777. 1 DEPARTMENT OF STATE HEALTH SERVICES 97 COMMUNICABLE DISEASES K RESPIRATORY SYNCYTIAL VIRUS §97.257 Database https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210820&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210820 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210820&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210820 03/11/2026 This subchapter establishes procedures and eligibility guidelines for programs under the Texas HIV Medication Program (THMP) as required in the Texas Health and Safety Code, §85.063.(1) THMP operates in accordance with federal AIDS Drug Assistance Program legislation to assist low-income individuals living with HIV with direct medication assistance for medications on the program formulary or costs associated with eligible health insurance policies, including premiums and medication cost-sharing (deductibles, copayments, and coinsurance) and Medicare prescription drug plans.(2) Program enrollment and services are subject to available funding. Source Note: The provisions of this §98.101 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.101 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210821&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210821 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210821&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210821 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Applicant--An individual who applies to the department for THMP services.(2) Commissioner--The Commissioner of the Department of State Health Services.(3) Department--The Department of State Health Services.(4) Eligible health insurance policy--A state, federal, or private health insurance policy that is approved by the THMP and covers at least one drug from each class of HIV-antiretroviral medication and covers appropriate primary care services.(5) Formulary--A list of drugs approved by the department that includes at least one drug from each class of HIV antiretroviral medications. https://www.dshs.texas.gov/hivstd/meds/files/formulary.pdf.(6) Full-LIS--Full Low-income subsidy. The Social Security Administration provides full-LIS to applicants with income and assets below specified limits.(7) HIV--Human immunodeficiency virus. Encompassing all stages of HIV, including HIV-related conditions and syndromes.(8) Legally responsible person--A parent, managing conservator, or other person that is legally responsible for the support of a minor or a ward.(9) Medicare prescription drug plan--A Medicare Part D prescription drug plan or the prescription drug component of a Medicare Part C Advantage Plan.(10) Minor--A person who is younger than 18 years of age and who has not been emancipated by a court or who is not married or recognized as an adult by the state of Texas.(11) Open enrollment--A time period during which one may freely enroll in or change one's selection of a health insurance plan or other benefit plan that is ordinarily subject to restrictions.(12) Out-of-pocket costs--The premium, copay, coinsurance, and deductible amounts that an individual would be expected to pay when enrolled in a health insurance plan or Medicare prescription drug plan.(13) Partial-LIS--Partial Low-income subsidy. The Social Security Administration provides partial-LIS to applicants with income and assets above the level of those qualifying for full-LIS, but still below specified limits.(14) Payor of last resort--A funding source that may be used only after all other available public and private funding sources have been accessed.(15) Qualifying event--A change of life circumstance that allows an individual to enroll in or change the selection of a health insurance plan or other benefit plan outside of open enrollment.(16) SPAP--The State Pharmacy Assistance Program. The SPAP is available to low-income individuals living with HIV who also have Medicare Part D.(17) Texas resident--An individual is considered a Texas resident if that person physically resides in Texas and intends to continue to reside within the state.(18) THMP--The Texas HIV Medication Program, which includes the AIDS Drug Assistance Program (ADAP), SPAP, and TIAP.(19) TIAP--Texas Insurance Assistance Program. TIAP provides premium and copay assistance with eligible health insurance policies. Source Note: The provisions of this §98.102 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.102 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210822&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210822 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210822&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210822 03/11/2026 (a) The department shall give priority to participation in THMP to eligible women and infants and to individuals younger than 18 years of age as specified in 42 U.S.C. 300ff-21, and Texas Health and Safety Code §85.062.(b) An individual is eligible to participate in THMP if the individual meets the following eligibility criteria:(1) provides proof of diagnosis of HIV;(2) is under the care of a physician, physician's assistant, or advanced practice nurse licensed to practice in the United States;(3) is a Texas resident; and(4) is at or below 200% of the federal poverty level and meets the financial eligibility criteria established by THMP Policy 220.001 https://www.dshs.texas.gov/hivstd/policy/policies/220-001.shtm; and:(A) is not covered for approved THMP medications under the Texas Medicaid Program, or has exhausted Medicaid pharmacy benefits for the given month;(B) does not qualify for assistance, receives less than full coverage, or needs assistance with out-of-pocket costs for approved THMP medications under any state compensation program, qualifying private health insurance policy, or under any other state or federal health benefits program;(C) meets THMP's payor of last resort criteria that is in accordance with state law, department policy, and corresponding federal grant conditions, in which Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87) (RWHAP) or State Services funds cannot be used as a payment source for any service that can be paid for or charged to any other billable source, and providers are expected to make reasonable efforts to secure other funding instead of RWHAP Part B or State Services funding, whenever possible; and(D) has an annual income that meets guidance as determined by:(i) an applicant's annual gross income (if single), or the combined annual gross income of the applicant and the applicant's spouse, minus a standard deduction applied in accordance with program policy;(ii) for a minor child, the (combined) annual gross income of the child's parent or parents, minus a standard deduction, and only the income of the parent or parents living in the same household as the child at the time of application or renewal is used to determine financial eligibility; and(iii) for an emancipated minor, financial eligibility is determined as set forth in this paragraph. Source Note: The provisions of this §98.103 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.103 THMP Eligibility Criteria https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210823&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210823 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210823&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210823 03/11/2026 (a) AIDS Drug Assistance Program (ADAP). In addition to §98.103 of this title (relating to THMP Eligibility Criteria), an individual must attest that the individual is not enrolled in any state, federal, or private health insurance policies or benefits programs that cover the individual's currently prescribed medications that are on the THMP formulary.(b) SPAP. In addition to §98.103 of this title, an individual must be enrolled in a Medicare prescription drug plan that covers the individual's current medications that are on the formulary and apply for low-income subsidy (LIS) assistance. Those approved with full-LIS are disenrolled from the SPAP program, while those with partial-LIS and who are denied LIS remain eligible for participation in SPAP. (Information on Medicare eligibility, Medicare prescription drug plans and LIS assistance can be found at http://www.medicare.gov.)(c) TIAP. In addition to §98.103 of this title, an individual must be enrolled in an eligible health insurance policy that covers the individual's current medications on the formulary, as updated. An applicant may be screened for TIAP during open enrollment or when the applicant has experienced a qualifying event. Source Note: The provisions of this §98.104 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.104 Specific Program Eligibility Criteria https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210824&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210824 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210824&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210824 03/11/2026 (a) New applicants to THMP. An individual meeting the eligibility requirements must submit a complete application for benefits to THMP, in the format specified by THMP, certifying that the statements made within the application are factual and true, submitted as instructed, and accompanied by the required supporting documentation. To request an application packet, please follow current procedures on THMP's webpage found at www.dshs.texas.gov/hivstd/meds.(b) Renewals. An individual must renew enrollment in THMP according to the procedures established by THMP. An individual must demonstrate continuing eligibility using THMP's renewal application and comply with all associated deadlines and requirements for accompanying documents.(c) Eligibility Determination.(1) Approved. If approved, the applicant is eligible for THMP services.(2) Incomplete. Any application that does not meet all requirements of this section is considered incomplete. Incomplete applications are not processed further, and the applicant is contacted concerning the insufficiency of the application.(3) Pending. THMP may, at the time of application and at any time during enrollment, verify the eligibility status of an enrolled individual to determine if the individual is continuing to meet the eligibility criteria of THMP. The individual must furnish requested documentation to THMP as directed. Until this is completed, the status of enrollment is considered pending.(4) Denial, non-renewal, and termination of benefits. An individual may be denied enrollment, be denied renewal, or have enrollment in THMP terminated for any of the following reasons:(A) failure to maintain Texas residency, or upon request, furnish evidence of such;(B) failure to continue to meet income requirements for eligibility or to provide income data as requested, as THMP shall periodically verify the financial status of an enrolled individual to determine if the individual continues to meet financial eligibility criteria;(C) failure to initially meet or continue to meet the medical requirements for eligibility;(D) become eligible for the full-LIS under Medicare Part D;(E) become incarcerated in a city, county, state, or federal jail or prison, in accordance with Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87), Health Resources and Services Administration (HRSA) Policy Clarification Notice (PCN) #18-02, and Texas Code of Criminal Procedure Article §104.002(a);(F) admitted or committed to a Texas state hospital or state supported living facility;(G) determined by THMP that the individual has made a material misstatement or misrepresentation on the individual's application or any document required to support the individual's application or renewal, or on submissions made to comply with subsection (a) or (b) of this section;(H) failure to notify THMP of changes to permanent home address or insurance coverage;(I) notified THMP in writing that the individual no longer wants to receive THMP benefits;(J) failure to request or use services during any period of six consecutive months; or(K) exhausted THMP program funds.(d) Denial, modification, suspension, or termination of services. An applicant or individual is governed by the procedures required by §98.106 of this title (relating to Appeal Process and Exceptions). Source Note: The provisions of this §98.105 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.105 Eligibility Determination Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210825&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210825 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210825&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210825 03/11/2026 (a) An individual whose application is denied, or whose services have been terminated by THMP, may appeal the department's decision within 60 days of postmark of the notification. An applicant, individual, or person legally responsible for an applicant or individual may initiate the appeal process by notifying the department's HIV/STD Prevention and Care Unit that the individual wishes to dispute the department's decision. The written notice must contain all arguments and supporting documents being put forward for the appeal. The notice should be addressed to the Department of State Health Services, HIV/STD Prevention and Care Unit, Texas HIV Medication Program, Attn: MSJA, Mail Code 1873, P.O. Box 149347, Austin, Texas, 78714-3947 or in another manner allowed by the department.(b) A department review panel will hear the appeal within 30 days of receipt of the written notice. The appellant will be notified by mail of the appeal. The panel shall consist of:(1) the TB/HIV/STD Section Director;(2) the HIV/STD Prevention and Care Unit Manager;(3) the Texas HIV Medication Program Manager; and(4) the Infectious Disease Medical Officer (or equivalent positions, in the event of a department reorganization).(c) The appellant may present the case in person or in another manner allowed by the department before the panel or rely on the written submissions. The issues on appeal and the arguments in support of those issues are limited to those already submitted in writing. Following review of the materials, and hearing from the appellant (if applicable), the panel will issue a written decision within 60 days of the hearing. The panel's decision shall be final for the eligibility determination that is appealed. The appellant may reapply to the program at any time in the future.(d) The department is not required to offer an opportunity to dispute the decision to deny, non-renew, or terminate if THMP's actions are the result of the exhaustion of THMP program funds. Source Note: The provisions of this §98.106 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.106 Appeals Process and Exceptions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210826&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210826 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210826&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210826 03/11/2026 THMP provides drugs at the best price available, including purchasing health insurance if the criteria are met, and THMP participates in the 340B Drug Pricing Program to ensure program medications are available at the best price.(1) AIDS Drug Assistance Program (ADAP) Medication Coverage.(A) The medications provided under ADAP are listed on the THMP formulary, found at https://www.dshs.texas.gov/hivstd/meds/files/formulary.pdf.(B) THMP does not approve the dispensing of ADAP medications in excess of a 90-day supply, or full bottle increments, whichever is greater. The program may also dispense medications in 30-day or 60-day supplies.(C) Prescribers must attest that certain medications meet specific prescribing requirements, including lab testing, before requesting these medications from THMP. These requirements are outlined in the THMP formulary, found at www.dshs.texas.gov/hivstd/meds/document.shtm.(D) The department may contract with a pharmaceutical wholesaler for purchase of drugs. The department distributes drugs to pharmacies participating in ADAP and to a mail order pharmaceutical distributor for the dispensing of drugs directly to individuals who reside outside areas covered by participating pharmacies.(E) The department delivers services directly or through external pharmacies approved by THMP that have signed a Memorandum of Agreement with the department.(F) A dispensing fee may be collected from the department by a participating pharmacy for each prescription dispensed in accordance with the existing Memorandum of Agreement with the department. Eligible individuals shall not be charged any dispensing fees directly by a participating pharmacy.(2) SPAP and TIAP Medication Coverage.(A) The department may contract with a claims processor to interface with plans that provide eligible health insurance plans on behalf of the programs.(B) Benefits payable by THMP:(i) Eligible health insurance policy out-of-pocket expenses, which include deductibles, copays, and coinsurance amounts.(ii) THMP may assist eligible individuals in obtaining public or private health insurance by providing insurance premium payment assistance to the insurance company, and if paying for such health insurance, it can reasonably be expected to be cost effective for THMP. Source Note: The provisions of this §98.107 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.107 THMP Benefits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210827&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210827 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210827&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210827 03/11/2026 (a) In the event of a statewide emergency declared by the Governor, THMP may temporarily adjust program operations to ensure that mission critical functions continue. These cost containment measures will be approved by the Commissioner in writing.(b) THMP funds must be used as payor of last resort and coordinated with other local, state, and federal funds, including Medicaid and Medicare.(1) To ensure THMP's expenditures do not exceed the budget, the department analyzes the latest actuarial projections for the upcoming year, including the average annual cost per individual and the projected number of individuals THMP will be able to serve using current budget figures. The department performs this analysis of THMP expenditures every quarter to determine if funds are sufficient to meet projected expenditures.(2) To make certain that expenditures do not exceed the program's budget, the department may implement the following temporary cost-containment measures as necessary.(c) If budgetary limitations exist, this information will be shared with stakeholders at least 60 days before implementation. The department has discretion to:(1) Restrict or prioritize covered services based upon:(A) medical necessity;(B) other third-party eligibility and projected third party payments for the different treatment modalities; or(C) caseloads and demands for services based on current or projected data.(2) Discontinue use of the standard deduction adjusting the applicant's gross annual income described in §98.103(b)(4)(D) of this title (relating to THMP Eligibility Criteria).(3) Lower the financial eligibility criteria established by THMP policy 220.001 https://www.dshs.texas.gov/hivstd/policy/policies/220-001.shtm to a level that is not lower than 125% of federal poverty level.(4) Change covered services by adding or deleting specific services or entire categories, making changes proportionally across a category or categories, using a combination of these methods, or establishing a waiting list of eligible applicants. Appropriate information is collected from each applicant who is placed on a waiting list. The information is used to facilitate contacting the applicant when benefits become available and to allow efficient enrollment application processing if the budgetary limitations loosen. In the event of a waiting list, the department shall give priority to participation in THMP to eligible women and infants and to individuals younger than 18 years of age.(d) As funds become available, the department will rescind the cost-containment measures in a manner which the department judges most appropriate given the circumstances at that time. Source Note: The provisions of this §98.108 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.108 Limitations and Cost Containment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210828&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210828 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210828&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210828 03/11/2026 (a) Nondiscrimination. The department operates the THMP in a manner that allows full participation of individuals, regardless of their race, color, national origin, age or disability. For purposes of THMP, discrimination based on gender or sexual orientation is prohibited.(b) Confidentiality. No information that could identify an individual applicant is released except as authorized by law and in accordance with §1.501 of this title (relating to Privacy of Health Information under the Health Insurance Portability and Accountability Act of 1996). An applicant is advised that, in addition to the department, the physicians, pharmacists, and designated Medicare prescription drug plan will be aware of the applicant's diagnosis.(c) Disclose. The department may use or disclose individual health information to provide, coordinate, or manage health care or related services, as allowed by law. This includes referring the individual to other health care resources. The department may contact a THMP applicant or individual to discuss enrollment benefits, resources for treatment, or other health-related information as appropriate.(d) Privacy notice. An individual may request a copy of the department's privacy notice by contacting the THMP. Source Note: The provisions of this §98.109 adopted to be effective November 17, 2022, 47 TexReg 7557. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.109 Nondiscrimination and Confidentiality https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201309&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201309 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=201309&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 201309 03/11/2026 (a) The committee. The Texas HIV Medication Advisory Committee is mandated under Texas Health and Safety Code Chapter 85, Subchapter K, and is governed under the terms of those statutory provisions and by this section. The purpose of the committee is to advise the executive commissioner and the Texas Department of State Health Services (department) in the development of procedures and guidelines for the Texas HIV Medication Program (program).(b) Tasks. The committee shall:(1) review the aims and the goals of the program;(2) evaluate ongoing program efforts;(3) recommend both short-range and long-range goals and objectives for medication needs;(4) recommend medications for addition to or deletion from the program's formulary; and(5) carry out any other tasks given to the committee by the executive commissioner.(c) Committee abolished. By August 1, 2030, the executive commissioner will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date.(d) Terms of office. The term of office of each member shall be six years. Members shall serve after expiration of their term until a replacement is appointed.(1) Members shall be appointed for staggered terms so that the terms of a substantially equivalent number of members will expire on December 31st of each even-numbered year.(2) If a vacancy occurs, a person may be appointed to serve the unexpired portion of that term.(e) Meetings. The committee shall meet only as necessary to conduct committee business.(1) A quorum for the purpose of transacting official business is six members.(2) The committee is authorized to transact official business only when in a legally constituted meeting with quorum present.(f) Attendance. Members shall attend committee meetings as scheduled. Members shall attend meetings of subcommittees to which they are assigned.(1) A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting.(2) It is grounds for removal from the committee if a member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability, is absent from more than half of the committee and subcommittee meetings during a calendar year, or is absent from at least three consecutive committee meetings. Source Note: The provisions of this §98.121 adopted to be effective October 28, 2012, 37 TexReg 8318; amended to be effective February 9, 2017, 42 TexReg 430; amended to be effective October 5, 2020, 45 TexReg 7041. 1 DEPARTMENT OF STATE HEALTH SERVICES 98 TEXAS HIV MEDICATION PROGRAM C TEXAS HIV MEDICATION PROGRAM §98.121 Texas HIV Medication Advisory Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158039 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158039 03/11/2026 (a) Purpose. This section implements the Texas Occupational Conditions Reporting Act, Health and Safety Code, Chapter 84, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules concerning the reporting and control of occupational conditions.(b) Definitions. The following words and terms, when used in these sections, shall have the following meanings unless the context clearly indicates otherwise.(1) Case--A person in whom an occupational condition is diagnosed by a physician or other health professional acting within the scope of the professional license, based upon clinical evaluation, interpretation of laboratory and/or roentgenographic findings, and an appropriate occupational history.(2) Commissioner--The commissioner of health.(3) Department--The Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756.(4) Local health authority--The chief administrative officer of a public health district or a local health department, or the physician who is to administer state and local laws relating to public health.(5) Occupational conditions--Those diseases, abnormal health conditions or laboratory findings that are caused by or are related to exposures in the workplace.(6) Reportable occupational condition--Any occupational disease, condition or laboratory finding for which an official report is required. See subsection (d) of this section.(7) Report of occupational condition--The notification to the appropriate authority of the occurrence of a specific occupational disease in a human, including all information required by the procedures established by this rule.(8) Suspected case--A case in which an occupational condition is suspected, but the final diagnosis is not yet made.(c) Reporting requirements.(1) It is the duty of every physician or health professional holding a license to practice in the State of Texas to report promptly to the local health authority each patient she or he shall examine and who has or is suspected of having any reportable occupational condition. The local health authority may authorize a staff member to transmit reports.(2) It is the duty of every person who is in charge of a clinical or hospital laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields microscopical, cultural, serological, chemical, or other evidence suggestive of a reportable condition to report promptly that information to the local health authority.(3) The reporting physician, health professional, or laboratory director shall make the report in writing. A local health authority may authorize one or more employees under his or her supervision to receive the report from the physician, health professional, or laboratory director by telephone; use of this alternative, if authorized, is at the option of the reporter. The local health authority shall implement a method of verifying the identity of the telephone caller when that person is unfamiliar to the employee.(4) The local health authority shall collect the reports and transmit the information at weekly intervals to the Environmental and Injury Epidemiology and Toxicology Unit, Environmental Epidemiology and Disease Registries Section, Department of State Health Services, Mail Code 1964, P.O. Box 149347, Austin, Texas, 78714-9347. Transmission may be made by mail or electronic transfer.(A) If by mail the reports shall be placed in a sealed envelope addressed to the attention of the Environmental and Injury Epidemiology and Toxicology Unit, Environmental Epidemiology and Disease Registries Section, Department of State Health Services, Mail Code 1964, P.O. Box 149347, Austin, Texas, 78714-9347, and marked "Confidential Medical Records."(B) If by electronic transmission, including facsimile transmission by telephone, it shall be in a manner and form authorized by the commissioner or his or her designee in each instance. Any electronic transmission of the reports must provide at least the same degree of protection against unauthorized disclosure as those of mail transmission. The commissioner or his or her designee shall, before authorizing such transmission, establish guidelines for establishing and conducting such transmission.(5) When an occupational condition is reported to a local health authority, and the person diagnosed as having the condition resides outside his or her area of local health jurisdiction, the local health authority receiving the report shall notify the appropriate local health authority where the person or persons reside. The department shall assist the local health authority in providing such notifications if requested.(d) Reportable conditions and information to be reported.(1) The reportable occupational conditions are: asbestosis, silicosis, blood lead levels in persons 15 years of age or older, and acute pesticide poisoning.(2) Reports for asbestosis and silicosis shall include all information collected by the reporting person and required to complete the most recent version of the department's Asbestosis and Silicosis Case Report Form F09-11626.(3) Reports for blood lead levels in persons 15 years of age and older shall include all information collected by the reporting person and required to complete the most recent version of the department's Adult Blood Lead Report Form F09-11624.(4) Reports for acute pesticide poisoning shall include all information collected by the reporting person and required to complete the most recent version of the department's Pesticide Poisoning Report Form EF09-11927.(e) General control measures for reportable occupational conditions. The commissioner or his or her duly authorized representative shall, as circumstances may require, proceed as follows:(1) investigation shall be made for the purpose of verifying the diagnosis, ascertaining the source of the causative agent, obtaining an occupational and employment history and discovering unreported cases;(2) collection of specimens of the body tissues, fluids, or discharges and of materials directly or indirectly associated with the case, as may be necessary in confirmation of the diagnosis, and their submission to a laboratory for examination;(3) obtaining samples of air or materials from the current or former business or place of employment of a case, as may be necessary to ascertain if a public health hazard exists. If a hazard is found the commissioner or his/her designee shall make appropriate recommendations concerning the hazard.(f) Confidential nature of case reporting.(1) All case reports received by the local health authority or the Department of State Health Services are confidential records and not public records. These records will be held in a secure location and accessed only by authorized personnel.(2) The department may use information obtained from reports or health records for statistical and epidemiological studies which may be public information as long as an individual is not identifiable. Source Note: The provisions of this §99.1 adopted to be effective October 11, 1985, 10 TexReg 3766; amended to be effective March 1, 1998, 23 TexReg 1581; amended to be effective May 23, 2002, 27 TexReg 4357; amended to be effective April 24, 2003, 28 TexReg 3333; amended to be effective October 25, 2007, 32 TexReg 7469; amended to be effective August 7, 2012, 37 TexReg 5787. 1 DEPARTMENT OF STATE HEALTH SERVICES 99 OCCUPATIONAL DISEASES §99.1 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197427&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197427 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197427&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197427 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Child--An individual younger than 18 years of age to whom a vaccine has been administered.(2) Consent--A statement signed by an individual or the individual's legally authorized representative agreeing that the individual's immunization history can be included in the immunization registry and that the individual's immunization record may be released from the immunization registry.(3) Data elements--The information:(A) consistent with 42 U.S.C., §300aa-25, as amended, defined as the information a provider who administers a vaccine is required to record in a medical record, including:(i) the date the vaccine is administered;(ii) the type of vaccine administered, vaccine manufacturer and lot number;(iii) the name, address, and if appropriate, the title of the provider administering the vaccine; and(iv) any adverse or unexpected events for a vaccine; and(B) relating to an immunization, antiviral, and/or other medication administered to prepare for a potential disaster, public health emergency, terrorist attack, hostile military or paramilitary action, or extraordinary law enforcement emergency or in response to a declared disaster, public health emergency, terrorist attack, hostile military or paramilitary action, or extraordinary law enforcement emergency.(4) Department--The Department of State Health Services.(5) Extraordinary Law Enforcement Emergency--Within the context of a public health emergency, a situation which requires extra staffing, overtime and/or extra-jurisdictional law enforcement forces.(6) First Responder--As defined by Texas Health and Safety Code, §161.0001.(7) Health information exchange--A health information exchange organization as defined by Texas Health and Safety Code, §182.151.(8) Hostile Military or Paramilitary Act--An attack or other use of force by an armed force of a nation or an organized unofficial group, against forces, property and/or infrastructure of the United States, state or local government.(9) Immediate family member--The parent, spouse, child, or sibling of an individual who resides in the same household as the individual.(10) Immunization history--An accounting of all vaccines that an individual has received, or evidence of immunity, and other identifying information.(11) Immunization record--A record containing the name and date of birth of the individual to whom a vaccine was administered; dates of vaccine administration; types of vaccine administered; and name and address of the provider that administered the vaccines; or other evidence of immunity to a vaccine-preventable disease.(12) Immunization registry--The database or single repository that contains immunization histories, which include necessary personal data for identification. This database is confidential, and access to content is limited to authorized users.(13) Individual--A child, or an adult 18 years of age or older, to whom a vaccine has been administered.(14) Individual's legally authorized representative--As defined by Texas Health and Safety Code, §161.0001.(15) Payor--An insurance company, a health maintenance organization, or another organization that pays a health care provider to provide health care benefits, including the administration of vaccines to an individual.(16) Potential disaster--An incident or event capable of causing widespread or severe damage, injury, or loss of life or property resulting from any natural or man-made cause, including fire, flood, earthquake, wind, storm, wave action, oil spill or other water contamination, volcanic activity, epidemic, air contamination, blight, drought, infestation, explosion, riot, hostile military or paramilitary action, or other public calamity requiring emergency action, or energy emergency.(17) Provider--Any physician, health care professional, or facility personnel duly licensed or authorized to administer vaccines.(18) Public health emergency--An occurrence or imminent threat of an illness or health condition, caused by bioterrorism, epidemic or pandemic disease, or novel and highly fatal infectious agent or biological toxin, that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability. Such illness or health condition includes, but is not limited to, an illness or health condition resulting from a natural disaster.(19) Terrorist attack--An activity that is dangerous to human life and/or potentially destructive of critical infrastructure or key resources and is intended to intimidate or coerce the civilian population, or influence or affect the conduct of a government by mass destruction, assassination, and/or kidnapping.(20) User--An entity or person authorized by the department to access immunization registry data.(21) Vaccine--Includes toxoids and other immunologic agents which are administered to an individual to elicit an immune response (immunization) and thus protect against infectious diseases. Source Note: The provisions of this §100.1 adopted to be effective May 6, 2004, 29 TexReg 4155; amended to be effective August 17, 2008, 33 TexReg 6384; amended to be effective April 2, 2017, 42 TexReg 1456; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197428&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197428 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197428&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197428 03/11/2026 (a) Except as provided by Texas Health and Safety Code, Chapter 161, Subchapter A, §161.00705, information that identifies an individual, and is received by the department for the immunization registry, is confidential and may be used by the department for registry purposes only. Unless specifically authorized by Texas Health and Safety Code, Chapter 161, Subchapter A, the department may not release immunization registry information to any person or entity without the electronic or written consent of the individual or the individual's legally authorized representative.(b) A confidentiality statement shall be signed electronically by an authorized representative of the user of the registry. Any user of the immunization registry shall protect the confidentiality of all immunization histories, records, and reports. Immunization registry information may only be accessed by limited persons, and used for the limited stated purposes, detailed at §100.5(e) of this title (relating to Receipt and Release of Immunization Registry Data). A person required to report information to the department for registry purposes or authorized to receive information from the immunization registry may not disclose identifiable information of an individual to any person or entity without the electronic or written consent of the individual or the individual's legally authorized representative, or except as provided by the Texas Occupations Code, Chapter 159, or the Texas Insurance Code, §602.053.(c) Immunization registry information is not subject to discovery, subpoena, or other means of legal compulsion for release to any person or entity, except as provided by Texas Health and Safety Code, Chapter 161, Subchapter A, Immunization registry information is not admissible in any civil, administrative, or criminal proceeding. Source Note: The provisions of this §100.2 adopted to be effective May 6, 2004, 29 TexReg 4155; amended to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.2 Confidentiality https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197429&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197429 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197429&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197429 03/11/2026 (a) A legally authorized representative of a child shall be informed, via the methodology described at subsection (b) of this section, that the department has established and maintains an immunization registry for the primary purpose of establishing and maintaining a single repository of immunization records to be used in aiding, coordinating, and promoting efficient and cost-effective childhood vaccine-preventable disease prevention and control efforts.(b) The department shall provide written materials and forms to providers for the purpose of informing legally authorized representatives about the immunization registry and specific information collected in that registry.(c) The department and providers may use the immunization registry to provide notices by mail, telephone, personal contact, or other electronic means to a child's legally authorized representative regarding the particular vaccines that the child may be due or overdue according to the department's immunization schedule.(d) The first time the department receives immunization registry data from a person or entity other than the child's legally authorized representative, for a child for whom the department has received consent to be included in the immunization registry, the department shall send a written notice to the child's legally authorized representative disclosing:(1) that providers and payors may be sending the child's immunization information to the department;(2) the information that is included in the immunization registry;(3) the entities or persons to whom the information may be released;(4) the purpose of the immunization registry;(5) the procedure to exclude a child from the immunization registry; and(6) the procedure to report an alleged violation if a legally authorized representative discovers a child is included in the immunization registry after exclusion has been requested. Source Note: The provisions of this §100.3 adopted to be effective May 6, 2004, 29 TexReg 4155; amended to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.3 Informing a Child's Legally Authorized Representative https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197430&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197430 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197430&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197430 03/11/2026 (a) A child's legally authorized representative may consent to the inclusion of the child's immunization history in the immunization registry by doing one of the following:(1) indicating consent at birth certificate registration, including by electronic signature;(2) submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services, Immunization Unit, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Unit, 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Unit at (800) 252-9152 to request a consent form;(3) completing written or electronic consent to be submitted to a health care provider, birth registrar, regional health information exchange, or local immunization registry, who may review that consent and affirm that consent has been obtained via an affirmation process as directed by the department.(b) Unless otherwise provided by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event), the department shall verify consent before including the reported information regarding the child in the immunization registry. Under Texas Health and Safety Code, §161.007(a)(5), the department may elect to verify consent by receiving affirmation from a health care provider, birth registrar, regional health information exchange, or local immunization registry that consent has been obtained. The department shall provide notice to a provider that submits data elements for an individual for whom consent cannot be verified. The notice shall contain instructions for obtaining and affirming consent and resubmitting the data elements to the department.(c) Consent is required to be obtained only one time, and is valid until the child becomes 18 years of age, unless the consent is withdrawn in writing.(d) A legally authorized representative of a child may withdraw consent for the child to be included in the immunization registry at any time by submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services, Immunization Unit, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Unit, 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Unit at (800) 252-9152 to request a consent withdrawal form. Unless otherwise provided by §100.7 of this title, the department shall remove information from the immunization registry for any individual for whom consent has been withdrawn, and the department shall send the legally authorized representative a written confirmation of the removal of the information. The department may not retain identifiable information about any individual for whom consent has been withdrawn except as provided for by §100.7 of this title.(e) A legally authorized representative may request exclusion of a child's immunization history from the immunization registry by doing one of the following:(1) indicating the request for exclusion at birth certificate registration, including by electronic signature; or(2) submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services, Immunization Unit, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Unit, 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Unit at (800) 252-9152 to request an exclusion form. Unless otherwise provided by §100.7 of this title, on receipt of a written request to exclude a child's immunization records from the immunization registry, the department shall send the legally authorized representative a written confirmation of receipt of the request, and shall exclude the child's records from the immunization registry. The department may not retain individually identifiable information about any individual for whom an exclusion has been requested, unless otherwise allowed under §100.7 of this title. Source Note: The provisions of this §100.4 adopted to be effective May 6, 2004, 29 TexReg 4155; amended to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.4 Immunization Registry Consent and Withdrawal Relating to a Child https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197431&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197431 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197431&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197431 03/11/2026 (a) The immunization registry must contain information on the immunization history obtained by the department under this chapter regarding:(1) each individual for whom consent has been obtained;(2) individuals immunized to prepare for or in response to an event under §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event); and(3) first responders or their immediate family members for whom a request has been submitted, as described at §100.8 of this title (relating to First Responder Immunization Information).(b) The department may obtain the data constituting an immunization record for an individual from a public health district, a local health department, the individual or the individual's legally authorized representative, a physician, a payor, or from any health care provider licensed (or otherwise legally authorized) to administer vaccines. Submission of this information must be according to the procedures and in the format prescribed by the department.(c) Except as provided by §100.7 and §100.8 of this title, the department shall verify consent before including information received under subsection (b) of this section in the immunization registry. The department may not retain identifiable information about an individual for whom consent cannot be verified.(d) When the department verifies consent under subsection (c) of this section, it may do so by any of the following, at its discretion:(1) manual or electronic review of the consent form document signed (including by electronic signature) by a legally authorized representative at birth certificate registration;(2) manual or electronic review of a consent form signed by a legally authorized representative and submitted to the department by mail to the Department of State Health Services, Immunization Unit, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Unit, 1100 West 49th Street, MC-1946, Austin, Texas 78756 (consent forms may also be received by facsimile);(3) affirmation by a health care provider, birth registrar, regional health information exchange, or local immunization registry that consent has been obtained, as described in Texas Health and Safety Code, §161.007(a)(5), and in a manner prescribed by the department.(e) Except as limited by subsections (f) and (g) of this section, the department may release the data constituting an immunization record:(1) to the individual or the individual's legally authorized representative; and(2) to the following entities, with those entities subject to the stated limitations:(A) a Texas public health district or a Texas local health department, for public health purposes within their areas of jurisdiction;(B) a physician or any health care provider licensed (or otherwise legally authorized) to administer vaccines in Texas, for treating the individual as a patient;(C) a Texas school or Texas child care facility, for an individual enrolled in that school or child care facility;(D) a payor currently authorized by the Texas Department of Insurance to operate in Texas, for immunization records related to the specific person in Texas covered under the payor's policy; (E) a state agency having legal custody of an individual; and(F) an employer of a first responder, with the prior written or electronic consent of the first responder, for verification of the first responder's immunization history.(3) Direct electronic access to the immunization registry information shall be limited to entities described in paragraph (2) of this subsection, for use under the stated limitations and subject to registration and access requirements as provided by the department.(f) For individuals immunized to prepare for, or in response to, an event covered by §100.7 of this title, the department may release information from the immunization registry as provided in §100.7(f) of this title.(g) For first responders or their immediate family members 18 years of age or older, the department may release information from the immunization registry as provided in §100.8(e) of this title.(h) Texas Health and Safety Code, §161.0105, provides limited liability protections, as described in those provisions.(i) The department may release nonidentifying summary statistics related to the immunization registry that do not individually identify an individual. Source Note: The provisions of this §100.5 adopted to be effective May 6, 2004, 29 TexReg 4155; amended to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.5 Receipt and Release of Immunization Registry Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197432&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197432 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197432&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197432 03/11/2026 (a) Data elements regarding an immunization record provided to the department under this section, whether electronically or by other means, shall be submitted in a format and manner prescribed by the department.(b) Except as otherwise provided by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event), a health care provider who administers an immunization to a child shall provide data elements regarding an immunization to the department within 30 days of administration of the vaccine.(c) A payor that receives data elements from a provider who administers an immunization to a child shall provide the data elements to the department within 30 days of receipt of the data elements from a provider.(d) A child's legally authorized representative may provide evidence of a child's immunization history directly to the department for inclusion in the immunization registry. The department shall ensure that the immunization history submitted by a child's legally authorized representative is medically verified immunization information by requiring the child's legally authorized representative to submit evidence that includes a copy of one or more of the following:(1) the child's medical record indicating the immunization history and including a provider's signature and the name and address of the provider;(2) a vaccine-specific invoice from a health care provider for the immunization;(3) vaccine-specific documentation showing that a claim for the immunization was paid by a payor;(4) an immunization record signed by a school official; or(5) an immunization history provided by a local or state immunization registry.(e) A provider shall, upon request of the department, provide additional information to clarify data elements submitted to the department.(f) The department shall provide instruction and education to providers about the immunization registry provider application and enrollment process and expedite processing of provider applications. Source Note: The provisions of this §100.6 adopted to be effective May 6, 2004, 29 TexReg 4155; amended to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.6 Reporting to the Immunization Registry, and Medical Verification, relating to a Child https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197433&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197433 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197433&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197433 03/11/2026 (a) The immunization registry shall contain information regarding individuals who receive an immunization, antiviral, or other medication administered:(1) to prepare for a potential disaster, public health emergency, terrorist attack, hostile military or paramilitary action, or an extraordinary law enforcement emergency event, as those terms are defined in §100.1 of this title (relating to Definitions);(2) in response to a declared disaster, public health emergency, terrorist attack, hostile military or paramilitary action or extraordinary law enforcement emergency event, as those terms are defined in §100.1 of this title.(b) A health care provider who administers an immunization, antiviral, or other medication as described in subsection (a) of this section shall provide the data elements to the department, within 30 days of that medical treatment, in a format and manner prescribed by the department.(c) The department shall track, in the immunization registry, adverse reactions to an immunization, antiviral, or other medication administered as described in subsection (a) of this section. A health care provider who administers such an immunization, antiviral, or other medication may provide data related to adverse reactions to the department, in a format and manner prescribed by the department, for inclusion in the immunization registry. Department tracking will be based on the reports it receives under this subsection.(d) Unless consent is obtained and verified, the individually identifiable information collected in the immunization registry under this section shall only be retained in the immunization registry for a period of five years following the end of the event as described in subsection (a) of this section. The end date of these occurrences shall be as specifically provided for by law. In the absence of law which specifically determines the end date, the department shall determine such an end date and post that date on its website.(e) An adult or an individual's legally authorized representative may consent in writing to the continued inclusion of the individual's information collected under this section in the immunization registry past the retention time period specified in subsection (d) of this section by:(1) mailing (or faxing) written or electronic notification to the department, in a format prescribed by the department, at: Department of State Health Services, Immunization Unit, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Unit, 1100 West 49th Street, MC-1946, Austin, Texas 78756, (a consent form may be obtained by calling the Immunization Unit at (800) 252-9152, or online at https://www.dshs.texas.gov/immunize/immtrac/; or(2) completing a consent form document, which must be verified by affirmation by a health care provider in a manner prescribed by the department.(f) The department may release the information collected in the immunization registry under this section with consent of the adult or an individual's legally authorized representative, or to a state agency or health care provider for:(1) the purposes outlined in Texas Health and Safety Code, Chapter 161, Subsection A; or(2) the purpose of aiding and coordinating communicable disease prevention and control efforts during an event as described in subsection (a) of this section. Source Note: The provisions of this §100.7 adopted to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.7 Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197434&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197434 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197434&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197434 03/11/2026 (a) An adult 18 years of age or older who is a first responder or an immediate family member of a first responder may request that a health care provider who administers an immunization to the adult provide the data elements regarding the immunization to the department for inclusion in the immunization registry.(b) A health care provider, on receipt of a request under subsection (a) of this section, shall submit the data elements to the department within 30 days of administration of the vaccine in a format and manner prescribed by the department. The department shall verify the request before including the information in the immunization registry. The department may elect to verify the request for inclusion in the immunization registry by obtaining an affirmation from the health care provider that a request has been received.(c) An adult 18 years of age or older who is a first responder or an immediate family member of a first responder may request inclusion of that adult's immunization history in the immunization registry by:(1) mailing written or electronic notification to the department, in a format prescribed by the department, at: Department of State Health Services, Immunization Unit , MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Unit, 1100 West 49th Street, MC-1946, Austin, Texas 78756, (a request form may be obtained by calling the Immunization Unit at (800) 252-9152, or online at https://www.dshs.texas.gov/immunize/immtrac/; or(2) completing a written request to the adult's health care provider, to be verified by affirmation (in a manner prescribed by the department) by the health care provider that such a request has been received.(d) The department shall ensure that the immunization history submitted by the adult 18 years of age or older who is a first responder or an immediate family member of a first responder under subsection (c)(1) of this section is medically verified immunization information by requiring the adult 18 years of age or older who is a first responder or an immediate family member of a first responder to submit evidence that includes a true and accurate copy of one or more of the following:(1) the adult's medical record indicating the immunization history and including a provider's signature and the name and address of the provider;(2) a vaccine-specific invoice from a health care provider for the immunization;(3) vaccine-specific documentation showing that a claim for the immunization was paid by a payor;(4) an immunization record signed by a school official; or(5) an immunization history provided by a local or state immunization registry.(e) The department may release the information collected in the immunization registry under this section with consent of the adult or to any health care provider licensed or otherwise authorized to administer vaccines.(f) An adult whose immunization records are included in the immunization registry under this section may send a written or electronic request that the department remove the information from the immunization registry. The department shall remove the adult's immunization records from the immunization registry not later than the 10th day after receiving a request. Source Note: The provisions of this §100.8 adopted to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.8 First Responder Immunization Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137409&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137409 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=137409&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 137409 03/11/2026 An immunization record obtained from the immunization registry shall be accepted as an official immunization record of the individual. Source Note: The provisions of this §100.9 adopted to be effective August 17, 2008, 33 TexReg 6384. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.9 Official Immunization Record https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197435&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197435 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197435&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197435 03/11/2026 (a) An adult or an individual's legally authorized representative may file a complaint with the department related to the department's alleged failure to comply with a request for exclusion of an individual from the immunization registry by mailing such a complaint to: Manager, Department of State Health Services, Immunization Unit, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Manager, Immunization Unit, Department of State Health Services, 1100 West 49th Street, MC-1946, Austin, Texas 78756; or by e-mail to the attention of Manager, Immunization Unit at feedback.ImmDirector@dshs.state.tx.us. The department shall respond to the written complaint within 30 days after receipt of that complaint.(b) An adult or an individual's legally authorized representative may report an incident of discrimination for requesting exclusion of an individual from the immunization registry, or for using an exemption for a required immunization, by mailing written notification to: Manager, Department of State Health Services, Immunization Unit, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Manager, Immunization Unit, Department of State Health Services, 1100 West 49th Street, MC-1946, Austin, Texas 78756; or by e-mail to the attention of Manager, Immunization Unit at feedback.ImmDirector@dshs.state.tx.us. The department shall respond to the written notification within 30 days after receipt of that notification.(c) The department shall report to the Legislative Budget Board, the governor, the lieutenant governor, the speaker of the House of Representatives, and appropriate committees of the legislature not later than September 30 of each even-numbered year. The report shall:(1) include the number of complaints received by the department related to the department's alleged failure to comply with requests for exclusion of individuals from the immunization registry;(2) identify all reported incidents of discrimination for requesting exclusion of individuals from the immunization registry or for using an exemption for a required immunization;(3) include the number of complaints received by the department related to the department's alleged failure to remove information from the immunization registry as required by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event) after an event described in that section; and(4) include the number of complaints received by the department related to the department's alleged failure to comply with written requests for the removal of information relating to first responders and their immediate family under §100.8 of this title (relating to First Responder Immunization Information). Source Note: The provisions of this §100.10 adopted to be effective August 17, 2008, 33 TexReg 6384; amended to be effective January 1, 2020, 44 TexReg 7984. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.10 Complaints https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183272&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183272 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183272&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183272 03/11/2026 (a) Notwithstanding Health and Safety Code, §161.0073 and §161.008, and subject to the provisions of the department's data usage agreement, a health information exchange, as defined in Health and Safety Code, Chapter 182, may access and transmit health-related information under Health and Safety Code, §161.007(d), §161.00705(a), §161.00706(b), and §161.008(i), if the access or transmittal is:(1) made for the purpose of assisting in the reporting of immunization registry information to the appropriate agency;(2) requested and authorized by the appropriate health care provider, practitioner, physician, facility, or other person who is required to report data elements regarding an immunization record as outlined in Health and Safety Code, Chapter 182;(3) made in accordance with the applicable consent requirements for the immunization registry under Health and Safety Code, Chapter 182; and(4) made in accordance with the requirements of Health and Safety Code, Chapter 182 and all other state and federal law.(b) A health information exchange may only use and disclose the information that it accesses or transmits under subsection (a) of this section in compliance with this chapter and all applicable state and federal law, and may not exchange, sell, trade, or otherwise make any prohibited use or disclosure of the information. Source Note: The provisions of this §100.11 adopted to be effective April 2, 2017, 42 TexReg 1456. 1 DEPARTMENT OF STATE HEALTH SERVICES 100 IMMUNIZATION REGISTRY §100.11 Authority of a Health Information Exchange https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213167&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213167 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213167&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213167 03/11/2026 The purpose of these rules is to implement Texas Health and Safety Code, Chapter 161, Subchapter P, "Disclosure of Ingredients in Cigarettes and Tobacco Products." Source Note: The provisions of this §101.1 adopted to be effective June 4, 1998, 23 TexReg 5687; amended to be effective April 2, 2023, 48 TexReg 1723. 1 DEPARTMENT OF STATE HEALTH SERVICES 101 TOBACCO §101.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213168&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213168 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213168&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213168 03/11/2026 The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.(1) Annual report--A tobacco manufacturer's annual report to the department, which provides the ingredient information.(2) Cigar--A roll, for smoking, of fermented tobacco that is wrapped in tobacco and from which the main stream of smoke produces an alkaline reaction to litmus paper.(3) Cigarette--A roll for smoking, made of tobacco or tobacco mixed with another ingredient and wrapped or covered with a material other than tobacco and that is not a cigar.(4) Department--The Texas Department of State Health Services.(5) Ingredient--Any ingredient, substance, chemical, or compound other than tobacco, water, or reconstituted tobacco sheet made wholly from tobacco, which is present in the product, including flavorants, processing aides, casing sauces, contaminants, combustion modifiers, and packing materials, to the full extent the manufacturer is aware of the presence of any such ingredient.(6) Manufacturer--A person who manufactures, fabricates, or assembles, or causes or arranges for the manufacture, fabrication, or assembly of cigarettes or tobacco products for sale or distribution.(7) Risks to public health--The possibility or actuality of adverse health effects associated with tobacco use, including nicotine addiction and adverse health effects associated with exposure to environmental tobacco smoke.(8) Tobacco product--(A) A cigar;(B) smoking tobacco, including granulated, plug-cut, crimp-cut, ready-rubbed, and any form of tobacco suitable for smoking in a pipe or as a cigarette;(C) chewing tobacco, including Cavendish, twist, plug, scrap, and any kind of tobacco suitable for chewing;(D) snuff or other preparations of pulverized tobacco; or(E) an article or product that is made of tobacco or a tobacco substitute and that is not a cigarette or an e-cigarette as defined by Texas Health and Safety Code §161.081. Source Note: The provisions of this §101.2 adopted to be effective June 4, 1998, 23 TexReg 5687; amended to be effective April 2, 2023, 48 TexReg 1723. 1 DEPARTMENT OF STATE HEALTH SERVICES 101 TOBACCO §101.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213169&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213169 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213169&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213169 03/11/2026 (a) Before December 1 of each year, the manufacturer of any cigarettes or tobacco product distributed in the State of Texas shall report to the department, in accordance with Texas Health and Safety Code, §161.352, the ingredients of any such cigarette or tobacco product. The annual report shall be sent to: Tobacco Prevention and Control Program, Texas Department of State Health Services, P.O. Box 149347, MC 1965, Austin, Texas 78714; or Tobacco Prevention and Control Program, Texas Department of State Health Services, 1100 West 49th Street, MC 1965, Austin, Texas 78756; or via email to tobacco.free@dshs.texas.gov.(b) Nothing in this section shall prohibit a manufacturer or distributor of cigarettes or tobacco products from selling such products to an in-state merchant for sale or distribution outside the state. Source Note: The provisions of this §101.3 adopted to be effective June 4, 1998, 23 TexReg 5687; amended to be effective May 16, 1999, 24 TexReg 3509; amended to be effective April 2, 2023, 48 TexReg 1723. 1 DEPARTMENT OF STATE HEALTH SERVICES 101 TOBACCO §101.3 General Requirements for Annual Reports by Manufacturers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213170&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213170 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213170&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213170 03/11/2026 In each annual report, a manufacturer shall provide the following for each brand, sub-brand, and generic unbranded cigarette or tobacco product, including cigars, distributed in the State of Texas.(1) A list of all ingredients in the cigarette or tobacco product listed in descending order according to weight, measure, or numerical count, other than tobacco, water, or a reconstituted tobacco sheet made wholly from tobacco. Each ingredient shall be reported by its chemical name and chemical abstract service registry number, if available, on the ingredient reporting form located on the department website: https://www.dshs.texas.gov/tobacco/contactus/.(2) The name, job title, address, and telephone number of the individual designated by the manufacturer as the department's contact person concerning Texas Health and Safety Code, Chapter 161, Subchapter P, and this chapter and person responsible for the accuracy of the annual report submitted. Source Note: The provisions of this §101.4 adopted to be effective June 4, 1998, 23 TexReg 5687; amended to be effective April 2, 2023, 48 TexReg 1723. 1 DEPARTMENT OF STATE HEALTH SERVICES 101 TOBACCO §101.4 Ingredient Reporting Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213171&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213171 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213171&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213171 03/11/2026 (a) The department tobacco program manager (manager) is responsible for the control of ingredient information. The manager shall designate in writing an individual to assume the responsibilities for control of ingredient information in case of the absence or unavailability of the manager.(b) The manager shall approve a list of department employees with demonstrated need to have access to the space or drive where the ingredient information contained in annual reports submitted pursuant to Texas Health and Safety Code, Chapter 161, Subchapter P, is retained (hereinafter "authorized individuals").(c) Authorized individuals shall not copy or reproduce by any means brand-specific reported ingredient information contained in an annual report. Authorized individuals shall take all precautions necessary to ensure that no unauthorized person overhears or otherwise intentionally or inadvertently receives such information.(d) Annual reports shall be retained according to the appropriate department record retention schedule. At the end of the retention period, annual reports shall be destroyed.(e) Storage Space.(1) Information identified by the manufacturer as confidential ingredient information in an annual report pursuant to Texas Health and Safety Code, Chapter 161, Subchapter P, that is submitted in hard paper copy shall be secured and maintained in a secure storage space.(2) Information identified by the manufacturer as confidential ingredient information in an annual report pursuant to Texas Health and Safety Code, Chapter 161, Subchapter P, that is submitted in electronic format (via email) shall be secured and maintained in a secure drive.(3) The storage space shall be secured at all times and only authorized individuals will have access to the storage space. Source Note: The provisions of this §101.7 adopted to be effective May 16, 1999, 24 TexReg 3509; amended to be effective April 2, 2023, 48 TexReg 1723. 1 DEPARTMENT OF STATE HEALTH SERVICES 101 TOBACCO §101.7 Security of Report Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213172&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213172 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213172&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213172 03/11/2026 (a) Information included in an annual report filed under this chapter is public information and is not confidential unless it is determined to be confidential under Texas Health and Safety Code §161.354. (b) Before releasing any information, the department shall: (1) submit the information to the attorney general with a request that the attorney general make the determinations called for under Texas Health and Safety Code §161.354(b) and (d), and Texas Government Code §552.110; (2) submit the information to the attorney general in accordance with procedures set out in the Texas Government Code, Chapter 552, and the attorney general's Public Information Act Handbook ; (3) contemporaneous with each submission under this subsection, notify the person who submitted the information so that person may exercise his or her rights under Texas Government Code §552.305; and (4) following an opinion from the attorney general under this subsection, which would allow release of any information, the submitter of the information shall be immediately notified, and the department shall delay release for 30 days to allow: (A) the department to make the determination called for in Texas Health and Safety Code, §161.354(c); and (B) the submitter of the information opportunity to obtain judicial review of the attorney general's opinion. Source Note: The provisions of this §101.10 adopted to be effective June 4, 1998, 23 TexReg 5687; amended to be effective April 2, 2023, 48 TexReg 1723. 1 DEPARTMENT OF STATE HEALTH SERVICES 101 TOBACCO §101.10 Public Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158830&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158830 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158830&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158830 03/11/2026 (a) This chapter implements the Health and Safety Code, §§12.131 - 12.139 and the responsibilities of the Department of State Health Services (department) under the Agreement Regarding Disposition of Tobacco Settlement Proceeds (agreement) filed on July 24, 1998, in United States District Court, Eastern District of Texas, in the case styled The State of Texas v. The American Tobacco Co., et al., No. 5-96CV-91. The term "agreement" includes the subsequent Clarification of Agreement Regarding Disposition of Settlement Proceeds filed on July 24, 1998, in that litigation.(b) The term "political subdivision" means a hospital district, another local political subdivision owning or maintaining a public hospital, or a county of the State of Texas responsible for providing indigent health care to the general public. The Health and Safety Code, Chapter 61, defines which entities are responsible for providing indigent health care to the general public. Source Note: The provisions of this §102.1 adopted to be effective February 3, 2000, 25 TexReg 579; amended to be effective November 20, 2003, 28 TexReg 10225; amended to be effective December 30, 2007, 32 TexReg 9631; amended to be effective October 7, 2012, 37 TexReg 7752. 1 DEPARTMENT OF STATE HEALTH SERVICES 102 DISTRIBUTION OF TOBACCO SETTLEMENT PROCEEDS TO POLITICAL SUBDIVISIONS §102.1 General https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158831&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158831 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158831&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158831 03/11/2026 (a) A political subdivision may receive a pro rata share of the annual distribution by the Comptroller of Public Accounts (comptroller) under the agreement. The department will certify to the comptroller the percentage of the annual distribution that each political subdivision is eligible to receive. The comptroller is responsible for transmitting the payments to the eligible political subdivisions.(b) The income earned through investment of the permanent trust account established under the agreement will be distributed in April of each year. Only the earnings of the account will be distributed. The corpus of the fund will remain in the permanent trust account.(c) A political subdivision that receives a pro rata share of the annual distribution has sole authority over the expenditure of those funds. The agreement does not require a political subdivision to expend any portion of the distribution for a specified purpose; however, any portion of the distribution expended for unreimbursed health care expenditures in a calendar year may be counted toward the political subdivision's pro rata share of the annual distribution in the subsequent year. Source Note: The provisions of this §102.2 adopted to be effective February 3, 2000, 25 TexReg 579; amended to be effective November 20, 2003, 28 TexReg 10225; amended to be effective December 30, 2007, 32 TexReg 9631; amended to be effective October 7, 2012, 37 TexReg 7752. 1 DEPARTMENT OF STATE HEALTH SERVICES 102 DISTRIBUTION OF TOBACCO SETTLEMENT PROCEEDS TO POLITICAL SUBDIVISIONS §102.2 Distributions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=180275&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 180275 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=180275&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 180275 03/11/2026 (a) General. A political subdivision may claim a pro rata share of the annual distribution based on its "unreimbursed health care expenditures" in the previous calendar year. These expenditures are defined in the agreement as "those actual expenditures made by a political subdivision which are directly attributable to the provision of health care services to the general public, either directly or by contract or agreement with a third party provider, and for which no reimbursement is made by or expected from any third party source or fund. (Lump Sum Trust Account or Permanent Trust Account payments shall not count as reimbursement.)" The term "unreimbursed expenditures" does not include contractual allowances or discounts for health care services required under a third party payor agreement.(b) Counties not wholly within a hospital district. For a county not wholly within a hospital district, the agreement further states that unreimbursed expenditures are to be calculated as "all unreimbursed amounts, including unreimbursed jail health care, expended by such county for health care services to the general public during that year, plus 15% of that total."(1) The following are examples for which expenditures, if unreimbursed, may be counted:(A) services within the scope of services that hospital districts are authorized by law to provide. These will typically be diagnostic and treatment services for individuals;(B) health care screening, laboratory, and health care case management services;(C) oral health care services;(D) expenditures made from funds in a trust or reserve account for the provision of health care services;(E) health care outreach and prevention efforts, including but not limited to media campaigns, education, counseling, and production and distribution of promotional literature. Typical target areas for these efforts include teenage smoking, child safety, and health hazards affecting the general public;(F) medical transportation, including transportation to and from medical appointments;(G) behavioral health care services, including a physician examination to determine if an individual is in need of mental health care;(H) capital expenditures for direct health care services, such as construction of ambulance facilities or clinics;(I) overhead costs for a health care facility;(J) employee salary and benefits to the extent the employee is engaged in patient health care or other health care services such as the activities described in subparagraph (E) of this paragraph;(K) emergency medical services; and(L) medical supplies or equipment used for the provision of health care services to the general public.(2) The following are examples for which expenditures may not be counted:(A) general administrative or overhead costs of the county not directly related to the provision of health care services such as costs of the county auditor, the county attorney or county commissioner meetings. These general administrative costs are considered to be included within the 15% added to the unreimbursed expenditures;(B) administrative supplies or equipment not directly related to the provision of health care services to the general public, such as computer paper, printers and copier machines;(C) amounts deposited in a trust or reserve account for the provision of health care services but not actually expended for such services;(D) environmental services such as mosquito control, water testing, septic tank inspection, and rabies control;(E) rental assistance for mental health patients;(F) time spent transporting inmates to and from court procedures, such as continued mental health commitments and medication hearings;(G) the amount of a tax abatement given in exchange for an agreement to provide health care services;(H) regulatory activities such as restaurant inspection;(I) 911 services;(J) first responder services;(K) autopsies, burials, and mortician services;(L) meal donation programs; and(M) services to the extent to which the county has received reimbursement or funds through federal or state programs including, but not limited to, county indigent health care, tertiary medical care, emergency medical services grants, permanent fund for children and public health grants, public health block grants, Title XVIII of the Social Security Act (Medicare), Title XIX of the Social Security Act (Medicaid), or crime victims compensation fund.(3) If the county expects to receive reimbursement or funds through federal or state programs, such as those listed in paragraph (2)(J) of this subsection, but has not received reimbursement or funds at the time the county files its annual expenditure statement with the department:(A) the county may include those expenditures which qualify as unreimbursed expenditures under this subsection in its annual expenditure statement filed with the department; and(B) once the county receives reimbursement or funds for the expenditures or any portion of the expenditures described in subparagraph (A) of this paragraph, the county shall subtract the amount of the reimbursement or funds from the amount of unreimbursed expenditures claimable on its next expenditure statement filed with the department.(c) Hospital districts. For a hospital district, the agreement further states that unreimbursed expenditures are to be calculated as "the total amount of taxes collected by the hospital district, together with the unreimbursed amounts expended by a county coterminous with such hospital district for jail health care."(1) The expenditures are the amount of taxes collected in the year for which the annual expenditure statement is filed, not the amount of taxes assessed. A hospital district may count taxes that are owed from previous years if those taxes are collected in the year for which the annual expenditure statement is filed.(2) A hospital district is entitled to claim the amount of its tax collections as unreimbursed expenditures, even if it does not own or operate a hospital.(d) Non-hospital district public hospitals. For a non-hospital district public hospital owned by a political subdivision, the agreement further states that unreimbursed expenditures are to be calculated as "the total unreimbursed amount of political subdivision funds paid to such public hospital by any political subdivision during that year."(1) As stated in subsection (a) of this section, unreimbursed expenditures are defined in the agreement as "those actual expenditures made by a political subdivision which are directly attributable to the provision of health care services to the general public, either directly or by contract or agreement with a third party provider, and for which no reimbursement is made by or expected from any third party source or fund. (Lump Sum Trust Account or Permanent Trust Account payments shall not count as reimbursement)."(2) Under this subsection, a political subdivision may claim political subdivision funds actually paid to the hospital owned by the political subdivision or transferred from a general revenue account of a political subdivision into the hospital's account(s) in order to provide funds for health care services to the general public.(3) A political subdivision may not claim political subdivision funds paid under paragraph (2) of this subsection when reimbursement is received by the hospital or political subdivision from any third party source or fund. Reimbursed funds are not "unreimbursed expenditures" under this subsection.(4) The term "unreimbursed expenditures" does not include contractual allowances or discounts for health care services under a third party payor agreement.(5) The annual distribution paid to a political subdivision under this subsection shall be made to the political subdivision(s) which owns the hospital, not to the hospital itself.(6) A county eligible for a pro rata share of the annual distribution under both subsection (b) and this subsection shall file an expenditure statement for each. Such a county may receive a single warrant from the comptroller.(7) If a county or city handles the financial transactions of its public hospital, rather than the public hospital handling those transactions directly, the county or city may count the unreimbursed expenditures it makes on behalf of the public hospital as funds paid to that hospital.(e) Political subdivisions that have sold or leased a public health care facility.(1) When a political subdivision has sold or leased its public health care facility(s) and accepted an agreement from the new owner or lessee of the facility(s) to provide indigent health care services, the political subdivision is receiving contracted services in lieu of cash as consideration for the sale or lease of the facility(s). In submitting its expenditure statement for the distribution, the political subdivision may claim the value of the health care services for indigent residents of the political subdivision performed by the purchaser or lessee of the facility as if they had been reimbursed using either the Medicaid Diagnosis Related Group (DRG) for the individual patients or the Medicaid interim rate for the facility.(2) When a political subdivision has sold or leased its public health care facility(s) and accepted profits or payments in consideration of the sale or lease, additional non-tax operating funds may result from the profits or payments attributable to the sale or lease. These profits or payments may be used to fund ongoing operations, indigent care obligations, or other statutorily authorized expenditures not otherwise funded by taxes. The profits or payments from the sale or lease that are expended on operations, indigent care, or other statutorily authorized expenditures in any given calendar year are countable, in addition to tax collections received by a hospital district, as unreimbursed expenditures under the agreement. As a result, the expenditures claimable by a political subdivision are increased by the amount of non-tax funding the political subdivision has spent from its accounts containing the profits or payments attributable to the sale or lease of the political subdivision's public health care facility(s), including the interest or investment proceeds from such profits or payments.(f) Procedures.(1) A political subdivision must submit a signed annual expenditure statement to the department, documenting its eligible expenditures for the preceding calendar year:(A) by delivery, fax, or electronic mail received by the department no later than 11:59 p.m. on March 31 of each year; or(B) by U.S. Postal Service mail or commercial mail carrier with a postmark reflecting a date no later than 11:59 p.m. on March 31 of each year. Private metered postmarks shall not be acceptable as proof of timely mailing.(2) If a statement is not received by the department in accordance with the date and methods outlined in paragraph (1) of this subsection, the political subdivision shall not receive a pro rata share of the annual distribution.(3) The department will designate the required format for the documentation. There will be a separate format for hospital districts, counties not wholly in a hospital district, and public hospitals not in a hospital district.(4) To calculate the percentage of the annual distribution to be paid to each political subdivision, the department will combine the eligible expenditures from all statements received, thus obtaining a statewide total. The department will then divide the statewide total into the amount in the expenditure statement submitted by each political subdivision.(5) By April 15 of each year, the department will certify to the comptroller the percentage of the annual distribution to be paid to each eligible political subdivision, based on the expenditure statements. Source Note: The provisions of this §102.3 adopted to be effective February 3, 2000, 25 TexReg 579; amended to be effective February 7, 2001, 26 TexReg 1142; amended to be effective February 6, 2003, 28 TexReg 956; amended to be effective November 20, 2003, 28 TexReg 10225; amended to be effective December 30, 2007, 32 TexReg 9631; amended to be effective October 7, 2012, 37 TexReg 7752; amended to be effective September 27, 2016, 41 TexReg 7488. 1 DEPARTMENT OF STATE HEALTH SERVICES 102 DISTRIBUTION OF TOBACCO SETTLEMENT PROCEEDS TO POLITICAL SUBDIVISIONS §102.3 Annual Claims https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158833&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158833 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158833&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158833 03/11/2026 (a) Regular audits of selected political subdivisions may be performed if the necessary funds and personnel are available to the department.(b) The department has the discretion to decide how and when to select political subdivisions for regular audits. Regular audits may be performed for any year for which a distribution was made under the agreement.(c) At the department's discretion, the department may perform the regular audits, contract with outside auditors to perform the regular audits, or contract with another state agency to perform the regular audits.(d) A regular audit may include a review of any audit or financial statement of the political subdivision performed by persons other than the department. A political subdivision being audited by the department shall make available to the department or its contractor such an audit, financial statement, or other supporting documentation at the department's or its contractor's request. Source Note: The provisions of this §102.4 adopted to be effective February 3, 2000, 25 TexReg 579; amended to be effective November 20, 2003, 28 TexReg 10225; amended to be effective December 30, 2007, 32 TexReg 9631; amended to be effective October 7, 2012, 37 TexReg 7752. 1 DEPARTMENT OF STATE HEALTH SERVICES 102 DISTRIBUTION OF TOBACCO SETTLEMENT PROCEEDS TO POLITICAL SUBDIVISIONS §102.4 Regular Audits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158834&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158834 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158834&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158834 03/11/2026 (a) A political subdivision or agency of this state may dispute information submitted by another political subdivision. A dispute shall be initiated by filing written notice with the department of the issue(s) disputed.(b) A dispute may concern a political subdivision's calculation of unreimbursed expenditures, not whether a political subdivision is entitled to a share of the annual distribution.(c) A dispute must be filed by December 31 of the year in which the disputed information was submitted.(d) An audit of the political subdivision that submitted the disputed information may be performed.(1) The audit shall be initiated by the department or the comptroller. The department or the comptroller shall choose the auditor which may be the department, the comptroller, an outside auditor, or another state agency.(2) The political subdivision shall fully cooperate in the audit. The audit may include a review of any audit or financial statement of the political subdivision.(e) The filing of a dispute will not affect the percentage of the annual distribution to be paid to the political subdivision for the year for which the information that is the subject of the dispute was submitted.(f) A political subdivision for which an audit indicates an overstatement may request in writing a hearing on the matter within 20 days of receiving written notice from the department of the audit findings. The notice shall state whether a monetary penalty is proposed. A monetary penalty may not exceed 10% of the overstated unreimbursed health care costs. A monetary penalty may be imposed if the political subdivision failed to exercise reasonable diligence to comply with the requirements of these rules.(g) If a hearing is requested, the hearing shall be a contested case under the Administrative Procedure Act, Government Code, Chapter 2001, and the department's formal hearing rules in Chapter 1 of this title (relating to Miscellaneous Provisions). If the department elects to impose a monetary penalty, the hearings officer shall consider from the parties evidence regarding, and issue findings of fact and conclusions of law about, whether the political subdivision failed to exercise reasonable diligence to comply with the requirements of these rules.(h) If a political subdivision fails to timely request a hearing or to appear at a scheduled hearing, the findings of the audit and any penalty amount shall be considered final and reported to the comptroller.(i) If after a hearing the department's hearing examiner, on behalf of the Executive Commissioner of the Health and Human Services Commission, finds an overstatement, the findings shall be considered final and reported to the comptroller. This section delegates to the hearing examiner authority to make findings under this section.(j) The costs of the audit shall be paid by the party to the dispute (the entity which originally invoked the dispute process or the political subdivision on which the audit was performed) which does not prevail in the dispute.(k) After a final decision following an audit and the opportunity for a hearing, if a political subdivision has overstated unreimbursed health care expenditures in the information submitted for any year, the department shall report that fact to the comptroller and shall reduce that political subdivision's percentage of the subsequent annual distribution appropriately.(l) If a monetary penalty is applied, the department shall also reduce the political subdivision's percentage of the subsequent annual distribution appropriately.(m) If a political subdivision is assessed the cost of an audit, the department shall report the amount assessed to the comptroller, and the comptroller may withhold that amount from the political subdivision's subsequent annual distribution. The comptroller may use the amount withheld to reimburse the general revenue fund for the cost of the audit. Source Note: The provisions of this §102.5 adopted to be effective February 3, 2000, 25 TexReg 579; amended to be effective November 20, 2003, 28 TexReg 10225; amended to be effective December 30, 2007, 32 TexReg 9631; amended to be effective October 7, 2012, 37 TexReg 7752. 1 DEPARTMENT OF STATE HEALTH SERVICES 102 DISTRIBUTION OF TOBACCO SETTLEMENT PROCEEDS TO POLITICAL SUBDIVISIONS §102.5 Disputes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224197&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224197 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224197&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224197 03/11/2026 (a) These sections implement the following Health and Safety Codes. (1) Chapter 92 authorizes the Executive Commissioner to adopt rules concerning the reporting and control of injuries. (2) Chapter 773, §773.112(c) and §773.113(a)(3), requires the department to establish and maintain a trauma reporting and analysis system. (3) The Texas Department of Health and the Texas Board of Health were abolished by Chapter 198, §1.18 and §1.26, 78th Legislature, Regular Session, 2003. Health and Safety Code, Chapter 1001, establishes the Department of State Health Services (department), which now administers these programs. Texas Government Code §524.0005, provides authority to the Executive Commissioner of the Health and Human Services Commission to adopt rules for the department. (b) The Executive Commissioner or the Executive Commissioner's designee shall, as circumstances may require, proceed as follows. (1) May contact a medical examiner, justice of the peace, physician, hospital, or acute or post-acute rehabilitation facility attending a person with a case or suspected case of a required reportable event. (2) May provide aggregate data with the suppression of values at the discretion of the Texas EMS & Trauma Registries. (3) May release data to other areas of the department. (4) May give information concerning the injury or its prevention to the patient or a responsible member of the patient's household to prevent further injury. (5) May collect, or cause to be collected, medical, demographic, or epidemiological information from any medical or laboratory record or file to help the department in the epidemiologic evaluation of injuries and their causes. (6) Investigation may be made by staff of the department for verifying the diagnosis, ascertaining the cause of the injury, obtaining a history of circumstances surrounding the injury, and discovering unreported cases. (A) May enter at reasonable times and inspect within reasonable limits, a public place or building, including a public conveyance, in the Commissioner's duty to prevent injury. (B) May not enter a private residence to conduct an investigation about the causes of injuries without first receiving permission from a lawful adult occupant of the residence. Source Note: The provisions of this §103.1 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457; amended to be effective April 1, 2025, 50 TexReg 995. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.1 Purpose and Purview https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183274&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183274 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183274&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183274 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Call for assistance--An event where an Emergency Medical Services (EMS) provider is activated via an internal communication system or by a 9-1-1 operator.(2) Case--A person in whom an injury is identified by a physician or medical examiner based upon clinical evaluation, interpretation of laboratory and/or radiological findings, and an appropriate exposure history.(3) Commissioner--Commissioner of the Department of State Health Services.(4) Data dictionaries--A collection of descriptions of the data elements in the Texas EMS & Trauma Registries database.(5) Department--The Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3180.(6) Electronic reporting--Submitting data by computer in a format prescribed by the department.(7) Emergency Medical Services (EMS) provider--A person or entity that uses, operates or maintains EMS vehicles and EMS personnel to provide EMS; as defined by Health and Safety Code, §773.003(11) and Chapter 157, Subchapter A, §157.2 of this title (relating to Definitions).(8) Health authority--A physician appointed as such under Texas Health and Safety Code, Chapter 121.(9) Injury--Damage to the body resulting from intentional or unintentional acute exposure to thermal, mechanical, electrical, or chemical energy, or from the absence of essentials such as heat or oxygen.(10) Investigation--Fieldwork designed to obtain more information about an incident.(11) Local health department--A department created under the Texas Health and Safety Code, Chapter 121.(12) No reportable data (NRD)--If the entity does not have any reportable event for a given month, the entity shall inform the Texas EMS & Trauma Registries monthly by providing the NRD submission.(13) Regional Registry--A system that collects, maintains and reports EMS provider runs and trauma data to the department for a designated area of the state.(14) Registries --The Texas EMS & Trauma Registries is the statewide database housed within the department; responsible for the collection, maintenance, and evaluation of medical and system information related to required reportable events as defined in this section.(15) Reporting entity--An EMS provider, a justice of the peace, a medical examiner, a physician, or an entity reporting on behalf of the physician including a hospital or an acute or post-acute rehabilitation facility.(16) Reportable event--Any injury or incident required to be reported under this chapter.(A) EMS run--A resulting action from a call for assistance where an EMS provider is dispatched to, responds to, provides care to or transports a person.(B) Traumatic brain injury (TBI)--An acquired injury to the brain, including brain injuries caused by anoxia due to submersion incidents.(C) Spinal cord injury (SCI)--An acute, traumatic lesion of the neural elements in the spinal canal, resulting in any degree of sensory deficit, motor deficits, or bladder/bowel dysfunction.(D) Submersion injury--The fatal or non-fatal process of experiencing respiratory impairment from submersion/immersion in liquid.(E) Significant trauma injuries--Other severely injured trauma patients whose injury meets the department's inclusion criteria based on the data dictionaries and admitted to a hospital inpatient setting for more than 48 hours, or died after receiving any evaluation or treatment, or was dead on arrival, or transferred into or out of a hospital.(17) Suspected case--A case in which an injury is assumed, but a diagnosis is not yet made, as in the example of justices of the peace.(18) Third-party services--Includes, but is not limited to a regional registry located in a trauma service area (TSA), a billing agency, or a data reporting agency.(19) Trauma--An injury or wound to a living body caused by the application of an external force, including but not limited to violence, burns, poisonings, submersion incidents, traumatic brain injuries, traumatic spinal cord injuries, and suffocations.(20) Trauma service area (TSA)--A multi-county area in which an emergency medical services and trauma care system has been developed by a Regional Advisory Council and has been recognized by the department. Source Note: The provisions of this §103.2 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183275&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183275 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183275&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183275 03/11/2026 (a) All information and records relating to injuries received by the local health authority or the department, including information electronically submitted to the Texas EMS & Trauma Registries and information from injury investigations, are sensitive, confidential, and not public records.(b) These records shall be held in a secure place and accessed only by authorized personnel. All communications pertaining to these records shall be clearly labeled "Confidential" and will follow established departmental internal protocols and procedures.(c) Information or records relating to any personal injury may not be released or made public on subpoena or otherwise, except that release may be made:(1) for statistical purposes, if released in a manner that prevents the identification of any person;(2) with the consent of each person identified in the information released; or(3) to medical personnel in a medical emergency to the extent necessary to protect the health or life of the named person.(d) The department may limit the release of record-level data for medical research to those studies with high scientific merit and have been approved by the department's Institutional Review Board.(e) A reporting entity may request in writing its own reportable data that has been submitted to the Registries. Source Note: The provisions of this §103.3 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.3 Confidentiality https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183276&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183276 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183276&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183276 03/11/2026 Injuries and events listed below to be reported are defined in §103.2 of this title (relating to Definitions).(1) EMS Provider--All EMS runs.(2) Justice of the peace--(A) Submersion injuries.(B) Traumatic brain injuries.(C) Spinal cord injuries.(3) Medical examiner--(A) Submersion injuries.(B) Traumatic brain injuries.(C) Spinal cord injuries.(4) Physician--(A) Submersion injuries.(B) Traumatic brain injuries.(C) Spinal cord injuries.(D) A physician shall be exempt from reporting if a hospital or acute or post-acute rehabilitation facility admitted the patient and fulfilled the reporting requirements as stated in §103.7 of this title (relating to Reporting Requirements for Hospitals) or §103.8 of this title (relating to Reporting Requirements for Acute or Post-Acute Rehabilitation Facilities).(5) Hospital (if reporting for a physician)--(A) Traumatic brain injuries.(B) Spinal cord injuries.(C) Submersion injuries.(D) Significant trauma injuries.(6) Acute or post-acute rehabilitation facility (if reporting for a physician)--(A) Traumatic brain injuries.(B) Spinal cord injuries.(7) The professionals or organizations listed in this section must send all reports of injuries and events listed in this section to the Texas EMS & Trauma Registries. If the above listed professionals or organizations choose to notify a local or regional health authority to respond on their behalf, the local or regional health authority must report to the Registries within ten workdays. Source Note: The provisions of this §103.4 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.4 Who Shall Report and List of Reportable Injuries and Events https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183277&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183277 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183277&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183277 03/11/2026 (a) General Information.(1) All data must be transmitted electronically to the Texas EMS & Trauma Registries within ninety calendar days of the date of call for assistance; monthly submissions are recommended.(2) EMS providers must report no reportable data (NRD) to the Registries monthly for any given month with no runs.(b) Data Elements and Methods.(1) Data elements currently defined by the appropriate data dictionaries must be submitted to the department's online Registries.(2) NRD --If an EMS provider has no calls for assistance, the EMS provider must provide an NRD submission to the Registries for that month.(c) Third-party Services.(1) An EMS provider may use third-party services to submit data to the Registries. A legally binding agreement must exist between the EMS provider and the third-party services. Documentation of the legally binding agreement must be provided to the department for third-party services to submit the data on behalf of the EMS provider within the Registries.(2) If an EMS provider uses the third-party services, the EMS provider is ultimately responsible for the complete, accurate and timely reporting of data to the Registries. Source Note: The provisions of this §103.5 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.5 Reporting Requirements for EMS Providers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183278&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183278 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183278&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183278 03/11/2026 (a) General Information. All data must be transmitted electronically to the Texas EMS & Trauma Registries within ninety calendar days of the date of examination; monthly submissions are recommended.(b) Data Elements and Methods.(1) Data elements defined by the appropriate data dictionaries for all required reportable events, must be submitted to the department's online Registries.(2) If a specialized reporting system exists for a required reportable event, then the case or suspected case must be submitted to all relevant reporting systems.(3) Hospitals can report the data elements as defined by the appropriate data dictionaries to the Registries on behalf of physicians.(c) Third-party Services.(1) A physician, medical examiner or justice of the peace may use third-party services to submit data to the Registries. A legally binding agreement must exist between the physician, medical examiner or justice of the peace and the third-party services. Documentation of the legally binding agreement must be provided to the department for third-party services to submit the data on behalf of the physician, medical examiner or justice of the peace.(2) A physician, medical examiner or justice of the peace uses the third-party services, the physician, medical examiner or justice of the peace is ultimately responsible for the complete, accurate and timely reporting of data to the Registries. Source Note: The provisions of this §103.6 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.6 Reporting Requirements for Physicians, Medical Examiners, and Justices of the Peace https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183279 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183279 03/11/2026 (a) General Information.(1) All data must be transmitted electronically to the Texas EMS & Trauma Registries within ninety calendar days of the date of discharge from their facility; monthly submissions are recommended.(2) Hospitals must report no reportable data (NRD) to the Registries monthly for any given month with no required reportable event.(b) Data Elements and Methods.(1) Data elements defined by the appropriate data dictionaries for all required reportable events, must be submitted to the department's online Registries.(2) If a specialized reporting system exists for a required reportable event, then the case or suspected case must be submitted to all relevant reporting systems.(c) Third-party Services.(1) A hospital may use third-party services to submit data to the Registries. A legally binding agreement must exist between the hospital and the third-party services. Documentation of the legally binding agreement must be provided to the department for third-party services to submit the data on behalf of the hospital within the Registries.(2) If a hospital uses the third-party services, the hospital is ultimately responsible for the complete, accurate and timely reporting of data to the Registries. Source Note: The provisions of this §103.7 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.7 Reporting Requirements for Hospitals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183280 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=183280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 183280 03/11/2026 (a) General Information.(1) All data must be transmitted electronically to the Texas EMS & Trauma Registries within ninety calendar days of the date of discharge from their facility; monthly submissions are recommended.(2) Acute or post-acute rehabilitation facilities must report no reportable data (NRD) to the Registries monthly for any given month with no required reportable event.(b) Data Elements and Methods.(1) Data elements currently defined by the appropriate data dictionaries for all required reportable events must be submitted to the department's online Registries.(2) If a specialized reporting system exists for a required reportable event, then the case or suspected case must be submitted to all relevant reporting systems.(c) Third-party Services.(1) An acute or post-acute rehabilitation facility may use third-party services to submit data to the Registries. A legally binding agreement must exist between the acute or post-acute rehabilitation facility and the third-party services. Documentation of the legally binding agreement must be provided to the department for third-party services to submit the data on behalf of the acute or post-acute rehabilitation facility within the Registries.(2) If an acute or post-acute rehabilitation facility uses the third-party services, the acute or post-acute rehabilitation facility is ultimately responsible for the complete, accurate and timely reporting of data to the Registries. Source Note: The provisions of this §103.8 adopted to be effective December 16, 2007, 32 TexReg 9130; amended to be effective April 2, 2017, 42 TexReg 1457. 1 DEPARTMENT OF STATE HEALTH SERVICES 103 INJURY PREVENTION AND CONTROL §103.8 Reporting Requirements for Acute or Post-Acute Rehabilitation Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150980&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150980 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150980&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150980 03/11/2026 The purpose of these sections is to establish standards for protective vests and bull riding helmets for children who participate in rodeos; and requirements for an education program on safety, including the proper use of protective gear for children planning to participate in rodeos. These standards are implemented under Health and Safety Code, Chapter 768. Source Note: The provisions of this §104.1 adopted to be effective March 20, 2011, 36 TexReg 1671. 1 DEPARTMENT OF STATE HEALTH SERVICES 104 CHILDREN PARTICIPATING IN RODEOS §104.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150981&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150981 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150981&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150981 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Bull riding helmet--A rodeo helmet that is designed to provide substantial protection for a person's head and face during bull riding. (2) Child or Children--A person under 18 years of age. (3) National Health Education Standards (NHES)--A statement from The Joint Committee on National Health Education Standards. National Health Education Standards: Achieving Excellence (2nd Edition). Atlanta: American Cancer Society, 2007, a nationally-accepted framework of health standards and expectations which aligns curriculum, instruction and assessment practices to promote personal, family and community health. (4) Promote--A primary or secondary school that helps or encourages; or advertises or advocates for a rodeo event to exist or flourish; or, encourages or advertises rodeo ticket or rodeo-related merchandise sales; or demonstrates acceptance of rodeo through advertising or other print or electronic publicity such as posters, Web sites or radio announcements. (5) Protective vest--Protective clothing that covers a person's chest and torso to prevent or mitigate injury to those areas. (6) Rodeo--An exhibition or competition, without regard to whether the participants are compensated, involving activities related to cowboy skills, including: (A) riding a horse, with or without a saddle, with the goal of remaining on the horse while it attempts to throw off the rider; (B) riding a bull; (C) roping an animal, including roping as part of a team; (D) wrestling a steer; and (E) riding a horse in a pattern around preset barrels or other obstacles. (7) Sponsor--A primary or secondary school that in any way finances, or provides other in-kind resources or services for a rodeo event carried out by another person or group; or, that is in any other way, responsible for a rodeo event. (8) Texas Essential Knowledge and Skills (TEKS)--The state-mandated set of learning objectives for students in Texas public schools. Source Note: The provisions of this §104.2 adopted to be effective March 20, 2011, 36 TexReg 1671. 1 DEPARTMENT OF STATE HEALTH SERVICES 104 CHILDREN PARTICIPATING IN RODEOS §104.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150982&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150982 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150982&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150982 03/11/2026 A child may not engage in, and a parent or legal guardian of the child may not knowingly or recklessly permit the child to engage in, bull riding, including engaging in bull riding outside a rodeo for the purpose of practicing bull riding, unless the child is wearing a protective vest and bull riding helmet. To satisfy the requirement of this section, the following applies.(1) The bull riding helmet worn by the child must meet the American Society for Testing and Materials (ASTM) standards for "Protective Headgear with Faceguard Used in Bull Riding; F 2530-05" or the most current version of the standards.(2) The protective vest worn by the child must meet ASTM standards for "Body Protectors Used in Horse Sports and Horseback Riding; F 1937 - 04" or the most current version of the standards.(3) These standards apply to the following.(A) Rodeos associated with primary and secondary schools.(B) Schools that sponsor, advertise or promote; or, are otherwise associated with a rodeo in which children who attend the school are likely to participate.(C) Children who are participating in or engaging in bull riding outside a rodeo for the purpose of practicing bull riding.(D) A parent or legal guardian of a child engaging in bull riding including outside the rodeo for the purpose of practice.(4) "Failure of a parent to comply" statement applies to these standards as specified in Health and Safety Code, §768.002. Source Note: The provisions of this §104.3 adopted to be effective March 20, 2011, 36 TexReg 1671. 1 DEPARTMENT OF STATE HEALTH SERVICES 104 CHILDREN PARTICIPATING IN RODEOS §104.3 Standards for Protective Vests and Bull Riding Helmets for Children Who Participate in Rodeos https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150983 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150983 03/11/2026 (a) Applies only to a primary or secondary school that sponsors, advertises or promotes; or, otherwise is associated with a rodeo in which children who attend the school are likely to participate.(b) Not more than one year before the first day of a rodeo associated with a primary or secondary school, the school will conduct a mandatory education program each school year on safety for children planning on participating in the rodeo.(c) A child may not participate in a rodeo associated with a child's school during a school year unless the child has completed the educational program.(d) The educational program will have the following requirements.(1) The educational program must cover the proper use of rodeo protective gear.(2) Criteria for program development should be based on the NHES for designing injury prevention and safety curricula.(3) Information taught must reflect the required age-appropriate TEKS that promote healthy behavior and reduce personal risk as it relates to injury prevention.(4) The method of delivery of the educational program may be an instructional video or any other instructional medium that contains information consistent with the TEKS and NHES.(5) Compliance with this section is equivalent to approval by the Department of State Health Services. Source Note: The provisions of this §104.4 adopted to be effective March 20, 2011, 36 TexReg 1671. 1 DEPARTMENT OF STATE HEALTH SERVICES 104 CHILDREN PARTICIPATING IN RODEOS §104.4 Requirements for an Educational Program on Safety https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150984 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=150984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 150984 03/11/2026 To allow preparation for children to fully participate in rodeos, these rules will be effective August 1, 2011. Source Note: The provisions of this §104.5 adopted to be effective March 20, 2011, 36 TexReg 1671. 1 DEPARTMENT OF STATE HEALTH SERVICES 104 CHILDREN PARTICIPATING IN RODEOS §104.5 Compliance Date of Rules https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213890&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213890 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213890&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213890 03/11/2026 The purpose of this section is to implement Texas Health and Safety Code, Chapter 241, Subchapter H, Hospital Level of Care Designations for Neonatal and Maternal Care, which requires a level of care designation of neonatal services to be eligible to receive reimbursement through the Medicaid program for neonatal services. Source Note: The provisions of this §133.181 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.181 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213891&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213891 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213891&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213891 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Attestation--A written statement, signed by the chief executive officer of the facility, verifying the results of a self-survey represent a complete and accurate assessment of the facility's capabilities required in this subchapter.(2) Available--Relating to staff who can be contacted for consultation at all times without delay.(3) Birth weight--The weight of the neonate recorded at time of birth.(A) Low birth weight--Birth weight less than 2500 grams (5 lbs., 8 oz.);(B) Very low birth weight (VLBW)--Birth weight less than 1500 grams (3 lbs., 5 oz.); and(C) Extremely low birth weight (ELBW)--Birth weight less than 1000 grams (2 lbs., 3 oz.).(4) CAP--Corrective Action Plan. A plan for the facility developed by the department that describes the actions required of the facility to correct identified deficiencies to ensure the applicable designation requirements are met.(5) Department--The Texas Department of State Health Services.(6) Designation--A formal recognition by the department of a facility's neonatal care capabilities and commitment for a period of three years.(7) EMS--Emergency medical services. Services used to respond to an individual's perceived need for immediate medical care.(8) Focused survey--A department-defined, modified facility survey by a department-approved survey organization or the department. The specific goal of this survey is to review designation requirements identified as not met to resolve a contingent designation or requirement deficiencies.(9) Gestational age--The age of a fetus or embryo determined by the amount of time that has elapsed since the first day of the mother's last menstrual period or the corresponding age of the gestation as estimated by a physician through a more accurate method.(10) High-risk infant--A newborn that has a greater chance of complications because of conditions that occur during fetal development, pregnancy conditions of the mother, or problems that may occur during labor or birth.(11) Immediately--Able to respond without delay, commonly referred to as STAT.(12) Infant--A child from birth to one year of age.(13) Inter-facility transport--Transfer of a patient from one health care facility to another health care facility.(14) Lactation consultant--A health care professional who specializes in the clinical management of breastfeeding.(15) Maternal--Pertaining to the mother.(16) NCPAP--Nasal continuous positive airway pressure.(17) Neonatal Program Oversight--A multidisciplinary process responsible for the administrative oversight of the neonatal program and having the authority for approving the defined neonatal program's policies, procedures, and guidelines for all phases of neonatal care provided by the facility, to include defining the necessary staff competencies, monitoring to ensure neonatal designation requirements are met, and the aggregate review of the neonatal Quality Assessment and Performance Improvement (QAPI) initiatives and outcomes. Neonatal Program Oversight may be performed through the neonatal program's performance improvement committee, multidisciplinary oversight committee, or other structured means.(18) Neonate--An infant from birth through 28 completed days.(19) NMD--Neonatal Medical Director.(20) NPM--Neonatal Program Manager.(21) NRP--Neonatal Resuscitation Program. A resuscitation course developed and administered jointly by the American Heart Association and the American Academy of Pediatrics.(22) On-site--At the facility and able to arrive at the patient bedside for urgent requests.(23) PCR--Perinatal Care Region. The PCRs are established for descriptive and regional planning purposes. The PCRs are geographically divided by counties and are integrated into the existing 22 Trauma Service Areas (TSAs) and the applicable Regional Advisory Council (RAC) of the TSA provided in §157.122 of this title (relating to Trauma Services Areas) and §157.123 of this title (relating to Regional Emergency Medical Services/Trauma Systems).(24) Perinatal--Of, relating to, or being the period around childbirth, especially the five months before and one month after birth.(25) POC--Plan of Correction. A report submitted to the department by the facility detailing how the facility will correct any deficiencies cited in the neonatal designation site survey summary or documented in the self-attestation.(26) Premature/prematurity--Birth at less than 37 weeks of gestation.(27) QAPI Plan--Quality Assessment and Performance Improvement Plan. QAPI is a data-driven and proactive approach to quality improvement. It combines two approaches - Quality Assessment (QA) and Performance Improvement (PI). QA is a process used to ensure services are meeting quality standards and assuring care reaches a defined level. PI is the continuous study and improvement process designed to improve system and patient outcomes.(28) RAC--Regional Advisory Council as described in §157.123 of this title.(29) Supervision--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.(30) Telehealth service--A health service, other than a telemedicine medical service, delivered by a health professional licensed, certified, or otherwise entitled to practice in this state and acting within the scope of the health professional's license, certification, or entitlement to a patient at a different physical location than the health professional using telecommunications or information technology as defined in Texas Occupations Code §111.001.(31) Telemedicine medical service--A health care service delivered by a physician licensed in this state, or health professional acting under the delegation and supervision of a physician licensed in this state and acting within the scope of the physician's or health professional's license to a patient at a different physical location than the physician or health professional using telecommunications or technology as defined in Texas Occupations Code §111.001.(32) TSA--Trauma Service Area as described in §157.122 of this title.(33) Urgent--Requiring action or attention within 30 minutes of notification. Source Note: The provisions of this §133.182 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.182 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213892&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213892 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213892&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213892 03/11/2026 (a) The department reviews the applicant documents and approves the appropriate level of facility designation.(b) A facility is defined under this subchapter as a single location where inpatients receive hospital services; or each location, if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license.(c) Each location must be considered separately for designation and the department approves the designation level for each location based on the location's ability to demonstrate designation criteria are met. A stand-alone children's facility that does not provide obstetrical services is exempt from obstetrical requirements.(d) The department determines requirements for the levels of neonatal designation. Facilities seeking Levels II, III, and IV neonatal designation must meet department-approved requirements validated by a department-approved survey organization.(e) Facilities seeking Level I neonatal designation must submit a self-survey and attest to meeting department-approved requirements.(f) The four levels of neonatal designation are:(1) Level I (Well Care). The Level I neonatal designated facility must:(A) provide care for mothers and their infants of generally more than or equal to 35 weeks gestational age who have routine, transient perinatal problems;(B) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served; and(C) provide the same level of care that the neonate would receive at a higher-level designated neonatal facility and complete an in-depth critical review and assessment of the care provided to these infants through the neonatal QAPI Plan and process if an infant less than 35 weeks gestational age is retained.(2) Level II (Special Care). The Level II neonatal designated facility must:(A) provide care for mothers and their infants of generally more than or equal to 32 weeks gestational age and birth weight more than or equal to 1500 grams who have physiologic immaturity or problems that are expected to resolve rapidly and are not anticipated to require subspecialty services on an urgent basis;(B) provide care, either by including assisted endotracheal ventilation for less than 24 hours or nasal continuous positive airway pressure (NCPAP) until the infant's condition improves, or arrange for appropriate transfer to a higher-level designated facility; and(C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served.(3) Level III (Neonatal Intensive Care). The Level III neonatal designated facility must:(A) provide care for mothers and comprehensive care for their infants of all gestational ages with mild to critical illnesses or requiring sustained life support;(B) ensure access to consultation to a full range of pediatric medical subspecialists and pediatric surgical specialists, and the capability to perform major pediatric surgery on-site or at another appropriate neonatal designated facility;(C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;(D) facilitate neonatal transports; and(E) provide outreach education related to trends identified through the neonatal QAPI Plan, specific requests, and system needs to lower-level neonatal designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(4) Level IV (Advanced Neonatal Intensive Care). The Level IV neonatal designated facility must:(A) provide care for mothers and comprehensive care for their infants of all gestational ages with the most complex and critical medical and surgical conditions or requiring sustained life support;(B) ensure access to a comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists available to arrive on-site, in person for consultation and care, and the capability to perform major pediatric surgery, including the surgical repair of complex conditions on-site;(C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;(D) facilitate neonatal transports; and(E) provide outreach education related to trends identified through the neonatal QAPI Plan, specific requests, and system needs to lower-level neonatal designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(g) Facilities seeking neonatal designation must undergo an on-site or virtual survey as outlined in this section and:(1) are responsible for scheduling a neonatal designation survey through a department-approved survey organization;(2) must notify the department of the neonatal designation survey date;(3) are responsible for expenses associated with the neonatal designation survey;(4) must not accept surveyors with any known conflict of interest; and(5) must provide the survey team access to records and documentation regarding the neonatal QAPI Plan and process related to neonatal patients. The department may determine that failure by a facility to provide access to these records does not meet the requirements of this subchapter.(h) If a known conflict of interest is present for the facility seeking neonatal designation, the facility must decline the assigned surveyor through the surveying organization. A conflict of interest exists when a surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public. The conflict of interest may include a surveyor who personally trained a key member of the facility's leadership in residency or fellowship, collaborated with a key member of the facility's leadership team professionally, participated in a designation consultation with the facility, had a previous working relationship with the facility or facility leaders, or conducted a designation survey for the facility within the past four years.(1) Surveyors cannot be from the same PCR or TSA region or a contiguous region of the facility's location.(2) Designation site survey summary and medical record reviews performed by a surveyor with an identified conflict of interest may not be accepted by the department.(i) The department, at its sole discretion, may appoint an observer to accompany the survey team with the observer costs borne by the department.(j) The survey team evaluates the facility's evidence that department-approved designation requirements are met and documents all requirements that are not met in the neonatal designation site survey summary and medical record reviews. Source Note: The provisions of this §133.183 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.183 General Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213893&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213893 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213893&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213893 03/11/2026 (a) A facility seeking neonatal designation or renewal of designation must submit a completed application packet.(1) The completed application packet includes:(A) an accurate and complete neonatal designation application for the requested level of designation;(B) a completed neonatal attestation and self-survey report for Level I applicants, or the documented neonatal designation site survey summary that validates the department requirements are met and the medical record reviews for Levels II, III and IV applicants, submitted to the department no later than 90 days after the neonatal designation site survey date;(C) if the facility has three or more department-approved designation requirements that are defined as not met in the neonatal designation site survey summary, the facility must contact the department's designation unit within 10 business days to discuss the Plan of Correction (POC);(D) the POC, if required by the department, which must include:(i) a statement of the cited designation requirement not met;(ii) a statement describing the corrective action taken by the facility seeking neonatal designation to meet the requirement;(iii) the title of the individuals responsible for ensuring the corrective actions are implemented;(iv) the date the corrective actions were implemented;(v) how the corrective actions will be monitored; and(vi) documented evidence that the POC was implemented within 90 days of the designation survey;(E) written evidence of annual participation in the applicable PCRs; and(F) any subsequent documents submitted by the date requested by the department.(2) The application includes full payment of the non-refundable, non-transferrable designation fee listed:(A) Level I neonatal facility applicants, the fees are as follows:(i) less than or equal to 100 licensed beds, the fee is $250.00; or(ii) more than 100 licensed beds, the fee is $750.00.(B) Level II neonatal facility applicants, the fee is $1,500.00.(C) Level III neonatal facility applicants, the fee is $2,000.00.(D) Level IV neonatal facility applicants, the fee is $2,500.00.(b) The application will not be processed if a facility seeking neonatal designation fails to submit the required application documents and total designation fee.(c) The neonatal designation renewal process, or a request to designate at a different level of care, or a change in ownership, or a change in physical address require the facility to notify the department and submit a complete designation application packet outlined in subsection (a)(1) and (2) of this section.(d) The facility must submit the required documents described in subsection (a)(1) and (2) of this section to the department no later than 90 days before the facility's current neonatal designation expiration date for all designation renewals.(e) The facility has the right to withdraw its application for neonatal designation any time before a designation approval.(f) The facility must seek neonatal designation renewal to maintain continual designation and prevent an interruption in designation.(g) The facility's neonatal designation will expire if the facility fails to provide a complete neonatal designation application packet to the department.(h) The neonatal designation application packet in its entirety, including any recommendations or follow-up from the department, and any opportunities for improvement, must be a written element of the facility's neonatal QAPI Plan and must be reviewed through this process, which is all subject to confidentiality as described in Texas Health and Safety Code, §241.184, Confidentiality; Privilege.(i) The department reviews the application packet to determine and approve the facility's level of neonatal designation.(j) The department defines the final neonatal designation level awarded to the facility, and this designation may be different than the level requested based on the neonatal designation site survey summary.(k) If the department determines the facility meets the requirements for neonatal designation, the department provides the facility with a designation award letter and a designation certificate.(1) The facility must display its neonatal designation certificate in a public area of the licensed premises that is readily visible to patients, employees, and visitors.(2) The facility must not alter the neonatal designation certificate. Any alteration voids neonatal designation for the remainder of that designation period.(l) The survey organization must provide the facility with a written, signed neonatal designation site survey summary, including medical record reviews, regarding their evaluation and validation of the facility's demonstration that neonatal designation requirements are met. The neonatal designation site survey summary must be forwarded to the facility no later than 30 days after the completion date of the survey. The facility is responsible for submitting a copy of the neonatal designation site survey summary and medical record reviews to the department, with the required documents to continue the designation process, within 90 days of completion of the site survey.(m) The department will approve designation of a facility that demonstrates the requirements are met.(n) A neonatal level of care designation must not be denied to a facility that meets the designation requirements for that level of care designation.(o) If a facility does not meet the designation requirements for the level of designation requested, the department will designate the facility at the highest level for which designation requirements are met.(p) If the department determines a facility does not meet the designation requirements for the level of designation requested, the department must provide written notification to the facility of the designation requirements not met and provide a Corrective Action Plan (CAP) to assist the facility in meeting the designation requirements. The CAP may include requiring the facility to have a focused survey or a complete re-survey.(1) The facility must submit to the department reports as required and outlined in the CAP. The department may require a second survey to ensure they meet the designation requirements. The cost of the second survey will be at the expense of the facility.(2) If the department substantiates actions taken by the facility demonstrating documented evidence that designation requirements are met, the department removes the contingencies.(q) If a facility disagrees with the designation level awarded by the department, it may request an appeal in writing to the EMS/Trauma Systems Section Director not later than 30 days after the designation award. The written appeal must be from the facility's Chief Executive Officer, Chief Medical Officer, or Chief Nursing Officer with documented evidence of how the facility meets the requirements for the requested designation level.(1) The EMS/Trauma Systems Section will establish a three-person appeal panel and follow approved appeal panel guidelines to assess the facility's designation appeal as referenced in Texas Health and Safety Code §241.1836.(2) If the designation appeal panel recommends the original determination, the EMS/Trauma Systems Section Director will give written notice of such to the facility not later than 30 days after the appeal panel's recommendation.(3) If the designation appeal panel disagrees with the department's original designation determination, the panel will recommend the appropriate level of neonatal designation to the department.(4) If a facility disagrees with the designation appeal panel's recommendation regarding its designation level, the facility can request a second appeal review with the department's Associate Commissioner for Consumer Protection Division. If the Associate Commissioner upholds the designation appeal panel's recommendation, the designation status will remain the same. If the Associate Commissioner disagrees with the designation appeal panel's recommendation, the Associate Commissioner will define the appropriate level and award designation. The department will send a notification letter of the second appeal decision within 30 days of receiving the second appeal request.(5) If the facility continues to disagree with the second level of appeal, the facility has a right to a hearing in the manner referenced in §133.121 of this title (relating to Enforcement Action).(r) Exceptions and Notifications(1) A designated neonatal facility must provide written or electronic notification of any significant change to the neonatal program impacting patient care. The notification must be provided to the following:(A) all emergency medical services (EMS) providers that transfer neonatal patients to or from the designated neonatal facility;(B) the hospitals to which it customarily transfers out or transfers in neonatal patients;(C) applicable PCRs and RACs; and(D) the department.(2) If the designated neonatal facility is unable to meet the requirements to maintain its current designation, it must submit to the department a POC as described in subsection (a)(1)(D) of this section, and a request for a temporary exception to the designation requirements. Any request for an exception must be submitted in writing from the facility's Chief Executive Officer and define the facility's timeline to meet the designation requirements. The department reviews the request and the POC, and either grants the exception with a specific timeline based on the public interest, geographic maternal care capabilities, and access to care, or denies the exception. If the facility is not granted an exception or it does not meet the designation requirements at the end of the exception period, the department will elect one of the following:(A) re-designate the facility at the level appropriate to its revised capabilities;(B) outline an agreement with the facility to satisfy all designation requirements for the level of care designation within a time specified under the agreement, which may not exceed the first anniversary of the effective date of the agreement; or(C) waive one specific designation requirement for a level of care designation if the facility meets all other designation requirements for the level of care designation and the department determines the waiver is justified considering:(i) the expected impact on accessibility of neonatal care in the geographic area served by the facility if the waiver is not granted and the expected impact on the quality of care and patient safety; or(ii) whether these services can be met by other facilities in the area or with telehealth/telemedicine services.(3) Waivers expire with the expiration of the current designation but may be renewed. The department may specify any conditions for ongoing reporting during this time.(4) The department maintains a current list on its internet website of facilities that have contingency agreements or an approved waiver with the department and an aggregated list of the designation requirements conditionally met or waived.(5) Facilities that have contingency agreements or an approved waiver with the department must post on the facility's internet website the nature and general terms of the agreement.(s) An application for a higher or lower level of neonatal designation may be submitted to the department at any time.(1) A designated neonatal facility that is increasing its neonatal capabilities may choose to apply for a higher-level of designation at any time. The facility must follow the designation process as described in subsection (a)(1) and (2) of this section to apply for the higher-level.(2) A designated neonatal facility that is unable to maintain the facility's current level of neonatal designation may choose to apply for a lower level of designation at any time.(t) If the facility is relinquishing its neonatal designation, the facility must provide 30 days written, advance notice of the relinquishment to the department, the applicable PCRs/RACs, EMS providers, and facilities it customarily transfers out or transfers in neonatal patients. The facility is responsible for continuing to provide neonatal care services or ensuring a plan for neonatal care continuity for the 30 days following the written notice of relinquishing its neonatal designation.(u) A hospital providing neonatal services must not use the terms "designated neonatal facility" or similar terminology in its signs, advertisements, facility internet website, social media, or in the printed materials and information it provides to the public, unless the facility is currently designated at that level of neonatal care.(v) During a virtual, on-site, or focused designation review, conducted by the department or survey organization, the department or surveyor has the right to review and evaluate neonatal patient records, neonatal multidisciplinary QAPI Plan documents, and any action specific to improving neonatal care and outcomes, as well as any other documents relevant to neonatal care in a designated neonatal facility or facility seeking neonatal designation to validate designation requirements are met.(w) The department and survey organization will comply with all relevant laws related to the confidentiality of records.(x) The department may deny, suspend, or revoke designation if a designated neonatal facility ceases to provide services to meet or maintain the designation requirements of this section. Source Note: The provisions of this §133.184 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.184 Designation Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213894&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213894 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213894&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213894 03/11/2026 (a) Neonatal Program Philosophy. Designated facilities must have a family-centered philosophy. Parents must have reasonable access to their infants at all times and be encouraged to participate in the care of their infants. The facility environment for perinatal care must meet the physiologic and psychosocial needs of the mothers, infants, and families.(b) Neonatal Program Plan. The facility must develop a written neonatal operational plan for the neonatal program that includes a detailed description of the scope of services and clinical resources available for all neonatal patients, mothers, and families. The plan must define the neonatal patient population evaluated, treated, transferred, or transported by the facility consistent with clinical guidelines based on current standards of neonatal practice ensuring the health and safety of patients.(1) The written Neonatal Program Plan must be reviewed and approved by Neonatal Program Oversight and be submitted to the facility's governing body for review and approval. The governing body must ensure the requirements of this section are implemented and enforced.(2) The written Neonatal Program Plan must include, at a minimum:(A) clinical guidelines based on current standards of neonatal practice, and policies and procedures that are adopted, implemented, and enforced by the neonatal program;(B) a process to ensure and validate these clinical guidelines based on current standards of neonatal practice, policies, and procedures, are reviewed and revised a minimum of every three years;(C) written triage, stabilization, and transfer guidelines for neonatal patients that include consultation and transport services;(D) the role and scope of telehealth/telemedicine practices, if utilized, including:(i) documented and approved written policies and procedures that outline the use of telehealth/telemedicine for inpatient hospital care or for consultation, including appropriate situations, scope of care, and documentation that is monitored through the neonatal QAPI Plan and process; and(ii) written and approved procedures to gain informed consent from the patient or designee for the use of telehealth/telemedicine, if utilized, that are monitored for variances;(E) written guidelines for discharge planning instructions and appropriate follow-up appointments for all neonates/infants;(F) written guidelines for the hospital disaster response, including a defined neonatal evacuation plan and process to relocate mothers and infants to appropriate levels of care with identified resources, and this process must be evaluated annually to ensure neonatal care can be sustained and adequate resources are available;(G) written minimal education and credentialing requirements for all staff participating in the care of neonatal patients, which are documented and monitored by the managers who have oversight of staff;(H) written requirements for providing continuing staff education, including annual competencies and skills assessment that is appropriate for the patient population served, which are documented and monitored by the managers who have oversight of staff;(I) documentation of meeting the requirement for a perinatal staff registered nurse to serve as a representative on the nurse staffing committee under §133.41 of this title (relating to Hospital Functions and Services);(J) measures to monitor the availability of all necessary equipment and services required to provide the appropriate level of care and support for the patient population served; and(K) documented guidelines for consulting support personnel with knowledge and skills in breastfeeding and lactation, which includes expected response times, defined roles, responsibilities, and expectations.(3) The facility must have a documented and approved neonatal QAPI Plan.(A) The Chief Executive Officer, Chief Medical Officer, and Chief Nursing Officer must implement a culture of safety for the facility and ensure adequate resources are allocated to support a concurrent, data-driven neonatal QAPI Plan.(B) The facility must demonstrate that the neonatal QAPI Plan consistently assesses the provision of neonatal care provided. The assessment must identify variances in care, the impact to the patient, and the appropriate levels of review. This process must identify opportunities for improvement and develop a plan of correction to address the variances in care or the system response. An action plan will track and analyze data through resolution or correction of the identified variance.(C) The neonatal program must measure, analyze, and track performance through defined quality indicators, core performance measures, and other aspects of performance that the facility adopts or develops to evaluate processes of care and patient outcomes. Summary reports of these findings are reported through the Neonatal Program Oversight.(D) All neonatal facilities must participate in a neonatal data initiative. Level III and IV neonatal facilities must participate in benchmarking programs to assess their outcomes as an element of the neonatal QAPI Plan.(E) The Neonatal Medical Director (NMD) must have the authority to make referrals for peer review, receive feedback from the peer review process, and ensure neonatal physician representation in the peer review process for neonatal cases.(F) The NMD and Neonatal Program Manager (NPM) must participate in PCR meetings, regional QAPI initiatives, and regional collaboratives, and submit requested data to assist with data analysis to evaluate regional outcomes as an element of the facility's neonatal QAPI Plan.(G) The facility must have documented evidence of neonatal QAPI summary reports reviewed and reported by Neonatal Program Oversight that monitor and ensure the provision of services or procedures through telehealth and telemedicine, if utilized, is in accordance with the standards of care applicable to the provision of the same service or procedure in an in-person setting.(H) The facility must have documented evidence of neonatal QAPI summary reports to support that aggregate neonatal data are consistently reviewed to identify developing trends, opportunities for improvement, and necessary corrective actions. Summary reports must be provided through the Neonatal Program Oversight, available for site surveyors, and submitted to the department as requested.(c) Medical Staff. The facility must have an organized, effective neonatal program that is recognized by the facility's medical staff and approved by the facility's governing body.(1) The credentialing of the neonatal medical staff must include a process for the delineation of privileges for neonatal care.(2) The neonatal medical staff must participate in ongoing staff and team-based education and training in the care of the neonatal patient.(d) Medical Director. There must be an identified NMD and an identified Transport Medical Director (TMD) if the facility has its own transport program. The NMD and TMD must be credentialed by the facility for treatment of neonatal patients and have their responsibilities and authority defined in a job description. The NMD and TMD must maintain a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.(1) The NMD is responsible for the provision of neonatal care services and must:(A) examine qualifications of medical staff and advanced practice providers requesting privileges to participate in neonatal/infant care, and make recommendations to the appropriate committee for such privileges;(B) ensure neonatal medical staff and advanced practice provider competencies in managing neonatal emergencies, complications, and resuscitation techniques;(C) monitor neonatal patient care from transport, to admission, stabilization, and operative intervention(s), as applicable, through discharge, and review variances in care through the neonatal QAPI Plan;(D) participate in ongoing neonatal staff and team-based education and training in the care of the neonatal patient;(E) oversee the inter-facility neonatal transport as appropriate;(F) collaborate with the NPM, maternal teams, consulting physicians, and nursing leaders and units providing neonatal care to include developing, implementing, or revising:(i) written policies, procedures, and guidelines for neonatal care that are implemented and monitored for variances;(ii) the neonatal QAPI Plan, specific reviews, and data initiatives;(iii) criteria for transfer, consultation, or higher-level of care; and(iv) medical staff, advanced practice providers, and personnel competencies, education, and training;(G) participate as a clinically active and practicing physician in neonatal care at the facility where medical director services are provided;(H) ensure that the neonatal QAPI Plan is specific to neonatal/infant care, is ongoing, data driven, and outcome based;(I) frequently lead the neonatal QAPI meetings with the NPM and participate in the Neonatal Program Oversight and other neonatal meetings, as appropriate;(J) maintain active staff privileges as defined in the facility's medical staff bylaws; and(K) develop and maintain collaborative relationships with other NMDs of designated neonatal facilities within the applicable PCR.(2) The TMD is responsible for the facility neonatal transport program and must:(A) collaborate with the transport team to develop, revise, and implement written policies, procedures, and guidelines, for neonatal care that are implemented and monitored for variances;(B) participate in ongoing transport staff competencies, education, and training;(C) review and evaluate transports from initial activation of the transport team through delivery of patient, resources, quality of patient care provided, and patient outcomes; and(D) integrate review findings into the overall neonatal QAPI Plan and process.(3) The NMD may also serve as the TMD.(e) NPM. The facility must identify an NPM who has the authority and oversight responsibilities written in his or her job description, for the provision of neonatal services through all phases of care, including discharge, and identifying variances in care for inclusion in the neonatal QAPI Plan.(1) The NPM must be a registered nurse with defined education, credentials, and experience for neonatal care applicable to the level of care being provided.(2) The NPM must maintain a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.(3) The NPM must:(A) ensure staff competency in resuscitation techniques;(B) participate in ongoing staff and team-based education and training in the care of the neonatal patient;(C) monitor utilization of telehealth/telemedicine, if used;(D) collaborate with the NMD, maternal program, consulting physicians, and nursing leaders and units providing neonatal care to include developing, implementing, or revising:(i) written policies, procedures, and guidelines for neonatal care that are implemented and monitored for variances;(ii) the neonatal QAPI Plan, specific reviews, and data initiatives;(iii) criteria for transfer, consultation, or higher-level of care; and(iv) staff competencies, education, and training;(E) regularly and actively participate in neonatal care at the facility where program manager services are provided;(F) consistently review the neonatal care provided and ensure the neonatal QAPI Plan is specific to neonatal/infant care, data driven, and outcome-based;(G) frequently lead the meetings and participate in Neonatal Program Oversight and other neonatal meetings as appropriate; and(H) develop and maintain collaborative relationships with other NPMs of designated neonatal facilities within the applicable PCR. Source Note: The provisions of this §133.185 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.185 Program Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213895&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213895 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213895&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213895 03/11/2026 (a) Level I (Well Care). The Level I neonatal designated facility must:(1) provide care for mothers and their infants of generally more than or equal to 35 weeks gestational age who have routine, transient perinatal problems;(2) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served; and(3) provide the same level of care that the neonate would receive at a higher-level designated neonatal facility and complete an in-depth critical review and assessment of the care provided to these infants through the neonatal QAPI Plan and process if an infant less than 35 weeks gestational age is retained.(b) Neonatal Medical Director (NMD). The NMD must be a physician who:(1) is a currently practicing pediatrician, family medicine physician, or physician specializing in obstetrics and gynecology with experience in the care of neonates/infants and with privileges in neonatal care;(2) maintains a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course;(3) demonstrates effective administrative skills and oversight of the neonatal QAPI Plan; and(4) completes annual continuing medical education specific to the care of neonates.(c) Program Functions and Services.(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure pregnant mothers who are at high risk of delivering a neonate that requires a higher-level of care are transferred to a higher-level facility before delivery unless the transfer would be unsafe.(2) The facility provides appropriate, supportive, and emergency care delivered by trained personnel for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery through the disposition of the patient.(3) The on-call physician, advanced practice nurse, or physician assistant must have documented special competence in the care of neonates, privileges and credentials to participate in neonatal/infant care reviewed by the NMD, and:(A) must maintain a current status of successful completion of the NRP or a department-approved equivalent course;(B) must complete annual continuing education specific to the care of neonates;(C) must arrive at the patient bedside within 30 minutes of an urgent request;(D) if not immediately available to respond or is covering more than one facility, must ensure appropriate back-up coverage is available, back-up call providers are documented in the neonatal on-call schedule and must be readily available to respond to the facility staff; and(E) the back-up call physician, advanced practice nurse, or physician assistant must arrive at the patient bedside within 30 minutes of an urgent request.(4) The facility must have written guidelines defining the availability of appropriate anesthesia, laboratory, radiology, respiratory, ultrasonography, and blood bank services on a 24-hour basis as described in §133.41 of this title (relating to Hospital Functions and Services).(A) If preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record.(B) The facility must ensure regular monitoring and comparison of the preliminary and final readings through the radiology QAPI Plan. Summary reports of activities must be presented at the Neonatal Program Oversight.(5) Pharmacy services must be in compliance with the requirements in §133.41 of this title and must have a pharmacist available at all times.(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must provide immediate supervision of the compounding process.(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and ensure:(i) the process is monitored through the pharmacy QAPI Plan; and(ii) summary reports of activities are presented to the Neonatal Program Oversight.(6) The facility must have personnel with appropriate training for managing neonates/infants, written policies, procedures, and guidelines specific to the facility for the stabilization and resuscitation of neonates based on current standards of professional practice. The facility must ensure the availability of personnel who can stabilize distressed neonates, including those less than 35 weeks gestation until they are transferred to a higher-level facility. Variances from these standards are monitored through the neonatal QAPI Plan and process.(A) Each birth must be attended by at least one person who maintains a current status of successful completion of the NRP or a department-equivalent course, whose primary focus is management of the neonate and initiating resuscitation.(B) At least one person must be immediately available on-site with the skills to perform a complete neonatal resuscitation including endotracheal intubation, establishment of vascular access, and administration of medications.(C) Additional personnel with current status of successful completion of the NRP, or a department-equivalent course, must be on-site and immediately available upon request for the following:(i) multiple birth deliveries, to care for each neonate;(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.(D) Variances from these standards are monitored through the neonatal QAPI Plan and process and reported at the Neonatal Program Oversight.(E) Neonatal resuscitative equipment, supplies, and medications must be immediately available for trained personnel to perform resuscitation and stabilization on any neonate/infant.(7) A registered nurse with experience in neonatal or perinatal care must provide supervision and coordination of staff education.(8) The neonatal program ensures the availability of support personnel with knowledge and skills in breastfeeding and lactation to assist and counsel mothers.(9) Social services, supportive spiritual care, and counseling must be provided as appropriate to meet the needs of the patient population served. Source Note: The provisions of this §133.186 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.186 Neonatal Designation Level I https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213896&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213896 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213896&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213896 03/11/2026 (a) Level II (Special Care). The Level II neonatal designated facility must:(1) provide care for mothers and their infants of generally more than or equal to 32 weeks gestational age and birth weight more than or equal to 1500 grams who have physiologic immaturity or problems that are expected to resolve rapidly and are not anticipated to require subspecialty services on an urgent basis; and(A) if a facility is located more than 75 miles from the nearest Level III or IV designated neonatal facility and retains a neonate less than 32 weeks of gestation or having a birth weight of less than 1500 grams, the facility must provide the same level of care that the neonate would receive at a higher-level designated neonatal facility; and(B) any facility that retains a neonate less than 32 weeks of gestation or a birth weight less than 1500 grams, must, through the neonatal QAPI Plan, complete an in-depth critical review and assessment of the care provided;(2) provide care, either by including assisted endotracheal ventilation for less than 24 hours or nasal continuous positive airway pressure (NCPAP) until the infant's condition improves or arrange for appropriate transfer to a higher-level designated facility; and(A) if the facility performs neonatal surgery, it must provide the same level of care that the neonate would receive at a higher-level designated facility; and(B) the neonatal surgical procedure and follow-up must be reviewed through the neonatal QAPI Plan; and(3) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served.(b) Neonatal Medical Director (NMD). The NMD must be a physician who:(1) is a board-eligible/certified neonatologist, with experience in the care of neonates/infants and maintains a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course; or(2) is a pediatrician or neonatologist by the effective date of this section who:(A) continuously provided neonatal care for the last consecutive two years and has experience and training in the care of neonates/infants, including assisted endotracheal ventilation and NCPAP management;(B) maintains a consultative relationship with a board-eligible/certified neonatologist;(C) demonstrates effective administrative skills and oversight of the neonatal QAPI Plan;(D) maintains a current status of successful completion of the NRP or a department-approved equivalent course; and(E) must complete annual continuing medical education specific to the care of neonates.(c) Program Functions and Services.(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure pregnant patients who are at high risk of delivering a neonate that requires a higher-level of care are transferred to a higher-level facility before delivery unless the transfer would be unsafe.(2) The facility provides appropriate, supportive, and emergency care delivered by trained personnel, for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery through the disposition of the patient.(3) The on-call physician, advanced practice nurse, or physician assistant must have documented special competence in the care of neonates, privileges and credentials to participate in neonatal/infant care reviewed by the NMD, and:(A) must maintain a current status of successful completion of the NRP or a department-approved equivalent course;(B) must complete annual continuing education specific to the care of neonates;(C) must arrive at the patient bedside within 30 minutes of an urgent request;(D) if not immediately available to respond or is covering more than one facility, must ensure appropriate back-up coverage is available, back-up call providers are documented in the neonatal on-call schedule and must be readily available to respond to the facility staff;(i) the back-up call physician, advanced practice nurse, or physician assistant must arrive at the patient bedside within 30 minutes of an urgent request; and(ii) the on-call staff must be on-site to provide ongoing care and to respond to emergencies when a neonate/infant is maintained on endotracheal ventilation.(4) The neonatal program ensures if surgeries are performed for neonates/infants, a surgeon privileged and credentialed to perform surgery on a neonate/infant is on-call and must arrive at the patient bedside within a time period consistent with current standards of professional practice and neonatal care. Surgeon response times must be reviewed and monitored through the neonatal QAPI Plan.(5) Anesthesia providers with pediatric experience and competence must provide services in compliance with the requirements in §133.41 of this title (relating to Hospital Functions and Services).(6) Dietitian or nutritionist with appropriate training and experience in neonatal nutrition provides services for the population served in compliance with the requirements in §133.41 of this title.(7) Laboratory services must be in compliance with the requirements in §133.41 of this title and must have:(A) personnel on-site at all times as defined by written management guidelines, which may include when a neonate/infant is maintained on endotracheal ventilation; and(B) a blood bank capable of providing blood and blood component therapy within the timelines defined in approved blood transfusion guidelines.(8) The facility must provide neonatal/infant blood gas monitoring capabilities.(9) Pharmacy services must be in compliance with the requirements in §133.41 of this title and must have a pharmacist with experience in neonatal/pediatric pharmacology available at all times.(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must provide immediate supervision of the compounding process.(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and ensure:(i) the process is monitored through the pharmacy QAPI Plan; and(ii) summary reports of activities are presented at the Neonatal Program Oversight.(C) Total parenteral nutrition appropriate for neonates/infants must be available, if requested.(10) A speech, occupational, or physical therapist with sufficient neonatal expertise must provide therapy services to meet the needs of the population served.(11) Radiology services must be in compliance with the requirements in §133.41 of this title, incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal patients, and must have:(A) personnel appropriately trained in the use of x-ray and ultrasound equipment;(B) personnel at the bedside within 30 minutes of an urgent request;(C) personnel appropriately trained, available on-site to provide ongoing care and to respond to emergencies when an infant is maintained on endotracheal ventilation;(D) interpretation capability of neonatal and perinatal x-rays and ultrasound studies are available at all times;(E) if preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record; and(F) regular monitoring and comparison of preliminary and final readings through the radiology QAPI Plan and provide summary reports of activities at the Neonatal Program Oversight.(12) A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed by the NMD, must be immediately available on-site when:(A) a neonate/infant is on a respiratory ventilator to provide ongoing care and to respond to emergencies; or(B) a neonate/infant is on a Continuous Positive Airway Pressure (CPAP) apparatus.(13) The facility must have staff with appropriate training for managing neonates/infants, written policies, procedures, and guidelines specific to the facility for the stabilization and resuscitation of neonates based on current standards of professional practice. Variances from these standards are monitored through the neonatal QAPI Plan.(A) Each birth must be attended by at least one person who maintains a current status of successful completion of the NRP or a department-approved equivalent course, whose primary focus is management of the neonate and initiating resuscitation.(B) At least one person must be immediately available on-site with the skills to perform a complete neonatal resuscitation including endotracheal intubation, establishment of vascular access, and administration of medications.(C) Additional personnel who maintain a current status of successful completion of the NRP or a department-approved equivalent course must be on-site and immediately available upon request for the following:(i) multiple birth deliveries, to care for each neonate;(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.(D) Variances from these standards are monitored through the neonatal QAPI Plan and process and reported at the Neonatal Program Oversight.(E) Neonatal resuscitative equipment, supplies, and medications must be immediately available for trained staff to perform resuscitation and stabilization on any neonate/infant.(14) A registered nurse with experience in neonatal care, including special care, or perinatal care must provide supervision and coordination of staff education.(15) Social services, supportive spiritual care, and counseling must be provided as appropriate to meet the needs of the patient population served.(16) Written and implemented policies and procedures to ensure the timely evaluation of retinopathy of prematurity, documented referral for treatment, and follow-up of an at-risk infant, which must be monitored through the neonatal QAPI Plan.(17) The neonatal program ensures the availability of support personnel with knowledge and expertise in breastfeeding and lactation to assist and counsel mothers.(18) The neonatal program ensures provisions for follow-through care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications. Source Note: The provisions of this §133.187 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.187 Neonatal Designation Level II https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213897&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213897 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213897&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213897 03/11/2026 (a) Level III (Neonatal Intensive Care). The Level III neonatal designated facility must:(1) provide care for mothers and comprehensive care for their infants of all gestational ages with mild to critical illnesses or requiring sustained life support;(2) ensure access to consultation to a full range of pediatric medical subspecialists and pediatric surgical specialists, and the capability to perform major pediatric surgery on-site or at another appropriate neonatal designated facility;(3) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;(4) facilitate neonatal transports; and(5) provide outreach education related to trends identified through the neonatal QAPI Plan, specific requests, and system needs to lower-level neonatal designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(b) Neonatal Medical Director (NMD). The NMD must be a physician who is a board-eligible/certified neonatologist with experience in the care of neonates/infants and maintains a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.(c) If the facility has its own transport program, there must be an identified Transport Medical Director (TMD). The TMD or Transport Medical Co-Director must be a physician who is a board-eligible/certified neonatologist or pediatrician with expertise and experience in neonatal/infant transport.(d) Program Functions and Services.(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure pregnant patients who are at high risk of delivering a neonate that requires a higher-level of care are transferred to a higher-level facility before delivery unless the transfer would be unsafe.(2) The facility provides appropriate, supportive, and emergency care delivered by trained personnel for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery through the disposition of the patient.(3) At least one of the following neonatal providers must be on-site and available at all times: pediatric hospitalists, neonatologists, neonatal nurse practitioners, or neonatal physician assistants, as appropriate, who must have documented competence in the management of severely ill neonates/infants, and privileges and credentials to participate in neonatal/infant care reviewed by the NMD and:(A) must maintain a current status of successful completion of the NRP or a department-approved equivalent course;(B) must complete annual continuing education specific to the care of neonates;(C) must have a neonatologist available for consultation at all times that arrives on-site within 30 minutes of an urgent request, if the on-site provider is not a neonatologist; and(D) if the neonatologist is covering more than one facility, must ensure the facility has a back-up neonatologist available, the back-up neonatologist is documented in the neonatal on-call schedule, and readily available to respond to the facility staff and arrive at the patient bedside within 30 minutes of an urgent request.(4) The neonatal program that performs surgeries for neonates/infants must have a surgeon privileged and credentialed to perform surgery on a neonate/infant on-call. The surgeon on-call must be available to arrive at the patient bedside within a time period consistent with current standards of professional practice and neonatal care. Surgeon response times must be reviewed and monitored through the neonatal QAPI Plan.(5) Anesthesiologists with pediatric expertise and competence must direct and evaluate anesthesia care provided to neonates in compliance with the requirements in §133.41 of this title.(6) Dietitian or nutritionist with appropriate training and experience in neonatal nutrition, plans diets that meet the needs of the neonate/infant and provides services for the population served, in compliance with the requirements in §133.41 of this title.(7) Laboratory services must be in compliance with the requirements in §133.41 of this title and must have:(A) laboratory personnel on-site at all times;(B) pediatric pathology services available for the population served;(C) pediatric surgical or intra-operative frozen section pathology services available in the operative suite at the request of the operating surgeon; and(D) a blood bank capable of providing blood and blood component therapy within the timelines defined in approved blood transfusion guidelines.(8) The facility must provide neonatal/infant blood gas monitoring capabilities.(9) Pharmacy services must be in compliance with the requirements in §133.41 of this title and must have a pharmacist with experience in neonatal/pediatric pharmacology available at all times.(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must provide immediate supervision of the compounding process;(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and ensure:(i) the process is monitored through the pharmacy QAPI Plan; and(ii) summary reports of activities are presented at the Neonatal Program Oversight.(C) Total parenteral nutrition appropriate for neonates/infants must be available.(10) Radiology services must be in compliance with the requirements in §133.41 of this title, incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal patients, and must have:(A) personnel appropriately trained in the use of x-ray equipment on-site and available at all times;(B) personnel appropriately trained in ultrasound, computed tomography, and cranial ultrasound equipment available on-site within a time period consistent with current standards of professional practice;(C) fluoroscopy available at all times;(D) neonatal diagnostic imaging studies and radiologists with pediatric expertise to interpret the neonatal diagnostic imaging studies, available at all times;(E) a radiologist with pediatric expertise to interpret images consistent with the patient condition and within a time period consistent with current standards of professional practice with monitoring of variances through the neonatal QAPI Plan and process;(F) preliminary findings documented in the medical record, if preliminary reading of imaging studies pending formal interpretation is performed; and(G) regular monitoring and comparison of the preliminary and final readings through the radiology QAPI Plan and provide summary reports of activities at the Neonatal Program Oversight.(11) Pediatric echocardiography with pediatric cardiology interpretation and consultation completed within a time period consistent with current standards of professional practice.(12) Speech, occupational, or physical therapists with neonatal/infant expertise and experience must:(A) evaluate and recommend management of feeding or swallowing disorders as appropriate for the patient's condition; and(B) provide therapy services to meet the needs of the population served.(13) A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed by the NMD, must be on-site and immediately available.(14) The facility must have staff with appropriate training for managing neonates/infants and written policies, procedures, and guidelines specific to the facility for the stabilization and resuscitation of neonates based on current standards of professional practice. Variances from these standards are monitored through the neonatal QAPI Plan.(A) Each birth must be attended by at least one person who maintains a current status of successful completion of the NRP or a department-approved equivalent course, and whose primary focus is management of the neonate and initiating resuscitation.(B) At least one person must be immediately available on-site with the skills to perform a complete neonatal resuscitation including endotracheal intubation, establishment of vascular access, and administration of medications.(C) Additional personnel who maintain a current status of successful completion of the NRP or a department-approved equivalent course must be on-site and immediately available upon request for the following:(i) multiple birth deliveries, to care for each neonate;(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.(D) Variances from these standards are monitored through the neonatal QAPI Plan and process and reported at the Neonatal Program Oversight.(E) Neonatal resuscitative equipment, supplies, and medications must be immediately available for trained staff to perform complete resuscitation and stabilization for each neonate/infant.(15) A registered nurse with experience in neonatal care, including neonatal intensive care, must provide supervision and coordination of staff education.(16) Social services, supportive spiritual care, and counseling must be provided as appropriate to meet the needs of the patient population served.(17) Written and implemented policies and procedures to ensure timely evaluation of retinopathy of prematurity, documented referral for treatment and follow-up of an at-risk infant, which must be monitored through the neonatal QAPI Plan.(18) The neonatal program ensures a certified lactation consultant must be available at all times to assist and counsel mothers.(19) The neonatal program ensures provisions for follow-through care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications. Source Note: The provisions of this §133.188 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.188 Neonatal Designation Level III https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213898 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213898 03/11/2026 (a) Level IV (Advanced Neonatal Intensive Care). The Level IV neonatal designated facility must:(1) provide care for the mothers and comprehensive care for their infants of all gestational ages with the most complex and critical medical and surgical conditions or requiring sustained life support;(2) ensure access to a comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists are available to arrive on-site in person for consultation and care, and the capability to perform major pediatric surgery including the surgical repair of complex conditions on-site;(3) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;(4) facilitate neonatal transports; and(5) provide outreach education related to trends identified through the neonatal QAPI Plan, specific requests, and system needs to lower-level neonatal designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(b) Neonatal Medical Director (NMD). The NMD must be a physician who is a board-eligible/certified neonatologist and maintains a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.(c) If the facility has its own transport program, there must be an identified Transport Medical Director (TMD). The TMD or Transport Medical Co-Director must be a physician who is a board-eligible/certified neonatologist with expertise and experience in neonatal/infant transport.(d) Program Functions and Services.(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure pregnant patients who are at high risk of delivering a neonate that requires specialized care are transferred to a facility with specialized care capabilities before delivery unless the transfer would be unsafe.(2) The facility provides appropriate, supportive, and emergency care delivered by trained personnel for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery, through the disposition of the patient.(3) A board-eligible/certified neonatologist, with documented competence in the management of the most complex and critically ill neonates/infants, with neonatal privileges and credentials reviewed by the NMD, must be on-site and immediately available at the neonate/infant bedside as requested. The neonatologist:(A) must maintain a current status of successful completion of the NRP or a department-approved equivalent course;(B) must complete annual continuing education specific to the care of neonates; and(C) must ensure the facility has a back-up neonatal provider if the neonatologist is not immediately available.(4) Pediatric anesthesiologists must direct and evaluate anesthesia care provided to neonates in compliance with the requirements in §133.41 of this title (relating to Hospital Functions and Services).(5) A comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists privileged and credentialed to participate in neonatal/infant care must be available to arrive on-site for in-person consultation and care within a time period consistent with current standards of professional practice and neonatal care. The pediatric medical and pediatric surgical subspecialists' response times must be reviewed and monitored through the neonatal QAPI Plan.(6) Dietitian or nutritionist with appropriate training and experience in neonatal nutrition, plans diets that meet the needs of the neonate/infant and critically ill neonatal patient and provides services for the population served, in compliance with the requirements in §133.41 of this title.(7) Laboratory services must be in compliance with the requirements in §133.41 of this title and must have:(A) appropriately trained and qualified laboratory personnel on-site at all times;(B) pediatric pathology services available for the population served;(C) pediatric surgical or intra-operative frozen section pathology services available in the operative suite at the request of the operating surgeon; and(D) a blood bank capable of providing blood and blood component therapy within the timelines defined in approved blood transfusion guidelines.(8) The facility must provide neonatal/infant blood gas monitoring capabilities.(9) Pharmacy services must be in compliance with the requirements in §133.41 of this title and must have a pharmacist with experience in neonatal/pediatric pharmacology available on-site at all times.(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must provide immediate supervision of the compounding process.(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and must ensure:(i) the process is monitored through the pharmacy QAPI plan; and(ii) summary reports of activities are presented at the Neonatal Program Oversight.(C) Total parenteral nutrition appropriate for neonates/infants must be available.(10) Radiology services must be in compliance with the requirements in §133.41 of this title, incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal patients, and must have:(A) personnel appropriately trained in the use of x-ray equipment on-site and available at all times;(B) personnel appropriately trained in ultrasound, computed tomography, and cranial ultrasound equipment be on-site within a time period consistent with current standards of professional practice;(C) fluoroscopy be available at all times;(D) neonatal diagnostic imaging studies and radiologists with pediatric expertise to interpret neonatal diagnostic imaging studies, available at all times;(E) a radiologist with pediatric expertise to interpret images consistent with the patient condition and within a time period consistent with current standards of professional practice with monitoring of variances through the neonatal QAPI Plan and process;(F) preliminary findings documented in the medical record, if preliminary reading of imaging studies pending formal interpretation is performed; and(G) regular monitoring and comparison of the preliminary and final readings through the radiology QAPI Plan and provide a summary report of activities at the Neonatal Program Oversight.(11) Pediatric echocardiography with pediatric cardiology interpretation and consultation completed within a time period consistent with current standards of professional practice.(12) Speech, occupational, or physical therapists with neonatal/infant expertise and experience must:(A) evaluate and recommend management of feeding and swallowing disorders as appropriate for the patient's condition; and(B) provide therapy services to meet the needs of the population served.(13) A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed and approved by the Neonatal Medical Director, must be on-site and immediately available.(14) The facility must have staff with appropriate training for managing neonates/infants, written policies, procedures, and guidelines specific to the facility for the stabilization and resuscitation of neonates/infants based on current standards of professional practice. Variances from these standards are monitored through the neonatal QAPI Plan.(A) Each birth must be attended by at least one person who maintains a current status of successful completion of the NRP or a department-approved equivalent course and whose primary focus is management of the neonate and initiating resuscitation.(B) At least one person must be immediately available on-site with the skills to perform a complete neonatal resuscitation including endotracheal intubation, establishment of vascular access and administration of medications.(C) Additional personnel who maintain a current status of successful completion of the NRP or a department-approved equivalent course must be on-site and immediately available upon request for the following:(i) multiple birth deliveries, to care for each neonate;(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.(D) Variances from these standards are monitored through the neonatal QAPI Plan and process and reported at the Neonatal Program Oversight.(E) Neonatal resuscitative equipment, supplies, and medications must be immediately available for trained staff to perform complete resuscitation and stabilization for each neonate/infant.(15) A registered nurse with experience in neonatal care, including advanced neonatal intensive care, must provide supervision and coordination of staff education.(16) Social services, supportive spiritual care, and counseling must be provided as appropriate to meet the needs of the patient population served.(17) Written and implemented policies and procedures to ensure timely evaluation and treatment of retinopathy of prematurity on-site by a pediatric ophthalmologist or retinal specialist with expertise in retinopathy of prematurity of an at-risk infant. Patient follow-up of retinopathy of prematurity must be documented and monitored through the neonatal QAPI Plan.(18) The neonatal program ensures a certified lactation consultant must be available at all times to assist and counsel mothers.(19) The neonatal program ensures provisions for follow-through care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications. Source Note: The provisions of this §133.189 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.189 Neonatal Designation Level IV https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213899&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213899 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213899&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213899 03/11/2026 (a) The survey team composition must be as follows:(1) Level I facilities neonatal program staff must conduct a self-survey, documenting the findings on the approved department survey form. The department may periodically require validation of the survey findings by an on-site review conducted by department staff.(2) Level II facilities must be surveyed by a multidisciplinary team that includes, at a minimum, one neonatologist and one neonatal nurse who:(A) have completed a department survey training course;(B) have observed a minimum of one neonatal survey;(C) are currently active in the management of neonatal patients and active in the neonatal QAPI Plan and process at a facility providing the same or a higher-level of neonatal care; and(D) meet the criteria outlined in the department survey guidelines.(3) Level III facilities must be surveyed by a multidisciplinary team that includes, at a minimum, one neonatologist, one neonatal nurse, and a pediatric surgeon when neonatal surgery is performed in the facility, who:(A) have completed a survey training course;(B) have observed a minimum of one neonatal survey;(C) are currently active in the management of neonatal patients and active in the neonatal QAPI Plan and process at a facility providing the same or a higher-level of neonatal care; and(D) meet the criteria outlined in the department survey guidelines.(4) Level IV facilities must be surveyed by a multidisciplinary team that includes, at a minimum, one neonatologist, one neonatal nurse, and one pediatric surgeon, who:(A) have completed a survey training course;(B) have observed a minimum of one neonatal survey;(C) are currently active in the management of neonatal patients and active in the neonatal QAPI Plan and process at a facility providing the same level of neonatal care; and(D) meet the criteria outlined in the department survey guidelines.(b) All members of the survey team, except department staff, must come from a PCR outside the facility's region or a contiguous region.(c) Survey team members cannot have a conflict of interest:(1) A conflict of interest exists when a surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public. The conflict of interest may include a surveyor who, within the past four years, has personally trained a key member of the facility's leadership in residency or fellowship, collaborated with a key member of the facility's leadership professionally, participated in a designation consultation with the facility, or conducted a designation survey for the facility.(2) If a designation survey occurs with a surveyor who has a conflict of interest, the department, in its sole discretion, may refuse to accept the neonatal designation site survey summary conducted by a surveyor with a conflict of interest.(d) The survey team must follow the department survey guidelines to evaluate and validate that the facility demonstrates the designation requirements are met.(e) The survey team must evaluate appropriate use of telehealth/telemedicine utilization for neonatal care.(f) All information and materials submitted by a facility to the department and a survey organization under Texas Health and Safety Code, §241.183(d) or this subchapter, are subject to confidentiality as articulated in Texas Health and Safety Code, §241.184, Confidentiality; Privilege, and are not subject to disclosure under Texas Government Code, Chapter 552, or discovery, subpoena, or other means of legal compulsion for release to any person. Source Note: The provisions of this §133.190 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.190 Survey Team https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213900&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213900 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=213900&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 213900 03/11/2026 (a) The PCR must consider and facilitate transfer agreements through regional coordination.(b) The PCR must coordinate regional perinatal system QAPI reviews.(c) The PCRs must not restrict patient referrals.(d) The PCR integrates with the Regional Advisory Council (RAC) system plans to ensure there is a written perinatal system plan specific to the regional area utilizing the RAC criteria and self-assessment tools.(e) The PCRs must be administratively supported by the RAC and must have fair and equitable representation on the board of the applicable RAC.(f) Each PCR may define data needs for regional collaboratives. Source Note: The provisions of this §133.191 adopted to be effective June 22, 2023, 48 TexReg 3226. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING J HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE §133.191 Perinatal Care Regions (PCRs) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212015 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212015 03/11/2026 The purpose of this subchapter is to implement Texas Health and Safety Code, Chapter 241, Subchapter H, Hospital Level of Care Designations for Neonatal and Maternal Care, which requires a level of care designation of maternal services to be eligible to receive reimbursement through the Medicaid program for maternal services. Source Note: The provisions of this §133.201 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.201 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212016 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212016 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) ACLS--Advanced Cardiovascular Life Support. A resuscitation course that was developed and is administered by the American Heart Association.(2) Antepartum--The period beginning on the date of conception and ending on delivery.(3) Attestation--A written statement, signed by the chief executive officer of the facility, verifying the results of a self-survey represent a complete and accurate assessment of the facility's capabilities required in this subchapter.(4) Available--Relating to staff who can be contacted for consultation at all times without delay.(5) Board-eligible--A physician who has completed a residency or fellowship and is eligible for board certification according to the applicable medical board.(6) CAP--Corrective Action Plan. A plan for the facility developed by the department that describes the actions required of the facility to correct identified deficiencies to ensure the applicable designation requirements are met.(7) Department--The Texas Department of State Health Services.(8) Designation--A formal recognition by the department of a facility's maternal care capabilities and commitment for a period of three years.(9) EMS--Emergency medical services. Services used to respond to an individual's perceived need for immediate medical care.(10) Focused Survey--A department-defined modified facility survey by a department-approved survey organization or the department. The specific goal of this survey is to review designation requirements identified as not met to resolve a contingent designation or requirement deficiencies.(11) Gestational age--The age of a fetus or embryo determined by the amount of time that has elapsed since the first day of the maternal patient's last menstrual period or the corresponding age of the gestation as estimated by a physician through a more accurate method.(12) High-risk infant--A newborn that has a greater chance of complications because of conditions that occur during fetal development, pregnancy conditions of the mother, or problems that may occur during labor or birth.(13) Immediately--Able to respond without delay, commonly referred to as STAT.(14) Infant--A child from birth to one year of age.(15) Intrapartum--During labor and delivery or childbirth.(16) Inter-facility transport--Transfer of a patient from one healthcare facility to another healthcare facility.(17) Lactation consultant--A health care professional who specializes in the clinical management of breastfeeding.(18) Maternal--Pertaining to the mother.(19) Maternal Program Oversight--A multidisciplinary process responsible for the administrative oversight of the maternal program and having the authority for approving the defined maternal program's policies, procedures, and guidelines for all phases of maternal care provided by the facility, to include defining the necessary staff competencies, monitoring to ensure maternal designation requirements are met, and the aggregate review of the maternal QAPI initiatives and outcomes. Maternal Program Oversight may be performed through the maternal program's performance improvement committee, multidisciplinary oversight committee, or other structured means.(20) MFM--Maternal Fetal Medicine.(21) MMD--Maternal Medical Director.(22) MPM--Maternal Program Manager.(23) Neonate--An infant from birth through 28 completed days after.(24) Obstetrics--Related to pregnancy, childbirth, and the postpartum period.(25) On-site--At the facility and able to arrive at the patient bedside for urgent requests.(26) PCR--Perinatal Care Region. The PCRs are established for descriptive and regional planning purposes. The PCRs are geographically divided by counties and are integrated into the existing 22 Trauma Service Areas (TSAs) and the applicable Regional Advisory Council (RAC) of the TSA provided in §157.122 of this title (relating to Trauma Services Areas) and §157.123 of this title (relating to Regional Emergency Medical Services/Trauma Systems).(27) Perinatal--Of, relating to, or being the period around childbirth, especially the five months before and one month after birth.(28) PASD--Placenta Accreta Spectrum Disorder. A disorder that includes placenta accreta, placenta increta, and placenta percreta.(29) POC--Plan of Correction. A report submitted to the department by the facility detailing how the facility will correct any deficiencies cited in the maternal designation site survey summary or documented in the self-attestation.(30) Premature/prematurity--Birth at less than 37 weeks of gestation.(31) Postpartum--The six-week period following pregnancy or delivery.(32) QAPI Plan--Quality Assessment and Performance Improvement Plan. QAPI is a data-driven and proactive approach to quality improvement. It combines two approaches - Quality Assessment (QA) and Performance Improvement (PI). QA is a process used to ensure services are meeting quality standards and assuring care reaches a defined level. PI is the continuous study and improvement process designed to improve system and patient outcomes.(33) RAC--Regional Advisory Council as described in §157.123 of this title.(34) Screening--Evaluation for the presence or absence of a disease or condition.(35) Supervision--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.(36) Telehealth service--A health service, other than a telemedicine medical service, delivered by a health professional licensed, certified, or otherwise entitled to practice in this state and acting within the scope of health professional's license, certification, or entitlement, to a patient at a different physical location than the health professional using telecommunications or information technology as defined in Texas Occupations Code §111.001.(37) Telemedicine medical service--A health care service delivered by a physician licensed in this state, or health professional acting under the delegation and supervision of a physician licensed in this state and acting within the scope of the physician's or health professional's license to a patient at a different physical location than the physician or health professional using telecommunications or technology as defined in Texas Occupations Code §111.001.(38) TSA--Trauma Service Area as described in §157.122 of this title.(39) Urgent--Requiring action or attention within 30 minutes of notification. Source Note: The provisions of this §133.202 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.202 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212017 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212017 03/11/2026 (a) The department reviews the applicant documents and approves the appropriate level of facility designation.(b) A facility is defined under this subchapter as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license.(c) Each location must be considered separately for designation and the department approves the designation level for each location based on the location's ability to demonstrate designation criteria are met.(d) The department determines requirements for the levels of maternal designation. Facilities seeking Levels II, III, and IV maternal designation must meet department-approved requirements validated by a department-approved survey organization.(e) Facilities seeking Level I maternal designation must submit a self-survey and attest to meeting department-approved requirements.(f) The four levels of maternal designation are:(1) Level I (Basic Care). The Level I maternal designated facility must:(A) provide care for pregnant and postpartum patients who are generally healthy and do not have medical, surgical, or obstetrical conditions that present a significant risk of maternal morbidity or mortality; and(B) have skilled personnel with documented training, competencies, and annual continuing education specific for the patient population served.(2) Level II (Specialty Care). The Level II maternal designated facility must:(A) provide care for pregnant and postpartum patients with medical, surgical, or obstetrical conditions that present a low to moderate risk of maternal morbidity or mortality; and(B) have skilled personnel with documented training, competencies, and annual continuing education specific for the patient population served.(3) Level III (Subspecialty Care). The Level III maternal designated facility must:(A) provide care for pregnant and postpartum patients with low risk conditions to significant complex medical, surgical, or obstetrical conditions that present a high risk of maternal morbidity or mortality;(B) ensure access to consultation to a full range of medical and maternal subspecialists and surgical specialists, and behavioral health specialists;(C) ensure capability to perform major surgery on-site;(D) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians or Obstetrics and Gynecology physicians with obstetrics training and privileges in maternal care;(E) have skilled personnel with documented training, competencies, and annual continuing education, specific for the population served;(F) facilitate transports; and(G) provide outreach education related to trends identified through the QAPI Plan, specific requests, and system needs to lower level designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(4) Level IV (Comprehensive Care). The Level IV maternal designated facility must:(A) provide comprehensive care for pregnant and postpartum patients with low risk conditions to the most complex medical, surgical or obstetrical conditions and their fetuses, that present a high risk of maternal morbidity or mortality;(B) ensure access to on-site consultation to a comprehensive range of medical and maternal subspecialists, surgical specialists, and behavioral health specialists;(C) ensure capability to perform major surgery on-site;(D) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians or Obstetrics and Gynecology physicians with obstetrics training, experience and privileges in maternal care;(E) have a maternal fetal medicine critical care team with expertise and privileges to manage or co-manage highly complex, critically ill or unstable maternal patients;(F) have a placenta accreta spectrum disorder multidisciplinary care team with expertise to complete risk factor screening, evaluation, diagnosis, consultation, and management of patients with anticipated or unanticipated placenta accreta spectrum disorder, including postpartum care;(G) have skilled personnel with documented training, competencies, and annual continuing education, specific for the patient population served;(H) facilitate transports; and(I) provide outreach education related to trends identified through the QAPI Plan, specific requests, and system needs to lower level designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(g) Facilities seeking maternal designation must undergo an on-site or virtual survey as outlined in this section and:(1) are responsible for scheduling a maternal designation survey through a department-approved survey organization;(2) must notify the department of the maternal designation survey date;(3) are responsible for expenses associated with the maternal designation survey;(4) must not accept surveyors with any conflict of interest; and(5) must provide the survey team access to records and documentation regarding the QAPI Plan and process related to maternal patients.(h) If a conflict of interest is present for a facility seeking maternal designation, the facility must decline the assigned surveyor through the surveying organization. A conflict of interest exists when a surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public. The conflict of interest may include a surveyor that personally trained a key member of the facility's leadership in residency or fellowship, collaborated with a key member of the facility's leadership professionally, participated in a designation consultation with the facility, had a previous working relationship with the facility or facility leaders, or conducted a designation survey for the facility within the past four years.(1) Surveyors cannot be from the same PCR or TSA region or a contiguous region of the facility's location.(2) Designation site survey summary and record reviews performed by a surveyor with an identified conflict of interest may not be accepted by the department.(i) The survey team evaluates the facility's evidence that department-approved designation requirements are met and documents all requirements that are not met in the maternal designation site survey and medical record reviews. Source Note: The provisions of this §133.203 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.203 General Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212018&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212018 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212018&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212018 03/11/2026 (a) A facility seeking maternal designation or renewal of designation must submit a completed application packet.(1) The completed application packet includes:(A) an accurate and complete maternal designation application for the requested level of designation;(B) a completed maternal attestation and self-survey report for Level I applicants or the documented maternal designation site survey summary that validates that department-approved designation requirements are met and the medical record reviews for Levels II, III, and IV applicants, submitted to the department no later than 90 days after the maternal designation site survey date;(C) If the facility has three or more department-approved designation requirements that are defined as not met, the facility must contact the department's designation unit within 10 business days to discuss the Plan of Correction (POC).(D) if required by the department, a POC that addresses all designation requirements defined as "not met" in the maternal designation site survey summary. The POC must include:(i) a statement of the cited designation requirement not met;(ii) a statement describing the corrective action taken by the facility seeking maternal designation to meet the requirement;(iii) the title of the individuals responsible for ensuring the corrective actions are implemented;(iv) the date the corrective actions were implemented;(v) how the corrective actions will be monitored; and(vi) documented evidence that the POC was implemented within 90 days of the designation survey;(E) written evidence of annual participation in the applicable PCRs; and(F) any subsequent documents submitted by the date requested by the department.(2) The application includes full payment of the non-refundable, non-transferrable designation fee listed:(A) Level I maternal facility applicants, the fees are as follows:(i) ≤100 licensed beds, the fee is $250.00; or(ii) >100 licensed beds, the fee is $750.00.(B) Level II maternal facility applicants, the fee is $1,500.00.(C) Level III maternal facility applicants, the fee is $2,000.00.(D) Level IV maternal facility applicants, the fee is $2,500.00.(b) The application will not be processed if a facility seeking maternal designation fails to submit the required application documents and total designation fee.(c) The maternal designation renewal process, or a request to designate at a different level of care, or a change in ownership, or change in physical address requires the facility to complete a designation renewal, which follows the same requirements outlined in subsection (a)(1) and (2) of this section.(d) The facility must submit the required documents described in subsection (a)(1) and (2) of this section to the department no later than 90 days before the facility's current maternal designation expiration date for all designation renewals.(e) The facility has the right to withdraw its application for maternal designation any time before a designation approval.(f) The facility must seek maternal designation renewal to maintain continual designation and prevent an interruption in designation.(g) The facility's maternal designation will expire if the facility fails to provide a complete maternal designation application packet to the department.(h) The maternal designation application packet in its entirety, including any recommendations or follow-up from the department, and any opportunities for improvement must be a written element of the facility's maternal QAPI Plan, and must be reviewed through this process, which is all subject to confidentiality as described in Texas Health and Safety Code, §241.184, Confidentiality; Privilege.(i) The department reviews the application packet to determine and approve the facility's level of maternal designation.(j) The department defines the final maternal designation level awarded to the facility and this designation may be different than the level requested based on the maternal designation site survey summary.(k) If the department determines the facility meets the requirements for maternal designation, the department provides the facility with a designation award letter and a designation certificate.(1) The facility must display its maternal designation certificate in a public area of the licensed premises that is readily visible to patients, employees, and visitors.(2) The facility must not alter the maternal designation certificate. Any alteration voids maternal designation for the remainder of that designation period.(l) The survey organization must provide the facility with a written, signed maternal designation site survey summary, including medical record reviews, regarding their evaluation and validation of the facility's demonstration that maternal designation requirements are met. This maternal designation site survey summary must be forwarded to the facility no later than 30 days after the completion date of the survey. The facility is responsible for submitting a copy of the maternal designation site survey summary and medical record reviews to the department with the required documents to continue the designation process within 90 days of completion of the site survey.(m) The department will approve designation of a facility that demonstrates the requirements are met.(n) A maternal level of care designation must not be denied to a facility that meets the designation requirements for that level of care designation.(o) If a facility does not meet the designation requirements for the level of designation requested, the department will designate the facility at the highest level for which designation requirements are met.(p) If the department determines a facility does not meet the designation requirements for the level of designation requested, the department must provide written notification to the facility of the designation requirements not met and provide a Corrective Action Plan (CAP) to assist the facility in meeting the designation requirement. The CAP may include requiring the facility to have a focused survey or a complete re-survey.(1) The facility must submit to the department reports required and outlined in the CAP. The department may require a second survey to ensure they meet the designation requirements. The cost of the second survey will be at the expense of the facility.(2) If the department substantiates actions taken by the facility demonstrating documented evidence that designation requirements are met, the department removes the contingencies.(q) If a facility disagrees with the designation level awarded by the department, it may request an appeal in writing to the EMS/Trauma Systems Section Director not later than 30 days after the designation award. The written appeal must be from the facility's Chief Executive Officer, Chief Medical Officer, or Chief Nursing Officer with documented evidence of how the facility meets the requirements for the requested designation level.(1) The EMS/Trauma Systems Section will establish a three-person appeal panel and follow approved appeal panel guidelines to assess the facility's designation appeal as referenced in Texas Health and Safety Code §241.1836.(2) If the designation appeal panel recommends the original determination, the EMS/Trauma Systems Section Director will give written notice of such to the facility not later than 30 days after the appeal panel's recommendation.(3) If the designation appeal panel disagrees with the department's original designation determination, the panel will recommend the appropriate level of maternal designation to the department.(4) If a facility disagrees with the designation appeal panel's recommendation regarding its designation level, the facility can request a second appeal review with the department's Associate Commissioner for Consumer Protection Division. If the Associate Commissioner upholds the designation appeal panel's recommendation, the designation status will remain the same. If the Associate Commissioner disagrees with the designation appeal panel's recommendation, the Associate Commissioner will define the appropriate level and award designation. The department will send a notification letter of the second appeal decision within 30 days of receiving the second appeal request.(5) If the facility continues to disagree with the second level of appeal, the facility has a right to a hearing in the manner referenced in §133.121 of this title (relating to Enforcement Action).(r) Exceptions and Notifications.(1) A designated maternal facility must provide written or electronic notification of any significant change to the maternal program impacting patient care. The notification must be provided to the following:(A) all emergency medical services (EMS) providers that transfer maternal patients to or from the designated maternal facility;(B) the hospitals to which it customarily transfers out or transfers in maternal patients;(C) applicable PCRs and RACs; and(D) the department.(2) If the designated maternal facility is unable to comply with requirements to maintain its current designation, it must submit to the department a POC as described in subsection (a)(1)(D)(i) - (vi) of this section, and a request for a temporary exception to the designation requirements. Any request for an exception must be submitted in writing from the Chief Executive Officer of the facility and define the facility's timeline to meet the designation requirements. The department reviews the request and the POC, and either grants the exception, with a specific timeline based on the public interest, geographic maternal care capabilities, and access to care, or denies the exception. If the facility is not granted an exception, or it does not meet the designation requirements at the end of the exception period, the department will elect one of the following:(A) re-designate the facility at the level appropriate to its revised capabilities;(B) outline an agreement with the facility to satisfy all designation requirements for the level of care designation within a time specified under the agreement, which may not exceed the first anniversary of the effective date of the agreement; or(C) waive one specific designation requirement for a level of care designation if the facility meets all other designation requirements for the level of care designation and the department determines the waiver is justified considering:(i) the expected impact on accessibility of maternal care in the geographic area served by the facility if the waiver is not granted and the expected impact on the quality of care and patient safety; or(ii) whether these services can be met by other facilities in the area or with telehealth/telemedicine services.(3) Waivers expire with the expiration of the current designation but may be renewed. The department may specify any conditions for ongoing reporting during this time.(4) The department maintains a current list on their internet website of designated facilities that have an approved waiver with the department and an aggregated list of the requirements waived.(5) Facilities that have contingency agreements or an approved waiver with the department must post on the facility's internet website the nature and general terms of the agreement.(s) An application for a higher or lower level of maternal designation may be submitted to the department at any time.(1) A designated maternal facility that is increasing its maternal capabilities may choose to apply for a higher level of designation at any time. The facility must follow the designation process as described in subsection (a)(1) and (2) of this section to apply for the higher level.(2) A designated maternal facility that is unable to maintain the facility's current level of maternal designation may choose to apply for a lower level of designation at any time.(t) If the facility is relinquishing its maternal designation, the facility must provide 30 days written, advance notice of the relinquishment to the department, the applicable PCRs/RACs, EMS providers, and facilities it customarily transfers out or transfers in maternal patients. The facility is responsible for continuing to provide maternal care services or ensuring a plan for maternal care continuity for the 30 days following the written notice of relinquishing its maternal designation.(u) A hospital providing maternal services must not use the terms "designated maternal facility," or similar terminology in its signs, advertisements, facility internet website, social media, or in the printed materials and information it provides to the public, unless the facility is currently designated at that level of maternal care.(v) During a virtual, on-site or focused designation review, conducted by the department or survey organization, the department or surveyor has the right to review and evaluate maternal patient records, maternal multidisciplinary QAPI Plan documents, and any action specific to improving maternal care and outcomes, as well as any other documents relevant to maternal care in a designated maternal facility or facility seeking maternal facility designation to validate designation requirements are met.(w) The department and survey organization will comply with all relevant laws related to the confidentiality of records.(x) The department may deny, suspend, or revoke designation if a designated maternal facility ceases to provide services to meet or maintain the designation requirements of this section. Source Note: The provisions of this §133.204 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.204 Designation Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212019 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212019 03/11/2026 (a) Maternal Program Philosophy. Designated facilities must have a family centered philosophy. The facility environment for perinatal care must meet the physiologic and psychosocial needs of the mothers, infants, and families. Parents must have reasonable access to their infants at all times and be encouraged to participate in the care of their infants.(b) Maternal Program Plan. The facility must develop a written maternal operational plan for the maternal program that includes a detailed description of the scope of services and clinical resources available for all maternal patients and families. The plan will define the maternal patient population evaluated, treated, transferred, or transported by the facility consistent with clinical guidelines based on current standards of maternal practice ensuring the health and safety of patients.(1) The written Maternal Program Plan must be reviewed and approved by Maternal Program Oversight and be submitted to the facility's governing body for review and approval. The governing body must ensure that the requirements of this section are implemented and enforced.(2) The written Maternal Program Plan must include, at a minimum:(A) clinical guidelines based on current standards of maternal practice, and policies and procedures that are adopted, implemented, and enforced by the maternal program;(B) a process to ensure and validate that these clinical guidelines based on current standards of maternal practice, policies, and procedures are reviewed and revised a minimum of every three years;(C) written triage, stabilization, and transfer guidelines for pregnant and postpartum patients that include consultation and transport services;(D) written guidelines or protocols for prevention, early identification, early diagnosis, and therapy for conditions that place the pregnant or postpartum patient at risk for morbidity or mortality;(E) the role and scope of telehealth/telemedicine practices if utilized, including:(i) documented and approved written policies and procedures that outline the use of telehealth/telemedicine for inpatient hospital care, or for inpatient consultation, including appropriate situations, scope of care, and documentation that is monitored through the QAPI Plan and process; and(ii) written and approved procedures to gain informed consent from the patient or designee for the use of telehealth/telemedicine, if utilized, that are monitored for compliance;(F) written guidelines for discharge planning instructions and appropriate follow up appointments for all mothers and infants;(G) written guidelines for the hospital disaster response, including a defined mother and infant evacuation plan and process to relocate mothers and infants to appropriate levels of care with identified resources, and this process must be evaluated annually to ensure maternal care can be sustained and adequate resources are available;(H) requirements for minimal credentials for all staff participating in the care of maternal patients;(I) provisions for providing continuing staff education, including annual competency and skills assessment that is appropriate for the patient population served;(J) a perinatal staff registered nurse as a representative on the nurse staffing committee under §133.41 of this title (relating to Hospital Functions and Services); and(K) the availability of all necessary equipment and services to provide the appropriate level of care and support of the patient population served.(3) The facility must have a documented QAPI Plan. The maternal program must measure, analyze, and track quality indicators and other aspects of performance that the facility adopts or develops that reflect processes of care and is outcome based.(A) The Chief Executive Officer, Chief Medical Officer, and Chief Nursing Officer must implement a culture of safety for the facility and ensure adequate resources are allocated to support a concurrent, data-driven maternal QAPI Plan.(B) The facility must demonstrate that the maternal QAPI Plan consistently assesses the provision of maternal care provided. The assessment will identify variances in care, the impact to the patient, and the appropriate levels of review. This process will identify opportunities for improvement and develop a plan of correction to address the variances in care or the system response. An action plan will track and analyze data through resolution or correction of the identified variance.(C) Maternal facilities must review their incidence and management of placenta accreta spectrum disorder through the QAPI Plan and report the incidence and outcomes through the Maternal Program Oversight.(D) The Maternal Medical Director (MMD) must have the authority to make referrals for peer review, receive feedback from the peer review process, and ensure maternal physician representation in the peer review process for maternal cases.(E) The MMD and the Maternal Program Manager (MPM) must participate in the PCR meetings, QAPI regional initiatives, and regional collaboratives, and submit requested data to assist with data analysis to evaluate regional outcomes as an element of their maternal QAPI Plan.(F) The facility must have documented evidence of maternal QAPI summary reports reviewed and reported by Maternal Program Oversight that monitor and ensure the provision of services or procedures through the telehealth and telemedicine, if utilized, is in accordance with the standard of care applicable to the provision of the same service or procedure in an in-person setting.(G) The facility must have documented evidence of maternal QAPI summary reports to support that aggregate maternal data are consistently reviewed to identify developing trends, opportunities for improvement, and necessary corrective actions. Summary reports must be provided through Maternal Program Oversight, available for site surveyors, and submitted to the department as requested.(c) Medical Staff. The facility must have an organized maternal program that is recognized by the facility's medical staff and approved by the facility's governing body.(1) The credentialing of the maternal medical staff must include a process for the delineation of privileges for maternal care.(2) The maternal medical staff must participate in ongoing staff and team-based education and training in the care of the maternal patient.(d) Medical Director. There must be an identified MMD and an identified Transport Medical Director (TMD) if the facility has its own transport program. The MMD and TMD must be credentialed by the facility for treatment of maternal patients and have their responsibilities and authority defined in a job description. The MMD is responsible for the provision of maternal care services and:(1) examining qualifications of medical staff requesting maternal privileges and making recommendations to the appropriate committee for such privileges;(2) assuring maternal medical staff competency in managing obstetrical emergencies, complications and resuscitation techniques;(3) monitoring maternal patient care from transport if applicable, to admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Plan;(4) participating in ongoing maternal staff and team-based education and training in the care of the maternal patient;(5) overseeing the inter-facility maternal transport;(6) collaborating with the MPM in areas to include developing or revising policies, procedures and guidelines, assuring medical staff and personnel competency, education and training; and the QAPI Plan;(7) frequently leading the maternal QAPI meetings with the MPM and participating in Maternal Program Oversight and other maternal meetings as appropriate;(8) ensuring that the QAPI Plan is specific to maternal and fetal care, is ongoing, data-driven and outcome-based;(9) participating as a clinically active and practicing physician in maternal care at the facility where medical director services are provided;(10) maintaining active staff privileges as defined in the facility's medical staff bylaws; and(11) developing collaborative relationships with other MMD(s) of designated facilities within the applicable Perinatal Care Region.(e) MPM. The facility must identify a MPM who has the authority and oversight responsibilities written in his or her job description for the provision of maternal services through all phases of care, including discharge and identifying variances in care for inclusion in the QAPI Plan and:(1) be a registered nurse with perinatal experience;(2) be a clinically active and practicing registered nurse participating in maternal care at the facility where program manager services are provided;(3) has the authority and responsibility to monitor the provision of maternal patient care services from admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Plan;(4) collaborates with the MMD in areas to include developing or revising policies, procedures and guidelines; assuring staff competency, education, and training and the QAPI Plan;(5) frequently leads the maternal QAPI meetings and participates in Maternal Program Oversight and other maternal meetings as appropriate;(6) ensures that the QAPI Plan is specific to maternal and fetal care, is ongoing, data-driven and outcome based, including telehealth/telemedicine utilization, when used; and(7) develops collaborative relationships with other MPM(s) of designated facilities within the applicable Perinatal Care Region. Source Note: The provisions of this §133.205 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.205 Program Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212020&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212020 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212020&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212020 03/11/2026 (a) Level I (Basic Care). The Level I maternal designated facility must:(1) provide care for pregnant and postpartum patients who are generally healthy, and do not have medical, surgical, or obstetrical conditions that present a significant risk of maternal morbidity or mortality; and(2) have skilled personnel with documented training, competencies, and annual continuing education specific for the patient population served.(b) Maternal Medical Director (MMD). The MMD must be a physician who:(1) is a family medicine physician or an obstetrics and gynecology physician, with obstetrics training and experience, and with privileges in maternal care;(2) demonstrates administrative skills and oversight of the Quality Assessment and Performance Improvement (QAPI) Plan; and(3) has completed annual continuing education specific to maternal care.(c) Program Functions and Services.(1) Triage and assessment of all patients admitted to the perinatal service.(A) Pregnant patients who are identified at high risk of delivering a neonate that requires a higher level of neonatal care than the scope of their neonatal facility must be transferred to a higher level neonatal designated facility before delivery unless the transfer is unsafe.(B) Pregnant or postpartum patients identified with conditions or complications that require a higher level of maternal care must be transferred to a higher level maternal designated facility unless the transfer is unsafe.(2) Provide care for patients with uncomplicated pregnancies with the capability to detect, stabilize, and initiate management of unanticipated maternal-fetal or maternal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a higher level of neonatal or maternal care.(3) An obstetrics and gynecology physician with obstetrics training and experience must be available for consultation, at all times.(4) Medical, surgical and behavioral health specialists must be available at all times for consultation appropriate to the patient population served.(5) Ensure that a qualified physician or certified nurse midwife with appropriate physician back-up is available to attend all deliveries or other obstetrical emergencies.(6) The family medicine physician, primary physician, or certified nurse midwife with competence in the care of pregnant patients, whose credentials have been reviewed by the MMD and is on call:(A) must arrive at the patient bedside within 30 minutes of an urgent request; and(B) must complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated conditions.(7) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:(A) must operate under guidelines reviewed and approved by the MMD; and(B) must have a formal arrangement with a physician with obstetrics training or experience, and with maternal privileges who must:(i) provide back-up and consultation;(ii) arrive at the patient bedside within 30 minutes of an urgent request; and(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.(8) An on-call schedule of providers, back-up providers, and provision for patients without a physician must be readily available to facility and maternal staff and posted on the labor and delivery unit.(9) Ensure that physicians providing back-up coverage must arrive at the patient bedside within 30 minutes of an urgent request.(10) Appropriate anesthesia, laboratory, pharmacy, radiology, respiratory therapy, ultrasonography and blood bank services must be available on a 24-hour basis as described in §133.41 of this title (relating to Hospital Functions and Services) respectively.(A) Anesthesia personnel with training and experience in obstetric anesthesia must be available at all times and arrive to the patient bedside within 30 minutes of an urgent request.(B) Laboratory and blood bank services must have guidelines or protocols for:(i) massive blood component transfusion;(ii) emergency release of blood components; and(iii) management of multiple blood component therapy.(C) Medical Imaging Services.(i) If preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record.(ii) There must be regular monitoring of the preliminary versus final reading in the QAPI Plan.(iii) Basic ultrasonographic imaging for maternal or fetal assessment, including interpretation available at all times.(iv) A portable ultrasound machine immediately available at all times to the labor and delivery and antepartum unit.(D) A pharmacist must be available for consultation at all times.(11) Obstetrical Services.(A) The ability to begin an emergency cesarean delivery and ensure the availability of a physician with the training, skills, and privileges to perform the surgery within a time period consistent with current standards of professional practice and maternal care.(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.(C) A trial of labor for patients with prior cesarean delivery must have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.(12) Resuscitation. The facility must have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS, or a department-approved equivalent course, and the skills to perform a complete resuscitation; and(B) ensures that resuscitation equipment, including difficult airway management equipment for pregnant and postpartum patients, is immediately available at all times to the labor and delivery, antepartum and postpartum areas.(13) The facility must have a written hospital preparedness and management plan for patients with placenta accreta spectrum disorder who are undiagnosed until delivery, including educating hospital and medical staff who may be involved in the treatment and management of placenta accreta spectrum disorder about risk factors, diagnosis, and management.(14) The facility must have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage or coagulopathy;(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;(C) placenta accreta spectrum disorder, including team education, risk factor screening, evaluation, diagnosis, fostering telemedicine medical services and referral as appropriate, treatment and multidisciplinary management of both anticipated and unanticipated placenta accreta spectrum disorder cases, including postpartum care;(D) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;(E) sepsis or systemic infection in the pregnant or postpartum patient;(F) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;(G) shoulder dystocia, including assessment of risk factors, counseling of patient, and multidisciplinary management; and(H) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.(15) Perinatal Education. A registered nurse with experience in maternal care must provide the supervision and coordination of staff education. Perinatal education for high risk events must be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.(16) Support personnel with knowledge and skills in breastfeeding and lactation to meet the needs of maternal patients must be available at all times.(17) Social services, pastoral care and bereavement services must be provided as appropriate to meet the needs of the patient population served.(18) Dietician or nutritionist available with appropriate training and experience for population served in compliance with the requirements in §133.41 of this title. Source Note: The provisions of this §133.206 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.206 Maternal Designation Level I https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212021&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212021 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212021&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212021 03/11/2026 (a) Level II (Specialty Care). The Level II maternal designated facility must:(1) provide care for pregnant and postpartum patients with medical, surgical, or obstetrical conditions that present a low to moderate risk of maternal morbidity or mortality; and(2) have skilled personnel with documented training, competencies, and annual continuing education specific for the patient population served.(b) Maternal Medical Director (MMD). The MMD must be a physician who:(1) is a family medicine physician, an obstetrics and gynecology physician, or maternal fetal medicine physician, all with obstetrics training and experience, and with privileges in maternal care;(2) demonstrates administrative skills and oversight of the Quality Assessment and Performance Improvement (QAPI) Plan; and(3) has completed annual continuing education specific to maternal care, including complicated conditions.(c) Program Functions and Services.(1) Triage and assessment of all patients admitted to the perinatal service.(A) Pregnant patients identified at high risk of delivering a neonate that requires a higher level of neonatal care than the scope of their neonatal facility must be transferred to a higher level neonatal designated facility before delivery unless the transfer is unsafe.(B) Pregnant or postpartum patients identified with conditions or complications that the managing physician determines require patient transfer to a higher level of maternal care must be transferred to a higher level maternal designated facility unless the transfer is unsafe.(2) Provide care for pregnant patients with the capability to detect, stabilize, and initiate management of unanticipated maternal-fetal or maternal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a higher level of neonatal or maternal care.(3) An obstetrics and gynecology physician or family medicine physician with obstetrics training and experience, including operative training, and with maternal privileges, must be available at all times and arrive at the patient bedside within 30 minutes of an urgent request. Facilities that utilize family medicine physicians in this role must have a written plan for responding to obstetrical emergencies that require services or procedures outside the scope of privileges granted to the family physician, and regularly monitor outcomes in their QAPI Plan.(4) A board-certified or board-eligible maternal fetal medicine physician must be available at all times for consultation.(5) Medical and surgical physicians must be available at all times and arrive at the patient bedside within 30 minutes of an urgent request.(6) Specialists, including behavioral health, must be available at all times for consultation appropriate to the patient population served.(7) Ensure that a qualified physician or certified nurse midwife with appropriate physician back-up is available to attend all deliveries or other obstetrical emergencies.(8) The primary provider caring for a pregnant or postpartum patient who is a family medicine physician with obstetrics training and experience, obstetrics and gynecology physician, maternal fetal medicine physician, or a certified nurse midwife, physician assistant or nurse practitioner with appropriate physician back-up, whose credentials have been reviewed by the MMD and is on-call:(A) must arrive at the patient bedside within 30 minutes of an urgent request; and(B) must complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated conditions.(9) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:(A) must operate under guidelines reviewed and approved by the MMD; and(B) must have a formal arrangement with a physician with obstetrics training or experience, and with maternal privileges who must:(i) provide back-up and consultation;(ii) arrive at the patient bedside within 30 minutes of an urgent request; and(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.(10) An on-call schedule of providers, back-up providers, and provision for patients without a physician must be readily available to facility and maternal staff and posted on the labor and delivery unit.(11) Ensure that the physician providing back-up coverage must arrive at the patient bedside within 30 minutes of an urgent request.(12) The appropriate anesthesia, laboratory, pharmacy, radiology, respiratory therapy, ultrasonography and blood bank services must be available on a 24-hour basis as described in §133.41 of this title (relating to Hospital Functions and Services) respectively.(A) Anesthesia personnel with training and experience in obstetric anesthesia must be available at all times and arrive to the patient bedside within 30 minutes of an urgent request.(B) An anesthesiologist with training or experience in obstetric anesthesia must be available at all times for consultation.(C) Laboratory and blood bank services must be capable of:(i) providing ABO-Rh specific or O-Rh negative blood, fresh frozen plasma or cryoprecipitate on-site at all times;(ii) implementing a massive transfusion protocol;(iii) ensuring guidelines for emergency release of blood components; and(iv) managing multiple blood component therapy.(D) Medical Imaging Services.(i) If preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record.(ii) There must be regular monitoring of the preliminary versus final reading in the QAPI Plan.(iii) Computed Tomography (CT) imaging and interpretation available at all times.(iv) Basic ultrasonographic imaging for maternal or fetal assessment, including interpretation must be available at all times.(v) A portable ultrasound machine immediately available at all times to the labor and delivery and antepartum unit.(E) A pharmacist must be available for consultation at all times.(13) Obstetrical Services.(A) The ability to begin an emergency cesarean delivery and ensure the availability of a physician with the training, skills, and privileges to perform the surgery within a time period consistent with current standards of professional practice and maternal care.(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.(C) A trial of labor for patients with prior cesarean delivery must have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.(14) Resuscitation. The facility must have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS, or a department-approved equivalent course, and the skills to perform a complete resuscitation; and(B) ensures that resuscitation equipment, for pregnant and postpartum patients, is readily available in the labor and delivery, antepartum and postpartum areas. Difficult airway management equipment must be immediately available at all times to these areas.(15) The facility must have a written hospital preparedness and management plan for patients with placenta accreta spectrum disorder who are undiagnosed until delivery, including educating hospital and medical staff who may be involved in the treatment and management of placenta accreta spectrum disorder about risk factors, diagnosis, and management.(16) The facility must have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage or coagulopathy;(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;(C) placenta accreta spectrum disorder, including team education, risk factor screening, evaluation, diagnosis, fostering telemedicine medical services and referral as appropriate, treatment and multidisciplinary management of both anticipated and unanticipated placenta accreta spectrum disorder cases, including postpartum care;(D) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;(E) sepsis or systemic infection in the pregnant or postpartum patient;(F) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;(G) shoulder dystocia, including assessment of risk factors, counseling of patient, and multidisciplinary management; and(H) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.(17) The facility must have nursing leadership and staff with training and experience in the provision of maternal nursing care who must coordinate with respective neonatal services.(18) Perinatal Education. A registered nurse with experience in maternal care, including moderately complex and ill obstetric patients, must provide the supervision and coordination of staff education. Perinatal education for high risk events must be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.(19) Support personnel with knowledge and skills in breastfeeding and lactation to meet the needs of maternal patients must be available at all times.(20) Social services, pastoral care and bereavement services must be provided as appropriate to meet the needs of the patient population served.(21) Dietician or nutritionist available with appropriate training and experience for population served in compliance with the requirements in §133.41 of this title. Source Note: The provisions of this §133.207 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.207 Maternal Designation Level II https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212022&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212022 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212022&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212022 03/11/2026 (a) A Level III (Subspecialty Care). The Level III maternal designated facility must:(1) provide care for pregnant and postpartum patients with low risk conditions to significant complex medical, surgical or obstetrical conditions that present a high risk of maternal morbidity or mortality;(2) ensure access to consultation to a full range of medical and maternal subspecialists, surgical specialists, and behavioral health specialists;(3) ensure capability to perform major surgery on-site;(4) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians or Obstetrics and Gynecology Physicians with obstetrics training and privileges in maternal care;(5) have skilled personnel with documented training, competencies, and annual continuing education, specific for the population served;(6) facilitate transports; and(7) provide outreach education related to trends identified through the QAPI Plan, specific requests, and system needs to lower level designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(b) Maternal Medical Director (MMD). The MMD must be a physician who:(1) is a board-certified obstetrics and gynecology physician with obstetrics training and experience, or a board-certified maternal fetal medicine physician, both with privileges in maternal care;(2) demonstrates administrative skills and oversight of the QAPI Plan; and(3) has completed annual continuing education specific to maternal care, including complicated conditions.(c) If the facility has its own transport program, there must be an identified Transport Medical Director (TMD). The TMD must be a physician who is a board-certified maternal fetal medicine specialist or board-certified obstetrics and gynecology physician with privileges and experience in obstetrical care and maternal transport.(d) Program Functions and Services.(1) Triage and assessment of all patients admitted to the perinatal service.(A) Pregnant patients who are identified at high risk of delivering a neonate that requires a higher level of neonatal care than the scope of their neonatal facility must be transferred to a higher level neonatal designated facility before delivery unless the transfer is unsafe.(B) Pregnant or postpartum patients identified with conditions or complications that require a higher level of maternal care must be transferred to a higher level maternal designated facility unless the transfer is unsafe.(2) Provide care for pregnant patients with the capability to detect, stabilize, and initiate management of unanticipated maternal-fetal or maternal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a higher level of neonatal or maternal care.(3) Supportive and emergency care must be delivered by appropriately trained personnel for unanticipated maternal-fetal problems that occur requiring a higher level of maternal care, until the patient is stabilized or transferred;(4) An obstetrics and gynecology physician with maternal privileges must be on-site at all times and available for urgent situations.(5) A board-certified or board-eligible Maternal Fetal Medicine physician with inpatient privileges must be available at all times for inpatient consultation and arrive at the patient bedside within 30 minutes of an urgent request to co-manage patients.(A) When telehealth or telemedicine is utilized for maternal fetal medicine co-management for non-urgent inpatient situations where an in-person response is not required, the facility must have the following:(i) a written plan for the appropriate use of telehealth/telemedicine for inpatient hospital care that is compliant with the Texas Medical Board Telemedicine rules, Texas Administrative Code, Title 22, Chapter 174, and the Texas Occupations Code, Chapter 111;(ii) a process for informed consent and agreement from the patient for the use of telehealth or telemedicine; and(iii) a maternal fetal medicine physician with inpatient privileges at the facility, who regularly participates in the on-site care of patients at the facility, has access to the patient's medical record, and participates as needed in the QAPI Plan and process for the facility's maternal program.(B) The facility has processes to monitor the compliance and outcomes of maternal telehealth and telemedicine encounters through the QAPI Plan.(C) The use of telemedicine for on call consultation does not substitute for the requirement of maternal fetal medicine availability for in-person consultation on complex and critically ill patients on a regular basis.(6) Intensive Care Services. The facility must provide critical care services for critically ill pregnant or postpartum patients, including fetal monitoring in the Intensive Care Unit (ICU), respiratory failure and ventilator support, procedure for emergency cesarean, coordination of nursing care, and consultative or co-management roles to facilitate collaboration.(7) Level III maternal designated facilities that serve as referral centers for placenta accreta spectrum disorder must fulfill all of the Level IV requirements for a Placenta Accreta Spectrum Disorder Team defined in §133.209 of this title (relating to Maternal Designation Level IV).(8) Medical and surgical physicians, including critical care specialists, must be available at all times and arrive at the patient bedside within 30 minutes of an urgent request.(9) Consultation by a behavioral health professional, with training or experience in maternal counseling must be available at all times and arrive by telemedicine or in-person when requested within a time period consistent with current standards of professional practice and maternal care.(10) Ensure that a qualified physician, or a certified nurse midwife with appropriate physician back-up, is available to attend all deliveries or other obstetrical emergencies.(11) The primary provider caring for a pregnant or postpartum patient who is a family medicine physician with obstetrics training and experience, obstetrics and gynecology physician, maternal fetal medicine physician, or a certified nurse midwife, physician assistant or nurse practitioner with appropriate physician back-up, whose credentials have been reviewed by the MMD and is on call:(A) must arrive at the patient bedside within 30 minutes for an urgent request; and(B) must complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated and critical conditions.(12) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:(A) must operate under guidelines reviewed and approved by the MMD; and(B) must have a formal arrangement with a physician with obstetrics training or experience, and with maternal privileges who must:(i) provide back-up and consultation;(ii) arrive at the patient bedside within 30 minutes of an urgent request; and(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.(13) An on-call schedule of providers, back-up providers, and provision for patients without a physician must be readily available to facility and maternal staff and posted on the labor and delivery unit.(14) Ensure that the physician providing back-up coverage must arrive at the patient bedside within 30 minutes for an urgent request.(15) Anesthesia Services must comply with the requirements found at §133.41 of this title (relating to Hospital Functions and Services) and must have:(A) anesthesia personnel with experience and expertise in obstetric anesthesia must be available on-site at all times;(B) a board-certified anesthesiologist with training or experience in obstetric anesthesia in charge of obstetric anesthesia services;(C) a board-certified or board-eligible anesthesiologist with training or experience in obstetric anesthesia, including critically ill obstetric patients available for consultation at all times, and arrive at the patient bedside within 30 minutes for urgent requests; and(D) anesthesia personnel on call, including back-up contact information, posted and readily available to the facility and maternal staff and posted in the labor and delivery area.(16) Laboratory Services must comply with the requirements found at §133.41 of this title and must have:(A) laboratory personnel on-site at all times;(B) a blood bank capable of:(i) providing ABO-Rh specific or O-Rh negative blood, fresh frozen plasma, cryoprecipitate, and platelet components on-site at the facility at all times;(ii) implementing a massive transfusion protocol;(iii) ensuring guidelines for emergency release of blood components; and(iv) managing multiple blood component therapy; and(C) perinatal pathology services available.(17) Medical Imaging Services must comply with the requirements found at §133.41 of this title and must have:(A) personnel appropriately trained in the use of x-ray equipment available on-site at all times;(B) advanced imaging, including computed tomography (CT), magnetic resonance imaging (MRI), and echocardiography available at all times;(C) interpretation of CT, MRI and echocardiography within a time period consistent with current standards of professional practice and maternal care;(D) basic ultrasonographic imaging for maternal or fetal assessment, including interpretation available at all times; and(E) a portable ultrasound machine available in the labor and delivery and antepartum unit.(18) Pharmacy services must comply with the requirements found in §133.41 of this title and must have a pharmacist with experience in perinatal pharmacology available at all times.(19) Respiratory Therapy Services must comply with the requirements found at §133.41 of this title and have a respiratory therapist immediately available on-site at all times.(20) Obstetrical Services.(A) The ability to begin an emergency cesarean delivery within a time period consistent with current standards of professional practice and maternal care.(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.(C) A trial of labor for patients with prior cesarean delivery must have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.(21) Resuscitation. The facility must have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS, or a department-approved equivalent course, and the skills to perform a complete resuscitation; and(B) ensures that resuscitation equipment, including difficult airway management equipment for pregnant and postpartum patients, is readily available in the labor and delivery, antepartum and postpartum areas.(22) The facility must have a written hospital preparedness and management plan for patients with placenta accreta spectrum disorder who are undiagnosed until delivery, including educating hospital and medical staff who may be involved in the treatment and management of placenta accreta spectrum disorder about risk factors, diagnosis, and management.(23) The facility must have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage or coagulopathy;(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;(C) placenta accreta spectrum disorder, including team education, risk factor screening, evaluation, diagnosis, fostering telemedicine medical services and referral as appropriate, treatment and multidisciplinary management of both anticipated and unanticipated placenta accreta spectrum disorder cases, including postpartum care;(D) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;(E) sepsis or systemic infection in the pregnant or postpartum patient;(F) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;(G) shoulder dystocia, including assessment of risk factors, counseling of patient, and multidisciplinary management; and(H) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.(24) The facility must have nursing leadership and staff with training and experience in the provision of maternal nursing care who must coordinate with respective neonatal services.(25) The facility must have a program for genetic diagnosis and counseling for genetic disorders, or a policy and process for consultation referral to an appropriate facility.(26) Perinatal Education. A registered nurse with experience in maternal care, including moderately complex and ill obstetric patients, must provide the supervision and coordination of staff education. Perinatal education for high risk events must be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.(27) Support personnel with knowledge and skills in breastfeeding to meet the needs of maternal patients must be available at all times.(28) A certified lactation consultant must be available at all times.(29) Social services, pastoral care and bereavement services must be provided as appropriate to meet the needs of the patient population served.(30) Dietician or nutritionist available with training and experience in maternal nutrition and can plan diets that meet the needs of the pregnant and postpartum patient must comply with the requirements in §133.41 of this title. Source Note: The provisions of this §133.208 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.208 Maternal Designation Level III https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212023&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212023 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212023&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212023 03/11/2026 (a) A Level IV (Comprehensive Care). The Level IV maternal designated facility must:(1) provide comprehensive care for pregnant and postpartum patients with low risk conditions to the most complex medical, surgical or obstetrical conditions and their fetuses, that present a high risk of maternal morbidity or mortality;(2) ensure access to on-site consultation to a comprehensive range of medical and maternal subspecialists, surgical specialists and behavioral health specialists;(3) ensure capability to perform major surgery on-site;(4) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians or Obstetrics and Gynecology physicians with obstetrics training, experience and privileges in maternal care;(5) have a maternal fetal medicine critical care team with expertise and privileges to manage or co-manage highly complex, critically ill or unstable maternal patients;(6) have a placenta accreta spectrum disorder multidisciplinary care team with expertise to complete risk factor screening, evaluation, diagnosis, consultation, and management of patients with anticipated or unanticipated placenta accreta spectrum disorder, including postpartum care;(7) have skilled personnel with documented training, competencies, and annual continuing education, specific for the patient population served;(8) facilitate transports; and(9) provide outreach education related to trends identified through the QAPI Plan, specific requests, and system needs to lower level designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.(b) Maternal Medical Director (MMD). The MMD must be a physician who:(1) is a board-certified obstetrics and gynecology physician with expertise in the area of critical care obstetrics; or a board-certified maternal fetal medicine physician, both with privileges in maternal care;(2) demonstrates administrative skills and oversight of the QAPI Plan; and(3) has completed annual continuing education specific to maternal care, including complicated conditions.(c) If the facility has its own transport program, there must be an identified Transport Medical Director (TMD). The TMD must be a physician who is a board-certified maternal fetal medicine physician or board-certified obstetrics and gynecology physician with obstetrics privileges, with expertise and experience in critically ill maternal transport.(d) Program Functions and Services.(1) Triage and assessment of all patients admitted to the perinatal service.(A) Pregnant patients who are identified at high risk of delivering a neonate that requires a higher level of neonatal care must be transferred to a higher level neonatal designated facility prior to delivery unless the transfer is unsafe.(B) Pregnant or postpartum patients identified with conditions or complications that require a service not available at the facility, must be transferred to an appropriate maternal designated facility unless the transfer is unsafe.(2) Supportive and emergency care must be delivered by appropriately trained personnel, for unanticipated maternal-fetal problems that occur during labor and delivery, through the disposition of the patient.(3) A board-certified or board-eligible obstetrics and gynecology physician with maternal privileges must be on-site at all times and available for urgent situations.(4) Ensure that a qualified physician, or a certified nurse midwife with appropriate physician back-up, is available to attend all deliveries or other obstetrical emergencies.(5) Intensive Care Services. The facility must have an adult Intensive Care Unit (ICU) and critical care capabilities for maternal patients, including:(A) a comprehensive range of medical and surgical critical care specialists and advanced subspecialists on the medical staff;(B) a maternal fetal medicine critical care team with experience and expertise in the care of complex or critically ill maternal patients available to co-manage maternal patients; and(C) availability of obstetric nursing and support personnel with experience in care for critically ill maternal patients.(6) Maternal Fetal Medicine Critical Care Team. The facility must have a Maternal Fetal Medicine (MFM) critical care team whose members have expertise to assume responsibility for pregnant or postpartum patients who are in critical condition or have complex medical conditions, including;(A) co-management of ICU-admitted obstetric patients;(B) a MFM team member with full obstetrical privileges available at all times for on-site consultation and management, and to arrive at the patient bedside within 30 minutes of an urgent request; and(C) a board-certified MFM physician with expertise in critical care obstetrics to lead the team.(7) Management of critically ill pregnant or postpartum patients, including fetal monitoring in the ICU, respiratory failure and ventilator support, procedure for emergency cesarean, coordination of nursing care, and consultative or co-management roles to facilitate collaboration.(8) The facility must have a Placenta Accreta Spectrum Disorder Team whose members have expertise in the diagnosis and management of pregnant or postpartum patients with anticipated and unanticipated placenta accreta spectrum disorder, including:(A) a multidisciplinary primary response team must be comprised of a minimum of the following:(i) an anesthesiologist with training and expertise in obstetrical anesthesiology;(ii) obstetrics and gynecology physician or maternal fetal medicine physician;(iii) surgeon or surgeons with expertise in pelvic, urologic, or gastroenterological surgery;(iv) neonatologist;(v) experienced nursing staff; and(vi) experienced operating room personnel;(B) a secondary response team must be comprised of a minimum of the following:(i) a radiologist with interventional radiology skills; and(ii) a blood bank or transfusion medicine specialist;(C) all primary and secondary response team members must have full hospital privileges; and(i) a representative of each component of the primary response team must be available at all times for inpatient consultation and management, and arrive at the bedside within 30 minutes of an urgent request to attend to a patient with placenta accreta spectrum disorder;(ii) a representative of each component of the secondary response team must be available at all times for consultation and management, and be available to arrive at the patient bedside within a time frame commensurate with the clinical situation and consistent with current standards;(D) representatives of each component of the primary and secondary response teams must participate in regular, ongoing staff and team-based education and training to care for patients with placenta accreta spectrum disorder;(E) a board-certified maternal fetal medicine physician or a board-certified obstetrics and gynecology physician, who has expertise in the diagnosis and management of placenta accreta spectrum disorder, must lead the team;(F) evidence that the facility participates in regular, ongoing outreach and education specific to placenta accreta spectrum disorder to other maternal facilities not specializing in placenta accreta spectrum disorder, inclusive of QAPI Plan;(G) a documented on-call schedule of primary and secondary response team members is readily available to the facility and maternal staff on the labor and delivery unit and operating suite; and(H) evidence that representatives of the primary and secondary response teams participate in the maternal program's QAPI process for the review of all placenta accreta spectrum disorder cases and assist the PCR with the review of placenta accreta spectrum disorder cases, as requested.(9) Behavioral Health Services.(A) Consultation by a behavioral health professional, with experience in maternal or neonatal counseling must be available on-site at all times for in-person visits when requested for prenatal, peri-operative, and postnatal needs of the patient within a time period consistent with current standards of professional practice and maternal care.(B) Consultation by a psychiatrist, with experience in maternal or neonatal counseling must be available for in-person visits when requested within a time period consistent with current standards of professional practice and maternal care.(10) The primary provider caring for a pregnant or postpartum patient who is a family medicine physician with obstetrics training and experience, obstetrics and gynecology physician, maternal fetal medicine physician, or a certified nurse midwife, physician assistant or nurse practitioner with appropriate physician back-up, whose credentials have been reviewed by the MMD and is on call:(A) must arrive at the patient bedside within 30 minutes for an urgent request; and(B) must complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated and critical conditions.(11) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:(A) must operate under guidelines reviewed and approved by the MMD; and(B) must have a formal arrangement with a physician with obstetrics training or experience, and with maternal privileges who must:(i) provide back-up and consultation;(ii) arrive at the patient bedside within 30 minutes of an urgent request; and(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.(12) An on-call schedule of providers, back-up providers, and provision for patients without a physician must be readily available to facility and maternal staff and posted on the labor and delivery unit.(13) Ensure that the physician providing back-up coverage must arrive at the patient bedside within 30 minutes for an urgent request.(14) Anesthesia Services must comply with the requirements found at §133.41 of this title (relating to Hospital Functions and Services) and must have:(A) anesthesia personnel with experience and expertise in obstetric anesthesia must be available on-site at all times;(B) a board-certified anesthesiologist with training or experience in obstetric anesthesia in charge of obstetric anesthesia services;(C) a board-certified or board-eligible anesthesiologist with training or experience in obstetric anesthesia, including critically ill obstetric patients available for consultation at all times, and arrive at the patient bedside within 30 minutes for urgent requests; and(D) anesthesia personnel on call, including back-up contact information, posted and readily available to the facility and maternal staff and posted in the labor and delivery area.(15) Laboratory Services must comply with the requirements found at §133.41 of this title and must have:(A) laboratory personnel on-site at all times;(B) a blood bank capable of:(i) providing ABO-Rh specific or O-Rh negative blood, fresh frozen plasma, cryoprecipitate, and platelet components on-site at all times;(ii) implementing a massive transfusion protocol;(iii) ensuring guidelines for emergency release of blood components; and(iv) managing multiple blood component therapy; and(C) perinatal pathology services available.(16) Medical Imaging Services must comply with the requirements found at §133.41 of this title and must have:(A) personnel appropriately trained in the use of x-ray equipment available on-site at all times;(B) advanced imaging, including computed tomography (CT), magnetic resonance imaging (MRI), and echocardiography available at all times;(C) interpretation of CT, MRI and echocardiography within a time period consistent with current standards of professional practice and maternal care;(D) a radiologist with critical interventional radiology skills available at all times;(E) advanced ultrasonographic imaging for maternal or fetal assessment, including interpretation available at all times; and(F) a portable ultrasound machine available in the labor and delivery and antepartum unit.(17) Pharmacy services must comply with the requirements found in §133.41 of this title and must have a pharmacist with experience in perinatal pharmacology available at all times.(18) Respiratory Therapy Services must comply with the requirements found at §133.41 of this title and must have a respiratory therapist immediately available on-site at all times.(19) Obstetrical Services.(A) The ability to begin an emergency cesarean delivery within a time period consistent with current standards of professional practice and maternal care.(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.(C) A trial of labor for patients with prior cesarean delivery must have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.(20) Resuscitation. The facility must have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS, or a department-approved equivalent course, and the skills to perform a complete resuscitation; and(B) ensures that resuscitation equipment, including difficult airway management equipment for pregnant and postpartum patients, is readily available in the labor and delivery, antepartum and postpartum areas.(21) The facility must have a written hospital preparedness and management plan for patients with placenta accreta spectrum disorder who are undiagnosed until delivery, including educating and training hospital and medical staff who may be involved in the treatment and management of placenta accreta spectrum disorder about risk factors, diagnosis, and management.(22) The facility must have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage or coagulopathy;(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;(C) placenta accreta spectrum disorder, including team education, risk factor screening, evaluation, diagnosis, fostering telemedicine medical services and referral as appropriate, treatment, and multidisciplinary management of both anticipated and unanticipated placenta accreta spectrum disorder cases, including postpartum care;(D) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;(E) sepsis or systemic infection in the pregnant or postpartum patient;(F) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;(G) shoulder dystocia, including assessment of risk factors, counseling of patient, and multidisciplinary management; and(H) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.(23) The facility must have nursing leadership and staff with training and experience in the provision of maternal critical care who must coordinate with respective neonatal services.(24) The facility must have a program for genetic diagnosis and counseling for genetic disorders, or a policy and process for consultation referral to an appropriate facility.(25) Perinatal Education. A registered nurse with experience in maternal care, including moderately complex and ill obstetric patients, must provide the supervision and coordination of staff education. Perinatal education for high risk events must be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.(26) Support personnel with knowledge and skills in breastfeeding to meet the needs of maternal patients must be available at all times.(27) A certified lactation consultant must be available at all times.(28) Social services, pastoral care and bereavement services must be provided as appropriate to meet the needs of the patient population served.(29) Dietician or nutritionist available with training and experience in maternal nutrition and can plan diets that meet the needs of the pregnant and postpartum patient and critically ill maternal patient must comply with the requirements in §133.41 of this title. Source Note: The provisions of this §133.209 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.209 Maternal Designation Level IV https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212024&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212024 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212024&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212024 03/11/2026 (a) The survey team composition must be as follows:(1) Level I facilities maternal program staff must conduct a self-survey, documenting the findings on the approved department survey form. The department may periodically require validation of the survey findings, by an on-site review conducted by department staff.(2) Level II facilities must be surveyed by a multidisciplinary team that includes at a minimum one obstetrics and gynecology physician and one maternal nurse who:(A) have completed a survey training course;(B) have observed a minimum of one maternal survey;(C) are currently active in the management of maternal patients and active in the maternal QAPI Plan and process at a facility providing the same or higher level of maternal care; and(D) meet the criteria outlined in the department survey guidelines.(3) Level III facilities must be surveyed by a multidisciplinary team that includes at a minimum, one obstetrics and gynecology physician or maternal fetal medicine physician and one maternal nurse, who:(A) have completed a survey training course;(B) have observed a minimum of one maternal survey;(C) are currently active in the management of maternal patients and active in the maternal QAPI Plan and process at a facility providing the same or higher level of maternal care; and(D) meet the criteria outlined in the department survey guidelines.(4) Level III facilities that serve as referral centers for placenta accreta spectrum disorder, must have a survey team that includes a maternal fetal medicine physician and a maternal nurse from a Level IV facility.(5) Level IV facilities must be surveyed by a multidisciplinary team that includes at a minimum, one obstetrics and gynecology physician, a maternal fetal medicine physician, and one maternal nurse, who:(A) have completed a survey training course;(B) have observed a minimum of one maternal survey;(C) are currently active in the management of maternal patients and active in the maternal QAPI plan and process at a facility providing Level IV maternal care; and(D) meet the criteria outlined in the department survey guidelines.(b) All members of the survey team, except department staff, must come from a Perinatal Care Region outside the facility's region or a contiguous region.(c) Survey team members cannot have a conflict of interest:(1) A conflict of interest exists when a surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public. The conflict of interest may include a surveyor personally trained a key member of the facility's leadership in residency or fellowship, collaborated with a key member of the facility's leadership professionally, participated in a designation consultation with the facility, had a previous working relationship with the facility or facility leaders, or conducted a designation survey for the facility within the past four years. Surveyors cannot be from the same PCR or TSA region or a contiguous region of the facility's location.(2) If a designation survey occurs with a surveyor who has an identified conflict of interest, the maternal designation site survey summary and medical record reviews may not be accepted by the department.(d) The survey team must follow the department survey guidelines to evaluate and validate that the facility demonstrates the designation requirements are met.(e) All information and materials submitted by a facility to the department and a survey organization under Texas Health and Safety Code, §241.183(d) or this subchapter, are subject to confidentiality as articulated in Texas Health and Safety Code, §241.184, Confidentiality; Privilege, and are not subject to disclosure under Texas Government Code, Chapter 552, or discovery, subpoena, or other means of legal compulsion for release to any person. Source Note: The provisions of this §133.210 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.210 Survey Team https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212025&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212025 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212025&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212025 03/11/2026 (a) The maternal medical director and maternal program manager must have evidence of annual participation in the PCR meetings, self-assessment, system development, perinatal activities, and collaboratives.(b) The PCR must consider and facilitate transfer agreements through regional coordination.(c) The PCR must coordinate regional perinatal system QAPI reviews.(d) The PCRs must not restrict patient referrals.(e) The PCR integrates with the Regional Advisory Council (RAC) system plans to ensure there is a written perinatal system plan specific to the regional area utilizing the RAC criteria and self-assessment tools.(f) The PCRs are administratively supported by the RAC and must have fair and equitable representation on the board of the applicable RAC.(g) Each PCR is responsible for defining data needs and regional collaboratives. Source Note: The provisions of this §133.211 adopted to be effective January 8, 2023, 47 TexReg 8986. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING K HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE §133.211 Perinatal Care Regions (PCRs) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187628&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187628 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187628&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187628 03/11/2026 The purpose of this subchapter is to implement Health and Safety Code, Chapter 32, Subchapter D, Centers of Excellence for Fetal Diagnosis and Therapy designation, to achieve healthy fetal outcomes in this state. Source Note: The provisions of this §133.221 adopted to be effective March 1, 2018, 43 TexReg 887. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING L CENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY §133.221 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187629 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187629 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Antenatal--Occurring or existing before birth, referring to both the care of the woman during pregnancy and the growth and development of the fetus.(2) Available--Relating to staff who can be contacted for consultation at all times without delay.(3) CEFDT--A facility designated as a Center of Excellence for Fetal Diagnosis and Therapy.(4) Commission--The Health and Human Services Commission.(5) Department--The Department of State Health Services.(6) Designation--A formal recognition by the department of a facility's fetal diagnosis and therapy care capabilities and commitment, for a period of three years.(7) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.(8) Fetal--Of, relating to, or being a fetus.(9) CEFDTMD--CEFDT Medical Director.(10) CEFDTPM--CEFDT Program Manager.(11) Innovation--A new method of investigation or an experiment undertaken to benefit an individual patient.(12) Level I evidence-based metrics--Evidence from a systematic review of all relevant randomized controlled trials (RCTs) or evidence-based clinical practice guidelines from major national perinatal organizations, based on systematic reviews of RCTs.(13) Maternal--Pertaining to the pregnant patient or mother.(14) Maternal-Fetal Patient--Pertaining to the pregnant patient and her fetus(es).(15) Office--Office of Emergency Medical Services (EMS)/Trauma Systems.(16) On-site--At the facility and able to rapidly arrive at the patient bedside for urgent requests.(17) PCR--Perinatal Care Region.(18) Perinatal--Of, relating to, or being the period around childbirth, especially the five months before and one month after birth.(19) Research--An investigation or experiment undertaken to create generalized knowledge about a particular subject.(20) Urgent--Requiring immediate action or attention. Source Note: The provisions of this §133.222 adopted to be effective March 1, 2018, 43 TexReg 887. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING L CENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY §133.222 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187630 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187630 03/11/2026 (a) The Office of EMS/Trauma Systems (office) shall recommend to the Executive Commissioner of the Health and Human Services Commission (executive commissioner) the designation of an applicant/healthcare facility as a Center of Excellence for Fetal Diagnosis and Therapy for each location of a facility, which the office deems appropriate.(b) A healthcare facility is defined under this subchapter as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license.(c) Each location shall be considered separately for designation and the office will determine the designation for that location, based on, but not limited to, the location's own resources and level of care capabilities; Perinatal Care Region (PCR) capabilities; and compliance with Chapter 133 of this title, (relating to Hospital Licensing).(d) A CEFDT shall:(1) provide the highest level of maternal, fetal, and neonatal care for patients with the least to most complex fetal conditions;(2) provide at a minimum, all fetal therapies and interventions proven effective antenatally based on level I evidence-based metrics;(3) have skilled medical staff and personnel with documented training, competencies and continuing education specific for the patient population served;(4) offer fetal diagnosis and therapy through an extensive multi-specialty clinical program that is affiliated and collaborates extensively with a medical school in this state;(5) demonstrate a significant commitment to research in and advancing the field of fetal diagnosis and therapy;(6) offer advanced training programs in fetal diagnosis and therapy;(7) provide appropriate long-term monitoring and follow-up care for patients, including measuring short-term and long-term patient diagnostic and therapeutic outcomes;(8) provide outreach and education to maternal and/or neonatal designated facilities, including the Quality Assessment and Performance Improvement (QAPI) process;(9) hold current verification for maternal-fetal surgical care from an organization approved by the department;(10) hold current verification from the American College of Surgeons as a Level I Children's Surgery Center;(11) be designated by the department as a Level IV Maternal Level of Care facility;(12) be designated by the department as a Level IV Neonatal Level of Care facility;(13) participate in CEFDT meetings twice a year as determined by the department:(A) for the purposes of mutual collaboration;(B) to discuss inclusion criteria for fetal intervention and biopsychosocial outcome variables both short-term and long-term; and(C) to participate in a multi-disciplinary performance improvement process; and(14) have facility specific treatment outcomes vetted and approved by the department for public posting on the facility website for public access and/or redirect the public to the facility specific outcomes posted on the department's website.(e) Facilities seeking designation shall be surveyed through an organization approved by the office to verify that the facility is meeting office-approved relevant requirements. The facility shall bear the cost of the survey. Source Note: The provisions of this §133.223 adopted to be effective March 1, 2018, 43 TexReg 887. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING L CENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY §133.223 General Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187631&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187631 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187631&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187631 03/11/2026 (a) Designation application packet. The applicant shall submit the packet that includes the following documents, to the Office of EMS/Trauma Systems (office) within 120 days of the facility's verification for maternal-fetal surgical care:(1) an accurate and complete designation application form for designation, including full payment of the designation fee as listed in subsection (d) of this section;(2) evidence of current Level IV Neonatal designation;(3) evidence of current Level IV Maternal designation;(4) evidence of current verification for maternal-fetal surgical care, including patient case reviews;(5) evidence of current verification from the American College of Surgeons as a Level I Children's Surgery Center, including patient case reviews;(6) a letter of support from the facility's governing board supporting provisions for the collection and evaluation of short-term and long-term outcomes;(7) evidence of participation in the CEFDT meetings twice a year;(8) evidence of outcomes posted for public access; and(9) any subsequent documents requested by the office.(b) Renewal of designation. The applicant shall submit the documents described in subsection (a)(1) - (9) of this section to the office not more than 180 days prior to the designation expiration date and at least 60 days prior to the designation expiration date.(c) If a facility seeking designation fails to meet the requirements in subsection (a)(1) - (9) of this section, the application shall be denied.(d) Non-refundable application fee of $2,500.00 for the three-year designation period shall be submitted with the application or renewal.(e) If a facility disagrees with the designation determination by the office for initial designation or renewal of designation, it may make an appeal in writing not later than 60 days after issuance of the determination to the director of the office. The written appeal must include a signed letter from the facility's governing board with an explanation of the basis for its appeal.(1) If the office upholds its original determination, the director of the office will give written notice of such to the facility not later than 30 days of its receipt of the applicant's complete written appeal.(2) The facility may, not later than 30 days of the office's issuance of written notification of its denial, submit a written request for further review. Such written appeal shall be submitted to the Associate Commissioner of the Consumer Protection Division (associate commissioner).(f) The survey organization shall provide the facility with a written, signed survey report regarding their evaluation of the facility's compliance with the Centers of Excellence for Fetal Diagnosis and Therapy designation requirements. This survey report shall be forwarded to the facility no later than 30 days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the office if it intends to continue the designation process.(g) The office shall review the application packet documents submitted by the facility, to determine compliance with the Centers of Excellence for Fetal Diagnosis and Therapy designation requirements.(1) A recommendation for designation shall be made to the executive commissioner based on compliance with the designation requirements.(2) A Centers of Excellence for Fetal Diagnosis and Therapy designation shall not be denied to a facility that meets the minimum requirements for designation.(A) If a facility disagrees with the office's decision regarding its designation application or status, it may request a secondary review by a designation review committee.(B) Membership on a designation review committee will:(i) be voluntary;(ii) be appointed by the office director;(iii) be representative of fetal diagnosis and therapy providers, and the highest levels of neonatal and maternal care designated facilities;(iv) exclude any representative with a conflict of interest; and(v) include representation from the office.(C) If a designation review committee disagrees with the office's recommendation, the records shall be referred to the associate commissioner for recommendation.(D) If a facility disagrees with the office's recommendation at the end of the secondary review, the facility has a right to a hearing, in accordance with a hearing request referenced in §133.121(9) of this title (relating to Enforcement Action), and Government Code, Chapter 2001. Source Note: The provisions of this §133.224 adopted to be effective March 1, 2018, 43 TexReg 887. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING L CENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY §133.224 Designation Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187632&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187632 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187632&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187632 03/11/2026 (a) A CEFDT shall provide patient-centered and family-centered health care. The environment for maternal-fetal care shall comprehensively meet the physiologic and psychosocial needs of the pregnant patient, their infants, and families.(b) Program Plan. The CEFDT shall develop a written plan of an organized program that includes a detailed description of the scope of services available to the maternal-fetal patient, defines the maternal-fetal patient population evaluated and/or treated by the CEFDT, which is consistent with accepted professional standards of practice for maternal-fetal care, and ensures the health and safety of patients.(1) The written plan and the program policies and procedures shall be reviewed and approved by the facility's governing body. The governing body shall ensure that the requirements of this section are implemented and enforced.(2) The written program plan shall include, at a minimum:(A) program policies and procedures that are:(i) based upon current standards of fetal diagnosis and therapy practice; and(ii) adopted, implemented and enforced for the maternal-fetal services it provides;(B) a periodic review and revision schedule for all maternal-fetal care policies and procedures;(C) a Quality Assessment/Performance Improvement (QAPI) Program as described in §133.41 of this title (relating to Hospital Functions and Services). The CEFDT shall demonstrate that the QAPI Program evaluates the provision of maternal-fetal care on an ongoing basis, identify opportunities for improvement, develop and implement improvement plans, and evaluate the implementation until a resolution is achieved. The QAPI Program shall measure, analyze, and track quality indicators or other aspects of performance that the CEFDT adopts or develops that reflect processes of care and is outcome based. Aggregate patient data must be continuously reviewed for trends. QAPI data must be submitted to the department as requested;(D) appropriate follow up for all infants through an established referral process;(E) short-term and long-term outcomes of the pregnant patient and her fetus(es) after fetal interventions will be monitored by the CEFDT;(F) requirements for minimal credentials for all staff participating in the care of maternal-fetal patients;(G) provisions for providing continuing staff education, including annual competency and skills assessment that is appropriate for the patient population served; and(H) procedures to ensure the availability of all necessary equipment and services to provide the appropriate level of care and support of the patient population served.(c) Medical Staff. The facility shall have an organized fetal therapy and diagnosis program that is recognized by the medical staff and approved by the facility's governing body. The credentialing of the medical staff shall include a process for the delineation of privileges for maternal-fetal care.(d) CEFDT Medical Director (CEFDTMD). There shall be an identified CEFDTMD responsible for the provision of fetal therapy and diagnosis services and credentialed by the facility for the treatment of maternal-fetal patients.(1) The CEFDTMD shall be a physician who:(A) is a board certified maternal-fetal medicine (MFM) physician or a board certified pediatric surgeon, with additional training and expertise in maternal-fetal care and fetal interventions;(B) demonstrates administrative skills and oversight of the CEFDT QAPI Program;(C) completes annual continuing medical education specific to fetal medicine and/or fetal interventions;(D) is a clinically active and practicing physician participating in maternal-fetal care and fetal interventions at the facility where medical director services are provided; and(E) maintains active staff maternal-fetal privileges as defined in the facility's medical staff bylaws.(2) The CEFDTMD shall have the authority and responsibility to monitor maternal-fetal patient care from outpatient navigation, admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Program.(3) The responsibilities and authority of the CEFDTMD shall include:(A) examining qualifications of medical staff requesting fetal diagnosis and therapy privileges and making recommendations to the appropriate committee for such privileges;(B) collaborating with the CEFDTPM in areas to include: developing and/or revising policies, procedures and guidelines for maternal-fetal care, assuring medical staff and personnel competency, education and training in maternal-fetal care; and directing the QAPI Program that is specific to maternal-fetal care and fetal interventions, is ongoing, data driven and outcome based;(C) frequently leading and participating in the CEFDT QAPI meetings;(D) participating in CEFDT meetings twice a year as determined by the department; and(E) providing an annual report of aggregate short-term and long-term outcomes data as requested by the department.(e) CEFDT Program Manager (CEFDTPM). There shall be an identified CEFDTPM responsible for the provision of fetal diagnosis and therapy clinical care services for maternal-fetal patients.(1) The CEFDTPM shall be a registered nurse who:(A) has experience and/or training in maternal-fetal care and fetal interventions;(B) demonstrates administrative skills and oversight of the CEFDT QAPI Program;(C) completes annual continuing education specific to maternal-fetal care and fetal interventions; and(D) is a clinically active and practicing registered nurse participating in maternal-fetal care at the facility where program manager services are provided.(2) The CEFDTPM shall have the authority and responsibility to monitor maternal-fetal patient care from outpatient navigation, admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Program.(3) The responsibilities and authority of the CEFDTPM shall include:(A) examining qualifications of staff providing maternal-fetal care services;(B) collaborating with the CEFDTMD in areas to include: developing and/or revising policies, procedures and guidelines for maternal-fetal care, assuring medical staff and personnel competency, education and training in maternal-fetal care; and directing the QAPI Program that is specific to maternal-fetal care and fetal interventions, is ongoing, data driven and outcome based;(C) frequently leading and participating in the CEFDT QAPI meetings;(D) participating in CEFDT meetings twice a year as determined by the department; and(E) providing an annual report of aggregate short-term and long-term outcomes data as requested by the department.(f) The facility shall identify medical staff responsible for the provision of maternal-fetal care services, available for in person consultation, and credentialed by the facility for the treatment of maternal-fetal patients, to include:(1) a board certified MFM physician, who shall:(A) have primary responsibility for the direct, comprehensive, and coordinated medical care of patients undergoing fetal interventions; and(B) be available at all times to the bedside within a time period consistent with current standards of professional practice and maternal-fetal care; and(2) a board certified pediatric surgeon with training and expertise in fetal intervention;(3) a board certified pediatric neurosurgeon with training and expertise in fetal intervention;(4) a board certified neonatologist with training and expertise in the care of neonates following fetal interventions;(5) a board certified pediatric cardiologist with expertise in the performance and interpretation of fetal echocardiography shall be available and provide interpretation within a time period consistent with current standards of professional practice and maternal-fetal care;(6) a board certified anesthesiologist with expertise in maternal-fetal physiology and uterine relaxation methods shall be available at all times for consultation and to arrive at the bedside if anesthesia is required for fetal interventions;(7) a board certified pediatric urologist;(8) a board certified pediatric nephrologist;(9) a board certified pediatric palliative care medicine physician; and(10) other board certified pediatric subspecialists, including cardiovascular surgery, craniofacial surgery, gastroenterology, orthopedic surgery, plastic surgery and rehabilitative medicine.(g) The identified medical staff responsible for the provision of maternal-fetal care services shall:(1) complete annual continuing medical education specific to maternal-fetal care and fetal interventions;(2) be a clinically active and practicing physician participating in maternal-fetal care and fetal interventions at the CEFDT; and(3) maintain active staff fetal diagnosis and therapy privileges as defined in the facility's medical staff bylaws.(h) Medical Ethicist. A medical ethicist with expertise in clinical perinatal medical ethics shall be an active member of the fetal diagnosis and therapy program, including frequent participation in conferences, and providing in person ethical consultations and participation in research.(i) Genetic Counseling. Board eligible/certified genetic counselors or a board eligible/certified physician with specialized training in prenatal genetic counseling shall be available for in person prenatal consultation as requested.(j) Palliative Care. Personnel with training and/or experience in palliative care shall be available at all times for in-person visits when requested for prenatal and postnatal counseling of families within a time period consistent with current standards of professional practice and maternal-fetal care.(1) Personnel shall have perinatal-specific training in the support of maternal and/or pediatric patients and families.(2) Personnel shall be trained to organize clinical protocols, birth plans, and to provide staff education.(k) Child Life Specialist. A child life specialist shall be available for in person consultation as requested and be licensed as a Certified Child Life Specialist.(l) Clinical Coordinators shall be identified as the primary point of contact for the family.(1) At least one Clinical Coordinator shall be a registered nurse with experience in maternal or neonatal care.(2) Clinical Coordinators engaged in research shall have completed the research ethics training/human subjects' protection training as appropriate.(m) Research Support.(1) Identify a research coordinator who shall have a Certified Clinical Research Professional or a Certified Clinical Research Associate credential or equivalent.(2) A research coordinator shall collect, analyze, and abstract data as needed for research and follow up of perinatal outcomes.(n) Medical Imaging Services.(1) A board certified pediatric radiologist with expertise in the interpretation of fetal Magnetic Resonance Imaging (MRI) shall be available and provide interpretation within 24 hours upon completion of study.(2) A Perinatal Sonographer shall:(A) be registered through the American Registry for Diagnostic Medical Sonography, Cardiovascular Credentialing International, American Registry for Radiologic Technologists, or an organization approved by the department; and(B) have documented continuing education as required for advanced certifications, and demonstrate competence in mainstream fetal diagnostic ultrasounds and new diagnostic modalities as available.(3) Ultrasound Imaging. The ultrasound unit shall be accredited by The American Institute of Ultrasound in Medicine or the American College of Radiology or an organization approved by the department.(4) Fetal Echocardiography. The facility's Fetal Echocardiography program shall be accredited by The American Institute of Ultrasound in Medicine or the Intersocietal Accreditation Commission or an organization approved by the department.(5) Magnetic Resonance Imaging (MRI). The facility's MRI program shall be accredited by The American College of Radiology or an organization approved by the department.(o) Laboratory Services.(1) Perinatal pathology services shall be available on-site.(2) Reference lab capabilities, or agreements with specialized testing centers, shall be available for specialized testing for perinatal genetic testing, fetal conditions, and infections.(p) CEFDT Innovation Committee (committee). A multidisciplinary, objective committee will review fetal interventions that are innovative, but not mainstream medicine or research.(1) The committee shall include medical and nursing personnel with maternal-fetal knowledge and expertise, ethicists, genetic counselors, and non-medical patient advocates, as appropriate for the proposed study.(2) The chair of the committee shall have an independent objective view of the proposed intervention.(3) The members of the committee may or may not be directly involved with the CEFDT, but shall not be directly involved in the proposed innovation.(4) The committee decisions shall be independent and without conflict of interest, either due to direct care of the patient or by affiliation or financial gain.(5) Documentation of in-depth discussions and actions implemented will be maintained by the CEFDT.(6) All non-standard fetal interventions shall have formal approval by the committee prior to the intervention.(7) The committee has the final authority to approve or disapprove the innovative intervention.(q) The CEFDT shall provide a monthly multidisciplinary conference, involving CEFDT medical staff, nurses, ethicists, and ancillary staff, to discuss the options for prenatal and postnatal management of fetal anomalies and other conditions. Emergent fetal interventions performed prior to the conference will be discussed at the next monthly meeting after the procedure. The facility shall maintain documentation of meetings, in depth discussion of the options, and plan for management for all fetal therapy patients. Source Note: The provisions of this §133.225 adopted to be effective March 1, 2018, 43 TexReg 887. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING L CENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY §133.225 Program Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187633&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187633 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187633&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187633 03/11/2026 (a) A CEFDT shall be surveyed by a team, approved by the office, which is multi-disciplinary and includes at a minimum one board certified physician that is active in the management of maternal-fetal patients and/or performs fetal interventions; and a nurse active in the management of maternal-fetal patients, at a facility providing the same level of maternal-fetal care. An additional surveyor may be requested by the facility or at the discretion of the office.(b) Office-credentialed surveyors must meet the following criteria:(1) have at least three years of experience in the care of maternal-fetal patients and/or fetal interventions;(2) be currently employed and clinically practicing in the coordination of care for maternal-fetal patients and fetal interventions;(3) have direct experience in the preparation for and successful completion of a Centers of Excellence for Fetal Diagnosis and Therapy verification and/or designation;(4) have successfully completed an office-approved Centers of Excellence for Fetal Diagnosis and Therapy site surveyor course and be successfully re-credentialed every four years; and(5) have current credentials as:(A) a registered nurse with maternal-fetal experience who has successfully completed an office-approved site survey internship; or(B) a physician who is board certified in the respective specialty, and has successfully completed an office-approved site survey internship.(c) All surveyors, except department staff, shall come from a Perinatal Care Region outside the facility's location and at least 100 miles from the facility. There shall be no business or patient care relationship or any potential conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.(d) The surveyors shall evaluate the facility's compliance with the designation criteria by:(1) reviewing medical records; staff rosters and schedules; documentation of QAPI Program activities, including peer review; the program plan; policies and procedures; and other documents relevant to fetal diagnosis and therapy services;(2) reviewing equipment and the physical plant; and(3) conducting interviews with facility personnel; surveyors may meet privately with individuals or groups of personnel. Source Note: The provisions of this §133.226 adopted to be effective March 1, 2018, 43 TexReg 887. 1 DEPARTMENT OF STATE HEALTH SERVICES 133 HOSPITAL LICENSING L CENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY §133.226 Surveyors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196313&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196313 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196313&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196313 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Applicant--A person who applies to the department for a certificate of competency as a promotor(a) or community health worker, an instructor, or a training program.(2) Certificate--Certificate issued to a promotor(a) or community health worker, instructor, or training program by the department.(3) Certified Training Curriculum--An educational, community health training curriculum approved by the department for the purpose of training promotores or community health workers or instructors.(4) Commission--The Texas Health and Human Services Commission.(5) Commissioner--The Commissioner of the Department of State Health Services.(6) Committee--Promotor(a) or Community Health Worker Training and Certification Advisory Committee.(7) Compensation--Receiving payment or receiving reimbursement for expenses.(8) Core Competencies--Key skills for a promotor(a) or community health worker required for certification by the department as listed in policy at www.dshs.texas.gov.(9) Department--The Department of State Health Services.(10) Executive Commissioner--The Executive Commissioner of the Texas Health and Human Services Commission.(11) Instructor--A person certified by the department to provide instruction and training in one or more core competencies to promotores or community health workers.(12) Program--The Promotor(a) or Community Health Worker Training and Certification Program established by the department to provide standards and guidelines for issuance of a certificate.(13) Promotor(a) or Community Health Worker--A person who, with or without compensation, provides a liaison between health care providers and patients through activities such as assisting in case conferences, providing patient education, making referrals to health and social services, conducting needs assessments, distributing surveys to identify barriers to health care delivery, making home visits, and providing bilingual language services.(14) Training program--An organization approved by the department to deliver a certified training curriculum to promotores or community health workers or instructors. Source Note: The provisions of this §146.1 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196314&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196314 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196314&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196314 03/11/2026 (a) The provisions of this chapter apply to:(1) a training program that delivers a certified training curriculum for promotores or community health workers;(2) an instructor representing that the instructor trains promotores or community health workers; or(3) a promotor(a) or community health worker representing that the promotor(a) or community health worker performs as a certified promotor(a) or community health worker.(b) Certification under this chapter is voluntary for a promotor(a) or community health worker who provides services without receiving compensation and mandatory for a promotor(a) or community health worker who provides services for compensation.(c) Application and certification procedures are outlined in policy and can be found online at www.dshs.texas.gov.(d) The department or commission may develop a specialty certification and continuing education for promotores or community health workers or instructors that may be certified by the department directly. Source Note: The provisions of this §146.2 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.2 Applicability and Exemption https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196315&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196315 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196315&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196315 03/11/2026 (a) Committee. The committee is established by the department under Health and Safety Code, §48.101.(b) Applicable law. The committee is subject to Government Code, Chapter 2110, concerning state agency advisory committees. In accordance with Section 2110.006, the department evaluates the committee annually. If the committee is not continued or consolidated, the committee shall be abolished on August 31, 2023.(c) Purpose and tasks.(1) The committee shall advise the department and the commission on the implementation of standards, guidelines, and requirements relating to the training and regulation of persons working as promotores or community health workers.(2) The committee shall advise the department on matters related to the employment and funding of promotores or community health workers.(3) The committee shall provide to the department recommendations for a sustainable Program for promotores or community health workers.(d) Composition. The committee shall be composed of nine members appointed by the Commissioner from the following categories:(1) five promotores or community health workers currently certified by the department;(2) one public member, which may include a consumer of community health worker services or a person with paid or volunteer experience in community health care or social services;(3) one member from the Higher Education Coordinating Board, or a higher education faculty member who has teaching experience in community health, public health or adult education and has trained promotores or community health workers; and(4) two professionals who work with promotores or community health workers in a community setting, including employers and representatives of non-profit community-based organizations or faith-based organizations.(e) Terms of office. The term of office of each member shall be three years, and a member may apply to be reappointed for up to one additional term.(1) If a vacancy occurs, a person shall be appointed to serve the unexpired portion of that term.(2) Members shall be appointed for staggered terms so that the terms of three members will expire on August 31st of each year.(f) Officers. The Commissioner shall appoint a member of the advisory committee as presiding officer after August 31st of each year.(1) The committee may elect a member of the advisory committee as an assistant presiding officer.(2) An officer position, either presiding or assistant presiding officer, must be occupied by a promotor(a) or a community health worker member.(3) Each officer shall serve until the next appointment of officers.(4) The presiding officer shall preside at all committee meetings at which the presiding officer is in attendance, call meetings in accordance with this section, appoint subcommittees of the committee as necessary, and cause proper reports to be made to the Executive Commissioner. The presiding officer may serve as an ex-officio member of any subcommittee of the committee.(5) The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. In case the office of presiding officer becomes vacant, the assistant presiding officer will serve until the Commissioner appoints a successor to complete the unexpired portion of the term of the office of presiding officer.(6) A member shall serve no more than two consecutive terms as an officer of the committee.(7) The committee may reference its officers by other terms, such as chairperson and vice-chairperson.(g) Meetings. The committee shall meet quarterly to conduct committee business.(1) A meeting may be called by agreement of department staff and either the presiding officer or at least three members of the committee.(2) Department staff makes meeting arrangements and contacts committee members to determine availability for a meeting date and place.(3) Each meeting of the committee shall be announced and conducted in accordance with the Open Meetings Act, Government Code, Chapter 551. The committee is not a "governmental body" as defined in the Open Meetings Act. Meetings may be conducted in person, through conference call, or by means of other technology.(4) Each member of the committee shall be informed of a committee meeting at least five working days before the meeting.(5) Five members of the committee shall constitute a quorum for the purpose of transacting official business.(6) The committee is authorized to transact official business only when in a legally constituted meeting with a quorum present, as specified in paragraph (3) of this subsection.(7) The agenda for each committee meeting shall include an item entitled public comment under which any person will be allowed to address the committee on matters relating to the business of the committee. Public comment procedures shall be in accordance with Health and Human Services policy.(h) Attendance. Members shall attend committee meetings as scheduled. Members shall attend meetings of subcommittees to which the member is assigned.(1) A member shall notify the presiding officer or appropriate department staff if a member is unable to attend a scheduled meeting.(2) It is grounds for removal from the committee if a member:(A) cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability;(B) is absent from more than half of the committee and subcommittee meetings during a calendar year; or(C) is absent from three consecutive committee meetings.(3) The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists.(i) Staff. The department provides staff support for the committee.(j) Procedures. Committee bylaws shall be the basis of parliamentary decisions except where otherwise provided by law or rule.(1) An action taken by the committee must be approved by a majority vote of the members voting once quorum is established.(2) Each member shall have one vote.(3) A member may not authorize another person to represent the member by proxy.(4) The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.(5) The department staff will take minutes of each committee meeting and the committee will review the minutes for possible approval at the next scheduled meeting.(k) Subcommittees. The committee may establish subcommittees as necessary to assist the committee in carrying out its duties.(1) The presiding officer shall appoint members of the committee to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer may also appoint nonmembers of the committee to serve on subcommittees. Subcommittee members shall serve for a term of one year expiring August 31.(2) Subcommittees shall be composed of no more than four members of the committee and no more than three nonmembers. The committee shall maintain a roster of each subcommittee.(3) Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the committee.(4) A subcommittee chairperson shall make regular reports to the advisory committee at each committee meeting or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting.(l) Statement by members.(1) The Executive Commissioner, the Commissioner, the department, and the committee shall not be bound in any way by any statement or action on the part of any committee member except when a statement or action is in pursuit of specific instructions from the Executive Commissioner, the Commissioner, the department, or committee.(2) The committee and its members shall follow the policy and provisions as outlined in the statement by members document in accordance with adopted committee bylaws.(m) Reports. The committee shall prepare and file an annual written report with the Commissioner.(1) The report shall list:(A) the meeting dates of the committee and any subcommittees;(B) the attendance records of its members;(C) a brief description of actions taken by the committee;(D) a description of how the committee has accomplished the tasks given to the committee by the department and the commission;(E) anticipated activities of the committee for the next year; and(F) any amendments to this section requested by the committee.(2) The report shall identify the costs related to the committee.(3) The report shall cover the meetings and activities in the immediate preceding calendar year and shall be filed with the Commissioner by April 30 of each year.(n) Reimbursement for expenses. In accordance with the requirements set forth in the Government Code, Chapter 2110, a committee member may receive reimbursement for the member's travel expenses incurred for each day the member engages in official committee business if authorized by the General Appropriations Act or budget execution process. The committee shall follow reimbursement requirements as outlined in the committee bylaws. Source Note: The provisions of this §146.3 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.3 Promotor(a) or Community Health Worker Training and Certification Advisory Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196316&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196316 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196316&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196316 03/11/2026 (a) Minimum eligibility requirements for training programs. The following requirements apply to organizations applying for certification:(1) physical location in Texas;(2) experience in training promotores or community health workers, health care professionals, or paraprofessionals and training experience within the past two years and related to the core competencies; and(3) affiliation with one or more instructors currently certified by the department.(b) Application requirements for training programs. The department specifies the required information and documentation that an applicant shall complete and notifies the applicant if the application is incomplete.(c) Application approval. The department approves an application which complies with the requirements set in policy and which properly documents applicant eligibility.(d) Disapproved applications.(1) The department may disapprove an application if the applicant:(A) has not met the eligibility and application requirements set out in this chapter; or(B) has failed or refused to properly complete or submit required information or has knowingly presented false or misleading information in the application process.(2) If the department determines that an application should not be approved because it is incomplete, the department gives the applicant written notice of the reason for the disapproval and the opportunity for re-application.(3) An applicant whose application has been disapproved for a reason other than that it is incomplete may appeal the disapproval under the fair hearing procedures found in Chapter 1, Subchapter C of this title (relating to Fair Hearing Procedures).(e) Changes of name and address. Training programs shall notify the department of changes in organization name, contact information, mailing address, or physical location within 30 calendar days after the change.(f) Certificate.(1) Upon approval of the application, the department issues the training program a certificate with an expiration date and a certificate number.(2) The department replaces a lost, damaged, or destroyed certificate upon written request.(g) Standards for the approval of certification and continuing education curricula. Training programs shall follow the guidelines set in policy regarding standards for certification and continuing education curricula for promotores or community health workers or instructors.(h) Training program responsibilities. A training program shall:(1) submit an addendum, in a format specified by the department and in compliance with policy, when revising a current, certified curriculum;(2) ensure curricula are provided by a certified instructor, unless otherwise approved by the department;(3) provide training to promotores or community health workers or instructors as applicable to the training program's certifications that includes:(A) at least one certification course per year; and(B) at least one continuing education course per certification cycle;(4) report the names of persons to the department who have successfully completed the training program within seven business days of program completion in a format specified by the department; and(5) maintain an accurate record of each person's attendance and participation for not less than three years.(i) Certificate renewal.(1) A training program shall renew the certificate every two years in accordance with policy. Failure to receive notification from the department before the expiration date will not excuse failure to file for renewal.(2) Failure to meet the requirements in subsection (h)(3) of this section shall result in denial of the certificate renewal.(j) Late renewals.(1) A training program whose certificate has expired for not more than one year may renew the certificate by submitting to the department the completed renewal application. The training program shall not provide training for community health workers or instructors until the certificate has been renewed. A certificate not renewed within one year after expiration cannot be renewed.(2) A training program whose certification has been expired for more than one year must meet the requirements under subsection (a) of this section and apply for a new certificate.(k) Right to inspect. The department reserves the right to inspect facilities and documentation and to monitor training programs. Source Note: The provisions of this §146.4 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.4 Certification of Training Programs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196317&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196317 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196317&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196317 03/11/2026 (a) Minimum eligibility requirements for instructor certification. The following requirements apply to persons applying for certification:(1) Texas residency;(2) at least 18 years of age;(3) lack of physical or mental impairment, which in accordance with the Americans with Disabilities Act interferes with the performance of duties or otherwise constitutes a hazard to the health or safety of the persons being served; and(4) achievement of core competencies in instruction or training as identified in policy through completion of certified competency-based instructor training within the past three years or through department verification of at least 1,000 hours related training experience within the past three years.(b) Application requirements for instructors. The department specifies the required information and documentation that an applicant shall complete and the department notifies the applicant if the application is incomplete.(c) Application approval. The department approves any application which complies with this chapter and which properly documents applicant eligibility, unless the application is disapproved under the provisions of subsection (d) of this section.(d) Disapproved applications.(1) The department may disapprove the application if the applicant:(A) has not met the eligibility and application requirements set out in this chapter;(B) has failed or refused to properly complete or submit any required information or has knowingly presented false or misleading information in the application process;(C) has engaged in unethical conduct as defined in §146.7 of this chapter (relating to Professional and Ethical Standards);(D) has been convicted of a felony or misdemeanor directly related to the duties and responsibilities of a promotor(a) or community health worker or instructor as set out in §146.8 of this chapter (relating to Enforcement); or(E) has developed an incapacity which in accordance with the Americans with Disabilities Act prevents the person from practicing with reasonable skill, competence, and safety to the public as the result of:(i) an illness;(ii) drug or alcohol dependency; or(iii) another physical or mental condition or illness.(2) If the department determines that the application should not be approved because it is incomplete, the department gives the applicant written notice of the reason for the disapproval and the opportunity for re-application.(3) If the department determines that the application should not be approved because experience requirements are not met, the department gives the applicant written notice of the reason for the disapproval and the opportunity for re-application after sufficient experience is obtained.(4) An applicant whose application has been disapproved for a reason other than paragraph (2) or (3) in this subsection, may appeal the disapproval under the fair hearing procedures found in Chapter 1, Subchapter C of this title (relating to Fair Hearing Procedures).(e) Changes of name and address.(1) The department changes the status of a certification to inactive upon receipt of notification that the certificate holder no longer lives in Texas.(2) Notification of name changes shall be submitted to the department and include a copy of a marriage certificate, court decree evidencing such change, Texas driver's license or identification card, or a social security card reflecting the new name before a certificate or identification card is issued by the department.(f) Certificate.(1) The department issues the instructor a certificate with an expiration date and a certificate number. An identification card shall be included for a certified instructor.(2) The department replaces a lost, damaged, or destroyed certificate or identification card upon written request.(g) An instructor must be affiliated with an approved training program in order to provide department-certified training to certified promotores or community health workers or instructors.(h) Certificate renewal.(1) An instructor shall renew the certificate every two years in accordance with policy. Failure to receive notification from the department before the expiration date will not excuse failure to file for renewal.(2) An instructor must complete at least 20 contact hours of continuing education acceptable to the department and related to the core competencies during each certification period.(3) Before certificate expiration, an instructor may request one 90-day extension to complete the continuing education requirement and apply for certificate renewal.(i) Late renewals.(1) A person whose certificate has expired for not more than one year may renew the certificate by submitting to the department the completed renewal application. An instructor must submit proof of compliance with continuing education requirements for renewal as set out in this section before the late renewal is effective. A certificate issued under this subsection shall expire two years from the date the previous certificate expired.(2) A person whose certification has been expired for more than one year must meet the requirements under subsection (a) of this section and apply for a new certificate. Source Note: The provisions of this §146.5 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.5 Eligibility Requirements and Application Procedures for Community Health Worker Instructors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196318&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196318 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196318&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196318 03/11/2026 (a) Minimum eligibility requirements for promotor(a) or community health worker certification. The following requirements apply to persons applying for certification:(1) Texas residency;(2) at least 16 years of age;(3) lack of physical or mental impairment, which in accordance with the Americans with Disabilities Act interferes with the performance of duties or otherwise constitutes a hazard to the health or safety of the persons being served; and(4) achievement of core competencies identified in policy through completion of a certified competency-based training provided by an approved training program within the past three years or through verification of at least 1,000 hours of related experience within the past three years.(b) Application requirements for a promotor(a) or community health worker. The department specifies the required information and documentation that an applicant shall complete and the department notifies the applicant if the application is incomplete.(c) Application approval. The department approves any application which complies with this chapter and which properly documents applicant eligibility, unless the application is disapproved under the provisions of subsection (d) of this section.(d) Disapproved applications.(1) The department may disapprove the application if the applicant:(A) has not met the eligibility and application requirements set out in this chapter;(B) has failed or refused to properly complete or submit any required information or has knowingly presented false or misleading information in the application process;(C) has engaged in unethical conduct as defined in §146.7 of this chapter (relating to Professional and Ethical Standards);(D) has been convicted of a felony or misdemeanor directly related to the duties and responsibilities of a promotor(a) or community health worker or instructor as set out in §146.8 of this chapter (relating to Enforcement); or(E) has developed an incapacity, which in accordance with the Americans with Disabilities Act prevents the person from practicing with reasonable skill, competence, and safety to the public as the result of:(i) an illness;(ii) drug or alcohol dependency; or(iii) another physical or mental condition or illness.(2) If the department determines that the application should not be approved because it is incomplete, the department gives the applicant written notice of the reason for the disapproval and the opportunity for re-application.(3) If the department determines that the application should not be approved because experience requirements are not met, the department gives the applicant written notice of the reason for the disapproval and the opportunity for re-application after sufficient experience is obtained.(4) An applicant whose application has been disapproved for a reason other than paragraph (2) or (3) of this subsection, may appeal the disapproval under the fair hearing procedures found in Chapter 1, Subchapter C of this title (relating to Fair Hearing Procedures).(e) Changes of name and address.(1) The department changes the status of a certification to inactive upon receipt of notification that the certificate holder no longer lives in Texas.(2) Notification of name changes must be submitted to the department and include a copy of a marriage certificate, court decree evidencing such change, Texas driver's license or identification card, or a social security card reflecting the new name before a certificate or identification card is issued by the department.(f) Certificate.(1) The department issues the promotor(a) or community health worker a certificate with an expiration date and a certificate number. An identification card shall be included for a promotor(a) or community health worker.(2) The department replaces a lost, damaged, or destroyed certificate or identification card upon written request.(g) Certificate renewal.(1) A promotor(a) or community health worker shall renew the certificate every two years in accordance with policy. Failure to receive notification from the department before the expiration date will not excuse failure to file for renewal.(2) A promotor(a) or community health worker must complete at least 20 contact hours of continuing education acceptable to the department and related to the core competencies during each certification period.(3) Before certificate expiration, a promotor(a) or community health worker may request one 90-day extension to complete the continuing education requirement and apply for certificate renewal.(h) Late renewals.(1) A person whose certificate has expired for not more than one year may renew the certificate by submitting to the department the completed renewal application. A promotor(a) or community health worker must also submit proof of compliance with continuing education requirements for renewal as set out in this section before the late renewal is effective. A certificate issued under this subsection shall expire two years from the date the previous certificate expired.(2) A person whose certification has been expired for more than one year must meet the requirements under subsection (a) of this section and apply for a new certificate. Source Note: The provisions of this §146.6 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.6 Eligibility Requirements and Application Procedures for Promotores or Community Health Workers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196319&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196319 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196319&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196319 03/11/2026 (a) A certified training program, instructor, and promotor(a) or community health worker shall observe and comply with the professional and ethical standards of practice set forth in this subchapter. A violation of the professional and ethical standards constitutes unethical conduct or conduct that discredits or tends to discredit the profession of promotores or community health workers or instructors and is grounds for disciplinary action.(1) Professional representation and responsibilities.(A) An instructor or promotor(a) or community health worker shall not misrepresent any professional qualifications or credentials or provide any information that is false, deceptive, or misleading.(B) An instructor or promotor(a) or community health worker shall not engage in conduct that is prohibited by state, federal, or local law, including those laws prohibiting the use, possession, or distribution of drugs or alcohol.(C) An instructor or promotor(a) or community health worker shall not discriminate based on race, creed, gender, sexual orientation, religion, national origin, age, physical disability, or economic status in the performance of community health work services or training.(D) An instructor or promotor(a) or community health worker shall maintain knowledge and skills for continuing professional competence by participating in continuing education programs and activities as set out in §146.5(h)(2) of this chapter (relating to Eligibility Requirements and Application Procedures for Community Health Worker Instructors) and §146.6(g)(2) of this chapter (relating to Eligibility Requirements and Application Procedures for Promotores or Community Health Workers), concerning continuing education requirements.(E) An instructor or promotor(a) or community health worker shall refrain from providing services that are outside the scope of the profession and shall refer a client for those services that the instructor or promotor(a) or community health worker is unable to meet.(F) An instructor or promotor(a) or community health worker shall be responsible for competent and efficient performance of the instructor or promotor(a) or community health worker assigned duties and shall report to the department incompetence and illegal or unethical conduct of members of the profession.(G) An instructor or promotor(a) or community health worker shall not retaliate against any person who reported in good faith to the department alleged incompetence; misrepresentation; or illegal, unethical, or negligent conduct of any instructor or promotor(a) or community health worker.(H) An instructor or promotor(a) or community health worker shall notify the department of changes in preferred mailing address and telephone number, and email address, if applicable.(I) A training program shall not make any misleading, deceptive, or false representation in connection with offering or obtaining approval of a certified curriculum.(J) A training program of a certified curriculum shall not discriminate in decisions regarding student recruitment, selection of applicants, training, or instruction based on race, creed, gender, sexual orientation, religion, national origin, age, physical disability, or economic status.(2) Relationships with clients.(A) An instructor or promotor(a) or community health worker shall not accept gratuities for preferential consideration of the client. The instructor or promotor(a) or community health worker shall guard against conflicts of interest.(B) An instructor or promotor(a) or community health worker shall not violate any provision of any federal or state statute or regulation relating to confidentiality of client communication and records. Source Note: The provisions of this §146.7 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.7 Professional and Ethical Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196320&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196320 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=196320&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 196320 03/11/2026 (a) The department may disapprove, suspend, or revoke a certification if the applicant or certification holder:(1) has a criminal conviction that relates to the duties and responsibilities of a training program, instructor, or promotor(a) or community health worker, based on:(A) the nature and seriousness of the crime;(B) the length of time since the crime occurred;(C) how the certification may have facilitated the crime; and(D) the extent to which certification could create an opportunity to engage in further criminal activity of a similar nature;(2) falsely represents oneself as a certified training program, instructor, or promotor(a) or community health worker without a certification issued under this chapter;(3) obtains or attempts to obtain a certification under this chapter using false information or through bribery;(4) violates §146.7 of this chapter (relating to Professional and Ethical Standards); or(5) has a certification in another jurisdiction denied, revoked, suspended, or otherwise subjected to adverse action.(b) In determining enforcement under this section, the department considers:(1) the pattern of behavior and severity of the violation;(2) the length of time since the violation occurred;(3) any potential harm to the public; and(4) any previous violation by the applicant or certification holder.(c) If the department disapproves, suspends, or revokes a certification under this section, the department gives the person written notice of the reason or reasons for the decision and the opportunity to request a fair hearing conducted under Chapter 1, Subchapter C of this title (relating to Fair Hearing Procedures).(d) A person whose certificate is disapproved or revoked under this section is ineligible for a certificate under this chapter for two years from the date of the disapproval or revocation. Upon disapproval, suspension, or revocation, the certificate holder shall return a certificate or an identification card to the department. Source Note: The provisions of this §146.8 adopted to be effective August 20, 2019, 44 TexReg 4317. 1 DEPARTMENT OF STATE HEALTH SERVICES 146 TRAINING AND CERTIFICATION OF PROMOTORES OR COMMUNITY HEALTH WORKERS §146.8 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=110933&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 110933 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=110933&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 110933 03/11/2026 (a) The purpose of this chapter is to implement the Emergency Medical Services Act, Health and Safety Code, Chapter 773.(b) This chapter will provide minimum requirements for an emergency medical services (EMS) provider license; authorization of EMS vehicles; emergency suspension, reprimand, suspension, probation, revocation, or denial of an EMS provider license; first responder organizations; EMS personnel certification and licensure; interstate reciprocity for EMS certification; EMS personnel recertification or relicensure; continuing education requirements; course coordinator and program instructor certification; disciplinary action for EMS personnel, course coordinators and program instructors; EMS training courses and course approval; Emergency Medical Information Operator training, instructor training, course approval and certification; certification or licensure of persons with criminal backgrounds; Out-of-Hospital Do-Not-Resuscitate orders; automated external defibrillators; requests for emergency care attendant training; fees; the establishment of trauma service areas; the establishment of regional EMS/trauma systems; requirements for trauma facility designation; and disciplinary actions for designated trauma facilities. Source Note: The provisions of this §157.1 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective June 1, 2004, 29 TexReg 4492. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE A EMERGENCY MEDICAL SERVICES - PART A §157.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222032&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222032 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222032&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222032 03/11/2026 The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:(1) Abandonment--Leaving a patient without appropriate medical care once patient contact has been established, unless emergency medical services personnel are following the medical director's protocols, a physician directive, or the patient signs a release; or turning the care of a patient over to an individual of lesser education when advanced treatment modalities have been initiated.(2) Accreditation--Formal recognition by a national association of a provider's service or an education program based on standards established by that association.(3) Act--Emergency Health Care Act, Texas Health and Safety Code Chapter 773.(4) Active pursuit of department designation as a trauma facility--An undesignated facility recognized by the department after applying for designation as a trauma facility and has met the requirement to be eligible for uncompensated trauma care funds.(5) Acute Stroke-Ready Level IV stroke facility--A hospital reviewed by a department-approved survey organization and meeting the national stroke standards of care for an acute stroke-ready facility as described in §157.133 of this chapter (relating to Requirements for Stroke Facility Designation).(6) Administrator of record (AOR)--The administrator for an emergency medical services (EMS) provider who meets the requirements of Texas Health and Safety Code §773.05712.(7) Advanced emergency medical technician (AEMT)--An individual certified by the department and minimally proficient in performing the basic life support skills required to provide emergency prehospital or interfacility care and initiating and maintaining under medical supervision, certain advanced life support procedures, including intravenous therapy and endotracheal or esophageal intubation.(8) Advanced Level II stroke facility--A hospital that completes a designation survey with a department-approved survey organization, meets the national stroke standards for Non-Comprehensive Thrombectomy Stroke Center, and meets the requirements of an Advanced Level II stroke facility as defined by §157.133 of this chapter.(9) Advanced Level III trauma facility--A hospital surveyed by a department-approved survey organization that meets the state requirements and American College of Surgeons (ACS) standards for a Level III trauma facility as described in §157.125 of this chapter (relating to Requirements for Trauma Facility Designation Effective Through August 31, 2025) and §157.126 of this chapter (relating to Trauma Facility Designation Requirements Effective on September 1, 2025).(10) Advanced life support (ALS)--Emergency prehospital or interfacility care that uses invasive medical acts and includes ALS assessment. The provision of advanced life support must be under the medical supervision and control of a licensed physician.(11) Advanced life support assessment--Assessment performed by an AEMT or paramedic that qualifies as advanced life support based upon initial dispatch information, when it could reasonably be believed the patient was suffering from an acute condition that may require advanced skills.(12) Advanced life support vehicle--A vehicle designed for transporting the sick and injured and meeting the requirements of §157.11 of this chapter (relating to Requirements for an EMS Provider License) as an ALS vehicle and having sufficient equipment and supplies for providing an advanced level of care based on national standards and the EMS provider's medical director-approved treatment protocols.(13) Advanced practice provider (APP)--A nurse practitioner or physician assistant reviewed and credentialed by the facility and may have additional credentialing to participate in the designation program.(14) Air ambulance provider--A person who operates, maintains, or leases a fixed-wing or rotor-wing air ambulance aircraft, equipped and staffed to provide a medical care environment on-board appropriate to the patient's needs. The term air ambulance provider is not synonymous with and does not refer to the Federal Aviation Administration (FAA) air carrier certificate holder unless the air ambulance provider maintains and controls the medical aspects consistent with EMS provider licensure.(15) Ambulance--A vehicle for transportation of the sick or injured patient to, from, or between places of treatment for an illness or injury and that provides out-of-hospital medical care to the patient.(16) American College of Surgeons (ACS)--The organization that sets the national standards for trauma centers, trauma verification, the National Trauma Data Standards (NTDS), National Trauma Data Bank (NTDB), Trauma Quality Improvement Program (TQIP), and regional system standards.(17) Approved survey organization--An organization that has received department authorization to conduct designation surveys, meeting the department's designation survey guidelines and expectations.(18) Authorized ambulance vehicle--A vehicle authorized to be operated by the licensed provider and meeting all criteria for approval as described in §157.11(e) of this chapter.(19) Bad debt--The unreimbursed cost for patient care to a hospital providing trauma care.(20) Basic Level IV trauma facility--A hospital managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually surveyed by a department-approved survey organization and meeting the state requirements and ACS standards, or a hospital managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually surveyed by the department or a department-approved survey organization, and meeting the state designation requirements for a Level IV trauma facility as described in §157.125 and §157.126 of this chapter.(21) Basic life support (BLS)--Emergency prehospital or interfacility care that uses noninvasive medical acts. The provision of basic life support will have sufficient equipment and supplies for providing basic-level care based on national standards and the EMS provider's medical director-approved treatment protocols.(22) Basic life support (BLS) vehicle--A vehicle designed for transporting the sick or injured and having sufficient equipment and supplies for providing basic life support based on national standards and the EMS provider's medical director-approved treatment protocols.(23) Bypass--Direction given to prehospital emergency medical services personnel by direct on-line medical control, or off-line medical director protocols to bypass the nearest facility for the most appropriate facility.(24) Calculation of the costs of uncompensated trauma care--A calculation of a hospital's total costs of uncompensated trauma care for patients meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria determined by summing its charges related to uncompensated trauma care as defined in §157.130 of this chapter (relating to Funds for Emergency Medical Services, Trauma Facilities, and Trauma Care Systems, and the Designated Trauma Facility and Emergency Services Account), then applying the cost-to-charge ratio derived in accordance with generally accepted accounting principles.(25) Candidate--An individual requesting emergency medical services personnel certification, licensure, recertification, or re-licensure from the department.(26) Certificant--Emergency medical services personnel with current certification from the department.(27) Charity care--The unreimbursed cost to a hospital providing health care services for an inpatient, emergency department, transferred, or expired person classified by the hospital as "financially indigent."(28) Commissioner--The commissioner of the Texas Department of State Health Services.(29) Comprehensive Level I stroke facility--A hospital surveyed by a department-approved survey organization meeting the national standards of care for a Comprehensive Stroke Center, participates in its local Regional Advisory Council (RAC), participates in the regional stroke plan, and submits data to the department, as requested as defined by §157.133 of this chapter.(30) Comprehensive Level I trauma facility--A hospital surveyed by a department-approved survey organization meeting the state designation requirements and ACS standards for a Level I trauma facility as described in §157.125 and §157.126 of this chapter.(31) Concurrent performance improvement--Performance improvement reviews occurring from prehospital, trauma activation, or admission through to discharge. The primary level of review must be completed within 14 days of discharge, 80 percent of the time.(32) Concurrent trauma registry abstraction--Trauma registry data abstraction and registry data entry occurring after the management of the trauma patient and completed within 60 days after the patient's discharge, 80 percent of the time.(33) Consumer Protection Division (CPD)--A division within the Texas Department of State Health Services responsible for the oversight of EMS provider licensure, certification, education, and complaint investigation. The division is responsible for the hospital designation process for trauma, stroke, maternal, and neonatal facilities; the RAC system development and advances; and funding, grant management, and distribution of funding for the division.(34) Contingent designation--A designation awarded to a facility with one to three unmet designation requirements. The department develops a corrective action plan (CAP) for the facility and the facility must complete this plan and meet requirements to remain designated. Contingent designations may require a focused survey to validate requirements are met. The facility must demonstrate requirements are met to maintain designation.(35) Contingent probationary designation--A designation awarded to a facility with four or more unmet designation requirements. The department develops a CAP for the facility and the facility must complete this plan and meet requirements to remain designated. The facility may be required to submit documentation reflecting the CAP to the department at defined intervals. Contingent probationary designation may require a full survey within 12 to 18 months after the original survey date. The facility must demonstrate requirements are met to maintain designation.(36) Corrective action plan (CAP)--A plan for the facility developed by the department describing the actions the facility is required to correct.(37) Cost-to-charges ratio--A ratio covering all applicable hospital costs and charges relating to inpatient care determined by the Texas Health and Human Services Commission from the hospital's Medicaid cost report.(38) County of licensure--The county in which the physical address of a licensed EMS provider is located, as indicated by the provider on the application for licensure that is filed with the department.(39) Course medical director--A Texas-licensed physician, approved by the department, with experience in and current knowledge of emergency care who must provide direction over all instruction and clinical practice required in EMS training courses.(40) Credit hour--Continuing education credit unit awarded for successful completion of a unit of learning activity as defined in §157.32 of this chapter (relating to Emergency Medical Services Education Program and Course Approval).(41) Critically injured person--An individual suffering with multi-system injuries or major single-system injury; the extent of the injury may be difficult to ascertain but has the potential of producing mortality or major disability.(42) Definitive care--The phase of care in which therapeutic interventions, treatments, or procedures are performed to stop or control an injury, illness, or disease and promote recovery.(43) Department--The Texas Department of State Health Services.(44) Designated facility administrator--Administrator responsible for the oversight, funding, contracts, and leadership of designated programs.(45) Designated infection control officer--A designated officer who serves as a liaison between the employer and the employees who have been or believe to have been exposed to a potentially life-threatening infectious disease through a person who was treated or transported by the EMS provider.(46) Designation--A formal recognition by the department of a hospital's capabilities, commitment, care practices, and participation in the RAC to serve as a designated facility.(47) Designation appeal--The process for a hospital that has been downgraded or denied a specific level of designation to appeal the designation decision.(48) Designation survey--An on-site or virtual review of a facility applicant to determine if it meets the criteria for a particular level of designation.(49) Dispatch--The sending of individuals and equipment by EMS for assessment, prompt efficient treatment, and transportation, if required, of a sick or injured patient.(50) Distance learning--A method of learning remotely without being in regular face-to-face contact with an instructor in the classroom.(51) Diversion--A procedure put into effect by a health care facility notifying EMS when that facility is unable to provide the level of care demanded by a patient's injuries or condition due to lack of capacity or capabilities, or when the facility has temporarily exhausted its resources and requesting patients be transported to another facility.(52) Emergency call--A call or other similar communication from a member of the public, as part of a 9-1-1 system or other emergency access communication system, made to obtain emergency medical services.(53) Emergency care attendant (ECA)--An individual who is certified by the department as minimally proficient in performing emergency prehospital care by providing initial aid that promotes comfort and avoids aggravation of an injury or illness.(54) Emergency medical services (EMS)--Services used to respond to an individual's perceived need for medical care and to prevent death or aggravation of physiological or psychological illness or injury.(55) EMS medical director--The licensed physician who provides medical supervision to the EMS personnel of a licensed EMS provider or a recognized first responder organization (FRO) under the terms of the Medical Practice Act (Texas Occupations Code Chapters 151 - 165) and rules promulgated by the Texas Medical Board; may also be called "off-line medical control."(56) Emergency medical services operator--An individual who, as an employee of a public or private agency, receives emergency calls and may provide medical information or medical instructions to the public during those emergency calls.(57) Emergency medical services personnel--(A) emergency care attendant (ECA);(B) emergency medical technician (EMT);(C) advanced emergency medical technician (AEMT);(D) emergency medical technician-paramedic (EMT-P); or(E) licensed paramedic (LP).(58) Emergency medical services provider--An organization that uses, operates, or maintains EMS vehicles and EMS personnel to provide emergency medical services.(59) Emergency medical services times--(A) Time of call--The date and time a phone rings at a public safety answering point (PSAP) or other designated entity, requesting EMS services.(B) Dispatch time--The date and time a responding EMS provider is notified by dispatch.(C) En route--The date and time the EMS vehicle starts moving to respond.(D) On scene--The date and time a responding EMS vehicle stops moving when it arrives at the location of the response.(E) At patient side--The date and time the EMS personnel of the responding EMS vehicle arrives at the patient's side.(F) Transport--The date and time the responding EMS vehicle leaves the location of the response and starts moving toward the destination.(G) Arrival time--The date and time the responding EMS vehicle arrives with the patient at the destination or transfer point.(H) Transfer of care--The date and time patient care is transferred to the destination health care staff or transfer point of health care.(I) Back in service--The date and time the EMS vehicle is back in service and available for another response.(60) Emergency medical services vehicle--(A) basic life support (BLS) vehicle;(B) advanced life support (ALS) vehicle;(C) mobile intensive care unit (MICU) vehicle;(D) MICU rotor-wing and MICU fixed-wing air medical vehicles; or(E) specialized emergency medical service vehicle.(61) Emergency medical services volunteer--EMS personnel who provide emergency prehospital or interfacility care in affiliation with a licensed EMS provider or a registered FRO without remuneration, except for reimbursement for expenses.(62) Emergency medical services volunteer provider--An EMS provider with at least 75 percent of personnel as volunteers and is a nonprofit organization. See §157.11 of this chapter regarding fee exemption.(63) Emergency medical technician (EMT)--An individual certified by the department as minimally proficient in performing emergency prehospital care necessary for basic life support and includes the control of hemorrhaging and cardiopulmonary resuscitation.(64) Emergency medical technician-paramedic (EMT-P)--An individual certified by the department as minimally proficient in performing emergency prehospital or interfacility care in health care facility's emergency or urgent care clinical setting, including a hospital emergency room and a freestanding emergency medical care facility, by providing advanced life support that includes initiation and maintenance under medical supervision of certain procedures, including intravenous therapy, endotracheal or esophageal intubation or both, electrical cardiac defibrillation or cardioversion, and drug therapy.(65) Emergency prehospital care--Care provided to the sick and injured within a health care facility's emergency or urgent care clinical setting, including a hospital emergency room and freestanding emergency medical care facility, before or during transportation to a medical facility, including any necessary stabilization of the sick or injured in connection with transportation.(66) Event--A variation from the established care management guidelines or system operations such as delays in response, delays in care, hospital event such as complications, or death. An event or variation in care creates a need for review of the care or system processes to identify opportunities for improvement.(67) Event resolution--An event, as described in paragraph (66) of this section, that is identified and reviewed to determine the impact to the patient and if opportunities for improvement in care or the system exist, with a specific action plan tracked with data analysis to demonstrate the action plan created the desired change to achieve the desired goal, and improved outcomes are sustained.(68) Extraordinary emergency--A serious, unexpected event or situation requiring immediate action to reduce or minimize disruption to established health care services within the EMS and trauma care system.(69) Field triage--The process of determining which facility is most appropriate for patients based on injury severity, time-sensitive disease factors, and facility availability. Refer to paragraph (104) of this section.(70) Financially indigent--An uninsured or underinsured patient unable to pay for the trauma services rendered based on the hospital's eligibility system.(71) First responder organization (FRO)--A group or association of certified EMS personnel that work in cooperation with licensed EMS providers.(72) Fixed location--The address as it appears on the initial or renewal EMS provider license application in which the patient care records and administrative departments are located.(73) Governmental entity--A county, a city or town, a school district, or a special district or authority created in accordance with the Texas Constitution, including a rural fire prevention district, an emergency services district, a water district, a municipal utility district, and a hospital district.(74) Governor's EMS and Trauma Advisory Council (GETAC)--An advisory council appointed by the Governor of Texas that provides professional recommendations to the EMS/Trauma System Section regarding EMS and trauma system development and serves as a forum for stakeholder input.(75) Inactive EMS provider status--The period of time when a licensed EMS provider is not able to respond to an EMS dispatch.(76) Industrial ambulance--Any vehicle owned and operated by an industrial facility as defined in the Texas Transportation Code §541.201 and used for initial transport or transfer of company employees who become urgently ill or injured on company premises to an appropriate health care facility.(77) Injury severity score (ISS)--An anatomical scoring system providing an overall score for trauma patients. The ISS standardizes the severity of trauma injuries based on the three worst abbreviated injury scales (AIS) from the body regions. These regions are the head and neck, face, chest, abdomen, extremity, and external as defined by the Association for the Advancement of Automotive Medicine (AAAM). The highest abbreviated injury score in the three most severely injured body regions have the scores squared, then added together to define the patient's ISS.(78) Interfacility care--Care provided while transporting a patient between health care facilities.(79) Legal entity name--The name of the lawful or legally standing association, corporation, partnership, proprietorship, trust, or individual. Has legal capacity to:(A) enter into agreements or contracts;(B) assume obligations;(C) incur and pay debts;(D) sue and be sued in its own right; and(E) to be accountable for illegal activities.(80) Level of harm--A classification system defining the impact of an event to the patient and assists in defining the urgency of review. There are five levels of harm used to define the impact to the patient as defined by the American Society for Health Care Risk Management:(A) No harm--The patient was not symptomatic or no symptoms were detected, and no treatment or intervention was required.(B) Mild harm--The patient was symptomatic, symptoms were mild, loss of function or harm was either minimal or intermediate but short-term, and no interventions or only minimal interventions were needed.(C) Moderate harm--The patient was symptomatic, required intervention such as additional operative procedure, therapeutic treatment, or an increased length of stay, required a higher level of care, or may experience long-term loss of function.(D) Severe harm--The patient was symptomatic, required life-saving or other major medical or surgical intervention, or may experience shortened life expectancy, and may experience major permanent or long-term loss of function.(E) Death harm--The event was a contributing factor in the patient's death.(81) Levels of review--Describes the levels of performance improvement review for an event in the designation program's quality improvement or performance improvement patient safety (PIPS) plan. There are four levels of review:(A) Primary level of review--Initial investigation of identified events by the facility's designation program performance improvement personnel to capture the event details and to validate and document the timeline, contributing factors, and level of harm. The program manager usually addresses system issues with no level of harm, including identifying the opportunities for improvement and action plan appropriate for the event, and keeping the program medical director updated. This must be written in the facility's performance improvement plan.(B) Secondary level of review--The level of review by the facility's designation program medical director in which the program personnel prepare the documentation and facts for the review. The program medical director reviews the documentation and either agrees or corrects the level of harm, defines the opportunities for improvement with action plans, or refers to the next level of review.(C) Tertiary level of review--The third level of review by the facility's designation program to evaluate care practices and compliance to defined management guidelines, identify opportunities for improvement, and define a plan of correction (POC). Minutes capturing the event, discussion, and identified opportunities for improvement with action plans must be documented.(D) Quaternary level of review--The highest level of review, which may be conducted by an entity external to the facility program as an element of the performance improvement plan. The event, review, and discussion of the event, and identified opportunities for improvement with action plans must be documented.(82) Licensee--A person who holds a current paramedic license from the department, or an organization that uses, maintains, or operates EMS vehicles and provides EMS personnel to provide emergency medical services, and who holds an EMS provider license from the department.(83) Major Level II trauma facility--A hospital surveyed by a department-approved survey organization meeting the state designation requirements and ACS standards for a Level II trauma facility as described in §157.125 and §157.126 of this chapter.(84) Major trauma patient--An individual with injuries, or potential injuries, who benefits from treatment at a trauma facility. The patient may or may not present with alterations in vital signs or level of consciousness, or with obvious, significant injuries, but has been involved in an event that produces a high index of suspicion for significant injury and potential disability. Co-morbid factors such as age or the presence of significant preexisting medical conditions are also considered. The patient initiates a system response to include field triage to the most appropriate designated trauma facility.(85) Medical control--The supervision of prehospital EMS providers and FROs by a licensed physician. This encompasses on-line (direct voice contact) and off-line (written protocol and procedural review).(86) Medical oversight--The assistance and management given to health care providers and entities involved in regional EMS/trauma systems planning by a physician or group of physicians designated to provide technical assistance to the EMS provider or FRO medical director.(87) Medical supervision--Direction given to EMS personnel by a licensed physician under the terms of the Medical Practice Act (Texas Occupations Code Chapters 151 - 165) and rules promulgated by the Texas Medical Board.(88) Mobile intensive care unit--A vehicle designed for transporting the sick or injured, meeting the requirements of the advanced life support vehicle, and having sufficient equipment and supplies to provide cardiac monitoring, defibrillation, cardioversion, drug therapy, and two-way communication with at least one paramedic on the vehicle when providing EMS.(89) National EMS Compact--The agreement among states to allow the day-to-day movement of EMS personnel across state boundaries.(90) National EMS Information System (NEMSIS)--A universal standard for how patient care information resulting from an EMS response is collected.(91) National Trauma Data Bank (NTDB)--The national repository for trauma registry data, defined by the ACS with inclusion criteria and data elements required for submission.(92) National Trauma Data Standards (NTDS)--The American College of Surgeons' standard data elements with definitions required for submission to the NTDB, as defined in paragraph (91) of this section.(93) Non-contiguous emergency department--A hospital emergency department located in a separate building, not contiguous with the designated facility. May be referred to as a satellite emergency department.(94) Off-line medical director--The licensed physician who provides approved protocols and medical supervision to the EMS personnel of a licensed EMS provider under the terms of the Medical Practice Act (Texas Occupations Code Chapters 151 - 165) and rules promulgated by the Texas Medical Board.(95) On-line course--A directed learning process comprised of educational information (articles, videos, images, web links), communication (messaging, discussion forums) for virtual learning, and measures to evaluate the student's knowledge.(96) Operational name--Name under which the business or operation is conducted and presented to the world.(97) Operational policies--Policies and procedures that are the basis for the provision of EMS and that include such areas as vehicle maintenance; proper maintenance and storage of supplies, equipment, medications, and patient care devices; complaint investigations; multi-casualty incidents; and hazardous materials; but do not include personnel or financial policies.(98) Operations Committee--Committee serving as the facility's trauma program administrative oversight for designation and responsible for the approval of trauma management guidelines, operational plan, and procedures within the program or system having the potential to impact care practices or designation.(99) Operative or surgical intervention--Any surgical procedure provided to address trauma injuries for patients taken directly from the scene, emergency department, or other hospital location to an operating suite for patients meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria.(100) Out of service vehicle--The period of time when a licensed EMS vehicle is unable to respond to an emergency or non-emergency response.(101) Performance improvement and patient safety (PIPS) plan--The written plan and processes for evaluating patient care, system response, and adherence to established patient management guidelines; defining variations from care or system response; assigning the level of harm and level of review; identifying opportunities for improvement; and developing the CAP. The CAP outlines data analysis and measures to track the action plan to ensure the desired changes are met and maintained to resolve the event. The medical director, program manager, and administrator have the authority and oversight over PIPS.(102) Plan of correction (POC)--A report submitted to the department by the facility detailing how the facility will correct one or multiple requirements defined as "not met" during a trauma designation survey review that is reported in the survey summary or documented in the self-attestation.(103) Practical exam--An evaluation that assesses the person's ability to perceive instructions and perform motor responses, also referred to as a psychomotor exam.(104) Prehospital triage--The process of identifying medical or injury acuity or the potential for severe injury based upon physiological criteria, injury patterns, and high-energy mechanisms and transporting patients to a facility appropriate for the patient's medical or injury needs. Prehospital triage for injured patients or time-sensitive disease events is guided by the approved prehospital triage guidelines adopted by the RAC and approved by the department. May also be referred to as "field triage" or "prehospital field triage."(105) Primary EMS provider response area--The geographic area in which an EMS agency routinely provides emergency EMS as agreed upon by a local or county governmental entity or by contract.(106) Primary Level III stroke facility--A hospital designated by the department and meets the department-approved national stroke standards of care for a primary stroke center, participates in its RAC, participates in the regional stroke plan, and submits data as requested by the department.(107) Protocols--A detailed, written set of instructions by the EMS provider's medical director, which may include delegated standing medical orders, to guide patient care or the performance of medical procedures as approved.(108) Public safety answering point (PSAP)--The call center responsible for answering calls to an emergency telephone number for ambulance services; sometimes called "public safety access point" or "dispatch center."(109) Quality management--Quality assessment, quality improvement, and performance improvement activities. See definition of PIPS in paragraph (101) of this section.(110) Receiving facility--A health care facility to which an EMS vehicle may transport a patient requiring prompt continuous medical care, or a facility receiving a patient being transferred for definitive care.(111) Recertification--The procedure for renewal of EMS certification.(112) Reciprocity--The recognition of certification or privileges granted to an individual from another state or recognized EMS system.(113) Regional Advisory Council (RAC)--A nonprofit organization recognized by the department and responsible for system coordination for the development, implementation, and maintenance of the regional trauma and emergency health care system within its geographic jurisdiction of the Trauma Service Area. A RAC must maintain 501(c)(3) status.(114) Regional Advisory Council Performance Improvement Plan--A written plan of the RAC's processes to review identified or referred events, identify opportunities for improvement, define action plans and data required to correct the event, and establish measures to evaluate the action plan through to event resolution.(115) Regional medical control--Physician supervision for prehospital EMS providers in a given trauma service area (TSA) or other geographic area intended to provide standardized oversight, treatment, and transport guidelines, which should, at minimum, follow the RAC's regional trauma and emergency health care system plan components related to these issues and 22 Texas Administrative Code §197.3 (relating to Off-line Medical Director).(116) Relicensure--The procedure for renewal of a paramedic license as described in §157.40 of this chapter (relating to Paramedic Licensure); the procedure for renewal of an EMS provider license as described in §157.11 of this chapter.(117) Response pending status--The status of an EMS vehicle that just delivered a patient to a final receiving facility and for which the dispatch center has another EMS response waiting.(118) Response ready--When an EMS vehicle is equipped and staffed in accordance with §157.11 of this chapter and is immediately available to respond to any emergency call 24-hours per day, seven days per week (24/7).(119) Rural county--A county with a population of less than 50,000 based on the latest estimated federal census population figures.(120) Scope of practice--The procedures, actions, and processes EMS personnel are authorized to perform as approved by the EMS provider's medical director.(121) Scope of services--The types of services and the resources to provide those services that a facility has available.(122) Severe trauma patient--A person with injuries or potential injuries defined as high-risk for mortality or disability and meeting trauma activation guidelines and meeting NTDB registry inclusion criteria benefitting from definitive treatment at a designated trauma facility. These patients may be identified by an alteration in vital signs or level of consciousness or by the presence of significant injuries and must initiate a level of trauma response defined by the facility, including prehospital triage to a designated trauma facility.(123) Simulation training--Training, typically scenario-based or skill-based, utilizing simulated patients or system events to improve or assess knowledge, competencies, or skills.(124) Sole provider--The only licensed EMS provider in a geographically contiguous service area and in which the next closest provider is greater than 20 miles from the limits of the area.(125) Specialized EMS vehicle--A vehicle designed for responding to and transporting sick or injured persons by any means of transportation other than by standard automotive ground ambulance or rotor or fixed-wing aircraft and that has sufficient staffing, equipment, and supplies to provide for the specialized needs of the patient transported. This category includes watercrafts, off-road vehicles, and specially designed, configured, or equipped vehicles used for transporting special care patients such as critical neonatal or burn patients.(126) Specialty resource centers--Entities caring for specific types of patients such as pediatric, cardiac, and burn injuries that have received certification, categorization, verification, or other forms of recognition by an appropriate agency regarding the capability to definitively treat these types of patients.(127) Staffing plan--A document indicating the overall working schedule patterns of EMS or hospital personnel.(128) Standard of care--Care equivalent to what any reasonable, prudent person of like education or certification level would have given in a similar situation, based on documented, evidence-based practices or adopted standard EMS curricula as adopted by reference in §157.32 of this chapter; also refers to the documented standards of care reflecting evidence-based practice.(129) State EMS Registry--State repository for the collection of EMS response data as defined in Chapter 103 of this title (relating to Injury Prevention and Control).(130) State Trauma Registry--Statewide database managed by the department; responsible for the collection, maintenance, and evaluation of medical and system information related to required reportable events as defined in Chapter 103 of this title.(131) Stroke--A time-sensitive medical condition occurring when the blood supply to the brain is reduced or blocked, caused by a ruptured blood vessel or clot, preventing brain tissue oxygenation.(132) Stroke activation--The process of mobilizing the stroke care team when a patient screens positive for stroke symptoms; may be referred to as a "stroke alert" or "code stroke."(133) Stroke facility--A hospital that has successfully completed the designation process and is capable of resuscitating and stabilizing, transferring, or providing definitive treatment to stroke patients and actively participates in its local RAC and system plan.(134) Stroke medical director (SMD)--A physician meeting the department's requirements for the stroke medical director and having the authority and oversight for the stroke program, including the performance improvement process, data management, and outcome reviews.(135) Stroke program manager (SPM)--A registered nurse meeting the requirements for the stroke program manager and having the authority and oversight for the stroke program, including the performance improvement process, data management, and outcome reviews.(136) Substation--An EMS provider station location, not the fixed station, and likely to provide rapid access to a location to which the EMS vehicle may be dispatched.(137) Telemedicine medical service--A health care service delivered by a physician licensed in this state, or a health professional acting under the delegation and supervision of a physician licensed in this state, and acting within the scope of the physician's or health professional's license to a patient at a different physical location than the physician or health professional using telecommunications or technology as defined in Texas Occupations Code §111.001.(138) Transport mode--As documented on the patient care record, the usage of emergency warning equipment when responding to an EMS dispatch and when transporting a patient to a receiving facility.(139) Trauma--An injury or wound to a living body caused by the application of an external force or violence, including burn injuries, and meeting the trauma program's trauma activation guidelines.(140) Trauma activation guidelines--Established criteria identifying the potential injury risk to the human body and defining the resources and response times required to evaluate, resuscitate, and stabilize the trauma patient. The guidelines must meet the national recommendations, but each trauma program defines the activation guidelines for the facility. The facility may choose to have one activation level, two activation levels, or three activation levels.(A) The highest level of trauma activation is commonly based on physiological changes in the patient's level of consciousness, airway or potential respiratory compromise, hypotension or signs of shock, significant hemorrhage, or evidence of severe trauma.(B) The second level of trauma activation is commonly based on the patient's physiological stability with anatomical injuries or mechanisms of injury having the potential for serious injuries.(C) The third level of trauma activation is designed for low-energy or single-system injuries that may require specialty service evaluation and intervention.(141) Trauma administrator--Administrator responsible for the facility oversight, funding, contracts, and collaborative leadership of the program, and serves as an interface with the chief executive team as defined by the facility's organizational structure.(142) Trauma and emergency health care system plan--The inclusive system that refers to the care rendered after a traumatic injury or time-sensitive disease or illness where the optimal outcome is the critical determinant. The system components encompass special populations, epidemiology, risk assessments, surveillance, regional leadership, system integration, business or finance models, prehospital care, definitive care facilities, system coordination for patient flow, prevention and outreach, rehabilitation, emergency preparedness and response, system performance improvement, data management, and research. These components are integrated into the regional self-assessment.(143) Trauma care--Care provided to an injured patient meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria and the continuum of care throughout the system, including discharge and follow-up care or transfer.(144) Trauma Designation Review Committee--Committee responsible for reviewing trauma designation appeals, reviewing requirement exception and waiver requests, and outlining specific requirements not met in order to identify potential opportunities to improve future rule amendments.(145) Trauma facility--A hospital that has successfully completed the designation process, is capable of resuscitating and stabilizing, transferring, or providing definitive treatment to patients meeting trauma activation criteria, and actively participates in its local RAC and the development of the regional trauma and emergency health care system plan.(146) Trauma medical director (TMD)--A physician meeting the requirements and demonstrating the competencies and leadership for the oversight and authority of the trauma program as defined by the level of designation and having the authority and oversight for the trauma program, including the performance improvement and patient safety processes, trauma registry, data management, peer review processes, outcome reviews, and participation in the RAC (TMD or designee) and the development of the regional trauma and emergency health care system plan.(147) Trauma patient--Any injured person who has been evaluated by a physician, a registered nurse, or EMS personnel, and found to require medical care in a trauma facility based on local or national medical standards.(148) Trauma program manager (TPM)--A registered nurse who in partnership with the TMD and hospital administration is responsible for oversight and authority of the trauma program as defined by the level of designation, including the trauma performance improvement and patient safety processes, trauma registry, data management, injury prevention, outreach education, outcome reviews, and research as appropriate to the level of designation.(149) Trauma Quality Improvement Program (TQIP)--The ACS risk-adjusted benchmarking program using submitted data to evaluate specific types of injuries and events to compare cohorts' outcomes with other trauma centers; assisting in defining opportunities for improvement in specific patient cohorts.(150) Trauma registrar--An individual meeting the requirements and whose job responsibilities include trauma patient data abstraction, trauma registry data entry, injury coding, and injury severity scoring, in addition to registry report writing and data management skills specific to the trauma registry and trauma program.(151) Trauma registry--A trauma facility database capturing required elements of trauma care for each patient.(152) Trauma service area--Described in §157.122 of this subchapter (relating to Trauma Service Areas).(153) Uncompensated trauma care--The sum of "charity care" and "bad debt." Contractual adjustments in reimbursement for trauma services based upon an agreement with a payor (including Medicaid, Medicare, Children's Health Insurance Program (CHIP), or other health insurance programs) are not uncompensated trauma care.(154) Urban county--A county with a population of 50,000 or more based on the latest estimated federal census population figures.(155) Verification--Process used by the ACS to review a facility seeking trauma verification to validate the defined standards are met with documented compliance for successful trauma center verification. If a Level I or Level II facility is not verified by the ACS, the department cannot designate the facility.(156) When in service--The period of time when an EMS vehicle is responding to an EMS dispatch, at the scene, or en route to a facility with a patient. Source Note: The provisions of this §157.2 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective February 12, 2017, 42 TexReg 430; amended to be effective November 24, 2024, 49 TexReg 9241. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE A EMERGENCY MEDICAL SERVICES - PART A §157.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182737&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182737 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182737&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182737 03/11/2026 (a) Purpose. The purpose of this section is to set out the time periods by which the Texas Department of State Health Services (department) reviews applications for completeness and processes applications to make an eligibility determination of applicants for various Emergency Medical Services (EMS) certifications, licenses and approvals. This section does not apply to applications for trauma facility designation, but does apply to applications for the following:(1) EMS Provider License,(2) First Responder Organization (FRO) license;(3) EMS Personnel Certifications;(4) Paramedic Licenses;(5) EMS Personnel Certification or Paramedic License via Reciprocity;(6) EMS Personnel Certification or Paramedic License via Upgrade;(7) EMS Course Coordinator certification;(8) EMS Instructor Certification;(9) EMS Information Operator Certification;(10) Comprehensive Clinical Management Program (CCMP) Approval;(11) EMS Education Program Approval;(12) EMS Course Approval;(13) EMS Continuing Education Provider Approval;(14) EMS Information Operator Instructor Certification;(15) EMS Information Operator Training Program Approval, and(16) EMS Information Operator Instructor Training Program Approval.(b) Period for Processing Initial or Renewal Application. This period begins on the date the department receives for review and processing a fully completed written initial or renewal application for any of those certifications, licenses or approvals listed in subsection (a)(1) - (16) of this section and ends on the date the department issues the certification or license, or sends a written notice proposing to deny granting the certification, license or approval. The certification, license or approval may be sent to the applicant in lieu of sending a notice of acceptance of an application.(1) This period will be no more than 60 calendar days.(2) This period will be no more than 120 calendar days for an EMS provider license initial applicant, seeking a variance from eligibility requirements.(3) This period may be no more than 180 days for an applicant of whom the department is conducting a criminal background investigation.(4) If the department receives information from any other person or source that would cause the department to begin a criminal background investigation of an applicant, this period may be no more than 180 days from the date the department sends written notice that it's conducting a criminal background investigation.(5) This period may be longer than noted periods, if an application is deficient and becomes subject to a continuing review of the application.(6) This period may be longer than noted periods, if the department proposes to deny the granting of a license, certification or approval and the applicant timely requests an administrative appeal hearing, thus causing a final determination to be made pursuant to timelines relative to Texas Government Code, Chapter 2001 and the department's appeal rules in this chapter.(c) Period for Continuing Review of an Initial or Renewal Application.(1) Incomplete Information. If an initial or renewal application is incomplete, the department will send written notice to the applicant that it is deficient and will specify what information is required to cure all deficiencies and make it complete and acceptable for filing. If the department is conducting a criminal background investigation of the applicant during its application review, it may send the applicant a request for information needed for its investigation to determine the applicant's continued eligibility. The department will send such notice, and/or request, by the 30th day of its receipt of a deficient application or receipt of information giving cause for a criminal background investigation. Once an application is subject to a continuing review of the application, the 60 day period for the department either to issue, or propose to deny, the license, certification or approval will be extended based upon the applicant's timeliness in providing the information and other factors related to the department's reviewing and processing the application.(A) Application Deficiency. If an application deficiency is based upon an absence of information required to make the application complete for filing, the applicant shall provide the required information to the department by the 30th day from the date that the department sent a written request for required information to cure the application's deficiencies.(B) Eligibility Deficiency. If an application deficiency is based upon the applicant's lack of fulfilling an eligibility requirement(s) that causes an absence of information required to make the application complete for filing, the applicant shall provide written notification to the department of such along with a time estimate as to when such eligibility requirement(s) will be fulfilled and shall do so by the 30th day from the date that the department sent a written request for required information to cure the application's deficiencies.(C) Criminal Background Investigation. If the department is conducting a criminal background investigation of the applicant during its application review and sends the applicant a request for information needed for its criminal background investigation, the applicant shall provide such requested information by the 30th day from the date that the department sent a written request for the required information.(2) Second Attempt to Cure Incomplete Information.(A) Application Deficiency Information. If the applicant timely provides any written information that attempts to respond to a notice of application deficiencies, but which still does not cure said deficiencies, the department will send a second written notice specifying what information is required to cure the deficiencies. The department will send this second written notice by the 30th day from the day it receives the information that attempts to satisfy its earlier request. The applicant shall provide the requested information to the department by the 30th day from the date the department sent its second written request for required information to cure the application's deficiencies.(B) Criminal Background Information - If the applicant timely provides any written information or documentation that does not completely fulfill an earlier request for information needed for a criminal background investigation, the department will send a second written notice specifying what information is needed for its investigation. The department will send this second written notice by the 30th day from the day it receives the information that attempts to satisfy its earlier request. The applicant shall provide the requested information to the department by the 30th day from the date the department sent its second written request for information needed for its investigation.(3) Complete Information. If the applicant timely provides information that cures application deficiencies and fully completes the application for filing or satisfactorily provides the requested information needed for a criminal background investigation to determine applicant's continuing eligibility, the department, by the 60th day from the date that the department receives such information, will either issue the certification, license or approval or send a written notice proposing to deny granting the certification, license or approval.(4) Failure to Cure Initial Application Deficiencies or Provide Complete Information.(A) If the department does not timely receive from the initial applicant any information in response to the department's first or second written notice of initial application deficiencies and request for curing information, the initial application is deemed to be withdrawn and/or void on the 30th day from the date the department sent its request, and the initial application fee is forfeited.(B) If the department does not timely receive from the initial applicant the requested information needed for its criminal background investigation to determine the initial applicant's continued eligibility, the department may propose to deny granting the initial certification, license or approval.(5) Failure to Cure Initial Application Deficiencies Related to Eligibility Requirements.(A) If an initial application for EMS Personnel Certifications, Paramedic Licenses, EMS Personnel Certification or Paramedic License via Reciprocity, EMS Personnel Certification or Paramedic License via Upgrade, EMS Course Coordinator certification, EMS Instructor Certification, EMS Information Operator Certification, EMS Information Operator Instructor Certification, is deficient because the applicant has not yet fulfilled certain eligibility requirements, outlined in this chapter, and the applicant has timely notified the department of such, the department may withhold making its determination to either grant or propose denying the certification or license for not more than two years after the application's filing date. If the applicant fails to timely provide the department with written substantial proof noting fulfillment of certain eligibility requirements, thus making the application complete for filing, within two years after the application filing date, the application is deemed to be withdrawn and/or void and the application fee is forfeited.(B) If an initial application for an EMS Provider License, FRO license, EMS Education Program Approval, EMS Course Approval, EMS Continuing Education Provider Approval, EMS Information Operator Training Program Approval, or EMS Information Operator Instructor Training Program Approval, is deficient because the applicant has not yet fulfilled certain eligibility requirements, outlined in this chapter, and the applicant has timely notified the department of such, the department may withhold making its determination to either grant or propose denying the certification, license or approval for not more than six months after the application's filing date. If the applicant fails to timely provide the department with information or written substantial proof noting fulfillment of certain eligibility requirements, thus making the application complete for filing, within six months after the application filing date, the application is deemed to be withdrawn and/or void and the application fee is forfeited.(d) Timeliness Issues Regarding a Renewal Application.(1) Continuance of License. If the department receives a sufficiently complete timely filed renewal application along with the full amount of the renewal fee prior to midnight of the expiration date of the certificate, license or approval to be renewed, the certificate, license or approval does not expire, but continues during the department's review of the application for completeness or, if applicable, its criminal background investigation of the applicant and continues during its processing of the application to make a determination either to grant, or propose to deny, the renewal of the certification, license or approval.(2) Expiration of License. If the department does not timely receive a renewal application and the correct amount of renewal fee, or only receives the application but not the full amount of the renewal fee prior to midnight of the expiration date of the certificate, license or approval to be renewed, then the certificate, license or approval expires at midnight of the expiration date. Even if the applicant untimely files the application with the full amount of the fee, the department will review the application for completeness and if the application is complete or later becomes timely completed, it will then process the application to determine eligibility either to renew, or otherwise to propose to deny the renewal of, the certification, license or approval. During that review and processing period, the person or entity will not be certified, licensed, or approved. If renewal is granted, the renewed license, certification or approval will begin on the date the department grants it, which most likely will not be on the date immediately following the expiration date. An untimely filed EMS provider renewal application will require the applicant to file an initial application and to meet EMS provider license requirements in effect for an initial applicant at that time.(3) Uncured Application Deficiencies. If the department does not timely receive from the applicant any information in response to the department's first or second written notice(s) of application deficiencies and request(s) for curing information, the department may propose to deny renewal of the license, certification or approval.(4) Incomplete Requested Criminal Background Information. If the department does not timely receive from the applicant any requested information needed to complete its criminal background investigation to determine the applicant's continued eligibility, the department may propose to deny renewal of the certification.(5) Proposed Denial of Renewal. If the department proposes to deny renewal for failure to timely provide requested information to cure application deficiencies or requested information to complete a criminal background information or for failure to meet eligibility requirements, and sends, via United States mail, written notice to the applicant proposing to deny renewal of the certification, license or approval and if the department timely receives from the applicant a written request for an administrative appeal hearing, the certificate, license or approval continues past its expiration date until a final determination is made pursuant to Texas Government Code, Chapter 2001 and the department's appeal rules in this chapter.(e) Notice to Last Known Address. The department will send letters, noting application deficiencies or other correspondence requesting necessary information, via U.S. mail, to the applicant's last known address on file with the department, unless it later changes its manner or policy on its notification process. It is the applicant's responsibility to timely notify the department of any change in its mailing address within ten days of such address change.(f) Prolonged Application Review Process by the Department. If the application review process is prolonged due to circumstances surrounding a general investigation or criminal background investigation of the applicant or due to any other administrative procedure within the department or other unexpected event, the department may extend the final review period regarding its review of the application and its making a final determination of the applicant's eligibility for initial or renewal certification, license or approval.(g) Reimbursement of fees.(1) In the event the application is not processed within the time periods as stated in subsections (b) and (c) of this section, the applicant has the right to request of the director of the Office of EMS and Trauma Systems full reimbursement of all filing fees paid in that particular application process. If the director does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied.(2) Good cause for exceeding the period established is considered to exist if:(A) the number of applications for licenses, registrations, certifications, and permits as appropriate to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year;(B) another public or private entity utilized in the application process caused the delay; or(C) other conditions existed giving good cause for exceeding the established periods.(h) Appeal. If the request for full reimbursement authorized by subsection (g) of this section is denied, the applicant may then appeal to the commissioner of health for a resolution of the dispute. The applicant shall give written notice to the commissioner that it requests full reimbursement of all filing fees paid because its application was not processed within the adopted time period. The director shall submit a written report to the commissioner, with a copy provided to the applicant, of the facts related to the processing of the application and good cause for exceeding the established time periods. The commissioner will review the report and any documentation submitted by the applicant, make the final decision on the matter, and provide written notification of his or her decision to the applicant and the director.(i) Sufficiently Complete Timely Filed Renewal Application. A renewal application that the department timely has received before the expiration date of a certificate, license or approval that contains all of the following:(1) correct, legible, dated, and signed by the applicant on either a department approved paper form or on an online form; and(2) the appropriate amount of application fee that has cleared the applicant's financial institution. Source Note: The provisions of this §157.3 adopted to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE A EMERGENCY MEDICAL SERVICES - PART A §157.3 Processing EMS Provider Licenses and Applications for EMS Personnel Certification and Licensure https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=110934&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 110934 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=110934&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 110934 03/11/2026 (a) The department may randomly and for cause audit the records relating to licensing or certification of individuals and/or entities which are currently certified or licensed by the department or which have applied for certification or licensure by the department.(b) The department may automatically audit certified or licensed EMS personnel or entities shown to be non-compliant in an immediately preceding audit.(c) Failure to notify the department of a current mailing address shall not absolve the certificant, licensee or entity from audit requirements.(d) Within 20 business days following notification of audit, certified or licensed EMS personnel or licensed entities shall submit documentation as specified by the department to verify compliance with any requirement set forth in Chapter 773 of the Texas Health and Safety Code or of the rules in this title.(e) Falsification of documentation shall be cause for reprimand, probation, suspension, or revocation of a certificate, license, provider license or EMS program/course approval in accordance with §157.16 of this title (relating to Emergency Suspension, Suspension, Probation, Revocation or Denial of a Provider License); and/or §157.32 of this title (relating to Emergency Medical Services Education Program and Course Approval); and/or §157.34 of this title (relating to Recertification); and/or §157.36 of this title (relating to Criteria for Denial and Disciplinary Actions for EMS Personnel and Voluntary Surrender of a Certificate or License); and/or §157.38 of this title (relating to Continuing Education); and/or §157.43 of this title (relating to Course Coordinator Certification); and/or §157.44 of this title (relating to Emergency Medical Service Instructor Certification). Source Note: The provisions of this §157.4 adopted to be effective June 1, 2004, 29 TexReg 4492. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE A EMERGENCY MEDICAL SERVICES - PART A §157.4 Audits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182738&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182738 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182738&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182738 03/11/2026 (a) EMS personnel and applicants for EMS certification or licensure may request an exemption to rules of this chapter by:(1) submitting an exemption request application form with a nonrefundable fee of $30, if applicable, in addition to any other applicable applications and fees required by this chapter;(2) providing a letter of explanation and other documented evidence which establishes that patient care will not be diminished, or the health and safety of the public affected, if the exemption is approved;(3) providing a signed and dated written statement of support from the medical director of the licensed emergency medical services (EMS) provider or registered first responder organization with whom the applicant is affiliated or will be affiliated; and(4) providing a written plan under which the applicable requirement will be met as soon as possible.(b) In determining whether to grant the exemption, the department shall take into consideration the best interests of the people in a rural area who are served by the licensed EMS provider or registered first responder organization with whom the applicant is affiliated or will be affiliated, if approved. For the purposes of this section, a rural area is defined to be:(1) a county of 50,000 or less; or(2) a sparsely populated area in a county with a population of more than 50,000, as determined by the Federal Office of Rural Health Policy designation (of rural areas within metropolitan areas).(c) If the request is approved, an exemption may be granted temporarily. The applicant will be notified by the department, in writing, and the notification shall include:(1) the date the exemption begins and expires;(2) an explicit statement which specifically describes the rule requirements exempted and any related conditions which must be met for the exemption to apply or continue to apply.(d) This exemption process may be utilized to temporarily allow a person in a rural area, described in subsection (b)(1) and (2) of this section, to practice at a higher level prior to receiving the higher level of certification.(1) To apply to receive this allowance for up to two months after course completion, the applicant must:(A) meet the requirements of subsection (a)(1) - (4) of this section;(B) be currently certified by the department as an ECA, EMT, or AEMT; and(C) submit a course completion certificate for the higher level of training.(2) If granted through written approval from the department, the candidate may practice at the higher level only if accompanied by an individual who is certified or licensed by the department at the same or a higher level of certification or licensure.(3) This allowance shall be automatically and immediately forfeited upon notification of the candidate's failure of the National Registry written or practical examination. Source Note: The provisions of this §157.5 adopted to be effective July 29, 2004, 29 TexReg 7103; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE A EMERGENCY MEDICAL SERVICES - PART A §157.5 Rule Exemption Requests https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223887&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223887 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=223887&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 223887 03/11/2026 (a) Purpose: Acquiring, issuing, and maintaining an EMS provider license.(b) EMS in Texas is a delegated practice, as written in Texas Occupations Code §157.003.(c) Application requirements for an EMS provider license.(1) An applicant for an initial EMS provider license must submit a completed application to the department on the required official forms, following the department's written process.(2) The nonrefundable application fee of $500 per provider plus $180 for each EMS vehicle to be operated under the license must accompany the application.(3) The department will process the EMS provider license application as per §157.3 of this chapter (relating to Processing EMS Provider Licenses and Applications for EMS Personnel Certification and Licensure).(4) An EMS provider holding a valid license or authorization from another state is exempt from holding a Texas EMS provider license if the provider:(A) serves an area that adjoins the State of Texas;(B) has a written mutual aid agreement with a licensed Texas EMS provider;(C) is requested to do so by a licensed Texas EMS provider;(D) responds into Texas for emergency mutual aid assistance; and(E) is obligated to perform to the same medical standards of care required by the home state.(5) A fixed-wing or rotor-wing air ambulance provider, appropriately licensed by the state governments of New Mexico, Oklahoma, Arkansas, Kansas, Colorado, or Louisiana, may apply for a reciprocal provider license. The application does not require staffing by Texas EMS certified or licensed personnel. A nonrefundable administrative fee of $500 per provider in addition to a nonrefundable fee of $180 for each EMS aircraft to be operated in Texas under the reciprocal license must accompany the application.(6) An applicant for an EMS provider license that provides emergency prehospital care is exempt from paying department licensing and authorization fees if the provider is staffed with at least 75 percent volunteer personnel, has no more than five full-time staff or equivalent, and is recognized as a §501(c)(3) nonprofit corporation by the Internal Revenue Service. An EMS provider who compensates a physician to provide medical supervision will be exempt from paying department licensing and authorization fees if all other requirements for fee exemption are met.(7) Required documents that must accompany a license application.(A) Document verifying volunteer status, if applicable.(B) Map and description of service area, a list of counties and cities in which applicant proposes to provide primary emergency service, and a list of all station locations with address and telephone and facsimile transmission numbers for each station.(C) Declaration of organization type and profit status.(D) Declaration of provider name.(i) The legal name of the EMS provider cannot include the name of the city, county, or regional advisory council (RAC) within or in part, unless written approval is given by the individual city, county, or RAC respectively.(ii) A proposed provider name is deemed to be the same name as an established licensed EMS provider if it meets the conditions listed in 1 Texas Administrative Code (TAC) §79.39 (relating to Same Defined) and therefore is not available if a comparison of the names reveals no differences.(E) Declaration of ownership.(F) Declaration of the address for the main location of the business, normal business hours, and proof of ownership or lease of the location.(i) The normal business hours must be posted for public viewing.(ii) A service area map must be provided.(iii) Only one EMS provider license will be issued to each fixed address.(iv) The applicant must attest no other licensed EMS provider is at the business location or address provided.(v) The EMS provider must remain in the same physical location for the period of licensure, unless the department approves a change in location.(G) A statement of an administrator of record under Texas Health and Safety Code §773.0571 or §773.05712.(H) The administrator of record statement must declare they:(i) are not employed or otherwise compensated by another private for-profit EMS provider;(ii) meet the qualifications required for an emergency medical technician certification or other health care professional license with a direct relationship to EMS and currently hold such certification or license issued by the State of Texas;(iii) have submitted to a criminal history record check at the applicant's expense as directed in §157.37 of this chapter (relating to Certification or Licensure of Persons With Criminal Backgrounds);(iv) have completed an initial education course approved by the department regarding state and federal laws and rules affecting EMS in the following areas:(I) Texas Health and Safety Code Chapter 773 and 25 TAC Chapter 157;(II) EMS dispatch processes;(III) EMS billing processes;(IV) Medical control accountability;(V) Quality improvement processes for EMS operations; and(v) have completed eight hours of continuing education related to the Texas and federal laws and rules related to EMS.(I) If the EMS provider held a license on September 1, 2013, and has an administrator of record with at least eight years of experience providing EMS, then the administrator of record statement is exempt from subparagraph(H)(ii) and (iii) of this paragraph.(J) EMS providers operated by a governmental entity are exempt from subparagraph (H) of this paragraph except for declaration of administrator of record.(K) Copies of Doing Business Under Assumed Name Certificates (DBA).(L) Completed EMS personnel form.(M) Staffing Plan describing how the EMS provider provides continuous coverage for the service area defined in documents submitted with the EMS provider application. The EMS provider must have a staffing plan that addresses coverage of the service area or must have a formal system to manage communication when not providing services after normal business hours.(N) Completed EMS vehicle form.(O) Declaration of an employed medical director and a copy of the signed contract or agreement with a physician currently licensed in the State of Texas, in good standing with the Texas Medical Board and in compliance with Texas Medical Board rules, 22 TAC Chapter 197, and Texas Occupations Code Title 3.(P) Completed medical director information form.(Q) Treatment and transport protocols and policies addressing the care to be provided to adult, pediatric, and neonatal patients, and as stated in Texas Health and Safety Code §773.112, must be approved and signed by the medical director.(R) A list of equipment as required on the EMS provider initial and renewal application, with identifiable or legible serial numbers, supplies, and medications approved and signed by the medical director.(S) Documentation that all required equipment is permitted to be used by the EMS provider and proof of ownership or long-term lease for all equipment necessary for the safe operation.(T) Documentation that each authorized vehicle will have its own set of equipment required for such vehicles to operate at the level of the service for which the provider is authorized.(U) Description of how the EMS provider will conduct quality assurance in coordination with the EMS provider medical director.(V) Documentation that the applicant or the management staff will begin or continue to participate in the local RAC.(W) Plan for how the provider will respond to disaster incidents, including mass casualty situations in coordination with local and regional plans.(i) An EMS provider must have a plan for providing transport for a dialysis patient who places an emergency 9-1-1 telephone call during a declared disaster. An alternative mode of transport may be used to move the patient directly to and from an outpatient end stage renal disease facility if the patient's normal and alternative modes of transportation cannot be used during the disaster. The plan will include a communication plan with the receiving facility prior to the patient being transported to a receiving facility.(ii) An EMS provider's plan under this subsection may prioritize providing transportation for a patient suffering from an acute emergency condition over transportation for a dialysis patient.(I) A "disaster" has the meaning assigned by Texas Government Code §418.004 and §418.014.(II) "End stage renal disease facility" has the meaning assigned by Texas Health and Safety Code §251.001(7).(X) Copies of written Mutual Aid or Inter-local Agreements with EMS providers.(Y) Documentation as required for subscription or membership program, if applicable.(Z) Certificate of Insurance, provided by the insurer, identifying the department as the certificate holder and indicating at least minimum motor vehicle liability coverage for each vehicle to be operated, and professional liability coverage. If applicant is a government subdivision, applicant must submit evidence of financial responsibility by self-insuring to the limit imposed by the tort claims provisions of the Texas Civil Practice and Remedies Code.(i) The applicant must maintain motor vehicle liability insurance as required under the Texas Transportation Code.(ii) The applicant must maintain professional liability insurance coverage in the minimum amount of $500,000 for each single occurrence for bodily injury or death and $100,000 for each single occurrence for injury to or destruction of property, as described in Texas Civil Practice and Remedies Code §101.023(c), or as necessary per state law, with a company licensed or deemed eligible by the Texas Department of Insurance to do business in Texas. Alternatively, the applicant may provide acceptable proof of self-insurance or captive insurance in order to secure payment for any loss or damage resulting from any occurrence arising out of, or caused by the care, or lack of care, of a patient.(iii) Liability of a unit of local government under this chapter is limited to money damages in a maximum amount of $100,000 for each person and $300,000 for each single occurrence for bodily injury or death and $100,000 for each single occurrence for injury to or destruction of property, as described in Texas Civil Practice and Remedies Code §101.023(d).(AA) Copies of vehicle titles, vehicle lease agreements, exempt registrations if applicant is a government subdivision, or an affidavit identifying applicant as the owner, lessee, or authorized operator for each vehicle to be operated under the license.(BB) Documentation showing the applicant and management staff possess sufficient EMS professional experience and qualifications as follows:(i) attestation that management staff have read the Texas Emergency Healthcare Act and the department's EMS rules in this chapter; and(ii) proof of one year experience or education provided by a nationally recognized organization on:(I) emergency medical dispatch processes;(II) EMS billing processes;(III) medical control accountability; and(IV) quality improvement processes for EMS operations.(CC) A copy of a letter of credit for obtaining or renewing an EMS provider license, issued by a federally insured bank or savings institution:(i) in the amount of:(I) $100,000 for the initial license and for renewal of the license on the second anniversary of the date the initial license is issued;(II) $75,000 for renewal of the license on the fourth anniversary of the date the initial license is issued;(III) $50,000 for renewal of the license on the sixth anniversary of the date the initial license is issued;(IV) $25,000 for renewal of the license on the eighth anniversary of the date the initial license is issued;(ii) that includes:(I) the names of all the parties involved in the transaction;(II) the name of the person or entity who owns the EMS provider operation and to whom the bank is issuing the letter of credit;(III) the name of the person or entity receiving the letter of credit; and(IV) an EMS provider directly operated by a governmental entity is exempt from this subsection.(DD) A copy of the surety bond in the amount of $50,000 issued to and provided to the Health and Human Services Commission by the applicant participating in the medical assistance program operated under Texas Human Resources Code Chapter 32, the Medicaid Managed Care Program operated under Texas Government Code Chapter 540, or the child health plan program operated under Texas Health and Safety Code Chapter 62. An EMS provider directly operated by a governmental entity is exempt from this subparagraph.(EE) Documentation showing applicant or management team has not been excluded from participation in the state Medicaid program.(FF) A copy of a governmental entity letter of approval that must:(i) be from the governing body of the municipality in which the applicant is located and is applying to provide EMS;(ii) be from the commissioner's court of the county in which the applicant is located and is applying to provide EMS, if the applicant is not located in a municipality;(iii) attest the addition of another licensed EMS provider will not interfere with or adversely affect the provision of EMS by the licensed EMS providers operating in the municipality or county;(iv) attest, if applicable, the addition of another licensed EMS provider will remedy an existing provider shortage that cannot be resolved using the licensed EMS providers operating in the municipality or county; and(v) attest the addition of another licensed EMS provider will not cause an oversupply of licensed EMS providers in the municipality or county.(8) Paragraph (7)(FF) of this subsection does not apply to the renewal of an EMS provider license, or to a municipality, county, emergency services district, hospital, or EMS volunteer provider organization in this state that applies for an EMS provider license.(9) An EMS provider is prohibited from expanding operations to or stationing any EMS vehicles in a municipality or county other than the municipality or county from which the provider obtained the letter of approval under this subsection until after the second anniversary of the date the provider's initial license was issued, unless the expansion or stationing occurs in connection with:(A) a contract awarded by another municipality or county for the provision of EMS;(B) an emergency response made in connection with an existing mutual aid agreement; or(C) an activation of a statewide emergency or disaster response by the department.(10) Paragraph (9) of this subsection does not apply to the renewal of an EMS provider license or to a municipality, county, emergency services district, hospital, or EMS volunteer provider organization in this state that applies for an EMS provider license.(11) Paragraph (9) of this subsection does not apply to fixed or rotor wing EMS providers.(d) EMS Provider License Issuance.(1) License.(A) Applicants who have submitted all required documents and who have met all the criteria for licensure will be issued a provider license effective for a period of two years from the date of issuance.(B) Licenses must be issued in the name of the applicant.(C) License expiration dates may be adjusted by the department to create licensing periods less than two years for administrative purposes.(D) An application for an initial license or for the renewal of a license may be denied to a person or legal entity who owns or has owned any portion of an EMS provider service or who operates or manages or has operated or managed any portion of an EMS provider service that has been sanctioned by or that has a proposed disciplinary action or sanction pending against it by the department or any other local, state, or federal agency.(E) The license will be issued in the form of a certificate that must be prominently displayed in a public area of the provider's primary place of business.(F) An EMS provider license issued by the department is not transferable to another person or entity.(2) Vehicle Authorization.(A) The department issues an authorization for each vehicle operated by the applicant meeting all criteria for approval as defined in this subsection.(B) A vehicle authorization is issued for the following levels of service. A provider may operate at a higher level of service based on appropriate staffing, equipment, and medical direction for that level. A vehicle authorization includes a level of care designation at one of the following levels:(i) Basic Life Support (BLS);(ii) BLS with Advanced Life Support (ALS) capability;(iii) BLS with Mobile Intensive Care Unit (MICU) capability;(iv) ALS;(v) ALS with MICU capability;(vi) MICU;(vii) Air Medical:(I) Rotor-wing; or(II) Fixed-wing; and(viii) Specialized.(C) Change of Vehicle Authorization. To change an authorization to a different level, the provider must submit a request with appropriate documentation to the department verifying the provider's ability to perform at the requested level. A $30 fee is required for each new authorization requested. The provider must not operate a vehicle until authorized by the department.(D) Vehicle Authorizations are not required to be specific to particular vehicles and may be interchangeably placed in other vehicles as necessary. The original Vehicle Authorization for the appropriate level of service must be prominently displayed in the patient compartment of each vehicle.(E) Vehicle Authorizations are not transferable between providers.(F) A replacement of a lost or damaged license or authorization may be issued, if requested, with a nonrefundable fee of $10.(3) Declaration of Business Operational Name and Administration.(A) The applicant must submit a list of all business operational names under which the service is operated. If the applicant intends to operate the service under a name or names different from that on the issued license, the applicant must submit certified copies of assumed name certificates.(B) A change in the operational name in which the service is operated requires a new application and a prorated fee as determined by the department. The department will issue a new provider number.(C) Name of Administrator of Record must be declared. The applicant must submit a notarized document declaring the full name, mailing address, email address, and telephone number of the chief administrator to whom the department addresses all official communications in regard to the license.(e) Vehicle Requirements.(1) All EMS vehicles must be adequately constructed, equipped, maintained, and operated to safely and efficiently render patient care, comfort, and transportation of adult, pediatric, and neonatal patients. A pediatric and neonatal equipment list must be based on endorsed pediatric equipment national standards within the approved equipment list required by the medical director.(2) EMS vehicles must allow the proper and safe storage and use of required equipment, supplies, and medications and must allow required procedures to be carried out in a safe and effective manner.(3) As approved by the department, EMS vehicles must meet a practical, efficient minimum national ambulance vehicle body type, dimension, and safety criteria standards.(4) When in service, all vehicles must have an environmental system within the patient compartment capable of heating or cooling the patient and staff, in accordance with the manufacturer specifications and that allows for protection of medication, according to manufacturer specifications, from extreme temperatures.(A) The provider must provide evidence of an operational policy that lists the parenteral pharmaceuticals authorized by the medical director.(B) The provider must document and describe the storage of pharmaceuticals authorized by the medical director and stored in accordance with the manufacturer and U.S. Federal Drug Administration (FDA) recommendations.(C) Compliance with the policy must be incorporated into the provider's Quality Assurance process and must be documented on unit readiness reports.(5) EMS vehicles must have operational two-way communication capable of contacting appropriate medical resources and as outlined in the current Texas interoperability plan unless the vehicle is designated as being out of service with the form provided by the department.(6) EMS vehicles must comply with all applicable federal, state, and local requirements unless the vehicle is designated out of service with the form provided by the department.(7) All EMS vehicles must have the name of the provider and a current department-issued EMS provider license number prominently displayed on both sides of the vehicle in at least 2-inch lettering and in contrasting color. The license number must have the letters TX prior to the license number. This requirement does not apply to fixed or rotor wing aircraft.(f) Substitution, Replacement, and Additional EMS Vehicles.(1) The EMS provider must notify the department within five business days if the EMS provider substitutes or replaces a vehicle. No fee is required for a vehicle substitution or replacement.(2) The EMS provider must notify the department if the EMS provider adds a vehicle to the provider's operational fleet prior to making the vehicle response ready. A vehicle authorization request must be submitted with a nonrefundable vehicle fee prior to the vehicle being placed into service.(g) Staffing Plan Required.(1) The applicant must submit a completed EMS Personnel Form listing each response person assigned to staff EMS vehicles by name, certification level, and department-issued certification or license identification number.(2) An EMS provider responsible for an emergency response area unable to provide continuous coverage within the declared service areas must publish public notices in local media, to include social media, of its inability to provide continuous response capability and include the days and hours of its operation. The EMS provider must notify all public safety answering points and all dispatch centers of the days and hours when unable to provide coverage. The EMS provider must submit evidence that reasonable attempts to secure coverage from other EMS providers were made.(3) The applicant must provide proof at license initiation and renewal that all licensed or certified personnel completed a jurisprudence examination approved by the department on state and federal laws and rules affecting EMS.(h) Minimum Staffing Required.(1) BLS--When response ready or in-service, authorized EMS vehicles operating at the BLS level must be staffed at a minimum with two emergency care attendants (ECAs) or higher certified or licensed staff.(2) BLS with ALS capability--When response ready or in-service, authorized EMS vehicles operating below the ALS level must be staffed with two ECAs. Full ALS status becomes active when staffed by an advanced emergency medical technician (AEMT) and an emergency medical technician (EMT) or higher certified or licensed staff.(3) BLS with MICU capability--When response ready or in-service, authorized EMS vehicles operating below the MICU level must be staffed with two ECAs. Full MICU status becomes active when staffed by a certified or licensed paramedic and an EMT or higher certified or licensed staff.(4) ALS--When response ready or in-service, authorized EMS vehicles operating at the ALS level must be staffed with one AEMT and one EMT or higher certified or licensed staff.(5) ALS with MICU capability--When response ready or in-service, authorized EMS vehicles operating below the MICU level must be staffed with one AEMT and one EMT. Full MICU status becomes active when staffed by a certified or licensed paramedic and an EMT or higher certified or licensed staff.(6) MICU--When response ready or in-service, authorized EMS vehicles operating at the MICU level must be staffed at a minimum with one certified or licensed paramedic and one EMT or higher certified or licensed staff.(7) Specialized--When response ready or in-service, EMS vehicles authorized to operate for a specialized purpose must be staffed with a minimum of two personnel appropriately licensed or certified as determined by the type and application of the specialized purpose and as approved by the medical director and the department.(8) For air ambulance staffing requirements refer to §157.12(f) of this subchapter (relating to Rotor-wing Air Ambulance Operations) or §157.13(g) of this subchapter (relating to Fixed-wing Air Ambulance Operations).(9) When response ready or in-service, authorized EMS vehicles may operate at a lower level than licensed by the department. When operating at the BLS level with an ALS MICU ambulance, the EMS provider must have an approved security plan for the ALS MICU medication as approved by the EMS provider medical director's protocol and policy.(10) As justified by patient needs, providers may utilize appropriately certified or licensed medical personnel in addition to those required by the designation levels. In addition to the care rendered by the required staff, the provider must be accountable for care rendered by any additional personnel.(i) Treatment and Transport Protocols Required. The protocols must include:(1) written policies related to patient care and delegated standing orders for patient treatment and transport, approved and signed by the provider's medical director;(2) an effective date;(3) the use of non-EMS certified or licensed medical personnel who, in addition to the EMS staff, may provide patient care on behalf of the provider or in the provider's EMS vehicles;(4) the use of all required, additional, or specialized medical equipment, supplies, and pharmaceuticals carried on each EMS vehicle in the provider's fleet;(5) identified delegated procedures for each EMS certification or license level utilized by the provider; and(6) the EMS medical director's approved protocols to be followed by on-duty EMS personnel within the EMS provider's geographical location, unless otherwise specified.(j) EMS Equipment, Supplies, Medical Devices, Parenteral Solutions, and Pharmaceuticals.(1) The EMS provider must submit a list, approved and signed by the medical director and fully supportive of and consistent with the treatment and transport protocols, of all medical equipment, supplies, medical devices, parenteral solutions, and pharmaceuticals to be carried. The list must specify the quantities of each item to be carried and the sizes and types of each item necessary to provide appropriate care for all age ranges appropriate to the needs of patients. The quantities listed must be appropriate to the provider's call volume, transport times, and restocking capabilities.(2) All patient care equipment and medical devices must be operational, appropriately secured in the vehicle at the time of providing patient care, and response ready. Supplies must be clean and fully operational. All patient care powered equipment must have a manual mechanical feature, spare batteries, or an alternative power source.(3) All solutions and pharmaceuticals must be up to date and be stored and maintained in accordance with the manufacturer's and U.S. FDA recommendations.(4) The requirements for air ambulance equipment and supplies are listed in §157.12(h) and §157.13(h) of this subchapter.(k) The following equipment must be present on each in-service EMS vehicle and on, or immediately available for, each response ready vehicle as required by the medical director's approved equipment list to include all state-required equipment. The equipment list must include equipment required for treatment and transport of adult, pediatric, and neonatal patients.(1) Basic Life Support (BLS):(A) equipment required to administer the BLS scope of practice and incorporate the knowledge, competencies, and basic skills of an EMT or ECA and additional skills as authorized by the EMS provider medical director; all BLS ambulances must be able to transport patients and perform the following treatments:(i) airway, ventilation, oxygenation;(ii) cardiovascular circulation;(iii) immobilization;(iv) medication administration - routes; and(v) single and multi-system trauma patients;(B) oropharyngeal airways;(C) portable and vehicle mounted suction;(D) bag valve mask units, oxygen capable;(E) portable and vehicle mounted oxygen;(F) oxygen delivery devices;(G) dressing and bandaging materials;(H) commercial tourniquet;(I) rigid cervical immobilization devices;(J) spinal immobilization devices;(K) extremity splints;(L) equipment to meet special patient needs;(M) equipment for determining and monitoring patient vital signs, condition or response to treatment;(N) pharmaceuticals, as required by the medical director protocols;(O) an external cardiac defibrillator appropriate to the staffing level with two sets of adult and two sets of pediatric pads;(P) a patient-transport device capable of being secured to the vehicle; the patient must be fully restrained per manufacturer recommendations; and(Q) an epinephrine auto injector or similar device capable of treating anaphylaxis.(2) Advanced Life Support (ALS):(A) equipment required to administer the ALS scope of practice and incorporate the knowledge, competencies, and basic and advanced skills of an AEMT and additional skills as authorized by the EMS provider medical director; all ALS ambulances must be able to transport patients and perform the following treatments:(i) airway, ventilation, oxygenation;(ii) cardiovascular circulation;(iii) immobilization;(iv) medication administration - routes;(v) intravenous (IV) initiation and maintenance of fluids; and(vi) single and multi-system trauma patients;(B) all required BLS equipment; and(C) advanced airway equipment.(3) Mobile Intensive Care Unit (MICU):(A) equipment required to administer the knowledge, competencies, and advanced skills of a paramedic, and additional skills as authorized by the EMS provider medical director; all MICU ambulances must be able to transport patients and perform the following treatments:(i) airway, ventilation, oxygenation;(ii) cardiovascular circulation;(iii) immobilization;(iv) medication administration - routes;(v) IV initiation and maintenance of fluids;(B) all required BLS and ALS equipment;(C) transmitting 12-lead capability cardiac monitor-defibrillator; and(D) pharmaceuticals as required by medical director protocols.(4) BLS with ALS Capability:(A) all required BLS equipment, even when in-service or response ready at the ALS level; and(B) all required ALS equipment, when in-service or response ready at the ALS level.(5) BLS with MICU Capability:(A) all required BLS equipment, even when in-service or response ready at the MICU level; and(B) all required MICU equipment, when in-service or response ready at the MICU level.(6) ALS with MICU Capability:(A) all required ALS equipment, even when in-service or response ready at the MICU level; and(B) all MICU equipment, when in-service or response ready at the MICU level.(7) Wave form capnography or carbon dioxide detection equipment must be used when performing or monitoring endotracheal intubation.(8) In addition to medical supplies and equipment as defined in this subsection, EMS vehicles must also have:(A) a complete and current copy of written or electronic formatted protocols approved and signed by the medical director, with a current and complete equipment, supply, and medication list available to the crew;(B) operable emergency warning devices;(C) personal protective equipment for the EMS vehicle staff, including at least:(i) protective, non-porous gloves;(ii) medical eye protection;(iii) medical respiratory protection available per crew member, meeting National Institute for Occupational Safety and Health (NIOSH)-approved N95 or greater standards;(iv) medical protective gowns or equivalent; and(v) personal cleansing supplies;(D) sharps container;(E) biohazard bags;(F) portable, battery-powered flashlight (not a pen-light);(G) a mounted, currently inspected, 5-pound ABC fire extinguisher (not applicable to air ambulances);(H) "No Smoking" signs posted in the patient compartment and cab of vehicle;(I) a current emergency response guidebook, or an electronic version that is available to the crew (for hazardous materials); and(J) 25 triage tags, or participation in the RAC triage plan.(9) As justified by specific patient needs, and when qualified personnel are available, EMS providers may appropriately utilize equipment in addition to what is required by the authorization levels. Such equipment must be consistent with protocols and patient-specific orders and must correspond to personnel qualifications.(l) National Accreditation. If a provider has been accredited through a national accrediting organization approved by the department and adheres to Texas staffing level requirements, the department may exempt the provider from portions of the license process. In addition to other licensing requirements, accredited providers must submit:(1) an accreditation self-study;(2) a copy of the formal accreditation certificate; and(3) any correspondence or updates to or from the accrediting organization that impact the provider's status.(m) Subscription or Membership Services. An EMS provider that operates or intends to operate a subscription or membership program for the provision of EMS within the provider's service area must meet all the requirements for an EMS provider license as established by, and rules adopted under, Texas Health and Safety Code Chapter 773. An EMS provider must obtain department approval prior to soliciting, advertising, or collecting subscription or membership fees. To obtain department approval for a subscription or membership program, the EMS provider must complete the following.(1) Obtain written authorization from the highest elected official (county judge or mayor) of the political subdivision where subscriptions will be sold. Written authorization must be obtained from each county judge if subscriptions are to be sold in multiple counties.(A) The county judge must provide written authorization if subscriptions are to be sold throughout a county.(B) The mayor may provide written authorization if subscriptions are sold exclusively within the boundaries of an incorporated town or city.(C) If an EMS provider is not the primary emergency provider in any area where they are going to sell a subscription plan, written notification must be provided to the participants receiving a subscription plan stating the EMS provider is not the primary emergency provider in that area. A copy of this documentation must be provided to the primary emergency provider and the department within 30 days before the beginning of any enrollment period.(2) Submit a copy of the contract used to enroll participants.(3) Maintain a current file of all advertising for the service and submit a copy of all advertising used to promote the subscription service within 30 days before the beginning of any enrollment period.(4) Comply with all state and federal regulations regarding billing and reimbursement for participants in the subscription service.(5) Provide evidence of financial responsibility by:(A) obtaining a surety bond payable to the department in an amount equal to the funds to be subscribed. The surety bond must be on a department bond form and be issued by a company licensed by or eligible to do business in the State of Texas; or(B) submitting satisfactory evidence of self-insurance in an amount equal to the funds to be subscribed if the provider is a function of a governmental entity.(6) Not deny emergency medical services to non-subscribers or subscribers of non-current status.(7) Be reviewed at least every year. The subscription program may be reviewed by the department at any time.(8) Furnish a list after each enrollment period with the names, addresses, dates of enrollment of each subscriber, and subscription fee paid by each subscriber.(9) Furnish the department beginning and ending dates of enrollment periods. Subscription service period must not exceed one year. Subscribers must not be charged more than a prorated fee for the remaining subscription service period.(10) Furnish the department with the total amount of funds collected each year.(11) Not offer membership nor accept members into the program who are Medicaid clients.(n) Responsibilities of the EMS Provider. During the license period, the EMS provider's responsibilities must include:(1) assuring all response ready and in-service vehicles are available 24 hours a day and seven days a week, maintained, operated, equipped, and staffed in accordance with the requirements of the provider's license, to include staffing, equipment, supplies, required insurance, and additional requirements per the current EMS provider's medical director-approved protocols and policies;(2) developing, implementing, maintaining, and evaluating an effective, ongoing, system-wide, data-driven, interdisciplinary quality assessment and performance improvement program, that must be individualized to the provider and include:(A) the standard of patient care as directed by medical director protocols and medical director input into the provider's policies and standard operating procedures;(B) a complaint management system;(C) monitoring the quality of patient care provided by the personnel and taking appropriate and immediate corrective action to ensure quality of care is maintained in accordance with the existing standards of care and the medical director signed, approved protocols; and(D) an ongoing program that achieves measurable improvement in patient care outcomes and reduction of medical errors;(3) providing an attestation or documentation its management staff will begin or continue to participate in the local RAC;(4) when an air ambulance is initiated through any other method than the local 9-1-1 system, requiring the air service providing the air ambulance to notify the local 9-1-1 center or the appropriate local response of the location of the response at time of launch; this would not include interfacility transports or scheduled transports;(5) ensuring all personnel are currently certified or licensed by the department;(6) assuring all personnel, when on an in-service vehicle or when on the scene of an emergency, are prominently identified by the last name and the first initial of the first name, the certification or license level, and the EMS provider's name; a provider may utilize an alternative identification system in incident-specific situations that pose a potential for danger if the individuals are identified by name;(7) assuring the confidentiality of patient information in compliance with federal and state laws;(8) assuring Informed Treatment or Transport Refusal forms are signed by all persons refusing service, or documenting incidents when a signed Informed Treatment or Transport Refusal form cannot be obtained;(9) assuring patient care reports are completed accurately and meet standards as outlined in 25 TAC Chapter 103;(10) assuring patient care reports are provided to facilities receiving the patient:(A) whenever operationally feasible, the report must be provided to the receiving facility at the time the patient is delivered, or a full written or computer-generated report delivered to the facility within 24 hours of the delivery of the patient;(B) if in a response-pending status, an abbreviated documented report must be provided at the time the patient is delivered and a completed written or computer-generated report delivered to the facility within 24 hours of the delivery of the patient;(C) the abbreviated report must document the patient's name and condition upon arrival at the scene; the prehospital care provided; the patient's condition during transport, including signs, symptoms, and responses to treatment during the transport; the call initiation time; dispatch time; scene arrival time; scene departure time; hospital arrival time; and the identification of the ambulance staff; and(D) in lieu of subparagraph (C) of this paragraph, personnel may follow the RAC process for providing abbreviated documentation to the receiving facility;(11) assuring all pharmaceuticals are stored according to conditions specified in the pharmaceutical storage policy approved by the EMS provider's medical director;(12) assuring staff completes a readiness inspection as written by the EMS provider's policy;(13) assuring there is a preventive maintenance plan for vehicles and equipment;(14) assuring staff has reviewed policies and procedures as approved by the EMS provider and the EMS provider medical director;(15) maintaining medical reports:(A) a licensed EMS provider must maintain adequate medical reports of a patient for a minimum of seven years from the anniversary date of the date of last treatment by the EMS provider;(B) if a patient was younger than 18 years of age when last treated by the provider, the medical reports of the patient must be maintained by the EMS provider until the patient reaches age 21 years or for seven years from the date of last treatment, whichever is longer;(C) an EMS provider may destroy medical records that relate to any civil, criminal, or administrative proceeding only if the provider knows the proceeding has been finally resolved;(D) EMS providers must retain medical records for a longer length of time when mandated by other federal or state statute or regulation;(E) EMS providers may transfer ownership of records to another licensed EMS provider only if the EMS provider, in writing, assumes ownership of the records and maintains the records consistent with this chapter;(F) destruction of medical records must be done in a manner that ensures continued confidentiality;(G) at the time of initial licensing and at each license renewal, the EMS provider and medical director must attest or provide documentation to the department, a plan for going out of business, selling, or transferring the business to ensure the proper maintenance of medical records as outlined in subparagraph (E) of this paragraph; and(H) the EMS provider must maintain all patient care records in the physical location that is the provider's primary place of business, unless the department approves an alternate location;(16) assuring all requested patient records are made promptly available to the medical director, hospital, or department;(17) assuring current protocols, equipment, supply and medication lists, and the correct original vehicle authorization at the appropriate level, are maintained on each response ready vehicle;(18) monitoring and enforcing compliance with all policies and protocols;(19) assuring provisions for the appropriate disposal of medical or biohazardous waste materials;(20) assuring ongoing compliance with the terms of first responder agreements;(21) assuring that all documents, reports, or information provided to the department and hospital are current, accurate, and complete;(22) assuring compliance with all federal and state laws and regulations and all local ordinances, policies, and codes, at all times;(23) assuring all response data required by the department are submitted in accordance with §103.5 of this title (relating to Reporting Requirements for EMS Providers);(24) assuring, whenever there is a change in the EMS provider's name or the service's operational assumed name, the printed name on the vehicles is changed accordingly within 30 days of the change;(25) assuring the department is notified within 30 business days whenever:(A) a vehicle is sold, substituted, or replaced;(B) there is a change in the level of service;(C) there is a change in the declared service area as written on an initial or renewal application;(D) there is a change in the official business mailing address;(E) there is a change in the physical location of the business or substations;(F) there is a change in the physical location of patient report file storage, to assure the department has access to these records at all times; or(G) there is a change of the administrator of record;(26) assuring the department is notified within one business day when there is a change of the medical director;(27) developing, implementing, and enforcing written operating policies and procedures required under this chapter or adopted by the licensee, assuring each employee (including volunteers) is provided a copy upon employment and whenever such policies or procedures are changed; a copy of the written operating policies and procedures must be made available to the department on request, and policies at a minimum must adequately address:(A) personal protective equipment;(B) immunizations available to staff;(C) infection control procedures;(D) management of possible exposure to communicable disease;(E) emergency vehicle operation;(F) contact information for the designated infection control officer for whom education based on U.S. Code Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136 has been documented;(G) credentialing of new response personnel before being assigned primary care responsibilities, which must include at a minimum:(i) a comprehensive orientation session of the services, policies, procedures, treatment and transport protocols, safety precautions, and the quality management process; and(ii) an internship period in which all new personnel practice under the supervision of, and are evaluated by, another more experienced person;(H) appropriate documentation of patient care;(I) vehicle checks, equipment, and readiness inspections; and(J) the security of medications, fluids, and controlled substances in compliance with local, state, and federal laws or rules;(28) assuring manufacturers' operating instructions for all critical patient care electronic and technical equipment utilized by the provider are available for all response personnel;(29) assuring the department is notified within five business days of a collision involving an in-service or response ready EMS vehicle that results in vehicle damage whenever:(A) the vehicle is rendered disabled and inoperable at the scene of the occurrence; or(B) there is a patient on board;(30) assuring the department is notified within one business day of a collision involving an in-service or response ready EMS vehicle that results in vehicle damage whenever there is personal injury or death to any person;(31) maintaining motor vehicle liability insurance as required under the Texas Transportation Code;(32) ensuring continuous coverage for the service area defined in documents submitted with the EMS provider application;(33) responding to requests for assistance from the highest elected official of a political subdivision or from the department during a declared emergency or mass casualty situation according to national, state, regional, or local plans, when authorized;(34) providing written notice to the department, RAC, and Emergency Medical Task Force, if the EMS provider will make staff and equipment available during a declared emergency or mass casualty situation, for a state or national mission, when authorized;(35) assuring all EMS personnel receive continuing education on the provider's anaphylaxis treatment protocols, and the provider must maintain education and training records to include date, time, and location of such education or training for all its EMS personnel;(36) immediately notifying the department in writing when operations cease in any service area;(37) assuring all patients transported by stretcher are in a department-authorized EMS vehicle; and(38) developing or adopting and then implementing policies, procedures, and protocols necessary for its operations as an EMS provider, and enforcing all such policies, procedures, and protocols.(o) License Renewal Process.(1) The provider is responsible for requesting license renewal application information.(2) EMS providers must submit a completed application, all other required documentation, and a nonrefundable license renewal fee, no later than 90 calendar days prior to the expiration date of the current license.(A) If a complete renewal application is received by the department 90 or more calendar days prior to the expiration date of the current license, the applicant must submit a nonrefundable application fee of $400 per provider plus $180 for each EMS vehicle.(B) If a complete renewal application is received by the department 60 or more days, but less than 90 calendar days, prior to the expiration date of the current license, the applicant must submit a nonrefundable application fee of $450 per provider plus $180 for each EMS vehicle.(C) If a complete renewal application is received by the department less than 60 days prior to the expiration of the current license, the applicant must submit a nonrefundable application fee of $500 per provider plus $180 for each EMS vehicle.(D) If the application for renewal is received by the department after the expiration date of the current license, that license expires on its expiration date. The EMS provider will be required to file a new initial application and follow the initial application process.(E) An EMS provider may not operate after its license has expired.(p) Provisional License. The department may issue an EMS provisional license if an urgent need exists in a service area when the department finds the applicant is in substantial compliance with the provisions of this section and if the public interest would be served. A provisional license is effective for no more than 30 days from the date of issuance.(1) An EMS provider may apply for a provisional license by submitting a written request and a nonrefundable fee of $30.(2) A provisional license issued by the department may be revoked at any time by the department, with written notice to the provider, when the department finds the provider is failing to provide appropriate service in accordance with this section or the provider is in violation of any of the requirements of this chapter.(q) Advertisements.(1) Any advertising by an EMS provider must not be misleading, false, or deceptive. When an EMS provider advertises in Texas or conducts business in Texas by regularly transporting patients from or within Texas, the provider is required to have a Texas EMS provider license.(2) An EMS provider must not advertise levels of patient care that it cannot provide at all times. The provider must not use a name, logo, artwork, phrase, or language that could mislead the public to believe a higher level of care is being provided.(3) An EMS provider that has more than five paid staff, but is composed of at least 75 percent volunteer EMS personnel, may advertise as a volunteer service.(r) Surveys, Inspections, and Investigations.(1) The department may conduct scheduled or unannounced on-site inspection or investigation of a provider's vehicles, offices, headquarters, and stations (hereinafter operations), at any reasonable time, including while services are being provided, to ensure compliance with Texas Health and Safety Code Chapter 773 and this chapter.(2) An applicant or licensee, by applying for or holding a license, consents to entry and inspection or investigation of any of its operations by the department, as provided for by Texas Health and Safety Code Chapter 773 and this chapter.(3) Department inspections or investigations to evaluate an EMS provider's compliance with the requirements of Texas Health and Safety Code Chapter 773 and this chapter, may include:(A) initial, prelicensure, and change in status inspections for the issuance of a new license;(B) routine inspection conducted at the department's discretion or prior to renewal;(C) follow-up on-site inspection, conducted to evaluate implementation of a plan of correction for deficiencies cited during a department investigation or inspection;(D) a complaint investigation, conducted in response to a report or complaint, as described in subsection (u) of this section, relating to complaint investigations; and(E) an inspection to determine if a person, company, or organization is offering or providing EMS service without a license, or to determine if EMS vehicles are being staffed by persons who do not hold Texas EMS certification or license.(4) The provider and medical director must cooperate with any department investigation or inspection, and must, consistent with applicable law, permit the department to examine the provider's grounds, buildings, books, records, and other documents and information maintained by or on behalf of the provider, that are necessary to evaluate compliance with applicable statutes, rules, plans of correction, and orders with which the EMS provider is required to comply. The EMS provider must permit the department, consistent with applicable law, to interview members of the governing authority, personnel, and patients.(5) The EMS provider must, consistent with applicable law, permit the department to copy or reproduce, or must provide photocopies to the department of any requested records or documents. If it is necessary for the department to remove records or other information (other than photocopies) from the provider's premises, the department will provide the EMS provider's governing authority or designee with a written statement of this fact, describing the information being removed and when it is expected to be returned. The department will make a reasonable effort, consistent with the circumstances, to return the records the same day.(6) The department holds an entrance conference with the EMS provider, governing authority, or designee before beginning the inspection or investigation, to explain, consistent with applicable law, the nature, scope, and estimated time schedule of the inspection or investigation.(7) Except for a complaint investigation or a follow-up visit, an inspection includes an evaluation of compliance with Texas Health and Safety Code Chapter 773 and the rules of this chapter. During the inspection, the department representative, unless otherwise provided for by law, informs the EMS provider's governing authority or designee of the preliminary findings and gives the provider a reasonable opportunity to submit additional facts or other information to the department representative in response to those findings.(8) When the inspection is complete, the department holds an exit conference with the provider, unless otherwise provided for by law, to inform the provider, to the extent permitted by law, of any preliminary findings of the inspection or investigation and gives the EMS provider the opportunity to provide additional information regarding the deficiencies cited. If no deficiencies are identified at the time of inspection, a statement indicating this fact may be left with the EMS provider's governing authority or designee. Such a statement does not constitute a department finding or certification the facility is in compliance.(9) If deficiencies are cited, the department provides the EMS provider's administrator of record and medical director with a written deficiency report no more than 30 calendar days after the exit conference.(A) The EMS provider's governing authority, designee, or person in charge at the time must sign an acknowledgement of the inspection and receipt of the written deficiency report and return it to the department. The signature does not indicate the EMS provider's agreement with, or admission to, the cited deficiencies unless the agreement or admission is explicitly stated.(B) No later than 30 calendar days after the EMS provider's receipt of the deficiency report, the EMS provider must return a written plan of correction to the department for each deficiency, including time frames for implementation, together with any additional evidence of compliance the EMS provider may have, regarding any cited deficiency. The department determines if the written plan of correction and proposed time frames for implementation are acceptable. If the plan is not acceptable, the department notifies the provider in writing no later than 30 days after receipt and requests a modified plan. The EMS provider must modify and resubmit the plan of correction no later than 30 calendar days after the EMS provider's receipt of the request. The EMS provider must correct the identified deficiencies and submit documentation to the department verifying completion of the corrective action within the time frames set forth in the plan of correction accepted by the department, or as otherwise specified by the department. The provider will be deemed to have received the deficiency report or other department correspondence mailed under this subparagraph once the department receives delivery notification from the postal service.(C) Regardless of the EMS provider's compliance with this subsection, the department's acceptance of the provider's plan of correction, or the provider's utilization of an informal compliance group review under paragraph (10) of this subsection, the department may, at any time, propose to take action as appropriate under §157.16 of this subchapter (relating to Emergency Suspension, Suspension, Probation, Revocation, Denial of a Provider License or Administrative Penalties).(10) The department inspector informs the provider's chief executive officer, designee, or person in charge at the time of the inspection, of the provider's right to an informal compliance group review. This review is available when there is disagreement with deficiencies cited by the inspector or investigator, which the provider was unable to resolve through submission of information to the inspector or additional information bearing on the deficiencies cited.(11) The department refers issues and complaints relating to the conduct or actions by licensed professionals to the appropriate licensing boards.(12) All initial applicants and the medical director must have an initial compliance survey by the department that evaluates all aspects of the applicant's proposed operations, including clinical care components and an inspection of all vehicles prior to the issuance of a license.(13) At renewal, randomly, or in response to a complaint, the department may conduct an unannounced compliance survey that includes inspection of a provider's vehicles, operations, or records to ensure compliance with this title at any time, including nights or weekends.(14) If a re-survey or inspection to ensure correction of a deficiency is conducted, the provider must pay a nonrefundable fee of $30 per vehicle needing a re-inspection.(s) Specialty Care Transports. A Specialty Care Transport is defined as the interfacility transfer by a department-licensed EMS provider of a critically ill or injured patient requiring specialized interventions, monitoring, or staffing. To qualify to function as a Specialty Care Transport the following minimum criteria must be met.(1) Qualifying Interventions:(A) patients with one or more of the following IV infusions: vasopressors; vasoactive compounds; antiarrhythmics; fibrinolytics; tocolytics; blood; blood products; or any other parenteral pharmaceutical unique to the patient's special health care needs; and(B) one or more of the following special monitors or procedures: mechanical ventilation; multiple monitors; cardiac balloon pump; external cardiac support (ventricular assist devices, etc.); and any other specialized device, vehicle, or procedure unique to the patient's health care needs.(2) Equipment. All specialized equipment and supplies appropriate to the required interventions must be available at the time of the transport.(3) Minimum Required Staffing.(A) One currently certified EMT-Basic and one currently certified or licensed paramedic with the additional training as defined in paragraph (4) of this subsection; or(B) a currently certified EMT-Basic and a currently certified or licensed paramedic accompanied by at least one of the following:(i) a registered nurse with special knowledge of the patient's care needs;(ii) a certified respiratory therapist;(iii) a licensed physician; or(iv) any other licensed health care professional designated by the transferring physician.(4) Additional Required Education and Training for Certified or Licensed Paramedics:(A) evidence of successful completion of post-paramedic education;(B) training and periodic skills verification in management of patients on ventilators;(C) training and periodic skills verification in 12 lead Electrocardiography (EKG) or other critical care monitoring devices;(D) training and periodic skill verification in drug infusion pumps, and cardiac or other critical care medications; and(E) training in any other specialized procedures or devices determined at the discretion of the EMS provider's medical director.(t) For all initial applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by Texas Government Code Section 2054.252 (relating to State Electronic Internet Portal Project), to recover costs associated with the initial application and renewal application processing.(u) Complaint Investigations.(1) Upon request, all licensed EMS providers must make available for a patient or legal guardian a written statement, supplied by the department, identifying the department as the responsible agency for conducting EMS provider and EMS personnel complaint investigations. The statement must inform persons they may direct a complaint to the Department of State Health Services, EMS Compliance Unit, by phone, or by email. The statement must provide the most current contact information, including the appropriate department group, address, local and toll-free telephone number, and email address for filing a complaint.(2) The department evaluates all complaints made against EMS providers or EMS personnel. Any complaint submitted to the department must be submitted by telephone, electronically, or in writing, using the department's current contact information for that purpose, as described in paragraph (1) of this subsection.(3) The department documents, evaluates, and prioritizes complaints and information received, based on the seriousness of the alleged violation and the level of risk to patients, personnel, and the public.(A) Allegations within the department's regulatory jurisdiction relating to emergency medical services are authorized for investigation under this chapter. Complaints received that are outside the department's jurisdiction may be referred to another appropriate agency for response.(B) The investigation is conducted on-site, by telephone, and through written correspondence.(4) The department conducts a prompt and thorough investigation of all reports or complaint allegations that may pose a threat of harm to the health and safety of patients or participants. Reports or complaints received by the department concerning alleged abuse, neglect, and exploitation will be addressed in accordance with Texas Human Resources Code Chapter 48 and Texas Family Code §261.101.(5) The department evaluates complaint allegations that do not pose a significant risk of harm to patients. Based on the nature and severity of the alleged incident, the department determines whether to investigate the complaint directly or to require the provider to conduct an internal investigation and submit its findings and supporting evidence to the department.(A) The department reviews findings of an EMS provider's internal investigation and may perform an additional investigation by the department. The department may request a plan of correction be completed by the provider in accordance with subsection (r) of this section (relating to inspections and investigations), and a proposal to take action against the provider under §157.16 of this subchapter.(B) The EMS provider under investigation must provide department staff access to all documents, evidence, and individuals related to the alleged violation, including all evidence and documentation relating to any internal investigations.(6) Once an internal EMS provider investigation or department investigation is complete, the department reviews the evidence from the investigation to evaluate whether the evidence substantiates the complaint and what corrective action, if any, is needed. Source Note: The provisions of this §157.11 adopted to be effective August 17, 2008, 33 TexReg 6395; amended to be effective August 10, 2014, 39 TexReg 5951; amended to be effective February 12, 2017, 42 TexReg 430; amended to be effective September 13, 2022, 47 TexReg 5484; amended to be effective February 10, 2025, 50 TexReg 771. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE B EMERGENCY MEDICAL SERVICES PROVIDER LICENSES §157.11 Requirements for an Emergency Medical Services (EMS) Provider License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182740&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182740 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182740&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182740 03/11/2026 (a) Rotary wing aircraft (helicopters) operated by a licensed emergency medical services (EMS) provider shall be at the mobile intensive care level. Persons or entities operating rotary wing air ambulances must direct and control the integrated activities of both the medical and aviation components. Although the aircraft operator is directly responsible to the Federal Aviation Administration (FAA) for the operation of the aircraft, typically the organization in charge of the medical functions directs the combined efforts of the aviation and medical components during patient transport operations. Licensed rotary wing aircraft must also meet the requirements of §157.11 of this title (relating to Requirements for an EMS Provider License) as long as the Airline Deregulation Act of 1978, 49 U.S.C. §41713 (b)(1) et seq. is not violated.(b) When being used as an ambulance, the helicopter shall:(1) be configured so that the medical personnel have adequate access to the patient in order to begin and maintain basic and advanced life support treatment;(2) have an entry that allows loading and unloading of a patient without excessive maneuvering (no more than 45 degrees about the lateral axis and 30 degrees about the longitudinal axis); and does not compromise functioning of monitoring systems, intravenous (IV) lines, or manual or mechanical ventilation;(3) have a supplemental lighting system in the event standard lighting is insufficient for patient care that includes:(A) a self-contained lighting system powered by a battery pack or a portable light with a battery source; and(B) a means to protect the pilot's night adaptation vision. (Use of red lighting or low intensity lighting in the patient care area is acceptable if not able to isolate the patient care area);(4) have an electric power outlet with an inverter or appropriate power source of sufficient output to meet the requirements of the complete specialized equipment package without compromising the operation of any electrical aircraft equipment;(5) have protection of the pilot's flight controls, throttles and radios from any intended or accidental interference by the patient, air medical personnel or equipment and supplies; and(6) have an internal medical configuration located so that air medical personnel can provide patient care consistent with the scope of care of the air medical service, to include:(A) the space necessary to ensure the patient's airway is maintained and to provide adequate ventilatory support from the secured, seat-belted position of the air medical personnel;(B) those aircraft with gaseous oxygen systems have equipment installed so that medical personnel can determine if oxygen is on by in-line pressure gauges mounted in the patient care area. Aircraft using liquid or gaseous oxygen should have equipment installed:(i) with each gas outlet clearly marked for identification;(ii) with oxygen flow capable of being stopped at the oxygen source from inside the aircraft; and(iii) so that the measurement of the liter flow and quantity of oxygen remaining is accessible to air medical personnel while in flight. All flow meters and outlets must be padded, flush mounted, or so located as to prevent injury to air medical personnel; or there shall be an operational policy stating that attendants wear helmets;(C) hangers/hooks available to secure (IV) solutions in place or a mechanism to provide high flow fluids if needed:(i) all IV hooks shall be padded, flush mounted, or so located as to prevent head trauma to the air medical personnel in the event of a hard landing or emergency with the aircraft; or an operational policy stating that attendants wear helmets; and(ii) glass containers shall not be used unless required by medication specifications and properly vented;(D) provision for medication which allows for protection from extreme temperatures if it becomes environmentally necessary;(E) secure positioning of cardiac monitors, defibrillators, and external pacers so that displays are visible to medical personnel; and(F) shall assure that all specialized medical equipment is secured throughout transport with adequately engineered designated mounts as approved by FAA.(c) An air ambulance provider shall meet the responsibilities of EMS providers as in §157.11 of this title (relating to Requirements for an EMS Provider License) and in addition shall:(1) submit proof that the rotor-wing aircraft provider carries bodily injury and property damage insurance with a company licensed to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the operation or use of any of the certificate holder's aircraft.(2) submit proof that the air ambulance provider carries professional liability insurance coverage in the minimum amount of $500,000 per occurrence, with a company licensed to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the care or lack of care of a patient;(3) submit a list of all aircraft with the registration number or "N" number for the helicopters in the possession of the provider.(4) submit a letter of agreement that all helicopters shall meet the specifications of subsection (b) of this section, if the aircraft is leased from a pool;(5) allow visual and physical inspection of each aircraft and of the equipment to be used on each vehicle for the purpose of determining compliance with the vehicle and equipment specifications within this section; and(6) submit a copy of current Federal Aviation Administration (FAA) carrier, operational, and airworthiness certification, as per U.S, Code of Federal Regulations, Title 14, Subchapter G, Part 135).(d) The air ambulance provider shall employ a medical director who shall meet the following qualifications:(1) be a physician approved by the department and in practice;(2) have knowledge and experience consistent with the transport of patients by air;(3) be knowledgeable in aeromedical physiology, stresses of flight, aircraft safety, patient care, and resource limitations of the aircraft, medical staff and equipment;(4) have access to consult with medical specialists for patient(s) whose illness and care needs are outside the medical director's area of practice;(5) shall comply with the requirements in the Medical Practice Act, Occupations Code, Chapters 151 - 168, and 22 Texas Administrative Code, Chapter 197; and(6) have knowledge on Texas EMS laws and regulations affecting local, regional and state operations.(e) The physician shall fulfill the following responsibilities:(1) ensure that there is a comprehensive plan/policy to address selection of appropriate aircraft, staffing and equipment;(2) be involved in the selection, hiring, educating, training and continuing education of all medical personnel;(3) be responsible for overseeing the development and maintenance of a continuous quality improvement program;(4) ensure that there is a plan to provide direction of patient care to the air medical personnel during transport. The system shall include on-line (radio/telephone) medical control, and/or an appropriate system for off-line medical control such as written guidelines, protocols, procedures, patient specific written orders or standing orders;(5) participate in any administrative decision making processes that affect patient care;(6) ensure that there is an adequate method for on-line medical control, and that there is a defined plan or procedure and resources in place to allow off-line medical control;(7) oversee the review, revision and validation of written medical policies and protocols annually for the treatment and transportation of adult, pediatric, and neonatal patients; and(8) attest to the following capabilities:(A) experience consistent with the transport of patients by air;(B) knowledge of aeromedical physiology, stresses of flight, aircraft safety, resources limitations of the aircraft;(C) knowledge on Texas EMS laws and regulations affecting local, regional and state operations; and(D) awareness that the EMS provider has provided safety education for ground emergency services personnel.(f) There shall be two Texas licensed/certified personnel on board the helicopter when in service. A waiver to the Texas license/certification may be granted for personnel employed by providers in New Mexico, Oklahoma, Arkansas, Kansas, Colorado and Louisiana who respond in Texas and are licensed in their respective state. Staffing of vehicles shall be as follows:(1) when responding to an emergency scene, at least one of the personnel shall be a paramedic;(2) when responding for an inter-facility transfer, at least one of the personnel performing patient care duties shall be a certified or licensed paramedic, registered nurse or physician. The qualifications and numbers of air medical personnel shall be appropriate to patient care needs;(3) when responding as in paragraphs (1) and (2) of this subsection, the second person may be a certified or licensed paramedic, registered nurse, or a physician; and(4) air medical personnel shall not be assigned or assume the cockpit duties of the flight crew members concurrent with patient care duties and responsibilities.(g) Documentation of successful completion of education specific to the helicopter transport environment in general and the licensee's operation specifically shall be required. The curriculum shall be consistent with the Department of Transportation (DOT) Air Medical Crew - National EMS Education Standards or equivalent program and each attendant's qualifications shall be documented.(h) Medical supplies and equipment shall be consistent with the service's scope of care as defined in the protocols/standing orders for adult, pediatric, and neonatal patients. Medical equipment shall be functional without interfering with the avionics nor should avionics interfere with the function of the medical equipment. Additionally, the following equipment, clean and in working order, must be on the aircraft or immediately available for all providers:(1) one or more stretchers capable of being secured in the aircraft which meet the following criteria:(A) can accommodate an adult, 6 feet tall, weighing 212 pounds. There shall be restraining devices or additional appliances available to provide adequate restraint of all patients including those under 60 pounds or 36 inches in height;(B) shall have the head of the primary stretcher, with recommended manufacturer's or FAA approved restraint system in place, capable of being elevated up to 30 degrees. The elevating section shall not interfere with or require that the patient or stretcher securing straps and hardware be removed or loosened;(C) shall be sturdy and rigid enough that it can support cardiopulmonary resuscitation. If a backboard or equivalent device is required to achieve this, such device will be readily available;(D) shall have a pad or mattress impervious to moisture and easily cleaned and disinfected according to Occupational Safety and Health Administration (OSHA) bloodborne pathogen requirements; and(E) shall have a supply of linen for each patient;(2) adequate amounts of oxygen and masks (for anticipated liter flow and length of flight with an emergency reserve) available for every mission;(3) one portable oxygen tank;(4) a back-up source of oxygen (of sufficient quantity to get safely to a facility for replacements). A back-up source may be the required portable tank if the tank is accessible in the patient care area during flight;(5) airway adjuncts as follows:(A) oropharyngeal airways in at least five assorted sizes, including for adult, pediatric, and neonatal patients; and(B) nasopharyngeal airways in at least three sizes with water soluble lubricant;(6) at least one suction unit which is portable (bulb syringes or foot pump is not acceptable);(7) the following items in amounts and sizes as specified on a list signed by the medical director:(A) IV solutions;(B) IV catheters;(C) endotracheal tubes;(D) medications;(E) any specialized equipment required in medical treatment protocols/standing orders;(F) pressure bag;(G) tourniquets, tape, dressings; and(H) container appropriate to contain used sharp devices (needles, scalpels) which meets OSHA requirements;(8) assessment equipment as follows:(A) equipment suitable to determine blood pressure of an adult, pediatric, and neonatal patients during flight;(B) stethoscope;(C) penlight/flashlight;(D) heavy duty bandage scissors;(E) pulse oximeter;(F) external cardiac pacing device; and(G) IV infusion pump capable of strict mechanical control of an IV infusion drip rate. Passive devices such as dial-a-flow are not acceptable;(9) bandages and dressings as follows:(A) sterile dressings such as 4x4s, abdominal pads;(B) bandages such as Kerlix, Kling; and(C) tape in various sizes;(10) container(s) and methods to collect, contain, and dispose of body fluids such as emesis, oral secretions, and blood consistent with OSHA bloodborne pathogen requirements;(11) infection control equipment. The licensee shall have a sufficient quantity of the following supplies for all air medical personnel, and each flight crew member, and all ground personnel with incidental exposure risks according to OSHA requirements which includes but is not limited to:(A) protective gloves;(B) protective gowns;(C) protective eyewear;(D) protective face masks, National Institute for Occupational Safety and Health (NIOSH) approved N95 or greater;(E) an approved bio-hazardous waste plastic bag or impervious container to receive and dispose of used supplies; and(F) handwashing capabilities or antiviral towelettes;(12) an adequate trash disposal system exclusive of bio-hazardous waste control provisions;(13) security of medications, fluids, and controlled substances shall be maintained by each air ambulance licensee in compliance with local, state, and federal drug laws;(14) 12-lead cardiac monitor defibrillator - DC battery powered portable monitor/defibrillator with paper printout, accessories and supplies, with sufficient power supply to meet demands of the mission;(15) quantity and type of drugs and specialized equipment as specified on the medical director's list;(16) permanently installed climate control equipment to provide an environment appropriate for the medical needs of patients; and(17) survival kit which shall include, but not be limited to, the following items which are appropriate to the terrain and environments the provider operates over:(A) instruction manual;(B) water;(C) shelter-space blanket;(D) knife;(E) signaling devices;(F) compass; and(G) fire starting items. Source Note: The provisions of this §157.12 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE B EMERGENCY MEDICAL SERVICES PROVIDER LICENSES §157.12 Rotor-wing Air Ambulance Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182741&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182741 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182741&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182741 03/11/2026 (a) Fixed wing aircraft operated by a licensed EMS provider shall be at the mobile intensive care level. Persons or entities operating fixed wing air ambulances must direct and control the integrated activities of both the medical and aviation components. Although the aircraft operator is directly responsible to the Federal Aviation Administration (FAA) for the operation of the aircraft, one organization, typically the one in charge of the medical functions, directs the combined efforts of the aviation and medical components during patient transport operations. Licensed fixed wing aircraft must also meet the requirements of §157.11 of this title (relating to Requirements for an EMS Provider License), as long as the rule does not violate the Federal Aviation Act of 1958, 49 U.S.C. §§ et seq. and Airline Deregulation Act of 1978, 49 U.S.C. §41713 (b)(1).(b) When being used as an ambulance, a fixed wing aircraft shall:(1) be multi-engine or be a single, turbo-prop engine capable of maintaining cabin pressurization;(2) maintain a cabin altitude consistent with patient diagnosis, condition, and destination;(3) be equipped and kept current for instrument flight rules (IFR) flight;(4) have a door large enough to allow a patient on a stretcher with the manufacturer's recommended or FAA approved stretcher restraint system in place to be enplaned without excessive maneuvering or tipping of the patient which compromises the function of monitoring devices, intravenous (IV) lines or ventilation equipment;(5) be designed or modified to accommodate at least one stretcher patient with the manufacturer's recommended or FAA approved stretcher restraint system in place;(6) have a lighting system which can provide adequate intensity to illuminate the patient care area and an adequate method (curtain, distance) to limit the cabin light from entering the cockpit and impeding cockpit crew vision during night operations;(7) have permanently installed climate control equipment to provide an environment appropriate for the medical needs of the patient(s);(8) have an interior cabin configuration large enough to accommodate the number of air medical personnel needed to provide care to the patient, as well as an adult stretcher in the cabin area with access to the patient. The configuration shall not impede the normal or emergency evacuation routes;(9) have an electrical system capable of servicing the power needs of electrically powered on-board patient care equipment;(10) have all installed and carry-on equipment secured using FAA-approved devices and methods;(11) shall assure that all specialized medical equipment is secured throughout transport with adequately engineered designated mounts as approved by FAA.(12) have sufficient space in the cabin area where the patient stretcher is installed so that equipment can be stored and secured with FAA approved devices in such a manner that it is accessible to the air medical personnel; and(13) have two FAA approved fire extinguishers approved for aircraft use. Each shall be fully charged with valid inspection certification and capable of extinguishing type A, B, or C fires. One extinguisher shall be accessible to the cockpit crew and one shall be in the cabin area accessible to the medical crew member.(c) An operator of aircraft in an air ambulance program shall be FAA certified as an air taxi and commercial operator (ACTO) with operation specifications allowing air ambulance operations.(d) The fixed-wing air ambulance provider shall meet the responsibilities of EMS providers as in §157.11 of this title (relating to Requirements for an EMS Provider License) and shall also:(1) submit proof that the fixed-wing aircraft provider carries bodily injury and property damage insurance with a company licensed to do business in Texas, in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the operation or use of any of the certificate holder's aircraft.(2) submit proof that the air ambulance provider carries professional liability insurance coverage in the minimum amount of $500,000 per occurrence, with a company licensed to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the care or lack of care of a patient; and(3) submit a letter of agreement that all fixed-wing aircraft shall meet the specifications of subsection (b) of this section, if the aircraft is leased from a pool; and(4) submit a copy of current Federal Aviation Administration Air Taxi and Commercial Operator Certification.(e) The air ambulance provider shall employ a medical director who shall meet the following qualifications:(1) be a physician approved by the Texas Department of Health and in practice;(2) have knowledge and experience consistent with the transport of patients by air;(3) be knowledgeable in aeromedical physiology, stresses of flight, aircraft safety, patient care, and resource limitations of the aircraft, medical staff and equipment;(4) have access to consult with medical specialists for patient(s) whose illness and care needs are outside the medical director's area of practice; and(5) shall comply with the requirements in the Medical Practice Act, Occupations Code, Chapters 151 - 168, and 22 Texas Administrative Code, Chapter 197;(f) The physician shall fulfill the following responsibilities:(1) ensure that there is a comprehensive plan/policy to address selection of appropriate aircraft, staffing and equipment;(2) be involved in the selection, hiring, educating, training and continuing education of all medical personnel;(3) be responsible for overseeing the development and maintenance of a continuous quality improvement program;(4) ensure that there is a plan to provide direction of patient care to the air medical personnel during transport. The system shall include on-line (radio/telephone) medical control, and/or an appropriate system for off-line medical control such as written guidelines, protocols, procedures, patient specific written orders or standing orders;(5) participate in administrative decision making processes that affect patient care;(6) ensure that there is an adequate method for on-line medical control, and that there is a defined plan or procedure and resources in place to allow off-line medical control;(7) oversee the review, revision and validation of written policies and protocols annually for the treatment and transportation of adult, pediatric, and neonatal patients to include a policy defining the specific instances in which a patient could be accompanied by only one attendant; and(8) attest to the following capabilities:(A) experience consistent with the transport of patients by air;(B) knowledge of aeromedical physiology, stresses of flight, aircraft safety, resources limitations of the aircraft;(C) knowledge on Texas EMS laws and regulations affecting local, regional and state operations;(D) awareness that the EMS provider has provided safety education for ground emergency services personnel.(g) There shall be at least one licensed or certified paramedic, registered nurse, or physician on board an air ambulance to perform patient care duties on that air ambulance. The qualifications and numbers of air medical personnel shall be appropriate to patient care needs. Personnel employed by providers who are based in another state, do not need Texas certification/licensure but shall be certified/licensed in their respective state.(1) Documentation of successful completion of education specific to the fixed-wing transport environment in general and the licensee's operation specifically shall be required. The curriculum shall be consistent with the Department of Transportation (DOT) Air Medical Crew - National EMS Education Standards, or equivalent program.(2) Each attendant's qualifications shall be documented.(3) Air medical personnel shall not be assigned or assume the cockpit duties of the flight crew members concurrent with patient care duties and responsibilities.(4) The aircraft shall be operated by a pilot or pilots certified in accordance with applicable Federal Aviation Regulations.(h) Medical supplies and equipment shall be consistent with the service's scope of care as defined in the protocols/standing orders for adult, pediatric, and neonatal patients. Medical equipment shall be functional without interfering with the avionics nor should avionics interfere with the function of the medical equipment. Additionally, the following equipment, clean and in working order, must be on the aircraft or immediately available for all providers:(1) one or more stretchers installed in the aircraft cabin which meet the following criteria:(A) can accommodate an adult, 6 feet tall, weighing 212 pounds except for a neonatal stretcher, with recommended manufacturer's or FAA approved restraint system in place, which has been fitted with an isolette. There shall be restraining devices or additional appliances available to provide adequate restraint of all patients including those under 60 pounds or 36 inches in height;(B) the head of each stretcher, with recommended manufacturer's or FAA approved restraint system in place, shall be capable of being elevated up to 45 degrees. The elevating section must hinge at or near the patient's hips and shall not interfere with or require that the patient or stretcher securing straps and hardware be removed or loosened;(C) each stretcher, with recommended manufacturer's or FAA approved restraint system in place, shall be positioned in the cabin to allow the air medical personnel clear view of the patient and shall ensure that medical personnel always have access to the patient's head and upper body for airway control procedures as well as sufficient space over the area where the patient's chest is to adequately perform closed chest compression or abdominal thrusts on the patient;(D) a pad or mattress impervious to moisture and easily cleaned and disinfected according to Occupation Safety and Health Administration (OSHA) bloodborne pathogen requirements;(E) a device to make the stretcher surface rigid enough if the surface of the stretcher under the patient's torso is not firm enough to support adequate chest compressions; and(F) shall have a supply of linen for each patient;(2) an adequate and manually-controlled supply of gaseous or liquid medical oxygen, attachments for humidification, and a variable flow regulator for each patient;(A) a humidifier, if used, shall be a sterile, disposable, one-time usage item;(B) the licensee shall have and demonstrate the method used to calculate the volume of oxygen required to provide sufficient oxygen for the patient's needs for the duration of the transport;(C) the licensee shall have a plan to provide the calculated volume of oxygen plus a reserve equal 1000 liters or the volume required to reach an appropriate airport, whichever is longer;(D) all necessary regulators, gauges and accessories shall be present and in good working order;(E) the oxygen system shall be securely fastened to the airframe using FAA approved restraining devices;(i) a separate emergency backup supply of oxygen of not less than 57 liters with regulator and flow meter;(ii) one adult, one child, one pediatric, one neonatal size non- rebreathing mask, one adult size nasal cannula and necessary connective tubings and appliances.(3) an electrically-powered suction apparatus with wide bore tubing, a large reservoir and various sizes suction catheters. The suction system may be built into the aircraft or provided with a portable unit. Backup suction is required and can be a manually operated device. (Bulb syringe not acceptable);(4) hand operated bag-valve-mask ventilators of adult, pediatric and infant sizes with clear masks in adult, pediatric, and neonatal patients. It shall be capable of use with a supplemental oxygen supply and have an oxygen reservoir;(5) airway adjuncts as follows:(A) oropharyngeal airways in at least five assorted sizes, including for adult, pediatric, and neonatal patients; and(B) nasopharyngeal airways in at least three sizes with water soluble lubricant;(6) assessment equipment as follows:(A) equipment suitable to determine blood pressure of the adult, pediatric, and neonatal patients during flight;(B) stethoscope;(C) penlight/flashlight;(D) heavy duty bandage scissors; and(E) pulse oximeter;(7) bandages and dressings as follows:(A) sterile dressings such as 4x4s, ABD pads;(B) bandages such as Kerlix, Kling; and(C) tape in various sizes.(8) container(s) and methods to collect, contain, and dispose of body fluids such as emesis, oral secretions, and blood consistent with OSHA bloodborne pathogen requirements;(9) urinal and bedpan with toilet tissue;(10) infection control equipment. The licensee shall have a sufficient quantity of the following supplies for all air medical personnel, each flight crew member, and all ground personnel with incidental exposure risks according to OSHA requirements which includes but is not limited to:(A) protective gloves;(B) protective gowns;(C) protective eyewear;(D) protective face masks, National Institute for Occupational Safety and Health (NIOSH) approved N95 or greater;(E) an approved bio-hazardous waste plastic bag or impervious container to receive and dispose of used supplies; and(F) handwashing capabilities or antiviral towelettes.(11) an adequate trash disposal system exclusive of bio-hazardous waste control provisions;(12) the following additional equipment in amounts and sizes specified by the medical director is required for an air ambulance provider to function at the advanced level:(A) advanced airway management equipment appropriate to the patient's needs;(B) sterile crystalloid solutions in plastic containers, IV catheters, and administration tubing sets;(C) hanger for IV solutions;(D) pressure bag;(E) tourniquets, tape, dressings;(F) container appropriate to contain used sharp devices, needles, scalpels which meets OSHA requirements;(G) a list signed by medical director defining quantities and types of drugs to be carried; and(H) any specialized equipment required in medical treatment protocols/standing orders.(13) cardiac monitor defibrillator-DC battery powered portable monitor/defibrillator with paper printout, accessories and supplies, with sufficient power supply to meet demands of the mission; and(14) survival kit which shall include, but not be limited to, the following items which are appropriate to the terrain and environments the provider operates over:(A) instruction manual;(B) water;(C) shelter-space blanket;(D) knife;(E) signaling devices;(F) compass; and(G) fire starting items.(i) A system for security of medications, fluids, and controlled substances shall be maintained by each air ambulance licensee in compliance with local, state, and federal drug laws.(j) The air ambulance provider shall own the following equipment or shall have a written lease agreement explaining the availability of the equipment for use when the patient's condition indicates the need:(1) external cardiac pacing device;(2) IV infusion pump capable of strict mechanical control of an IV infusion drip rate. Passive devices such as dial-a-flow are not acceptable; and(3) a mechanical ventilator that can deliver up to 100% oxygen concentration at pressures, rates and volumes appropriate for the size of the patient. Source Note: The provisions of this §157.13 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE B EMERGENCY MEDICAL SERVICES PROVIDER LICENSES §157.13 Fixed-wing Air Ambulance Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182742&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182742 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182742&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182742 03/11/2026 (a) A First Responder Organization (FRO) is a group or association of certified emergency medical services personnel that works in cooperation with a licensed emergency medical services provider to:(1) routinely respond to medical emergency situations;(2) utilize personnel who are emergency medical services (EMS) certified by the Texas Department of State Health Services (department); and(3) provide on-scene patient care to the ill and injured and does not transport patients.(b) Individuals or organizations meeting the description in subsection (a) of this section must comply with the requirements outlined in this section including submission of an application for a license.(c) Application requirements for an FRO affiliated with a licensed EMS Provider.(1) A Basic Life Support (BLS) or Advanced Life Support (ALS) First Responder Organization affiliated with a Texas licensed EMS Provider must apply for an FRO license by submitting a completed application to the department. A complete application consists of the following:(A) provider license application form;(B) personnel list including social security number or EMS personnel identification (ID) number and certification/licensure level;(C) description and map of the service area;(D) staffing plan including days of the week and hours of the day the FRO will be available for response;(E) written affiliation agreement with the primary licensed EMS provider in the service area. The primary licensed EMS provider must provide a letter attesting that the following items have been reviewed and approved by the director and medical director of the EMS provider:(i) level(s) of certification/licensure of FRO personnel providing care;(ii) response, dispatch and treatment protocols including an equipment and supply list approved by the medical director of the licensed EMS provider to treat adult, pediatric and neonatal patients;(iii) description of how the FRO receives notification of calls;(iv) patient care reporting procedures;(v) process for the assessment of care provided by the FRO personnel;(vi) response code policies for FRO personnel;(vii) on-scene chain-of-command policies;(viii) policies regarding FRO personnel canceling en route EMS units;(ix) policies regarding FRO personnel accompanying patients in EMS providers vehicles including when FRO personnel hold the highest certification or licensure on the scene; and(x) patient confidentiality.(F) It is not necessary to submit the individual items in subparagraph (E)(i) - (x) of this paragraph with the application, if each is referenced in the affiliation agreement. All items listed in this paragraph must be immediately available for review by department personnel upon request during unannounced site visits or complaint investigations.(2) Any FRO which is, or has a contract with, an entity such as a business, corporation or department and whose first responder employees or members are compensated by that entity for providing first responder service shall pay a nonrefundable $60 application fee. If the license is issued for less than 12 months, the nonrefundable fee shall be $30. The FRO personnel described in this paragraph are not exempt from the payment of certification or license application fees.(3) Applicants that meet all the requirements shall be issued an FRO license. The license may be valid for up to 2 years, but may be issued for less than 2 years for administrative purposes.(4) Although not required, the FRO license application may be submitted with the license application of the affiliated EMS provider. The FRO is responsible for submitting fees, if applicable.(5) An affiliation agreement between a licensed EMS provider and a licensed FRO does not automatically imply any legal liability beyond the agreements listed in paragraph (1)(E) of this subsection.(6) A violation of statute or rule by an FRO will not implicate the affiliated EMS provider unless both organizations are involved in the violation. Likewise, a violation of statute or rule by an affiliated EMS provider does not implicate the FRO unless both organizations are involved in the violation.(d) Application requirements for an FRO not affiliated with a licensed EMS provider.(1) A BLS first responder organization not affiliated with a licensed EMS provider may apply for an FRO License by submitting a completed application to the department. A complete application consists of the following:(A) application form;(B) personnel list including social security number or personnel ID number and certification/licensure level;(C) description and map of the service area;(D) staffing plan including days of the week and hours of the day the FRO will be available for response;(E) response, dispatch and treatment protocols including an equipment and supply list approved by the FRO medical director;(F) letter of recognition from the primary licensed 911 EMS Provider or from the highest elected city/county official in the service area and a written explanation why the EMS provider will not enter into an agreement with the FRO;(G) description of how the FRO receives notification of calls; and(H) process for the assessment of care provided by the FRO personnel.(I) The application for a FRO license will be considered incomplete if any items listed in subparagraphs (A) - (H) of this paragraph are not enclosed with the application.(J) All items listed in subparagraphs (A) - (H) of this paragraph must be immediately available for review by department personnel if requested during unannounced site visits or complaint investigations.(2) An ALS first responder organization not affiliated with a licensed EMS provider may apply for an FRO License by submitting a completed application to the department. A complete application consists of the following:(A) application form;(B) personnel list including social security number or personnel ID number and certification/licensure level;(C) description and map of the service area; and(D) staffing plan including days of the week and hours of the day the FRO will be available for response.(E) The FRO shall have an agreement with all licensed EMS providers and their medical directors who routinely transport patients treated by the FRO's personnel. Each agreement shall be approved by the person responsible for the FRO, director and medical director of each licensed EMS provider. At a minimum, the agreements shall address:(i) the level(s) of certification/licensure of FRO personnel providing care;(ii) the response, dispatch and treatment protocols including an equipment and supply list approved by the FRO medical director and a letter of approval from the medical director(s) of the licensed transporting providers with whom the FRO has agreements;(iii) a description of how the FRO receives notification of calls;(iv) patient care reporting procedures;(v) a process for the assessment of care provided by FRO personnel;(vi) response code policies for FRO personnel;(vii) on-scene chain-of-command policies;(viii) policies regarding FRO personnel canceling en route EMS units;(ix) policies regarding FRO personnel accompanying patients in provider's vehicles including when FRO personnel hold the highest certification or licensure on the scene; and(x) patient confidentiality.(F) The application for a FRO license is incomplete if any items listed in this paragraph are not enclosed with the application.(G) All items listed in this paragraph must be immediately available for review by department personnel if requested during unannounced site visits or complaint investigations.(3) Any FRO which is, or has a contract with, an entity such as a business, corporation or department and whose first responder employees or members are compensated by that entity for providing first responder services shall pay a nonrefundable $60 application fee. If the license is issued for less than 12 months, the nonrefundable fee shall be $30. The FRO personnel described in this paragraph are not exempt from the payment of certification and license application fees.(4) Applicants that meet all the requirements for a license shall be issued an FRO license. The license is issued for 2 years. For administrative purposes, it may be issued for less than 2 years.(e) Responsibilities of the FRO. During the license period the FRO's responsibilities shall include:(1) assuring ongoing compliance with the terms of all EMS provider agreement(s);(2) assuring the existence of and adherence to a quality assurance plan which shall, at a minimum, include:(A) the standard of patient care and the medical director's protocols;(B) pharmaceutical storage;(C) readiness inspections;(D) preventive maintenance of medical equipment and vehicles owned by the FRO;(E) policies and procedures;(F) complaint management; and(G) patient care reporting and documentation;(3) ensuring that all medical personnel are currently certified or licensed by the department;(4) assuring that all personnel on the scene of an emergency are prominently identified by, at least, the last name and the first initial of the first name, the certification or license level and the FRO name. An FRO may utilize an alternative identification system in incident specific situations that pose a potential for danger if the individuals are identified by name;(5) assuring that all vehicles utilized by FRO personnel carry proof of first responder registration or have the name of the FRO prominently displayed and visible from the outside of the vehicle while on the scene of an emergency;(6) assuring the confidentiality of all patient information is in compliance with all federal and state laws;(7) developing and adhering to an agreement between the primary transport provider and first responder organization concerning the use of patient refusal forms and documentation for incidents when an informed treatment refusal form cannot be obtained;(8) developing and adhering to an agreement between the primary transport provider and first responder organization concerning the maintenance of FRO records;(9) assuring that patient care reports are completed accurately for all patients:(A) the report shall be accurate, complete and clearly written; and(B) the report shall document, at a minimum, the patient's name, the patient's condition when first contacted by FRO personnel; the prehospital care provided; the dispatch time; scene arrival time; and the identification of the FRO personnel who provided care to the patient;(10) assuring that all relevant patient care information is supplied in writing to the licensed EMS provider at the time the patient is transferred to the provider;(11) assuring that a full written report is provided, upon request, within 1 business day to the transport provider and/or hospital facility where the patient was delivered;(12) assuring that all requested patient records are made promptly available to the first responder organization's medical director;(13) assuring that current protocols are available to all certified or licensed personnel;(14) monitoring and enforcing compliance with all policies;(15) assuring provisions for the appropriate disposal of medical and/or biohazardous waste materials;(16) assuring that all documents, reports or information provided to the department are current, accurate and complete;(17) assuring compliance with all federal and state laws and regulations and all local ordinances, policies and codes at all times;(18) assuring that the department is notified within 5 business days whenever there is a change:(A) in the level of service;(B) in the declared service area;(C) in the official business mailing address;(D) in the physical location of the first responder organization;(E) in the physical location of patient report file storage, to assure that the department has access to these records at all times;(F) of the administrator;(G) of the e-mail address; or(H) of the EMS providers associated with the FRO.(19) assuring that the department is notified within 1 business day when a change of the medical director has occurred;(20) assuring the FRO has written operating policies, procedures and medical protocols and provides all medical personnel a copy initially and whenever such policies, procedures and/or medical protocols are changed. A copy of the written operating policies, procedures and medical protocols shall be made available to the department upon request. At a minimum, policies shall adequately address:(A) personal protective equipment;(B) immunizations available to personnel;(C) infection control procedures;(D) contact information for the designated infection control officer for whom education based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136 has been documented;(E) management of possible exposure to communicable disease;(F) credentialing of new response personnel before being assigned to respond to emergencies. The credentialing process shall include, at minimum:(i) a comprehensive orientation session of the FRO's policies and procedures, safety precautions, and quality management process; and(ii) an internship period in which all new personnel practice under the supervision of, and are evaluated by, another more experienced person, if operationally feasible; and(G) appropriate documentation of patient care;(21) assuring that all documents, reports or information provided to the department are current, truthful and correct;(22) assuring that the department is notified within 1 business day of a collision involving an FRO vehicle responding to a scene or while at the scene of an emergency and resulting in personal injury or death of any person;(23) maintaining motor vehicle and professional liability insurance as required by the Texas Transportation Code under Subchapter D, §601.071 and §601.072, for all vehicles owned or operated by the FRO;(24) providing continuous coverage for the service area as defined in the staffing plan; and(25) responding to requests for assistance from the highest elected official of a political subdivision or from the department during a declared emergency or mass casualty situation.(f) License renewal.(1) The department may notify the FRO at least 90 days before the expiration date of the current license at the address shown in the current records of the department. If a notice of expiration is not received, it is the responsibility of the FRO to notify the department and request license renewal application information.(2) FROs shall submit a completed application and nonrefundable fee, if applicable, and must verify compliance with the requirements of the license.(g) License denial. A license may be denied for, but not limited to, the following reasons:(1) failure to meet requirements for an FRO license in accordance with this section;(2) previous failure to meet the responsibilities of an FRO as described in this section;(3) falsifying any information, record or document required for an FRO license;(4) misrepresenting any requirements for an FRO license or renewal of an FRO license;(5) history of criminal activity while licensed as an FRO;(6) history of disciplinary action relating to the FRO license; and/or(7) issuing a check for application for an FRO license which is subsequently returned to the department unpaid.(h) License revocation criteria. An FRO license may be revoked or suspended for failure to meet the responsibilities of a licensed FRO as described in this section.(i) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority to recover costs associated with the application and renewal application processing through Texas Online. Source Note: The provisions of this §157.14 adopted to be effective August 31, 2006, 31 TexReg 6739; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE B EMERGENCY MEDICAL SERVICES PROVIDER LICENSES §157.14 Requirements for a First Responder Organization License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182743&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182743 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182743&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182743 03/11/2026 (a) Emergency Suspension. The Texas Department of State Health Services (department), may issue an emergency suspension order to any licensed emergency medical services (EMS) provider if the department has reasonable cause to believe that the conduct of any licensed provider creates an imminent danger to public health or safety.(1) An emergency suspension issued by the department is effective immediately without a hearing or notice to the license holder. Notice to the license holder shall be presumed established on the date that a copy of the signed emergency suspension order is sent to the individual listed as the administrator of record at the address shown in the current records of the department.(2) A copy of the emergency suspension order shall be sent to the provider's listed medical director, to the EMS provider, and to all government entities, institutions or facilities with which the license holder is known to be associated to the addresses shown in the current records of the department.(3) If a written request for a hearing is received from the suspended license holder, the department shall conduct a hearing not earlier than the 10th day nor later than the thirtieth day after the date on which a hearing request is received to determine if the emergency suspension is to be continued, modified or rescinded. The hearing and appeal from any disciplinary action related to the hearing shall be governed by the Administrative Procedure Act, Government Code, Chapter 2001.(b) Administrative penalty. An administrative penalty may be assessed when an EMS provider is in violation of the Health and Safety Code, Chapter 773, 25 Texas Administrative Code, Chapter 157, or the reasons outlined in subsections (c) and (d) of this section.(c) Accountability. An EMS provider retains ultimate responsibility for the operation of the service. A licensed EMS provider may not claim a defense when one or more staff members, acting with or without the consent and knowledge of the license holder, commit(s) multiple violations in this section, or perform(s) contrary to EMS standards while on EMS business for the provider. The department shall consider the EMS provider's current policies and procedures when staff violate rules or EMS standards.(d) Nonemergency suspension or revocation. An EMS provider license may be suspended or revoked for, but not limited to, the following reasons:(1) failing to comply with any requirement of provider licensure as defined in §157.11 of this title (relating to Requirements for an EMS Provider License);(2) operating the service while the license is under suspension;(3) falsifying or altering a license issued by the department;(4) failing to correct deficiencies as instructed by the department;(5) obtaining or attempting to obtain or assisting another to obtain a provider license or personnel certification by fraud, forgery, deception, or misrepresentation;(6) providing false or misleading advertising and/or making false or misleading claims to clients or the public about the service;(7) failing to operate a subscription service/membership program according to provisions in §157.11 of this title;(8) failing to maintain patient confidentiality according to standards and department regulations;(9) discriminating in the provision of services based on national origin, race, color, creed, religion, gender, sexual orientation, age, physical or mental disability;(10) falsifying a patient care record or any other document or record resulting from or pertaining to EMS Provider responsibilities;(11) obtaining any fee or benefit by fraud, coercion, theft, deception, or misrepresentation;(12) failing to give the department true and complete information when asked, regarding any alleged or actual violation of the Health and Safety Code, Chapter 773;(13) failing to pay an administrative penalty in full within established time frames;(14) failing to staff each vehicle deemed to be in service or response ready with appropriately and currently certified personnel;(15) operating, directing, or allowing staff to operate vehicle warning devices unnecessarily or inappropriately;(16) operating, directing, or allowing any person to operate any vehicle on EMS business while under the influence of any substance that inhibits the mental or physical capacities of that person;(17) having been found to have operated, directed, or allowed staff to operate any vehicle while on EMS business in a reckless or unsafe manner and/or in a manner that is dangerous to the health or safety of any person;(18) operating, directing, or allowing staff to operate any vehicle that is not mechanically safe, clean and in good operating condition; and/or(19) having been found in violation of any local, state, or national code or regulation pertaining to EMS operations or business practices; and/or violating any rule or standard that could jeopardize the health or safety of any person.(e) Denial of a license. A license may be denied for, but not limited to, the following reasons:(1) failing to meet the licensing requirements outlined in §157.11 of this title;(2) one of the owners having a history of a misdemeanor or felony which the department has determined may put the safety of any person; at risk;(3) previous conduct while holding an EMS provider license which could put any person at risk;(4) the EMS provider has received disciplinary action in another state or by a federal agency;(5) falsifying or misrepresenting any fact or requirement on or for an application or related document for a provider license or EMS personnel license/certificate; and/or(6) issuing a check for application for a provider license which is returned to the department unpaid.(f) Notification. If the department proposes to deny, suspend, revoke, or probate a license, the EMS provider license holder and the administrator of record shall be notified at the address shown in the current records of the department. The notice shall state the alleged facts or conduct to warrant the proposed action and state that the license holder may request a hearing.(g) Hearing Request.(1) A request for a hearing shall be in writing and submitted to the department and postmarked no later than 30 days after the date of the notice. The hearing shall be conducted pursuant to the Administrative Procedure Act, Government Code, Chapter 2001.(2) If the candidate, applicant or licensee does not request a hearing in writing within 30 days after proper notice, the individual is deemed to have waived the opportunity for a hearing as outlined in the notice.(h) Probation. The department may probate any penalty assessed under this section and may specify terms and conditions of any probation issued.(i) Re-application.(1) Two years after denial or revocation of a license, or the voluntary surrender of a license while disciplinary action is pending, an individual may petition the department in writing for re-application for licensure. Expiration of a certificate or license during the suspension period shall not affect the two-year waiting period required before a petition can be submitted.(2) The petitioner bears the burden of proving fitness for licensure.(3) The department may allow an application for licensure if there is proof that the health, safety, and confidence of the public will be protected.(4) The department may deny any petitioner if, in the judgement of the department, the reason for the original action continues to exist or if the petitioner has failed to offer sufficient proof that there is no longer a threat to public health, safety, and/or confidence.(5) If the application is allowed, the petitioner shall be required to meet the requirements as described in §157.11 of this title and in addition shall meet the terms of probation in subsection (h) of this section.(j) Expiration of a license during suspension. A provider whose license expires during a suspension period shall not reapply for licensure until the end of the suspension period.(k) Surrender of a license. Surrender of a license shall not deprive the department of jurisdiction in regard to disciplinary action against the license holder. A provider who wishes to surrender his or her license prior to the expiration of the license may do so by:(1) completing a Surrender of License statement; and(2) in the event that a disciplinary action is pending or reasonably imminent, the licensee shall acknowledge that the surrender constitutes a plea of "no contest" to the allegations upon which the disciplinary action is predicated, acknowledging that the surrender is a "no contest" plea in the event that a disciplinary action is pending or reasonably imminent.(l) Notification of disposition. An order of final disposition of any disciplinary action shall be sent to the license holder at the address shown in the current records of the department. A copy of the order shall also be sent to the provider's medical director and to any government entity, institution or facility with which the license holder is known to be associated at the address shown in the current records of the department. Source Note: The provisions of this §157.16 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE B EMERGENCY MEDICAL SERVICES PROVIDER LICENSES §157.16 Emergency Suspension, Suspension, Probation, Revocation, Denial of a Provider License or Administrative Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=146745&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 146745 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=146745&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 146745 03/11/2026 (a) Purpose. The purpose of this section shall be to establish a statewide OOH-DNR protocol as required in the Health and Safety Code, Title 2, Chapter 166.(b) Out-of-Hospital DNR order. An OOH-DNR order may be issued by an attending physician for any patient. That attending physician has responsibility for ensuring that the form is filled out in its entirety and that the information regarding the existence of an OOH-DNR order is entered into the patient's medical record.(c) Protocol development. An OOH-DNR protocol in accordance with this section, shall apply to all out-of-hospital settings including cardiac arrests which occur during interfacility transport. The protocol shall include the following:(1) a copy of the Department of State Health Services (department) standardized OOH-DNR order form listing the designated treatments that shall be withdrawn or withheld. Those treatments shall be:(A) cardiopulmonary resuscitation;(B) advanced airway management;(C) artificial ventilation;(D) defibrillation; and(E) transcutaneous cardiac pacing.(2) an explanation of the patient identification process to include an option to use a department-standardized identification device such as a necklace or bracelet; and(3) an on-site OOH-DNR dispute resolution process which includes contacting an appropriate physician.(d) Recordkeeping. Records shall be maintained on each incident in which an OOH-DNR order or OOH-DNR identification device is encountered by responding healthcare professionals, and the number of cases where there is an on-site revocation of the DNR order shall be recorded.(1) The data documented should include:(A) an assessment of patient's physical condition;(B) whether an identification device or an OOH-DNR form was used to confirm DNR status and patient identification number;(C) any problems relating to the implementation of the OOH-DNR order;(D) the name of the patient's attending physician; and (E) the full name, address, telephone number, and relationship to patient of any witness used to identify the patient.(2) These records must be maintained and shall meet records retention requirements for each health care profession.(3) If the patient is transported, the original OOH-DNR order or a copy of the original order will be kept with the patient.(4) Copies of the original OOH-DNR order may be put on file with concerned parties, and the original order shall remain in the possession of the patient, a legal guardian, or the healthcare facility responsible for the patient's care.(e) Out-of-state OOH-DNR Orders. Personnel may accept an OOH-DNR order or device that has been executed in any other state, if there is no reason to question the authenticity of the order or device.(f) Failure to honor an OOH-DNR order. If there are any indications of unnatural or suspicious circumstances, the provider shall begin resuscitation efforts until such time as a physician directs otherwise.(g) Pregnant persons. A person may not withhold the designated treatments listed in subsection (c)(1) from a person known by responding healthcare professionals to be pregnant.(h) Out-of-Hospital DNR Form. The executive commissioner or the commissioner's appointees shall furnish the department's OOH-DNR order forms to physicians, clinics, hospitals, nursing homes, hospices and home health agencies throughout the state upon request.(1) The form shall contain all the information as prescribed in the Health and Safety Code, Chapter 166.(2) The form shall be 8-1/2 inches by 11 inches, printed front and back, and in the format specified by the department as follows. Attached Graphic(i) Out-of-Hospital DNR Identification devices. As an optional means of identification, a patient may obtain, at patient's expense, an OOH-DNR device. An OOH-DNR device, as approved by the Department of State Health Services, must meet the following requirements: (1) An intact, unaltered, easily identifiable plastic identification OOH-DNR bracelet, with the word "Texas" (or a representation of the geographical shape of Texas and the word "STOP" imposed over the shape) and the words "Do Not Resuscitate," shall be honored by qualified EMS personnel in lieu of an original OOH-DNR order form.(2) An intact, unaltered, easily identifiable metal bracelet or necklace inscribed with the words, "Texas Do Not Resuscitate - OOH" shall be honored by qualified EMS personnel in lieu of an OOH-DNR order form.(3) The person or entity who provides an OOH-DNR identification device to an individual shall send with the identification device a statement with the words, "Pursuant to Health and Safety Code, §166.090, this identification device may only be worn by a person who has executed a valid out-of-hospital DNR order." Source Note: The provisions of this §157.25 adopted to be effective June 15, 2000, 25 TexReg 5656; amended to be effective February 7, 2001, 26 TexReg 1143; amended to be effective July 29, 2004, 29 TexReg 7103; amended to be effective July 6, 2010, 35 TexReg 5888. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE B EMERGENCY MEDICAL SERVICES PROVIDER LICENSES §157.25 Out-of-Hospital Do Not Resuscitate (OOH-DNR) Order https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182744&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182744 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182744&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182744 03/11/2026 (a) Emergency medical services (EMS) Education Program Standards. An EMS Education Program shall meet national education training standards that address at least the following areas:(1) program sponsorship;(2) program direction and administration;(3) medical direction;(4) instructor personnel;(5) financial resources;(6) physical resources, including classroom and laboratory facilities, equipment and supplies, and learning resources;(7) clinical and field internship resources;(8) academic and administrative policies, procedures and records requirements;(9) program evaluation;(10) curriculum; and(11) delivery of instruction by distance learning technology.(b) Consideration of training standards. The department shall base the education and training standards on applicable national standards and guidelines for evaluation and approval of EMS education programs adopted by national accrediting organizations.(c) Curriculum(1) Emergency Care Attendant (ECA).(A) The minimum curriculum shall include all content required by the current national Emergency Medical Responder (EMR) educational standards and competencies as defined in the National EMS Education Standards by the United States Department of Transportation (DOT).(B) In addition to the minimum curriculum in subparagraph (A) of this paragraph, the curriculum shall include the following subjects:(i) recognition and identification of hazardous materials as defined by the Federal Emergency Management Agency curriculum, "Recognizing and Identifying Hazardous Materials";(ii) airway/ventilation adjuncts; to include use of the bag-valve mask, oxygen administration and oral suctioning;(iii) measurement of baseline vital signs to include pulse, respiration and blood pressure by palpation and auscultation;(iv) spinal motion restriction, to include sizing and application of cervical collars and short/long spinal motion restriction devices to supine, seated, and standing patients;(v) patient assessment;(vi) bandaging, splinting, and traction splinting;(vii) cardiac arrest management, including use of the semi-automatic external defibrillator;(viii) equipment used to lift and move patients;(ix) communications and documentation; and(x) ambulance operations, to include emergency vehicle laws.(C) The course shall include a minimum of 60 clock hours of classroom and laboratory instruction in the approved curriculum.(2) Emergency Medical Technician (EMT).(A) The minimum curriculum shall include all content required by the current national EMT educational standards and competencies as defined in the National EMS Education Standards by DOT.(B) The course shall include a minimum of 150 clock hours of classroom, laboratory, clinical, and field instruction which shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed to develop the competencies defined in the minimum curriculum.(3) Advanced Emergency Medical Technician (AEMT).(A) The minimum curriculum shall include all content required by the current national Advanced Emergency Medical Technician (AEMT) standards and competencies as defined in the National EMS Education Standards by DOT. The following areas must be addressed as outlined in the AEMT national educational standards and the Health and Safety Code, §773.048:(i) roles and responsibilities of the paramedic;(ii) well being of the paramedic;(iii) illness and injury prevention;(iv) medical/legal issues;(v) ethics;(vi) general principles of pathophysiology;(vii) pharmacology;(viii) venous access and medication administration;(ix) therapeutic communications;(x) life span development;(xi) patient assessment;(xii) airway management and ventilation, including endotracheal intubation; and(xiii) trauma.(B) The course shall include a minimum of 250 clock hours of classroom, laboratory, clinical, and field instruction which shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed to develop the competencies defined in the AEMT national educational standards.(C) A student shall have a current EMT certification from the department or National Registry prior to beginning and throughout field and clinical rotations in an AEMT course.(4) Emergency Medical Technician-Paramedic (EMT-P).(A) The minimum curriculum shall include all content required by the current national paramedic education standards and competencies in the National EMS Education Standards as defined by DOT.(B) The course shall include a minimum of 1000 clock hours of classroom, laboratory, clinical and field instruction which shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed to develop the competencies defined in the minimum curriculum.(C) A student shall have a current EMT or AEMT certification from the department or current EMT, EMT-I or AEMT certification from the National Registry prior to beginning and throughout field and clinical rotations in an EMT-P course.(d) Sponsorship.(1) EMS Education programs shall be sponsored by organizations or individuals with adequate resources and dedication to carry out successful educational endeavors.(2) Program sponsors shall provide appropriate oversight and supervision to ensure that programs:(A) are educationally and fiscally sound;(B) meet the responsibilities listed in subsection (o) of this section; and(C) has the required equipment and resources to conduct the program.(e) Levels of program approval.(1) A program may be approved as a basic EMS training program or an advanced training program.(2) ECA and EMT training shall be conducted by a basic program and may be conducted by an advanced program.(3) AEMT and EMT-P training shall be conducted by an advanced program.(4) An advanced program shall be considered to have met the requirements for approval as a basic program.(5) The education programs must have the authority or ownership to provide the program.(6) Approval of a program by the department is not transferable.(f) Currently approved programs. Programs that have obtained approval as of the effective date of this rule shall be considered to have met the requirements of subsections (g) or (h) of this section appropriate to their current level of approval. Paramedic programs must provide proof of accreditation by the Commission on Accreditation of Allied Health Education Programs (CAAHEP)/Committee on Accreditation of Emergency Medical Services Professions (CoAEMSP), or a national accrediting organization recognized by the department. Alternatively, the program may provide a letter of review from CAAHEP/CoAEMSP or a national accrediting organization recognized by the department stating the education program has submitted the appropriate documentation that indicates it being in pursuit of accreditation as defined by that organization.(g) Basic approval requirements. To receive approval for a basic program, an applicant shall:(1) submit a letter of sponsorship;(2) submit letters of intent from qualified providers of clinical and field internship experience appropriate to the level of training;(3) have at least one course coordinator certified as an EMT or higher;(4) have a program director who contributes an adequate amount of time to assure the success of the program. In addition to other responsibilities, the program director shall be responsible for the development, organization, administration, periodic review and effectiveness of the program. In addition to other duties, the program director may function as a course coordinator if appropriately certified; and shall:(A) routinely review student performance to assure adequate progress toward completion of the program;(B) review and supervise the quality of instruction provided by the program; and(C) document that each graduating student has achieved the desired level of competence prior to graduation;(5) have a medical director to the level or content of training. The medical director shall be a licensed physician approved by the department with experience in and current knowledge of emergency care. The medical director shall be knowledgeable about educational programs for EMS personnel. In addition to other duties assigned by the program, the medical director shall:(A) review and approve the educational content of the program's curricula;(B) review and approve the quality of medical instruction provided by the program; and(C) attest that each graduating student has achieved the desired level of competence prior to graduation;(6) have an advisory committee representing the program's communities of interest (individuals, groups of individuals, or institutions impacted by the program) designated and charged with assisting the program director and medical director in formulating appropriate goals and standards, monitoring needs and expectations and ensuring program responsiveness to change;(7) submit a completed application to the appropriate regional office;(8) demonstrate substantial compliance with the EMS education standards by successfully completing the self-study/on site review process; and(9) provide a name and contact information for the designated infection control officer and document education for the designated infection control officer based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136.(h) Advanced approval requirements. To approve an advanced program, an applicant shall:(1) have successfully operated a basic program;(2) submit documentation of sponsorship by a regionally accredited post-secondary educational institution or a health care institution accredited by an organization recognized by the department, or any other entity meeting standards and criteria for sponsoring advanced EMS courses;(3) submit letters of intent from qualified providers of clinical and field internship experience appropriate to the level of training offered;(4) have at least one advanced course coordinator certified at or above the highest level of training to be offered by the program;(5) have a program director who contributes an adequate amount of time to assure the success of the program. In addition to other responsibilities, the program director shall be responsible for the development, organization, administration, periodic review and effectiveness of the program; and shall:(A) routinely review student performance to assure adequate progress toward completion of the program;(B) review and supervise the quality of instruction provided by the program; and(C) document that each graduating student has achieved the desired level of competence prior to graduation;(6) have a medical director who shall be a licensed physician approved by the department with experience in and current knowledge of emergency care. The medical director shall be knowledgeable about educational programs for EMS personnel. In addition to other duties assigned by the program, the medical director shall:(A) review and approve the educational content of the program's curricula;(B) review and approve the quality of medical instruction provided by the program; and(C) attest that each graduating student has achieved the desired level of competence prior to graduation;(7) have an advisory committee representing the program's communities of interest (individuals, groups of individuals, or institutions impacted by the program) designated and charged with assisting the program director and medical director in formulating appropriate goals and standards, monitoring needs and expectations and ensuring program responsiveness to change;(8) submit a completed application to the appropriate regional office;(9) demonstrate substantial compliance with the EMS education standards by successfully completing the self-study/on-site review process outlined in the national education and training standards; and(10) provide a name and contact information for the designated infection control officer and document education for the designated infection control officer based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136.(i) Self-study requirements.(1) A self-study is a self-evaluation and compilation of documents that describes the proposed or existing program's overall process. It shall explain and/or document the program's organizational structure, resources, facilities, record keeping, personnel and their qualifications, policies and procedures, text books, course delivery methods used, clinical and field affiliations, student to patient contact matrix, psychomotor competency evaluations, a copy of all advertisements, documents provided to students and describe what is necessary for students to complete the program.(2) All proposed and/or existing programs must provide a self-study at the basic (ECA and EMT) and/or advanced (AEMT and Paramedic) level. Programs that offer paramedic education may submit a copy of a self-study submitted to national accrediting organizations to meet this requirement. However, they must submit supplemental documentation to demonstrate substantial compliance with the EMS education standards of this section.(A) Each applicant for an EMS Program must submit a self-study that contains the following items:(i) an organizational chart;(ii) a description of the ownership and sponsorship of the proposed or existing program;(iii) a description of financial resources;(iv) a description of the record keeping process for maintaining program, course, and student records;(v) a description of the facilities;(vi) a description of learning resources;(vii) a description of equipment and supplies;(viii) a description of personnel (faculty and staff) and qualifications;(ix) a description of the instructor /faculty credentialing, evaluation and continuing education process.(x) a description of the clinical and field internship affiliations;(xi) a description of the student to patient contact ratio and how it will be tracked and monitored. If an existing program at renewal, include a student patient contact ratio report;(xii) a description of the text books and curriculum;(xiii) a description of the psychomotor competency evaluation process;(xiv) a copy of any policies and procedures used for faculty, staff and students, that address the following:(I) attendance, tardiness, and participation;(II) program medical director change;(III) cheating;(IV) clinical and field internship;(V) complaint resolution;(VI) conduct, safety and health;(VII) counseling and coaching of students;(VIII) dress and hygiene requirements;(IX) grading;(X) grievance and appeals;(XI) immunizations;(XII) policies for the prevention of sexual harassment;(XIII) policies for the prevention of discrimination based on race, sex, creed, national origin, sexual preference, age, handicap or medical problems;(XIV) psychomotor competency evaluation;(XV) record keeping and access to records;(XVI) student faculty relationships;(XVII) student screening and enrollment;(XVIII) test review and makeup; and(XIX) tuition and/or fee reimbursement.(XX) Provide a name and contact information for the designated infection control officer, and document education for the designated infection control officer based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136.(xv) a sample of all advertisements and any documents given to potential students, students and exiting students; and(xvi) a description of any and all requirements for a student to complete a course.(j) Provisional approval. If following the department's review of the self-study, the applicant is found to be in substantial compliance with established national EMS education standards, the department shall issue a provisional approval.(k) Lack of substantial compliance. If following the department's review of the self-study, the applicant is not found in substantial compliance with EMS education standards, the program director and sponsor shall receive a written report detailing:(1) any deficiencies; and(2) specific recommendations for improvement that will be necessary before provisional approval may be granted.(l) On-site review. After the completion of a provisionally-approved program's first course, an on-site review shall be conducted. The on-site review process is the department inspector's review of a proposed and/or existing program's records plan, self-study, equipment, facilities and clinical and field internship facilities, and student-to-patient contact ratios.(1) If the program is found to be in substantial compliance with established EMS education standards and all fees and expenses associated with the self-study and on-site review have been paid, the department shall approve the program for a period of four years and issue an approval number. The program director and sponsor shall receive a written report of the site-review team's findings, including areas of exceptional strength, areas of weakness and recommendations for improvement.(2) If the program is not in substantial compliance with established EMS education standards, the program director and sponsor shall receive a written report detailing deficiencies and specific requirements for improvement. Depending on the nature and severity of the identified deficiencies within the program, the program may or may not be allowed to continue training activities. In all cases, the department in consultation with program officials shall devise a remedial plan for the deficiencies.(3) Upon completion of a remedial plan a program shall be approved for a period of four years.(m) Exception to sponsorship requirements for advanced programs.(1) If an urgent need for an advanced program or an EMS operator instructor program exists in an area and cannot be met by an entity that meets the sponsorship requirements defined in subsection (d) of this section, a licensed EMS provider may request the department to grant an exception to allow the EMS provider to sponsor an advanced program.(2) Such request must be submitted in writing and must include the following:(A) documentation of the need for an advanced program and of the urgency of the situation;(B) documentation that the EMS provider has successfully operated a basic program;(C) documentation of attempts by the EMS provider to affiliate with an entity that meets the requirements of subsection (h)(2) of this section;(D) a letter from the EMS provider agreeing to assume all responsibilities of advanced program sponsorship;(E) letters of intent from qualified providers of clinical and field internship experience appropriate to the level of training to be offered; and(F) a letter of intent from a medical director who will agree to perform the responsibilities listed in subsection (h)(6) of this section.(3) In determining whether the request for an exception is to be approved or denied, the department shall consider, but not be limited to, the following issues:(A) the quality of the basic program previously operated by the EMS provider;(B) evidence that the EMS provider possesses the resources and dedication necessary to operate an advanced program that complies with the EMS education standards;(C) the efforts of the EMS provider to affiliate with an entity that meets the requirements of subsection (h)(2) of this section;(D) the availability of an approved advanced program within a reasonable distance of the affected area;(E) the availability of an approved advanced program that will provide training to the affected area by outreach or distance learning technology;(F) the probable impact on existing approved advanced programs if the exception is approved;(G) the probable adverse consequences to the public health or safety if the exception is not approved; and(H) the written support by the program medical director.(4) After evaluation by the department, the EMS provider shall be notified in writing of the approval or denial of the request.(5) An exception to the requirements of subsection (h)(2) of this section shall meet all other requirements of subsection (h) of this section, including completion of the self-study and the on-site review process, and shall demonstrate substantial compliance with the EMS education standards before being granted approval by the department.(n) National accreditation for paramedic education/training programs.(1) In addition to the requirements listed in subsection (h) of this section, all EMS education/training programs currently conducting paramedic education and training must meet the following requirements to receive approval as a paramedic education and training program:(A) provide proof of accreditation by the CAAHEP/CoAEMSP, or a national accrediting organization recognized by the department; or(B) provide documentation from CAAHEP/CoAEMSP or a national accrediting organization recognized by the department stating the education program has submitted the appropriate documentation that indicates it being in pursuit of accreditation as defined by the CAAHEP/CoAEMSP or a national accrediting organization recognized by the department. The education/training program that is deemed as pursuing accreditation may be temporarily approved by the department. In order to receive program approval, the education/training program must be accredited and provide proof of their accreditation by the national accrediting organization to the department.(2) If the education/training program is not accredited or has their accreditation revoked by the national accrediting organization the program will not be allowed to conduct a paramedic education or training course until the program becomes accredited or the program is recognized by the national accrediting organization as being in pursuit of accreditation.(3) Initial or current education programs that are not accredited and would like to offer paramedic education and training on or after January 1, 2013 must:(A) be approved by the department as an EMS basic education program, according to subsection (g) of this section;(B) submit the appropriate application and fees to the department;(C) meet the accreditation standards set by CAAHEP/CoAEMSP or another department approved national accrediting organization in order for the department to issue the applicant a temporary approval to conduct paramedic education or training courses; and(D) provide proof of accreditation by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department. If the training program does not become accredited the program will not be allowed to conduct another paramedic education or training course until the program becomes accredited or the department receives notification from the accrediting organization that the program is recognized as being in pursuit of accreditation as defined by the accrediting organization.(4) If a program has been accredited by CAAHEP/CoAEMSP or a national accrediting organization recognized by the department, the department may exempt the program from the program approval or re-approval process.(5) Programs accredited by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department shall provide the department with copies of:(A) the accreditation self study;(B) the accreditation letter or certificate; and(C) any correspondence or updates to or from the national accrediting organization that impact the program's status.(6) On request of the department, programs shall permit the department's representatives to participate in site visits performed by national accrediting organizations.(7) If the department takes disciplinary action against a nationally accredited program for violations that could indicate substantial noncompliance with a national accrediting organization's essentials or standards, the department shall advise the national accrediting organization of the action and the evidence on which the action was based.(8) If a program's national accreditation lapses or is withdrawn, the program shall meet all requirements of this subsection or subsection (g) or (h) of this section within a reasonable period of time as determined by the department.(o) Denial of program approval. A program may be denied approval, provisional approval, or re-approval for, but not limited to, the following reasons:(1) failure to meet the requirements established in subsection (g), (h) or (m) of this section;(2) failure, or previous failure, to meet program responsibilities as defined in subsection (p) of the this section;(3) conduct, or previous conduct, that is grounds for suspension or revocation of program approval as defined in subsection (u) of this section;(4) falsifying any information, record, or document required for program approval, provisional approval, or re-approval;(5) misrepresenting any requirements for program approval, provisional approval, or re-approval;(6) failing or refusing to submit a self-study or a required report of progress toward remediation of a documented program weakness or areas of non-compliance within a reasonable period of time as determined by the department;(7) failing or refusing to accept an on-site program review by a reasonably scheduled date as determined by the department;(8) issuing a check to the department which is returned unpaid;(9) being charged with criminal activity while approved to provide EMS training;(10) having disciplinary action imposed by the department on the provider license, personnel certification or licensure, or program for violation of any provision of Health and Safety Code, Chapter 773 or 25 Texas Administrative Code, Chapter 157; or(11) failure of a paramedic program to become accredited or maintain their accreditation by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department.(p) Responsibilities. A program shall be responsible to:(1) plan for and evaluate the overall operation of the program;(2) provide supervision and oversight of all courses for which the program is responsible;(3) act as liaison between students, the sponsoring organization and the department;(4) submit course notifications and approval applications, along with nonrefundable fees if applicable, to the department;(5) assure availability of classroom(s) and other facilities necessary to provide for instruction and convenience of the students enrolled in courses for which the program is responsible;(6) screen student applications, verify prerequisite certification if applicable and select students;(7) schedule classes and assign course coordinators and/or instructors;(8) verify the certification, license, or other proper credentials of all personnel who instruct in the program's courses;(9) maintain an adequate inventory of training equipment, supplies and audio- visual resources based on the National EMS Education Standards, and course medical director;(10) assure that training equipment and supplies are available and operational for each laboratory session;(11) secure and maintain affiliations with clinical, and field internship facilities necessary to meet the instructional objectives of all courses for which the program is responsible;(12) develop field internship and clinical objectives for all courses for which the program is responsible;(13) train and evaluate internship preceptors;(14) obtain written acknowledgement from the field internship EMS provider medical director, if students will be conducting advanced-level skills as part of their field internship with that EMS provider;(15) maintain all course records for a minimum of 5 years;(16) along with the course coordinator develop and use valid and reliable written examinations, skills proficiency verifications, and other student evaluations;(17) along with the course coordinator and medical director, supervise and evaluate the effectiveness of personnel who instruct in the program's courses;(18) along with the course coordinator and medical director, supervise and evaluate the effectiveness of the clinical and EMS field internship training;(19) along with the course coordinator, attest to the successful course completion of all students who meet the programs requirements for completion;(20) provide the department with information and reports necessary for planning, administrative, regulatory, or investigative purposes;(21) provide the department with any information that will affect the program's interaction with the department, including but not limited to changes in:(A) program director;(B) course coordinators;(C) medical director;(D) classroom training facilities;(E) clinical or field internship facilities; and(F) program's physical and mailing address;(22) provide proof of accreditation by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department;(23) submit a roster of all enrolled students when requested by the department;(24) submit a final student roster when requested by the department; and(25) online and or distance learning classes, programs and courses must meet the same standards as outlined in this section.(q) Program Re-approval.(1) Prior to the expiration of a program's approval period, the department shall send a notice of expiration to the program at the address shown in the current records of the department.(2) If a program has not received notice of expiration from the department 45 days prior to the expiration, it is the program's duty to notify the department and request an application for re-approval. Failure to apply for re-approval shall result in expiration of approval.(3) Programs that have obtained approval as of the effective date of this rule shall be considered to have met the requirements of subsection (g) or (h) of this section appropriate to their current level of approval.(4) To be eligible for re-approval, the program shall meet all the requirements in subsections (g), (h) or (m) of this section as appropriate to the level of approval requested; and(A) prepare an update to the program's self-study that addresses significant changes in the program's personnel, structure, curriculum, resources, policies, or procedures;(B) document progress toward correction of any deficiencies identified by the program or the department through the self-study and on-site review process;(C) host an on-site review if one is deemed necessary by the department or requested by the program; and(D) a paramedic program must provide documentation of current accreditation from CoAEMSP or another national accrediting organization recognized by the department.(r) Fees.(1) The following nonrefundable fees shall apply:(A) $30 for review of a basic self-study, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training;(B) $90 for conducting a basic site visit;(C) $60 for review of an advanced self-study, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training;(D) $250 for conducting an advanced site visit;(E) $30 for processing a basic course notification or approval application, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training; and(F) $60 for processing an advanced course notification or approval application, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training.(2) Program approvals shall be issued only after all required nonrefundable fees have been paid.(s) Course Notification and Approval.(1) Each course conducted by an approved program shall be approved by notice from the department and the issuance of an assigned course number. A program shall not start a course, advertise a course, or collect tuition and/or fees from prospective students until the course is approved by the department and the assigned course number issued.(2) The program director of an approved program shall submit notice of intent to conduct a course and the appropriate fee, if required, to the department on a form provided by the department at least 30 days prior to the proposed start date of the course. The notification shall include the following information:(A) training level of course;(B) dates and times classes are to be conducted;(C) physical location of the classroom;(D) identification of clinical sites and internship providers, if required;(E) name of principle instructor;(F) enrollment status;(G) anticipated number of students;(H) number of contact hours;(I) amount of tuition to be charged;(J) proposed ending date of the course; and(K) signature of the program director.(3) A nonrefundable course fee, unless program is not remunerated for the course in any way, shall be submitted as follows:(A) $30 for a Basic Course (ECA or EMT);(B) $60 for an Advanced Course (AEMT or Paramedic);(C) $30 for an EMS Instructor Course; and(D) $60 for an Emergency Medical Information Operator Instructor Course.(4) The department may require submission of a written course approval application, in accordance with the guidelines set forth in the education and training standards, in lieu of the course notification from programs which:(A) have not successfully completed a site visit review;(B) have proposed courses which do not conform to the approved parameters of the current program standards;(C) have not conducted a course of the same level in the previous 12 months; or(D) the department has probable cause to suspect are in noncompliance with the provisions of this chapter.(t) Denial of a course notification or course approval. A course may be denied for, but not limited to the following:(1) submission of an incomplete application;(2) failure to meet all requirements as outlined in this section;(3) failure of the program to hold current approval to conduct the level of the course proposed;(4) failure to follow the guidelines for submission of the course notification or course approval application and supporting documents;(5) falsification or misrepresentation of any information required for course notification or course approval; and/or(6) issuing a check which is returned unpaid.(u) Disciplinary actions.(1) Emergency suspension. The department may issue an emergency order to suspend a program's approval if the department has reasonable cause to believe that the conduct of the program creates an immediate danger to the public health or safety.(A) An emergency suspension shall be effective immediately without a hearing or written notice to the program. Notice to the program shall be presumed established on the date that a copy of the emergency suspension order is sent to the address shown in the current records of the department. Notice shall also be sent to the program's sponsoring entity.(B) If a written request for a hearing is received from the program, the department shall conduct a hearing not earlier than the 10th day nor later than the 30th day after the date on which the hearing request is received to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and appeal from any disciplinary action related to the hearing shall be governed by the Administrative Procedure Act, Government Code, Chapter 2001.(2) Non-emergency suspension or revocation. A program's approval may be suspended or revoked for, but not limited to, the following reasons:(A) failing to comply with the responsibilities of a program as defined in subsection (o) of this section;(B) failing to maintain sponsorship as identified in the program application and self-study;(C) failing to maintain employment of at least one course coordinator whose current certifications are appropriate for the level of the program;(D) falsifying a program approval application, a self-study, a course notification or course approval application, or any supporting documentation;(E) falsifying a course completion certificate or any other document that verifies course activity and/or is a part of the course record;(F) assisting another to obtain or to attempt to obtain personnel certification or recertification by fraud, forgery, deception, or misrepresentation;(G) failing to complete and submit course notifications or course approval applications and student documents within established time frames;(H) offering or attempting to offer courses above the program's level of approval;(I) compromising or failing to maintain the integrity of a department-approved training course or program;(J) failing to maintain professionalism in a department-approved training course or program;(K) demonstrating a lack of supervision of course coordinators or personnel instructing in the program's courses;(L) compromising an examination or examination process administered or approved by the department;(M) accepting any benefit to which there is no entitlement or benefitting in any manner through fraud, deception, misrepresentation, theft, misappropriation, or coercion;(N) failing to maintain appropriate policies, procedures, and safeguards to ensure the safety of students, instructors, or other course participants;(O) allowing recurrent use of inadequate, inoperable, or malfunctioning equipment;(P) maintaining a passing rate on the examinations for certification or licensure that is statistically and significantly lower than the state average;(Q) failing to maintain the fiscal integrity of the program;(R) issuing a check to the department which is returned unpaid;(S) failing to maintain records for initial or continuing education courses;(T) demonstrating unwillingness or inability to comply with the Health and Safety Code and/or rules adopted thereunder;(U) failing to give the department true and complete information when asked regarding any alleged or actual violation of the Health and Safety Code or the rules adopted thereunder;(V) committing a violation within 24 months of being placed on probation;(W) offering or attempting to offer courses during a period when the program's approval is suspended;(X) a paramedic program receiving revocation of their accreditation by CAAHEP/CoAEMSP or any other organization that provides nationally recognized EMS accreditation; and/or(Y) for starting a course, program or class before receiving official approval from the department.(3) Notification. If the department proposes to suspend or revoke a program's approval, the program shall be notified at the address shown in the current records of the department. The notice shall state the alleged facts or conduct warranting the action and state that the program has an opportunity to request a hearing in accordance with Administrative Procedure Act, Government Code, Chapter 2001.(A) The program may request a hearing. The request shall be in writing and submitted to the department.(B) If the program does not request a hearing within 30 days after the date of the notice of opportunity, the program waives the opportunity for a hearing and the department shall implement its proposal.(4) Probation. The department may probate any penalty assessed under this section and may specify terms and conditions of any probation issued.(5) Re-application.(A) Two years after the revocation or denial of approval, the program may petition the department in writing for the opportunity to reapply.(B) The department shall evaluate the petition and may allow or deny the opportunity to submit an application.(C) In evaluating a petition for permission to reapply, the department shall consider, but is not limited to, the following issues:(i) likelihood of a repeat of the violation that led to revocation;(ii) the petitioner's overall record as a program;(iii) letters of support or recommendation;(iv) letters of protest or non-support of the petition; and(v) the need for training in the area the program would serve.(D) The petitioner shall be notified within 60 days at the address shown in the current records of the department of the decision to allow or deny the submission of an application for re-approval.(6) A program whose approval expires during a suspension or revocation period may not petition to reapply until the end of the suspension or revocation period.(v) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with the application and renewal application processing through Texas Online. Source Note: The provisions of this §157.32 adopted to be effective February 7, 2001, 26 TexReg 1145; amended to be effective June 1, 2004, 29 TexReg 4492; amended to be effective August 16, 2012, 37 TexReg 6035; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.32 Emergency Medical Services Education Program and Course Approval https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197187&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197187 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197187&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197187 03/11/2026 (a) Certification requirements. A candidate for emergency medical services (EMS) certification shall:(1) be at least 18 years of age;(2) have a high school diploma or GED certificate:(A) the high school diploma must be from a school accredited by the Texas Education Agency (TEA) or a corresponding agency from another state. Candidates who received a high school education in another country must have their transcript evaluated by a foreign credentials evaluation service that attests to its equivalency. A home school diploma is acceptable;(B) an emergency care attendant (ECA) who provides emergency medical care exclusively as a volunteer for a licensed provider or registered FRO is exempt from paragraph (2) of this subsection.(3) have successfully completed a Department of State Health Services (department)-approved course; and(4) The candidate has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.(5) submit an application, meeting the requirements in §157.3 of this title (relating to Processing EMS Provider Licenses and Applications for EMS Personnel Certification and Licensing), and the following nonrefundable fees as applicable:(A) $60 for emergency care attendant (ECA) or emergency medical technician (EMT);(B) $90 for AEMT or EMT-paramedic (EMT-P); and(C) EMS volunteer--no fee. However, if such an individual receives compensation during the certification period, the exemption ceases and the individual shall pay a prorated fee to the department based on the number of years remaining in the certification period when employment begins. The nonrefundable fee for ECA or EMT certification shall be $15 per each year remaining in the certification. The nonrefundable fee for AEMT or EMT-P shall be $22.50 per each year remaining in the certification. Any portion of a year will count as a full year;(6) provide evidence of current active or inactive National Registry certification at the appropriate level. National Registry First Responder certification is considered the appropriate corresponding certification level for an ECA; and(7) submit fingerprints through the state approved fingerprinting service to undergo an FBI fingerprint criminal history check.(b) Length of certification. A candidate who meets the requirements of subsection (a) of this section shall be certified for four years beginning on the date of issuance of a certificate and wallet-size certificate. A candidate must verify current certification before staffing an EMS vehicle. Certification may be verified by the applicant's receipt of the official department identification card, by using the department's certification website.(c) Scheduling authority for certification examinations.(1) Examinations shall be administered at regularly scheduled times in various locations across the state.(2) The candidate shall be responsible for making appropriate arrangements for the examination.(3) The department is not required to set special examination schedules for a single candidate or for a specific group of candidates.(d) Time limits for completing requirements.(1) An initial candidate for certification shall complete all requirements for certification no later than two years after the candidate's course completion date. The application will expire two years from the date the mailed application is postmarked, or the date a faxed, online submission or hand- delivered application is received at the department.(A) The National Registry certification described in subsection (a)(5) of this section must remain current until the final requirement for state certification is met.(B) The applicant shall update the application if any changes occur between the time of original submission and the time the final requirement for certification is met.(2) A candidate who does not complete all requirements for certification within two years of the candidate's initial course completion date must meet the requirements of subsection (a) of this section, including the completion of another initial course to achieve certification.(e) Non-transferability of certificate. A certificate is not transferable. A duplicate certificate may be issued if requested with a nonrefundable fee of $10.(f) A candidate may apply for a lower level than the level of National Registry certification held.(g) Voluntary downgrades.(1) An individual who holds a current Texas EMS certification or paramedic license may be certified at a lower level voluntarily for the remainder of the certification period by submitting an application for the lower level certification and the applicable nonrefundable fee as required in subsection (a)(4) of this section.(2) On the date the downgrade is final, the previous higher level of certification/license shall be surrendered. To regain the original higher level of certification, the candidate shall follow late recertification procedures according to §157.34(e) of this title (relating to Recertification), within one year after the surrender date.(h) Inactive certification. A certified EMT, AEMT, or EMT-P may make application to the department for inactive certification at any time during the certification period or within one year after the certificate expiration date.(1) The request for inactive certification shall be accompanied by a nonrefundable fee of $30 in addition to the regular nonrefundable fee in subsection (a)(4)(A) and (B) of this section. If the final requirement is completed during the one-year period after expiration, the application fees listed in §157.34(e) of this title will be required. Volunteers are not exempt from inactive fees.(2) Period of inactive certification.(A) The inactive certification period shall begin upon date of issuance of the notice of inactive certification and remain in effect until the end of the original active certification period for those candidates who are currently certified. The candidate's active certification is surrendered upon issuance of the notice of inactive certification.(B) If the candidate is within the final year of active certification and chooses to renew with inactive certification, the inactive certification begins on the first day after the expiration of the current active certificate and shall remain in effect for four years.(C) If the candidate applies during and/or completes the final requirement for inactive certification within one year after the expiration of active certification, the inactive certification period shall remain in effect for four years from the date of issuance of the notice of inactive certification.(3) While on inactive certification, a person shall not practice other than to act as a bystander rendering first aid or cardiopulmonary resuscitation (CPR) or the use of an Automated External Defibrillator in the capacity of a layperson. Practicing in any other capacity for compensation or as a volunteer shall be cause for denial of reentry and decertification.(4) An individual shall not simultaneously hold inactive and active certification.(i) Reciprocity.(1) A person who is currently certified by the National Registry but did not complete a department-approved course may apply for the equal or lower level Texas certification by submitting a reciprocity application and a nonrefundable fee of $120.(A) Applicants holding National Registry AEMT certification may be required to submit written verification of proficiency of AEMT skills from an approved education program.(B) National Registry first responder certification is not eligible for reciprocity at the ECA level.(C) A candidate will not be eligible for reciprocity if the National Registry certification expires prior to the completion of all requirements for certification as listed in this section.(D) A candidate who meets the requirements of this section shall be certified for four years beginning on the date of issuance of a certificate and wallet-size certificate.(E) The candidate has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.(2) A person currently certified by another state may apply for equal or lower level Texas certification by submitting a reciprocity application and a nonrefundable fee of $120.(A) The candidate must pass the National Registry assessment exam.(B) Applicants holding AEMT out-of-state certification must submit written proof of proficiency on all of the AEMT skills signed by a Texas certified EMS coordinator or instructor.(C) All applicants shall submit fingerprints through the state approved fingerprinting service to undergo an FBI fingerprint criminal history check.(D) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.(E) Reciprocity is not allowed for the ECA level.(F) A candidate will not be eligible for reciprocity if the out-of-state certification expires prior to the completion of all requirements for certification as listed in this section.(G) A candidate who meets the requirements of this section shall be certified for four years beginning on the date of issuance of a certificate and wallet-size certificate.(3) Personnel receiving department issued certification through reciprocity must recertify prior to the expiration of the certificate by following the requirements in §157.34 of this title.(j) Equivalency.(1) Candidates meeting the following criteria may apply for certification only through the equivalency process as described in this subsection:(A) an individual who completed EMS training outside the United States or its possessions;(B) an individual who is certified or licensed in another healthcare discipline;(C) an individual whose department issued EMS certification or license has been expired for more than one year; or(D) an individual who has held department issued inactive certification for more than four years.(2) A candidate applying for certification by equivalency shall:(A) submit a copy of the curriculum and work history completed by the candidate to a regionally accredited post-secondary institution approved by the department to sponsor an EMS education program for its review;(B) obtain a course completion document that verifies that the program is satisfied that all curriculum requirements have been met. Evaluations of curricula conducted by post-secondary educational institutions under this subsection shall be consistent with the institution's established policies and procedures for awarding credit by transfer or advanced placement;(C) the candidate may then apply for initial certification with the department as described in subsection (a) of this section; and(D) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.(k) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.(l) Applicant immunization history.(1) If the applicant's immunization history is included in the immunization registry as defined by Health and Safety Code §161.007, the department shall provide the applicant notice of the applicant's immunization history using information from the immunization registry.(2) If the applicant's immunization history is not included in the immunization registry, the department shall provide:(A) details about the program developed under Health and Safety Code, §161.00707; and(B) the specific risks to emergency medical services personnel when responding rapidly to an emergency of exposure to and infection by a potentially serious or deadly communicable disease that an immunization may prevent.(m) Responsibilities of the EMS personnel. During the license period, the EMS Personnel responsibilities shall include:(1) making accurate, complete and/or clearly written patient care reports including documenting a patient's condition upon the EMS personnel's arrival at the scene and patient's status during transport, including signs, symptoms, and responses during duration of transport as per EMS provider's approved policy;(2) reporting to the employer, appropriate legal authority or the department, of abuse or injury to a patient or the public within 24 hours or the next business day after the event;(3) following the approved medical director's protocol and policies;(4) taking precautions to prevent the misappropriation of medications, supplies, equipment, personal items, or money belonging to the patient, employer or any person or entity;(5) maintaining skill and knowledge to perform the duties or meet the responsibilities required of current level of EMS certification; and(6) notifying the department of a current and/or valid mailing address within 30 days of any changes. Source Note: The provisions of this §157.33 adopted to be effective August 31, 2006, 31 TexReg 6739; amended to be effective February 12, 2017, 42 TexReg 430; amended to be effective December 5, 2019, 44 TexReg 7396. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.33 Certification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197188&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197188 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197188&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197188 03/11/2026 (a) Recertification requirements. (1) Not later than the 30th day before the date a person's certificate is scheduled to expire, the Department of State Health Services (department) may send to the person a notice of expiration at the address shown in the current records of the department. (2) If a certificant has not received a notice of expiration from the department 30 days prior to the expiration, it is the duty of the certificant to notify the department and to request an application for recertification or download an application from the Internet. (3) To maintain certification status without a lapse, an applicant shall submit a completed application for recertification and shall meet all requirements for renewal of the current certification prior to the expiration date of the current certificate, but no earlier than one year prior to the expiration date. (4) The certificant shall submit the following non-refundable fees as applicable: (A) $60 for Emergency Care Attendant (ECA) or Emergency Medical Technician (EMT); (B) $90 for Advanced EMT (AEMT), EMT-Intermediate (EMT-I), or EMT-Paramedic (EMT-P); and (C) EMS volunteer--no fee. However, if such an individual receives compensation during the certification period, the exemption ceases and the individual shall pay a prorated fee to the department based on the number of years remaining in the certification period when employment begins. The non-refundable fee for ECA or EMT certification shall be $15 per each year remaining in the certification. The non-refundable fee for AEMT or EMT-P shall be $22.50 per each year remaining in the certification. Any portion of a year will count as a full year. (5) Recertification by voluntary downgrade. An individual who holds a Texas EMS certification or paramedic license may renew at a lower level by meeting the requirements of this subsection. The applicant must meet the requirements for the lower level of certification requested as described in subsection (b) or (f) or (g) of this section. On the date the downgrade is final, the previous higher level of certification becomes invalid. To regain the original higher level of certification, the candidate shall meet the late recertification requirements outlined in subsection (g) of this section, within one year after the expiration date. (6) A certificate is not transferable. (7) Military personnel. A person certified by the department who is deployed in support of military, security, or other action by the United Nations Security Council, a national emergency declared by the President of the United States, or a declaration of war by the United States Congress is eligible for recertification under timely recertification requirements from the person's date of demobilization until one calendar year after the date of demobilization but will not be certified during that period. (A) In addition to requirements described in this subsection, the candidate shall submit a copy of deployment and demobilization orders. (B) The four-year certification will commence on issue date of the certificate. (b) Recertification options. Upon submission of a completed application for recertification, the applicant shall commit to, and recertify through one of the options described in paragraphs (1) - (5) of this subsection. (1) Option 1--Written Examination Recertification Process. (A) The applicant shall pass the National Registry assessment exam. An overall score of 70 is considered to be passing. (B) If the applicant fails the examination for recertification, the applicant may attempt two retests of the examination after: (i) submitting a retest application for each attempt at any eligible level; and (ii) submitting a non-refundable retest fee of $30 for each attempt. (C) For each subsequent retest attempt, an applicant may apply for and retest at a lower level by complying with paragraph (1)(B) of this subsection, if applicable. (D) An applicant who selects option 1 and attempts the exam but does not pass the National Registry assessment examination may not gain recertification by any other option and shall not qualify for inactive certification addressed in §157.33(h) of this title (relating to Certification) or subsection (f) or (g) of this section. (E) An applicant who does not pass the third attempt at the National Registry assessment examination: (i) shall successfully complete a Formal Recertification Course as described in paragraph (4) of this subsection; and (ii) shall submit a course completion certificate of the Formal recertification course, reflecting that the course was completed after the 2nd retest failure; and (iii) shall pass the National Registry assessment examination in accordance with the provisions in subparagraphs (A) - (D) of this paragraph. (iv) shall not qualify for more than a total of six attempts at the exam, in any combination of levels attempted. (F) The certification status of an applicant who does not successfully complete the examination recertification process as described in paragraph (1)(A) - (E) of this subsection shall expire on the date of the current certificate. (G) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies. (2) Option 2--Continuing Education Recertification Process. (A) The certificant shall attest to accrual of department approved EMS continuing education as specified in §157.38 of this title (relating to Continuing Education); and (B) the applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies. (3) Option 3--National Registry Recertification Process. (A) The applicant shall attest to and hold current National Registry certification at the time of applying for recertification; and (B) the applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies. (4) Option 4--Formal Course Recertification Process. The applicant shall attest to successful completion of a department approved recertification course. (A) The recertification course shall be a formal structured interactive training course as approved by the department and conducted within the four-year certification period. (B) The minimum contact hours required for recertification courses are: Attached Graphic(C) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies. (5) Option 5--CCMP Recertification Process. An applicant affiliated with an EMS provider that has a department-approved Comprehensive Clinical Management Program (CCMP) may be recertified if: (A) the applicant is currently credentialed in the provider's CCMP; (B) the applicant has been enrolled in the provider's CCMP for at least six continuous months; (C) the applicant submits to the department a signed written statement by the CCMP's medical director, attesting to the applicant's successful participation in and completion of the provider's CCMP; and (D) The applicant has completed a state approved jurisprudence examination to determine the knowledge that the applicant has on state EMS laws, rules, and policies. (6) If a candidate wishes to change options (other than option 1), another application form must be submitted. An additional fee is not required if the candidate completes all requirements within the same time period of the original submission. (c) After verification by the department of the information submitted by the applicant, that the information is true, correct and complete with regard to the applicant meeting recertification requirements by the certification expiration date, the department shall recertify the applicant for four years, commencing on the day following the expiration date of the most recent certificate. A candidate must verify current certification before staffing an EMS vehicle. Certification may be verified by the applicant's receipt of the official department identification card, by using the department's certification website, or by contacting the department directly. (d) Applicant immunization history.(1) If the applicant's immunization history is included in the immunization registry as defined by Health and Safety Code, §161.007, the department shall provide notice of the applicant's immunization history using information from the immunization registry.(2) If the applicant's immunization history is not included in the immunization registry, the department shall provide:(A) details about the program developed under Health and Safety Code §161.00707; and(B) the specific risks to emergency medical services personnel when responding rapidly to an emergency of exposure to and infection by a potentially serious or deadly communicable disease that an immunization may prevent.(e) Late recertification. (1) The candidate whose certification has expired shall be considered late, non-certified and shall not function in the capacity of an EMS certificant or represent that he is EMS certified until recertification is issued. (2) A candidate whose certificate has been expired for 90 days or less may renew the certificate by submitting an application accompanied by a non-refundable renewal fee that is equal to 1-1/2 times the normally required application renewal fee for that level as listed in subsection (a)(4) of this section. Applicant shall meet one of the recertification options described in subsection (b)(1) - (5) of this section and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of 1-1/2 times the normally required application renewal fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance. (3) A candidate whose certificate has been expired for more than 90 days but less than one year may renew the certificate by submitting an application accompanied by a non-refundable renewal fee that is equal to two times the normally required application renewal fee as listed in subsection (a)(4) of this section. Applicant shall meet one of the recertification options described in subsection (b)(2) - (6) of this section and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times the fee shall be necessary. (4) The applicant shall be recertified for a period of four years beginning on the date of issuance. (5) A candidate whose certificate has been expired for one year or more may not renew the certificate. The candidate may become certified by complying with the requirements of §157.33(a) or (j) of this title. (6) A candidate who was certified in this state, moved to another state, and is currently certified or licensed and has been in practice in the other state for two years preceding the date of application may become certified without reexamination. The candidate may gain recertification by: (A) submitting to the department a non-refundable fee that is equal to two times the normally required renewal fee for certification as listed in subsection (a)(4) of this section; and (B) attesting to regular practice of emergency medical care in the other state for the two years preceding the date of application. (f) Renewal of inactive certification. (1) To renew inactive certification, an applicant holding inactive certification shall submit an application and the non-refundable fee as described in §157.33(a)(4) of this title. The $30 inactive fee is not required for renewal when renewing inactive certification. A candidate who meets requirements for inactive renewal shall be awarded inactive certification for a period of four years beginning on the first day after the expiration of the previous inactive certification. (2) A candidate whose inactive certification has been expired for 90 days or less may renew the inactive certification during the 90 day period after expiration of the certification upon submitting a fee of 1-1/2 times the normally required renewal fee as described in subsection (a)(4) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of 1-1/2 times the fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance. (3) A candidate whose inactive certification has been expired more than 90 days but less than one year may renew the inactive certification upon submitting a fee of two times the normally required renewal fee as described in subsection (a)(4) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times the fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance. (4) A candidate whose inactive certificate has been expired more than one year must regain active certification before reapplying for inactive certification as described in subsection (g) of this section. (g) Inactive to active certification. (1) An inactive certificant prior to the expiration of the first four-year inactive certification period may obtain active certification by submitting an application and the non-refundable fee to the department, as described in subsection (a)(4) of this section and by completing one of the following options: (A) Option 1--meet the normal four year continuing education requirement for certification renewal as listed in subsection (b)(2) of this section, submit verification of skills proficiency from an approved education program or recognized physician by the department, and pass the National Registry EMT cognitive assessment exam. (B) Option 2--complete a department approved recertification course, and pass the National Registry EMT psychomotor (practical) exam and cognitive assessment exam. (2) A certificant who has held inactive certification for more than four years may return to active certification only by completing requirements described in §157.33(a) or (j) of this title. (h) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §157.34 adopted to be effective August 31, 2006, 31 TexReg 6739; amended to be effective February 12, 2017, 42 TexReg 430; amended to be effective December 5, 2019, 44 TexReg 7396. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.34 Recertification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182747&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182747 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182747&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182747 03/11/2026 (a) Emergency Suspension. The commissioner or his/her designee shall issue an emergency suspension order to any emergency medical services (EMS) certificant or licensee if the commissioner or his/her designee has reasonable cause to believe that the conduct of any certificant or licensee creates an imminent danger to public health or safety.(1) An emergency suspension issued by the commissioner or designee shall be effective immediately without a hearing on notice to the certificant or licensee. Notice to the certificant or licensee shall be established on the date that a copy of the signed emergency suspension order is sent to the address shown in the current records of the department.(2) A copy of the emergency suspension order shall be sent to any licensed EMS provider, first responder organization, medical director, institution or facility with which the certificant or licensee is known to be associated, at the address shown in the current records of the department.(3) If a written request for a hearing is received from the suspended individual within 15 days of the date of suspension, the department shall conduct a hearing not later than the thirtieth day after the date on which a hearing request is received to determine if the emergency suspension is to be continued, modified or rescinded. The hearing and appeal from any disciplinary action related to the hearing shall be governed by the Administrative Procedure Act, Government Code, Chapter 2001.(b) Disciplinary Action. The department may suspend, revoke, or refuse to renew an EMS certification or paramedic license, or may reprimand a certificant or licensed paramedic for, but not limited to, the following reasons:(1) violating any provision of the Health and Safety Code, Chapter 773, and/or 25 Texas Administrative Code, as well as Federal, State, or local laws, rules or regulations affecting, but not limited to, the practice of EMS;(2) any conduct which is criminal in nature and/or any conduct which is in violation of any criminal, civil and/or administrative code or statute;(3) failing to make accurate, complete and/or clearly written patient care reports documenting a patient's condition upon arrival at the scene, the prehospital care provided, and patient's status during transport, including signs, symptoms, and responses during duration of transport as per EMS provider's approved policy;(4) falsifying any EMS record; patient record or report; or making false or misleading statements in a oral report; or destroying a patient care report;(5) disclosing confidential information or knowledge concerning a patient except where required or allowed by law;(6) causing or permitting physical or emotional abuse or injury to a patient or the public, and/or failing to report such abuse or injury to the employer, appropriate legal authority and/or the department(7) failing to report to the employer, appropriate legal authority or the department, the event of abuse or injury to a patient or the public within 24 hours or the next business day after the event;(8) failure to follow the medical director's protocol, performing advanced level or invasive treatment without medical direction or supervision, or practicing beyond the scope of certification or licensure;(9) failing to respond to a call while on duty and/or leaving duty assignment without proper authority;(10) abandoning a patient;(11) turning over the care of a patient or delegating EMS functions to a person who lacks the education, training, experience, or knowledge to provide appropriate level of care for the patient;(12) failing to comply with the terms of a department ordered probation or suspension;(13) issuing a check to the department which has been returned to the department or its agent unpaid;(14) discriminating in any way based on real or perceived conditions of national origin, race, color, creed, religion, sex, sexual orientation, age, physical disability, mental disability, or economic status;(15) misrepresenting level of any certification or licensure;(16) misappropriating medications, supplies, equipment, personal items, or money belonging to the patient, employer or any other person or entity;(17) failing to take precautions to prevent misappropriating medications, supplies, equipment, personal items, or money belonging to the patient, employer or any person or entity;(18) falsifying or altering, or assisting another in falsifying or altering, any department application, EMS certificate or license; or using or possessing any such altered certificate or license;(19) committing any offense during the period of a suspension/probation or repeating any offense for which a suspension/probation was imposed within the two-year period immediately following the end of the suspension or probation;(20) cheating and/or assisting another to cheat on any examination, written or psychomotor, by any provider licensed by the department or any institution or entity conducting EMS education and/or training or providing an EMS examination leading to obtaining certification or renewing certification or license;(21) obtaining or attempting to obtain and/or assisting another in obtaining or attempting to obtain, any advantage, benefit, favor or gain by fraud, forgery, deception, misrepresentation, untruth or subterfuge;(22) illegally possessing, dispensing, administering or distributing, or attempting to illegally dispense, administer, or distribute controlled substances as defined by the Health and Safety Code, Chapter 481 and/or Chapter 483;(23) having received disciplinary action relating to an EMS certificate or license or another health provider certificate or license issued in another state or in a U.S. Territory or in another nation, or having received disciplinary action relating to another health provider certificate or license issued in Texas;(24) failing or refusing to timely give the department full and complete information requested by the department;(25) failing to notify the department of a change in his or her criminal history within 30 business days of the issuance of a court order, which resulted in him or her being convicted or placed on a deferred adjudication community supervision or deferred disposition for any criminal offense, other than any class C misdemeanor not directly related to EMS or other than any offense noted in §157.37(e)(5) of this title (relating to Certification or Licensure of Persons With Criminal Backgrounds);(26) failing to notify the department within 5 business days of his or her being arrested, charged or indicted for any criminal offense, other than any class C misdemeanor not directly related to EMS or other than any offense noted in §157.37(e)(5) of this title;(27) failing to notify the department of a change in his or her criminal history within 5 business days of the issuance of a court order, which resulted in him or her being convicted or placed on deferred adjudication community supervision, or deferred disposition for any offense noted in §157.37(e)(5) of this title;(28) failing to notify the department within 5 business days of his or her being arrested, charged or indicted for a criminal offense noted in §157.37(e)(5) of this title;(29) having been convicted or placed on deferred adjudication community supervision, or deferred disposition for a criminal offense that directly relates to the duties and responsibilities of EMS personnel, as determined by the provisions of §157.37 of this title, except that a person's EMS certification or paramedic license shall be revoked if the certificant or licensed paramedic is convicted, or placed on deferred adjudication community supervision or deferred disposition for a criminal offense, noted in §157.37(e)(5) of this title;(30) failing to timely complete any portion of the criminal history evaluation process, including submission of fingerprints, or timely providing information requested by the department within 60 days of notification to do so, in accordance with provisions in §157.37 of this title;(31) engaging in any conduct that jeopardizes or has the potential to jeopardize the health or safety of any person;(32) using alcohol or drugs to such an extent that in the opinion of the commissioner or his/her designee, the health or safety of any persons or may be endangered;(33) failure by the employee, of an employer drug screening test right before, after or during an assigned EMS work or volunteer shift;(34) resigning employment or refusing by the employee, of an employer drug screening test right before, after or during an assigned EMS work or volunteer shift;(35) engaging in any activity that betrays the patient privacy perspective or public trust and confidence in EMS;(36) failing to maintain a substantial amount of skill, knowledge and/or academic acuity to timely and/or accurately perform the duties or meet the responsibilities required of a certified emergency medical technician or licensed paramedic;(37) delegating medical functions to other EMS personnel without approval from the medical director per approved protocols;(38) failing to transport a patient and/or transport a patient to the appropriate medical facility according to the criteria for selection of a patient's destination established by the medical director;(39) failing to document no-transports and refusals of care and/or follow the criteria under which a patient might not be transported, as established by the medical director;(40) failing to contact medical control and/or the medical director as required by the medical director's protocols and/or EMS provider's policy and procedure when caring for or transporting a patient;(41) failing to protect and/or advocate for patients/clients and/or the public from unnecessary risk of harm from another EMS certified or licensed personnel;(42) falsifying employment or volunteer medical profession applications and/or failing to answer specific questions that would have affected the decision to employ or otherwise utilize while certified or licensed as an EMS personnel;(43) behaving in a disruptive manner toward other EMS personnel, law enforcement, firefighters, hospital personnel, other medical personnel, patients, family members or others, that interferes with patient care or could be reasonably expected to adversely impact the quality of care rendered to a patient;(44) failing to notify the department no later than 30 days of a current and/or valid mailing address;(45) falsifying or altering clinical and/or internship documents for EMS students;(46) falsifying or failing to complete daily readiness checks on EMS vehicles, medical supplies and/or equipment as required by EMS employers;(47) engaging in acts of dishonesty which relate to the EMS profession and/or as determined by the department;(48) behavior that exploits the EMS personnel-patient relationship in a sexual way. This behavior is non-diagnostic and/or non-therapeutic, may be verbal or physical, and may include expressions or gestures that have sexual connotation or that a reasonable person would construe as such;(49) falsifying information provided to the department; and(50) engaging in a pattern of behavior that demonstrates routine response to medical emergencies without being under the policies and procedures of an EMS provider and/or first responder organization, and/or providing patient care without medical direction when required.(c) Criteria for Denial of EMS Certification, or Paramedic Licensure. An EMS certification or paramedic license may be denied for, but not limited to, the following reasons:(1) failing to meet standards as required in this section;(2) previous conduct of the applicant during the performance of duties that are similar to those required of EMS personnel, whether performed as a volunteer or for compensation, but which such previous conduct that was committed is contrary to accepted standards of conduct as described or required in this section or Health and Safety Code, Chapter 773;(3) having been convicted or placed on deferred adjudication community supervision, or deferred disposition for a criminal offense that directly relates to the duties and responsibilities of EMS personnel, as determined by the provisions of §157.37 of this title, except that a person's application for EMS certification or paramedic license shall be denied if the applicant is convicted, or placed on deferred adjudication community supervision or deferred disposition for a criminal offense, described in §157.37(e)(5) of this title;(4) receiving disciplinary action relating to a certificate or license issued to the applicant in Texas, in another state, or in a U.S. territory, or in another nation, or by the National Registry of Emergency Medical Technicians' (NREMT), or any other organization that provides national recognized for EMS certification;(5) falsifying any Texas application for certification or licensure or falsifying any application or documentation used to acquire registration, certification or licensure;(6) issuing payment to the department which has been returned to the department or its agent;(7) misrepresenting any requirements for certification, recertification, licensure, or licensure renewal;(8) staffing an EMS vehicle deemed to be in service while the person's previously issued certification or license is expired, suspended or has been revoked; and/or(9) failing to maintain a substantial amount of skill, knowledge and/or academic acuity to timely and/or accurately perform the duties or meet the responsibilities required of a certified emergency medical technician or licensed paramedic.(d) Notification. If the department proposes to suspend, revoke, or not renew an EMS certificate or license, or reprimand a certificant or licensed paramedic, or deny a person's application for an EMS certification or paramedic license, or disqualify a prescreening petition's eligibility to acquire an EMS certification or paramedic license, the certificant, licensed paramedic, applicant or petitioner shall be notified at the address as shown in the current records of the department. The notice must state the alleged facts or conduct to warrant the proposed action and state that the individual may request an appeal hearing.(e) Appeal Hearing Request.(1) A request for an appeal hearing shall be in writing and submitted to the department and postmarked within 30 days after the date of the notice. The appeal hearing and any appeal from that hearing shall be conducted pursuant to the Administrative Procedure Act, Government Code, Chapter 2001.(2) If the applicant, certificant, licensed paramedic, or petitioner does not request a hearing in writing within 30 days after notice, the individual is deemed to have waived the opportunity for an appeal hearing and the department may take the proposed action.(f) Probation.(1) The department may probate the suspension of an EMS certification or paramedic license and as a probationary condition may require the certificant or licensee to:(A) report regularly to the department on matters that are the basis of the probation;(B) limit practice to the areas prescribed by the department;(C) continue or review professional education until the person attains a degree of skill satisfactory to the department in those areas that are the basis of the probation; and/or(D) complete or continue to meet certain requirements or conditions related to the circumstances surrounding the certificant's or licensee's rule violations or background to assure that he or she will continue to meet and maintain general EMS standards.(2) Because of certain circumstances or conduct in the background of a person making an initial application for an EMS certification or paramedic license, the department may grant the certification or license, but place the person on probation, subject to the person meeting certain probationary conditions during the certification or licensure period to assure that the person will meet and maintain general EMS standards.(3) Any person, whose EMS certification or paramedic license has been revoked by the department and who later regains certification or licensee under this section, shall be placed on probation for one year and be required to meet certain conditions to assure that he or she will meet and maintain general EMS standards.(g) Reapplication.(1) Two years after denial, revocation of a license, or the voluntary surrender of a certificate or license while disciplinary action is pending, an individual may petition the department in writing for reapplication for certification or licensure. Expiration of a certificate or license during the suspension period shall not affect the two-year waiting period required before a petition can be submitted.(2) The petitioner bears the burden of proving fitness for certification or licensure.(3) The department may allow the petitioner to file an application for certification or licensure if there is proof that the health, safety, and confidence of the public will be protected.(4) The department may deny any petitioner if, in the judgement of the commissioner or designee, the reason for the original action continues to exist or if the petitioner has failed to offer sufficient proof that there is no longer a threat to public health, safety, and/or confidence.(5) If the reapplication is allowed, the petitioner shall be required to meet the requirements for licensure as described in §157.40 of this title (relating to Paramedic Licensure), or certification as described in §157.33 of this title (relating to Certification), §157.43 of this title (relating to Course Coordinator Certification), or §157.44 of this title (relating to Emergency Medical Service Instructor Certification) and in addition shall meet the terms of probation in subsection (f) of this section.(h) Surrender of a certificate or license. Surrender of a certificate or license shall not deprive the department of jurisdiction in regard to disciplinary action against the certificant or licensee. An individual who wishes to surrender his or her certification or license prior to the expiration of the certificate or license may do so by:(1) completing a Surrender of Certificate or License statement; and(2) in the event that a disciplinary action is pending or reasonably imminent, the certificant or licensee must acknowledge that the surrender constitutes a plea of "no contest" to the allegations upon which the disciplinary action is predicated.(i) Notification of disposition. A copy of the order of final disposition of proposed disciplinary action shall be sent to any licensed EMS provider, first responder organization, medical director, institution or facility with which the certificant or licensee is known to be associated at the address shown in the current records of the department. Source Note: The provisions of this §157.36 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective July 6, 2010, 35 TexReg 5888; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.36 Criteria for Denial and Disciplinary Actions for EMS Personnel and Applicants and Voluntary Surrender of a Certificate or License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=146770&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 146770 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=146770&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 146770 03/11/2026 (a) Purpose. This section lists guidelines and criteria for establishing the eligibility of persons with criminal backgrounds for certification or continued certification as emergency medical services (EMS) personnel or licensure or continued licensure as paramedics. The Department of State Health Services (department) will apply the requirements of the Health and Safety Code, Chapter 773, Subchapter C, and will consider and review the criteria listed in the Health and Safety Code, Chapter 773, Subchapter C, §§773.0615, 773.0616, and 773.0617, to determine a person's EMS certification eligibility before enrollment in an EMS education and training course, or to determine whether to deny, suspend or revoke an EMS certification or paramedic license based upon the person's criminal history.(b) Department Access to Criminal History Record Information.(1) The department is entitled to obtain criminal history information maintained by the Department of Public Safety, the Federal Bureau of Investigation Identification Division, or any other law enforcement agency to investigate and determine the EMS certification eligibility of a person who has filed a petition for a pre-enrollment criminal history prescreening or an initial application for EMS certification or a reciprocity application for EMS certification or paramedic licensure or the continued certification/licensure eligibility of a certificant or licensed paramedic.(2) A person who has filed a petition for a pre-enrollment criminal history prescreening or an initial application for EMS certification or a reciprocity application for EMS certification or licensure or an EMS certificant or licensed paramedic who has disclosed a criminal history record or who has a known criminal history record shall timely submit a complete set of his or her fingerprints along with the appropriate processing fee to the Texas Department of Public Safety (DPS), as required under the Government Code, §411.087 and/or §411.110.(3) With respect to a prescreening petitioner or an applicant for EMS certification or licensure who has a criminal history record, the department is authorized to close a petition or application file and deem that the petition or application is withdrawn when the petitioner or applicant has failed to respond to the department's request(s) for information during its prescreening or investigation within 60 days of said request(s).(c) Petition for Criminal History Prescreening. The department may provide a prescreening criminal history record check for persons interested in pursuing an EMS certification or licensure to determine the person's eligibility for certification before enrolling in an EMS educational or training program approved by the department. A petition for prescreening is not considered an application for initial or renewal certification or licensure. To request a criminal history prescreening, the petitioner shall:(1) submit a completed Petition for Criminal History Prescreening form;(2) submit a nonrefundable fee of $50;(3) complete and return all Criminal History Prescreening documents provided to the petitioner by the department and timely provide documents and information requested by the department;(4) submit his or her complete fingerprints along with the appropriate processing fee to the Texas Department of Public Safety, as required under the Government Code, §411.087 and/or §411.110;(5) submit or arrange for submission of all court documentation to the department, including final court orders noting sentencing information, conditions of probation, releases from probation, revocation of probation, and any other information relating to the petitioner's criminal history, or other information requested by the department;(6) shall inform the department of any new court actions or petitioner's criminal activities that have developed or become a part of his or her criminal history, to include, but not be limited to, any new arrests, criminal charges or indictments, criminal investigations, motions to revoke probation, etc. since filing the prescreening petition with the department; and/or(7) be subject to a department criminal history investigation, if and when the petitioner subsequently files an application for EMS certification.(d) Limitation on Information Required for Certification/License Renewal. For the renewal of an EMS certification or paramedic license, the department:(1) may not require an applicant to provide any unchanged criminal history information already included in one or more of the applicant's previously filed initial or renewal applications for EMS certification or paramedic licensure; and(2) may require the applicant to provide only new information relevant to the period occurring since the date of the applicant's last initial or renewal application for EMS certification or paramedic licensure, including information relevant to any new department requirement applicable to the certification or license held by the applicant.(e) Criminal History Evaluation Criteria.(1) For a person who has been convicted of, or placed on deferred adjudication community supervision or deferred disposition for any offense, other than those listed under paragraph (5) of this subsection, that relates directly to the duties and responsibilities of EMS personnel, the department may:(A) deny to the person an initial or renewed EMS certification or paramedic licensure or the person's opportunity to take a certification or paramedic licensure examination;(B) disqualify the person's eligibility to acquire an EMS certificate or paramedic license; or(C) revoke or suspend the person's EMS certification or paramedic license.(2) In determining whether an offense, other than those listed under paragraph (5) of this subsection relates directly to the duties and responsibilities of EMS personnel, the department shall consider and review the following:(A) the Health and Safety Code, Chapter 773, Subchapter C, §773.0615;(B) the nature and seriousness of the crime;(C) the relationship of the crime to the purposes for requiring a certificate or license to engage in the occupation;(D) the extent to which involvement in EMS would afford a certificant or licensee an opportunity to engage in further criminal activity of the same type as that in which the person previously has been involved; and(E) the relationship of the crime to the ability, capacity, or fitness required to perform the duties and discharge the responsibilities of the EMS profession.(3) In determining the fitness to perform the duties and discharge the responsibilities of emergency medical services personnel for a person who has been convicted of, or placed on deferred adjudication community supervision or deferred disposition for, any offense other than those listed under paragraph (5) of this subsection the department shall consider, in addition to the factors listed in paragraph (2) of this subsection:(A) the extent and nature of the person's past criminal activity;(B) the age of the person when the crime was committed;(C) the amount of time that has elapsed since the person's last criminal activity;(D) the conduct and work activity of the person before and after the criminal activity;(E) evidence of the person's rehabilitation or rehabilitative effort while incarcerated, after release, or since imposition of deferred adjudication community supervision, or receiving deferred disposition; and(F) other evidence of the person's fitness, including letters of recommendation from:(i) prosecutors, law enforcement officers, correctional officers, or community supervision officers who prosecuted, arrested, or had custodial or other responsibility for the person;(ii) the sheriff or chief of police in the community where the person resides; and(iii) any other person in contact with the person.(G) the petitioner, applicant, certificant, or licensed paramedic has the responsibility, to the extent possible, to obtain and provide to the department the recommendations of the persons required by subparagraph (F) of this paragraph; and(H) in addition to providing evidence related to the factors under paragraph (2) of this subsection, the petitioner, applicant, certificant, or licensed paramedic shall furnish proof in the form required by the department that the petitioner, applicant, certificant, or licensed paramedic has:(i) maintained a record of steady employment;(ii) supported the applicant's or certificate holder's dependents;(iii) maintained a record of good conduct; and(iv) paid all outstanding court costs, supervision fees, fines, and restitution ordered in any criminal case in which the petitioner, applicant, certificant, or licensed paramedic has been convicted, been placed on deferred adjudication community supervision, or received deferred disposition.(4) The following crimes are considered to directly relate to the certification and licensure of EMS personnel because of their nature and seriousness and because they impact the ability to carry out the duties and responsibilities associated with patient care and public safety and shall be considered and reviewed:(A) offenses under the Health and Safety Code, Chapter 773;(B) under the Transportation Code, except offenses for which points are assessed under the Transportation Code, §708.052;(C) offenses under the Alcoholic Beverage Code;(D) offenses under the Health and Safety Code, Texas Controlled Substances Act, Chapters 481, 482 and 483, relating to substance abuse;(E) offenses under Department of Public Safety of the State of Texas, Government Code, Chapter 411, Subchapter H, relating to the license to carry a concealed handgun;(F) offenses under the following titles of the Texas Penal Code:(i) Title 4 - offenses of attempting or conspiring to commit any of the offenses in this clause;(ii) Title 5 - offenses against the person;(iii) Title 6 - offenses against the family;(iv) Title 7 - offenses against property;(v) Title 8 - offenses against public administration;(vi) Title 9 - offenses against public order and decency;(vii) Title 10 - offenses against public health, safety, and morals; and/or(viii) Title 11 - offenses involving organized crime.(G) Offenses listed in subparagraph (F)(i) - (viii) of this paragraph are not exclusive in that the department may consider similar criminal convictions from other state, federal, foreign or military jurisdictions which, although not listed in subparagraph (F)(i) - (viii) of this paragraph indicate the lack of ability, capacity, or fitness of the individual to perform the duties and responsibilities of EMS personnel.(5) A person shall be disqualified from eligibility to acquire an EMS certification, or a person's initial or renewal application for EMS certification or paramedic licensure shall be denied, or a person's EMS certification or paramedic license, whether active or inactive, shall be revoked if the petitioner, applicant, certificant, or licensed paramedic is convicted of or placed on deferred adjudication community supervisor or deferred disposition, on or after September 1, 2009, for:(A) an offense listed in Code of Criminal Procedure, Article 42.12, §3g(a)(1)(A) - (H), as follows:(i) murder;(ii) capital murder;(iii) indecency with a child;(iv) aggravated kidnapping;(v) aggravated sexual assault;(vi) aggravated robbery;(vii) substance abuse offenses, as described in Health and Safety Code, Chapter 481, for which punishment is increased under:(I) Health and Safety Code, §481.140, regarding the use of a child in the commission of an offense; or(II) Health and Safety Code, §481.134(c), (d), (e) or (f), regarding an offense committed within a drug free zone, if it is shown that the defendant has been previously convicted of an offense for which punishment was increased under one of those subsections.(viii) sexual assault;(B) an offense, other than an offense described by subparagraph (A) of this paragraph, committed on or after September 1, 2009, for which the person is subject to register as a sex offender under Code of Criminal Procedure, Chapter 62.(f) Documentation Required During Criminal History Prescreening or Investigation. During a criminal history prescreening or investigation, it shall be the responsibility of the prescreening petitioner, applicant for EMS certification or paramedic licensure, or certificant or licensed paramedic to obtain and send to the department for each criminal offense in his or her criminal history the entire court record, including final court orders noting sentencing information, conditions of probation, revocation of or release from probation, and any other information relating to the petitioner's criminal history, or requested by the department, along with any recommendations of the prosecution, and/or law enforcement and/or correctional authorities regarding the offense(s). The petitioner, applicant, certificant, or licensed paramedic shall also furnish documentation acceptable to the department of prior/current employment status, evidence of court-ordered and/or voluntary rehabilitation, evidence of good conduct in their community, and evidence of payment of all outstanding court costs, supervision fees, fines, and restitution as ordered in the criminal cases in which they have been convicted, placed on deferred adjudication community supervision, deferred disposition.(g) Notice and Appeal Procedures. Notice and appeal procedures in §157.36(d) and (e) of this title (relating to Criteria for Denial and Disciplinary Actions for EMS Personnel and Applicants and Voluntary Surrender of a Certificate or License) applicable for a person that the department proposes disqualification from eligibility to acquire an EMS certification, or denial of an application for EMS certification or paramedic licensure, or suspension or revocation of a EMS certification or paramedic license based on the requirements and/or criteria outlined in this section as it relates to a person's criminal history record for any offense other than those listed under subsection (e)(5) of this section. Source Note: The provisions of this §157.37 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective July 6, 2010, 35 TexReg 5888. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.37 Certification or Licensure of Persons With Criminal Backgrounds https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182748&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182748 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182748&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182748 03/11/2026 (a) Purpose. The purpose of this section is to establish minimum standards and guidelines for educational activities that may be used by EMS personnel to earn continuing education (CE) contact hours toward recertification or relicensure in accordance with §157.34 of this title, (relating to Recertification) and §157.40 of this title, (relating to Paramedic Licensure). The EMS continuing education consists of educational activities designed to promote and enrich knowledge, improve skills, and develop attitudes for the enhancement of professional practice, thus improving the quality of emergency medical services provided to the public.(b) Local Credentialing and Authorization to Practice. Nothing in this section is intended to restrict the authority of EMS providers or medical directors to establish higher standards and requirements for continuing education activities that must be completed to acquire or maintain authorization to practice within a local or regional EMS system.(c) Content requirements. Candidates at each certification level shall, at a minimum, accrue department-approved CE in the following content areas.Attached Graphic(d) Definitions. The following words and terms, when used in this section shall have the following meanings, unless the context clearly indicates otherwise:(1) Accrediting agency--An organization approved by the department as having met predetermined criteria to approve programs and providers of EMS continuing education.(2) Approved--Recognized as having met established standards and pre-determined criteria of the accrediting agencies which have been approved by the department. Applies to EMS continuing education providers and programs.(3) Continuing Education Audit--Examination and verification of EMS continuing education contact hours claimed to have been successfully and timely completed by certified or licensed EMS personnel.(4) Classroom instruction--Workshops, seminars, conferences, or short-term courses that an individual personally attends and which is directly related to one of the content areas noted in subsection (c) of this section.(5) Clinical learning experiences--Faculty-planned and guided learning experiences designed to assist students to meet course objectives in the noted content areas of subsection (c) of this section and to apply EMS knowledge and skills in the direct care of patients. These experiences can include settings in laboratories, acute medical care facilities, extended medical care facilities, and participation in other department approved health related activities. Practice approved by the Texas Higher Education Coordinating Board may also be considered a form of clinical experience under these rules.(6) Contact hour--Fifty consecutive minutes of participation in a learning activity.(7) Continuing education--Educational activities that are related to the content areas noted in subsection (c) of this section and are designed to promote and enrich knowledge, improve skills, and develop attitudes for the enhancement of professional practice, thus improving the quality of emergency medical services provided to the public.(8) Continuing education program--An organized educational activity designed and evaluated to meet a set of behavioral objectives, which may be presented in one session, or a series of sessions, designed to enhance or elevate EMS knowledge and practice of certified or licensed EMS personnel.(9) Credit course--A specific set of learning experiences offered at a regionally accredited institution of higher education for semester or quarter credit hours.(10) Continuing Education Provider--An individual, partnership, organization, agency, or institution that offers EMS continuing education programs, courses, credit courses, classroom instruction, or other EMS educational activities.(11) Course--An organized and specific set of learning experiences offered by an approved provider. Courses include credit and continuing education courses, short-term courses, organized clinical learning experiences and other coherent sequences of learning experiences, approved by the department.(12) Self-directed study--An educational activity in which the learner takes the initiative and the responsibility for assessing, planning, implementing, and evaluating the activity. Self-directed study may include program development, home study, electronically programmed instruction, and authorship.(e) Types of Acceptable Continuing Education.(1) In this section "approved educational activities" refers to workshops, seminars, conferences, short-term courses, credit courses or continuing education courses provided by accredited institutions of higher education, clinical learning experiences, individualized instruction, distributive learning courses, and other learning activities that are related to EMS approved protocols and skills or that enhance the professional EMS practice of the certified or licensed EMS personnel. (2) Continuing education contact hours applied toward EMS recertification or relicensure may be earned by participating in approved educational activities that are offered or sponsored by:(A) A continuing education provider, approved under subsection (g) of this section.(B) A hospital or other health-care facility accredited by the Joint Commission on Accreditation of Health Care Organizations.(C) A person, agency, entity, or organization approved by the department as an EMS continuing education provider.(D) A person, agency, entity, or organization recognized by a national association or organization representing members of the emergency medical services profession that has been approved by the department.(E) A state or national organization in a related field such as medicine, nursing, respiratory care, and similar fields of health care practice that has been approved by the department.(3) Developing, teaching or presenting activities defined in paragraph (1) of this subsection.(A) Precepting students in the clinical or field internship phases of Initial education. Contact hours for precepting of students may be accrued only in Additional Approved Category content area.(B) Participating in a self-directed study of an EMS related topic or issue that results in the participant making written findings and conclusions of the study which becomes published in an EMS related textbook, or in a state or national EMS related journal or magazine, or which results in the presentation of the findings and conclusions of the study in a department approved workshop, seminar, conference or class, and which is directed toward, or is applicable to, the EMS profession.(f) Activities Unacceptable as Continuing Education. The following activities are not acceptable toward re-certification or re-licensure.(1) Education incidental to the regular professional activities of EMS personnel such as learning occurring from experience or personal research which is not published.(2) Orientation programs sponsored by employers to provide employees with information about the philosophy, goals, policies, procedures, role expectations, and physical facilities of a specific workplace.(3) Meetings and activities such as in-service programs that are required as part of employment unless the in-service training is a type of acceptable continuing education under subsection (e) of this section.(4) Organizational activity such as serving on committees, councils, or as an officer or board member in a professional organization. (5) Institutions of higher education credit courses that are audited. (6) Courses in basic cardiopulmonary resuscitation or other instructional activities designed for lay persons, including first aid courses.(7) Any experience that does not fit the types of acceptable continuing education defined under subsection (e) of this section.(8) Any identical CE repeated more than once during the accrual period.(g) Approval of Continuing Education Provider.(1) No person, agency, entity, or organization shall offer continuing education for emergency medical services personnel unless the department has authorized that person, agency, entity, or organization to be an approved continuing education provider.(2) A person, agency, entity, or organization seeking approval as a continuing education provider shall file an application with the department along with a nonrefundable fee of $60 in accordance with the course approval process described in §157.32 of this title (relating to Emergency Medical Services Education Program and Course Approval).(3) The applicant shall certify on the application that:(A) all programs offered by the provider for EMS continuing education will comply with the appropriate criteria defined in subsection (h) of this section;(B) the provider shall be responsible for verifying successful completion by a participant of each program and shall provide a certificate of completion to the participants; and(C) the provider shall be responsible for verifying that continuing education program(s) has physician medical oversight when the education is involving patient care.(4) The department may require applicants for approval as continuing education providers to:(A) demonstrate they possess the financial, administrative, and educational resources necessary to provide the type(s) of educational activities proposed; and(B) provide evidence that they are capable of designing and delivering educational activities that comply with the appropriate criteria defined in subsection (h) of this section.(h) Criteria for Acceptable Continuing Education Activity. (1) The following criteria have been established to guide EMS personnel in selecting appropriate programs and to guide providers of EMS continuing education in planning and presenting activities. The following criteria shall apply to all activities except those involving self-directed study concluding in a published writing or a presentation, as described in subsection (g)(3)(B) of this section.(A) The program's content, teaching methodologies, and evaluation methods shall be based on written learning objectives which are specific, attainable, measurable, and descriptive of expected learner outcomes.(B) The target audience shall be identified and there shall be evidence of program planning based on the needs of the potential target audience.(C) Content shall be relevant to emergency medical services practice and/or health care, shall be related to and consistent with the program's objectives, and shall provide for the professional growth and/or maintenance of the certificant or licensee.(D) Principles of adult education shall be used in the design and delivery of the program.(E) There shall be documentation of the program developer's expertise in the content area.(F) Learning experiences and teaching methods shall be appropriate to achieve the objectives of the program.(G) Time allotted for each activity shall be sufficient for the learner to meet the objectives of the program.(H) The program shall include activities to evaluate participant achievement of the program's learning objectives with clearly defined, stated criteria for successful completion.(I) Participants shall complete a written evaluation of the program and instruction. Regional, State and/or National conferences may be exempt from this requirement.(J) The continuing education provider shall timely furnish each participant with a written record of the participant's successful completion of the EMS educational activity. The record shall specify the name of the continuing education provider, the title, date and location of the educational activity, a description of the content area, the number of contact hours awarded, and the name of the organization granting approval.(K) Program records of a continuing education provider shall be maintained by the provider for a minimum period of five years from the date of the program completion and shall include target audience, objectives, and documentation of instructor qualifications, teaching strategies and materials, evaluation instruments and results, and a list of names of participants.(2) Classroom Instruction. In addition to the criteria listed in paragraph (1) of this subsection, programs consisting of or including a component of classroom or laboratory instruction shall meet the following criteria.(A) The program shall be at least one contact hour in length.(B) There shall be documentation of the instructor's expertise in the content area.(C) A schedule of the program shall be provided which describes content with corresponding time frames.(D) Facilities and educational resources shall be adequate to implement the program.(3) Clinical Instruction. In addition to the criteria listed in paragraph (1) of this subsection, programs consisting of or including a component of clinical instruction shall meet the following criteria.(A) There shall be documentation of a formal relationship between the program's provider and all facilities serving as sites for clinical instruction.(B) Facilities used for clinical instruction must provide access to types of patients in sufficient variety and number to enable students to meet the program's objectives.(C) Individuals who possess appropriate expertise and credentials shall provide clinical supervision and instruction.(D) Continuing education student participants shall possess appropriate insurance for professional liability while engaging in clinical activities.(E) Provide a name and contact information for the designated infection control officer and document education for the designated infection control officer based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136.(4) Individualized Instruction. In addition to the criteria listed in paragraph (1) of this subsection, programs consisting of individualized instruction, including programmed instruction, directed study, or directed research shall meet the following criteria.(A) Instruction shall follow a logical sequence based on the program's stated learning objectives.(B) Instruction shall involve the learner in an active response to the educational materials presented.(C) The amount of instructional time applied shall be appropriate to the learning objectives specified.(D) Provider shall insure that contact hours are awarded to the actual certificant to whom intended.(5) Individual submission by the participant of study activity for review by the department. The following information must be submitted for review.(A) A course syllabus defining the content, the learning objectives, the dates and times of presentation, and the number of contact hours.(B) A description of the presenters' qualifications and expertise.(C) Verification by the presenter of successful participation. (i) Additional Criteria for Specific Continuing Education Programs. In addition to those listed in subsection (h) of this section, the following guidelines shall apply to the selection and/or planning and implementation of specific CE programs.(1) Semester or quarter credit hour courses.(A) The course shall be within the framework of a curriculum that leads to a degree in emergency medical services or any credit hour course relevant to emergency health care.(B) Certified or licensed EMS personnel, upon audit, shall be able to present an official transcript or official evidence indicating successful completion of the course with a passing grade.(2) Certified or licensed EMS personnel, upon request by the department, shall provide documentation on the accredited institution's letterhead giving the name of program, location, dates, subjects taught, and total clock hours of teaching or instruction for all continuing education activity, including credit hour courses. Documentation may include course completion certificates, diplomas, and/or transcripts.(3) Authorship.(A) Certified or licensed EMS personnel may receive EMS continuing education contact hours for participating in an approved self-directed study that results in the participant making written findings and conclusions of the study which becomes published in an EMS related textbook, or in a state or national EMS related journal or magazine, or which results in the presentation of the findings and conclusions of the study in a department approved workshop, seminar, conference or class, and which is directed toward, or is applicable to, the EMS profession.(B) Continuing education contact hours shall be awarded only once to the certificant or licensee making written findings and conclusions that result from a department approved self-directed study that becomes published or presented as described in subparagraph (3)(A) of this paragraph.(4) Out of state programs. A continuing education activity successfully attended and completed or undertaken in a jurisdiction outside Texas may be accepted for continuing education if all criteria are met and if it is approved by the department.(j) Responsibilities of certified or licensed EMS personnel. (1) It shall be the responsibility of the certified or licensed EMS personnel to select and participate in continuing education activities that meet the criteria listed in subsection (h) and (i) of this section.(2) The certified or licensed EMS personnel shall be responsible for maintaining written certifications of successful completions of EMS continuing education courses or educational activities for five years after the dates of completion. These records shall document successful completion, specifying the name of the EMS continuing education provider, the title, description, date, and location of the educational activity, a description of the content area, the number of contact hours awarded, and the organization granting approval. Complete and accurate copies of these shall be timely submitted to the department upon the department's request.(3) Complete and accurate copies of this written documentation shall be timely submitted to the department upon the department's request.(k) Audit.(1) The department may audit the records of individuals seeking recertification through continuing education.(2) The department may audit specific certified or licensed EMS personnel in response to a complaint, or if there is reason to suspect that the certified or licensed EMS personnel may have given false or inaccurate information about the continuing education requirements completed.(3) An audit shall be automatic for certified or licensed EMS personnel who have been found non-compliant in an immediately preceding audit.(4) Failure to notify the department of a current mailing address shall not absolve the certificant from audit requirements.(5) Within 30 days following notification of audit, certified or licensed EMS personnel shall submit documentation as specified in subsection (j)(2) of this section and any additional documentation the department determines is necessary to verify compliance with continuing education requirements.(6) The department may use on-site observation, audits of records, and other appropriate methods to evaluate the performance of continuing education providers. Evaluation of a continuing education provider may take place randomly, in response to a complaint, or if there is reason to suspect that a continuing education provider is not complying with the criteria established by subsections (h) and (i) of this section.(7) Falsification of CE documentation or official evidence of completion of CE shall be cause for reprimand, probation, suspension, or revocation of a certificate or license as described in §157.36 of this title (relating to Criteria for Denial and Disciplinary Actions for EMS Personnel and Voluntary Surrender of a Certificate or License).(8) Falsification of CE documentation or official evidence of completion by a CE provider or failure to comply with the criteria established by subsections (h) and (i) of this section shall be cause for reprimand, probated suspension, suspension, or revocation of approval. (l) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §157.38 adopted to be effective September 1, 2002, 27 TexReg 7810; amended to be effective June 1, 2004, 29 TexReg 4492; amended to be effective August 17, 2008, 33 TexReg 6395; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.38 Continuing Education https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=134316&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 134316 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=134316&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 134316 03/11/2026 (a) Purpose and Scope. This section establishes eligibility requirements and minimum training standards that a Texas licensed emergency medical services (EMS) provider must have and maintain to receive approval by the department for the provider to conduct a Comprehensive Clinical Management Program for Texas certified or licensed EMS personnel employed by or affiliated with that EMS provider, such that those personnel can become recertified or relicensed pursuant to §157.34(b)(5) of this title (relating to Recertification). The program will assure that EMS personnel affiliated with the EMS provider conducting the program will receive continuing EMS education, quality improvement, intensified individualized monitoring, mentoring, assessment and ongoing professional development as required by the standards outlined in this section.(b) Definitions.(1) CCMP--A comprehensive clinical management program is a recertification training program conducted by a licensed EMS provider for EMS personnel employed by or affiliated with the EMS provider such that the EMS personnel can meet recertification or relicensure requirements as outlined in §157.34(b)(5) of this title.(2) CCMP Coordinator--Person responsible for the administrative functions of the CCMP program. However, the EMS provider, approved to conduct a CCMP, is the person or entity having the ultimate and overall responsibility for continually meeting state requirements for CCMP approval.(3) Credentialing Process--The process by which an EMS provider continually verifies and assesses the qualifications and competencies of EMS personnel to provide patient care services.(4) CCMP Survey Organization--A department recognized organization, which manages a CCMP survey team comprised of members as described and referenced in subsection (f) of this section for the purpose of conducting a survey, based upon the standards outlined in this section, of EMS providers seeking CCMP approval.(5) Preceptor--A person who holds a department EMS personnel certificate or license or other licensed medical professional approved by the medical director and who is employed by or volunteers for an EMS provider to train and evaluate EMS personnel.(6) Quality Improvement Process--An ongoing system that includes retrospective review, concurrent review, and prospective forecasting of clinical care. Quality improvement also combines a circular response through measurement of identified goals and sentinel events identifying opportunities for improvement, reeducation, process design, and measurement of corrective efforts.(7) Self Study--A document developed by the EMS provider that outlines its planning, preparation and qualifications to conduct a CCMP and include 6 months of operational data.(8) Survey--The onsite visit(s) conducted by a department recognized CCMP survey organization that evaluates an EMS provider applying for department approval to conduct a CCMP.(9) Sentinel Event--An unexpected event that triggers, or has the potential to trigger, an immediate investigation and/or response. This event usually relates to the care of a patient or the well-being of EMS personnel, such that the event causes or has the potential to cause death, serious physical or psychological injury to either the patient or the EMS personnel or the public.(c) CCMP Eligibility Requirements.(1) The applicant must hold a current Texas EMS provider license, continuously valid for at least 5 years prior to the date of the application.(2) The applicant must not have received a department disciplinary sanction as an EMS provider, not including a reprimand or an administrative penalty of $2000 or less, during the 2 years immediately preceding the application filing date.(3) Any physician who the applicant has employed or contracted with to function as its medical director or as its full-time or part-time consultant, must be in good standing with the Texas Medical Board or predecessor agency to practice medicine in Texas.(4) A person holding more than one EMS provider license that is applying for department approval to conduct a CCMP shall be required to apply separately for each of its licenses. A CCMP approval will only be allowed per one EMS provider license. A CCMP may not extend beyond one EMS provider license and its affiliated First Responder Organization(s).(5) Although an EMS provider approved to conduct a CCMP may require the EMS personnel, employed by or affiliated with that provider, to participate in and to meet the objectives of its own CCMP, those personnel may still utilize another option, listed in §157.34(b) of this title, to achieve individual EMS personnel state recertification or relicensure.(6) The applicant must have submitted no less than two years of required data, prior to the initial CCMP survey, to the Texas EMS/Trauma Registry.(d) Application Process for CCMP Approval.(1) A sufficiently complete application shall include:(A) a full non-refundable CCMP approval application fee payment of $60.00;(B) department application form with all fields correctly and legibly filled in, dated, and signed with original signatures of the EMS director, CCMP coordinator, and EMS provider's medical director; and(C) all required documents to include an accurate and complete CCMP self-study. This self-study shall be submitted in an electronic format as required and described by the department and shall sufficiently and accurately address those topics outlined in subsection (h) of this section.(2) Initial Application Form Review Period. Within 30 days from the date the department receives an initial written application for CCMP approval from an applicant, the department will send to the applicant a written notice that either the application form is complete and accepted for filing, or the application form is incomplete, and noting the application's deficiencies and the additional information required for the application to be accepted for filing.(3) Continuing Application Form Review Period. Within 14 days from the date that the department receives any written information from the applicant that attempts to respond to an earlier department notice of any application deficiencies and notice of the need for additional information to resolve the deficiencies, the department will send the applicant a written notice that either the application form is finally complete and accepted for filing or that the application form is still incomplete, and specifying any remaining application deficiencies and the additional information required for it to be accepted for filing.(4) Final Application Form Review Period. Within 14 days from the date that the department receives from the applicant the last item or piece of information to resolve all previously noted deficiencies necessary to complete the application, the department will send written notice to the applicant that the application is finally complete and accepted for filing.(5) Failure to Correct Application Form Deficiencies. If the department does not receive from an applicant the items or information requested by the department to correct the deficiencies in the application form by the 10th day after the date that the department has sent written notice to the applicant noting that the application form is incomplete for filing and noting the application's deficiencies and the additional information required for it to be accepted for filing, then the application is deemed to be withdrawn and void. The application fee will not be refunded.(6) Initiation of Survey. After the department notifies applicant that the application form is sufficiently complete and is accepted for filing, the EMS provider can initiate the survey process to be conducted by a department recognized CCMP survey organization.(7) Final Period for Full Application Review. The final period for full application review will begin on the date that the department timely receives from the applicant's survey organization a true and correct written survey report, the department's review of which will be the last stage of the application review process, and end on the date that the department sends written notice to the applicant that the application for CCMP approval is granted, or that it proposes to deny the application. This period is 60 days.(8) CCMP Approval Period. The department's grant of approval to an EMS provider to conduct a CCMP will be valid for four years from the date that approval is granted, unless the EMS provider later surrenders its CCMP approval or the department revokes the approval.(e) Application Process to Renew CCMP Approval.(1) No later than the 120th day prior to the expiration date of the existing CCMP approval, an EMS provider, who is requesting renewal of CCMP approval, shall:(A) timely file a sufficiently completed renewal application form according to the application filing process, as described in subsection (d) of this section;(B) have been timely re-surveyed by a department recognized CCMP survey organization, in advance to allow for report submission described in subparagraph (C) of this paragraph; and(C) ensure that the CCMP survey organization, that has conducted the survey, has filed with the department and that the department has received from the survey organization a complete survey report.(2) If a renewal applicant meets the requirements in subsection (1) of this section no later than the 120th day prior to the expiration date of its existing CCMP approval, the existing CCMP approval does not expire until the applicant's eligibility for renewal of its CCMP approval has been finally determined, as described in Texas Government Code, §2001.054. If the department provides the applicant with a written notice proposing the denial of its renewal application or placement of limitations upon the renewal of approval, and if the department timely receives from the applicant a written request for an administrative appeal hearing to contest the proposed denial or limitation, the existing CCMP approval does not expire until the last day for the applicant to seek a state district court judicial review of the agency order or a later date fixed by order of the reviewing court.(3) If a renewal applicant fails to meet the requirements in subsection (1) of this section, no later than 120 days prior to the expiration date of its existing CCMP approval, the existing CCMP approval expires on its expiration date.(4) Any EMS personnel that are participating in the applicant's existing CCMP may lose their eligibility to renew their individual EMS certifications or licenses under §157.34(b)(5) of this title, after the expiration date of the existing approved CCMP within which the EMS personnel are participating. If a CCMP approval expires, as set forth in paragraphs (2) or (3) of this subsection, EMS personnel who continue to participate with that CCMP after its expiration date will no longer be allowed credit toward continuing education hours needed for certification or licensure renewal, unless approved by the department.(f) CCMP Survey.(1) The applicant shall seek review and approval of its self-study by a department recognized CCMP survey organization.(2) The applicant shall notify the department of the date the survey will begin, the name of the CCMP survey organization, the composition of the survey team, and the names of the survey team members, no later than the 30th day prior to the date the CCMP survey will begin.(3) The applicant shall be responsible for any cost and expenses associated with the survey.(4) The department, at its discretion, may assign a department staff member and/or appoint an observer to accompany the survey team.(5) The survey team shall contain members that have a multi-disciplinary background to include at a minimum: one EMS medical director, one EMS educator and one EMS administrator. The department may require additional surveyors and surveyors with other professional backgrounds, depending upon, but not limited to, the type of EMS provider, the kind of population it serves, and factors noted in the self-study. If such is required, the department will notify the applicant of the additional required surveyors within 20 days after the date that the department has notified the applicant that its application is complete and accepted for filing.(6) All members of the survey team, except department staff, shall come from a Trauma Service Area that the applicant is not affiliated with and at least 100 miles from the provider unless otherwise approved by the department at least 20 days before the date the survey is to begin. There shall be no direct business or patient care relationship or any potential conflict of interest between the CCMP survey members, or any of the individual survey members' places of employment or affiliation with a volunteer EMS provider, and the applicant being surveyed. The survey team shall not be composed solely with members from a single EMS provider.(7) Department recognized survey organization team members at minimum shall:(A) have at least five years experience in active management and leadership of an EMS system using CCMP principles;(B) be currently employed with or volunteering for, and be actively managing within an EMS system using CCMP principles;(C) have adequate direct experience in assisting an EMS provider in preparing for a CCMP survey and in obtaining CCMP approval; and(D) have completed a department-approved CCMP survey course and/or participation in a survey internship.(8) The department at its discretion may exempt survey team members from having to meet the requirements noted in paragraph (7)(A), (B) or (C) of this subsection, if the number of qualified survey team members in the applicant's general geographical area is inadequate to form a survey team. The CCMP survey organization must make a written request showing sufficient cause for the department to grant an exemption.(9) The survey organization with its survey team members shall professionally and accurately evaluate and make written findings of the EMS provider's ability to effectively meet and maintain CCMP standards described in subsection (h) of this section.(g) Survey Documentation and Reporting Timetable.(1) The survey organization shall utilize the department's CCMP survey form and shall provide the department and the provider with an accurate and complete written survey report, signed by all survey team members, regarding its evaluation of the applicant's compliance with CCMP standards, no later than 30th calendar day after the completion date of the survey.(2) The CCMP survey(s), and the resulting survey documentation, and the applicant's CCMP survey organization's submission of the survey report and related documentation to the department shall be completed no later than two years after the date the department sent notice to the applicant that its application was accepted for filing. Failure to timely complete all of the above within two years from the date that the department sent notice to the applicant that its application was accepted for filing will be deemed to be a withdrawal of the EMS provider's application for CCMP approval.(3) The department reserves the right to request from the applicant, and the applicant shall be obligated to produce no later than the 10th day after having received such request, true and correct copies of any survey reports that the applicant received from its survey organization related to any initial surveys, conducted prior to any final survey.(4) CCMP Final Survey Report. The survey report, completed by the department recognized CCMP survey organization, shall accurately document the survey organization's findings and its evaluation of the EMS provider's ability to effectively meet the minimum standards required to obtain and to maintain CCMP department approval as outlined in subsection (h) of this section.(h) CCMP Minimum Standards. To receive and maintain department approval to conduct a CCMP, an EMS provider shall:(1) assure that an initial assessment of new EMS personnel has been conducted by providing documentation of:(A) a written assessment of didactic knowledge evaluation, specific to the certification level of the applicant and focusing on the clinical information (evaluation cannot be the department or NREMT exam, and should utilize numeric scoring - not pass/fail - to assess individuals' level of preparedness);(B) a situation-based practical evaluation;(C) a background investigation process of EMS personnel, which includes verification of certification/licensure and administrative/disciplinary history through the department, work history and driving record;(D) a detailed job description; and(E) a screening process to ensure the minimum requirements are met, and which includes significant medical director involvement.(2) credential EMS personnel by providing documentation of:(A) a state certification/licensure verification process;(B) a process for EMS personnel to demonstrate skills proficiency to the satisfaction of the medical director;(C) a process for reintegration (i.e. bringing an individual from inactive or administrative status back into active practice in the field);(D) a process for bi-annual field evaluation by a preceptor (field training officer or similar position) which includes demonstration of adequate patient care and scene control skills, appropriate conduct for EMS personnel, etc.; and(E) a policy that defines the EMS personnel covered by the CCMP program (only individuals credentialed by the medical director will be eligible for renewal through §157.34(b)(5) of this title).(3) assure and maintain a preceptor selection, development and training process; developed with the medical director's input and approval.(4) assure EMS personnel internship by providing documentation of:(A) a process in which interns ride as a third person until the preceptor establishes the intern has met pre-established competencies as defined by the medical director;(B) a process in which interns ride as the second person until the preceptor establishes the intern has met prerequisites for independent duty as determined by the medical director;(C) a process in which the intern must demonstrate proficiency to at least two different preceptors;(D) a process in which the intern evaluates the internship program; and(E) a process in which the medical director reviews and ensures that all predetermined competencies are met before being released from internship.(5) assure and maintain professional development of EMS personnel by maintaining and providing documentation:(A) of professional development training of EMS personnel in the following amounts per year: EMT-P--24 hours, EMT-I--20 hours, EMT--16 hours, ECA--10 hours;(B) that other staff (flight nurses and communications personnel) are required to obtain at least the minimum continuing education hours as directed by the appropriate certifying or licensing authority;(C) that EMS personnel receive continuing education on at least a semiannual or quarterly basis;(D) that the continuing education instruction spans the three learning domains which include cognitive, affective and psychomotor;(E) that demonstrates programmatic strengths and performance improvement plans for weaknesses;(F) that the continuing education clinical content is defined and approved by the medical director;(G) that 50% of the continuing education is in-person training; and(H) of consistent instructional delivery by all instructors.(6) assure and maintain protocol/standard of care management by providing documentation of:(A) ongoing protocol review, updated according to current literature, practice techniques, executed and approved by the medical director;(B) a process for assessing the relative benefit from protocol revisions;(C) a process for protocol knowledge assessment among EMS personnel protocol assessment that reflects the ongoing protocol review and revision, with structure and content defined and approved by the medical director, and a defined remediation process with established timelines;(D) a process for protocol criteria to be jointly defined by the medical director and EMS provider administration; and(E) a reassessment/re-education process and timeline that clearly identifies the criteria for identification of weakness and successful completion of re-education; or revocation of credentials if unsuccessful.(7) assure and maintain a quality improvement program by providing documentation of:(A) a five component problem-solving process with the following components: assessment, goal setting, plan development, intervention, and progress evaluation;(B) an assessment of the provider's daily activities;(C) measurable clinical indicators that are regularly assessed for compliance with established thresholds;(D) an appropriate, organized and prioritized monitoring and evaluation system for compliance with documentation standards, correct protocol selection and appropriate patient care;(E) assessment of key performance indicators such as personnel/staffing, response and averaging with correct statistical monitoring, clinical care (skills performance, protocol selection, patient assessment, etc.), customer relations program, education, administrative/operational policies;(F) a monthly random chart review of all runs (at least 5% or 30, whichever is greater) for compliance with documentation standards, correct protocol selection, and appropriate patient care;(G) an annual cardiac arrest survival analysis in accordance with current acceptable criteria; and(H) tracking individual performance of skills (5 minimum), appropriate for that level of certification or licensure, for each EMS personnel.(8) assure and maintain a complaint resolution process/management by providing documentation of:(A) a centralized location for receiving complaints;(B) an established triage process to appropriately direct complaint resolution to potential disciplinary or quality improvement avenues;(C) a process that ensures the timely reporting of any rule or law violations to appropriate licensing and government authorities; and(D) a process to track/trend the nature of each complaint and feed data into a quality improvement program.(9) assure and maintain a system to respond to sentinel event response process/management; by providing documentation of:(A) a process to appropriately direct the response to emergency problems such as equipment failures, supply deficiency, medication errors, fleet failures, etc.;(B) appropriate record-keeping and tracking of sentinel events; and(C) a process to investigate sentinel events which involves the appropriate parties.(10) assure and maintain an ongoing corrective action process by providing documentation of:(A) annual documentation of the results of the quality improvement efforts and formal complaint tracking process, including content of continuing education or individual training sessions to resolve identified deficiencies;(B) evidence to resolve and reassess identified deficiencies;(C) a process to determine whether deficiencies are individual or system oriented;(D) a developed reporting structure that includes a public performance report;(E) a policy and methods regarding privilege/confidentiality;(F) a process of remediation and improvement strategies which comply with DSHS continuing education requirements, as appropriate; and(G) evidence of medical director involvement in the process.(11) assure committee(s) are established and maintained to identify, plan, implement and evaluate opportunities to improve performance in all areas of the EMS system.(12) assure that the medical director qualifications, experience, involvement and responsibilities are maintained by providing documentation that the medical director:(A) is registered as the EMS provider's medical director with the department;(B) meets requirements of 22 TAC, Chapter 197 (relating to Emergency Medical Service) of the Texas Medical Board;(C) is an active participant in the local Regional Advisory Committee; and(D) has completed a course in EMS medical direction.(13) assure that the CCMP coordinator qualifications, experience, involvement and responsibilities are maintained by providing documentation that:(A) the CCMP coordinator is responsible for the administrative functions of the CCMP program;(B) the dedication of staff time is sufficient to fulfill the programmatic requirements of the CCMP;(C) a CCMP organizational chart clearly describes the administrative reporting structure of the CCMP program;(D) there is evidence to demonstrate that quality improvement experience and/or training is sufficient to implement and maintain CCMP standards; and(E) shall complete a department approved CCMP workshop of at least 8 hours.(i) Probation, Suspension, Revocation or Denial of Initial or Renewal CCMP Approval. The department may probate, suspend, revoke, or deny initial or renewal approval for an EMS provider to conduct a CCMP for, but not limited to, the following noted reasons:(1) the EMS provider fails to meet or maintain the CCMP minimum standards or the eligibility requirements, outlined in this section;(2) the EMS Provider fails to meet or maintain those responsibilities required or standards, outlined in §157.11 of this title (relating to Requirements for an EMS Provider);(3) the EMS provider falsifies or makes misrepresentations in any documentations communications regarding its applications seeking department approval to conduct a CCMP;(4) the provider falsifies or makes misrepresentations in any documentations or communications regarding its conducting a CCMP; or(5) the EMS provider is found to have committed any of the violations, outlined in §157.16 of this title (relating to Emergency Suspension, Suspension, Probation, Revocation or Denial of a Provider License) that serves as a basis for such department disciplinary actions as: a reprimand, a monetary administrative penalty assessment, EMS provider license suspension, probated suspension of an EMS provider license, revocation of license, emergency suspension of license.(j) Appeal Procedure for Proposed Denial, Probated Suspension, Suspension, or Revocation of CCMP Approval.(1) If the department proposes to deny, suspend, or revoke its approval given for an EMS provider to conduct a CCMP, the department will send written notification of such to the EMS provider's last known address as shown in the current records of the department. The notice will state the alleged facts or conduct to warrant the proposed action and state that the EMS provider may request an administrative hearing.(2) An EMS provider's request for an administrative appeal hearing to contest the proposed action shall be in writing and submitted to the department within 15 days after the date that the department sent written notice to the EMS provider of the department's proposed action. The appeal hearing shall be conducted pursuant to the Administrative Procedure Act, Government Code, Chapter 2001.(3) If the department does not receive a written notice of its request for an administrative appeal hearing from the EMS provider by the 15th day after the date the department sent written notice to the EMS provider of the department's proposed action, the EMS provider is deemed to have waived the opportunity for a hearing and the department may take the proposed action.(k) Probation. The department may probate the suspension of approval of a CCMP and specify terms and conditions of any probated suspension accessed.(l) Surrender of CCMP Approval.(1) An EMS provider shall use a department approved surrender form to document its surrender to the department of its CCMP approval.(2) An EMS provider's surrender of a CCMP approval to the department shall not deprive the department of jurisdiction in regard to any disciplinary action against the EMS provider.(3) In the event that any department proposed disciplinary against the EMS provider is pending or is reasonably imminent, the EMS provider must acknowledge that the surrender of its CCMP approval constitutes a plea of "no contest" to the allegations upon which the proposed disciplinary action is predicated.(m) Reapplication After Surrender, Denial, or Revocation. An EMS provider, whose EMS provider license or approval to conduct a CCMP has either been surrendered while disciplinary action is pending or is reasonably imminent or which has been denied or revoked, cannot apply for, nor receive, approval to conduct a CCMP until 2 years after the date of the denial, revocation or such surrender of the EMS provider license or CCMP approval. An EMS provider who files an application for CCMP approval at least 2 years after the date of such surrender, denial or revocation of its previous EMS provider license or CCMP approval, shall provide evidence, and have the burden to show, that the reasons for the earlier denial, revocation, or such surrender of its previous EMS provider license or CCMP approval, no longer exists.(n) Notification of Disposition. A summary of the department's order, outlining the final disposition of any proposed disciplinary action and the basis for such may be placed upon the department's website. A copy of such order may be sent to the licensed EMS provider, and the medical director.(o) Medical Director Attestation of CCMP Participation. With regard to EMS personnel, employed by or affiliated with an EMS provider having approval to conduct a CCMP, the EMS provider's medical director shall timely provide to such EMS personnel a document, signed and dated by the medical director, attesting to such EMS personnel's participation in that CCMP.(1) The document shall acknowledge that the EMS personnel is currently participating in the CCMP and shall specify the amount of time, including the beginning date that the EMS personnel participated in the CCMP.(2) For those personnel who leave the CCMP the medical director within 30 days of their departure (or sooner, if needed) shall provide to the EMS personnel documentation, attesting to such EMS personnel's participation in that CCMP and attesting to the amount of time, including the beginning date and ending date, that the EMS personnel participated in the CCMP.(3) Those EMS personnel, who have departed from an approved CCMP and who are making application for recertification or relicensure, wholly or partly through §157.34(b)(5) of this title, utilizing a medical director's signed document that attests to the EMS personnel's participation in a CCMP, will be given by the department a prorated continuing education credit, in six month increments, for the amount of time the person was participating in a CCMP.(4) Those continuing education credit hours, used to satisfy those continuing education requirements of a CCMP by EMS personnel who have departed from that CCMP, cannot be credited or used again to supplement any remaining number of continuing education hours needed by EMS personnel to gain recertification or relicensure. Only continuing education hours gained by EMS personnel that were not used to satisfy a CCMP's requirements can be used to supplement the department's recertification or relicensure requirements. Source Note: The provisions of this §157.39 adopted to be effective December 27, 2007, 32 TexReg 9632. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.39 Comprehensive Clinical Management Program Approval https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126195&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126195 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=126195&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 126195 03/11/2026 (a) Requirements for paramedic licensure.(1) A currently certified paramedic may apply for a paramedic license if the candidate has at least one of the following degrees from an institution of post secondary education which has been accredited by an agency recognized by the U.S. Department of Education as an approved accrediting authority:(A) an associate degree in emergency medical services (EMS);(B) a baccalaureate degree; or(C) a postgraduate degree.(2) Initial paramedic license. A candidate for initial paramedic licensure under this section shall:(A) be at least 18 years of age;(B) submit an application and a nonrefundable fee, if applicable, of $120; EMS volunteer--no fee; however, if the applicant later receives compensation during the renewed licensure period, the exemption ceases and the individual shall pay a prorated fee to the Department of State Health Services (department) based on the number of years remaining in the licensure period when employment begins. The non-refundable fee shall be $30 per each year remaining in the licensure. Any portion of a year that the licensed paramedic receives compensation for his paramedic service will count as a full year;(C) provide evidence of current active or inactive National Registry certification at the appropriate level;(D) have met the appropriate requirements in paragraph (1) of this subsection;(E) submit an official transcript from an accredited institution of post secondary education showing successful completion of at least one of the academic degrees referenced in paragraph (1) of this subsection;(F) An initial candidate not currently holding a current EMT-paramedic certification shall complete all requirements for licensure no later than two years after the candidate's course completion date. A candidate holding a current EMT-paramedic certification may apply at any time.(G) The application will expire two years from the date the mailed application is postmarked, or the date a faxed, online submission or hand-delivered application is received at the department.(i) The National Registry certification described in subparagraph (C) of this paragraph must remain current until the final requirement for paramedic licensure is met.(ii) The applicant shall update the application if any changes occur between the time of original submission until the final requirement for licensure is met.(3) Verification of information. After verification by the department of the information submitted by the candidate, a candidate who meets the requirements will be issued a paramedic license valid for a period of four years from the date of issuance of the license. A candidate must verify current licensure before staffing an EMS vehicle. Licensure may be verified by the applicant's receipt of the official department identification card, by using the department's certification website, or by contacting the department directly.(4) The license is not transferable.(5) Duplicate copies of the paramedic license may be issued, by the department to replace lost credentials for a fee of $10.(6) A licensed paramedic may not hold another department EMS certification except for that of EMS course coordinator or EMS instructor.(b) Renewal of paramedic license.(1) Prior to the expiration of a license, the department may send a notice of expiration by United States mail or electronic mail to the licensee at the address shown in current records of the department. It is the responsibility of the licensed paramedic to notify the bureau of any change of address.(2) If a licensed paramedic has not received notice of expiration from the department at least 30 days prior to the expiration of the license, it is the duty of the license holder to notify the department and request an application for renewal of the license. Failure to apply timely for renewal of the license shall result in expiration of the license.(3) To maintain licensure status without a lapse, an applicant shall submit an application and fee (if applicable) for renewal of a license and shall complete all requirements for renewal of the license prior to the expiration date, but no earlier than one year prior to the expiration date.(A) The licensee shall submit a non-refundable fee of $120 with the application.(B) EMS volunteer--no fee. However, if the applicant later receives compensation during the renewed licensure period, the exemption ceases and the individual shall pay a prorated fee to the department based on the number of years remaining in the licensure period when employment begins. The non-refundable fee shall be $30 per each year remaining in the licensure. Any portion of a year that the licensed paramedic receives compensation for his paramedic service will count as a full year.(C) Applicants holding a paramedic license may renew by completing any of the recertification options listed in §157.34(b) of this title (relating to Recertification). A licensee selecting Option 2, as defined in §157.34(b)(2) of this title, and in accordance with §157.38 of this title (relating to Continuing Education) may substitute up to 12 contact hours in the "Preparatory" content area and up to 48 contact hours of continuing education in the "Additional Approved Categories" area with any course of non-clinical professional development study approved by the licensee's medical director.(4) After verification by the department of the information submitted, the paramedic license will be renewed for four years beginning on the day following the expiration date of the license. A new wallet-size card will be issued by the department.(5) A license is not transferable.(6) Military personnel. A licensed paramedic who is deployed in support of military, security, or other action by the United Nations Security Council, a national emergency declared by the President of the United States, or a declaration of war by the United States Congress, is eligible for relicensure under timely relicensure requirements from the person's date of demobilization until one calendar year after the date of demobilization, but will not be licensed during that period.(A) In addition to requirements described in this subsection, the candidate shall submit a copy of deployment and demobilization orders.(B) If all requirements are not completed within one year after date of demobilization, the candidate must meet the requirements of late paramedic relicensure within one additional year, as described in subsection (c) of this section.(c) Late paramedic relicensure.(1) Following the expiration date of the paramedic license, a candidate shall not be considered licensed and may not function in the capacity of an EMS licensee or certificant or represent that he is licensed or certified until relicensure is issued.(2) A candidate whose paramedic license has been expired for 90 days or less may renew the license by submitting an application accompanied by a non-refundable renewal fee that is equal to 1-1/2 times the normally required application renewal fee for that level as listed in subsection (a)(2)(B) of this section. The applicant shall meet one of the recertification options described in subsection §157.34(b) of this title and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of one and one-half of the fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance.(3) A candidate whose paramedic license has been expired for more than 90 days but less than one year may renew the license by submitting an application accompanied by a non-refundable renewal fee that is equal to two times the normally required application renewal fee as listed in subsection (a)(2)(B) of this section. Applicant shall meet one of the recertification options described in §157.34(b) of this title and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times fee shall be necessary.(4) The applicant shall be licensed for a period of four years beginning on the date of issuance.(5) A candidate whose license has been expired for one year or more may not renew the license. The candidate may become licensed by complying with the requirements of paragraph (2) of this subsection and §157.33(j) of this title (relating to Certification).(d) Voluntary downgrades refer to §157.33(g) of this title.(e) Renewal by voluntary downgrade refer to §157.34(a)(5) of this title.(f) Inactive paramedic licensure. A licensed paramedic may make application to the department for inactive licensure at any time during the license period or within one year after the license expiration date.(1) The request for inactive licensure shall be accompanied by a nonrefundable fee of $30 in addition to the regular nonrefundable application fee in subsection (a)(2)(B) of this section. If the final requirement is completed during the three month period after expiration, the application is considered late and the total fee required will be 1-1/2 times the amount in subsection (a)(2)(B) of this section. Volunteers are not exempt from inactive fees.(2) Period of inactive paramedic licensure.(A) The inactive license period shall begin upon date of issuance of the notice of inactive license and remain in effect until the end of the original active license period for those candidates who are currently licensed. The candidate's active license is surrendered upon issuance of the notice of inactive certification.(B) If the candidate is within the final year of active licensure and chooses to renew with inactive licensure, the inactive licensure begins on the first day after the expiration of the current active license and shall remain in effect for four years.(C) If the candidate applies during and/or completes the final requirement for inactive licensure within one year after the expiration of active license, the inactive license period shall remain in effect for four years from the date of issuance of the notice of inactive licensure.(3) While holding an inactive licensure, a person shall not practice other than to act as a bystander rendering first aid or cardiopulmonary resuscitation (CPR) or the use of an Automated External Defibrillator in the capacity of a layperson. Practicing in any other capacity for compensation or as a volunteer shall be cause for denial of reentry and decertification.(4) An individual shall not simultaneously hold inactive and active EMS personnel certification and/or licensure.(5) Renewal of inactive licensure.(A) To renew an inactive license, the applicant shall submit an application and the non-refundable fee, as described in subsection (a)(2)(B) of this section before expiration of the inactive license period. A candidate who meets requirements for inactive renewal shall be awarded an inactive license for a period of four years beginning on the first day after the expiration of the previous inactive license.(B) A candidate whose inactive license has been expired for 90 days or less may renew the inactive license during the 90 day period after expiration of the license upon submitting a fee of 1-1/2 times the normally required renewal fee as described in subsection (a)(2)(B) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of 1-1/2 times the normally required renewal fee shall be necessary. The applicant shall be relicensed for a period of four years beginning on the date of issuance.(C) A candidate whose inactive license has been expired more than 90 days but less than one year may renew the inactive license upon submitting a fee of two times the normally required renewal fee as described in subsection (a)(2)(B) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times the normally required renewal fee shall be necessary. The applicant shall be relicensed for a period of four years beginning on the date of issuance.(D) A candidate whose inactive license has been expired more than one year must regain active licensure before reapplying for an inactive license as described in §157.33(j) of this title.(g) Inactive to active licensure.(1) An inactive licensed paramedic prior to the expiration of the first four-year inactive licensure period may obtain active licensure by submitting an application and the non-refundable fee to the department, as described in subsection (a)(2)(B) of this section and by completing one of the following options:(A) Option 1--meet the normal 4 year CE requirement for paramedic license renewal as listed in §157.34(b)(2) of this title, submit verification of skills proficiency from an approved education program, and pass the national registry assessment exam.(B) Option 2--complete a department approved recertification course, and pass the national registry assessment exam.(2) A licensee who has held an inactive paramedic license more than four years may return to active licensure only by completing requirements described in subsection (a)(2) of this section or §157.33(j) of this title.(h) Reciprocity. A person currently certified by the National Registry and/or certified or licensed as a paramedic in another state, who meets all the requirements of subsection (a)(1), (2)(B), (D), (E) and (G) of this section may apply for paramedic licensure by submitting an application along with a nonrefundable fee of $120 and meeting the requirements set forth in §157.33(i) of this title.(1) After the department evaluates the application and verifies that the requirements for reciprocity have been met, the candidate will be licensed in Texas for four years from the issuance date of the paramedic license.(2) Prior to the expiration of the reciprocity license, the certificant shall reapply and renew the license according to the requirements of subsection (b) of this section.(i) Equivalency. Candidates meeting the following criteria may apply for a paramedic license upon successful completion of the equivalency process as described in subsection (a)(1), (2)(B), (D), (E) and (G) of this section and §157.33(j) of this title:(1) an individual who completed EMS training outside the United States or its possessions;(2) an individual who is certified or licensed in another healthcare discipline;(3) an individual whose department issued EMS certification or license has been expired for more than one year; or(4) an individual who has held department issued inactive certification or license for more than four years.(j) Conversion from inactive paramedic certification to inactive paramedic licensure. A certified paramedic currently holding inactive certification who meets all other criteria as defined in subsection (a)(1) of this section may apply for inactive licensure.(1) The inactive certificant shall:(A) submit an application for inactive licensure to the department along with a nonrefundable fee of $120; and(B) submit evidence of the issuance of a degree from an accredited college or university as defined in subsection (a)(1) of this section.(2) After verification by the department of the information submitted, an inactive paramedic license will be issued for four years beginning on the day of issuance.(k) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §157.40 adopted to be effective August 31, 2006, 31 TexReg 6739. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL §157.40 Paramedic Licensure https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182749&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182749 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182749&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182749 03/11/2026 (a) General.(1) A course coordinator is an individual who has the overall responsibility for conducting an emergency medical services (EMS) training course under the direction of an approved EMS training program (program).(2) A course coordinator must be certified as at least an emergency medical technician (EMT), and must be certified or licensed at or above the level of the course being coordinated.(3) Course coordinator certification is dependent on the individual's EMS personnel certification and is subject to the same status as that personnel certification. If the department imposes disciplinary action in accordance with §157.16 of this title (relating to Emergency Suspension, Suspension, Probation, Revocation or Denial of a Provider License) or §157.36 of this title (relating to Criteria for Denial and Disciplinary Actions for EMS Personnel and Voluntary Surrender of a Certificate or License), the action shall also be imposed automatically and immediately on the individual's course coordinator certification.(b) Levels of certification. Course coordinators may be certified as a basic coordinator or as an advanced coordinator.(c) Currently certified course coordinators. Course coordinators certified on the effective date of this rule shall be considered to have met the requirements of subsection (d) or (e) of this section appropriate to their current level of certification.(d) Basic coordinator requirements. To be certified as a basic course coordinator, the candidate shall:(1) submit an application for basic course coordinator certification along with the nonrefundable fee of $60 to the Texas Department of State Health Services (department) except a fee shall not be required if compensation is not received for coordinating training courses or programs;(2) have been certified as an EMT or higher for at least 4 consecutive years;(3) have been a certified EMS instructor for at least two consecutive years;(4) have documented not less than 120 hours of instruction for initial EMS certificants; or have successfully conducted an EMT-Basic course;(5) submit documentation of positive evaluations as a certified instructor;(6) be affiliated with and operate under the supervision of a licensed provider, an EMS medical director, a teaching hospital, a regionally accredited post-secondary educational institution and/or a health care institution accredited by an organization recognized by the department;(7) submit letters of intent from qualified providers of clinical and field internship experience;(8) have successfully completed a department-sponsored course coordinator training course; and(9) after completing all the above requirements, pass the EMS coordinator exam and retest, if necessary, no later than one year after course completion date. The nonrefundable retest fee is $30, except a fee shall not be required if compensation is not received for coordinating training courses or programs. If requirements are not completed within one year after course completion date, the candidate must meet the requirements of subsection (d) of this section including the completion of another initial course to be certified.(e) Advanced coordinator requirements. To be certified as an advanced course coordinator, the candidate shall:(1) submit an application for advanced course coordinator certification along with the nonrefundable fee of $60 to the department; except a fee shall not be required if compensation is not received for coordinating training courses or programs;(2) have an associate degree, a bachelor degree, or an advanced degree;(3) have been a certified EMS instructor for at least four consecutive years or as a basic course coordinator for two consecutive years;(4) have been certified/licensed as an paramedic for at least 4 consecutive years;(5) have documented not less than 240 hours of instruction for initial EMS certificants;(6) submit documentation of positive evaluations as a certified instructor or as a basic coordinator;(7) be affiliated with and operate under the supervision of a regionally accredited post-secondary educational institution, a health care institution accredited by an organization recognized by the department, or another entity approved by the department to sponsor an advanced training program in accordance with §157.32 of this title (relating to EMS Education Program and Course Approval);(8) submit a letter of intent from qualified providers of clinical and field internship experience;(9) have successfully completed a department-sponsored course coordinator training course;(10) after completing all the above requirements, pass the EMS coordinator exam and retest, if necessary, no later than one year after course completion date. The nonrefundable retest fee is $30, except a fee shall not be required if compensation is not received for coordinating training courses or programs. If requirements are not completed within one year after course completion date, the candidate must meet the requirements of subsection (e) of this section including the completion of another initial course to be certified; and(11) candidates who hold current basic coordinator certification and are applying for advanced coordinator certification must complete all requirements of this subsection except paragraphs (e)(9) and (e)(10) of this subsection.(f) Period of Certification. After verification by the department of the information submitted by the candidate, the candidate who meets the requirements of the applicable subsection (d) or (e) of this section shall be certified as a course coordinator for two years commencing on the date of issuance of the certificate.(g) Course coordinator training. All course coordinator courses shall be conducted by the department or by the department in conjunction with a regionally accredited post-secondary educational institution approved by the department to sponsor a training program. Criteria for admission to coordinator training shall be as follows:(1) the candidate for admission to course coordinator training will meet the requirements of subsection (d) or (e) of this section as appropriate to the level of certification desired;(2) the candidate shall submit a resume and completed application to the appropriate department regional EMS office;(3) the appropriate department regional EMS director will forward the application and attachments to the appropriate training facility with a recommendation regarding the candidate's admission status; and(4) successful candidates will be given a seat in the class based on availability and admissions requirements.(h) Responsibilities. Course coordinator shall have the following responsibilities:(1) plan for and evaluate the overall operation of assigned courses;(2) provide supervision and oversight for assigned courses;(3) act as liaison between the students, personnel instructing in assigned courses, the program, and the department;(4) coordinate submission of course approval documents and fees, if applicable, for assigned courses to the department;(5) assure availability of classrooms and other facilities necessary to provide for the instruction and convenience of students enrolled in assigned courses;(6) in cooperation with the training program, process student applications and select students;(7) schedule classes and assign program instructors;(8) assure that training equipment and supplies are available and operational for each laboratory session;(9) maintain effective relationships with clinical and field internships facilities necessary to meeting the instructional objectives of assigned courses;(10) develop field internship and clinical objectives for assigned courses;(11) obtain written acknowledgement from the field internship EMS provider medical director, if students will be conducting advanced-level skills as part of their field internship with that EMS provider;(12) train and evaluate internship preceptors;(13) in cooperation with the training program, maintain all course records for a minimum of five years;(14) in cooperation with the training program coordinate course written examinations, skills proficiency verifications, and other student evaluations;(15) in cooperation with the training program evaluate the effectiveness of the personnel who instruct in assigned courses;(16) in cooperation with the training program supervise and evaluate the effectiveness of the clinical and field internship training for assigned courses;(17) in cooperation with the training program attest to the successful course completion of all students who meet the program's requirements for completion;(18) provide students with written information on the Texas process to gain certification or licensure;(19) educate students on current Texas EMS laws, policies and rules;(20) provide written notification to the department within 24 hours or the next normal business day when leaving as the course coordinator for an ongoing EMS program; and(21) provide to the program within 24 hours or the next normal business day all course material for an ongoing EMS program.(i) Exception. A program may request the department to grant an exception to allow a person not currently certified as a course coordinator to temporarily perform the duties listed in subsection (h) of this section.(1) Such request must be submitted in writing and must include the following:(A) documentation of the urgency of the situation;(B) a letter from the program endorsing the individual who is to temporarily perform the duties of course coordinator; and(C) letters of intent from qualified providers of clinical and field internship experiences appropriate to the level of training to be offered; and(D) a letter of intent from a medical director.(2) In determining whether the request for an exception is to be approved or denied, the department shall consider but not be limited to the following issues:(A) resignation of a previous course coordinator or the inability of a course coordinator to complete a current training course;(B) need for training in an area where a certified course coordinator is not available within a reasonable distance and training is unavailable through no outreach or distance learning technology; and(C) the probable adverse consequences to prehospital emergency care, if the exception is not approved.(3) After evaluation by the department, the program shall be notified, in writing, of the approval or denial of the request.(4) An individual who is approved shall be considered a temporary course coordinator for not more than two years . If all requirements for course coordinator certification are not met in the two-year period, the approved training program with which the coordinator is affiliated must demonstrate a continuing need for the exception. If the department does not continue the exception, temporary status shall cease and the individual may no longer function as a temporary course coordinator.(j) Recertification.(1) Prior to the expiration of a course coordinator certificate, the department shall send a notice of expiration to the certificant at the address shown in the current records of the department. It is the responsibility of course coordinators to notify the department of any change of address.(2) If a certificant has not received notice of expiration from the department 30 days prior to the expiration, it is the duty of the certificant to notify the department and request an application for recertification. Failure to apply for recertification shall result in expiration of the certificate.(3) To be eligible for recertification, the course coordinator shall meet recertification requirements during the latest coordinator certification period and:(A) maintain active EMS certification as required in subsection (a)(2) of this section;(B) attend updates for course coordinator as required by the department;(C) maintain association with:(i) an approved basic or advanced program if recertifying as a basic coordinator;(ii) an approved advanced program if recertifying as an advanced coordinator;(D) maintain affiliation with entities which provide clinical and field internship experience;(E) submit an application for recertification and a nonrefundable fee as in subsection (d) or (e) of this section;(F) submit documentation of observing or providing at least 8 hours of emergency medical care by a licensed EMS provider, first responder organization or clinical site.(4) After verification by the department of the information submitted the course coordinator who meets the requirements of subsection (d) or (e) of this section shall be recertified for two years commencing on the date following the expiration of the last certificate.(k) Late recertification.(1) An application for recertification shall be considered late if the application and nonrefundable fee are received after the most recent certificate has expired and if all requirements for recertification are not met prior to the end of the most recent certification period.(2) A course coordinator who has not recertified prior to the end of his most recent certification period is not certified and may not perform the duties of a course coordinator.(l) To be eligible for recertification, the candidate shall meet the following:(1) A candidate whose certificate has been expired for 90 days or less may renew the certificate by submitting an application and paying a nonrefundable renewal fee that is equal to 1-1/2 times the normally required application renewal fee for that level as listed in subsection (d) or (e) of this section.(2) A candidate whose certificate has been expired for more than 90 days but less than one year may renew the certificate by submitting an application and paying a nonrefundable renewal fee that is equal to two times the normally required application renewal fee as listed in subsection (d) or (e) of this section.(3) A candidate must complete of all requirements for recertification no later than one year after the expiration of the most recent certificate.(4) After verification by the department of the information submitted by the candidate, the candidate who meets the requirements of this subsection shall be recertified for two years commencing on the day of issuance of a certificate.(5) A candidate whose certification is expired more than one year must meet the requirements of subsection (d) or (e) of this section including the completion of another initial course to be certified.(m) Disciplinary actions.(1) Administrative penalty. The department may impose an administrative penalty on a course coordinator not to exceed $7,500 per day per violation of the Health and Safety Code or the rules adopted thereunder.(2) Emergency suspension. The department may issue an emergency order to suspend a course coordinator's certification if the department has reasonable cause to believe the conduct of the certified course coordinator creates an imminent danger to the public health and safety.(A) An emergency suspension shall be effective immediately without a hearing or notice to the certificate holder. Notice shall be established on the date that a copy of the signed emergency suspension order is sent to the address shown in the current records of the department. Notice shall also be given to any sponsoring entity.(B) If a written request for a hearing is received from the certificate holder within 15 days of the suspension, the department shall conduct a hearing not later than the 30th day after the date on which a hearing request is received to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and appeal from any disciplinary action related to the hearing shall be governed by the Administrative Procedure Act, Government Code, Chapter 2001.(3) Reprimand, suspension, or revocation. A course coordinator may be reprimanded or the course coordinator's certification may be suspended or revoked for, but not limited to the following:(A) failing to maintain active status EMS personnel certification at the appropriate level;(B) failing to comply with the responsibilities of a course coordinator as defined in subsection (h) of this section;(C) falsifying an application for EMS certification or licensure;(D) falsifying a program approval application, a self-study, a course approval application, or any supporting documentation;(E) falsifying a course completion certificate or any other document that records or verifies course activity and/or is a part of the course record;(F) assisting another to obtain or to attempt to obtain personnel certification or recertification by fraud, forgery, deception, or misrepresentation;(G) failing to complete and submit the course applications and student documents within established time frames;(H) coordinating or attempting to coordinate a course above the coordinator's level of certification;(I) compromising or failing to maintain the order, discipline and fairness of a department-approved course or program;(J) allowing inadequate class presentations in a course for which the coordinator is responsible;(K) demonstrating a lack of supervision of personnel instructing in courses for which the coordinator is responsible;(L) compromising an examination or examination process administered or approved by the department;(M) cheating or assisting another in cheating on an EMS examination, other evaluation or any other activity offered or conducted by the department, a training program approved by the department, or a provider licensed by the department;(N) accepting any benefit to which there is no entitlement or benefits in any manner through fraud, deception, falsification, misrepresentation, theft, misappropriation, or coercion;(O) failing to maintain appropriate policies, procedures and safeguards to ensure the safety of students, instructors or other class participants;(P) allowing recurrent use of inadequate, inoperable, or malfunctioning equipment;(Q) failing to maintain the fiscal integrity of a course for which the coordinator is responsible;(R) issuing a check to the department which is returned unpaid;(S) failing to maintain education course records;(T) demonstrating unwillingness or inability to comply with the Health and Safety Code and/or the rules adopted thereunder;(U) failing to give the department true and complete information when asked regarding any alleged or actual violation of the Health and Safety Code, or the rules adopted thereunder, or failing to report a violation;(V) functioning or attempting to function as a course coordinator during a period of suspension which may be cause for suspension of the coordinator certification;(W) committing any violation during a probationary period;(X) failing to report a violation of the Health and Safety Code, Chapter 773, or the rules adopted thereunder;(Y) failing to notify the department when any current EMS student or student applicant, or certified or licensed program employee is arrested for, or received a conviction, deferred adjudication or deferred prosecution for, any crime, upon the coordinator's discovery of such;(Z) failing to notify the department of a conviction, deferred adjudication, or deferred prosecution for a crime which directly relates to the person's ability to carry out the duties and responsibilities of an EMS personnel or EMS course coordinator, per the guidelines and criteria outlined in §157.37 of this title; and(AA) demonstrating unprofessional conduct such as, but not limited to the following:(i) retaliation;(ii) discrimination; shall not discriminate on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status, in any of its activities or operations.(iii) verbal or physical abuse; or(iv) inappropriate physical or sexual contact.(4) Notification. If the department proposes to suspend or revoke a course coordinator's certificate, the course coordinator shall be notified at the address shown in the current records of the department. The notice must state the alleged facts or conduct warranting the action and state that the course coordinator has an opportunity to request a hearing in accordance with the Administrative Procedure Act, Government Code, Chapter 2001.(A) The course coordinator may request a hearing after the date of the notice. This request shall be in writing and submitted to the department.(B) If the course coordinator does not request a hearing within 30 days after the date of the notice of opportunity, the course coordinator waives the opportunity for a hearing and the department shall implement its proposal.(5) Probation. The department may probate any penalty assessed under this section and may specify terms and conditions of any probation issued.(6) Reapplication.(A) Two years after the revocation of a certificate, an individual may petition the department, in writing, for the opportunity to reapply for certification.(B) The department shall evaluate the petition and may allow or deny the opportunity to reapply for certification.(C) in evaluating a petition for permission to reapply for certification the department shall consider but is not limited to the following issues:(i) the likelihood of a repeat of the actions or inactions that led to revocation;(ii) the petitioners overall record as a course coordinator;(iii) letters of support or recommendation;(iv) letters of protest or nonsupport of the petition; and(v) the need for the services of a course coordinator in the given area the course coordinator would serve.(D) The petitioner shall be notified of the department's decision to allow or deny the submission of reapplication for certification within 60 days of the submission of the request.(E) A course coordinator whose certificate expires during a suspension or revocation period may not petition to reapply for certification until the end of the suspension or revocation period.(n) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §157.43 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective June 1, 2004, 29 TexReg 4492; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE D EMERGENCY MEDICAL SERVICES PERSONNEL CERTIFICATION §157.43 Course Coordinator Certification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182750&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182750 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=182750&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 182750 03/11/2026 (a) General.(1) A certified emergency medical service (EMS) instructor is an individual who has received training approved by the Texas Department of State Health Services (department) to conduct the classroom or laboratory portion of an EMS training course.(2) An instructor must be currently certified at the emergency medical technician (EMT) level or higher and may not instruct knowledge or skills above the current level of personnel certification.(3) Instructor certification is dependent on the individual's EMS personnel certification and is subject to the same status as that personnel certification. If the department imposes disciplinary action in accordance with §157.16 of this title (relating to Emergency Suspension, Suspension, Probation, Revocation or Denial of a Provider License) or §157.36 of this title (relating to Criteria for Denial and Disciplinary Actions for EMS Personnel and Voluntary Surrender of a Certificate or License), the action shall also be imposed automatically and immediately on the individual's instructor certification.(b) Certification. To obtain certification, a candidate shall:(1) have a high school diploma or a general educational development (GED) certificate;(2) have active Texas EMS personnel certification;(3) complete a training program using an instructor training curriculum approved by the department; or(4) successfully complete a methods of teaching course or other type of instructor training course approved by the department; the course completed shall be a minimum of 40 hours and all requirements shall be completed within one year of the completion date on the course certificate, and the department may exempt those applicants who are already certified in those courses; or(5) an instructor candidate who has a degree in secondary or higher education, a secondary teaching certificate or is currently certified as an EMS Instructor in another state shall submit documentation to verify the degree, teaching certificate or out-of-state instructor certificate;(6) submit an application to the department with a nonrefundable fee of $30 to the department, except a fee shall not be required if compensation is not received for instructing training courses or programs; and a course completion document from a department-approved instructor course; and(7) pass the instructor examination administered or approved by the department.(8) The instructor candidate who does not pass the department-administered exam may have one opportunity to retest by submitting the retest application and $30 retest fee, if applicable. The retest must be completed no later than one year after the course completion date. The candidate who fails the retest must complete another instructor course to become eligible for instructor certification.(c) Currently certified instructors shall be considered to have met the qualifications in this section.(d) Period of certification. After verification by the department of the information submitted by the candidate, the candidate who meets the requirements of subsection (b) of this section shall be certified as an instructor for two years commencing on the date of issuance of the certificate.(e) Responsibilities. An instructor shall have the following responsibilities:(1) conduct classroom and laboratory sessions in accordance with lesson objectives as assigned by the course coordinator;(2) conduct skills proficiency verifications and other student evaluations as assigned by the course coordinator;(3) assist the course coordinator in preparing and maintaining records and performing other duties necessary to insure the integrity, efficiency and effectiveness of the course;(4) adhere to the curriculum standards as referenced in §157.32 of this title (relating to Emergency Medical Services Education Program and Course Approval);(5) adhere to the standards outlined in the department's EMS Education and Training Manual;(6) provide supervision and oversight for assigned courses;(7) function as the liaison between the students, the course coordinator, the program, and the department;(8) ensure that the facilities, including the classroom and lab areas, are conducive to a positive learning environment;(9) ensure that equipment and supplies are clean, in working order, and of adequate quality and quantity to provide a positive learning environment;(10) properly administer and maintain integrity of the skills proficiency verifications and other student evaluations during a course;(11) properly and accurately inform students of the requirements, processes, and paperwork necessary for Texas EMS certification or licensure;(12) properly and accurately inform students of the laws and rules regulating EMS, including requirements for staffing Texas EMS vehicles; and(13) maintain the overall classroom setting and/or course presentation to ensure the integrity, efficiency, and/or effectiveness of the course.(f) Recertification.(1) Prior to the expiration of a certificate, the department shall send a notice of expiration to the certificant at the address shown in the current records of the department. It is the responsibility of EMS personnel to notify the department of any change of address.(2) If a certificant has not received notice of expiration from the department 30 days prior to the expiration, the certificant shall request an application for recertification from the department or download an application from the Internet. Failure to apply for recertification shall result in expiration of the certificate.(3) To be eligible for recertification, the instructor shall meet recertification requirements during the latest instructor certification period:(A) maintain active status EMS certification;(B) submit documentation of observing or providing at least 8 hours of emergency medical care by or with a licensed EMS provider, first responder organization or clinical site; and(C) submit the application for recertification and a nonrefundable fee of $30.(4) After verification by the department of the information submitted, the candidate who meets the requirements of this section shall be recertified for two years commencing on the day following the expiration of the current certificate.(g) Late recertification.(1) An application for renewal of a certificate shall be considered late if:(A) the application and nonrefundable fee are received after the most recent certificate has expired; or(B) all requirements for recertification are not met prior to the end of the most recent certification period.(2) An instructor who has not recertified prior to the end of his most recent certification period is not certified.(h) Recertification. To be eligible for recertification, the candidate shall meet the following:(1) A candidate whose certificate has been expired for 90 days or less may renew the certificate by submitting an application and paying a nonrefundable renewal fee that is equal to 1-1/2 times the normally required application renewal fee for that level as listed in subsection (b)(6) of this section;(2) A candidate whose certificate has been expired for more than 90 days but less than one year may renew the certificate by submitting an application and paying a nonrefundable renewal fee that is equal to two times the normally required application renewal fee as listed in subsection (b)(6) of this section.(3) A candidate must complete all the requirements for recertification no later than one year after the expiration of the most recent certificate.(4) After verification by the department of the information submitted by the candidate, the candidate who meets the requirements of this subsection shall be recertified for two years commencing on the day of issuance of a certificate.(5) A candidate whose certification is expired more than one year must meet the requirements of subsection (b) of this section.(i) Disciplinary action.(1) Emergency suspension. The department may issue an emergency order to suspend an instructor certification if the department has reasonable cause to believe the conduct of the certified instructor creates an imminent danger to the public health or safety.(A) An emergency suspension shall be effective immediately without a hearing or written notice to the certificate holder. Notice to the certificant shall be established on the date that a copy of the signed emergency suspension order is sent to the address shown in the current records of the department, or by return receipt. Notice shall also be sent to any sponsoring entity.(B) If a written request for a hearing is received from the certificate holder within 15 days of the date of notice, the department shall conduct a hearing not later than the 30th day after the date on which a hearing request is received to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and appeal from a disciplinary action related to the hearing shall be in accordance with the Administrative Procedure Act, Government Code, Chapter 2001.(2) The department may suspend, revoke, or refuse to renew an instructor certification, or may reprimand an instructor for, but not limited to, the following reasons:(A) failing to maintain a current and active Texas EMS personnel certification at the appropriate level;(B) failing to comply with the responsibilities of an instructor as in subsection (e) of this section;(C) falsifying or assisting another person in falsifying an application for EMS certification;(D) falsifying or assisting another person in falsifying a program approval application, a self-study, a course approval application, or any supporting documentation;(E) falsifying or assisting another person in falsifying a course completion certificate or any other document that records or verifies course activity and/or is a part of the course record;(F) compromising department or program standards for verification of skills proficiency or falsifying proficiency verification records;(G) obtaining, or attempting to obtain, or assisting another person in obtaining or attempting to obtain certification or recertification by fraud, deception, falsification, theft, misappropriation, coercion, forgery, or misrepresentation;(H) failing to complete and submit student documents within the established time frames;(I) compromising or failing to maintain the order, discipline and fairness of a department-approved course or program;(J) delivering or allowing inadequate class presentations;(K) compromising an examination or examination process administered or approved by the department;(L) cheating or assisting another in cheating on an EMS examination, other evaluation or any other activity offered or conducted by the department, a training program approved by the department, or a provider licensed by the department;(M) accepting any benefit to which there is no entitlement or benefits in any manner through fraud, deception, falsification, misrepresentation, theft, misappropriation or coercion;(N) failing to maintain appropriate policies, procedures and safeguards to ensure the safety of students, fellow instructors or other class participants;(O) allowing recurrent use of inadequate, inoperable, or malfunctioning equipment;(P) issuing a check to the department which is returned unpaid;(Q) failing to maintain education course records for initial or continuing education (CE) courses;(R) demonstrating an unwillingness or inability to comply with the Health and Safety Code and rules adopted thereunder;(S) failing to give the department true and complete information when asked regarding any alleged or actual violation of the Health and Safety Code, or the rules adopted thereunder, or failing to report a violation;(T) committing any violation during a probationary period;(U) functioning or attempting to function as an instructor during a period of suspension shall be cause for revocation of the instructor certification;(V) failing to report a violation of the Health and Safety Code, Chapter 773, or the rules adopted thereunder;(W) failing to notify the department when any current EMS student, student applicant, or certified or licensed program employee is arrested for, or received a conviction, deferred adjudication or deferred prosecution, for any crime, upon the instructor's discovery of such;(X) failing to notify the department of a conviction, deferred adjudication, or deferred prosecution for a crime which directly relates to the person's ability to carry out the duties and responsibilities of an EMS personnel or EMS instructor, per the guidelines and criteria outlined in §157.37 of this title;(Y) displaying unprofessional conduct such as, but not limited to the following:(i) retaliation;(ii) discrimination on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status, in any of its activities or operations;(iii) verbal or physical abuse; or(iv) inappropriate physical or sexual contact.(Z) unprofessional conduct such as, but not limited to the following:(i) retaliation;(ii) discrimination;(iii) verbal or physical abuse; or(iv) inappropriate physical or sexual contact.(AA) failing to maintain a substantial amount of skill, knowledge and/or academic acuity to timely and/or accurately carry out the duties of an EMS Instructor;(BB) failing to meet standards as required in this section;(CC) previous conduct on the part of the applicant during the performance of duties relating to the responsibilities of EMT personnel or an EMS Instructor that is contrary to accepted standards of conduct as described in Chapter 157 of this title;(DD) disciplinary action relating to a certificate or license issued in another state; and/or(EE) misrepresenting any requirements for certification or licensure.(3) Notification. If the department proposes to take disciplinary action against an EMS instructor, the certificant shall be notified at the address shown in the current records of the department. The notice must state the alleged facts or conduct warranting the action and state that the certificant has an opportunity to request a hearing.(A) The certificant may request a hearing within 15 days after the date of the notice. This request shall be in writing and submitted to the department. The hearing shall be conducted pursuant to the Administrative Procedure Act, Government Code, Chapter 2001.(B) If the certificant does not request a hearing, after being sent the notice of opportunity, the certificant waives the opportunity for a hearing and the department shall implement its proposal.(4) Probation. The department may probate any penalty assessed under this section and may specify terms and conditions of any probation issued.(5) Reapplication.(A) Two years after the revocation, denial, or the voluntary surrender of an instructor certification while disciplinary action is pending, an individual may petition the department, in writing, for the opportunity to reapply for certification. Expiration of a certificate during the suspension period shall not affect the two-year waiting period required before a petition can be submitted.(B) The department shall evaluate the petition and may allow or deny the opportunity to submit an application for recertification. The petitioner bears the burden of proving fitness for certification.(C) In evaluating a petition for permission to reapply for certification the department shall consider, but is not limited to, the following issues:(i) the likelihood of a repeat of the actions or inactions that led to revocation;(ii) the petitioners overall record as an instructor;(iii) letters of support or recommendation;(iv) letters in protest or nonsupport of the petition; and(v) the need for the services of an instructor in a given area.(D) The petitioner shall be notified of the department's decision to allow or deny the submission of reapplication within 60 days of the request.(j) Surrender of a certificate. Surrender of a certificate shall not deprive the department of jurisdiction in regard to disciplinary action against the certificant. An individual who wishes to surrender his or her certification prior to the expiration of the certificate may do so by:(1) completing a Surrender of Certificate statement; and(2) in the event that a disciplinary action is pending or reasonably imminent, the certificant must acknowledge that the surrender constitutes a pleas of "no contest" to the allegations upon which the disciplinary action is predicated.(k) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §157.44 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective June 1, 2004, 29 TexReg 4492; amended to be effective August 17, 2008, 33 TexReg 6395; amended to be effective February 12, 2017, 42 TexReg 430. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE D EMERGENCY MEDICAL SERVICES PERSONNEL CERTIFICATION §157.44 Emergency Medical Service Instructor Certification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152853&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152853 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152853&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152853 03/11/2026 (a) Purpose. The purpose of this section is to establish standards and requirements related to protocols for delivery of emergency medical information to members of the public during medical emergencies; certification of emergency medical services (EMS) information operators; approval of training programs for EMS information operators; certification of EMS information operator instructors; and approval of EMS information operator instructor training programs.(b) Provision of medical information.(1) An EMS information operator may provide medical information to a member of the public during an emergency call if the information operator has successfully completed an EMS information operator training program approved by the Texas Department of State Health Services (department) and holds a certificate issued under the provisions of this section or holds equivalent credentials recognized by the department; and(2) An EMS information operator may provide medical information to a member of the public during an emergency call if the information provided conforms to the protocol and medical direction for delivery of the information adopted by the department under the provisions of subsection (c) of this section.(c) Protocols for delivery of medical information.(1) The department shall approve the use of protocols for delivery of medical information to a member of the public by EMS information operators during an emergency call if it determines that the protocols are substantially equivalent to the Emergency Medical Dispatch (EMD) Protocol Reference System (PRS) as referenced by the National Highway Traffic Safety Administration in the EMD National Standard Curriculum and are approved by a physician who is providing medical direction for the delivery of the medical information.(2) Delivery of medical information to a member of the public by EMS information operators during an emergency call shall be conducted under the medical direction of a physician who shall have reviewed and approved:(A) the protocol to be used; and(B) a system for assuring the quality of the information and the process followed in providing the information.(d) EMS information operator certification.(1) To become certified as an EMS information operator, a candidate must meet the following criteria:(A) be at least 18 years of age;(B) hold current evidence of completion of a nationally recognized basic CPR course approved by the department which includes written and skills proficiency examinations;(C) have completed, within one year prior to application, a department-approved EMS information operator training program as defined in subsection (g)(1) and (2) of this section; and(D) pass an EMS information operator written examination and skills proficiency evaluation which have been approved by the department.(2) A candidate who does not pass the written EMS information operator examination may retest one time within 90 days of attempting the initial examination.(3) A candidate who does not pass the written EMS information operator reexamination shall be required to complete another department-approved EMS information operator training program as defined in subsection (g)(1) and (2) of this section.(4) Certification as an EMS Information Operator shall be valid for a period of four years commencing on the date the certificate is issued.(e) Recognition by equivalent credentials. Upon written request to the department and submission of its program's curriculum, the department may approve credentials issued by an emergency medical dispatch certification agency, organization, or by another state as being equivalent to EMS information operator certification.(f) Recertification. If an EMS information operator has not received notice of expiration of the certification it is the individual's responsibility to locate an EMS information operator instructor for recertification.(1) To be eligible for recertification as an EMS information operator the individual shall:(A) maintain current CPR certification; and(B) complete 12 hours of continuing education in any of the following areas or activities:(i) protocol review;(ii) planning and management;(iii) quality assurance; and(iv) non-traditional educational programs.(2) An EMS information operator meeting the requirements in paragraphs (A) and (B) of this subsection shall be issued a certificate valid for four years commencing on the date of issuance.(g) EMS information operator training programs.(1) EMS information operator training programs shall be conducted by a certified EMS information operator instructor who has met the requirements established in subsection (h)(1) of this section.(2) The standards for EMS information operator training and operations shall be in accordance with the EMD National Standard Curriculum.(3) The course shall consist of not less than 24 hours of classroom instruction in, but not limited to, the following content areas:(A) roles and responsibilities;(B) legal and liability issues;(C) EMD concepts;(D) obtaining information from callers;(E) resource allocation;(F) providing emergency care instruction;(G) introduction to the EMD PRS;(H) introduction to chief complaint types; and(I) EMS system overview.(h) Course approval.(1) Prior to starting a course, an EMS information operator instructor shall:(A) submit a completed and signed course approval application;(B) submit a non-refundable course approval fee of $60, except a fee shall not be required if the EMS information operator instructor is not to be compensated for providing EMS information operator training;(C) submit a course outline listing content by contact hours and instructor names; and(D) submit a copy of the PRS protocols to be used.(2) If the course approval application meets the criteria established in this section, the EMS information operator instructor shall receive a letter of approval from the department with an assigned course number.(3) Representatives of the department may monitor courses at any time for compliance and quality with on-site observation and other methods as deemed necessary.(i) Denial of course application.(1) Reasons for denial of course approval include, but are not limited to, the following:(A) failure of an EMS information operator instructor to hold current certification in accordance with subsection (j)(1) of this section;(B) issuing a check which is returned unpaid;(C) submission of an incomplete course approval application;(D) failure to meet minimum course content requirements;(E) starting or advertising a course without prior approval from the department; and(F) failing to maintain affiliation with a sponsoring agency as defined in subsection (j)(1)(D) of this section.(2) If a course approval application is denied, the EMS information operator instructor shall receive a letter from the department detailing the specific reasons for the denial.(j) EMS information operator instructor certification.(1) To become certified as an EMS information operator instructor, a person must:(A) be at least 18 years of age;(B) hold a high school diploma or GED certificate;(C) hold certification as an EMS information operator;(D) have a written agreement or verified affiliation with an EMS provider, a licensed health care facility, an institution of post secondary education, a law enforcement agency, a fire department, a public emergency dispatch agency, or other public safety agency;(E) have completed, within one year prior to application, a department-approved EMS information operator instructor training program or hold EMS Instructor certification;(F) submit an application to the department with a nonrefundable fee of $60, except a fee shall not be required if the candidate is not to be compensated for providing EMS information operator training; and(G) pass an EMS information operator instructor written examination administered or approved by the department.(2) After verification by the department of the information submitted by the candidate, the candidate who meets the requirements in subsection (j)(1) of this section shall be certified for a period of two years commencing on the date of issuance of the certificate.(3) Persons holding EMS information operator instructor certification from any department-approved training program prior to the effective date of this rule are considered to have met the requirements as set forth in this section and may apply for certification by submitting to the department:(A) a written application with a nonrefundable fee of $60, except a fee shall not be required if the candidate is not to be compensated for providing EMS information operator training; and(B) documentation of current EMS information operator instructor certification.(4) Retesting.(A) A certificant who does not pass the department's written examination may retest after:(i) submitting an application to retest; and(ii) paying a nonrefundable fee of $30, if applicable.(B) A certificant who does not pass a retest shall meet the requirements in subsection (k)(1) of this section.(k) EMS information operator instructor recertification.(1) Prior to the expiration of an EMS information operator instructor certification, the department shall send a notice of expiration to the certificant at the address shown in the current records of the department. It is the responsibility of EMS information operator instructor to notify the department of any change of address.(2) If an EMS information operator instructor has not received notice of expiration from the department 45 days prior to the expiration, it is the duty of the EMS information operator instructor to notify the department and request an application for recertification. Failure to apply for recertification shall result in expiration of the certificate.(3) To be eligible for recertification, the EMS information operator instructor shall:(A) maintain current active certification or licensure as an EMT or above;(B) maintain current active EMS Instructor certification;(C) maintain an agreement or affiliation with sponsoring agency or organization as defined in subsection (j)(1)(D) of this section;(D) submit an application for recertification with a nonrefundable fee of $60, except a fee shall not be required if the candidate is not to be compensated for providing EMS information operator instructor training; and(E) instruct at least one EMS information operator training program each year.(4) After verification by the department of the information submitted, the EMS information operator instructor who meets the requirements of paragraph (3) of this subsection shall be recertified for two years beginning on the date following the expiration of the last certificate.(5) An EMS information operator instructor who has not met all requirements for recertification prior to the end of the certification period is not certified and shall not perform the duties of an EMS information operator instructor.(6) An EMS information operator instructor whose certification has been expired for 90 days or less may renew the certificate by meeting the provisions in paragraph (3)(A) - (C) of this subsection and submitting an application and a renewal fee that is equal to 1-1/2 times the normally required application renewal fee.(7) An EMS information operator instructor whose certification has been expired for more than 90 days but less than one year may renew the certificate by meeting the provisions in paragraph (3)(A) - (C) of this subsection and submitting an application and a renewal fee that is equal to two times the normally required application renewal fee.(8) An EMS information operator instructor whose certification has been expired for one year or more shall complete the requirements in subsection (j)(1) of this section.(l) EMS information operator instructor training.(1) All EMS information operator instructor training courses shall be conducted by a regionally accredited post-secondary educational institution which is approved as an EMS education program.(2) EMS information operator instructor training courses shall follow a department-approved curriculum.(m) Responsibilities of an EMS information operator instructor. The responsibilities of an EMS information operator instructor shall be to:(1) process student applications and select students;(2) schedule courses and assign instructors;(3) verify the certification, license, or other proper credentials of all personnel who instruct in the program's courses;(4) meet at least the minimum requirements for course curriculum established by the department for EMS information operator initial and refresher training;(5) maintain in conjunction with the sponsoring agency or organization, all EMS information operator training course records for a minimum of 5 years;(6) attest to the successful course completion of all students who meet the program's requirements for completion;(7) provide candidates who have satisfied the requirements in subsection (d)(1) of this section with documentation on a form approved by the department, of certification that meets the requirements established by the department. Documentation shall include the candidate's name, a unique identification number, date of successful completion of the EMS information operator training and the training program's approval number;(8) maintain in conjunction with the sponsoring agency or organization, a list of the names, addresses, social security numbers and the date the training was completed of each individual who successfully completes EMS information operator training for a minimum of five years;(9) verify EMS information operator certification upon request of a certificant, a licensed EMS provider, a public safety agency, the department, or another individual or entity authorized by law;(10) provide the department with information and reports necessary for planning, administrative, regulatory, or investigative purposes; and(11) provide certified EMS information operators who have met the requirements in subsection (f) of this section, relating to recertification, with documentation on a form approved by the department renewing the certification.(n) Disciplinary Action. An EMS information operator instructor shall be subject to the same disciplinary actions set forth in §157.44 of this title (relating to Emergency Medical Service Instructor Certification).(o) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by texas.gov, to recover costs associated with application and renewal application processing through texas.gov. Source Note: The provisions of this §157.49 adopted to be effective December 10, 2000, 25 TexReg 12174; amended to be effective June 1, 2004, 29 TexReg 4492; amended to be effective September 11, 2011, 36 TexReg 5689. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE D EMERGENCY MEDICAL SERVICES PERSONNEL CERTIFICATION §157.49 Emergency Medical Services Operator and Operator Instructor Training and Certification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207784&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207784 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207784&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207784 03/11/2026 (a) Trauma service areas (TSAs) are established for effective coordination, oversight, system development and enhancements, and delivery of trauma, stroke, perinatal, acute care, disaster response, and emergency medical services (EMS) in geographical regions consistent with national standards.(b) Texas is geographically divided into defined TSAs. Each TSA shall:(1) contain no fewer than three Texas counties;(2) use county borders to geographically define the TSA boundaries; and(3) have at least one designated trauma facility within its boundaries that has or exceeds the advanced Level III trauma facility designation requirements as defined in §157.125 of this title (relating to Requirements for Trauma Facility Designation).(c) The Department of State Health Services (department) shall maintain the current list of counties included in each TSA and make the list available on the department's website: dshs.texas.gov.(d) The realignment of a county to a different TSA may be initiated by the department or at the request of the Regional Advisory Council (RAC), provided the transferring county is contiguous to the county in the receiving TSA.(1) The requesting RAC shall submit a request to the Director of EMS/Trauma Systems Section specifying:(A) reasons for realignment request such as a decrease in EMS transport time, access to higher levels of care, or access to additional resources;(B) existing patient routing patterns used by both EMS providers and health care facilities, including distances and transport times involved in this patient routing;(C) a list of all health care facilities and all first responder organizations, EMS providers, and county governments affected by the requested realignment; and(D) documentation that the RAC of the receiving TSA agrees with the proposed re-alignment.(2) The requesting RAC shall forward copies of the request to all impacted health care facilities' chief executive officer, first responder organizations, EMS provider medical directors, and county governments.(3) The department evaluates the re-alignment request based on the impact to patient care, including transport times, access to higher levels of care facilities, or resources. Source Note: The provisions of this §157.122 adopted to be effective February 17, 2022, 47 TexReg 650. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS §157.122 Trauma Service Areas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222033&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222033 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222033&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222033 03/11/2026 (a) The department recognizes a Regional Advisory Council (RAC) as the coordinating entity for the development and advancement of the regional trauma and emergency health care system within the defined trauma service area (TSA) as described in §157.122 of this subchapter (relating to Trauma Service Areas).(1) The department recognizes only one RAC for each TSA.(2) Trauma, prehospital, perinatal, stroke, cardiac, disaster response, and emergency health care stakeholders in the TSA must be eligible for participation or membership in the RAC.(b) A RAC must meet the following requirements to be recognized as a RAC:(1) maintain incorporation as an entity exempt from federal income tax under §501(a) of the United States Internal Revenue Code of 1986, and its subsequent amendments, by being listed as an exempt organization under §501(c)(3) of the code, and to be eligible to receive, distribute, and utilize the emergency medical services (EMS), uncompensated care, and TSA allotments;(2) submit required documentation to the department that includes, at a minimum, the following:(A) a summary of regional trauma, prehospital, pediatric, geriatric, perinatal, stroke, cardiac, and emergency health care system activities;(B) evidence of an annual summary of the EMS, trauma, and emergency health care system performance improvement plan; and(C) a completed regional self-assessment by the end of each odd state fiscal year, and a current trauma and emergency health care system plan by the end of each even state fiscal year, with documented evidence the performance criteria are met;(3) maintain external financial audits and financial statements as defined by the department; and(4) maintain a current website to communicate with regional stakeholders.(c) Each RAC must develop and maintain a regionally specific comprehensive trauma and emergency health care system plan. The plan must include all counties within the TSA and must be based on current industry standards and guidelines.(1) The trauma and emergency health care system plan must address the following elements:(A) epidemiology data resources available;(B) integration of regional stakeholders, identified coalitions, and community partners pertinent to the priorities and needs identified through the regional self-assessment;(C) regional guidelines for prehospital field triage and destination, treatment, transport, and transfer of patients with time-sensitive health care injuries or illnesses;(D) prevention and outreach activities guided by data available;(E) system coordination and patient flow;(F) meaningful participation in regional disaster preparedness, planning, response, recovery, after-action review, data tracking needs, and support of the hospital preparedness stakeholders, including the identified health care coalition and the department;(G) identification of system-wide health care education sponsored or coordinated through the RAC;(H) execution of a systems performance improvement plan that aligns with the state system performance improvement plan, and includes regional outcome data;(I) current pediatric readiness capabilities that identifies opportunities to improve pediatric readiness within the region;(J) integration of public health and business community stakeholders; and(K) guidelines to support regional research projects.(2) All health care entities and identified coalition partners should participate in the regional planning process.(d) A RAC must maintain the ability to collect and report data from each hospital within the TSA to facilitate emergency preparedness and response planning for a public health disaster, public health emergency, or outbreak of communicable disease, in a manner directed by the department and consistent with Texas Health and Safety Code §§81.027, 81.0443, 81.0444, and 81.0445.(1) Unless otherwise directed by the department, at least once each calendar quarter, a RAC must collect and report to the department the following data from each hospital in their TSA:(A) general beds available and occupied;(B) intensive care unit (ICU) beds available and occupied;(C) emergency department visits;(D) hospital admissions;(E) ventilators available and in use; and(F) hospital deaths.(2) The department may request more or less frequent collection or reporting or may request different information from individual RACs to adequately prepare for and respond to any public health disaster, public health emergency, outbreak of communicable disease, or federal reporting requirement relating to emergency preparedness and response.(3) RACs must make the collected data publicly available by posting the data on the RAC's internet website.(e) A RAC with at least one county within the region located on the international border of Texas and at least one county within the region adjacent to the Gulf of Mexico must provide guidelines and protocols related to trauma patient transfer and related services meeting the following requirements.(1) The RAC must develop an advisory committee composed of equal representation from designated trauma facilities within the RAC.(2) The advisory committee must develop regional protocols for managing the dispatch, triage, transport, and transfer of patients.(A) The advisory committee must periodically review patient transfers ensuring the applicable protocols are met.(B) Each hospital and EMS provider operating within this TSA must collect and report to the RAC data on patients transferred outside of the TSA following the developed and approved regional protocols.(C) The advisory committee and activities must be integrated into the regional trauma and emergency health care system plan.(f) A RAC must meet the defined performance criteria to ensure the mission of the regional system is maintained. A RAC must:(1) notify the department and RAC membership within five days of the loss of capabilities to maintain the infrastructure to oversee and maintain the regional systems as required by the provisions within subsections (a) and (b) of this section or the department contract;(2) provide the department with a plan of correction (POC) no more than 90 days from the onset of the deficiency for the RAC; and(3) comply with the provisions of subsections (a) and (b) of this section, all current state and system standards as described in this chapter, and all guidelines and procedures as set forth in the regional trauma and emergency health care system plan.(g) If a RAC chooses to relinquish services, it must provide at least a 30-day written advance notice to the department, all RAC membership, RAC coalition partners, and county judges within the impacted TSA.(1) The RAC must submit a written plan to the department for approval before the 30-day notice to relinquish services.(2) The RAC funding and assets must be dissolved in accordance with state and federal requirements.(3) The department must consider options of realigning the TSA with another RAC to continue services.(h) The department has the authority to schedule conferences, in-person or virtual, with 10-calendar days advanced notice, to review, inspect, evaluate, and audit all RAC documents to validate the department RAC performance criteria are met.(i) RACs must maintain virtual options for stakeholder participation in committees or other activities. Source Note: The provisions of this §157.123 adopted to be effective November 24, 2024, 49 TexReg 9241. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS §157.123 Regional Advisory Councils https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222034&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222034 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222034&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222034 03/11/2026 (a) The Emergency Medical Services (EMS)/Trauma Systems Section recommends to the Commissioner of the Department of State Health Services (commissioner) the designation of an applicant facility (facility) as a trauma facility at the level for each location of a facility the department deems appropriate. Trauma designation surveys conducted on or before August 31, 2025, are evaluated on the requirements of this section. For surveys conducted on or after September 1, 2025, see §157.126 of this subchapter (relating to Trauma Facility Designation Requirements Effective on September 1, 2025) for the requirements.(1) Comprehensive (Level I) trauma facility designation--The facility, including a free-standing children's facility, meets the current American College of Surgeons (ACS) essential criteria for a verified Level I trauma center; meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate Regional Advisory Council (RAC); has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry.(2) Major (Level II) trauma facility designation--The facility, including a free-standing children's facility, meets the current ACS essential criteria for a verified Level II trauma center; meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry.(3) Advanced (Level III) trauma facility designation--The facility meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry. A free-standing children's facility, in addition to meeting the requirements listed in this section, must meet the current ACS essential criteria for a verified Level III trauma center.(4) Basic (Level IV) trauma facility designation--The facility meets the "Basic Trauma Facility Criteria" in subsection (y) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry.(b) A health care facility is defined in this subchapter as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license. Each location is considered separately for designation and the department will determine the designation level for that location, based on, but not limited to, the location's own resources and levels of care capabilities; Trauma Service Area (TSA) capabilities; and the essential criteria and requirements outlined in subsection (a)(1) - (4) of this section. The final determination of the level of designation may not be the level requested by the facility.(c) The designation process consists of three phases.(1) First phase--The application phase begins with submitting to the department a timely and sufficient application for designation as a trauma facility and ends when the survey report is received by the department.(2) Second phase--The review phase begins with the department's review of the survey report and ends with its recommendation to the commissioner whether to designate the facility and at what level. This phase also includes an appeal procedure governed by the department's rules for a contested case hearing and by Texas Administrative Procedure Act, Texas Government Code Chapter 2001, and the department's formal hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(3) Third phase--The final phase begins with the commissioner reviewing the recommendation and ends with the commissioner's final decision.(d) For a facility seeking initial designation, a timely and sufficient application must include:(1) the department's current "Complete Application" form for the appropriate level, with all fields correctly and legibly filled-in and all requested documents attached, hand-delivered, or sent by postal services to the department;(2) full payment of the designation fee enclosed with the submitted "Complete Application" form;(3) any subsequent documents submitted by the date requested by the department;(4) a trauma designation survey completed within one year of the date of the receipt of the application by the department; and(5) a complete survey report, including patient care reviews, that is within 90 days of the date of the survey and is submitted to the department.(e) If a hospital seeking initial designation fails to meet the requirements in subsection (d)(1) - (5) of this section, the application is denied.(f) For a facility seeking re-designation, a timely and sufficient application must include:(1) the department's current "Complete Application" form for the appropriate level, with all fields correctly and legibly filled-in and all requested documents attached, submitted to the department one year before the expiration of the current designation;(2) full payment of the designation fee enclosed with the submitted "Complete Application" form;(3) any subsequent documents submitted by the date requested by the department; and(4) a complete survey report, including patient care reviews, that is within 90 days of the date of the survey and is submitted to the department and at least 60 days before the expiration of the current designation.(g) If a health care facility seeking re-designation fails to meet the requirements outlined in subsection (f)(1) - (4) of this section, the original designation will expire on its expiration date.(h) The department's analysis of the submitted "Complete Application" form may result in recommendations for corrective action when deficiencies are noted and must include a review of:(1) the evidence of current participation in RAC and regional trauma and emergency health care system planning; and(2) the completeness and appropriateness of the application materials submitted, including the submission of a non-refundable application fee as follows:(A) for Level I and Level II trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $5,000 and a lower limit of $4,000;(B) for Level III trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $2,500 and a lower limit of $1,500; and(C) for Level IV trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $1000 and a lower limit of $500.(i) When a "Complete Application" form for initial designation or re-designation from a facility is received, the department will determine the level it deems appropriate for pursuit of designation or re-designation for each facility location based on: the facility's resources and levels of care capabilities, TSA resources, and the essential criteria for Levels I, II, III, and IV trauma facilities. In general, physician services capabilities described in the application must be in place 24-hours a day/7 days a week. In determining whether a physician services capability is present, the department may use the concept of substantial compliance that is defined as having said physician services capability at least 90% of the time.(1) If a facility disagrees with the level determined by the department to be appropriate for pursuit of designation or re-designation, it may make an appeal in writing within 60 days to the EMS/Trauma Systems Section director. The written appeal must include a signed letter from the facility's governing board with an explanation as to why designation at the level determined by the department would not be in the best interest of the citizens of the affected TSA or the citizens of the State of Texas.(2) If the department upholds its original determination, the EMS/Trauma Systems Section director will give written notice of such to the facility within 30 days of its receipt of the applicant's complete written appeal.(3) The facility may, within 30 days of the department sending written notification of its denial, submit a written request for further review. Such written appeal is submitted to the associate commissioner, Consumer Protection Division.(j) When the analysis of the "Complete Application" form results in acknowledgement by the department that the facility is seeking an appropriate level of designation or re-designation, the facility may then contract for the survey, as follows.(1) Level I and II facilities and all free-standing children's facilities must request a survey through the ACS trauma verification program.(2) Level III facilities must request a survey through the ACS trauma verification program or through a department-approved survey organization.(3) Level IV facilities must request a survey through a department-approved survey organization, or by a department-credentialed surveyor.(4) The facility must notify the department of the date of the planned survey and the composition of the survey team.(5) The facility is responsible for any expenses associated with the survey.(6) The department, at its discretion, may appoint a designation coordinator to accompany the survey team. In this event, the cost for the designation coordinator is borne by the department.(k) The survey team composition must be as follows.(1) Level I or Level II facilities must be surveyed by a team that is multidisciplinary and includes at a minimum: two general surgeons, an emergency physician, and a trauma nurse all active in the management of trauma patients.(2) Free-standing children's facilities of all levels must be surveyed by a team consistent with current ACS policy and includes at a minimum: a pediatric surgeon, a general surgeon, a pediatric emergency physician, and a pediatric trauma nurse coordinator or a trauma nurse coordinator with pediatric experience.(3) Level III facilities must be surveyed by a team that is multidisciplinary and includes at a minimum: a trauma surgeon and a trauma nurse (ACS or department-credentialed), both active in the management of trauma patients.(4) Level IV facilities must be surveyed by a department-credentialed representative, registered nurse, or licensed physician. A second surveyor may be requested by the facility or by the department.(5) Department-credentialed surveyors must meet the following criteria:(A) have at least three years' experience in the care of trauma patients;(B) be currently employed in the coordination of care for trauma patients;(C) have direct experience in the preparation for and successful completion of trauma facility verification or designation;(D) have successfully completed a department-approved trauma facility site surveyor course and be successfully re-credentialed every four years; and(E) have current credentials as follows:(i) for nurses: Trauma Nurses Core Course (TNCC) or Advanced Trauma Course for Nurses (ATCN); and Pediatric Advanced Life Support (PALS) or Emergency Nurses Pediatric Course (ENPC);(ii) for physicians: Advanced Trauma Life Support (ATLS); and(iii) have successfully completed a site survey internship.(6) All members of the survey team, except department staff, must come from a TSA outside the facility's location and at least 100 miles from the facility. There must be no business or patient care relationship or any potential conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.(l) The survey team evaluates the facility's compliance with the designation criteria, by:(1) reviewing medical records; staff rosters and schedules; process improvement committee meeting minutes; and other documents relevant to trauma care;(2) reviewing equipment and the physical plant;(3) conducting interviews with facility personnel;(4) evaluating compliance with participation in the State Trauma Registry; and(5) evaluating appropriate use of telemedicine capabilities where applicable.(m) The site survey report in its entirety must be part of a facility's performance improvement program and subject to confidentiality as articulated in the Texas Health and Safety Code §773.095.(n) The surveyor must provide the facility with a written, signed survey report regarding the evaluation of the facility's compliance with trauma facility criteria. This survey report must be forwarded to the facility within 30 calendar days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the department if it intends to continue the designation process.(o) The department must review the findings of the survey report for compliance with trauma facility criteria.(1) A recommendation for designation must be made to the commissioner based on meeting the designation requirements.(2) If a facility does not meet the criteria for the level of designation deemed appropriate by the department, the department must notify the facility of the requirements it must meet to achieve the appropriate level of designation.(3) If a facility does not meet the requirements, the department must notify the facility of deficiencies and recommend corrective action.(A) The facility must submit to the department a report that outlines the corrective action taken. The department may require a second survey to ensure compliance with the criteria. If the department substantiates action that brings the facility into compliance with the criteria, the department recommends designation to the commissioner.(B) If a facility disagrees with the department's decision regarding its designation application or status, it may request a secondary review by a designation review committee. Membership on a designation review committee will:(i) be voluntary;(ii) be appointed by the EMS/Trauma Systems Section director;(iii) be representative of trauma care providers and appropriate levels of designated trauma facilities; and(iv) include representation from the department and the Trauma Systems Committee of the Governor's EMS and Trauma Advisory Council (GETAC).(C) If a designation review committee disagrees with the department's recommendation for corrective action, the records must be referred to the associate commissioner for recommendation to the commissioner.(D) If a facility disagrees with the department's recommendation at the end of the secondary review, the facility has a right to a hearing, governed by the department's rules for a contested case hearing and by Texas Administrative Procedure Act, Texas Government Code Chapter 2001, and the department's formal hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(p) The facility has the right to withdraw its application at any time before being recommended for trauma facility designation by the department.(q) If the associate commissioner concurs with the recommendation to designate, the facility receives a letter and a certificate of designation valid for three years. Additional actions, such as a site review or submission of information/reports to maintain designation, may be required by the department.(r) It is necessary to repeat the designation process as described in this section prior to expiration of a facility's designation or the designation expires.(s) A designated trauma facility must comply with the provisions of this chapter; all current state and system standards as described in this chapter; all policies, protocols, and procedures as set forth in the system plan; and meet the following requirements.(1) Continue its commitment to provide the resources, personnel, equipment, and response as required by its designation level.(2) Participate in the State Trauma Registry. Data submission requirements for designation purposes are as follows.(A) Initial designation--Six months of data prior to the initial designation survey must be uploaded. Subsequent to initial designation, data should be uploaded to the State Trauma Registry on at least a quarterly basis (with monthly submissions recommended) as indicated in Chapter 103 of this title (relating to Injury Prevention and Control).(B) Re-designation--The facility's trauma registry should be current with at least quarterly uploads of data to the State Trauma Registry (monthly submissions recommended) as indicated in Chapter 103 of this title.(3) Notify the department, its RAC, and other affected RACs of all changes that affect air medical access to designated landing sites.(A) Non-emergent changes must be implemented no earlier than 120 days after a written notification process.(B) Emergency changes related to safety may be implemented immediately along with immediate notification to department, the RAC, and appropriate air medical providers.(C) Conflicts relating to helipad air medical access changes must be negotiated between the facility and the EMS provider.(D) Any unresolved issues must be managed utilizing the nonbinding alternative dispute resolution (ADR) process of the RAC in which the helipad is located.(4) Within five days, notify the department; its RAC and other affected RACs; and the health care facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in if temporarily unable to comply with a designation. If the health care facility intends to meet the requirements and maintain current designation status, it must also submit to the department a plan for corrective action and a request for a temporary exception to requirements within five days.(A) If the requested essential requirements exception is not critical to the operations of the health care facility's trauma program and the department determines the facility has intent to meet the requirements, a 30-day to 90-day exception period from the onset date of the deficiency may be granted for the facility to meet requirements.(B) If the requested essential requirements exception is critical to the operations of the health care facility's trauma program and the department determines the facility has intent to meet requirements, no greater than a 30-day exception period from the onset date of the deficiency may be granted for the facility to meet requirements. Essential requirements that are critical include:(i) neurological surgery capabilities (Level I, II);(ii) orthopedic surgery capabilities (Level I, II, III);(iii) general/trauma surgery capabilities (Level I, II, III);(iv) anesthesiology (Levels I, II, III);(v) emergency physicians (all levels);(vi) trauma medical director (all levels);(vii) trauma program manager (all levels); and(viii) trauma registry (all levels).(C) If the health care facility has not met the requirements at the end of the exception period, the department may at its discretion elect one of the following.(i) Allow the facility to request designation at the level appropriate to its revised capabilities.(ii) Propose to re-designate the facility at the level appropriate to its revised capabilities.(iii) Propose to suspend the facility's designation status. If the facility is amenable to this action, the department will develop a corrective action plan for the facility and a specific timeline for the facility to meet the requirements.(iv) Propose to extend the facility's temporary exception to criteria for an additional period not to exceed 90 days. The department will develop a corrective action plan for the facility and a specific timeline for the facility to meet the requirements.(I) Suspensions of a facility's designation status and exceptions to criteria for facilities are documented on the EMS Trauma Systems Section website.(II) If the facility disagrees with a proposal by the department or is unable or unwilling to meet the department-imposed timelines for completion of specific actions plans, it may request a secondary review by a designation review committee as defined in subsection (o)(3)(B) of this section.(III) The department may at its discretion choose to activate a designation review committee at any time to solicit technical advice regarding criteria deficiencies.(IV) If the designation review committee disagrees with the department's recommendation for corrective actions, the case is referred to the associate commissioner for recommendation to the commissioner.(V) If a facility disagrees with the department's recommendation at the end of the secondary review process, the facility has a right to a hearing, governed by the department's rules for a contested case hearing and by Texas Administrative Procedure Act, Texas Government Code Chapter 2001, and the department's formal hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(VI) Designated trauma facilities seeking exceptions to essential criteria have the right to withdraw the request at any time prior to resolution of the final appeal process.(5) Notify the department; its RAC and other affected RACs; and the health care facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in if it no longer provides trauma services commensurate with its designation level.(A) If the facility chooses to apply for a lower level of trauma designation, it may do so at any time; however, it is necessary to repeat the designation process. There must be a review by the department to determine if a full survey is required.(B) If the facility chooses to relinquish its trauma designation, it must provide at least 30 days' notice to the RAC and the department.(6) Within 30 days, notify the department; its RAC and other affected RACs; and the health care facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in, of the change if it adds capabilities beyond those that define its existing trauma designation level.(A) It is necessary to repeat the trauma designation process.(B) There must be a review by the department to determine if a full survey is required.(t) Any facility seeking trauma designation must have measures in place that define the trauma patient population managed at the facility or at each of its locations, and the ability to track trauma patients throughout the course of care within the facility or at each of its locations to maximize funding opportunities for uncompensated care.(u) A health care facility may not use the terms "trauma facility," "trauma hospital," "trauma center," or similar terminology in its signs or advertisements or in the printed materials and information it provides to the public unless the health care facility is currently designated as a trauma facility according to the process described in this section.(v) The department has the right to review, inspect, evaluate, and audit all trauma patient records, trauma performance improvement committee minutes, and other documents relevant to trauma care in any designated trauma facility or applicant facility at any time to verify meeting requirements in the statute and this section, including the designation requirements. The department maintains confidentiality of such records to the extent authorized by the Texas Public Information Act, Texas Government Code Chapter 552, and consistent with current laws and regulations related to the Health Insurance Portability and Accountability Act of 1996. Such inspections must be scheduled by the department when deemed appropriate. The department provides a copy of the survey report, for surveys conducted by or contracted for the department, and the results to the health care facility.(w) The department may grant an exception to this section if it finds meeting requirements in this section would not be in the best interests of the persons served in the affected local system.(x) Advanced (Level III) Trauma Facility Requirements. An advanced trauma facility (Level III) provides resuscitation, stabilization, and assessment of injured patients and either provides treatment or arranges for appropriate transfer to a higher level designated trauma facility.(1) The facility must identify a trauma medical director (TMD) responsible for the provision of trauma care and must have a defined job description and organizational chart delineating the TMD's role and responsibilities. The TMD must be a physician who meets the following:(A) is a general surgeon;(B) is currently credentialed in ATLS or an equivalent department-approved course;(C) is charged with overall management of trauma services provided by thefacility;(D) must have the authority and responsibility for the clinical oversight of the trauma program, including:(i) credentialing of medical staff who provide trauma care;(ii) recommending trauma team privileges;(iii) providing trauma care;(iv) developing trauma management guidelines;(v) collaborating with nursing to address educational needs; and(vi) developing, implementing, and maintaining the trauma performance improvement and patient safety (PIPS) plan with the trauma program manager (TPM);(E) must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients and must:(i) have current board-certification or board-eligibility;(ii) complete nine hours of trauma-related continuing medical education per year;(iii) comply with trauma management guidelines; and(iv) participate in the trauma PIPS program;(F) must participate in a leadership role in the facility, community, and emergency management (disaster) response committee; and(G) should participate in the development of the regional trauma system plan.(2) An identified TPM is a registered nurse and must:(A) successfully complete and remain current in the TNCC or ATCN or an equivalent department-approved course;(B) successfully complete and remain current in a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC);(C) have the authority and responsibility to monitor trauma patient care from emergency department (ED) admission through operative intervention, intensive care unit (ICU) care, stabilization, rehabilitation care, and discharge, including the trauma PIPS program;(D) have a defined job description and organizational chart delineating the TPM's role and responsibilities;(E) participate in a leadership role in the facility, community, and regional emergency management (disaster) response committee;(F) be full-time; and(G) complete a course designed for their role that provides essential information on the structure, process, organization, and administrative responsibilities of a PIPS program to include a department-approved trauma outcomes and performance improvement course.(3) The trauma program must have written trauma management guidelines, developed with approval by the trauma multidisciplinary committee and facility's medical staff with evidence of implementation, for:(A) trauma team activation;(B) trauma resuscitation guidelines for the roles and responsibilities of team members during a resuscitation;(C) triage, admission, and transfer of trauma patients; and(D) trauma management guidelines specific to the trauma population managed by the facility as defined by the State Trauma Registry.(4) All major, severe, and critical trauma patients must be admitted to an appropriate surgeon and all multi-system trauma patients must be admitted to a general surgeon.(5) A general surgeon participating in trauma-call coverage must:(A) be credentialed in ATLS or an equivalent department-approved course at least one time if board-certification maintained; and(B) be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain:(i) current board-certification or board-eligibility, or must maintain current ATLS or an equivalent department-approved course;(ii) nine hours of trauma-related continuing medical education per year;(iii) compliance with trauma management guidelines;(iv) participation in the trauma PIPS program; and(v) attendance at 50 percent or more of multidisciplinary and peer review trauma committee meetings.(6) A non-board-certified general surgeon desiring inclusion in a facility's trauma program must meet the ACS guidelines as specified in its most current version of the "Resources for Optimal Care of the Injured Patient," Alternate Criteria section.(7) The general surgeon must be present in the ED at the time of arrival of the highest level of trauma activation or within 30 minutes of notification of the trauma activation. This must be continuously monitored by the trauma PIPS program.(8) In facilities with surgical residency programs, evaluation and treatment may be started by a team of surgeons that must include a post-graduate year four (PGY4) or more senior surgical resident who is a member of that facility's residency program. The attending surgeon must participate in major therapeutic decisions, be present in the emergency department for major resuscitations, be present in the emergency department for the highest and secondary trauma activations, and be present at operative procedures. These must be continuously monitored by the trauma PIPS program.(9) When the attending surgeon is not activated initially and an urgent surgical consult is necessary, the maximum response time of the attending surgeon is 60 minutes from notification to physical presence at the patient's bedside. This must be continuously monitored by the trauma PIPS program.(10) There must be a published on-call schedule for obtaining general surgery care. There must be a documented system for obtaining general surgical care for situations when the attending general surgeon on-call is not available. This must be continuously monitored by the trauma PIPS program.(11) An orthopedic surgeon participating in trauma-call coverage must be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain:(A) current board-certification, board-eligibility, or meet ACS standards as specified in its current addition of "Resources for Optimal Care of the Injured Patient," Alternate Criteria section;(B) compliance with trauma management guidelines; and(C) participation in the trauma PIPS program.(12) An orthopedic surgeon providing trauma coverage must be promptly available (physically present) at the major, severe, or critical trauma patient's bedside within 30 minutes of request by the attending trauma surgeon or emergency physician, from inside or outside the facility. This must be continuously monitored by the trauma PIPS program.(13) When the orthopedic surgeon is not activated initially and an urgent surgical consult is necessary, the maximum response time of the orthopedic surgeon is 60 minutes from notification to physical presence at the patient's bedside. This must be continuously monitored by the trauma PIPS program.(14) There must be a published on-call schedule for obtaining orthopedic surgery care. There must be a documented system for obtaining orthopedic surgery care for situations when the attending orthopedic surgeon on-call is not available. This must be continuously monitored by the trauma PIPS program.(15) The orthopedic surgeon representative to the multidisciplinary trauma committee maintains nine hours of trauma-related continuing medical education per year and attends 50 percent or more of multidisciplinary and peer review trauma committee meetings.(16) When a Level III facility has either full-time, routine, or limited neurosurgical coverage, a neurosurgeon participating in trauma-call coverage must be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain:(A) current board-certification, board-eligibility, or meet ACS standards as specified in its current addition of "Resources for Optimal Care of the Injured Patient," Alternate Criteria section;(B) compliance with trauma management guidelines; and(C) participation in the trauma PIPS program.(17) A neurosurgeon providing trauma coverage must be promptly available (physically present) at the major, severe, or critical trauma patient's bedside and neurosurgical evaluation must occur within 30 minutes for the following criteria: severe traumatic brain injury (TBI) with a Glasgow coma scale (GCS) less than 9 and computed tomography (CT) evidence of TBI; moderate TBI with GCS of 9-12 and CT evidence of potential intracranial lesion; and neurological deficit produced by a potential spinal cord injury. When a neurosurgical advanced practice provider (APP) or neurosurgical resident is utilized, there must be documented evidence of consultation with the neurosurgical attending on-call prior to implementation of the plan of care. This must be continuously monitored by the trauma PIPS program, including the consult times and response times.(18) When the neurosurgeon is not notified of the initial activation or was not consulted by the evaluating team and it has been determined by the emergency physician or trauma surgeon that an urgent neurosurgical consult is necessary, the maximum response time of the neurosurgeon is 60 minutes from notification to physical presence at the patient's bedside. This must be continuously monitored by the trauma PIPS program.(19) There must be a published on-call schedule for obtaining neurosurgical care.(20) There must be a documented system for obtaining neurosurgical care for situations when the neurosurgeon on-call is not available. This must be continuously monitored by the trauma PIPS program.(21) The neurosurgeon representative to the multidisciplinary trauma committee must have nine hours of trauma-related continuing medical education per year and attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(22) An emergency physician must be available in the emergency department 24-hours a day and physicians providing trauma coverage must meet the following:(A) be credentialed by the facility to provide emergency medical services; and(B) be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and must maintain:(i) current board-certification, board-eligibility, or maintain current ATLS or an equivalent department-approved course;(ii) compliance with trauma management guidelines; and(iii) participation in the trauma PIPS program.(23) A board-certified emergency medicine physician providing trauma coverage must have successfully completed an ATLS Student Course or an equivalent department-approved ATLS course at least once.(24) Current ATLS verification is required for all physicians who work in the emergency department and are not board-certified in Emergency Medicine.(25) The emergency physician representative to the multidisciplinary trauma committee must have nine hours of trauma-related continuing medical education per year and attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(26) The radiology physician on-call must respond within 30 minutes of request, from inside or outside the facility. This system must be continuously monitored by the trauma PIPS program.(27) The anesthesiology physician on-call must respond within 30 minutes of request, from inside or outside the facility. This system must be continuously monitored by the trauma PIPS program.(A) Requirements may be fulfilled by a member of the anesthesia care team credentialed by the TMD to participate in the resuscitation and treatment of trauma patients that may include:(i) current board certification or board eligibility;(ii) trauma continuing education;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(B) The anesthesiology physician representative to the multidisciplinary trauma committee that provides trauma coverage to the facility must attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(28) All nurses caring for trauma patients throughout the continuum of care have ongoing documented knowledge and skill in trauma nursing for patients of all ages to include trauma specific orientation, annual clinical competencies, and continuing education.(29) Written guidelines for nursing care of trauma patients for all units (e.g., ED, ICU, Operating Room (OR), Post Anesthesia Care Unit (PACU), Medical/Surgical Units) in the facility must be implemented.(30) The facility must have a written plan, developed by the facility, for acquisition of additional staff on a 24-hour basis to support units with increased patient acuity, and multiple emergency procedures and admissions (i.e., a written disaster plan.)(31) The facility must have emergency services available 24-hours a day.(A) The ED must have a designated physician director.(B) The ED must have physicians with special competence in the care of critically injured patients, designated as members of the trauma team, and physically present in the ED 24-hours per day. Neither a facility's telemedical capabilities nor the physical presence of advanced practice providers (APPs) satisfies this requirement.(C) APPs who participate in trauma patient resuscitations and telemedicine-support physicians who participate in the care of major, severe, or critical trauma patients must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients and must maintain:(i) board-certification or board-eligibility in specialty, or current ATLS or an equivalent department-approved ATLS course;(ii) nine hours of trauma-related continuing medical education per year;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(D) The ED physician must be activated on EMS communication with the ED or after a primary assessment of patients who arrive to the ED by private vehicle for the highest level of trauma activation and must respond within 30 minutes from notification of the trauma activation. This must be monitored in the trauma PIPS program.(E) A minimum of two registered nurses who have trauma nursing training must participate in the highest level trauma activations.(F) All registered nursing staff responding to the highest levels of trauma activations must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., Advanced Cardiac Life Support (ACLS) or an equivalent department-approved course), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course. A free-standing children's facility is exempt from the ACLS requirement.(G) Nursing documentation for trauma activation patients must be systematic and meet the trauma primary and secondary assessment guidelines.(H) 100 percent of nursing staff must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., ACLS or an equivalent department-approved course), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course, within 18 months of date of employment in the ED.(I) 100 percent of a free-standing children's facility nursing staff who care for trauma patients must have successfully completed and hold current credentials in a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC) and TNCC or ATCN or an equivalent department-approved course, within 18 months of date of employment in the ED.(J) Two-way communication with all pre-hospital emergency medical services vehicles must be available.(K) Equipment and services for the evaluation and resuscitation of, and to provide life support for, critically or seriously injured patients of all ages must include:(i) airway control and ventilation equipment including laryngoscope and endotracheal tubes of all sizes, bag-valve-mask devices (BVMs), pocket masks, advanced airway management devices, and oxygen;(ii) mechanical ventilator;(iii) pulse oximetry and capnography;(iv) suction device;(v) electrocardiograph, oscilloscope, and defibrillator;(vi) internal age-specific paddles;(vii) all standard intravenous fluids and administration devices, including large-bore intravenous catheters and a rapid infuser system;(viii) sterile surgical sets for procedures standard for the emergency department such as thoracostomy, venous cutdown, central line insertion, thoracotomy, diagnostic peritoneal lavage (if performed at facility), airway control/cricothyrotomy, etc.;(ix) drugs and supplies necessary for emergency care;(x) cervical spine stabilization device;(xi) length-based body weight and tracheal tube size evaluation system (e.g., a current Broselow tape) and resuscitation medications and equipment that are dose-appropriate for all ages;(xii) long bone stabilization device;(xiii) pelvic stabilization device;(xiv) thermal control equipment for patients and a rapid warming device for blood and fluids; and(xv) non-invasive continuous blood pressure monitoring devices.(32) Imaging capability must be available, with an in-house technician 24-hours a day or on-call and responding within 30 minutes of request. This must be continuously monitored by the trauma PIPS program.(33) Psychosocial support services must be available for staff, patients, and their families.(34) Operating room services must be available 24-hours a day.(A) With advanced notice, the operating room must be opened and ready to accept a patient within 30 minutes. This must be continuously monitored by the trauma PIPS program.(B) Equipment for all trauma patient populations and anticipated special requirements must include:(i) thermal control equipment for patient and for blood and fluids;(ii) imaging capability including c-arm image intensifier with technologist available 24-hours a day;(iii) endoscopes, all varieties, and bronchoscope;(iv) equipment for long bone and pelvic fixation;(v) rapid infuser system;(vi) appropriate monitoring and resuscitation equipment;(vii) capability to measure pulmonary capillary wedge pressure; and(viii) capability to measure invasive systemic arterial pressure.(35) A PACU or surgical ICU must be available for trauma patients following operative interventions and include the following.(A) Registered nurses and other essential personnel 24-hours a day.(B) Appropriate monitoring and resuscitation equipment.(C) Pulse oximetry and capnography.(D) Thermal control equipment for patients and a rapid warming device for blood and fluids.(36) An ICU must be available for trauma patients 24-hours a day and include the following.(A) Designated surgical director or surgical co-director responsible for setting policies and administration related to trauma ICU patients. A physician providing this coverage must be a surgeon credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain:(i) board-certification, board-eligibility, or current in ATLS or an equivalent department-approved course;(ii) trauma continuing medical education;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(B) Physician, credentialed in critical care by the TMD, on duty in ICU 24-hours a day or immediately available from in-facility. Arrangements for 24-hour surgical coverage of all trauma patients must be provided for emergencies and routine care. This must be continuously monitored by the trauma PIPS program.(C) Registered nurse-patient minimum ratio of 1:2 on each shift for patients identified as critical acuity.(D) Appropriate monitoring and resuscitation equipment.(E) Pulse oximetry and capnography.(F) Thermal control equipment for patients and a rapid warming device for blood and fluids.(G) Capability to measure pulmonary capillary wedge pressure.(H) Capability to measure invasive systemic arterial pressure.(37) Respiratory services in-house and must be available 24-hours per day.(38) Clinical laboratory services must be available 24-hours per day and provide the following.(A) Standard analyses of blood, urine, and other body fluids, including microsampling.(B) Blood typing and cross-matching, to include massive transfusion guidelines and emergency release of blood guidelines.(C) Comprehensive blood bank or access to a community central blood bank and adequate facility storage.(D) Coagulation studies.(E) Blood gases and pH determinations.(F) Microbiology.(G) Drug and alcohol screening.(H) Infectious disease standard operating procedures.(I) Serum and urine osmolality.(39) Special imaging capabilities must be available.(A) Sonography is available 24-hours per day or on-call and if notified, responds within 30 minutes of notification.(B) Computerized tomography (CT) is available on-call 24-hours per day and if notified, responds within 30 minutes. This must be continuously monitored by the trauma PIPS program.(C) Angiography of all types is available 24-hours per day and if on-call, responds within 30 minutes.(D) Nuclear scanning is available and responds as defined in the trauma management guidelines.(40) Acute hemodialysis capability is available or transfer agreements are documented if not available.(41) Established criteria for care of burn patients with a process to expedite the transfer of burn patients to a burn center or higher level of care.(42) In circumstances where a designated spinal cord injury rehabilitation center exists in the region, early transfer should be considered and transfer agreements in effect.(43) In circumstances where a moderate to severe head injury center exists in the region, transfer should be considered in selected patients and transfer agreements in effect.(44) Physician-directed rehabilitation service, staffed by personnel trained in rehabilitation care and properly equipped for care of the injured patient, or transfer guidelines to a rehabilitation facility for patients needing a higher level of care or specialty services, including:(A) physical therapy;(B) occupational therapy; and(C) speech therapy.(45) Social services must be available to assist with management of trauma patients.(46) The facility must have a defined trauma PIPS plan approved by the TMD, TPM, and the multidisciplinary committee.(A) On initial designation, a facility must have completed at least six months of reviews on all qualifying trauma records with evidence of "loop closure" on identified variances. Compliance with internal trauma management guidelines must be evident.(B) On re-designation, a facility must show continuous PIPS activities throughout its designation and a rolling current three-year period must be available for review at all times.(C) Minimum PIPS inclusion criteria must include: all trauma team activations (including those discharged from the ED); all trauma deaths; all identified facility events; transfers-in and transfers-out; and readmissions within 48 hours after discharge.(D) The trauma PIPS program must be organized and include a pediatric-specific component with trauma audit filters.(i) Review of trauma medical records for appropriateness and quality of care.(ii) Documented evidence of identification of all variances from trauma management guidelines and system response guidelines, with in-depth critical review.(iii) Documented evidence of corrective actions implemented to address all identified variances with tracking of data analysis.(iv) Documented evidence of secondary level of review and participation by the TMD.(v) Morbidity and mortality review including decisions by the TMD as to whether the trauma management guidelines were followed.(vi) Documented resolutions "loop closure" of all identified variance to prevent future recurrences.(vii) Specific reviews of all trauma deaths and other specified cases, including complications, utilizing age-specific criteria.(viii) Multidisciplinary hospital trauma PIPS committee structure in place.(E) Multidisciplinary trauma committee meetings for PIPS activities must include department communication, data review, and measures for problem solving.(F) Multidisciplinary trauma conferences must include all disciplines caring for trauma patients. This conference must be for the purpose of addressing PIPS activities and continuing education.(G) Feedback regarding trauma patient transfers-in must be provided to all transferring facilities.(H) Feedback regarding trauma patient transfers-out must be obtained from receiving facilities.(I) The trauma program must maintain a trauma registry or utilize the State Trauma Registry for data entry of NTDB registry inclusion criteria patients. Trauma registry data must be submitted to the State Trauma Registry on at least a quarterly basis.(J) The trauma program must participate in the RAC's performance improvement (PI) program, including adherence to regional guidelines, submitting data preapproved by the RAC membership such as summaries of transfer delays and transfers to facilities outside of the RAC.(K) The trauma program must track the times and reasons for diversion must be documented and reviewed by the trauma PIPS program and multidisciplinary committee.(L) The trauma program must maintain published on-call schedules must be maintained for general surgeons, orthopedic surgeons, neurosurgeons, anesthesia, radiology, and other major specialists, if available.(M) The trauma program must have performance improvement personnel dedicated to and specific for the trauma program.(47) The trauma program must participate in the regional trauma system per RAC requirements.(48) The trauma program must have a process to expedite the transfer of major, severe, or critical trauma patients to include written management guidelines, written transfer agreements, and participation in a regional trauma system transfer plan for patients needing higher level of care or specialty services.(49) The facility must have a system for establishing an appropriate landing zone near the facility (if rotor-wing services are available).(50) The trauma program must provide education and consultations to physicians of the community and outlying areas.(51) The trauma program must have an identified individual to coordinate the facility's community outreach programs for the public and professionals.(52) The trauma program must have a public education program to address specific injuries identified by the facility's trauma registry. Documented participation in a RAC injury prevention program is acceptable.(53) The trauma program must have formal programs in trauma continuing education provided by facility for staff or in collaboration with the RAC, based on needs identified from the trauma PIPS program for:(A) staff physicians;(B) nurses;(C) allied health personnel, including advanced practice providers;(D) community physicians; and(E) pre-hospital personnel.(54) The facility may participate in trauma-related research.(y) Basic (Level IV) Trauma Facility Requirements. A Basic Trauma Facility (Level IV) provides resuscitation, stabilization, and arranges for appropriate transfer of trauma patients requiring a higher level of definitive care.(1) The facility must identify a TMD responsible for the provision of trauma care and must have a defined job description and organizational chart delineating the TMD's role and responsibilities. The TMD must be a physician who meets the following:(A) is currently credentialed in ATLS or an equivalent department-approved course;(B) is charged with overall management of trauma services provided by the facility;(C) must have the authority and responsibility for the clinical oversight of the trauma program, including:(i) credentialing of medical staff who provide trauma care;(ii) providing trauma care;(iii) developing trauma management guidelines;(iv) collaborating with nursing to address educational needs; and(v) developing and implementing the trauma PIPS plan with the TPM;(D) must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients and must:(i) have current board-certification or board-eligibility in surgery, emergency medicine or family medicine, or must maintain current ATLS or an equivalent department-approved course;(ii) complete nine hours of trauma-related continuing medical education per year;(iii) comply with trauma management guidelines; and(iv) participate in the trauma PIPS program;(E) must participate in a leadership role in the facility, community, and emergency management (disaster) response committee; and(F) should participate in the development of the regional trauma system plan.(2) An identified TPM is a registered nurse and must:(A) successfully complete and remain current in the TNCC or ATCN or an equivalent department-approved course;(B) successfully complete and remain current in a nationally recognized pediatric advanced life support course (e.g., PALS or the ENPC);(C) have the authority and responsibility to monitor trauma patient care from ED admission through operative intervention, ICU care, stabilization, rehabilitation care, and discharge, including the trauma PIPS program;(D) have a defined job description and organizational chart delineating the TPM's role and responsibilities;(E) participate in a leadership role in the facility, community, and regional emergency management (disaster) response committee;(F) ensure the TPM hours dedicated to the trauma program maintains a concurrent PIPS process and trauma registry; and(G) complete a course designed for their role that provides essential information on the structure, process, organization, and administrative responsibilities of a PIPS program to include a department-approved trauma outcomes and performance improvement course.(3) An identified Trauma Registrar or TPM must have appropriate training (e.g., the Association for the Advancement of Automotive Medicine (AAAM) course) in injury severity scaling. Typically, one full-time equivalent (FTE) employee dedicated to the registry is required to process approximately 500 patients annually.(4) Written trauma management guidelines must be developed with approval by the TMD, TPM, and the facility's medical staff with evidence of implementation, for:(A) trauma team activation, including defined response times;(B) trauma resuscitation, defining the roles and responsibilities of team members during a resuscitation;(C) triage, admission, and transfer of trauma patients; and(D) trauma management specific to the trauma population managed by the facility as defined by the trauma registry.(5) The emergency department must have physician coverage 24-hours per day. The physician providing coverage in the ED must be credentialed by the facility to provide emergency medical services.(A) A physician providing trauma coverage must be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and must maintain:(i) current board-certification or board-eligibility in emergency medicine or family medicine, or current ATLS or an equivalent department-approved course;(ii) nine hours of trauma-related continuing medical education per year;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(B) A board-certified emergency medicine physician providing trauma coverage must have successfully completed an ATLS Student Course or an equivalent department-approved ATLS course, at least once.(C) Current ATLS verification is required for all physicians who work in the ED and are not board-certified in emergency medicine.(D) The emergency physician representative to the multidisciplinary committee that provides trauma coverage to the facility must attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(6) Radiology physician services must be available.(7) Anesthesiology may be fulfilled by a member of the anesthesia care team credentialed in assessing emergent situations in trauma patients and providing any indicated treatment if operative services are provided.(8) All nurses caring for trauma patients throughout the continuum of care must have ongoing documented knowledge and skill in trauma nursing for patients of all ages to include trauma specific orientation, annual clinical competencies, and continuing education.(9) Written guidelines for nursing care of trauma patients for all units (i.e., ED, ICU, OR, PACU, medical/surgical units) in the facility must be implemented.(10) The facility must have a written plan, developed by the facility, for acquisition of additional staff on a 24-hour basis to support units with increased patient acuity, multiple emergency procedures, and admissions (i.e., written disaster plan.)(11) The facility must have emergency services available 24-hours a day.(A) Physician on-call schedule must be published.(B) Physicians with special competence in the care of critically injured patients, designated as members of the trauma team and on-call (if not in-house 24/7) must be promptly available within 30 minutes of request from inside or outside the facility. Neither a facility's telemedicine medical service capabilities nor the physical presence of APPs satisfy this requirement with the exception of the following:(i) A health care facility located in a county with a population of less than 30,000 may satisfy a Level IV trauma facility designation requirement relating to physicians through the use of telemedicine medical service in which an on-call physician who has special competence in the care of critically injured patients provides patient assessment, diagnosis, consultation, or treatment, or transfers medical data to a physician, advanced practice registered nurse, or physician assistants located at the facility; and(ii) APPs and telemedicine-support physicians who participate in the care of major, severe, or critical trauma patients must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients, to include requirements such as current board-certification or board-eligibility in surgery or emergency medicine, nine hours of trauma-related continuing medical education per year, compliance with trauma management guidelines, and participation in the trauma PIPS program.(C) The ED physician must be activated on EMS communication with the ED or after a primary assessment of patients who arrive to the ED by private vehicle for the highest level of trauma activation and must respond within 30 minutes from notification. This must be continuously monitored in the trauma PIPS program.(D) A minimum of one and preferably two registered nurses who have trauma nursing training must participate in initial resuscitation of the highest level of trauma activations.(E) All registered nursing staff responding to the highest levels of trauma activations must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., ACLS or an equivalent department-approved course ), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course.(F) 100 percent of nursing staff must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., ACLS or an equivalent department-approved course ), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course, within 18 months of date of employment in the ED.(G) Nursing documentation for trauma activation patients must be systematic and meet the trauma primary and secondary assessment guidelines.(H) Two-way communication with all pre-hospital emergency medical services vehicles must be available.(I) Equipment and services for the evaluation and resuscitation of, and to provide life support for, critically or seriously injured patients of all ages must include:(i) airway control and ventilation equipment including laryngoscope and endotracheal tubes of all sizes, BVMs, pocket masks, advanced airway management devices, and oxygen;(ii) mechanical ventilator;(iii) pulse oximetry and capnography;(iv) suction device;(v) electrocardiograph, oscilloscope, and defibrillator;(vi) all standard intravenous fluids and administration devices, including large-bore intravenous catheters and a rapid infuser system;(vii) sterile surgical sets for procedures standard for the ED such as thoracostomy, central line insertion, thoracotomy if surgeons participate in trauma care, airway control/cricothyrotomy, etc.;(viii) drugs and supplies necessary for emergency care;(ix) cervical spine stabilization device;(x) length-based body weight & tracheal tube size evaluation system (e.g., a current Broselow tape) and resuscitation medications and equipment that are dose-appropriate for all ages;(xi) long bone stabilization device;(xii) pelvic stabilization device;(xiii) thermal control equipment for patients and a rapid warming device for blood and fluids; and(xiv) non-invasive continuous blood pressure monitoring devices.(12) Clinical laboratory services must be available 24-hours per day and provide the following.(A) Call-back process for trauma activations available within 30 minutes. This must be continuously monitored in the trauma PIPS program.(B) Standard analyses of blood, urine, and other body fluids, including microsampling.(C) Blood-typing and cross-matching with a minimum of two units of universal packed red blood cells (PRBCs) immediately available.(D) Capability for immediate release of blood for a transfusion and measures to obtain additional blood supply.(E) Coagulation studies.(F) Blood gases and pH determinations.(G) Drug and alcohol screening.(13) Imaging capabilities must be available 24-hours per day. Call-back process for trauma activations must be available within 30 minutes. This must be continuously monitored in the trauma PIPS program.(14) The trauma program must have a defined trauma PIPS plan approved by the TMD, TPM, and the trauma multidisciplinary committee.(A) On initial designation, a facility must have completed at least six months of reviews on all qualifying trauma records with evidence of "loop closure" on identified variances. Compliance with internal trauma management guidelines must be evident.(B) On re-designation, a facility must show continuous PIPS activities throughout its designation and a rolling current three-year period must be available for review at all times.(C) Minimum PIPS inclusion criteria includes: all trauma team activations (including those discharged from the ED); all trauma deaths; all identified facility events; transfers-in and transfers-out; and readmissions within 48-hours after discharge.(D) The trauma PIPS program must be organized and include a pediatric-specific component with trauma audit filters.(i) Review of trauma medical records for appropriateness and quality of care.(ii) Documented evidence of identification of all variances from trauma management guidelines and system response guidelines, with in-depth critical review.(iii) Documentation of corrective actions implemented to address all identified variances with tracking of data analysis.(iv) Documented evidence of secondary level of review and participation by the TMD.(v) Morbidity and mortality review including decisions by the TMD as to whether the trauma management guidelines were followed.(vi) Documented resolutions "loop closure" of all identified issues to prevent future recurrences.(vii) Specific reviews of all trauma deaths and other specified cases, including complications, utilizing age-specific criteria.(viii) Multidisciplinary facility trauma PIPS committee structure must be in place and include department communication, data review, and measures for problem solving.(E) Feedback regarding trauma patient transfers-out must be obtained from receiving facilities.(F) Facility must maintain a trauma registry or utilize the State Trauma Registry for data entry of patients meeting NTDB registry inclusion criteria. Trauma registry data must be submitted to the State Trauma Registry on at least a quarterly basis.(G) Participation with the RAC's PI program, including adherence to regional guidelines, submitting data preapproved by the membership to the RAC such as summaries of transfer delays and transfers to facilities outside of the RAC.(H) Times and reasons for diversion must be documented and reviewed by the trauma PIPS program and multidisciplinary committee.(15) The trauma program must participate in the regional trauma system per RAC requirements.(16) The trauma program must have processes in place to expedite the transfer of major, severe, or critical trauma patients to include written management guidelines, written transfer agreements, and participation in a regional trauma system transfer plan for patients needing higher level of care or specialty services.(17) The facility must have a system in place for establishing an appropriate landing zone in close proximity to the facility (if rotor-wing services are available).(18) Facility may participate in a RAC injury prevention program.(19) Formal programs in trauma continuing education must be provided by the facility or in collaboration with the RAC or their health care system based on needs identified from the trauma PIPS program for:(A) staff physicians;(B) nurses; and(C) allied health personnel, including APPs. Source Note: The provisions of this §157.125 adopted to be effective December 26, 2006, 31 TexReg 10300; amended to be effective December 5, 2019, 44 TexReg 7396; amended to be effective November 24, 2024, 49 TexReg 9241. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS §157.125 Requirements for Trauma Facility Designation Effective Through August 31, 2025 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222035 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222035 03/11/2026 (a) The department designates hospital applicants as trauma facilities, which are part of the trauma and emergency health care system. Hospitals must meet the designation requirements specific to the level of designation requested by September 1, 2025. Trauma designation surveys conducted on or after September 1, 2025, are evaluated on the requirements in this section.(b) The facility seeking trauma designation submits a completed designation application packet to the department. The department reviews the facility application documents for the appropriate level of designation. The complete designation application packet must include the following:(1) a trauma designation application for the requested level of trauma designation;(2) a completed department designation assessment questionnaire;(3) the documented trauma designation survey summary report that includes findings of requirements met and medical record reviews;(4) evidence of documented data validation and quarterly submission to the State Trauma Registry and National Trauma Data Bank (NTDB) (if applicable) for the past 12 months;(5) evidence of the facility's trauma program and Trauma Medical Director (TMD) or designee participation at Regional Advisory Council (RAC) meetings throughout the designation cycle; and(6) full payment of the non-refundable, non-transferrable designation fee.(c) The department reviews the designation application packet to determine and approve the facility's level of trauma designation. The department defines the final trauma designation level awarded to the facility and this designation may be different than the level requested based on the designation site survey summary. If the department determines the facility meets the requirements for trauma designation the department provides the facility with a designation award letter and a designation certificate. The facility must display its trauma designation certificate in a public area of the licensed premises that is readily visible to patients, employees, and visitors.(d) Eligibility requirements for trauma designation.(1) Health care facilities eligible for trauma designation include:(A) a hospital in Texas, licensed or otherwise, in accordance with Texas Health and Safety Code Chapter 241;(B) a hospital owned and operated by the State of Texas; or(C) a hospital owned and operated by the federal government, in Texas.(2) Each hospital must demonstrate the capability to stabilize and transfer or treat an acute trauma patient, have written trauma management guidelines for the hospital, have a written operational plan, and have a written trauma performance improvement and patient safety (PIPS) plan.(3) Each hospital operating on a single hospital license with multiple locations (multi-location license) may apply for trauma designation separately by physical location for each designation.(A) Hospital departments or services within a hospital must not be designated separately.(B) Hospital departments located in a separate building not contiguous with the designated facility must not be designated separately.(C) Each non-contiguous emergency department of a hospital operating on a single hospital license must have trauma patient care and transfers monitored through the main hospital's trauma program.(e) A facility is defined under subsection (d) of this section as a single location where inpatients receive hospital services and inpatient care.(1) Each facility location must meet the requirements for designation. The department defines the designation level based on the facility's ability to demonstrate designation requirements are met.(2) Each facility must submit a separate trauma designation application based on its resources and the level of designation the facility is seeking.(3) If there are multiple hospitals covered under a single hospital license, each hospital or physical location where inpatients receive hospital services and care may seek designation.(4) Trauma designation is issued for the physical location and to the legal owner of the operations of the designated facility and is non-transferable.(f) Facilities seeking trauma designation must meet department-approved requirements and have them validated by a department-approved survey organization.(g) The four levels of trauma designation are as follows.(1) Comprehensive trauma facility designation (Level I). The facility, including a free-standing children's facility, must:(A) meet the current American College of Surgeons (ACS) trauma verification standards for Level I and receive a letter of verification from the ACS;(B) meet the state trauma designation requirements;(C) meet the participation requirements for the local RAC;(D) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(E) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 (relating to Injury Prevention and Control).(2) Major trauma facility designation (Level II). The facility, including a free-standing children's facility, must:(A) meet the current ACS trauma verification standards for Level II and receive a letter of verification from the ACS;(B) meet the state trauma designation requirements;(C) meet the participation requirements for the local RAC;(D) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(E) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(3) Advanced trauma facility designation (Level III). The facility, including a free-standing children's facility, must:(A) meet the current ACS trauma verification standards for Level III and receive a letter of verification from the ACS, or complete a designation survey conducted by a department-approved survey organization;(B) meet the state trauma designation requirements;(C) meet the participation requirements for the local RAC;(D) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(E) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(4) Basic trauma facility designation (Level IV). The facility, including a free-standing children's facility:(A) Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must:(i) meet the current ACS trauma verification standards for Level IV and complete a designation survey conducted by a department-approved survey organization;(ii) meet the state trauma designation requirements;(iii) meet the participation requirements for the local RAC;(iv) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(v) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(B) Level IV facilities managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually must:(i) meet the defined state trauma designation requirements and complete a designation survey with the department or with a department-approved survey organization;(ii) meet the participation requirements for the local RAC;(iii) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(iv) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(h) All facilities seeking trauma designation must meet the following requirements.(1) Facilities must have documented evidence of participation in the local RAC.(2) Facilities must have evidence of quarterly trauma data submissions to the State Trauma Registry for patients that meet NTDB registry inclusion criteria, following the National Trauma Data Standards (NTDS) definitions and state definitions.(3) Facilities must have emergency medical services (EMS) communication capabilities.(4) Facilities must have provisions to capture the EMS wristband number or measures for patient tracking in resuscitation documentation.(5) Facilities must have provisions to provide and document EMS hand-off.(6) Facilities must have landing zone capabilities or system processes to establish a landing zone (when rotor-wing capabilities are available) with appropriate staff safety training.(7) Facilities must have a process to provide feedback to EMS providers.(8) All levels of trauma facilities must have written trauma management guidelines specific to the hospital that align with evidence-based practices and current national standards, which must be reviewed a minimum of every three years. These guidelines must be specific to the trauma patient population managed by the facility. Guidelines must be established for the following:(A) trauma activation and response time based on national recommendations;(B) trauma resuscitation and documentation;(C) consultation services requests and response;(D) admission and transfer;(E) screening, management, and appropriate interventions or referral for both suspected and confirmed abuse of all patient populations; and(F) massive transfusion.(9) Facilities must have defined documentation of trauma management guidelines pertinent to the care of trauma patients in all nursing units providing care to the trauma patient.(10) The written trauma management guidelines must be monitored though the trauma PIPS process.(11) The trauma program must have provisions for the availability of all necessary equipment and services to administer the appropriate level of care and support for the injured patient meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria through the continuum of care to discharge or transfer.(12) All levels of adult trauma facilities must meet and maintain the Emergency Medical Services for Children's Pediatric Readiness Criteria, as evidenced by the following:(A) annual completion of the on-line National Pediatric Readiness Project assessment (https://pedsready.org), including a written plan of correction (POC) for identified opportunities for improvement that is monitored through the trauma PIPS plan until resolution;(B) pediatric equipment and resources immediately available at the facility, and staff with defined and documented competency skills and training on the pediatric equipment;(C) education and training requirements for Emergency Nursing Pediatric Course (ENPC) or Pediatric Advanced Life Support (PALS) for the nurses responding to pediatric trauma activations;(D) assessments and documentation include Glasgow Coma Score (GCS); complete vital signs to include temperature, heart rate, respirations, and blood pressure; pain assessment; and weight recorded in kilograms;(E) serial vital signs, GCS, and pain assessments are completed and documented for the highest level of trauma activations or when shock, a traumatic brain injury, or multi-system injuries are identified;(F) pediatric imaging guidelines and processes addressing pediatric age or weight-based appropriate dosing for studies imparting radiation consistent with the ALARA (as low as reasonably achievable) principle; and(G) documented evidence the trauma facility has completed a pediatric trauma resuscitation simulation with medical staff participation every six months, including a completed critique identifying opportunities for improvement integrated into the trauma performance improvement initiatives and tracked until the identified opportunities are corrected. An adult trauma facility managing 200 or more patients less than 15 years of age with an injury severity score (ISS) of 9 or greater is exempt from this requirement of pediatric trauma simulations. If the facility has responded to an actual pediatric trauma resuscitation event during a six-month period, the facility is exempt from this training but must have documented evidence of participation in the after-action-review.(13) Free-standing children's trauma facilities must have resources and equipment immediately available for adult trauma resuscitations, adherence to the nursing requirements for Trauma Nurse Core Course (TNCC) or Advanced Trauma Care for Nurses (ATCN), documented evidence the trauma program has completed an adult trauma resuscitation simulation with medical staff participation every six months, including a completed critique identifying opportunities for improvement integrated into the trauma performance improvement initiatives and tracked until the identified opportunities are corrected. Free-standing children's trauma facilities managing 200 adult patients 15 years or older with an ISS of 9 or greater are exempt from this requirement for adult trauma simulations.(14) Rural Level IV trauma facilities in a county with a population less than 30,000 may utilize telemedicine resources with an Advanced Practice Provider (APP) available to respond to the trauma patient's bedside within 30 minutes of notification, with written resuscitation and trauma management guidelines monitored through the trauma performance improvement and patient safety processes.(A) The APP must be current in Advance Trauma Life Support (ATLS) training, annually maintain an average nine hours of trauma-related continuing medical education, and demonstrate adherence to the trauma patient management guidelines and documentation standards.(B) The facility must have a documented telemedicine physician credentialing process.(C) All assessments, physician orders, and interventions initiated through telemedicine must be documented in the patient's medical record.(15) Telemedicine in trauma facilities in a county with a population of 30,000 or more, if utilized, must have a documented physician credentialing process, written trauma protocols for utilization of telemedicine including physician response times, and measures to ensure the trauma management guidelines and evidence-based practice are monitored through the trauma performance improvement and patient safety processes.(A) Telemedicine cannot replace the requirement for the trauma on-call physician to respond to the trauma activations in-person, to conduct inpatient rounds, or to respond to emergency requests from the inpatient units, when requested.(B) All telemedicine assessments, physician orders, and interventions initiated through telemedicine must be documented in the patient's medical record.(C) Telemedicine services or the telemedicine physician may be requested to assist in trauma performance improvement committee reviews.(16) The trauma medical director (TMD) must define the role and expectations of the hospitalist or intensivist in providing care to the admitted injured patient meeting trauma activation guidelines and meeting NTDB registry inclusion criteria.(17) A trauma program manager (TPM) or designee must be a participating member of the nurse staffing committee.(18) The facility must maintain medical records facilitating the documentation of trauma patient arrival, level of activation, physician response and team response times, EMS hand-off, wristband number or patient tracking identifier, resuscitation, assessments, vital signs, GCS, serial evaluation of needs, interventions, patient response to interventions, reassessments, and re-evaluation through all phases of care to discharge or transfer out of the facility.(19) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have an organized, effective trauma service recognized in the medical staff bylaws or rules and regulations and approved by the governing body. Medical staff credentialing must include a process for requesting and granting delineation of privileges for the TMD to oversee the providers participating in trauma call coverage, the trauma panel, and trauma management through all phases of care.(20) Level I, II, and III facilities must have a TMD with requirements aligned with the current ACS standards specific to the level of designation requested and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have a TMD with a defined job description that is a surgeon, emergency medicine physician, or family practice physician that is board-certified in their specialty, current in ATLS, and meet the other ACS standards specific to the TMD for the level of designation requested. The TMD must complete a trauma performance improvement course approved by the department.(21) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have an identified TPM responsible for monitoring trauma patient care throughout the continuum of care, from pre-hospital management to trauma activation, inpatient admission, and transfer or discharge, to include transfer follow-up as appropriate. The TPM must be a registered nurse with clinical background in trauma care and must have completed a trauma performance improvement course approved by the department and the Association for the Advancement of Automotive Medicine (AAAM) Injury Scaling Course, and have current TNCC or ATCN, Emergency Nursing Pediatric Course (ENPC) or Pediatric Advanced Life Support (PALS), and Advanced Cardiac Life Support (ACLS) certifications. It is recommended for the TPM to complete courses specific to the TPM role. The role must be only for that facility and cannot cover multiple facilities. The TPM authority and responsibilities are aligned with the current ACS standards for the specific level of designation.(22) The facility must have an organizational structure that facilitates the TPM's review of trauma care from admission to discharge, allowing for recommendations to improve care through all phases of care, and a reporting structure to an administrator having the authority to recommend and monitor facility system changes and oversee the trauma program.(23) All levels of trauma facilities must maintain a continuous trauma PIPS plan. The plan must be data-driven and must:(A) identify variances in care or system response events for review, including factors that led to the event, delays in care, hospital events such as complications, and all trauma deaths;(B) define the levels of harm;(C) define levels of review;(D) identify factors that led to the event;(E) identify opportunities for improvement;(F) establish action plans to address the opportunities for improvement;(G) monitor the action plan until the desired change is met and sustained;(H) establish a concurrent PIPS process;(I) meet staffing standards that align with the ACS standards for performance improvement personnel; and(J) utilize terminology for classifying morbidity and mortality with the terms:(i) morbidity or mortality without opportunity;(ii) morbidity or mortality with opportunity for improvement; and(iii) morbidity or mortality with regional opportunity for improvement.(24) The trauma PIPS plan must be approved by the TMD, TPM, and the trauma operations committee and be disseminated to all departments providing care to the trauma patient. The departments must ensure staff are knowledgeable of the responsibilities in the trauma PIPS plan and the requested data and information to be presented at the trauma operations committee.(25) The Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must demonstrate that the TMD chairs the secondary level of performance review, chairs the trauma multidisciplinary peer review committee, and co-chairs the trauma operations committee with the TPM.(26) The trauma PIPS plan must outline the roles and responsibilities of the trauma operations committee and its membership.(27) The trauma facility must document and include in its trauma PIPS plan the external review of the trauma verification and designation assessment questionnaire, designation survey documents, the designation survey summary report, including the medical record reviews, and all communication with the department.(28) Trauma facilities must submit required trauma registry data every 90 days or quarterly to the State Trauma Registry and have documented evidence of data validation and correction of identified errors or blank fields.(A) All levels of trauma facilities must demonstrate the current ACS standards for staffing requirements for the trauma registry are met.(B) Trauma facilities utilizing a pool of trauma registrars must have an identified trauma registrar from the pool assigned to the facility to ensure data requests are addressed in a timely manner.(29) All levels of trauma facilities must demonstrate the registered nurses assigned to care for arriving patients meeting trauma activation guidelines have current TNCC or ATCN, ENPC or PALS, and Advanced Cardiac Life Support certifications. Those new to the facility or the facility's trauma resuscitation area must meet these requirements within 18 months.(30) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have evidence the trauma program surgeons, trauma liaisons, trauma program personnel, operating suite leaders, and critical care medical director and nursing leaders complete a mass casualty response training on their roles, potential job functions, and job action sheets, to ensure competency regarding actions required for surge capacity, capabilities, and patient flow management from resuscitation to inpatient admission, operative suite, and critical care units or intensive care units during a multiple casualty or mass casualty event. If the facility has responded to an actual mass casualty event during a 12-month period, the facility is exempt from this training but must have documented evidence of participation in the after-action review.(31) Level IV facilities managing 101 or more patients meeting NTDB registry inclusion criteria annually must:(A) meet the current ACS Level IV standards and defined state requirements;(B) have 24-hour on-site coverage by an emergency physician credentialed by the hospital and approved by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and respond to trauma activation patients within 30 minutes of request;(C) have documented guidelines for trauma activations, resuscitation guidelines, documentation standards, and patient transfers, and measures to monitor the guidelines through the trauma performance improvement process. Transfer reviews must include the time of arrival, transfer decision time, transfer acceptance time, transport arrival time, and time transferred;(D) have documented management guidelines specific to the trauma patients admitted at the facility based on trauma registry data;(E) have a written trauma PIPS plan that, at minimum, monitors:(i) trauma team activations;(ii) trauma team member response times;(iii) trauma resuscitation guidelines;(iv) documentation standards;(v) trauma management guidelines;(vi) pediatric trauma resuscitation guidelines;(vii) transfer guidelines; and(viii) all trauma deaths; and(F) have provisions for a multidisciplinary trauma peer review committee and a trauma operations committee.(32) Level IV facilities managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually must:(A) have 24-hour emergency services coverage by a physician credentialed by the hospital and approved by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and respond to trauma activation patients within 30 minutes of request;(B) have a TMD overseeing and monitoring the trauma care provided and who is current in ATLS;(C) have a TPM who is a registered nurse and must:(i) complete a trauma performance improvement course and a trauma program manager course approved by the department;(ii) complete a registry AAAM Injury Scoring Course;(iii) have current TNCC or ATCN, ENPC or PALS, and ACLS certifications; and(iv) oversee and monitor trauma care provided;(D) have documented guidelines for trauma team activation with response times, resuscitation guidelines, and documentation standards for resuscitation through admission, transfer, or discharge;(E) have documented management guidelines specific for the trauma patients admitted to the facility;(F) have documented transfer guidelines that are monitored to identify the arrival time, decision to transfer time, time of transfer acceptance, time of transport arrival, and time of transfer;(G) have a trauma PIPS plan that, at minimum, monitors:(i) trauma team activations;(ii) trauma team member response times;(iii) trauma resuscitation guidelines;(iv) documentation standards;(v) trauma management guidelines;(vi) pediatric trauma resuscitation guidelines;(vii) transfer guidelines; and(viii) all trauma deaths;(H) have provisions for a trauma multidisciplinary peer review process and operational oversight integrated into the hospitals performance review or quality review processes;(I) have provisions for a trauma registry and submit the NTDB data to the State Trauma Registry quarterly to include each patient's ISS;(J) have conventional radiology available 24-hours per day;(K) have laboratory services available 24-hours per day for standard analysis of blood, urine, and other body fluids, including microbiologic sampling when appropriate;(L) have blood bank capabilities including typing and cross-matching and have a minimum of two universal packed red blood cell units available; and(M) participate in the local RAC.(i) A facility seeking trauma designation or renewal of designation must submit the completed designation application packet, have the required documents available at the time of the designation survey, and submit the designation survey summary report and medical record reviews following the completed designation survey.(1) A complete application packet contains the following:(A) a trauma designation application for the requested level of trauma designation;(B) a completed department designation assessment questionnaire;(C) the documented trauma designation survey summary report that includes findings of requirements met and medical record reviews;(D) evidence of documented data validation and quarterly submission to the State Trauma Registry and NTDB (if applicable) for the past 12 months;(E) evidence of the facility's trauma program participation at RAC meetings throughout the designation cycle;(F) full payment of the non-refundable, non-transferrable designation fee and department remit form submitted to the department Cash Branch per the designation application instructions; and(G) the documentation in subparagraphs (A), (B), (D), and (E) of this paragraph must be submitted to the department and department-approved survey organization no less than 45 days before the facility's scheduled designation survey.(2) The facility must have the required documents available and organized for the actual designation survey, including:(A) documentation of a minimum of 12 months of trauma performance improvement and patient safety reviews, including minutes and attendance of the trauma operations meetings and the trauma multidisciplinary peer review committee meetings, all trauma-documented management guidelines or evidence-based practice guidelines, and all trauma-related policies, procedures, and diversion times;(B) evidence of 12 months of trauma registry submissions to the State Trauma Registry;(C) documentation of all injury prevention, outreach education, public education, and research activities (if applicable); and(D) documentation to reflect designation requirements are met.(3) Not later than 90 days after the trauma designation survey, the facility must submit to the department the following documentation:(A) the documented trauma designation survey summary report that includes the requirements met and not met, and the medical record reviews; and(B) a POC, if required by the department, which addresses all designation requirements defined as "not met" in the trauma designation survey summary report, which must include:(i) a statement of the cited designation requirement not met;(ii) a statement describing the corrective actions taken by the facility seeking trauma designation to meet the requirement;(iii) the title of the individuals responsible for ensuring the corrective actions are implemented and monitored;(iv) the date the corrective actions are implemented;(v) a statement on how the corrective actions will be monitored and what data are measured to identify change;(vi) documented evidence the POC is implemented within 60 days of the survey date; and(vii) any subsequent documents requested by the department.(4) The application includes full payment of the appropriate non-refundable, non-transferrable designation fee.(A) For Level I and Level II trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $5,000 and a lower limit of $4,000.(B) For Level III trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $2,500 and a lower limit of $1,500.(C) For Level IV trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $1000 and a lower limit of $500.(5) All application documents except the designation fee are submitted electronically to the department.(j) Facilities seeking initial trauma designation must complete a scheduled conference call with the department and include the facility's chief executive officer (CEO), CNO, chief operating officer (COO), trauma administrator or executive leader, TMD, and TPM before scheduling the designation survey. The following information must be provided to the department before the scheduled conference call with the department:(1) job descriptions for the TMD, TPM, and trauma registrar;(2) trauma operational plan;(3) trauma PIPS plan;(4) trauma activation and trauma management guidelines; and(5) trauma registry procedures.(k) Facilities seeking designation renewal must submit the required documents described in subsection (i) of this section to the department no later than 90 days before the facility's current trauma designation expiration date.(l) The application will not be processed if a facility seeking trauma designation fails to submit the required application documents and designation fee.(m) A facility requesting designation at a different level of care or experiencing a change in ownership or a change in physical address must notify the department and submit a complete designation application packet and application fee.(n) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must schedule a designation survey with a department-approved survey organization. All aspects of the designation survey process must follow the department designation survey guidelines. All initial designation surveys must be performed in person unless approval for virtual review is given by the department.(1) Facilities requesting Level I and II trauma facility designation must request a verification survey through the ACS trauma verification program. This includes pediatric stand-alone facilities.(2) Level III facilities must request a designation survey through either the ACS trauma verification program or through a department-approved survey organization.(3) Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must schedule a designation survey with a department-approved survey organization.(4) Level IV facilities managing 100 or less trauma patients meeting the NTDB registry inclusion criteria annually must schedule a designation survey with the department or the facility's executive officers may request a designation survey with a department-approved survey organization.(5) The facility must notify the department of the date of the scheduled designation survey a minimum of 60 days before the survey.(6) The facility is responsible for any expenses associated with the designation survey.(7) The department, at its discretion, may appoint a designation coordinator to participate in the survey process. The designation coordinator's costs are borne by the department.(o) The survey team composition must be as follows:(1) Level I or Level II facilities must be reviewed by a team of surveyors who do not practice in Texas and who currently participate in the management or oversight of trauma patients at a verified or designated Level I or II trauma facility. The survey team must include:(A) two surgeons;(B) an emergency medicine physician; and(C) a registered nurse with trauma expertise.(2) Level III facilities must be reviewed by a team of surveyors currently participating in the management or oversight of trauma patients at a verified or designated Level I, II, or III trauma facility. The survey team must include:(A) a surgeon; and(B) a registered nurse with trauma expertise.(3) Level IV facilities must be reviewed by surveyors determined by the facility's number of trauma patients meeting NTDB registry inclusion criteria annually that are managed by the facility.(A) Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually with:(i) evidence of trauma patients having operative interventions, being admitted to the ICU, or having an ISS of 15 or greater must be reviewed by:(I) a surgeon; and(II) a registered nurse with trauma expertise;(ii) no evidence of operative interventions, but trauma patients are admitted to the ICU and have an ISS of 15 or greater must be reviewed by:(I) a surgeon, emergency medicine physician, or family practice physician who has the role of TMD or trauma liaison at their facility; and(II) a registered nurse with trauma expertise;(iii) no evidence of operative interventions or ICU admissions must be reviewed by:(I) a surgeon, emergency medicine physician, family practice physician; or(II) a registered nurse with trauma expertise.(B) Level IV facilities managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually have the option of requesting a designation survey by:(i) the department; or(ii) a department-approved survey organization. If this option is chosen, the survey team must include:(I) a surgeon, an emergency medicine physician, or family practice physician, currently serving in the role of TMD or trauma liaison; or(II) a registered nurse with trauma expertise.(p) Trauma facilities seeking designation or redesignation and department-approved survey organizations must follow the department survey guidelines and ensure all surveyors follow these guidelines.(1) All members of the survey team for Level III or IV, except department staff, must not be from the same TSA or a contiguous TSA of the facility's location without the written approval from the department. There must be no business or patient care relationship or any known conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.(2) The facility must not accept surveyors with any known conflict of interest. If a conflict of interest is present, the facility seeking trauma designation must decline the assigned surveyor through the survey organization.(A) A conflict of interest exists when the surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public.(B) The conflict of interest may include a surveyor who, in the past four years:(i) has trained or supervised key hospital or medical staff in residency or fellowship;(ii) collaborated professionally with key members of the facility's leadership team;(iii) was employed in the same health care system in state or out of state;(iv) participated in a designation consultation with the facility;(v) had a previous working relationship with the facility or facility leader;(vi) conducted a designation survey for the facility; or(vii) is the EMS medical director for an agency that routinely transports trauma patients to the facility.(3) If a designation survey occurs with a surveyor who has a known conflict of interest, the trauma designation survey summary report and medical record review may not be accepted by the department.(4) A survey organization must complete an application requesting to perform designation surveys in Texas and be approved by the department. Each organization must renew its application every four years.(q) Level I and II facilities using the ACS verification program who receive a Type I or three or more Type II standards not met, and Level III facilities surveyed by a department-approved survey organization with four or more requirements not met, must schedule a conference call with the department.(r) If a health care facility seeking re-designation fails to meet the requirements outlined in subsection (j) of this section, the original designation expires on its expiration date. The facility must wait six months and begin the process again to continue as a designated trauma facility.(s) If a facility disagrees with the designation level awarded by the department, the CEO, CNO, or COO may request an appeal, in writing, sent to the EMS/Trauma Systems Section director not later than 30 days after the issuance date of a designation award.(1) All written appeals are reviewed quarterly by the EMS/Trauma Systems Section director in conjunction with the Trauma Designation Review Committee.(A) The Trauma Designation Review Committee consists of the following individuals for trauma designation appeals, exception requests, or contingent designation survey summaries:(i) chair of Governor's EMS and Trauma Advisory Council (GETAC);(ii) chair of the GETAC Trauma System Committee;(iii) current president of the Texas Trauma Coordinators Forum;(iv) two individuals who each have a minimum of 10 years of trauma facility oversight as an administrator, medical director, program manager, or program liaison, all selected by the current chair of GETAC and approved by the EMS/Trauma Systems Section director and Consumer Protection Division (CPD) associate commissioner; and(v) three department representatives from the EMS/Trauma Systems Section.(B) The Trauma Designation Review Committee meetings are closed to maintain confidentiality for all reviews.(C) The GETAC chair and the chair of the Trauma System Committee are required to attend the Trauma Designation Review Committee, in addition to a minimum of three of the other members, to conduct meetings with the purpose of reviewing trauma facility designation appeals, exception requests, and contingent designation survey summaries that identify requirements not met. Agreement from a majority of the members present is required.(2) If the Trauma Designation Review Committee supports the department's designation determination, the EMS/Trauma Systems Section director gives written notice of the review and determination to the facility not later than 30 days after the committee's recommendation.(3) If the Trauma Designation Review Committee recommends a different level of designation, it will provide the recommendation to the department. The department reviews the recommendation and determines the approved level of designation. Additional actions, such as a focused review, re-survey, or submission of information and reports to maintain designation, may be required by the department for identified designation requirements not met or only partially met.(4) If a facility disagrees with the department's awarded level of designation, the facility may request a second appeal review with the department's CPD associate commissioner. The appeal must be submitted to the EMS/Trauma Systems Section no later than 15 days after the issuance date of the department's designation. If the CPD associate commissioner disagrees with the Trauma Designation Review Committee's recommendation, the CPD associate commissioner decides the appropriate level of designation awarded. The department sends a notification letter of the second appeal decision within 30 days of receiving the second appeal request.(5) If the facility continues to disagree with the second level of appeal, the facility may request a hearing, governed by the department's rules for a contested case hearing and by Texas Administrative Procedure Act, Texas Government Code Chapter 2001, and the department's formal hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(t) All designated facilities must follow the exceptions and notifications process outlined in the following paragraphs.(1) A designated trauma facility must provide written or electronic notification of any significant change to the trauma program impacting the capacity or capabilities to manage and care for a trauma patient. The notification must be provided to:(A) all EMS providers that transfer trauma patients to or from the designated trauma facility;(B) the hospitals to which it customarily transfers out or from which it transfers in trauma patients;(C) applicable RACs; and(D) the department.(2) If the designated trauma facility is unable to meet the requirements to maintain its current designation, it must submit to the department a documented POC and a request for a temporary exception to the designation requirements. Any request for an exception must be submitted in writing from the facility's CEO and define the facility's timeline to meet the designation requirements. The department reviews the request and the POC and either grants the exception with a timeline based on access to care, including geographic location, other levels of trauma facilities available, transport times, impact on trauma outcomes, and the regional trauma system, or denies the exception. If the facility is not granted an exception or it does not meet the designation requirements at the end of the exception period, the department elects one of the following:(A) review the exception request with the Trauma Designation Review Committee with consideration of geographic location, access to trauma care in the local area of the facility, and impact on the regional trauma system;(B) re-designate the facility at the level appropriate to its revised capabilities;(C) outline an agreement with the facility to satisfy all designation requirements for the level of care designation within a time specified under the agreement, which may not exceed the first anniversary of the effective date of the agreement; or(D) accept the facility's relinquishing of its trauma designation certificate.(3) If the facility is relinquishing its trauma designation, the facility must provide 30 day written advance notice of the relinquishment to the department. The facility informs the applicable RACs, EMS providers, and facilities to which it customarily transfers out or from which it transfers in trauma patients. The facility is responsible for continuing to provide trauma care services or ensuring a plan for trauma care continuity for 30 days following the written notice of relinquishment of its trauma designation.(u) A designated trauma facility may choose to apply for a higher level of designation at any time. The facility must follow the initial designation process described in subsection (i) of this section to apply for a higher level of trauma designation. The facility must not claim or advertise the higher level of designation until the facility has received written notification of the award of the higher level of designation.(v) A hospital providing trauma services must not use or authorize the use of any public communication or advertising containing false, misleading, or deceptive claims regarding its trauma designation status. Public communication or advertising is deemed false, misleading, or deceptive if the facility uses these, or similar, terms:(1) trauma facility, trauma hospital, trauma center, functioning as a trauma center, serving as a trauma center, or similar terminology if the facility is not currently designated as a trauma center or designated trauma center at that level; or(2) comprehensive Level I trauma center, major Level II trauma center, advanced Level III trauma center, basic Level IV trauma center, or similar terminology in its signs, website, advertisements, social media, or in the printed materials and information it provides to the public that are different than the current designation level awarded by the department.(w) During a virtual, on-site, or focused designation review conducted by the department or a department-approved survey organization, the department or surveyor has the right to review and evaluate the following documentation to validate designation requirements are met in this section and the Texas Health and Safety Code Chapter 773:(1) trauma patient medical records;(2) trauma PIPS plan and process documents;(3) appropriate committee documentation for attendance, meeting minutes, and documents demonstrating why the case was referred, the date reviewed, pertinent discussion, and any actions taken specific to improving trauma care and outcomes; and(4) documents relevant to trauma care in a designated trauma facility or facility seeking trauma facility designation to validate evidence designation requirements are met.(x) The department and department-approved survey organizations must comply with all relevant laws related to the confidentiality of such records. Source Note: The provisions of this §157.126 adopted to be effective November 24, 2024, 49 TexReg 9241. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS §157.126 Trauma Facility Designation Requirements Effective on September 1, 2025 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222036&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222036 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222036&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222036 03/11/2026 (a) A facility's application for designation may be denied or a facility's designation may be suspended or revoked for failure to meet designation requirements, or for any of the following reasons:(1) failure to comply with the statute and this chapter;(2) willful preparation or filing of false reports or records;(3) fraud or deceit in obtaining or attempting to obtain designation status;(4) failure to submit data to the State Trauma Registry;(5) failure to maintain required licenses, designations, and accreditations or when disciplinary action has been taken against the health care facility by a state or national licensing agency;(6) failure to have appropriate staff, equipment, or resources required for designation routinely available;(7) unauthorized disclosure of medical or other confidential information;(8) alteration or inappropriate destruction of medical records; or(9) refusal to render care because of a patient's race, color, sex, pregnancy, national origin, religion, sexual preference, age, disability, medical condition, or inability to pay.(b) Intermittent failure of a facility to meet designation criteria is not grounds for denial, suspension, or revocation by the department, if the circumstances under which the failure occurred:(1) do not reflect an overall deterioration in quality of trauma care; and(2) are corrected within a reasonable timeframe by the facility.(c) If the department proposes to deny, suspend, or revoke a designation, the department must notify the facility at the address shown in current department records. The notice must state the alleged facts that warrant the proposed action and state the facility has an opportunity to appeal the proposed action through the Trauma Designation Review Committee as described in §157.126(s) of this subchapter (relating to Trauma Facility Designation Requirements Effective on September 1, 2025) or request a hearing in the manner referenced for contested cases in Texas Government Code Chapter 2001.(1) A request for a hearing must be in writing and submitted to the department within 15 days of the issuance date.(2) If the facility fails to submit a written request for a hearing, it will be deemed to have waived the opportunity for a hearing and the proposed action will be ordered.(d) Six months after the denial of an applicant facility's designation, the applicant facility may reapply for facility designation.(e) One year after the revocation of a facility's designation, the facility may reapply for designation. The department may deny designation if the department determines the reason for the revocation continues to exist or if the facility otherwise does not continuously meet the designation requirements.(f) The department informs the facility of the potential funding implications related to the designation denial, suspension, or revocation as outlined in:(1) 1 Texas Administrative Code §355.8052 and §355.8065; and(2) Section 157.130 of this subchapter (relating to Funds for Emergency Medical Services, Trauma Facilities, and Trauma Care Systems, and the Designated Trauma Facility and Emergency Medical Services Account). Source Note: The provisions of this §157.128 adopted to be effective September 1, 2000, 25 TexReg 3749; amended to be effective December 26, 2006, 31 TexReg 10300; amended to be effective November 24, 2024, 49 TexReg 9241. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS §157.128 Denial, Suspension, and Revocation of Trauma Facility Designation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222037&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222037 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222037&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222037 03/11/2026 (a) Allocations determination under Texas Health and Safety Code §773.122 and Health and Safety Code Chapter 780.(1) Department determination. The department determines each year:(A) eligibility criteria for emergency medical services (EMS), trauma service area (TSA), and hospital allocations; and(B) the amount of EMS, TSA, and hospital allocations based on language described in Texas Health and Safety Code §773.122 and Chapter 780.(2) Eligibility requirements. To be eligible for funding from the accounts, all potential recipients must maintain the regional participation requirements.(3) Extraordinary emergency funding.(A) To be eligible to receive extraordinary emergency funding, an entity must meet the following requirements:(i) be a licensed EMS provider, a designated trauma facility, or a recognized first responder organization (FRO);(ii) submit a completed application and any additional documentation requested by the department; and(iii) provide documentation of active participation in its local Regional Advisory Council (RAC).(B) Incomplete applications will not be considered for extraordinary emergency funding.(4) EMS allocation.(A) The department contracts with each eligible RAC to distribute the county funds to eligible EMS providers based within counties aligned with the relevant TSA.(i) The department evaluates submitted support documents per the contract statement of work. Awarded funds must be used in addition to current operational EMS funding of eligible recipients and must not supplant the operational budget.(ii) Funds are allocated by county to be awarded to eligible providers in each county. Funds are non-transferable to other counties within the RAC if there are no eligible providers in a county.(B) Eligible EMS providers may contribute funds for a specified purpose within the TSA when:(i) all EMS providers received communication regarding the intent of the contributed funds;(ii) the EMS providers voted and approved by majority vote to contribute funds; and(iii) all EMS providers that did not support contributing funds, receive the eligible funding.(C) To be eligible for funding from the EMS allocation, providers must:(i) maintain and comply with all licensure requirements as described in §157.11 of this chapter (relating to Requirements for an EMS Provider License);(ii) follow RAC regional guidelines regarding patient destination and transport in all TSAs where EMS is provided and verified by each RAC;(iii) notify the RACs of any potential eligibility to receive funds and meet the RACs' participation requirements, if a provider is contracted to provide EMS within a county of any one TSA and whose county of licensure is another county not in or contiguous with that TSA; and(iv) provide the department evidence of a contract or letter of agreement with each additional county government or taxing authority in which EMS is provided in any county beyond its county of licensure.(D) Contracts or letters of agreement must be submitted to the department on or before the stated department contract deadline of the respective year and provide evidence of continued coverage throughout the effective contract dates for which the eligibility of the EMS provider is being considered.(E) EMS providers with contracts or letters of agreement on file with the department meeting the effective contract dates do not need to resubmit a copy of the contract or letter of agreement unless it has expired or will expire before the effective date of the next contract.(F) The submitted contracts or letters of agreement must include effective dates to determine continued eligibility.(G) Inter-facility transfer letters of agreement and contracts or mutual aid letters of agreement and contracts do not meet the requirement of a county contract.(H) EMS providers are responsible for ensuring all contracts or letters of agreement have been received by the department on or before the listed deadline to be considered for eligibility.(I) Air ambulance providers must meet the same requirements as ground transport EMS providers to be eligible to receive funds from a specific county other than the county of licensure.(J) If an EMS provider is licensed in a particular county for a service area considered a geo-political subdivision and whose boundary lines cross multiple county lines, it will be considered eligible for the EMS Allocation for all counties overlapped by that geo-political subdivision's boundary lines. Verification from local jurisdictions will be requested for every county that comprises the geo-political subdivision to determine funding eligibility for each county. The eligibility of EMS providers whose county of licensure is in a geo-political subdivision other than those listed in clauses (i) - (v) of this subparagraph will be evaluated on a case-by-case basis. Geo-political subdivisions include:(i) municipalities;(ii) school districts;(iii) emergency service districts (ESDs);(iv) utility districts; or(v) prison districts.(5) TSA allocation.(A) The department contracts with eligible RACs to distribute the funds for the operation of the 22 TSAs and for equipment, communications, education, and training for the areas.(B) To be eligible to distribute funding on behalf of eligible recipients in each county to the TSA, a RAC must be:(i) officially recognized by the department as described in §157.123 of this subchapter (relating to Regional Advisory Councils);(ii) in compliance with all RAC performance criteria, have a current RAC self-assessment, and have a current regional trauma and emergency health care system plan; and(iii) incorporated as an entity exempt from federal income tax under Section 501(a), Internal Revenue Code of 1986, and its subsequent amendments by being listed as an exempt organization under Section 501(c)(3).(C) The TSA allocation distributed under this paragraph is based on the relative geographic size and population of each TSA and on the relative amount of trauma care provided.(6) Hospital allocation. The department distributes funds to designated trauma facilities to subsidize a portion of uncompensated trauma care provided or to enhance the facility's delivery of trauma care.(A) Funds distributed from the hospital allocations are made based on:(i) the hospital being designated as a trauma facility by the department as defined in Texas Health and Safety Code Chapter 773;(ii) the percentage of the hospital's uncompensated trauma care cost for patients meeting the National Trauma Data Bank (NTDB) registry inclusion criteria relative to the total uncompensated trauma care cost reported for the identified patient population by qualified facilities that year;(iii) availability of funds; and(iv) submission of a complete application to the department within the stated time frame. Incomplete applications will not be considered.(B) Additional information may be requested by the department to determine eligibility for funding.(C) A designated trauma facility in receipt of funding from the hospital allocation that fails to maintain its designation as required in §157.125 of this subchapter (relating to Requirements for Trauma Facility Designation Effective Through August 31, 2025) and §157.126 of this subchapter (relating to Trauma Facility Designation Requirements Effective on September 1, 2025), must return to the department all hospital allocation funds received in the prior 12 months within 90 days of failure to maintain trauma designation.(D) The department may grant an exception to subparagraph (C) of this paragraph if it finds compliance with this section would not be in the best interest of the persons served in the affected local system.(E) A facility must have no outstanding balance owed to the department or other state agencies before receiving any future disbursements from the hospital allocation.(7) Department allocations. The department's process for funding allocations defined in this subsection applies to the account defined in Texas Health and Safety Code Chapter 780 and includes designated trauma facilities and those in active pursuit of trauma designation in the funding allocation.(8) Department unawarded designation. An undesignated facility in active pursuit of designation but that has not been awarded a trauma designation by the department pursuant to Texas Health and Safety Code §780.004 must return to the department all funds received from the hospital allocation, plus a penalty of 10 percent of the awarded amount.(b) Calculation methods. Calculation of county portions of the EMS allocation, the RAC portions of the TSA allocation, and the hospital allocation are:(1) EMS allocation.(A) EMS allocation is derived by adjusting the weight of the statutory criteria to ensure, as closely as possible:(i) 40 percent of the funds go to urban counties; and(ii) 60 percent of the funds go to rural counties.(B) An individual county's portion of the EMS allocation is based on its geographic size, population, and the number of emergency health care runs, multiplied by adjustment factors determined by the department, so the distribution approximates the required percentages for urban and rural counties.(C) The formula is:(i) the county's population multiplied by an adjustment factor;(ii) plus, the county's geographic size multiplied by an adjustment factor;(iii) plus, the county's total emergency health care runs multiplied by an adjustment factor;(iv) divided by 3; and(v) multiplied by the total EMS allocation.(D) The adjustment factors are manipulated so the distribution approximates the required percentages for urban and rural counties.(E) Total emergency health care runs are the number of emergency patient care records electronically transmitted to the department in a given calendar year by EMS providers.(2) TSA allocation.(A) The TSA allocation is based on its relative geographic size, population, and trauma care provided as compared to all other TSAs.(B) The formula is:(i) the TSA's percentage of the state's total population;(ii) plus, the TSA's percentage of the state's total geographic size;(iii) plus, the TSA's percentage of the state's total trauma care;(iv) divided by 3; and(v) multiplied by the total TSA allocation.(C) Total trauma care is the number of trauma patient records electronically transmitted to the department in a given calendar year by EMS providers and hospitals.(3) Hospital allocation.(A) Distributions, including unexpended portions of the EMS and TSA allocations, are determined by an annual application process.(B) An annual application must be submitted each state fiscal year. Incomplete applications will not be considered for the hospital allocation calculation.(C) Based on the information provided in the approved application, each facility will receive allocations as follows.(i) An equal amount, not to exceed 20 percent of the available hospital allocation, to reimburse designated trauma facilities and those facilities in active pursuit of designation under the program.(ii) Any funds not allocated in paragraphs (1) and (2) of this subsection are included in the distribution formula in subparagraph (E) of this paragraph.(D) If the total cost of uncompensated trauma care for patients meeting NTDB registry inclusion criteria exceeds the amount appropriated from the account, minus the amount referred to in subparagraph (C)(i) of this paragraph, the department allocates funds based on a facility's percentage of uncompensated trauma care costs in relation to the total uncompensated trauma care cost reported by qualified hospitals for the funding year.(E) The hospital allocation formula for trauma designated facilities is:(i) the facility's reported costs of uncompensated trauma care;(ii) minus any collections received by the facility for any portion of the facility's uncompensated trauma care previously reported for the purposes of this section;(iii) divided by the total reported costs of uncompensated trauma care by eligible facilities; and(iv) multiplied by the total money available after reducing the amount to be distributed in subparagraph (C)(i) of this paragraph.(F) The reporting period of a facility's uncompensated trauma care must apply to costs incurred during the preceding calendar year.(c) Loss of funding eligibility. If the department finds an EMS provider, RAC, or hospital has violated Texas Health and Safety Code Chapter 773 or fails to comply with this chapter, the department may withhold account monies for a period of one to three years, depending upon the seriousness of the infraction. Source Note: The provisions of this §157.130 adopted to be effective November 24, 2024, 49 TexReg 9241. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS §157.130 Funds for Emergency Medical Services, Trauma Facilities, and Trauma Care Systems, and the Designated Trauma Facility and Emergency Medical Services Account https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207785&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207785 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207785&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207785 03/11/2026 (a) The department ensures that stroke facility designation promotes the goal, objective, and purpose of the stroke system.(1) The goal of the stroke system is to reduce the morbidity and mortality of the stroke victim, subsequently referred to as a stroke patient.(2) The objective of the stroke system is to improve the overall care of stroke patients by rapidly recognizing the signs of a stroke and transporting the potential stroke patient to the appropriate level of stroke facility, in the appropriate time, with the appropriate level of resources.(b) The department determines requirements for the levels of stroke facility designation. Hospitals seeking stroke facility designation must demonstrate compliance to department-approved national stroke standard requirements located on the DSHS EMS/Trauma Systems Stroke Designation Webpage: https://dshs.texas.gov/emstraumasystems/stroke.shtm. Hospitals must have compliance with the requirements validated by a department-approved survey organization. The hospital must submit:(1) a completed application for the stroke facility designation, and an annual summary of the stroke Quality Assessment and Performance Improvement (QAPI) plan;(2) the documented stroke designation site survey summary that includes the requirement compliance findings and the medical record summaries;(3) evidence of successful verification issued by the survey organization; and(4) full payment of the non-refundable, non-transferrable designation fee located on the DSHS EMS/Trauma Systems Stroke Designation Webpage: https://dshs.texas.gov/emstraumasystems/stroke.shtm.(c) Minimum requirements for stroke designation.(1) Health care facilities eligible for stroke designation include:(A) a hospital in Texas, licensed or otherwise meeting the description in accordance with Chapter 133 of this title (relating to Hospital Licensing);(B) a hospital owned and operated by the State of Texas; or(C) a hospital owned and operated by the federal government in Texas.(2) Each hospital shall demonstrate the capability to provide stabilization and transfer or treatment for an acute stroke patient, written stroke standards of care, and a written stroke QAPI plan.(3) Each hospital operating on a single hospital license with multiple locations (multi-location license) may apply for stroke designation separately by physical location for each designation.(A) Hospital departments or services within a hospital shall not be designated separately.(B) Hospital departments located in a separate building, which is not contiguous with the designated facility, shall not be designated separately.(C) Each emergency department of a hospital operating on a single hospital license must provide the same level of emergency stroke care for patients.(D) Stroke designation is issued for the physical location and to the legal owner of the operations of the designated facility and is non-transferable.(4) If applicable, the designated stroke facility shall include stroke patients received at the non-contiguous departments in the facility's stroke database and stroke performance improvement process.(d) The four levels of stroke designation and the requirements for each are:(1) Comprehensive (Level I) stroke designation. The hospital must meet the department-approved national stroke standards of care for a Comprehensive Stroke Center, participate in the hospital's Regional Advisory Council (RAC) and regional stroke plan, and submit data to the department as requested.(2) Advanced (Level II) stroke designation. The hospital must meet the department-approved national stroke standards of care for a non-Comprehensive Thrombectomy Stroke Center, participate in the hospital's RAC and regional stroke plan, and submit data to the department as requested.(3) Primary (Level III) stroke designation. The hospital must meet the department-approved national stroke standards of care for a Primary Stroke Center, participate in the hospital's RAC and regional stroke plan, and submit data to the department as requested.(4) Acute Stroke-Ready (Level IV) stroke designation. The hospital must meet the department-approved national stroke standards of care for an Acute Stroke-Ready Center, participate in the hospital's RAC and regional stroke plan, and submit data to the department as requested.(e) Designation of a hospital as a stroke facility is valid for the length of the approved stroke survey organization's stroke certification.(f) A hospital seeking stroke facility designation must undergo an onsite or virtual survey as outlined in this section.(1) The hospital is responsible for scheduling a stroke designation survey through a department-approved survey organization. Approved survey organizations are located on the DSHS EMS/Trauma Systems Stroke Designation Webpage: https://dshs.texas.gov/emstraumasystems/stroke.shtm.(2) The hospital provides written or electronic notification to the department of the stroke designation survey date a minimum of 30 days prior to the survey.(3) The hospital is responsible for expenses associated with the stroke designation survey.(4) The hospital does not accept surveyors with any conflict of interest. If a conflict of interest is present, the hospital must decline the assigned surveyor through the surveying organization. A conflict of interest exists when the surveyor has a current or past relationship with the hospital or key hospital staff members to the degree that the relationship may appear to cause bias. The conflict of interest includes a previous working relationship, residency training, or participation in a consultation program for the hospital within the past five years.(5) The department, at its discretion, may appoint an observer to accompany the survey team, with the observer costs borne by the department.(6) The survey team evaluates the hospital's compliance with the department-approved national stroke standards of care requirements and documents all noncompliance issues identified in the survey report and patient care reviews. The surveyors must review ten stroke patient medical record reviews and the associated QAPI related documents and summarize these reviews to include in the hospital's stroke facility designation application.(7) The hospital shall provide the survey team access to records regarding the QAPI plan to include peer review activities related to the stroke patient. Failure to provide access to these records will result in a determination by the department that the hospital seeking stroke facility designation is not in compliance with Texas Health and Safety Code, Chapter 773, and the rules in this chapter.(g) A hospital seeking stroke facility designation must submit a completed application packet.(1) The completed application packet includes:(A) an accurate and complete stroke designation application for the requested level of designation and an annual summary of the stroke QAPI plan;(B) full payment of the non-refundable, non-transferrable designation fee located on the DSHS EMS/Trauma Systems Stroke Designation Webpage: https://dshs.texas.gov/emstraumasystems/stroke.shtm;(C) the documented stroke designation site survey summary that includes the requirement compliance findings and the medical record summaries, and the report is submitted to the department no later than 60 days after the stroke site survey date;(D) evidence of successful verification issued by the survey organization;(E) if required by the department, a plan of correction (POC) that addresses all requirements with identified non-compliance findings in the survey report and the POC shall include:(i) a statement identifying the specific designation requirement the facility has not met or is in non-compliance;(ii) a statement describing the corrective action by the facility seeking stroke facility designation to ensure compliance with the defined requirement;(iii) the title of the individuals responsible for ensuring the corrective actions are implemented;(iv) the date the corrective actions will be implemented;(v) how the corrective actions will be monitored;(vi) supporting documentation of the requirement reaching compliance; and(vii) corrective actions that will be implemented within 60 days from the date the facility seeking stroke facility designation received the official survey summary report;(F) written evidence of participation in the applicable RACs; and(G) any additional documents requested by the department.(2) If a hospital seeking stroke facility designation fails to submit the required application documents and fee listed in paragraph (1) of this subsection, the application will not be processed.(3) The stroke facility designation renewal process, a request to change the level of designation, or a change in ownership requiring re-designation follows the same requirements outlined in paragraph (1) of this subsection.(A) The hospital must submit the required documents described in paragraph (1) of this subsection to the department no later than 90 days before the facility's stroke designation expiration date.(B) The hospital must submit the stroke designation fee in full payment with the required application documents.(4) The hospital has the right to withdraw its application for stroke facility designation any time before being recommended for designation by the department.(5) The hospital must submit an application packet to renew its stroke facility designation no later than 90 days before the facility's stroke designation expiration date.(6) The facility's stroke designation will expire if the facility fails to provide a complete stroke designation application packet to the department by its current designation's expiration date.(7) The stroke designation application packet, in its entirety, must be written as an element of the facility's QAPI plan and subject to confidentiality as described in Texas Health and Safety Code, §773.095.(8) The department reviews the application packet to determine the recommended stroke facility designation.(9) The department determines the final stroke facility designation level awarded to the hospital. The designation level may be different than the level requested based on the documented stroke designation site survey summary that includes the requirement compliance findings and the medical record summaries.(10) If the department determines the hospital meets the requirements for stroke facility designation, the department provides the hospital with a designation award letter and a designation certificate.(A) The hospital shall display its stroke facility designation certificate in a public area of the licensed premises that is readily visible to patients, employees, and visitors.(B) The hospital shall not alter the stroke facility designation certificate. Any alteration voids stroke designation for the remainder of that designation period.(h) If a hospital disagrees with the department's decision regarding its designation status, the hospital has a right to a hearing, in accordance with Texas Government Code, Chapter 2001.(i) Exceptions and Notifications.(1) A designated stroke facility must provide written or electronic notification of any temporary event or decision preventing the facility from complying with requirements of its current stroke designation level. This notification shall outline the stroke facility requirements the facility is not able to maintain compliance with and be provided to the following:(A) all emergency medical services (EMS) providers that transfer stroke patients to or from the designated stroke facility;(B) the health care facilities to which it customarily transfers-out or transfers-in stroke patients;(C) applicable RACs; and(D) the department.(2) If the designated stroke facility has an interruption in capabilities or capacity critical to the evaluation and treatment of a stroke patient, the facility will immediately notify local EMS providers, referring facilities, and their RAC by written or electronic communication with time-stamp capabilities, a phone call to their local medical control, and change their status through the RAC communication system such as EMResources or WEBEOC. This notification must occur within 60 minutes of the recognition of the loss in capabilities.(3) If the designated stroke facility is unable to comply with requirements to maintain its current designation status, it shall submit to the department a POC as described in subsection (g)(1)(E) of this section, and a request for a temporary exception to the requirements. Any request for an exception shall be submitted in writing from the chief executive officer of the facility and define the facility's plan of correction with a timeline to become compliant with the stroke facility requirements. The department shall review the request and the POC, and either grant the exception, with a specific timeline based on the public interest, or deny the exception. If the facility is not granted an exception, or it is not compliant to the requirements at the end of the exception period, the department shall elect one of the following:(A) re-designate the facility at the level appropriate to its revised capabilities; or(B) accept the facility's surrender of its stroke facility designation certificate and designation award letter after the requirements in subsection (k) of this section have been completed.(j) An application for a higher or lower level of stroke facility designation may be submitted to the department at any time.(1) A designated stroke facility that is increasing its stroke capabilities may choose to apply for a higher level of designation at any time. The facility must follow the designation process as described in subsection (g)(1) of this section to apply for the higher level.(2) A designated stroke facility that is unable to maintain compliance with the facility's current level of stroke designation may choose to apply for a lower level of designation at any time.(k) If the facility chooses to relinquish its stroke facility designation, the facility shall provide a 30 days written, advance notice prior to the relinquishment of the designation to the department, the applicable RACs, EMS providers, and health care facilities it customarily transfers-out or transfers-in stroke patients. The facility is responsible to continue providing stroke care services and ensure that stroke care continuity for the region remains in place for the 30 days following the notice of relinquishing its stroke designation.(l) A hospital shall not use or authorize the use of any public communication or advertising containing false, misleading, or deceptive claims regarding its stroke designation status. Public communication or advertising shall be deemed false, misleading, or deceptive if the facility uses these terms:(1) "stroke facility," "stroke hospital," "stroke center," or similar terminology and the facility is not currently designated as a stroke facility in accordance with this section; or(2) "comprehensive Level I stroke center," "advanced Level II stroke center," "primary Level III stroke center," "acute stroke ready Level IV center," or similar terminology in its signs, advertisements or in the printed materials the facility provides to the public, unless the hospital is currently designated at that defined level of stroke facility in accordance with this section.(m) The department has the right to review, inspect, evaluate, and audit all stroke patient records, stroke multidisciplinary QAPI plan documents, and peer review activities, as well as, any other documents relevant to stroke care in a designated stroke facility or facility seeking stroke facility designation at any time to verify compliance with the Texas Health and Safety Code, Chapter 773 and this section.(n) The department maintains confidentiality of such records to the extent authorized by Texas Government Code, Chapter 552.(o) Stroke designation site review of the hospital applying for stroke facility designation will be scheduled with the department-approved survey organization and follow the department survey guidelines.(p) The department may deny, suspend, or revoke a stroke facility designation if a designated stroke facility ceases to provide services to meet or maintain compliance with the requirements of this section or if it violates the Chapter 133 of this title, concerning requirements resulting in enforcement action. Source Note: The provisions of this §157.133 adopted to be effective February 17, 2022, 47 TexReg 650. 1 DEPARTMENT OF STATE HEALTH SERVICES 157 EMERGENCY MEDICAL CARE G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS §157.133 Requirements for Stroke Facility Designation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161323&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161323 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161323&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161323 03/11/2026 The purpose of this subchapter is to protect public health by establishing standardized rules for the control and eradication of rabies in the State of Texas, in accordance with the Texas Health and Safety Code, Chapter 826. Source Note: The provisions of this §169.21 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.21 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161324&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161324 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161324&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161324 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. Unless defined in this section, all words have definitions as provided in the Texas Health and Safety Code, §826.002. (1) Animal--Any mammal, domesticated or wild. (2) Assistance animal--An animal that is specially trained or equipped to help a person with a disability and that: (A) is used by a person with a disability who has satisfactorily completed a specific course of training in the use of the animal; and (B) has been trained by an organization generally recognized by agencies involved in the rehabilitation of persons with disabilities as reputable and competent to provide animals with training of this type. (3) Cat--Any domestic cat, excluding hybrids. (4) Confinement--The restriction of an animal to an area, in isolation from other animals and people, except for contact necessary for its care. (5) Currently vaccinated--Vaccinated and satisfying all the following criteria. (A) The animal must have been vaccinated against rabies with a vaccine licensed by the United States Department of Agriculture (USDA) for that species at or after the minimum age requirement and using the recommended route of administration for the vaccine. (B) At least 30 days have elapsed since the initial vaccination. (C) The time elapsed since the most recent vaccination has not exceeded the recommended interval for booster vaccination as established by the manufacturer. (6) Custodian--A person or agency which feeds, shelters, harbors, owns, has possession or control of, or has the responsibility to control an animal. (7) Department--The Department of State Health Services. (8) Dog--Any domestic dog, excluding hybrids. (9) Domestic animal--Any animal normally adapted to live in intimate association with humans or for the advantage of humans. (10) Domestic ferret--Any Mustela putorius furo. (11) Euthanatize--To cause the death of an animal implementing a technique that is in accordance with the methods, recommendations, and procedures prepared by the American Veterinary Medical Association (AVMA) and set forth in the latest edition of the AVMA Guidelines on Euthanasia and: (A) rapidly produces unconsciousness and death with minimal pain or distress; or (B) utilizes anesthesia produced by an agent that causes painless loss of consciousness and death following such loss of consciousness. (12) Health service region--A contiguous group of Texas counties, so designated by the Executive Commissioner of the Health and Human Services Commission. (13) High-risk animals--Those animals which have a high probability of transmitting rabies; they include skunks, bats, foxes, coyotes, and raccoons. (14) Housing facility--Any room, building, or area used to contain a primary enclosure or enclosures. (15) Hybrid--Any offspring of two animals of different species. (16) Impoundment--The collecting and confining of an animal by a government entity or government contractor pursuant to a state or local ordinance. (17) Impoundment facility--An enclosure or a structure in which an animal is collected or confined by a government entity or government contractor pursuant to a state or local ordinance. (18) Local rabies control authority--The officer designated by the municipal or county governing body under the Texas Health and Safety Code, §826.017. (19) Low-risk animals--Those animals which have a low probability of transmitting rabies; they include all animals of the orders Didelphimorphia, Insectivora, Rodentia, Lagomorpha, and Xenarthra. (20) Observation period--The time following a potential rabies exposure during which the health status of the animal responsible for the potential exposure must be monitored. The observation period for dogs, cats, and domestic ferrets (only) is 10 days (240 hours); the observation period for other animals, not including those defined as high risk, unless otherwise specified in §169.27 of this title (relating to Quarantine Method and Testing), or low risk, is 30 days. All observation periods are calculated from the time of the potential exposure. (21) Police service animal--An animal as defined in the Texas Penal Code, §38.151. (22) Potential exposure--An incident in which an animal has bitten a human or in which there is probable cause to believe that an animal has otherwise exposed a human to rabies; also referred to as a potential rabies exposure. (23) Primary enclosure--Any structure used to immediately restrict an animal or animals to a limited amount of space, such as a room, pen, run, cage, compartment, or hutch. (24) Quarantine facility--A structure where animals are held for rabies observation. (25) Quarantine period--That portion of the observation period during which an animal that has potentially exposed a human to rabies is under physical confinement for observation as provided for in §169.27 of this title. (26) Sanitize--To make visibly clean followed by the use of a disinfectant to destroy disease-producing agents. (27) Suitable Specimen--For rabies testing, a whole bat or small rodent, a head with brain and brain stem intact, or a complete transverse cross section of the brain stem and tissue from at least one of the following: cerebellum and/or hippocampus. (28) Unowned animal--Any animal for which a custodian has not been identified. (29) Vaccinated--Properly administered by or under the direct supervision of a veterinarian with a rabies vaccine licensed for use in that species by the USDA. (30) Veterinarian--A person licensed to practice veterinary medicine in the United States. (31) Zoonosis Control Branch--The branch within the department to which the responsibility for administering this subchapter is assigned. Source Note: The provisions of this §169.22 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective August 21, 1996, 21 TexReg 7660; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective February 18, 2003, 28 TexReg 1389; amended to be effective March 19, 2003, 28 TexReg 2341; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.22 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161325&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161325 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161325&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161325 03/11/2026 The department's Zoonosis Control Branch will assume the responsibility of collecting, analyzing, and preparing monthly and annual summaries of rabies activity in the state. These reports will be forwarded to national, state, and municipal agencies as requested, and selected statistics will be sent to veterinary medical and animal control organizations throughout the state. Source Note: The provisions of this §169.23 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 5, 1982, 7 TexReg 744; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.23 Information Relating to the Control of Rabies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161326&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161326 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161326&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161326 03/11/2026 Preexposure rabies vaccinations should be administered to individuals whose activities place them at a significant risk of exposure to rabies, in accordance with the recommendations of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). Source Note: The provisions of this §169.24 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.24 Preexposure Rabies Vaccination https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161327&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161327 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161327&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161327 03/11/2026 (a) Any person having knowledge of a potential rabies exposure to a human will report the incident to the local rabies control authority as soon as possible after the incident. This requirement does not apply to contacts with low-risk animals as defined in §169.22 of this title (relating to Definitions).(b) The custodian of an animal that has potentially exposed a person to rabies will place that animal in quarantine or submit it for testing as prescribed in §169.27 of this title (relating to Quarantine Method and Testing).(c) The local rabies control authority will investigate each potential rabies exposure and assure appropriate resolution, in accordance with §169.27 of this title. Source Note: The provisions of this §169.25 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 5, 1982, 7 TexReg 744; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.25 Reports of Human Exposure to Rabies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161328&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161328 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161328&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161328 03/11/2026 (a) Generally. (1) Structural strength. Housing facilities shall be structurally sound and shall be maintained in good repair in order to protect the animals from injury, to contain them, and to prevent transmission of diseases. (2) Water and electric power. Reliable and adequate electric power, if required to comply with other provisions of this subchapter, and adequate fresh, clean water shall be available. (3) Storage. Supplies of food and bedding shall be stored in facilities which adequately protect such supplies against infestation or contamination by vermin. Refrigeration shall be provided for supplies of perishable food. Non-perishable foods, such as dry food, do not require refrigeration. Open bags of non-perishable dry food should be sealed or stored in sealed cans, and unopened bags should be stacked on pallets or shelves with at least 12 inches of clearance between the floor and the first level to enable effective inspection and cleaning practices. (4) Waste disposal. Provision shall be made for the removal and disposal of animal and food wastes, bedding, dead animals, and debris. Disposal facilities shall be so provided and operated as to minimize vermin infestations, odors, and disease hazards. A suitable method shall be provided to rapidly and safely remove water and other liquid waste from housing facilities. Housing facilities should be designed to have animal excreta removed through sanitary sewers, septic systems, or garbage. All closed drainage systems should be equipped with traps, vents, and acceptable drain covers to exclude rodents and prevent any backup of sewer gas and odors into the facility. (5) Washrooms and sinks. Facilities for personal hygiene, such as washrooms, basins, or sinks, shall be provided for employees. (6) Management. The manager of a facility should be either an individual who has satisfactorily completed an appropriate training course or a veterinarian. (7) Records. Records shall be kept on each animal processed through the housing facility. At a minimum, the records shall document the animal's description, impoundment date, disposition date, and method of disposition. Records shall be available for inspection by the department. (8) Heating. Adequate shelter shall be provided to protect animals from any form of cold or inclement weather and direct effects of wind, rain, or snow. Auxiliary heat or clean, dry bedding material shall be provided any time the ambient temperature falls below 50 degrees Fahrenheit (10 degrees Celsius) when animals are present. If supplemental bedding material is used during cold weather, quantities should be adequate to prevent hypothermia as temperatures drop. (9) Cooling and Ventilation. Adequate shelter shall be provided to protect animals from any form of overheating and direct rays of the sun. Facilities shall be provided with fresh air either by means of windows, doors, vents, fans, or air conditioning and shall be ventilated so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as fans or air conditioning, shall be provided in indoor facilities when the ambient temperature is 85 degrees Fahrenheit (29.5 degrees Celsius) or higher when animals are present. (10) Lighting. Housing facilities shall have ample light of sufficient intensity to permit routine inspection and cleaning. Primary enclosures shall be situated to protect the animals from excessive illumination. (11) Construction. Housing facilities must be constructed in such a manner that they will protect the animal and not create a health risk or public nuisance. The building surfaces shall be constructed and maintained so that they are impervious to moisture and may be readily sanitized. Floors shall be made of durable, nonabsorbent material. (12) Primary enclosures. Primary enclosures should be designed based upon enclosure guidelines prepared by The Association of Shelter Veterinarians and set forth in the latest edition of the Guidelines for Standards of Care in Animal Shelters. Primary enclosures shall: (A) be structurally sound and maintained in good repair; (B) provide convenient access to clean food and water; (C) enable the animal to remain dry and clean; (D) be constructed and maintained so that the surfaces are impervious to moisture and may be readily sanitized; (E) be constructed so as to protect the animal's feet and legs from injury; and (F) provide sufficient space to allow each animal to make normal postural adjustments without touching the top of the enclosure, including turning freely, standing easily, sitting, stretching, moving its head, lying in a comfortable position with limbs extended, and moving and assuming a comfortable posture for feeding, drinking, urinating, and defecating. (b) Feeding. (1) All food shall be free from contamination, wholesome, palatable, and of sufficient quality and nutritive value to meet the normal daily requirements for the condition, size, and age of the animal. (2) Dogs and cats shall be fed at least once a day or more often as appropriate for the age and condition of the animal, except as directed by a veterinarian. (3) Domestic ferrets shall have continuous access to food. (4) All other animals shall be fed appropriately as described on the packaging of a commercial, species-specific food, except as directed by a veterinarian. (5) Food receptacles shall be accessible to all animals and shall be located so as to minimize contamination by excreta. Food receptacles shall be durable and kept clean and sanitary. Disposable food receptacles may be used but must be discarded after each feeding or, for domestic ferrets, after 24 hours of use. Self feeders may be used for feeding dry foods to animals acclimated to their use. (c) Watering. If fresh, clean water is not accessible to all animals at all times, it shall be offered to them at least twice daily for periods of not less than one hour, except as directed by a veterinarian. Drinking bottles may be used for animals acclimated to their use. Domestic ferrets shall have fresh, clean water accessible at all times, provided in drinking bottles of appropriate size to maintain a fresh supply. Water receptacles shall be kept clean and sanitary. (d) Sanitation. (1) Cleaning of primary enclosures. Excreta shall be removed from primary enclosures as often as necessary to prevent contamination of the inhabitants, but not less than daily. (2) Sanitation of primary enclosures. Cages, rooms, and pens shall be maintained in a sanitary condition. (3) Building and premises. Building and premises shall be kept clean. (e) Pest Control. A regular program for the control of insects, ectoparasites, and other pests shall be established and maintained. The facility shall be free of visible signs of rodents and keep other vermin infestations to a minimum at all times. Each pesticide must be used in accordance with its manufacturer's label instructions. (f) Outdoor facilities are acceptable under this section provided those facilities meet all the requirements of this section. (g) This section applies to all animal shelters located in counties with a population of 75,000 or greater as required by the Texas Health and Safety Code, Chapter 823, and to all quarantine or impoundment facilities regardless of county population. Source Note: The provisions of this §169.26 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective August 21, 1996, 21 TexReg 7660; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective February 18, 2003, 28 TexReg 1389; amended to be effective July 21, 2004, 29 TexReg 6936; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.26 Facilities for the Quarantining or Impounding of Animals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161329&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161329 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161329&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161329 03/11/2026 (a) When a dog, cat, or domestic ferret that has bitten a human has been identified, the custodian will place the animal (regardless of its vaccination status) in quarantine as defined in the Texas Health and Safety Code, §826.002, until the end of the 10-day observation period. The animal must also be quarantined if there is probable cause to believe that it has otherwise exposed a human to rabies. The observation period will begin at the time of the exposure. The animal must be placed in a department-licensed quarantine facility specified by the local rabies control authority and observed at least twice daily. However, the local rabies control authority may allow the animal to be quarantined in a veterinary clinic. As an alternative to quarantine at a department-licensed facility or a veterinary clinic, the local rabies control authority may allow home confinement. To allow home confinement, the following criteria must be met.(1) A secure enclosure approved by the local rabies control authority must be used to prevent escape.(2) The animal has been vaccinated against rabies and the time elapsed since the most recent vaccination has not exceeded the manufacturer recommendations for the vaccine. If an unvaccinated animal is not over 16 weeks of age at the time of the potential exposure, it may be allowed home confinement.(3) During the confinement period, the animal's custodian must monitor the animal's behavior and health status and immediately notify the local rabies control authority if any change is noted.(4) The local rabies control authority or a veterinarian must observe the animal at least on the first and last days of the home confinement.(5) The animal was not a stray as defined in the Texas Health and Safety Code, §826.002, at the time of the potential exposure.(b) If the potential rabies exposure described in subsection (a) of this section occurs in a city or county other than where the animal's custodian resides, the animal may be transferred to a department-licensed quarantine facility or a veterinary clinic in the city or county of the custodian's residence or allowed home confinement, if applicable, if there is mutual agreement to do so between the local rabies control authorities for the city or county where the exposure occurred and where the custodian resides.(c) The alternative to quarantining (to include home confining) a dog, cat, or domestic ferret that has bitten or otherwise potentially exposed a person to rabies as described in subsection (a) of this section is to have the animal euthanatized in such a manner that the brain is not damaged and a suitable specimen submitted to a department-designated laboratory for rabies testing. A list of department-designated laboratories may be found on the department's website or may be obtained from any of the department's regional Zoonosis Control offices.(d) A domestic animal that has potentially exposed a human to rabies and has been designated by the local rabies control authority as unowned may be euthanatized. If the animal is euthanatized, a suitable specimen shall be submitted for rabies testing.(e) "Free-roaming animals" as used in this section includes animals that have been in captivity less than 200 days immediately prior to the potential exposure and those that are not in captivity. If the animal implicated in the potential exposure is a free-roaming high-risk animal, it shall be euthanatized and a suitable specimen submitted for rabies testing. If the animal implicated in the potential exposure is a high-risk animal that has been in captivity without contact with free-roaming animals for 200 days or more immediately prior to the potential exposure or is less than 200 days old, has always been in captivity without contact with free-roaming animals, and is the progeny of a dam that has been in captivity without contact with free-roaming animals for 200 days or more immediately prior to the potential exposure, the local rabies control authority shall conduct a risk assessment to gauge the probability that the animal could have been exposed to rabies and, therefore, poses a public health risk. If the probability that the animal implicated in the potential exposure could have had animal contact conducive to rabies transmission is low and the potential exposure poses a negligible public health risk, the local rabies control authority may require that the animal involved in the potential exposure be quarantined at a department-licensed quarantine facility or a veterinary clinic or confined elsewhere as deemed appropriate by the local rabies control authority for a 30-day observation period as an alternative to euthanatizing and testing. The local rabies control authority or a veterinarian must observe the animal at least on the first and last days of the quarantine or confinement that was deemed appropriate by the local rabies control authority.(f) If the animal implicated in the potential exposure is a low-risk animal, neither quarantine nor rabies testing will be required unless the local rabies control authority has cause to believe the animal is rabid, in which case it shall be euthanatized and a suitable specimen submitted for rabies testing.(g) The local rabies control authority may require an animal that has inflicted multiple bite wounds, punctures, or lacerations to a person to be euthanatized. If the animal is euthanatized, a suitable specimen shall be submitted for rabies testing.(h) If the animal implicated in the potential exposure is not included in subsection (a), (b), (c), (d), (f), or (g) of this section or the portion of subsection (e) of this section pertaining to a free-roaming high-risk animal, the animal either will be euthanatized and a suitable specimen submitted for rabies testing or the local rabies control authority may require the animal to be quarantined at a department-licensed quarantine facility or a veterinary clinic or confined elsewhere as deemed appropriate by the local rabies control authority for the 30-day observation period as an alternative to euthanatizing and testing. The local rabies control authority's decision on whether to quarantine or euthanatize and test those other animals described in subsection (e) of this section will be determined by risk-assessment parameters as described in subsection (e) of this section. If the potential rabies exposure occurs in a city or county other than where the animal's custodian resides, the animal may be transferred to a department-licensed quarantine facility or a veterinary clinic in the city or county of the custodian's residence or allowed confinement deemed appropriate if there is mutual agreement to do so between the local rabies control authorities for the city or county where the exposure occurred and where the custodian resides. During the observation period, the animal's custodian must monitor the animal's behavior and health status and immediately notify the local rabies control authority if any change is noted. The local rabies control authority or a veterinarian must observe the animal at least on the first and last days of the quarantine or confinement that was deemed appropriate by the local rabies control authority.(i) Any animal required to be quarantined under this section that cannot be maintained in secure quarantine shall be euthanatized and a suitable specimen submitted for rabies testing.(j) All laboratory specimens referred to in subsections (c) - (i) of this section shall be submitted in accordance with §169.33 of this title (relating to Submission of Specimens for Laboratory Examination).(k) At the discretion of the local rabies control authority, assistance animals may not be required to be placed in quarantine (to include confinement) during the observation period. During the applicable observation period, the animal's custodian must monitor the animal's behavior and health status and immediately notify the local rabies control authority if any change is noted. The local rabies control authority or a veterinarian must observe the animal at least at the beginning and on the last day of the applicable observation period.(l) Police service animals are exempted from quarantine per the Texas Health and Safety Code, §826.048, including confinement. During the applicable observation period, the animal's custodian must monitor the animal's behavior and health status and immediately notify the local rabies control authority if any change is noted.(m) Animals should not be vaccinated against rabies or receive other vaccinations or non-essential medications that may complicate assessment of behavioral change or health status during the observation period; however, animals may be treated for medical problems that are diagnosed by a veterinarian and are not related to rabies. If the animal becomes ill during the observation period, the local rabies control authority must be notified by the person having possession of the animal. Source Note: The provisions of this §169.27 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective August 21, 1996, 21 TexReg 7660; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective March 19, 2003, 28 TexReg 2341; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.27 Quarantine Method and Testing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161330&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161330 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161330&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161330 03/11/2026 (a) Quarantine procedures.(1) A quarantine facility shall have and use written standard operating procedures (SOP) specific for that facility to ensure effective and safe quarantine procedures. The SOP shall be posted in the quarantine facility, or otherwise be readily available to all employees in the quarantine facility, and adhered to by each employee.(2) An animal that is quarantined because it may have exposed a human to rabies must be maintained in a primary enclosure, separated from all other animals by a solid partition so that there is no possibility of physical contact between animals. An empty chamber between animals is not an acceptable alternative. To prevent rabies transmission, handling of quarantined animals shall be minimized and carried out in a manner that avoids physical contact of other animals and people with the saliva of quarantined animals. Individuals handling quarantined animals should utilize appropriate personal protective equipment. To prevent escape, the primary enclosure must be enclosed on all sides, including the top. Quarantine cages, runs, or rooms must have "Rabies Quarantine" signs posted.(b) Facilities planning. Any entity desiring to construct a quarantine facility shall submit plans to the department for review prior to beginning construction of a new facility or significant renovation to an existing facility.(c) Inspection requirements of quarantine facilities.(1) It will be the responsibility of the department to inspect all quarantine facilities, including those operated by government contractors. The inspection of the premises will be accomplished during ordinary business hours. All deficiencies will be documented in writing. Those that are of sufficient significance to affect the humane care or security of any animal housed within the facility must be corrected within a reasonable period of time.(2) The inspections will be accomplished annually and more frequently when significant discrepancies have been identified. Any facility that does not achieve acceptable standards will not be licensed for rabies quarantine operations.(3) The quarantine facility manager has the right to appeal the results of the inspection. If the opinion of management of the quarantine facility is in conflict with the inspection, he or she may request a review of the inspection by the manager of the department's Zoonosis Control Branch, who will then notify the regional director's office of the health service region in which the quarantine facility is located that an appeal has been submitted. The appeal listed in this paragraph will be made in writing and submitted within 30 days of the inspection. After receipt of the appeal, the department will have 60 days to respond. Source Note: The provisions of this §169.28 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.28 Requirements of a Quarantine Facility https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161331&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161331 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161331&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161331 03/11/2026 (a) The custodian (excluding animal shelters as defined in the Texas Health and Safety Code, §823.001) of each dog or cat shall have the animal vaccinated against rabies by 16 weeks of age. The animal must be vaccinated by or under the direct supervision of a veterinarian with rabies vaccine licensed by the United States Department of Agriculture for that species at or after the minimum age requirement and using the recommended route of administration for the vaccine. If a previously vaccinated animal is overdue for a booster, once revaccinated, the animal will be considered currently vaccinated; the animal should be placed on a vaccination schedule according to the maximum labeled duration of immunity for the most recently administered vaccine. The attending veterinarian has discretion as to when the subsequent vaccination will be scheduled as long as the revaccination due date does not exceed the recommended interval for booster vaccination as established by the manufacturer or vaccination requirements instituted by local ordinance. Livestock, domestic ferrets, and wolf-dog hybrids should be vaccinated against rabies. Among livestock species, vaccination of equines and others that have frequent contact with humans is strongly advised. The administration of a rabies vaccine in a species for which no licensed vaccine is available is at the discretion of the veterinarian; however, an animal receiving a rabies vaccine under these conditions will not be considered to be vaccinated against rabies virus in potential rabies exposure situations.(b) An official rabies vaccination certificate shall be issued for each animal by the veterinarian responsible for administration of the vaccine and contain the following information:(1) custodian's name, address, and telephone number;(2) animal identification-species, sex (including neutered if applicable), approximate age, size (pounds), predominant breed, and colors;(3) vaccine used-product name, manufacturer, and serial number;(4) date vaccinated;(5) revaccination due date;(6) rabies tag number if a tag is issued;(7) veterinarian's signature, signature stamp, or computerized signature, plus address and license number.(c) Each veterinarian who issues a rabies vaccination certificate, or the veterinary practice where the certificate was issued, shall retain a readily retrievable copy of the certificate for a period of not less than five years.(d) If a veterinarian ceases the practice of veterinary medicine, the duplicate rabies vaccination certificates retained by that practice shall be turned over to the local rabies control authority. This does not apply to the sale or lease of a practice, when the records of the practice are transferred to a new owner.(e) The custodian shall retain each rabies vaccination certificate until the animal receives a subsequent booster and shall produce the certificate upon request by any local rabies control authority, public health official, or animal control, law enforcement, or peace officer when the request is part of the requester's official duty. Source Note: The provisions of this §169.29 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective August 21, 1996, 21 TexReg 7660; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective March 19, 2003, 28 TexReg 2341; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.29 Vaccination Requirement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161332&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161332 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161332&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161332 03/11/2026 (a) Not currently vaccinated animals that have been bitten by, directly exposed by physical contact with, or directly exposed to the fresh tissues of a rabid animal shall be:(1) euthanatized; or(2) immediately vaccinated against rabies, placed in confinement for 90 days, and given booster vaccinations during the third and eighth weeks of confinement. For young animals, additional vaccinations may be necessary to ensure that the animal receives at least two vaccinations at or after the age prescribed by the United States Department of Agriculture (USDA) for the vaccine administered.(b) Currently vaccinated animals that have been bitten by, directly exposed by physical contact with, or directly exposed to the fresh tissues of a rabid animal shall be:(1) euthanatized; or(2) immediately given a booster rabies vaccination and placed in confinement for 45 days.(c) These provisions apply only to domestic animals for which a USDA-licensed rabies vaccine is available.(d) In situations where none of the requirements of this section are applicable, the recommendations contained in the latest edition of the publication titled Compendium of Animal Rabies Prevention and Control, published by the National Association of State Public Health Veterinarians, should be followed. The administration of a rabies vaccine in a species for which no licensed vaccine is available is at the discretion of the veterinarian; however, an animal receiving a rabies vaccine under these conditions will not be considered to be vaccinated against rabies virus in potential rabies exposure situations. Source Note: The provisions of this §169.30 adopted to be effective March 5, 1982, 7 TexReg 745; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.30 Disposition of Domestic Animals Exposed to Rabies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161333&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161333 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161333&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161333 03/11/2026 Each dog and cat 12 weeks of age or older to be transported into Texas for any purpose shall be admitted only when vaccinated against rabies and the time elapsed since the most recent vaccination has not exceeded the manufacturer recommendations for the vaccine. If an initial vaccination was administered less than 30 days prior to arrival, the custodian should confine the dog or cat for the balance of the 30 days. Additionally, documentation must be provided by a vaccination certificate showing the date of vaccination, vaccine used, revaccination due date, identification information for the vaccinated animal, contact information of the animal's custodian, and signature, signature stamp, or computerized signature and contact information of the veterinarian responsible for administration of the vaccine. If the dog or cat is less than 12 weeks of age, the custodian should confine the animal until 30 days subsequent to its initial vaccination. Source Note: The provisions of this §169.31 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 5, 1982, 7 TexReg 744; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective March 19, 2003, 28 TexReg 2341; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.31 Interstate Movement of Dogs and Cats into Texas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161334&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161334 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161334&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161334 03/11/2026 The federal government regulates the entry of pets into the United States; requirements set forth in this section are in addition to meeting federal requirements. If the department receives a federal importation notice, the department may request the local rabies control authority in the area where the animal will be located to monitor the notice for compliance. Contingent upon the department receiving notification of an importation-compliance failure, the department may report the failure to the appropriate authority. Each dog and cat 12 weeks of age or older to be transported into Texas for any purpose shall be admitted only when vaccinated against rabies and the time elapsed since the most recent vaccination has not exceeded the manufacturer recommendations for the vaccine. If an initial vaccination was administered less than 30 days prior to arrival in the United States, the custodian must confine the dog or cat for the balance of the 30 days. Additionally, documentation must be provided by a vaccination certificate or passport showing the date of vaccination, vaccine used, revaccination due date, identification information for the vaccinated animal, contact information of the animal's custodian, and signature, signature stamp, or computerized signature and contact information of the veterinarian responsible for administration of the vaccine. If the dog or cat is less than 12 weeks of age, the custodian shall confine the animal until 30 days subsequent to its initial vaccination. Source Note: The provisions of this §169.32 adopted to be effective April 1, 1980, 5 TexReg 812; amended to be effective March 19, 2003, 28 TexReg 2341; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.32 International Movement of Dogs and Cats into Texas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161335&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161335 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161335&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161335 03/11/2026 Preparation of specimens either for shipment or for personal delivery for rabies diagnosis shall include the following.(1) Damage to the brain caused by shooting or other traumatizing procedures shall be avoided.(2) The head of the suspect animal shall be separated from the body by a qualified person wearing appropriate personal protective equipment as soon as possible after the death of the animal. Only the head shall be submitted with the exception that whole bats and small rodents may be submitted. If only the brain is submitted rather than the entire head, the minimum tissue requirements for rabies testing are a complete transverse cross section of the brain stem and tissue from at least one of the following: cerebellum and/or hippocampus. Submissions that do not meet these tissue requirements will be considered unsatisfactory due to a lack of sufficient material.(3) The specimen shall be immediately chilled to between 32 degrees Fahrenheit and 45 degrees Fahrenheit either in a refrigerator or by packing for shipping with sufficient amounts of refrigerants in the container; the specimen should not be frozen. When shipping, sufficient refrigerant shall be added so the specimen will remain chilled for a minimum of 48 hours. Do not use dry ice. Gel packs or similar refrigerants are recommended. Ice is not recommended.(4) If specimens are shipped, containment in compliance with requirements in the Code of Federal Regulations (CFR), Title 49, shall be used for packing. Packing methods shall prevent leakage and provide for proper identification (such as an identification number) of the specimen.(5) A completed department Form G-9, Rabies Submission Form, which is available at the department's Laboratory Services Section, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, is required for each specimen submitted to the department's Laboratory Services Section. Each form must contain the same identification information provided with the specimen as stated in paragraph (4) of this section. Submission form(s) shall be contained in a water-proof bag.(6) Labeling on the outside of the shipping container shall be legible and include:(A) name, address, and telephone number of the laboratory;(B) name, return address, and telephone number of the shipper;(C) language in compliance with requirements in the CFR, Title 49, pertaining to the shipment of infectious substances for diagnostic purposes; and(D) the following information: "RABIES IDENTIFICATION TEAM, LABORATORY SERVICES SECTION - REFRIGERATE ON ARRIVAL."(7) The following procedures are required for shipment:(A) shipment shall be by bus or other reliable carrier; the department does not recommend the United States Postal Service. If an overnight carrier (other than bus) is used, ship the specimen such that it will arrive by Friday or delay shipment until Monday. Do not ship via overnight carrier on Friday or the day before a holiday. These services do not deliver to the department on the weekend or on holidays;(B) a shipping receipt will be obtained and retained by the shipper;(C) at the time of the shipment, the shipper shall notify laboratory personnel of the shipment via telephone or laboratory-approved electronic format; and(D) the shipper shall provide the return postage (in the form of stamps, not money) if return of the shipping container is desired.(8) Paragraphs (5) and (6) of this section apply to specimens submitted to the department's Laboratory Services Section. The appropriate form, labeling instructions, and shipping requirements for another department-designated laboratory can be obtained by contacting that laboratory; a list of these laboratories with their contact information will be maintained on the department's website. Source Note: The provisions of this §169.33 adopted to be effective August 24, 1982, 7 TexReg 2993; amended to be effective March 29, 1988, 13 TexReg 1337; amended to be effective February 22, 1993, 18 TexReg 845; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective March 19, 2003, 28 TexReg 2341; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.33 Submission of Specimens for Laboratory Examination https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161336&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161336 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161336&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161336 03/11/2026 (a) Declaration. The Executive Commissioner of the Health and Human Services Commission (HHSC) declares a statewide rabies quarantine.(1) Statewide quarantine. The area is defined by the borders of the State of Texas.(2) It is illegal to transport animals subject to the statewide rabies quarantine from, to, or within the State of Texas.(3) Animals subject to the statewide rabies quarantine include any live species of fox, skunk, coyote, or raccoon indigenous or naturalized to North America.(4) Transport exceptions. Animals subject to the statewide rabies quarantine may be transported by peace officers and individuals hired or contracted by local, state, or federal government agencies to deal with stray animals when such transport is a part of their official duty. These animals may also be transported by employees of zoos or other institutions accredited by the Association of Zoos and Aquariums when such transport is part of their official duty; educators permitted by the Texas Parks and Wildlife Department for educational display; rehabilitators permitted by the Texas Parks and Wildlife Department; an entity issued authorization for nuisance fur-bearing animal relocation from the Texas Parks and Wildlife Department; and pest management professionals licensed by the Texas Department of Agriculture. If an exempt individual transports such animals for release, the animals must be released within a ten-mile radius or within ten miles of the city limits of where they were originally captured and the release must be within the county in which they were originally captured.(b) Executive Commissioner of the HHSC's designee. The Executive Commissioner of the HHSC's designee is the commissioner of the Department of State Health Services, whom the Executive Commissioner of the HHSC appoints to act as his or her designee as described in the Texas Health and Safety Code, §826.045. Source Note: The provisions of this §169.34 adopted to be effective May 17, 1995, 20 TexReg 3332; amended to be effective February 21, 1996, 21 TexReg 963; amended to be effective July 12, 1998, 23 TexReg 7224; amended to be effective December 20, 2007, 32 TexReg 9341; amended to be effective March 31, 2013, 38 TexReg 1994. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL A RABIES CONTROL AND ERADICATION §169.34 Statewide Quarantine https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164488&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164488 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164488&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164488 03/11/2026 The purpose of this subchapter is to set minimum standards for allowable methods of euthanasia for an animal(s) in the custody of an animal shelter, in accordance with the Texas Health and Safety Code, Chapter 821. Source Note: The provisions of this §169.81 adopted to be effective May 6, 2004, 29 TexReg 4168; amended to be effective July 12, 2009, 34 TexReg 4527; amended to be effective December 1, 2013, 38 TexReg 8246. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL D STANDARDS FOR ALLOWABLE METHODS OF EUTHANASIA FOR ANIMALS IN THE CUSTODY OF AN ANIMAL SHELTER §169.81 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164485&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164485 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164485&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164485 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Animal shelter--A facility that collects, impounds, or keeps stray, homeless, abandoned, or unwanted animals.(2) Department--The Department of State Health Services. Source Note: The provisions of this §169.82 adopted to be effective May 6, 2004, 29 TexReg 4168; amended to be effective July 12, 2009, 34 TexReg 4527; amended to be effective December 1, 2013, 38 TexReg 8246. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL D STANDARDS FOR ALLOWABLE METHODS OF EUTHANASIA FOR ANIMALS IN THE CUSTODY OF AN ANIMAL SHELTER §169.82 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164486&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164486 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164486&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164486 03/11/2026 Prior to euthanasia, each animal should first be scanned for microchip identification and searched for identification tattoos; at a minimum, the abdomen, inner thighs, and inside ear flaps should be searched for tattoos. If identification is located on an animal or the animal is wearing a tag(s), reasonable efforts to locate and notify the animal's owner shall be made and documented prior to euthanasia. Source Note: The provisions of this §169.83 adopted to be effective July 12, 2009, 34 TexReg 4527; amended to be effective December 1, 2013, 38 TexReg 8246. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL D STANDARDS FOR ALLOWABLE METHODS OF EUTHANASIA FOR ANIMALS IN THE CUSTODY OF AN ANIMAL SHELTER §169.83 Animal Identification and Owner Notification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164487&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164487 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=164487&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 164487 03/11/2026 (a) Only sodium pentobarbital may be used to euthanize a dog or cat in the custody of an animal shelter. (b) When sodium pentobarbital is used to euthanize a dog or cat, the following requirements apply. (1) The preferential route of administration of sodium pentobarbital is intravenous injection by hypodermic needle. Other routes considered to be acceptable are: (A) intraperitoneal injection by hypodermic needle; or (B) intra-organ, limited to intraosseous, intracardiac, intrahepatic, intrasplenic, and intrarenal, injection by hypodermic needle. (2) Any injection must be administered using a new, undamaged sterilized hypodermic needle of a size suitable for the size and species of the animal. (3) Injection shall be conducted in an area out of public view and out of the view of another animal, except when euthanizing unweaned/nursing animals with their mother; when euthanizing a mother animal with her offspring, the mother animal shall be euthanized first immediately followed by euthanasia of her offspring. Additionally, the carcass(es) of any animal(s) shall be removed from the euthanasia area prior to a live animal(s) entering that area. (4) The area used for injection shall be in a quiet location and have sufficient lighting to allow for visual accuracy during the injection process. (5) A dose of sodium pentobarbital appropriate for the animal's weight shall be administered to that animal through the route most appropriate for that animal. (6) Each animal given sodium pentobarbital by intraperitoneal injection must be given 3 to 4 times the intravenous dose. (7) Each animal given sodium pentobarbital by intraperitoneal injection shall be placed in a quiet, darkened area and, except when euthanizing unweaned/nursing animals with their mother, separated from physical contact with any other animal(s) during the dying process. When euthanizing a mother animal with her offspring, the mother animal shall be euthanized first immediately followed by euthanasia of her offspring. (8) Intra-organ injection shall not be used unless the animal is unconscious or anesthetized so that the animal is unable to feel pain. (9) The carcass of any animal(s) euthanized by sodium pentobarbital must be stored and disposed of in a manner that minimizes the potential for scavenging by animals or humans. (c) Any animal other than a dog or cat, including birds and reptiles, in the custody of an animal shelter shall be humanely euthanized only in accordance with the methods, recommendations, and procedures of the American Veterinary Medical Association (AVMA) in the latest edition of the AVMA Guidelines for the Euthanasia of Animals applicable to that species of animal. (d) When commercially compressed carbon monoxide gas is used to euthanize an animal(s), the following requirements apply. (1) It must be performed in a commercially manufactured carbon monoxide chamber or one designed and constructed, at a minimum, to equal the effectiveness of a commercially manufactured chamber. (2) The chamber must be located outdoors or in a well-ventilated room. (3) The chamber must be airtight and equipped with the following: (A) an exhaust fan for indoor chambers which is capable of evacuating all gas from the chamber prior to the chamber being opened and is connected by a gas-type duct to the outdoors; (B) a gas flow regulator and flow meter for the canister; (C) a gas concentration gauge; (D) an accurate temperature gauge for monitoring the interior of the chamber; (E) if located indoors, a carbon monoxide monitor on the exterior of the chamber that is connected to an audible alarm system, which will sound in the room containing the chamber; (F) explosion-proof electrical equipment if equipment is exposed to carbon monoxide; (G) a view-port with either internal lighting or external lighting sufficient to allow visual surveillance of any animal(s) within the chamber; and (H) if designed to euthanize more than one animal at a time, independent sections or cages to separate individual animals. (4) The gas concentration process must achieve at least a 6% carbon monoxide gas concentration not to exceed 10% due to flammability and explosiveness throughout the chamber within 5 minutes after the introduction of carbon monoxide into the chamber is initiated. (5) The ambient temperature inside the chamber should not exceed 85 degrees Fahrenheit (29.4 degrees Celsius) when it contains a live animal(s). For an outdoor chamber, achievement may be facilitated by use of the chamber during early morning. (6) All equipment, as specified in paragraph (3)(A) - (H) of this subsection, must be in proper working order and used at all times during the operation of the chamber. (7) An animal(s) must be left in the chamber with a continuous gas supply for a minimum of 15 minutes. (8) The chamber must be thoroughly vented prior to removing any carcasses. (9) The chamber must be thoroughly cleaned after the completion of each cycle. Chamber surfaces must be constructed and maintained so they are impervious to moisture and can be readily sanitized. (10) Operation, maintenance, and safety instructions and guidelines must be displayed prominently in the area containing the chamber. (11) Carbon monoxide shall not be used to euthanize any animal reasonably presumed to be less than 16 weeks of age. Carbon monoxide shall also not be used to euthanize any animal that could be anticipated to have decreased respiratory function, such as the elderly, sick, injured, or pregnant. Such animals may be resistant to the effects of carbon monoxide and the time required to achieve death in these animals may be significantly increased. In animals with decreased respiratory function, carbon monoxide levels rise slowly, making it more likely that these animals will experience elevated levels of stress. (12) Only compatible animals of the same species may be placed in the chamber simultaneously. (13) No live animal(s) may be placed in the chamber with a dead animal(s). (e) Prior to using any method of euthanasia, all available measures should be taken to minimize the fear, anxiety, and distress of the animal scheduled for euthanasia. (f) When using any of the allowable methods of euthanasia, each animal must be monitored between the time euthanasia procedures have commenced and the time death occurs, and the animal's body must not be disposed of until death is confirmed by examination of the animal for cessation of vital signs. (g) As specified under the Texas Health and Safety Code, §821.055, a person (excluding licensed veterinarians) may not euthanize any animal in the custody of an animal shelter unless the person has successfully completed a training course in the proper methods and techniques for euthanizing animals not later than three years before the date the person euthanizes the animal. The training course must be pre-approved by the department. A person has until the 120th day following the date of initial employment to complete this training. Source Note: The provisions of this §169.84 adopted to be effective July 12, 2009, 34 TexReg 4527; amended to be effective December 1, 2013, 38 TexReg 8246. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL D STANDARDS FOR ALLOWABLE METHODS OF EUTHANASIA FOR ANIMALS IN THE CUSTODY OF AN ANIMAL SHELTER §169.84 Allowable Methods of Euthanasia https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=172465&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 172465 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=172465&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 172465 03/11/2026 (a) Purpose.(1) As authorized by the Texas Health and Safety Code, §828.014, relating to the animal friendly account, the department shall institute and administer grants under this subchapter.(2) The grants shall be known as a part of the "Department of State Health Services Animal Friendly Account."(3) This subchapter governs the administration of the account, the submission and review of grant applications, and the award of the grants.(b) Definitions. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Closing date--Date specified in the request for proposals as the date on which applications must be received or postmarked.(2) Custodian--A person or agency which feeds, shelters, harbors, owns, has possession or control of, or has the responsibility to control an animal.(3) Department--The Department of State Health Services.(4) Local nonprofit veterinary medical association--An organization set up by and comprised of several volunteer veterinarians in their immediate region for the purpose of presenting continuing education, planning group activities, or discussing issues common to their professional field.(5) Nonprofit organization--A private, nonprofit, tax-exempt corporation, association or organization under Internal Revenue Code of 1986, §501(c)(3) (26 United States Code §501(c)(3)).(6) Releasing agency--A public or private animal pound, shelter, or humane organization. The term does not include an individual who occasionally renders humane assistance or shelter in the individual's home to a dog or cat.(7) Sterilization--The surgical removal of the reproductive organs of a dog or cat or the use of nonsurgical methods and technologies approved by the United States Food and Drug Administration or the United States Department of Agriculture to permanently render the animal unable to reproduce. Surgery or nonsurgical sterilization must be performed in accordance with Health and Safety Code, §828.012.(c) Philosophy.(1) The intent of the grants is to increase the sterilization of dogs and cats owned by the general public at minimal or no cost.(2) Grant funds will not be used to:(A) augment a releasing agency's adoption sterilization program; or(B) fund programs that do not operate within the State of Texas.(3) One grant per grant period will be awarded per agency for the sterilization of dogs and/or cats.(d) Sources and Allocation of Funds.(1) Funds for the grants shall be provided in accordance with the Texas Health and Safety Code, §828.014, relating to the animal friendly account.(2) All grants shall be awarded competitively according to the provisions of this subchapter.(3) Grants shall be made only to the extent that funds are available in the animal friendly account.(4) The department shall have the authority and discretion to:(A) determine the purpose(s) of the grants pursuant to law and this subchapter;(B) approve or deny grant applications;(C) determine the number, size, and duration of grants; and(D) modify or terminate grants.(5) The department shall not be liable, nor shall grant funds be used, for any costs incurred by applicants in the development, preparation, submission, or review of applications.(e) Eligibility for Grants. Eligible applicants include:(1) a releasing agency;(2) an organization that is qualified as a charitable organization under the Internal Revenue Code, §501(c)(3), that has as its primary purpose:(A) animal welfare; or(B) sterilizing animals owned by the general public at minimal or no cost; or(3) a local nonprofit veterinary medical association that has an established program for sterilizing animals owned by the general public at minimal or no cost.(f) Requirements for Grants.(1) The department shall specify reasonable requirements for grant applications.(2) Applicants for grants shall submit as a part of their application a plan of how they intend to provide sterilization services to their target population, compliant with the Texas Health and Safety Code, Chapter 828, and this section.(3) Grant recipients shall make quarterly reports to the department in a form and at a time determined by the department.(g) Procedures for Grant Announcements.(1) Before applications are requested, the department shall distribute a notice of grant availability throughout the state (such as by mail or email). The notices will include details about the grants, instructions for obtaining a request for proposals, and the names of persons to contact in the department for further information.(2) The department shall maintain a list of persons and organizations to be notified of request for proposals. Any person or organization wanting to be placed on the list should contact: Animal Friendly Account, Zoonosis Control Branch, Mail Code 1956, P. O. Box 149347, Austin, Texas 78714-9347.(3) The department shall develop and publish one or more request for proposals, which shall contain details concerning, but not limited to, the following:(A) the nature and purpose(s) of the grants;(B) the total amount of funds available for the grants under each part;(C) the maximum and minimum dollar amounts that will be awarded for individual grants and for individual grantees;(D) the information and format required for grant applications;(E) information about the criteria used to judge grant applications; and(F) the closing date.(h) Procedures for Grant Applications.(1) The department may specify any reasonable requirements for grant applications, including, but not limited to, length, format, authentication, and supporting documentation.(2) Applications that are incomplete or substantially inconsistent with the requirements of this subchapter may be rejected without further consideration at the discretion of the department.(3) Applications received after the closing date will not be considered, unless the closing date is extended by the department.(4) Applicants will be given a minimum of 60 calendar days to file applications after a request for proposals is published. Applications must be received by the department on or before the closing date specified in the request for proposals. Applications received after the closing date must be postmarked with a date equal to or prior to the closing date.(i) Competitive Review Process.(1) Each application shall be reviewed by the department for completeness, relevance to the published request for proposals, adherence to department policies, general quality, technical merit, and budget appropriateness.(2) The department's review process shall be completed within 45 days after the closing date.(j) Selection Criteria.(1) No grant shall be approved unless, in the opinion of the department:(A) the application contains an explanation as to why provision of low-cost sterilization for pets will help minimize pet-overpopulation in their community;(B) the application includes a workable plan to provide sterilization of dogs and cats for the general public at low or no cost;(C) the application includes a method to report the number, species, and sex of animals sterilized;(D) the applicant specifies how the general public will be made aware of the availability of low-cost sterilization; and(E) the applicant has a written non-discrimination policy in place to ensure that no person is discriminated against on the grounds of race, color, religion, sex, national origin, age, or disability.(2) A grant application will be given funding preference, in a manner determined by the department and announced in the request for proposals, to the extent that it:(A) includes an outreach program targeting pet custodians;(B) documents the intent and ability of the applicant to communicate and collaborate with the local health departments, animal control agencies, animal welfare agencies, veterinary organizations, and human services organizations;(C) demonstrates a low cost for sterilization on a per animal basis, thereby maximizing the number of animals which can be sterilized; and(D) contains such other information or criteria that the department may specify and include in the request for proposals.(k) Project Approval. Grant recipients shall execute a contract with the department. The contract shall detail items such as budget, reporting requirements, general provisions for department grant contracts, and any other specifics that might apply to the award.(l) Continuation Funding.(1) Grant recipients may be eligible for continuation funding. The department will consider the grant recipient's accomplishments, progress toward stated goals and objectives, award of past grants, and development of alternative funding. Applications shall be submitted in accordance with this subchapter.(2) The department will award continuation grants after a review of applications in accordance with the provisions of this subchapter. Source Note: The provisions of this §169.102 adopted to be effective September 9, 2001, 26 TexReg 6713; amended to be effective March 31, 2004, 29 TexReg 3226; amended to be effective April 11, 2006, 31 TexReg 3047; amended to be effective October 18, 2010, 35 TexReg 9297; amended to be effective June 7, 2015, 40 TexReg 3174. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL E DOG AND CAT STERILIZATION §169.102 Department of State Health Services Animal Friendly Account https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=180902&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 180902 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=180902&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 180902 03/11/2026 (a) The Texas Health and Safety Code, §81.352, requires retail stores that sell reptiles to post warning signs and distribute written warnings regarding reptile-associated salmonellosis to purchasers in accordance with the form and content designated by the Executive Commissioner.(b) The warning signs must meet the following guidelines.(1) The sign must be a minimum of 8.5 x 11 inches with fonts that are clearly visible and readily draw attention to the notice.(2) The signs must be prominently displayed at each location where reptiles are displayed, housed, or held.(3) At a minimum, the contents of the sign must include the following recommendations for preventing transmission of Salmonella from reptiles to humans.(A) Wash your hands thoroughly with soap and running water after feeding reptiles, handling reptiles or reptile cages, or contacting reptile feces or the water from reptile containers or aquariums. If soap and water are not immediately available, use a hand sanitizer and then wash your hands with soap and water as soon as possible. Wash your hands before you touch your mouth and before you prepare, serve, or consume food or drinks. Adults should supervise hand washing for young children.(B) Avoid contact with reptiles and any items that have been in contact with reptiles if you are a person at increased risk for infection or serious complications of salmonellosis, which, for instance, includes children younger than 5 years of age, adults aged 65 or older, and persons whose immune systems have been weakened by pregnancy, disease (for example, cancer), or certain medical treatments or procedures (for example, chemotherapy or organ transplantations). Keep reptiles out of households or facilities that include such at-risk persons. Consider removing any reptile from your residence and relocating it to a new home before a newborn baby is added to the household.(C) Do not allow reptiles to roam freely throughout the home or living area. Wash and disinfect surfaces that a reptile or its cage has contacted. Wash any clothing that a reptile has contacted. (D) Keep reptiles out of kitchens and other areas where food or drink is stored, prepared, served, or consumed. Do not use kitchen sinks to bathe reptiles or to wash their dishes, cages, or aquariums. If bathtubs are used for these purposes, clean them thoroughly and disinfect them with bleach. It is preferable to bathe reptiles in a container (such as a small tub or bin) designated for this use and to clean bathing containers, dishes, cages, or aquariums outside the house in a manner that prevents contact of the discarded material with other people and pets. Wear disposable gloves when washing bathing containers, dishes, cages, or aquariums. Wash your hands after removing the gloves.(4) The sign must also contain a statement that reptiles carry Salmonella bacteria, which can make people sick, but reptiles may not appear to be sick.(c) The written warnings, such as fliers or pamphlets, must contain the same information and statements as required in subsection (b)(3)(A) - (D) and (4) of this section. The written warnings must also contain a statement that purchasers of reptiles can contact their local health department for questions pertaining to Salmonella. (d) A sign or poster prepared by and containing the approved logo of the Centers for Disease Control and Prevention pertaining to disease prevention of reptile-associated salmonellosis when handling or housing reptiles may be used to meet the required content for the warning sign; however, the written warning must still contain the required content as described in subsection (b)(3)(A) - (D) and (4) of this section, plus the local health department statement as described in subsection (c) of this section. All signs and posters must meet the guidelines set forth in subsection (b)(1) and (2) of this section. Source Note: The provisions of this §169.121 adopted to be effective March 14, 2002, 27 TexReg 1797; amended to be effective September 14, 2006, 31 TexReg 7352; amended to be effective February 10, 2011, 36 TexReg 549; amended to be effective November 13, 2016, 41 TexReg 8823. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL F REPTILE-ASSOCIATED SALMONELLOSIS §169.121 Reptile-Associated Salmonellosis https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184888&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184888 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184888&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184888 03/11/2026 (a) Definitions.(1) Key components of facilities for confining dangerous wild animals and restricting public contact with the animals are the primary enclosure and the perimeter fence.(A) Primary enclosure--Any structure used to immediately restrict an animal(s) to a limited amount of space, including a cage, pen, run, room, compartment, or hutch.(B) Perimeter fence--A barrier surrounding the area containing the primary enclosure(s) that restricts public access to the area.(2) Where specified in this section, primary enclosures for dangerous wild animals shall be equipped to provide for a safe, healthy, and humane environment for the animals; prevent escape by the animals; and protect and enhance the public's health and safety. Such equipment includes, but is not limited to:(A) Safety entrance--A protected, secure area that can be entered by a keeper that prevents animal escape and safeguards the keeper, or a device that can be activated by a keeper that prevents animal escape and safeguards entry.(B) Shelter (including such structures as nest boxes or dens)--An enclosed structure that provides protection from the elements and from extremes in temperature that are detrimental to the health and welfare of the animal(s). Such a structure may vary in size depending on the security and biological needs of the species; it shall be large enough to accommodate all the animals in the enclosure simultaneously. Such a structure shall be within, attached to, or adjacent to the primary enclosure and be readily accessible to the animal(s).(C) Elevated platform or perching area--A surface or structure, either natural or manmade, positioned above the floor or above the grade level of the primary enclosure that will provide a resting area for the animal(s).(D) Gnawing and chewing items--Natural or artificial materials that provide for the health of teeth, so as to keep teeth sharp, remove tartar, and promote general oral hygiene. Gnawing items include, but are not limited to, logs and trees. Chewing items include, but are not limited to, woody stems, knuckle bones, and rawhide objects. Suitability is dependent upon species of animal.(b) General Requirements.(1) Primary enclosures for housing dangerous wild animals shall be sufficiently strong to prevent escape and to protect the animal(s) from injury and shall be equipped with perimeter fences to prevent any public contact with the animal(s). Perimeter fences may be constructed from materials such as fencing, landscaping, or close-mesh wire, provided that materials used are safe and effective in preventing public contact.(2) All primary enclosures less than or equal to 1,000 square feet shall be covered at the top to prevent escape.(3) A perimeter fence, sufficient to deter entry by the public, shall be a minimum of 8 feet in height and shall completely surround the premises where the animal(s) is housed or exercised outdoors. Perimeter fences constructed of materials, such as chain link or welded wire, that allow objects to be passed through them shall be at least 3 feet from the primary enclosure or appropriately enclosed exercise area.(c) Structural Requirements for Primary Enclosures. In addition to the size and equipment requirements for primary enclosures, dangerous wild animals shall be caged in accordance with the following requirements.(1) All primary enclosures shall be equipped with a safety entrance. Such entrances shall include a double-door mechanism, interconnecting cages, a lock-down area, or other comparable devices that will prevent escape and safeguard the keeper. Safety entrances shall be constructed of materials that are of equivalent strength or greater than that prescribed for cage construction for that particular species. The area occupied by the safety entrance shall be in addition to the space requirements for the primary enclosure.(2) All primary enclosures constructed of chain link or other approved materials shall be well braced and securely anchored at or below ground level to prevent escape by digging or erosion. Metal clamps, ties, or braces used in the construction of enclosures shall be of strength equivalent to or greater than the material required for primary enclosure construction for the particular species.(3) Additional minimum requirements for specific species and hybrids of those species shall be as follows.(A) Chimpanzees, gorillas, and orangutans.(i) Outdoor facilities--Construction material shall consist of steel bars, 2-inch galvanized pipe, masonry block, or their strength equivalent or greater. Shotcrete walls can also be utilized; if used in uncovered enclosures, it must be applied appropriately to avoid formation of any holds that could be used for climbing.(ii) Indoor facilities--Potential escape routes shall be equipped, at minimum, with steel bars, 2-inch galvanized pipe, or equivalent.(B) Baboons, jaguars, tigers, lions, leopards, cougars, cheetahs, bears, and hyenas.(i) Outdoor facilities--Construction material shall consist of not less than 9-gauge chain link or equivalent. Shotcrete walls can also be utilized; if used in uncovered enclosures, it must be applied appropriately to avoid formation of any holds that could be used for climbing.(ii) Indoor facilities--Potential escape routes shall be equipped with wire or grating of not less than 9-gauge or equivalent.(C) Ocelots, servals, lynxes, bobcats, caracals, coyotes, and jackals.(i) Outdoor facilities--Construction material shall consist of not less than 12-gauge chain link or equivalent. Shotcrete walls can also be utilized; if used in uncovered enclosures, it must be applied appropriately to avoid formation of any holds that could be used for climbing.(ii) Indoor facilities--Potential escape routes shall be equipped with wire or grating not less than 12-gauge or equivalent.(d) Primary Enclosure Size and Equipment Requirements. No dangerous wild animal shall be confined in any primary enclosure that contains more individual animals than specified in this section, is smaller in dimension than specified in this section, or is not equipped as specified in this section. The area occupied by pools, ponds, or lakes shall be in addition to the space requirements for the primary enclosure. Specifications in this section also pertain to hybrids of designated species.(1) Primates.(A) In addition to species-related requirements of this section, each primary enclosure shall have accessible devices to provide physical stimulation or manipulation compatible with the species. Each device shall be noninjurious and may include, but is not limited to, boxes, balls, mirrors, foraging items, or pools. The area occupied by pools shall be in addition to the space requirements for the primary enclosure.(B) Each primary enclosure shall have perching area(s) and shelter(s) that will accommodate all animals in the enclosure simultaneously.(C) Each primary enclosure shall have horizontal and vertical climbing structures appropriate for the species.(D) Primates shall not be kept in uncovered enclosures. However, for enclosures over 1,000 square feet in which a cover is not feasible, humane alternative measures shall be taken to prevent escape; these measures shall not compromise the health and safety of the public or the health, safety, and overall welfare of the animal(s). Such measures may include, but are not limited to, increased fence heights; electrified wires on fences; fence placement distant from trees or other structures that an animal(s) can climb; and/or water moats surrounding the enclosure. The owner shall seek and provide proof of consultation with a zoological organization or association to confirm that the escape-prevention measure(s) implemented are appropriate and effective for the enclosed primate(s).(E) Requirements for specific primate species are as follows:(i) Baboons. For one animal, the primary enclosure shall have a minimum floor area of 100 square feet with a wall or fence at least 10 feet high. For each additional animal, primary enclosure size shall be increased by at least 100 square feet.(ii) Chimpanzees, orangutans, and gorillas. For one animal, the primary enclosure shall have a minimum floor area of 400 square feet with a wall or fence at least 10 feet high. For each additional animal, primary enclosure size shall be increased by at least 350 square feet.(2) Wild felines.(A) In addition to requirements of this section, each primary enclosure shall be equipped with a shelter(s) large enough to accommodate all the animals in the enclosure simultaneously.(B) Each primary enclosure shall have accessible devices to provide physical stimulation or manipulation compatible with the species. Each device shall be noninjurious and may include, but is not limited to, boxes, balls, bones, barrels, drums, rawhide materials, or pools. The area occupied by a pool shall be in addition to the space requirements for the primary enclosure.(C) Each primary enclosure shall have an elevated platform(s) large enough to accommodate all animals in the enclosure simultaneously.(D) Each primary enclosure shall have at least one claw log.(E) Requirements for specific species of wild felines are as follows:(i) Lions and tigers.(I) For one animal, the primary enclosure shall have a minimum floor area of 300 square feet with a wall or fence at least 8 feet high. For each additional animal, primary enclosure size shall be increased by at least 150 square feet.(II) Primary enclosures over 1,000 square feet (if uncovered) shall have vertical jump walls at least 12 feet high with an attached 45-degree inward-angle overhang at least 3 feet wide or jump walls at least 16 feet high without an overhang. The inward-angle fencing shall be made of the same material as the vertical fencing.(ii) Cheetahs.(I) For one animal, the primary enclosure shall have a minimum floor area of 300 square feet with a wall or fence at least 8 feet high. For each additional animal, primary enclosure size shall be increased by at least 150 square feet.(II) Primary enclosures over 1,000 square feet (if uncovered) shall have vertical jump walls at least 10 feet high with an attached 45-degree inward-angle overhang at least 2 feet wide or 12 feet high without an overhang. The inward-angle fencing shall be made of the same material as the vertical fencing.(iii) Jaguars, leopards, and cougars.(I) For one animal, the primary enclosure shall have a minimum floor area of 300 square feet with a wall or fence at least 12 feet high. For each additional animal, primary enclosure size shall be increased by at least 100 square feet.(II) Jaguars, leopards, and cougars shall not be kept in uncovered enclosures.(iv) Bobcats, lynxes, ocelots, caracals, and servals.(I) For one animal, the primary enclosure shall have a minimum floor area of 100 square feet with a wall or fence at least 8 feet high. For each additional animal, primary enclosure size shall be increased by at least 50 square feet.(II) Bobcats, lynxes, ocelots, caracals, and servals shall not be kept in uncovered enclosures. However, for enclosures over 1,000 square feet in which a cover is not feasible, humane alternative measures shall be taken to prevent escape; these measures shall not compromise the health and safety of the public or the health, safety, and overall welfare of the animal(s). Such measures may include, but are not limited to, increased fence heights; electrified wires on fences; overhangs on fences; predator guards on trees; and/or fence placement distant from trees or other structures that an animal(s) can climb. The owner shall seek and provide proof of consultation with a zoological organization or association to confirm that the escape-prevention measure(s) implemented are appropriate and effective for the enclosed feline(s).(3) Bears.(A) In addition to the requirements of this section, each primary enclosure shall be equipped with a shelter(s) that shall accommodate all animals in the enclosure simultaneously.(B) Each primary enclosure shall have accessible devices to provide physical stimulation or manipulation compatible with the species. Each device shall be noninjurious and may include, but is not limited to, boxes, balls, bones, barrels, drums, climbing apparatus, or foraging items.(C) Each primary enclosure shall have an elevated platform(s) for resting that will accommodate all animals in the enclosure simultaneously.(D) Bears should be kept in covered enclosures or enclosures with an attached 45-degree inward-angle overhang at least 3 feet wide.(E) Requirements for specific types of bears are as follows:(i) Sun bears.(I) For one animal, the primary enclosure shall have a minimum floor area of 300 square feet with a wall or fence at least 8 feet high if covered or at least 12 feet high if uncovered. For each additional animal, primary enclosure size shall be increased by at least 150 square feet.(II) Each primary enclosure shall have, as a minimum, a 3-foot by 4-foot pool of water, 2 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.(ii) Black bears and Asiatic bears.(I) For one animal, the primary enclosure shall have a minimum floor area of 400 square feet with a wall or fence at least 8 feet high if covered or at least 12 feet high if uncovered. For each additional animal, primary enclosure size shall be increased by at least 175 square feet.(II) Each primary enclosure shall have, as a minimum, a 4-foot by 6-foot pool of water, 3 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.(iii) Brown bears and polar bears.(I) For one animal, the primary enclosure shall have a minimum floor area of 500 square feet with a wall or fence at least 10 feet high if covered or at least 12 feet high if uncovered. For each additional animal, primary enclosure size shall be increased by at least 200 square feet.(II) Each primary enclosure for brown bears shall have, as a minimum, a 6-foot by 10-foot pool of water, 4 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.(III) Each primary enclosure for polar bears shall have, as a minimum, a 10-foot by 10-foot pool of water, 5 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.(4) Coyotes, jackals, and hyenas.(A) In addition to the requirements of this section, each primary enclosure shall be equipped with a shelter(s) that shall accommodate all the animals in the enclosure simultaneously.(B) Each primary enclosure shall have accessible devices to provide physical stimulation or manipulation compatible with the species. Each device shall be noninjurious and may include, but is not limited to, boxes, balls, bones, barrels, drums, rawhide materials, or pools. The area occupied by a pool shall be in addition to the space requirements for the primary enclosure.(C) For one animal, the primary enclosure shall have a minimum floor area of 150 square feet (200 square feet for hyenas) with a wall or fence at least 6 feet high. For each additional animal, primary enclosure size shall be increased by at least 100 square feet.(D) Each primary enclosure shall have an elevated platform(s) large enough to accommodate all animals in the enclosure simultaneously.(E) Uncovered primary enclosures shall have vertical jump walls at least 8 feet high with an attached 45-degree inward-angle overhang at least 2 feet wide or jump walls at least 10 feet high without an overhang. The inward-angle fencing shall be made of the same material as the vertical fencing. Source Note: The provisions of this §169.131 adopted to be effective March 14, 2002, 27 TexReg 1798; amended to be effective September 14, 2006, 31 TexReg 7352; amended to be effective February 10, 2011, 36 TexReg 550; amended to be effective July 26, 2017, 42 TexReg 3643. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL G CAGING REQUIREMENTS AND STANDARDS FOR DANGEROUS WILD ANIMALS §169.131 Caging Requirements and Standards for Dangerous Wild Animals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184887&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184887 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184887&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184887 03/11/2026 (a) Texas Health and Safety Code, §822.103, requires that a person must obtain a certificate of registration for a dangerous wild animal issued by an animal registration agency. The animal registration agency must include the following information on the certificate of registration:(1) issuance date;(2) certificate number;(3) filing fee ($20 per animal) along with the department's mailing address as listed in subsection (b) of this section and a statement that the fee must be submitted to the department along with a copy of the certificate;(4) name, address, and phone number of the owner of the dangerous wild animal;(5) name and address of the animal registration agency;(6) species, sex, age, color, distinguishing marks, and other features (for example, ear notch, tattoo, sterilization status) of the dangerous wild animal;(7) the address of where the dangerous wild animal is kept;(8) the expiration date (or a statement that the certificate expires one year from the issuance date) unless the certificate is revoked, that the certificate is non-transferable, and that the certificate must be displayed at the location where the dangerous wild animal is kept; and(9) the signature of the authorized person at the animal registration agency.(b) Texas Health and Safety Code, §822.106, requires that not later than the 10th day after the date a person receives the certificate of registration, the person shall file a clear and legible copy of the certificate of registration with the Texas Department of State Health Services, Zoonosis Control, P. O. Box 149347, Mail Code 1956, Austin, Texas 78714-9347. The fee for filing the certificate is $20 per animal, submitted with the copy of the certificate. Source Note: The provisions of this §169.132 adopted to be effective February 10, 2011, 36 TexReg 550; amended to be effective July 26, 2017, 42 TexReg 3643. 1 DEPARTMENT OF STATE HEALTH SERVICES 169 ZOONOSIS CONTROL G CAGING REQUIREMENTS AND STANDARDS FOR DANGEROUS WILD ANIMALS §169.132 Registration, Fee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162911&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162911 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162911&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162911 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Applicant--A person who requests a service pertaining to a record of birth or death, verification of marriage or divorce, or release of personal data. (Also, see definition for properly qualified applicant).(2) Birth records--Records governing births filed pursuant to the Texas Vital Statistics Act, the Health and Safety Code, Title 3.(3) Certified--A certified statement, form, or letter, of the facts stated on the form or document as filed in the Vital Statistics Unit, certified by the State Registrar or duly appointed designee, over the respective signature and may bear the seal of the Vital Statistics Unit.(4) Certified copy--An abstract or photocopy of the original record issued as filed with the Vital Statistics Unit, and issued on a designated form or security paper which shall bear the "state seal," the Texas Department of State Health Services, Vital Statistics Unit or the seal of their office, and the facsimile signature of the State Registrar or the local registration official.(5) Dead body--A lifeless human body or such parts of the human body or the bones thereof from the state of which it may be reasonably concluded that death occurred.(6) Disinterment--To exhume, unbury, or take out of the grave.(7) Death records--Records governing deaths and fetal deaths filed pursuant to the Texas Vital Statistics Act.(8) Department--The Texas Department of State Health Services, formerly known as the Texas Department of Health.(9) Embalming--The act of disinfecting or preserving a human dead body, entire or in part, by the use of chemical substances, fluids, or gases in the body; or by the introduction of the same into the body by vascular or hypodermic injection; or by direct application into the organs or cavities; or by any other method intended to disinfect or preserve a dead body or restore body tissues and structures.(10) Fetal death (stillbirth)--Death prior to the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of pregnancy; the death is indicated by the fact that after such separation, the fetus does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles.(11) Genealogist--An individual who traces the descent of persons or families. He or she may be an individual family member or a person hired by the family to trace a family tree or do family research.(12) Identification of applicant--Each applicant must present a current form of government issued photo identification along with his or her application. If the applicant is unable to present a current form of photo identification, two valid supporting forms of identification may be presented, one of which bears the applicant's signature.(13) Immediate family member--The registrant, his or her guardian, or the children, spouses, parents, siblings, or grandparents of the registrant.(14) Indexes--An index to or listing of birth records, death records, applications for marriage licenses, and reports of divorce or annulment of marriage.(A) Consolidated indexes--These indexes are vital records consisting of more than one event year. Consolidated indexes may be prepared for any vital event at the discretion of the State Registrar in the form prescribed.(B) General birth and death indexes--These indexes are maintained or established by the Vital Statistics Unit or a local registration official which shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, the state or local file number, the name of the father, the maiden name of the mother, and sex of the registrant.(C) Summary birth and death index--These indexes are maintained or established by the Vital Statistics Unit or a local registration official which shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, and sex of the registrant.(15) Interment--Burial or the act of placing in a grave.(16) Legal representative (personal representative or agent)--An attorney in fact, a funeral director, or any other person designated by affidavit, contract, or court order acting on behalf and for the benefit of the registrant or his or her immediate family. In order to determine the need for protection for personal property rights when the legal representative is acting on behalf and for the benefit of the registrant or the registrant's immediate family or other entity having a direct and tangible interest in the record, the State Registrar, Local Registrar, or county clerk shall require a designation document or an attested statement to that effect.(17) Live birth--The complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of pregnancy, which, after such separation, breathes or shows any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached; each product of such a birth is considered live born.(18) Local registration official--A county clerk or person authorized by the Vital Statistics Act to maintain a duplicate system of records for each birth, death, or fetal death that occurs in the person's jurisdiction.(19) Non-institutional birth--A birth occurring outside a hospital or birthing center licensed by the Texas Department of State Health Services.(20) Person in charge of interment--Any person who places or causes to be placed a fetus, dead body or the ashes, after cremation, in a grave, vault, urn, or other receptacle, or otherwise disposes thereof.(21) Properly qualified applicant (qualified applicant)--The registrant, or immediate family member either by blood, marriage or adoption, his or her guardian, or his or her legal agent or representative. Local, state and federal law enforcement or governmental agencies and other persons may be designated as properly qualified applicants by demonstrating a direct and tangible interest in the record when the information in the record is necessary to implement a statutory provision or to protect a personal legal property right. A properly qualified applicant may also be a person who has submitted an application for a request to release personal information and has been approved as outlined in §181.11 of this title (relating to Requests for Personal Data).(22) Registrant--The individual named on the certificate of birth, death, or fetal death; application for marriage license; or report of divorce or annulment of marriage.(23) Registrar--The State Registrar or a Local Registrar as recognized by the Texas Department of State Health Services, Vital Statistics Unit.(24) Research copy--A plain paper noncertified reproduction of the complete original document or a portion of the original document.(25) Search--The act of examining the files and/or indexes maintained by the Vital Statistics Unit for a specific record or information.(26) Signature--The name of a person written with his or her own hand; or by an electronic process approved by the State Registrar.(27) State Registrar--The Unit Director of the Vital Statistics Unit, Texas Department of State Health Services.(28) Supplemental Birth Certificate--A new birth certificate prepared and filed by the Vital Statistics Unit, which is based upon a paternity determination, or adoption. This new birth certificate replaces the original certificate of birth.(29) Birth Verification--A noncertified statement only of the registrant's name, date of birth, and place of birth as it appears on the birth index filed with the Vital Statistics Unit.(30) Death Verification--A noncertified statement only of the registrant's name, date of death, and place of death as it appears on the death index filed with the Vital Statistics Unit.(31) Fetal Death Verification--A noncertified statement only of the registrant's name, date of delivery, and place of delivery as it appears on the fetal death index filed with the Vital Statistics Unit.(32) Marriage Verification--A noncertified statement only of the registrant's name, date of marriage, and place of marriage as it appears on the application for marriage license index filed with the Vital Statistics Unit.(33) Report of Divorce or Annulment of Marriage Verification--A noncertified statement only of the registrant's name, date of divorce, and place of divorce as it appears on the report of divorce or annulment of marriage index as it appears on the birth index filed with the Vital Statistics Unit.(34) Vital statistics--The registration, preparation, transcription, collection, compilation, distribution and preservation of data pertaining to births, adoptions, paternity determinations, deaths, fetal deaths, suits affecting parent child relationship, court of continuing jurisdiction, marital status, and such other data as deemed necessary by the department.(35) Vital Statistics Act--The Health and Safety Code, Title 3.(36) Vital Statistics Unit--The office, formally known as the Bureau of Vital Statistics, within the Texas Department of State Health Services, formerly known as the Texas Department of Health, charged with the implementation of the Texas Vital Statistics Act. Source Note: The provisions of this §181.1 adopted to be effective January 1, 1976; amended to be effective October 8, 1990, 15 TexReg 5603; amended to be effective November 19, 1991, 16 TexReg 6297; amended to be effective July 17, 1995, 20 TexReg 4687; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206794&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206794 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206794&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206794 03/11/2026 (a) The funeral director, or person acting as such, who assumes custody of a dead body or fetus shall obtain an electronically filed report of death through a Vital Statistics Section system or complete a report of death before transporting the body. The report of death shall within 24 hours be mailed or otherwise transmitted to the Local Registrar of the district in which the death occurred or in which the body was found. A copy of the completed or electronically filed report of death as prescribed by the Vital Statistics Section shall serve as authority to transport or bury the body or fetus within this state.(b) If a dead body or fetus is to be removed from this state, transported by common carrier within this state, or cremated, the funeral director, or person acting as such, shall obtain a burial-transit permit from the Local Registrar where the death certificate is or will be filed, or from the State Registrar electronically through a Vital Statistics Section electronic death registration system. The registrar shall not issue a burial-transit permit until a certificate of death, completed in so far as possible, has been presented (See §181.6 of this title (relating to Disinterment)).(c) The funeral director, or person acting as such, shall furnish the sexton or other person in charge of a cemetery with the information required.(d) If a county elects to expedite death certificates pursuant to Texas Health and Safety Code §193.0025, the funeral director, or person acting as such, who assumes custody of the dead body or fetus will work with the Local Registrar to ensure that a copy of the decedent's death certificate is issued to the requestor not later than 48 hours after the requestor's request if all statutory requirements are met. The department, using existing resources and programs to the extent possible, shall provide technical support. Source Note: The provisions of this §181.2 adopted to be effective January 1, 1976; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896; amended to be effective November 24, 2021, 46 TexReg 7884. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.2 Assuming Custody of Body https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103034&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103034 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103034&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103034 03/11/2026 (a) Bodies shipped by common carrier.(1) Any body shipped by common carrier must be placed in either:(A) a sound casket enclosed in a strong outside shipping case; or(B) a metal container specifically designed for this purpose.(2) If the body is not embalmed or is in a state of decomposition, it may be shipped only after enclosure in an air-tight metal casket encased in a strong outside shipping case or in a sound casket encased in an air-tight metal or metal lined shipping case.(3) Shipping containers and requirements for the shipping of dead bodies must meet or exceed any requirement imposed by the shipping company, the receiving state or foreign country.(4) When any body is to be transported by common carrier, the burial-transit permit shall be enclosed in a strong envelope and attached to the shipping case. No separate transit permit shall be required.(b) Bodies transported by means other than common carrier.(1) Any body transported by means other than a common carrier must be encased in a container which insures against seepage of fluid and the escape of offensive odors, provided, however, that bodies transported by a licensed funeral director in a vehicle used for such purpose need not be so encased.(2) If a dead body is to be transported by means other than a common carrier and for a purpose other than preparation or storage, the report of death form shall be enclosed in a strong envelope and attached to the container in which the body is enclosed.(c) Duties of transportation companies. No transportation company shall accept any body for shipment until it has been ascertained that a properly completed burial-transit permit accompanies the body. Source Note: The provisions of this §181.3 adopted to be effective January 1, 1976; amended to be effective October 8, 1990, 15 TexReg 5603; amended to be effective July 3, 2003, 28 TexReg 4904. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.3 Transportation of Dead Bodies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103035 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103035 03/11/2026 No human body may be held in any place or be in transit more than 24 hours after death and pending final disposition unless either maintained at a temperature within the range of 34 degrees - 40 degrees Fahrenheit, or is embalmed by a licensed embalmer in a manner approved by the Texas Funeral Service Commission, or by an embalmer licensed to practice in the state where death occurred or is encased in a container which insures against seepage of fluid and the escape of offensive odors. Source Note: The provisions of this §181.4 adopted to be effective January 1, 1976; amended to be effective October 8, 1990, 15 TexReg 5603; amended to be effective July 3, 2003, 28 TexReg 4904. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.4 Preservation of Bodies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113755&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113755 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113755&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113755 03/11/2026 (a) The department adopts by reference the rules of the Texas Funeral Service Commission in 22 TAC §203.16, covering minimum standards for embalming.(b) The rules adopted by reference in subsection (a) of this section shall not require or infer a requirement for the embalming of a dead body prior to burial or cremation. Source Note: The provisions of this §181.5 adopted to be effective January 1, 1976; amended to be effective October 8, 1990, 15 TexReg 5603; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.5 Embalming and Standards of the Funeral Industry https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162913&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162913 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162913&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162913 03/11/2026 (a) Except as is authorized for a justice of the peace acting as coroner or medical examiner under the Code of Criminal Procedure, Chapter 49, remains may not be removed from a cemetery except on written order of the State Registrar or the State Registrar's designee.(b) The licensed funeral director or professional archeologist to whom the disinterment permit is issued shall be responsible for the proper conduct of the disinterment and removal.(c) The State Registrar shall issue a disinterment permit so as to provide a copy for the State Registrar, a copy retained by the funeral director or professional archeologist to whom issued, a copy filed with the sexton or person in charge of the cemetery in which the disinterment is to be made, and a copy for the Local Registrar of the district in which the death occurred. The State Registrar and the Local Registrar shall file the disinterment permit as an amendment to the death certificate and consider it part of the death certificate. The State Registrar and the Local Registrar shall include a copy of the disinterment permit with any future certified copies of the death certificate that are issued.(d) A disinterment permit shall not be required if a body is to be disinterred and reinterred in the same cemetery.(e) A disinterment permit shall not be required to remove cremains.(f) Cremation is considered to be a final disposition of remains.(g) A disinterred body must be transported in a container which insures against the seepage of fluid or the escape of offensive odors. When shipped by common carrier, a disinterred body must be enclosed in an airtight metal casket encased in a strong outside shipping case, or in a sound casket encased in an airtight metal or metal-lined shipping case. This requirement shall not apply if the disinterred remains involve no soft parts.(h) The disinterment permit issued by the State Registrar shall serve as the authority to disinter, transport by means other than a common carrier, and re-inter a body within this state. (See §181.2 of this title (relating to Assuming Custody of Body).)(i) A body kept in a receiving vault shall not be regarded as a disinterred body until after the expiration of 30 days.(j) All disinterred remains kept in receiving vaults shall be thoroughly embalmed in a manner approved by the Texas Funeral Service Commission and shall be enclosed in a permanently sealed casket.(k) The licensed funeral director or embalmer requesting a disinterment permit shall be responsible for obtaining a written consent of the cemetery, the owner of the plot, and the decedent's next-of-kin.(l) The licensed funeral director or embalmer requesting a disinterment permit shall be responsible for obtaining a written consent order from the county judge to disinter a body from a grave when the cemetery, plot owner, and the decedent's next-of-kin are unknown. Source Note: The provisions of this §181.6 adopted to be effective January 1, 1976; amended to be effective November 19, 1991, 16 TexReg 6297; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.6 Disinterment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113757&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113757 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113757&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113757 03/11/2026 (a) A certificate of fetal death shall be filed for any fetus weighing 350 grams or more, or if the weight is unknown, a fetus aged 20 weeks or more as calculated from the start date of the last normal menstrual period to the date of delivery.(b) A certificate of fetal death shall be considered properly filed:(1) when all of the items thereon have been satisfactorily and definitely answered; and(2) when the certificate has been presented for filing to the local registrar of the registration district in which the fetal death (stillbirth) occurred or the fetus was found. A certificate of fetal death (stillbirth) shall be filed with the local registrar within five days after the date of fetal death (stillbirth). Source Note: The provisions of this §181.7 adopted to be effective January 1, 1976; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.7 Fetal Death (Stillbirth) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162914&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162914 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162914&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162914 03/11/2026 (a) When a supplemental certificate of birth is prepared and filed based on adoption or paternity determination, a copy of the supplemental birth certificate shall be forwarded to each local registration official in whose office is recorded the original birth record of such child.(b) Wherever possible, the local registration official shall remove from his or her files the original birth record and:(1) Shred any paper birth records using a cross cut paper shredder; and(2) Remove any birth records stored in electronic format from storage media using validated overwriting technologies and methods/tools that clear data using 1-3 overwrites in accordance with National Institute of Standards and Technologies (NIST) "Guidelines for Media Sanitation" (Publication SP-800-88).(c) Where it is not possible to remove the original birth record, the local registration official shall cancel such record in such manner as to preclude the disclosure of any information contained therein. In its place he or she shall substitute the supplemental certificate of birth.(d) A certificate of adoption for a child born outside the State of Texas shall, when received by the Vital Statistics Unit be forwarded to the proper registration official of the state or territory in which such birth occurred. (For foreign adoptions, see §181.29 of this title (relating to Foreign Adoptions)).(e) Where application is made for the filing of a supplemental certificate based on paternity, the applicant shall submit to the Vital Statistics Unit an Application for New Birth Certificate Based on Parentage (VS-166) signed by both parents in the presence of a Notary Public, and:(1) a certified copy of the certificate of marriage indicating the subsequent marriage of the parents; or(2) a copy of the Acknowledgment of Paternity (VS-159.1) that has been properly filed by the Vital Statistics Unit; or(3) a certified copy of the court decree establishing paternity. If a court decree is presented, the Application for New Birth Certificate Based on Parentage only has to be signed by one of the parents in the presence of a Notary Public.(4) a certified copy of the court decree establishing a gestational agreement. The Application for New Birth Certificate Based on Parentage must be signed by at least one parent in the presence of a Notary Public.(f) Voluntary Paternity must have a written consent of both parents. Source Note: The provisions of this §181.8 adopted to be effective January 1, 1976; amended to be effective August 9, 1998, 23 TexReg 7809; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.8 Supplemental Birth Certificates https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162915&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162915 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162915&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162915 03/11/2026 (a) After the supplemental certificate of birth based on paternity is filed, any information disclosed from the record shall be made from the supplemental certificate, and access to the original certificate of birth and related documents shall not be authorized except upon order of a court of competent jurisdiction.(b) The Vital Statistics Unit shall notify the Office of the Attorney General, the Title IV-D agency for the State of Texas, in a manner agreed by both agencies of any supplemental birth records based upon acknowledgement of paternity. Source Note: The provisions of this §181.9 adopted to be effective September 4, 1984, 9 TexReg 4502; amended to be effective August 9, 1998, 23 TexReg 7809; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.9 Access to Paternity Files https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162916&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162916 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162916&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162916 03/11/2026 (a) This section establishes requirements governing the control of public accessibility to birth records and in order to ensure the confidentiality of adoption placements.(b) Availability of birth records generally.(1) Copies of birth records are available for request by the public for searching or inspection, in accordance with Government Code, §552.115, on or after the 75th anniversary of the date of birth as shown on the record filed with the Vital Statistics Unit or the local registration official. Original birth records shall not be made available to the public in the interest of preservation of the records.(2) The local registration official, upon receipt of a record of birth based on adoption or paternity must delete or expunge the birth record filed at the time of the event. Source Note: The provisions of this §181.10 adopted to be effective January 29, 1988, 12 TexReg 4785; amended to be effective October 8, 1990, 15 TexReg 5603; amended to be effective March 16, 2000, 25 TexReg 2068; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.10 Availability of Birth Records to Ensure Confidentiality of Adoption Placement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162917&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162917 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162917&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162917 03/11/2026 (a) The purpose of this section is to describe the criteria that the Committee on Requests for Personal Data will use in reviewing and recommending disposition when an application for personal data is received.(b) The Commissioner and/or his designee shall appoint a Committee on Requests for Personal Data (Committee) that serves in an advisory capacity. The committee reviews and makes recommendations regarding requests for personal data to be used for research purposes or for the official use of governmental agencies.(c) Procedures.(1) If the department receives a request for personal data, the release of which has been determined to be legally discretionary, and there is a question as to whether the data should be released, the request shall be referred to the committee for its review and recommendation. The committee will review the request and make a recommendation regarding release to the commissioner or his designee.(2) The committee will require each applicant for personal data to complete the application form as prescribed by the committee.(3) If the personal data is released, a copy of the final project report, any publication, or presentation must be furnished to the committee. The department will be given credit as the source of the data.(4) It is department policy to disapprove applications involving contact with any person, institution, or agency identified on the record unless the committee determines that there are substantial overriding reasons for the contact.(5) It is department policy to disapprove applications involving research that does not serve a valid scientific or public health purpose.(6) The Vital Statistics Unit shall charge the statutory fee for each vital record research copy as provided in the Health and Safety Code, §191.0045.(7) Personal data application requests need to be submitted to the department's Institutional Review Committee if any of the following apply to the requested research:(A) sponsored by the department;(B) conducted by or under the direction of department employees or agents;(C) conducted by or under the direction of department employees or agents using department property of facilities, or;(D) involves the use of department nonpublic information to identify or contact human research subjects or prospective subjects. Source Note: The provisions of this §181.11 adopted to be effective May 10, 1988, 13 TexReg 2032; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.11 Requests for Personal Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162918&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162918 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162918&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162918 03/11/2026 (a) The State Registrar shall determine the items of information to be contained on certificates of birth. The format of the items will be designated on department forms.(b) The State Registrar shall prescribe a User Agreement for the orderly implementation of electronic birth registration.(c) Hospitals, licensed birthing centers, midwives, and local registration officials must comply with the User Agreement in order to participate in electronic birth registration.(d) The Vital Statistics Unit may discontinue any institution or individual's participation in electronic birth registration for failure to comply with the User Agreement. Source Note: The provisions of this §181.13 adopted to be effective October 7, 1996, 21 TexReg 9236; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.13 Birth Certificate Form and Content https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113761&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113761 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113761&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113761 03/11/2026 (a) The State Registrar shall determine the items of information to be contained on certificates of death and fetal death. The format of the items will be designated in forms entitled "Certificate of Death" and "Certificate of Fetal Death".(b) Funeral directors or other persons in charge of disposition or in charge of removal of a body from a registration district for disposition may prepare and file the Certificate of Death and the Certificate of Fetal Death. Source Note: The provisions of this §181.14 adopted to be effective August 19, 1999, 24 TexReg 630; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS A MISCELLANEOUS PROVISIONS §181.14 Death and Fetal Death Certificate Form and Content https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162919&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162919 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162919&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162919 03/11/2026 (a) Purpose. The purpose of this section is to describe:(1) the criteria that the State Registrar will use in refusing to issue a certified copy of a record of birth, death, or fetal death when information is received that may contradict the information shown in such record; and(2) the hearing procedures the department will use when the applicant wants to appeal the State Registrar's proposed refusal.(b) Criteria for refusal. The criteria for refusal to issue a certified copy of a record is based on information the State Registrar receives that contradicts the information shown in the record, such as:(1) an order issued by a court of competent jurisdiction finding that the information shown in a record is false;(2) a copy of an original record showing that the event in question occurred in a jurisdiction other than the State of Texas;(3) affidavits executed by registrants, parents, attendants, or persons authorized to administer oaths attesting to the falsification of information in a record.(c) Hearing procedures.(1) If the State Registrar proposes to refuse to issue a certified copy, the applicant shall receive written notification of the refusal, the reason for the refusal and his or her right to request a hearing before the department to determine if there is evidence to support the State Registrar's proposed action.(2) If the applicant wants a hearing, he or she shall submit a written request for a hearing to the State Registrar within 20 days after receiving the notice of proposed refusal.(3) The State Registrar, upon receiving the written request for hearing, shall request the department's Office of General Counsel to initiate a hearing procedure in accordance with the department's hearing procedures, contained in §§1.51-1.55 of this title.(4) The State Registrar shall notify the applicant in writing when the hearing request has been sent to the Office of General Counsel. The notice shall include a copy of the department's hearing procedures. Source Note: The provisions of this §181.21 adopted to be effective February 1, 1984, 8 TexReg 5406; amended to be effective March 16, 2000, 25 TexReg 2068; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.21 Refusal To Issue Certified Copies of Records of Birth, Death, or Fetal Death https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221279 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221279 03/11/2026 (a) The fee for a certified copy or research copy of a birth record is $22.00.(b) The fee for a certified copy or research copy of a death or fetal death record is $20.00. The fee for each additional copy of the same record requested in the same order is $3.00.(c) The fee for an heirloom birth certificate is $50.00.(d) The fee for an heirloom wedding anniversary certificate is $50.00.(e) The fee for a search of a vital record or information on file within the Vital Statistics Section is $10.00.(f) The fee for a verification of a birth record is $22.00.(g) The fee for a verification of a marriage, divorce, or death record is $20.00.(h) The fee for a photocopy of a marriage license application is $20.00.(i) The fee for a certificate of birth resulting in stillbirth is $20.00.(j) The fee for a file sealed by adoption or parentage determination is $10.00.(k) The fee for a non-certified copy of an original birth certificate to an adult adoptee is $10.00.(l) The fee for an identification of the court that granted an adoption is $10.00.(m) The fee for an amendment to a birth, death, or fetal death record is $15.00.(n) The fee for a new birth record based on adoption or parentage determination is $25.00.(o) The fee for a delayed record of birth is $25.00.(p) The fee for a Paternity Registry inquiry is $10.00.(q) The fee for an Acknowledgment of Paternity Registry inquiry is $10.00. The fee includes a certified copy of the Acknowledgement of Paternity, if found.(r) The fee for enrolling in the Central Adoption Registry is $30.00.(s) The fee for expedited service is $25.00 for each application submission, in addition to required application fees.(t) The fee for a disinterment permit is $25.00.(u) The fee for a certified birth record is waived for an applicant who appears in person to obtain a certified copy from the department or a Local Registrar and states the certified record is required for the purpose of obtaining an election identification certificate issued pursuant to Transportation Code Chapter 521A.(v) The fee for a certified copy of a birth record is waived for an applicant who states the applicant is a victim, or child of a victim, of dating or family violence, pursuant to Texas Health and Safety Code §191.00491, who is fleeing a living situation due to dating or family violence and does not have personal identification documents. Source Note: The provisions of this §181.22 adopted to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective December 1, 2005, 30 TexReg 7876; amended to be effective August 11, 2013, 38 TexReg 4896; amended to be effective October 21, 2013, 38 TexReg 7307; amended to be effective November 24, 2021, 46 TexReg 7884; amended to be effective November 20, 2024, 49 TexReg 8584. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.22 Fees Charged for Vital Records Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162921&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162921 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162921&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162921 03/11/2026 (a) The State Registrar shall establish and maintain an index of all vital records filed within the Vital Statistics Unit. Local registration officials shall establish and maintain an index of all vital records filed within their local registration area.(b) Birth indexes.(1) General birth indexes maintained or established by the Vital Statistics Unit or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, the state or local file number, the name of the father, the maiden name of the mother, and sex of the registrant.(2) A general birth index is public information and available to the public to the extent the index relates to a birth record that is public on or after the 75th anniversary of the date of birth as shown on the record unless the fact of an adoption or paternity determination can be revealed or broken or if the index contains specific identifying information relating to the parents of the child who is the subject of an adoption placement. The Vital Statistics Unit and local registration officials shall expunge or delete any state or local file numbers included in any general birth index made available to the public because such file numbers may be used to discover information concerning specific adoptions, paternity determinations, or the identity of the parents of children who are the subjects of adoption placements.(3) A summary birth index maintained or established by the Vital Statistics Unit or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, and sex of the registrant. A summary birth index or any listings of birth records are not available to the public for searching or inspection if the fact of adoption or paternity determination can be revealed from specific identifying information.(c) Death indexes.(1) A general death index maintained or established by the Vital Statistics Unit or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials; the date of the event; the county of occurrence; the registrant's social security number, sex, and marital status; the name of the registrant's spouse, if applicable; and the state or local file number.(2) A general death index is public information and available to the public to the extent the index relates to a death record that is public on or after the 25th anniversary of the date of death as shown on the record.(3) A summary death index maintained or established by the Vital Statistics Unit or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, and sex of the registrant.(d) Indexes to marriage and divorce records shall be cross-referenced by the names of the husband and wife and include the date of the event and county of occurrence.(e) Consolidated indexes are indexes of vital records consisting of more than one event year. Consolidated indexes may be prepared for any vital event at the discretion of the State Registrar in the form prescribed. Source Note: The provisions of this §181.23 adopted to be effective November 19, 1991, 16 TexReg 6297; amended to be effective March 16, 2000, 25 TexReg 2068; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.23 Indexes for Vital Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162922&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162922 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162922&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162922 03/11/2026 (a) Abused birth record.(1) Any birth record that has had 10 certifications issued since the original date of filing shall be considered as an abused record. Such a notation shall be made on the birth record.(2) Local Registrars shall notify the Vital Statistics Unit of any abused record. Requests for additional certifications shall be made to the Vital Statistics Unit.(3) When the State Registrar receives a request for an abused birth record, he/she shall refuse to issue any additional certifications until the registrant, minor registrant's parent who is not excluded by law, or registrant's guardian has satisfactorily explained, the reason for the additional request(s).(b) Misused record.(1) A misused record is any birth or death record that has been used by any person for any fraudulent or illegal purpose.(2) Upon notification or determination that a record has been misused, the State Registrar shall attach a flag or notice to the record.(c) Flagged record.(1) A flagged record is any record with a notation that a request was received to not issue the record or to which an addendum, based on evidence of contradictory birth facts, has been attached. The registrant, minor registrant's parent who is not excluded by law, or registrant's guardian can request that no further copies of the record be released. After such request, the State Registrar may place a flag on the record.(2) The Vital Statistics Unit will flag the record of any missing child who is under the age of eleven, when notified by a law enforcement agency or the Missing Persons Clearinghouse.(3) When a record has a notation, or addendum, the State and Local Registrar shall refuse to issue such a record until the conditions as stated on the notation, or addendum have been satisfied and the registrant or the requesting party has been notified.(d) A hearing may be requested as provided in §181.21 of this title (relating to Refusal to Issue Certified Copies of Records of Birth, Death, or Fetal Death) to determine if flagged, abused, misused or records with an addendum or notation should be issued. Source Note: The provisions of this §181.24 adopted to be effective November 19, 1991, 16 TexReg 6298; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.24 Abused, Misused, or Flagged Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162923&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162923 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162923&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162923 03/11/2026 (a) The Vital Statistics Unit shall furnish application forms for a marriage license to each county clerk in the format as prescribed by the State Registrar.(b) The application form shall contain at a minimum the items and information prescribed in the Texas Family Code, §2.004.(c) When reproduced locally by the county clerk, the form shall be identical in content, format, and size as prescribed by the Vital Statistics Unit.(d) Although the Vital Statistics Unit is the custodian of marriage applications in the State of Texas, the county of record is the custodian of all marriage licenses it registers. Therefore, any amendment to the marriage license will be reflected at the county, and not at the state level.(e) To amend the marriage license, both parties are responsible for executing a notarized affidavit stating the error.(f) The affidavit to amend the marriage license must contain:(1) the full names of applicants, including the maiden surname of the female applicant;(2) the date on which the marriage occurred;(3) a statement identifying the error to be corrected; and(4) the corrected statement.(g) Upon receipt of the notarized affidavit, the county clerk shall file it as an amendment to the marriage license.(h) The affidavit is considered part of the marriage license.(i) The county clerk shall include a copy of the affidavit with any future certified copy of the marriage license issued by the clerk. Source Note: The provisions of this §181.25 adopted to be effective November 19, 1991, 16 TexReg 6297; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.25 Application for Marriage License and Affidavit of Correction to Marriage License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162924&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162924 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162924&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162924 03/11/2026 (a) All certificates of birth shall be filed as required by the Health and Safety Code, §192.001.(1) Births occurring in a licensed institution shall be filed as required by the Health and Safety Code, §192.003. Licensed institutions include hospitals and birthing centers licensed by the department.(2) Births occurring outside licensed institutions shall be filed as described in this section.(b) A registered, certified, or documented health care provider's signature on the birth certificate, or participation in electronic birth registration shall serve as prima facie evidence of the essential elements of proof required in subsection (c) of this section. The Local Registrar may accept certificates by mail when the signature of the registered, certified, or documented health care provider is on file with that registrar's office.(c) The essential elements to register a non-institutional birth are:(1) evidence of pregnancy;(2) evidence that there was an infant born alive;(3) evidence that the birth occurred in the registration district; and(4) evidence that the infant's birth occurred on the date stated.(d) Evidence of pregnancy, such as but not limited to:(1) prenatal record;(2) a statement from a physician or other health care provider qualified to determine pregnancy;(3) a home visit by a public health nurse or other health care provider; or(4) other evidence acceptable to the Local Registrar.(e) Evidence that there was an infant born alive, such as, but not limited to:(1) a statement from the physician or other health care provider who saw or examined the infant;(2) an observation of the infant during a home visit by a public health nurse; or(3) other evidence acceptable to the Local Registrar.(f) Evidence that the birth occurred in the registration district, such as, but not limited to the following.(1) If the live birth occurred in the mother's residence:(A) a rent receipt that includes the mother's name and address;(B) any type of utility, telephone, or other bill that includes the mother's name and address;(C) a credit or debit card receipt that includes the date and location of the transaction;(D) a driver's license, or a State-issued identification card, which includes the mother's current residence on the face of the license/card; or(E) other evidence acceptable to the Local Registrar.(2) If the live birth occurred outside of the mother's place of residence, and the mother is a resident of this State, such evidence shall consist of:(A) an affidavit from the tenant of the premises where the live birth occurred, that the mother was present on those premises at the time of the live birth;(B) evidence of the affiant's residence similar to that required in paragraph (1) of this subsection;(C) evidence of the mother's residence in the State similar to that required in paragraph (1) of this subsection; or(D) other evidence acceptable to the Local Registrar.(3) If the mother is not a resident of this State, such evidence must consist of clear and convincing evidence acceptable to the Local Registrar.(g) Evidence that infant's birth occurred on the date stated, includes but is not limited to:(1) prenatal record;(2) a statement from a physician or other health care provider qualified to determine the date of birth; or(3) other evidence acceptable to the Local Registrar.(h) A birth as described in subsection (c) of this section shall only be filed upon personal presentation of the following evidence by the individual responsible for the preparation and registering of the certificate. An identifying document, with photograph, shall be presented in the following order of preference:(1) a passport or certificate of naturalization;(2) a military service or military dependent identification card;(3) a United States government identification card, or national identification card issued by another country;(4) a current driver's license or other state identification card;(5) an alien registration receipt card; or(6) an employee or student identification card, with photograph.(i) A certificate of birth concerning a child who is between one and four years of age may only be filed by the State Registrar. The State Registrar shall require the same proof and documentation as previously mentioned in this section and, in addition, an affidavit of the parents and the attendant, if any, as to why the certificate was not timely filed. If the proof and documentation are not available, the certificate may only be filed as prescribed by the Health and Safety Code, §192.027.(j) Each Local Registrar shall notify the State Registrar's office of any suspicious documents or records submitted or filed with his/her office.(k) Blank birth certificate forms shall only be issued to licensed institutions, certified nurse midwives, documented midwives, and individuals by the Local Registrar or the State Registrar in reasonable amounts. No blank birth certificate forms shall be distributed by mail to any one other than a registered, certified, or documented health care provider. Source Note: The provisions of this §181.26 adopted to be effective November 19, 1991, 16 TexReg 6298; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.26 Filing of Birth Certificates for Infants Born Outside of a Licensed Institution https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162925&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162925 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162925&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162925 03/11/2026 (a) The purpose of this section is to implement Texas Occupations Code, Chapter 651, and Health and Safety Code, Chapters 193 and 195. In an effort to better protect the public health, safety and welfare, it is the legislative intent of the laws for the Texas Department of State Health Services (department) and the Texas Funeral Service Commission (TFSC) to adopt by rule a memorandum of understanding to facilitate cooperation between the agencies by establishing joint procedures and describing the actual duties of each agency for the referral, investigation, and resolution of complaints affecting the administration and enforcement of state laws relating to vital statistics and the licensing of funeral directors and funeral establishments.(b) The department adopts by reference 22 TAC §201.16 of the TFSC rules. Source Note: The provisions of this §181.27 adopted to be effective July 3, 2003, 28 TexReg 4904; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.27 Memorandum of Understanding with the Texas Funeral Service Commission https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=209830&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 209830 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=209830&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 209830 03/11/2026 (a) Birth certificates.(1) The State Registrar, Local Registrar, or county clerk shall issue only two types of certified copies:(A) a full reproduction of the legal portion of the original record as filed in their office with any addendum(s); or(B) an abstract of birth facts, taken from the original record. Probate records and delayed records may not be abstracted. An abstract shall be issued in one of three styles:(i) a standard certified abstract;(ii) an electronic or computer generated certified abstract prepared in accordance with Health and Safety Code, §192.005 or §192.011, or when the condition of the original record does not permit full reproduction; or(iii) an heirloom style certified abstract which may only be issued by the State Registrar.(2) Each certified copy of a record, or abstract of birth facts, shall be issued over the signature or facsimile thereof of the officer to whom the record is entrusted, and shall bear the seal of their office, and a statement of certification:(A) either as a part of the custodian's files; or(B) as authorized to be issued from the State Registrar's file.(3) All certified copies of birth records shall include the following information, if known:(A) state or local file number;(B) given name(s);(C) surname;(D) date of birth;(E) state, and city or county of birth;(F) sex;(G) father's name;(H) mother's maiden name;(I) date of filing;(J) date certified copy issued;(K) certification statement;(L) signature or facsimile signature of the custodian; and(M) the seal of their office.(b) Death certificates.(1) The State Registrar, Local Registrar, or county clerk shall issue only two types of certified copies:(A) a full reproduction of the original record and any addenda as filed in their office; or(B) a certified abstract of death facts, taken from the original record.(2) All certified copies of death records shall include:(A) state or local file number;(B) given name(s);(C) surname;(D) date of death;(E) date of birth;(F) state, city or county of death;(G) sex;(H) date of filing;(I) date certified copy issued;(J) certification statement;(K) signature or facsimile signature of the custodian; and(L) the seal of their office.(c) Security features. No certified copy or abstract shall be issued unless the issuing office provides security features in the paper used for issuance. Each sheet or document shall be made on paper which contains as a minimum the following security features in accordance with the security standards adopted by the department:(1) consecutive numbers;(2) background security features;(3) security printing techniques, such as engraved border, latent images, microprinting, rainbow printing, tactile printing, and copy evident;(4) sensitized security paper;(5) security inks, such as erasable inks, fluorescent inks, thermochromic inks, and color shifting inks; and(6) non-optical brightener paper.(d) Record retention. An electronic record or paper application that includes the date issued, document control number, name, address and signature, and a photocopy or facsimile of the form of identification to whom the record was issued shall be made and maintained for a period of three years from the date issued.(e) The Vital Statistics Unit will develop standards for procurement parameters regarding the purchase and distribution of the issuing medium for birth certificates, including paper.(f) The Vital Statistics Unit will explore options regarding establishment of a central database for the issuance of certified copies and abstracts of birth certificates by State and Local Registrars.(g) The Vital Statistics Unit will develop standards to limit access to archived paper birth certificates and set standards for the paper used to print certified copies and abstracts of birth.(h) Properly Qualified Applicant Acceptable Documentation.(1) In accordance with Health and Safety Code, §191.051, "Certified Copies," all lobby and mail-in applications submitted to obtain certified documents must meet the guidelines set out in this rule.(2) All applicants for certified documents must present proof of identity acceptable to the State Registrar.(3) All requests for certified documents must be submitted on a state-approved application or in a format that is acceptable to the State Registrar.(4) All lobby and mail-in applications submitted to obtain certified documents must contain the applicant's signature.(5) All applicants must sufficiently identify the vital record that is of interest at the time of request.(6) All primary identification documents must have a United States issuance origin.(7) All identification documents must be verifiable by the source that issued the document.(8) The Vital Statistics Unit shall retain a photocopy of all documents submitted and accepted as proof of identification in accordance with the retention period in subsection (e) of this section.(9) All applicants must present identification consistent with the following identification requirements:(A) primary identification outlined in paragraph (10) of this subsection; or(B) secondary identification reflected in paragraph (11) of this subsection; and(C) supporting documentation stated in paragraph (12) of this subsection.(10) Primary Identification.(A) Primary Identification documents do not require supporting instruments, unless otherwise specified.(B) All acceptable Primary Identification documents must be current and valid.(C) The applicant's identification must contain the applicant's name and photograph that establishes the applicant's identity.(D) Acceptable forms of Primary Identification:(i) Driver's License;(ii) Federal or State Identification card;(iii) Federal, State or City law enforcement employment identification card, or employment badge accompanied by employment identification card;(iv) Offender Identification card issued by the Department of Criminal Justice correctional facility or institution;(v) Military Identification card;(vi) Department of Homeland Security, United States Citizenship and Immigration Services (USCIS) issued:(I) Employment Authorization Document (EAD);(II) Permanent Resident Card (green card);(III) Travel Documents:(-a-) Re-entry Permit;(-b-) Refugee Travel Permit; or(-c-) Advance Parole.(IV) SENTRI Card; or(V) U.S. Citizen Identification Card.(vii) United States Department of State issued:(I) Border Crossing Card (B1 for business or pleasure or B2 medical purposes); or(II) Visa.(viii) Concealed Handgun License;(ix) Pilot's license; or(x) United States Passport.(11) Secondary identification.(A) In the absence of a form of primary identification, applicants are permitted to submit secondary forms of identification to establish proof of their identity.(B) When submitting secondary forms of identification, applicants are required to produce:(i) two forms of Acceptable Secondary Identification, of different types; or(ii) one form of Acceptable Secondary Identification, plus two forms of Acceptable Supporting Identification of different types.(C) When submitting secondary forms of identification, the documents combined must confirm the identity of the applicant. At least one of the documents must contain the applicant's name, signature, or identifiable photo of the applicant.(D) Acceptable forms of secondary identification:(i) Current student identification;(ii) Any Primary Identification that is expired;(iii) Signed Social Security card, or Numident;(iv) DD Form 214 Certificate of Release;(v) Medicaid card;(vi) Medicare card;(vii) Veterans Affairs card;(viii) Medical insurance card;(ix) Foreign Passport accompanied by a Visa issued by the United States Department of State;(x) Foreign Passport in accordance with the United States Department of State, Visa Waiver Program;(xi) Certified birth certificate from the Department of State (FS-240, DS-1350 or FS-545);(xii) Private Company Employment Identification card;(xiii) Form I-94 - accompanied by the applicant's Visa or Passport;(xiv) Mexican voter registration card; or(xv) Foreign Identification with identifiable photo of applicant.(12) Supporting Identification--Other records or documents that verify the applicant's identity. The Vital Statistics Unit refers to their policy for acceptable supporting identification. The examining or supervisory personnel may determine that a supporting identification document may meet the department's requirements in establishing identity. Source Note: The provisions of this §181.28 adopted to be effective March 16, 1995, 20 TexReg 1559; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896; amended to be effective August 21, 2022, 47 TexReg 4985. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.28 Instructions and Requirements for Issuance of Certified Copies of Vital Records by the State Registrar, Local Registrar, or County Clerk https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162927&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162927 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162927&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162927 03/11/2026 (a) Purpose. The purpose of this section is to establish guidelines for the procedure of filing adoptions for residents of the State of Texas who adopt children in foreign countries.(b) A certified copy of the decree of adoption granted in a foreign country and information with translation into the English language relating to the adoptive parent(s) and adoptee should be submitted to a court of competent jurisdiction of this state for validation. It is the responsibility of the applicant(s) to have all required documents translated into the English language. An official certificate of adoption must be prepared and submitted to the Vital Statistics Unit by the clerk of the court validating the foreign adoption.(c) Certificate of birth. The State Registrar shall prepare a new certificate of birth for a person born in a foreign country, and adopted under the laws of a foreign country or under the laws of this state, when the State Registrar receives the following from a resident of this state:(1) a request by the resident adoptive parent(s) to file a new certificate of birth in the adoptive parent(s') names;(2) an official certificate of adoption prepared and filed in accordance with the laws of this state by the court which registered or validated the adoption; and(3) payment of all applicable fees.(d) Guidelines. The State Registrar shall use the following guidelines when preparing a new certificate of birth.(1) The State Registrar shall not alter or change the place of birth or the date of birth from the information contained in the documentation presented.(2) The new certificate shall be prepared on the current certificate form in the same manner as an in-state adoption is prepared and reflect the foreign country of birth.(3) As prescribed in the Health and Safety Code, §192.008, all documentation used to prepare the new certificate of birth shall be placed in a sealed file and accessed by an applicant only upon presentation of a certified copy of an order from the Texas district court that validated the foreign adoption.(4) Once a file is sealed, a standard fee shall be charged for a search for a file and any copies of records issued as prescribed in Health and Safety Code, §191.0045.(e) Exceptions. The guidelines, as stated in subsection (d) of this section, do not apply if a child was born in a foreign country and was a citizen of the United States at the time of birth. This record may only be processed by the United States Department of State. Source Note: The provisions of this §181.29 adopted to be effective July 17, 1995, 20 TexReg 4687; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.29 Foreign Adoptions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206796&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206796 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206796&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206796 03/11/2026 (a) An amending certificate (medical amendment) may be filed with the appropriate Local Registrar or State Registrar electronically through a Vital Statistics Section electronic death registration system to complete or correct medical certification information on a certificate of death that is incomplete or inaccurate. The medical amendment must be in a format as prescribed by the department.(b) Once the original death certificate is registered, if a justice of the peace (JP) or medical examiner's office (ME) has subsequently conducted an inquest as authorized by the Code of Criminal Procedure, Chapter 49, the medical amendment may be filed by the JP or ME that conducted the inquest.(c) The registrar shall carefully examine each medical amendment when presented for registration to determine if it is complete as required by the State Registrar's instructions.(d) If the medical amendment is incomplete or unsatisfactory, the registrar shall call attention to the error or omission in the return.(e) The registrar shall number the medical amendment with the same file number assigned to the original death certificate. The Local Registrar shall sign each medical amendment to attest to the date the amendment is filed in the Local Registrar's office. The signature may be either electronic, handwritten or a facsimile stamp. The medical amendment shall be attached to and become a part of the legal record of the death if the amendment is accepted for filing.(f) The registrar shall duplicate the medical amendment as authorized by the Local Government Code, Chapters 201 or 204. The duplicate shall be permanently preserved in the Local Registrar's office as the local record, in the manner directed by the State Registrar.(g) The registrar shall forward all original non-electronic, medical amendments to the State Registrar within 10 days of filing. Source Note: The provisions of this §181.30 adopted to be effective August 9, 1998, 23 TexReg 7810; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896; amended to be effective November 24, 2021, 46 TexReg 7884. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.30 Instructions and Requirements for Filing of Amendments to Medical Certification of Certificate of Death with a Local Registrar https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162929 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162929 03/11/2026 (a) The court that renders a decree of adoption shall send to the Vital Statistics Unit a certificate of adoption on Form VS-160. The clerk of the court shall send the form not later than the 10th day of the first month after the month in which the court renders the adoption decree. The certificate shall include the information as prescribed in Texas Family Code, §108.003.(b) When the Vital Statistics Unit determines that a certificate of adoption filed with the State Registrar requires correction, the Vital Statistics Unit shall mail the certificate directly to the attorney of record for correction. Upon correction, the attorney shall return the corrected certificate to the Vital Statistics Unit. If there is no attorney of record, the Vital Statistics Unit shall mail a photocopy of the certificate to the clerk of the court for correction.(c) When the clerk of the court collects the $15 fee required by the Texas Family Code, §108.006(b), for each adoption petition filed, the clerk shall attach the fee to the certificate of adoption(s), and forward to the Vital Statistics Unit, as provided in subsection (a) of this section to Vital Statistics Unit - Mail Code 2096, P.O. Box 12040, Austin, Texas 78711-2040. Source Note: The provisions of this §181.31 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.31 Minimum Requirements for Adoption Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162930&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162930 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162930&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162930 03/11/2026 (a) At or prior to the time a child-placing agency ceases to function as a child-placing agency, it shall notify the Texas Department of State Health Services-Vital Statistics Unit, where its adoption records shall be kept for permanent safekeeping.(b) The Vital Statistics Unit maintains many records of closed adoption agencies and is one entity a child-placing agency may designate to preserve its adoption records. An agency may also designate another Texas licensed child-placing agency to preserve its records.(c) If a child-placing agency designates the Vital Statistics Unit to house its records, the agency shall assume the responsibility of shipping the records to a designation specified by the Vital Statistics Unit. The agency must ensure that the records are free from insects and rodents, and mildew-free and dry. The records shall be shipped in sturdy cardboard boxes (no larger than 12 inches x 15 inches) via an insured carrier.(1) Each record series shall be alphabetized by the birth mother's maiden name or the birth mother's name at the time of relinquishment. The adoptive parents' file and the child's file shall be placed behind the birth mother's file. Each file shall include the birth mother's name as a cross-reference. Staples, paper clips and brackets shall be removed.(2) The agency must provide two index cards for each adoption file, one that cross-references the birth mother's name with the adoptive parents' and adoptee's name, and one cross-referencing the adoptive parents' names with the birth mother's and adoptee's name. Each card must include the date of birth of each child and the child's adoptive name. The information may also be provided electronically in a format compatible or acceptable to the Vital Statistics Unit's standards.(d) If the child-placing agency designates the Vital Statistics Unit to maintain and preserve its records, a redacted or de-identified copy of the birth and/or adoption record shall be prepared by the Vital Statistics Unit for a qualified requestor under the Texas Family Code, §162.018, Access to Information. Charges for copies shall be as allowed by the Open Records Act, Government Code, Chapter 552.(e) If a birth relative provides post-adoption medical or social information to the Vital Statistics Unit and the Vital Statistics Unit houses the records of the closed child-placing agency, the Vital Statistics Unit may place the information with the original child-placing agency's file. If a birth relative provides post-adoption medical or social information to the Vital Statistics Unit, the adoption occurred outside of a licensed child-placing agency, and the Vital Statistics Unit readily identifies the sealed adoption file, the Vital Statistics Unit shall place the updated information in the Health, Social, Education and Genetic History record series in the date received and cross-referenced in the Vital Statistics Unit's database.(1) The Vital Statistics Unit shall make a diligent effort to locate the last known address of the adoptive parents and attempt to inform them of their right to examine the redacted or de-identified portion of the record.(2) Upon request of a qualified requestor under Texas Family Code, §162.006, Right to Examine Records, the information will be prepared and redacted or de-identified for release to that person.(f) If a child is biologically unrelated to the prospective adoptive parents and placed outside of a licensed child-placing agency, the adopting attorney shall provide to the Vital Statistics Unit a copy of the Health, Social, Education and Genetic History report (HSEGH) as prescribed by the Family Code. Within a reasonable amount to time, the Vital Statistics Unit shall provide a certificate to the adopting attorney acknowledging receipt of the report.(g) International adoptions. If a child born in a foreign country is placed with prospective adoptive parent(s) who reside in this state and the child is being adopted in this state, the adopting attorney shall file a HSEGH with the Vital Statistics Unit along with all foreign documents relating to the child's history prior to being placed for adoption, along with each document's English translation. If no information is available about the child prior to placement with its prospective adoptive parent(s), the adopting parents may state that no other information except for the aforementioned documents is available concerning the child's background.(h) The HSEGH report as described in subsections (e)-(g) of this section shall be legible and ready for microfilming or scanning. Source Note: The provisions of this §181.32 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.32 Maintenance of Out-of-Business Child-Placing Agency Records and Health, Social, Educational and Genetic History Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162931&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162931 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162931&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162931 03/11/2026 (a) Catastrophe is defined in the Health and Safety Code, §193.010.(b) When catastrophe is deemed the cause of death, the Local Registrar shall prepare and file the certificate of death.(c) The Local Registrar shall only prepare and file a certificate of death caused by catastrophe if:(1) the body has not been found; and(2) an affidavit has been submitted to the Local Registrar according to the guidelines set forth in the Health and Safety Code, §193.010(b), and the affiant has followed the specific criteria laid out in Health and Safety Code, §193.010(b).(d) The Vital Statistics Unit may prepare and file a certificate of death by catastrophe for a minor or a person for whom a guardian has been appointed who is the subject of a custody or guardianship dispute only if all parties to the dispute submit an affidavit under the Health and Safety Code, §193.010(b).(e) A registrar completing a certificate of death that is a death by catastrophe shall complete the cause of death information as follows.(1) Type the words, "Death by Catastrophe" in item number 33, Part 1a.(2) Do not complete the rest of item 33.(3) Complete items 36 through 39 if known.(4) Items 40a through 40f and 41 must be completed on all certificates of death by catastrophe. Source Note: The provisions of this §181.33 adopted to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.33 Instructions and Requirements for Registering a Certificate of Death by Catastrophe https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162932&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162932 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162932&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162932 03/11/2026 (a) Healthcare facilities in this state at which assisted reproduction procedures are performed under gestational agreements must report reproduction procedures under gestational agreements and the current status of embryos created for said procedures on the Report of Assisted Reproduction Procedures Under Gestational Agreements.(b) The Vital Statistics Unit in accordance with the guidelines of Texas Family Code, §160.763 shall prescribe the form and content of the reporting form.(c) Reporting healthcare facilities must submit this report to the Vital Statistics Unit on a yearly basis.(d) The reporting form must be submitted no later than January 31st for the previous calendar year. Source Note: The provisions of this §181.34 adopted to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS B VITAL RECORDS §181.34 Instructions and Requirements for Reporting Assisted Reproduction Procedures Performed by a Health Care Facility Under a Gestational Agreement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=102999&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 102999 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=102999&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 102999 03/11/2026 (a) An agency, licensed by the Texas Department of Protective and Regulatory Services (PRS) which applies the minimum standards and guidelines for child-placing agencies to place children for adoption, or an association of those agencies, that was in existence on or before January 1, 1984, may establish or operate a voluntary adoption registry, but only in compliance with the Texas Family Code, §§162.401 - 162.422.(b) The bureau shall operate a Central Adoption Registry in compliance with the Texas Family Code, §§162.401-162.422.(c) An adoptee, a birth parent or a biological sibling may register with the registry of the agency through which the adoptee was adopted or placed for adoption and with the Central Adoption Registry. If the client initially registers with the child-placing agency's registry, that registry shall forward a copy of the registrant's application, along with appropriate identification, to the Central Adoption Registry. Source Note: The provisions of this §181.41 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS C CENTRAL ADOPTION REGISTRY §181.41 Mutual Consent Voluntary Adoption Registries https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162934&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162934 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162934&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162934 03/11/2026 (a) At the time an adoption order is rendered, the district court that grants the adoption shall provide to the adoptive parents information provided by the Vital Statistics Unit describing the functions of voluntary adoption registries. If the adopted child is 14 years of age or older, the court shall provide the information to the child.(b) A licensed child-placing agency shall provide to each of the adopted child's known biological parents similar information when the parent signs an affidavit of relinquishment of parental rights, an affidavit of status of child, or an affidavit of waiver of interest in a child.(c) The information shall include the right of the child or biological parent to refuse to participate in the registry. Source Note: The provisions of this §181.42 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS C CENTRAL ADOPTION REGISTRY §181.42 Adoption Information by the Courts or Child-Placing Agencies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162935&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162935 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162935&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162935 03/11/2026 (a) An authorized voluntary adoption registry shall send to the Central Adoption Registry (CAR) duplicate information of all registrant information it maintains in its registry. This includes all registrant file information and Form VS - 2271. The child-placing agency's adoption case files are not needed, unless the information contained in those files provides information to benefit or aid the match process. Registrant information shall also include proof of age and identity of each registrant, and all known names, dates of birth, and places of birth of each person for whom the registrant is searching, if known. Subsequent documentation including address changes of the registrant received by the registry shall be forwarded to the CAR.(b) Registrant information obtained by a registry on or after June 1, 1999, shall be forwarded to the CAR by the 15th day of the following month after the registration application becomes active.(c) If a match is identified by the CAR between two applicants, and one of the applicants is registered only with an authorized registry and not the CAR, the CAR shall notify that agency's registry and confirm the biological relationship. The CAR shall then notify the applicant who is registered with the CAR that a match has been made and allow the applicant to either decide to register with the other matching registry or to request matching procedures with only the CAR. If the latter is chosen, the CAR shall provide to the agency's registry copies of all documentation used during and up to the release of identifying information. If the applicant who is registered only with the CAR requests matching procedures with the agency's registry, then the CAR shall release any documentation necessary for the agency's registry to coordinate the release of identifying information. The registry shall provide to the CAR copies of all documentation used during and up to the release of identifying information. Source Note: The provisions of this §181.43 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS C CENTRAL ADOPTION REGISTRY §181.43 Requirement to Send Information to the Central Adoption Registry and the Coordination of the Release of Identifying Information with an Authorized Registry https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162936&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162936 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162936&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162936 03/11/2026 (a) The Vital Statistics Unit charges a fee of $5.00 to determine if a child-placing agency that operates its own registry was involved in a specified adoption. An eligible applicant may send the inquiry, along with the appropriate fee and proof of age and identity to the Vital Statistics Unit - Mail Code 2096, Attention: Central Adoption Registry (CAR), P.O. Box 140123, Austin, Texas 78714-0123 or may inquire in person at the Vital Statistics Unit, 1100 West 49th Street, Austin, Texas.(b) Each applicant must provide proof of age and identity, in the form of a photo ID and, if the applicant's name has changed due to marriage, a copy of his or her birth certificate or marriage certificate. If the applicant is a birth sibling, a copy of his/her birth certificate must be included. If his or her name has been legally changed, a certified copy of the court order verifying the name change shall accompany the request.(c) The CAR shall provide the child-placing agency's name, address, telephone number, and E-mail address, if appropriate, if that agency operates its own registry to which a person may apply. If the CAR finds inconclusive information to determine which agency handled the adoption, the person is entitled to apply only to the CAR. Source Note: The provisions of this §181.44 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS C CENTRAL ADOPTION REGISTRY §181.44 Inquiry through the Central Index https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162937&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162937 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162937&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162937 03/11/2026 (a) To register with the Central Adoption Registry (CAR) or any other authorized registry as defined in Texas Family Code, §162.403(b), a person must comply with the following requirements:(1) complete registration form (VS - 2271) and any other information the authorized registry deems necessary to identify the person(s) the applicant is searching for. Form VS - 2271 shall provide a space to include the registry's mailing address if different than the CAR; and(2) provide proof of age and identity, in the form of a government-issued photo ID and, if the applicant's name has changed due to marriage, a copy of his or her birth certificate or marriage certificate. If the applicant is a birth sibling, a copy of his/her birth certificate shall be included. If his or her name has been legally changed, a certified copy of the court order shall accompany the registration form; and(3) meet the eligibility requirement for registration in the Texas Family Code, §162.406.(b) If the applicant is a male birth parent, he may register, but will not be recognized as a birth parent unless:(1) the birth mother in her application to the registry names him as the biological father and other information on the adoptee is consistent with the father's claim of paternity;(2) he was adjudicated as or presumed to be the biological father under Texas Family Code, Chapter 160; or(3) he signed a consent to adoption, affidavit of relinquishment, affidavit of waiver of interest in the child, or other written instrument releasing the child for adoption. If he signed a document or other instrument denying or refusing to admit paternity, he shall not be recognized as a birth parent.(c) A registrant's application will be reviewed within 45 days after the date the application is received. If accepted, an application is valid for 99 years unless a shorter period is specified or the registration is withdrawn. Source Note: The provisions of this §181.45 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904; amended to be effective July 22, 2004, 29 TexReg 6936; amended to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS C CENTRAL ADOPTION REGISTRY §181.45 Registration in the Voluntary Adoption Registry System https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103003&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103003 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103003&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103003 03/11/2026 (a) If the administrator of any authorized voluntary adoption registry matches a registrant with another registrant, each registrant shall be notified by certified mail, return receipt requested and delivery restricted to addressee only, that a match has been made. The notice shall state the sex and type of birth relative the registry has matched with the adoptee.(b) The notification must also state that the registrant:(1) may withdraw his registration before identifying information is released;(2) must sign a consent to disclosure;(3) must participate in at least one hour of counseling with a social worker or mental health professional who has expertise in postadoption counseling to prepare the registrant for the reunion. A mental health professional must have at least a bachelor's degree from an accredited college with a major in social work, psychology, sociology, counseling or other related field. The mental health professional is not required to be licensed in the field of mental health, but must have expertise in postadoption counseling;(4) must prove that the counseling requirement has been completed by requesting written notification which includes a brief synopsis of the counseling provided and the counselor's recommendations; and(5) provide any other information that the registry deems appropriate for the success of the reunion. Source Note: The provisions of this §181.46 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS C CENTRAL ADOPTION REGISTRY §181.46 Notification of a Match and Requirements for Release of Information by Participating Voluntary Adoption Registries https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103005&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103005 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103005&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103005 03/11/2026 (a) Each authorized adoption registry shall ensure that the confidentiality of the records in the registry shall be maintained and may not be disclosed except in the manner authorized by the Family Code, Chapter 162.(b) The administrator of any authorized adoption registry releases identifying information to registrants, who have not withdrawn their registrations and who have consented in writing to disclosure. Disclosure may include the registrant's information.(c) If the registrant is a birth parent, is deceased at the time the match has been made, and consented to the postdeath disclosure of identity, information may be released provided that:(1) each child of the deceased birth parent is an adult; or(2) the surviving parent, guardian, managing conservator or legal custodian of each child has consented in writing to the release of information.(d) If a match cannot be made because of the death of an adoptee, a birth parent or biological sibling who has not registered or who registered and did not agree to the postdeath disclosure, the Central Adoption Registry shall notify the affected registrant. If appropriate, the registry may disclose nonidentifying information concerning the cause of death, any underlying causes leading up to the cause of death and other non-identifying information about the deceased. Source Note: The provisions of this §181.47 adopted to be effective March 4, 1999, 24 TexReg 1618; amended to be effective July 3, 2003, 28 TexReg 4904. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS C CENTRAL ADOPTION REGISTRY §181.47 Confidentiality and Release of Information by All Voluntary Adoption Registries https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162938&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162938 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162938&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162938 03/11/2026 The purpose of this subchapter is to establish certification requirements for the person required to register the birth of a child in this state as set forth by Health and Safety Code, Chapter 192, Subchapter A, General Registration Provisions. The person required to register the birth of a child in this state must meet the requirements of the birth registrar certification and must abide by the rules of this subchapter. Source Note: The provisions of this §181.50 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS D BIRTH REGISTRATION CERTIFICATION §181.50 Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162939&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162939 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162939&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162939 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Acknowledgment of Paternity Training--Training from the Office of the Attorney General as prescribed in 1 TAC Chapter 55, concerning Child Support Enforcement.(2) Application for Birth Registrar Certification/Re-certification--An online application prescribed and provided by the Vital Statistics Unit to assess the knowledge and skills of a birth registrar.(3) Birth registrar--Person responsible for filing a birth certificate as prescribed in Health and Safety Code, §192.003(a) and (b).(4) Birth Registrar Certification (BRC)--A certification program required for all birth registrars.(5) Certification period--The certification period two years from certification date.(6) Continuing education--Educational training that contributes to the advancement, extension, and enhancement of the professional skills and knowledge of the birth registrar in the practice of registering births in this state and be open to all birth registrars.(7) Hour of continuing education--A 50 minute clock hour completed by a birth registrar in attendance at an approved continuing education program.(8) Midwife--An individual currently licensed under the Texas Board of Nursing as an Advanced Practice Registered Nurse as defined in 22 TAC Chapter 222, or an individual currently licensed with the Texas Midwifery Board to legally practice midwifery in this state.(9) Physician--An individual currently licensed under the Texas Medical Board to actively practice medicine in this state.(10) Texas Electronic Registrar (TER) - Birth Registration Online Training Course--An online birth training provided by the Vital Statistics Unit. Source Note: The provisions of this §181.51 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS D BIRTH REGISTRATION CERTIFICATION §181.51 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162940&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162940 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162940&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162940 03/11/2026 (a) Certification Required. A birth registrar may not complete any aspect of the birth registration process without holding a current certification issued by the Vital Statistics Unit.(b) Certification Process. Certification for Birth Registrars requires the completion of the following:(1) Acknowledgment of Paternity training course;(2) TER--Birth Registration online training course;(3) be a TER user with an individual User Identification and password;(4) oath of confidentiality (on file at facility);(5) a completed Application for Birth Registrar Certification/Re-certification; and(6) physicians, midwives or persons acting as midwives must provide current licensing information with their respective licensing bodies.(c) Re-certification Process. Birth registrars who actively register births in this state are required to obtain 8 hours of continuing education every two-year renewal period.(d) The certification renewal period issued under subsection (a) of this section is two years beginning on the 1st day of the month following the issuance of the certification to the birth registrar.(e) Birth registration processes occurring at facilities or by midwives may be inspected upon the submission of an Application for Birth Registrar Certification/ Re-certification.(f) Certain Grounds for Denial or Revocation of a Certification are as follows. The Vital Statistics Unit may refuse to issue a new certification or to renew a certification or may revoke a certification of a birth registrar if it determines that the certification application contains false information, or has violated the electronic registration user agreement as prescribed by §181.13 of this title (relating to Birth Certificate Form and Consent). Source Note: The provisions of this §181.52 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS D BIRTH REGISTRATION CERTIFICATION §181.52 Certification Requirements and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162941&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162941 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162941&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162941 03/11/2026 (a) Purpose. Each birth registrar holding an active certification and registering births in this state is required to participate in continuing education as a condition of certification renewal.(b) Credit hours required.(1) Birth registrars who actively register births in this state are required to obtain 8 hours of continuing education every two-year renewal period. A birth registrar may receive credit for a course only once during a renewal period.(2) The following are mandatory continuing education hours and subjects for each renewal period.(A) Electronic Registration - 1 credit hours. This course must at least cover principals of electronic birth registration for this state.(B) Other training - 7 credit hours. These approved courses should cover laws, rules, best practices, policies and procedures relevant to the registration of births in this state.(3) It is the responsibility of the licensee to track the number of hours accumulated during a certification period.(4) Failure to comply. The Vital Statistics Unit will not renew the certification of an individual who fails to obtain the continuing education requirements of this section.(5) Any birth registrar receiving credit for continuing education obtained fraudulently shall be reported and/or investigated by the State Registrar or the State Registrar's representative and, if necessary, shall report a violation of this section to the appropriate district or county attorney for prosecution. Source Note: The provisions of this §181.53 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS D BIRTH REGISTRATION CERTIFICATION §181.53 Continuing Education https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162942&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162942 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162942&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162942 03/11/2026 (a) Each birth registrar must complete an online Application for Birth Registrar Certification/Re-Certification provided by the Vital Statistics Unit.(b) The completed Application for Birth Registrar Certification/Re-Certification must be submitted, along with the other certification requirements set forth by this subchapter, on or before the end of the certification renewal period.(c) Each birth registrar must permanently retain a completed copy of the Application for Birth Registrar Certification/Re-Certification. This retention may be in an electronic format.(d) Birth registrars knowingly making a false statement on the Application for Birth Registrar Certification/Re-Certification will be subject to immediate revocation of their certification and have their electronic registration privileges revoked. Source Note: The provisions of this §181.54 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS D BIRTH REGISTRATION CERTIFICATION §181.54 Application for Birth Registrar Certification/Re-Certification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162948&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162948 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162948&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162948 03/11/2026 (a) When a certificate of birth of a person born in this state has not been registered before the one-year anniversary of the date of birth, a delayed certificate of birth may be submitted in accordance with regulations of the Vital Statistics Unit. No delayed certificate of birth shall be registered until the evidentiary requirements as specified in regulation have been met.(b) A certificate of birth submitted under this section shall be marked "Delayed" and show the date of registration. The delayed certificate of birth shall contain a summary statement of the evidence submitted in support of the delayed registration. Probate records and delayed records may not be abstracted.(c) An application to file a delayed certificate of birth for a birth in this state not registered before the one-year anniversary of the date of birth shall be made to the State Registrar.(d) No delayed certificate of birth shall be registered for a deceased person.(e) When an applicant as defined by regulation does not submit the minimum documentation required in the regulations for delayed registration or when the State Registrar has cause to question the validity or adequacy of the applicant's (sworn, notarized, witnessed) statement or the documentary evidence, and if the deficiencies are not corrected, the State Registrar shall not register the delayed certificate of birth. The State Registrar shall advise the applicant of the reasons for this action, and shall further advise the applicant of his or her right to file a petition in the county probate court of the county in which the birth occurred for an order establishing a record of the person's date of birth, place of birth, and parentage.(f) The State Registrar may provide for the dismissal of an application that is not actively pursued. Source Note: The provisions of this §181.60 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS E DELAYED REGISTRATION §181.60 Delayed Certification of Birth https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162943&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162943 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162943&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162943 03/11/2026 (a) Any person 18 years of age or older born in the State of Texas whose birth is not recorded in this state may request the registration of a delayed certificate of birth, subject to these regulations and instructions issued by the State Registrar. The information on the form must be subscribed and sworn to, before an official authorized to administer oaths, by:(1) the person whose birth is to be registered; or(2) the person's parent, legal guardian, or legal representative if the person is incompetent to swear to the information.(b) Each application for a delayed certificate of birth shall be signed and sworn to, before an official authorized to administer oaths, by the person whose birth is to be registered if such person is 18 years of age or over and is competent to sign and swear to the accuracy of the facts stated therein; otherwise the application shall be signed and sworn to by the person's parent, legal guardian, or legal representative if the person is incompetent to swear to the information. Source Note: The provisions of this §181.61 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS E DELAYED REGISTRATION §181.61 Who May Request the Registration of a Delayed Certificate of Birth https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214248&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214248 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214248&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214248 03/11/2026 (a) To be acceptable for registration:(1) the name of the person at the time of the birth and the date and place of birth entered on a delayed registration of birth shall be supported by at least:(A) two documents, only one of which may be an affidavit of personal knowledge, if the birth occurred at least four years but less than 15 years before the date of the application; or(B) three documents, only one of which may be an affidavit of personal knowledge, if the birth occurred 15 or more years before the date of the application; and(2) at least one piece of acceptable documentary evidence shall establish to the satisfaction of the State Registrar the name of at least one parent.(b) The State Registrar shall determine the acceptability of all documentary evidence submitted.(1) Documents must be from independent sources and shall be in the form of the original record or a duly certified copy thereof or a signed statement from the custodian of the record or document.(2) Documents may include but are not limited to:(A) census records;(B) hospital records;(C) military records;(D) Social Security records;(E) school records; or(F) other documents as designated by the State Registrar.(3) For persons 15 years of age or older, all documents submitted in evidence, other than an affidavit of personal knowledge, must be at least five years old.(4) At least one document submitted in evidence should have been created within the first 10 years of life.(5) Documents shall not contain contradictory information regarding the person's name, date of birth, and place of birth. The identity of at least one parent must be established by information that does not contradict any other information available to the State Registrar. If documents contain contradictory information regarding a second parent, and the delayed certificate of birth is accepted for registration, then no information for the second parent will be recorded on the certificate. Source Note: The provisions of this §181.62 adopted to be effective August 11, 2013, 38 TexReg 4896; amended to be effective July 18, 2023, 48 TexReg 3911. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS E DELAYED REGISTRATION §181.62 Documentary Evidence; Requirements and Acceptability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162945&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162945 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162945&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162945 03/11/2026 (a) The State Registrar or his or her designated representative shall abstract on the delayed certificate of birth a description of each document submitted to support the facts. This description shall include:(1) the title or description of the document;(2) the name and address of the custodial organization, if any;(3) the creation date of the original document; and(4) all birth facts required by §181.62 of this title (relating to Documentary Evidence; Requirements and Acceptability) contained in each document accepted as evidence.(b) Original documents submitted in support of the delayed certificate of birth shall be returned to the applicant after review. Copies of all items submitted shall be maintained and indexed by the State Registrar. Source Note: The provisions of this §181.63 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS E DELAYED REGISTRATION §181.63 Abstraction of Documentary Evidence https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162946&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162946 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162946&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162946 03/11/2026 The State Registrar, or his or her designated representative, shall verify:(1) that no prior certificate of birth is registered in this state for the person whose birth is to be recorded;(2) that he or she has reviewed the evidence submitted to establish the facts of birth; and(3) that the abstract of the evidence appearing on the delayed certificate of birth accurately reflects the nature and content of the document. Source Note: The provisions of this §181.64 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS E DELAYED REGISTRATION §181.64 Verification by the State Registrar https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162947&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162947 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=162947&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 162947 03/11/2026 An application for a delayed certificate of birth that has not been completed within one year from the date of application may be dismissed at the discretion of the State Registrar. Upon dismissal, the State Registrar shall so advise the applicant and documents submitted in support of such registration shall be returned to the applicant. Source Note: The provisions of this §181.65 adopted to be effective August 11, 2013, 38 TexReg 4896. 1 DEPARTMENT OF STATE HEALTH SERVICES 181 VITAL STATISTICS E DELAYED REGISTRATION §181.65 Dismissal After One Year https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197377&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197377 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197377&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197377 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) AHRQ--Agency for Healthcare Research and Quality.(2) Ambulatory surgical center--A facility licensed under Texas Health and Safety Code, Chapter 243.(3) CMS--Centers for Medicare and Medicaid Services under the United States Department of Health and Human Services.(4) Comments--Notes or explanations submitted by the health care facilities concerning the department's compilation and summary of the facilities' data that is made available to the public as described in the Texas Health and Safety Code, §98.106.(5) Data--Facility and patient level information reported to the department for the purposes of monitoring health care-associated infections and preventable adverse events.(6) Data summary--Facility level information prepared by the department for each health care facility required to report in this state to facilitate comparisons of risk-adjusted infection rates and preventable adverse events.(7) Department--Department of State Health Services.(8) Device days--The number of patients in a special care setting who have one or more central lines for each day of the month, determined at the same time each day of the reporting quarter.(9) Facility contact--Person identified by the health care facility responsible for coordinating communications related to data submission, verification and approval of data summary.(10) Facility Identification Number--The unique, distinguishable, uniform number used to identify each health care facility.(11) Fall--A sudden, unintended, uncontrolled downward displacement of a patient's body to the ground or other object.(12) General hospital--A hospital licensed under Texas Health and Safety Code, Chapter 241, or a hospital that provides surgical or obstetrical services and that is maintained or operated by the state.(13) Great vessels--Primary blood vessels to include aorta, pulmonary artery, superior vena cava, inferior vena cava, brachiocephalic veins, internal jugular veins, subclavian veins, external iliac veins, common femoral veins, and in neonates, the umbilical artery or umbilical vein.(14) HAI--Health care-associated infection. Localized or symptomatic condition resulting from an adverse reaction to an infectious agent or its toxins to which a patient is exposed in the course of the delivery of health care to the patient.(15) HAI data--Patient level information identifying the patient, procedures and events required by this chapter, infections resulting from those procedures or events, and causative pathogens when laboratory confirmed.(16) Health care facility or facility--A general hospital or ambulatory surgical center.(17) ICD-CM--The International Classification of Diseases, Clinical Modification that is used to code and classify morbidity data from the inpatient and outpatient records of hospitals, ambulatory surgical centers, and physician offices.(18) Incident--A patient safety event that reached the patient, whether or not the patient was harmed.(19) Inpatient -An admission to an acute care hospital for medical treatment as defined by the NHSN.(20) Mild Harm--Bodily or psychological injury results in the minimal symptoms or loss of function, or injury limited to the additional treatment, monitoring and/or increased length of stay.(21) Moderate Harm--Bodily or psychological injury adversely affecting functional ability or quality of life, but not at the levels of severe harm.(22) Near Miss--A patient safety event that did not reach the patient.(23) NHSN--Centers for Disease Control and Prevention's National Healthcare Safety Network or its successor.(24) NHSN-reported PAE--A preventable adverse event as defined by NQF or CMS which is reported through NHSN.(25) NQF--National Quality Forum.(26) No Harm--A patient safety incident that reached the patient, but no harm was evident.(27) PSO--Patient safety organization.(28) Pressure Ulcer--Localized injury to the skin and/or underlying tissue that usually occurs over a bony prominence as a result of pressure, or pressure in combination with shear and/or friction.(29) PAE--Preventable adverse event. Examples of PAEs are given in Texas Health and Safety Code, §98.1045.(30) Reporting quarters--First quarter: January 1 through March 31; Second quarter: April 1 through June 30; Third quarter: July 1 through September 30; Fourth quarter: October 1 through December 31.(31) Risk adjustment--A statistical method to account for a patient's severity of illness and the likelihood of development of a health care-associated infection (e.g., duration of procedure in minutes, wound class, and American Society of Anesthesiology (ASA) score).(32) SRE--Serious Reportable Event. Also known as a "never event."(33) Severe Harm--Bodily or psychological injury that interferes significantly with the functional ability or quality of life.(34) TxHSN--Texas Health Care Safety Network.(35) TxHSN-reported PAE--A preventable adverse event as defined in §200.7 of this title (relating to Schedule for HAI and PAE Reporting) reported through the TxHSN portal or its successor.(36) Validation--The process of comparing data received by the department to original patient and facility records to ascertain the accuracy of reported data compared to the case definition.(37) Verification--Review of data submitted electronically to assure completeness and internal consistency. Source Note: The provisions of this §200.1 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective January 18, 2015, 40 TexReg 245; amended to be effective January 1, 2020, 44 TexReg 7713. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197378&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197378 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197378&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197378 03/11/2026 (a) All general hospitals and ambulatory surgical centers in operation during any part of a reporting quarter described in §200.1 of this title (relating to Definitions) shall submit HAI data, including whether the HAI contributed to a patient's death, and the death of a patient as specified in §§200.3 - 200.7 of this title (relating to How to Report; Which Events to Report; Data to Report; When to Initiate Reporting; and Schedule for HAI and PAE Reporting) to NHSN. PAE information as specified in §200.6 of this title shall be reported via the TxHSN portal or its successor.(b) Facilities that fail to comply with reporting requirements are subject to the enforcement provisions of Texas Health and Safety Code, Chapter 98, Subchapter D.(c) HAI or PAE data submission does not constitute the report of a disease as defined and required in Chapter 97 of this title (relating to Communicable Diseases).(d) HAI, including whether the HAI contributed to a patient's death, or PAE data submission does not constitute annual events or incident reporting as defined in §133.49 of this title (relating to Reporting Requirements), or §135.26 of this title (relating to Reporting Requirements).(e) The facility shall ensure that the department has accurate email and phone information for a facility contact. The facility shall ensure that communications from the department are continuously monitored even if the position is vacant for any reason (vacation, illness, etc.). Source Note: The provisions of this §200.2 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective September 17, 2014, 39 TexReg 7340; amended to be effective January 18, 2015, 40 TexReg 245; amended to be effective January 1, 2020, 44 TexReg 7713. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.2 General Reporting Guidelines for Health Care-Associated Infection and Preventable Adverse Event Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197379&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197379 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197379&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197379 03/11/2026 (a) Facilities shall submit HAI and NHSN-reported PAEs, including whether the HAI or NHSN-reported PAE contributed to a patient's death to NHSN. Health care facilities shall report TxHSN-reported PAEs through the TxHSN portal or its successor.(b) Facilities shall comply with the process prescribed by this chapter and NHSN to allow the department access to HAI data, including whether the HAI contributed to a patient's death, and/or designated PAE data as specified in §§200.3 - 200.7 of this title (relating to How to Report; Which Events to Report; Data to Report; When to Initiate Reporting; and Schedule for HAI and PAE Reporting).(c) Facilities shall use their facility identification number to identify their facility in the electronic data and correspondence with the department. Each facility meeting the definition of ambulatory surgical center or general hospital as defined in §200.1(2) and (12) of this title (relating to Definitions) shall have its own facility identification number.(1) CMS certified health care facilities shall use the CMS-assigned provider number.(2) If a facility has multiple campuses associated by ownership, each site shall each use a unique CMS provider number. In the event that a facility is not CMS certified or a facility operates multiple facilities under one CMS number, the facility shall use the identification number assigned by NHSN.(3) The relationship between CMS-assigned and NHSN-assigned facility identifiers and the name and license number of the facility is public information.(d) The department shall notify the facility contact by email 90 calendar days in advance of any change in requirements for reporting HAI data, including whether the HAI contributed to a patient's death, and designated PAE data.(e) Facilities shall report PAE data as defined in §200.4 and §200.6 of this title.(1) For HAI reporting, if the facility treating the patient performed the procedure, the facility shall report the infection to NHSN according to the surveillance methods described by NHSN and this chapter. For NHSN-reported PAE reporting, if the event occurred in the facility treating the patient, the facility shall report the event to NHSN according the surveillance methods described by NHSN and this chapter.(2) For PAE reporting, TxHSN-reported PAEs identified at the same facility that the PAE occurred, shall be reported through the TxHSN portal or its successor as described in this chapter.(3) For HAI and NHSN-reported PAE reporting, if the facility treating the patient did not perform the procedure, the treating facility shall notify the facility that performed the procedure, document the notification, and maintain this documentation for audit purposes. The facility that performed the procedure shall verify the data related to the infection. The performing facility shall report the HAI or NHSN-reported PAE to NHSN according to the surveillance methods described by NHSN and this chapter.(4) For TxHSN-reported PAEs, if the facility that identified the PAE is not the facility responsible for the event, the facility that identified the PAE shall notify the facility where the event occurred, document the notification, and maintain this documentation for audit purposes. The facility in which the event occurred shall report the PAE to TxHSN or its successor according to the methods described by the department and this chapter. Source Note: The provisions of this §200.3 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective September 17, 2014, 39 TexReg 7340; amended to be effective January 18, 2015, 40 TexReg 245; amended to be effective January 1, 2020, 44 TexReg 7713. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.3 How to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197380&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197380 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197380&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197380 03/11/2026 (a) ICD-CM codes as designated by the federal NHSN shall constitute the definition of events listed in this rule. Facilities shall adapt to changes in ICD-CM specifications as directed by NHSN and the department.(b) A health care facility shall report HAI data to the department for any HAI occurring in the facility that CMS requires to be reported through NHSN. The HAI data must include the causative pathogen if the infection is laboratory-confirmed. A current list of reportable HAIs can be found at HAITexas.org.(c) A health care facility shall report each HAI to the department under this section regardless of the facility's participation in Medicare.(d) Facilities shall report whether the HAI or the NHSN-reported PAE contributed to a patient's death either directly or by exacerbating an existing disease condition which then led to death.(e) A health care facility shall report any of the following preventable adverse events involving the facility's patient. A current list of reportable PAEs can be found at PAETexas.org.(1) A health care-associated adverse condition or event for which the Medicare program will not provide additional payment to the facility under a policy adopted by the federal Centers for Medicare and Medicaid Services.(2) An event included in the list of adverse events identified by the National Quality Forum.(3) The executive commissioner may exclude an adverse event from the reporting requirement if the executive commissioner, in consultation with the advisory panel, determines that the adverse event is not an appropriate indicator of a preventable adverse event.(f) Facilities shall also report denominator data as indicated in TxHSN protocols for TxHSN-reported PAEs. For the HAI events identified in this section for calculation of risk adjusted infection rates as required in Texas Health and Safety Code, §98.106(b), NHSN protocols shall be used for the determination of denominator data for HAI and NHSN-reported PAEs. The following facility information shall be entered by the facility for each reporting period.(1) Number of beds.(2) Number of surgeries or invasive procedures performed during the reporting period.(3) Number of patient days.(g) If a facility has no HAI and/or PAE during the reporting period, facilities shall report this information through NHSN for HAI and NHSN-reported PAEs. Facilities shall report the absence of TxHSN-reported PAEs through the TxHSN portal or its successor. Source Note: The provisions of this §200.4 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective September 17, 2014, 39 TexReg 7340; amended to be effective January 18, 2015, 40 TexReg 245; amended to be effective January 1, 2020, 44 TexReg 7713. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.4 Which Events to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197381&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197381 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197381&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197381 03/11/2026 Data required to be submitted in §200.4 of this title (relating to Which Events to Report) shall be reported using the training, enrollment, case definitions and protocols required by the department in coordination with NHSN. Specific modules and variables will be identified for facilities prior to the enrollment deadline through training, departmental website (HAITexas.org and PAETexas.org), and notification of the facility contact. Content or data element changes will be communicated in the same manner 90 calendar days in advance of the change. Source Note: The provisions of this §200.5 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective January 1, 2020, 44 TexReg 7713. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.5 Data to Report https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197382&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197382 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197382&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197382 03/11/2026 (a) All health care facilities who meet the criteria in §200.4 of this title (relating to Which Events to Report) shall enroll in NHSN within 90 calendar days of the designation of NHSN as the secure electronic interface to report HAI or NHSN-reported PAE data. In addition, all health care facilities shall notify the department to obtain TxHSN user accounts and report TxHSN-reported PAEs through TxHSN or its successor. Facilities will be required to do this within 90 calendar days of when TxHSN-reported PAEs are required to be reported or for newly reporting facilities, within 90 days of becoming eligible to report TxHSN-reported PAEs.(b) Facilities shall submit HAI and designated PAE data beginning with the entire reporting quarter of the effective date in subsection (a) of this section.(c) Facilities that are required to report after this initial enrollment period (e.g., newly licensed, change in provider status, etc.) shall enroll within 90 calendar days of the date the facilities become eligible to report in accordance with §200.2 of this title (relating to General Reporting Guidelines for Health Care-Associated Infection and Preventable Adverse Event Data) and §200.3 of this title (relating to How to Report) and shall submit data beginning with the entire reporting quarter after becoming eligible. Source Note: The provisions of this §200.6 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective September 17, 2014, 39 TexReg 7340; amended to be effective January 18, 2015, 40 TexReg 245; amended to be effective January 1, 2020, 44 TexReg 7713. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.6 When to Initiate Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171178&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171178 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171178&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171178 03/11/2026 (a) Facilities shall submit HAI and designated PAE data according to the following schedule in Table 1. Attached Graphic(1) HAI and designated PAE data for device days and procedures occurring between January 1 and March 31 shall be submitted no later than May 31 of the same calendar year.(2) HAI and designated PAE data for device days and procedures occurring between April 1 and June 30 shall be submitted no later than August 31, of the same calendar year.(3) HAI and designated PAE data for device days and procedures occurring between July 1 and September 30 shall be submitted no later than November 30 of the same calendar year. (4) HAI and designated PAE data for device days and procedures occurring between October 1 and December 31 shall be submitted no later than February 28 of the following calendar year. (b) If any of the dates in subsection (a) of this section fall on a weekend or holiday, facilities shall submit on the following business day. (c) Reporting of deaths shall follow the same reporting time line as HAI and PAE reporting in this section.(d) Health care facilities shall begin reporting TxHSN-reported PAEs data as outlined starting on January 1, 2015.(1) Facilities will report the following PAEs effective January 1, 2015.(A) Surgeries or invasive procedures involving a surgery on the wrong site, wrong patient, wrong procedure or a foreign object retained after surgery.(B) Patient death or severe harm associated with unsafe administration of blood or blood products.(C) Patient death or severe harm associated with a fall in a health care facility resulting in a fracture, dislocation, intracranial injury, crushing injury, burn or other injury.(D) Post-operative death of an ASA Class 1 Patient.(E) Discharge or release of a patient of any age, who is unable to make decisions, to someone other than an authorized person.(F) Perinatal death or severe harm (maternal or neonatal) associated with labor or deliver in a low-risk pregnancy while being cared for in a health care facility.(G) Patient death or severe harm resulting from failure to follow up or communicate laboratory, pathology or radiology test results.(H) Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, wrong gas, or are contaminated by toxic substances.(I) Patient death or severe harm associated with use of physical restraints or bedrails while being cared for in a health care facility.(J) Abduction of a patient of any age.(K) Sexual abuse or assault of a patient within or on the grounds of a health care facility.(L) Patient death or severe harm of a patient resulting from a physical assault that occurs within or on the grounds of a health care facility.(M) Patient death or severe harm resulting from the irretrievable loss of an irreplaceable biological specimen. (2) Facilities will report the following PAEs effective January 1, 2016.(A) Stage III, Stage IV or Unstageable pressure ulcer acquired after admission/presentation to a health care facility.(B) Patient death or severe harm associated with patient elopement.(C) Patient suicide, attempted suicide or self-harm that results in severe harm, while being cared for in a health care facility.(D) Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist or other licensed health care provider.(E) Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) after total knee replacement or after hip replacement.(F) Patient death or severe harm associated with an electric shock while being cared for in a health care facility.(G) Patient death or severe harm associated with a burn incurred from any source while being cared for in a health care facility.(H) Iatrogenic Pneumothorax with venous catheterization.(I) Patient death or severe harm associated with the introduction of a metallic object into the MRI area.(3) Facilities will report the following PAEs effective January 1, 2017.(A) Patient death or severe harm associated with intravascular air embolism that occurs while being cared for in a health care facility. (B) Poor glycemic control: diabetic ketoacidosis.(C) Poor glycemic controls: nonketonic hyperosmolar coma.(D) Poor glycemic control: hypoglycemic coma.(E) Poor glycemic control: secondary diabetes with ketoacidosis.(F) Poor glycemic control: secondary diabetes with hyperosmolarity.(G) Artificial insemination with the wrong donor sperm or wrong egg.(H) Patient death or severe harm associated with the use of contaminated drugs/devices or biologics provided by the health care facility.(I) Patient death or severe harm associated with the use or function of a device in patient care, in which the device is used or functions other than as intended.(J) Patient death or severe harm associated with a medication error.(K) Surgical site infections following a spinal procedure, shoulder procedure, elbow procedure, laparoscopic gastric bypass, gastroenterostomy, laparoscopic gastric restrictive surgery or cardiac implantable electronic device.(4) Amendments to this list of PAEs may be adopted at the discretion of the executive commissioner as recommended by CMS and NQF. Source Note: The provisions of this §200.7 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective September 17, 2014, 39 TexReg 7340; amended to be effective January 18, 2015, 40 TexReg 245. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.7 Schedule for HAI and PAE Reporting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171179&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171179 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=171179&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 171179 03/11/2026 (a) Data verification.(1) The department shall establish acceptance criteria to ensure the accuracy and completeness of all data submitted to the department and will make these criteria available.(2) The department will notify the facility contact by email to acknowledge receipt of data and to communicate its acceptability within 15 calendar days after the facility data submission deadline described in §200.7 of this title (relating to Schedule for HAI and PAE Reporting). This notification will include specific information on any errors found.(b) Correction of Errors and Disputes.(1) Facilities shall correct all identified errors, including data determined to be missing, and resubmit the corrected data through NHSN or its successor for HAI and NHSN-reported PAEs. Facilities shall correct data for TxHSN-reported PAEs through the TxHSN portal or its successor.(2) Corrections shall be submitted according to the following schedule.(A) Not later than June 30 for HAI and designated PAE data for device days and procedures occurring between January 1 and March 31.(B) Not later than September 30 for HAI and designated PAE data for device days and procedures occurring between April 1 through June 30.(C) Not later than December 31 for HAI and designated PAE data for device days and procedures occurring between July 1 through September 30.(D) Not later than March 31 for HAI and designated PAE data for device days and procedures occurring between October 1 through December 31.(3) If the facility is unable to correct an identified error or disputes one or more of the identified errors, the facility contact shall notify the department by email, fax, or in writing the reasons why these are the best available data within 15 calendar days of receipt of notice of corrections.(4) Data corrections that occur following publication of a data summary shall be submitted to NHSN or its successor for HAI and NHSN-reported PAEs. Data corrections for TxHSN-reported PAEs that occur following publication of a data summary shall be submitted through TxHSN or its successor.(c) If any of the dates listed in subsection (b) of this section fall on a weekend or holiday, facilities shall submit on the following business day.(d) Death data verification and correction shall follow the same schedule time line as HAI and PAE reporting in this section. Source Note: The provisions of this §200.8 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective September 17, 2014, 39 TexReg 7340; amended to be effective January 18, 2015, 40 TexReg 245. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.8 Verification of Health Care-Associated Infection and Preventable Adverse Event Data and Correction of Errors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158079 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158079 03/11/2026 (a) Development of data summary.(1) The department shall compile a data summary for each reporting facility. The data summary shall be made available to the public on an Internet website in a format to be determined by the department.(2) The data summary shall be based on data submitted by the facility and may include raw numbers for numerator and denominator, rates, risk-adjustments, and state and national comparative data.(3) Facilities that have failed to submit data or submitted data in a format other than that specified by the department shall be identified in the summary made available to the public.(4) Data summaries based on data that the department has determined to be inaccurate or incomplete which has not or cannot be corrected by the facility in a timely fashion shall be included in the data summary. Explanatory notes shall be included in the summary to inform the public of the nature of the data deficiencies.(5) Data displays shall be based on the best available data at the time the summaries are completed.(b) Facility comments.(1) Prior to publication of the data summary for public use, the department shall notify the facility contact by email of the opportunity to submit comments for publication with the data summary.(2) The facility contact shall submit comments using the format determined by the department or indicate that the facility does not wish to comment.(3) The comments shall be 1,250 characters in length or less.(4) The department shall review facility comments to assure that they are concise and pertain only to the facility and the current data. The department may edit comments that are not concise or do not pertain only to the facility and current data.(5) Comments are due to the department on or before October 30 of the same calendar year for summaries of data collected January 1 through June 30 and on or before April 30 of the following calendar year for summaries of data collected July 1 through December 31. Source Note: The provisions of this §200.9 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.9 Data Summary Display https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161580&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161580 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=161580&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 161580 03/11/2026 All data submitted by facilities are subject to data validation. When requested by the department, a health care facility shall provide the department access to, copies of and/or information from the facility documents and records underlying and documenting the data submitted, as well as other patient related documentation deemed necessary to validate facility data. Source Note: The provisions of this §200.10 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective April 21, 2013, 38 TexReg 2363. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS A CONTROL OF COMMUNICABLE DISEASES §200.10 Data Validation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178564&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178564 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178564&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178564 03/11/2026 (a) The committee. The Healthcare Safety Advisory Committee (committee) is appointed under and governed by this section.(b) Applicable law. The committee is subject to Texas Government Code, Chapter 2110.(c) Purpose. The purpose of the committee is to provide a forum to obtain stakeholder input on program initiatives and proposals for consideration by the Emerging and Acute Infectious Disease Branch (EAIDB) of the Texas Department of State Health Services.(d) Tasks.(1) The committee provides stakeholder feedback related to program initiatives.(2) The committee participates in workgroups to develop guidance related to program activities as requested by EAIDB.(e) Reports to the department.(1) The committee files an annual written report with the Executive Commissioner.(A) The report includes:(i) the meeting dates of the committee;(ii) the member attendance records;(iii) a brief description of actions taken by the committee;(iv) committee accomplishments;(v) the status of any committee recommended rules for consideration by the department and the commission;(vi) anticipated committee activities of the committee; and(vii) any amendments to this section requested by the committee.(viii) identifies the costs related to the committee, including the cost of agency staff time spent in support of the committee's activities and the source of funds used to support the committee's activities.(B) The report covers the meetings and activities in the immediate preceding calendar year and is filed with the HHSC Executive Commissioner each February of the following calendar year.(2) The committee files an annual written report with the Texas Legislature regarding any policy recommendations made to the HHSC Executive Commissioner.(f) Date of abolition. The committee is abolished September 1, 2020.(g) Composition.(1) The committee is composed of 13 (voting and non-voting) members appointed by the Executive Commissioner.(2) The composition of the committee includes:(A) two infection prevention and control professionals who:(i) are certified by the Certification Board of Infection Control and Epidemiology; and(ii) are practicing in a healthcare facility in this state;(B) two healthcare safety professionals who:(i) are practicing in a healthcare facility in this state; and(ii) are employed as professionals in quality assessment and performance improvement;(C) three board-certified physicians who:(i) are licensed to practice medicine in this state under Texas Occupations Code, Chapter 155;(ii) have active medical staff privileges at a healthcare facility in this state; and(iii) have demonstrated expertise in the area(s) of quality assessment and performance improvement, healthcare safety, health care epidemiology, antimicrobial resistance activities, or infection control in health care facilities;(D) two healthcare facility administrators;(E) one licensed pharmacist in this state who:(i) has experience in systems to reduce medication errors and in antibiotic stewardship activities; and(ii) is practicing in a healthcare facility in this state;(F) one nonvoting member who is a department employee representing the licensing of hospitals or ambulatory surgical centers; and(G) two members who represent the public as consumers.(3) Geographic representation will be considered among equally qualified appointees for each committee position.(h) Terms of office. Except as may be necessary to stagger terms, the term of office of each member is two years.(1) Members are appointed so that the terms of members expire on December 31st of each even-numbered year.(2) If a vacancy occurs, a person is appointed to serve the unexpired portion of that term.(i) Officers. The committee selects a presiding officer and an assistant presiding officer from its members.(1) The presiding officer and assistant presiding officer serve until December 31st of each even-numbered year. Both the presiding officer and the assistant presiding officer may retain office until his or her replacement is appointed.(2) The presiding officer:(A) presides at all committee meetings in which he or she is in attendance;(B) calls meetings in accordance with this section;(C) appoints subcommittees of the committee as necessary;(D) causes proper reports to be made to the Executive Commissioner; and(E) may serve as an ex-officio member of any subcommittee of the committee.(3) The assistant presiding officer performs the duties of the presiding officer in case of the absence or disability of the presiding officer. If the office of presiding officer becomes vacant, the assistant presiding officer serves as presiding officer until the committee selects a new presiding officer.(4) A member shall serve no more than two consecutive terms as presiding officer or assistant presiding officer.(5) The committee may reference its officers by other terms, such as chairperson and vice-chairperson.(j) Meetings. The committee meets as necessary as determined by the department, up to four times per year, to conduct business.(1) The committee meets at the call of the presiding officer.(2) Meeting arrangements are made by department staff.(3) The committee is not a "governmental body" as defined in the Open Meetings Act, Texas Government Code, Chapter 551. Meetings may be conducted in person, through teleconference call, or by means of other technology.(4) The committee provides stakeholder feedback only. The committee has no authority to conduct "official business" on the part of the department.(5) The agenda for each committee meeting includes an opportunity for new business or for any member to address the committee on matters relating to committee business.(6) The agenda for each committee meeting also includes an item entitled public comment under which any person is allowed to address the committee on matters relating to business. The presiding officer may establish procedures for public comment, including a time limit on each comment.(k) Attendance. Members attend committee meetings as scheduled.(1) A member notifies the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting.(2) It is grounds for removal from the committee if a member:(A) cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability;(B) is absent from more than half of the committee meetings during a calendar year; or(C) is absent from at least three consecutive committee meetings.(3) The validity of an action of the committee is not affected by the fact that it is taken when grounds for removal of a member exists per paragraph (2) of this subsection.(l) Staff. Staff support for the committee is provided by the department.(m) Procedures. Roberts Rules of Order are the basis of parliamentary decisions, except where otherwise provided by law or rule.(1) Any action taken by the committee must be approved by a majority vote of the members present, once quorum is established.(2) Each member has one vote.(3) A member may not authorize another individual to represent the member by proxy.(4) The committee makes decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.(5) Minutes of each committee meeting are taken by department staff and approved by the committee at the next scheduled meeting.(n) Statement by members.(1) The commission, the department, and the committee are not bound in any way by any statement, recommendation, or action on the part of any committee member, except when a statement or action is in pursuit of specific instructions from the commission, the department, or the committee.(2) The committee and its members may not participate in legislative activity in the name of the commission, the department, or the committee except with approval through the commission's legislative process. Committee members are not prohibited from representing themselves or other entities in the legislative process.(3) A committee member may not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.(4) A committee member may not disclose confidential information acquired through his or her committee membership.(5) A committee member may not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.(6) A committee member who has a personal or private interest in a matter pending before the committee must publicly disclose the fact in a committee meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the committee member has a direct pecuniary interest in the matter, but does not include the committee member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.(o) Reimbursement for expenses. In accordance with the requirements set forth in Texas Government Code, Chapter 2110, a committee member may receive reimbursement for the member's expenses incurred for each day the member engages in official committee business if authorized by the General Appropriations Act or budget execution process.(1) Only travel expenses for the two consumer representatives are reimbursed for each meeting attended.(2) A committee member who is an employee of a state agency, other than the department, may not receive reimbursement for expenses from the department.(3) Each member who is to be reimbursed for expenses submits to department staff the member's receipts for expenses and any required official forms not later than 14 days after each committee meeting.(4) Requests for reimbursement of expenses are made on official state vouchers prepared by department staff. Source Note: The provisions of this §200.40 adopted to be effective June 26, 2016, 41 TexReg 4488. 1 DEPARTMENT OF STATE HEALTH SERVICES 200 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS AND PREVENTABLE ADVERSE EVENTS B HEALTHCARE SAFETY ADVISORY COMMITTEE §200.40 Healthcare Safety Advisory Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13554&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13554 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13554&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13554 03/11/2026 (a) These sections pertain to flammability and flammable hazards only, as they are established by Texas Civil Statutes, Article 4476-13, and all manufacturers, processors, importers, distributors, and retailers of hazardous flammable articles are invited to acquaint themselves with the contents of this information in order that they may more readily and effectively comply with the requirements of Texas Civil Statutes, Article 4476-13 and these sections.(b) Periodic changes and/or up-dates in these regulations will be required as technology and product development changes and such amendments shall be subject to required notice and hearing procedures. Changes necessary to the maintenance of conformity between state and federal regulations shall be made, on a temporary basis, by administrative action of the department, as authorized under §205.26(g) of this title (relating to Special Provisions), when it has been determined that the delay of formal amendment procedures will create a condition of conflict between state and federal regulations.(c) These sections are concerned with types or classes of items which may properly be described as flammable hazards, as the term is used in Texas Civil Statutes, Article 4476-13. It is hereby stipulated that the scope of these regulations shall include, but not be limited to these items or articles specifically named in these regulations, but shall also include any and all similar or related items, not named herein, which might be in a place of access to children or intended for use in a household or put to a reasonable and customary use, as determined by application of the legal rule of "acts of a reasonable and prudent man.'(d) These sections are designed to conform with applicable provisions and requirements of the Federal Flammable Fabrics Act, Federal Hazardous Substance Act, and Federal Standards for Flammability of Children's Clothing in so far as these acts and standards relate to acceptance criterion, performance levels and test procedures. Variations between these regulations and the above noted acts and standards are in compliance with specific requirements of the Texas Hazardous Substance Act; they are supplemental to the minimum Federal requirements and are not in conflict with such requirements.(e) The provisions of this subchapter are applicable specifically and exclusively to the flammability characteristics and/or flammability hazards of the products, materials, or articles which may be defined in these regulations.(f) All rules, regulations, administrative rulings, and/or policy statements issued prior to the effective date of these regulations and in conflict herewith shall be superseded by these regulations upon their final adoption by the Texas State Board of Health. Source Note: The provisions of this §205.21 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY B FLAMMABILITY RULES §205.21 Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=10214&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 10214 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=10214&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 10214 03/11/2026 The definition of terms contained in the Act, §1, shall be applicable also to such terms when used in sections promulgated under the Act. The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:(1) Act--Senate Bill 362, 62nd Legislature, and all amendments thereto (Texas Penal Code Article 726-3, §1-12).(2) Accompanying literature--Any placard, pamphlet, booklet, book, sign, or other written, printed, or graphic matter or visual device that provides directions for use, written or otherwise, and is used in connection with the display, sale, demonstration, or merchandising of a flammable substance intended for, or packaged in a form suitable for, use in the household or by children.(3) Banned hazardous substance--(A) Any article of clothing (other than diapers) intended for the use of children which is not in compliance with flammability standards for such clothing established by the department shall be declared to be a banned hazardous substance by the department. The determination by the department that the Articles of clothing of a specified range of sizes are intended for the use of a child 14 years or younger shall be conclusive.(B) Any toy or other article other than clothing intended for use by children, which is a hazardous substance, or which bears or contains a hazardous substance in a manner susceptible of access by a child to whom the toy or other article is entrusted, shall be declared to be a banned hazardous substance by the department.(C) Any hazardous substance intended, or packaged in a form suitable for use in a household, which, notwithstanding cautionary labeling required by this Act, is potentially so dangerous or hazardous when present or used in a household, that the protection of the public health and safety can be adequately served only by keeping the substance out of the channels of commerce, shall be declared to be a banned hazardous substance by the department.(D) Any article subject to the provisions of this Act which cannot be labeled adequately to protect the public health and safety, or which presents an imminent danger to the public health and safety, shall be declared a banned hazardous substance by the department.(E) The provisions of this section do not apply to any toy or article such as chemical sets which by reason of functional purpose requires the inclusion of a hazardous substance, and which bears labeling which in the judgment of the department gives adequate directions and warnings for safe use, and is intended for use by children who have attained sufficient maturity and may reasonably be expected to read and heed these directions and warnings; nor do the provisions of this section apply to the manufacture, sale, distribution, or use of fireworks of any class.(4) Children's clothing--Any article of clothing, unless otherwise excluded, up to and including size 14X.(5) Children's sleepwear--Any product of wearing apparel up to and including size 14X, such as nightgowns, pajamas, or similar or related items, such as robes, intended to be worn primarily for sleeping or activities related to sleeping. Diapers and underwear are excluded from this definition.(6) Commerce--Any and all commerce within the State of Texas and subject to the jurisdiction thereof; and includes the operation of any business or service establishment.(7) Department--The Texas Department of Health Resources.(8) Flammable mixture--A mixture of substances whose composite product displays flammable characteristics due to antagonistic reactions of the substances. The flammability of such mixtures shall be determined by tests of the mixture itself, using prescribed method of test, rather than tests of the component parts.(9) Hazardous substance--Any substance or mixture of substances which is toxic, corrosive, flammable, an irritant, a strong sensitizer, or generates pressure through decomposition, heat, or other means, if the substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonable foreseeable handling or use, including reasonable foreseeable ingestion by children, and any radioactive substance if with respect to the substance as used in a particular class of article or as packaged, the department finds by regulation that the substance is sufficiently hazardous to require labeling in accordance with the provisions of this Act in order to protect the public health. The term "hazardous substance' does not apply to economic pesticides subject to the State or Federal Insecticide, Fungicide, and Rodenticide Act nor to foods, drugs, and cosmetics subject to the Federal Food, Drug, and Cosmetic Act or to beverages complying with or subject to the Federal Alcohol Administration Act, or to the Texas Food, Drug, and Cosmetic Act, nor to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a private residence, nor does it apply to or include any source material, special nuclear material, or byproduct material as defined in the Federal Atomic Energy Act of 1954, as amended, and regulations issued pursuant thereto by the Atomic Energy Commission.(10) Intended for, or packaged in a form suitable for, use in the household or by children--Any flammable substance, whether or not packaged, that under any customary or reasonably foreseeable condition of purchase, storage, or use may be brought into or around a house, apartment, or other place where people dwell, or in or around any related building or shed, including but not limited to a garage, carport or storage shed.(A) Exception: The term does not apply to small quantities of industrial supplies taken into a home temporarily by a repairman since such quantities may have been removed from a properly labeled bulk supply source.(B) Size of unit or container shall not be the only index of whether the article is suitable for use in or around the household. The test shall be whether under any reasonably foreseeable condition of purchase, storage, or use the article may be found in or around a dwelling.(11) Label--A display of written, printed, or graphic matter upon the immediate container of any substance, or in the case of an article which is unpackaged or is not packaged in an immediate container intended or suitable for delivery to the ultimate consumer, a display of this matter directly on the article involved or on a tag or other suitable material affixed thereto.(12) Person--Includes any individual, partnership, corporation, or association, or legal representative or agent.(13) Prominently and conspicuously--Under customary conditions of purchase, storage, and use, the required information shall be visible, noticeable, and in clear and legible type, in the English language (unless otherwise stipulated per the Act, §2(b), and such type shall contrast in typography, layout, or color with other printed matter on any required label.(14) Proximate result--A result that follows in the course of events without unforeseeable, intervening, independent cause.(15) Reasonably foreseeable handling or use--Includes the reasonably foreseeable accidental handling or use, not only by the purchaser or intended user of the product, but by all others in a household, especially children.(16) Rule, rules, regulations, and rules and regulations--The rules and regulations prescribed by the department pursuant to the Act, §5(a). For purpose of use herein these terms shall be synonymous and may be used interchangeably.(17) Size 14X--The size defined as 14X in customary marketing and sizing practice or in the Department of Commerce Voluntary Product Standard, previously identified as Commercial Standard CS151-50 "Body Measurements for the Sizing of Apparel for Infants, Babies, Toddlers, and Children," where such standard is applicable.(18) Substantial personal injury or substantial illness--Any injury or illness of a significant nature. Such injury or illness need not be severe or serious, however, the term substantial shall exclude wholly insignificant or negligible injury or illness. Source Note: The provisions of this §205.22 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY B FLAMMABILITY RULES §205.22 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211362&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211362 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211362&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211362 03/11/2026 The application of these sections must, by direction of Texas Civil Statutes Article 4476-13, be directed toward groups, types, or classes of flammable substances, rather than individual products. This section clearly establishes these classifications and the degree of flammability which must be considered for purposes of labeling.(1) Solids. The flammability characteristics of solids shall be classified as "flammable' or "extremely flammable,' as follows:(A) Flammable solids. A solid shall be deemed "flammable' if, when tested by the method prescribed in paragraph 191.14(A)(2) of the Federal Hazardous Substances Act, 15 United States Code §1251 et. seq., it ignites and burns with a self-sustained flame at a rate greater than 1/10 of an inch per second along its major axis.(B) Extremely flammable solids. A solid substance shall be deemed "extremely flammable" if it ignites and burns at an ambient temperature of 80 degrees Fahrenheit or less when subjected to friction, or to percussion, or to an electrical spark.(2) Liquids. The flammability characteristics of liquid shall be classified as "flammable' or "extremely flammable,' as follows:(A) Flammable liquids. A liquid substance shall be deemed "flammable" when such substance has a flash point of above 20 degrees Fahrenheit to and including 80 degrees Fahrenheit as determined by the Tagliabue open cup test.(B) Extremely flammable liquids. A liquid substance shall be deemed "extremely flammable" when such substance has a flash point at or below 20 degrees Fahrenheit as determined by the Tagliabue open cup test.(3) Contents of self-pressurized containers. The flammability characteristics of the contents of self-pressurized containers shall be classified as "flammable' or "extremely flammable,' as follows:(A) Flammable contents. Contents of self-pressurized containers shall be deemed "flammable' if, when tested by the method prescribed in the addendum, a flame projection exceeding 18 inches is obtained at full valve opening or a flashback (a flame extending back to the dispenser) is obtained at any degree of valve opening.(B) Extremely flammable contents. Contents of self-pressurized containers shall be deemed "extremely flammable' if, when tested by the method prescribed in paragraph 191.14(A)(2) of the Federal Hazardous Substances Act, 15 United States Code, §1251 et. seq., flashback (a flame extending back to the dispenser) is obtained at any degree of valve opening and the flashpoint, when tested by the method prescribed, is less than 20°F.(4) Toys or other articles.(A) A toy or other article, other than clothing, intended for use by children, which is a hazardous flammable substance, or which bears or contains a hazardous flammable substance in a manner which is susceptible to access by a child to whom the toy or other article is entrusted, or which is intended or packaged in a form suitable for use in the household or by children, shall be subject to all provisions of the Act or rules and regulations pertaining thereto, or both.(B) The degree of flammability and the extent of the hazard of toys and other household Articles shall be determined by application of the text procedures and criterion established for any or all of the component parts as they may be defined under other sections of these regulations.(5) Children's clothing.(A) Pursuant to the directives of the Act, as it pertains to clothing, and the requirements of existing federal standards on children's sleepwear, regulations are to be promulgated herein which conform to the requirements of both state and federal mandates.(B) Due to the fact that standards or regulations for clothing and materials are more extensive, more subject to change (as technology changes), and more restrictive in their overall interpretation, we believe that the best interest of all parties can be served by establishing flammability regulations for clothing under a separate section or rule in order that this problem might be considered as a total unit. In order to accomplish this, we have devoted subparagraph (C) of this paragraph to the subject of clothing and materials for clothing.(C) Children's clothing-general comments and provisions.(i) In compliance with the requirements of the Act, it is incumbent upon the department to consider and promulgate regulations that address themselves to all clothing (other than diapers) intended for use by children 14 years or younger.(ii) Due to the wide diversity in the relationship of size to age and in the absence of satisfactory factual evidence upon which to base such a relationship, the department is herewith invoking its authority, under the Act, §3(a), and determining that, under customary and reasonable practices, clothing sizes from 0-14X, inclusive, provide an adequate range of sizes intended for use of children 14 years or younger.(iii) It should be noted that the Act provides for regulation of outer clothing as well as sleepwear. Because of the basic differences in materials used, fabric weights, weave, fit, findings, trim, uses, and general flammable characteristics and because of the varied reactions of these different features to the standard test procedures prescribed by the U.S. Department of Commerce for testing of fabric flammability, the department feels that such items of clothing should be considered as three separate types: children's sleepwear sizes 0-6X, children's sleepwear sizes 7-14, and children's clothing (other than sleepwear, diapers and underwear) sizes 0-14.(iv) Note: All parties at interest should hereby be advised that test procedures are presently being evaluated in order to determine performance capabilities for outer garment fabrics and for sleepwear sizes 7-14 and that standards and regulations along with test procedures will be promulgated and announced on or before July 29, 1973. Such standards shall, of course, be in conformity with any federal efforts, in this category, which might be announced prior to the July 29, 1973, date, and appropriate compliance dates shall be established in accord with legal requirements and recognition of the necessary 12-month notice period.(D) Priority classifications of children's clothing. For purposes of these sections, children's clothing shall be considered in three separate types with each type comprised of a particular group of Articles identified either by size, range, type of clothing, or both. These types shall be identified as follows:(i) Type I. Children's sleepwear, sizes 0-6X.(ii) Type II. Children's sleepwear, sizes 7-14.(iii) Type III. Children's clothing (exclusive of sleepwear, diapers, and underwear), sizes 0-14. Source Note: The provisions of this §205.23 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY B FLAMMABILITY RULES §205.23 Classes of Substances https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=10215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 10215 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=10215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 10215 03/11/2026 (a) Children's sleepwear (Type I), sizes 0-6X inclusive.(1) Definitions. In addition to the definitions given in section 2 of the Federal Flammable Fabrics Act, as amended (Sec. 1, 81 Stat, 568, 15 United States Code 1191), section 7.2 of the Procedures (33 F.R. 14642, Oct. 1, 1968) and §205.21 of this title (relating to Scope), the following definitions apply for the purposes of this section:(A) Children's sleepwear-As used in this subsection, means any product of wearing apparel up to and including size 6X, such as nightgowns, pajamas, or similar or related items, such as robes, intended to be worn primarily for sleeping or activities related to sleeping. Diapers and underwear are excluded from this definition.(B) Size 6X-The size defined as 6X in Department of Commerce Voluntary Product Standard, previously identified as Commercial Standard, CS 151-50, "Body Measurements for the Sizing of Apparel for Infants, Babies, Toddlers, and Children,' unless otherwise defined in the context herein.(C) Item-Any product of children's sleepwear, or any fabric or related material intended or promoted for use in children's sleepwear.(D) Trim-Decorative materials, such as ribbons, laces, embroidery, or ornaments. This definition does not include:(i) individual pieces less than two inches in their longest dimension, provided that such pieces do not constitute or cover in aggregate a total or more than 20 square inches of the item; or(ii) functional materials (findings), such as zippers, buttons or elastic bands, used in the construction of garments.(E) Acceptance criterion-The maximum char length and residual flame time which an item may exhibit in order to comply with this standard.(F) Char length--The distance from the original lower edge of the specimen exposed to the flame in accordance with the procedure specified in 16 CFR 1615, §4 (Test Procedure) to the end of the tear or void in the charred, burned, or damaged area, the tear being made in accordance with the procedure specified in 16 CFR 1615, §4(d)(2) (Test Procedure).(G) Residual flame time-The time from removal of the burner from the specimen to the final extinction of molten material or other fragments flaming on the base of the cabinet.(H) Afterglow-The continuation of glowing of parts of a specimen after flaming has ceased.(2) Scope and application.(A) This standard provides a test method to determine the flammability of items of children's sleepwear.(B) All items of children's sleepwear must meet the acceptance criterion, except during the period set out in 16 C.F.R. 1615, §5(b) (Test Procedure).(3) General requirements.(A) Summary of test method. Five conditioned specimens, 8.9 centimeters by 25.4 centimeters (3.5 inches by 10 inches) are suspended one at a time vertically in holders in a prescribed cabinet and subjected to a standard flame along their bottom edge for a specified time under controlled conditions. The char length and residual flame time are measured.(B) Acceptance criterion. An item meets the acceptance criterion if:(i) the average char length of five specimens does not exceed 17.8 centimeters (7.0 inches);(ii) no individual specimen has a char length of 25.4 centimeters (10 inches) ; and(iii) no individual specimen has a residual flame time greater than 10 seconds, when the testing is done in accordance with specified test method.(4) Labeling requirements.(A) Care labels. All items of children's sleepwear shall be labeled with precautionary instructions to protect the items from agents or treatments which are known to cause deterioration of their flame resistance. If the item has been initially tested under 16 C.F.R. 1615, §4(d)(4) (Test Procedure) after one washing and drying, it shall be labeled with instructions to wash before wearing. Such labels shall be permanent and otherwise in accordance with rules and regulations established by the Federal Trade Commission.(B) Temporary requirement of noncomplying items. Items of noncomplying children's sleepwear which are manufactured during the 12 months following the effective date of the regulation shall, prior to introduction into commerce, be prominently, permanently, and conspicuously labeled with the following statement: "Flammable (Does Not Meet U. S. Department of Commerce Standard DOC FF 3-71.) Should not be worn near sources of fire.' Such labels should be in accordance with the rules and regulations established by the Federal Trade Commission and this department.(b) Children's sleepwear (Type II), sizes 7-14 inclusive.(1) Definitions. Definitions applicable to this section shall be identical to those definitions set out in subsection (a)(1) of this section with the single exception of size range.(2) Scope and application.(A) This standard shall provide an adequate test method to determine the flammability of items of children's sleepwear, sizes 7-14 inclusive.(B) All items of children's sleepwear (Type II) must meet the acceptance criterion to be established on or before July 29, 1973, subject to the stipulated 12-month lead time.(3) General requirements. General requirements for Type II sleepwear shall be stipulated at the time of adoption of final standards and test method for Type II articles.(4) Labeling requirements. Labeling requirements for Type II sleepwear, if necessary, shall be stipulated at the time of adoption of final standards and test method for Type II articles. No specific labeling requirements for Type II sleepwear are established by these rules at this time; however, the department will accept and, in fact, does encourage the use of positive labeling for those garments that pass Federal Standard DOC FF 3-71, with amendments and use of the Department of Commerce sampling plan, as published in the Federal Register, Volume 37, Number 75, Tuesday, April 18, 1972.(c) Children's clothing (Type III) (exclusive of sleepwear, diapers, and underwear), sizes 0-14.(1) Definitions. Definitions established in subsection (a)(1)(E)-(H) of this section shall also be applicable to this section and shall be augmented by additional specific definitions upon adoption of final standard for Type III garments.(2) Scope and Application.(A) This standard shall provide an adequate test method to determine the flammability of items of children's clothing, sizes 0-14 inclusive, exclusive of sleepwear, diapers, and underwear.(B) All items of children's clothing (Type III) must meet the acceptance criterion to be established on or before July 29, 1973, subject to the stipulated 12-month lead time.(3) General requirements. General requirements for Type III clothing shall be stipulated at the time of adoption of final standards and test method for Type III Articles.(4) Labeling requirements. Labeling requirements for Type III clothing, if necessary, shall be stipulated at the time of final adoption of standards and test method for Type III Articles. Source Note: The provisions of this §205.24 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY B FLAMMABILITY RULES §205.24 Children's Clothing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211363&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211363 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211363&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211363 03/11/2026 (a) General requirements.(1) The signal word, the statement of the principal hazard or hazards, and instructions to read carefully any cautionary information that may be placed elsewhere on the label shall appear together on the main panel of the label. Such information shall be placed together and distinctively apart from other wording or designs. The necessary prominence shall be achieved by placement within the borders of a square or rectangle with or without a borderline, and by use of suitable contrasts with the background achieved by distinctive typography or color, and by both color and typography when needed.(2) If the product is "extremely flammable" as defined in §205.23 of this title (relating to Classes of Substances), the labeling shall also include in conjunction with the word "danger" the words "extremely flammable." The word "danger" is considered a signal word as that term is used in paragraph (1) of this subsection.(3) The signal word and statement of hazard shall be in capital letters. The size of the signal word (including the word "danger" is required) shall be of a size bearing a reasonable relationship to the other type on the main panel, but shall not be less than 18 point type, and the size of the statement of hazard shall not be less than 12 point type, unless the label space on the container is too small to accommodate such type size. When the size of the label space requires a reduction in typesize, the reduction shall be made to a size no smaller than is necessary and in no event to a size smaller than six point type.(4) All the items of label information required by the Act, §2, (or by regulations prescribing additional information under §205.24 of this title (relating to Children's Clothing) and this section) may appear on the main panel; but if they do not, all such items not required by paragraph (1) of this subsection to appear on the main panel shall be placed together in a distinctive place elsewhere on the label with adequate contrast achieved by typography, color, or layout except that the name and place of business of the manufacturer, packer, distributor, or seller may appear separately on the same or on a different panel. The type size used shall bear a reasonable relationship to the printing on the panel involved and shall be no smaller than 10 point unless the available label space requires reductions, in which event it shall be reduced no smaller than six point type unless because of small label space an exemption has been granted under the Act, §5(a).(5) Collapsible metal tubes containing hazardous flammable substances shall be labeled so that all items of label information required by the Act, §2, or by regulations prescribing additional information shall appear as close to the dispensing end of the container as possible. The size, placement, and conspicuousness of these statements shall conform with paragraphs (1), (3), and (4) of this subsection.(6) Unpackaged hazardous substances intended or in a form suitable for use in or around a household or by children shall be labeled so that all items of information required by the Act or by regulations in this part shall appear upon the article itself. In instances where such labeling is impracticable because of the size or nature of the article, the required cautionary labeling must be displayed by means of a tag or other suitable material that is securely affixed to the article so that the labeling will remain attached throughout conditions of merchandising and distribution to the ultimate consumer. The size, placement, and conspicuousness of these statements shall conform with paragraphs (1), (3) and (4) of this subsection.(b) Special requirements.(1) Labeling requirements for accompanying literature. When any accompanying literature includes or bears any directions for use (by printed word, picture, design, or combination of such methods) such placard, pamphlet, booklet, book, sign, or other graphic or visual device shall bear all the information required by §2 of the Act and this section.(2) Substances determined to be "special hazards." Whenever the department determines that for a particular hazardous substance, intended or packaged in a form suitable for use in the household or by children, the requirements in the Act, §2, are not adequate for the protection of the public health and safety because of some special hazard, the department shall, by appropriate action, specify such reasonable variations or additional label requirements that it finds are necessary for the protection of the public health and safety. Such order shall specify a date that is not less than 90 days after that order is published (unless emergency conditions stated in the order specify an earlier date) after which any such hazardous substance intended or packaged in a form suitable for use in the household or by children, that fails to bear a label in accordance with such order shall be deemed to be a misbranded hazardous substance.(3) Substances with multiple hazards.(A) Any article that presents more than one type of hazard (for example, if the article is both "toxic" and "flammable") must be labeled with an affirmative statement of each such hazard; instructions for handling and storage of articles that require special care in handling and storage because of more than one type of hazard presented by the article, as well as the common or usual name (or the chemical name if there is no common or usual name for each hazardous component present in the article).(B) Label information referring to the possibility of one hazard may be combined with parallel information concerning any additional hazards presented by the article; provided, that the resulting condensed label statement shall contain all of the information needed for dealing with each type of hazard presented by the article.(c) Specific label requirements.(1) Extremely flammable contact adhesives; labeling.(A) Extremely flammable contact adhesives, also known as contact bonding cements, when distributed in containers intended or suitable for household use may be misbranded under the Act if the containers fail to bear a warning statement adequate for the protection of the public health and safety.(B) The following warning statement is considered as a minimum cautionary labeling adequate to meet the requirements of section 2 of the Act with respect to containers of more than 1/2 pint of contact adhesive and similar liquid or semiliquid articles having a flashpoint at or below 20°F as determined by the method in §205.23 of this title (relating to Classes of Substances) when the only hazard foreseeable is that caused by the extreme flammability of the mixture:DANGEREXTREMELY FLAMMABLEVAPORS MAY CAUSE FLASH FIRE(C) The words that are in capital letters in the warning statement set forth in subparagraph (B) of this paragraph should be printed on the main (front) panel or panels of the container in capital letters of the type size specified. The balance of the cautionary information may appear together on another panel provided the front panel bears a statement such as "Read carefully other cautions on 40 panel,' the blank being filled in with the identification of the specific label panel bearing the balance of the cautionary labeling. It is recommended that a borderline be used in conjunction with the cautionary labeling.(D) If an article has additional hazards, or contains ingredients listed in section 1 of the Act as requiring special labeling, appropriate additional front and rear panel precautionary labeling is required.(2) Children's sleepwear. Temporary labeling requirements of noncomplying items. Items of noncomplying children's sleepwear which are manufactured during the 12 months following the effective date of the standard shall, prior to introduction into commerce, be prominently, permanently, and conspicuously labeled with the following statement: "Flammable (Does not meet U. S. Department of Commerce Standard DOC FF 3-71). Should not be worn near sources of fire.' Such labels should be in accordance with the rules and regulations established by the Federal Trade Commission and this department.(d) Label restrictions.(1) Deceptive use of disclaimers.(2) A hazardous substance shall not be deemed to have met the requirements of the Act, §2, if there appears in or on the label or in accompanying literature words, statements, designs, or other graphic material that in any manner negates or disclaims any of the label statements required by the Act: for example, the statement on a toxic or irritant substance, such as "Harmless" or "Safe around pets." Source Note: The provisions of this §205.25 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY B FLAMMABILITY RULES §205.25 Labeling Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=10216&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 10216 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=10216&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 10216 03/11/2026 (a) Effective date. It is hereby stipulated that the effective date of these regulations shall be July 29, 1972.(b) Application of regulations. Necessary enforcement procedures, under these sections, shall apply equally to manufacturers, importers, distributors, and retailers, and responsibility for removal of proven hazardous flammable substances from the channels of commerce shall be shared equally by all parties concerned.(c) Exceptions.(1) Items subject to provisions of these sections which are "in inventory' or "with the trade' on the effective date of these sections shall be exempt. All concerned parties shall be required to maintain records verifying that these items offered for sale, after the effective date of these sections, are eligible for exemption.(2) If the department, through a determination of fact, finds that any such fabric, related material, or other product is so highly flammable as to be dangerous when used by consumers for the purpose for which it is intended, the department may under such conditions as the commissioner may prescribe, withdraw, or limit the exemption for such fabric, related material, or other product and declare such product a banned hazardous substance pending outcome of a hearing on the merits of the case.(d) Compliance dates. Compliance dates for products subject to these sections shall be as follows:(1) Liquids, solids, and self-pressurized containers. Compliance date-July 29, 1972.(2) Children's sleepwear (Type I), 0-6X. Compliance date-July 29, 1972.(3) Children's sleepwear (Type II), 7-14X. Compliance date-12 months from date of final adoption of adequate standards and test methods, such standards and methods to be proposed on or before July 29, 1973.(4) Children's clothing (Type III), 0-14X - (excluding sleepwear, diapers, and underwear). Compliance date-12 months from date of final adoption of adequate standards and test methods, such standards and methods to be proposed on or before July 29, 1973.(5) Toys. In order to provide sufficient lead time and being aware of the nature of marketing processes of such items, the department hereby establishes two dates for implementation: Effective date for regulations and provisions for toys shall be July 29, 1972. Such date shall serve as a notice of intent by the department. Compliance date shall be July 29, 1973, and compliance requirements shall apply to all subject items delivered into the commerce, of this state, after this date.(6) Other household articles. Compliance dates for such articles shall be determined on the basis of a reasonable and adequate warning period after a determination by the department that specific articles or classes of articles require regulation within the framework of the Act.(e) Records. It shall be incumbent upon all concerned parties to maintain adequate records relating to all articles subject to provisions of these sections. Such records shall provide necessary information regarding manufacturing source, quantity, distribution, dates, record of any guarantees furnished, and record of any test performed, where applicable. With specific regard to flammable fabrics, it is noted that records required by rules and regulations under the Federal Flammable Fabrics Act are acceptable, and it is hereby stipulated that records requirement under these sections shall be identical to the federal requirements of both the Department of Commerce and the Federal Trade Commission, as they relate to articles covered by these sections. All records required by these sections shall be available to an authorized agent of the department in accordance with section 4(a) and (b) and section 6(1) of the Act.(f) Disposition of rejected units.(1) Fabrics, related materials, or garments. Units of fabric, related materials, and/or garments which have been subjected to required test procedures, including the approved sampling plan, and have been rejected shall not be reinspected, used, or promoted for use in children's clothing as defined in the definition of children's clothing set forth in §205.22 of this title (relating to Definitions) except after reworking to improve flammability characteristics and subsequent retesting in accordance with the procedures previously set forth.(2) Records. Records of all unit sizes, test results, and the disposition of rejected units must be maintained by the manufacturer, in accordance with the rules and regulations established by the Federal Trade Commission and, hereby adopted by reference, by the department.(g) Questions of conflict. It is hereby provided that questions of conflict between state and federal regulations shall be subject to decision by administrative action by the department, with approval of the commissioner, until such time as formal procedures for amendment can be considered by the State Board of Health.(h) Severability. If any section or provision of these rules, regulations, and standards or the application of that section or provisions to any person, situation, or circumstance is for any reason adjudged invalid, the adjudication does not affect any other section or provision of these rules, regulations, and standards or the application of the adjudicated section or provision to any other person, situation or circumstance. The Texas State Board of Health declares that it would have adopted the valid portions and applications of these sections without the invalid part, and to this end, the provisions of these sections are declared to be severable. Source Note: The provisions of this §205.26 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY B FLAMMABILITY RULES §205.26 Special Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118410&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118410 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118410&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118410 03/11/2026 (a) Purpose. The purpose of these rules is to implement the requirements of the Texas Hazardous Substances Act, Health and Safety Code, Chapter 501, covering the labeling of hazardous substances.(b) Scope. These rules cover the types or classes of items which are hazardous substances and the labeling requirements, restrictions, and exemptions.(c) Federal requirements. These rules are designed to conform to and be supplemental to the applicable provisions and requirements of the Federal Hazardous Substances Act, 15 USC §1261, et seq. Source Note: The provisions of this §205.41 adopted to be effective January 1, 1984, 8 TexReg 4749; amended to be effective January 1, 2005, 29 TexReg 11978. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY C LABELING OF HAZARDOUS SUBSTANCES §205.41 Introduction https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118411&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118411 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118411&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118411 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Hazardous Substance Act, Health and Safety Code, Chapter 501.(2) Commerce--Any and all commerce within the State of Texas and subject to the jurisdiction thereof, and includes the operation of any business or service establishment.(3) Corrosive--Any substance which, in contact with living tissue, will cause destruction of that tissue by chemical action. It does not refer to chemical action on inanimate surfaces.(4) Department--Department of State Health Services.(5) Federal Hazardous Substances Act--The Federal Hazardous Substances Act, 15 United States Code §1261, et seq.(6) Flammable--Applies to any substance which has a flash point of above 20 degrees Fahrenheit to and including 80 degrees Fahrenheit, as determined by the tagliabue open cup tester, a device for testing the flash point of volatile flammable materials having flash points below 175 degrees Fahrenheit. Any substance which has a flash point at or below 20 degrees Fahrenheit as determined by the tagliabue open cup tester, shall be designated "extremely flammable." However, the flammability of solids, children's clothing, and of the contents of self-pressurized containers shall be determined by methods found by the department to be generally applicable to these materials or containers, and shall be established by rules issued by the department.(7) Hazardous substance--(A) any substance or mixture of substances which is toxic, corrosive, extremely flammable, flammable, combustible, an irritant, or a strong sensitizer, or that generates pressure through decomposition, heat, or other means, if the substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonable foreseeable handling or use, including reasonable foreseeable ingestion by children; or(B) any toy or other article other than clothing intended for use by children which presents an electrical, mechanical, or thermal hazard; and(C) any radioactive substance if, with respect to the substance as used in a particular class of article or as packaged, the department finds by rule that the substance is sufficiently hazardous to require labeling in accordance with the provisions of this Act in order to protect the public health. The term "hazardous substance" does not apply to any one of the following:(i) economic pesticides subject to the State Pesticide Regulation Act, Agriculture Code, Chapter 76;(ii) foods, drugs, and cosmetics subject to the Federal Food, Drug, and Cosmetic Act, 21 United States Code §301, et seq.;(iii) beverages complying with or subject to the Federal Alcohol Administration Act, 27 United States Code §201, et seq.;(iv) the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431;(v) substances intended for use as fuels when stored in containers and used in the heating, cooking, or refrigeration system of a private residence; or(vi) any source material, special nuclear material, or by-product material as defined in the Federal Atomic Energy Act of 1954, 42 United States Code §2011, et seq., as amended, and regulations issued pursuant thereto by the Atomic Energy Commission.(8) Highly toxic--(A) any substance which produces death within 14 days in half or more than half of a group of 10 or more laboratory white rats each weighing between 200 and 300 grams, at a single dose of 50 milligrams or less per kilogram of body weight, when orally administered, or when inhaled continuously for a period of one hour or less at an atmospheric concentration of 200 parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, if the inhaled concentration is likely to be encountered by any person when the substance is used in any reasonably foreseeable manner; or(B) which produces death within 14 days in half or more than half of a group of 10 or more rabbits tested in a dosage of 200 milligrams or less per kilogram of body weight, when administered by continuous contact with the bare skin for 24 hours or less;(C) however, if the department finds that available data based on human experience indicate results different from those obtained on animals, the human data shall take precedence.(9) Immediate container--Does not include package liners.(10) Irritant--Any noncorrosive substance which, on immediate, prolonged, or repeated contact with normal living tissue, will induce a local inflammatory reaction.(11) Label--A display of written, printed, or graphic matter upon the immediate container of any substance, or in the case of an article which is unpackaged or is not packaged, in an immediate container intended or suitable for delivery to the ultimate consumer, a display of this matter directly on the article involved or on a tag or other suitable material affixed thereto.(12) Misbranded hazardous substance--A hazardous substance (including a toy, or other Article intended for use by children, which is a hazardous substance, or which bears or contains a hazardous substance, in a manner which is susceptible of access by a child to whom the toy or other article is entrusted, intended, or packaged in a form suitable for use in the household or by children), which fails to bear a proper label as required by the Act, §2, and by these sections.(13) Person--Any individual, partnership, corporation or association, or legal representative or agent.(14) Strong sensitizer--Any substance which will cause on normal living tissue, through an allergic or photodynamic process, a hypersensitivity which becomes evident on reapplication of the same substances. Before designating any substance as a strong sensitizer, the department, upon consideration of the frequency of occurrence and severity of the reaction, shall find that the substance has a significant potential for causing hypersensitivity.(15) Toxic--Any substance other than a radioactive substance which has the capacity to produce personal injury or illness to any person through ingestion, inhalation, or absorption through any body surface. Source Note: The provision of this §205.42 adopted to be effective January 1, 1984, 8 TexReg 4749; amended to be effective January 1, 2005, 29 TexReg 11978. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY C LABELING OF HAZARDOUS SUBSTANCES §205.42 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=86560&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 86560 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=86560&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 86560 03/11/2026 (a) Required information on the label. A hazardous substance shall be considered a misbranded hazardous substance unless the hazardous substance bears a label which states conspicuously:(1) the name and place of business of the manufacturer, packer, distributor, or seller;(2) the common or usual name or the chemical name (if there be no common or usual name) of the hazardous substance or of each component which contributes substantially to its hazard, unless the department by rule permits or requires the use of a recognized generic name;(3) the signal word "Danger" on substances which are extremely flammable, corrosive, or highly toxic;(4) the signal word "Warning" or "Caution" on all other hazardous substances;(5) an affirmative statement of the principal hazard or hazards, such as "Flammable," "Combustible," "Vapor Harmful," "Causes Burns," "Absorbed Through Skin," or similar wording descriptive of the hazard;(6) precautionary measures describing the action to be followed or avoided, except when modified by rule of the department;(7) instruction, when necessary or appropriate, for first-aid treatment;(8) the word "Poison" and the "Skull and Crossbones" symbol for any hazardous substance which is defined as "highly toxic" under these rules. The word "poison" is not a signal word and shall not replace, but shall be in addition to, the signal word;(9) instructions for handling and storage of packages which require special care in handling or storage; and(10) the statement, "Keep out of the reach of children" or its practical equivalent, or, if the Article is intended for use by children and is not a banned hazardous substance, adequate directions for the protection of children from the hazard.(b) Placing the information on the label. Information contained in subsection (a) of this section shall be placed on the label in the following manner.(1) The "signal word," the "statement of principal hazard or hazards," and instructions to read carefully any cautionary information that may be placed elsewhere on the label shall appear together on the main panel of the label. Such information shall be placed together and distinctively apart from other wording or designs. The necessary prominence shall be achieved by placement within the borders of a square or rectangle with or without a borderline, and by use of suitable contrasts with the background achieved by distinctive typography or color, and by both color and typography when needed.(2) The area of the principal display panel is the area of the side or surface of the immediate container, or of the side or surface of any outer container or wrapping, that bears the labeling designed to be the most prominently displayed, shown, presented, or examined under conditions of retail sale. This area is not limited to the portion of the surface covered with labeling; rather, it includes the entire surface. Flanges at the tops and bottoms of cans, conical shoulders of cans, handles, and shoulders and necks of bottles and jars are excluded in measuring the area. For the purposes of determining the proper type size for cautionary labeling, the area of the principal display panel, or other panel bearing cautionary labeling, is to be computed as follows.(A) In the case of a rectangular package, where one entire side is the principal display panel, the product of the height times the width of that side shall be the area of the principal display panel.(B) In the case of a cylindrical or nearly cylindrical container or tube on which the principal display panel appears on the side, the area of the principal display panel shall be 40% of the product of the height of the container times its circumference.(C) In the case of any other shape of container, the area of the principal display panel shall be 40% of the total surface of the container, excluding those areas, such as flanges at the tops and bottoms. However, if such a container presents an obvious principal display panel (such as an oval or hour-glass shaped area on the side of a container for dishwashing detergent), the area to be measured shall be the entire area of the obvious principal display panel.(3) The type sizes used for the signal word, statements of hazard, and all other precautionary and first aid labeling required by these regulations shall be determined in the following manner.(A) The term "type size" refers to the height of the actual printed image of each upper case or capital letter as it appears on the label. The size of cautionary labeling shall be reasonably related to the type size of any other printing appearing on the same panel, but in any case must meet the minimum size requirements in Table 1, as follows:Attached Graphic(B) When an item of labeling is required to be in a specified type size, all upper case or capital letters must be at least equal in height to the required type size, and all other letters must be the same style as the upper case or capital letters. Unless otherwise specified in the regulations, the type size of all cautionary statements appearing on any display panel shall comply with the specifications in Table 1 when the area of the display panel is measured by the method in paragraph (2) of this subsection.(C) If all of the required cautionary labeling does not appear on the principal display panel, the statement to "Read carefully other cautions on the ________ panel," or its practical equivalent, must appear in, as a minimum, the same type size as that required in Table 1 for the other cautionary material which appears elsewhere on the label of a hazardous substance. The size of the cautionary labeling that does not appear on the principal display panel is determined by the area of the panel on which it does appear.(4) Collapsible metal tubes containing hazardous substances shall be labeled so that all items of the label information required by subsection (a) of this section or by regulations prescribing additional information, shall appear as close to the dispensing end of the container as possible. The size, placement, and conspicuousness of these statements shall conform with this subsection.(5) Unpackaged hazardous substances intended or in a form suitable for use in or around a household or by children shall be labeled so that all items or information required by the Act or by these rules shall appear on the article itself. In instances where such labeling is impracticable because of the size or nature of the article, the required cautionary labeling must be displayed by means of a tag or other suitable material that is securely affixed to the article so that the labeling will remain attached throughout conditions of merchandising and distribution to the ultimate consumer. The size, placement, and conspicuousness of these statements shall conform with paragraphs (1)-(3) of this subsection.(6) Whenever the statement of the principal hazard or hazards itself provides the precautionary measures to be followed or avoided, a clear statement of the principal hazard will satisfy the requirements of subsection (a)(5) and (6) of this section. When the statement of the precautionary measures in effect provides for instruction for first-aid treatment, the statement of the precautionary measures will satisfy the requirements of subsection (a)(6) and (7) of this section.(7) When any accompanying literature includes or bears any directions for use (by printed word, picture, design, or combination thereof), such placard, pamphlet, booklet, book, sign, or other graphic or visual device shall bear all the information required by subsection (a) of this section. (8) Any article that presents more than one type of hazard (for example, if the article is both toxic and flammable) must be labeled with the following:(A) an affirmative statement of each such hazard;(B) the precautionary measures describing the action to be followed or avoided for each such hazard, instructions when necessary or appropriate, for first-aid treatment of persons suffering from the ill effects that may result from each such hazard;(C) instructions for handling and storage of articles that require special care in handling and storage because of more than one hazard presented by the article; and(D) the common or usual name (or the chemical name if there is no common or usual name) for each hazardous component present in the article. Label information referring to the possibility of one hazard may be combined with parallel information concerning any additional hazards presented by the article if the resulting condensed statement contains all of the information needed for dealing with each type of hazard presented by the article.(9) Self-pressurized containers that fail to bear a warning statement adequate for the protection of the public health and safety may be misbranded under the Act and these rules, except as otherwise provided pursuant to the Federal Hazardous Substances Act, §3. The following warning statement will be considered as meeting the requirements of subsection (a) of this section if the only hazard associated with the article is that the contents are under pressure: "Warning-Contents Under Pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 degrees Fahrenheit. Keep out of the reach of children." The word "caution" may be substituted for the word "warning." A practical equivalent may be substituted for the statement, "Keep out of the reach of children." (c) Label restrictions regarding deceptive use of disclaimers. A hazardous substance shall not be deemed to have met the requirements of the Act, §2, if there appears in or on the label or in accompanying literature words, statements, designs, or other graphic material that in any manner negates or disclaims any of the label statements required by the Act; for example, the statement on a toxic or irritant substance, such as "Harmless" or "Safe around pets."(d) Exemptions for unlabeled containers.(1) Except as provided by this paragraph and paragraphs (2) and (3) of this subsection, a shipment or other delivery of a hazardous substance that in accordance with the practice of the trade is to be labeled in substantial quantity at an establishment other than that where originally manufactured or packed shall be exempt during the time of introduction into and movement in commerce and during the time of holding in that establishment from compliance with the labeling requirements as set forth in the Act and in subsections (a) and (b) of this section if:(A) the person who introduced the shipment or delivery into commerce is the operator of the establishment where the hazardous substance is to be received and labeled; or(B) the person who introduced the shipment or delivery is not the operator, and the shipment or delivery is made to the establishment under a written agreement, signed by and containing the post office address of the person and the operator, and containing whatever specifications for the labeling of the hazardous substance that are necessary to insure, if such specifications are followed, that the hazardous substance will not be misbranded within the meaning of the Act upon completion of the labeling. The person and the operator shall each keep a copy of the agreement until two years after the final shipment or delivery under the agreement has been completed and shall make copies of the agreement available for inspection upon request of any properly authorized employee of the department.(2) An exemption of a shipment or delivery of a hazardous substance under paragraph (1)(A) of this subsection shall, at the beginning of the act of removing the shipment or delivery of any part thereof from the establishment, become void from the beginning if the hazardous substance comprising the shipment, delivery, or part is misbranded within the meaning of the Act when so removed. (3) An exemption of a shipment or delivery of a hazardous substance paragraph (1) (B) of this subsection shall become void from the beginning with respect to the person who introduced the shipment or delivery into commerce upon refusal by that person to make available for inspection a copy of the agreement as required by paragraph (1)(B) of this subsection.(4) An exemption of a shipment or other delivery of a hazardous substance under paragraph (1)(B) of this subsection shall expire:(A) at the beginning of the act of removing the shipment or delivery, or any part thereof, from the establishment if the hazardous substance comprising the shipment, delivery, or part is misbranded within the meaning of the Act when so removed; or(B) upon refusal by the operator of the establishment where the hazardous substance is to be labeled, to make available for inspection a copy of the agreement required by paragraph (1)(B) of this subsection.(e) Exemptions under the Federal Hazardous Substances Act. As required by Title 16, C.F.R., Chapter II, §1500.7, nothing within these rules shall be construed as preempting any portion of the Federal Hazardous Substances Act or federal regulations adopted thereunder. Therefore, any and all exemptions for the labeling of hazardous products as set forth within Chapter II, §1500.7, or which may be granted from time to time by the U.S. Consumer Product Safety Commission, are also exempt from the labeling requirements of the Act. Source Note: The provisions of this §205.43 adopted to be effective January 1, 1984, 8 TexReg 4749; amended to be effective February 27, 1987, 12 TexReg 503. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY C LABELING OF HAZARDOUS SUBSTANCES §205.43 Labeling Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=123060&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 123060 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=123060&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 123060 03/11/2026 (a) Purpose and scope. The Texas Hazardous Substances Act, Health and Safety Code, Chapter 501, requires manufacturers of hazardous substances whose products are distributed in Texas to file a registration statement with the department prior to doing business in the state; establishes a registration fee; and requires the adoption of rules covering the registration statement, the procedures for filing it, and procedures for denying, suspending, or canceling the registration statement. This section is intended to accomplish the statutory purpose.(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. In addition, the definitions used in §205.42 of this title (relating to Definitions) apply to this section.(1) Distribute.(A) dissemination of a hazardous substance to the general public under one's own brand (private label); or(B) dissemination of a hazardous substance as a wholly owned subsidiary of the business or establishment that manufactured, imported, or packaged the product.(2) Hazardous substance.(A) The term "hazardous substance" applies to the following:(i) any substance or mixture of substances which is toxic, corrosive, extremely flammable, flammable, combustible, an irritant, or a strong sensitizer, or that generates pressure through decomposition, heat, or other means, if the substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonable foreseeable handling or use, including reasonably foreseeable ingestion by children;(ii) any toy or other article other than clothing intended for use by children which presents an electrical, mechanical, or thermal hazard; or(iii) any radioactive substance if, with respect to the substance as used in a particular class of article or as packaged, the department finds by rule that the substance is sufficiently hazardous to require labeling in accordance with the provisions of Health and Safety Code, Chapter 501, in order to protect the public health.(B) The term "hazardous substance" does not apply to economic pesticides subject to the State or Federal Insecticide, Fungicide, and Rodenticide Act, or to foods, drugs, and cosmetics subject to the Federal Food, Drug and Cosmetic Act, or to beverages complying with or subject to the Federal Alcohol Administration Act or the Texas Food, Drug and Cosmetic Act, or to substances intended for use as fuels when stored in containers and used in the heating, cooking, or refrigeration system of a private residence, or to any source material, special nuclear material, or by-product material as defined in the Federal Atomic Energy Act of 1954, as amended, and regulations issued pursuant thereto by the Atomic Energy Commission.(3) Manufacturer--Any person who manufactures, imports, repacks, or distributes a hazardous substance. The term does not include a retailer who distributes a hazardous substance to the general public, except that a retailer who distributes a hazardous substance made to its specifications is considered to be a manufacturer.(4) Retailer--The parent corporation, proprietorship, or partnership operating a chain of stores; or if there is only one location, the term shall refer to that location.(c) Basic requirement. A manufacturer whose products are distributed in the State of Texas or who distributes a hazardous substance in this state under the person's private brand name shall have on file with the department a registration statement accompanied by a registration fee in accordance with this section.(d) Term of registration statement. Prior to January 1, 2005, the term of a registration statement is one year and expires on the anniversary of the effective date, unless renewed. Effective January 1, 2005, the term of all licenses is two years. Some licenses will be renewed for a one-year term in 2005, in a manner to be determined by the department and two years thereafter.(e) Registration statement.(1) A manufacturer's registration statement shall be signed and verified, shall be made on a registration form furnished by the department, and shall contain the following information:(A) the name under which the manufacturing, importing, repacking, or distributing is conducted;(B) the address of each place of business or establishment being registered shall be contained on the registration statement;(C) if the business is a sole proprietorship, the name of the proprietor shall be included;(D) if the business is a partnership, the names of the partners shall be included;(E) if the business is a corporation, the names of the officers and directors shall be included;(F) if the business is of any other kind than the ones described in subparagraphs (C) - (E) of this paragraph, the names of those persons in a managerial position shall be included.(2) Registration forms may be obtained from the Environmental and Sanitation Licensing Group, Regulatory Licensing Unit, Health Care Quality Section, Division for Regulatory Services, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756.(f) Registration fees.(1) Each initial registration statement and each refiling of the registration shall be accompanied by a registration fee of $630 for a two-year term.(2) The fee shall be paid by money order, certified check, or personal check and shall be made payable to the Department of State Health Services. Cash payment is not acceptable.(g) Texas Online Fees. The department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with processing registration statements specified under this section through Texas Online, in accordance with the Texas Government Code, Chapter 2054, §2054.111 (relating to Use of Texas Online Project).(h) Special provisions. Manufacturers of hazardous substances, whose products are distributed for sale in Texas and whose products might normally be banned, but who meet specific exemption criteria enabling their products to be sold in Texas shall file registration statements accompanied by a registration fee in accordance with this section. Some examples are:(1) toy electric trains with special labeling, exempting the products from the ban on toys presenting an electrical hazard; and(2) toy caps which are exempt from the classification as a banned hazardous substance by special labeling and peak sound pressure levels.(i) Refusal to accept, cancel, revoke, or suspend a registration statement.(1) After notice and opportunity for a hearing, the department may refuse to accept or may cancel, revoke, or suspend a manufacturer's registration if the manufacturer fails to make payment of the fee required in this section.(2) The hearing described in paragraph (1) of this subsection shall be conducted in accordance with the Administrative Procedure Act, Texas Government Code, Chapter 2001 and the department's sections on formal hearings, §§1.21, 1.23, 1.25 and 1.27 of this title (relating to Formal Hearing Procedures). Source Note: The provisions of this §205.44 adopted to be effective October 11, 1985, 10 TexReg 3767; amended to be effective February 27, 1987, 12 TexReg 503; amended to be effective January 1, 2005, 29 TexReg 11978; amended to be effective February 1, 2006, 31 TexReg 497. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY C LABELING OF HAZARDOUS SUBSTANCES §205.44 Registration Fee for Manufacturers of Hazardous Substances https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96073&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96073 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96073&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96073 03/11/2026 The purpose of these sections is to implement the provisions of the Health and Safety Code, Chapter 485, concerning the retail sale of abusable volatile chemicals. These sections cover definitions, applications for issuance and renewal of permits to sell abusable volatile chemicals, permit fees, and department procedures for approving, denying, and renewing permits. These sections also cover the assessment of administrative penalties. Source Note: The provisions of this §205.51 adopted to be effective August 19, 2002, 27 TexReg 7532. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.51 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118400&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118400 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118400&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118400 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Abusable volatile chemical--(A) A chemical, including aerosol paint that:(i) is packaged in a container subject to the labeling requirements concerning precautions against inhalation established under the Federal Hazardous Substances Act (15 U.S.C. §1261 et seq.), as amended, and regulations adopted under that Act and is labeled with the statement of principal hazard on the principal display panel "VAPOR HARMFUL" or other labeling requirement subsequently established under that Act or by those regulations;(ii) when inhaled, ingested, or otherwise introduced into a person's body, may:(I) affect the person's central nervous system;(II) create or induce in the person a condition of intoxication, hallucination, or elation; or(III) change, distort, or disturb the person's eyesight, thinking process, balance, or coordination; and(iii) is not:(I) a pesticide subject to Agriculture Code, Chapter 76 or to the Federal Environmental Pesticide Control Act of 1972 (7 U.S.C. §136 et seq.), as amended;(II) a food, drug, or cosmetic subject to Health and Safety Code, Chapter 431 or to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.), as amended; or(III) a beverage subject to the Federal Alcohol Administration Act (27 U.S.C. §201 et seq.), as amended; or(B) nitrous oxide that is not:(i) a pesticide subject to Agriculture Code, Chapter 76 or to the Federal Environmental Pesticide Control Act of 1972 (7 U.S.C. §136 et seq.), as amended;(ii) a food, drug, or cosmetic subject to Health and Safety Code, Chapter 431 or to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.), as amended; or(iii) a beverage subject to the Federal Alcohol Administration Act (27 U.S.C. §201 et seq.), as amended.(2) Act--The Abusable Volatile Chemical Act, Health and Safety Code, Chapter 485.(3) Aerosol paint--An aerosolized paint product, including a clear or pigmented lacquer or finish.(4) Commissioner--The commissioner of state health services.(5) Deliver--To make the actual or constructive transfer from one person to another of an abusable volatile chemical, regardless of whether there is an agency relationship. The term includes an offer to sell an abusable volatile chemical.(6) Delivery--The act of delivering.(7) Department--The Texas Department of Health or its successor.(8) Inhalant paraphernalia--Equipment or materials of any kind that are intended for use in inhaling, ingesting, or otherwise introducing into the human body an abusable volatile chemical. The term includes a tube, balloon, bag, fabric, bottle, or other container used to concentrate or hold in suspension an abusable volatile chemical, or vapors of the chemical.(9) Permit--A volatile chemical sales permit.(10) Permit holder--A person who has a valid volatile chemical sales permit.(11) Retailer--Any business or location which sells to the general public, without restrictions to limit purchases to institutional or industrial clients only.(12) Sell--Includes a conveyance, exchange, barter, or trade.(13) Volatile chemical sales permit--A permit authorizing a retailer to sell at retail abusable volatile chemicals. Source Note: The provisions of this §205.52 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.52 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118401&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118401 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118401&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118401 03/11/2026 The department's responsibilities under the Act are carried out through the Texas Department of Health or its successor, Product Safety Division or its successor. Inquiries regarding this Act may be addressed to: Texas Department of Health or its successor, Product Safety Division or its successor, 1100 West 49th Street, Austin, Texas 78756. Source Note: The provisions of this §205.53 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.53 Responsibility for Implementation of Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118402&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118402 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118402&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118402 03/11/2026 (a) A person may not sell an abusable volatile chemical at retail unless the person or the person's employer has, at the time of the sale, a valid volatile chemical sales permit for the location of the sale. A separate permit is required for each location at which an abusable volatile chemical is sold.(1) Prior to January 1, 2005, the term of all permits is one year and expires on the anniversary of the effective date, unless renewed. Effective January 1, 2005, the term of all licenses is two years. Some licenses will be renewed for a one-year term in 2005, in a manner to be determined by the department and two years thereafter; and(2) Texas Online Fees. The department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with processing permit applications specified under this subchapter through Texas Online, in accordance with the Texas Government Code, Chapter 2054, §2054.111 (relating to Use of Texas Online Project).(b) To be eligible for the issuance or renewal of a volatile chemical sales permit, an applicant or permit holder must:(1) hold a valid sales tax permit that has been issued to the applicant;(2) complete and return an application form as required by the department under §205.56 of this title (relating to Permit Application), signing and dating the form attesting to the accuracy of all information contained therein;(3) pay to the department an application or a renewal fee for each location at which an abusable volatile chemical may be sold by the applicant as required by the department under §205.57 of this title (relating to Permit Fee).(c) A permit is not valid if the permit holder has been convicted more than once in the preceding year of any offense that is committed:(1) at the location for which the permit is issued; and(2) under the Health and Safety Code, Chapter 485, §§485.031 - 485.033 (relating to Criminal Acts).(d) In addition to the requirements in subsections (a) and (b) of this section, the following conditions shall be met by permit holders:(1) permit holder shall not sell or deliver abusable volatile chemicals to a person under 18 years of age;(2) permit holder must have the permit or a copy of the permit available for inspection at the location for which the permit is issued following the requirements of §205.59 of this title (relating to Permit Available for Inspection);(3) permit holder shall post a volatile chemical warning sign at the location for which the permit is issued following the requirements of §205.60 of this title (relating to Requirement to Post Warning Sign); and(4) permit holder that displays aerosol paint at the location for which the permit is issued or renewed shall restrict access to the aerosol paint following the requirements of §205.61 of this title (relating to Restriction of Access to Aerosol Paint).(e) A permit may not be transferred to a new location or to a new owner. Source Note: The provisions of this §205.54 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.54 Permit Requirements and Conditions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118403&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118403 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118403&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118403 03/11/2026 (a) The department shall issue a permit to a person who meets the requirements of this section, §205.54 of this title (relating to Permit Requirements and Conditions), §205.56 of this title (relating to Permit Application), and §205.57 of this title (relating to Permit Fee).(b) The permit holder may renew the permit by filing a renewal application accompanied by a renewal fee following the requirements described in subsection (a) of this section.(c) At least 45 days before a permit expires the department, as a service to the permit holder, will send a renewal notice to the last known address of the permit holder. It is the responsibility of the permit holder to keep the department informed of their current mailing address and to timely renew their permit whether or not they have received the notification from the department.(d) If a permit holder submits a completed permit renewal application and fee to the department postmarked on or before the permit expiration date, the existing permit does not expire until the application has been finally determined by the department. If the application is denied or the terms of the new permit are limited, the existing permit does not expire until the last day for seeking review of the agency order or a later date fixed by order of the reviewing court. Source Note: The provisions of this §205.55 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.55 Issuance and Renewal of Permit https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118404&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118404 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118404&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118404 03/11/2026 (a) Application for an initial or renewal permit must be made on an approved application form which may be obtained from the Product Safety Division or its successor, Texas Department of Health or its successor, 1100 West 49th Street, Austin, Texas 78756.(b) A separate application form must be completed and submitted for each specific business location.(c) The application form shall be accurately completed and signed by the applicant or its authorized representative and shall be accompanied by the appropriate permit fee to be considered complete. The department shall notify the applicant of any deficiencies in their application, and shall allow the applicant or permit holder to provide the missing information or permit fee within 30 days of the deficiency letter or the application will be denied under §205.58 of this title (relating to Permit Denial). All blanks on the application form shall be completely filled in or the application may not be processed.(d) The department shall issue or deny a permit for retail sale of abusable volatile chemicals within 60 days after the date on which the department receives the completed application and appropriate fee.(e) The department may, after the filing of an application, require additional information that the department considers necessary to determine whether the permit should be issued. Source Note: The provisions of this §205.56 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.56 Permit Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=123058&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 123058 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=123058&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 123058 03/11/2026 (a) Each application form submitted for a permit shall be accompanied by a fee of $55 for a two-year term.(b) The fee shall be paid by money order, certified check, or personal check and shall be made payable to the Department of State Health Services. Payment in cash shall not be accepted.(c) A separate application fee is required for each retail location.(d) The department may prorate permit fees to provide for a common expiration date on request from persons holding and/or applying for more than one permit. Source Note: The provisions of this §205.57 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective February 1, 2006, 31 TexReg 497. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.57 Permit Fee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118409&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118409 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118409&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118409 03/11/2026 (a) An application for an initial or renewal permit will be denied by the department if the applicant fails to submit a completed application, pay the appropriate permit fee, or provide requested information within 30 days after notification by the department as required under §205.56 of this title (relating to Permit Application) and §205.57 of this title (relating to Permit Fee).(b) If an application is denied, the department shall notify the applicant or permit holder within 60 days of the receipt of the completed application form and appropriate fee. The department shall include in the notice the reasons for the denial. The application fee will not be returned.(c) A proceeding to contest the denial of a volatile chemical sales permit under this section is governed by the Administrative Procedure Act, Texas Government Code, Chapter 2001, and the department's sections on formal hearings, §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures). Source Note: The provisions of this §205.58 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.58 Permit Denial https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96082&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96082 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96082&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96082 03/11/2026 A permit holder must have the volatile chemical sales permit or a copy of the permit available for inspection by the public or the department at each location where the permit holder sells an abusable volatile chemical. Source Note: The provisions of this §205.59 adopted to be effective August 19, 2002, 27 TexReg 7532. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.59 Permit Available for Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118405&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118405 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118405&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118405 03/11/2026 (a) A business establishment that sells abusable volatile chemicals at retail shall display a volatile chemical warning sign, in English and Spanish, that states the following: "It is unlawful for a person to sell or deliver abusable volatile chemicals to a person under 18 years of age. Except in limited situations, such an offense is a state jail felony. It is also unlawful for a person to abuse a volatile chemical by inhaling, ingesting, applying, using, or possessing with intent to inhale, ingest, apply, or use a volatile chemical in a manner designed to affect the central nervous system. Such an offense is a Class B misdemeanor."(b) A current version of the volatile chemical warning sign shall be clearly posted in a conspicuous and prominent place at the location where the permit holder sells abusable volatile chemicals. At a minimum, at least one warning sign must be posted at the location for which the permit is issued. Permit holders may post additional warning signs at multiple sites within this location to ensure that the sign is easily visible to patrons of the establishment.(c) The volatile chemical warning sign shall measure at least 8-1/2 by 11 inches and must be typed, typeset, or mechanically produced with lettering that is clearly legible. The letters shall not be smaller than 12 characters per inch. The word "WARNING" shall be included in bold capital letters at least 1/3 inch high and located above the wording required in subsection (a) of this section.(d) To assist permit holders in complying with subsection (a) of this section, the department shall make warning signs available for use and photocopying by permit holders. Warning signs may be obtained free of charge from the Environmental and Sanitation Licensing Group, Regulatory Licensing Unit, Health Care Quality Section, Division of Regulatory Services, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756.(e) Permit holders may add the following additional information to the warning sign as long as the wording required by subsection (a) of this section is included: the name, address, and telephone number of the business establishment's contact for responding to questions from patrons. Source Note: The provisions of this §205.60 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.60 Requirement to Post Warning Sign https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96079 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96079 03/11/2026 (a) A business establishment that holds a volatile chemical sales permit under §205.54 of this title (relating to Permit Requirements and Conditions) and that displays aerosol paint shall display the paint:(1) in a place that is in the line of sight of a cashier or in the line of sight from a workstation normally continuously occupied during business hours;(2) in a manner that makes the paint accessible to a patron of the business establishment only with the assistance of an employee of the establishment; or(3) in an area electronically protected, or viewed by surveillance equipment that is monitored, during business hours.(b) This section does not apply to a business establishment that has in place a computerized checkout system at the point of sale for merchandise that alerts the cashier that a person purchasing aerosol paint must be 18 years of age or older.(c) This section applies only to a business establishment that is located in a county with a population of 75,000 or more. Source Note: The provisions of this §205.61 adopted to be effective August 19, 2002, 27 TexReg 7532. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.61 Restriction of Access to Aerosol Paint https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96084&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96084 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96084&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96084 03/11/2026 (a) The department may impose an administrative penalty on a person who sells abusable volatile chemicals at retail and who commits a prohibited act under this section; no finding of knowledge is required to impose an administrative penalty, except as noted in subsection (e) of this section.(b) A person commits a prohibited act under this section if the person sells or delivers an abusable volatile chemical to a person who is younger than 18 years of age.(c) It is a defense to the violation listed in subsection (b) of this section if:(1) the abusable volatile chemical that was delivered contains additive material that effectively discourages intentional abuse by inhalation; or(2) the person making the delivery is not the manufacturer of the chemical and the manufacturer of the chemical failed to label the chemical with the statement of principal hazard on the principal display panel "VAPOR HARMFUL" or other labeling requirement subsequently established under the Federal Hazardous Substances Act (15 U.S.C. §1261 et seq.), as amended, or regulations subsequently adopted under that Act.(d) It is an affirmative defense to the violation listed in subsection (b) of this section if:(1) the person making the delivery is an adult having supervisory responsibility over the person younger than 18 years of age and:(A) the adult permits the use of the abusable volatile chemical only under the adult's direct supervision and in the adult's presence and only for its intended purpose; and(B) the adult removes the chemical from the person younger than 18 years of age on completion of that use; or(2) the person to whom the abusable volatile chemical was sold or delivered presented to the seller at retail an apparently valid Texas driver's license or an identification certificate, issued by the Department of Public Safety of the State of Texas and containing a physical description consistent with the person's appearance, that purported to establish that the person was 18 years of age or older.(e) A person commits a prohibited act under this section if the person delivers or sells inhalant paraphernalia and at the time of the act knows or should have known that the person who receives or is intended to receive the paraphernalia intends that it be used to inhale, ingest, apply, use, or otherwise introduce into the human body a substance containing a volatile chemical. Source Note: The provisions of this §205.62 adopted to be effective August 19, 2002, 27 TexReg 7532. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.62 Prohibited Acts https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118406&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118406 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118406&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118406 03/11/2026 (a) The department shall monitor and enforce compliance with the Act and any rule or order adopted by the commissioner or department to administer the Act.(b) Compliance inspections or investigations may be conducted by a department representative during normal operating hours to determine if a person is in violation of the Act or a rule or order adopted by the commissioner or department to administer the Act.(c) A department representative, upon presenting the department identification card, shall have the right to enter all retail facilities during normal operating hours to inspect and investigate for compliance with these sections, including to review records, to question any person, or to locate or identify abusable volatile chemicals held for retail sale.(d) A department representative is not required to notify in advance or seek permission to conduct inspections or investigations. It is a violation of this chapter for a person to interfere with, deny, or delay an inspection or investigation conducted by a department representative. Source Note: The provisions of this §205.63 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.63 Compliance Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96086&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96086 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96086&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96086 03/11/2026 (a) The department may assess an administrative penalty against a person who sells an abusable volatile chemical at retail who violates the Act or a rule or order adopted under this Act.(b) A penalty collected under this subchapter shall be deposited in the state treasury in the general revenue fund.(c) The amount of the penalty may not exceed $1,000 for each violation, and each day a violation continues or occurs is a separate violation for purposes of imposing a penalty. The total amount of the penalty assessed for a violation continuing or occurring on separate days under this subsection may not exceed $5,000.(d) In determining the amount of the administrative penalty, the department shall consider:(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;(2) the threat to health or safety caused by the violation;(3) the history of previous violations;(4) the amount necessary to deter a future violation;(5) whether the violator demonstrated good faith, including when applicable whether the violator made good faith efforts to correct the violation; and(6) any other matter that justice may require.(e) Violations will be classified in one of three severity levels.(1) Critical Violation. Severity Level III includes violations that are most significant and have a direct negative impact on public health and safety. The penalty for a Level III violation on first occurrence is up to $1000 per day, per violation. The same violation continuing for more than one day is a separate violation. Examples of Level III violations include but are not limited to:(A) operating without a valid volatile chemical sales permit for the location at which abusable volatile chemicals are sold in violation of §205.54 of this title (relating to Permit Requirements and Conditions);(B) operating under a permit issued to another person or for another location, in violation of §205.54 of this title;(C) falsifying information required on the volatile chemical sales permit application under §205.56 of this title (relating to Permit Application);(D) failing to establish controls to restrict a person under the age of 18 years from access to aerosol paints displayed for retail sale at a business establishment as required under §205.61(a) of this title (relating to Restriction of Access to Aerosol Paint);(E) interfering with, denying, or delaying department representatives in conducting an inspection at the location at which abusable volatile chemicals may be sold as required under §205.63 of this title (relating to Compliance Inspections); or(F) committing any of the prohibited acts listed under §205.62 of this title (relating to Prohibited Acts).(2) Serious violation. Severity Level II includes violations that are significant and which, if not corrected, could threaten public health and safety. The penalty for a Level II violation on first occurrence is up to $750 per day, per violation. The same violation continuing for more than one day constitutes a separate violation. Examples of Level II violations include, but are not limited to:(A) failing to have a volatile chemical sales permit available for inspection by the public or department as required under §205.59 of this title (relating to Permit Available for Inspection);(B) failing to display a volatile chemical warning sign as required under §205.60(a) of this title (relating to Requirement to Post Sign); or(C) failing to ensure that the controls established under §205.61(a) of this title (relating to Restriction of Access to Aerosol Paint) are adequate to restrict a person under the age of 18 from access to aerosol paints.(3) Significant violation. Severity Level I includes violations that are of more than minor significance and, if left uncorrected, could lead to more serious circumstances. The penalty for a Level I violation on first occurrence is up to $500 per day, per violation. The same violation continuing for more than one day constitutes a separate violation. Examples of Level I violations include, but are not limited to:(A) failing to post a volatile chemical warning sign in a conspicuous and prominent place as required under §205.60(b) of this title; or(B) posting a volatile chemical warning sign that does not comply with the requirements under §205.60(c) of this title. Source Note: The provisions of this §205.64 adopted to be effective August 19, 2002, 27 TexReg 7532. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.64 Administrative Penalty https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96087&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96087 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=96087&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 96087 03/11/2026 (a) If the department initially determines that a violation occurred, the department shall give written notice of the report by certified mail to the person.(b) The notice must include:(1) a brief summary of the alleged violation;(2) a statement of the amount of the proposed penalty; and(3) a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both.(c) Not later than the 20th day after the date on which the notice is received, the person notified may, in writing:(1) accept the determination and recommended penalty of the department;(2) request a settlement conference; or(3) request a hearing on the occurrence of the violation, the amount of the penalty, or both. A person may request both a settlement conference and a hearing in the same letter.(d) If the person accepts the determination and recommended penalty or if the person fails to respond in a timely manner to the notice, the commissioner or the commissioner's designee shall issue an order approving the determination and imposing the recommended penalty. Source Note: The provisions of this §205.65 adopted to be effective August 19, 2002, 27 TexReg 7532. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.65 Notice of Violation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118407&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118407 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118407&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118407 03/11/2026 A proceeding to impose the penalty is considered to be a contested case subject to the Administrative Procedure Act, Texas Government Code Chapter 2001, the department's sections on formal hearings, §§1.21, 1.23, 1.25 and 1.27, and the provisions of the Act found in the Health and Safety Code, Chapter 485, Subchapter D. Source Note: The provisions of this §205.66 adopted to be effective August 19, 2002, 27 TexReg 7532; amended to be effective January 1, 2005, 29 TexReg 11979. 1 DEPARTMENT OF STATE HEALTH SERVICES 205 PRODUCT SAFETY D INHALANT ABUSE §205.66 Administrative Hearing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205017 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205017 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Abnormalities of milk--The following types of lacteal secretions are not suitable for sale:(A) abnormal milk that is visibly changed in color, odor, or texture; or(B) undesirable milk expected to be unsuitable for consumption, such as milk containing colostrum or blood; or(C) contaminated milk unfit for human consumption due to treatment of the animal with any products not labeled for lactating dairy animals, antibiotics which have not met the withhold requirements, or treatment with medicines or insecticides not approved for use on dairy animals by the United States Food and Drug Administration (FDA) or the Environmental Protection Agency.(2) Acidified milk--The food produced by souring cream, milk, partially skimmed milk, or skim milk or any combination, with acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-lactone, hydrochloric acid, lactic acid, malic acid, phosphoric acid, succinic acid, or tartaric acid, with or without the addition of characterizing microbial organisms. Acidified milk is further defined in Title 21, Code of Federal Regulations (CFR), §131.111.(3) Acidified sour cream--The product resulting from the souring of pasteurized cream with safe and suitable acidifiers, with or without addition of lactic acid producing bacteria, and as further defined in Title 21, CFR, §131.162.(4) Adulterated milk and milk products--Any milk or milk product shall be deemed to be adulterated if:(A) it bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health;(B) it bears or contains any added poisonous or deleterious substance for which no safe tolerance has been established by State or Federal regulation, or in excess of such tolerance if one has been established;(C) it consists, in whole or in part, of any substance unfit for human consumption;(D) it has been produced, prepared, packed, or held under unsanitary conditions;(E) its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;(F) any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight or reduce its quality or strength or make it appear better or of greater value than it is;(G) any milk or milk product shall be deemed to be adulterated if one or more of the conditions described in the Federal Food, Drug and Cosmetic Act, §402, as amended (21 U.S.C. §342) exist; or(H) it is deemed by the department to be abnormal milk.(5) Approved Source--A supply of food or products that complies with applicable state and federal laws and is licensed, if required, and inspected by the regulatory authority having jurisdiction over the processing and distribution of food or products.(6) Aseptic processing--The term "aseptic processing," when used to describe a milk product, means that the product has been subjected to sufficient heat processing, and packaged in a hermetically sealed container, to conform to the applicable requirements of Title 21, CFR, Part 113 and maintain the commercial sterility of the product under normal non-refrigerated conditions.(7) Aseptically processed milk and milk products--Products hermetically sealed in a container and so thermally processed in conformance with Title 21, CFR, Part 113 and the provisions of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Adopted Regulations and Standards), so as to render the product free of microorganisms capable of reproducing in the product under normal non-refrigeration conditions of storage and distribution. The product shall be free of viable microorganisms (including spores) of public health significance.(8) Automatic milking installation (AMI)--The entire installation of one or more milking units, including the hardware and software utilized in the operation of individual automatic milking units, the animal selection system, the automatic milking machine, the milk cooling system, the system for cleaning and sanitizing the automatic milking unit, the teat cleaning system, and the alarm systems associated with the process of milking, cooling, cleaning, and sanitization.(9) Batch number--A designation that is printed on the label of the milk product that allows the history of its production and packaging to be traced.(10) Bulk milk hauler/sampler--A bulk milk hauler/sampler is any person who collects official samples and may transport raw milk from a farm and/or raw milk products to or from a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer, and has in his or her possession a certification from the department.(11) Bulk milk pickup tanker--A vehicle, including the truck, tank and those appurtenances necessary for its use, used by a milk hauler to transport bulk raw milk for pasteurization from a dairy farm to a milk plant, receiving station, or transfer station.(12) Certified milk sampler--Any industry personnel, other than the milk hauler or dairy plant sampler who collects milk or stores an official milk sample.(13) C-I-P or cleaned-in-place--The procedure by which sanitary pipelines or pieces of equipment are mechanically cleaned-in-place by circulation.(14) Concentrated (condensed) milk--A fluid product, unsterilized and unsweetened, resulting from the removal of a considerable portion of the water from the milk, which, when combined with potable water in accordance with instructions printed on the container, results in a product conforming to the milkfat and milk solids not fat levels of milk as defined in this section.(15) Concentrated (condensed) milk products--Homogenized concentrated (condensed) milk, concentrated (condensed) skim milk, concentrated (condensed) low fat milk, and similar concentrated (condensed) products made from concentrated (condensed) milk or concentrated (condensed) skim milk, and which, when combined with potable water in accordance with instructions printed on the container, conform to the definitions of the corresponding milk products in this section.(16) Cream--The liquid milk product, high in milkfat, separated from milk, which may have been adjusted by adding thereto: milk, concentrated (condensed) milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk, and contains not less than 18% milkfat.(17) Cultured milk--The food produced by culturing cream, milk, partially skimmed milk, or skim milk, used alone or in combination with characterizing microbial organisms. Cultured milk is further defined in Title 21, CFR, §131.112.(18) Dairy farm--Any place or premises where one or more cows or goats are kept, and from which a part or all of the milk or milk products is provided, sold, or offered for sale to a milk plant or transfer station.(19) Dairy plant sampler--A department employee responsible for the collection of official samples for regulatory purposes.(20) Dairy product--Butter, cheese, dry cream, plastic cream, dry whole milk, nonfat dry milk, dry buttermilk, dry whey, whey protein concentrates, evaporated milk (whole or skim), condensed whole milk and condensed skim milk (plain or sweetened), and such other products derived from milk, as may be specified under the statutory standard for butter (Title 21, U.S.C. Part 321a), and the Federal Standards of Identity for Cheese and Related Cheese Products (Title 21, CFR, Part 133).(21) Department--The Department of State Health Services, the Commissioner of Health, or an authorized representative of the Commissioner.(22) Distributor--Any person who offers for sale or sells to another person any pasteurized milk, pasteurized milk products, dairy product, or frozen dessert product.(23) Drug--The term "drug" includes:(A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States or official National Formulary, or any supplement to any of them;(B) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals;(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and(D) articles intended for use as a component of any articles specified in subparagraphs (A), (B) or (C) of this paragraph, but does not include devices or their components, parts or accessories.(24) Eggnog--The food containing cream, milk, partially skimmed milk, or skim milk, used alone or in combination, liquid egg yolk, frozen egg yolk, dried egg yolk, liquid whole eggs, frozen whole eggs, dried whole eggs, or any one or more of the foregoing egg yolk containing products with liquid egg white or frozen egg white, and a nutritive carbohydrate sweetener. Eggnog is further defined in Title 21, CFR, §131.170.(25) Federal Food, Drug, and Cosmetic Act--The United States laws pertaining to food, drugs, and cosmetics as specified in 21 U.S.C. §301, et seq.(26) Food allergen--A major food allergen is:(A) milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or(B) a food ingredient that contains protein derived from a food specified in subparagraph (A) of this paragraph, except the following:(i) any highly refined oil derived from a food specified in subparagraph (A) of this paragraph, and any ingredient derived from such highly refined oil; or(ii) a food ingredient that is exempt under U.S.C. Title 21 Chapter 9, Subchapter IV, §343(w)(6) and (7).(27) Food allergen cross-contact--The unintentional incorporation of a food allergen into a food.(28) Freezer--A piece of equipment which converts mix and/or other ingredients to a hardened or semi-hardened state using the technique of freezing during processing or manufacturing of those products commonly known as ice cream, ice cream mix, frozen dessert, frozen dessert mix, and nondairy frozen dessert mix.(29) Frozen dessert--Any of the following: ice cream, light ice cream, ice milk, frozen custard, fruit sherbet, non-fruit water ice, frozen dietary dairy dessert, frozen yogurt, quiescently frozen confection, quiescently frozen dairy confection, mellorine, lorine, parevine, freezer-made milk shake, or nondairy frozen dessert. The term also includes mix used in the freezing of one of those frozen desserts.(30) Frozen dessert manufacturer or plant--A person who manufactures, processes, converts, partially freezes or freezes any mix, be it dairy, nondairy frozen desserts for distribution or sale at wholesale. This definition shall not include a frozen dessert retail establishment.(31) Frozen dietary dairy dessert and frozen dietary dessert--A food for any special dietary use, prepared by freezing, with or without agitation, composed of a pasteurized mix which may contain fat, protein, carbohydrates, flavoring, stabilizers, emulsifiers, vitamins, and minerals.(32) Frozen low fat yogurt and mix (also called low fat frozen yogurt)--Complies with the provisions of frozen yogurt, except that:(A) the milk fat content of the finished food is not less than 0.5%, but not more than 2.0%; and(B) the name of the food is "frozen low fat yogurt."(33) Frozen low fat yogurt dry mix--The unfrozen dry powdered combination of ingredients which, when combined with potable water and when frozen while stirring, will produce a product conforming to the definition of frozen low fat yogurt.(34) Frozen milk concentrate--A frozen milk product with a composition of milkfat and milk solids not fat in such proportions that when a given volume of concentrate is mixed with a given volume of water the reconstituted product conforms to the milkfat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported, and sold in the frozen state.(35) Frozen skim milk yogurt--Complies with the provision of frozen yogurt, except that:(A) the milkfat content of the finished food is less than 0.5%; and(B) the name of the food is either "frozen skim milk yogurt" or "frozen nonfat yogurt."(36) Frozen yogurt--(A) Frozen yogurt is the food which is prepared by freezing, while stirring, a mix composed of one or more of the optional dairy ingredients provided for in ice cream and frozen custard, and which may contain other safe and suitable ingredients.(B) The dairy ingredient(s), with or without other ingredients, is/are pasteurized and subsequently cultured with bacterial cultures acceptable to the state health authority.(C) The titratable acidity of the cultured frozen yogurt is not less than 0.5%, calculated as lactic acid, except if the frozen yogurt is flavored by the addition of a non-fruit characterizing ingredient(s).(D) The milkfat content of frozen yogurt is not less than 3.25% by weight, except that when bulky characterizing ingredients are used the percentage milkfat is not less than 2.5%.(E) The finished frozen yogurt shall weigh not less than five pounds per gallon.(F) The name of the food is "frozen yogurt."(37) Goat milk--The normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one or more healthy goats. Goat milk sold in retail packages shall contain not less than 2.5% milkfat and not less than 7.5% milk solids not fat. The word "milk" includes goat milk.(38) Goat milk ice cream--The food defined in Title 21, CFR, §135.115.(39) Grade A dry milk and whey products--Products which have been produced for use in Grade A pasteurized or aseptically processed milk products and which have been manufactured under the provisions of the most current revision of the "Grade A Pasteurized Milk Ordinance."(40) Grade A Pasteurized Milk Ordinance--The document published by the United States Department of Health and Human Services, Public Health Service/Food and Drug Administration. The document consists of the following parts: The Grade A Pasteurized Milk Ordinance with Administrative Procedures; illustrations, tables, supplements, appendices; and an index. Copies are on file in the Milk Group, Consumer Protection Division, Department of State Health Services, 8407 Wall Street, Austin, Texas, and are available for review during normal business hours. For purposes of this chapter, "U.S. Public Health Services Grade A Pasteurized Milk Ordinance" is an equivalent term.(41) Grade A raw milk and Grade A raw milk products--Milk products that are manufactured in compliance with the provisions of Subchapter B of this chapter (relating to Grade A Raw Milk and Raw Milk Products), and are offered for sale to the public without pasteurization.(A) These products include, but are not limited to plain raw milk, raw flavored milk, raw low-fat milk, raw low-fat flavored milk, raw skim milk, raw skim flavored milk, raw cultured milk, raw cultured low fat milk, raw cultured skim milk, raw cream, raw heavy cream, raw light cream, raw sour cream, raw acidified sour cream, raw cultured sour cream, raw light whipping cream, raw heavy whipping cream, raw whipped cream, raw light whipped cream, raw plain yogurt, raw flavored yogurt, raw low fat yogurt, raw nonfat yogurt, raw drinkable yogurt, raw drinkable probiotic yogurt, raw buttermilk, raw half-and-half, raw sour half-and-half, raw acidified sour half-and-half, raw cultured sour half-and-half, raw eggnog, raw whey, raw flavored whey, raw whey protein, raw flavored whey protein, and raw keifer.(B) Grade A raw milk and raw milk products do not include the following.(i) Infant formula, ice cream or other frozen desserts, butter, or raw cheese that is not aged a minimum of 60 days.(ii) Raw milk or raw milk products that are a blend of raw milk from more than one raw milk processer dairy farm.(42) Grade A raw milk processor--A person who processes milk as defined in paragraph (55) of this section, that is produced in compliance with the provisions of Subchapter B of this chapter and is offered for sale to the public without pasteurization.(43) Grade A raw milk processor dairy farm--Any place or premise where one or more lactating animals (cows, goats, sheep, water buffalo, or other hooved animals) are kept, and from which a part of or all the raw milk and raw milk products are produced, processed, bottled, and offered, sold, or offered for sale to the public.(44) Half-and-half--The food consisting of a mixture of milk and cream which contains not less than 10.5% but less than 18% milkfat. Half-and-half is further defined in Title 21, CFR, §131.180.(45) Heavy cream or heavy whipping cream--Cream which contains not less than 36% milkfat and as further defined in Title 21, CFR, §131.150.(46) Hermetically sealed container--A container that is designed and intended to be secure against the entry of microorganisms and thereby maintain the commercial sterility of its contents after processing.(47) Homogenized--Milk or a milk product has been treated to ensure breakup of the fat globules to such an extent that, after 48 hours of quiescent storage at 4.4 degrees Celsius (40 degrees Fahrenheit), no visible cream separation occurs on the milk; and the fat percentage of the top 100 milliliters of milk in a quart, or of proportionate volumes in containers of other sizes, does not differ by more than 10% from the fat percentage of the remaining milk as determined after thorough mixing.(48) Ice cream and frozen custard--The foods defined in Title 21, CFR, §135.110.(49) Label--A display of written, printed, or graphic matter upon the immediate container of a product or wrappers accompanying such a container.(50) Light cream--Cream which contains not less than 18% but less than 30% milkfat, and as further defined in Title 21, CFR, §131.155.(51) Light whipping cream--Cream which contains not less than 30% but less than 36% milkfat, and as further defined in Title 21, CFR, §131.157.(52) Lorine--The food prepared from the same ingredients and in the same manner prescribed for mellorine and complies with all the provisions for mellorine except that:(A) its content of fat is at least 2% but less than 6%;(B) its content of milk solids not fat is not less than 10%;(C) caseinates may be added when the content of total milk solids is not less than 10%;(D) the provision for reduction in fat and milk solids not fat from the addition of bulky ingredients in mellorine does not apply;(E) the quantity of food solids per gallon is not less than 1.2 pounds; and(F) the name of the food is "Lorine."(53) Low fat yogurt--The food produced by culturing cream, milk, partially skimmed milk, or skim milk, used alone or in combination with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. Low fat yogurt is further defined in Title 21, CFR, §131.203.(54) Mellorine--The food defined in Title 21, CFR, §135.130(a) - (d).(55) Milk--The lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, sheep, goats, water buffaloes or other hooved animals, and as further defined in Title 21, CFR, §131.110.(56) Milk hauler--A person who transports raw milk and raw milk products to or from a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(57) Milk plant--Any place, premises or establishment where milk or milk products are collected, handled, processed, dried, stored, pasteurized, ultra-pasteurized aseptically processed, bottled, or prepared for distribution. This term also means a processing plant, manufacturing plant, or bottling plant in these sections.(58) Milk producer--Any person who operates a producer dairy farm and provides, sells, or offers milk for sale to a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(59) Milk products--(A) Milk products include cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated (condensed) milk, concentrated (condensed) milk products, reduced fat milk, nonfat (skim) milk, low fat milk, frozen milk concentrate, eggnog, buttermilk, cultured milk, cultured low fat milk, cultured nonfat (skim) milk, yogurt, low fat yogurt, nonfat yogurt, acidified milk, acidified low fat milk, acidified nonfat (skim) milk, low-sodium milk, low-sodium low fat milk, low-sodium nonfat (skim) milk, lactose-reduced milk, lactose-reduced low fat milk, lactose-reduced nonfat (skim) milk, aseptically processed and packaged milk and milk products as defined in this section, milk, low fat milk, or nonfat (skim) milk with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification of milk products defined herein.(B) Milk products also include those dairy foods made by modifying the federally standardized products listed in this section in accordance with Title 21, CFR, §130.10, Requirements for foods named by use of nutrient content claim and standardized term.(C) This definition shall include those milk and milk products, as defined herein, which have been aseptically processed and then packaged.(D) Milk and milk products which have been retort processed after packaging or which have been concentrated, condensed, or dried are included in this definition only if they are used as an ingredient to produce any milk or milk product defined herein, or if they are labeled as Grade A.(E) This definition is not intended to include dietary products (except as defined herein), infant formula, ice cream or other desserts, butter, or cheese.(60) Milk tank truck--The term used to describe both a bulk milk pickup tanker and a milk transport tank.(61) Milk tank truck cleaning facility--Any place, premise, or establishment, separate from a milk plant, receiving, or transfer station, where a milk tank truck is cleaned and sanitized.(62) Milk tank truck driver--A milk tank truck driver is any person who transports raw or pasteurized milk products to or from a milk plant, receiving station, or transfer station. Any transportation of a direct farm pickup requires the milk tank truck driver to have responsibility for accompanying official samples.(63) Milk transport tank or tanker--A vehicle, including the truck and tank, used by a milk hauler to transport bulk shipments of milk from a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer to another milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(64) Milk transportation company--An entity responsible for ensuring milk tank trucks are in compliance with the provisions of Subchapter D of this chapter (relating to Bulk Milk Regulations).(65) Misbranded milk and milk products--Milk and milk products are misbranded if:(A) their container bears or is accompanied by any false or misleading written, printed, or graphic matter;(B) milk labeling does not conform to the definitions as contained in this chapter;(C) they are not labeled in accordance with §217.24 of this title (relating to Labeling) for Grade A Raw Milk and Raw Milk Products; §217.43 of this title (relating to Labeling) for Rules for the Manufacture of Frozen Desserts; and §217.81 of this title (relating to Labeling) for Dairy Products and Milk for Manufacturing Purposes; or(D) one or more of the conditions described in the Federal Food, Drug and Cosmetic Act, §403, as amended (21 U.S.C. §343) exists.(66) Multi-use container--Any container having a product-contact surface and used in the packaging, handling, storing, or serving of milk or milk products, which, if it remains in good repair and is properly washed and sanitized, may be utilized for multiple usage.(67) Nondairy frozen dessert--(A) Nondairy frozen dessert is the food which is prepared by freezing, while stirring, a nondairy frozen dessert mix composed of one or more of the optional characterizing ingredients specified in subparagraph (B) of this paragraph, sweetened with one or more of the optional sweetening ingredients specified in subparagraph (C) of this paragraph. The nondairy product, with or without water added, may be seasoned with salt. One or more of the ingredients specified in subparagraph (D) of this paragraph may be used. Pasteurization is not required. The optional caseinates specified in subparagraph (D)(i) of this paragraph are deemed not to be dairy products.(B) The optional flavoring ingredients referred to in subparagraph (A) of this paragraph are natural and artificial flavoring and characterizing food ingredients.(C) The optional sweetening ingredients referred to in subparagraph (A) of this paragraph are sugar (sucrose), dextrose, invert sugar (paste or syrup), glucose syrup, dried glucose syrup, corn sweetener, dried corn sweetener, malt syrup, malt extract, dried malt syrup, dried malt extract, maltose syrup and dried maltose syrup.(D) Other optional ingredients referred to in subparagraph (A) of this paragraph are:(i) casein prepared by precipitation with gums, ammonium, caseinate, calcium caseinate, potassium caseinate, or sodium caseinate;(ii) hydrogenated and partially hydrogenated vegetable oil;(iii) dipotassium phosphate;(iv) coloring, including artificial coloring;(v) monoglycerides, diglycerides, or polysorbates; and(vi) thickening ingredients such as agar-agar, algin (sodium alginate), egg white, gelatin, gum acacia, guar seed gum, gum karaya, locus bean gum, oat gum, gum tragacanth, hydroxypropyl, cethyl cellulose, carrageenan, salts of carrageenan, furcelleran, salts of furcelleran, propulene glycol alginate, pectin, psyllium seed husk, and sodium carvoxymethylcellulose.(E) Such nondairy frozen desserts are deemed "processed" when manufactured as a dry powdered mix. The addition of water is merely the manner in which such nondairy frozen desserts are served.(F) The label shall comply with labeling requirements for frozen desserts with the additional clear and concise statement that the product is nondairy.(68) Nonfat yogurt--The food produced by culturing skim milk, used alone or in combination with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. Nonfat yogurt is further defined in Title 21, CFR, §131.206.(69) Non-grade A dairy product manufacturer--Any place, premise, or establishment where dairy products are produced or prepared for distribution for human consumption but is not subject to Grade A requirements.(70) Novelties--Frozen desserts, either alone or in combination with other foods such as cookies, wafers, cones, coating, confections, etc., which are packaged in single-serving units.(71) Official laboratory--A biological, chemical or physical laboratory which is under the supervision of the department conducting the analysis of milk, milk products, milk for manufacturing, or frozen dessert. Full service laboratories are official laboratories.(72) Officially designated laboratory--A commercial laboratory or a milk industry laboratory officially designated by the department for the analysis of milk, milk products, milk for manufacturing, or frozen desserts.(73) Overrun--The increase in volume of frozen product over the volume of the mix due to air being whipped into the product during the freezing process. It is expressed as a percent of the volume of the mix.(74) Pasteurization--(A) The process of heating every particle of milk or milk product, in properly designed and operated equipment, and held continuously at or above a certain temperature for at least the corresponding specified time referenced in the most current revision of the "Grade A Pasteurized Milk Ordinance."(B) Provided further, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by the FDA as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.(75) Permit--A license or certification to engage in the activity listed on the permit, license, or certificate.(76) Person--The word "person" shall include any individual, plant operator, partnership, corporation, company, firm, trustee, association, or institution.(77) Principal Display Panel--The part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.(78) Producer dairy farm--Any place or premises where one or more lactating animals (cows, goats or sheep, water buffalo, or other hooved animal) are kept, and from which a part or all of the milk or milk products is provided, sold, or offered for sale to a milk plant, transfer station, receiving station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(79) Quiescently frozen confection--A clean and wholesome frozen, sweetened, flavored product in the manufacture of which freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). This confection may be acidulated with food grade acid, may contain water, may be made with or without added natural or artificial flavoring, and with or without harmless coloring. The finished product contains not less than 17% by weight of total food solids. No processing or mixing shall be used that develops in the finished food mix any physical expansion in excess of 10%.(80) Quiescently frozen dairy confection--A clean and wholesome frozen product made from water, milk products and sugar, with added harmless natural or artificial flavoring, with or without added coloring, with or without added stabilizer, with or without added emulsifier; and in the manufacture of which freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). It contains not less than 13% by weight of total milk solids, and not less than 33% by weight of total food solids. In the production of quiescently frozen dairy confections, no processing or mixing before quiescently freezing is used that develops in the finished confection mix any physical expansion in excess of 10%.(81) Receiving station--Any place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.(82) Reconstituted or recombined milk and milk products--Milk or milk products defined in this section which result from reconstituting or recombining of milk constituents with potable water when appropriate.(83) Regulatory agency--The Department of State Health Services. For purposes of this chapter, Texas Department of Health is an equivalent term.(84) Safe and suitable--Ingredients which perform an appropriate function in the food in which they are used, and are used at a level no higher than necessary to achieve their intended purpose in the food.(85) Sale--The term "sale" or "sell" means a monetary transaction, barter, offer, or trade that involves the transfer of milk, milk products, raw milk, raw milk products, dairy products, or frozen dessert products. The term also includes transactions conducted as part of animal shares or animal pools, unless it involves the transfer of milk from the farmer to a person holding an ownership interest in the producing animals, who shares costs in proportion to their ownership interest, and only receives milk in proportion to their ownership interest as memorialized in a written agreement.(86) Sanitization--The application of any effective method or substance to a clean surface for the destruction of pathogens and other organisms as far as is practicable. Such treatment shall not adversely affect the equipment, the milk or milk product, or the health of consumers, and shall be acceptable to the regulatory agency.(87) Sherbet--The food defined in Title 21, CFR, §135.140.(88) Single service container--Any container having a milk product or frozen dessert, in contact with the containers surface and used in the packaging, handling, storing, or serving frozen desserts and/or milk products, which is intended for one usage only.(89) Sour cream or cultured sour cream--The product resulting from the souring, by lactic acid producing bacteria, of pasteurized cream, and as further defined in Title 21, CFR, §131.160.(90) Standard methods--Reference to the latest edition of "Standard Methods for the Examination of Dairy Products," a publication of the American Public Health Association, Washington, D.C.(91) Sterilized--The condition of piping equipment and containers achieved by the application of heat, chemical sterilant(s), or other appropriate treatment that renders the piping, equipment, and containers free of viable microorganisms.(92) 3-A Sanitary Standards and Accepted Practices--The standards for dairy equipment and accepted practices formulated by the 3-A Steering Committee representing the International Association for Food Protection, the U.S. Public Health Service, and the Dairy Industry Committee that are published by the International Association of Milk, Food, and Environmental Sanitarians, 6200 Aurora Avenue, #200W, Des Moines, Iowa 50322.(93) 3-A Steering Committee--The committee composed of appointees from the International Association for Food Protection, and the Food and Drug Administration/Public Health Service that reviews and establishes standards for production and processing equipment intended for use in this country.(94) Thermometer--A temperature measuring device that is either mercury-in-glass, alcohol/spirit-in-glass, electronic/digital, or dial immersed in liquid and accurate within the appropriate range of designated use.(95) Transfer station--Any place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.(96) Ultra-pasteurized--The term "ultra-pasteurized," when used to describe a dairy product, means that such product shall have been thermally processed at or above 138 degrees Celsius (280 degrees Fahrenheit) for at least two seconds, either before or after packaging, so as to extend a product shelf life under refrigerated conditions.(97) Unloading station--Any receiving station, transfer station, or milk processing plant where milk or milk products are unloaded from milk tank trucks.(98) Water ices--The foods defined in Title 21, CFR, §135.160.(99) Whipped cream--Cream or light whipping cream, into which air or gas has been incorporated.(100) Whipped light cream--Light cream into which air or gas has been incorporated.(101) Yogurt--The food produced by culturing cream, milk, partially skimmed milk, or skim milk, used alone or in combination with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. Yogurt is further defined in Title 21, CFR, §131.200. Source Note: The provisions of this §217.1 adopted to be effective July 4, 2010, 35 TexReg 3038; amended to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY A GRADE SPECIFICATIONS AND REQUIREMENTS FOR MILK §217.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225724&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225724 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225724&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225724 03/11/2026 (a) The Department of State Health Services (DSHS) adopts by reference the most current revision of the "Grade A Pasteurized Milk Ordinance," published by the United States Department of Health and Human Services, Public Health Service/Food and Drug Administration.(b) DSHS adopts by reference the most current revision of 21 Code of Federal Regulations (CFR) Part 117, Subpart A, General Provisions, Subpart B, Current Good Manufacturing Practice, and Subpart C, Hazard Analysis and Risk-Based Preventative Controls.(c) DSHS adopts by reference the most current revision of the documents published by the United States Department of Health and Human Services, Public Health Service/Food and Drug Administration entitled:(1) Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments;(2) Methods for Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Product Manufacturers; and(3) Evaluation of Milk Laboratories. Source Note: The provisions of this §217.2 adopted to be effective July 4, 2010, 35 TexReg 3038; amended to be effective May 17, 2021, 46 TexReg 3128; amended to be effective August 3, 2025, 50 TexReg 4935. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY A GRADE SPECIFICATIONS AND REQUIREMENTS FOR MILK §217.2 Adopted Regulations and Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205019 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205019 03/11/2026 The purpose of these rules is to regulate the production, handling, sampling, examination, grading, labeling and sale of Grade A raw milk and Grade A raw milk products at the dairy farm; the inspection of dairy herds and dairy farms; and the issuing and revocation of permits and related penalties. Source Note: The provisions of this §217.21 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.21 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205021&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205021 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205021&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205021 03/11/2026 No person shall, within the State of Texas, produce, sell, offer for sale, or have in possession with intent to sell, any milk or milk product which is adulterated, misbranded, or ungraded. Source Note: The provisions of this §217.22 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.22 Adulterated or Misbranded Milk or Milk Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205022&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205022 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205022&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205022 03/11/2026 A person must have a permit to sell or provide Grade A raw milk and Grade A raw milk products. A person must comply with the provisions of this subchapter to receive a Grade A Raw for Retail Milk permit. Source Note: The provisions of this §217.23 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.23 Permits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205023&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205023 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205023&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205023 03/11/2026 (a) All bottles, containers, and packages enclosing Grade A raw milk and Grade A raw milk products as defined in §217.1(41) of this title (relating to Definitions) must be conspicuously labeled immediately upon bottling on the principal display panel to include:(1) the product name, which must contain the phrase "Grade A Raw" and include the product name as given in the definition in §217.1(41) of this title;(2) the batch number of the Grade A raw milk or Grade A raw milk products, which must consist of the date the Grade A raw milk or Grade A raw milk product was bottled or packaged;(3) the quantity of the contents;(4) the name, address, zip code, telephone number, and permit number of the Grade A raw milk processor;(5) all ingredients listed in descending order of predominance;(6) any allergens that must be identified with bold letters in the ingredient statement or having a "Contains" statement immediately after the ingredient statement; and(7) the following statement: "This product contains unpasteurized milk. Consuming raw foods, including raw dairy products, may increase your risk of foodborne illness. Persons at higher risk for foodborne illness include pregnant and nursing women, children, the elderly, and people with weakened immune systems."(b) Labeling information is required on all bottles, containers or packages of Grade A raw milk and Grade A raw milk products and must be in letters of an acceptable size, font, and color satisfactory to the department and must contain no marks or words which are misleading. All labeling must be easily legible under ordinary conditions of purchase. All labeling on Grade A raw milk and Grade A raw milk product containers must be approved by the department before the distribution or sale of the Grade A raw milk or Grade A raw milk product. Source Note: The provisions of this §217.24 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.24 Labeling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205020&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205020 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205020&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205020 03/11/2026 (a) Each Grade A raw milk processor dairy farm whose milk is produced and intended for consumption within the State of Texas must be inspected by the department before the issuance of a permit.(b) Following the issuance of a permit, each Grade A raw milk processor dairy farm shall be inspected at least quarterly by the department.(c) A violation of the requirements set forth in §217.27 of this title (relating to Standards for Grade A Raw Milk and Raw Milk Products) shall be denoted on the Grade A raw milk processor dairy farm inspection form.(d) A copy of the most recent inspection report must be posted in a conspicuous place on an inside wall of the Grade A raw milk processor dairy farm.(e) Every Grade A raw milk processor must allow officially designated persons to access all parts of the dairy farm during normal business hours to determine compliance with the provisions of this subchapter.(f) Every Grade A raw milk processor must furnish the department, upon request, for official use only, a true statement of the actual quantities of Grade A raw milk and Grade A raw milk products sold, records of inspections, and temperature records.(g) When a condition is found which constitutes an imminent health hazard, the department may take immediate enforcement action. Source Note: The provisions of this §217.25 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.25 Inspection of Grade A Raw Milk Processor Dairy Farms https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205024&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205024 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205024&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205024 03/11/2026 (a) The department will sample, at least quarterly, each Grade A raw milk processor dairy farm whose Grade A raw milk and Grade A raw milk products are produced and intended for consumption within the State of Texas.(b) At a minimum, cooling temperature checks, antibiotic tests, somatic cell counts, bacterial counts, coliform counts, pathogenic bacteria, water adulteration and random aflatoxin testing are performed on Grade A raw milk and Grade A raw milk product samples.(c) Samples shall be analyzed at an official or officially designated laboratory as defined in §217.1(71) and §217.1(72) of this title (relating to Definitions).(d) The coliform sample required by subsection (b) of this section may be collected by a certified sampler and submitted to an official or officially designated laboratory as defined in §217.1(71) and §217.1(72) of this title at the expense of the Grade A raw milk processor. The lab report must be provided to the department within seven days after receiving the results. To meet the requirements of subsection (b) of this section, samples must be collected in January, April, July, and October. The Grade A raw milk processor must notify the department in writing informing the department that the Grade A raw milk processor will be responsible for collecting its own coliform sample. The notice form must be received at least 30 days before the collection month. If a dairy provides such notice and then fails to collect and submit the milk sample as provided in the rules of this subchapter, the department shall collect coliform samples for a period of 12 months for that dairy.(e) Whenever the pathogenic bacteria, coliform counts, bacteria counts, somatic cell counts, water adulteration, or cooling temperatures of a sample exceed the limit of the standard for the Grade A raw milk or Grade A raw milk product, an additional sample shall be collected by the department on a date determined by the department.(f) The department may issue a detention, recall order, cessation from commerce, or emergency order, in accordance with §217.92 of this title (relating to Enforcement) or seek court action, whenever a consecutive sample violates the standards of this subchapter for bacteria counts, somatic cell counts, coliform counts, water adulteration, or cooling temperatures.(g) The department may issue a detention, recall order, cessation from commerce, or emergency order, in accordance with §217.92 of this title or seek court action, if a sample exceeds standards in §217.27 of this title (relating to Standards for Grade A Raw Milk and Raw Milk Products) for antibiotic, pathogenic bacteria, or aflatoxin. The sampled product exceeding the standards must be removed from supplies intended for human consumption. Source Note: The provisions of this §217.26 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.26 Examination of Grade A Raw Milk and Grade A Raw Milk Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205025&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205025 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205025&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205025 03/11/2026 All Grade A raw milk and Grade A raw milk products must be produced and handled in conformity with the following chemical, bacteriological, and temperature standards, and the sanitation requirements stated in §217.28 of this title (relating to Sanitation Requirements for Grade A Raw Milk and Raw Milk Products).(1) Temperature: Cooled to 45 degrees Fahrenheit (7 degrees Celsius) or less within two hours after milking.(2) Antibiotics: No positive results on drug residue detection methods.(3) Somatic Cells: Individual raw milk shall not exceed 750,000 cell count per milliliter (ml). Goat milk shall not exceed 1,500,000 per ml.(4) Bacteria Limits: 20,000 per ml. Cultured products are exempt from this standard.(5) Coliform: Not to exceed 10 per ml.(6) Pathogen: Zero.(7) Aflatoxin: less than 0.5 parts per billion (ppb).(8) Water Adulteration: cryoscope reading of -0.524 or above. Source Note: The provisions of this §217.27 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.27 Standards for Grade A Raw Milk and Raw Milk Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205026&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205026 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205026&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205026 03/11/2026 (a) Abnormalities in milk.(1) Milk from animals treated with or exposed to insecticides not approved for use on dairy cattle by the U.S. Environmental Protection Agency must not be offered for sale.(2) The department may require additional tests for the detection of abnormalities in milk.(3) Milk containing abnormalities must be handled and disposed of to prevent the infection of other animals and the contamination of milk utensils and equipment. Milk containing abnormalities may not be offered for human consumption.(4) Animals secreting milk with abnormalities must be milked last or with separate equipment, in order to prevent the contamination of the wholesome supply.(5) Equipment, utensils, and containers used for the handling of milk containing abnormalities must not be used for the handling of milk to be offered for sale, unless they are first cleaned and sanitized.(b) Milking barn, stable, parlor, or Automatic Milking Installation (AMI)--construction.(1) A milking barn, stable, parlor, or AMI must be present on all Grade A raw milk processor dairy farms to house the milking herd during milking time operations. The areas used for milking purposes must:(A) have floors constructed of concrete or equally impervious material graded to drain, which are smooth, easily cleanable, maintained in good repair, and free of excessive breaks or worn areas that may create pools of water, wastes, or other liquids;(B) have gutters and feed troughs constructed of good quality concrete or equally impervious material;(C) be constructed to ensure manure does not pile or pool in the milking barn, stable, parlor, or AMI and is approved by the department;(D) have finished walls and ceilings that are smooth, easily cleanable, impervious to moisture, light colored, dust tight, and in good repair;(E) have ceilings that are dust-tight;(F) have wall partitions, doors, shelves, and windows kept in good repair, and surfaces must be refinished whenever wear or discoloration is evident;(G) ensure feed stored overhead does not allow the sifting of chaff and dust into the milking barn, stable, parlor, or AMI;(H) ensure hay openings have a dust-tight door, which is kept closed during milking operations;(I) have separate stalls or pens for non-lactating animals;(J) have lighting equivalent of at least 10 foot candles in all working areas during milking hours;(K) provide sufficient air space and air circulation to prevent condensation and excessive odors throughout the milking barn, stable, parlor, or AMI;(L) not be overcrowded; and(M) have dust-tight covered boxes, bins, or separate storage facilities for ground, chopped, or concentrated feed.(2) The department may approve a barn without four walls extending from floor to roof, or a shed-type barn, provided the requirements of subsection (c) of this section, concerning animals and fowl entering the barn are met. Animal-housing areas (stables without stanchions, such as loose housing tables, pen stables, resting barns, free stall barns, holding barns, loafing sheds, wandering sheds) may be of shed-type construction, provided no milking is conducted therein.(c) Milking barn, stable, parlor, or AMI--cleanliness.(1) The interior of the milking barn, stable, parlor, or AMI must be kept clean.(2) Leftover feed in feed mangers must appear dry and fresh.(3) The bedding material, if used, must be free from excessive manure.(4) Outside surfaces of pipeline systems located in the milking barn, stable, parlor, or AMI must be clean.(5) All animal pens, if not separated from the milking barn, stable, parlor, or AMI, must be clean.(6) Swine and fowl must be kept out of the milking barn, parlor, and AMI.(7) Gravity flow manure channels in milking barns, if used, must be maintained and be cleaned.(8) Floors must be cleaned after each milking.(A) In barns provided with water under pressure, the floors must be scrubbed after each milking with a stiff-bristled brush.(B) In barns in which water under pressure is not available, the floors may be brushed dry and limed, or have phosphate applied evenly in a thin coat. Care should be exercised to prevent caking of the lime.(d) Animal yard.(1) The animal yards, which are the enclosed or unenclosed areas adjacent to the milking barn, and AMIs in which the animals may congregate, including animal housing areas and feed lots, must be graded and drained and must have no standing pools of water or accumulations of animal manure.(2) Animal lanes must be reasonably dry.(3) Approaches to the barn door, surroundings of stock watering, and feeding stations must be solid to the footing of the animal.(4) Loafing and animal housing areas must have animal droppings and soiled bedding removed, or clean bedding added, at sufficient intervals to prevent the soiling of the animal's udders and flanks.(5) Waste feed must not accumulate.(6) Manure packs must be properly drained and must provide reasonably firm footing.(7) Swine must be kept out of the animal yard.(e) Milkhouse or room--construction and facilities.(1) A milkhouse or room of sufficient size, a minimum of 30 inch spacing around equipment to allow for cleaning and inspection on all sides, must be provided for the cooling, handling, and storing of milk, and the washing, sanitizing, and storing of milk containers and utensils except as provided for in subsection (l) of this section.(2) The milkhouse floor must be smooth, easily cleanable, and constructed of concrete or equally impervious material. The floors must be maintained in good repair free of cracks, breaks, depressions, and surface peeling.(3) The floor shall be sloped to drain to prevent pools of standing water.(4) The joints between the floor and walls must be watertight.(5) Liquid waste shall be disposed of in a sanitary manner. All floor drains shall be accessible and shall be trapped if connected to a sanitary sewer system.(6) The walls and ceilings must be smooth, easily cleanable, impervious to moisture, covered with light colored paint, and in good repair.(7) Surfaces and joints must be tight and smooth.(8) The milkhouse must have a minimum of 20 foot candles of adequate natural or artificial light.(9) The milkhouse must be adequately ventilated to minimize odors and condensation of floors, walls, ceilings, and clean utensils.(10) Vents, if installed, and lighting fixtures must be installed to preclude the contamination of bulk milk tanks or clean utensil storage areas.(11) The milkhouse shall be used for no other purpose than milkhouse operations as described in §217.28(e)(1) of this subchapter (relating to Sanitation Requirements for Grade A Raw Milk and Raw Milk Products).(12) There shall be no direct opening from the milkhouse into any barn, stable, parlor, AMI, or room used for domestic purposes, except that an opening between the milkhouse and milking barn, stable, parlor, or AMI is permitted when a tight-fitting, self-closing solid door is provided.(13) A vestibule must comply with the applicable milkhouse construction requirements.(14) Water under pressure must be piped into the milkhouse.(15) The milkhouse must be provided with facilities for heating water in sufficient quantity and necessary temperatures, based on the cleaning agent''s specifications, for the effective cleaning of all equipment and utensils.(16) The milkhouse shall be equipped with a two-compartment wash vat of sufficient size to accommodate the largest utensil and container used.(17) A refrigerator of sufficient size must:(A) be provided for storage of cooling bottled Grade A raw milk and Grade A raw milk products;(B) be capable of maintaining the Grade A raw milk and Grade A raw milk products at the proper temperature; and(C) be equipped with a suitable thermometer approved by the department before use.(f) Milkhouse or room-cleanliness.(1) The floors, walls, ceilings, windows, tables, shelves, cabinets, wash vats, non-product-contact surfaces of milk containers, utensils and equipment, and other milkroom equipment must be clean.(2) Only articles directly related to milkroom activities are allowed in the milkroom. The milkroom must be kept free of trash, animals, and fowl.(3) Vestibules must be kept clean.(g) Toilet.(1) Every Grade A raw milk processor dairy farm shall provide one or more toilets, conveniently located by the milking barn, parlor, stable, AMI, and the milkroom. The toilet room must be properly constructed with walls, floors, and ceilings that are smooth, easily cleanable, impervious to moisture, light colored, and operated and maintained in a sanitary manner.(2) Human defecation or urination must only occur in the toilet room.(3) The toilet room must not open directly into the milkroom.(4) Doors to toilet rooms must be tight-fitting and self-closing, and all outer openings in toilet rooms must be screened or otherwise protected against the entrance of flies.(5) The toilet room shall be cleaned and kept free of odors.(6) The toilet must be connected to a public sewer system or to an individual sewage-disposal system and must be constructed and operated in accordance with the most current revision of the Texas Commission on Environmental Quality rules regulating on-site sewage facilities.(h) Water supply.(1) A Grade A raw milk processor dairy farm''s water source must meet the following requirements to establish the absence of coliform bacteria and thus be considered a "safe water source":(A) Water samples must be taken before the permit approval of the physical structure and found negative for the presence of coliform bacteria.(B) Water samples must be taken after any repair, alteration, or maintenance of the water supply system and found negative for the presence of coliform bacteria.(C) Water hauled to the Grade A raw processor dairy farm must be sampled for the presence of coliform bacteria at the point of use.(2) Water for milkhouse and milking operations must be from a supply properly located, protected, and operated, easily accessible, and of adequate sanitary quality, and must be a safe water source.(A) All water supply systems must be approved as safe and comply with the specifications of the Texas Commission on Environmental Quality 30 TAC §290.41.(B) No cross-connections between a safe water supply and any unsafe or questionable water supply or any other source of pollution are permitted.(C) There must be no submerged inlets through which a safe water supply may be contaminated.(D) The water source must be located and constructed in a manner that neither the underground nor surface contamination from any sewage systems, or other pollution can reach the water supply. Well casing and seal must be located above the ground surface.(E) All new water supply systems, which have been repaired or otherwise become contaminated, must be thoroughly disinfected and approved as safe before being placed in use.(F) All containers and tanks used in the transportation of water must be sealed and protected from possible contamination and must be approved by the department before use.(i) The containers and tanks must be thoroughly cleaned and have a bacteriological treatment before filling with potable water to be used at the dairy farm.(ii) To minimize the possibility of contamination of the water during the transfer from the potable tanks to the elevated or ground-water storage at the dairy farm, a suitable pump, hose, and fittings must be provided.(iii) When the pump, hose, and fittings are not being used, the outlets must be capped and stored in a suitable dust proof enclosure to prevent contamination.(iv) The storage tank at the dairy farm must be constructed of impervious material, provided with a dust and rainproof cover, and provided with an approved vent and roof hatch.(v) All reservoirs must be disinfected before placing them into service.(i) Containers, utensils and equipment--construction.(1) All multi-use containers, equipment, and utensils used in the handling, or storage of Grade A raw milk and Grade A raw milk products must be made of smooth, nonabsorbent, corrosion resistant, nontoxic materials, free of breaks, and be easily cleaned. Safe materials of the following types are allowed:(A) stainless steel of the American Iron and Steel Institute (AISI) 300 series;(B) equally corrosion-resistant, nontoxic metal;(C) heat-resistant glass; or(D) plastic or rubber and rubberlike materials, which:(i) are relatively inert, resistant to scratching, scoring, decomposition, crazing, chipping, and distorting under normal use conditions;(ii) are nontoxic, fat-resistant, relatively nonabsorbent, relatively soluble, and do not release component chemicals or impart flavor or odor to the product; and(iii) must maintain these properties under repeated use conditions.(2) All milk pails used for foremilk stripping must be seamless and hooded.(3) Strainers, if used, must be of perforated metal design, or constructed to utilize single-service strainer media. Multiple-use woven material must not be used for straining milk.(4) All single-service articles must be manufactured, packaged, transported, and handled in a sanitary manner and obtained from an approved source.(5) Articles intended by the manufacturer for single-service use must not be reused.(6) Farm holding/cooling tanks with welded sanitary piping must be smooth and free from pits, cracks, or inclusions.(7) Cleaned-in-place milk pipelines and return solution lines must be self-draining.(8) Gaskets, if used, must be self-positioning and of material meeting specifications described in §217.28(i)(1) of this subchapter, and must form a smooth, flush interior surface.(9) If gaskets are not used, all fittings must have self-positioning faces designed to form a smooth, flush interior surface.(10) All interior surfaces of welded joints in pipelines must be smooth and free of pits, cracks, and inclusions.(11) Detailed plans for cleaned-in-place pipeline systems must be submitted to the department for written approval before installation. No alteration or addition may be made to any milk pipeline system without prior written approval from the department.(12) All milking machines, including heads, milk claws, milk tubing, and other milk-contact surfaces, must be easily cleaned and inspected. Pipelines, milking equipment, and other equipment requiring a screwdriver or special tool must be easily accessible for inspection and the necessary tools must be available at the milkhouse.(13) Farm holding/cooling tanks and welded sanitary piping must comply with all applicable requirements set forth in this section.(j) Containers, utensils and equipment--cleaning. The product-contact surfaces of all multi-use containers, equipment, and utensils used in the handling, storage, or transportation of milk must be cleaned after each usage.(k) Containers, utensils and equipment--sanitization. The product-contact surfaces of all multi-use containers, equipment and utensils used in the handling, storage, or transportation of milk must be sanitized before each usage by one of the following methods, or by an equally effective method:(1) Complete immersion in hot water at a temperature of at least 170 degrees Fahrenheit (77 degrees Celsius) as determined by use of a suitable accurate thermometer (at the outlet) for at least five minutes; or(2) Complete immersion for at least one minute in, or exposure for at least one minute to, a flow of a chemical sanitizer which must meet the manufacturer's recommendation of acceptable strength for milk contact surfaces. All product-contact surfaces must be wetted by the sanitizing solution, and piping must be filled. Sanitizing sprays may be used.(A) Chemical solution, once used, may not be reused for sanitizing.(B) When chemicals are used for sanitization, a test kit or device accurately measuring parts per million concentration must be provided and used. The solution must be tested before use.(l) Containers, utensils and equipment--storage.(1) All containers, utensils and equipment used in the handling, storage, or transportation of milk, unless stored in sanitizing solutions, must be stored to ensure complete drainage and be protected from contamination before use.(2) Pipeline milking equipment, such as milk claws, inflations, weight jars, meters, milk hoses, milk receivers, and milk pumps, which are designed for mechanical cleaning, may be stored in the milking barn, parlor, or AMI only if the pipeline milking equipment is designed, installed, and operated to protect the product and solution contact surfaces from contamination at all times.(3) When manual cleaning of product-contact surfaces is necessary, the cleaning must be done in the milkhouse.(4) Clean cans or other containers may only be stored in the milkhouse.(5) Strainer pads, parchment papers, gaskets, and similar single-service articles must be stored in a suitable container or cabinet and protected against contamination.(6) Single service bottles must be stored at least six inches above the floor in a storage area.(m) Containers, utensils and equipment--handling.(1) After sanitizing, all containers, utensils, and equipment must be handled in such manner as to prevent contamination of any milk product-contact surfaces, including farm holding or cooling tank openings, and outlets.(2) Any sanitized milk product-contact surface exposed to contamination must be cleaned and sanitized before use.(n) Milking flanks, udders, and teats.(1) Milking must be done in the milking barn, stable, parlor, or AMI.(2) The flanks, udders, bellies, and tails of all milking animals must be free from visible dirt and other debris.(3) The hair on the udders shall be of such length that it is not incorporated with the teat in the inflation during milking.(4) All brushing must be completed before milking.(5) The udders and teats of all milking animals shall be cleaned and treated with an approved sanitizing solution just before the time of milking and must be dry before milking.(6) Wet hand milking is prohibited.(o) Milking--surcingles, milk stools, and antikickers.(1) Surcingles, milk stools, and antikickers must be kept clean and stored above the floor in a clean place in the milking barn, stable, parlor, or milkhouse when not in use.(2) Milk stools must not be padded and must be constructed to be easily cleaned.(p) Protection from contamination.(1) Equipment and operations within the milking barn, AMI, and milkhouse shall be located to prevent overcrowding or contamination of cleaned and sanitized containers or utensils.(2) No milk shall be strained, poured, transferred, or stored unless it is properly protected from contamination.(3) During milking, pipelines and equipment used to contain milk and milk products must be effectively separated from tanks or circuits containing cleaning and sanitizing solutions.(4) All milk which has overflowed, leaked, spilled, or been improperly handled must be discarded.(5) All milk product-contact surfaces or containers, equipment, and utensils must be covered or otherwise protected to prevent the access of insects, dust, condensation, and other contamination.(6) All openings, including valves and piping attached to milk storage and transport tanks, pumps, or vats, must be capped or otherwise properly protected. Gravity-type strainers in the milkhouse do not have to be covered.(7) Milk pipelines used to convey milk from pre-coolers to the bulk tank must be fitted with effective drip deflectors.(8) The receiving receptacle must be raised above the floor or placed at a distance from the cows to protect it against manure and splash when milk is poured or strained in the milking barn. The receiving receptacle must have a tight-fitting cover, which must be closed except when milk is being poured.(9) Each pail or container of milk must be transferred immediately after milking from the milking barn, stable, parlor, or AMI into the milkhouse.(10) Pails, cans, and other equipment containing milk must be properly covered during transfer and storage.(11) Air under pressure used for the agitation or movement or milk, or being directed at a milk-contact surface, must be free of oil, dust, rust, excessive moisture, extraneous materials, and odor.(12) Antibiotics and medicinal products must be stored in a manner that does not contaminate the milk or any milk product-contact surface.(q) Bottling and capping.(1) All bottling and capping must be performed on approved mechanical equipment. Hand capping is allowed, provided:(A) milk is withdrawn through the bottom (outlet) valve of the tank, and dipping out of the tank is prohibited;(B) containers for transporting milk from tank to filling area are constructed of seamless, stainless steel material, and sanitized before usage; and(C) filling of food grade containers is performed in a sanitary manner to preclude possible contamination, and food grade container filling by the consumer is prohibited.(2) Returnable food grade containers must be washed, rinsed, and sanitized before filling. Lids for returnable food grade containers must not be reused. Sanitized, food grade containers must be provided by the dairy farm.(A) There shall be a separate room with three-compartment wash vat for washing, rinsing, and sanitizing of returnable food grade containers at the dairy farm.(B) Single-service food grade containers, returnable food grade containers, and lids must come from a licensed and inspected entity. Single-service food grade containers may not be reused.(C) All caps or single-service lids must be kept immersed in a 50 parts per million chlorine solution for a minimum of one minute and immediately placed on the container.(D) The operator must wear disposable plastic gloves while filling and capping.(r) Personnel--hand washing facilities.(1) Adequate hand-washing facilities must be provided, maintained in good repair, and located convenient to the milkhouse, milking barn, stable, parlor, AMI, and flush toilet.(2) Hand-washing facilities must include:(A) a lavatory fixture with hot and cold running water;(B) soap or detergent; and(C) single-service individual sanitary towels.(3) Utensil wash and rinse vats may not be used for hand-washing facilities.(s) Personnel--cleanliness.(1) Employees hands must be washed, clean, and dried with an individual sanitary towel immediately before milking, before performing any milkhouse function, and immediately after the interruption of any of these activities.(2) Employees performing any activity inside the milkhouse or milking area shall wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.(t) Cooling.(1) Raw milk must be cooled to 45 degrees Fahrenheit (7 degrees Celsius) or less within two hours after milking.(2) Recirculated cold water used in plate, tubular coolers, or heat exchangers must be from a safe source and protected from contamination. The water shall be tested semiannually and found free of bacteria by an official or officially designated laboratory.(u) Insect and rodent control.(1) Effective measures shall be taken to prevent the contamination of milk, containers, equipment, and utensils by insects and rodents.(2) Surroundings must be kept neat, clean, and free of conditions, which might harbor or create conditions conducive to the breeding of insects and rodents.(3) During fly season, manure must:(A) be spread directly on the fields;(B) stored for not more than four days in a pile on the ground surface, and then spread on the fields;(C) stored for not more than seven days in an impervious-floored bin, or on an impervious-curbed platform and then spread on the fields;(D) stored in a tight-screened and trapped manure shed;(E) effectively treated with larvicides; or(F) disposed of in any other manner that controls insect breeding.(4) Manure packs in loafing areas, stables without stanchions, pen stables, resting barns, wandering sheds, and free-stall housing must be properly bedded and managed to prevent fly breeding.(5) Milkrooms must be free of insects and rodents.(6) Milkrooms must be effectively protected against the entrance of vermin.(7) Exterior milkhouse doors must be tight and self-closing. Screen doors must open outward.(8) Insecticides and rodenticides not approved for use in the milkhouse may not be stored in the milkhouse.(9) Only insecticides and rodenticides approved for use by the department and registered with the U.S. Environmental Protection Agency may be used for insect and rodent control.(10) Insecticides and rodenticides must be applied in accordance with state pesticide law, the manufacturer''s label directions, and to prevent the contamination of milk, milk containers, equipment, utensils, feed, and water. Source Note: The provisions of this §217.28 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.28 Sanitation Requirements for Grade A Raw Milk and Raw Milk Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205027&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205027 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205027&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205027 03/11/2026 (a) All herds and additions thereto shall be tested and found free of tuberculosis and brucellosis before any milk therefrom is sold. All required tests in this section must be performed by a licensed veterinarian or a veterinarian in the employment of an appropriate state or federal agency.(b) All herds must be retested at least every 12 months and found free of tuberculosis and brucellosis. All test results must be provided to the department.(c) All bovine herds must participate in the brucellosis milk ring testing program conducted by the Texas Animal Health Commission.(d) For diseases other than brucellosis and tuberculosis, the department shall require physical, chemical, or bacteriological tests as it deems necessary.(1) The diagnosis of other diseases in dairy animals shall be based upon the findings of a licensed veterinarian or a veterinarian in the employment of an appropriate state or federal agency.(2) Any diseased animal disclosed by such tests shall be disposed of in a method approved by the department. Source Note: The provisions of this §217.29 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.29 Animal Health https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205028&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205028 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205028&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205028 03/11/2026 Properly prepared plans for all milkhouses, milking barns, stables, Automatic Milking Installations (AMIs) and parlors regulated under this subchapter, which are hereafter constructed, reconstructed, or extensively altered, shall be submitted to the department for written approval before work is begun. Source Note: The provisions of this §217.30 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.30 Plans for Grade A Raw Milk Processor Dairy Farms https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205030&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205030 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205030&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205030 03/11/2026 (a) Grade A raw milk and Grade A raw milk products may be sold by the Grade A raw milk processor directly to the consumer at the raw milk processor dairy farm, provided that such producer has been issued a Grade A Raw for Retail Permit in accordance with §217.91 of this title (relating to Milk Facilities and Operations Permit and Frozen Dessert License Procedures), and complies with this subchapter.(b) Grade A raw milk and Grade A raw milk products may be delivered by the permitted processor, or the permitted processor''s employee, to a location determined by the processor and customer, as long as the distribution does not violate a local ordinance, provided that the permitted processor:(1) Ensures all Grade A raw milk and Grade A raw milk products are delivered in refrigerated sanitary equipment.(A) If ice is used to keep Grade A raw milk and Grade A raw milk products cold, the ice must come from an approved source or made with approved potable water source and must not contain any dirt, debris, or other contaminations.(B) Grade A raw milk and Grade A raw milk products must not be completely submerged in ice.(2) Ensures the Grade A raw milk and Grade A raw milk products internal temperature is maintained at or below 45 degrees Fahrenheit during processing, transportation, and delivery.(3) Includes a temperature-control-sample in each delivery that is representative of half the size of the largest container for each delivery, and ensures the internal temperature reading of the Grade A raw milk and Grade A raw milk product is maintained at or below 45 degrees Fahrenheit (7 degrees Celsius).(4) Grade A raw milk and Grade A raw milk products must not be frozen unless unfrozen samples are available for the department to sample. The unfrozen samples must be representative of the most current milking. Source Note: The provisions of this §217.31 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.31 Selling of Raw Milk to the Consumer https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205031&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205031 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205031&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205031 03/11/2026 (a) Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness; open lesion, including boils, sores, or infected wounds; or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, must be excluded from any operations which may be expected to result in such contamination until the condition is corrected, unless conditions, such as open lesions, boils, and infected wounds are adequately covered (e.g. by an impermeable cover). Personnel must be instructed to report such health conditions to their supervisors.(b) When reasonable cause exists to suspect the possibility of transmission of infection from any person concerned with the handling of milk, the department is authorized to require any or all the following measures:(1) the immediate exclusion of that person from milk handling;(2) the immediate exclusion of the milk supply concerned from distribution and use; and(3) adequate medical and bacteriological examination of the person, of the person''s associates, and their body discharges. Source Note: The provisions of this §217.32 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.32 Disease Control and Employee Health https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205032&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205032 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205032&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205032 03/11/2026 (a) Records for the production, processing, bottling, and all sales of Grade A raw milk and Grade A raw milk products must be maintained and provided to the department, upon request, and must include the following.(1) The monitoring of all temperature controls during the production, processing, bottling, sale, and delivery.(2) The corrective actions taken when there is a failure to maintain product at the required temperature of 45 degrees Fahrenheit (7 degrees Celsius).(3) The amount of Grade A raw milk and Grade A raw milk products produced daily.(4) The amount of Grade A raw milk and Grade A raw milk products processed daily.(5) The amount of Grade A raw milk and Grade A raw milk products sold and delivered daily.(6) The batch number for each Grade A raw milk and Grade A raw milk product that is bottled daily.(7) Herd health records, which must be provided to the department annually.(b) A processor must post the most recent lab results in the milk house or store front and notify customers that testing results performed in §217.26 of this title (relating to Examination of Grade A Raw Milk and Grade A Raw Milk Products) are available upon request. The previous six months testing results must be supplied to the customer within 24 hours of the request. Source Note: The provisions of this §217.33 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.33 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205029&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205029 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205029&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205029 03/11/2026 Technologies not addressed in current rule must be approved and accepted by the department before implementation and use. Source Note: The provisions of this §217.34 adopted to be effective May 17, 2021, 46 TexReg 3128. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY B GRADE A RAW MILK AND RAW MILK PRODUCTS §217.34 New Technologies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145208&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145208 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145208&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145208 03/11/2026 These sections provide for uniformity of inspections of the premises of frozen desserts manufacturers; protect the health and safety of consumers by preventing the manufacture or distribution of frozen desserts, products sold in semblance of frozen desserts, or mixes for those products that do not meet state requirements or related requirements of purity or labeling; and assist manufacturers in meeting state requirements. Source Note: The provisions of this §217.41 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.41 Introduction https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145209&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145209 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145209&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145209 03/11/2026 Every frozen desserts manufacturer located in the State of Texas, and every frozen desserts manufacturer that exports frozen desserts into the State of Texas shall secure a permit. Only a person who complies with the requirements of these rules shall be entitled to receive and retain such a permit. Source Note: The provisions of this §217.42 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.42 Permits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145210&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145210 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145210&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145210 03/11/2026 (a) The labeling on all packages or containers of frozen desserts or mix designed for sale at retail shall clearly and conspicuously include:(1) the name of the food as provided for in the definitions and standards established by this chapter;(2) quantity of contents;(3) name and address of the manufacturer, packer or distributor, provided that, in addition, the manufacturer's plant code number shall appear if the manufacturer's name and address are not included on the label; and(4) flavor labeling, if the food contains any added characterizing ingredients.(b) The label information shall be in letters of a size, style and color which are approved by the department, and shall contain no marks or words which are misleading. The label may contain ingredient and/or nutrition information, provided the information is in compliance with Title 21, Code of Federal Regulations. Source Note: The provisions of this §217.43 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.43 Labeling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145211&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145211 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145211&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145211 03/11/2026 (a) Prior to the issuance of a permit, and at least once every three months thereafter, the department shall inspect all frozen desserts plants within the State of Texas, the products of which are intended for consumption within the State of Texas, and shall make as many additional inspections as are necessary for the enforcement of these rules. If the department representative discovers the violation of any sanitation requirement, a representative shall make a second inspection after a lapse of such time as the representative may deem necessary for the defect to be remedied, but not before the lapse of three days. The second inspection shall be used in determining compliance with these regulations. Any violation of the same sanitation requirement of these regulations on two consecutive inspections shall be the basis for immediate suspension of permit.(b) The original copy of the inspection report shall be posted by the department in a conspicuous place upon an inside wall of the frozen desserts plant and said inspection report shall not be defaced or removed by any person except the department. Another copy of such inspection report shall be filed with the records of the department.(c) Every processor or manufacturer of mix or frozen desserts shall permit upon request a department representative access to all parts of the frozen dessert or mix establishment; and shall furnish the department, upon request, a true statement of the actual quantities of mix or frozen desserts used or produced. Source Note: The provisions of this §217.44 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.44 Inspection of Frozen Desserts Plants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145212&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145212 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145212&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145212 03/11/2026 (a) During any consecutive six months, at least four samples of raw milk intended for use in the manufacture of frozen desserts shall be collected and examined by the department. In addition, during any consecutive six months, the department shall collect and examine at least four samples of frozen desserts from dairy retail stores, food service establishments, grocery stores, and other places where frozen desserts are sold may be examined periodically as determined by the department. Proprietors of such establishments shall furnish the department, upon request, with the names of all distributors from whom frozen desserts, or frozen desserts mix are obtained. The examination of samples of pasteurized mix, and/or frozen desserts shall be performed in an official laboratory or in an officially designated laboratory. (b) Bacterial counts, coliform determinations, phosphatase, tests, and other laboratory and screening tests shall conform to the procedures in the latest edition of "Standard Methods for the Examination of Dairy Products" of the American Public Health Association. Examinations and tests shall include such other biological, chemical, and physical determinations as the department shall deem necessary for the detection of adulteration. (c) Whenever two of the last four consecutive bacterial counts, coliform determinations, or cooling temperatures taken on separate days exceed the limit of the standard for the milk, cream, milk products, mix or frozen desserts, the department shall send a written notice thereof to the person concerned. This notice shall be in effect so long as two of the last four consecutive samples exceed the limit of the standards. An additional sample shall be taken within 21 days of the date of such notice, but not before the lapse of three days. Immediate product suspension or other appropriate department or court action shall be instituted whenever the standard is violated by three of the last five bacterial counts, coliform determinations or cooling temperatures of samples collected within the six-month period. (d) The department shall establish the frequency of sampling pasteurized mix or frozen desserts during each six month period for adequate pasteurization as determined by a phosphatase test. In the case of a confirmed positive result, the probable cause shall be determined by and corrected to the satisfaction of the department before the mix is frozen or the frozen dessert is sold. (e) No process or manipulation other than pasteurization as set forth in §217.1 of this title (relating to Definitions), processing methods integral therewith, and appropriate refrigeration shall be applied to milk and milk products for the purpose of removing or deactivating organisms, provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by the United States Food and Drug Administration (FDA) as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department. (f) Raw milk for use in the manufacture of frozen desserts shall comply with all standards set forth in §217.73 of this title (relating to Raw Milk for Manufacturing Purposes). (g) Frozen desserts and mix shall comply with the following standards: (1) bacterial, coliform, and temperature standards for pasteurized mix and frozen desserts as shown in the following chart: Attached Graphic(2) bacterial, coliform, and temperature standards for nondairy frozen desserts and nondairy frozen desserts mix as shown in the following chart: Attached Graphic Source Note: The provisions of this §217.45 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.45 Examination and Standards for Frozen Desserts https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145213&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145213 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145213&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145213 03/11/2026 (a) Floors. The floors of all rooms in which mix, frozen desserts, or their ingredients are manufactured, processed, or frozen, or in which containers and utensils are washed, shall be constructed of concrete or other equally impervious and easily cleaned material, and shall be smooth, properly drained, provided with trapped drains, and kept clean and in good repair; provided, that cold storage rooms used for storing frozen desserts and cold storage rooms used for storing milk, cream, or milk products, frozen fruits, frozen eggs, and comparable ingredients need not be provided with floor drains but the floors shall be sloped to drain to one or more exits, and shall be kept clean and in good repair; provided that, dry storage rooms need not be drained and tight wood floor construction is optional. Provided further, that the construction requirements of this item shall be waived in the case of frozen desserts establishments, if that portion of the room in which the freezer is installed and the room in which containers or utensils are washed have floors of metal, durable grades of linoleum or plastic, or tight wood impregnated with plastic in lieu of concrete.(b) Walls and ceilings. Walls and ceilings of rooms in which mix, frozen desserts, or their ingredients are manufactured, processed, or frozen, or in which containers or utensils are washed shall have easily cleanable, washable light-colored surfaces, and shall be kept clean and in good repair.(c) Doors and windows. Unless other effective means are provided to prevent the access of flies, all openings to the outer air shall be effectively screened, and all doors shall be self-closing.(d) Lighting and ventilation.(1) All rooms shall be well lighted.(2) All rooms shall be well ventilated.(e) Miscellaneous protection from contamination.(1) Frozen desserts plant operations shall be located and conducted as to prevent any contamination of the ice cream, ice cream mix, frozen desserts, frozen desserts mix, or their ingredients, or of cleaned equipment.(A) All milk, milk products, cream, mix or frozen desserts that have been spilled, overflowed, or leaked shall be discarded.(B) All milk, milk products, cream or mix drained from equipment at the end of a run shall be handled in a sanitary manner and shall be re-pasteurized.(C) All necessary and appropriate means shall be used for the elimination of flies, other insects and rodents.(D) Rooms shall be free of flies.(E) There shall be separate rooms for:(i) pasteurization, processing, cooling, freezing, and packaging operations; and(ii) the washing and bactericidal treatment of multi-use containers.(F) Unless all milk, cream, mix or milk products are received in bulk transport tanks, a receiving room separate from rooms as defined in subparagraph (E)(i) and (ii) of this paragraph shall also be required; provided, that the requirement in subparagraph (E)(i) of this paragraph shall be satisfied when a frozen dessert manufacturer blends, freezes, and packages in a manner to prevent contamination; provided further, that frozen desserts, milk, milk products, and ingredients shall not be unloaded directly into the room or rooms used for pasteurizing.(G) Pasteurized mix or frozen desserts shall not be permitted to come in contact with equipment or containers with which unpasteurized mix, frozen desserts, cream, milk or milk products have been in contact, unless such equipment has first been thoroughly cleaned and subjected to a bactericidal treatment.(H) Rooms in which milk or milk products, cream, mix or frozen desserts are handled or stored shall not open into any stable or living quarters.(I) The milk plant, frozen dessert plant, containers, utensils, and equipment shall be used for no purpose other than the processing of milk, cream, milk products, mix, and frozen desserts, and the operation incident thereto, except as may be approved in writing by the department.(2) The pump-out of the transport tank shall be done in an area where a cover extends over the complete transport tank or, where climatic and operating conditions require, in a completely enclosed area. Pump-out operations must be protected in such a manner as to prevent product contamination. If the area is not completely enclosed or doors of the unloading area are open during unloading, a suitable filter is required for the manhole or the air inlet vent.(3) The agitating and sampling of the transport tank milk shall be accomplished in such a manner as to provide maximum protection against product contamination. In no instance shall this be done at a place other than an approved unloading station.(4) The frozen dessert plant shall record the following information on each load of milk received, and maintain these records for a period of not less than 90 days:(A) the date the load was received;(B) the time received;(C) the number of pounds in the load;(D) the temperature of the milk or milk products when received;(E) the permit number of the truck delivering the milk; and(F) the name of the station operator receiving the milk.(5) If the frozen dessert plant is also utilized as the milk tank truck cleaning facility, the transport tank cleaning tag shall be removed and kept with the other records for a period of 15 days.(6) In no case shall milk or milk products be received from a transport tank that appears to be damaged, dirty, or does not have a cleaning tag attached without the written permission of the department.(f) Toilet facilities. Every frozen desserts plant shall be provided with conveniently located toilet facilities conforming with the state, local and county ordinances. Toilet rooms shall not open into any room in which mix is processed or handled. The doors of all toilet rooms shall be self-closing. Toilet rooms shall be kept in a clean condition, in good repair and well ventilated. A sign directing employees to wash their hands before returning to work shall be posted in all toilet rooms used by employees.(g) Water supply. The water supply shall be easily accessible, adequate, and of a safe sanitary quality.(h) Hand-washing facilities. Convenient hand-washing facilities shall be provided, including hot and cold running water, soap, and approved sanitary towels. Hand-washing facilities shall be kept clean. The use of a common towel is prohibited. Employees shall not resume work after using the toilet room without washing their hands.(i) Sanitary piping and fittings. All piping and fittings used to conduct milk, cream, milk products, mix or frozen desserts shall be of sanitary design and construction which meets 3-A Sanitary Standards and Accepted Practices. Mix, frozen desserts, fluid milk products, and ingredients shall be conducted from one piece of equipment to another only by sanitary piping and fittings.(j) Construction and repair of containers, utensils, and equipment.(1) All multi-use containers, utensils, and equipment with which mix, frozen desserts, milk, cream, and milk products, and ingredients come in contact shall be of smooth, impervious, noncorrodible, nontoxic, relatively low absorbent material; shall be easily cleanable and shall be kept in good repair.(2) All single-service containers, closures, gaskets, and other articles shall be manufactured, packaged, transported, and handled in a sanitary manner.(k) Disposal of wastes. All wastes shall be disposed of in a sanitary manner. All plumbing and appurtenances thereto shall be so designed and installed as to prevent the contamination of frozen desserts or any ingredient, utensil, container, or equipment by drip, condensation, or backflow.(l) Cleaning and bactericidal treatment of multi-use utensils, containers, and equipment. All multi-use containers and utensils shall be thoroughly cleaned after each use and all equipment shall be thoroughly cleaned at least once each day of use, unless the department has reviewed and accepted information in writing, supporting the cleaning of multi-use containers and utensils at frequencies extending beyond one day or 72 hours in the case of storage tanks, or 44 hours in the case of evaporators, which are continuously operated. Supporting information shall be submitted to and approved by the department prior to initiating the qualification period if required. Any significant equipment or processing changes shall be communicated to the department, and may result in a re-verification of the extended run proposal, if it is determined that the change could potentially affect the safety of the finished milk or milk product(s).(m) Storage of multi-use utensils, containers, and equipment. After cleaning, all multi-use utensils, containers, and equipment shall be stored to drain dry, and in such a manner as not to be contaminated before usage.(n) Storage of single-service containers, utensils, and materials. Caps, parchment papers, wrappers, liners, gaskets and single-service sticks, spoons, covers, and containers for frozen desserts, mix, or their ingredients shall be purchased and stored only in sanitary tubes, wrappings, or cartons; shall be kept thereafter in a clean, dry place until used; and shall be handled in a sanitary manner. Reuse of single-service articles is prohibited.(o) Handling of containers and equipment. Between bactericidal treatment and usage, and during usage, containers and equipment shall not be handled or operated in such a manner as to permit contamination of the mix, frozen desserts, or their ingredients. Pasteurized mix and frozen desserts shall not be permitted to come into contact with equipment with which unpasteurized mix, milk, cream, or milk products have been in contact, unless the equipment has been thoroughly cleaned and effectively subjected to an approved bactericidal process.(p) Pasteurization of mix.(1) Every particle of the combined milk, cream, milk product, or other ingredients used in the manufacture of a frozen dessert mix shall be heated and held at temperatures of not less than 155 degrees Fahrenheit for not less than 30 minutes; 180 degrees Fahrenheit for not less than 15 seconds; or 175 degrees Fahrenheit for not less than 25 seconds.(2) All pasteurization equipment and related appurtenances shall meet construction and operational requirements outlined in the latest edition of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance).(3) Nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by the United States Food and Drug Administration (FDA) as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.(q) Cooling and handling. All milk, cream, and milk products in fluid form received at the frozen desserts plant for use in frozen desserts mix shall be cooled to a temperature of 45 degrees Fahrenheit or less and maintained at that temperature until pasteurized; and all pasteurized mix shall be cooled in approved equipment to a temperature of 45 degrees Fahrenheit or less and shall be maintained thereat until frozen.(r) Packaging and dispensing. Packaging, cutting, molding, dispensing, and other preparation of mix, or frozen desserts, or their ingredients shall be done in a sanitary manner. Containers shall be completely covered immediately after filling unless dispensed to a patron. Closures, covers, and wrappers shall be handled in such a manner as to prevent contamination of the package content.(s) Returns. Packaged mix, or frozen desserts which have physically left the premises or the frozen dessert plant shall not be re-pasteurized to be sold or used for making frozen desserts.(t) Overflow and spillage. Product drip or overflow, or spilled mix, or frozen desserts, or their ingredients, shall not be sold for human consumption.(u) Personnel health. No person while affected with any disease in a communicable form, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, or an acute respiratory infection, shall engage in pasteurizing, handling of ingredients, filling, packaging, or freezing operations or in any capacity in which there is a likelihood of such person contaminating mix and frozen desserts, or mix and frozen dessert-contact surfaces with pathogenic organisms, or transmitting disease to other individuals; and no person known or suspected of being affected with any such disease or condition shall be employed in such a capacity. If the management of the frozen desserts plant has reason to suspect that any employee has contracted any disease in a communicable form or has become a carrier of such disease, the employee shall notify the department immediately.(v) Personnel cleanliness. All persons who come in contact with milk, cream, milk products, mix, and frozen desserts containers or equipment, shall wear clean outer garments, hair restraints and shall keep their hands clean at all times while engaged in such work.(w) Vehicles.(1) All vehicles used for the transportation of mix, frozen desserts, cream, milk, and milk products shall be constructed and operated so as to protect their contents from the sun and contamination. Such vehicles shall be kept clean, and no substance capable of contaminating mix, frozen desserts, cream, milk, and milk products shall be transported therein. Such vehicles shall have the name of the distributor prominently displayed thereon.(2) Tank cars and tank trucks used for transporting mix, cream, milk, and milk products shall comply with the construction, cleaning, bactericidal treatment, storing, and handling requirements of subsections (e), (j), (l), and (m) of this section. Each shipment shall be sealed and labeled in a manner approved by the department.(x) Ingredients. All mix and frozen dessert ingredients shall be clean, have a fresh wholesome flavor and odor and normal appearance, be of satisfactory quality, and be stored, handled, and processed in a sanitary manner.(y) Raw product storage.(1) All milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration. Raw milk in storage tanks within the dairy plant shall be handled in such a manner as to minimize bacterial increase and shall be maintained at 45 degrees Fahrenheit or lower until processing begins. This does not preclude holding milk at higher temperatures for a period of time, where applicable to particular manufacturing or processing practices.(2) The bacteriological quality of commingled raw milk for use in the manufacture of frozen desserts shall not exceed 500,000 per milliliter. Source Note: The provisions of this §217.46 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.46 Sanitation Standards for Frozen Desserts Plants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145214&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145214 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145214&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145214 03/11/2026 No frozen desserts that have been manufactured in Texas shall be sold to the final consumer or to restaurants, soda fountains, grocery stores, dairy stores, or similar establishments within the State of Texas, unless it has been manufactured and frozen in a plant conforming with the requirements of this subchapter. Source Note: The provisions of this §217.47 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.47 Frozen Desserts Which May Be Sold https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145215 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145215 03/11/2026 Except as permitted by the department, no person shall transfer frozen desserts from one container to another on the street, or in any vehicle or store, or in any place except under sanitary conditions. Source Note: The provisions of this §217.48 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.48 Transferring and Dispensing Frozen Desserts https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145216&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145216 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145216&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145216 03/11/2026 (a) Generally. Frozen desserts from points beyond the limits of routine inspection of the State of Texas may be sold in the State of Texas, provided they are manufactured and/or pasteurized under provisions which are substantially equivalent to the requirements of this regulation as determined in writing by the department.(b) Approval of supplies. Subject to laboratory tests upon arrival, the department shall approve, without inspection, supplies of frozen dessert mix, and frozen desserts from an area not under the department's routine inspection:(1) when these products are manufactured and/or pasteurized under regulations equivalent to those of this regulation; or(2) when these products are under routine official supervision. Source Note: The provisions of this §217.49 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.49 Mix and Frozen Desserts from Points Beyond the Limits of Routine Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145217&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145217 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145217&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145217 03/11/2026 (a) All frozen desserts plants in the State of Texas, which are constructed or extensively altered, shall obtain signed approval from the department for said construction before work is begun.(b) All new frozen desserts plants applying for a permit, and all new construction, reconstruction, or extensive alterations made shall comply with the requirements of this regulation. Source Note: The provisions of this §217.50 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.50 Plans for Construction and Reconstruction of Frozen Desserts Plants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145218&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145218 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145218&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145218 03/11/2026 When probable cause exists to suspect the possibility of infection from any person concerned with the handling of mix, frozen desserts, or their ingredients, the department is authorized to require any or all of the following measures:(1) the immediate exclusion of that person from handling mix, frozen desserts, or their ingredients;(2) the immediate exclusion of the mix or frozen desserts concerned from distribution and use; and(3) adequate medical examination of the person before returning to frozen dessert handling. Source Note: The provisions of this §217.51 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY C RULES FOR THE MANUFACTURE OF FROZEN DESSERTS §217.51 Procedure When Infection Is Suspected https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145219&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145219 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145219&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145219 03/11/2026 (a) Requirements for bulk milk hauler/sampler certifications.(1) Each hauler/sampler shall complete a comprehensive training program provided by the department, which shall include a course teaching specific procedures necessary to properly handle milk from the dairy farm to the plant, receiving station, or transfer station. This program shall further include practical field training sufficient to develop a proficient working knowledge of proper bulk milk handling procedures.(2) After training has been completed, each hauler/sampler shall pass a qualifying examination administered by the department. Candidates failing the exam with a score of less than 70%, shall be denied permits or licenses until they can achieve a passing score of 70%. The examination should be adequate enough to determine if a bulk milk hauler/sampler is competent. The exam shall be composed of a minimum of 20 total questions broken down into the following areas:(A) six questions relating to sanitation and personal cleanliness;(B) six questions relating to sampling and weighing procedures;(C) four questions relating to equipment, including proper use, care, cleaning, etc.; and(D) four questions relating to proper record keeping requirements.(3) An industry sponsored training program may be used in lieu of this program, provided that:(A) such training program meets or exceeds the minimum standards and requirements set forth in these regulations;(B) the department has issued a letter indicating the acceptance of the training program; and(C) the qualifying examination is administered by the department.(4) Bulk milk haulers/samplers successfully qualifying by examination and who have been satisfactorily evaluated in the field will be certified by the department to perform milk hauler/sampler duties. Only those milk haulers/samplers having certification issued by the department or by the authorized Regulatory Agency of another state will be allowed to remove milk from a farm bulk milk tank and collect milk samples for laboratory examination.(5) All official milk samplers, including bulk milk haulers/samplers, shall be evaluated at least once every 24 months by the department or by the authorized Regulatory Agency of another state.(6) The department may issue temporary hauler/sampler certifications in emergency situations without the prescribed examinations, evaluation and training program, provided acceptable certification of competence is made by the employer of the individual. A temporary permit is only valid for 30 days.(7) The department may suspend a hauler/sampler certification when, upon investigation, the department finds a violation of any of the following:(A) this subchapter; or(B) §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance).(b) Procedure and Handling Requirements.(1) Each bulk milk pickup tanker shall be supplied with sanitized sample bottles or bags, other sampling equipment, and supplies necessary, as required in §217.2 of this title to clean and sanitize multi-use equipment used in sampling and pickup operations.(2) All bulk milk haulers operating bulk milk pickup tankers shall make available to the department upon request a copy of the load manifest and a current list of producers for each route pickup load with the following information:(A) the producer name and number in the order of milk pickup;(B) the time of arrival at each dairy;(C) the time of arrival at the unloading station;(D) the name and address of the unloading station; and(E) the hauler/sampler name and driver's license number. Source Note: The provisions of this §217.61 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY D BULK MILK REGULATIONS §217.61 Bulk Milk Hauler/Sampler Qualifications and Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145220&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145220 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145220&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145220 03/11/2026 (a) Farm bulk milk tanks shall have a capacity adequate for production between routine pickups. The time between pickups shall not exceed every other day. Milk must be of sufficient quantity for adequate mechanical agitation at the completion of the first milking.(b) Farm bulk milk tanks shall be equipped with an indicating thermometer, the sensor of which shall be located to permit the registering of the temperature of the contents when the tank contains no more than 20% of its calibrated capacity.(c) Farm bulk milk tanks will be equipped with easily accessible sampling ports or a sample cock.(d) Farm bulk milk tanks shall comply with the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance). Source Note: The provisions of this §217.62 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY D BULK MILK REGULATIONS §217.62 Bulk Milk Holding Tanks https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145221&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145221 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145221&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145221 03/11/2026 (a) Each milk tank truck used to transport milk or milk products to or from a dairy farm, milk plant, or receiving station, shall be permitted by the department or by the authorized Regulatory Agency of another state. Failure to obtain a permit may result in the milk tank truck and its contents being immediately removed from Grade A or food use.(b) All vehicles and milk tank trucks containing milk or milk products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents. The permit sticker issued by the department shall be placed near the outlet valve of the tanker truck or trailer.(c) All milk tank trucks must be inspected prior to the issuance of a permit and a minimum of once each 12 months thereafter. The requirement for this annual inspection does not eliminate or supersede other licenses or permits required by any other official regulatory agency. The owner or manager of the milk transportation company will report verbally or in writing to the department, within ten days, any milk transport tanks taken out of service or severely damaged.(d) Milk tank trucks must be operated in compliance with the following provisions.(1) Permanently installed milk tank truck washing equipment must be in compliance with the current edition of the 3-A Sanitary Standards and Accepted Practices at the time of installation and be approved by the department. This equipment shall be so designed that it will properly clean and sanitize all milk-contact surfaces when connected to a cleaning system at an approved milk tank truck cleaning facility.(2) Each bulk milk pickup tanker shall be provided with adequate space for sanitary storage, without overcrowding, of fittings, valves, milk pumps, racks for milk conducting equipment, wrenches, sample bottles, dippers, solutions for washing and sanitizing milk contact equipment, and all other equipment used for milk handling and sampling purposes.(3) When compartment milk tank trucks are used, Grade A milk shall not be permitted to be hauled in one compartment while ungraded milk or another product is being hauled in another compartment on the same tanker.(4) Agitating and sampling milk in a milk tank truck shall be accomplished in such a manner as to provide maximum protection against product contamination. In no instance shall these activities be performed at a place other than a location approved by the department.(5) Milk tank trucks may not be used to transport poisonous or toxic substances.(6) Milk tank trucks transporting pasteurized milk or milk products that will not be re-pasteurized at the receiving milk processing plant shall not be used to transport raw milk, raw egg products, or any other product determined by the department to be a source of microbiological or chemical contamination. Source Note: The provisions of this §217.63 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY D BULK MILK REGULATIONS §217.63 Milk Tank Trucks https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145222&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145222 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145222&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145222 03/11/2026 (a) Milk tank truck unloading stations.(1) When the milk tank truck unloading station is a receiving station or a milk processing plant, it shall comply with the following sanitation requirements for Grade A pasteurized milk as specified in the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance): floors; walls and ceilings; doors and windows; lighting and ventilation; toilet-sewage disposal facilities; water supply; hand-washing facilities; milk plant cleanliness; sanitary piping; construction and repair of containers and equipment; cleaning and sanitizing of containers and equipment; storage of cleaned containers and equipment; storage of single service containers, utensils, and materials; protection from contamination; cooling of milk; personnel cleanliness; and surroundings.(2) When the unloading station is a transfer station, it shall comply with all the requirements of a receiving station except that the provisions for walls, ceilings, doors and windows are not required unless climatic and operation conditions interfere with safe handling of the milk. Overhead protection shall be provided in all cases.(3) The pump-out of the milk tank truck shall be done in an area where a cover extends over the complete transport tank or, when climatic and operating conditions require, in a completely enclosed area. Pump-out operations must be protected in such a manner as to prevent product contamination. If the area is not completely enclosed or doors of the unloading area are open during unloading, a suitable filter is required for the manhole or the air inlet vent.(4) The agitating and sampling of the transport tank milk shall be accomplished in such a manner as to provide maximum protection against product contamination. The unloading station shall provide the necessary equipment to adequately agitate the milk in the transport tank. The milk shall be agitated for a minimum of 15 minutes prior to obtaining samples. The department may approve alternative procedures to achieve adequate agitation. Samples shall be collected only by certified milk samplers. In no instance shall agitation and sampling be done at a place other than a location approved by the department.(5) The unloading station shall record the following information on each load of milk received, and maintain these records for a period of not less than 90 days:(A) the date the load was received;(B) the time received;(C) the number of pounds in the load;(D) the temperature of the milk upon receipt;(E) the permit number of the milk tank truck delivering the milk;(F) the name of the station operator receiving the milk; and(G) the manifest with the driver's license number of the sample collector.(6) In no case shall milk be received from a milk tank truck that appears to be damaged, dirty, or does not have a current cleaning tag without the permission of the department.(b) Milk Tank Truck Cleaning Facilities.(1) It shall be the responsibility of each unloading station to provide a milk tank truck cleaning facility. The milk tank truck cleaning facility may be an integral part of the unloading station or a separate facility. When the milk tank truck cleaning facility is a separate facility, it shall be located convenient to and in the proximity of the unloading station. All milk tank trucks that transport milk and milk products as permitted by the department, shall be washed and sanitized at a permitted milk plant, receiving station, transfer station, or milk tank truck cleaning facility.(2) The milk tank truck cleaning facility shall comply with the following sanitation requirements for Grade A pasteurized milk unloading stations of the "Grade A Pasteurized Milk Ordinance:" floors; walls and ceilings; doors and windows; lighting and ventilation; toilet-sewage disposal facilities; water supply; hand-washing facilities; milk plant cleanliness; sanitary piping; construction and repair of containers and equipment; cleaning and sanitizing of containers and equipment; storage of cleaned containers and equipment; storage of single service containers, utensils, and materials; protection from contamination; cooling of milk; personnel cleanliness; and surroundings.(3) An unloading station which receives milk in milk tank trucks equipped with permanently installed tank washers will provide a milk tank truck cleaning facility equipped with the following:(A) adequate water heating facilities;(B) tanks of an adequate size to hold the rinse, wash, and sanitizing solution;(C) a wash pump which will deliver the cleaning and sanitizing solution to the milk-contact surface of the milk tank truck at an adequate rate and velocity;(D) a removal pump which will remove rinse and cleaning solutions from the milk tank truck as fast as such solutions are pumped into the milk tank truck;(E) a screening device shall be provided which will prevent the passage of any foreign material into the system that would adversely affect the performance of the spray device(s), and located so as to be easily cleaned and sanitized;(F) a temperature recorder which meets the applicable requirements of the most current revision of the "Grade A Pasteurized Milk Ordinance" shall be provided. In addition, a pressure indicator should be provided. These may be an integral unit or separate units. The temperature sensor should be located in the return solution line. The pressure sensor shall be located in the solution-rinse line downstream from the pressure supply pump. Recording charts shall be properly identified (showing date, permit number of transportation tank cleaned, operator's initials, etc.) and kept on file for not less than 90 days;(G) the necessary equipment shall be provided for the cleaning of transport tank pumps, gaskets, hoses, etc., which do not clean in place (CIP). Equipment shall be provided to clean the hoses by circulation of cleaning solution in conjunction with the clean-out-of-place (COP) vat that is equipped with a temperature recorder which meets the applicable requirements of the most current revision of the "Grade A Pasteurized Milk Ordinance;" however, if an integrated CIP system designed to clean transport tanker, milk pumps, gaskets, hoses and appurtenances, by circulation is provided, the following criteria must be met:(i) a temperature recorder that complies with the applicable requirements of the most current revision of the "Grade A Pasteurized Milk Ordinance" and a pressure recorder shall be provided;(ii) the extended tube holder for cleaning milk hoses and receiving hoses shall be of adequate length to accommodate hoses of 35 feet maximum length;(iii) the CIP system shall provide a cleaning regimen for a pre-rinse, wash, post-rinse and sanitizing of the transport tanker, milk pumps, gaskets, hoses, receiving hose, and appurtenances;(iv) the CIP system shall be capable of a minimum wash temperature of 135 degrees Fahrenheit and minimum circulation flow rate of five feet per second; and(v) all equipment and utensils shall be in compliance with the standards outlined in the current edition of the 3-A Sanitary Standards and Accepted Practices at the time of installation;(H) all equipment and utensils must be in compliance with the current edition of the 3-A Sanitary Standards and Accepted Practices at the time of installation; and(I) a cleaning regimen shall be established and posted in the milk tank truck cleaning facility. This regimen shall provide for a pre-rinse and sanitizing of the milk tank truck. The wash solution must have a minimum temperature in the return line of 135 degrees Fahrenheit.(4) The department may permit an unloading station to utilize a milk tank truck cleaning facility equipped only with portable tank washing equipment (drop in washers) or with the equipment and personnel necessary for manual tank cleaning, providing the station can demonstrate the capability of effectively cleaning and sanitizing the milk tank trucks. In no case will milk tank trucks equipped with installed tank washers be unloaded into said unloading stations without the permission of the department. This permission will be granted only in emergency situations.(5) The milk tank truck and appurtenances shall be thoroughly cleaned after each use and all equipment shall be thoroughly cleaned at least once each day used. It is allowable to pick up multiple loads continuously within a 24-hour period, provided the milk tank truck is washed after each day's use.(6) The milk tank truck and appurtenances shall be sanitized immediately after washing with an approved sanitizer. The milk tank truck shall be sanitized by pumping the sanitizing solution through the wash-rinse system. When the time elapsed after cleaning and sanitizing, and before its first use, exceeds 96 hours, the tank must be re-sanitized.(7) A cleaning and sanitizing tag shall be affixed to the outlet valve of the milk tank truck until the milk tank truck is next washed and sanitized. When the milk tank truck is washed and sanitized, the previous cleaning and sanitizing tag shall be removed and stored at the location where the milk tank truck was washed for a period of not less than 15 days. The tag shall bear the following information:(A) the milk tank truck permit number;(B) the date and time it was cleaned and sanitized;(C) the name and location of the cleaning station; and(D) the name of the person who cleaned and sanitized the milk tank truck. Source Note: The provisions of this §217.64 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY D BULK MILK REGULATIONS §217.64 Unloading Stations and Milk Tank Truck Cleaning Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145223&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145223 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145223&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145223 03/11/2026 Duties and responsibilities of the Bulk Milk Hauler/Sampler shall be in compliance with §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance). In addition the Bulk Milk Hauler/Sampler shall:(1) agitate the farm bulk milk tank for a minimum of ten minutes. Larger tanks may require more time; and(2) deliver producer samples to designated place and personnel as approved by the department. Source Note: The provisions of this §217.65 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY D BULK MILK REGULATIONS §217.65 Responsibilities of the Bulk Milk Hauler/Sampler https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145224&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145224 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145224&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145224 03/11/2026 Every manufacturer of dairy products located in the State of Texas, shall obtain a milk plant permit. Farms producing milk for manufacturing purposes shall obtain a producer dairy farm permit. Only a person who complies with the requirements of these rules shall be entitled to receive and retain a permit. Source Note: The provisions of this §217.71 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.71 Permits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145225&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145225 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145225&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145225 03/11/2026 (a) Each dairy product manufacturer located within the State of Texas shall be inspected by the department prior to the issuance of a permit. Following the issuance of a permit, each dairy product manufacturer shall be inspected at least once every three months. When the violation of any of the requirements set forth in §217.74 of this title (relating to Requirements for Milk Plants Producing Dairy Products) are found to exist, the violation will be brought to the attention of the dairy product manufacturer, and a second inspection shall be required after the time deemed necessary to remedy the violation, but not before the lapse of three days. This second inspection shall be used to determine compliance with the requirements of §217.74 of this title. Any violation of the same requirements of §217.74 of this title on the second inspection shall be the basis for permit suspension in accordance with §217.92 of this title (relating to Enforcement) and/or court action.(b) One copy of the inspection report shall be provided to the operator, or other responsible person and be posted in a conspicuous place on an inside wall of the establishment. The inspection report shall not be defaced and shall be made available to the department upon request. An identical copy of the inspection report shall be filed with the records of the department.(c) Every dairy product manufacturer, upon the request of the department, shall permit access of officially designated persons to all parts of their establishment or facilities to determine compliance with these rules. A distributor or milk plant operator shall furnish the department, upon request, a true statement of the actual quantities of milk and milk products purchased and sold.(d) All plans for the construction, reconstruction, or alterations other than those to repair or perform maintenance on existing facilities of a dairy product manufacturer must be submitted to the department for approval before construction is begun.(e) When a condition is found which constitutes an imminent health hazard, the department shall suspend the permit immediately. A dairy product manufacturer found violating any requirement must be notified in writing. The requirement of giving written notice shall be deemed to have been satisfied by the handing to the operator, or by the posting, of an inspection report, as required by this section. After receipt of a notice of violation, but before the allotted time has elapsed, the dairy product manufacturer shall have an opportunity to appeal or request an extension of the time allowed for correction. Source Note: The provisions of this §217.72 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.72 Inspection of Dairy Product Manufacturers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145226&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145226 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145226&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145226 03/11/2026 (a) Raw milk for manufacturing purposes shall be produced from producer dairy farms that hold a valid Grade A permit. Dairies that are permitted to sell Grade A Raw Milk for Pasteurization, but have had their permit temporarily suspended because of violations of Grade A standards for bacterial count, somatic cell count, or added water may be eligible to sell milk for manufacturing purposes for a period not to exceed 14 days, provided that the most recent bacterial count of milk does not exceed 500,000 per milliliter.(b) The appearance of acceptable raw milk shall be normal and free of sediment when examined visually or by test procedure. It shall not show any abnormal condition (including, but not limited to curdled, ropy, bloody or mastitic condition), as indicated by sight or other test procedures. The milk shall be free from objectionable feed and other off-odors. It shall be free of excessive sediment.(c) Milk for manufacturing purposes shall not contain aflatoxin residues of 0.5 parts per billion or greater.(d) Milk for manufacturing purposes shall contain no drug residues. Source Note: The provisions of this §217.73 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.73 Raw Milk for Manufacturing Purposes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145227&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145227 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145227&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145227 03/11/2026 (a) General requirements.(1) Plant cleanliness. All rooms in which dairy products are handled, processed or stored, or in which containers, utensils and/or equipment are washed or stored, shall be kept clean, neat and free of evidence of insects and rodents. Only insecticides and rodenticides approved for use by the department and/or registered with the U.S. Environmental Protection Agency (EPA) shall be used for insect and rodent control. Only equipment directly related to processing operations or the handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, condensing, drying, packaging, and bulk milk or milk product storage rooms. All piping, floors, walls, ceilings, fans, shelves, tables and the non-product-contact surfaces of other facilities and equipment shall be clean. No trash, solid waste or waste dry product shall be stored within the milk plant, except in covered containers. Excessive product dust shall be kept under effective control by the use of exhaust and collective systems designed for in-plant dust control. Tailings and materials collected from exhaust collective systems shall not be used for human consumption.(2) Surroundings. The adjacent surroundings shall be free from refuse, rubbish, and waste materials to prevent harborage of rodents, insects, and other vermin. The premises shall be kept in a clean and orderly condition, and shall be free from strong or foul odors, or smoke. Construction and maintenance of adjacent plant traffic areas shall be of concrete, asphalt, or similar material to keep dust and mud to a minimum.(3) Drainage. A suitable drainage system shall be provided which will allow rapid drainage of all water from plant buildings and driveways, including surface water around the plant and on the premises, and all such water shall be disposed of in such a manner as to prevent a nuisance or health hazard and in compliance with state, district, and local regulations.(b) Buildings.(1) The building or buildings shall be of sound construction and shall be kept in good repair to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs, and cats. All service pipe openings through outside walls shall be sealed around the opening or provided with tight metal collars.(2) All openings to the outer air shall be effectively protected by: screening or effective electric screen panels; fans or air curtains which provide sufficient air velocity so as to prevent the entrance of insects; properly constructed flaps where it is impractical to use self-closing doors or air curtains; or any effective combination of the above or by any other method which prevents the entrance of insects. All outer doors shall be tight and self-closing. Screen doors shall open outward. All outer openings shall be rodent-proofed to the extent necessary to prevent the entry of rodents.(3) The walls, ceilings, partitions, and posts of rooms in which milk or dairy products are processed, manufactured, handled, packaged, or stored (except dry storage of packaged finished products and supplies) or in which utensils are washed and stored, shall be smooth with material that is light colored, resistant to moisture, and easy to keep clean.(4) Floors.(A) The floors of all rooms in which milk or dairy products are processed, manufactured, packaged, or stored or in which utensils are washed shall be constructed of tile laid with impervious joint material, concrete, or other equally impervious material. The floors shall be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing, and all openings to the drains shall be equipped with traps properly constructed and kept in good repair.(B) Sound, smooth wood floors which can be kept clean, may be used in rooms where new containers and supplies and packaged finished products are stored.(5) Lighting and ventilation.(A) Adequate light sources shall be provided (natural, artificial or a combination of both) which furnish at least 20 foot-candles (220 lux) of light in all working areas. This shall apply to all rooms where milk or milk products are handled, processed, packaged, or stored; or where containers, utensils and/or equipment are washed. Dry storage and cold storage rooms shall be provided with at least five foot-candles (55 lux) of light.(B) Ventilation in all rooms shall be sufficient to keep them reasonably free of odors and excessive condensation on equipment, walls and ceilings.(C) Pressurized ventilating systems, if used, shall have a filtered air intake.(D) For milk plants that condense and/or dry milk or milk products, ventilating systems in packaging rooms, where used, shall be separate systems and where possible have the ducts installed in a vertical position.(6) Rooms and compartments.(A) Pasteurizing, processing, reconstitution, cooling, condensing, drying, and packaging of milk and milk products shall be conducted in a single room, or separate rooms, but not in the same room used for the cleaning of milk cans, portable storage bins, bottles and cases, or the unloading and/or cleaning and sanitizing of milk tank trucks, provided that these rooms may be separated by solid partitioning doors that are kept closed. Handwashing of milk cans, portable storage bins, bottles and cases may be permitted in a single room, provided that these operations are conducted in a manner that precludes contamination of the finished dairy product. Cooling, either plate or tubular, may be done in the room where milk tank trucks are unloaded and/or cleaned and sanitized. Separation/clarification of raw milk may be done in an enclosed room where milk tank trucks are unloaded and/or cleaned and sanitized.(B) Coolers and freezers. Coolers and freezers where dairy products are stored shall be clean, dry and maintained at a uniform temperature and humidity to protect the product from deterioration, and minimize the growth of mold. Circulation of air shall maintain uniform temperature and humidity at all times. Coolers and freezers shall be free from rodents, insects, and pests. Shelves shall be kept clean and dry. Refrigeration units shall have provisions for collecting and disposing of condensate.(i) Bulk milk and milk products shall be handled and stored to maintain an internal temperature of 45 degrees F or below.(ii) Packaged milk and milk products shall be handled and stored to maintain an internal temperature of 41 degrees F or below.(iii) Freezers shall be maintained so that frozen food remains frozen at all times.(C) Supply rooms. The supply rooms used for the storing of packaging materials, containers, and miscellaneous ingredients shall be kept clean, dry, orderly, free from insects, rodents, and mold, and maintained in good repair. These items stored therein shall be adequately protected from dust, dirt, or other extraneous matter, and so arranged on racks, shelves, or pallets to permit access to the supplies and cleaning and inspection of the room. Insecticides, rodenticides and cleaning compounds shall be properly labeled and segregated, and stored in a separate room or cabinet away from milk, dairy products, ingredients, or packaging supplies.(D) Boiler and tool rooms. The boiler and tool rooms shall be separated from other rooms where milk and dairy products are processed, manufactured, packaged, handled, or stored. The rooms shall be kept orderly and reasonably free from dust and dirt.(E) Toilet and dressing rooms. Toilet facilities shall be provided and be conveniently located. Toilet rooms may not open directly into any room in which milk and/or milk products are processed, condensed or dried, and stored. Toilet rooms shall be completely enclosed and have tight-fitting, self-closing doors. Dressing rooms, toilet rooms, and fixtures are kept in a clean condition, in good repair and are well ventilated and well lighted. Toilet tissue and easily cleanable covered waste receptacles shall be provided in toilet rooms. All plumbing shall be installed to meet the applicable provisions of the state or local plumbing code. Sewage and other liquid wastes shall be disposed of in a sanitary manner, and non-water-carried sewage disposal facilities shall not be used.(F) Starter facilities. Sanitary facilities shall be provided for the handling of starter cultures.(7) Handwashing facilities. Handwashing facilities shall be provided, including hot and cold running water, soap or other detergents, and sanitary single-service towels or air dryers. The facilities shall be located in or adjacent to toilet and dressing rooms and also at such other places in the plant as may be essential to the cleanliness of all personnel handling products. Vats for washing equipment or utensils shall not be used as handwashing facilities. Self-closing metal or plastic containers shall be provided for used towels and other wastes.(8) Drinking water facilities. Drinking water facilities shall be provided in the plant and shall be conveniently located.(c) Facilities.(1) Water supply.(A) Water for milk plant purposes shall be from an adequate supply, properly located, protected, and operated. It shall be easily accessible and of a safe, sanitary quality.(B) The water supply shall be approved as safe by the State Water Control Authority and, in the case of individual water systems, complies with the specification outlined in Appendix D of the most current revision of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance), and the Bacteriological Standards outlined in Appendix G of the most current revision of the "Grade A Pasteurized Milk Ordinance."(C) There shall be no cross-connection between the safe water supply and any unsafe or questionable water supply, or any source of pollution through which the safe water supply might become contaminated. A connection between the water supply piping and a make-up tank, such as for cooling or condensing, unless protected by an air gap or effective backflow preventer, constitutes a violation of this requirement. An approved air gap is defined as the unobstructed vertical distance through the free atmosphere of at least twice the diameter of the largest incoming water supply pipe or faucet to the flood level of the vessel or receptacle. The distance of the air gap is to be measured from the bottom of the potable inlet supply pipe or faucet to the top of the effective overflow, i.e., flood level rim or internal overflow, of the vessel. In no case, may the effective air gap be less than one inch (2.54 cm).(D) Condensing water for milk or milk product evaporators, and water used to produce vacuum and/or to condense vapors in vacuum heat processing equipment, shall be from a source complying with subparagraph (B) of this paragraph. When approved by the department, water from sources not complying with subparagraph (B) of this paragraph, may be used when the evaporator or vacuum heat equipment is constructed and operated to preclude contamination of such equipment, or its contents, by condensing water or by water used to produce vacuum. Means of preventing such contamination are:(i) use of a surface type condenser in which the condensing water is physically separated from the vapors and condensate; or(ii) use of reliable safeguards to prevent the overflow of condensing water from the condenser into the evaporator. Such safeguards include a barometric leg extending at least 35 feet vertically from the invert of the outgoing condensing water line to the free level at which the leg discharges, or a safety shutoff valve, located on the water feed line to the condenser, automatically actuated by a control which will shut off the in-flowing water when the water level rises above a predetermined point in the condenser. This valve may be actuated by water, air or electricity, and shall be designed so that failure of the primary motivating power will automatically stop the flow of water into the condenser.(E) Condensing water for milk or milk product evaporators, complying with subparagraph (D) of this paragraph, and water reclaimed from milk or milk products may be reused when all necessary means of protection are afforded and it complies with the procedures outlined in Appendix D, Part V of the most current revision of the "Grade A Pasteurized Milk Ordinance."(F) New individual water supplies and water supply systems, which have been repaired or otherwise become contaminated, shall be disinfected before being placed in use. The supply shall be made free of the disinfectant by pumping to waste before any sample for bacteriological testing shall be collected.(G) Samples for bacteriological testing of individual water supplies shall be taken upon the initial approval of the physical structure, each six months thereafter, and when any repair or alteration of the water supply system has been made. Samples shall be taken by the department and examinations shall be conducted in an official laboratory. To determine if water samples have been taken at the frequency established in this section, the interval shall include the designated six month period plus the remaining days of the month in which the sample is due.(H) Current records of water test results are retained by the department.(I) A potable water supply, which meets the criteria of this section, may be connected to the product feed line of a steam vacuum evaporator, provided that the water supply is protected at the point of connection by an approved backflow prevention device.(2) Air under pressure which is in direct contact with milk and milk products and milk product-contact surfaces.(A) Filter media. Air intake and pipeline filters shall consist of fiberglass with a downstream backing dense enough to prevent fiberglass breakoff from passing through cotton flannel, wool flannel, spun metal, electrostatic material, or other equally acceptable filtering media, which are non-shedding and which do not release to the air, toxic volatiles or volatiles which may impart any flavor or odor to the milk or milk product.(B) Filter performance. Intake air filter efficiency shall be at least 98% using air cleaner coarse test dust. Final filter efficiency shall be at least 99% as measured by the Dioctylphthalate Fog Method (DOP) test (with a mean particle diameter of 0.3 microns). When commercially sterile air is required, the final filter efficiency shall be at least 99.99% as measured by the DOP test.(C) Air supply equipment. The compressing equipment shall be designed to preclude contamination of the air with lubricant vapors and fumes. Oil-free air may be produced by one of the following methods or their equivalent:(i) use of a carbon ring piston compressor;(ii) use of oil-lubricated compressor with effective provision for removal of any oil vapor by cooling the compressed air; or(iii) water-lubricated or non-lubricated blowers. The air supply shall be taken from a clean space or from relatively clean outer air and shall pass through a filter upstream from the compressing equipment. This filter shall be located and constructed so that it is easily accessible for examination and the filter media are easily removable for cleaning or replacing. The filter shall be protected from weather, drainage, water, product spillage, and physical damage.(D) Moisture removal equipment. Air under pressure systems in excess of one bar, i.e., 103.5 kPa (15 psi), shall be provided with methods of moisture removal. The removal of moisture may be achieved by condensation and coalescing filtration or absorption, or equivalent, to prevent free water in the system. If it is necessary to cool the compressed air, an after-cooler shall be installed between the compressor and the air storage tank for the purpose of removing moisture from the compressed air.(E) Filters and moisture traps. Filters shall be constructed so as to ensure effective passage of air through the filter media only. The coalescing filter and associated traps shall be located in the air pipeline downstream from the compressing equipment, and from the air tank, if one is used. The filter shall be readily accessible for examination, cleaning, and for replacing the filter media. The moisture trap shall be equipped with a petcock or other means for draining accumulated water. When coalescing filters are used, a means shall be provided to measure the differential pressure across the filter. The differential pressure device is required to indicate the need for filter media replacement. All coalescing filter housings shall be provided with a means of removing the condensed liquid from the filtration device. This can be accomplished by an automatic or manual drain installed on the base of the filter housing. The final filter media shall be disposable. The filter media shall be located in the air line upstream from, and as close as possible to, the point of application except that a final filter shall not be required where the compressing equipment is of a fan or blower type and operating at a pressure of less than one (1) bar, i.e., 103.5 kPa (15 psi). Electronic air cleaners utilizing electrostatic precipitation principles to collect particulate matter may be used. Disposable filter media shall not be cleaned and reused.(F) Air piping. The air piping from the compressing equipment to the filter and moisture trap shall be readily drainable. A milk or milk product check-valve of sanitary design shall be installed in the air piping, downstream from the disposable media filter, to prevent backflow of milk or milk product into the air pipeline, except that a check-valve shall not be required if the air piping enters the milk or milk product zone from a point higher than the milk or milk product overflow level, which is open to the atmosphere, or is for dry product applications, or for other dry application where liquids are not present. When a check-valve is not required, plastic or rubber or rubber-like tubing and suitable compatible fittings and connections made of plastic or stainless steel may be used between the final filter and the point of application. Air distribution piping and fittings after the final filter shall be of corrosion-resistant materials. Air distribution piping, fittings and gaskets between the discharge of the sanitary check-valve to the processing equipment shall be sanitary piping.(3) Culinary steam for milk and milk products. The following methods and procedures will provide steam of culinary quality for use in the processing of milk and milk products.(A) Source of boiler feed water. Potable water or water supplies, acceptable to the department, shall be used.(B) Feed water treatment. Feed water may be treated, if necessary, for proper boiler care and operation. Boiler feed water treatment and control shall be under the supervision of trained personnel or a firm specializing in industrial water conditioning. Such personnel shall be informed that the steam is to be used for culinary purposes. Pretreatment of feed waters for boilers or steam generating systems to reduce water hardness, before entering the boiler or steam generator by ion exchange or other acceptable procedures, is preferable to the addition of conditioning compounds to boiler waters. Only compounds complying with Title 21, Code of Federal Regulations (CFR), §173.310, may be used to prevent corrosion and scale in boilers, or to facilitate sludge removal. Amounts of the boiler water treatment compounds greater than the minimum necessary for controlling boiler scale or other boiler water treatment purposes shall not be used. No greater amount of steam than necessary shall be used for the treatment and/or pasteurization of milk and milk products. It should be noted that tannin, which is also frequently added to boiler water to facilitate sludge removal during boiler blow-down, has been reported to give rise to odor problems, and should be used with caution. Boiler compounds containing cyclohexylmine, morpholine, octadecylamine, diethylaminoethanol, trisodium nitrilotriacetae, and hydrazine shall not be permitted for use in steam in contact with milk and milk products.(C) Boiler operation. A supply of clean, dry saturated steam is necessary for proper equipment operation. Boilers and steam generation equipment shall be operated in such a manner as to prevent foaming, priming, carryover and excessive entrainment of boiler water into the steam. Carryover of boiler water additives can result in the production of milk or milk product off-flavors. Manufacturers' instructions regarding recommended water level and blow-down should be consulted and rigorously followed. The blow-down of the boiler should be carefully watched, so that an overconcentration of the boiler water solids and foaming is avoided. It is recommended that periodic analyses be made of condensate samples. Such samples should be taken from the line between the final steam separating equipment and the point of the introduction of steam into the milk or milk product.(4) Disposal of wastes. Dairy wastes shall be properly disposed of from the plant and premises. The sewer system shall have sufficient slope and capacity to readily remove all waste from the various processing operations. Where a public sewer is not available, all wastes shall be properly disposed of in a manner in compliance with local and state regulations. Containers used for the collection and holding of wastes shall be constructed of metal, plastic, or other equally impervious material and kept covered with tight-fitting lids and placed outside the plant on a concrete slab or on a rack raised at least 12 inches above the floor. Alternatively, waste containers may be kept inside an enclosed, clean, and fly-proof room. Solid wastes shall be disposed of at regular intervals to prevent the unsanitary accumulation of waste.(d) Equipment and utensils - General construction, repair, and installation.(1) All multi-use containers and equipment that milk and milk products come into contact with shall be of smooth, impervious, corrosion-resistant, non-toxic material shall be constructed for ease of cleaning and shall be kept in good repair. All single-service containers, closures, gaskets and other articles that milk and milk products come in contact with shall be non-toxic and shall have been manufactured, packaged, transported and handled in a sanitary manner. Articles intended for single-service use shall not be reused.(2) All equipment and piping shall be designed and installed so as to be easily accessible for cleaning, and shall be kept in good repair, free from cracks and corroded surfaces. New or rearranged equipment shall be set away from any wall or spaced in such a manner as to facilitate cleaning and to maintain good housekeeping. All parts or interior surfaces of equipment, pipes (except certain piping cleaned in place) or fittings, including valves and connections, shall be accessible for inspection. Milk and dairy product pumps shall be of a sanitary type and easily dismantled for cleaning or shall be of approved construction to allow effective cleaning in place in accordance with 3-A Sanitary Standards.(3) All CIP systems shall comply with the 3-A Sanitary Practices for permanently installed sanitary product, pipelines, and cleaning systems.(4) All joints in containers, utensils and equipment shall be flush and finished as smooth as adjoining surfaces, or if the surface is vitreous, it must be continuous. Tile floors are not acceptable in dryers. Joints on equipment coming in contact with dry milk or milk products only or used for hot air piping may be sealed by other acceptable means. Where a rotating shaft is inserted through a surface with which milk or milk products come into contact, the joint between the moving and stationary surfaces shall be close fitting. Grease and oil from gears, bearings, and cables shall be kept out of the milk and milk products. Where a thermometer or temperature sensing element is inserted through a surface with which milk or milk products come into contact a pressure-tight seal shall be provided ahead of all threads and crevices.(5) Can washers. Can washers shall have sufficient capacity and ability to discharge a clean, dry can and cover and shall be kept properly timed in accordance with the instructions of the manufacturer. The water and steam lines supplying the washer shall maintain a uniform pressure and be equipped with pressure regulating valves.(6) Product storage tanks or vats. Storage tanks or vats shall be fully enclosed or tightly covered and well insulated. The entire interior surface, agitator and all appurtenances shall be accessible for thorough cleaning and inspection. Any opening at the top of the tank or vat including the entrance of the shaft shall be protected against the entrance of dust, moisture, insects, oil, or grease. The sight glasses, if used, shall be sound, clear, and in good repair. Vats which have hanged covers shall be so designed that moisture or dust on the surface cannot enter the vat when the covers are raised. If the storage tanks or vats are equipped with air agitation, the system shall be of an approved type and properly installed in accordance with the 3-A Accepted Practices for Supplying Air Under Pressure. Storage tanks or vats intended to hold product for longer than approximately eight hours shall be equipped with refrigeration and/or have insulation. All new storage tanks or vats shall meet the appropriate 3-A Sanitary Standards and shall be equipped with thermometers in good operating order.(7) Surface coolers. Surface coolers shall be equipped with hinged or removable covers for the protection of the product. The edges of the fins shall be so designed as to divert condensate on non-product-contact surfaces away from product-contact surfaces. All gaskets or swivel connections shall be leak proof.(8) Plate-type heat exchangers. Plate-type heat exchangers shall meet the 3-A Sanitary Standards for Construction and Installation. All gaskets shall be tight and kept in good operating order. Plates shall be opened for inspection by the operator at sufficiently frequent intervals to determine if the equipment is clean and in good repair (e.g. free of dents, holes, broken gaskets and cracks). A cleaning regimen shall be posted to insure cleaning procedures between inspection periods.(9) Internal return tubular heat exchangers. Internal return tubular heat exchangers shall meet the 3-A Sanitary Standards for Construction and Installation.(10) Pumps. Pumps used for milk and dairy products shall be of the sanitary type and constructed to meet 3-A Sanitary Standards. Unless pumps are specifically designed for effective cleaning in place, they shall be disassembled and thoroughly cleaned after use.(11) New equipment and replacements. New equipment and replacements, including all plastic parts, rubber and rubber-like materials for parts and gaskets having product-contact surfaces, shall meet the 3-A Sanitary Standards. If equipment or replacements are not approved by 3-A Sanitary Standards, such equipment and replacements shall meet the general requirements of this section.(e) Personnel cleanliness. All employees shall wash their hands before beginning work and upon returning to work after using toilet facilities, eating, smoking, or otherwise soiling their hands. They shall keep their hands clean and follow good hygienic practices while on duty. Expectorating or use of tobacco in any form shall be prohibited in each room and compartment where any milk, dairy product, or supplies are prepared, stored, or otherwise handled. All persons shall wear clean outer garments while engaged in the handling, processing, storage, transporting, or packaging of dairy products. Clean outer garments shall also be worn by persons handling containers, utensils, and equipment used for these activities. Adequate hair coverings shall be worn by all persons engaged in receiving, testing, processing, packaging, or handling of dairy products.(f) Personnel health. No person afflicted with a communicable disease shall be permitted in any room or compartment where milk and milk products are prepared, manufactured, or otherwise handled. No person who has a discharging or infected wound, sore or lesion on hands, arms, or other exposed portion of the body shall work in any dairy processing rooms or in any capacity which brings them into direct contact with associated milk or milk product-contact surfaces. Milk plant operators who have received verifiable and confirmed reports from or about employees who have these conditions and who have handled pasteurized milk or milk products or associated milk or milk product-contact surfaces, shall immediately report these facts to the department. Milk plant employees or applicants to whom a conditional offer of employment has been made shall be instructed by the milk plant that the employee or applicant is responsible to report to the milk plant management, in a manner that allows the milk plant to prevent the likelihood of the transmission of diseases that are transmissible through foods, if the employee or applicant:(1) is diagnosed with an illness due to Hepatitis A virus, Salmonella typhi, Shigella species, Norovirus, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli 0157:H7, enterohemorrhagic Escherichia coli, enterotoxigenic Escherichia coli, Campylobacter jejuni, Entamoeba histolytica, Giardia lamblia, Non-typhoidal Salmonella, Rotovirus, Taenia solium, Yersinia enterocolitica, Vibrio cholerae O1 or other infectious or communicable disease that has been declared by the U.S. Secretary of Health and Human Services (HHS) to be transmissible to others through the handling of food, or has been clearly shown to be transmissible based upon verifiable epidemiological data; or(2) is exposed to, or suspected of causing, a confirmed foodborne disease outbreak of one of the diseases specified in paragraph (1) of this subsection, including an outbreak at an event such as a family or communal meal, (e.g., church supper or ethnic festival) because the employee or applicant:(A) prepared food implicated in the outbreak; or(B) consumed food implicated in the outbreak; or(C) consumed food at the event prepared by a person who is infected or ill.(3) lives in the same household as a person who attends or works in a day care center, school or similar institution if the institution experiencing a confirmed outbreak of one of the diseases specified in paragraph (1) of this subsection. Similarly, milk plant employees shall be instructed by the milk plant management to report to the milk plant management if the employee, or applicant:(4) has a symptom associated with acute gastrointestinal illness such as: Abdominal cramps or discomfort, diarrhea, fever, loss of appetite for three or more days, vomiting, jaundice; or(5) has a pustular lesion such as a boil or infected wound that is:(A) on the hands, wrists or exposed portions of the arms, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier; or(B) on other parts of the body if the lesion is open or draining, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier.(g) Raw product storage.(1) All milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration. Raw milk in storage tanks within the dairy plant shall be handled in such a manner as to minimize bacterial increase and shall be maintained at 45 degrees Fahrenheit or lower until processing begins. This does not preclude holding milk at higher temperatures for a period of time, where applicable to particular manufacturing or processing practices.(2) The bacteriological quality of commingled raw milk for use in dairy products for manufacturing purposes shall not exceed 500,000 per ml.(3) During any consecutive six months, at least four samples of raw milk intended for use in manufactured milk products shall be taken by and examined by the department.(h) Pasteurization. When pasteurization is required, or when a product is designated "pasteurized," every particle of the milk or milk product shall be subjected to such temperatures and holding periods in properly designed and operated equipment sufficient to ensure proper pasteurization of the product in accordance with the most current revision of the "Grade A Pasteurized Milk Ordinance." Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.(i) Composition and wholesomeness. All necessary precautions shall be taken to prevent contamination or adulteration of the milk or dairy products during manufacturing in accordance with these rules. All substances and ingredients used in the processing or manufacturing of any dairy product shall be subject to inspection and shall be wholesome and practically free from impurities.(j) Cleaning and sanitizing treatment.(1) All multi-use containers and utensils shall be thoroughly cleaned after each use and all equipment shall be thoroughly cleaned at least once each day used, unless the department has reviewed and accepted information, in consultation with FDA, supporting the cleaning of multi-use containers and utensils at frequencies extending beyond one day or 72 hours in the case of storage tanks, or 44 hours in the case of evaporators, which are continuously operated. Approval by the department will be conveyed in writing. Supporting information shall be submitted to and approved by the department prior to initiating the qualification period if required. Any significant equipment or processing changes shall be communicated to the department, and may result in a re-verification of the extended run proposal, if it is determined that the change could potentially affect the safety of the finished milk or milk product(s). The supporting information may include but is not limited to:(A) statement of proposal, including desired cleaning frequency;(B) product and equipment description;(C) intended use and consumers;(D) distribution and storage temperatures of product;(E) diagram of process of interest;(F) process parameters, including temperature and times;(G) hazard evaluation and safety assessment; and(H) review of equipment for sanitary design.(2) When indicated by a hazard evaluation and safety assessment, a plan for initial qualification shall be developed to address identified critical process parameters.(3) Storage tanks shall be cleaned when emptied and shall be emptied at least every 72 hours. Records must be available to the department to verify that milk storage in these tanks does not exceed 72 hours. These records shall be available for at least the previous three months or from the time of the last regulatory inspection, whichever is longer. Storage tanks, which are used to store raw milk or milk products or heat-treated milk products longer than 24 hours and silo tanks used for the storage of raw milk or milk products or heat-treated milk products shall be equipped with a seven day temperature recording device complying with the specifications of the most current revision of the Grade A Pasteurized Milk Ordinance.(4) Evaporators shall be cleaned at the end of a continuous operation, not to exceed 44 hours, and records must be available to the department to verify that the operation time does not exceed 44 hours. Drying equipment, cloth-collector systems, packaging equipment and multi-use dry milk products and dry whey storage containers shall be cleaned at intervals and by methods recommended by the manufacturer and approved in writing by the department. Such methods may include cleaning without water by use of vacuum cleaners, brushes, or scrapers. After cleaning, such equipment is sanitized by a method approved in writing by the department. Cloth collector systems and all dry product-contact surfaces downstream from the dryer shall be sanitized or purged at intervals and by methods recommended by the manufacturer and approved by the department. Storage bins used to transport dry milk or milk products shall be dry cleaned after each usage and washed and sanitized at regular intervals.(5) All milk tank trucks that transport milk and milk products shall be washed and sanitized at a permitted milk plant, receiving station, transfer station, or milk tank truck cleaning facility. The milk tank truck shall be cleaned and sanitized prior to its first use. When the time elapsed after cleaning and sanitizing, and before its first use, exceeds 96 hours, the tank must be re-sanitized. Whenever a milk tank truck has been cleaned and sanitized, as required by the department, it shall bear a tag or a record shall be made showing the date, time, place and signature or initials of the employee or contract operator doing the work, unless the milk tank truck delivers to only one receiving facility where responsibility for cleaning and sanitizing can be definitely established without tagging. The tag shall be removed at the location where the milk tank truck is next washed and sanitized and kept on file for 15 days.(6) Pipelines and/or equipment designed for mechanical cleaning shall meet the following requirements.(A) An effective cleaning and sanitizing regimen for each separate cleaning circuit shall be followed.(B) A temperature recording device, complying with the most current revision of the Grade A Pasteurized Milk Ordinance, or a recording device which provides sufficient information to adequately evaluate the cleaning and sanitizing regimen which is approved by the department in writing, shall be installed in the return solution line or other appropriate area to record the temperature and time during which the line or equipment is exposed to cleaning and sanitizing solutions. For purposes of this section, recording devices which produce records not meeting the specifications of the most current revision of the "Grade A Pasteurized Milk Ordinance" may be acceptable if:(i) the device provides a continuous record of the monitoring of the cleaning cycle time and temperature, cleaning solution velocity or cleaning pump operation and the presence or strength of cleaning chemicals for each cleaning cycle;(ii) the record shows a typical pattern of each circuit cleaned, so that changes in the cleaning regimen may be readily detected; or(iii) electronic storage of required cleaning records, with or without hard copy printouts, may be acceptable, provided, the electronically generated records are readily available. Electronic records must meet the criteria of this section and those provisions of with the most current revision of the Grade A Pasteurized Milk Ordinance, which are determined to be applicable by the department and FDA. Except that, electronic storage of required cleaning records, with or without hard copy, shall be acceptable, provided the computer and computer generated records are readily available and meet the criteria of this section and Title 21, CFR, Part 11.(k) Packaging and labeling.(1) Containers:(A) The size, style, and type of packaging used for dairy products shall be packaged in materials which will cover and protect the quality of the contents during storage and regular channels of trade and under conditions of handling. The weights and shape within each size or style shall be as nearly uniform as is practical.(B) Packaging materials for dairy products shall be selected which will provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation. In addition, the wrapper shall be resistant to puncturing, tearing, cracking, or breaking under normal conditions of handling, shipping, and storage. When special-type packaging is used, the instructions of the manufacturers shall be followed closely as to its application and methods of closure.(2) Packaging and repackaging. Packaging dairy products or cutting and repackaging all styles of dairy products shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the equipment and packaging material shall be free from mold and bacterial contamination. Methods for checking the level of contamination shall be as prescribed by the most current edition of "Standard Methods for the Examination of Dairy Products" of the American Public Health Association as defined in §217.1 of this title (relating to Definitions).(3) Labeling. All commercial bulk packages containing dairy products manufactured under the provisions of this subpart shall be adequately and legibly marked with the name of the product, name and address of processor or manufacturer or other assigned plant identification, lot number, and any other identification as may be required by the department. Consumer packaged products shall be legibly marked with the name of the product, name and address of packer, manufacturer, or distributor.(l) Storage of finished product.(1) Dry storage. The product shall be stored at least 18 inches from the wall in aisles, rows, or sections and lots, in such a manner as to be orderly and easily accessible for inspection. Rooms should be cleaned regularly. Care shall be taken in the storage of any other product foreign to dairy products in the same room, in order to prevent impairment or damage to the dairy product from mold, absorbed odors, or vermin or insect infestation. Control of humidity and temperature shall be maintained at all times to prevent conditions detrimental to the product and container.(2) Refrigerated storage. The finished product shall be placed on shelves, dunnage, or pallets and identified. It shall be stored under temperatures that will best maintain the initial quality. The product shall not be exposed to anything from which it might absorb any foreign odors or be contaminated by drippage or condensation. Source Note: The provisions of this §217.74 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.74 Requirements for Milk Plants Producing Dairy Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145228&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145228 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145228&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145228 03/11/2026 (a) Sanitation and construction requirements. Facility and equipment shall be constructed and maintained in compliance with §217.74 of this title (relating to Requirements for Milk Plants Producing Dairy Products) and the most current revision of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance).(b) Operations and operating procedures for pasteurization. All milk, buttermilk, and whey used in the manufacture of dry dairy products shall be pasteurized at the plant where dried, except that condensed whey and acidified buttermilk containing 40% or more solids may be transported to another plant for drying without repasteurization. When pasteurization is required, or when a product is designated "pasteurized," every particle of the milk or milk product shall be subjected to such temperatures and holding periods in properly designed and operated equipment to ensure proper pasteurization of the product in accordance with the most current revision of the "Grade A Pasteurized Milk Ordinance." Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.(c) Product adulteration. All necessary precautions shall be taken throughout the entire operation to prevent the adulteration of one product with another. The commingling of one type of liquid or dry product with another shall be considered an adulteration of both products. This does not prohibit the standardization of like products or the production of specific products for special uses provided labeling requirements are met as set forth in 21 Code of Federal Regulations, Parts 133 and 135.(d) Checking quality. All milk products and dry milk products shall be subject to inspection and analysis by the dairy plant for quality and condition throughout each processing operation. Line samples shall be taken as an aid to quality control in addition to the regular routine analysis made on the finished products.(e) Requirements for instant nonfat dry milk.(1) Sampling and testing. All instant nonfat dry milk offered for sale shall be sampled and tested by the department routinely for the purpose of ensuring that the product meets requirements in accordance with the most current edition of "Standard Methods for the Examination of Dairy Products" of the American Public Health Association, as defined in §217.1 of this title (relating to Definitions).(2) Requirements for instant nonfat dry milk.(A) Flavor and odor. The flavor and odor shall be sweet, pleasing and desirable but may possess the following flavors to a slight degree:(i) chalky;(ii) cooked;(iii) feed; or(iv) flat.(B) Physical appearance. The physical appearance shall possess a uniform white to light cream natural color and shall be free-flowing and free from lumps except those that readily break up with very slight pressure.(C) Bacterial estimate. The standard plate count shall not be more than 30,000 per gram.(D) Coliform count. The coliform count shall not be more than 10 per gram.(E) Milkfat content. The milkfat shall not be more than 1.25%.(F) Moisture count. The moisture shall not be more than 4.5%.(G) Scorched particle content. Scorched particles shall not be more than 15 milligrams per gram.(H) Solubility index. The solubility index shall not be more than 1 milliliter.(I) Titratable acidity. The titratable acidity shall not be more than 0.15%.(J) Dispersibility. The dispersibility shall not be less than 85%.(K) Direct microscopic clump count. The direct microscopic clump count shall not be more than 75 million per gram. Source Note: The provisions of this §217.75 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.75 Supplemental Requirements for Plants Manufacturing, Processing and Packaging Instant Nonfat Dry Milk, Nonfat Dry Milk, Dry Whole Milk, Dry Buttermilk, Dry Whey, and Other Dry Milk Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145198&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145198 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145198&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145198 03/11/2026 (a) Rooms and compartments - Coolers and freezers. The coolers and freezers shall be equipped with facilities for maintaining temperature and humidity conditions to protect the quality and condition of the products during storage or during tempering prior to further processing. Coolers and freezers shall be kept clean, orderly, free from insects, rodents, and mold, and maintained in good repair. Coolers and freezers shall be adequately lighted and proper circulation of air shall be maintained at all times. The floors, walls, and ceilings shall be of such construction as to permit thorough cleaning.(b) Churn rooms. Churn rooms, in addition to meeting standards of proper construction and sanitation, shall be equipped to ensure that the air is kept free from odors and vapors by means of adequate ventilation and exhaust systems or air conditioning and heating facilities.(c) Print and bulk packaging rooms. Rooms used for packaging print or bulk butter and related products shall, in addition to meeting standards of proper construction and sanitation, provide an atmosphere relatively free from mold (no more than 10 mold colonies per cubic foot of air), dust or other airborne contamination and be maintained at a reasonable room temperature.(d) Equipment and utensils - General construction, repair, and installation. All equipment and utensils necessary to the manufacture of butter and related products shall meet the same general requirements as outlined in §217.74 of this title (relating to Requirements for Milk Plants Producing Dairy Products). In addition, the following requirements shall be met for other equipment.(1) Continuous churn. All product-contact surfaces shall be of non-corrosive material. All nonmetallic product-contact surfaces shall comply with 3-A Standards for Plastic, Rubber, and Rubber-Like Materials. All product-contact surfaces shall be readily accessible for cleaning and inspection.(2) Conventional churn. Churns shall be constructed of aluminum, stainless steel or equally corrosion-resistant metal, free from cracks, and in good repair. All gasket material shall be fat resistant, nontoxic and durable. Seals around the churn doors shall be tight.(3) Bulk butter trucks, boats and packers. Bulk butter trucks, boats and packers shall be constructed of aluminum, stainless steel or equally corrosion-resistant metal free from cracks, seams and must have a surface that is smooth and easily cleanable.(4) Butter, frozen or plastic cream melting machine. Shavers, shredders or melting machines used for rapid melting of butter, frozen or plastic cream shall be of stainless steel or equally corrosion-resistant metal, sanitary construction, and readily cleanable in accordance with 3-A Sanitary Standards.(5) Printing equipment. All printing equipment shall be designed to be readily demountable for cleaning of product-contact surfaces. All product-contact surfaces shall be aluminum, stainless steel or equally corrosion-resistant metal, or plastic, rubber and rubber like material which meet 3-A Standards, except that conveyors may be constructed of material which can be properly cleaned and maintained in good repair.(6) Brine tanks. Brine tanks used for the treating of parchment liners shall be constructed of non-corrosive material and have an adequate and safe means of heating the salt solution for the treatment of the liners. The tank shall also be provided with a drainage outlet.(7) Starter vats. Bulk starter vats shall be of stainless steel or equally corrosion-resistant metal and constructed according to applicable 3-A Sanitary Standards. The vats shall be in good repair, equipped with tight-fitting lids, and have temperature controls.(e) Operations and operating procedures for pasteurization. The milk or cream shall be pasteurized at the plant where the milk or cream is processed into the finished product.(1) Cream for buttermaking. The cream for buttermaking shall be pasteurized at a temperature of not less than 165 degrees Fahrenheit for not less than 30 minutes or at a minimum temperature of not less than 185 degrees Fahrenheit for not less than 15 seconds. Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by the Food and Drug Administration (FDA) as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act (FFDCA). Only such FDA recognized processes and no other shall be considered by the department.(2) Cream for plastic or frozen cream. The pasteurization of cream for plastic or frozen cream shall be accomplished in the same manner as in subsection (a) of this section, except that the temperature for the vat method shall be not less then 170 degrees Fahrenheit for not less than 30 minutes, or not less than 190 degrees Fahrenheit for not less than 15 seconds. Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in 21 U.S.C. §343(h)(3) of the FFDCA. Only such FDA recognized processes and no other shall be considered by the department.(f) Composition and wholesomeness. All ingredients used in the manufacture of butter and related products shall be subject to inspection and shall be wholesome and free from impurities. Chlorinating facilities shall be provided for butter wash water if needed, and all other precautions shall be taken to prevent contamination of products.(g) Containers.(1) Containers used for the packaging of butter and related products shall be containers or packaging material that will protect the quality of the contents in regular channels of trade. Caps or covers which extend over the lip of the container shall be used on all cups or tubs containing two pounds or less to protect the product from contamination during subsequent handling.(2) Liners and wrappers.(A) Supplies of parchment liners, wrappers, and other packaging material shall be protected against dust, mold, and other possible contamination.(B) Prior to use, parchment liners for bulk butter packages shall be completely immersed in a boiling salt in a container constructed of stainless steel or other equally noncorrosive material. The liners shall be maintained in the solution for not less than 30 minutes. The solution should consist of at least 15 pounds of salt for every 85 pounds of water and shall be strengthened or changed as frequently as necessary to keep the solution full strength and in good condition.(C) Other liners such as polyethylene shall be treated or handled in such a manner as to prevent contamination of the liner prior to filling.(3) Filling bulk butter containers. The lined butter containers shall be protected from possible contamination prior to filling.(4) Printing and packaging. Printing and packaging of consumer size containers of butter shall be conducted under sanitary conditions.(5) General identification. Commercial bulk shipping containers shall be legibly marked with the name of the product, net weight, name and address of manufacturer, processor or distributor or other assigned plant identification (manufacturer's lot number, churn number, etc.). Packages of plastic or frozen cream shall be marked with the percent of milkfat.(6) Storage of finished product in coolers. All products shall be kept under refrigeration at temperatures of 40 degrees Fahrenheit or lower after packaging and until ready for distribution or shipment. The products shall not be placed directly on floors or exposed to foreign odors or conditions such as drippage due to condensation which might cause package or product damage.(7) Storage of finished product in freezer.(A) Sharp freezers. Plastic cream or frozen cream intended for storage shall be placed in quick freezer rooms immediately after packaging, for rapid and complete freezing within 24 hours. The packages shall be piled or spaced in such a manner that air can freely circulate between and around the packages. The rooms shall be maintained at -10 degrees Fahrenheit or lower and shall be equipped to provide sufficient high-velocity air circulation for rapid freezing. After the products have been completely frozen, they may be transferred to a freezer storage room for continued storage.(B) Freezer storage.(i) The room shall be maintained at a temperature of 0 degree Fahrenheit or lower. Adequate air circulation is desirable.(ii) Butter intended to be held more than 30 days shall be placed in a freezer room as soon as possible after packaging. If not frozen before being placed in the freezer, the packages shall be spaced in such a manner as to permit rapid freezing and repiled, if necessary, at a later time. Source Note: The provisions of this §217.76 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.76 Supplemental Requirements for Plants Manufacturing, Processing, and Packaging Butter and Related Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145199&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145199 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145199&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145199 03/11/2026 (a) Sanitation and construction requirements. Effective six months after adoption of these rules, facilities shall be constructed and maintained in compliance with §217.74 of this title (relating to Requirements for Milk Plants Producing Dairy Products). In addition, the following requirements shall be met.(1) Rooms and compartments.(A) Starter rooms. Starter rooms or areas shall be properly equipped and maintained for the propagation and handling of starter cultures. All necessary precautions shall be taken to prevent contamination of starter, of the room, equipment, and the air therein (such as filtered air, locked doors, and entry by only specified personnel).(B) Make rooms. The rooms, or areas, in which the cheese is manufactured shall be of adequate size and the vats adequately spaced to permit movement around the vats and presses for proper cleaning and satisfactory working conditions. Adequate ventilation shall be provided.(C) Drying rooms. If cheese is to be paraffined, a drying room, or area, of adequate size shall be provided to accommodate the maximum production of cheese during the flush period. Shelving and air circulation shall be provided for proper drying. Temperature and humidity control facilities shall be provided.(D) Paraffining rooms. For rind cheese, a separate room or compartment shall be provided for paraffining and boxing the cheese. The room or compartment shall be of adequate size and the temperature maintained near the temperature of the drying room to avoid sweating of the cheese prior to paraffining.(E) Rindless block wrapping area. For rindless blocks, a space shall be provided for proper wrapping and boxing of the cheese. The area shall be free from dust, condensation, mold or other conditions which may contaminate the surface of the cheese or contribute to an unsatisfactory packaging of the cheese.(F) Coolers or curing rooms. Coolers, curing rooms, or areas where cheese is held for curing or storage shall be clean and maintained at the uniform temperature and humidity to protect the cheese. Circulation of air shall be maintained at all times. The rooms shall be free from rodents, insects, and pests. The shelves shall be kept clean and dry.(G) Cutting and packaging rooms. When small packages of cheese are cut and wrapped, a separate room, or area, shall be provided for the cleaning and preparation of the bulk cheese. In addition, a separate room shall be provided for the cutting and wrapping operation. The rooms shall be well lighted, ventilated, and provided with filtered air. Air movement shall be outward to minimize the entrance of unfiltered air into the cutting and packaging room.(2) Equipment and utensils--General construction, repair, and installation. All equipment and utensils necessary to the manufacture of cheese and related products shall meet the same general requirements as outlined in §217.74 of this title. In addition, for certain other equipment, the following requirements shall be met.(A) Starter vats. Bulk starter vats shall be of stainless steel or equally corrosion-resistant metal and shall be in good repair, equipped with tight-fitting lids and have adequate temperature controls such as valves or indicating and/or recording thermometers. New vats shall be constructed according to the applicable 3-A Sanitary Standards.(B) Cheese vats.(i) The vats used for making cheese shall be of metal construction with adequate jacket capacity for uniform heating in accordance with 3-A Sanitary Standards. The inner liner shall be minimum 16-gauge stainless steel or other equally corrosion-resistant metal, properly pitched from side to center and from rear to front for adequate drainage. The liner shall be smooth, free from excessive dents or creases and shall extend over the edge of the outer jacket. The outer jacket, when metal, shall be constructed of stainless steel or other metal which can be kept clean and sanitary. The junction of the liner and outer jackets shall be constructed to prevent milk or cheese from entering the inner jacket.(ii) The vat shall be equipped with a suitable sanitary outlet valve. Effective valves shall be provided and properly maintained to control the application of heat to the vat.(C) Mechanical agitators. The mechanical agitators shall be of sanitary construction. The carriage and track shall be constructed to prevent the dropping of dirt or grease into the vat. Metal blades, forks, or stirrers shall be constructed of stainless steel and of material approved in the 3-A Sanitary Standards for Plastic and Rubber or Rubberlike Materials, and shall be free from rough or sharp edges which might scratch the equipment or remove metal particles.(D) Curd mill and miscellaneous equipment. Knives, hand rakes, shovels, paddles, strainers, and miscellaneous equipment shall be stainless steel or of material approved in the 3-A Sanitary Standards for Plastic and Rubberlike Material. The product-contact surfaces of the curd mill shall be of stainless steel. All pieces of equipment shall be so constructed that they can be kept clean. The wires in the curd knives shall be stainless steel, kept tight and replaced when necessary. All guards shall be in place.(E) Hoops and followers. The hoops, forms, and followers shall be constructed of stainless steel, heavy tinned steel, or other approved suitable material in accordance with 3-A Sanitary Standards. If tinned, they shall be kept tinned and free from rust. All hoops, forms, and followers shall be kept in good repair. Drums or other special forms used to press and store cheese shall be clean and sanitary.(F) Press. The cheese press shall be constructed of stainless steel or other approved material and all surfaces, seams, and openings readily cleanable. The pressure device shall be the continuous type. Press cloths shall be maintained in good repair and in a sanitary condition. Single-service press cloths shall be used only once.(G) Rindless cheese press. The press used to heat-seal the wrapper applied to rindless cheese shall have square interior corners, reasonably smooth interior surface and controls that shall provide uniform pressure and heat equally to all surfaces.(H) Paraffin tanks. The metal tank shall be adequate in size, have wood rather than metal racks to support the cheese, heat controls, and an indicating thermometer. The cheese wax shall be kept clean.(b) Operations and operating procedures.(1) Cheese from pasteurized milk. When pasteurization is required, or when a product is designated "pasteurized," every particle of the milk or milk product shall be subjected to such temperatures and holding periods in properly designed and operated equipment to ensure proper pasteurization of the product in accordance with the most current revision of the U.S. Public Health Service, FDA, Grade A Pasteurized Milk Ordinance. Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.(2) Cheese from unpasteurized milk shall conform to the processing and aging requirements of the most current revision of Title 21, Code of Federal Regulations, Part 133.(3) Whey disposal.(A) Adequate sanitary facilities shall be provided for the disposal of whey. If outside, necessary precautions shall be taken to minimize flies, insects, and objectionable odors.(B) Whey or whey products intended for human food shall at all times be handled in a sanitary manner in accordance with the procedures of this subpart as specified for handling milk and dairy products.(4) Packaging and repackaging. Packaging rindless cheese or cutting and repackaging all styles of bulk cheese shall be conducted under sanitary conditions. The atmosphere of the packaging rooms, the equipment and the packaging material shall be free from mold and bacterial contamination.(5) General identification. Each bulk cheese shall be legibly marked with the name of the product, code or date of manufacture, vat number, officially designated code number or name and address of manufacturer. Each consumer sized container shall be plainly marked with the name and address of the manufacturer, packer or distributor, net weight of the contents, and name of product. Source Note: The provisions of this §217.77 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.77 Supplemental Requirements for Plants Manufacturing and Packaging Cheese https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145200 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145200 03/11/2026 (a) Equipment and utensils - General construction, repair, and installation. All equipment and utensils necessary to the manufacture of pasteurized process cheese and related products shall meet the same general requirements as outlined in §217.74 of this title (relating to Requirements for Milk Plants Producing Dairy Products). In addition for certain other equipment, the following requirements shall be met.(1) Conveyors. Conveyors shall be constructed of material which can be cleaned, will not rust or otherwise contaminate the cheese, and maintained in good repair.(2) Grinders or shredders. The grinders or shredders used in the preparation of the trimmed and cleaned natural cheese for the cookers shall be adequate in size. Product-contact surfaces shall be of corrosion-resistant material, and of such construction as to prevent contamination of the cheese and allow thorough cleaning of all parts and product-contact surfaces.(3) Cookers. The cookers shall be the steam jacketed or direct steam type. They shall be constructed of stainless steel or other equally corrosion-resistant material. All product-contact surfaces shall be readily accessible for cleaning. Each cooker shall be equipped with an indicating thermometer and a temperature recording device. The recording thermometer stem may be placed in the cooker if satisfactory time charts are used; if not, the stem shall be placed in the hotwell or filler hopper. Steam check valves on direct steam type cookers shall be mounted flush with cooker wall, be constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line shall be constructed of stainless steel pipes and fittings which can be readily cleaned. If direct steam is applied to the product, only culinary steam shall be used.(4) Fillers. The hoppers of all fillers shall be covered, but the cover may have sight ports. If necessary, the hopper may have an agitator to prevent buildup on side walls. The filler valves and head shall be kept in good repair, capable of accurate measurements.(b) Operations and operating procedures.(1) Trimming and cleaning. Natural cheese shall be cleaned free of all nonedible portions. Paraffin and bandages as well as rind surface, mold, unclean areas, or any other part which could contaminate or adulterate the product, shall be removed.(2) Cooking the batch. Each batch of cheese within the cooker, including the optional ingredients, shall be thoroughly commingled and the contents cooked at a temperature of at least 158 degrees Fahrenheit and held at that temperature for not less than 30 seconds. Care shall be taken to prevent the entrance of cheese particles or ingredients after the cooker batch of cheese has reached the final heating temperature. After holding for the required period of time, the hot cheese shall be emptied from the cooker as quickly as possible.(3) Forming containers. Containers, either lined or unlined, shall be assembled and stored in a sanitary manner to prevent contamination in accordance with 3-A Sanitary Standards. The handling of containers by filler crews shall be done with extreme care and observance of personal cleanliness. Preforming and assembling of pouch liners and containers shall be kept to a minimum and the supply rotated to limit the length of time containers are exposed to possible contamination prior to filling.(4) Filling containers. Hot fluid cheese from the cookers may be held in hot wells or hoppers to ensure a constant and even supply of processed cheese to the filler or slice former. Filler valves shall effectively measure the desired amount of product into the pouch or containers in a sanitary manner and shall cut off sharply without drip or drag of cheese across the opening. A system shall be used to maintain weight control. Damaged packages shall be removed from production. The cheese may be salvaged into sanitary containers and added back to cookers.(5) Closing and sealing containers. Pouches, liners, or containers having product-contact surfaces after filling shall be folded or closed and sealed in a sanitary manner, preferably by mechanical means, to ensure against contamination. Each container shall be coded in such a manner to be easily identified as to date of manufacture by lot or sublot number. Source Note: The provisions of this §217.78 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.78 Supplemental Requirements for Plants Manufacturing, Processing, and Packaging Pasteurized Process Cheese and Related Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145201&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145201 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145201&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145201 03/11/2026 (a) Sanitation and construction requirements. Facility and equipment shall be constructed and maintained in compliance with §217.74 of this title (relating to Requirements for Milk Plants Producing Dairy Products), and the most current revision of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance). In addition, for certain other equipment, the following requirements shall be met.(1) Evaporators and vacuum pans. All equipment used in the removal of moisture from milk or milk products for the purpose of concentrating the solids shall meet the requirements of the 3-A Sanitary Standards for Milk and Milk Products Evaporators and Vacuum Pans. All new or used replacements for this type of equipment shall meet the appropriate 3-A Sanitary Standards.(2) Fillers. Both gravity-and vacuum-type fillers shall be of sanitary design and all product-contact surfaces, if metal, shall be made of stainless steel or equally corrosion-resistant material; except that certain evaporated milk fillers having brass parts shall be approved by the department if free from corroded surfaces and kept in good repair. Nonmetallic product-contact surfaces shall meet the requirements for 3-A Sanitary Standards for Rubber and Rubberlike Materials or for Multiple-Use Plastic Materials. Fillers shall be designed so that they will contaminate or detract from the quality of the product being packaged.(3) Batch or continuous in-container sterilizers shall be equipped with accurate temperature controls and effective valves to regulate the sterilization process. The equipment shall be maintained in such a manner to ensure control of the length of time of processing and to minimize the number of damaged containers.(4) Homogenizers, where applicable, shall be used to reduce the size of the fat particles and to evenly disperse them in the product. New homogenizers shall meet the applicable 3-A Sanitary Standards.(b) Operations and operating procedures regarding pasteurization. When pasteurization is required, or when a product is designated "pasteurized," every particle of the milk or milk product shall be subjected to such temperatures and holding periods in properly designed and operated equipment as will ensure proper pasteurization of the product in accordance with the most current revision of the "Grade A Pasteurized Milk Ordinance." Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.(c) Filling containers.(1) The filling of small containers with product shall be done in a sanitary manner. The containers shall not contaminate or detract from the quality of the product. After filling, the container shall be hermetically sealed.(2) Bulk containers for unsterilized product shall protect the product from contamination in storage or transit. The bulk container (including bulk tankers) shall be cleaned and sanitized before filling and filled and closed in a sanitary manner.(d) Storage. Facilities shall be provided for the storage and handling of finished product. Source Note: The provisions of this §217.79 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.79 Supplemental Requirements for Plants Manufacturing, Processing, and Packaging Evaporated or Condensed Milk Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145202&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145202 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145202&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145202 03/11/2026 Dairy Product Manufacturers shall test for drug residues in their incoming raw milk supply fulfilling all industry responsibilities as outlined in the most current revision of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance). Source Note: The provisions of this §217.80 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.80 Drug Residue Monitoring https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145203&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145203 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145203&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145203 03/11/2026 (a) All bottles, containers and packages containing "milk" or "milk products" defined in §217.1 of this title (relating to Definitions) shall be labeled in accordance with the Title 21, Code of Federal Regulations, Subchapter B-Food for Human Consumption. In addition, except milk tank trucks, storage tanks and cans of raw milk from individual dairy farms, they shall be conspicuously marked with:(1) The identity of the milk plant where pasteurized, ultra-pasteurized, aseptically processed, condensed and/or dried.(2) The words "keep refrigerated after opening" for aseptically processed milk and milk products.(3) The common name of the hooved mammal producing the milk shall precede the name of the milk or milk product when the product is from or is made from other than cattle's milk such as "Goat," "Sheep," "Water Buffalo," or "Other Hooved Mammal" milk or milk products respectively.(4) The word "reconstituted" or "recombined" if the product is made by reconstitution or recombination.(5) A code or lot number identifying the contents with a specific date, run, or batch of the product, and the quantity of the contents of the container.(b) All vehicles and milk tank trucks containing milk or milk products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents. Milk tank trucks transporting raw, heat-treated or pasteurized milk and milk products to a milk plant from another milk plant, receiving station or transfer station are required to be marked with the name and address of the milk plant or hauler and shall be sealed. In addition, for each such shipment, a shipping statement shall be prepared containing at least the following information:(1) shipper's name, address and permit number on the weight ticket or manifest;(2) permit identification of hauler, if not an employee of the shipper;(3) point of origin of shipment;(4) tanker identification number;(5) name of product;(6) weight of product;(7) temperature of product when loaded;(8) date of shipment;(9) name of supervising Regulatory Agency at the point of origin of shipment;(10) whether the contents are raw, pasteurized, or in the case of cream, low fat or skim milk, whether it has been heat-treated;(11) seal number on inlet, outlet, wash connections and vents; and(12) grade of product.(c) All cans of raw milk from individual dairy farms shall be identified by the name or number of the individual milk producer. Each milk tank truck containing milk shall be accompanied by documentation, weigh ticket or manifest. Source Note: The provisions of this §217.81 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY E DAIRY PRODUCTS AND MILK FOR MANUFACTURING PURPOSES §217.81 Labeling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145204&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145204 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145204&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145204 03/11/2026 (a) Permit/license required. A current permit/license is required for every dairy farm, milk plant, receiving station, transfer station, raw for retail milk dairy farm, milk tank truck, dairy product manufacturer, and frozen dessert manufacturer located and operating in the State of Texas. Every milk plant and frozen dessert manufacturer that imports milk, milk products, or frozen desserts into the State of Texas is required to obtain a current permit/license. Permits are issued for a two-year term.(1) All dairy farm, milk plant, receiving station, transfer station, raw for retail milk dairy farm, milk tank truck, dairy product manufacturer, and frozen dessert manufacturer, and operations located in Texas shall be approved by the department based on an inspection prior to the issuance of a permit.(2) Permit or license fees once submitted are non-refundable.(3) A current permit or license shall only be issued when all past due fees (including inspection fees under subsection (h) of this section) and late fees have been paid for all years of operation in Texas.(b) Application. Applications may be obtained by visiting the Department of State Health Services at 8407 Wall Street, Austin, Texas or by contacting the Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347. Applications are also available on-line at www.dshs.state.tx.us/fdlicense. The applicant must submit an accurate and complete application accompanied with a permit or license fee payable to the department prior to an inspection.(c) Permit/license fees.(1) Permitted or licensed facilities and operations shall pay the following fees. If applications are made after March 1 of any year, the fee will be prorated.(A) Milk plant:(i) $800 for a two-year license;(ii) $600 pro-rated; and(iii) $400 for a two-year license that is amended during the current licensure period due to minor change.(B) Producer dairy farm:(i) $200 for a two-year license;(ii) $150 pro-rated; and(iii) $100 for a two-year license that is amended during the current licensure period due to minor change.(C) Receiving and transfer station:(i) $800 for a two-year license;(ii) $600 pro-rated; and(iii) $400 for a two-year license that is amended during the current licensure period due to minor change.(D) Milk transport tanker:(i) $200 for a two-year license;(ii) $150 pro-rated; and(iii) $100 for a two-year license that is amended during the current licensure period due to minor change.(E) Grade A raw for retail:(i) $800 for a two-year license;(ii) $600 pro-rated; and(iii) $400 for a two-year license that is amended during the current licensure period due to minor change.(F) Frozen dessert manufacturers:(i) $800 for a two-year license;(ii) $600 pro-rated; and(iii) $400 for a two-year license that is amended during the current licensure period due to minor change.(G) Dairy product manufacturer:(i) $800 for a two-year license;(ii) $600 pro-rated; and(iii) $400 for a two-year license that is amended during the current licensure period due to minor change.(2) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees in amounts determined by the Texas Online Authority to recover costs associated with application and renewal application processing through Texas Online.(d) Renewal of a permit/license.(1) Milk plants, producer dairy farms, receiving and transfer stations, Grade "A" raw for retail, dairy product manufacturer, and frozen dessert manufacturers must submit a renewal application and the required fee prior to September 1 of the year before the permit license expires. A person who submits a renewal application and required fee after the expiration date shall pay an additional $100 as a delinquency fee.(2) Milk transport tankers must submit a renewal application and required fee prior to September 1 of the year before the permit license expires. All tankers shall have an inspection no more than one year old on file prior to issuance of the renewal permit sticker.(3) Milk plants, Grade "A" raw for retail, and frozen dessert manufacturers' permit or license shall only be issued when all past due inspection fees are current.(e) Amendment of permit/license.(1) Fee. A permit/license that is amended for a change of name or a change in location of a permitted place of business will require submission of an application for amendment, and the required fee for the "minor change" amendment pursuant to subsection (c) of this section.(2) Change of ownership. A permit is not transferable and will require submission of a new application and fee as outlined in subsection (c) of this section.(3) The department must be notified in writing at least 30 days prior to the effective date of the name, ownership, or location change and will require submission of a new application and two-year license as outlined in subsection (a) of this section.(f) All applicants shall comply with Subchapter T, §1.301 of this title (relating to Suspension of License for Failure to Pay Child Support).(g) Applicability of other law.(1) Health and Safety Code (HSC), Chapter 431, applies to the conduct of a person licensed under HSC, Chapter 440, and to a frozen dessert, a product sold in semblance of a frozen dessert, or a mix for one of those products subject to HSC, Chapter 440. A frozen dessert, a product sold in semblance of a frozen dessert, or a mix for one of those products is a "food" for purposes of HSC, Chapter 431.(2) A person who holds a license under HSC, Chapter 440, related to the manufacturing of a product regulated under that chapter, and is engaging in conduct within the scope of that license, is not required to hold a license as a food manufacturer, food wholesaler, or warehouse operator under HSC, Chapter 431, Subchapter J.(3) Health and Safety Code, Chapter 431, applies to the conduct of a person licensed under HSC, Chapter 435, and to milk or a milk product subject to HSC, Chapter 435. Milk or a milk product is a "food" for purposes of HSC, Chapter 431.(4) A person who holds a license under HSC, Chapter 435, related to the processing, producing, bottling, receiving, transferring, or transporting of Grade "A" milk or milk products, or dairy products, and who is engaging in conduct within the scope of that permit, is not required to hold a license as a food manufacturer, food wholesaler, or warehouse operator under HSC, Chapter 431, Subchapter J.(h) Inspection fees.(1) All milk or milk products processed, manufactured, or bottled by milk plants, and offered for sale within the State of Texas shall be assessed a $0.045 per hundredweight inspection fee or shall pay a minimum fee of $5 each month, whichever is greater. This fee shall be assessed on a monthly basis. The inspection fee includes the cost of analyzing samples for milk or milk products. Milk plants shall submit monthly production data to the department no later than 15 days after the end of each reporting month as designated by the department, accompanied by the fee required by this section. Each milk plant is required to furnish, upon request from the department, production records for the preceding three years for auditing purposes. This fee shall be considered delinquent if it is not received by the department within 30 days after the end of the reporting period.(2) All frozen desserts manufactured by frozen dessert manufacturing plants and offered for sale within the State of Texas shall be assessed a $0.015 per hundredweight inspection fee or shall pay a minimum fee of $5 each month, whichever is greater. This fee shall be assessed on a monthly basis. The inspection fee includes the cost for analyzing frozen dessert samples. Manufacturers shall submit monthly production data to the department no later than 15 days after the end of each monthly reporting period designated by the department, accompanied by the required fee. Also, each plant will be required to furnish, upon request, production records for the preceding three years for auditing purposes. This fee shall be considered delinquent if it is not received by the department within 30 days after the end of the reporting period.(3) All dairy products manufactured in Texas shall be assessed a $0.015 per hundredweight inspection fee or shall pay a minimum fee of $5 each month, whichever is greater. This fee shall be assessed on a monthly basis. The inspection fee includes the cost for analyzing samples. Manufacturers shall submit monthly production data to the department no later than 15 days after the end of each monthly reporting period designated by the department, accompanied by the required fee. Also, each plant will be required to furnish, upon request, production records for the preceding three years for auditing purposes. This fee shall be considered delinquent if it is not received by the department within 30 days after the end of the reporting period. Source Note: The provisions of this §217.91 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY F PERMITS, FEES AND ENFORCEMENT §217.91 Milk Facilities and Operations Permit and Frozen Dessert License Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145205&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145205 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145205&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145205 03/11/2026 (a) Tagging unsanitary equipment, utensils, and rooms. The department representative may attach a tag or other appropriate marking device to any equipment, utensil, or room in a dairy farm, milk plant, receiving station, transfer station, raw for retail dairy farm, milk tank truck, or frozen dessert manufacturer that the representative determines is unsanitary or is a health hazard. No equipment, utensil, or room so tagged shall be used until a department representative removes the tag following adequate cleaning and sanitization. Such tag shall not be removed by anyone other than a department representative.(b) Detained products. A department representative shall attach a tag or other appropriate marking device to any milk, milk product, dairy product, frozen dessert, Grade A retail raw milk, or Grade A retail raw milk product that is or is suspected of being adulterated or misbranded. The tag indicates notice that the product is detained. No person shall remove the tagged products from the premises or dispose of the product by sale or otherwise without prior written approval from the department or a court order.(c) Suspension of Health and Safety Code (HSC), Chapter 435, permit. The department may suspend a permit issued under HSC, Chapter 435, whenever there is reason to believe that a public health hazard exists, or whenever a permit holder has violated any of the sections of this chapter, or whenever the permit holder has interfered with the department or its agents in the performance of its duties. A written notice of the violation will be provided to the permit holder, and the permit holder shall have 72 hours to correct the violation(s). The written notice may be served by a copy of the inspection report handed to the permit holder or operator or may be posted at the place of business. After receipt of the notice, but prior to the expiration of the 72 hours, the permit holder may request an extension of the time to correct the violation(s). The permit holder who has been served with a written notice of violation and suspension may request an informal regulatory conference on the facts of the violation. The informal regulatory conference shall be held within 72 hours of the request, notwithstanding any time allotted for correction. A permit holder who disagrees with the outcome of an informal regulatory conference may make a written request for a hearing. The hearing will be conducted pursuant to §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures) and the Administrative Procedure Act, Government Code, Chapter 2001.(d) Immediate suspension of HSC, Chapter 435, permit. Immediate suspension of a permit under this subsection shall occur when the milk or milk product involved creates, or appears to create, an imminent hazard to the public health; or in any case of a willful refusal to permit an inspection; or when the bacteria counts, coliform counts, somatic cell counts or cooling temperatures are in violation of the requirements of §217.27(e) of this title (relating to Examination of Milk and Milk Products), §217.28 of this title (relating to Standards for Grade A Raw for Retail Milk and Milk Products), or §217.45 of this title (relating to Examination and Standards for Frozen Desserts); or when adulteration by inhibitors or water is identified; or if any pathogenic bacteria is isolated. A permit that is immediately suspended shall remain suspended until the department determines that the violation has been corrected. The permit holder may make a written request for a hearing to contest the suspension. The hearing will be conducted pursuant to §§1.21, 1.23, 1.25, and 1.27 of this title and the Administrative Procedure Act, Government Code, Chapter 2001.(e) Revocation of HSC, Chapter 435, permits. The department may revoke a permit issued under HSC, Chapter 435, if the permit holder is delinquent in the remittance of the permit fee or the inspection fee. The department may revoke a permit for noncompliance with the requirements of this chapter. The department will provide written notice of the reasons for the proposal to revoke, and the opportunity to request a hearing. The permit holder may make a written request for a hearing within 20 days of receipt of the written notice proposing revocation. The permit holder may also request an informal hearing conference without waiving the right to a hearing. The hearing will be conducted pursuant to §§1.21, 1.23, 1.25, and 1.27 of this title and the Administrative Procedure Act, Government Code, Chapter 2001.(f) Denial, suspension, and revocation of license issued under frozen desserts, HSC, Chapter 440. The department may deny an application for a license, may suspend a license, or may revoke a license issued under HSC, Chapter 440, for violations of HSC, Chapter 440, or these sections. The license holder may request a hearing in writing to contest the denial, suspension, or revocation. The license holder may also request an informal hearing conference without waiving the right to a hearing. The hearing will be conducted pursuant to §§1.21, 1.23, 1.25, and 1.27 of this title and the Administrative Procedure Act, Government Code, Chapter 2001.(g) Election of penalties. The penalty authorized by HSC, Chapter 435, is subject to either the sanctions prescribed in the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance) for products covered by the "Grade A Pasteurized Milk Ordinance," or any civil or administrative penalty sanctions otherwise imposed by HSC, Chapter 431, or sanctions found in other law for products not covered by the Grade A Pasteurized Milk Ordinance.(h) Administrative penalties. For products not covered by the "Grade A Pasteurized Milk Ordinance," administrative penalties, as provided in the Health and Safety Code, §§431.054 - 431.058, and in §229.261 of this title (relating to Assessment of Administrative Penalties), may be assessed against a person who violates HSC, Chapter 435 or 440, this chapter or a rule or order adopted under this chapter, who holds a permit or license under HSC, Chapter 435 or 440, or who is regulated under this chapter. Source Note: The provisions of this §217.92 adopted to be effective July 4, 2010, 35 TexReg 3038. 1 DEPARTMENT OF STATE HEALTH SERVICES 217 MILK AND DAIRY F PERMITS, FEES AND ENFORCEMENT §217.92 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202267&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202267 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202267&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202267 03/11/2026 This subchapter establishes the procedures for milk laboratories to become accredited or approved laboratories under state law, Texas Health and Safety Code, Chapters 12 and 435. Source Note: The provisions of this §218.1 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES A EVALUATION OF MILK LABORATORIES §218.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202268&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202268 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202268&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202268 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.(1) Accreditation--An official approval granted by the department to a laboratory. The accreditation only permits analysis of milk and dairy samples in accordance with the applicable rules based on the process outlined in this subchapter. Accreditation is granted to a laboratory that is capable of correctly performing the analyses for which it is accredited. Accreditation does not imply that the department certifies the results produced by the accredited laboratory.(2) Antibiotic milk laboratory--A laboratory only authorized to screen for antibiotics in milk manufacturing.(3) Approval--An official approval granted by the department to a laboratory. The approval only permits analysis of milk samples for antibiotic testing in accordance with applicable rules based on the process outlined in this subchapter. Approval is granted to a laboratory that is capable of correctly performing analyses for which it is approved. Approval does not imply that the department certifies the results produced by the approved laboratory.(4) Department--The Department of State Health Services.(5) Evaluation--An onsite inspection performed by the department that includes a fact-finding process in which information and observations are collected for the purpose of evaluation of the laboratory's compliance with established accreditation or approval standards.(6) Officially designated laboratory--A commercial laboratory or a milk industry laboratory officially designated by the department for the analysis of milk, milk products, milk for manufacturing, or frozen desserts.(7) Official laboratory--A biological, chemical, or physical laboratory, which is under the direct supervision of the department for the analysis of milk, milk products, milk for manufacturing, or frozen desserts. Official laboratories include full service laboratories.(8) Split samples--An annual proficiency testing program that includes bacterial count, coliform count, somatic cell count, presence of antibiotics, presence of phosphatase, and presence of added water, contingent on the milk laboratory accreditation or approval, which is coordinated by the Milk and Dairy Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754, to determine if the milk laboratory is qualified in performing the analyses. Source Note: The provisions of this §218.2 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES A EVALUATION OF MILK LABORATORIES §218.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202269&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202269 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202269&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202269 03/11/2026 The department adopts by reference the document entitled, Evaluation of Milk Laboratories, as amended, published by the U.S. Department of Health and Human Services, Public Health Service, U.S. Food and Drug Administration, and the National Conference on Interstate Milk Shipments. The document provides the procedures for the evaluation of milk laboratories. Copies are available online at http://www.dshs.texas.gov/milk and for review during normal business hours in the Milk and Dairy Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754. Source Note: The provisions of this §218.3 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES A EVALUATION OF MILK LABORATORIES §218.3 Evaluation of Milk Laboratories https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202270&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202270 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202270&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202270 03/11/2026 (a) A laboratory must submit an application for accreditation or approval to the department on a form specified by the department at http://www.dshs.texas.gov/milk.(b) A laboratory may apply for accreditation in a single category or any combination of categories from the following list:(1) antibiotic milk laboratory;(2) milk industry laboratory; or(3) full service milk laboratory.(c) A laboratory may apply for approval as an antibiotic milk laboratory.(d) The department shall perform an evaluation for each milk laboratory applying for accreditation or approval. Source Note: The provisions of this §218.4 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES A EVALUATION OF MILK LABORATORIES §218.4 Accreditation or Approval Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202271&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202271 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202271&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202271 03/11/2026 (a) The requirements specified in §218.3 of this title (relating to Evaluation of Milk Laboratories) are minimum standards for a laboratory applying for or renewing accreditation or approval in Texas. These specifications are available online at http://www.dshs.texas.gov/milk and for review during normal business hours at the Milk and Dairy Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754.(b) Each applicant laboratory will be evaluated, at a minimum on the following factors:(1) milk testing procedure performance of staff;(2) quality assurance plan;(3) manuals of procedures;(4) performance on split samples;(5) equipment;(6) calibrations and standards;(7) methodology;(8) facilities;(9) sample acceptance policies;(10) sample tracking;(11) record keeping;(12) reporting; and(13) interpretation of results.(c) A laboratory must meet all minimum standards, pass annual split samples, and pass an onsite inspection at least biennially to be accredited or approved. Source Note: The provisions of this §218.5 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES A EVALUATION OF MILK LABORATORIES §218.5 Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202272&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202272 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202272&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202272 03/11/2026 The department may conduct onsite inspections of laboratories to ascertain adherence to minimum standards as specified in §218.3 of this title (relating to Evaluation of Milk Laboratories) and the effectiveness of the accreditation or approval standards. For laboratories for which the department serves as both the evaluating and accreditation or approval authority, onsite inspections will be conducted at least biennially. Source Note: The provisions of this §218.6 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES A EVALUATION OF MILK LABORATORIES §218.6 Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202273&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202273 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202273&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202273 03/11/2026 (a) A laboratory that fails to meet requirements may be placed on provisionally accredited or approved status:(1) by scoring outside the acceptable limits on a set of split samples;(2) by having serious deficiencies at the time of an onsite inspection; or(3) by failing to notify the department within 30 days of major changes which might impair analytical capability (personnel, equipment, or location).(b) Failure on two consecutive split samples or failure to correct major deficiencies following an onsite inspection, within 60 days, may result in the withdrawal of accreditation or approval. Withdrawal of accreditation or approval shall remain in effect until measures are taken by the laboratory to attain compliance and an additional onsite inspection determines that the major deficiencies are corrected at a time that is agreeable for both parties.(c) Accreditation or approval may be suspended or revoked immediately if the minimum standards of the U.S. Food and Drug Administration require suspension or revocation, or if continued operation of the laboratory will jeopardize public health.(d) Accreditation or approval shall be revoked for a laboratory that submits as its own work the results for analysis of any split samples that was analyzed by a different laboratory. The laboratory may not reapply for accreditation or approval for a period of not less than three years. Source Note: The provisions of this §218.7 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES A EVALUATION OF MILK LABORATORIES §218.7 Withdrawal of Accreditation or Approval https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202274&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202274 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202274&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202274 03/11/2026 This subchapter establishes the procedures for shellfish laboratories to be conforming under state law, Texas Health and Safety Code, Chapters 12 and 435. Source Note: The provisions of this §218.21 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES B EVALUATION OF SHELLFISH LABORATORIES §218.21 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202275&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202275 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202275&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202275 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.(1) Conforming status--An official status granted by the department to a laboratory. The official status permits the analysis of shellfish samples in accordance with applicable rules based on the process outlined in this subchapter. Conforming status means that a laboratory has been found to be capable of correctly performing the analyses for which it is approved.(2) Critical nonconformity--A deviation of a laboratory requirement which has the highest likelihood of adversely affecting the quality of the analytical results.(3) Department--The Department of State Health Services.(4) Evaluation--A fact-finding process performed by the department in which information and observations are collected for the purpose of evaluating the laboratory's compliance with established standards. Evaluation includes an onsite inspection but can, under a certain circumstance, be conducted by desk audit.(5) Key nonconformity--A deviation of laboratory requirement that has a significant potential to adversely affect the quality of the analytical results.(6) Other nonconformity--A deviation of a laboratory requirement which does not normally compromise the quality of the analytical results, but generally serves to enhance the overall operation of the laboratory. Source Note: The provisions of this §218.22 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES B EVALUATION OF SHELLFISH LABORATORIES §218.22 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202276&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202276 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202276&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202276 03/11/2026 The department adopts by reference the document entitled National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, as amended, published by the U.S. Department of Health and Human Services, Public Health Service, U.S. Food and Drug Administration, and the Interstate Shellfish Sanitation Conference. The document provides the procedures for the evaluation of shellfish laboratories. Copies are available online at http://www.dshs.texas.gov/seafood and for review during normal business hours at the Seafood and Aquatic Life Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754. Source Note: The provisions of this §218.23 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES B EVALUATION OF SHELLFISH LABORATORIES §218.23 National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202277&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202277 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202277&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202277 03/11/2026 (a) The minimum standards for conforming status are specified in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish), and the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists. These specifications are available online at http://www.dshs.texas.gov/seafood and for review during normal business hours at the Seafood and Aquatic Life Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754.(b) Each laboratory will be evaluated, at a minimum on the following factors:(1) credentials and performance of staff;(2) quality assurance plan;(3) manuals of procedures;(4) staff training program;(5) corrective action for any deficiencies and nonconformities;(6) performance on proficiency test samples;(7) equipment;(8) calibrations and standards;(9) methodology;(10) facilities;(11) sample acceptance policies;(12) sample tracking;(13) record keeping;(14) reporting; and(15) interpretation of results.(c) A laboratory must meet all minimum standards and pass an inspection at a minimum of every three years to maintain conforming status.(d) Laboratory status is determined by the number and types of nonconformities found in the evaluation using the specifications in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish), and the standardized criteria contained in the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists. Source Note: The provisions of this §218.24 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES B EVALUATION OF SHELLFISH LABORATORIES §218.24 Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202278&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202278 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202278&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202278 03/11/2026 The department may conduct onsite inspections of laboratories to ascertain adherence to minimum standards as specified in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish) and the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists. Inspections will be conducted on at least a three-year basis. Source Note: The provisions of this §218.25 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES B EVALUATION OF SHELLFISH LABORATORIES §218.25 Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202279 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202279&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202279 03/11/2026 (a) A laboratory found to be in conforming status, with noted nonconformities, has up to 90 days to successfully correct all nonconformities noted in the evaluation. After this period, the laboratory's status will be downgraded to nonconforming if any key nonconformities remain to be successfully corrected. As a result, data being generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.(b) A laboratory found to be in provisionally conforming status has up to 60 days to successfully correct all nonconformities noted in the evaluation. After this period, the laboratory's status will be assigned to one of the following.(1) Conforming status if all critical and key nonconformities have been successfully corrected.(2) Nonconforming status if any critical or key nonconformities remain to be successfully corrected. As a result, data generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.(c) A laboratory found to be in nonconforming status has up to 30 days to demonstrate successful correction of all nonconformities found. After this period, the laboratory's status will be assigned to one of the following.(1) Conforming status if all critical and key nonconformities have been successfully corrected.(2) Nonconforming status if any critical or key nonconformities remain to be successfully corrected. As a result, data generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.(d) If a laboratory is found to be in nonconforming status for failure to successfully implement the required corrective action, or for having repeated critical or key nonconformities in consecutive evaluations, then the department will ensure that an action plan is developed to correct the situation in an acceptable and expeditious manner or discontinue use of the laboratory to support the National Shellfish Sanitation Program. Source Note: The provisions of this §218.26 adopted to be effective December 22, 2020, 45 TexReg 9214. 1 DEPARTMENT OF STATE HEALTH SERVICES 218 EVALUATION OF MILK AND SHELLFISH LABORATORIES B EVALUATION OF SHELLFISH LABORATORIES §218.26 Withdrawal of Conforming Status https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202280 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202280 03/11/2026 (a) This subchapter provides for the registration of rendering businesses; transporters of renderable raw materials and dead animals; and locations where a rendering business is conducted.(b) The Texas Meat and Poultry Inspection Act, Texas Health and Safety Code, Chapter 433, provides the department with the authority to adopt rules consistent with the chapter as necessary pursuant to the enforcement of this chapter.(c) No person may cause, suffer, or allow the operation, management, or maintenance of a rendering business or rendering business location without registering with the department in accordance with this subchapter.(d) All rendering businesses and rendering business locations shall comply with the minimum standards specified in this subchapter in addition to existing standards contained in Texas Health and Safety Code, Chapter 144 and the Texas Meat and Poultry Inspection Act, Texas Health and Safety Code, Chapter 433, relating to adulteration and misbranding.(e) Any person who transports renderable raw materials or dead animals from any place within this state to any place outside of the borders of this state must be registered with the department. Source Note: The provisions of this §221.1 adopted to be effective December 10, 2000, 25 TexReg 12175; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective December 23, 2020, 45 TexReg 9215. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE A TRANSPORTING DEAD ANIMALS AND RENDERING §221.1 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202281&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202281 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202281&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202281 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.(1) Commissioner--Commissioner of the Department of State Health Services.(2) Dead animal--The whole or substantially whole carcass of a dead or fallen domestic animal, or domesticated wild animal, that was not slaughtered for human consumption.(3) Dead animal hauler--A person who collects and disposes of dead animals for commercial purposes.(4) Department--The Department of State Health Services.(5) Department representative--An employee of the department designated by the commissioner to enforce Texas Health and Safety Code, Chapter 144, and the Texas Meat and Poultry Inspection Act, Texas Health and Safety Code, Chapter 433.(6) Disposal--The burying, burning, cooking, processing, or rendering of dead animals or of renderable raw materials.(7) Employee--A person who:(A) is a legal employee of a rendering establishment; and(B) handles or operates rendering equipment, utensils, containers, packaging materials or vehicles, owned or leased by the rendering establishment which are used to transport renderable raw material, recyclable cooking oil and/or waste cooking grease, and dead animals.(8) Feed grade fats and oils--Those fats or oils which have been obtained from edible fat and oil processing and include fatty acid products that result from the commercial rendering of animal tissues and from the processing of edible vegetables and plants.(9) Grease trap (brown grease)/grit trap waste--Industrial grade oil as defined in paragraph (10) of this section and as such is not suitable for use as animal feed or topical cosmetics.(10) Industrial grade oil--A product not suitable for use in livestock feeds, and includes:(A) tall oils--resinous by-product from the manufacturing of chemical wood pulp;(B) by-products which have been used in or derived from nonfood manufacturing processes;(C) salvage or sludge type oils which may consist in part of feed grade material, but which may also contain potential contaminants from a manufacturing process or the environment; and(D) oils exposed to pesticides, polychlorinated biphenyls (PCBs), industrial chemicals, heavy metals, or other adulterants.(11) Inedible kitchen grease--Any unprocessed or partially processed grease, fat, or oil previously used in the cooking or preparation of food for human consumption and no longer suitable for such use.(12) Nuisance--Any situation or condition that constitutes a nuisance under the Texas Health and Safety Code, §341.011.(13) Person--An individual, firm, partnership, association, corporation, trust, company, or organization, and includes an agent, officer, or employee of that individual or entity.(14) Pests--Any objectionable animal or insect, including rodents, flies, larvae, and birds.(15) Processing--An operation or combination of operations through which materials derived from a dead animal or renderable raw material sources are:(A) prepared for disposal at a rendering establishment;(B) stored; or(C) treated for commercial use or disposition, other than as food for human consumption.(16) Recyclable cooking oil--Any unprocessed or partially processed grease, fat, or oil previously used in the cooking or preparation of food for human consumption and intended for recycling by being used or reused as:(A) an ingredient in a process to make a product; or(B) an effective substitute for a commercial product.(17) Related station--An operation or facility that is necessary, useful, or incidental to the operation of a rendering establishment and that is operated or maintained separately from the rendering establishment.(18) Rendering business--The collection, transportation, disposal, or storage of dead animals or renderable raw materials for commercial purposes at locations where dead animals or renderable raw materials are rendered, boiled, processed, stored, transferred, or otherwise prepared, either as a separate business or in connection with any other established business.(19) Rendering establishment--An establishment or part of an establishment, a plant, or any other premise at which dead animals or renderable raw materials are rendered, boiled, processed, or otherwise prepared to obtain a product for commercial use or disposition, other than as food for human consumption. The term includes all other operations and facilities that are necessary or incidental to the establishment.(20) Renderable raw material--Any unprocessed or partially processed material of animal or plant origin, other than a dead animal, that is to be processed by rendering establishments. The term includes:(A) animals, poultry, or fish slaughtered or processed for human consumption but that are unsuitable for that use;(B) the inedible products and by-products of animals, poultry, or fish slaughtered or processed for human consumption;(C) parts from dead animals;(D) whole or partial carcasses of dead poultry or fish;(E) waste cooking greases; and(F) recyclable cooking oil.(21) Renderable raw material hauler--A person who collects or transports renderable raw materials for commercial purposes.(22) Renderable raw material hauling vehicle--Any motorized vehicle or detachable trailer used in the collection, receipt, transportation, delivery, transfer, or storage of renderable raw materials for commercial purposes.(23) Transfer station--A facility at which renderable raw materials are transferred from one conveyance to another.(24) Waste cooking grease--Any unprocessed or partially processed grease, fat, or oil previously used in the cooking or preparation of food for human consumption and no longer suitable for such use, also defined as inedible kitchen grease.(25) Waste cooking grease hauler--Any person who collects, receives, transports, delivers, transfers, or stores incidental to such activities renderable raw material for commercial purposes, whether or not such person is required to register with the department. Source Note: The provisions of this §221.2 adopted to be effective December 10, 2000, 25 TexReg 12175; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective December 23, 2020, 45 TexReg 9215. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE A TRANSPORTING DEAD ANIMALS AND RENDERING §221.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202282&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202282 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=202282&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 202282 03/11/2026 (a) Registering requirements. All rendering businesses, renderable raw material haulers and dead animal haulers shall register with the department unless an exemption applies in subsection (b) of this section. A registration is required for each business and place of business operated as a:(1) rendering establishment;(2) related station;(3) transfer station;(4) renderable raw material hauler;(5) dead animal hauler; or(6) combination dead animal and renderable raw material hauler.(b) Exemptions from registering requirements. Rendering business registering requirements do not apply to the following:(1) a person who slaughters, butchers, manufactures, or sells animal flesh or products only for use as food for human consumption, unless the person also performs rendering operations or processes as defined in this subchapter;(2) a person who transports or disposes of the bodies of animals slaughtered for use as food for human consumption or the products of these bodies only for that purpose;(3) an individual who disposes of the individual's own animal; or(4) a governmental agency that collects, transports, or disposes of dead animals and renderable raw materials.(c) Procedures for registration. To register as a rendering business, renderable raw material hauler or dead animal hauler, a person shall complete department registration forms, which can be obtained from the Department of State Health Services, Meat Safety Assurance Section. A rendering business, renderable raw material hauler or dead animal hauler must register with the department before accepting any renderable raw material. Source Note: The provisions of this §221.3 adopted to be effective December 10, 2000, 25 TexReg 12175; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective December 23, 2020, 45 TexReg 9215. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE A TRANSPORTING DEAD ANIMALS AND RENDERING §221.3 Registration Requirements, Exemptions, and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224198&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224198 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224198&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224198 03/11/2026 (a) The department adopts by reference the following federal regulations in the Code of Federal Regulations (CFR), as amended. (1) 9 CFR Part 301, Terminology; Adulteration and Misbranding Standards;(2) 9 CFR Part 303, Exemptions, except §303.1(a)(2)(i); (3) 9 CFR Part 304, Application for Inspection; Grant of Inspection;(4) 9 CFR Part 305, Official Numbers; Inauguration of Inspection; Withdrawal of Inspection; Reports of Violation;(5) 9 CFR Part 306, Assignment and Authorities of Program Employees;(6) 9 CFR Part 307, Facilities for Inspection;(7) 9 CFR Part 309, Ante-Mortem Inspection;(8) 9 CFR Part 310, Post-Mortem Inspection;(9) 9 CFR Part 311, Disposal of Diseased or Otherwise Adulterated Carcasses and Parts;(10) 9 CFR Part 312, Official Marks, Devices and Certificates; (11) 9 CFR Part 313, Humane Slaughter of Livestock;(12) 9 CFR Part 314, Handling and Disposal of Condemned or Other Inedible Products at Official Establishments;(13) 9 CFR Part 315, Rendering or Other Disposal of Carcasses and Parts Passed for Cooking;(14) 9 CFR Part 316, Marking Products and Their Containers; (15) 9 CFR Part 317, Labeling, Marking Devices, and Containers;(16) 9 CFR Part 318, Entry into Official Establishments; Reinspection and Preparation of Products;(17) 9 CFR Part 319, Definitions and Standards of Identity or Composition, with the following requirements applying, except in the case of restaurant menus and signs:(A) the label of products prepared from bison meat must contain the words "bison meat," "North American bison meat," or "Native American bison meat"; and(B) the label of products prepared from buffalo meat must contain the words "water buffalo meat," or "Asian buffalo meat";(18) 9 CFR Part 320, Records, Registration, and Reports;(19) 9 CFR Part 321, Cooperation with States and Territories; (20) 9 CFR Part 322, Exports;(21) 9 CFR Part 325, Transportation;(22) 9 CFR Part 327, Imported Products;(23) 9 CFR Part 329, Detention; Seizure and Condemnation; Criminal Offenses;(24) 9 CFR Part 331, Special Provisions for Designated States and Territories; and for Designation of Establishments Which Endanger Public Health and for Such Designated Establishments;(25) 9 CFR Part 335, Rules of Practice Governing Proceedings Under the Federal Meat Inspection Act;(26) 9 CFR Part 350, Special Services Relating to Meat and Other Products;(27) 9 CFR Part 352, Exotic Animals and Horses; Voluntary Inspection, except 9 CFR §352, Subpart B;(28) 9 CFR Part 354, Voluntary Inspection of Rabbits and Edible Products Thereof;(29) 9 CFR Part 362, Voluntary Poultry Inspection Regulations; (30) 9 CFR Part 381, Poultry Products Inspection Regulations, except §381.10(a)(3) through §381.10(c);(31) 9 CFR Part 416, Sanitation;(32) 9 CFR Part 417, Hazard Analysis and Critical Control Point Systems;(33) 9 CFR Part 418, Recalls;(34) 9 CFR Part 424, Preparation and Processing Operations; (35) 9 CFR Part 430, Requirements for Specific Classes of Product;(36) 9 CFR Part 441, Consumer Protection Standards: Raw Products;(37) 9 CFR Part 442, Quantity of Contents Labeling and Procedures and Requirements for Accurate Weights; and(38) 9 CFR Part 500, Rules of Practice.(b) Copies of these regulations are available via the Internet at www.dshs.texas.gov/meat-safety. Source Note: The provisions of this §221.11 adopted to be effective March 15, 1995, 20 TexReg 1417; amended to be effective April 17, 1997, 22 TexReg 3421; amended to be effective June 21, 2000, 25 TexReg 5901; amended to be effective March 14, 2002, 27 TexReg 1801; amended to be effective November 7, 2002, 27 TexReg 10391; amended to be effective May 6, 2004, 29 TexReg 4174; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective November 23, 2014, 39 TexReg 9017; amended to be effective December 23, 2020, 45 TexReg 9215; amended to be effective February 25, 2025, 50 TexReg 995. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE B MEAT AND POULTRY INSPECTION §221.11 Federal Regulations on Meat and Poultry Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224199&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224199 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224199&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224199 03/11/2026 (a) Introduction. The purpose of this subchapter is to protect the public health by establishing uniform rules to assure that meat and poultry products are clean, wholesome, and truthfully labeled.(b) Definitions. The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Meat and Poultry Inspection Act, Texas Health and Safety Code Chapter 433.(2) Adulterated--A carcass, part of a carcass, or a meat food product where:(A) any part of it is the product of an animal that has died in a manner other than by slaughter;(B) any part of it consists of a filthy, putrid, or decomposed substance or is for another reason unsound, unhealthy, unwholesome, or otherwise unfit for human food; or(C) it contains, because of administration of any substance to a live animal or otherwise, an added poison or harmful substance that makes the carcass, part of the carcass, or meat food unfit for human food.(3) Alternate source food animals--Animals slaughtered and processed for food that are amenable to inspection under the Act but are not amenable to inspection under the Federal Meat Inspection Act (21 United States Code (USC) §601 et seq.) or Federal Poultry Products Inspection Act (21 USC §451 et seq.).(4) Animal share--An ownership interest, conveyed and documented before slaughter, in one or more identified livestock animals created by a contract between a livestock producer, who owns the livestock, and a prospective co-owner of the livestock.(A) Animal shares are defined portions of one or more specifically identified livestock and do not apply to groups of livestock or herds.(B) Purchase, acquisition, or ownership of animal shares is limited to an individual co-owner. Animal shares may not be purchased, acquired, or owned by groups, businesses, or organizations.(C) A livestock producer may, but is not required to, own a share of the individual livestock animal at the time of slaughter.(5) Bison--An animal known by the scientific name Bovidae bison, commonly known as the North American prairie bison; or an animal known by the scientific name Bovidae bison athabascae, commonly known as the Canadian wood bison.(6) Bison meat--The meat or flesh of a bison.(7) Buffalo--An animal known by the scientific name Bovidae bubalus, commonly known as the Asian Indian buffalo, water buffalo, or caraboa; an animal known by the scientific name Bovidae syncerus caffer, commonly known as the African buffalo or the Cape buffalo; an animal known by the scientific name Bovidae anoa depressicornis, commonly known as the Celebes buffalo; or an animal known by the scientific name Bovidae anoa mindorenis, commonly known as the Philippine buffalo or Mindoro buffalo.(8) Buffalo meat--The carcass, part of the carcass, or meat food product made in whole or part of a buffalo.(9) Change in ownership--(A) A change in the business organization operating the business that changes the legal entity responsible for operation of the business; or(B) any change in control of the business.(10) Commissioner--Commissioner of the Department of State Health Services. For the purposes of this subchapter, the term "Secretary," when used in 9 Code of Federal Regulations (CFR), means commissioner.(11) Custom exempt operation--(A) The slaughtering of livestock or the processing of an uninspected carcass or parts thereof for the owner of that livestock animal, carcass, or parts; a member of the owner's household; or a nonpaying guest or employee of the owner in accordance with Texas Health and Safety Code §433.006; or(B) the selling of livestock to be slaughtered and processed by the purchaser on premises owned or operated by the seller for the exclusive use of the purchaser; a member of the owner's household; or a nonpaying guest or employee of the owner in accordance with Texas Health and Safety Code §433.006.(12) Custom processor--A person who prepares meat food products from uninspected livestock carcasses or parts thereof for the owner of those carcasses or parts for the exclusive use of the owner, a member of the owner's household, or a nonpaying guest or employee of the owner in accordance with Texas Health and Safety Code §433.006.(13) Custom slaughterer--A person who slaughters livestock for a custom exempt operation in accordance with Texas Health and Safety Code §433.006. Custom slaughter includes all activities related to slaughter, including restraining livestock, cleaning or preparing any equipment used for slaughter such as tools and knives, and cleaning and preparing the slaughter facility.(14) Department--The Department of State Health Services. For the purposes of this subchapter, when using the federal regulations adopted by reference in §221.11 of this subchapter (relating to Federal Regulations on Meat and Poultry Inspection), the terms "United States Department of Agriculture" or "department" mean the Department of State Health Services.(15) Disfavored--Having a negative impact upon the determination to award a Grant of Custom Exemption, Grant of Inspection, or Grant of Voluntary Inspection.(16) Exotic animal--A member of a species of game not indigenous to this state, including axis deer, nilgai antelope, or other cloven hoofed ruminant animal.(17) Federal regulations--Chapter 9 of the Code of Federal Regulations (CFR) as adopted by reference in §221.11 of this subchapter.(18) Feral swine--Nondomestic descendants of domestic swine that have either escaped or were released and subsequently developed survival skills necessary to thrive in the wild. Some feral swine are outcrossed with "Russian boar." Live feral swine delivered to an establishment are subject to the same regulations as domestic swine.(19) Game animals--Wild animals, not amenable to the Act, for which the hunter must obtain a hunting license from the Texas Parks and Wildlife Department before hunting animals, such as white-tailed deer, mule deer, pronghorn antelope, and big horn sheep.(20) Grant of Custom Exemption--An authorization from the department to engage in a business of custom slaughtering or processing livestock for the owner of the livestock. This exemption is limited to the exclusive use for the owner, a member of the owner's household, or a nonpaying guest or employee of the owner, in accordance with Texas Health and Safety Code §433.006, provided that the following conditions are met:(A) the establishment slaughters only sound, healthy livestock and conducts all processing and handling under sanitary standards and procedures resulting in meat products that are not adulterated; (B) the product meets the marking and labeling requirements as specified in §221.14 of this subchapter (relating to Custom Exempt Slaughter and Processing; Animal Share and Low-Volume Poultry or Rabbit Slaughter Operations); and(C) the establishment maintains records as specified in §221.14 of this subchapter.(21) Grant of Inspection--An authorization issued by the department to engage in a business subject to inspection under the Act.(22) Grant of Voluntary Inspection--An authorization from the department to engage in a business subject to inspection of alternate source food animals under the Act.(23) Granted establishment--Any establishment with a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption.(24) Heat-treated--Meat or poultry products that are offered for human consumption following heat processing.(25) Humane Slaughter--In the case of cattle, calves, horses, mules, sheep, swine, and other livestock, all animals are rendered insensible to pain by a single blow or gunshot or electrical, chemical, or other means that is rapid and effective, before being shackled, hoisted, thrown, cast, or cut.(26) Livestock--Cattle, sheep, swine, goats, horses, mules, other equines, poultry, domestic rabbits, exotic animals, or domesticated game birds.(27) Livestock producer--A person actively engaged in livestock production or husbandry.(28) Low-volume livestock operation--For purposes of this subchapter, a low-volume livestock operation includes an establishment that processes fewer than 10,000 domestic rabbits or more than 1,000 but fewer than 10,000 poultry in a calendar year. The term does not include an establishment that processes 1,000 or fewer poultry raised by the operator of the establishment in a calendar year or processes fewer than 500 domestic rabbits in a calendar year.(29) Meat--Has the meaning assigned by 9 CFR §301.2. The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805.(30) Meat food product--Has the meaning assigned by 9 CFR §301.2. The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805. (31) Meat Safety Assurance Section--The organization overseen by the state director, within the Department of State Health Services, responsible for meat safety in granted establishments and associated in-commerce products in Texas. For the purposes of this subchapter, the term "Food Safety and Inspection Service (FSIS)," when used in federal regulations adopted by reference by the department in §221.11 of this subchapter, means the Meat Safety Assurance Section.(32) Official slaughter establishments premises--Locations where animals are held, including lots, pens, cages, and facilities associated with the holding and movement of livestock or poultry intended for slaughter. These facilities specifically include antemortem pens, suspect pens, alleyways, driveways, unloading areas, and adjoining pens that contain livestock intended for slaughter.(33) Person--Any individual, partnership, association, corporation, or unincorporated business organization.(34) Poultry--Any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs, also termed young pigeons from one to about 30 days of age), whether live or dead. The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805.(35) Poultry or Rabbit Exemption--Registration with the department for a person to engage in a low-volume livestock operation of slaughtering and processing poultry, rabbits, or both. The person must raise the animals on their own property and personally distribute the carcasses and parts to retail consumers, restaurants, or other retail establishments, provided the following conditions are met:(A) the person slaughters 500 or more but fewer than 10,000 domestic rabbits or more than 1,000 but fewer than 10,000 poultry in a calendar year;(B) the person does not buy or sell other poultry or rabbit products (except live chicks, baby rabbits, and breeding stock);(C) the person slaughters only sound, healthy poultry or rabbits and conducts all processes and handling under sanitary standards and procedures resulting in poultry or rabbit products that are not adulterated;(D) the product meets the marking and labeling requirements as specified in §221.14(e)(4) of this subchapter; and(E) the poultry is not a ratite.(36) Poultry product--Has the meaning assigned by 9 CFR §381.1(b). The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805. (37) Ratite--Poultry such as ostrich, emus, or rhea.(38) Responsibly connected person--An officer, partner, director, managerial or executive employee, holder or owner of 10 percent or more of the business's voting stock.(39) Ritual cut--The simultaneous and instantaneous severance of the carotid arteries with a sharp instrument in accordance with the ritual requirements of the Jewish faith or any other religious faith that prescribes a method of slaughter whereby the animal suffers loss of consciousness by anemia of the brain.(40) Slaughter--Methods of death, for the purpose of food, under sanitary conditions.(41) State director--For the purposes of this subchapter, the term "administrator," when used in federal regulations adopted by reference by the department in §221.11 of this subchapter, means state director.(c) Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption.(1) Basic requirements.(A) A person must not engage in a business subject to the Act unless that person has met the standards established by the Act, the federal regulations as adopted by the department, and this subchapter, and has obtained the appropriate Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption issued by the department.(B) A person must not engage in custom operations unless that person has met the standards established by the Act, the federal regulations, and this subchapter, and has obtained a Grant of Custom Exemption issued by the department.(C) A person must not engage in exempted poultry or rabbit slaughter and processing operations unless that person has met the standards established by the Act, the federal regulations, and this subchapter, and has registered with the department, if required. (D) A person must not engage in alternate food source livestock slaughter and processing operations unless that person has met the standards established by the Act, the federal regulations, and this subchapter, and has obtained a Grant of Voluntary Inspection issued by the department. Hunter-killed exotic game animals processed exclusively for donation to a non-profit food bank, as defined by Texas Government Code §418.026(a), do not require inspection.(E) The establishment must display the Grant of Inspection, Grant of Voluntary Inspection, and Grant of Custom Exemption in a prominent place at the physical business location, easily visible to the public.(F) All regulated establishments operating as a livestock or animal dealer, by conducting on-premises livestock or poultry sales, must also comply with all regulatory requirements required as an animal or livestock seller, dealer, broker, or market.(2) Application.(A) To apply for a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption, a person must complete department application forms, which can be obtained from the department's Meat Safety Assurance Section.(B) Upon submission of an application for a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption, the applicant must prove that the establishment meets all regulatory requirements for the grant.(C) The department must conduct an inspection to verify whether the establishment meets all regulatory requirements for the grant. Additionally, the department must ensure that the grant application contains all necessary information to issue a grant and determine if any responsibly connected persons are unfit to engage in any business requiring inspection or whose compliance history is subject to the application being disfavored as defined by this section. The department must notify the applicant of the results in accordance with policy, after receiving a complete and accurate application and making the required determinations.(i) If the establishment meets all regulatory requirements and no responsibly connected persons associated with the establishment are subject to the application being disfavored as defined by this section, the department will provide the applicant with the appropriate grant.(ii) If the establishment does not meet all regulatory requirements, the department will provide the applicant with a listing of the regulatory requirements that the establishment failed to meet. In this case, the applicant may reapply when the applicant can support that the establishment meets all regulatory requirements for the grant.(iii) If the establishment meets all regulatory requirements, the department may deny the application if one or more responsibly connected person(s) associated with the establishment is subject to the application being disfavored as defined by this section.(3) Duration. The applicant who has complied with the standards in the Act, the federal regulations, and this subchapter will receive a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption for an indefinite period subject to the denial, suspension, and revocation provisions in paragraph (6) of this subsection.(4) Non-transferable. A Grant of Inspection, Grant of Voluntary Inspection, and Grant of Custom Exemption is not transferable to another person.(5) Change of ownership. Any person operating a business under a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption from the department must notify the department of any change in ownership of that business and relinquish the current grant to the department. The new owner must apply for a new grant on forms provided by the department. This notification and new application must be approved before the new ownership begins operations.(6) Denial, suspension, and revocation.(A) The department may deny a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption to any applicant who does not comply with the standards of the Act, the federal regulations, and this subchapter.(B) The department will consider the compliance history of the establishment and any responsibly connected person(s) to determine whether to deny, revoke, or suspend a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption. The department will review all compliance history records maintained according to the department's Records Retention Policy. A disfavored application may lead to denial, revocation, or suspension. An application indicating the following will be disfavored:(i) an establishment or responsibly connected person(s) is unfit to engage in any business requiring inspection according to 9 CFR §500.6(a)(9); or(ii) a connection with an establishment or responsibly connected person(s) whose compliance history includes revocation, surrendered grant while enforcement actions are pending, or default on a previous enforcement action or agreement with the department.(C) The department may suspend or revoke a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption of any person who violates the standards of the Act, the federal regulations, this subchapter, and engages in conduct described in §221.12(c)(6)(B) of this subsection.(D) The department may suspend a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption if an establishment is inactive for a period in excess of 30 calendar days.(E) An establishment, where a grant has been suspended, must undergo reinspection before reinstatement of the grant.(F) A person whose grant has been denied, suspended, or revoked is entitled to an opportunity for a formal hearing in accordance with §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(7) Meat and poultry establishments and related industries. (A) For the purpose of conducting an inspection or performing any other inspection program duty, the department representatives must have access to the premises and to every part of an establishment that slaughters livestock or otherwise prepares or processes meat or poultry products subject to inspection. The official badge of a department representative is sufficient identification to allow the representative admittance to all parts of such an establishment and its premises at all times, day or night.(B) At all reasonable hours, any person subject to record keeping requirements under the Act or this chapter (whether holding or not holding a Grant of Inspection or exemption therefrom) must permit access to a department representative upon presentation of credentials. The department representative may examine the facilities and inventory. The department representative may also examine and copy records specified in this chapter.(C) All inspected establishments must enter into a work schedule agreement with the department. Work schedule agreements may be made for a maximum of 40 hours per week and do not include operations on weekends or official holidays. Work schedule agreements may be altered by the department due to inspector availability, other conditions inhibiting the ability of the department to provide inspection services, or to conserve resources, as necessary. Custom exempt establishments must communicate the intended hours of operation to the department at least five (5) business days before commencing operations to facilitate inspection. Mobile slaughter and mobile processing establishments, whether inspected or custom exempt, must communicate the intended location to the department at least five (5) business days before commencing operations to facilitate inspection. Deviation from these requirements, or the requirements set forth in 9 CFR §307.4, require prior written approval from the department.(8) Disposition of livestock not eligible for entry into commerce.(A) Livestock deemed ineligible for entry into commerce by the department may be slaughtered and processed under all applicable custom exemption rules and regulations if the department veterinarian determines such actions to be appropriate and that the livestock appear to be in such a condition that the resulting meat or meat food product may be fit for human consumption.(B) All abnormal livestock, including livestock intended for slaughter and processing under custom exemption, must be presented for inspection at an establishment with a Grant of Inspection during hours of inspected operation.(9) Requirements for the humane treatment of livestock, excluding poultry and domesticated game birds, at granted establishments. (A) Livestock pens, driveways, ramps, gates, restraining devices, and all other facilities must be maintained in good repair and free from sharp or protruding objects that may cause injury or pain to the animals. Floors of livestock pens, driveways, ramps, restraining devices, and all other facilities must be constructed and maintained so as to provide good footing for livestock.(B) A pen sufficient to protect livestock from the adverse climatic conditions of the locale is required at granted establishments that hold animals overnight or through the day.(C) Animals must have access to water in all holding pens and, if held longer than 24 hours, access to feed. There must be sufficient room in the holding pen for animals held overnight to lie down. Disabled livestock must be separated from non-disabled livestock while being held in the establishments holding pens.(D) Livestock must be humanely slaughtered in accordance with this section and 9 CFR §313, adopted by reference in §221.11 of this subchapter.(i) Stunning instruments must be maintained in good repair and available for inspection by a department representative.(ii) Inhumane treatment of animals is prohibited, and any observed inhumane treatment of animals is subject to regulatory control actions and enforcement actions.(E) Establishments conducting ritual slaughter in accordance with 7 USC §1902(b).(i) Establishments conducting ritual slaughter must have a completed document signed and dated by an appropriate religious authority, including the name, title, address, and other contact information of the appropriate religious authority. The document must describe and attest to the conduct of ritual slaughter at that establishment. This document must list, by name, the individuals authorized to perform ritual slaughter at that establishment. Individuals not specifically listed on the current document are not authorized to perform the ritual cut at the establishment unless an effective stunning procedure is utilized before the ritual cut. Any modification of the procedures, individuals authorized to perform ritual slaughter, or religious authority information requires completing an updated document. An individual listed on the current document may be assisted in the ritual slaughter by other establishment employees not listed on the document.(ii) Establishments conducting ritual slaughter in accordance with 7 USC §1902(b) are exempt from the stunning requirements of this section and the requirements of 9 CFR §§313.2(f), 313.5, 313.15, 313.16, 313.30, and 313.50(c) pertaining to stunning methods provided the following.(I) Animals are humanely restrained and adequately restrained to prevent harm to the animal throughout the slaughter process.(II) The ritual cut severs both carotid arteries immediately and simultaneously in a single cut unless an effective stunning procedure is utilized before the ritual cut.(III) Animals are fully unconscious before being shackled, hoisted, thrown, cast, or cut except for the ritual cut.(10) Good Commercial Practices for Poultry. Poultry and domesticated game birds are to be slaughtered in a manner that ensures breathing has stopped before scalding, so birds do not drown. Slaughter must result in thorough bleeding of the poultry carcass. The slaughtering of poultry and domesticated game birds must comply with 9 CFR §381.90. Poultry and domesticated game bird carcasses showing evidence of having died from causes other than slaughter are considered adulterated and must be condemned. As required in 9 CFR §381.65(b), the department requires poultry and domesticated game birds be slaughtered in accordance with good commercial practices. Source Note: The provisions of this §221.12 adopted to be effective March 15, 1995, 20 TexReg 1417; amended to be effective December 1, 1995, 20 TexReg 9275; amended to be effective April 17, 1997, 22 TexReg 3421; amended to be effective June 21, 2000, 25 TexReg 5901; amended to be effective March 14, 2002, 27 TexReg 1801; amended to be effective April 24, 2003, 28 TexReg 3336; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective December 23, 2020, 45 TexReg 9215; amended to be effective February 25, 2025, 50 TexReg 995. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE B MEAT AND POULTRY INSPECTION §221.12 Meat and Poultry Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224200 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224200&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224200 03/11/2026 (a) Administrative Penalties. The purpose of this section is to establish the criteria and procedures by which the commissioner will assess administrative penalties for violations relating to provisions of the Act, these rules, licenses, and orders issued pursuant to the Act or the rules.(1) Determining the amount of the penalty. In determining the amount of the penalty, the commissioner must consider the criteria described in paragraphs (2) - (6) of this subsection.(2) The seriousness of the violation.(A) Violations must be categorized by one of the following severity levels.(i) Severity Level I covers violations that are most significant and have a direct negative impact on, or represent a threat to, public health and safety. Violations include:(I) adulteration;(II) intentional and egregious inhumane treatment of animals;(III) failure to remove known adulterated product from commerce; and(IV) misbranding, false representation, or false advertising resulting in a danger to the public or improper monetary gain of over $25,000 by the violator.(ii) Severity Level II covers violations that are very significant and impact public health and safety. Violations include:(I) adulteration;(II) repetitive egregious inhumane treatment of animals;(III) slaughter of animals without a Grant of Inspection or Grant of Custom Exemption (when required by the department);(IV) violation of a regulatory control action;(V) bribery, coercion, or interference with inspection or attempted bribery, coercion, or interference with inspection; and(VI) misbranding, false representation, or false advertising resulting in the entry of potentially harmful products into commerce or improper monetary gain of over $10,000 by the violator.(iii) Severity Level III covers violations that are significant and which, if not corrected, could adversely impact public health and safety. Violations include:(I) adulteration;(II) egregious or repetitive non-egregious inhumane treatment of animals;(III) failure to remove known misbranded product from commerce;(IV) misbranding, false representation, or false advertising resulting in public health risk or improper monetary gain of over $1,000 by the violator;(V) producing product without a Grant of Inspection or Grant of Custom Exemption (when required by the department);(VI) failing to correct significant deficiencies in Hazard Analysis and Critical Control Point plans, Sanitation Standard Operating Procedures; and(VII) problems involving food contact surfaces.(iv) Severity Level IV covers violations that are of more than minor significance, and if left uncorrected, would lead to more serious circumstances. Violations include:(I) non-egregious inhumane treatment of animals;(II) misbranding, false representation, or false advertising resulting in monetary gain of under $1,000 by the violator;(III) failure to correct minor deficiencies in Hazard Analysis and Critical Control Point plans or Sanitation Standard Operating Procedures; and(IV) problems involving non-food-contact surfaces.(v) Severity Level V covers violations where minor noncompliant practices by a violator create some risk for production of adulterated product in the production environment. Violations include: (I) failure by the establishment to correct minor noncompliant deficiencies in the production environment that do not involve product handling or product contact surfaces;(II) failing to correct incidental noncompliance;(III) general disrepair;(IV) conditions that could potentially cause inhumane treatment of animals; and(V) misbranding, false representation, or false advertising that does not result in public health risk or monetary gain by the violator.(B) The severity of a violation must be increased if the violation involves deception or other indications of willfulness. In determining the severity of a violation, the department must take into account the economic benefit gained by a person through noncompliance. (3) History of previous violations. The department may consider previous violations. Repetitive violations may be considered when determining the severity of a violation and may result in increased penalties within a severity level or elevation to a higher severity level.(4) Demonstrated good faith. The department may consider demonstrated good faith. The base penalty may be reduced if good faith efforts to correct a violation have been made or are being made. Good faith effort must be determined on a case-by-case basis and be fully documented.(5) Hazard to public health and safety. The department may consider the hazard to public health and safety. The base penalty must be increased when a direct hazard to public health or safety is involved, with consideration to:(A) whether any disease or injuries have occurred from the violation;(B) whether any existing conditions contributed to a situation that could expose humans to a health hazard; or(C) whether the consequences would be of an immediate or long-range hazard.(6) Other matters. The commissioner may consider other matters as justice may require.(7) Levels of penalties.(A) The department will impose different levels of penalties for different severity level violations as follows:Attached Graphic(B) Each day a violation continues may be considered a separate violation.(8) Assessment, payment, and refund procedures.(A) The commissioner may assess an administrative penalty only after a person charged with a violation is given an opportunity for an administrative hearing under Texas Health and Safety Code §433.095; Texas Government Code Chapter 2001; and the department's formal hearing procedures in Chapter 1 of this title (relating to Miscellaneous Provisions).(B) Payment of an administrative penalty must be made under the provision of Texas Health and Safety Code §433.096.(C) Refund of an administrative penalty must be made under the provisions of Texas Health and Safety Code §433.097.(b) Criminal Penalties.(1) Interference with inspection.(A) A person commits an offense if the person with criminal negligence interrupts, disrupts, impedes, or otherwise interferes with a livestock inspector while the inspector is performing a duty under the Act.(B) An offense under this section is a Class B misdemeanor. (C) It is a defense to prosecution under this section that the interruption, disruption, impediment, or interference alleged consisted of speech only.(2) General.(A) A person commits an offense if the person violates a provision of the Act or these rules for which these rules do not provide another criminal penalty.(B) Except as provided by paragraph (2)(C) of this subsection, an offense under this section is punishable by a fine of not more than $1,000, imprisonment for not more than one year, or both.(C) If an offense under this section involves intent to defraud, or distribution or attempted distribution of an adulterated article except adulteration described by Texas Health and Safety Code §433.004(11), (12), or (13), the offense is punishable by a fine of not more than $10,000, imprisonment for not more than three years, or both.(D) A person does not commit an offense under this section by receiving for transportation an article in violation of the Act if the receipt is in good faith and if the person furnishes, on request of a representative of the commissioner:(i) the name and address of the person from whom the article is received; and(ii) any document pertaining to the delivery of the article.(E) This section does not require the commissioner to report for prosecution, or for institution of complaint or injunction proceedings, a minor violation of this chapter if the commissioner believes the public interest will be adequately served by a suitable written warning notice.(3) Injunction.(A) If it appears a person has violated or is violating the Act or a rule adopted under the Act, the commissioner may request the attorney general or the district attorney or county attorney in the jurisdiction where the violation is alleged to have occurred, is occurring, or may occur to institute a civil suit for:(i) an order enjoining the violation; or(ii) a permanent or temporary injunction, a temporary restraining order, or other appropriate remedy, if the commissioner shows the person has engaged in or is engaging in a violation.(B) Venue for a suit brought under this section is in the county in which the violation occurred or in Travis County.(C) The commissioner or the attorney general may recover reasonable expenses incurred in obtaining injunctive relief under this section, including investigation and court costs, reasonable attorney's fees, witness fees, and other expenses. The expenses recovered by the commissioner under this section may be used for the administration and enforcement of Texas Health and Safety Code Chapter 433. The expenses recovered by the attorney general may be used by the attorney general for any purpose.(4) Emergency withdrawal of mark or suspension of inspection services.(A) The commissioner or the commissioner's designee may immediately withhold the mark of inspection or suspend or withdraw inspection services if:(i) the commissioner or the commissioner's designee determines a violation of the Act or these rules presents an imminent threat to public health and safety; or(ii) a person affiliated with the processing establishment impedes an inspection under this chapter, including assaulting, threatening to assault, intimidating, or interfering with a department employee.(B) An affected person is entitled to a review of an action of the commissioner or the commissioner's designee under subparagraph (A) of this paragraph in the same manner that a refusal or withdrawal of inspection services may be reviewed under Texas Health and Safe Code §433.028.(C) For purposes of this section only, the definition of "imminent threat" to public health and safety includes:(i) the establishment produced and shipped adulterated or misbranded product as defined under Texas Health and Safety Code 3.004 and §433.005;(ii) the establishment does not have or has an inadequate Hazard Analysis and Critical Control Point plan as specified in 9 Code of Federal Regulations (CFR) §417.6;(iii) the establishment does not have Sanitation Standard Operating Procedures as specified in 9 CFR §§416.11 - 416.16;(iv) sanitary conditions are such that products in the establishment are or would be rendered adulterated under Texas Health and Safety Code §433.004; or(v) the establishment violated the terms of a regulatory control action as specified in Texas Health and Safety Code §433.030, 9 CFR §310.4, or 9 CFR §416.6.(D) This section in no way restricts or prohibits the department from taking action under Texas Health and Safety Code Chapter 431, Texas Health and Safety Code §433.008, the Federal Meat Inspection Act (21 United States Code (USC) 12), and the Poultry Products Inspection Act (21 USC 10) and the regulations adopted in §221.11 of this subchapter (relating to Federal Regulations on Meat and Poultry Inspection). Source Note: The provisions of this §221.13 adopted to be effective March 15, 1995, 20 TexReg 1417; amended to be effective June 21, 2000, 25 TexReg 5901; amended to be effective March 14, 2002, 27 TexReg 1801; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective February 25, 2025, 50 TexReg 995. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE B MEAT AND POULTRY INSPECTION §221.13 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224201&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224201 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224201&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224201 03/11/2026 (a) Custom Exempt Slaughter and Processing Operation Requirements. The requirements of this section apply to the custom exempt slaughter and custom exempt processing of uninspected livestock.(1) Record keeping.(A) Operators of facilities conducting custom exempt operations must keep records for a period of two years from the date of slaughter or processing.(B) The records must be available to department representatives on request.(C) Additional records that must be kept include records such as bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any livestock or carcass, meat, or meat food product is purchased, sold, shipped, received, transported, or otherwise handled by the custom slaughter establishment.(D) If the custom exempt establishment also maintains a retail meat outlet, the records requirements in subparagraph (C) of this paragraph must be separately maintained.(2) Containers used for meat food products, paper, or other materials in contact with meat food products.(A) To avoid adulteration of product, containers must be lined with suitable material of good quality before packing.(B) Containers and trucks or other means of conveyance in which any carcass or part is transported to the owner must be kept in a clean and sanitary condition.(C) Paper or other materials used for covering or lining containers and the cargo space of trucks or other means of conveyance must be of a kind that does not tear during use but remains intact and does not disintegrate when moistened by the product.(D) Boxes and any containers used as tote boxes must be clean and stored off the floor in a manner sufficient to prevent the creation of insanitary conditions and to ensure product is not adulterated.(3) Tagging insanitary equipment, utensils, rooms, and carcasses.(A) A department representative may attach a "Texas Rejected" tag to any equipment, utensil, room, or compartment at a custom exempt establishment that a department representative determines is insanitary and a health hazard. No equipment, utensil, room, or compartment, so tagged, may be used until untagged or released by a department representative. Such tags may not be removed by anyone other than a department representative.(B) A department representative who determines a carcass or parts are adulterated, unfit for human food, is from an unhealthy or unsound animal, or could result in a health hazard, may attach a "Texas Retained" tag to the carcass and parts, document the reason for attaching the tag on a form specified by the department, and deliver the form to the operator of the custom exempt establishment. The owner of the carcass and parts must be notified by the plant operator and advised of the potential health risk. The custom exempt establishment must ensure the owner of the carcass and parts either authorizes the voluntary destruction and denaturing of the carcass and all parts or agrees to remove the carcass and parts from the custom exempt establishment. Under no circumstances may the carcass and parts be further processed at the establishment.(4) Denaturing procedures. Carcasses, parts thereof, meat, and meat food products that are adulterated or not returned to the owner must be adequately denatured or decharacterized to preclude use as human food. Before the denaturing agents are applied, carcasses and carcass parts must be freely slashed or sectioned. The denaturing agent must be mixed with all of the carcasses or carcass parts to be denatured and must be applied in such quantity and manner that it cannot be removed by washing or soaking. A sufficient amount of the appropriate agent must be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food.(b) Custom Slaughter Requirements. The requirements of this section apply to the custom slaughter of livestock by any person, as defined in §221.12(b) of this subchapter (relating to Meat and Poultry Inspection), delivered by or for the owner for such slaughter, not for sale to the public, and for the exclusive use of the owner, a member of the owner's household, or a nonpaying guest or employee of the owner. The requirements of this section do not apply to hunter-killed game animals, hunter-killed exotic animals, or hunter-killed feral swine.(1) Animals for slaughter. Only healthy animals, exhibiting no abnormalities, may be accepted for custom slaughter at custom slaughter establishments. Unhealthy or unsound animals are those that exhibit any condition not normally expected in a healthy and sound member of that species.(A) Examples of abnormal or unsound animals include animals that are not able to get up, or animals that have a missing or abnormal eye, swellings, rectal or vaginal prolapse, ocular or nasal discharge, a cough, or a limp.(B) Animals that have an obviously recent break of the lower leg (below the stifle or elbow) and are able to walk and stand are not considered to be unsound or unhealthy if no other abnormal conditions are noted.(2) Record keeping. Custom slaughter records must contain the name, address, and telephone number of the owner of each animal presented, the date the animal was slaughtered, the species, and brief description of the livestock. If a custom processor accepts farm-slaughtered animals for custom processing, records must contain a signed statement from the animal owner that the animal was healthy and exhibited no abnormalities, other than an obviously recent break to the lower leg (below the stifle or elbow), and was able to walk and stand at the time of slaughter.(3) Sanitary methods. Custom slaughter establishments, including mobile operations, must be maintained in sanitary condition. Each custom slaughter establishment must comply with the requirements of 9 Code of Federal Regulations (CFR) Part 416, adopted under §221.11 of this subchapter (relating to Federal Regulations on Meat and Poultry Inspection). Establishments that accept farm-slaughtered livestock must complete and document cleaning and sanitization of all surfaces and equipment used in the processing of the farm-slaughtered livestock before those surfaces and equipment may be used to process other products. (4) Specified risk materials from cattle; handling and disposition. Each custom slaughter establishment must comply with the requirements of 9 CFR §310.22, adopted under §221.11 of this subchapter.(5) Custom exempt slaughter operators must adhere to the humane treatment of livestock as outlined in §221.12(c)(9) of this subchapter.(6) Custom exempt slaughter operators must adhere to the humane treatment of poultry and domesticated game birds as outlined in §221.12(c)(10) of this subchapter.(7) Inhumane treatment of animals observed by a department representative will result in the attaching of a "Texas Rejected" tag to the deficient equipment, facility structure, or the stunning area causing the inhumane treatment. No equipment, area, or facility so tagged may be used until untagged or released by the department representative.(8) Marking and labeling of custom prepared products. Carcasses and parts therefrom that are prepared on a custom basis must be marked at the time of preparation with the term "Not for Sale" in letters at least 3/8 inch in height, and must also be identified with the owner's name or a code that allows identification of the carcass or carcass part to its owner. Ink used for marking such products must be labeled for such purpose. Ink containing FD&C Violet No. 1 must t be used.(9) Requirements concerning procedures.(A) Heads from animals slaughtered by gunshot to the head must not be used for food purposes. Such heads must be denatured in accordance with this section and placed into containers marked "INEDIBLE." Heads with gunshot wounds may be returned to the owner only after they have been freely slashed and adequately denatured to preclude use for human food.(B) Cattle paunches and hog stomachs intended for use in preparing meat food products must be emptied of contents immediately upon removal from the carcass and thoroughly cleaned on all surfaces and parts.(C) Carcasses must not be adulterated, as defined in §221.12(b)(2) of this subchapter, when placed in coolers.(10) Requirements concerning ingredients. All ingredients and other articles used in the preparation of any carcass must be clean, sound, healthful, wholesome, and not result in the adulteration of the carcass. A letter of guaranty from the manufacturer stating the ingredient or article is safe when used in contact with food must be obtained by the custom slaughter establishment and made available upon request to the department representative.(c) Custom processing requirements. The requirements of this section apply to the custom processing by any person of uninspected livestock carcasses or parts, delivered by or for the owner thereof for such processing. These products are not for sale to the public and are for the exclusive use of the owner, a member of the owner's household, or a nonpaying guest or employee of the owner. The requirements of this section do not apply to hunter-killed game animals, hunter-killed exotic animals, or hunter-killed feral swine.(1) Carcasses and parts for processing. No adulterated carcasses or parts as defined in §221.12(b)(2) of this subchapter may be accepted for custom processing.(2) Record keeping. Temperature monitoring records must be maintained by the custom processor for heat-treated or ready-to-eat products. These records must include the temperature attained and time held during heating and the time and temperatures during the cool down process.(3) Sanitary methods. Custom processing establishments, including mobile operations, must be maintained in sanitary condition. Each custom processing establishment must comply with the requirements of 9 CFR Part 416, adopted under §221.11 of this subchapter.(4) Specified risk materials from cattle; handling and disposition. Each custom slaughter establishment must comply with the requirements of 9 CFR §310.22, adopted under §221.11 of this subchapter.(5) Death by other means than slaughter. Carcasses, or parts thereof, derived from animals that have died through circumstances other than slaughter. This includes animals such as roadkill or animals that have died by disease, trauma, or other accident. Such animals may not enter or be processed by a granted establishment.(6) Marking and labeling of custom prepared products.(A) Products that are custom prepared must be packaged immediately after preparation and must be labeled with the term "Not For Sale" in lettering not less than 3/8 inch in height. Such custom prepared products or containers must also bear the owner's name and any additional labeling, such as product cut or description.(B) Safe handling instructions must accompany every customer's raw or not fully cooked products. The information must be in lettering no smaller than 1/16 of an inch in size and may be placed on each product package, placed on each tote box or bag containing packaged product, or given as a flyer to the customer with the product. The safe handling instructions must be placed immediately after the heading in subparagraph (A) of this paragraph and must include the following or similar statements.(i) "Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions."(ii) "Keep refrigerated or frozen. Thaw in refrigerator or microwave." However, any portion of this statement in conflict with the product's specific handling instructions may be omitted (e.g., some products may have instructions to cook without thawing). A graphic illustration of a refrigerator must be displayed next to this statement.(iii) "Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry." A graphic illustration of soapy hands under a faucet must be displayed next to this statement.(iv) "Cook thoroughly." A graphic illustration of a skillet must be displayed next to this statement.(v) "Keep hot foods hot. Refrigerate leftovers immediately or discard." A graphic illustration of a thermometer must be displayed next to the statement.(7) Requirements concerning procedures.(A) Uninspected heads from custom slaughtered animals may not be sold or used in the preparation of meat food products unless prepared specifically for the owner of the animal for personal use.(B) Heads for use in the preparation of meat food products must be split and the bodies of the teeth, the turbinates and ethmoid bones, ear tubes, and horn butts removed, and the heads then thoroughly cleaned.(C) Bones and parts of bones must be removed from product intended for chopping or grinding.(D) Kidneys for use in the preparation of meat food products must first be freely sectioned and then thoroughly soaked and washed.(E) Clotted blood must be removed from livestock hearts before they are used in the preparation of meat food products.(F) Product must not be adulterated, as defined in §221.12(b)(2) of this subchapter, when placed in coolers or freezers.(G) Frozen product may be defrosted in water or thawed in a manner not conducive to promoting bacterial growth or resulting in adulteration of the product.(8) Requirements concerning ingredients.(A) All ingredients and other articles used in the preparation of any product must be clean, sound, healthful, wholesome, and not result in the adulteration of product. A letter of guaranty from the manufacturer stating the ingredient or article is safe when used as an ingredient or in contact with food must be obtained by the custom processor and made available upon request to the department representative.(B) Ingredients for use in any product may not contain any pesticide chemical or other residues in excess of levels permitted under the federal Food, Drug, and Cosmetic Act.(9) Approval of substances for use.(A) No substance may be used in the preparation of any product unless it is a Food and Drug Administration-approved food additive.(B) No product may contain any substance that would render it adulterated.(C) Nitrates must not be used in curing bacon.(i) Nitrites in the form of sodium nitrite may be used at 120 parts per million (ppm) ingoing (or in the form of potassium nitrite at 148 ppm ingoing) maximum for injected, massaged, or immersion cured bacon; and 550 ppm of sodium ascorbate or sodium erythorbate (isoascorbate) for injected, massaged, or immersion cured bacon must be used.(ii) Sodium or potassium nitrite may be used at 2 pounds to 100 gallons pickle at 10% pump level; 1 ounce to 100 pounds meat (dry cure).(iii) Sodium ascorbate or sodium erythorbate (isoascorbate) may be used at 87.5 ounces to 100 gallons pickle at 10% pump level; 7/8 ounces to 100 pounds meat; or 10% solution to surfaces of cut meat.(iv) Sodium nitrite must not exceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly.(D) When curing products other than bacon, nitrites, nitrates, or combination must not result in more than 200 ppm of nitrite in the finished product.(i) Sodium or potassium nitrite may be used at 2 pounds to 100 gallons pickle at 10% pump level; 1 ounce to 100 pounds meat (dry cure); or 1/4 ounce to 100 pounds chopped meat or meat byproduct.(ii) Sodium or potassium nitrate may be used at 7 pounds to 100 gallons pickle; 3-1/2 ounces to 100 pounds meat (dry cure); or 2-3/4 ounces to 100 pounds chopped meat. (Nitrates may not be used in bacon.)(10) Prescribed treatment of heat-treated meat and poultry products.(A) All forms of fresh meat and poultry, including fresh unsmoked sausage and pork such as bacon and jowls, are classified as products that are customarily well cooked in the home before being consumed. Therefore, the treatment of such products to destroy pathogens is not required.(B) Meat and poultry products, which are not customarily cooked or may not be cooked before consumption because they have the appearance of being fully cooked, must not contain pathogens.(i) Heat-treated, dry, semi-dry, and fermented meat products are required to be heated to an internal temperature according to the following chart:Attached Graphic(ii) Heat treated, dry, semi-dry, and fermented poultry products are required to be heated to an internal temperature according to the following chart:Attached Graphic(iii) Heat treated meat and poultry products that must be stored under refrigerated temperatures must be cooled quickly to prevent bacterial growth. During cooling, the product's maximum internal temperature must not remain between 130 degrees Fahrenheit and 80 degrees Fahrenheit for more than 1-1/2 hours nor between 80 degrees Fahrenheit and 40 degrees Fahrenheit for more than 5 hours. Custom processors may slowly cool cured products in accordance with Meat Safety Assurance (MSA) Directive 7111.1, Verification Procedures for Lethality and Stabilization, which may be viewed at www.dshs.texas.gov/meat-safety, or other substantiated support.(iv) Custom processors not utilizing a heating step as described in clauses (i), (ii), and (iii) of this subparagraph must submit an alternate procedure, describing the method utilized in determining safety, to a department representative.(v) Custom processors may produce heat-treated or ready-to-eat custom products, including chorizo, at temperatures other than those listed in clauses (i), (ii), and (iii) of this subparagraph when requested to do so by the owner of the product. The custom processor must obtain a signed statement from the owner of the product stating the risks associated with eating under-cooked meat products are understood.(C) When necessary to comply with the requirements of this section, smokehouses, drying rooms, and other compartments used in the treatment of meat and poultry products to destroy pathogens must be suitably equipped with accurate automatic recording thermometers by the operator of the custom processing establishment.(d) Animal Share Exemption Requirements. Livestock co-owned under an animal share program may be exempted from inspection under Texas Health and Safety Code §433.006 and are eligible to be custom slaughtered or custom processed under subsections (a) and (b) of this section. Livestock producers and custom exempt operators engaging in animal share programs must comply with the requirements of this subsection in addition to the requirements contained in subsections (a) and (b) of this section. Each animal share applies to one particular, identified livestock animal. A livestock producer may sell shares of more than one animal to a particular co-owner as long as those shares are collectively consistent with amounts for personal use. Each animal share is reflective of a defined percentage of the livestock animal on either a per animal basis or a percentage of portions, cuts, or products produced from the livestock animal. Livestock ownership must be documented and 100% of the animal must be designated before slaughter.(1) Animals for slaughter.(A) Animals presented for slaughter under an animal share must comply with all other requirements for animals slaughtered at the facility providing the slaughtering and processing services.(B) Animals under an animal share must be slaughtered at the facility providing the slaughtering and processing services and may not be slaughtered on ungranted premises and be presented for custom processing only.(C) The meat and meat food products are:(i) prepared from livestock subject to an animal share and delivered to the establishment preparing the products by a co-owner of the livestock or the livestock producer boarding the livestock; and(ii) following preparation, delivered directly to the co-owner or co-owners by either the custom exempt operator or the livestock producer.(D) The custom operator or livestock producer that delivers the product to the co-owner or co-owners is responsible for maintaining the product in wholesome, sanitary conditions, including maintaining the product under proper storage temperature and conditions until the product is delivered. If the livestock producer holds the product on behalf of the co-owner, the livestock producer must comply with all other regulatory requirements pertaining to the storage of such products.(2) Recordkeeping.(A) Custom exempt operators must:(i) maintain records and make them available as required by §221.14 of this subchapter;(ii) document the name, address, and telephone number of each co-owner of the animal share livestock animal presented. These documents must also include the date the livestock animal was delivered, the species, and amount defined as a percentage, based on either the entire animal or particular portions, cuts, or products, delivered to each co-owner;(iii) maintain additional records, including bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any carcass, meat, or meat food product is purchased, sold, shipped, received, transported, or otherwise handled by the custom processor; and(iv) provide to the livestock producer or co-owner, upon delivery of the meat or meat food products, written notice that conspicuously displays the warning that the department has not inspected the meat or meat food products.(B) Livestock producers must:(i) provide a bill of sale to the co-owner conveying an ownership interest in the animal;(ii) complete a written agreement, which, at a minimum, includes:(I) a provision authorizing the livestock producer to board the livestock and arrange preparation of the livestock as meat and meat food products for the co-owner; and(II) a provision entitling the co-owner to a share of meat and meat food products derived from the livestock;(iii) provide to the co-owner information describing the standards the livestock producer followed in maintaining livestock health and preparing the meat and meat food products derived from the livestock; and(iv) provide to the co-owner, upon delivery of the meat or meat food products, written notice that conspicuously displays the warning that the department has not inspected the meat or meat food products.(3) Marking and labeling of custom prepared animal share products.(A) Animal share meat and meat food products must be marked and labeled under the requirements in subsections (b)(8) and (c)(6) of this section.(B) On delivery of the meat or meat food products to the co-owner, the custom exempt operator must provide to the co-owner notice that the department has not inspected the meat or meat food products in:(i) a separate written statement that conspicuously displays the warning; or(ii) a warning statement conspicuously displayed on a label affixed to the meat or meat food product packaging.(4) Enforcement. A person may not sell, donate, or commercially redistribute meat or meat food products produced under this section. A person who violates this section is liable for a civil penalty in the amount of $10,000 for each violation as provided by §221.13(a)(2)(A)(ii) of this subchapter.(e) Low-Volume Poultry or Rabbit Slaughter Operations Requirements.(1) Animals for slaughter. Adulterated poultry or rabbits, as defined in §221.12(b)(2) of this subchapter, may not be slaughtered for the purpose of selling the carcass or parts for food. Only healthy poultry and rabbits, exhibiting no abnormalities, may be slaughtered for sale as food. Unhealthy or unsound poultry and rabbits are those that exhibit any condition not normally expected to be exhibited in a healthy and sound member of that species. Examples of abnormal or unsound animals include animals that are not able to get up, or animals that have a missing or abnormal eye, swellings, rectal or vaginal prolapse, ocular or nasal discharge, a cough, or a limp.(2) Record keeping.(A) Operators of facilities conducting slaughter under a Poultry or Rabbit Exemption must keep records such as bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any livestock or carcass, meat, or meat food product is purchased, sold, shipped, received, transported, or otherwise handled for a period of two years, beginning on January 1 of the previous year plus the current year to date.(B) The records must be available to department representatives on request.(3) Sanitary methods. Low-volume poultry or rabbit slaughter operations must be maintained in sanitary condition.(4) Marking and labeling of products. Carcasses and parts there from that are prepared under the Poultry or Rabbit Exemption must be packaged and the container must be marked with each of the following in letters at least 1/4 inch in height, unless otherwise stated:(A) the slaughterer's name and address and the term "Exempted P.L. 90-492" and the statement "Not Produced Under Inspection";(B) the common or usual name of the product, or a truthful descriptive designation of the product;(C) a special handling label such as, "Keep Refrigerated," "Keep Frozen," "Keep Refrigerated or Frozen," "Perishable - Keep Under Refrigeration," or any other similar statement that the establishment has received approval from the department to use; and(D) safe handling instructions must be in lettering no smaller than 1/16 of an inch in size and must be prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.(i) Safe handling information. The safe handling information must be presented on the label under the heading "Safe Handling Instructions," which must be set in type size larger than the print size of the rationale statement and safe handling statement. The safe handling information must be set off by a border and must be one color type printed on a single-color contrasting background whenever practical.(ii) Rationale statement. The safe handling instructions must include the following rationale statement, "This product was prepared from meat or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions." This statement must be placed immediately after the heading for safe handling instructions in clause (i) of this subparagraph and before the safe handling statement in clause (iii) of this subparagraph.(iii) Safe handling statement. The safe handling instructions must include the following safe handling statements.(I) "Keep refrigerated or frozen. Thaw in refrigerator or microwave." Any portion of this statement in conflict with the product's specific handling instructions may be omitted (e.g., some products may have specific instructions to cook without thawing). A graphic illustration of a refrigerator must be displayed next to the statement.(II) "Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry." A graphic illustration of soapy hands under a faucet must be displayed next to the statement.(III) "Cook thoroughly." A graphic illustration of a skillet must be displayed next to the statement.(IV) "Keep hot foods hot. Refrigerate leftovers immediately or discard." A graphic illustration of a thermometer must be displayed next to the statement. Source Note: The provisions of this §221.14 adopted to be effective April 17, 1997, 22 TexReg 3421; amended to be effective June 21, 2000, 25 TexReg 5901; amended to be effective March 14, 2002, 27 TexReg 1801; amended to be effective November 7, 2002, 27 TexReg 10391; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective December 23, 2020, 45 TexReg 9215; amended to be effective February 25, 2025, 50 TexReg 995. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE B MEAT AND POULTRY INSPECTION §221.14 Custom Exempt Slaughter and Processing; Animal Share and Low-Volume Poultry or Rabbit Slaughter Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224202&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224202 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224202&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224202 03/11/2026 (a) Requirements. Specific requirements of this section are in addition to those required by the rules adopted for inspection of livestock, under the Texas Meat and Poultry Inspection Act, and federal regulations as listed in §221.11 of this subchapter (relating to Federal Regulations on Meat and Poultry Inspection).(b) Fees. Fees are assessed in one-half hour increments for inspection services, provided by a department inspector to a facility holding a grant of inspection, as specified in §221.16 of this subchapter (relating to Fees). Failure of a grant holder to promptly pay invoices will result in cessation of overtime inspection services. Inspection time includes:(1) the inspector's time in the field during a hunt;(2) the inspector's time spent completing inspection records;(3) the inspector's time spent waiting for any purpose to facilitate the processor;(4) the inspector's time for travel between hunt sites; and(5) the inspector's time for travel from the inspector's official duty location to the field site and return.(c) Sanitary Dressing Procedures. The following are general guidelines of sanitary dressing applicable to all species of livestock slaughtered.(1) The person performing slaughter operations must not permit any contamination of edible portions of the carcass with materials such as feces, urine, hair, ingesta, milk, bile, pathological tissues and exudates, or other filth. All controls of slaughter and dressing procedures must be aimed at accomplishing this purpose.(2) Slaughter operations must be conducted in a manner that precludes contamination, i.e., adequate separation of carcasses, parts, and viscera during dressing; routine cleaning and disinfection of certain equipment and hand tools; design and arrangement of equipment to prevent the contact of successive carcasses and parts; and appropriately located, functional lavatories and disinfection units.(3) In the event contamination does occur, it must be handled promptly and in a manner that ensures adequate protection to the remaining product. Contamination with feces, milk, pus, or pathological tissue or exudate must be promptly removed by trimming. Removal must be complete. Enough tissue must be removed so only clean meat remains. Scraping with the edge or back of a knife, wiping with a cloth or towel, or the use of a water spray are unacceptable procedures for removal of this type of contamination.(d) Exotic Animals.(1) Sanitation. All slaughter operations are to be conducted in a way that precludes contamination. The following conditions, at a minimum, must be met.(A) The slaughter facility unit must be constructed of smooth and impervious material capable of being thoroughly cleaned and sanitized before commencing operations and must be so maintained.(B) Potable water must be used in conjunction with exotic animal slaughter procedures. Water from private water wells must be tested for potability by an approved laboratory within six months before use. Water from portable water tanks must be tested by an approved laboratory every six months to determine that potable water remains potable after being in the portable tanks. Results of such testing must be made available to the department inspector.(C) Hot water at a temperature adequate to facilitate equipment and unit sanitization during pre-operational and operational sanitation procedures is required on the skinning and evisceration floor. A procedure utilizing chemical sanitization in lieu of hot water may be used.(D) Mobile as well as fixed slaughter units must provide adequate measures to control flies, other insects, and dust.(E) Inedible by-products must be handled in a manner that does not create an insanitary condition or adulteration and ensures inedibles are not diverted to human food. When containers are used to remove inedibles from the premises, such containers must be marked "INEDIBLE" in letters at least two inches high. An adequate amount of denaturant in accordance with 9 Code of Federal Regulations (CFR) §314.3 must be used on all products placed in the "INEDIBLE" containers.(2) Ante-mortem procedures.(A) The producer must certify by completing and signing form MSA-71, Microchip Certification and Drug Advisory For Alternate Food Animal Species, whether the animal or animals have been identified with a microchip device.(B) For mobile and field slaughter, once an animal has been shot, the animal will be exsanguinated as soon as possible in the field with a properly sanitized knife. The assigned inspector will examine and inspect each animal before its entry into the processing facility to ensure the animals being harvested appear to have been healthy and were killed by the harvester.(C) For field slaughter, environmental temperature may affect the time that may lapse before it is necessary to return to the mobile slaughter unit or processing facility for skinning and eviscerating. High environmental temperature may shorten the time lapse before dressing, as dressing must begin before the carcass becomes distended due to gas formation in the interstitial tissues or in the small intestine. The department inspector has the final decision in determining the actual time allowed between exsanguination and skinning; however, a 2-1/2 hour time lapse may not be exceeded.(3) Post-mortem procedures.(A) The vehicle used for transporting the slaughtered exotic animals must be clean before use and must be cleaned as needed, during the operation.(B) Dressing procedures are to begin at the slaughter unit or facility as soon as practical after slaughter.(C) Heads from animals slaughtered by gunshot to the head must not be used for food purposes. Such heads must be denatured and placed into inedible containers.(D) In the event an animal is shot in an area other than the head, the resulting wound area and bruised areas must be trimmed of all contamination.(E) The dressing of any animal whether it be the removal of a foot, head, or any part is strictly forbidden in any area other than inside the slaughter unit, regardless of the size of the animal. However, the removal of the antlers only is permitted before entering the slaughter facility.(4) Dressing procedures.(A) Persons butchering an animal must keep hands as clean as possible. Adequate hand washing facilities must be readily available.(B) Skinning operations must be conducted in a sanitary manner.(C) As the pelt is removed, care must be taken to prevent contamination of the carcass by dirty hands, knife, or pelt.(D) If a pelt puller is used in such a manner the carcass is raised to a horizontal position, the carcasses of the female animals must be checked closely for urine leakage.(E) Heads must remain with the carcass until inspection is completed. Nasal and oral cavities should be flushed before heads are placed on inspection tables.(F) Overall washing of carcasses must be accomplished before any openings are made for inspection or evisceration; however, any feces, ingesta, or milk must be trimmed before washing. The washer must take care to prevent filling the rectum with water during washing operations.(G) The knife or other instrument used to open the breast must be disinfected after each use.(H) The bung is not to be dropped until washing is completed. After opening the pelvic area, the neck of the bladder and the dropped bung should be grasped firmly and held until they clear the body cavity.(I) Evisceration must be accomplished in a manner that precludes contamination of the carcass with contents from the bladder or intestine; viscera are to be placed in an inspection pan.(J) If intestines are to be saved, contamination should be prevented by stripping or tying between the large and small intestine before removing from the table and sending to the next station.(5) Processing. Processing of carcasses must be conducted in a manner and location that complies with requirements for processing all livestock carcasses, including the provisions adopted under §221.11 of this subchapter. Source Note: The provisions of this §221.15 adopted to be effective June 21, 2000, 25 TexReg 5901; amended to be effective March 14, 2002, 27 TexReg 1801; amended to be effective August 28, 2003, 28 TexReg 6868; amended to be effective January 1, 2005, 29 TexReg 11979; amended to be effective December 23, 2020, 45 TexReg 9215; amended to be effective February 25, 2025, 50 TexReg 995. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE B MEAT AND POULTRY INSPECTION §221.15 Inspection of Alternate Source Food Animals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224203&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224203 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224203&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224203 03/11/2026 Special fees for inspection services.(1) Inspection time. Inspection time may include:(A) the inspector's time for performing inspection services;(B) the inspector's time for completing inspection records;(C) the inspector's time for waiting for any purpose to facilitate the slaughterer or processor to begin regulated activity; and(D) the inspector's time for traveling to perform inspection services.(2) Fees. Fees are assessed in one-half hour increments for inspection services. Invoices are due upon receipt and become delinquent 30 calendar days from the date on the invoice. Inspection services will not be performed for any establishment having a delinquent account.(3) Overtime and holiday rate. The overtime and holiday rate for inspection services is $60 per hour, per department employee.(4) Rate. Rate for inspections not required by state or federal meat and poultry inspection laws. The rate for special inspections is $60 per hour, per program employee.(5) Overtime and special inspection services. Overtime and special inspection services are subject to the availability of inspectors. Source Note: The provisions of this §221.16 adopted to be effective December 23, 2020, 45 TexReg 9215; amended to be effective February 25, 2025, 50 TexReg 995. 1 DEPARTMENT OF STATE HEALTH SERVICES 221 MEAT SAFETY ASSURANCE B MEAT AND POULTRY INSPECTION §221.16 Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101813&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101813 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101813&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101813 03/11/2026 The Texas Department of Health (department) adopts by reference the publication entitled "Guidelines for the Establishment and Operation of a Donor Human Milk Bank", Ninth Edition, 2000, as amended, written by the Human Milk Banking Association of North America, Inc.(1) A copy of the guidelines are on file at the Texas Department of Health, Bureau of Food and Drug Safety, 1100 West 49th Street, Austin, Texas 78756, and may be viewed during normal working hours.(2) The guidelines may be viewed on the Texas Department of Health's Bureau of Food and Drug Safety website at www.tdh.state.tx.us/bfds. Source Note: The provisions of this §227.1 adopted to be effective April 24, 2003, 28 TexReg 3337. 1 DEPARTMENT OF STATE HEALTH SERVICES 227 MINIMUM GUIDELINES FOR HUMAN DONOR MILK BANKS §227.1 Minimum Guidelines https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205687&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205687 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205687&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205687 03/11/2026 (a) The purpose of this chapter is to implement Texas Health and Safety Code, Chapter 437, Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, and Roadside Food Vendors.(b) The department adopts by reference the U.S. Food and Drug Administration (FDA) Food Code 2017 (Food Code) and the Supplement to the 2017 Food Code.(c) The department does not adopt by reference the following sections, paragraphs, and subparagraph of the FDA Food Code, 3-202.13, 3-202.14(C), 3-202.18(A), 5-102.11, 5-102.13, 5-102.14, 5-104.11(B)(1), 6-101.11(B), 6-202.18, 8-201.11, 8-202.10, 8-203.10, 8-302.11-14, 8-303.10-30, 8-304.10, 8-304.20, 8-401.10, 8-401.20, 8-402.10, 8-402.20-40, 8-403.40, and 8-501.10-40, and the definitions for "accredited program," "drinking water," "food establishment," "game animal," "general use pesticide," "public water system," "regulatory authority," "safe material," "service animal," and "vending machine location."(d) In the event of a conflict, Texas law and rules in this chapter prevail over the adopted Food Code. Source Note: The provisions of this §228.1 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS A GENERAL PROVISIONS §228.1 Purpose and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205688&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205688 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205688&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205688 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise.(1) Accredited program--Food manager certification program that has been evaluated and listed by the department and conforms to standards set by the department in §229.172 of this title (relating to Accreditation of Certified Food Management Programs).(2) Adulterated food--A food deemed to be adulterated as specified in the Texas Health and Safety Code, §431.081.(3) Bed and breakfast extended--An establishment with more than seven rooms for rent or an establishment that provides food service other than breakfast to overnight guests.(4) Bed and breakfast food establishment--A bed and breakfast that provides food service to customers in addition to its overnight guests.(5) Bed and breakfast limited--An establishment that has seven or fewer rooms for rent, serves breakfast to overnight guests, and is not a retail food establishment.(6) Central preparation facility--An approved and permitted facility or space where food is prepared, stored, and packaged.(7) Code of Federal Regulations (CFR)--Citations to the CFR refer sequentially to the Title, Part, and Section numbers, such as 40 CFR 180.194 refers to Title 40, Part 180, Section 194.(8) Common carrier--An individual or business that advertises to the public that it is available for hire to transport people or property, including food, in exchange for a fee.(9) Cottage food production operation--An individual, operating out of the individual's home, who:(A) produces at the individual's home:(i) a baked good that is not a time and temperature control for safety food (TCS food), as defined in §229.661(b)(13) of this title (relating to Cottage Food Production Operations);(ii) candy;(iii) coated and uncoated nuts;(iv) unroasted nut butters;(v) fruit butters;(vi) a canned jam or jelly;(vii) a fruit pie;(viii) dehydrated fruit or vegetables, including dried beans;(ix) popcorn and popcorn snacks;(x) cereal, including granola;(xi) dry mix;(xii) vinegar;(xiii) pickled fruit or vegetables, including beets and carrots, that are preserved in vinegar, brine, or a similar solution at an equilibrium pH value of 4.6 or less;(xiv) mustard;(xv) roasted coffee or dry tea;(xvi) a dried herb or dried-herb mix;(xvii) plant-based acidified canned goods;(xviii) fermented vegetable products, including products that are refrigerated to preserve quality;(xix) frozen raw and uncut fruit or vegetables; or(xx) any other food that is not a TCS food, as defined in §229.661(b)(13) of this title.(B) has an annual gross income of $50,000 or less from the sale of food described by subparagraph (A) of this paragraph;(C) sells foods produced under subparagraph (A) of this paragraph only directly to consumers; and(D) delivers products to the consumer at the point of sale or another location designated by the consumer.(10) Department--The Texas Department of State Health Services.(11) Drinking water--Traditionally known as "potable water" and that meets the standards set forth in 30 TAC Chapter 290, Subchapter F (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems). Drinking water includes the term "water" except where the term used connotes that the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater," and "non-drinking water."(12) Event--A unique public gathering at which food products are served and for which an appropriate regulatory authority grants permission, whether by permit, license, or another official written document.(13) Exotic animal--Member of a species of game animals not indigenous to this state, including axis deer, nilgai antelope, red sheep, or other cloven-hoofed ruminant animals.(14) Food establishment--(A) A food establishment is an operation that:(i) stores, prepares, packages, serves, or vends food directly to the consumer, or otherwise provides food for human consumption, such as a restaurant, retail food store, satellite or catered feeding location, catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people, market, vending machine location, self-service food market, conveyance used to transport people, institution, or food bank; and(ii) relinquishes possession of food to a consumer directly, or indirectly through a delivery service, such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.(B) Food establishment includes:(i) an element of the operation, such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location and where consumption is on or off the premises regardless if there is a charge for the food.(C) Food establishment does not include:(i) an establishment that offers only prepackaged foods that are not TCS foods;(ii) a produce stand that only offers whole, uncut fresh fruits and vegetables;(iii) a food processing plant, including one that is located on the premises of a food establishment;(iv) a cottage food production operation;(v) a bed and breakfast limited as defined in this section; or(vi) a private home that receives catered or home-delivered food.(15) Game animals--Wild animals that are indigenous to this state and not amenable to the Texas Meat and Poultry Inspection Act, Texas Health and Safety Code, Chapter 433, for which the hunter must obtain a hunting license from the Texas Parks and Wildlife Department before hunting animals, such as white-tailed deer, mule deer, pronghorn antelope, and big horn sheep.(16) General use pesticide--A pesticide that is not classified by the United States Environmental Protection Agency for restricted use as specified in 40 CFR §152.175 or is not limited to use by or under the direct supervision of a certified applicator licensed by the Texas Department of Agriculture or by the Texas Structural Pest Control Service as applicable.(17) Group residence--A private or public housing corporation or institutional facility that provides living quarters and meals. The term includes a domicile for unrelated persons, such as a retirement home, correctional facility, or a long-term care facility.(18) Livestock--Cattle, bison, sheep, swine, goats, horses, mules, other equine, poultry, domesticated rabbits, exotic animals, or domesticated game birds.(19) Mobile food unit (MFU)--A vehicle-mounted, self or otherwise propelled, self-contained food service operation designed to be readily movable (including catering trucks, trailers, push carts, and roadside vendors) and used to store, prepare, display, serve or sell food. An MFU must completely retain its mobility at all times. An MFU does not include a stand or a booth. A roadside food vendor is classified as an MFU.(20) Outfitter operation--Any operation, such as trail rides, bus tours, harbor cruises, or river raft trips, in which food is offered to patrons and which operates out of a central preparation location or food establishment.(21) Plumbing Code--The International Plumbing Code, as amended, including appendices C, E, F, and G, published by the International Code Council as amended by 16 TAC §70.101 (relating to Amendments to Mandatory Building Code), the Uniform Plumbing Code, as amended, including appendices required by the regulatory authority, as published by the International Association of Plumbing and Mechanical Officials as referenced in Occupations Code, Title 8, Chapter 1301, §255 (relating to Adoption of Plumbing Codes), or a Plumbing Code adopted by a local regulatory authority, whichever is more stringent.(22) Private water system--A drinking water system that is not connected to a public water system and not regulated by the Texas Commission on Environmental Quality.(23) Public water system--A drinking water system that complies with 30 TAC §§290.101 - 290.122 (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems).(24) Pushcart--A non-self-propelled MFU limited to serving foods requiring a limited amount of preparation as authorized by the regulatory authority and readily movable by one or two persons. A pushcart is classified as an MFU. A pushcart does not include non-self-propelled units owned and operated within a retail food store. This type of MFU requires the support of a central preparation facility.(25) Regulatory authority--The department, the local (municipality, county, or public health district), federal enforcement body, or authorized representative having jurisdiction over the food establishment.(26) Roadside food vendor--A person who operates a mobile retail food store from a temporary location adjacent to a public road or highway. Food is not prepared or processed by a roadside food vendor. A roadside food vendor is classified as an MFU.(27) Safe material--An article manufactured from or composed of materials that may not reasonably be expected to result either directly or indirectly in the article becoming a component of or otherwise affecting the characteristics of any food. An additive that is used as specified in the Texas Health and Safety Code, Chapter 431, or other materials that are not additives and that are used in conformity with applicable regulations of the U.S. Food and Drug Administration.(28) Self-service food market--A market that is unstaffed and offers prepackaged non-TCS food and prepackaged refrigerated or frozen TCS food that is stored in equipment that complies with §228.225 of this chapter (relating to Self-Service Food Market).(29) Service animal--A canine that is individually trained to do work or perform tasks for the benefit of an individual with a disability, including a physical, sensory, psychiatric, intellectual or other mental disability as specified in Texas Health and Safety Code, §437.023.(30) Vending machine location--The room, enclosure, space, or area where one or more vending machines are installed and operated and that includes the storage areas and areas on the premises that are used to service and maintain the vending machines. This does not include self-service food markets. Source Note: The provisions of this §228.2 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS A GENERAL PROVISIONS §228.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205689&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205689 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205689&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205689 03/11/2026 (a) The original food manager certificate shall be posted in the food establishment in a location that is conspicuous to consumers.(b) Except as specified in subsection (c) of this section, a certified food protection manager shall be present at the food establishment during all hours of operation as required in Food Code, §2-101.11 and §2-102.12.(c) Food establishments deemed by the regulatory authority to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and extent of food preparation, such as but not limited to:(1) establishments that handle only prepackaged food and do not package food;(2) establishments that do not prepare or handle exposed Time/Temperature Control for Safety (TCS); or(3) temporary food establishments are exempt from the requirements in subsection (b) of this section.(d) All food employees, except for the certified food protection manager, shall successfully complete an accredited food handler training course, within 30 days of employment. This requirement does not apply to temporary food establishments.(e) The food establishment shall maintain on premises a certificate of completion of the food handler training course for each food employee. Source Note: The provisions of this §228.31 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS B MANAGEMENT AND PERSONNEL §228.31 Certified Food Protection Manager and Food Handler Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205690&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205690 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205690&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205690 03/11/2026 A food establishment shall post a sign or poster, clearly visible to food employees, by all handwashing sinks. The sign or poster shall notify food employees to report symptoms and diagnosis information about their health as it relates to diseases that are transmissible through food. Source Note: The provisions of this §228.32 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS B MANAGEMENT AND PERSONNEL §228.32 Reporting Symptoms and Diagnosis Signage https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215655&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215655 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215655&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215655 03/11/2026 (a) A food establishment shall display a poster relating to food allergen awareness in an area of the establishment regularly accessible to the establishment's food service employees.(b) The food allergen awareness poster shall be identical or substantially similar to the sample poster displayed on the department website. If not identical, the poster shall, at a minimum, display the following information in a clear and straightforward manner:(1) the risk of an allergic reaction to a food allergen;(2) symptoms of an allergic reaction;(3) the major food allergens, as determined by federal law and regulations of the United States Food and Drug Administration;(4) the procedures for preventing an allergic reaction; and(5) appropriate responses for assisting an individual who is having an allergic reaction. Source Note: The provisions of this §228.33 adopted to be effective December 1, 2023, 48 TexReg 6917. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS B MANAGEMENT AND PERSONNEL §228.33 Food Allergen Awareness Poster Required https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205694&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205694 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205694&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205694 03/11/2026 (a) Exotic animals. If exotic animals are received for sale or service, they shall:(1) be commercially raised for food; and(A) raised, slaughtered, processed, and deemed to be "inspected and approved" under an inspection program administered by United States Department of Agriculture (USDA) in accordance with 9 CFR 352, Exotic Animals; Voluntary Inspection; or(B) raised, slaughtered, processed, and deemed to be "inspected and passed" under a meat and poultry inspection program administered by the department or any other state meat inspection program deemed equal to USDA inspection;(2) as allowed by law, for exotic animals that are live caught, be slaughtered and processed as required in paragraph (1)(A) or (B) of this subsection; and(3) as allowed by law, for exotic animals that are field dressed:(A) receive an antemortem and postmortem examination by the appropriate inspection personnel as described in paragraph (1)(A) or (B) of this subsection; and(B) be transported and processed according to the requirements specified by the appropriate regulatory authority as described in paragraph (1)(A) or (B) of this subsection.(b) Cooking. Exotic animals shall be cooked to heat all parts of the food to a temperature and for a time that complies with one of the methods for cooking game animals according to Food Code, §3-401.11, and under a voluntary inspection program as specified in subsection(a) of this section. Source Note: The provisions of this §228.61 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS C FOOD §228.61 Approved Sources for Exotic Game Animals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205691&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205691 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205691&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205691 03/11/2026 (a) Temperature.(1) Grade A pasteurized milk shall be received in refrigerated equipment that maintains an ambient air temperature of seven degrees Celsius (45 degrees Fahrenheit) or less.(2) Molluscan shellfish shall be received in refrigerated equipment or on ice that maintains a temperature of seven degrees Celsius (45 degrees Fahrenheit) or less, as required in the Texas Molluscan Shellfish Rules, §241.61(a) of this title (relating to Molluscan Shell Stock Temperature Control).(b) Chicken Eggs. Chicken eggs shall be received clean and sound and may not exceed the restricted egg tolerances for U.S. Consumer Grade B as specified in 7 CFR 56, Voluntary Grading of Shell Eggs and United States Standards, Grades, and Weight Classes for Shell Eggs, and 9 CFR 590, Inspection of Eggs and Egg Products.(c) Frozen milk products. Frozen milk products, such as ice cream, shall be obtained pasteurized in accordance with the Frozen Desserts Manufacturer Licensing Act, Texas Health and Safety Code, Chapter 440, and 21 CFR 135, Frozen Desserts.(d) Shell stock identification. Shell stock shall be obtained in containers bearing legible source identification tags or labels that are affixed by the harvester or dealer that depurates, ships, or reships the shell stock, as specified in §§241.50 - 241.71 of this title (relating to Molluscan Shellfish). Source Note: The provisions of this §228.62 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS C FOOD §228.62 Specifications for Receiving https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205692&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205692 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205692&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205692 03/11/2026 A card, sign, or other effective means of notification shall be displayed to notify consumers that clean tableware is to be used upon return to self-service areas, such as salad bars and buffets as specified in Food Code, §3-304.16. Source Note: The provisions of this §228.63 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS C FOOD §228.63 Buffet Notification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205693&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205693 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205693&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205693 03/11/2026 (a) Previous service. Except as specified in paragraphs (1) and (2) of this subsection, foods which have been previously served to a consumer may not be donated.(1) Packaged time and temperature control for safety foods (TCS foods), such as unopened milk, may be re-served or donated if immediately stored in a cooling bin maintained at five degrees Celsius (41 degrees Fahrenheit) or below.(2) The following food products may be re-served or donated.(A) Packaged non-TCS foods.(B) Whole fruit, such as apples or bananas.(b) Unpackaged and unserved foods. Unpackaged and unserved TCS foods may be donated if:(1) the temperature of the food is at or below five degrees Celsius (41 degrees Fahrenheit), or an ambient temperature of seven degrees Celsius (45 degrees Fahrenheit) for raw shell eggs, at the time of donation, and is protected from contamination;(2) the food has been at or above 57 degrees Celsius (135 degrees Fahrenheit) during hot holding and service, and subsequently refrigerated to meet the time and temperature requirements in Food Code, §3-501.14 and §3-501.15, or maintained at proper holding temperatures required in Food Code, §3-501.16;(3) the donor can substantiate that the food recipient has the facilities to meet the transportation, storage, and reheating requirements of this chapter; and(4) the food is to be transported by the food recipient directly to a consumer, the recipient only needs to meet the transportation requirements in this chapter, including holding temperatures.(c) Labeling. Donated foods transported offsite shall be labeled with the name of the food, the source of the food, and the date of preparation.(d) Shelf life. Donated TCS foods may not exceed the shelf life for leftover foods outlined in this chapter.(e) Damaged foods. Heavily rim or seam-dented canned foods, or packaged foods without the manufacturer's complete labeling shall not be donated.(f) Distressed foods.(1) Foods which are considered distressed, such as foods which have been subjected to fire, flooding, excessive heat, smoke, radiation, other environmental contamination, or prolonged storage shall not be directly donated for consumption by the consumer.(2) Such foods in paragraph (1) of this subsection may be sold or donated to a licensed food salvage establishment if permitted under the provisions of the Texas Health and Safety Code 432. Source Note: The provisions of this §228.64 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS C FOOD §228.64 Donation of Foods https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205696&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205696 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205696&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205696 03/11/2026 A water source obtained from other than a community public water system shall be sampled and analyzed in accordance with the requirements found in 30 TAC Chapter 290, Subchapter F (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems), concerning transient noncommunity water systems. Source Note: The provisions of this §228.141 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS E WATER, PLUMBING, AND WASTE §228.141 Source https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205697&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205697 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205697&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205697 03/11/2026 (a) Public and private water systems.(1) Water from a public water system shall meet 40 CFR 141 - National Primary Drinking Water Regulations, state drinking water quality standards in accordance with 30 TAC §§290.38 - 290.47 (relating to Rules and Regulations for Public Water Systems), and 30 TAC §§290.101 - 290.114, 290.117 - 290.119, 290.121, and 290.122 (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems); and(2) Water from a nonpublic water system shall meet the requirements of 30 TAC Chapter 290, Subchapter F (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems), pertaining to transient noncommunity water systems.(b) Sampling. Water from a nonpublic water system shall be sampled and tested according to 30 TAC Chapter 290, Subchapter F, concerning transient noncommunity water systems, except nondrinking water.(c) Sample report. The most recent sample report for the nonpublic water system shall be retained on file in the food establishment, or the report shall be maintained as specified in 30 TAC Chapter 290, Subchapter F, concerning transient noncommunity water systems. Source Note: The provisions of this §228.142 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS E WATER, PLUMBING, AND WASTE §228.142 Water Quality Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205695&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205695 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205695&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205695 03/11/2026 Nonpublic water mains, water pumps, pipes, hoses, connections, and other appurtenances shall meet the requirements of 30 TAC Chapter 290, Subchapter F (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems), concerning transient noncommunity water systems. Source Note: The provisions of this §228.143 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS E WATER, PLUMBING, AND WASTE §228.143 Water Distribution, Delivery, and Retention Systems https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205698&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205698 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205698&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205698 03/11/2026 (a) Walls including non-supporting partitions, wall covering and ceilings of the walk-in refrigeration units, food preparation areas, equipment and utensil washing areas, toilet rooms and vestibules should be light in color or meet the requirements and approval of the regulatory authority.(b) Darker-colored coverings for the items listed in subsection (a) of this section may require additional lighting, as specified in Food Code, §6-303.11, or meet the requirements set by the regulatory authority, to allow cleaning of the surface. Source Note: The provisions of this §228.171 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS F PHYSICAL FACILITIES §228.171 Wall and Ceiling Coverings and Coatings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205699&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205699 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205699&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205699 03/11/2026 Dogs may be allowed in outdoor dining areas of a food establishment if:(1) the establishment posts a sign in a conspicuous location in the area stating that dogs are allowed;(2) the customer and dog access the area directly from the exterior of the establishment;(3) the dog does not enter the interior of the establishment;(4) the customer keeps the dog on a leash and controls the dog;(5) the customer does not allow the dog on a seat, table, countertop, or similar surface; and(6) in the area, the establishment does not:(A) prepare food; or(B) permit open food other than food that is being served to a customer; and(7) the requirements specified in this section do not apply to service animals or service animals in training. Source Note: The provisions of this §228.172 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS F PHYSICAL FACILITIES §228.172 Dogs in Outdoor Dining Areas of a Food Establishment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205712&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205712 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205712&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205712 03/11/2026 A first aid kit shall be provided in all food establishments. Source Note: The provisions of this §228.211 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS G POISONOUS OR TOXIC MATERIALS §228.211 First Aid Supplies, Availability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205700&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205700 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205700&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205700 03/11/2026 (a) Mobile food unit provisions.(1) General. Except as otherwise provided in this paragraph and in paragraph (2) of this subsection, the regulatory authority:(A) may impose additional requirements to protect against health hazards related to the conduct of the food establishment as a mobile operation;(B) may prohibit the sale of some or all time and temperature control for safety foods (TCS foods); and(C) when no health hazard will result, may waive or modify requirements of this section relating to physical facilities, except those requirements as specified in paragraphs (7) - (9) of this subsection, subsection (c)(1)(A) - (E) of this section, and Food Code, Subparts 3-401, 3-402, 3-403, 3-404, and 3-501.(2) Restricted operation. A mobile food unit (MFU) that serves only food that is prepared, packaged in individual servings, transported and stored under conditions meeting the requirements of this chapter, or beverages that are non-time and temperature control for safety food and are dispensed from covered urns or other protected equipment, need not comply with the requirements of this chapter, relating to the necessity of water and sewage systems nor to those requirements, relating to the cleaning and sanitization of equipment and utensils if the required equipment for cleaning and sanitization exists at its central preparation facility.(3) Readily movable.(A) The regulatory authority prohibits alteration, removal, attachments, additions, placement, or change in, under, or upon the MFU that prevents or otherwise reduces ready mobility.(B) A regulatory authority may require an MFU to come, on an annual basis or as often as required, to a location designated by the regulatory authority as proof that the MFU is readily moveable.(4) Initial Permitting Inspection. The regulatory authority requires an MFU to come to a location designated by the regulatory authority. The mobile unit must be totally operable at time of inspection, including handwash facilities, warewash facilities, refrigeration, and wastewater disposal. Required documentation to have available includes:(A) Certified Food Protection Manager Certification.(B) Central Preparation Facility Authorization (if required). A signed letter of authorization is required, to verify facility use, if the central preparation facility is not owned by the mobile unit operator.(C) Central Preparation Facility Inspection Report. A copy of the most current health inspection of the central preparation facility must be maintained on the mobile unit at all times.(D) Servicing Area Authorization. A signed letter of authorization may be required by the regulatory authority to verify service area use, if the servicing area is not owned by the mobile unit operator.(E) Menu. A menu of all food items to be sold.(5) Single-service articles. An MFU shall provide only single service articles for use by the consumer.(6) Equipment, numbers, and capacities.(A) Cooling, heating, and holding capacities. Equipment for cooling and heating food, and holding cold and hot food, shall be sufficient in number and capacity to provide food temperatures as specified under Food Code, Chapter 3 - Food.(B) Manual warewashing, sink compartment requirements.(i) A sink with at least three compartments shall be provided for manually washing, rinsing, and sanitizing equipment and utensils as specified in Food Code, Paragraph 4-301.12(A).(ii) Sink compartments shall be large enough to accommodate immersion of the largest equipment and utensils as specified in Food Code, Paragraph 4-301.12(B).(C) At least one handwashing sink shall be available for convenient use by employees and properly provisioned in accordance with Food Code, §6-301.11-12.(7) Mobile water system materials, design, and operation. MFU water systems shall meet the requirements of Food Code, Part 5-3.(8) MFU drinking water tank shall meet the requirements of Food Code, §5-303.13.(A) Fill hose and water holding tank shall be labeled as "Potable Water."(B) Drinking water in an MFU holding tank shall be tested for contamination by sampling upon request by the regulatory authority.(9) Sewage and other liquid waste.(A) If liquid waste results from operation of an MFU, the waste shall be stored in a permanently installed retention tank for waste retention.(B) A leak-proof sewage holding tank in an MFU shall meet the requirements of Food Code, §5-401.11 for capacity and drainage.(C) All connections on the vehicle for servicing the MFU waste disposal facilities shall be of a different size or type than those used for supplying potable water to the MFU.(D) Discharge liquid waste shall not be discharged from the retention tank while the MFU is in motion.(E) Flushing a waste retention tank shall meet the requirements of Food Code, §5-402.15. (F) Removing MFU wastes shall meet the requirements of Food Code, §5-402.14.(G) Liquid waste holding tank shall be labeled as "waste water."(10) MFU water and wastewater exemption.(A) A roadside vendor that sells only prepackaged food is exempt from the requirements of this chapter relating to water and wastewater.(B) An MFU that prepares food requiring no water for operations and no hand contact with food is exempt from the requirements of this chapter relating to water and wastewater if the required cleaning and sanitization equipment exists at its central preparation facility. Chemically treated towelettes for handwashing may be used as specified in Food Code, Paragraph 5-203.11(C).(11) Toilet rooms, convenience and accessibility. Toilet rooms shall be conveniently located and accessible to employees during all hours of operation.(b) Central preparation facility.(1) Supplies, cleaning, and servicing operations. An MFU shall operate from a central preparation facility or other fixed food establishment and shall report to such location daily for supplies, cleaning, and servicing operations.(2) Construction. The central preparation facility or other fixed food establishment, used as a base of operation for an MFU, shall be constructed and operated in compliance with the requirements of Food Code, Chapter 6 - Physical Facilities.(c) Outdoor servicing area and operations.(1) Protection.(A) An MFU servicing area shall include at least overhead protection for any supplying, cleaning, or servicing operation. Those areas used only for the loading of water or the discharge of sewage and other liquid waste, through the use of a closed system of hoses, need not be provided with overhead protection.(B) Within the servicing area, the location provided for the flushing and drainage of liquid wastes shall be separate from the location provided for potable water servicing and for the loading and unloading of food and related supplies.(C) A servicing area will not be required where only packaged food is placed on the MFU or where an MFU does not contain waste retention tanks.(D) The surface of the servicing area shall be constructed of a smooth nonabsorbent material, such as concrete or machine-laid asphalt and shall be maintained in good repair, kept clean, and be graded to drain.(E) Potable water servicing equipment shall be installed in the servicing area according to the Plumbing Code and shall be stored and handled in a way that protects the water and equipment from contamination.(2) Construction exemption. The construction of the walls and ceilings of the servicing area is exempted from the provisions of Food Code, §6-201.11. Source Note: The provisions of this §228.221 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS H REQUIREMENTS APPLICABLE TO CERTAIN ESTABLISHMENTS §228.221 Mobile Food Units https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205701&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205701 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205701&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205701 03/11/2026 (a) General. The regulatory authority may impose additional requirements to protect against health hazards related to the conduct of the temporary food establishment, may prohibit the sale of some or all time and temperature control for safety foods (TCS foods), and when no health hazard will result, such as children's neighborhood beverage stands, may waive or modify requirements of this chapter.(1) Foods that are not prepared on-site or that require extensive preparation or cooking must be prepared at a licensed food establishment.(2) Each temporary establishment may be required by the regulatory authority to have at least one person on-site who has a minimum of an accredited food handler certification.(b) Food temperatures. All food temperature requirements shall be met as contained in Food Code, Subparts 3-202, 3-401-403, and 3-501, §228.62 of this chapter (relating to Specifications for Receiving), and §228.64 of this chapter (relating to Donation of Foods).(c) Ice. Ice that is consumed or that contacts food shall have been made under conditions meeting the requirements of Food Code, Chapter 3 - Food. The ice shall be obtained only in blocked, chipped, crushed, or cubed form and in single-use safe plastic or wet-strength paper bags filled and sealed at the point of manufacture. Ice for consumption shall be held in the bags until it is dispensed and be dispensed in a way that protects it from contamination.(d) Equipment and utensils.(1) Design and construction. Equipment and utensils shall be designed and constructed to be durable and to retain their characteristic qualities under normal use conditions.(2) Location and installation. Equipment shall be located and installed and cleaned in a way that prevents food contamination and that also facilitates cleaning of the temporary food establishment.(3) Hot and cold holding equipment. Equipment for cooling or heating food and holding cold or hot food shall be adequate in number and capacity to provide food temperatures as specified in Food Code, Subparts 3-401-403 and 3-501.(4) Protection from contamination. Food-contact surfaces of equipment shall be protected from contamination by consumers and other sources. Where necessary to prevent contamination, effective shields for such equipment shall be provided.(5) Alternative manual warewashing. Alternative manual warewashing equipment, such as receptacles that substitute for the compartments of a three-compartment sink, may be used when there are special cleaning needs or constraints and the regulatory authority has approved the use of alternative equipment. Each compartment shall be large enough to immerse the largest piece of equipment that will be used. A means to heat water must also be provided.(e) Single-service articles. A temporary food establishment shall provide only single-service articles for use by the consumer.(f) Water.(1) Water from an approved source shall be made available in a temporary food establishment for food preparation, handwashing, and for cleaning and sanitizing utensils and equipment.(2) Water does not need to be under pressure but shall come from approved sources which include:(A) commercially bottled drinking water;(B) closed portable water containers;(C) enclosed vehicular water tanks;(D) on-premise water storage tanks; or(E) piping, tubing or hoses connected to an approved source.(g) Wet storage. Packaged food may not be stored in direct contact with ice or water if the food is subject to the entry of water because of the nature of its packaging, wrapping, or container or its positioning in the ice or water.(h) Sewage. All waste water and sewage generated from the temporary food establishment shall be disposed of through an approved sanitary sewage system that is:(1) a public sewage system; or(2) an individual sewage disposal system that is sized, constructed, maintained, and operated according to 30 TAC Chapter 285 (relating to On-Site Sewage Facilities).(i) Handwashing. Handwashing facilities shall include a container with a spigot that provides potable, clean, warm water; a wastewater container; soap; disposable towels; and a waste receptacle. Handwashing facilities are not required if the only food items offered are commercially pre-packaged foods that are dispensed in their original containers.(j) Floors. If graded to drain, a floor may be concrete, machine-laid asphalt, dirt, or gravel covered with mats, ply-wood, removable platforms, duckboards if covered with mats, or other suitable materials approved by the regulatory authority, such as tarps, that effectively control dust and mud.(k) Ceilings and outer openings of food preparation areas.(1) Walls and Ceilings. Walls and ceilings shall be made of wood, canvas, or other materials that protect the interior of the establishment from the weather, windblown dust, birds, and debris.(2) Outer openings. The outer openings shall be protected against entry of insects and rodents by:(A) 16 mesh to 25.4 millimeters (16 mesh to 1 inch) screens;(B) properly designed and installed air curtains; or(C) other effective means.(3) Exclusion provision. Paragraph (2) of this subsection does not apply if flying insects and other pests are absent due to the location of the temporary food establishment or other limiting conditions. Source Note: The provisions of this §228.222 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS H REQUIREMENTS APPLICABLE TO CERTAIN ESTABLISHMENTS §228.222 Temporary Food Establishments https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205702&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205702 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205702&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205702 03/11/2026 (a) General.(1) A bed and breakfast extended, in addition to licensing with the applicable regulatory authority, shall comply with the minimum requirements of this section if the establishment:(A) has more than seven rooms for rent; or(B) provides food service other than breakfast to overnight guests.(2) A bed and breakfast food establishment that provides food service to customers in addition to its overnight guests must comply with the rules and regulations applicable to retail food establishments, including licensing with the applicable regulatory authority.(3) A bed and breakfast limited:(A) has seven or fewer rooms for rent;(B) serves only breakfast to overnight guests;(C) is not a retail food establishment; and(D) complies with subsection (b) of this section.(b) Certified food protection manager. The owner or manager shall successfully complete a food manager's certification course accredited by this department.(c) Food supplies. Food shall be obtained from approved sources in accordance with Food Code, Subpart 3-201, §228.61 of this chapter (relating to Approved Sources for Exotic Game Animals), and §228.62 of this chapter (relating to Specifications for Receiving) and shall be in sound condition and be safe for human consumption.(d) Food preparation and protection.(1) Food preparation and protection. Food shall be prepared and protected in accordance with Food Code, Chapter 3 - Food.(2) Temperature requirements. All food temperature requirements shall be met as contained in Food Code, Subparts 3-202, 3-401-403, and 3-501, §228.62 of this chapter, and §228.64 of this chapter (relating to Donation of Foods).(e) Cleaning and sanitizing.(1) Manual. A three-compartment sink shall be used if washing, rinsing, and sanitizing of utensils and equipment is done manually; or a two-compartment sink may be utilized if single service tableware is provided, and if an approved detergent sanitizer is used.(2) Mechanical. Cleaning and sanitizing may be done by spray-type or immersion dishwashing machines or by any other type of machine or device if it is demonstrated that it thoroughly cleans and sanitizes equipment and utensils either by chemical or mechanical sanitization.(f) Personal hygiene. Employees shall conform to good hygienic practices as required in in Food Code, Subparts 2-301-304 and 2-401-402.(g) Employee restrooms. A restroom shall be available for use by employees.(h) Equipment and utensil design and construction. All equipment and utensils shall be constructed of safe materials and maintained in good repair.(i) Handwash sinks.(1) Location. An accessible and conveniently located handwash sink shall be provided in or immediately adjacent to food preparation areas and restrooms.(2) Intended use. Handwash sinks shall be used for no other purpose other than handwashing.(j) Food-contact surfaces. All food contact surfaces, counters, or work surfaces in the bed and breakfast establishment shall be smooth, non-absorbent and easily cleanable.(k) Insect proof/rodent proof.(1) Construction. Food service preparation and storage areas shall be constructed and maintained to prevent the entry of pests and other vermin.(2) Chemical control. Pesticides and rodenticides shall be applied in accordance with Food Code, Subpart 7-206.(l) Equipment. Equipment shall be provided to maintain time and temperature control for safety foods (TCS foods) at the temperatures required in accordance with Food Code, Chapter 3 - Food.(m) Garbage receptacles. Impervious receptacles shall be provided for storage of garbage and refuse.(n) Sewage. Sewage shall be disposed through an approved facility that is:(1) a public sewage system; or(2) an individual sewage disposal system that is sized, constructed, maintained, and operated according to law in 30 TAC Chapter 285 (relating to On-Site Sewage Facilities).(o) Water supply. Hot and cold water under pressure shall be provided and shall be from an approved source that meets the standards in accordance with:(1) state drinking water quality standards in accordance with 30 TAC §§290.38 - 290.47 (relating to Rules and Regulations for Public Water Systems), and 30 TAC §§290.101 - 290.114, 290.117 - 290.119, 290.121, and 290.122 (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems); or(2) private water system standards as provided in 30 TAC Chapter 290, Subchapter F (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems), concerning transient noncommunity water systems. Source Note: The provisions of this §228.223 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS H REQUIREMENTS APPLICABLE TO CERTAIN ESTABLISHMENTS §228.223 Bed and Breakfast https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205703&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205703 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205703&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205703 03/11/2026 (a) General. Requirements in this section are specific for outfitter operations. The regulatory authority may impose additional requirements to protect against health hazards that may be specific to these operations.(b) Food supplies. Food supplies, including ice, shall be obtained from approved sources described in Food Code, §3-201.11-17 (relating to Sources), §228.61 of this chapter (relating to Approved Sources for Exotic Game Animals), and §228.62 of this chapter (relating to Specifications for Receiving). No home-prepared products shall be offered.(c) Food temperatures. All food temperature requirements shall be met as contained in Food Code, Subparts 3-202, 3-401-403, and 3-501, §228.62 of this chapter, and §228.64 of this chapter (relating to Donation of Foods).(d) Food preparation and protection for excursions.(1) Except for paragraphs (2) - (4) of this subsection, all food shall be prepared and protected in central preparation facility and meet requirements contained in Food Code, Chapter 3 - Food.(2) Only commercially prepackaged ready-to-eat foods or ready-to-eat foods that have been prepared and packaged with no cooking at a central preparation facility may be served.(3) Raw time and temperature control for safety foods (TCS foods) may be cooked on-site if cooked and immediately served.(4) All food must be stored to protect from contamination in accordance with Food Code, Chapter 3 - Food.(5) TCS foods that require complex preparation must be served within the first 24 hours of the excursion departure time.(6) Leftovers. Leftover food shall not be re-heated or re-served.(e) Warewashing.(1) Alternative manual warewashing equipment, such as receptacles that substitute for the compartments of a multi-compartment sink, may be used for washing and sanitizing utensils when approved by the regulatory authority.(2) An outfitter operation without effective facilities for cleaning and sanitizing tableware shall only provide single-service articles for use by food employees and consumers.(f) Ice usage.(1) Ice that is used for cooling food may not be used for human consumption.(2) Ice used for human consumption must be stored in a clean sanitized container that is properly constructed and maintained in good repair.(g) Potable water.(1) Potable water shall be used on excursions for human consumption, food preparation, handwashing, and for cleaning and sanitizing utensils and equipment.(2) Potable water must be stored in a clean sanitized container that is easily cleanable and good condition.(h) Handwashing.(1) Handwashing facilities shall include:(A) a container with a spigot that can be turned on to allow potable, clean, water;(B) a wastewater container;(C) soap;(D) disposable towels; and(E) a waste receptacle.(2) Handwashing facilities are not required if the only food items offered are commercially prepackaged foods that are dispensed in their original containers.(i) Equipment. All equipment and utensils intended for food contact shall be approved for food use.(j) Thermometers. Thermometers shall be provided, accurate, and accessible during excursions.(k) Garbage receptacles. Impervious receptacles shall be provided for storage of garbage and refuse.(l) Certified food protection manager. If food other than pre-packaged ready-to-eat food is being served, at least one guide or instructor of the outfitter operation, who is on the excursion, shall successfully complete a food manager's certification course accredited by this department.(m) Central preparation facility. An outfitter operation must have a central preparation facility as specified in §228.2(20) of this chapter (relating to Definitions). Source Note: The provisions of this §228.224 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS H REQUIREMENTS APPLICABLE TO CERTAIN ESTABLISHMENTS §228.224 Outfitter Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205704&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205704 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205704&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205704 03/11/2026 (a) Self-service food markets shall comply with the minimum standards of this section.(b) Self-service food markets shall:(1) be equipped with 24/7 video surveillance records of consumers viewing, selecting, handling, and purchasing products that identify these consumers. Video surveillance records must be maintained and available for the regulatory authority for a period of 14 calendar days from the date of the video; and(2) provide information to the regulatory authority as to the responsible party that will be available for routine inspections.(c) Pre-packaged food sold at a self-service food market shall:(1) meet the labeling requirements as specified in Food Code, Paragraph 3-201.11(C); and(2) be tamper evident.(d) A food specified in Food Code, Paragraphs 3-501.17(A) or (B) or §3-501.18 shall be discarded if it:(1) exceeds the temperature or time specified in Food Code, Paragraphs 3-501.17(A) and (B), except time that the product is frozen;(2) is in a container or package that does not bear an expiration date or day; or(3) is not appropriately marked with a date or day that exceeds the temperature and time combination as specified in Food Code, Paragraphs 3-501.17(A) and (B).(e) All self-service food market display-units offering refrigerated, time and temperature control for safety foods (TCS foods) shall have an automatic shut-off control or a plan approved by the regulatory authority that prevents the market or market equipment from dispensing food if:(1) there is a power failure, mechanical failure, or other condition that results in failure of the equipment to maintain food temperatures as specified under Food Code, Chapter 4 - Equipment, Utensils, and Linens; and(2) where a condition specified in paragraph (1) of this subsection occurs, until the equipment is serviced and restocked with food that has been maintained at temperatures specified in Food Code, Subparts 3-202, 3-401-403, and 3-501, §228.62 of this chapter (relating to Specifications for Receiving), and §228.64 of this chapter (relating to Donation of Foods).(f) When a condition specified in subsection (e)(1) of this section occurs, the ambient temperature may not exceed five degrees Celsius (41 degrees Fahrenheit), or seven degrees Celsius (45 degrees Fahrenheit) for a unit holding raw shell eggs only, for more than 30 minutes immediately after the display is filled, serviced, or restocked.(g) All self-service food market display-units offering TCS food, shall be:(1) equipped with a self-closing door; or(2) maintained at five degrees Celsius (41 degrees Fahrenheit), or seven degrees Celsius (45 degrees Fahrenheit) for raw shell eggs, if it is an open display unit.(h) Self-service food markets shall have a sign readily visible from the automated payment kiosk stating:(1) the name of the business to whom complaints or comments shall be addressed;(2) the address of the business responsible for the market; and(3) the responsible business's telephone number and email or web information, when applicable.(i) When a retail food establishment operating as a self-service food market incorporates the provision in this section, it will not be required to maintain a person in charge onsite as specified in Food Code, Paragraph 2-101.11(A). Source Note: The provisions of this §228.225 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS H REQUIREMENTS APPLICABLE TO CERTAIN ESTABLISHMENTS §228.225 Self-Service Food Market https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205706&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205706 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205706&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205706 03/11/2026 Plans may be required by the regulatory authority for:(1) the construction of a food establishment;(2) the conversion of an existing structure for use as a food establishment; or(3) the remodeling of a food establishment or a change of type of food establishment or food operation, or under the conditions set by the regulatory authority, if the regulatory authority determines that plans and specifications are necessary to ensure compliance with this section. Source Note: The provisions of this §228.241 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS I COMPLIANCE §228.241 Facility and Operating Plans https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205707&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205707 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205707&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205707 03/11/2026 In accordance with the requirements of the Public Information Act, Texas Government Code, Chapter 552, the regulatory authority shall treat as confidential the information that meets the criteria specified in law for a trade secret and is contained on inspection report forms and in the plans and specifications submitted as specified in Food Code, §8-201.12 and §8-201.14. Source Note: The provisions of this §228.242 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS I COMPLIANCE §228.242 Confidentiality, Trade Secrets https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205708&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205708 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205708&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205708 03/11/2026 The regulatory authority may conduct one or more preoperational inspections to verify that the food establishment is constructed and equipped in accordance with the approved plans and approved modifications of those plans, has established standard operating procedures as specified in Food Code, Paragraph 8-201.12(E), and is in compliance with this chapter. Source Note: The provisions of this §228.243 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS I COMPLIANCE §228.243 Construction Inspection and Approval, Preoperational Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205709&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205709 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205709&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205709 03/11/2026 The regulatory authority shall inspect each food establishment based upon an assessment of the food establishment's history of compliance with this chapter and the potential for causing foodborne illness by evaluating:(1) past performance, for nonconformance with Food Code or Hazard Analysis Critical Control Point (HACCP) plan requirements that are priority items or priority foundation items;(2) past performance, for numerous or repeat violations of code or HACCP plan requirements that are core items;(3) past performance, for complaints investigated and found to be valid;(4) the hazards associated with the particular foods that are prepared, stored, or served;(5) the type of operation including the methods and extent of food storage, preparation, and service;(6) the number of people served;(7) whether the population served is a highly susceptible population; and(8) any other risk factors deemed relevant to the operation by the regulatory authority. Source Note: The provisions of this §228.244 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS I COMPLIANCE §228.244 Performance and Risk Based Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205710&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205710 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205710&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205710 03/11/2026 (a) Competency of inspectors. An individual conducting inspections of retail food establishments should be a Registered Professional Sanitarian in Texas or a Sanitarian-in-Training in Texas, as defined in 16 TAC Chapter 119, or should meet the U.S. Food and Drug Administration Voluntary National Retail Food Regulatory Program Standards basic curriculum and field training elements in order to:(1) assure application of basic scientific principles, including Hazard Analysis Critical Control Point principles of food safety, during inspections;(2) properly conduct foodborne illness investigations;(3) assure uniformity in the interpretations of this chapter; and(4) assure fair and uniform enforcement of this chapter.(b) Verification and documentation of correction. In the case of temporary food establishments, all priority and priority foundation items must be corrected immediately, and other violations must be corrected within 24 hours or sooner if required by the regulatory authority. If violations are not corrected, the establishment shall immediately cease food operations upon execution of an Emergency Suspension or Closing Order until authorized to resume by the regulatory authority. Source Note: The provisions of this §228.245 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS I COMPLIANCE §228.245 Competency of Inspectors and Access https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205711&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205711 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205711&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205711 03/11/2026 Removal of restriction or exclusion. The regulatory authority shall release a food employee or conditional employee from restriction or exclusion according to Texas Health and Safety Code, §438.033, and the conditions specified under Food Code, §2-201.13. Source Note: The provisions of this §228.246 adopted to be effective August 8, 2021, 46 TexReg 4686. 1 DEPARTMENT OF STATE HEALTH SERVICES 228 RETAIL FOOD ESTABLISHMENTS I COMPLIANCE §228.246 Investigation and Control https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207506&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207506 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207506&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207506 03/11/2026 This subchapter provides the minimum standards for submission of prescription drug price data. Source Note: The provisions of this §229.1 adopted to be effective January 17, 2022, 47 TexReg 86. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG A PRESCRIPTION DRUG PRICE DISCLOSURE §229.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207507&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207507 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207507&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207507 03/11/2026 The following words and terms when used in this subchapter shall have the following meaning unless the context clearly indicates otherwise.(1) Department--Department of State Health Services.(2) Calendar year--January 1 through December 31 of each year.(3) Exclusivity--A Federal Drug Administration (FDA) granted delay on approval of competitor drugs that attaches upon FDA's approval of a drug.(4) Patent--A property right issued by the United States Patent and Trademark Office to exclude others from making, using, offering for sale, or selling an invention for a limited time.(5) Patent exclusivity--Rights resulting from a drug manufacturer holding an unexpired patent, or exclusivity, or both. Source Note: The provisions of this §229.2 adopted to be effective January 17, 2022, 47 TexReg 86. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG A PRESCRIPTION DRUG PRICE DISCLOSURE §229.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207508&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207508 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207508&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207508 03/11/2026 This subchapter applies to all prescription drug manufacturers reporting drug price information. A fee of $250 shall be submitted with each submitted annual report and price increase report. Source Note: The provisions of this §229.3 adopted to be effective January 17, 2022, 47 TexReg 86. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG A PRESCRIPTION DRUG PRICE DISCLOSURE §229.3 Fee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207509&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207509 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207509&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207509 03/11/2026 (a) The department shall assess administrative penalties in accordance with the requirements of:(1) Texas Health and Safety Code Chapter 441;(2) this subchapter;(3) Texas Government Code, Chapter 2001; and(4) the department's formal hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(b) The department shall assess administrative penalties based upon one or more of the following criteria:(1) the Pharmaceutical Drug Manufacturer's previous violations;(2) the seriousness of the violation;(3) the Pharmaceutical Drug Manufacturer's demonstrated good faith; and(4) any other matters as justice may require.(c) Each day a violation continues may be considered a separate violation. Source Note: The provisions of this §229.4 adopted to be effective January 17, 2022, 47 TexReg 86. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG A PRESCRIPTION DRUG PRICE DISCLOSURE §229.4 Administrative Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149446&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149446 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118446&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118446 03/11/2026 These sections provide for the licensing and regulation of food salvage establishments and brokers to prevent the sale or distribution of adulterated or misbranded foods to consumers. Source Note: The provisions of this §229.541 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.541 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118447&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118447 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118447&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118447 03/11/2026 (a) A salvage establishment or salvage broker who is subject to these sections and who is also involved in the reconditioning, sale, or distribution of distressed or salvaged medical devices, drugs, or cosmetics must comply with the applicable requirements in Subchapter BB of this chapter (relating to Regulation of Drug Salvage Establishments and Brokers), Subchapter CC of this chapter (relating to Regulation of Device Salvage Establishments and Brokers), and Subchapter DD of this chapter (relating to Regulation of Cosmetic Salvage Establishments and Brokers).(b) The Department of State Health Services (department) adopts by reference the following federal laws and regulations:(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code (U.S.C.), §301 et seq. as amended;(2) Fair Packaging and Labeling Act, 15 U.S.C.. §1451 et seq. as amended;(3) Section 501(c)(3), Internal Revenue Code of 1986, as amended; and(4) 21 Code of Federal Regulations (CFR), Part 178, Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers, as amended.(c) Copies of these laws and regulations are indexed and filed at the department, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at http://www.dshs.state.tx.us/license.shtm.(d) Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable federal laws and regulations. Source Note: The provisions of this §229.542 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.542 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118448&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118448 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118448&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118448 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter 432.(2) Adulterated food--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.081.(3) Authorized Agent--An employee of the department who is designated by the commissioner to enforce the provisions of this chapter.(4) Change of ownership--A sole proprietor who transfers all or part of the salvage establishment or salvage broker business to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a salvage establishment or salvage broker business owned by a partnership; a corporate sale, transfer; reorganization; or merger of the corporation which owns the salvage establishment or salvage broker business if the sale, transfer, reorganization, or merger causes a change in the salvage establishment's or salvage broker business' ownership to another person or persons; or if any other type of association, the removal, addition, or substitution of a person or persons as a principal of such association.(5) Commissioner--The Commissioner of Health or his successor.(6) Department--The Department of State Health Services.(7) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component; part, or accessory; that is:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.(8) Distressed food--Any food that is adulterated or misbranded within the meaning of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §§431.081 and 431.082. The term includes food that:(A) has lost its labeling or is otherwise unidentified;(B) has been subjected to prolonged or improper storage, including insanitary conditions whereby the food may have become contaminated with filth or whereby it may be rendered injurious to health;(C) has been subjected for any reason to abnormal environmental conditions, including temperature extremes, humidity, smoke, water, fumes, pressure, or radiation;(D) has been rendered unsafe or unsuitable for human consumption or use for any other reason.(9) Drug--(A) an article or substance recognized in the official United States Pharmacopoeia, the official Homeopathic Pharmacopoeia of the United States, and the official National Formulary, or any supplement of them;(B) an article or substance designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;(C) an article or substance, other than food, intended to affect the structure or any function of the body of man or other animals; or(D) an article or substance intended for use as a component of any article or substance specified in this definition.(10) Food--(A) any article of food or drink for man;(B) chewing gum; or(C) an article used for components of any such article.(11) Food reclamation center--A facility or person that engages in the reconditioning or inventorying, separating, and disposing of distressed food on a fee for service basis. Distressed food may originate from a wholesale distributor, manufacturer, or retail facility, and may be handled within said facility by someone other than the distributor, manufacturer, or retail facility. For the purpose of licensing under these sections, a food reclamation center is a salvage establishment.(12) Labeling--All labels and other written, printed, or graphic matter:(A) upon any article or any of its containers or wrappers; or(B) accompanying such article.(13) Manufacture--The combining, purifying, processing, packing, or repacking of food for wholesale or retail sale.(14) Manufacturer--Includes a person who represents himself as responsible for the purity and proper labeling of a food.(15) Misbranded food--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.082.(16) Nonprofit organization--An organization which has received an exemption from federal taxation under 26 U.S.C., §501(c)(3).(17) Nonsalvageable food--Distressed food, as defined in this section, which cannot be safely or practically reconditioned.(18) Packaged food--Any container or wrapping in which food is enclosed for use in the delivery or display of such commodities. This term includes containers or wrapping for consumer, institutional, bulk products and any of their original shipping containers.(19) Perishable--Capable of spoilage or deterioration due to improper refrigeration or handling.(20) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity.(21) Personnel--Any person employed by a salvage establishment or salvage broker who does or may in any manner handle or come in contact with the handling, storing, transporting, or selling and distributing of salvageable or salvaged food.(22) Place of business--Each location from which a salvage establishment or salvage broker operates.(23) Potentially hazardous food--A food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic microorganisms; the growth and toxin production of Clostridium botulinum; or in raw shell eggs, the growth of Salmonella enteritidis.(24) Reconditioning--Any appropriate process or procedure by which distressed food can be brought into compliance with the standards of the department for consumption or use by the public. In addition, all reconditioned food must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(25) Sale or distribution--The act of selling or distributing, whether for compensation or not, and includes delivery, holding, or offering for sale, transfer, auction, storage, or other means of handling or trafficking.(26) Salvage broker--A person who engages in the business of selling, distributing, or otherwise trafficking in any distressed or salvaged food, drug, device, or cosmetic and who does not operate a salvage establishment.(27) Salvage establishment--Any place of business engaged in reconditioning or by other means salvaging distressed food, drugs, devices, or cosmetics or that sells, buys, or distributes for human use any salvaged food, drug, device, or cosmetic. For the purpose of licensing under these sections, a food reclamation center is a salvage establishment.(28) Salvage operator--A person who is engaged in the business of operating a salvage establishment.(29) Salvage warehouse--A separate storage facility used by a salvage broker or salvage establishment for the purpose of holding distressed or salvaged food.(30) Salvageable food--Any distressed food, as defined in this section, which can be reconditioned to departmental standards.(31) Salvaged food--Any distressed food that has been reconditioned.(32) Sanitize--Adequate treatment of surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other microorganisms. Such treatments shall not adversely affect the product, shall meet the requirements of 21 CFR, §178.1010 as amended, and shall be safe to the consumer.(33) Vehicles--Any truck, car, bus, or other means by which distressed, salvageable, or salvaged food is transported from one location to another. Source Note: The provisions of this §229.543 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.543 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118449&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118449 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118449&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118449 03/11/2026 (a) A person is exempt from licensing under these sections if the person is:(1) a manufacturer, distributor, or processor of a food who in the normal course of business engages in the activities of reconditioning the items manufactured, distributed, or processed by or for that person and not purchased by that person solely for the purpose of reconditioning and sale;(2) a common carrier or a common carrier's agent who disposes of or otherwise transfers undamaged or distressed foods to a person who is exempt under this section or to a currently licensed salvage broker or salvage operator;(3) a person who transfers distressed food to a licensed salvage broker or salvage operator; or(4) a nonprofit organization that distributes food to the needy under the provisions of the Good Faith Donor Act, Civil Practice and Remedies Code, Chapter 76, but does not recondition such food.(b) An exemption from the licensing requirements under these sections does not constitute an exemption from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 or the rules adopted to administer and enforce the Act.(c) A salvage establishment or salvage broker engaging in conduct within the scope of the license issued under §229.545 of this title (relating to Licensing Requirements and Procedures) is not required to also be licensed under Health and Safety Code, Chapter 431. An exemption from the licensing requirements under Health and Safety Code, Chapter 431, does not constitute an exemption from other applicable provisions of the Health and Safety Code Chapter 431 or the rules adopted to administer and enforce the chapter. Source Note: The provisions of this §229.544 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.544 Exemptions and Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118450&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118450 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118450&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118450 03/11/2026 (a) General. Except as provided by §§229.544, 229.574, 229.604, and 229.634 of this title (relating to Exemptions and Applicability), it shall be unlawful for any person to operate a salvage establishment or operate as a salvage broker within the State of Texas, who does not possess a current and valid license issued by the department.(b) Licensing of out-of-state salvage establishments and brokers. A person who operates a salvage establishment or acts as a salvage broker outside this state may not sell, distribute, or otherwise traffic in distressed or salvaged food, drugs, devices, or cosmetics within this state unless the person holds a license from the department.(c) Reports from other jurisdictions. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with these sections and with the provisions of the Act.(d) New place of business. Each person acquiring or establishing a place of business for the purpose of operating a salvage establishment or operating as a salvage broker shall apply for and obtain a license of such business prior to beginning operation.(e) Two or more places of business. If the salvage establishment or salvage broker operates more than one place of business, the salvage establishment or salvage broker shall license each place of business separately.(f) License application. License application forms may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756 or online at http://www.dshs.state.tx.us/license.shtm.(g) Contents of license application. The salvage establishment or salvage broker license application shall be signed and verified, submitted on a form furnished by the department, and shall include the following information:(1) the name of the legal entity to be licensed, including the name under which the business is conducted;(2) the address of the place of business to be licensed and the mailing address if different;(3) the name, residence address, and driver's license number of the responsible individual in charge at the place of business;(4) the hours of operation of each place of business;(5) the address of any salvage warehouse used by a salvage establishment or salvage broker;(6) if a sole proprietorship, the name of the proprietor; if a partnership, the names of all partners; if a corporation, the names and titles of all officers; in any other association, those in a managerial capacity; and(7) a statement signed and verified by the sole proprietor, managing partner, corporate officer, or person in a managerial capacity for an association that acknowledges the applicant has read, understood, and agrees to abide by the provisions of these sections and those of the Act.(h) Issuance of license. In accordance with §229.281 of this title (relating to Processing License/Permit Applications Relating to Food and Drug Operations), the department may license a salvage establishment or salvage broker who meets the requirements of these sections, and pays all fees in compliance with §229.546 of this title (relating to Licensing Fees).(i) Transfer of license. Licenses shall not be transferable from one person to another or from one place of business to another.(j) Display of license. The license shall be displayed in an open public area at each place of business and each salvage operator shall have a copy of a valid license in each vehicle used by the salvage operator to transport distressed food.(k) License term. Unless a license is amended as provided in subsection (o) of this section, or is revoked or suspended as provided in §229.554 of this title (relating to Enforcement and Penalties), the license is valid for one or two years as determined by the department.(l) Renewal of license.(1) The license application as outlined in subsections (f) and (g) of this section and nonrefundable licensing fees as outlined in §229.546 of this title (relating to Licensing Fees) for each place of business shall be submitted to the department 30 days prior to the expiration date of the current license. A person who files a renewal application after the expiration date shall pay an additional $100 as a delinquency fee.(2) The department shall renew the license for a one or two-year term as determined by the department, if the licensee is in compliance with these sections and has paid all required fees, including any past due and delinquency fees.(m) Completeness of license applications. Failure to complete the license application form may result in the denial of a license.(n) Report of changes. The license holder shall notify the department in writing within ten days of any change, including change in location, name, or ownership of a salvage establishment or salvage broker, which would render the information contained in the license application no longer accurate. Failure to inform the department within ten days of a change in information required in the initial license application may result in enforcement action as described in §229.554 of this title.(o) Amendment of license. A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business will require submission of fees as outlined in §229.546 of this title (relating to Licensing Fees).(p) Return of license. A license issued under these sections shall be returned to the department if the place of business:(1) ceases business or otherwise ceases operation on a permanent basis;(2) relocates;(3) changes the name of the business under which the salvage establishment or salvage broker operates; or(4) changes ownership. Source Note: The provisions of this §229.545 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.545 Licensing Requirements and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118451&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118451 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118451&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118451 03/11/2026 (a) Licensing fees.(1) All applicants for a license or a renewal license must pay a licensing fee. All fees are nonrefundable. License fees are as follows:(A) $600 for a one-year license; or(B) $1,200 for a two-year license.(2) Delinquency fee. A salvage establishment or salvage broker shall pay a $100 delinquency fee if:(A) the renewal license application is submitted or the renewal license fee is paid after the expiration date of the current license; or(B) the initial license application is submitted or the initial license fee is paid more than 30 days following the effective date of a change in location, name, or ownership of an existing salvage establishment or salvage broker as described in §229.545(o) of this title (relating to Licensing Requirements and Procedures).(3) Reinspection fee. A salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to §229.554 of this title (relating to Enforcement and Penalties), shall pay a nonrefundable inspection fee of $600.(b) Consolidation of license terms. The department may, upon receipt of a written request from a license holder, prorate a license fee for the purpose of consolidating the license renewal dates of multiple licenses issued in the name of the license holder.(c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person is a nonprofit organization, as described in the Internal Revenue Code of 1986, §501(c)(3), as amended or a nonprofit affiliate of the organization, to the extent otherwise permitted by law.(d) Texas Online. Applicants may submit applications and renewal applications for a license under these sections electronically by the Internet through Texas Online at www.texasonline.state.tx.us. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §229.546 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.546 Licensing Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118452&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118452 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118452&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118452 03/11/2026 (a) Employee health requirements. No person known to be or suspected of being affected with any disease in a communicable form, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, or respiratory infection, shall work in an area of a salvage establishment or for a salvage broker in any capacity in which there is any possibility of such person contaminating salvageable or salvaged food with pathogenic organisms, or transmitting disease to other individuals.(b) Personal cleanliness.(1) All personnel while working in direct contact with salvageable food or while engaged in reconditioning, repacking, or otherwise handling any ingredients or components of salvageable food shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty.(2) Personnel engaged in reconditioning salvageable food shall wash their hands thoroughly in a department approved hand-washing facility before starting work and as often as may be necessary to remove soil and contamination.(3) No person shall resume work after visiting the toilet room without first washing their hands. Source Note: The provisions of this §229.547 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.547 Personnel https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118453&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118453 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118453&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118453 03/11/2026 (a) Buildings. Buildings used by salvage establishments and salvage brokers shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.(b) Floor construction.(1) The floor surfaces in all rooms and areas in which salvageable or salvaged food is stored or processed and in which utensils are washed, and walk-in refrigerators, dressing or locker rooms, and toilet rooms, shall be constructed to be smooth and easily cleanable.(2) Any floor that is exposed to water or liquids shall be constructed and maintained to be nonabsorbent(3) All floors shall be kept clean and in good repair.(4) Floor drains shall be provided in all rooms where floors are subjected to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.(c) Walls and ceilings. Walls and ceilings of all rooms shall be clean, smooth, and in good repair.(d) Lighting. Adequate lighting shall be provided in hand-washing areas, dressing and locker rooms, toilet rooms, and in areas where salvageable or salvaged foods are examined, processed, stored and where equipment or tools are cleaned.(1) Where personnel are inspecting, sorting, or reconditioning distressed food, at least 540 lux (50 foot candles) of light shall be provided at the work surface.(2) At all other areas of the facility where light is required, at least 110 lux (10 foot candles) of light shall be provided when measured at a distance of 30 inches above the floor.(e) Ventilation.(1) All rooms, in which salvageable or salvaged food is reconditioned or utensils are washed, dressing or locker rooms, toilet rooms, and garbage and rubbish storage areas shall be well ventilated.(2) Ventilation hoods and related equipment when used shall be designed to prevent condensation from dripping onto salvageable food or onto work surfaces.(3) Filters, when used, shall be readily removable for cleaning or replacement.(4) Ventilation systems shall comply with applicable federal, state, and local fire prevention and air pollution requirements.(f) Locker area. Adequate facilities shall be provided for the orderly storage of personnel clothing and personal belongings.(g) Cleanliness of facilities.(1) All parts of the salvage establishment or salvage warehouse and its premises shall be kept neat, clean, and free of litter and rubbish.(2) Cleaning operations shall be conducted in such a manner as to prevent contamination of salvageable and salvaged food.(3) None of the operations connected with a salvage establishment or salvage warehouse shall be conducted in any room used as an employee lounge or toilet facility, or living or sleeping quarters.(4) Soiled coats and aprons shall be kept in suitable containers until removed for laundering.(5) No birds or animals shall be allowed in any areas used for the conduct of salvage establishment operations or the storage of salvageable and salvaged food.(h) Vehicles. Vehicles used to transport distressed, salvageable, or salvaged food shall be maintained in a clean and sanitary condition to protect the product from contamination. Source Note: The provisions of this §229.548 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.548 Construction and Maintenance of Physical Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118454&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118454 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118454&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118454 03/11/2026 (a) Water supply. The water supply shall be adequate, of a safe sanitary quality, and from a source constructed and operated in accordance with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(b) Sewage. All sewage, including liquid waste, shall be disposed of in a public sewerage system or, in the absence thereof, in a manner applicable with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(c) Plumbing. Plumbing shall be sized, installed, and maintained in accordance with applicable state and local plumbing codes.(d) Toilet facilities.(1) Each salvage establishment shall provide its employees with adequate and conveniently located toilet facilities.(2) Toilet facilities, including rooms and fixtures, shall be kept in a clean condition and in good repair at all times.(3) The doors of all toilet rooms shall be self-closing.(4) Toilet tissue shall be provided.(5) Easily cleanable receptacles shall be provided for waste materials, and such receptacles in toilet rooms for women shall be covered.(6) Where the use of non-water-carried sewage disposal facilities are approved by the department, they shall be located at least 100 linear feet from the salvage establishment and from any well or stream.(e) Hand-washing facilities. Each salvage establishment shall be provided with adequate, conveniently located hand-washing facilities for its personnel, including a lavatory or lavatories, equipped with hot and cold or tempered running water, hand-cleansing soap or detergent, and approved sanitary towels or other approved hand-drying devices. Such facilities shall be kept clean and in good repair.(f) Garbage and refuse.(1) All organic or organic-containing refuse shall be kept in leak proof, non-absorbent containers which shall be kept covered with tight-fitting lids when filled or stored, or not in continuous use. Such containers shall be covered when stored and stored either in a vermin-proof room or enclosure or in a waste refrigerator.(2) Paper, cardboard, unused equipment, and non organic refuse shall be stored in containers, rooms, or areas in such a manner to prevent it from becoming a source of contamination or pest harborage.(3) Adequate cleaning facilities shall be provided, and each container, room, or area shall be thoroughly cleaned after the emptying or removal of refuse.(4) All refuse shall be disposed of with sufficient frequency and in such a manner as to prevent contamination.(5) All refuse shall be disposed of in accordance with all applicable state and local requirements, including requirements for solid waste disposal as referenced in Title 30, Texas Administrative Code, Chapters 330 and 335.(g) Insect and rodent control. Effective measures shall be taken to protect against the entrance into the salvage establishment or salvage warehouse and the breeding or presence on the premises of rodents, insects, and other vermin. Source Note: The provisions of this §229.549 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.549 Sanitary Facilities and Controls https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118455&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118455 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118455&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118455 03/11/2026 (a) Notice to the department.(1) When the source of distressed food is the result of a natural disaster, accident, power failure, or other emergency, the salvage establishment or salvage broker shall make contact with the department's Bureau of Food and Drug Safety within 24 hours after their initial awareness of the emergency and prior to any removal of distressed food from the place at which it was located when it became distressed.(2) If emergency removal of distressed food referenced in subsection (a)(1) of this section is required, notice to the department shall be made as soon thereafter as possible. It shall be the duty of the salvage establishment or salvage broker to make contact with the department's Bureau of Food and Drug Safety within 48 hours whenever distressed foods subject to the provisions of this subsection are obtained.(3) Distressed food shall not be moved out of the State of Texas without prior approval of the department and the responsible state agency in the state to receive the food. Concurrence shall also be obtained from the U.S. Food and Drug Administration, or U.S. Department of Agriculture, Food Safety and Inspection Service, prior to interstate movement.(b) Protection of salvageable and salvaged food.(1) All salvageable and salvaged food stored by salvage establishments or salvage brokers shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such food.(2) All salvageable and salvaged food, while being stored or processed at a salvage establishment, salvage warehouse, or during transportation, shall be protected from contamination.(3) Poisonous and toxic materials shall be identified and handled under such conditions as will not contaminate other salvageable or salvaged food, or constitute a hazard to personnel.(c) Segregation of food. All salvageable food shall be promptly sorted and segregated from nonsalvageable food to prevent further contamination of the distressed food to be salvaged or offered for sale or distribution.(d) Nonsalvageable food.(1) Containers, including metal and glass containers with press caps, screw caps, pull rings, or other types of openings which have been in contact with nonpotable water, liquid foam, or other deleterious substances, as a result of fire fighting efforts, flood, sewer backups, or similar mishaps, shall be deemed unfit for sale or distribution, i.e., nonsalvageable food as defined in §229.543(18) of this title (relating to Definitions).(2) Disposal of Nonsalvageable food in facilities without department approved Standard Operating Procedures (SOPs). All nonsalvageable food shall be disposed of as in §229.549 of this title (relating to Sanitary Facilities and Controls).(3) Disposal of Nonsalvageable food in facilities with department approved SOPs as described in §229.554 of this title (relating to Standard Operating Procedures).(A) all nonsalvageable food, except as specified in subparagraph (B) of this paragraph, shall be disposed of according to §229.549 of this title (relating to Sanitary Facilities and Controls).(B) bread, nonmeat pastry products, and produce that have been completely removed from all packaging may be disposed of by alternate means as described in subparagraph (A) of this paragraph according to any applicable requirements of Title 30, Texas Administrative Code (TAC), Chapters 330, 332, and 335, or Title 4, TAC, Chapter 55.(4) Distressed food which is deemed to be nonsalvageable by a duly authorized agent of the department shall, at the request of the agent, be destroyed under the supervision of that agent at the expense of the owner.(e) Transporting of distressed food.(1) Distressed food shall be moved from the site of a fire, flood, sewer backup, wreck, or other cause as expeditiously as possible after compliance with subsection (a) of this section so as not to become putrid, rodent or insect defiled, or otherwise hazardous to public health.(2) All distressed and salvageable food of a perishable nature shall, prior to reconditioning, be transported only in vehicles provided with adequate refrigeration, if necessary, for product maintenance.(f) Handling of distressed articles other than foods. If distressed articles other than foods are also salvaged, they shall be handled separately so as to prevent contamination from poisonous and toxic materials or other contaminants.(g) Cross-contamination protection. Sufficient precautions shall be taken to prevent cross-contamination (animal feed to human food, etc.) among the various types of foods which are salvageable or salvaged.(h) Salvageable food. All salvageable food shall be reconditioned prior to sale or distribution except for such sale or distribution to a person holding a valid license to engage in a salvage operation.(i) Reconditioned food. All reconditioned food must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(j) Labeling. All salvaged food must be labeled in accordance with the requirements of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301, et seq. as amended; the Fair Packaging and Labeling Act, 15 U.S.C., §1451 et seq. as amended; and the federal regulations promulgated under those Acts.(k) Salvage warehouses. A person may not use a salvage warehouse to recondition food or sell to consumers. Source Note: The provisions of this §229.550 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.550 General Provisions for Handling and Movement of Distressed Food https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118456&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118456 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118456&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118456 03/11/2026 (a) Good manufacturing practices. A person must follow and comply with the requirements of §§229.211 - 229.222 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food) in the handling and reconditioning of all distressed and/or salvaged food.(b) Perishable foods. All perishable foods shall be kept at a temperature that will provide protection against spoilage.(c) Potentially hazardous foods. All potentially hazardous foods shall be maintained at a safe temperature, 41 degrees Fahrenheit (5 degrees Celsius) or below; 140 degrees Fahrenheit (60 degrees Celsius) or above.(d) Frozen Foods. Frozen foods shall be kept frozen at all times.(e) Distressed or nonsalvageable food.(1) All metal cans of food offered for sale or distribution shall be essentially free from rust (pitting) and dents (especially at rim, end double seams, and/or side seams).(2) Leakers, springers, flippers, and swells shall be deemed unfit for sale or distribution.(f) Metal containers of food. All metal containers of food, other than those mentioned in subsection (e) of this section, whose integrity has not been compromised and whose integrity would not be compromised by the reconditioning, and which have been partially or totally submerged in water, liquid foam, or other deleterious substances as the result of flood, sewer backup, or other reasons shall, after thorough cleaning, be subjected to sanitizing rinse of a concentration of 100 parts per million (ppm) available chlorine for a minimum period of one minute, or shall be sanitized by another method approved by the department. They shall subsequently be treated to inhibit rust formation.(g) Label removal.(1) Any cans or tins showing surface rust shall have labels removed, the outer surface cleaned by buffing, a protective coating applied where necessary, and shall be relabeled.(2) Relabeling of other salvageable nonmetal (glass, plastic, etc.) containers shall be required when original labels are missing or illegible.(h) Relabeling. All salvaged food in containers shall be provided with labels meeting the requirements in §229.550(j) of this title (relating to General Provisions for Handling and Movement of Distressed Food). Where original labels are removed from containers which are to be resold or redistributed, the replacement labels must show the name and address of the salvage establishment. Source Note: The provisions of this §229.551 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.551 Handling Distressed Food https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118457&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118457 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118457&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118457 03/11/2026 (a) Inventory records without department approved written Standard Operating Procedures (SOPs). A written record or receipt of distressed, salvageable, and salvaged food shall be maintained by the salvage establishment or salvage broker and shall include:(1) the common name including brand name or manufacturer and quantity of the food received;(2) the source of the distressed food;(3) the date received;(4) a brief description of the type of damage (fire, flood, warehouse damage, overstock, etc.); and(5) the name of the individual or business that purchases any such food for the purpose of sale or distribution and the date of any such transaction.(b) Inventory records with department approved written Standard Operating Procedures. If a firm maintains and implements SOPs approved by the department as described in §229.554 of this title (relating to Standard Operating Procedures).(1) A written record or receipt of distressed, salvageable, and salvaged food shall be maintained by the salvage establishment or salvage broker and shall include:(A) a general description of the distressed merchandise received;(B) the source of the distressed merchandise;(C) the date received;(D) the type of damage (fire, flood, warehouse, etc.); and(E) the name of the individual or business that purchases any such food for the purpose of sale or distribution and the date of any such transaction.(2) The firm shall maintain records verifying the implementation of the approved SOPs. The records will include type of activity performed, date and time of each activity, and initials of person performing the activity.(c) Retention of records. All records required in these sections shall be kept at the place of business of the salvage establishment or salvage broker for a period of two years following the completion of transactions involving a lot of food.(d) Electronic records. Records required by these sections which are maintained by the salvage establishment or salvage broker on computer systems shall be regularly copied, at least monthly, and updated on storage media other than the hard drive of the computer. An electronic record must be retrievable as a printed copy. Source Note: The provisions of this §229.552 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.552 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118458&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118458 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118458&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118458 03/11/2026 (a) Inspection. To enforce these sections of the Act, the commissioner, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:(1) enter at reasonable times the place of business of a salvage establishment or salvage broker;(2) enter a salvage warehouse used to store or hold distressed or salvaged food;(3) enter a vehicle being used to transport or hold distressed or salvaged food; or(4) inspect at reasonable times, any place of business of a salvage establishment or salvage broker, salvage warehouse, or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.(b) Access to records. A person who is required to maintain records referenced in these sections or under the Act, or a person who is in charge or custody of those records shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times access to review, copy, and verify the records.(c) Access to records showing movement in commerce. A person who is subject to licensing under §229.545 of this title (relating to Licensing Requirements and Procedures) or a person, including a common carrier or the common carrier's agent, who disposes of or otherwise transfers distressed or salvaged food shall, at the request of the commissioner or an authorized agent, permit the commissioner or authorized agent at all reasonable times access to review, copy, and verify all records showing:(1) the movement in commerce of any distressed or salvaged food;(2) the holding of any distressed or salvaged food after movement in commerce; and(3) the quantity, shipper, and consignee of any distressed or salvaged food.(d) Receipt for samples. An authorized agent or health authority who makes an inspection of a place of business, including any vehicle or salvage warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, shall give to the owner, operator, or the owner's or operator's agent a receipt describing the sample. Source Note: The provisions of this §229.553 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.553 Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118459&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118459 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118459&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118459 03/11/2026 (a) Standard Operating Procedures. Each establishment should have and implement written standard operating procedures (herein referred to as SOP) to ensure conformance with conditions and practices as specified in this subchapter and applicable §§229.211 - 229.222 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food). The SOP should specify how the establishment will meet these conditions and practices.(b) Monitoring of SOPs. Each processor should monitor the conditions and practices described in the SOP with sufficient frequency to ensure, at a minimum, conformance with conditions and practices specified in this subchapter and applicable §§229.211 - 229.222 of this title appropriate to the facility and that relate to the following:(1) personnel practices and training;(2) construction and maintenance of facilities;(3) sanitary controls;(4) transportation of distressed and/or reconditioned product;(5) product evaluation and reconditioning;(6) disposal of nonsalvageable food; and(7) records.(c) SOP records. Each processor should maintain records that, at a minimum, document the monitoring prescribed by subsection (b) of this section. These records are subject to the requirements of §229.552 of this title (relating to Records). Source Note: The provisions of this §229.554 adopted to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.554 Standard Operating Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118460&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118460 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118460&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118460 03/11/2026 (a) General license actions. The department may deny, suspend, or revoke the license of an applicant or licensee who fails to comply with any one of the following:(1) failure to comply with the Act or these sections;(2) falsification of information provided in an application for a license;(3) refusal to allow the department to conduct an inspection or collect samples;(4) interference with the department in the performance of its duties;(5) removal or disposal of a detained food in violation of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §431.021; or(6) failure to information the department of any salvage warehouse(s) at the time of an inspection or when requested by the department.(b) Emergency license suspensions.(1) The department may suspend a license without notice when there is an imminent threat to the health or safety of the public.(2) If an emergency suspension order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(c) Hearings.(1) Any hearings for the denial, suspension, or revocation of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title.(2) Within 20 days after the postmark date of the department's written notice of proposed denial, suspension, or revocation, the applicant or licensee may request a hearing in writing from the department. If the applicant or licensee does not request a hearing during the required time period, then the applicant or licensee is deemed to have waived his/her right to a hearing.(d) Reinstatement of license.(1) A person whose application for a license has been denied or whose license has been placed under an emergency suspension may request a reinspection for the purpose of granting or reinstating a license not later than the 30th day after the denial or emergency suspension. Not later than the 10th day after the receipt of a written request from the applicant or licensee, the department shall make a reinspection.(2) As regards a nonemergency suspension or a revocation, the licensee may request at any time, an inspection for reinstating the license or for issuing a new license.(3) If, after inspection, the department determines that the applicant or licensee meets the requirements of the Act or these sections, the department shall reinstate the license or issue a new license, as appropriate.(4) Reinspection fee. Except as provided for in §229.546(c) of this title (relating to Licensing Fees), a salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to this section shall pay a nonrefundable inspection fee of $600.(e) Emergency order.(1) General. The commissioner or the commissioner's designee may issue an emergency order, either mandatory or prohibitory, concerning the sale or distribution of distressed food in the department's jurisdiction if the commissioner or the commissioner's designee determines that:(A) the sale or distribution of those foods creates or poses an immediate and serious threat to human life or health; and(B) other procedures available to the department to remedy or prevent the threat will result in unreasonable delay.(2) Absence of notice and hearing. The commissioner or the commissioner's designee may issue the emergency order without notice and hearing if the commissioner or the commissioner's designee determines it is necessary under the circumstances.(3) Hearings. If an emergency order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be governed by §§1.21, 1.23, 1.25, and 1.27 of this title.(f) Administrative penalty. If a person violates these sections, or an order adopted, or license issued under the Act, the commissioner may assess an administrative penalty against the person.(1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.(2) In determining the amount of the penalty, the commissioner shall consider the following criteria:(A) the person's previous violations;(B) the seriousness of the violation;(C) any hazard to the health and safety of the public;(D) the person's demonstrated good faith; and(E) other matters as justice may require.(3) Violations subject to this subsection shall be categorized into severity levels as determined in §229.261 of this title (relating to Assessment of Administrative Penalties).(4) Hearings, appeals from, and judicial review of final administrative decisions under this subsection shall be conducted according to the contested case provisions of the Government Code, Chapter 2001, and §§1.21, 1.23, 1.25, and 1.27 of this title.(5) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.(6) If a hearing is held, the commissioner shall make findings of fact and shall issue a written decision regarding the occurrence of the violation and the amount of the penalty.(7) If the person charged with the violation does not request a hearing, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.(8) After making a determination under this subsection that a penalty is to be assessed, the commissioner shall issue an order requiring that the person pay the penalty.(9) The commissioner may consolidate a hearing held under this subsection with another proceeding.(10) Not later than the 30th day after the date of issuance of an order finding that a violation has occurred, the commissioner shall inform the person against whom the order is issued of the amount of the penalty. Source Note: The provisions of this §229.555 adopted to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG AA REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS §229.555 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118461&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118461 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149446&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149446 03/11/2026 The following words and terms, when used in this subchapter, must have the following meanings, unless the context clearly indicates otherwise.(1) Charitable drug donor--A licensed convalescent or nursing home or related institution, licensed hospice, hospital, physician, pharmacy, or a pharmaceutical seller or manufacturer who donates drugs pursuant to a qualified patient assistance program, or that donates drugs to a charitable medical clinic. A charitable drug donor is a wholesale drug distributor.(2) Charitable medical clinic--A clinic, including a licensed pharmacy that is a community pharmaceutical access program provider, that provides medical care or drugs without charge or for a substantially reduced charge, complies with the insurance requirements of Civil Practice and Remedies Code, Chapter 84, and is exempt from federal income tax under Internal Revenue Code of 1986, §501(a) by being listed as an exempt organization in §501(c)(3) or (4) of the Internal Revenue Code, and is operated exclusively for the promotion of social welfare by being primarily engaged in promoting the common good and general welfare of the people in a community.(3) Community pharmaceutical access program--A program offered by a licensed pharmacy under which the pharmacy assists financially disadvantaged persons to access prescription drugs at no charge or at a substantially reduced charge.(4) Department--The Department of State Health Services.(5) Dispense--To prepare, package, compound, or label in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the user's agent under a practitioner's lawful order.(6) Drug sample--A unit of a drug that is not intended to be sold and is intended to promote the sale of the drug.(7) Manufacture--The process of preparing, propagating, compounding, processing, packaging, repackaging, labeling, testing, or quality control of a drug or drug product, but does not include compounding that is done within the practice of pharmacy and pursuant to a prescription from a practitioner for a patient.(8) Manufacturer--A person, other than a charitable drug donor, as defined in Civil Practice and Remedies Code, Chapter 82.(9) Patient assistance program--A qualified program offered by a pharmaceutical manufacturer under which the manufacturer provides drugs to financially disadvantaged persons at no charge or at a substantially reduced cost. The term does not include the provision of a drug as part of a clinical trial.(10) Person--An individual, partnership, corporation, or association.(11) Qualified program--Any program sponsored by a pharmaceutical manufacturer.(12) Seller--A person, other than a charitable drug donor, as defined in Civil Practice and Remedies Code, Chapter 82, who is engaged in the business of distributing or otherwise placing, for any commercial purpose, in the stream of commerce for use or consumption, a product or any component part thereof.(13) Wholesale distribution--Distribution to a person other than a consumer or patient including, but not limited to, distribution to any person by a manufacturer, repacker, own-label distributor, jobber, private label distributor, broker, manufacturer warehouse, distributor warehouse, or other warehouse, manufacturer's exclusive distributor, drug wholesaler or distributor, distributor, independent wholesale drug trader, specialty wholesale distributor, third party logistics provider, retail pharmacy that conducts wholesale distribution, and pharmacy warehouse that conducts wholesale distribution. Source Note: The provisions of this §229.21 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG B DONATION OF UNUSED DRUGS §229.21 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149447&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149447 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149447&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149447 03/11/2026 A charitable medical clinic may receive a drug donated by a charitable drug donor for dispensing to a patient of the charitable medical clinic, provided that the following requirements are met.(1) The charitable drug donor must be licensed with the department as a wholesale drug distributor. Manufacturers who participate in a patient assistance program and physicians who donate samples will not be required to license with the department.(2) The donated drugs must be dangerous drugs as defined in Health and Safety Code, Chapter 483, entitled "Texas Dangerous Drug Act."(3) Donated drugs may not be controlled substances as defined in Health and Safety Code, Chapter 481, entitled "Texas Controlled Substances Act."(4) All donated drugs must be approved by the Food and Drug Administration (FDA) and intended for human use.(5) Donation of drug samples must comply with Title 21, Code of Federal Regulations (CFR), §203.39.(6) Previously dispensed drugs shall not be donated.(7) The charitable drug donor must verify that the requesting charity is legitimate.(A) Verification shall include copies of documents proving the charitable medical clinic's status as exempt from federal income tax; address, telephone number, and name of contact person at the charitable medical clinic.(B) Documentation of verification must be retained by the charitable drug donor for three years.(8) A drug donated by a charitable drug donor shall be received by a charitable medical clinic in the manufacturer's unopened original tamper-evident packaging with its labeling intact.(9) Delivery of a donated drug to a recipient charitable medical clinic shall be completed by an authorized agent or employee of the recipient charitable medical clinic or by the charitable drug donor. All deliveries shall be made in person. The authorized agent or employee shall present his or her official state identification to the recipient upon delivery.(10) The recipient charitable medical clinic shall prepare at the time of collection or delivery of drugs a complete and accurate donation record, a copy of which shall be retained by the recipient charitable medical clinic for at least three years, containing the following information:(A) a signed written statement from the charitable drug donor that the drugs have been properly stored in accordance with the manufacturer's instructions;(B) a verifiable name, address, and telephone number of the charitable drug donor;(C) the manufacturer, brand name, quantity, and lot or control number of the drugs donated;(D) the date of the donation; and(E) a copy of official state identification of the authorized agent or employee of the charitable drug donor.(11) A donated drug shall not be dispensed to a patient until it has been examined by a registered pharmacist at the recipient charitable medical clinic to confirm that the donation record accurately describes the drug delivered, and to confirm in his or her professional judgment that no drug is adulterated or misbranded for any reason including, but not limited to, the following:(A) the drug is out of date;(B) the labeling has become mutilated, obscured, or detached from the drug packaging;(C) the drug shows evidence of having been stored or shipped under conditions that might adversely affect its stability, integrity, or effectiveness;(D) the drug has been recalled or is no longer marketed; or(E) the drug is otherwise possibly contaminated, deteriorated, or adulterated.(12) Documentation of the examination of the drug and the drug donation record by the registered pharmacist shall be retained by the charitable medical clinic for three years after the date of examination.(13) The recipient charitable medical clinic shall dispose of any drug found to be adulterated/misbranded by destroying it. The charitable medical clinic shall retain complete records of the disposition of all destroyed drugs for three years from the date of destruction.(14) Each recipient charitable medical clinic shall conduct, at least annually, an inventory of drug stocks and shall prepare a report reconciling the results of each inventory with the most recent prior inventory. Drug inventory discrepancies and reconciliation problems shall be investigated by the charitable medical clinic and outcomes documented. All reports of reconciliation, investigation, and outcome shall be retained by the charitable medical clinic for three years.(15) All charitable drug donors shall comply with the existing statutory standards contained in the Texas Health and Safety Code, Chapter 431 and the requirements of §229.251 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices."(16) A charitable medical clinic shall immediately notify the Drugs and Medical Devices Group at (512) 834-6755, of becoming aware of a significant loss or theft of drugs; and a copy of the inventory reconciliation, investigation, and outcome report shall be forwarded to the Drugs and Medical Devices Group, Mail Code 1987, P.O. Box 149347, Austin, TX 78714-9347 within five days of the telephone notification.(17) A charitable drug donor shall promptly notify in writing a charitable medical clinic to which donations have been made, if the donor becomes aware of a recall or other situation pertaining to the safety and efficacy of the previously donated drugs. Documentation of this notice shall be retained for three years after the date of notification. Source Note: The provisions of this §229.22 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG B DONATION OF UNUSED DRUGS §229.22 Donation of Drugs to Charitable Medical Clinics https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149441&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149441 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149441&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149441 03/11/2026 A nursing home may donate certain drugs or drug samples, due for destruction, to a foreign country provided the following requirements are met.(1) The drugs to be donated are in the manufacturer's unopened original tamper-evident packaging with its labeling intact.(2) Previously dispensed drugs shall not be donated.(3) Controlled substances as defined in Health and Safety Code, Chapter 481, entitled "Texas Controlled Substances Act," shall not be donated.(4) A drug shall not be shipped to a foreign country until it has been examined by a registered pharmacist at the nursing home to confirm, in his or her professional judgment, that it is not adulterated or misbranded for any reason including, but not limited to, the following:(A) the drug is out of date;(B) the labeling has become mutilated, obscured, or detached from the drug packaging;(C) the drug shows evidence of having been stored or shipped under conditions that might adversely affect its stability, integrity, or effectiveness;(D) the drug has been recalled or is no longer marketed; or(E) the drug is otherwise possibly contaminated, deteriorated, or adulterated.(5) The nursing home shall destroy any drug or drug sample found to be unsuitable, and retain documentation for three years from the date of destruction.(6) Shipment. A drug described in this section may be exported to any country, if the drug complies with the laws of that country and if the nursing home has documented the prior consent of the foreign recipient. Documentation of consent shall be retained by the nursing home for three years after the date of consent. All drug donations should be packed in accordance with international shipping regulations, and be accompanied by a detailed packing list which specifies the contents of each carton and any special storage conditions. Drugs should not be mixed with other supplies in the same carton.(7) Eligible countries for export. The nursing home shall make a good faith effort to determine that shipment of drugs to a selected foreign country is not prohibited. If no evidence of prohibition is found, then shipment may proceed. Documentation of this effort shall be retained for three years from the date of shipment. The nursing home shall contact the following:(A) the Office of Foreign Assets Control (OFAC) of the U.S. Department of the Treasury, and the Bureau of Export Administration of the United States Department of Commerce at or (202) 622-1260; or(B) any other agency that provides information about the prohibition of certain shipments to foreign countries.(8) The nursing home shall prepare a complete and accurate donation record, a copy of which shall be retained by the nursing home for at least three years, containing the following information:(A) the name, address, city, country, and telephone number of the licensed practitioner, charitable medical clinic, or foreign recipient receiving the donation;(B) documentation of prior consent from the foreign recipient;(C) the manufacturer, brand name, quantity, and lot or control number of the drugs to be donated; and(D) the date of the donation.(9) All nursing homes who donate drugs to foreign recipients shall comply with the existing statutory standards contained in the Health and Safety Code, Chapter 431, and the requirements of §229.251 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices," and §229.429 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices."(10) A nursing home shall notify a foreign recipient to whom donations have been made, if the nursing home becomes aware of a recall or other situation pertaining to the safety and efficacy of the previously donated drugs. Documentation of this notice shall be retained for three years after the date of notification. Source Note: The provisions of this §229.23 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG B DONATION OF UNUSED DRUGS §229.23 Donation of Drugs From Nursing Homes to Foreign Countries https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149443&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149443 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149443&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149443 03/11/2026 All charitable medical clinics (including licensed pharmacies that are a community pharmaceutical access program provider as defined at §229.21(3) of this title (relating to Definitions) shall comply with the laws and rules pertaining to dispensing of prescription drugs as contained in the Occupations Code, Chapters 551- 566, and 569 (relating to the Texas Pharmacy Act); and 22 Texas Administrative Code, Chapters 281- 311 (relating to the Texas State Board of Pharmacy). Source Note: The provisions of this §229.24 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG B DONATION OF UNUSED DRUGS §229.24 Dispensing of Drugs From Charitable Medical Clinics https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149444&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149444 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149444&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149444 03/11/2026 (a) All charitable drug donors in Texas shall obtain a wholesale drug distributor license annually with the department.(b) Charitable drug donors are exempt from the license fee, but otherwise are subject to and must comply with the requirements of this chapter.(c) If the United States Food and Drug Administration (FDA) determines, with respect to a product that is a combination of a drug and a device that the primary mode of action of the product is as a drug, a person who engages in donation of the product is subject to licensing as described in this section.(d) License forms. License application forms may be obtained from the department at 1100 West 49th Street, Austin, Texas 78756 or online at http://www.dshs.state.tx.us/license.shtm.(e) License statement. The charitable drug donors' licensing statement shall be signed and verified by the owner, partner, president, or corporate designee (authorized person), shall be made on the department furnished license form, and shall contain the following information:(1) the legal name under which the business is conducted;(2) the address of each place of business that is licensed;(3) if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state; or if any other type of association, then the names of the principals of such association;(4) the names, residence addresses, and valid driver's license of those individuals in an actual administrative capacity which, in the case of proprietorship, shall be the managing proprietor, partnership, the managing partner, corporation, the officers and directors, or those in a managerial capacity in any other type of association; and(5) for each place of business, the residence addresses of the individuals in charge thereof.(f) Two or more places of business. If the charitable drug donor operates more than one place of business, the charitable drug donor shall license each place of business separately.(g) Pre-licensing inspection. The applicant shall cooperate with any pre-licensing inspection by the department of the charitable drug donor's facilities. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with the minimum standards in this chapter for applicants located out-of-state.(h) Issuance of license. The department may license a charitable drug donor who meets the requirements of this section, and §229.251 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices," and §229.429 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices."(i) The initial license shall be valid for two years from the date of issuance which becomes the anniversary date.(j) The renewal license shall be valid for two years from the anniversary date.(k) Renewal of license.(1) Each year, the charitable drug donor shall renew its license following the requirements of this section, and §229.253 of this title.(2) A person who holds a license issued by the department under the Health and Safety Code, Chapter 431 shall renew the license by submitting an application for renewal on a form prescribed by the department. A licensee must submit for renewal before the expiration date of the current license. A person who submits a renewal application after the expiration date must pay an additional $100 as a delinquency fee.(3) A licensee who fails to submit a renewal application prior to the current licensure expiration date and continues operations may be subject to the enforcement and penalty provisions in §229.252 and §229.430 of this title (relating to Enforcement and Penalties), and/or the refusal, cancellation, suspension and revocation provisions in §229.250 and §229.428 of this title (relating to Refusal, Cancellation, Suspension or Revocation of License).(l) Amendment of license. A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business required under the Health and Safety Code, §431.206 will require submission of a new application as required by this section.(m) Notification of change of location of place of business. Not fewer than 30 days in advance of the change, the licensee shall notify the department in writing of the licensee's intent to change the location of a licensed place of business. The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location. Not more than ten days after the completion of the change of location, the licensee shall notify the department in writing to verify the change of location, the address of the new location, and the name and residence address of the individual in charge of the business at the new address. Notice will be deemed adequate if the licensee provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the department.(n) Exemption from licensing. Persons who engage in the following charitable donations of prescription drugs for use in humans are exempt from the licensing requirements of this subchapter, to the extent that the donation does not violate the Health and Safety Code, Chapter 481, the Texas Controlled Substances Act, or Chapter 483, the Texas Dangerous Drug Act:(1) intracompany donation;(2) the donation of a drug by a charitable medical clinic to a nonprofit affiliate of the organization to the extent otherwise permitted by law;(3) the donation of a drug or an offer to donate a drug among hospitals or other health care entities that is under common control. For the purpose of this subsection, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise; and(4) the donation of drug samples by manufacturers' representatives.(o) Donation of drugs. The provisions of this section regarding the donation of drugs shall be considered to include the manufacture, production, processing, packaging, exposure, offer, possession, and holding of any such article for donation; and the donation, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct of any drug place of business.(p) Minimum standards. All charitable drug donors not engaged in manufacturing, processing, packing, or holding of drugs shall comply with the minimum standards specified in subsection (q) of this section as it applies to the firm's operations, and to the existing statutory standards contained in the Health and Safety Code, Chapter 431. All charitable drug donors engaged in manufacturing, processing, packing, or holding of drugs shall comply with subsections (q) and (r) of this section as it applies to the firm's operations, and to the existing statutory standards contained in the Health and Safety Code, Chapter 431. For the purpose of this section, the policies described in the United States Food and Drug Administration's Compliance Policy Guides as they apply to drugs shall be the policies of the department.(q) Current good manufacturing practices in manufacturing, processing, packing, or holding of drugs by drug manufacturers.(1) The department adopts by reference Title 21, CFR, Part 210, §§210.1 - 210.3, titled "Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs"; and Part 211, §§211.1 - 211.208 entitled "Current Good Manufacturing Practice for Finished Pharmaceuticals," as those regulations apply to any building under the control of a drug manufacturer where drugs are manufactured, processed, packaged, or held.(2) Copies are indexed and filed in the office of the Drugs and Medical Devices Group, Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.(r) Requirements for charitable drug donors.(1) The department adopts by reference Title 21, CFR, Part 205, §§205.1 - 205.50, 1994, as amended, entitled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors," for prescription drugs, and all charitable drug donors are subject to and must comply with these regulations.(2) Copies are indexed and filed in the office of the Drugs and Medical Devices Group, Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.(3) Prescription drug means any drug, human, or veterinary, required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to the Federal Food, Drug, and Cosmetic Act, §503(b).(4) Legend drugs. A charitable drug donor shall not possess, sell, or transfer drugs whose labels bear the legend "Caution: Federal law prohibits dispensing without prescription" or "Rx Only," unless that person is authorized to possess, sell, or transfer such drugs in compliance with the Health and Safety Code, Chapter 431, Texas Food, Drug, and Cosmetic Act, Subchapter I; and the Health and Safety Code, Chapter 483, Texas Dangerous Drug Act. Source Note: The provisions of this §229.25 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG B DONATION OF UNUSED DRUGS §229.25 Minimum Requirements for Licensing as a Charitable Drug Donor https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149445&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149445 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=149445&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 149445 03/11/2026 (a) The department may, after providing an opportunity for a hearing, refuse to license a charitable drug donor, or may revoke or suspend the license for violations of the requirements in §§229.21 - 229.25 of this title (relating to Donation of Unused Drugs), §229.251 and §229.429 of this title (relating to Minimum Standards for Licensure), and for violations of Health and Safety Code, Chapter 431, including §431.021 (prohibited acts).(b) Hearing. Any hearing for the refusal, revocation, or suspension of a license is governed by the department's formal hearing procedures in Chapter 1 of this title (relating to Texas Board of Health) and the Government Code, Chapter 2001, Administrative Procedure Act. Source Note: The provisions of this §229.26 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG B DONATION OF UNUSED DRUGS §229.26 Enforcement - Refusal, Revocation, or Suspension of License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13603&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13603 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118461&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118461 03/11/2026 These sections provide for the licensing and regulation of drug salvage establishments and brokers in order to prevent the sale or distribution of adulterated or misbranded drugs to consumers. Source Note: The provisions of this §229.571 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.571 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118462&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118462 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118462&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118462 03/11/2026 (a) A salvage establishment or salvage broker who is subject to these sections and who is also involved in the reconditioning, sale, or distribution of distressed or salvaged medical devices, foods, or cosmetics must comply with the applicable requirements in Subchapter AA of this chapter (relating to Regulation of Food Salvage Establishments and Brokers), Subchapter CC of this chapter (relating to Regulation of Device Salvage Establishments and Brokers), and Subchapter DD of this chapter (relating to Regulation of Cosmetic Salvage Establishments and Brokers).(b) The Department of State Health Services (department) adopts by reference the following federal laws and regulations:(1) Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq. as amended;(2) Fair Packaging and Labeling Act, 15 U.S.C., §1451 et seq. as amended;(3) Section 501(c)(3), Internal Revenue Code of 1986, as amended;(4) 21 Code of Federal Regulations (CFR), Part 205, §§205.1 - 205.50, titled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors," as amended;(5) 21 CFR Part 210, §§210.1 - 210.3, titled "Current Good Manufacturing, Processing, Packing, or Holding of Drugs" as amended, and §§211.1 - 211.208, titled "Current Good Manufacturing Practice for Finished Pharmaceuticals" as amended.(c) Copies of these laws and regulations are indexed and filed at the department, located at 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at http://www.dshs.state.tx.us/license.shtm.(d) Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable federal laws and regulations. Source Note: The provisions of this §229.572 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.572 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118463&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118463 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118463&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118463 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter 432.(2) Adulterated drug--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.111.(3) Authorized Agent--An employee of the department who is designated by the commissioner to enforce the provisions of this chapter.(4) Change of ownership--A sole proprietor who transfers all or part of the salvage establishment or salvage broker business to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a salvage establishment or salvage broker business owned by a partnership; a corporate sale, transfer; reorganization; or merger of the corporation which owns the salvage establishment or salvage broker business if the sale, transfer, reorganization, or merger causes a change in the salvage establishment's or salvage broker business's ownership to another person or persons; or if any other type of association, the removal, addition, or substitution of a person or persons as a principal of such association.(5) Commissioner--The Commissioner of Health, or his successor.(6) Department--The Department of State Health Services.(7) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component; part, or accessory; that is:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in manor other animals; or(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.(8) Distressed drug--Any drug that is adulterated or misbranded within the meaning of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §§431.111 and 431.112. The term includes a drug that:(A) has lost its labeling or is otherwise unidentified;(B) has been subjected to prolonged or improper storage, including unsanitary conditions whereby the drug may have become contaminated with filth or whereby it may be been rendered injurious to health;(C) has been subjected for any reason to abnormal environmental condition, including temperature extremes, humidity, smoke, water, fumes, pressure, or radiation;(D) has been subjected to conditions that result in either its strength, purity, or quality falling below that which it purports or is represented to possess; or(E) has been rendered unsafe or unsuitable for human consumption or use for any other reason.(9) Drug--(A) an article or substance recognized in the official United States Pharmacopoeia, the official Homeopathic Pharmacopoeia of the United States, the official National Formulary, or any supplement of them;(B) an article or substance designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;(C) an article or substance, other than food, intended to affect the structure or any function of the body of man or other animals; or(D) an article or substance intended for use as a component of any article or substance specified in this definition.(10) Drug Manufacturer--Includes a person who manufactures, prepares, propagates, compounds, processes, repackages, or changes the container, wrapper, or labeling of any drug.(11) Food--(A) any article of food or drink for man;(B) chewing gum; or(C) an article used for components of any such article.(12) Labeling--All labels and other written, printed, or graphic matter:(A) upon any article or any of its containers or wrappers; or(B) accompanying such article.(13) Manufacture--The combining, preparing, propagation, compounding, purifying, processing, packing, repacking, wrapping, and labeling of drugs.(14) Misbranded drug--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.112.(15) Nonprofit organization--An organization that has received an exemption from federal taxation under 26 U.S.C., §501(c)(3).(16) Nonsalvageable drug--Distressed drug, as defined in this section, which cannot be safely or practically reconditioned.(17) Perishable--Capable of spoilage or deterioration due to improper refrigeration or handling.(18) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity.(19) Personnel--Any person employed by a salvage establishment or salvage broker who does or may in any manner handle or come in contact with the handling, storing, transporting, or selling and distributing of salvageable or salvaged drugs.(20) Place of business--Each location from which a salvage establishment or salvage broker operates.(21) Practitioner--A person licensed by the Texas State Board of Medical Examiners, State Board of Dental Examiners, Texas State Board of Podiatric Medical Examiners, Texas Optometry Board, or State Board of Veterinary Medical Examiners to prescribe and administer prescription drugs.(22) Reconditioning--Any appropriate process or procedure by which distressed drugs can be brought into compliance with the standards of the department for consumption or use by the public. In addition, all reconditioned drugs must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(23) Sale or distribution--The act of selling or distributing, whether for compensation or not, and includes delivery, holding, or offering for sale, transfer, auction, storage, or other means of handling or trafficking.(24) Salvage broker--A person who engages in the business of selling, distributing, or otherwise trafficking in any distressed or salvaged food, drug, device, or cosmetic and who does not operate a salvage establishment.(25) Salvage establishment--Any place of business engaged in reconditioning or by other means salvaging distressed food, drugs, devices, or cosmetics, or that sells, buys, or distributes for human use any salvaged food, drug, device, or cosmetic. For the purpose of licensing under these sections, a drug reclamation center is a salvage establishment.(26) Salvage operator--A person who is engaged in the business of operating a salvage establishment.(27) Salvage warehouse--A separate storage facility used by a salvage broker or salvage establishment for the purpose of holding distressed or salvaged drug.(28) Salvageable drug--Any distressed drug, as defined in this section, which can be reconditioned to departmental standards.(29) Salvaged drug--Any distressed drug that has been reconditioned.(30) Sanitize--Adequate treatment of surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other microorganisms. Such treatments shall not adversely affect the product and shall be safe to the consumer.(31) Vehicles--Any truck, car, bus, or other means by which distressed, salvageable, or salvaged drugs is transported from one location to another. Source Note: The provisions of this §229.573 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.573 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118464&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118464 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118464&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118464 03/11/2026 (a) A person is exempt from licensing under these sections if the person is:(1) a manufacturer, distributor, or processor of a drug who in the normal course of business engages in the activities of reconditioning the items manufactured, distributed, or processed by or for that person and not purchased by that person solely for the purpose of reconditioning and sale;(2) a common carrier or a common carrier's agent who disposes of or otherwise transfers undamaged or distressed drugs to a person who is exempt under this section or to a currently licensed salvage broker or salvage operator; or(3) a person who transfers distressed drugs to a licensed salvage broker or salvage operator.(b) An exemption from the licensing requirements under these sections does not constitute an exemption from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, or the rules adopted to administer and enforce the Act.(c) A salvage establishment or salvage broker who is engaging only within the scope of the license issued under §229.575 of this title (relating to Licensing Requirements and Procedures) is not required to be licensed under Health and Safety Code, Chapter 431. An exemption from licensing requirements under Health and Safety Code, Chapter 431, does not constitute an exemption from other applicable provisions of the Health and Safety Code, Chapter 431, or the rules adopted to administer and enforce the chapter. Source Note: The provisions of this §229.574 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.574 Exemptions and Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118465&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118465 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118465&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118465 03/11/2026 (a) General. Except as provided by §229.574 of this title (relating to Exemptions and Applicability), it shall be unlawful for any person to operate a salvage establishment or operate as a salvage broker within the State of Texas, who does not possess a current and valid license issued by the department.(b) Licensing of out-of-state salvage establishments and brokers. A person who operates a salvage establishment or acts as a salvage broker outside this state may not sell, distribute, or otherwise traffic in distressed or salvaged food, drugs, devices, or cosmetics within this state unless the person holds a license from the department.(c) Reports from other jurisdictions. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with these sections and with the provisions of the Act.(d) New place of business. Each person acquiring or establishing a place of business for the purpose of operating a salvage establishment or operating as a salvage broker shall apply for and obtain a license of such business prior to beginning operations.(e) Two or more places of business. If the salvage establishment or salvage broker operates more than one place of business, the salvage establishment or salvage broker shall license each place of business separately.(f) License application. License application forms may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756 or online at http://www.dshs.state.tx.us/license.shtm.(g) Contents of license application. The salvage establishment or salvage broker license application shall be signed and verified, submitted on a license application form furnished by the department, and shall include the following information:(1) the name of the legal entity to be licensed, including the name under which the business is conducted;(2) the address of the place of business to be licensed and the mailing address if different;(3) the address of any salvage warehouse used by a salvage establishment or salvage broker;(4) if a sole proprietorship, the name of the proprietor; if a partnership, the names of all partners; if a corporation, the names and titles of all officers; in any other association, those in a managerial capacity; and(5) a statement signed and verified by the sole proprietor, managing partner, corporate officer, or person in a managerial capacity for an association that acknowledges the applicant has read, understood, and agrees to abide by the provisions of these sections and those of the Act.(h) Issuance of license. In accordance with §229.281 of this title (relating to Processing License/Permit Applications Relating to Food and Drug Operations), the department may license a salvage establishment or salvage broker who meets the requirements of these sections and pays all fees in compliance with §229.276 of this title (Licensing Fees).(i) Transfer of license. Licenses shall not be transferable from one person to another or from one place of business to another.(j) Display of license. The license shall be displayed in an open public area at each place of business and each salvage operator shall have a copy of a valid license in each vehicle used by the salvage operator to transport distressed drugs.(k) License term. Unless a license is amended as provided in subsection (o) of this section, or is revoked or suspended as provided in §229.584 of this title (relating to Enforcement and Penalties), the license is valid for one or two years as determined by the department.(l) Renewal of license.(1) The license application as outlined in subsection (g) of this section and nonrefundable licensing fees as outlined in §229.576 of this title (relating to Licensing Fees) for each place of business shall be submitted to the department prior to the expiration date of the current license. A person who files a renewal application after the expiration date shall pay an additional $100 as a delinquency fee.(2) The department shall renew the license for a one or two-year term as determined by the department if the licensee is in compliance with these sections and has paid all required fees, including any past due and delinquency fees.(m) Completeness of license applications. Failure to complete the initial or renewal license application form may result in the denial of a license.(n) Report of changes. The license holder shall notify the department in writing within ten days of any change, including change in location, name, or ownership of a salvage establishment or salvage broker, which would render the information contained in the initial license application no longer accurate. Failure to inform the department within ten days of a change in information required in the initial license application may result in enforcement action as described in §229.584 of this title.(o) Amendment of license. A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business will require submission of fees as outlined in §229.576 of this title (relating to Licensing Fees).(p) Return of license. A license issued under these sections shall be returned to the department if the place of business:(1) ceases business or otherwise ceases operation on a permanent basis;(2) relocates;(3) changes the name of the business under which the salvage establishment or salvage broker operates; or(4) changes ownership. Source Note: The provisions of this §229.575 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.575 Licensing Requirements and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118466&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118466 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118466&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118466 03/11/2026 (a) Licensing fees.(1) All applicants for a license or a renewal license must pay a licensing fee. All fees are nonrefundable. The license fees are as follows:(A) $600 for a one-year license; or(B) $1,200 for a two-year license.(2) Delinquency fee. A salvage establishment or salvage broker must pay a $100 delinquency fee if:(A) the renewal license application is submitted or the renewal license fee is paid after the expiration date of the current license; or(B) the initial license application is submitted or the initial license fee is paid more than 30 days following the effective date of a change in location, name, or ownership of an existing salvage establishment or salvage broker as described in §229.575(o) of this title (relating to Licensing Requirements and Procedures).(3) Reinspection fee. A salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to §229.584 of this title (relating to Enforcement and Penalties), shall pay a nonrefundable inspection fee of $600.(b) Consolidation of license terms. The department may, upon receipt of a written request from a license holder, prorate a license fee for the purpose of consolidating the license renewal dates of multiple licenses issued in the name of the license holder.(c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person is a nonprofit organization, as described in the Internal Revenue Code of 1986, §501(c)(3), as amended, or a nonprofit affiliate of the organization, to the extent otherwise permitted by law.(d) Texas Online. Applicants may submit applications and renewal applications for a license under these sections electronically by the Internet through Texas Online at www.texasonline.state.tx.us. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §229.576 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.576 Licensing Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118467&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118467 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118467&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118467 03/11/2026 (a) Employee health requirements. No person known to be or suspected of being affected with any communicable disease, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, or respiratory infection, shall work in an area of a salvage establishment or for a salvage broker in any capacity when there is any possibility of such person contaminating salvageable or salvaged drugs with pathogenic organisms, or transmitting disease to other individuals.(b) Personal cleanliness.(1) All personnel while working in direct contact with salvageable drugs or while engaged in reconditioning, repacking, or otherwise handling any ingredients or components of salvageable drugs shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty.(2) Personnel engaged in reconditioning salvageable drugs shall wash their hands thoroughly in a department approved hand-washing facility before starting work, and as often as may be necessary to remove soil and contamination.(3) No person shall resume work after visiting the toilet room without first washing their hands. Source Note: The provisions of this §229.577 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.577 Personnel https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118473&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118473 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118473&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118473 03/11/2026 (a) Buildings. Buildings used by salvage establishments and salvage brokers shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.(b) Floor construction.(1) The floor surfaces in all rooms and areas in which salvageable or salvaged drugs are stored or processed and in which utensils are washed, and walk-in refrigerators, dressing or locker rooms, and toilet rooms, shall be constructed to be smooth and easily cleanable.(2) Any floor that is exposed to water or liquids shall be nonabsorbent.(3) All floors shall be kept clean and in good repair.(4) Floor drains shall be provided in all rooms where floors are subjected to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.(c) Walls and ceilings. Walls and ceilings of all rooms shall be clean, smooth, and in good repair.(d) Lighting. Appropriate lighting shall be provided in hand washing areas, dressing and locker rooms, and toilet rooms and in areas where salvageable or salvaged devices are examined, processed, stored and where equipment or tools are cleaned.(1) Where personnel are inspecting, sorting, or reconditioning distressed drug, at least 540 lux (50 foot candles) of light shall be provided at the work surface.(2) At all other areas of the facility where light is required, at least 110 lux (ten foot candles) of light shall be provided when measured at a distance of 30 inches above the floor.(e) Ventilation.(1) All rooms, in which salvageable or salvaged drugs are reconditioned or utensils are washed, dressing or locker rooms, toilet rooms, and garbage and rubbish storage areas shall be well ventilated.(2) Ventilation hoods and related equipment shall be designed to prevent condensation from dripping onto salvageable drugs or onto work surfaces.(3) Filters shall be readily removable for cleaning or replacement.(4) Ventilation systems shall comply with applicable federal, state, and local fire prevention and air pollution requirements.(f) Locker area. Appropriate facilities shall be provided for the orderly storage of personnel clothing and personal belongings.(g) Cleanliness of facilities.(1) All parts of the salvage establishment or salvage warehouse and its premises shall be kept neat, clean, and free of litter and rubbish.(2) Cleaning operations shall be conducted in such a manner as to prevent contamination of salvageable and salvaged drugs.(3) None of the operations connected with a salvage establishment or salvage warehouse shall be conducted in any room used as an employee lounge or toilet facility, or living or sleeping quarters.(4) Soiled coats and aprons shall be kept in suitable containers until removed for laundering.(5) No birds or animals shall be allowed in any areas used for the conduct of salvage establishment operations or the storage of salvageable and salvaged drugs.(h) Vehicles. Vehicles used to transport distressed, salvageable, or salvaged drugs shall be maintained in a clean and sanitary condition to protect the product from contamination. Source Note: The provisions of this §229.578 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.578 Construction and Maintenance of Physical Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118468&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118468 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118468&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118468 03/11/2026 (a) Water supply. The water supply shall be adequate, of a safe and sanitary quality, and from a source constructed and operated in accordance with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(b) Sewage. All sewage, including liquid waste, shall be disposed of in a public sewerage system or, in the absence thereof, in a manner applicable with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(c) Plumbing. Plumbing shall be sized, installed, and maintained in accordance with applicable state and local plumbing codes.(d) Toilet facilities.(1) Each salvage establishment shall provide its employees with adequate and conveniently located toilet facilities.(2) Toilet facilities, including rooms and fixtures, shall be kept in a clean condition and in good repair at all times.(3) All toilet room doors shall be self-closing.(4) Toilet tissue shall be provided.(5) Easily cleanable covered receptacles shall be provided for waste materials in all toilet rooms.(6) Where the use of non-water-carried sewage disposal facilities are approved by the department they shall be located at least 100 linear feet from the salvage establishment and from any well or stream.(e) Hand-washing facilities. Each salvage establishment shall be provided with adequate, conveniently located hand-washing facilities for its personnel, including a lavatory or lavatories, equipped with hot and cold or tempered running water, hand-cleansing soap or detergent, and approved sanitary towels or other approved hand-drying devices. Such facilities shall be kept clean and in good repair.(f) Garbage and refuse.(1) All organic or organic-containing refuse shall be kept in leak proof, non-absorbent containers which shall be kept covered with tight-fitting lids when filled or stored, or not in continuous use. Such containers shall be covered when stored and stored either in a vermin-proof room or enclosure or in a waste refrigerator.(2) Paper, cardboard, unused equipment, and non organic refuse shall be stored in containers, rooms, or areas in such a manner to prevent it from becoming a source of contamination or pest harborage.(3) Adequate cleaning facilities shall be provided, and each container, room, or area shall be thoroughly cleaned after the emptying or removal of refuse.(4) All refuse shall be disposed of with sufficient frequency and in such a manner as to prevent contamination.(5) All refuse shall be disposed of in accordance with all applicable state and local requirements, including requirements for solid waste disposal as referenced in Title 30, Texas Administrative Code, Chapters 330, 335, and 336.(g) Insect and rodent control. Effective measures shall be taken to protect against the entrance, breeding or presence of rodents, insects, and other vermin within the salvage establishment or salvage warehouse. Source Note: The provisions of this §229.579 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.579 Sanitary Facilities and Controls https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118469&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118469 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118469&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118469 03/11/2026 (a) Notice to the department.(1) When the source of distressed drugs is the result of a natural disaster, accident, power failure, or other emergency, the salvage establishment or salvage broker shall make contact with the department within 24 hours after their initial awareness of the emergency and prior to any removal of distressed drugs from the place at which it was located when it became distressed.(2) If emergency removal of distressed drugs referenced in subsection (a)(1) of this section is required, notice to the department shall be made as soon thereafter as possible. It shall be the duty of the salvage establishment or salvage broker to make contact with the department within 48 hours whenever distressed drugs subject to the provisions of this subsection are obtained.(3) Distressed drugs referenced in this subsection shall not be moved out of the State of Texas without prior approval of the department and the responsible state agency in the state to receive the drugs. Concurrence shall also be obtained from the U.S. Food and Drug Administration, or U.S. Department of Agriculture, Food Safety and Inspection Service, prior to interstate movement.(b) Protection of Salvageable and Salvaged Drugs.(1) All salvageable and salvaged drugs stored by salvage establishments or salvage brokers shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs.(2) All salvageable and salvaged drugs, while being stored or processed at a salvage establishment, salvage warehouse, or during transportation, shall be protected from contamination.(3) Poisonous and toxic materials shall be identified and handled under such conditions as will not contaminate other salvageable or salvaged drugs, or constitute a hazard to personnel.(c) Segregation of drugs. All salvageable drugs shall be promptly sorted and segregated from nonsalvageable drugs to prevent further contamination of the distressed drugs to be salvaged or offered for sale or distribution.(d) Nonsalvageable drugs.(1) Containers, including metal and glass containers with press caps, screw caps, pull rings, or other types of openings which have been in contact with nonpotable water, liquid foam, or other deleterious substances, as a result of fire fighting efforts, flood, sewer backups, or similar mishaps, shall be deemed unfit for sale or distribution, i.e., nonsalvageable drugs as defined in §229.573(17) of this title (relating to Definitions).(2) Nonsalvageable drugs shall be disposed of as in §229.579 of this title (relating to Sanitary Facilities and Controls).(3) Distressed drugs which are deemed to be nonsalvageable by a duly authorized agent of the Texas Department of Health shall, at the request of the agent, be destroyed under the supervision of that agent at the expense of the owner.(e) Transporting of distressed drugs.(1) Distressed drugs shall be moved from the site of a fire, flood, sewer backup, wreck, or other cause as expeditiously as possible after compliance with subsection (a) of this section so as not to become putrid, rodent or insect defiled, or otherwise hazardous to public health.(2) All distressed and salvageable drugs of a perishable nature shall be transported only in vehicles provided with adequate refrigeration, if necessary, for product maintenance prior to reconditioning.(f) Handling of distressed articles other than drugs. If distressed articles other than drugs are also salvaged, they shall be handled separately so as to prevent contamination from poisonous and toxic materials or other contaminants.(g) Cross-contamination protection. Sufficient precautions shall be taken to prevent cross-contamination among the various types of drugs that are salvageable or salvaged.(h) Salvageable drugs. All salvageable drugs shall be reconditioned prior to sale or distribution except for such sale or distribution to a person holding a valid license to engage in a salvage operation.(i) Reconditioned drugs. All reconditioned drugs must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(j) Labeling. All salvaged drugs must be labeled in accordance with the requirements of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq. as amended; the Fair Packaging and Labeling Act, 15 U.S.C., §1451 et seq. as amended; and the federal regulations promulgated under those Acts.(k) Salvage warehouses. A person may not use a salvage warehouse to recondition drugs or sell to consumers. Source Note: The provisions of this §229.580 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.580 General Provisions for Handling and Movement of Distressed Drugs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118470&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118470 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118470&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118470 03/11/2026 (a) Good manufacturing practices. A person must follow and comply with the requirements in 21 CFR, Parts 205, §§205.1 - 205.50, titled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors," as amended, 21 CFR Part 210, §§210.1 - 210.3, titled "Current Good Manufacturing, Processing, Packing, or Holding of Drugs" as amended, and §§211.1 - 211.208, titled "Current Good Manufacturing Practice for Finished Pharmaceuticals" as amended, in the handling and reconditioning of all salvaged drugs.(b) Distressed or nonsalvageable drugs. All distressed or nonsalvageable drugs shall be disposed of in accordance with §229.579(f) of this title (relating to Sanitary Facilities and Controls).(c) Relabeling. All salvaged drugs in containers shall be provided with labels meeting the requirements in §229.580(i) of this title (relating to General Provisions for Handling and Movement of Distressed Drugs). When original labels are removed from containers that are to be resold or redistributed, the replacement labels must show the name and address of the salvage establishment.(d) Procedures. All salvage establishments shall have written procedure for identifying and retrieving over-the-counter and prescription drug products that are subject to recall. Source Note: The provisions of this §229.581 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.581 Handling Distressed Drugs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118471&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118471 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118471&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118471 03/11/2026 (a) Inventory Records. A written record or receipt of distressed, salvageable, and salvaged drugs shall be maintained by the salvage establishment or salvage broker and shall include:(1) the common name and brand name or manufacturer and quantity of the drugs received;(2) the source of the distressed, salvageable, and salvaged drugs;(3) the date received;(4) a brief description of the type or cause of damage (fire, flood, wreck, prolonged storage, warehouse damage, etc.); and(5) the name of the individual or business that purchases any such drugs for the purpose of sale or distribution and the date of any such transaction.(b) Retention of records. All records required in these sections shall be kept at the place of business of the salvage establishment or salvage broker for a period of two years following the completion of transactions involving a lot of drugs.(c) Electronic records. Records required by these sections which are maintained by the salvage establishment or salvage broker on computer systems shall be regularly copied, at least monthly, and updated on storage media other than the hard drive of the computer. An electronic record must be retrievable as a printed copy. Source Note: The provisions of this §229.582 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.582 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118472&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118472 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118472&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118472 03/11/2026 (a) Inspection. To enforce these sections or the Act, the commissioner, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:(1) enter at reasonable times the place of business of a salvage establishment or salvage broker;(2) enter a salvage warehouse used to store or hold distressed or salvaged drug;(3) enter a vehicle being used to transport or hold distressed or salvaged drug; or(4) inspect at reasonable times, any place of business of a salvage establishment or salvage broker, salvage warehouse, or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.(b) Access to records. A person who is required to maintain records referenced in these sections or under the Act or a person who is in charge or custody of those records shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times access to review, copy, and verify the records.(c) Access to records showing movement in commerce. A person who is subject to licensing under §229.575 of this title (relating to Licensing Requirements and Procedures) or a person, including a common carrier or a common carrier's agent, who disposes of or otherwise transfers distressed or salvaged drugs shall, at the request of the commissioner or an authorized agent, permit the commissioner or authorized agent at all reasonable times access to review, copy, and verify all records showing:(1) the movement in commerce of any distressed or salvaged drug;(2) the holding of any distressed or salvaged drug after movement in commerce; and(3) the quantity, shipper, and consignee of any distressed or salvaged drug.(d) Receipt for samples. An authorized agent or health authority who makes an inspection of a place of business, including any vehicle or salvage warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, shall give to the owner, operator, or the owner's or operator's agent a receipt describing the sample. Source Note: The provisions of this §229.583 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.583 Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118474&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118474 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118474&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118474 03/11/2026 (a) General license actions. The department may deny, suspend, or revoke the license of an applicant or licensee who fails to comply with any of the following:(1) failure to comply with the Act or these sections;(2) falsification of information provided in an application for a license;(3) refuses to allow the department to conduct an inspection or collect samples;(4) interferes with the department in the performance of its duties;(5) removes or disposes of a detained drugs in violation of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §431.021; or(6) fails to inform the department of any salvage warehouse(s) at the time of an inspection or when requested by the department.(b) Emergency license suspensions.(1) The department may suspend a license without notice when there is an imminent threat to the health or safety of the public.(2) If an emergency suspension order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be held under departmental formal hearing rules governed by §§1.21, 1.23, 1.25 and 1.27 of this title (relating to Formal Hearing Procedures).(c) Hearings.(1) Any hearings for the denial, suspension, or revocation of a license are governed by §§1.21, 1.23, 1.25 and 1.27 of this title.(2) Within 20 days after the postmark date of the department's written notice of proposed denial, suspension, or revocation, the applicant or licensee may request a hearing in writing from the department. If the applicant or licensee does not request a hearing during the required time period, then the applicant or licensee is deemed to have waived his/her right to a hearing.(d) Reinstatement of license.(1) A person whose application for a license has been denied or whose license has been placed under an emergency suspension may request a reinspection for the purpose of granting or reinstating a license not later than the 30th day after the denial or emergency suspension. Not later than the tenth day after the receipt of a written request from the applicant or licensee, the department shall make a reinspection.(2) As regards a nonemergency suspension or a revocation, the licensee may request at any time, an inspection for reinstating the license or for issuing a new license.(3) If, after inspection, the department determines that the applicant or licensee meets the requirements of the Act or these sections, the department shall reinstate the license or issue a new license, as appropriate.(4) Reinspection fee. Except as provided for in §229.576(c) of this title (relating to Licensing Fees), a salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to this section shall pay a nonrefundable inspection fee of $600.(e) Emergency order.(1) General. The commissioner or the commissioner's designee may issue an emergency order, either mandatory or prohibitory, concerning the sale or distribution of distressed drugs in the department's jurisdiction if the commissioner or the commissioner's designee determines that:(A) the sale or distribution of those drugs creates or poses an immediate and serious threat to human life or health; and(B) other procedures available to the department to remedy or prevent the threat will result in unreasonable delay.(2) Absence of notice and hearing. The commissioner or the commissioner's designee may issue the emergency order without notice and hearing if the commissioner or the commissioner's designee determines it is necessary under the circumstances.(3) Hearings. If an emergency order is issued without a hearing, the department shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be governed by §§1.21, 1.23, 1.25 and 1.27 of this title.(f) Administrative penalty. If a person violates these sections, or an order adopted or license issued under the Act, the commissioner may assess an administrative penalty against the person.(1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.(2) In determining the amount of the penalty, the commissioner shall consider the following criteria:(A) the person's previous violations;(B) the seriousness of the violation;(C) any hazard to the health and safety of the public;(D) the person's demonstrated good faith; and(E) other matters as justice may require.(3) Violations subject to this subsection shall be categorized into severity levels as determined in §229.261 of this title (relating to Assessment of Administrative Penalties).(4) Hearings, appeals from, and judicial review of final administrative decisions under this subsection shall be conducted according to the contested case provisions of the Government Code, Chapter 2001, and §§1.21, 1.23, 1.25, and 1.27 of this title.(5) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.(6) If a hearing is held, the commissioner shall make findings of fact and shall issue a written decision regarding the occurrence of the violation and the amount of the penalty.(7) If the person charged with the violation does not request a hearing, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.(8) After making a determination under this subsection that a penalty is to be assessed, the commissioner shall issue an order requiring that the person pay the penalty.(9) The commissioner may consolidate a hearing held under this subsection with another proceeding.(10) Not later than the 30th day after the date of issuance of an order finding that a violation has occurred, the commissioner shall inform the person against whom the order is issued of the amount of the penalty. Source Note: The provisions of this §229.584 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG BB REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS §229.584 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98528&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98528 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13603&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13603 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:(1) Products consisting substantially of beef--A meat food product consisting of 5.0% or more of beef, and/or having visible beef of any quantity, shall be considered as consisting substantially of beef and hereinafter referred to as beef product.(2) State agency--Any agency, department, board, or commission of the state or any state eleemosynary, educational, rehabilitative, correctional, or custodial facility.(3) Subdivision--Any county, incorporated city, or town, or any school, junior-college, water, hospital, reclamation, or other special-purpose district. Source Note: The provisions of this §229.31 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG C PURCHASE OF DOMESTIC BEEF §229.31 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13604 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13604 03/11/2026 (a) Purchasing officials of state agencies and subdivisions shall require affidavits or certification by the vendor that the beef or beef product purchased is not imported from outside the United States of America.(1) Such affidavits or certification shall have attached an affidavit or certification from each previous buyer or seller of the beef product sold to the state agency or subdivision stating that each beef product was derived exclusively from domestic beef.(2) Where the beef product is canned, an attached affidavit or certification from the packer or manufacturer of the beef product stating that such beef product was derived exclusively from domestic beef shall constitute compliance with paragraph (1) of this subsection.(3) The vendor affidavits or certification shall include a statement that the beef product sold and delivered is that to which the attached affidavit(s) or certification(s) refer.(4) The affidavits or certification required of the vendor by this section may be contained within a signed bid under circumstances where a bid is required.(b) State agencies and subdivisions purchasing beef and beef products shall keep records to produce upon demand for at least two years from date of purchase, indicating the following for each purchase and delivery.(1) The common or usual name and amount of each beef product.(2) Date of purchase and date of delivery.(3) Name of vendor.(4) Product certification. Source Note: The provisions of this §229.32 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG C PURCHASE OF DOMESTIC BEEF §229.32 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2356&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2356 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2356&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2356 03/11/2026 State agencies and subdivisions having cause to believe beef and/or beef products purchased and delivered are not in compliance with the requirements of Texas Civil Statutes Article 4476-3(b), and these regulations, shall immediately and any other individual may report the same to the Division of Food and Drugs, Bureau of Consumer Health Protection, Texas Department of Health Resources, 1100 West 49th Street, Austin, Texas 78756, giving full particulars. Source Note: The provisions of this §229.33 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG C PURCHASE OF DOMESTIC BEEF §229.33 Reporting Violations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220589&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220589 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98528&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98528 03/11/2026 These sections provide for the licensing and regulation of device salvage establishments and brokers to prevent the sale or distribution of adulterated or misbranded devices to consumers. Source Note: The provisions of this §229.601 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.601 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118511&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118511 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118511&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118511 03/11/2026 (a) A salvage establishment or salvage broker who is subject to these sections and who is also involved in the reconditioning, sale or distribution of distressed or salvaged food, drugs, or cosmetics must comply with the applicable requirements in Subchapter AA of this chapter (relating to Regulation of Food Salvage Establishments and Brokers), Subchapter BB of this chapter (relating to Regulation of Drug Salvage Establishments and Brokers), and Subchapter DD of this chapter (relating to Regulation of Cosmetic Salvage Establishments and Brokers).(b) The Department of State Health Services (department) adopts by reference the following federal laws and regulations:(1) Fair Packaging and Labeling Act, 15 United States Code (U.S.C.), §1451 et seq., as amended;(2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq., as amended;(3) §501(c)(3), Internal Revenue Code of 1986, as amended;(4) 21 Code of Federal Regulations (CFR), Part 801, as amended;(5) 21 CFR, Subchapter J, Radiological Health, as amended; and(6) 21 CFR, Part 820, Quality System Regulation, as amended.(c) Copies of the laws and regulations referenced in subsection (b) are indexed and filed at the department, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at http://www.dshs.state.tx.us/license.shtm.(d) Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable state and federal laws and regulations. Source Note: The provisions of this §229.602 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11985. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.602 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118512&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118512 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118512&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118512 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter 432.(2) Adulterated device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.111.(3) Authorized agent--an employee of the department who is designated by the commissioner to enforce the provisions of this chapter.(4) Change of ownership--A sole proprietor who transfers all or part of the salvage establishment or salvage broker business to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a salvage establishment or salvage broker business owned by a partnership; a corporate sale, transfer; reorganization; or merger of the corporation which owns the salvage establishment or salvage broker business if the sale, transfer, reorganization, or merger causes a change in the salvage establishment's or salvage broker business's ownership to another person or persons; or if any other type of association, the removal, addition, or substitution of a person or persons as a principal of such association.(5) Class I exempt device--A class I device not labeled or otherwise represented as sterile that has been determined by the U.S. Food and Drug Administration to be exempt from the current good manufacturing practice requirements in 21 CFR, Part 820 (quality system regulation), except for general requirements concerning records (21 CFR, §820.180) and complaint files (21 CFR, §820.198).(6) Class I device--A device determined by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, §513, to be subject to only the general controls authorized by or under §§501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the Federal Food, Drug, and Cosmetic Act.(7) Class II device--A device determined by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, §513, to be subject to or eventually subject to special controls, such as performance standards, postmarket surveillance, patient registries, or guidance documents.(8) Class III device--A device determined by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, §513, to be subject to or eventually subject to the premarket approval requirements in the Federal Food, Drug, and Cosmetic Act, §515.(9) Commissioner--The Commissioner of Health or his successor.(10) Cosmetic--Any article or substance intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearances; or an article or substance for use as a component of such an article, except that the term does not include soap.(11) Department--The Department of State Health Services.(12) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component; part, or accessory; that is:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.(13) Device manufacturer--A person who manufactures, fabricates, assembles; or processes a finished device. The term includes a person who repackages or relabels a finished device. The term does not include a person who only distributes a finished device.(14) Distressed device--Any device that is adulterated or misbranded within the meaning of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §§431.111 and 431.112. The term includes a device that:(A) has lost its labeling or is otherwise unidentified;(B) has been subjected to prolonged or improper storage, including insanitary conditions whereby the device may have been contaminated with filth or whereby it may have been rendered injurious to health;(C) has been subjected for any reason to abnormal environmental conditions, including temperature extremes, humidity, smoke, water, fumes, pressure, or radiation;(D) has been subjected to conditions that result in either its strength, purity, or quality falling below that which it purports or is represented to possess; or(E) may have been rendered unsafe or unsuitable for its intended use according to the manufacturer's recommendations or specifications; or for any reason other than those specified by this paragraph.(15) Drug--(A) an article or substance recognized in the official United States Pharmacopoeia, the official Homeopathic Pharmacopoeia of the United States, the official National Formulary, or any supplement of them;(B) an article or substance designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;(C) an article or substance, other than food, intended to affect the structure or any function of the body of man or other animals; or(D) an article or substance intended for use as a component of any article or substance specified in this definition.(16) Finished device--A device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.(17) Flea market--A location at which booths or similar spaces are rented or otherwise made available temporarily to two or more persons and at which the persons offer tangible personal property for sale.(18) Food--(A) any article of food or drink for man;(B) chewing gum; or(C) an article used for components of any such article.(19) Labeling--All labels and other written, printed, or graphic matter:(A) upon any article or any of its containers or wrappers; or(B) accompanying such article.(20) Misbranded device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.112.(21) Nonprofit organization--An organization that has received an exemption from federal taxation under 26 U.S.C., §501(c)(3).(22) Nonsalvageable device--A distressed device, as defined in this section, which cannot be safely or practically reconditioned.(23) Person--Includes individual, partnership, corporation, and association.(24) Personnel--Any person employed by a salvage establishment or salvage broker who does or may in any manner handle or come in contact with the handling; storing; transporting; or selling and distributing of salvageable or salvaged devices.(25) Place of business--Each location from which a salvage establishment or salvage broker operates. The term does not include a salvage warehouse.(26) Practitioner--A person licensed by the Texas State Board of Medical Examiners, State Board of Dental Examiners, Texas State Board of Podiatric Medical Examiners, Texas Optometry Board, or State Board of Veterinary Medical Examiners to prescribe and administer prescription devices.(27) Prescription device--A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which adequate directions for use cannot be prepared.(28) Quality audit--An independent examination of a salvage establishment, including the organizational structure and responsibilities, procedures, and processes necessary to ensure that such resources and activities comply with the requirements of these sections and result in the adequate reconditioning of a distressed device.(29) Reconditioning--Any appropriate process or procedure by which a distressed device can be brought into compliance with the standards of the department for use by the public. In addition, all reconditioned devices must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(30) Sale or distribution--The act of selling or distributing, whether for compensation or not; and includes delivery; holding; or offering for sale; transfer, auction; storage; or other means of handling or trafficking.(31) Salvage broker--A person who engages in the business of selling, distributing, or otherwise trafficking in any distressed or salvaged food, drug, device, or cosmetic and who does not operate a salvage establishment.(32) Salvage establishment--Any place of business engaged in reconditioning or by other means salvaging distressed food, drugs, devices, or cosmetics, or that sells, buys, or distributes for human use any salvaged food, drug, device, or cosmetic.(33) Salvage operator--A person who is engaged in the business of operating a salvage establishment.(34) Salvage warehouse--A separate storage facility used by a salvage broker or salvage establishment for the purpose of holding distressed or salvaged devices.(35) Salvageable device--Any distressed device, as defined in this section, which can be reconditioned to departmental standards.(36) Salvaged device--Any distressed device that has been reconditioned.(37) Vehicle--Any truck, car, bus, or other means by which distressed, salvageable, or salvaged devices are transported from one location to another. Source Note: The provisions of this §229.603 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11985. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.603 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98532&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98532 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98532&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98532 03/11/2026 (a) A person is exempt from licensing under these sections if the person is:(1) a manufacturer or distributor of a device who in the normal course of business engages in the activities of reconditioning the device manufactured or distributed by or for that person and not purchased by that person solely for the purpose of reconditioning and sale;(2) a person who is a common carrier or the common carrier's agent, who disposes of or otherwise transfers an undamaged or distressed device to a person who is exempt under this section or to a licensed salvage broker or salvage operator; or(3) a person who transfers a distressed device to a licensed salvage broker or salvage operator.(b) An exemption from the licensing requirements under these sections does not constitute an exemption from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 or the rules adopted to administer and enforce the Act.(c) A salvage establishment or salvage broker who is engaging in conduct within the scope of the license issued under §229.605 of this title (relating to Licensing Requirements and Procedures) is not required to also be licensed under Health and Safety Code, Chapter 431. An exemption from the licensing requirements under Health and Safety Code, Chapter 431, does not constitute an exemption from other applicable provisions of Health and Safety Code, Chapter 431, or the rules adopted to administer and enforce the chapter.(d) These sections do not apply to the sale or distribution of previously used devices that are not distressed devices and have been determined to function properly and meet manufacturer's performance specifications. Acceptable determinations of functionality shall include at least one of the following:(1) certification statements;(2) reports of inspection, installation, or calibration; or(3) product conformance affidavits.(e) All certification statements, reports, and conformance affidavits referenced in subsection (d) of this section shall be completed, signed and dated no more than 14 days prior to the time of sale or distribution by:(1) a qualified representative of the seller;(2) a qualified representative of a hospital licensed under Health and Safety Code, Chapter 241;(3) a person licensed under these sections; or(4) a state or federal regulatory agency having knowledge or jurisdiction over the devices subject to any sale or distribution. Source Note: The provisions of this §229.604 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.604 Exemptions and Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118513&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118513 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118513&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118513 03/11/2026 (a) General. Except as provided by §229.604(a) of this title (relating to Exemptions and Applicability), it shall be unlawful for any person to operate a salvage establishment or act as a salvage broker within this state, who does not possess a current and valid license issued by the department.(b) Licensing of out-of-state salvage establishments and brokers. A person who operates a salvage establishment or acts as a salvage broker outside this state may not sell, distribute, or otherwise traffic in distressed or salvaged food, drugs, devices, or cosmetics within this state unless the person holds a license from the department.(c) Reports from other jurisdictions. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with these sections and with the provisions of the Act.(d) New place of business. Each person acquiring or establishing a place of business for the purpose of operating a salvage establishment or operating as a salvage broker shall apply for and obtain a license of such business prior to beginning operation.(e) Two or more places of business. If the salvage establishment or salvage broker operates more than one place of business, the salvage establishment or salvage broker shall license each place of business separately.(f) License application. License application forms may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756 or online at http://www.dshs.state.tx.us/license.shtm.(g) Contents of license application. The application for licensing as a salvage establishment or salvage broker shall be signed and verified, submitted on a license application form furnished by the department, and shall include the following information:(1) the name of the legal entity to be licensed, including the name under which the business is conducted;(2) the address of the place of business to be licensed and the mailing address or billing address if different;(3) the name, residence address, and driver's license number of the responsible individual in charge at the place of business;(4) the hours of operation of each place of business;(5) the address of any salvage warehouse used by a salvage establishment or salvage broker;(6) if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state and corporation charter number; or if any other type of association, then the names of the principals of such association; and(7) a statement signed and verified by the sole proprietor, managing partner, corporate officer, or person in a managerial capacity for an association that acknowledges the applicant has read, understood, and agrees to abide by the provisions of these sections and those of the Act.(h) Issuance of license. In accordance with §229.281 of this title (Processing License/Permit Applications Relating to Food and Drug Operations), the department may license a salvage establishment or salvage broker who meets the requirements of these sections and pays all fees in compliance with §229.606 of this title (Licensing Fees).(i) Transfer of license. Licenses shall not be transferable from one person to another or from one place of business to another.(j) Display of license. The license shall be displayed in an open public area at each place of business and each salvage operator shall have a copy of a valid license in each vehicle used by the salvage operator to transport distressed devices.(k) License term. Unless the license is amended as provided in subsection (o) of this section or revoked or suspended as provided in §229.614 of this title (relating to Enforcement and Penalties), the license is valid for one or two years as determined by the department.(l) Renewal of license.(1) The license application as outlined in subsections (f) and (g) of this section and nonrefundable licensing fee(s) as outlined in §229.606 of this title (relating to Licensing Fees) for each place of business shall be submitted to the department prior to the expiration date of the current license. A person who files a renewal application after the expiration date shall pay an additional $100 as a delinquency fee.(2) The department shall renew the license for a one or two-year term as determined by the department if the licensee is in compliance with these sections and has paid all required fees, including any past due and delinquency fees.(m) Completeness of license applications. Failure to complete the license application form may result in the denial of a license.(n) Report of changes. The license holder shall notify the department in writing within ten days of any change, including a change in location, name or ownership of a salvage establishment or salvage broker, which would render the information contained in the license application no longer accurate. Failure to inform the department within ten days of a change in the information required in the license application may result in enforcement action as described in 229.614 of this title.(o) Amendment of license. A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business will require submission of an application as outlined in subsection (g) of this section and submission of fees as outlined in §229.606 of this title (relating to Licensing Fees).(p) Return of license. A license issued under these sections shall be returned to the department if the place of business:(1) ceases business or otherwise ceases operation on a permanent basis;(2) relocates;(3) changes the name of the business under which the salvage establishment or salvage broker operates; or(4) changes ownership. Source Note: The provisions of this §229.605 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11985. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.605 Licensing Requirements and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118514&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118514 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118514&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118514 03/11/2026 (a) Licensing fees.(1) All applicants for a license or a renewal license must pay a license fee. All fees are nonrefundable. The license fees are as follows:(A) $600 for a one-year license; or(B) $1,200 for a two-year license.(2) Delinquency fee. A salvage establishment or salvage broker must pay a $100 delinquency fee if:(A) the renewal license application is submitted or the renewal license fee is paid after the expiration date of the current license; or(B) the initial license application is submitted or the initial license fee is paid more than 30 days following the effective date of a change in location, name, or ownership of an existing salvage establishment or salvage broker as described in §229.605(o) of this title (relating to Licensing Requirements and Procedures).(3) Reinspection fee. A salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to §229.614 of this title (relating to Enforcement and Penalties), shall pay a nonrefundable inspection fee of $600.(4) Texas Online. Applicants may submit applications and renewal applications for a license under these sections electronically by the Internet through Texas Online at www.texasonline.state.tx.us. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with license application and processing through Texas Online.(b) Consolidation of license terms. The department may, upon receipt of a written request from a license holder, prorate a license fee for the purpose of consolidating the license renewal dates of multiple licenses issued in the name of the license holder.(c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person is a nonprofit organization, as described in the Internal Revenue Code of 1986, §501(c)(3), as amended, or a nonprofit affiliate of the organization, to the extent otherwise permitted by law. Source Note: The provisions of this §229.606 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11985. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.606 Licensing Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98526&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98526 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98526&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98526 03/11/2026 (a) Employee health requirements. No person known to be or suspected of being affected with any disease in a communicable form, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, or respiratory infection, shall work in an area of a salvage establishment or for a salvage broker in any capacity in which there is any possibility of such person contaminating salvageable or salvaged devices with pathogenic organisms, or transmitting disease to other individuals.(b) Personal cleanliness.(1) All personnel while working in direct contact with salvageable devices or while engaged in reconditioning, repacking, or otherwise handling any components or accessories of salvageable devices shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty.(2) Personnel engaged in reconditioning salvageable devices shall wash their hands thoroughly in a department approved hand-washing facility before starting work, and as often as may be necessary to remove soil and contamination.(3) No person shall resume work after visiting the toilet room without first washing their hands. Source Note: The provisions of this §229.607 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.607 Personnel https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98527&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98527 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98527&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98527 03/11/2026 (a) Buildings. Buildings used by salvage establishments and salvage brokers shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.(b) Floor construction.(1) The floor surfaces in all rooms and areas in which salvageable or salvaged devices are stored or processed and in which tools or equipment are washed, and walk-in refrigerators, dressing or locker rooms and toilet rooms, shall be constructed to be smooth and easily cleanable.(2) Any floor that is exposed to water or liquids shall be constructed and maintained to be nonabsorbent.(3) All floors shall be kept clean and in good repair.(4) Floor drains shall be provided in all rooms where floors are subjected to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.(c) Walls and ceilings. Walls and ceilings of all rooms shall be clean, smooth, and in good repair.(d) Lighting. Adequate lighting shall be provided in handwashing areas, dressing and locker rooms, and toilet rooms and in all areas where salvageable or salvaged devices are examined, processed, or stored and where equipment or tools are cleaned.(1) Where personnel are inspecting, sorting, or reconditioning distressed devices, at least 540 lux (50 foot candles) of light shall be provided at the work surface.(2) At all other areas of the facility where light is required, at least 110 lux (ten foot candles) of light shall be provided when measured at a distance of 30 inches above the floor.(e) Ventilation.(1) All rooms, in which salvageable or salvaged devices are reconditioned or tools or equipment are washed, dressing or locker rooms, toilet rooms, and garbage and refuse storage areas shall be well ventilated.(2) Ventilation hoods and related equipment when used shall be designed to prevent condensation from dripping onto salvageable devices or onto work surfaces.(3) Filters, when used, shall be readily removable for cleaning or replacement.(4) Ventilation systems shall comply with applicable federal, state, and local fire prevention and air pollution requirements.(f) Locker area. Adequate facilities shall be provided for the orderly storage of personnel clothing and personal belongings.(g) Cleanliness of facilities.(1) All parts of the salvage establishment or salvage warehouse and its premises shall be kept neat, clean, and free of litter and refuse.(2) Cleaning operations shall be conducted in such a manner as to prevent contamination of salvageable and salvaged devices.(3) None of the operations connected with a salvage establishment or salvage warehouse shall be conducted in any room used as a personnel lounge or toilet facility, or living or sleeping quarters.(4) Soiled coats and aprons shall be kept in suitable containers until removed for laundering.(5) No birds or animals shall be allowed in any areas used for the conduct of salvage establishment operations or the storage of salvageable and salvaged devices, except that guide dogs accompanying blind persons shall be permitted in sales areas.(h) Vehicles. Vehicles used to transport distressed, salvageable, or salvaged devices shall be maintained in a clean and sanitary condition to protect the product from contamination. Source Note: The provisions of this §229.608 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.608 Construction and Maintenance of Physical Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98515&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98515 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98515&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98515 03/11/2026 (a) Water supply. The water supply shall be adequate, of a safe, sanitary quality, and from a source constructed and operated in accordance with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(b) Sewage. All sewage, including liquid waste, shall be disposed of in a public sewerage system or, in the absence thereof, in a manner applicable with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(c) Plumbing. Plumbing shall be sized, installed, and maintained in accordance with applicable state and local plumbing codes.(d) Toilet facilities.(1) Each salvage establishment shall provide its personnel with adequate and conveniently located toilet facilities.(2) Toilet facilities, including rooms and fixtures, shall be kept in a clean condition and in good repair at all times.(3) The doors of all toilet rooms shall be self-closing.(4) Toilet tissue shall be provided.(5) Easily cleanable receptacles shall be provided for waste materials, and such receptacles in toilet rooms for women shall be covered.(6) Where the use of non-water-carried sewage disposal facilities are approved by the department they shall be located at least 100 linear feet from the salvage establishment and from any well or stream.(e) Hand-washing facilities. Each salvage establishment shall be provided with adequate, conveniently located hand-washing facilities for its personnel, including a lavatory or lavatories equipped with hot and cold or tempered running water, hand-cleansing soap or detergent, and approved sanitary towels or other approved hand-drying devices. Such facilities shall be kept clean and in good repair.(f) Garbage and refuse.(1) All organic or organic-containing refuse shall be kept in leak proof, non-absorbent containers which shall be kept covered with tight-fitting lids when filled or stored, or not in continuous use. Such containers shall be covered when stored and stored in either a vermin-proof room or enclosure or in a waste refrigerator. Paper, cardboard, unused equipment, and non-organic refuse shall be stored in containers, rooms, or areas in such a manner to prevent it from becoming a source of contamination or pest harborage.(2) Adequate cleaning facilities shall be provided, and each container, room, or area shall be thoroughly cleaned after the emptying or removal of refuse.(3) All refuse shall be disposed of with sufficient frequency and in such a manner as to prevent contamination.(4) All refuse shall be disposed of in accordance with all applicable state and local requirements, including requirements for solid waste disposal as referenced in Title 30, Texas Administrative Code, Chapters 330, 335, and 336.(g) Insect and rodent control. Effective measures shall be taken to protect against the entrance into the salvage establishment or salvage warehouse, and the breeding or presence on the premises of rodents, insects, and other vermin. Source Note: The provisions of this §229.609 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.609 Sanitary Facilities and Controls https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98512&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98512 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98512&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98512 03/11/2026 (a) Notice to the department.(1) When the source of distressed devices is the result of a natural disaster, accident, power failure, or other emergency, the salvage establishment or salvage broker shall make contact with the department's Bureau of Food and Drug Safety within 24 hours after their initial awareness of the emergency and prior to any removal of distressed devices from the place at which it was located when it became distressed.(2) If emergency removal of distressed devices referenced in subsection (a)(1) is required, notice to the department shall be made as soon thereafter as possible. It shall be the duty of the salvage establishment or salvage broker to make contact with the department's Bureau of Food and Drug Safety within 48 hours whenever distressed devices subject to the provisions of this subsection are obtained.(3) Distressed devices referenced in subsection (a)(1) shall not be moved out of the State of Texas without the prior approval of the department and the responsible state agency in the state to receive the devices. Concurrence shall also be obtained from the U.S. Food and Drug Administration prior to interstate movement.(b) Protection of salvageable and salvaged devices.(1) All salvageable and salvaged devices stored by salvage establishments or salvage brokers shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such devices.(2) All salvageable and salvaged devices, while being stored or processed at a salvage establishment, salvage warehouse, or during transportation, shall be protected from contamination.(3) Poisonous and toxic materials shall be identified and handled under such conditions as will not contaminate other salvageable or salvaged devices, or constitute a hazard to personnel.(c) Segregation of devices. All salvageable devices shall be promptly sorted and segregated from nonsalvageable devices to prevent further contamination of the distressed devices to be salvaged or offered for sale or distribution.(d) Nonsalvageable devices.(1) Containers, including metal and glass containers with press caps, screw caps, pull rings, or other types of openings which have been in contact with nonpotable water, liquid foam, or other deleterious substances, as a result of fire fighting efforts, flood, sewer backups, or similar mishaps, shall be deemed unfit for sale or distribution, i.e., nonsalvageable devices as defined in §229.603(23) of this title (relating to Definitions).(2) Nonsalvageable devices shall be disposed of as in §229.609(f)(4) of this title (relating to Sanitary Facilities and Controls) or §229.611(o) of this title (relating to Reconditioning Distressed Devices); or by delivery to a waste reclamation (recycling) facility for destruction.(3) Distressed devices which are deemed to be nonsalvageable by a duly authorized agent of the department shall, at the request of the agent, be destroyed under the supervision of that agent at the expense of the owner.(e) Transporting of distressed devices.(1) Distressed devices shall be moved from the site of a fire, flood, sewer backup, wreck, or other cause as expeditiously as possible after compliance with subsection (a) of this section, if applicable, so as not to become hazardous to public health.(2) All distressed devices of a temperature sensitive nature shall, prior to reconditioning, be transported only in vehicles capable of maintaining adequate temperatures, if necessary, for product integrity.(f) Handling of distressed articles other than devices. If distressed articles other than devices are also salvaged, they shall be handled separately so as to prevent contamination from poisonous and toxic materials or other contaminants.(g) Cross-contamination protection. Sufficient precautions shall be taken to prevent cross-contamination among the various types of devices that are salvageable or salvaged. Source Note: The provisions of this §229.610 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.610 General Provisions for Handling and Movement of Distressed Devices https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118516&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118516 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118516&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118516 03/11/2026 (a) Salvageable devices. All salvageable devices shall be reconditioned prior to sale or distribution except for such sale or distribution to a person holding a valid license to engage in a salvage operation or as provided for in subsection (o) of this section.(b) Reconditioned devices. All reconditioned devices must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(c) General labeling. All salvaged devices must be labeled in accordance with the requirements of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq., as amended; the Fair Packaging and Labeling Act, 15 U.S.C., §1451 et seq., as amended; and the federal regulations promulgated under those Acts.(d) Reconditioned Labeling. In addition to the general labeling requirements found in subsection (c) of this section, all reconditioned devices shall be labeled with the statement "Reconditioned by (name and business address of the salvage establishment responsible for the reconditioning of the device)."(e) Salvage warehouses. A person may not use a salvage warehouse to recondition devices or sell to consumers.(f) Personnel. Each salvage establishment that engages in the reconditioning of devices shall have sufficient personnel with the necessary education, background, training, and experience to assure that all reconditioning activities are correctly performed. With the exception of class I exempt devices, training of personnel engaged in the reconditioning of class I, II, or III devices shall be documented.(g) Operating procedures. Each salvage establishment that engages in the reconditioning of devices shall establish, maintain, and implement written procedures for identifying devices during all stages of receipt, reconditioning, distribution, and installation to prevent mixups.(h) Inspection, measuring, and test equipment.(1) Each salvage establishment that engages in the reconditioning of devices shall ensure that all inspection, measuring, and test equipment used in the reconditioning of devices is:(A) suitable for its intended purpose and capable of producing valid results; and(B) routinely calibrated, inspected, checked, and maintained.(2) Each salvage establishment that engages in the reconditioning of class II and III devices shall establish and maintain calibration records for inspection, measuring, and test equipment to include:(A) the equipment identification;(B) dates of calibration;(C) the person performing each calibration; and(D) the next scheduled calibration date.(i) Device history record. With the exception of class I exempt devices, each salvage establishment that engages in the reconditioning of class I, II, or III devices shall establish and maintain a device history record for each batch, lot, or unit reconditioned to ensure that devices are reconditioned in accordance with manufacturer's specifications. The device history record shall include the following information:(1) the dates of reconditioning;(2) the quantity reconditioned;(3) the quantity released for distribution;(4) the acceptance records which demonstrate the device is reconditioned in accordance with the device master record;(5) copies of any labeling required by these sections; and(6) any device identification or control number used.(j) Device master record. Each salvage establishment that engages in the reconditioning of class II or III devices shall establish and maintain device master records for each type of class II or III device reconditioned. The device master record shall include, or refer to the location of, the following information:(1) device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications;(2) reconditioning process specifications, including the appropriate equipment specifications, reconditioning methods, reconditioning procedures, and reconditioning environment specifications;(3) final acceptance procedures and specifications, including acceptance criteria and the inspection, measuring, and test equipment to be used;(4) packaging and labeling specifications, including methods and processes used; and(5) installation, maintenance, and servicing procedures and methods.(k) Complaint files. Each salvage establishment and salvage broker that engages in the reconditioning or distribution of distressed or salvaged devices shall establish and maintain complaint files. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated. All records of investigation shall include:(1) the name of the device;(2) the date the complaint was received;(3) any device identification(s) and control number(s) used;(4) the name, address, and phone number of the complainant;(5) whether the complaint is associated with any illness or injury involving the device;(6) the nature and details of the complaint;(7) the dates and results of the investigation;(8) any corrective action taken;(9) any reply to the complainant; and(10) the name and signature of the person formally designated by the salvage establishment or salvage broker as responsible for investigating all complaints.(l) Internal audits. Each salvage establishment that engages in the reconditioning of class II or III devices shall establish, maintain, and implement written procedures for conducting an internal quality audit and shall conduct such an audit at least annually. The dates and results of the audit shall be documented, including any deficiencies found and the corrective action taken to address the deficiencies.(m) Corrective and preventative action. Each salvage establishment that engages in the reconditioning of class II or III devices shall document any action taken by the salvage establishment to correct or prevent any nonconformities relating to a salvaged class II or III device or to the reconditioning of a class II or III device.(n) Device remanufacturers. Those salvage establishments who are also device remanufacturers shall comply with these sections and with the device manufacturer requirements in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, Subchapter L, including the applicable requirements in 21 CFR, Part 820 (quality system regulation).(o) Sale or distribution of unreconditioned devices.(1) A person licensed under §229.605(a) of this title (relating to Licensing Requirements and Procedures) who is unable to recondition a salvageable device in accordance with this chapter may sell or distribute the device if such device:(A) is sold or distributed to a person licensed under §229.605(a) of this title (relating to Licensing Requirements and Procedures);(B) is sold or distributed to a person located outside this state who is responsible for the reconditioning of the device prior to sale or distribution to the ultimate consumer located outside Texas. Each salvage establishment or salvage broker who sells or distributes a salvageable device to such a person shall maintain documentation that discloses the person is aware that the device requires reconditioning and that the person is authorized to perform such reconditioning under laws applicable to the state in which the person is located; or(C) is a non-prescription device to be used solely for a non-medical purpose (e.g. research, teaching, or analysis) and not introduced into commercial distribution for use on man or other animals, provided these conditions of sale or distribution are disclosed to the purchaser in writing.(2) At a minimum, all written disclosure records required in paragraph (1)(B)-(C) of this subsection shall:(A) include the information required by §229.612(a) of this title (relating to Records);(B) include a statement regarding the conditions of sale or distribution that is signed by both the seller and purchaser, and contains the address and telephone number of both the seller and purchaser; and(C) be retained as required in §229.612(b) of this title (relating to Records).(p) Sale or distribution of prescription devices.(1) A prescription device in the possession of a salvage establishment or salvage broker licensed under these sections of this subchapter is exempt from Health and Safety Code, §431.112(f)(1), relating to labeling bearing adequate directions for use, providing it meets the requirements of 21 CFR, §801.109 (prescription devices) and 21 CFR, §801.110 (retail exemption for prescription devices).(2) Each salvage establishment or salvage broker who sells or distributes a prescription device shall establish and maintain a record for every prescription device, showing the identity and quantity received, date of receipt, and the disposition of each device.(3) Each salvage establishment or salvage broker who delivers a prescription device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device.(q) Sale of contact lenses at flea markets. Persons at flea markets may not sell contact lens devices unless:(1) the person selling the contact lenses has complied with the requirements of Business and Commerce Code, §35.55; and(2) the person selling the contact lenses has complied with the requirements of the Texas Contact Lens Prescription Act, Texas Civil Statutes, Article 4552-A. Source Note: The provisions of this §229.611 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11985. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.611 Reconditioning Distressed Devices https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98494&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98494 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98494&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98494 03/11/2026 (a) Inventory Records. A written record or receipt of all distressed, salvageable, and salvaged devices shall be maintained by the salvage establishment or salvage broker and shall include:(1) the common name, the brand name or manufacturer, and quantity of the device received;(2) the source of the distressed device;(3) the date received;(4) a brief description of the type or cause of damage (fire, flood, wreck, prolonged storage, warehouse damage, etc.);(5) the name of the individual or business that purchases any such device for the purpose of sale or distribution and the date of any such transaction; and(6) the date and final disposition of the device (reconditioned, unreconditioned, destroyed, etc.).(b) Retention of records. All records required in these sections shall be kept at the place of business of the salvage establishment or salvage broker for a period of two years following the completion of any transaction involving a device.(c) Electronic records. Records required by these sections which are maintained by the salvage establishment or salvage broker on computer systems shall be regularly copied, at least monthly, and updated on storage media other than the hard drive of the computer. An electronic record must be retrievable as a printed copy. Source Note: The provisions of this §229.612 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.612 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98492&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98492 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98492&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98492 03/11/2026 (a) Inspection. To enforce these sections or the Act, the commissioner or an authorized agent may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:(1) enter at reasonable times the place of business of a salvage establishment or salvage broker;(2) enter a salvage warehouse used to store or hold distressed or salvaged devices;(3) enter a vehicle being used to transport or hold distressed or salvaged devices; or(4) inspect at reasonable times, any place of business of a salvage establishment or salvage broker, salvage warehouse, or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.(b) Access to required records. A person who is required to maintain records referenced in these sections or under the Act or a person who is in charge or custody of those records shall, at the request of the commissioner or an authorized agent, permit the commissioner or authorized agent at all reasonable times access to review, copy, and verify the records.(c) Access to records showing movement in commerce. A person who is subject to licensing under §229.605 of this title (relating to Licensing Requirements and Procedures) or a person, including a common carrier or the common carrier's agent, who disposes of or otherwise transfers distressed or salvaged devices shall, at the request of the commissioner or an authorized agent, permit the commissioner or authorized agent at all reasonable times access to review, copy, and verify all records showing:(1) the movement in commerce of any distressed or salvaged device;(2) the holding of any distressed or salvaged device after movement in commerce; and(3) the quantity, shipper, and consignee of any distressed or salvaged device.(d) Receipt for samples. The commissioner or an authorized agent who makes an inspection of a place of business, including any vehicle or salvage warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, shall give to the owner, operator, or the owner's or operator's agent a receipt describing the sample.(e) Detained or embargoed device. In accordance with Subchapter C, Chapter 431, the commissioner or an authorized agent may detain or embargo a distressed device that is in the possession of a person operating as a salvage establishment or acting as a salvage broker. The commissioner or authorized agent may not detain a distressed device in the possession of a person licensed under §229.605 of this title and that is being held for the purpose of reconditioning unless the commissioner or authorized agent finds or has probable cause to believe that the device cannot be adequately reconditioned in accordance with the chapter and these sections. Source Note: The provisions of this §229.613 adopted to be effective December 17, 2002, 27 TexReg 11751. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.613 Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118515&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118515 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118515&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118515 03/11/2026 (a) General license actions. The department may deny, suspend, or revoke the license of an applicant or licensee who fails to comply with any one of the following:(1) failure to comply with the Act or these sections;(2) falsification of information provided in an application for a license;(3) refusal to allow the department to conduct an inspection or collect samples;(4) interference with the department in the performance of its duties;(5) removal or disposal of a detained food in violation of the Texas, Food, Drug, and Cosmetic Act, Health and Safety Code, §431.021; or(6) failure to inform the department of any salvage warehouse(s) at the time of an inspection or when requested by the department.(b) Emergency license suspensions.(1) The department may suspend a license without notice when there is an imminent threat to the health or safety of the public.(2) If an emergency suspension order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be held under departmental formal hearing rules governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(c) Hearings.(1) Any hearings for the denial, suspension, or revocation of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(2) Within 20 days after the postmark date of the department's written notice of proposed denial, suspension, or revocation, the applicant or licensee may request a hearing in writing from the department. If the applicant or licensee does not request a hearing during the required time period, then the applicant or licensee is deemed to have waived his/her right to a hearing.(d) Reinstatement of license.(1) A person whose application for a license has been denied or whose license has been placed under an emergency suspension may request a reinspection for the purpose of granting or reinstating a license not later than the 30th day after the denial or emergency suspension. Not later than the tenth day after the receipt of a written request from the applicant or licensee, the department shall make a reinspection.(2) As regards a nonemergency suspension or a revocation, the licensee may request at any time, an inspection for reinstating the license or for issuing a new license.(3) If, after inspection, the department determines that the applicant or licensee meets the requirements of the Act or these sections, the department shall reinstate the license or issue a new license, as appropriate.(4) Reinspection fee. Except as provided for in §229.606(c) of this title (relating to Licensing Fees), a salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to this section shall pay a nonrefundable inspection fee of $600.(e) Emergency order.(1) General. The commissioner or the commissioner's designee may issue an emergency order, either mandatory or prohibitory, concerning the sale or distribution of distressed devices in the department's jurisdiction if the commissioner or the commissioner's designee determines that:(A) the sale or distribution of those devices creates or poses an immediate and serious threat to human life or health; and(B) other procedures available to the department to remedy or prevent the threat will result in unreasonable delay.(2) Absence of notice and hearing. The commissioner or the commissioner's designee may issue the emergency order without notice and hearing if the commissioner or the commissioner's designee determines it is necessary under the circumstances.(3) Hearings. If an emergency order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(f) Administrative penalty. If a person violates these sections, or an order adopted or license issued under the Act, the commissioner may assess an administrative penalty against the person.(1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.(2) In determining the amount of the penalty, the commissioner shall consider the following criteria:(A) the person's previous violations;(B) the seriousness of the violation;(C) any hazard to the health and safety of the public;(D) the person's demonstrated good faith; and(E) other matters as justice may require.(3) Violations subject to this subsection shall be categorized into severity levels as determined in §229.261 of this title (relating to Assessment of Administrative or Civil Penalties).(4) Hearings, appeals from, and judicial review of final administrative decisions under this subsection shall be conducted according to the contested case provisions of the Government Code, Chapter 2001, and §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(5) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.(6) If a hearing is held, the commissioner shall make findings of fact and shall issue a written decision regarding the occurrence of the violation and the amount of the penalty.(7) If the person charged with the violation does not request a hearing, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.(8) After making a determination under this subsection that a penalty is to be assessed, the commissioner shall issue an order requiring that the person pay the penalty.(9) The commissioner may consolidate a hearing held under this subsection with another proceeding.(10) Not later than the 30th day after the date of issuance of an order finding that a violation has occurred, the commissioner shall inform the person against whom the order is issued of the amount of the penalty. Source Note: The provisions of this §229.614 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11985. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG CC REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS §229.614 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118489&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118489 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220589&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220589 03/11/2026 (a) This subchapter sets forth the requirements for the sale of cosmetics in this state.(b) Cosmetic means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleaning, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of those articles. The term does not include soap. Source Note: The provisions of this §229.40 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG D REGULATION OF COSMETICS §229.40 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220590&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220590 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220590&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220590 03/11/2026 (a) The department adopts by reference the following laws and regulations:(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §301, et seq., as amended;(2) 21 Code of Federal Regulations (CFR) Part 70, Color Additives, as amended;(3) 21 CFR Part 73, Listing of Color Additives Exempt From Certification, as amended;(4) 21 CFR Part 74, Listing of Color Additives Subject to Certification, as amended;(5) 21 CFR Part 81, General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;(6) 21 CFR Part 82, Listing of Certified Provisionally Listed Colors and Specifications, as amended;(7) 21 CFR Part 700, General, as amended;(8) 21 CFR Part 701, Cosmetic Labeling, as amended; and(9) 21 CFR Part 740, Cosmetic Product Warning Statements, as amended.(b) Electronic copies of these laws and regulations are available online at www.dshs.texas.gov.(c) Nothing in this subchapter relieves any person of the responsibility for compliance with other applicable Texas and federal laws and regulations. Source Note: The provisions of this §229.41 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG D REGULATION OF COSMETICS §229.41 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124750&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124750 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118489&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118489 03/11/2026 These sections provide for the licensing and regulation of cosmetic salvage establishments and brokers in order to prevent the sale or distribution of adulterated or misbranded cosmetics to consumers. Source Note: The provisions of this §229.631 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.631 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118488&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118488 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118488&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118488 03/11/2026 (a) A salvage establishment or salvage broker who is subject to these sections and who is also involved in the reconditioning, sale or distribution of distressed or salvaged food, drugs, or devices must comply with the applicable requirements in Subchapter AA of this chapter (relating to Regulation of Food Salvage Establishments and Brokers), Subchapter BB of this chapter (relating to Regulation of Drug Salvage Establishments and Brokers), and Subchapter CC of this chapter (relating to Regulation of Device Salvage Establishments and Brokers).(b) The Department of State Health Services (department) adopts by reference the following federal laws and regulations:(1) Fair Packaging and Labeling Act, 15 United States Code (U.S.C.), §1451 et seq. as amended;(2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq. as amended;(3) §501(c)(3), Internal Revenue Code of 1986, as amended;(4) 21 Code of Federal Regulations (CFR), Parts 701 & 740, as amended;(c) Copies of the laws and regulations referenced in subsection (b) are indexed and filed at the department, located at 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at http://www.dshs.state.tx.us/license.shtm.(d) Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable state and federal laws and regulations. Source Note: The provisions of this §229.632 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.632 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118490&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118490 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118490&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118490 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter 432.(2) Adulterated cosmetic--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.141.(3) Authorized agent--an employee of the department who is designated by the commissioner to enforce the provisions of this chapter.(4) Change of ownership--A sole proprietor who transfers all or part of the salvage establishment or salvage broker business to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a salvage establishment or salvage broker business owned by a partnership; a corporate sale, transfer; reorganization; or merger of the corporation which owns the salvage establishment or salvage broker business if the sale, transfer, reorganization, or merger causes a change in the salvage establishment's or salvage broker business's ownership to another person or persons; or if any other type of association, the removal, addition, or substitution of a person or persons as a principal of such association.(5) Commissioner--The Commissioner of Health or his successor.(6) Cosmetic--Any article or substance intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearances; or an article or substance for use as a component of such an article, except that the term does not include soap.(7) Cosmetic manufacturer--Includes a person who represents himself as responsible for the purity and proper labeling of a cosmetic.(8) Department--The Department of State Health Services.(9) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component; part, or accessory; that is:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.(10) Distressed cosmetic--Any cosmetic that is adulterated or misbranded within the meaning of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §§431.141 and 431.142. The term includes a cosmetic that:(A) has lost its labeling or is otherwise unidentified;(B) has been subjected to prolonged or improper storage, including insanitary conditions whereby the cosmetic may have been contaminated with filth or whereby it may have been rendered injurious to health;(C) has been subjected for any reason to abnormal environmental conditions, including temperature extremes, humidity, smoke, water, fumes, pressure, or radiation;(D) has been subjected to conditions that result in either its strength, purity, or quality falling below that which it purports or is represented to possess; or(E) may have been rendered unsafe or unsuitable for its intended use according to the manufacturer's recommendations or specifications; or for any reason other than those specified by this paragraph.(11) Drug--(A) an article or substance recognized in the official United States Pharmacopoeia, the official Homeopathic Pharmacopoeia of the United States, the official National Formulary, or any supplement of them;(B) an article or substance designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;(C) an article or substance, other than food, intended to affect the structure or any function of the body of man or other animals; or(D) an article or substance intended for use as a component of any article or substance specified in this definition.(12) Food--(A) any article of food or drink for man;(B) chewing gum; or(C) an article used for components of any such article.(13) Labeling--All labels and other written, printed, or graphic matter:(A) upon any article or any of its containers or wrappers; or(B) accompanying such article.(14) Manufacture--The combining, preparing, propagation, compounding, purifying, processing, packing, repacking, wrapping, and labeling of cosmetics.(15) Misbranded cosmetic--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.142.(16) Nonprofit organization--An organization that has received an exemption from federal taxation under 26 U.S.C., §501(c)(3).(17) Nonsalvageable cosmetic--A distressed cosmetic, as defined in this section; which cannot be safely or practically reconditioned.(18) Person--Includes individual, partnership, corporation, and association.(19) Personnel--Any person employed by a salvage establishment or salvage broker who does or may in any manner handle or come in contact with the handling; storing; transporting; or selling and distributing of salvageable or salvaged cosmetics.(20) Place of business--Each location from which a salvage establishment or salvage broker operates. The term does not include a salvage warehouse.(21) Reconditioning--Any appropriate process or procedure by which a distressed cosmetic can be brought into compliance with the standards of the department for use by the public. In addition, all reconditioned cosmetics must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(22) Sale or distribution--The act of selling or distributing, whether for compensation or not; and includes delivery; holding; or offering for sale; transfer, auction; storage; or other means of handling or trafficking.(23) Salvage broker--A person who engages in the business of selling, distributing, or otherwise trafficking in any distressed or salvaged food, drug, device, or cosmetic and who does not operate a salvage establishment.(24) Salvage establishment--Any place of business engaged in reconditioning or by other means salvaging distressed food, drugs, devices, or cosmetics or that sells, buys, or distributes for human use any salvaged food, drug, device, or cosmetic.(25) Salvage operator--A person who is engaged in the business of operating a salvage establishment.(26) Salvage warehouse--A separate storage facility used by a salvage broker or salvage establishment for the purpose of holding distressed or salvaged cosmetics.(27) Salvageable cosmetic--Any distressed cosmetic, as defined in this section, which can be reconditioned to departmental standards.(28) Salvaged cosmetics--Any distressed cosmetic that has been reconditioned.(29) Sanitize--Adequate treatment of surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other microorganisms. Such treatments shall not adversely affect the product and shall be safe to the consumer.(30) Vehicle(s)--Any truck, car, bus, or other means by which distressed, salvageable, or salvaged cosmetics are transported from one location to another. Source Note: The provisions of this §229.633 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.633 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118491&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118491 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118491&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118491 03/11/2026 (a) A person is exempt from licensing under these sections if the person is:(1) a manufacturer or distributor of a cosmetic who in the normal course of business engages in the activities of reconditioning the cosmetic manufactured or distributed by or for that person and not purchased by that person solely for the purpose of reconditioning and sale;(2) a person who is a common carrier or a common carrier's agent, who disposes of or otherwise transfers an undamaged or distressed cosmetic to a person who is exempt under this section or to a currently licensed salvage broker or salvage operator; or(3) a person who transfers a distressed cosmetic to a licensed salvage broker or salvage operator.(b) An exemption from the licensing requirements under these sections does not constitute an exemption from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, or the rules adopted to administer and enforce the Act.(c) A salvage establishment or salvage broker who is engaging in conduct within the scope of the license issued under §229.635 of this title (relating to Licensing Requirements and Procedures) is not required to also be licensed under Health and Safety Code, Chapter 431. An exemption from the licensing requirements under Health and Safety Code, Chapter 431, does not constitute an exemption from other applicable provisions of Health and Safety Code, Chapter 431, or the rules adopted to administer and enforce the chapter. Source Note: The provisions of this §229.634 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.634 Exemptions and Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118492&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118492 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118492&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118492 03/11/2026 (a) General. Except as provided by §229.634(a) of this title (relating to Exemptions and Applicability), it shall be unlawful for any person to operate a salvage establishment or act as a salvage broker within this state, who does not possess a current and valid license issued by the department.(b) Licensing of out-of-state salvage establishments and brokers. A person who operates a salvage establishment or acts as a salvage broker outside this state may not sell, distribute, or otherwise traffic in distressed or salvaged food, drugs, devices, or cosmetics within this state unless the person holds a license from the department.(c) Reports from other jurisdictions. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with these sections and with the provisions of the Act.(d) New place of business. Each person acquiring or establishing a place of business for the purpose of operating a salvage establishment or operating as a salvage broker shall apply for and obtain a license of such business prior to beginning operations.(e) Two or more places of business. If the salvage establishment or salvage broker operates more than one place of business, the salvage establishment or salvage broker shall license each place of business separately.(f) License application. License application forms may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756 or online at http://www.dshs.state.tx.us/license.shtm.(g) Contents of license application. The application for licensing as a salvage establishment or salvage broker shall be signed and verified, submitted on a license application form furnished by the department, and shall include the following information:(1) the name of the legal entity to be licensed; including the name under which the business is conducted;(2) the address of the place of business to be licensed and the mailing address or billing address if different;(3) the name, residence address, and driver's license number of the responsible individual in charge at the place of business;(4) the hours of operation of each place of business;(5) the address of any salvage warehouse used by a salvage establishment or salvage broker;(6) if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state and corporation charter number; or if any other type of association, then the names of the principals of such association; and(7) a statement signed and verified by the sole proprietor, managing partner, corporate officer, or person in a managerial capacity for an association that acknowledges the applicant has read, understood, and agrees to abide by the provisions of these sections and those of the Act.(h) Issuance of license. In accordance with §229.281 of this title (relating to Processing License/Permit Applications Relating to Food and Drug Operations), the department may license a salvage establishment or salvage broker who meets the requirements of these sections, and pays all fees in compliance with §229.636 of this title (relating to Licensing Fees).(i) Transfer of license. Licenses shall not be transferable from one person to another or from one place of business to another.(j) Display of license. The license shall be displayed in an open public area at each place of business and each salvage operator shall have a copy of a valid license in each vehicle used by the salvage operator to transport distressed cosmetics.(k) License term. Unless a license is amended as provided in subsection (o) of this section, or is revoked or suspended as provided in §229.644 of this title (relating to Enforcement and Penalties), the license is valid for one or two years as determined by the department.(l) Renewal of license.(1) The license application as outlined in subsections (f) and (g) of this section and nonrefundable licensing fees as outlined in §229.636 of this title (relating to Licensing Fees) for each place of business shall be submitted to the department prior to the expiration date of the current license. A person who files a renewal application after the expiration date shall pay an additional $100 as a delinquency fee.(2) The department shall renew the license for a one or two-year term as determined by the department, if the licensee is in compliance with these sections and has paid all required fees, including any past due and delinquency fees.(m) Completeness of license applications. Failure to complete the license application form may result in the denial of a license.(n) Report of changes. The license holder shall notify the department in writing within ten days of any change, including a change in location, name or ownership of a salvage establishment or salvage broker, which would render the information contained in the license application no longer accurate. Failure to inform the department within ten days of a change in the information required in the initial license application may result in enforcement action as described in §229.644 of this title (relating to Enforcement and Penalties).(o) Amendment of license. A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business will require submission of an application as outlined in subsection (g) of this section and submission of fees as outlined in §229.636 of this title (relating to Licensing Fees).(p) Return of license. A license issued under these sections shall be returned to the department if the place of business:(1) ceases business or otherwise ceases operation on a permanent basis;(2) relocates;(3) changes the name of the business under which the salvage establishment or salvage broker operates; or(4) changes ownership. Source Note: The provisions of this §229.635 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.635 Licensing Requirements and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118493&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118493 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118493&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118493 03/11/2026 (a) Licensing fees.(1) All applicants for a license or a renewal license must pay a license fee. All fees are nonrefundable. The license fees are as follows:(A) $600 for a one-year license; or(B) $1,200 for a two-year license.(2) Delinquency fee. A salvage establishment or salvage broker must pay a $100 delinquency fee if:(A) the renewal license application is submitted or the renewal license fee is paid after the expiration date of the current license; or(B) the initial license application is submitted or the initial license fee is paid more than 30 days following the effective date of a change in location, name, or ownership of an existing salvage establishment or salvage broker as described in §229.635(o) of this title (relating to Licensing Requirements and Procedures).(3) Reinspection fee. A salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to §229.644 of this title (relating to Enforcement and Penalties), shall pay a nonrefundable inspection fee of $600.(b) Consolidation of license terms. The department may, upon receipt of a written request from a license holder, prorate a license fee for the purpose of consolidating the license renewal dates of multiple licenses issued in the name of the license holder.(c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person is a nonprofit organization, as described in the Internal Revenue Code of 1986, §501(c)(3), as amended, or a nonprofit affiliate of the organization, to the extent otherwise permitted by law.(d) Texas Online. Applicants may submit applications and renewal applications for a license under these sections electronically by the Internet through Texas Online at www.texasonline.state.tx.us. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online. Source Note: The provisions of this §229.636 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.636 Licensing Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118494&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118494 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118494&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118494 03/11/2026 (a) Employee health requirements. No person known to be or suspected of being affected with any communicable disease, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, or respiratory infection, shall work in an area of a salvage establishment or for a salvage broker in any capacity when there is any possibility of such person contaminating salvageable or salvaged cosmetics with pathogenic organisms, or transmitting disease to other individuals.(b) Personal cleanliness.(1) All personnel while working in direct contact with salvageable cosmetics or while engaged in reconditioning, repacking, or otherwise handling any components or accessories of salvageable cosmetics shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty.(2) Personnel engaged in reconditioning salvageable cosmetics shall wash their hands thoroughly in a department approved hand-washing facility before starting work, and as often as may be necessary to remove soil and contamination.(3) No person shall resume work after visiting the toilet room without first washing their hands. Source Note: The provisions of this §229.637 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.637 Personnel https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118495&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118495 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118495&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118495 03/11/2026 (a) Buildings. Buildings used by salvage establishments and salvage brokers shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.(b) Floor construction.(1) The floor surfaces in all rooms and areas in which salvageable or salvaged cosmetics are stored or processed and in which tools or equipment are washed, and walk-in refrigerators, dressing or locker rooms and toilet rooms, shall be constructed to be smooth and easily cleanable.(2) Any floor that is exposed to water or liquids shall be nonabsorbent.(3) All floors shall be kept clean and in good repair.(4) Floor drains shall be provided in all rooms where floors are subjected to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.(c) Walls and ceilings. Walls and ceilings of all rooms shall be clean, smooth, and in good repair.(d) Lighting. Appropriate lighting shall be provided in handwashing areas, dressing and locker rooms, and toilet rooms and in all areas where salvageable or salvaged cosmetics are examined, processed, or stored and where equipment or tools are cleaned.(1) Where personnel are inspecting, sorting, or reconditioning distressed cosmetics, at least 540 lux (50 foot candles) of light shall be provided at the work surface.(2) At all other areas of the facility where light is required, at least 110 lux (ten foot candles) of light shall be provided when measured at a distance of 30 inches above the floor.(e) Ventilation.(1) All rooms, in which salvageable or salvaged cosmetics are reconditioned or utensils are washed, dressing or locker rooms, toilet rooms, and garbage and refuse storage areas shall be well ventilated.(2) Ventilation hoods and related equipment shall be designed to prevent condensation from dripping onto salvageable cosmetics or onto work surfaces.(3) Filters shall be readily removable for cleaning or replacement.(4) Ventilation systems shall comply with applicable federal, state, and local fire prevention and air pollution requirements.(f) Locker area. Appropriate facilities shall be provided for the orderly storage of personnel clothing and personal belongings.(g) Cleanliness of facilities.(1) All parts of the salvage establishment or salvage warehouse and its premises shall be kept neat, clean, and free of litter and refuse.(2) Cleaning operations shall be conducted in such a manner as to prevent contamination of salvageable and salvaged cosmetics.(3) None of the operations connected with a salvage establishment or salvage warehouse shall be conducted in any room used as a personnel lounge or toilet facility, or living or sleeping quarters.(4) Soiled coats and aprons shall be kept in suitable containers until removed for laundering.(5) No birds or animals shall be allowed in any areas used for the conduct of salvage establishment operations or the storage of salvageable and salvaged cosmetics, except that guide dogs accompanying blind persons shall be permitted in sales areas.(h) Vehicles. Vehicles used to transport distressed, salvageable, or salvaged cosmetics shall be maintained in a clean and sanitary condition to protect the product from contamination. Source Note: The provisions of this §229.638 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.638 Construction and Maintenance of Physical Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118496&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118496 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118496&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118496 03/11/2026 (a) Water supply. The water supply shall be adequate, of a safe and sanitary quality, and from a source constructed and operated in accordance with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(b) Sewage. All sewage, including liquid waste, shall be disposed of in a public sewerage system or, in the absence thereof, in a manner applicable with the Minimum Standards of Sanitation and Health Protection, Health and Safety Code, Chapter 341, and rules promulgated under this chapter.(c) Plumbing. Plumbing shall be sized, installed, and maintained in accordance with applicable state and local plumbing codes.(d) Toilet facilities.(1) Each salvage establishment shall provide its personnel with adequate and conveniently located toilet facilities.(2) Toilet facilities, including rooms and fixtures, shall be kept in a clean condition and in good repair at all times.(3) All toilet rooms shall be self-closing.(4) Toilet tissue shall be provided.(5) Easily cleanable covered receptacles shall be provided for waste materials in all toilet rooms.(6) Where the use of non-water-carried sewage disposal facilities are approved by the department they shall be located at least 100 linear feet from the salvage establishment and from any well or stream.(e) Hand-washing facilities. Each salvage establishment shall be provided with adequate, conveniently located hand-washing facilities for its personnel, including a lavatory or lavatories equipped with hot and cold or tempered running water, hand-cleansing soap or detergent, and approved sanitary towels or other approved hand-drying devices. Such facilities shall be kept clean and in good repair.(f) Garbage and refuse.(1) All organic or organic-containing refuse shall be kept in leak proof, non-absorbent containers which shall be kept covered with tight-fitting lids when filled or stored, or not in continuous use. Such containers shall be covered when stored and stored in either a vermin-proof room or enclosure or in a waste refrigerator. Paper, cardboard, unused equipment, and non-organic refuse shall be stored in containers, rooms, or areas in such a manner to prevent it from becoming a source of contamination or pest harborage.(2) Adequate cleaning facilities shall be provided, and each container, room, or area shall be thoroughly cleaned after the emptying or removal of refuse.(3) All refuse shall be disposed of with sufficient frequency and in such a manner as to prevent contamination.(4) All refuse shall be disposed of in accordance with all applicable state and local requirements, including requirements for solid waste disposal as referenced in Title 30, Texas Administrative Code, Chapters 330, 335, and 336.(g) Insect and rodent control. Effective measures shall be taken to protect against the entrance, breeding or presence of rodents, insects, and other vermin within the salvage establishment or salvage warehouse. Source Note: The provisions of this §229.639 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.639 Sanitary Facilities and Controls https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118497&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118497 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118497&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118497 03/11/2026 (a) Notice to the department.(1) When the source of distressed cosmetics is the result of a natural disaster, accident, power failure, or other emergency, the salvage establishment or salvage broker shall make contact with the department within 24 hours after their initial awareness of the emergency and prior to any removal of distressed cosmetics from the place at which it was located when it became distressed.(2) If emergency removal of distressed cosmetics referenced in subsection (a)(1) of this section is required, notice to the department shall be made as soon thereafter as possible. It shall be the duty of the salvage establishment or salvage broker to make contact with the department within 48 hours whenever distressed cosmetics subject to the provisions subsection (a)(1) of this section are obtained.(3) Distressed cosmetics referenced in this subsection shall not be moved out of the State of Texas without prior approval of the department and the responsible state agency in the state to receive the cosmetics. Concurrence shall also be obtained from the U.S. Food and Drug Administration prior to interstate movement.(b) Protection of salvageable and salvaged cosmetics.(1) All salvageable and salvaged cosmetics stored by salvage establishments or salvage brokers shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such cosmetics.(2) All salvageable and salvaged cosmetics, while being stored or processed at a salvage establishment, salvage warehouse, or during transportation, shall be protected from contamination.(3) Poisonous and toxic materials shall be identified and handled under such conditions as will not contaminate other salvageable or salvaged cosmetics, or constitute a hazard to personnel.(c) Segregation of cosmetics. All salvageable cosmetics shall be promptly sorted and segregated from nonsalvageable cosmetics to prevent further contamination of the distressed cosmetics to be salvaged or offered for sale or distribution.(d) Nonsalvageable cosmetics.(1) Containers, including metal and glass containers with press caps, screw caps, pull rings, or other types of openings which have been in contact with nonpotable water, liquid foam, or other deleterious substances, as a result of fire fighting efforts, flood, sewer backups, or similar mishaps, shall be deemed unfit for sale or distribution, i.e., nonsalvageable cosmetics as defined in §229.633(18) of this title (relating to Definitions).(2) Nonsalvageable cosmetics shall be disposed of as in §229.639(f)(4) of this title (relating to Sanitary Facilities and Controls) or §229.641(b) of this title (relating to Handling Distressed Cosmetics); or by delivery to a waste reclamation (recycling) facility for destruction.(3) Distressed cosmetics which are deemed to be nonsalvageable by a duly authorized agent of the department shall, at the request of the agent, be destroyed under the supervision of that agent at the expense of the owner.(e) Transporting of distressed cosmetics.(1) Distressed cosmetics shall be moved from the site of a fire, flood, sewer backup, wreck, or other cause as expeditiously as possible after compliance with subsection (a) of this section, if applicable, so as not to become hazardous to public health.(2) All distressed cosmetics of a temperature sensitive nature shall be transported only in vehicles capable of maintaining adequate temperatures, if necessary, for product integrity prior to reconditioning.(f) Handling of distressed articles other than cosmetics. If distressed articles other than cosmetics are also salvaged, they shall be handled separately so as to prevent contamination from poisonous and toxic materials or other contaminants.(g) Cross-contamination protection. Sufficient precautions shall be taken to prevent cross-contamination among the various types of cosmetics that are salvageable or salvaged(h) Reconditioned cosmetics. All reconditioned cosmetics must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(i) Labeling. All salvaged cosmetics must be labeled in accordance with the requirements of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq. as amended; the Fair Packaging and Labeling Act, 15 U.S.C., §1451 et seq. as amended; and the federal regulations promulgated under those Acts.(j) Salvage warehouses. A person may not use a salvage warehouse to recondition cosmetics or sell to consumers. Source Note: The provisions of this §229.640 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.640 General Provisions for Handling and Movement of Distressed Cosmetics https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118498&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118498 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118498&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118498 03/11/2026 (a) Good manufacturing practices. A person must follow and comply with the requirements in 21 CFR, Part 701, titled "Cosmetic Labeling" and 21 CFR, Part 740, titled "Cosmetic Product Warning Statements" as amended, in the handling and reconditioning of all salvaged cosmetics.(b) Distressed or nonsalvageable cosmetics. All distressed or nonsalvageable cosmetics shall be destroyed.(c) Relabeling. All salvaged cosmetics in containers shall be provided with labels meeting the requirements in §229.640(i) of this title (relating to General Provisions for Handling and Movement of Distressed Cosmetics). When original labels are removed from containers that are to be resold or redistributed, the replacement labels must show the name and address of the salvage establishment. Source Note: The provisions of this §229.641 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.641 Handling Distressed Cosmetics https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118499&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118499 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118499&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118499 03/11/2026 (a) Inventory Records. A written record or receipt of distressed, salvageable, and salvaged cosmetics shall be maintained by the salvage establishment or salvage broker and shall include:(1) the common name including brand name or manufacturer and quantity of the cosmetics received;(2) the source of the distressed, salvageable, and salvaged cosmetics;(3) the date received;(4) a brief description of the type or cause of damage (fire, flood, wreck, prolonged storage, warehouse damage, etc.); and(5) the name of the individual or business that purchases any such cosmetics for the purpose of sale or distribution and the date of any such transaction.(b) Retention of records. All records required in these sections shall be kept at the place of business of the salvage establishment or salvage broker for a period of two years following the completion of transactions involving a lot of cosmetics.(c) Electronic records. Records required by these sections which are maintained by the salvage establishment or salvage broker on computer systems shall be regularly copied, at least monthly, and updated on storage media other than the hard drive of the computer. An electronic record must be retrievable as a printed copy. Source Note: The provisions of this §229.642 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.642 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118500&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118500 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118500&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118500 03/11/2026 (a) Inspection. To enforce these sections or the Act, the commissioner or an authorized agent may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:(1) enter at reasonable times the place of business of a salvage establishment or salvage broker;(2) enter a salvage warehouse used to store or hold distressed or salvaged cosmetics;(3) enter a vehicle being used to transport or hold distressed or salvaged cosmetics; or(4) inspect at reasonable times, any place of business of a salvage establishment or salvage broker, salvage warehouse, or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.(b) Access to records. A person who is required to maintain records referenced in these sections or under the Act or a person who is in charge or custody of those records shall, at the request of the commissioner or an authorized agent, permit the commissioner or authorized agent at all reasonable times access to review, copy, and verify the records.(c) Access to records showing movement in commerce. A person who is subject to licensing under §229.635 of this title (relating to Licensing Requirements and Procedures) or a person, including a common carrier or a common carrier's agent, who disposes of or otherwise transfers distressed or salvaged cosmetics shall, at the request of the commissioner or an authorized agent, permit the commissioner or authorized agent at all reasonable times access to review, copy, and verify all records showing:(1) the movement in commerce of any distressed or salvaged cosmetic;(2) the holding of any distressed or salvaged cosmetic after movement in commerce; and(3) the quantity, shipper, and consignee of any distressed or salvaged cosmetics.(d) Receipt for samples. The commissioner or an authorized agent who makes an inspection of a place of business, including any vehicle or salvage warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, shall give to the owner, operator, or the owner's or operator's agent a receipt describing the sample. Source Note: The provisions of this §229.643 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.643 Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118501&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118501 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118501&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118501 03/11/2026 (a) General license actions. The department may deny, suspend, or revoke the license of an applicant or licensee who fails to comply with any one of the following:(1) failure to comply with the Act or these sections;(2) falsification of information provided in an application for a license;(3) refuses to allow the department to conduct an inspection or collect samples;(4) interferes with the department in the performance of its duties;(5) removes or disposes of a detained cosmetic in violation of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, §431.021; or(6) fails to inform the department of any salvage warehouse(s) at the time of an inspection or when requested by the department.(b) Emergency license suspensions.(1) The department may suspend a license without notice when there is an imminent threat to the health or safety of the public.(2) If an emergency suspension order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be held under departmental formal hearing rules governed by §§1.21, 1.23, 1.25 and 1.27 of this title (relating to Formal Hearing Procedures).(c) Hearings.(1) Any hearings for the denial, suspension, or revocation of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(2) Within 20 days after the postmark date of the department's written notice of proposed denial, suspension, or revocation, the applicant or licensee may request a hearing in writing from the department. If the applicant or licensee does not request a hearing during the required time period, then the applicant or licensee is deemed to have waived his/her right to a hearing.(d) Reinstatement of license.(1) A person whose application for a license has been denied or whose license has been placed under an emergency suspension may request a reinspection for the purpose of granting or reinstating a license not later than the 30th day after the denial or emergency suspension. Not later than the tenth day after the receipt of a written request from the applicant or licensee, the department shall make a reinspection.(2) As regards a nonemergency suspension or a revocation, the licensee may request at any time, an inspection for reinstating the license or for issuing a new license.(3) If, after inspection, the department determines that the applicant or licensee meets the requirements of the Act or these sections, the department shall reinstate the license or issue a new license, as appropriate.(4) Reinspection fee. Except as provided for in §229.636(c) of this title (relating to Licensing Fees), a salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to this section shall pay a nonrefundable inspection fee of $600.(e) Emergency order.(1) General. The commissioner or the commissioner's designee may issue an emergency order, either mandatory or prohibitory, concerning the sale or distribution of distressed cosmetics in the department's jurisdiction if the commissioner or the commissioner's designee determines that:(A) the sale or distribution of those cosmetics creates or poses an immediate and serious threat to human life or health; and(B) other procedures available to the department to remedy or prevent the threat will result in unreasonable delay.(2) Absence of notice and hearing. The commissioner or the commissioner's designee may issue the emergency order without notice and hearing if the commissioner or the commissioner's designee determines it is necessary under the circumstances.(3) Hearings. If an emergency order is issued without a hearing, the department shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be governed by §§1.21, 1.23, 1.25 and 1.27 of this title (relating to Formal Hearing Procedures).(f) Administrative penalty. If a person violates these sections, or an order adopted or license issued under the Act, the commissioner may assess an administrative penalty against the person.(1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.(2) In determining the amount of the penalty, the commissioner shall consider the following criteria:(A) the person's previous violations;(B) the seriousness of the violation;(C) any hazard to the health and safety of the public;(D) the person's demonstrated good faith; and(E) other matters as justice may require.(3) Violations subject to this subsection shall be categorized into severity levels as determined in §229.261 of this title (relating to Assessment of Administrative Penalties).(4) Hearings, appeals from, and judicial review of final administrative decisions under this subsection shall be conducted according to the contested case provisions of the Government Code, Chapter 2001, and §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(5) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.(6) If a hearing is held, the commissioner shall make findings of fact and shall issue a written decision regarding the occurrence of the violation and the amount of the penalty.(7) If the person charged with the violation does not request a hearing, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.(8) After making a determination under this subsection that a penalty is to be assessed, the commissioner shall issue an order requiring that the person pay the penalty.(9) The commissioner may consolidate a hearing held under this subsection with another proceeding.(10) Not later than the 30th day after the date of issuance of an order finding that a violation has occurred, the commissioner shall inform the person against whom the order is issued of the amount of the penalty. Source Note: The provisions of this §229.644 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11986. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG DD REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS §229.644 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210339&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210339 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210339&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210339 03/11/2026 (a) Purpose. The purpose of this section is to implement Texas Health and Safety Code, Chapter 437, related to cottage food production operations, which requires the department to adopt rules for labeling and production of foods by cottage food production operations.(b) Definitions. The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Acidified canned goods--Food with a finished equilibrium pH value of 4.6 or less that is thermally processed before being placed in an airtight container.(2) Baked good--A food item prepared by baking the item in an oven, which includes cookies, cakes, breads, Danishes, donuts, pastries, pies, and other items that are prepared by baking.(3) Cottage food production operation (operator)--An individual, operating out of the individual's home, who:(A) produces at the individual's home:(i) a baked good that is not a time and temperature control for safety food (TCS food), as defined in paragraph (13) of this subsection;(ii) candy;(iii) coated and uncoated nuts;(iv) unroasted nut butters;(v) fruit butters;(vi) a canned jam or jelly;(vii) a fruit pie;(viii) dehydrated fruit or vegetables, including dried beans;(ix) popcorn and popcorn snacks;(x) cereal, including granola;(xi) dry mix;(xii) vinegar;(xiii) pickled fruit or vegetables, including beets and carrots, that are preserved in vinegar, brine, or a similar solution at an equilibrium pH value of 4.6 or less;(xiv) mustard;(xv) roasted coffee or dry tea;(xvi) a dried herb or dried-herb mix;(xvii) plant-based acidified canned goods;(xviii) fermented vegetable products, including products that are refrigerated to preserve quality;(xix) frozen raw and uncut fruit or vegetables; or(xx) any other food that is not a TCS food, as defined in paragraph (13) of this subsection.(B) has an annual gross income of $50,000 or less from the sale of food described by subparagraph (A) of this paragraph;(C) sells foods produced under subparagraph (A) of this paragraph only directly to consumers; and(D) delivers products to the consumer at the point of sale or another location designated by the consumer.(4) Department--The Texas Department of State Health Services.(5) Executive Commissioner--The Executive Commissioner of the Texas Health and Human Services Commission.(6) Farm stand--A premises owned and operated by a producer of agricultural food products at which the producer or other persons may offer for sale produce or foods described in paragraph (3) of this subsection.(7) Farmers' market--A designated location used for a recurring event at which a majority of the vendors are farmers or other food producers who sell food directly to consumers. A farmers' market must include at least two vendors who meet the definition of "farmer" defined at §229.702(2) of this title (relating to Definitions) and may include vendors who meet the definition of "food producer" as defined at §229.702(6) of this title. In addition, a farmers' market may include vendors who are not "farmers" or "food producers," provided that "farmers" and "food producers" constitute the majority of vendors who participate in the market throughout the year.(8) Fermented vegetable product--A low-acid vegetable food product subjected to the action of certain microorganisms that produce acid during their growth and reduce the pH value of the food to 4.6 or less.(9) Food establishment--(A) Food establishment is an operation that:(i) stores, prepares, packages, serves, or vends food directly to the consumer, or otherwise provides food for human consumption, such as a restaurant, retail food store, satellite or catered feeding location, catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people, market, vending machine location, self-service food market, conveyance used to transport people, institution, or food bank; and(ii) relinquishes possession of food to a consumer directly, or indirectly through a delivery service, such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.(B) Food establishment includes:(i) an element of the operation, such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location, unless the vending or feeding location is permitted by the regulatory authority; and(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location and where consumption is on or off the premises, regardless of whether there is a charge for the food.(C) Food establishment does not include:(i) an establishment that offers only prepackaged foods that are not TCS foods;(ii) a produce stand that only offers whole, uncut fresh fruit and vegetables;(iii) a food processing plant, including one that is located on the premises of a food establishment;(iv) a cottage food production operation or home kitchen preparing non-TCS food for service at a religious or charitable function;(v) a bed and breakfast limited as defined in §228.223 of this title (relating to Bed and Breakfast); or(vi) a private home that receives catered or home-delivered food.(10) Herbs--The leafy green parts of a plant (either fresh or dried) used for culinary purposes and not for medicinal uses.(11) Home--A primary residence that contains a kitchen and appliances designed for common residential usage.(12) Process authority--A person who has expert knowledge acquired through appropriate training and experience in the pickling, fermenting, or acidification and processing of pickled, fermented, or acidified foods.(13) Time and temperature control for safety food (TCS food)--A food that requires time and temperature control for safety to limit pathogen growth or toxin production. The term includes a food that must be held under proper temperature controls, such as refrigeration, to prevent the growth of bacteria that may cause human illness. A TCS food may include a food that contains protein and moisture and is neutral or slightly acidic, such as meat, poultry, fish, and shellfish products, pasteurized and unpasteurized milk and dairy products, raw seed sprouts, baked goods that require refrigeration, including cream or custard pies or cakes, and ice products. The term does not include a food that uses TCS food as ingredients if the final food product does not require time or temperature control for safety to limit pathogen growth or toxin production.(c) Complaints. The department shall maintain a record of a complaint made by a person against an operator.(d) Packaging and labeling requirements for cottage food production operations. All foods prepared by an operator shall be packaged and labeled in a manner that prevents product contamination.(1) The label information shall include:(A) the name and physical address of the cottage food production operation;(B) the common or usual name of the product;(C) disclosure of any major food allergens, such as eggs, nuts, soy, peanuts, milk, wheat, fish, or shellfish used in the product; and(D) the following statement: "This food is made in a home kitchen and is not inspected by the Texas Department of State Health Services or a local health department."(2) Labels must be legible.(3) A food item is not required to be packaged if it is too large or bulky for conventional packaging. For these food items, the information required under paragraph (1) of this subsection shall be provided to the consumer on an invoice or receipt.(4) A label for frozen raw and uncut fruit or vegetables must include the following statement in at least 12-point font when sold: "SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria, keep this food frozen until preparing for consumption" on the label or on an invoice or receipt provided with the frozen fruit or vegetables.(5) Advertising media of cottage food products for health, disease, or other claims must be consistent with those claims allowed by the Code of Federal Regulations Title 21, Part 101, Subparts D, E, and F.(e) Certain sales by cottage food production operations prohibited or restricted.(1) An operator may not sell any of the foods described in this section at wholesale.(2) An operator may sell a food described in this section in this state through the internet or by mail-order only if:(A) the consumer purchases the food through the internet or by mail-order from the operator and the operator personally delivers the food to the consumer; and(B) subject to paragraph (3) of this subsection, before the operator accepts payment for the food, the operator provides all labeling information required by subsection (d) of this section to the consumer by:(i) posting a legible statement on the cottage food production operation's internet website;(ii) publishing the information in a catalog; or(iii) otherwise communicating the information to the consumer.(3) The operator that sells a food described by subsection (b)(3)(A) of this section in this state in the manner described by paragraph (2) of this subsection:(A) is not required to include the address of the cottage food production operation in the labeling information required under subsection (d)(1)(A) of this section before the operator accepts payment for the food; and(B) shall provide the address of the cottage food production operation on the label of the food in the manner required by subsection (d)(1)(A) of this section after the operator accepts payment for the food.(f) Requirements for sale of certain cottage food products.(1) An operator that sells to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods shall:(A) use a recipe that:(i) is from a source approved by the department under paragraph (4) of this subsection;(ii) has been tested by an appropriately certified laboratory that confirmed the finished fruit or vegetable product or plant-based acidified canned good has an equilibrium pH value of 4.6 or less; or(iii) is approved by a qualified process authority; or(B) if the operation does not use a recipe described by subparagraph (A) of this paragraph, test each batch of the recipe with a calibrated pH meter to confirm the finished fruit or vegetable product or plant-based acidified canned good has an equilibrium pH value of 4.6 or less.(2) An operator may not sell to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods before the operator complies with paragraph (1) of this subsection.(3) For each batch of pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods, an operator must:(A) label the batch with a unique number; and(B) for a period of at least 12 months, keep a record that includes:(i) the batch number;(ii) the recipe used by the producer;(iii) the source of the recipe or testing results, as applicable; and(iv) the date the batch was prepared.(4) The department shall:(A) approve sources for recipes that an operator may use to produce pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods; and(B) semiannually post on the department's internet website a list of the approved sources for recipes, appropriately certified laboratories, and qualified process authorities.(5) This subsection does not apply to a pickled cucumber preserved in vinegar, brine, or similar solution.(g) Requirements for the sale of frozen raw and uncut fruit or vegetables. An operator that sells to consumers frozen raw and uncut fruit or vegetables shall:(1) store and deliver the frozen raw and uncut fruit or vegetables at an air temperature of not more than 32 degrees Fahrenheit; and(2) label the frozen raw and uncut fruit or vegetables in accordance with subsection (d)(4) of this section.(h) A cottage food production operation is not exempt from meeting the application of Texas Health and Safety Code, §431.045, Emergency Order; §431.0495, Recall Orders; and §431.247, Delegation of Powers or Duties. The department or local health authority may act to prevent an immediate and serious threat to human life or health.(i) Prohibition for Cottage Food Production Operations. A cottage food production operation may not sell TCS foods to customers.(j) Production of Cottage Food Products - Basic Food Safety Education or Training Requirements.(1) An individual who operates a cottage food production operation must have successfully completed a basic food safety education or training program for food handlers accredited under Texas Health and Safety Code, Chapter 438, Subchapter D.(2) An individual may not process, prepare, package, or handle cottage food products unless the individual:(A) meets the requirements of paragraph (1) of this subsection;(B) is directly supervised by an individual described by paragraph (1) of this subsection; or(C) is a member of the household in which the cottage food products are produced. Source Note: The provisions of this §229.661 adopted to be effective July 22, 2012, 37 TexReg 5276; amended to be effective August 3, 2014, 39 TexReg 5759; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective January 1, 2020, 44 TexReg 7985; amended to be effective October 9, 2022, 47 TexReg 6583. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG EE COTTAGE FOOD PRODUCTION OPERATIONS §229.661 Cottage Food Production Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168070 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124750&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124750 03/11/2026 (a) Purpose. These sections establish definitions and standards for the processing and bottling of drinking and vended water. The sections also will supplement §§229.181 - 229.184 of this title (relating to Licensure of Manufacturers of Food and Wholesale Distributors of Food - Including Good Manufacturing Practices) and federal regulations in Title 21, Code of Federal Regulations, Part 165 concerning standards of quality, and Part 129 concerning processing and bottling of bottled drinking water.(b) Requirements for specific standardized beverages. The department adopts by reference Title 21 Code of Federal Regulations, §165.110 concerning the identity, nomenclature, other label statements and label declarations for both bottled and vended water, except as modified by the Texas Board of Health in §229.85(b) of this title (relating to Labeling and Advertising).(c) Definitions. The following words and terms, when used in this chapter, shall pertain to both bottled and vended water and shall have the following meanings unless the context clearly indicates otherwise.(1) Approved source (when used in reference to a plant's product water or operations water)--A source of water and the water therefrom, whether it be from a spring, artesian well, drilled well, municipal water supply, or any other source, that has been inspected and the water sampled, analyzed, and found to be of a safe and sanitary quality according to applicable laws and regulations of State and local government agencies having jurisdiction. The presence in the plant of current certificates or notifications of approval from the government agency or agencies having jurisdiction constitutes approval of the source and the water supply.(2) Artesian water--Water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer is "artesian water" or "artesian well water."(3) Bottled water--Water that is intended for human consumption and that is sealed in bottled or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents.(4) Department--Department of State Health Services.(5) Distilled water--Water which has been produced by a process of distillation and meets the definition of purified water in the United States Pharmacopeia, 23rd revision, January 1, 1995, which the department adopts by reference. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852).(6) Drinking water--All water from the point of the approved source intended for the purpose of human consumption or which may be used in the preparation of foods or beverages.(7) Fluoridated water--Water containing added fluoride.(8) Ground water--Water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure.(9) Mineral water--Water containing not less than 250 parts per million (ppm) total dissolved solids (TDS), coming from a source tapped at one or more bore holes or springs, originating from a geologically or physically protected underground water source.(10) Person--Includes individual, partnership, corporation, or association.(11) Purified water--Water that has been produced by distillation, deionization, reverse osmosis, or other suitable processes and that meets the definition of "purified water" in the United States Pharmacopoeia, 23rd revision, January 1, 1995, which the department adopts by reference. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852).(12) Sparkling bottled water--Water that after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide that it had at emergence from the source.(13) Spring water--Water derived from an underground formation from which water flows naturally to the surface of the earth.(14) Sterile water or sterilized water--Water that meets requirements under "Sterility Tests" in the United States Pharmacopeia, 23rd revision, January 1, 1995, which the department adopts by reference. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852).(15) Vended water--Vended water is:(A) water dispensed from any vending machine; or(B) servings of water dispensed in bulk by any operator or consumer from any water dispensing device.(16) Vending machine--Any self-service device which upon insertion of a coin, coins, or token, or upon receipt of payment by other means, dispenses servings of water in bulk, without the necessity of refilling the machine between each operation.(17) Water dispensing device--Any water unit that dispenses water in bulk without the necessity of refilling the machine between operations. This term includes stores that are manned by an operator at all times in which consumers bring containers to be filled by the operator, facilities that are not manned by an operator and where consumers dispense their own water, and vending machines. A water dispensing device may have several dispensing faucets in the case of a store. However, each vending machine is considered a separate water dispensing device.(18) Well water--Water taken from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer.(d) Other requirements for specific standardized beverages.(1) Artesian water may be collected with the assistance of external force to enhance the natural underground pressure. On request, a bottler or vendor shall demonstrate to the department that the water level stands at some height above the top of the aquifer.(2) For bottled water or drinking water, fluoride may be optionally added within the limitations established in 21 Code of Federal Regulations (CFR) Part 165.110(b)(4)(ii). Bottled water may be used as an ingredient in beverages (e.g., diluted juices, flavored bottled waters). It does not include those food ingredients that are declared in ingredient labeling as "water," "carbonated water," "disinfected water," "filtered water," "seltzer water," "soda water," "sparkling water," and "tonic water." The processing and bottling of bottled water shall comply with applicable regulations in 21 CFR, Part 129.(3) For fluoridated water, the total fluoride content levels cannot exceed levels contained in 21 CFR 165.110(b)(4)(ii).(4) Ground water must not be under the direct influence of surface water as defined in 40 CFR 141.2.(5) Mineral water shall be distinguished from other types of water by its constant level and relative proportions of minerals and trace elements at the point of emergence from the source, due account being taken of the cycles of natural fluctuations. No minerals may be added to this water.(6) Water processed by demineralization that meets the purified water definition may alternatively be called "demineralized water." Alternatively, water that has been processed by deionization may be called "deionized water," and water processed by distillation may be called "distilled water," and water that has been processed by reverse osmosis may be called "reverse osmosis water." Also, if the water has been processed by either of the previously listed methods the water may be called "(blank) drinking water," with the blank being filled in with one of the defined terms describing the method of processing.(7) Spring water shall be collected only at the spring or through a bore hole tapping the underground formation feeding the spring. There shall be a natural force causing the water to flow to the surface through a natural orifice. The location of the spring shall be identified. Spring water collected with the use of an external force shall be from the same underground stratum as the spring, as shown be a measurable hydraulic connection using a hydrogeologically valid method between the bore hole and the natural spring, and shall have all the physical properties, before treatment, and be of the same composition and quality, as the water that flows naturally to the surface of the earth. If spring water is collected with the use of an external force, water must continue to flow naturally to the surface of the earth through the spring's natural orifice. Source Note: The provisions of this §229.81 adopted to be effective September 12, 1988, 13 TexReg 4336; amended to be effective June 11, 1990, 15 TexReg 3013; amended to be effective November 19, 1996, 21 TexReg 11371; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.81 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124751&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124751 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124751&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124751 03/11/2026 Bottled water must be sampled in accordance with the compliance procedures of Title 21, Code of Federal Regulations, Part 129. All required analyses must be performed by a laboratory acceptable to the department, certified by the U.S. Environmental Protection Agency (EPA), or certified by the primacy enforcement authority in any state which has been granted primacy by EPA or certified by a third party organization acceptable to a primacy state. Source Note: The provisions of this §229.82 adopted to be effective September 12, 1988, 13 TexReg 4336; amended to be effective November 19, 1996, 21 TexReg 11371; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.82 Sampling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124752&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124752 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124752&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124752 03/11/2026 (a) Water that is distributed by truck or trailer in lieu of distribution piping, shall comply with the Health and Safety Code, Chapter 431, Subchapter C, concerning drinking water standards and rules adopted thereunder by the Texas Commission on Environmental Quality, 30 Texas Administrative Code (TAC), §§290.44(i) (relating to Water Distribution).(b) A person receiving water transported by truck or trailer shall test and record the chlorine residual for compliance with the required minimum chlorine residual (30 TAC, §290.44(i)(2)(K)).(c) Operational records detailing the amount of water received, the source of the water, and the chlorine residual readings, shall be maintained by the person receiving water that has been transported by truck or trailer. The records shall be kept at the receiving facility for a period of two years and be available for inspection upon request. Source Note: The provisions of this §229.83 adopted to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.83 Water Hauling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124753&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124753 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124753&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124753 03/11/2026 Bottled and vended water production including transporting, processing, packaging, and storage, shall be conducted under such standards and controls as are necessary to minimize the potential for microbiological contamination of the finished product. These standards and controls shall include the following.(1) Bottled and vended water shall be subject to effective germicidal treatment by ozonation, chlorination, exposure to ultraviolet light, or other equivalent disinfection approved by the department.(2) Bottled and vended water shall not be transported or stored in bulk tanks or processed through equipment or lines used for any non-food product.(3) In order to minimize the potential for microbiological contamination of the finished product, non-carbonated bottled water shall not be transported, stored, processed, or bottled in or through lines through which has passed milk, fruit juice, or other food products likely to contribute nutrients for microbial growth. However, multifood fillers may be used for the filling of bottled water as long as the fillers are properly cleaned and sanitized prior to the bottling of water, and provided that they are in compliance with Title 21, Code of Federal Regulations, §129.80. Any parts which are not designed to be cleaned-in-place shall be disassembled and removed, and shall be cleaned and sanitized prior to reassembly. Source Note: The provisions of this §229.84 adopted to be effective September 12, 1988, 13 TexReg 4336; amended to be effective November 19, 1996, 21 TexReg 11371; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.84 Standards for Microbiological Control https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124754&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124754 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124754&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124754 03/11/2026 (a) Claims of medicinal and health-giving properties shall not be placed on labels and references shall not be made to bacterial purity or to laboratory examinations which may have been made by department laboratories.(b) The label must state the source of all artesian water, spring water, mineral water, well water, or drinking water sold. Source refers to the point of origin. Examples: Brook Hollow Spring Water from Buck Hollow, Arkansas; drinking water obtained from Austin municipal water supply, Austin, Texas; well water from Bandera, Texas. Except that water processed by distillation, deionization, reverse osmosis, or other suitable process that alters the water's physical properties enabling it to meet the definition of purified as defined in §229.81(c)(11) of this title (relating to General Provisions) is not required to state the source. This exception only applies if all the water used in the finished product is processed to meet the definition of purified.(c) Other label statements.(1) If the Total Dissolved Solids (TDS) content of Mineral water is below 500 ppm, or if it is greater than 1,500 ppm, the statement "low mineral content" or the statement "high mineral content," respectively, shall appear on the principal display panel following the statement of identity in type size at least one-half the size of the statement of identity but in no case less that one-sixteenth of an inch. If the TDS of mineral water is between 500 and 1,500 ppm, no additional statement need appear.(2) When the label or labeling of a bottled water product states or implies (e.g., through label statements or vignettes with reference to infants) that the bottled water is for use in feeding infants, and the product is not commercially sterile, the product label shall bear conspicuously and on the principal display panel the statement "Not sterile. Use as directed by physician or by labeling directions for use of infant formula." Source Note: The provisions of this §229.85 adopted to be effective September 12, 1988, 13 TexReg 4336; amended to be effective November 19, 1996, 21 TexReg 11371; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.85 Labeling and Advertising https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124755&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124755 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124755&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124755 03/11/2026 (a) Water dispensing device requirements are as follows.(1) Any device from which any operator or consumer dispenses servings of water in bulk shall comply with Title 21, Code of Federal Regulations (CFR), §129.40, Equipment and Procedures, and §165.110, Requirements for Specific Standardized Beverages. Except §129.40, the provision pertaining to the cleaning, sanitizing, filling, and capping or sealing of containers shall not apply to containers furnished by the consumer.(2) Water dispensing devices shall:(A) be designed and constructed to permit thorough cleaning, sanitization, and maintenance of all exterior and interior surfaces and component parts;(B) have all parts and surfaces that come into contact with the water constructed of corrosion-resistant, and nonabsorbent material acceptable to the department and capable of withstanding repeated cleaning and sanitizing treatment;(C) be designed so all treatment of the water by distillation, ion-exchange, filtration, ultraviolet light, reverse osmosis, mineral addition, or any other acceptable process is done in an effective manner;(D) have an effective system of collection and handling of drip, spillage, and overflow of water;(E) have a backflow prevention device approved by the department or local authority for all connections with the water supply;(F) disinfect water by ultraviolet light or other method approved by the department immediately prior to delivery into the customer's container;(G) comply with the American Water Works Association (AWWA) specifications for granular activated carbon if used in the treatment of potable water (AWWA B604-74);(H) be maintained in a clean and sanitary condition; and(I) be free from dirt and vermin.(b) Vending machines, in addition to requirements in subsection (a) of this section, shall:(1) have a recessed or guarded corrosion-resistant dispensing spout;(2) be equipped with monitoring devices designed to shut down operation of the machine when the disinfection unit fails to function;(3) be equipped with a self-closing, tight-fitting door on the vending compartment;(4) be located in an area that can be maintained in clean condition and in a manner that avoids insect and rodent harborage; and(5) display in a position clearly visible to customers, the following information:(A) the name and address of the operator;(B) a statement to the effect that the water is obtained from an approved source; and(C) a local or toll-free telephone number that may be called for further information, service, or complaints.(c) Service, sampling and records shall meet the following requirements.(1) All parts and surfaces of the water dispensing device shall be maintained in clean condition by the vended water operator. The dispensing chamber and dispensing nozzle shall be cleaned and sanitized each time the device is serviced; whereas, all surfaces in contact with the vended water shall be maintained as a deposit free, visibly clean system. A record of cleaning and maintenance operations shall be kept by the operator for each water dispensing device for a period of two years and be available for inspection upon request.(2) The vended water from each water dispensing device shall have a bacteriological analysis conducted a minimum of once every 90 calendar days and if required by the department, shall also be analyzed for other physical, chemical, or microbiological parameters.(A) Sample results reported as coliform positive or unsuitable for analysis shall be submitted by facsimile to the department within 24 hours of receipt of the sample results from a laboratory acceptable to the department. The person shall submit the results to the Foods Group, Policy/Standards/Quality Assurance Unit by facsimile at (512) 834-6681, or by e-mail at Feedback.MFD@dshs.state.tx.us.(B) The person operating a water dispensing device shall maintain the original of all sample results for a period of two years. The drinking water analyses shall be performed by a laboratory acceptable to the department. A copy of the analysis shall be available for review and copying during inspections.(3) Each person operating a water dispensing device shall maintain a written maintenance program. The written maintenance program shall include written servicing instructions for the operator; technical manuals for the machine and water treatment appurtenances involved; and records of service. The written maintenance program shall be available for inspection by the department.(4) The vended water operator shall clean and perform servicing of the water vending machine a minimum of once per month.(A) More frequent cleaning and servicing may be required to maintain sanitation or as required by the manufacturer of the equipment.(B) Sampling results of positive coliform or unsuitable for analysis are indications that servicing of machine may be required at a higher frequency than once per month as detailed in paragraph (5) of this subsection.(5) Methods of testing for maximum contaminant levels (MCLs) for microbiological contaminants in water dispensed from water dispensing devices shall be performed as follows:(A) if any sample collected from a water dispensing device is determined to be unsatisfactory for any reason (i.e. coliform positive or unsuitable for analysis), the operator shall notify the department in accordance with paragraph (2)(A) of this subsection; and(B) the water dispensing device shall be cleaned, sanitized and resampled immediately. Until the sample results are known the device shall remain out of service; and(C) if after being cleaned and sanitized, the vended water is determined to be unsatisfactory, the machine shall remain out of service until the source of the contamination has been located and corrected and a negative sample obtained. The negative sample result shall be maintained in accordance with paragraph (2)(B) of this subsection. Source Note: The provisions of this §229.86 adopted to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.86 Processing of Vended Water https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124756&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124756 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124756&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124756 03/11/2026 Sources in Texas shall comply with the following requirements.(1) Public water systems. Sources in Texas which are public water systems shall comply with the Texas Health and Safety Code, Chapter 341, Subchapter C, concerning drinking water standards and rules adopted by the Texas Commission on Environmental Quality, at 30 Texas Administrative Code (TAC), §§290.101 - 290.122 (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Supply Systems), and §§290.38 - 290.47 (relating to Rules and Regulations for Public Water Systems).(2) Other sources. Any other sources in Texas shall comply with 30 TAC §§290.101 - 290.121 concerning drinking water standards, and 30 TAC §§290.38 - 290.43 and 290.46 concerning rules and regulations for public water systems, except where variances are permitted in §229.81 of this title (relating to General Provisions).(3) Compliance with these sections is required as if the source were a public water system. Source Note: The provisions of this §229.87 adopted to be effective February 7, 2000, 25 TexReg 798; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.87 Requirements for Approved Sources https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124757&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124757 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124757&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124757 03/11/2026 A person may not furnish bottled or vended water to the public or for distribution to the public unless the bottled or vended water operator holds a certificate under this chapter.(1) A person may not furnish bottled water to the public or for distribution to the public unless the processing, bottling and distribution of the bottled water is performed by or under the full-time supervision of a bottled and vended water operator who holds a certificate under this chapter.(2) A person may not furnish vended water to the public or for distribution to the public unless the processing, bottling and distribution of the vended water is performed by or under the guidance and control of a bottled and vended water operator who holds a certificate under this chapter. Source Note: The provisions of this §229.88 adopted to be effective February 7, 2000, 25 TexReg 798; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.88 Certificates of Competency https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124758&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124758 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124758&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124758 03/11/2026 (a) After payment of the required fee, an applicant shall pass a written examination prescribed by the department. To pass the examination for a certificate, the applicant must achieve a score of 70% or more on the examination.(1) The examination must be taken within 90 days of the date the department receives the fee. If the 90-day time frame lapses without the applicant taking the examination, the applicant must submit a new application and fee in order to take the examination.(2) If the applicant fails the examination, the applicant may repeat the examination 30 days after the failed examination. The applicant must reapply and pay a re-application fee of $50.(b) An instructor may administer the department's examination provided the instructor signs and complies with the department's security agreement. Source Note: The provisions of this §229.89 adopted to be effective February 7, 2000, 25 TexReg 798; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.89 Examination https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124759&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124759 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124759&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124759 03/11/2026 (a) This subsection applies to all new and renewal applications.(1) Certification fee--$100.(2) Renewal fee--$100.(3) A certificate can be obtained by submitting an application with the $100 certification fee and receiving a passing score on the examination. Certificates can be renewed by submitting a completed application with the $100 renewal fee. Certificates are valid for two years from the date of issuance or renewal. Certificates expire two years from the date of issuance. Fees will not be prorated. If the department has not received a completed application for renewal within 60 days following the expiration date, the certificate holder shall submit a new application and retake the examination.(b) An applicant or holder of a certificate shall pay the required fee before taking the examination or receiving a certificate.(c) All fees shall be made payable to the Department of State Health Services and are not refundable.(d) All applicants shall be in compliance with §1.301 of this title (relating to Suspension of License for Failure to Pay Child Support). Source Note: The provisions of this §229.90 adopted to be effective February 7, 2000, 25 TexReg 798; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective April 1, 2004, 29 TexReg 3228; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.90 Certification and Renewal Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124760&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124760 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124760&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124760 03/11/2026 (a) Basis for suspension. The certificate shall be suspended if the operator practices fraud or deceit against the department or the public; or fails to use reasonable care, judgment or application of knowledge in the performance of their duties.(b) Basis for denial. The certificate shall be denied if it is found:(1) that the application is incomplete or false;(2) that the operator obtained the certificate through fraud or deceit; or(3) that the operator practiced fraud or deceit; or failed to use reasonable care, judgment or application of knowledge in the performance of their duties.(c) Basis for revocation. The certificate shall be revoked if it is found:(1) that the certificate was issued in error;(2) that the operator obtained the certificate through fraud, deceit or through the submission of incorrect data on the application; or(3) that the operator practiced fraud and deceit, or failed to use reasonable care, judgment or application of knowledge in the performance of their duties.(d) Examination of charges. When the department has reason to believe that charges against an operator may be valid, the department shall notify the operator by personal service or certified mail at his last known address:(1) of the charges;(2) that it intends to conduct an examination of the charges; and(3) that the operator may request a formal hearing.(e) Formal hearings. The department shall conduct hearings in accordance with the Administrative Procedure Act, Texas Government Code §§2001.051 - 2001.902; and the department's formal hearing procedures in §§1.21, 1.23, 1.25 and 1.27 of this title (relating to Formal Hearing Procedures). Source Note: The provisions of this §229.91 adopted to be effective February 7, 2000, 25 TexReg 798; amended to be effective July 3, 2003, 28 TexReg 4908; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG F PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER §229.91 Suspension, Denial, or Revocation of Certificate https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124718&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124718 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168070 03/11/2026 (a) The purpose of this subchapter is to implement rules under Health and Safety Code, Chapter 437, as they relate to food temperature requirements and permits at farmers' markets.(b) This subchapter does not apply to a farmers' market in a county:(1) that has a population of less than 50,000; and(2) over which no local health department has jurisdiction.(c) A person who sells or provides samples of meat or poultry or food containing meat or poultry shall comply with Health and Safety Code, Chapter 433.(d) This section does not authorize the sale of or provision of samples of raw milk or raw milk products at a farmers' market. Source Note: The provisions of this §229.701 adopted to be effective August 3, 2014, 39 TexReg 5760. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG FF FARMERS' MARKETS §229.701 Purpose and Applicability https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210340&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210340 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210340&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210340 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Department--The Texas Department of State Health Services.(2) Farmer--A person or entity that produces agricultural products including, but not limited to, fruits, vegetables, fungi, grains, fiber, honey, dairy products, meat, poultry, or eggs, by practice of the agricultural arts upon land that the person or entity owns, rents, leases, or to which the person or entity otherwise has access.(3) Farmers' market--A designated location used for a recurring event at which a majority of the vendors are farmers or other food producers who sell food directly to consumers. A farmers' market must include at least two vendors who meet the definition of "farmer" as defined in paragraph (2) of this section and may include vendors who meet the definition of "food producer" as defined in paragraph (6) of this section. In addition, a farmers' market may include vendors who are not "farmers" or "food producers," provided that "farmers" and "food producers" constitute the majority of vendors who participate in the market throughout the year.(4) Fish--As defined in the U.S. Food and Drug Administration Food Code 2017 (Food Code) §1-201.10(B).(5) Food--An agricultural, apicultural, horticultural, silvicultural, viticultural, or vegetable product for human consumption, in either its natural or processed state, that has been produced or processed or otherwise has had value added to the product in this state. The term includes:(A) fish or other aquatic species;(B) livestock, a livestock product, or livestock by-product;(C) planting seed;(D) poultry, a poultry product, or a poultry by-product;(E) wildlife processed for food or by-products;(F) a product made from a product described in this paragraph by a farmer or other producer who grew or processed the product; or(G) produce.(6) Food producer--A person who grew, raised, processed, prepared, manufactured, or otherwise added value to the food product the person is selling. The term does not include a person who only packaged or repackaged a food product.(7) Potable water--Drinking water.(8) Poultry--A live or dead domesticated bird.(9) Produce--Fresh fruit or vegetables.(10) Sample--A bite-sized portion of food or foods offered free of charge to demonstrate its characteristics and does not include a whole meal, an individual portion, or a whole sandwich.(11) Time and temperature control for safety food (TCS food) (formerly Potentially Hazardous Food)--As defined in the Food Code §1-201.10(B). Source Note: The provisions of this §229.702 adopted to be effective August 3, 2014, 39 TexReg 5760; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective October 9, 2022, 47 TexReg 6583. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG FF FARMERS' MARKETS §229.702 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210341&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210341 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210341&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210341 03/11/2026 The department or the local health department may issue a permit to a farmer or food producer who sells food at a farmers' market. Regardless of what the permit is called, the following parameters from Texas Health and Safety Code §437.0065(c) apply. The permit:(1) must be valid for a term of not less than one year;(2) may impose an annual fee in an amount not to exceed $100.00 for issuance or renewal; and(3) must cover sales at all farmers' markets, farm stands, and farms within the jurisdiction of the permitting authority. Source Note: The provisions of this §229.703 adopted to be effective August 3, 2014, 39 TexReg 5760; amended to be effective October 9, 2022, 47 TexReg 6583. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG FF FARMERS' MARKETS §229.703 Permits https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210342&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210342 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=210342&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 210342 03/11/2026 (a) TCS food sold, distributed, or prepared on-site at a farmers' market, and TCS food transported to or from a farmers' market, shall meet the requirements of this section.(b) Frozen food. Stored frozen foods shall be maintained frozen.(c) Hot and cold holding. TCS food sold at, prepared on site at, or transported to or from a farm or farmers' market shall be maintained at:(1) 5 degrees Celsius (41 degrees Fahrenheit) or below; or(2) 54 degrees Celsius (135 degrees Fahrenheit) or above.(d) Cooking of raw animal foods. Raw animal foods shall be cooked to heat all parts of the food to the following applicable temperatures:(1) poultry, ground poultry, stuffing with poultry, meat, and fish to 74 degrees Celsius (165 degrees Fahrenheit) for < 1 second (instantaneous);(2) ground meat, ground pork, ground fish, and injected meats to 68 degrees Celsius (155 degrees Fahrenheit) for 17 seconds;(3) beef, pork, meat, fish, and raw shell eggs for immediate service to 63 degrees Celsius (145 degrees Fahrenheit) for 15 seconds;(4) prepackaged TCS food that has been commercially processed to 57 degrees Celsius (135 degrees Fahrenheit);(5) a raw or undercooked whole-muscle, intact beef steak may be served if:(A) the steak is labeled to indicate that it meets the definition of "whole-muscle, intact beef" as defined in the Food Code §1-201.10(B); and(B) the steak is cooked on both the top and bottom to a surface temperature of 63 degrees Celsius (145 degrees Fahrenheit) or above and a cooked color change is achieved on all external surfaces; and(6) raw animal foods cooked in a microwave oven shall be:(A) rotated or stirred throughout or midway during cooking to compensate for uneven distribution of heat;(B) covered to retain surface moisture;(C) heated to a temperature of at least 74 degrees Celsius (165 degrees Fahrenheit) in all parts of the food; and(D) allowed to stand covered for 2 minutes after cooking to obtain temperature equilibrium.(e) Cooking fruit and vegetables. Fruit and vegetables that are cooked shall be heated to a temperature of 57 degrees Celsius (135 degrees Fahrenheit).(f) Eggs. A farmer or egg producer that sells eggs directly to the consumer at a farm or farmers' market shall maintain the eggs at an ambient air temperature of 7 degrees Celsius (45 degrees Fahrenheit) as specified in the Food Code §3-501.16(B). Source Note: The provisions of this §229.704 adopted to be effective August 3, 2014, 39 TexReg 5760; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective October 9, 2022, 47 TexReg 6583. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG FF FARMERS' MARKETS §229.704 Temperature Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185023&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185023 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124718&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124718 03/11/2026 These sections supplement §§229.181 - 229.184 of this title (relating to Licensure of Food Manufacturers and Food Wholesalers - Including Good Manufacturing Practices and Good Warehousing Practices in Manufacturing, Packing and Holding Human Food) and §§229.211 - 229.222 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing or Holding Human Food). Source Note: The provisions of this §229.111 adopted to be effective March 19, 2001, 26 TexReg 2194; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG G MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE §229.111 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124719&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124719 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124719&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124719 03/11/2026 The following words and terms, when used in these sections, have the following meanings unless the context clearly indicates otherwise.(1) Approved laboratory--An approved laboratory is one which is acceptable to the department, certified by the U.S. Environmental Protection Agency (EPA) or certified by the primacy enforcement authority in any state which has been granted primacy by EPA or certified by a third party organization acceptable to a primacy state.(2) Approved source (when used in reference to a plant's product water or operations water)--A source of water and the water there from, whether it be from a spring, artesian well, drilled well, municipal water supply or any source, that has been inspected and the water sampled, analyzed and found to be safe and sanitary quality according to applicable laws and regulations of State and local government agencies having jurisdiction. The presence in the plant of current certificates or notifications of approval from the government agency or agencies having jurisdiction constitutes approval of the source and the water supply.(3) Department--Department of State Health Services (DSHS). Source Note: The provisions of this §229.112 adopted to be effective March 19, 2001, 26 TexReg 2194; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG G MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE §229.112 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124720&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124720 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124720&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124720 03/11/2026 (a) Requirements for approved source. Sources in Texas shall comply with the following requirements:(1) Public water systems. Sources in Texas which are public water systems shall comply with the Texas Health and Safety Code, Chapter 341, Subchapter C, concerning drinking water standards and rules adopted by the Texas Commission for Environmental Quality, at 30 Texas Administrative Code (TAC), §§290.101 - 290.122 (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Supply Systems), and 30 TAC, §§290.38 - 290.47 (relating to Rules and Regulations for Public Water Systems);(2) Other sources. Any other sources in Texas shall comply with 30 TAC, §§290.101 - 290.122 concerning drinking water standards and 30 TAC, §§290.38 - 290.43 and §290.46 concerning rules and regulations for public water systems.(3) Compliance with these sections is required as if the source were a public water system.(b) Sampling requirements.(1) Approved community public water systems as defined by 30 TAC §290.38(8) and (41) (relating to Definitions). No additional source water sampling is required.(2) Source water obtained from other than a public water system. Source water obtained from other than a community public water system shall be sampled in accordance with 30 TAC, §§290.101 - 290.122 for transient non-community water systems. Source Note: The provisions of this §229.113 adopted to be effective March 19, 2001, 26 TexReg 2194; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG G MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE §229.113 Source Water https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124721&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124721 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124721&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124721 03/11/2026 (a) Packaged ice shall be labeled according to Health and Safety Code, Chapter 431, and Title 21, Code of Federal Regulations, Part 101, Food Labeling.(b) Label information shall include:(1) the common name of the food;(2) the accurate declaration of the net weight; and(3) the name and place of business of the manufacturer, packer, or distributor.(c) The label should bear a code representing the package date and location for positive lot identification in the event of product recalls or customer notifications. If packaged ice is distributed without such coding, all ice products may be included within the scope of any recall or notification. Source Note: The provisions of this §229.114 adopted to be effective March 19, 2001, 26 TexReg 2194; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG G MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE §229.114 Labeling of Packaged Ice https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124722&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124722 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124722&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124722 03/11/2026 (a) Ice equipment. Equipment used in ice plants or as part of the facilities producing ice at point of use including, but not limited to, portable can fillers, core sucking devices, drop tubes, tank lids, ice cans, ice manufacturing and ice dispensers shall be handled and maintained in such a manner as to prevent contamination. Equipment shall be located away from areas that could cause contamination such as toilets, vestibules and openings to the outside. If at any time equipment is suspected as having been contaminated by improper handling, this equipment shall be sanitized.(b) Block ice facilities.(1) In order to minimize the possibility of contamination of ice during freezing, the operator employed on the tank floor shall use footwear which is limited to use only on the tank room floor. This footwear cannot be worn when leaving the tank room floor for any purpose. Only authorized persons are to be permitted on the tank room floor or within the ice storage rooms. Signs shall be posted stating that only authorized persons are allowed on the tank room floor and in ice storage vaults.(2) Ice storage vaults. Ice storage vaults must be kept under sanitary conditions and shall be maintained in such a condition as to prevent possible flooding of rooms with waste material. All vaults shall be provided with suitable drains. To prevent possible contamination of ice, all accumulations of rust, fungus growth, mold or slime shall be controlled. Source Note: The provisions of this §229.115 adopted to be effective March 19, 2001, 26 TexReg 2194; amended to be effective June 4, 2006, 31 TexReg 4432. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG G MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE §229.115 Ice Equipment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215656 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185023&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185023 03/11/2026 (a) Except for non-covered businesses as defined in §229.802 of this title (relating to Definitions) and as provided for in subsection (b) of this section, the requirements of this subchapter apply to shippers, receivers, loaders, and food transporters engaged in transportation operations whether or not the food is being offered for or enters interstate commerce. The requirements of this subchapter apply in addition to any other requirements of this chapter that are applicable to the transportation of food, e.g., in §§229.210 - 229.225 of this title (relating to Current Good Manufacturing and Good Warehousing Practice in Manufacturing, Packing, or Holding of Human Food) and §§229.541 - 229.555 of this title (relating to Regulation of Food Salvage Establishments and Brokers).(b) The requirements of this subchapter do not apply to shippers, receivers, loaders, or food transporters when they are engaged in transportation operations:(1) Of food that is transshipped through the United States to another country; or(2) Of food that is imported for future export, in accordance with the Federal Food, Drug, and Cosmetic Act, §801(d)(3) and that is neither consumed nor distributed in the United States; or(3) Of food when it is located in food facilities as defined in 21 Code of Federal Regulations, §1.227, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 United States Code 601 et seq.), the Poultry Products Inspection Act (21 United State Code 451 et seq.), or the Egg Products Inspection Act (21 United States Code 1031 et seq.)(c) The criteria and definitions of this subchapter apply in determining whether food is adulterated within the meaning of Texas Health and Safety Code, §431.081(a) in that the food has been transported or offered for transport by a shipper, food transporter by motor vehicle, loader, or receiver engaged in transportation operations under conditions that are not in compliance with this subchapter.(d) The failure by a shipper, food transporter by motor vehicle, loader, or receiver engaged in transportation operations to comply with the requirements of this subchapter is a prohibited act under Texas Health and Safety Code, §431.021. Source Note: The provisions of this §229.801 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG GG SANITARY TRANSPORTATION OF HUMAN FOODS §229.801 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185021&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185021 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185021&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185021 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise. Those definitions and interpretations of terms of the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431, are also applicable when used in this subchapter.(1) Adequate--That which is needed to accomplish the intended purpose in keeping with good public health practice.(2) Bulk vehicle--A tank truck, hopper truck, cargo tank, portable tank, freight container, or hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.(3) Carrier--Any person who transports food while operating as a parcel delivery service.(4) Cross-contact--The unintentional incorporation of a food allergen into food.(5) Farm--Means:(A) Primary production farm. A primary production farm is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term "farm" includes operations that, in addition to these activities:(i) pack or hold raw agricultural commodities;(ii) pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in clause (iii)(II)(-a-) of this subparagraph; and(iii) manufacture/process food, provided that:(I) all food used in such activities is consumed on that farm or another farm under the same management; or(II) any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:(-a-) drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);(-b-) treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and;(-c-) packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or(B) secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described in subparagraph (A)(ii) and (iii) of this paragraph.(6) Food allergen--A major food allergen is:(A) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.(B) A food ingredient that contains protein derived from a food specified in subparagraph (A) of this paragraph, except the following:(i) any highly refined oil derived from a food specified in subparagraph (A) of this paragraph and any ingredient derived from such highly refined oil.(ii) a food ingredient that is exempt under United States Code Title 21 Chapter 9, Subchapter IV, §343(w)(6) and (7).(7) Food contact substance--Any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.(8) Food not completely enclosed by a container--Any food that is placed into a container in such a manner that it is partially open to the surrounding environment. Examples of such containers include an open wooden basket or crate, an open cardboard box, a vented cardboard box with a top, or a vented plastic bag. This term does not include food transported in a bulk vehicle as defined in this subchapter.(9) Food Transporter--Any person who physically moves food by vehicle in commerce within the United States; and excludes carriers as defined in this subchapter.(10) Full-time equivalent employee--A term used to represent the number of employees of a business entity for the purpose of determining whether the business is a small business. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a whole number, round down to the next lowest whole number.(11) Loader--A person that loads food onto a motor or during transportation operations.(12) Non-covered business--A shipper, loader, receiver, or food transporter engaged in transportation operations that has less than $500,000, as adjusted for inflation, in average annual revenues, calculated on a rolling basis, during the 3-year period preceding the applicable calendar year. For the purpose of determining an entity's 3-year average revenue threshold as adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011.(13) Operating temperature--A temperature sufficient to ensure that under foreseeable circumstances of temperature variation during transport, e.g., seasonal conditions, refrigeration unit defrosting, multiple vehicle loading and unloading stops, and type of food product, the operation will meet the requirements of §229.804(a)(3) of this title (relating to Transportation Operations).(14) Pest--Any objectionable animals or insects including birds, rodents, flies, and larvae.(15) Receiver--Any person who receives food at a point in the United States after transportation, whether or not that person represents the final point of receipt for the food.(16) Shipper--A person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a food transporter or multiple food transporters sequentially.(17) Small business--A business employing fewer than 500 full-time equivalent employees except that for food transporters by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to §229.801(a) of this title (relating to Purpose and Scope) having less than $27,500,000 in annual receipts.(18) Transportation--Any movement of food in by motor vehicle or in commerce within the United States.(19) Transportation equipment--Equipment used in food transportation operations, e.g., bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and unloading systems. Transportation equipment also includes a trailer not attached to a tractor.(20) Transportation operations--All activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment. Transportation operations do not include any activities associated with the transportation of food that is completely enclosed by a container except a food that requires temperature control for safety, compressed food gases, food contact substances, human food byproducts transported for use as animal food without further processing, or live food animals except molluscan shellfish. In addition, transportation operations do not include any transportation activities that are performed by a farm.(21) Vehicle--A land conveyance that is motorized, e.g., a motor vehicle, which is used in transportation operations.(22) Vehicle Used To Transport Food--A vehicle used to transport or hold food in commerce within Texas. Source Note: The provisions of this §229.802 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG GG SANITARY TRANSPORTATION OF HUMAN FOODS §229.802 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185022&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185022 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185022&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185022 03/11/2026 (a) Vehicles and transportation equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming adulterated within the meaning of Texas Health and Safety Code, §431.081(a)(1), (2), and (4) during transportation operations.(b) Vehicles and transportation equipment must be maintained in such a sanitary condition for their intended use as to prevent the food they transport from becoming adulterated during transportation operations.(c) Vehicles and transportation equipment used in transportation operations for food requiring temperature control for safety must be designed, maintained, and equipped as necessary to provide adequate temperature control to prevent the food from becoming adulterated during transportation operations.(d) Vehicles and transportation equipment must be stored in a manner that prevents it from harboring pests or becoming contaminated in any other manner that could result in food for which it will be used becoming adulterated during transportation operations. Source Note: The provisions of this §229.803 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG GG SANITARY TRANSPORTATION OF HUMAN FOODS §229.803 Vehicles and Transportation Equipment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185024&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185024 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185024&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185024 03/11/2026 (a) General requirements.(1) Unless stated otherwise in this section, the requirements of this section apply to all shippers, food transporters, loaders, and receivers engaged in transportation operations. A person may be subject to these requirements in multiple capacities, e.g., the shipper may also be the loader and the food transporter, if the person also performs the functions of those respective persons as defined in this subchapter. An entity subject to this subchapter (shipper, loader, food transporter, or receiver) may reassign, in a written agreement, its responsibilities under this subchapter to another party subject to this subchapter. The written agreement is subject to the records requirements of §229.806(d) of this title (relating to Records).(2) Responsibility for ensuring that transportation operations are carried out in compliance with all requirements in this subchapter must be assigned to competent supervisory personnel.(3) All transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming adulterated during transportation operations including:(A) Taking effective measures such as segregation, isolation, or the use of packaging to protect food from contamination by raw foods and nonfood items in the same load.(B) Taking effective measures such as segregation, isolation, or other protective measures, such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations.(C) Taking effective measures to ensure that food that requires temperature control for safety is transported under food specific adequate temperature control.(4) The type of food, and its production stage, e.g., raw material, ingredient or finished food, must be considered in determining the necessary conditions and controls for the transportation operation.(5) Shippers, receivers, loaders, and food transporters, which are under the ownership or operational control of a single legal entity, as an alternative to meeting the requirements of subsections (b), (d), and (e) of this section may conduct transportation operations in conformance with common, integrated written procedures that ensure the sanitary transportation of food consistent with the requirements of this section. The written procedures are subject to the records requirements of §229.806(e) of this title.(6) If a shipper, loader, receiver, or food transporter becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food adulterated during transportation, the food shall not be sold or otherwise distributed, and these persons must take appropriate action including, as necessary, communication with other parties to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food adulterated.(b) Requirements applicable to shippers engaged in transportation operations.(1) Unless the shipper takes other measures in accordance with paragraph (3) of this subsection to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, i.e., that will prevent the food from becoming adulterated, the shipper must specify to the food transporter and, when necessary, the loader, in writing, all necessary sanitary specifications for the food transporter's vehicle and transportation equipment to achieve this purpose, including any specific design specifications and cleaning procedures. One-time notification shall be sufficient unless the design requirements and cleaning procedures required for sanitary transport change based upon the type of food being transported, in which case the shipper shall so notify the food transporter in writing before the shipment. The information submitted by the shipper to the food transporter is subject to the records requirements in §229.806(a) of this title.(2) Unless the shipper takes other measures in accordance with paragraph (5) of this subsection to ensure that adequate temperature control is provided during the transportation of food that requires temperature control for safety under the conditions of shipment, a shipper of such food must specify in writing to the food transporter, except a food transporter who transports the food in a thermally insulated tank, and, when necessary, the loader, an operating temperature for the transportation operation including, if necessary, the pre-cooling phase. One-time notification shall be sufficient unless a factor, e.g., the conditions of shipment, changes, necessitating a change in the operating temperature, in which case the shipper shall so notify the food transporter in writing before the shipment. The information submitted by the shipper to the food transporter is subject to the records requirements in §229.806(a) of this title.(3) A shipper must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, adequate to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, i.e., will prevent the food from becoming unsafe during the transportation operation. Measures to implement these procedures may be accomplished by the shipper or by the food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title.(4) A shipper of food transported in bulk must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, adequate to ensure that a previous cargo does not make the food unsafe. Measures to ensure the safety of the food may be accomplished by the shipper or by the food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title.(5) The shipper of food that requires temperature control for safety under the conditions of shipment must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, to ensure that the food is transported under adequate temperature control. Measures to ensure the safety of the food may be accomplished by the shipper or by the food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title and must include measures equivalent to those specified for food transporters under subsection (e)(1) - (3) of this section.(c) Requirements applicable to loaders engaged in transportation operations.(1) Before loading food not completely enclosed by a container onto a vehicle or into transportation equipment the loader must determine, considering, as appropriate, specifications provided by the shipper in accordance with subsection (b)(1) of this section, that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, e.g., it is in adequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation. This may be accomplished by any appropriate means.(2) Before loading food that requires temperature control for safety, the loader must verify, considering, as appropriate, specifications provided by the shipper in accordance with subsection (b)(2) of this section, that each mechanically refrigerated cold storage compartment or container is adequately prepared for the transportation of such food, including that it has been properly pre-cooled, if necessary, and meets other sanitary conditions for food transportation.(d) Requirements applicable to receivers engaged in transportation operations. Upon receipt of food that requires temperature control for safety under the conditions of shipment, the receiver must take steps to adequately assess that the food was not subjected to significant temperature abuse, such as determining the food's temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors.(e) Requirements applicable to food transporters engaged in transportation operations. When the food transporter and shipper have a written agreement that the food transporter is responsible, in whole or in part, for sanitary conditions during the transportation operation, the food transporter is responsible for the following functions as applicable per the agreement:(1) A food transporter must ensure that vehicles and transportation equipment meet the shipper's specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation.(2) A food transporter must, once the transportation operation is complete and if requested by the receiver, provide the operating temperature specified by the shipper in accordance with subsection (b)(2) of this section and, if requested by the shipper or receiver, demonstrate that it has maintained temperature conditions during the transportation operation consistent with the operating temperature specified by the shipper in accordance with subsection (b)(2) of this section. Such demonstration may be accomplished by any appropriate means agreeable to the food transporter and shipper, such as the food transporter presenting measurements of the ambient temperature upon loading and unloading or time/temperature data taken during the shipment.(3) Before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for use for the transportation of food that requires temperature control for safety under the conditions of the shipment during transportation, a food transporter must pre-cool each mechanically refrigerated cold storage compartment as specified by the shipper in accordance with subsection (b)(2) of this section.(4) If requested by the shipper, a food transporter that offers a bulk vehicle for food transportation must provide information to the shipper that identifies the previous cargo transported in the vehicle.(5) If requested by the shipper, a food transporter that offers a bulk vehicle for food transportation must provide information to the shipper that describes the most recent cleaning of the bulk vehicle.(6) A food transporter must develop and implement written procedures subject to the records requirements of §229.806(b) of this title that:(A) Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the food transporter provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition as required by §229.803(b) of this title (relating to Vehicles and Transportation Equipment);(B) Describe how it will comply with the provisions for temperature control in paragraph (2) of this subsection; and(C) Describe how it will comply with the provisions for the use of bulk vehicles in paragraphs (4) and (5) of this subsection. Source Note: The provisions of this §229.804 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG GG SANITARY TRANSPORTATION OF HUMAN FOODS §229.804 Transportation Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185025&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185025 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185025&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185025 03/11/2026 (a) When the food transporter and shipper have agreed in a written contract that the food transporter is responsible, in whole or in part, for the sanitary conditions during transportation operations, the food transporter must provide adequate training to personnel engaged in transportation operations that provides an awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems, and the responsibilities of the food transporter under this subchapter. The training must be provided upon hiring and as needed thereafter.(b) Food transporters must establish and maintain records documenting the training described in subsection (a) of this section. Such records must include the date of the training, the type of training, and the person(s) trained. These records are subject to the records requirements of §229.806(c) of this title (relating to Records). Source Note: The provisions of this §229.805 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG GG SANITARY TRANSPORTATION OF HUMAN FOODS §229.805 Training https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185026&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185026 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185026&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185026 03/11/2026 (a) Shippers must retain records.(1) That demonstrate that they provide specifications and operating temperatures to food transporters as required by §229.804(b)(1) and (2) of this title (relating to Transportation Operations) as a regular part of their transportation operations for a period of 12 months beyond the termination of the agreements with the food transporters.(2) Of written agreements and the written procedures required by §229.804(b)(3) - (5) of this title for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.(b) Food transporters must retain records of the written procedures required by §229.804(e)(6) of this title for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.(c) Food transporters must retain training records required by §229.805(b) of this title (relating to Training) for a period of 12 months beyond when the person identified in any such records stops performing the duties for which the training was provided.(d) Any person subject to this subchapter must retain any other written agreements assigning tasks in compliance with this subchapter for a period of 12 months beyond the termination of the agreements.(e) Shippers, receivers, loaders, and food transporters, which operate under the ownership or control of a single legal entity in accordance with the provisions of §229.804(a)(5) of this title, must retain records of the written procedures for a period of 12 months beyond when the procedures are in use in their transportation operations.(f) Shippers, receivers, loaders, and food transporters must make all records required by this subchapter available to a duly authorized individual promptly upon oral or written request.(g) All records required by this subchapter must be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records.(h) Except for the written procedures required by §229.804(e)(6)(A) of this title, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The written procedures required by §229.804(e)(6)(A) of this title must remain onsite as long as the procedures are in use in transportation operations. Electronic records are considered to be onsite if they are accessible from an onsite location. Source Note: The provisions of this §229.806 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG GG SANITARY TRANSPORTATION OF HUMAN FOODS §229.806 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185027&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185027 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185027&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185027 03/11/2026 Waivers from the requirements of this subchapter are granted or revoked by the United States Food and Drug Administration as set forth in 21 Code of Federal Regulations §§1.914 - 1.934. Source Note: The provisions of this §229.807 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG GG SANITARY TRANSPORTATION OF HUMAN FOODS §229.807 Waivers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221098&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221098 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221098&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221098 03/11/2026 The purpose of this subchapter is to implement Texas Health and Safety Code Chapter 431, which requires the Department of State Health Services to adopt rules related to analogue food products. This subchapter addresses analogue food products only. Source Note: The provisions of this §229.901 adopted to be effective October 9, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG HH LABELING OF ANALOGUE PRODUCTS §229.901 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221099&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221099 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221099&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221099 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise. Terms defined and interpreted in the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431, when used in this subchapter also apply.(1) Analogue product--A food product made to resemble the texture, flavor, appearance, or other aesthetic qualities or chemical characteristics of any specific type of egg, egg product, fish, meat, meat food product, poultry, or poultry product. Such products are made by combining processed plant products, insects, or fungus with food additives.(2) Cell-cultured product--A food product made by harvesting animal cells and artificially replicating those cells in a growth medium in a laboratory to produce tissue.(3) Close proximity--Means:(A) immediately before or after the product name or statement of identity; or,(B) in the line of the label immediately before or after the line containing the product name or statement of identity; or,(C) within the same phrase or sentence containing the product name or statement of identity.(4) Egg--Has the meaning assigned by Section 4(g), Egg Products Inspection Act (21 United States Code (USC) §1033(g)). The term does not include an analogue product or a cell-cultured product.(5) Egg product--Has the meaning assigned by Section 4(f), Egg Products Inspection Act (21 USC §1033(f)). The term does not include an analogue product or a cell-cultured product.(6) Fish--Has the meaning assigned by Section 403 of the Federal Food, Drug and Cosmetic Act (21 USC §343(q)(4)(E)). The term does not include an analogue product or a cell-cultured product.(7) Meat--Has the meaning assigned by 9 Code of Federal Regulations (CFR) §301.2. The term does not include an analogue product or a cell-cultured product.(8) Meat food product--Has the meaning assigned by Section 1(j), Federal Meat Inspection Act (21 USC §601(j)). The term does not include an analogue product or a cell-cultured product.(9) Poultry--Has the meaning assigned by Section 4(e), Poultry Products Inspection Act (21 USC §453(e)). The term does not include an analogue product or a cell-cultured product.(10) Poultry product--Has the meaning assigned by Section 4(f), Poultry Products Inspection Act (21 USC §453(f)). The term does not include an analogue product or a cell-cultured product.(11) Product name--For purposes of this subchapter, product name is the trade name or brand name of their product, which must be clarified by a statement of identity.(12) Statement of identity--Means:(A) the name specified in or required by any applicable federal law or regulation; or,(B) the common or usual name of the food; or,(C) an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. Source Note: The provisions of this §229.902 adopted to be effective October 9, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG HH LABELING OF ANALOGUE PRODUCTS §229.902 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221100&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221100 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221100&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221100 03/11/2026 One of the following statements must be shown prominently on the product label in close proximity to and in type size equal to or greater than the product name or statement of identity:(1) analogue;(2) meatless;(3) plant-based;(4) made from plants; or(5) a similar qualifying term or disclaimer intended to clearly communicate to a consumer the contents of the product. Source Note: The provisions of this §229.903 adopted to be effective October 9, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG HH LABELING OF ANALOGUE PRODUCTS §229.903 Labeling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227672&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227672 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227672&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227672 03/11/2026 (a) This subchapter implements Texas Health and Safety Code (HSC) Chapter 431. HSC Chapter 431 requires the Department of State Health Services (DSHS) to adopt rules about warning labels on foods that have specific ingredients and requires rules for website disclosures if food that is subject to the warning label requirements is offered for sale in Texas on the manufacturer's or retailer's website.(b) This subchapter applies to:(1) any manufacturer that offers a food product for sale in Texas, no matter where the food product was originally made;(2) any ingredient meant to be consumed by humans, which the United States Food and Drug Administration (FDA) requires to be listed on the food label; and(3) food product labels developed or copyrighted on or after January 1, 2027. For purposes of this subchapter, any change to a food product label on or after January 1, 2027, must follow the rules in §229.1004 of this subchapter (relating to Warning Label Requirements) unless exempt.(c) The department adopts by reference:(1) 21 Code of Federal Regulations (CFR) Part 70, Color Additives, Subpart B, Packaging and Labeling, as amended;(2) 21 CFR Part 73, Listing of Color Additives Exempt From Certification, Subpart A, Foods, as amended;(3) 21 CFR Part 74, Listing of Color Additives Subject to Certification, Subpart A, Foods, as amended;(4) 21 CFR Part 81, General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;(5) 21 CFR Part 82, Listing of Certified Provisionally Listed Colors and Specifications, as amended; and(6) 21 CFR Part 101, Food Labeling, as amended. Source Note: The provisions of this §229.1001 adopted to be effective February 23, 2026, 51 TexReg 1156. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG II WARNING LABEL REQUIREMENTS FOR FOOD §229.1001 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227673&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227673 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227673&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227673 03/11/2026 (a) Dietary supplement--A product a person can consume that has a "dietary ingredient" to add to the diet. A "dietary ingredient" includes vitamins and minerals, herbs, amino acids, enzymes, live bacteria (called "probiotics"), or other substances found in food. The dietary supplement can also be a mix or concentrate of any of these ingredients.(b) Drug--Articles that are:(1) listed in the official United States Pharmacopoeia National Formulary (USP-NF) or any of the USP-NF supplements;(2) intended for diagnosing, curing, mitigating, treating, or preventing diseases in humans or animals;(3) other than food, meant to influence the structure or any function of the body of humans or animals; and(4) intended to be used as a component of any article mentioned in this definition.(5) The term does not include devices or their parts, components, or accessories.(6) A food for which a claim is made in accordance with Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 United States Code (U.S.C.) §301), and for which the claim is approved by the United States Secretary of Health and Human Services, is not a drug solely because the label or labeling contains such a claim.(c) Food--Any article used by humans for food or drink, including chewing gum and items used as ingredients in other food or drink.(d) Food manufacturer--A person who combines, purifies, processes, or packages food to sell through a wholesale outlet. This term also includes:(1) a retail outlet that packages or labels food before selling it; and(2) a person responsible for the purity and proper labeling of a food item by labeling the food with the person's name and address.(e) Raw agricultural commodity--Any food in its natural state, including all fruits that can be washed, colored, or treated in their unpeeled form before being marketed. Treatment includes waxing, fumigating, or removing foreign objects or other parts of the plant, such as leaves, stems, and husks. This definition excludes transforming a harvested raw agricultural commodity into processed food by actions such as cutting, cooking, heating, chopping, irradiating, or pasteurizing. (f) Restaurant--A place where food is made and sold directly to people for immediate consumption, examples include:(1) cafeterias;(2) lunchrooms;(3) cafes;(4) bistros;(5) fast food places;(6) food stands;(7) saloons;(8) taverns;(9) bars;(10) lounges;(11) catering facilities;(12) hospital kitchens;(13) day care kitchens; and(14) nursing home kitchens.(15) "Restaurant" does not include places that provide food for interstate travel, central kitchens, and other similar places that don't serve food directly to the consumer.(16) For purposes of this subchapter, a restaurant is a food establishment as defined in other department rules, including:(A) §229.371 of this chapter (relating to Definitions); (B) §229.471 of this chapter (relating to Definitions); and(C) §228.2 of this title (relating to Definitions).(g) Retail food establishment--A place that sells food products directly to consumers as its primary function, like:(1) grocery stores;(2) convenience stores;(3) vending machines; and(4) some farm-run businesses.(5) "Retail food establishment" includes places that make, process, pack, or store food to sell directly to consumers. The value of food products sold directly to consumers must be higher than the sales of food products to all other buyers. "Consumers" does not include businesses.(6) For purposes of this subchapter, a retail food establishment is also known as a food establishment as defined in other department rules, including:(A) §229.371 of this chapter;(B) §229.471 of this chapter; and(C) §228.2 of this title. Source Note: The provisions of this §229.1002 adopted to be effective February 23, 2026, 51 TexReg 1156. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG II WARNING LABEL REQUIREMENTS FOR FOOD §229.1002 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227674&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227674 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227674&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227674 03/11/2026 This subchapter does not apply to:(1) an ingredient used in a product that is not meant for humans to consume;(2) food labeled, prepared, served, or sold in a restaurant; (3) food labeled, prepared, or served in a retail food establishment;(4) a product regulated by the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS);(5) a product labeled with a governmental warning with a recommendation from the surgeon general of the United States Public Health Service (USPHS);(6) a drug or dietary supplement; or(7) a pesticide chemical, soil or plant nutrient, or other agricultural chemical used in the production, storage, or transportation of a raw agricultural commodity. Source Note: The provisions of this §229.1003 adopted to be effective February 23, 2026, 51 TexReg 1156. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG II WARNING LABEL REQUIREMENTS FOR FOOD §229.1003 Exemptions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227675&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227675 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227675&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227675 03/11/2026 (a) Food that contains any of the following ingredients must include a warning label described in subsection (b) of this section: (1) acetylated esters of mono- and diglycerides (acetic acid ester);(2) anisole;(3) azodicarbonamide (ADA);(4) bleached flour;(5) blue 1 (CAS 3844-45-9);(6) blue 2 (CAS 860-22-0);(7) bromated flour;(8) butylated hydroxyanisole (BHA);(9) butylated hydroxytoluene (BHT);(10) calcium bromate;(11) canthaxanthin;(12) certified food colors by the United States Food and Drug Administration (FDA);(13) citrus red 2 (CAS 6358-53-8);(14) diacetyl;(15) diacetyl tartaric and fatty acid esters of mono and diglycerides (DATEM);(16) dimethylamylamine (DMAA);(17) dioctyl sodium sulfosuccinate (DSS);(18) ficin;(19) green 3 (CAS 2353-45-9);(20) interesterified palm oil;(21) interesterified soybean oil;(22) lactylated fatty acid esters of glycerol and propylene glycol;(23) lye;(24) morpholine;(25) olestra;(26) partially hydrogenated oil (PHO);(27) potassium aluminum sulfate;(28) potassium bromate;(29) potassium iodate;(30) propylene oxide;(31) propylparaben;(32) red 3 (CAS 16423-68-0);(33) red 4 (CAS 4548-53-2);(34) red 40 (CAS 25956-17-6);(35) sodium aluminum sulfate;(36) sodium lauryl sulfate;(37) sodium stearyl fumarate;(38) stearyl tartrate;(39) synthetic trans fatty acid;(40) thiodipropionic acid;(41) titanium dioxide;(42) toluene;(43) yellow 5 (CAS 1934-21-0); or(44) yellow 6 (CAS 2783-94-0).(b) The warning label must include the following statement, if the food contains an ingredient listed in subsection (a) of this section: "WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom." The warning label must:(1) be printed in a font size not smaller than the smallest font used to disclose other consumer information required by the FDA;(2) be placed in a prominent and reasonably visible location; and(3) have sufficiently high contrast with the immediate background to ensure the warning is likely to be seen and understood by the ordinary individual under customary conditions of purchase and use.(c) Food manufacturers and retailers who sell their products via internet that require warning labels under subsection (a) of this section must provide all labeling information required by subsection (b) of this section to consumers by:(1) posting a legible statement on the manufacturer's or retailer's website on which the product is offered for sale;(2) posting pictures of the food product label in which the warning label appears on the website; or(3) providing the information in other ways to the consumer. Source Note: The provisions of this §229.1004 adopted to be effective February 23, 2026, 51 TexReg 1156. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG II WARNING LABEL REQUIREMENTS FOR FOOD §229.1004 Warning Label Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227676&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227676 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227676&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227676 03/11/2026 (a) Criminal penalties stated in Texas Health and Safety Code (HSC) §431.059 can be imposed for violations of this subchapter. (b) Civil penalties stated in HSC §431.0585 can be imposed for violations of this subchapter.(c) Administrative penalties as described in HSC §431.054, §431.055, §431.056, §431.057, and §431.058, and §229.261 of this chapter (relating to Assessment of Administrative Penalties), can be imposed for violations of the previously stated sections. Before a penalty is imposed, the person accused of a violation must be given an opportunity for a hearing. (d) Hearings regarding administrative penalties and emergency orders will be held according to, Texas Government Code §§2001.051 - 2001.902, and the department's formal hearing rules in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures). (e) The commissioner or the commissioner's designee may issue emergency orders according to HSC §431.045. Source Note: The provisions of this §229.1005 adopted to be effective February 23, 2026, 51 TexReg 1156. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG II WARNING LABEL REQUIREMENTS FOR FOOD §229.1005 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125098&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125098 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215656 03/11/2026 (a) Purpose. This section is intended to provide the framework for accrediting manager level food safety training programs in accordance with the Texas Health and Safety Code, Chapter 438, Subchapter D, Food Service Programs. A uniform standard governing the accreditation of food safety programs enhances the recognition of reciprocity among regulatory agencies and reduces the expense of duplicate education incurred when food establishment managers work in multiple regulatory jurisdictions. Education of the food establishment manager provides more qualified personnel, thereby reducing the risk of foodborne illness outbreaks caused by improper food preparation and handling techniques.(b) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise.(1) Accredited certified food manager training program--A certified food manager training and testing program approved by the department that meets the standards set forth in this section.(2) Alternative training methods--Training other than classroom, including but not limited to distance learning, computerized training programs, and correspondence courses.(3) ANSI-CFP Program Accreditation--Accreditation by the American National Standard Institute (ANSI) and the Conference for Food Protection (CFP), which accredit programs as outlined in the CFP Standards for Accreditation of Food Protection Manager Certification Programs. (4) Certificate--The documentation issued by a department-approved ANSI-CFP Program examination licensee verifying that an individual has complied with the requirements of this section.(5) Certification--The process whereby a certified food manager certificate is issued.(6) Certified food manager--A person who has demonstrated that he or she has the knowledge, skills and abilities required to protect the public from foodborne illness by means of successfully completing a certified food manager examination and becoming certified as described in this section.(7) Certified food manager examination--A department-approved ANSI-CFP Program accredited on-site examination for food manager certification. (8) Certified food manager program; certified food management program--A training program accredited by the department that provides food safety education for food establishment managers and administers a certified food manager examination for certification or recertification purposes.(A) Certification program--A certified food manager program whose course work consists of a minimum of 14 hours of instruction on food safety topics which may include traditional or alternative methods of training, including distance education, and at least a one-hour certified food manager examination.(B) Recertification program--A certified food manager program whose course work consists of a minimum of six hours of instruction on food safety topics, which may include traditional or alternative methods of training, including distance education, and a certified food manager examination.(9) Continuing education--Documented professional education or activities that provide for the continued proficiency of a certified food management program instructor.(10) Department--The Texas Department of State Health Services.(11) Food--A raw, cooked, or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.(12) Food establishment--(A) Food establishment means an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:(i) such as a restaurant; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and(ii) that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.(B) Food establishment includes:(i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.(C) Food establishment does not include:(i) an establishment that offers only prepackaged foods that are not potentially hazardous;(ii) a produce stand that only offers whole, uncut fresh fruits and vegetables;(iii) a food processing plant;(iv) a kitchen in a private home if only food that is not potentially hazardous is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law;(v) an area where food that is prepared as specified in clause (iv) of this subparagraph is sold or offered for human consumption; (vi) a Bed and Breakfast Limited facility as defined in these rules; or(vii) a private home that receives catered or home-delivered food.(13) Law--Applicable local, state and federal statutes, regulations and ordinances.(14) Licensee--The individual, corporation or company that is licensed by the department to operate certified food management programs.(15) On-site examination--An ANSI-CFP Program accredited paper and computer-based examination for food manager certification administered by a certified food manager program.(16) Person--An association, corporation, partnership, individual, or other legal entity, government or governmental subdivision or agency.(17) Qualified instructor--An individual whose educational background and work experience meet the requirements for approval as a qualified food management program instructor as described in this section.(18) Reciprocity--Acceptance by state and local regulatory authorities of a department-approved certified food manager certificate.(19) Regulatory authority--The local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.(20) Single entity--A corporation that educates only its own employees.(21) Sponsor--An individual designated in writing to the department, by the licensee, as the person responsible for administrative management of the certified food manager program.(22) Two-Year Renewal Certificate--The certificate issued by the department from May 6, 2004 to April 24, 2008, verifying that a certified food manager has completed the application and submission of fees for renewal of a department-issued certificate.(c) Certified food manager.(1) Certified food manager responsibilities. Responsibilities of a certified food manager include:(A) identifying hazards in the day-to-day operation of a food establishment that provides food for human consumption;(B) developing or implementing specific policies, procedures or standards aimed at preventing foodborne illness;(C) coordinating, training, supervising or directing food preparation activities, and taking corrective action as needed to protect the health of the consumer;(D) training the food establishment employees on the principles of food safety; and(E) conducting in-house self-inspections of daily operations on a periodic basis to ensure that policies and procedures concerning food safety are being followed.(2) Certification by training and food safety examination. To be certified, a food manager shall complete an accredited certified food management certification or recertification program and pass a certified food manager examination. A state-approved examination for issuance or renewal of a food manager certificate must test an applicant on the food allergen awareness information described by Texas Health and Safety Code §437.027(b).(3) Certificate reciprocity. Department-approved food manager certificates shall be recognized statewide by regulatory authorities as the only valid proof of successful completion of a department-accredited certified food management program.(4) Certificate availability. The original certified food manager certificate shall be posted in a location in the food establishment that is conspicuous to consumers.(d) Certification program course curriculum. A certification program shall include a minimum of 14 hours of food safety training utilizing the training and time requirements in Texas Health and Safety Code, §438.043(a).(e) Recertification program course curriculum. A recertification training program shall include a minimum of six hours of food safety training.(f) Requirements for qualification of instructors. The instructors for all certified food management programs shall be department-qualified prior to teaching a class. The instructors for all certified food management programs shall meet the qualifications in these rules. Instructors meeting these qualifications shall be approved for the two-year permit term of the certified food management program licensee. The completed application form shall be submitted to the department through the accredited certified food management program licensee.(1) New instructors. A completed application for new instructors shall be submitted by the program licensee to the department with the following documentation:(A) the completed and signed application form;(B) a copy of a valid food management certificate; and(C) verification of education or experience in food safety documented by one of the following:(i) an associate or higher college degree from an accredited institution in a major related to food safety or environmental health, evidenced by a copy of the candidate's diploma or transcript;(ii) five years of food establishment work experience as a food manager verified in an attached resume; or(iii) two years of regulatory food inspection experience verified in an attached resume.(2) Nationally accredited program instructors. Nationally accredited program instructors who have met the minimum standards as set forth by this section shall be given reciprocity when instructing and administering an ANSI-CFP Program Accreditation examination.(g) Responsibilities of qualified instructors.(1) Compliance with certified food management program laws and rules. All qualified instructors are responsible for compliance with applicable certified food management program laws and rules.(2) Training requirements. All qualified instructors are responsible for instructing the course content as specified in subsection (o)(3) of this section, and meeting the training time requirements as specified in subsection (n)(6) of this section.(h) Requirements for the renewal of qualified instructors. In order to renew an instructor's qualification, the program licensee shall comply with the requirements of this subsection.(1) Contact hours for continuing education. Certified food management programs shall submit a renewal application and documentation of five contact hours of continuing education for each instructor during the two-year certified food manager program license period to maintain qualification as a certified food manager program instructor. (2) Accepted continuing education topics. Continuing education topics may include areas in food safety or instruction enhancement. (3) Verification of continuing education. The following may be used for continuing education:(A) a certificate of completion for a course or seminar with the participant's name, course name, date and number of contact hours earned;(B) a college transcript with course description; or(C) other documentation of attendance as approved by the department.(i) On-site examination. ANSI-CFP Program accredited food safety certification examinations shall be the only department-approved paper and computer-based certified food manager examinations.(j) Certified food manager certificates.(1) General certificate issuance. Certificates shall be issued by the department-approved examination provider. Candidates whose certificates are issued after successful passage of a department-approved examination shall be deemed to meet the requirements for food manager certification.(2) Certificate period. A certified food manager certificate issued by a department-approved examination provider under this section shall comply with the CFP Standards for Accreditation of Food Protection Manager Certification Programs, §7.3, Effective Date of Certificate, as amended.(3) Recertification. Candidates may become recertified by taking a recertification class and passing a department-approved examination, or by passing an examination as described in §229.176(i)(3) of this title (relating to Certification of Food Managers).(4) Certification through single entity corporations. Candidates from accredited single entity corporations may receive food manager certificates as described in this section, except that the food manager certificate shall:(A) clearly indicate that the certificate is valid for food manager duties performed for the single entity only;(B) be recognized by regulatory authorities for only that single entity; and(C) not receive reciprocity or recertification.(k) Department certificate.(1) Two-year renewal certificate. Certified food manager certificates issued by the department from May 6, 2004 to April 24, 2008, shall be renewed every two years and may be renewed two times.(2) Department certificate replacement. An individual requesting a certified food manager certificate replacement shall submit a completed written application to the department with the appropriate non-refundable fee. Replacement certificates will bear the same expiration date as the original certificate.(l) Department certificate fees.(1) Two-year renewal certificate fee. The fee for renewal of a two-year certificate issued shall be $10.(2) Replacement certificate fee. A replacement certificate fee for the department examination shall be $15.(3) Texas.gov fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by Texas.gov, to recover costs associated with application and renewal application processing through Texas.gov.(m) Licensing of single entity certified food management programs. In addition to the licensing requirements as specified in subsection (n) of this section, a corporation wishing to use a single entity option, which offers course length and topic requirements as specified in Texas Health and Safety Code, §438.043(a), shall submit to the department:(1) a copy of the course syllabus; and(2) a copy of the course curriculum.(n) Licensing of certified food management program licensee. The department shall issue a license of accreditation to each certified food management program licensee who has demonstrated compliance with this section. A license issued under these rules shall expire two years from the date of issuance. This license is not transferable on change of ownership, name, or site location.(1) Application. A person wishing to apply for a certification or recertification certified food management program license shall submit a completed application to the department.(2) Security agreement. The licensee shall submit a signed security agreement stating that individual examination items, examination item banks, certified food manager certification examinations, examination answer sheets, and candidate scores shall be secure at all times, and during administration that the examinations shall remain secure.(3) Certified food management program license fee. The completed license application shall include the appropriate non-refundable fee as specified in subsection (p)(1) of this section.(4) Sponsor. The licensee may designate a certified food manager program sponsor as the person responsible for the administrative management of the program.(5) Qualified instructor. The licensee shall provide a list of all qualified food management program instructors who plan to teach an accredited certification or recertification course to the department. A completed instructor application, along with other necessary documentation shall be submitted for all non-qualified instructors. (6) Course syllabus. The licensee shall provide a course syllabus to the department verifying the minimum of 14 hours of training for a certification program as specified in subsection (d) of this section and a minimum of six hours of training for a recertification program as specified in subsection (e) of this section. The training methods shall be designated on the application. A course curriculum shall be available for review to verify the course syllabus.(7) Certification examination. Department-approved examinations utilized by the certified food management programs shall be designated on the completed application.(o) Responsibilities of a licensee.(1) Compliance with certified food management program laws and rules. The licensee is responsible for compliance with applicable certified food management program laws and rules.(2) Payment of fees. All fees shall be non-refundable and paid as specified in subsection (p) of this section.(3) Certified food management program course content. All certified food management programs shall be taught utilizing the training and time requirements in Texas Health and Safety Code, §438.043(a). (4) Change of sponsor. The licensee shall notify the department in writing of the name of the new program sponsor.(5) Change of qualified instructor. The licensee shall ensure that only a department-qualified instructor serves as the instructor for the certified food management program. All new instructors shall complete the application for new instructors that shall be submitted by the licensee to the department with the applicable documentation. Licensees shall instruct all new instructors on the applicable laws and rules and administrative responsibilities.(p) Required fees. All fees are payable to the Department of State Health Services and are non-refundable. Licensees shall submit fees with the appropriate form that relates to the fee category. A current license shall only be issued when all past due fees and late fees are paid for all years of operation in Texas. The fees shall be:(1) Certified food manager program license fee for initial, renewal, or change of ownership. The certified food manger program license fee shall be $600 for a two-year license for each certification or recertification program.(2) Certified food manager program amended license fee. Program amendment fees shall be $300 for each certification or recertification program.(3) Late fee. Certified food manager licensees submitting a completed renewal application to the department after the expiration date shall pay an additional $100 as a late fee.(4) Texas.gov fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by Texas.gov, to recover costs associated with application and renewal application processing through Texas.gov.(q) Certified food management program registry. The department shall maintain a program registry of all accredited certification and recertification programs. The registry shall be made available on the department website.(r) Department audits. Audits of examination and classroom may be conducted to assess program compliance. Audits may be based on analysis of data compiled by the department. The licensee shall allow personnel authorized by the department access for the purposes of an audit.(s) Denial, suspension and revocation of program accreditation. An accredited food manager program license may be denied, suspended or revoked for the following reasons:(1) breach of the security agreement;(2) delinquency in payment of fees as described in this section; or(3) violation of the provisions of this section.(t) Denial, suspension and revocation procedures. Denial, suspension and revocation procedures under this section shall be conducted in accordance with the Administrative Procedure Act, Texas Government Code, Chapter 2001.(u) Suspension of License Relating to Child Support and Child Custody.(1) On receipt of a final court order or attorney general's order suspending a license due to failure to pay child support or for failure to comply with the terms of a court order providing for the possession of or access to a child, the department shall immediately determine if a license has been issued to the obligator named and:(A) record the suspension of the license in the department's records;(B) report the suspension as appropriate; and(C) demand surrender of the suspended license.(2) The department shall implement the terms of a final court or attorney general's order suspending a license without additional review or hearing. The board will provide notice as appropriate to the licensee or to others concerned with the license.(3) The department may not modify, remand, reverse, vacate, or stay a court or attorney general's order suspending a license issued under the Texas Family Code, Chapter 232, and may not review, vacate, or reconsider the terms of an order.(4) A licensee who is the subject of a final court or attorney general's order suspending his or her license is not entitled to a refund for any fee paid to the department.(5) If a suspension overlaps a license renewal period, an individual with a license suspended under this section shall comply with the normal renewal procedures in the Act and this chapter; however, the license will not be renewed until subsections (l) and (m) of this section are met. Source Note: The provisions of this §229.172 adopted to be effective January 20, 2010, 35 TexReg 377; amended to be effective December 1, 2023, 48 TexReg 6918. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG K TEXAS FOOD ESTABLISHMENTS §229.172 Accreditation of Certified Food Management Programs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215657&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215657 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215657&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215657 03/11/2026 (a) Purpose. This section is intended to provide the framework of certification requirements for food managers in accordance with Texas Health and Safety Code, Chapter 438, Subchapter G, Certification of Food Managers, supports demonstration of food safety knowledge, thereby reducing the risk of foodborne illness outbreaks caused by improper food preparation and handling techniques.(b) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise.(1) ANSI-CFP Program Accreditation--Accreditation by the American National Standards Institute (ANSI) and the Conference for Food Protection (CFP), which accredit programs as outlined in the CFP: Standards for Accreditation of Food Protection Manager Certification Programs.(2) Certificate--The documentation issued by a department-approved Internet examination provider licensee or an ANSI-CFP Program examination licensee verifying that an individual has complied with the requirements of this section.(3) Certification--The process whereby a certified food manager certificate is issued.(4) Certified food manager--A person who has demonstrated that he or she has the knowledge, skills and abilities required to protect the public from foodborne illness by means of successfully completing a certified food manager examination and becoming certified as described in this section.(5) Certified food manager examination--A department-approved Internet examination or an ANSI-CFP Program accredited on-site examination for food manager certification.(6) Department--The Texas Department of State Health Services.(7) Examination site--The physical location at which the department-approved examination is administered.(8) Food--A raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.(9) Food establishment--(A) Food establishment means an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:(i) such as a restaurant; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and(ii) that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.(B) Food establishment includes:(i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.(C) Food establishment does not include:(i) an establishment that offers only prepackaged foods that are not potentially hazardous;(ii) a produce stand that only offers whole, uncut fresh fruits and vegetables;(iii) a food processing plant;(iv) a kitchen in a private home if only food that is not potentially hazardous is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law;(v) an area where food that is prepared as specified in clause (iv) of this subparagraph is sold or offered for human consumption; (vi) a Bed and Breakfast Limited facility as defined in these rules; or(vii) a private home that receives catered or home-delivered food.(10) Internet examination--A department-approved examination delivery system utilizing the Internet for food manager certification.(11) Law--Applicable local, state and federal statutes, regulations and ordinances.(12) Licensee--The individual, corporation, or company that is licensed by the department to administer a department-approved examination for food manager certification.(13) On-site examination--An ANSI-CFP Program accredited paper and computer-based examination for food manager certification administered by a certified food manager program.(14) Person--An association, corporation, partnership, individual or other legal entity, government or governmental subdivision or agency.(15) Personal validation question--A question designed to establish the identity of the candidate taking a certified food manager examination by requiring an answer related to the candidate's personal information such as a driver's license number, address, date of birth, or other similar information that is unique to the candidate.(16) Reciprocity--Acceptance by state and local regulatory authorities of a department-approved certified food manager certificate.(17) Regulatory authority--The local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.(18) Two-Year Renewal Certificate--The certificate issued by the department from May 6, 2004 to April 24, 2008, verifying that a certified food manager has completed the application and submission of fees for renewal of a department-issued certificate.(c) Certified food manager.(1) Certified food manager responsibilities. Responsibilities of a certified food manager include:(A) identifying hazards in the day-to-day operation of a food establishment that provides food for human consumption;(B) developing or implementing specific policies, procedures or standards aimed at preventing foodborne illness;(C) coordinating training, supervising or directing food preparation activities and taking corrective action as needed to protect the health of the consumer;(D) training the food establishment employees on the principles of food safety; and(E) conducting in-house self-inspection of daily operations on a periodic basis to ensure that policies and procedures concerning food safety are being followed.(2) Certification by a food safety examination. To be certified, a food manager shall pass a department-approved Internet examination or an accredited ANSI-CFP Program on-site examination. A state-approved examination for issuance or renewal of a food manager certificate must test an applicant on the food allergen awareness information described by Texas Health and Safety Code §437.027(b).(3) Certificate reciprocity. A certificate issued to an individual who successfully completes a department-approved examination shall be accepted as meeting the training and examination requirements under Texas Health and Safety Code, §438.046(b).(4) Certificate availability. The original food manager certificate shall be posted in a location in the food establishment that is conspicuous to consumers.(d) On-site examination. ANSI-CFP Program accredited food safety certification examinations shall be the only department-approved paper and computer-based examinations.(e) Internet examinations. A department-approved examination utilizing the Internet for delivery shall meet the examination criteria outlined in this section.(f) Responsibilities for Internet examination providers.(1) Compliance with food manager laws and rules. Internet examination providers are responsible for compliance with food manager laws and rules applicable to Internet examinations in this section.(2) Examination Security Agreement. Internet examination providers shall submit the department security agreement signed by the certified food manager Internet examination provider licensee.(3) Examination security. Candidates taking Internet examinations shall be advised on the application that outside training materials or assistance shall not be used during administration of the examination and that appropriate measures shall be taken to assure that the examination is not compromised.(g) Internet examination development. Internet examination development shall meet the criteria established by the CFP Standards for Accreditation of Food Manager Certification Programs, §4.0, Food Safety Certification Examination Development, as amended with the exception of the proctor requirement at §4.14.(1) Examination questions. Internet examinations shall consist of a minimum of 75 statistically valid questions that are administered at one time following any voluntary training that may precede the examination.(2) Examination forms. Each candidate shall receive a unique form of the examination with regard to question sequence.(3) Time allotment for non-proctored Internet examination providers. Time allotted for administration of non-proctored examinations shall not exceed 90 minutes.(h) Internet examination administration.(1) Registration requirements for Internet examinations. The licensee shall register the candidates and require the candidates to:(A) verify their identity;(B) provide responses to ten personal validation questions; and(C) maintain examination security.(2) Licensee examination disclosure information. The licensee shall inform the candidate that:(A) reference materials shall not be used during the examination;(B) the candidate shall not receive assistance from anyone during the examination; and(C) examination questions shall not be replicated in any fashion.(3) Personal validation questions. The licensee shall verify a candidate's identity throughout the examination. The personal validation process shall include the following elements:(A) a minimum of five personal validation questions selected from the ten questions provided during registration shall be incorporated at various times during the examination;(B) the personal validation questions shall be randomly generated with respect to time and order;(C) the same personal validation questions shall not be asked more than once during the same examination; and(D) the examination session shall cease and the candidate shall be automatically exited from the examination if a candidate answers a personal validation question incorrectly.(4) System support. The Internet examination provider licensee shall include the following Internet examination system capabilities and security measures:(A) capability to browse or review previously completed examination questions;(B) capability to navigate logically and systematically through the examination;(C) technical support personnel for Internet examination issues;(D) security of personal candidate information in transit and at rest;(E) a back-up and disaster recovery system capability; and(F) assurance that examination data is maintained in a secure and safe environment and readily available to the department.(5) Reporting requirements for non-proctored Internet examination administrators. Internet examination administrators who administer examinations in non-proctored locations shall submit a semi-annual report to enable the department to evaluate examination security and system performance for each language in which the examination is offered. The report shall include:(A) statistical data to enable measurement of central tendency, ranges of examination scores, standard deviation, standard error of measurement, and examination cut score;(B) number of examinations administered;(C) number and percentage of candidates passing the examination;(D) number of personal validation questions used;(E) number of examinations discontinued due to incorrect responses to personal validation questions; and(F) statistics describing the performance of each item used on the examinations administered during the six-month period.(i) Certified food manager certificates.(1) General certificate issuance. Certificates shall be issued by the department-approved examination provider. Candidates whose certificates are issued after successful passage of a department-approved examination shall be deemed to meet the requirements for food manager certification.(2) Certificate period. A certified food manager certificate issued by a department-approved examination provider under this section shall comply with the CFP Standards for Accreditation of Food Protection Manager Certification Programs, §7.3, Effective Date of Certificate.(3) Recertification. Candidates may become recertified by passing a department-approved examination.(j) Department certificates.(1) Two-year renewal certificate. Food manager certificates issued by the department from May 6, 2004 to April 24, 2008, shall be renewed every two years and may be renewed two times.(2) Department certificate replacement. An individual requesting a certified food manager certificate replacement shall submit a completed written application to the department with the appropriate non-refundable fee. Replacement certificates will bear the same expiration date as the original certificate.(k) Department certificate fees. All fees are payable to the Department of State Health Services and are non-refundable. Fees shall be submitted with the appropriate form that relates to the fee category. A current license shall only be issued when all past due fees and late fees are paid for all years of operation in Texas. Fees shall be:(1) Two-year renewal certificate fee. The fee for a two-year renewal certificate shall be $10.(2) Replacement certificate fee. A replacement certificate fee for the department examination shall be $15.(3) Texas.gov fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by Texas.gov, to recover costs associated with application and renewal application processing through Texas.gov.(l) Licensing of certified food manager licensee. The department shall issue a license to a certified food manager licensee meeting the requirements of this section. A license issued under these rules shall expire two years from the date of issuance. A license is not transferable on change of ownership, name, or examination site location.(1) Application. Persons wishing to apply for a certified food manager license shall submit a completed application to the department. (2) Security agreement. The licensee shall submit a signed security agreement that individual examination items, examination item banks, certified food manager certification examinations, examination answer sheets, and candidate scores shall be secure at all times, and during administration that the examinations shall remain secure.(3) Certified food manager licensee fee. The completed license application shall include the appropriate non-refundable fee as specified in subsection (n)(1) of this section.(4) Certification examination. Department-approved examination(s) utilized by the certified food manager licensee shall be designated on the application.(5) Number of examination sites utilized. The license application shall indicate the number of examination sites to be utilized under the certified food manager license.(m) Responsibilities of licensee.(1) Compliance with food manager laws and rules. The licensee is responsible for compliance with applicable food manager laws and rules.(2) Payment of fees. All fees shall be non-refundable and paid as specified in subsection (n) of this section.(n) Required fees. All fees are payable to the Department of State Health Services and are non-refundable. Fees shall be submitted with the appropriate form that relates to the fee category. A current license shall only be issued when all past due fees and late fees are paid for all years of operation in Texas. Fees shall be:(1) Certified food manager licensee fee. Certified food manager licenses shall be valid for a two-year period and fees shall be based on the number of examination sites at which the licensee administers the examinations based on the following scale:(A) one site:(i) the two-year license fee for initial, renewal, or change of ownership shall be $400; and(ii) a license fee for a program amendment during the current licensure period shall be $200;(B) two to ten sites:(i) the two-year license fee for initial, renewal, or change of ownership shall be $1,000; and(ii) a license fee for a program amendment during the current licensure period shall be $500;(C) over ten sites:(i) the two-year license fee for initial, renewal, or change of ownership shall be $2,000; and(ii) a license fee for a program amendment during the current licensure period shall be $1,000.(2) Late fee. A certified food manager licensee submitting a completed renewal application to the department after the expiration date shall pay an additional $100 as a late fee.(3) Texas.gov fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by Texas.gov, to recover costs associated with application and renewal application processing through Texas.gov.(o) Certified food manager licensee registry. The department shall maintain a registry of all certified food manager licensees. The registry shall be made available on the department website.(p) Department audits. Audits of certified food manager licensees may be conducted to assess compliance with these rules. Audits may be based on analysis of data compiled by the department. Licensees shall allow personnel authorized by the department access for the purposes of an audit.(q) Denial, suspension and revocation of certified food manager license. A certified food manager license may be denied, suspended or revoked for the following reasons:(1) breach of the security agreement;(2) delinquency in payment of fees as described in this section; or(3) violation of the provisions of this section.(r) Denial, suspension and revocation procedures. Denial, suspension and revocation procedures under this section shall be conducted in accordance with the Administrative Procedure Act, Texas Government Code, Chapter 2001.(s) Suspension of License Relating to Child Support and Child Custody.(1) On receipt of a final court order or attorney general's order suspending a license due to failure to pay child support or for failure to comply with the terms of a court order providing for the possession of or access to a child, the department shall immediately determine if a license has been issued to the obligator named and:(A) record the suspension of the license in the department's records;(B) report the suspension as appropriate; and(C) demand surrender of the suspended license.(2) The department shall implement the terms of a final court or attorney general's order suspending a license without additional review or hearing. The board will provide notice as appropriate to the licensee or to others concerned with the license.(3) The department may not modify, remand, reverse, vacate, or stay a court or attorney general's order suspending a license issued under the Texas Family Code, Chapter 232, and may not review, vacate, or reconsider the terms of an order.(4) A licensee who is the subject of a final court or attorney general's order suspending his or her license is not entitled to a refund for any fee paid to the department.(5) If a suspension overlaps a license renewal period, an individual with a license suspended under this section shall comply with the normal renewal procedures in the Act and this chapter; however, the license will not be renewed until subsections (j) and (k) of this section are met. Source Note: The provisions of this §229.176 adopted to be effective January 20, 2010, 35 TexReg 377; amended to be effective December 1, 2023, 48 TexReg 6918. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG K TEXAS FOOD ESTABLISHMENTS §229.176 Certification of Food Managers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215658&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215658 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215658&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215658 03/11/2026 (a) Purpose. The purpose of this section is to implement a food manager certification requirement as authorized in the Texas Health and Safety Code, Chapter 437, §437.0076(b). Certification of food managers after testing on food safety principles reduces the risk of foodborne illness outbreaks caused by improper food preparation and handling techniques.(b) Food manager certification required. One certified food manager must be employed by each food establishment permitted under Texas Health and Safety Code, §437.0055. Certification must be obtained by passing a department approved examination at an approved examination site and meeting all requirements in Texas Health and Safety Code, Chapter 438, Subchapter G, and §229.176 of this title (relating to Certification of Food Managers).(c) Food manager certification exemptions. The following food establishments are exempt from the requirements in subsection (b) of this section:(1) establishments that handle only prepackaged food and do not package food as exempted in Texas Health and Safety Code, §437.0076(c);(2) child care facilities as exempted by Texas Health and Safety Code, §437.0076(f);(3) establishments that do not prepare or handle exposed Time/Temperature Control for Safety (TCS) food--(formerly Potentially Hazardous Food (PHF)), as defined in 2017 FDA Food Code 1-201.10; or(4) nonprofit organizations as defined in §229.371(9) of this title (relating to Permitting Retail Food Establishments).(d) Responsibilities of a certified food manager. Responsibilities of a certified food manager include:(1) identifying hazards in the day-to-day operation of a food establishment that provide food for human consumption;(2) developing or implementing specific policies, procedures or standards to prevent foodborne illness;(3) supervising or directing food preparation activities and ensuring appropriate corrective actions are taken as needed to protect the health of the consumer;(4) training the food establishment employees on the principles of food safety; and(5) performing in-house self-inspections of daily operations on a periodic basis to ensure that policies and procedures concerning food safety are being followed.(e) Certificate reciprocity. A certificate issued to an individual who successfully completes a department approved examination shall be accepted as meeting the training and testing requirements under Texas Health and Safety Code, §438.046(b).(f) Certificate posting. The original food manager certificate shall be posted in a location in the food establishment that is conspicuous to consumers. Source Note: The provisions of this §229.177 adopted to be effective July 7, 2002, 27 TexReg 5783; amended to be effective April 24, 2008, 33 TexReg 3278; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective December 1, 2023, 48 TexReg 6918. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG K TEXAS FOOD ESTABLISHMENTS §229.177 Certification of Food Managers in Areas Under the Department of State Health Services Permitting Jurisdiction https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215659&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215659 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215659&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215659 03/11/2026 (a) Purpose. This section is intended to provide the framework for accrediting food safety education or training programs for food handlers in accordance with the Texas Health and Safety Code Chapter 438, Subchapter D, §438.0431. A uniform standard governing the accreditation of food handler programs enhances the recognition of reciprocity among regulatory agencies and reduces the expense of duplicate education incurred when food handlers work in multiple regulatory jurisdictions. Education of the food handlers provides more qualified employees, thereby reducing the risk of foodborne illness outbreaks caused by improper food preparation and handling techniques.(b) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise.(1) Accredited food handler program--A program approved by the department that meets the standards set forth in this section.(2) Department--The Texas Department of State Health Services.(3) Food--A raw, cooked, or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.(4) Food establishment--(A) Food establishment means an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:(i) such as a restaurant; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and(ii) that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.(B) Food establishment includes:(i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.(C) Food establishment does not include:(i) an establishment that offers only prepackaged foods that are not potentially hazardous;(ii) a produce stand that only offers whole, uncut fresh fruits and vegetables;(iii) a food processing plant;(iv) a kitchen in a private home if only food that is not potentially hazardous is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law;(v) an area where food that is prepared as specified in clause (iv) of this subparagraph is sold or offered for human consumption;(vi) a Bed and Breakfast Limited facility as defined in these rules; or(vii) a private home that receives catered or home-delivered food.(5) Food handler--A food service employee who works with unpackaged food, food equipment or utensils, or food contact surfaces.(6) Law--Applicable local, state and federal statutes, regulations and ordinances.(7) Licensee--The individual, corporation or company that is licensed by the department to operate certified food handler programs.(8) Person--An association, corporation, individual, partnership or other legal entity, government or governmental subdivision or agency.(9) Reciprocity--Acceptance by state and local regulatory authorities of a food handler certificate issued by a department accredited food handler program.(10) Regulatory authority--The local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.(11) Sponsor--An individual designated in writing to the department, by the licensee, as the person responsible for administrative management of the program.(c) Food handler education and training program. The department may accredit an education or training program for basic food safety. The program shall include employee knowledge, responsibilities and training as required in Chapter 228 of this title (relating to Retail Food Establishments).(1) Education or training course curriculum. A food handler training or education course shall include the following basic food safety principles.(A) Foodborne disease outbreak. Instruction on foodborne disease outbreak shall include the definition of foodborne disease outbreak, the causes and preventive measures, including employee reporting requirements as defined in Chapter 228, Subchapter B of this title (relating to Management and Personnel).(B) Good hygienic practices. Instruction on good hygienic practices shall include the procedures as required in Chapter 228, Subchapter B of this title.(C) Preventing contamination by employees. Instruction shall include the training as required in Chapter 228, Subchapter C of this title (relating to Food), regarding the training requirements for contact with ready to eat food with their bare hands.(D) Cross Contamination. Instruction on cross contamination shall include procedures on the prevention of cross-contamination of foods, sanitization methods and corrective actions as required in 2017 FDA Food Code, Chapters 3 and 4.(E) Time and temperature. Instruction shall include time and temperature control of foods to limit pathogen growth or toxin production as required in Chapter 228, Subchapter C of this title.(F) Food Allergen Awareness. Instruction shall include the food allergen awareness information described by Texas Health and Safety Code §437.027(b).(2) Course length. The course length may not exceed two hours.(3) Course examination. A training or education program may require a participant to achieve a passing score on an examination to successfully complete the course.(4) Internet programs. A program accredited under this section may be delivered through the Internet.(d) Food handler certificate.(1) Certificate period. A food handler certificate issued by an accredited food handler program shall be valid for two years.(2) Certificate reciprocity. Department accredited food handler program issued certificates shall be recognized statewide by regulatory authorities as the valid proof of successful completion of a department accredited food handler program.(e) Licensing of an accredited food handler program licensee. The department shall issue a license of accreditation to each certified food handler program licensee who has demonstrated compliance with this section. A license issued under these rules will expire two years from the date of issuance. This license is not transferable on change of ownership, or site location.(f) Responsibilities of a licensee.(1) Compliance with certified food handler program law and rules. The licensee is responsible for compliance with applicable certified food handler program law and rules.(2) Payment of fees. All fees shall be non-refundable and paid as specified in subsection (g) of this section.(g) Required fees. All fees are payable to the department and are non-refundable. Fees must be submitted with the appropriate completed application that relates to the fee category. A current license shall only be issued when all past due fees and late fees are paid for all years of operation in Texas.(1) Accredited food handler program license fee for initial, renewal, or change of ownership. A program fee shall be $600 for a two-year license for each food handler program.(2) Accredited food handler program amended license fee. Program amendment fees shall be $300.(3) Late fee. Accredited food handler program licensees submitting a completed renewal application to the department after the expiration date shall pay an additional $100 as a late fee.(4) Texas.gov fee. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by Texas.gov, to recover costs associated with application and renewal application processing through Texas.gov.(h) Certified food handler program registry. The department shall maintain a program registry of all accredited food handler programs. The registry shall be made available on the department website.(i) Department audits. Classroom audits may be conducted to assess program compliance. Licensee shall allow personnel authorized by the department access for the purposes of an audit. Audits may be based on analysis of data compiled by the department.(j) Denial, suspension and revocation of program accreditation. An accredited food handler program license may be denied, suspended or revoked for the following reasons:(1) a licensee is delinquent in payment of fees as described in this section; or(2) violation of the provisions of this section.(k) Denial, suspension and revocation procedures. Denial, suspension and revocation procedures under this section shall be conducted in accordance with the Administrative Procedure Act, Texas Government Code, Chapter 2001.(l) Suspension of License Relating to Child Support and Child Custody.(1) On receipt of a final court order or attorney general's order suspending a license due to failure to pay child support or for failure to comply with the terms of a court order providing for the possession of or access to a child, the department shall immediately determine if a license has been issued to the obligator named, and:(A) record the suspension of the license in the department's records;(B) report the suspension as appropriate; and(C) demand surrender of the suspended license.(2) The department shall implement the terms of a final court or attorney general's order suspending a license without additional review or hearing. The board will provide notice as appropriate to the licensee or to others concerned with the license.(3) The department may not modify, remand, reverse, vacate, or stay a court or attorney general's order suspending a license issued under the Texas Family Code, Chapter 232, and may not review, vacate, or reconsider the terms of an order.(4) A licensee who is the subject of a final court or attorney general's order suspending his or her license is not entitled to a refund for any fee paid to the department.(5) If a suspension overlaps a license renewal period, an individual with a license suspended under this section shall comply with the normal renewal procedures in the Act, and this chapter; however, the license will not be renewed until subsection (g) of this section is met. Source Note: The provisions of this §229.178 adopted to be effective April 24, 2008, 33 TexReg 3278; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective December 1, 2023, 48 TexReg 6918. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG K TEXAS FOOD ESTABLISHMENTS §229.178 Accreditation of Food Handler Education or Training Programs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113796&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113796 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113796&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113796 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Direct seller--An individual:(A) who is not affiliated with a permanent retail establishment and who engages in the business of:(i) in-person sales of prepackaged nonperishable foods, including dietary supplements, to a buyer on a buy-sell basis, a deposit-commission basis, or a similar basis for resale in a home; or(ii) sales of prepackaged nonperishable foods, including dietary supplements, in a home;(B) who receives substantially all remuneration for a service, whether in cash or other form of payment, which is directly related to sales or other output, including the performance of the service, and not to the number of hours worked; or(C) who performs services under a written contract between the individual and the person for whom the service is performed, and the contract provides that the individual is not treated as an employee with respect to federal tax purposes.(2) Food--Any article of food or drink for man; chewing gum; or an article used for components of any such article.(3) Food manufacturer--A person who combines, purifies, processes, or packages food for sale through a wholesale outlet. The term also includes a retail outlet that packages or labels food before sale and a person that represents itself as responsible for the purity and proper labeling of an article of food by labeling the food with the person's name and address.(4) Food service establishment--Any place where food is prepared and intended for individual portion service, and includes the site at which individual portions are provided. The term includes any such place regardless of whether consumption is on or off the premises and regardless of whether there is a charge for the food. The term also includes delicatessen-type operations that prepare sandwiches intended for individual portion service. The term does not include private homes where food is prepared or served for individual family consumption, retail food stores, the location of food vending machines, and supply vehicles.(5) Food wholesaler--A person who distributes food for resale, either through a retail outlet owned by that person or through sales to another person. The term "food wholesaler" shall not include a commissary which distributes food primarily intended for immediate consumption on the premises of a retail outlet under common ownership or an establishment engaged solely in the distribution of nonalcoholic beverages in sealed containers.(6) Manufacture--The process of combining or purifying food or packaging food for sale to a person at wholesale or retail, and includes repackaging, labeling, or relabeling of any food.(7) Package--Any container or wrapping in which a consumer commodity is enclosed for use in the delivery or display of that consumer commodity to retail purchasers. The term includes wrapped meats enclosed in papers or other materials as prepared by the manufacturers thereof for sale. The term does not include:(A) shipping containers or wrappings used solely for the transportation of a consumer commodity in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors; or(B) shipping containers or outer wrappings used by retailers to ship or deliver a commodity to retail customers if the containers and wrappings do not bear printed matter relating to any particular commodity.(8) Place of business--Each location where a person manufactures food, where food for wholesale is distributed, or a warehouse where food is stored.(9) Sale--The manufacture, production, processing, packaging, exposure, offer, possession, or holding of any such article for sale; and the sale, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct of any food, drug, or device place of business.(10) Warehouse--Any structure used for the storage of food.(11) Warehouse operator--A person that operates a warehouse where food is stored. Source Note: The provisions of this §229.181 adopted to be effective July 21, 2004, 29 TexReg 6940. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG L LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS §229.181 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158917&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158917 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158917&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158917 03/11/2026 (a) License/registration required.(1) A person who manufactures food must obtain a food manufacturer's license for each place of business as described in subsection (b)(1) or (2) of this section; also, a food manufacturer who distributes its own food, and/or food from another manufacturer must only obtain a food manufacturer's license. When calculating the amount of the licensing fee, the manufacturer must include the total for all food manufactured and wholesaled from the place of business.(2) A person who distributes food, but who does not manufacture food, must obtain a food wholesaler's license for each place of business as described in subsection (b)(3) or (4) of this section.(3) A person who distributes food, but who does not manufacture food, and who chooses to store that food with a warehouse operator licensed under subsection (b)(8) or (9) of this section, must register as a food wholesaler under subsection (b)(7) of this section.(4) A person who distributes food and drugs, food and medical devices, or food and drugs and medical devices, must obtain a wholesaler with combination products license, as described in subsection (b)(5) or (6) of this section, for each place of business; this license is required even if the products are stored in a separate warehouse or with a warehouse operator licensed under subsection (b)(8) or (9) of this section.(5) A warehouse operator storing food for a registered food wholesaler must obtain a warehouse operator license as described in subsection (b)(8) or (9) of this section for each such warehouse. A warehouse operator who distributes only food is required to obtain only a warehouse operator license. A warehouse operator who distributes combination products (food and drugs, food and medical devices, or food, drugs, and medical devices) and is also required to obtain a wholesaler's license under subsection (b)(5) or (6) of this section will be issued only one license. The license fee to be paid will be the higher of the two applicable fees.(6) A warehouse operated by a food manufacturer which is totally separate from any manufacturing location, including locations from which foods are held for limited periods of time for distribution, must obtain a warehouse operator license as described in subsection (b)(8) or (9) of this section for each such warehouse.(7) A retail food store that also manufactures food and is required to be permitted by the Department of State Health Services (department) pursuant to Health and Safety Code, Chapter 437, and the Texas Food Establishment Regulations, §229.370 and §229.371 of this title (relating to Permitting Retail Food Establishments), will be issued only one license or permit. The license or permit fee to be paid will be the higher of the two applicable fees.(8) A wholesaler who distributes combination products and who is also required to be licensed as a warehouse operator under this section will be issued only one license. The license fee to be paid will be the higher of the two applicable fees.(9) A food manufacturer required to be licensed exclusively pursuant to Health and Safety Code, Chapter 432, relating to Food, Drug, Device and Cosmetic Salvage, Chapter 433, relating to Meat and Poultry Inspection, Chapter 435, relating to Dairy Products, Chapter 436, relating to Aquatic Life, or Chapter 440, relating to Frozen Desserts, is not required to license pursuant to this chapter.(b) Licensing and registration fees.(1) Food manufacturer. No person may operate or conduct business as a food manufacturer in this state without first obtaining a license from the department. Licenses issued under this subsection expire two years from the start date of the regulated activity. All applicants for a new or renewal food manufacturer's license shall pay a license fee.(A) For each place of business having gross annual manufactured food sales of $0.00 - $9,999.99, the fees are:(i) $100 for a two-year license;(ii) $100 for a two-year license that is amended due to a change of ownership; and(iii) $50 for a two-year license that is amended during the current licensure period due to minor changes.(B) For each place of business having gross annual manufactured food sales of $10,000 - $24,999.99, the fees are:(i) $150 for a two-year license;(ii) $150 for a two-year license that is amended due to a change of ownership; and(iii) $75 for a two-year license that is amended during the current licensure period due to minor changes.(C) For each place of business having gross annual manufactured food sales of $25,000 - $99,999.99, the fees are:(i) $250 for a two-year license;(ii) $250 for a two-year license that is amended due to a change of ownership; and(iii) $125 for a two-year license that is amended during the current licensure period due to minor changes.(D) For each place of business having gross annual manufactured food sales of $100,000 - $199,999.99, the fees are:(i) $560 for a two-year license;(ii) $560 for a two-year license that is amended due to a change of ownership; and(iii) $280 for a two-year license that is amended during the current licensure period due to minor changes.(E) For each place of business having gross annual manufactured food sales of $200,000 - $999,999.99, the fees are:(i) $900 for a two-year license;(ii) $900 for a two-year license that is amended due to a change of ownership; and(iii) $450 for a two-year license that is amended during the current licensure period due to minor changes.(F) For each place of business having gross annual manufactured food sales of $1 million - $9,999,999.99, the fees are:(i) $1,120 for a two-year license;(ii) $1,120 for a two-year license that is amended due to a change of ownership; and(iii) $560 for a two-year license that is amended during the current licensure period due to minor changes.(G) For each place of business having gross annual manufactured food sales greater than or equal to $10 million, the fees are:(i) $1,680 for a two-year license;(ii) $1,680 for a two-year license that is amended due to a change of ownership; and(iii) $840 for a two-year license that is amended during the current licensure period due to minor changes.(2) Food wholesaler. No person may operate or conduct business as a food wholesaler in this state without first obtaining a food wholesaler's license from the department. Licenses issued under this subsection expire two years from the start date of the regulated activity. Except as provided for in paragraph (4) of this subsection, all food wholesalers shall pay a license fee.(A) For each place of business having gross annual food sales of $0.00 - $199,999.99, the fees are:(i) $250 for a two-year license;(ii) $250 for a two-year license that is amended due to a change of ownership; and(iii) $125 for a two-year license that is amended during the current licensure period due to minor changes.(B) For each place of business having gross annual food sales of $200,000 - $499,999.99, the fees are:(i) $450 for a two-year license;(ii) $450 for a two-year license that is amended due to a change of ownership; and(iii) $225 for a two-year license that is amended during the current licensure period due to minor changes.(C) For each place of business having gross annual food sales of $500,000 - $999,999.99, the fees are:(i) $680 for a two-year license;(ii) $680 for a two-year license that is amended due to a change of ownership; and(iii) $340 for a two-year license that is amended during the current licensure period due to minor changes.(D) For each place of business having gross annual food sales of $1 million - $9,999,999.99, the fees are:(i) $900 for a two-year license;(ii) $900 for a two-year license that is amended due to a change of ownership; and(iii) $450 for a two-year license that is amended during the current licensure period due to minor changes.(E) For each place of business having gross annual food sales of greater than or equal to $10 million, the fees are:(i) $1,350 for a two-year license;(ii) $1,350 for a two-year license that is amended due to a change of ownership; and(iii) $675 for a two-year license that is amended during the current licensure period due to minor changes.(3) Wholesaler with combination products. A person who is required to be licensed as a food wholesaler under this section and who is also required to be licensed as a wholesale distributor of drugs under §229.249(a) of this title (relating to Licensure Fees) or as a device distributor under §229.439(a)(1) of this title (relating to Licensure Fees) shall pay a combined licensure fee for each place of business. The licensure fee shall be based on the combined gross annual sales of these regulated products (foods, drugs, and/or devices).(A) For each place of business having combined gross annual sales of $0.00 - $199,999.99, the fees are:(i) $520 for a two-year license;(ii) $520 for a two-year license that is amended due to a change of ownership; and(iii) $260 for a license that is amended during the current licensure period due to minor changes.(B) For each place of business having combined gross annual sales of $200,000 - $499,999.99, the fees are:(i) $780 for a two-year license;(ii) $780 for a two-year license that is amended due to a change of ownership; and(iii) $390 for a license that is amended during the current licensure period due to minor changes.(C) For each place of business having combined gross annual sales of $500,000 - $999,999.99, the fees are:(i) $1,040 for a two-year license;(ii) $1,040 for a two-year license that is amended due to a change of ownership; and(iii) $520 for a license that is amended during the current licensure period due to minor changes.(D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99, the fees are:(i) $1,300 for a two-year license;(ii) $1,300 for a two-year license that is amended due to a change of ownership; and(iii) $650 for a license that is amended during the current licensure period due to minor changes.(E) For each place of business having combined gross annual sales greater than or equal to $10 million, the fees are:(i) $1,950 for a two-year license;(ii) $1,950 for a two-year license that is amended due to a change of ownership; and(iii) $975 for a license that is amended during the current licensure period due to minor changes.(4) Food wholesaler registration. Except as provided in paragraph (3) of this subsection, a food wholesaler is not required to obtain a license under this section for a place of business if all of the food distributed from that place of business will be stored in a warehouse licensed under this section. A food wholesaler that is not required to obtain a license for a place of business under this section shall register each place of business with the department pursuant to subsection (d)(2) of this section, but only one registration fee must be paid by each such food wholesaler. A food wholesaler who meets this subsection's requirements shall pay a registration fee of $100. A registration issued under this subsection expires two years from the start date of the regulated activity.(5) Warehouse operator. No person may operate or conduct business as a warehouse operator in this state without first obtaining a license from the department. Licenses issued under this subsection expire two years from the start date of the regulated activity. License fees are based on the maximum amount of square feet dedicated to food storage during the licensing period. A warehouse operator shall pay a license fee.(A) For each place of business having food storage of 0 - 6,000 square feet, the fees are:(i) $350 for a two-year license;(ii) $350 for a two-year license that is amended due to a change of ownership; and(iii) $175 for a two-year license that is amended during the current licensure period due to minor changes.(B) For each place of business having food storage of 6,001 - 24,000 square feet, the fees are:(i) $700 for a two-year license;(ii) $700 for a two-year license that is amended due to a change of ownership; and(iii) $350 for a two-year license that is amended during the current licensure period due to minor changes.(C) For each place of business having food storage of 24,001 - 75,000 square feet, the fees are:(i) $1,050 for a two-year license;(ii) $1,050 for a two-year license that is amended due to a change of ownership; and(iii) $525 for a two-year license that is amended during the current licensure period due to minor changes.(D) For each place of business having food storage of 75,001 - 250,000 square feet, the fees are:(i) $1,400 for a two-year license;(ii) $1,400 for a two-year license that is amended due to a change of ownership; and(iii) $700 for a two-year license that is amended during the current licensure period due to minor changes.(E) For each place of business having food storage of 250,001 or more square feet, the fees are:(i) $2,000 for a two-year license;(ii) $2,000 for a two-year license that is amended due to a change of ownership; and(iii) $1,000 for a two-year license that is amended during the current licensure period due to minor changes.(6) A firm that has more than one business location may request a one-time proration of fees when applying for a license for each new location. Upon approval by the department, the expiration date of the license for the new location will be established the same as the firm's previously licensed locations.(7) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Department of Information Resources, to recover costs associated with application and renewal application processing through tex.gov.(8) All license/registration fees paid under this section are non-refundable.(9) If the license/registration category changes during the license period, the license shall be renewed in the proper category at the time of renewal.(c) License/registration forms. License/registration forms may be obtained from the department, located at 1100 West 49th Street, Austin, Texas 78756-3182, or from the website at www.dshs.state.tx.us/fdlicense/apps.shtm.(d) License/registration application. All food manufacturers, food wholesalers, and warehouse operators shall file a license application on a form authorized by the department.(1) The application form shall be signed and verified, and shall contain the following information:(A) the name of the legal entity to be licensed, including the name under which the business is conducted;(B) the physical address of the place of business;(C) the mailing address of the place of business;(D) if a sole proprietorship, the name of the proprietor; if a partnership, the names of all partners; if a corporation, the name of the corporation, the date and place of incorporation and name and address of its registered agent in the state; or if any other type of association, the names of the principals of such association;(E) the names of those individuals in an actual administrative capacity which, in the case of a sole proprietorship shall be the managing proprietor; in a partnership, the managing partner; in a corporation, the officers and directors; in any other association, those in a managerial capacity; and(F) a list of categories of gross annual sales or square footage as applicable, which must be marked and adhered to by the licensee in the determination and paying of the license fee.(2) Food wholesalers who meet the requirements to register under subsection (b)(7) of this section, must submit a registration form authorized by the department which shall be signed and verified, and contain the following information:(A) the name of the legal entity to be registered, including the name under which the business is conducted;(B) the name, telephone number, and physical addresses of the licensed warehouses where the food wholesaler's food products are or will be stored;(C) the physical address where the food wholesaler's distribution records are located and available for review upon inspection;(D) the mailing address and telephone number where the food wholesaler may be contacted; and(E) a description of the type of food products being distributed by the food wholesaler.(e) Two or more establishments. If the food manufacturer, food wholesaler, or warehouse operator operates more than one place of business, each place of business shall be licensed separately by listing the name and address of each place of business on the license application.(f) Issuance of license/registration. The department may license/register a manufacturer, food wholesaler, or warehouse operator who meets the requirements of this section and §229.183 of this title (relating to Minimum Standards for Licensure/Registration).(1) The initial license/registration shall be valid for two years from the date the license/registration was issued.(2) The renewal license/registration shall be valid for two years from the date the license/registration was issued.(3) A current license/registration shall only be issued when all past due fees and late fees are paid.(g) Renewal of license/registration.(1) For each licensing/registration period, the food manufacturer, food wholesaler, or warehouse operator shall renew its license/registration as applicable following the requirements of this section and §229.183 of this title.(2) A person who holds a license/registration issued by the department under the Health and Safety Code shall renew the license/registration by filing an application for renewal on a form authorized by the department accompanied by the appropriate licensing/registration fee. A licensee/registrant must file for renewal before the expiration date of the current license. A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee.(3) Failure to submit the renewal during the licensing/registration period may subject the food manufacturer, food wholesaler, or warehouse operator to the offense provisions under the Health and Safety Code, Chapter 431, to the provision of §229.184 of this title (relating to the Refusal, Revocation, or Suspension of License/Registration), and to the provisions of §229.222 of this title (relating to Enforcement).(h) Amendment of license/registration.(1) Fees. A license or registration that is amended during the licensing or registration period, including a change of name, ownership (change in legal entity), or a notification of a change in the location of a licensed or registered place of business required under the Health and Safety Code, §431.2251, will require a new application and submission of license or registration fees as outlined in subsection (b) of this section.(2) Change in name, ownership, status, or location of business.(A) Not later than the 31st day before the date of the change in the name, status, or location of a licensed/registered place of business, the license/registration holder shall provide written notice to the department of the intended change. The notice shall include, as applicable:(i) The new name of the legal entity to be licensed or registered, including the name under which the business is conducted;(ii) The physical and mailing address of the new location;(iii) The name and physical address of the licensed warehouse where the food wholesaler's food products will be stored;(iv) The physical address where the food wholesaler's distribution records are located and available for review upon inspection; and(v) The mailing address and telephone number where the food wholesaler may be contacted.(B) Not later than the 10th day after completion of the change of location, the licensee or registrant shall forward to the department the name and residence address of the individual in charge of the new place of business.(C) Notice is considered adequate if the licensee or registrant provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the department at Regulatory Licensing Unit, Food and Drug Licensing Group, Mail Code 2835, P.O. Box 149347, Austin, Texas 78714-9347.(i) This section does not apply to:(1) a person, firm, or corporation that harvests, packages, or washes raw fruits or vegetables for shipment at the location of harvest;(2) a direct seller who is not otherwise engaged in manufacturing;(3) a person engaged solely in the distribution of alcoholic beverages in sealed containers by holders of licenses or permits issued under the Alcoholic Beverage Code, Chapters 19, 20, 21, 23, 64, or 65;(4) a food service establishment or a commissary which distributes food primarily intended for immediate consumption on the premises of a retail outlet under common ownership unless the business regularly engages in the labeling, combining, and purifying of food which is either sold for resale or packaged for sale in other than individual portions; or(5) a restaurant that provides food for immediate human consumption to a political subdivision or to a licensed nonprofit organization if the restaurant would not otherwise be considered a food wholesaler. Source Note: The provisions of this §229.182 adopted to be effective July 21, 2004, 29 TexReg 6940; amended to be effective February 1, 2006, 31 TexReg 501; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective October 11, 2012, 37 TexReg 8027. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG L LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS §229.182 Licensing/Registration Fee and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113798&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113798 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113798&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113798 03/11/2026 Food manufacturers, food wholesalers, and warehouse operators.(1) All food manufacturers, and warehouse operators in Texas shall comply with §§229.211 - 229.221 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food) in addition to the existing standards contained in the Health and Safety Code, Chapters 431, 434, and 438.(2) All food wholesalers in Texas, including those food wholesalers registered under §229.182 of this title (relating to Licensing/Registration Fees and Procedures), shall comply with §§229.211 - 229.219 of this title, in addition to the existing standards contained in the Health and Safety Code, Chapters 431, 434, and 438.(3) Living areas. No manufacturing or holding of foods for distribution shall be conducted in any room used as living or sleeping quarters. All food manufacturing and storage shall be separated from any living or sleeping quarters by complete partitioning.(4) Food labeling. If a person, firm, or corporation labels an article of food, the label shall meet the requirements of the Health and Safety Code, Chapter 431. Source Note: The provisions of this §229.183 adopted to be effective July 21, 2004, 29 TexReg 6940. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG L LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS §229.183 Minimum Standards for Licensure/Registration https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113799&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113799 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=113799&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 113799 03/11/2026 (a) Basis. The department may, after providing an opportunity for a hearing, refuse an application for a license/registration from a food manufacturer, food wholesaler, or warehouse operator, or may revoke or suspend a license/registration for violations of the requirements in §229.182 of this title (relating to Licensing/Registration Fee and Procedures), and §229.183 of this title (relating to Minimum Standards for Licensure/Registration), or for interference with the department in the performance of its duty under these rules.(b) Hearings. Any hearings for the refusal, revocation, or suspension of a license/registration are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures). Source Note: The provisions of this §229.184 adopted to be effective July 21, 2004, 29 TexReg 6940. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG L LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS §229.184 Refusal, Revocation, or Suspension of Licensure/Registration https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185005&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185005 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185005&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185005 03/11/2026 (a) This subchapter applies to every person engaged in food manufacturing and/or wholesale food distribution regardless of the license or permit held under §§229.181 - 229.184 of this title (relating to Licensure of Food Manufacturers, Food Wholesalers, and Warehouse Operators), §§229.370 - 229.374 of this title (relating to Permitting Retail Food Establishments), and §§229.541 - 229.555 of this title (relating to Regulation of Food Salvage Establishments and Brokers), or if the person is exempt from licensure. Retail food establishments, such as grocery stores and restaurants that are located outside the jurisdiction of a local health authority, must also comply with the requirements of Chapter 228 of this title (relating to Retail Food) except for the manufacture or wholesale of food as defined by the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, §431.221(2) and (3). Retail establishments that are located within the jurisdiction of a local health authority that permits and inspects retail food establishments and that are required to license as a food manufacturer under §§229.181 - 229.184 of this title, must also comply with the applicable rules enforced by the local health authority.(b) The criteria and definitions in this subchapter apply in determining whether a food is adulterated within the meaning of Texas Health and Safety Code, §431.081(a)(3) in that the food has been manufactured under such conditions that it is unfit for food; or within the meaning of Texas Health and Safety Code, §431.081(a)(4) in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.(c) Food subject to the requirements of these sections may also be subject to specific regulations found in Title 21, Code of Federal Regulations Parts 1-199, or in other sections of this title (25 Texas Administrative Code Chapter 229).(d) The department adopts by reference the following laws and regulations(1) United States Code Title 21 Chapter 9, Subchapter IV, §343(w) et seq. as amended;(2) 21 Code of Federal Regulations §§1.20-1.22 and §1.24, General Enforcement Regulations, as amended;(3) 21 Code of Federal Regulations §70.20 and §70.25, Color Additives, as amended;(4) 21 Code of Federal Regulations Part 73 Subpart A, Listing of Color Additives Exempt from Certification, as amended;(5) 21 Code of Federal Regulations Part 74 Subpart A, Listing of Color Additives Subject to Certification, as amended;(6) 21 Code of Federal Regulations Part 81. General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;(7) 21 Code of Federal Regulations Part 82, Listing of Certified Provisionally Listed colors and Specifications, as amended;(8) 21 Code of Federal Regulations §100.155, General, as amended;(9) 21 Code of Federal Regulations Part 101, Food Labeling, as amended;(10) 21 Code of Federal Regulations Part 102, Common or Usual Name for Non Standardized Foods, as amended;(11) 21 Code of Federal Regulations Part 104, Nutritional Quality Guidelines for Foods, as amended;(12) 21 Code of Federal Regulations Part 105, Foods for Special Dietary Use, as amended;(13) 21 Code of Federal Regulations Part 106, Infant Formula Quality Control Procedures, as amended;(14) 21 Code of Federal Regulations Part 107, Infant Formula, as amended;(15) 21 Code of Federal Regulations Part 108, Emergency Permit Control, as amended;(16) 21 Code of Federal Regulations Part 109, Unavoidable Contaminants in Food for Human Consumption and Food Packaging Material, as amended;(17) 21 Code of Federal Regulations Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, as amended;(18) 21 Code of Federal Regulations Part 114, Acidified Foods, as amended;(19) 21 Code of Federal Regulations Part 117 Subpart C, D, F, and G, Current Good Manufacturing Practice, Hazard Analysis, and risk Based Preventive Controls for Human Food, as amended;(20) 21 Code of Federal Regulations Part 120, Hazard Analysis and Critical Control Point (HACCP) Systems, as amended;(21) 21 Code of Federal Regulations Part 123, Fish and Fishery Products, as amended;(22) 21 Code of Federal Regulations Part 129, Processing and Bottling of Bottled Drinking Water, as amended;(23) 21 Code of Federal Regulations Part 130, Food Standards: General, as amended;(24) 21 Code of Federal Regulations Part 131, Milk and Cream, as amended;(25) 21 Code of Federal Regulations Part 133, Cheese and Related Cheese Products, as amended;(26) 21 Code of Federal Regulations Part 135, Frozen Desserts, as amended;(27) 21 Code of Federal Regulations Part 136; Bakery Products, as amended;(28) 21 Code of Federal Regulations Part 137, Cereal Flours and Related Products, as amended;(29) 21 Code of Federal Regulations Part 139, Macaroni and Noodle Products, as amended;(30) 21 Code of Federal Regulations Part 145, Canned Fruits, as amended;(31) 21 Code of Federal Regulations Part 146, Canned Fruit Juices, as amended;(32) 21 Code of Federal Regulations Part 150, Fruit Butters, Jellies, Preserves, and Related Products, as amended;(33) 21 Code of Federal Regulations Part 152, Fruit Pies, as amended;(34) 21 Code of Federal Regulations Part 155, Canned Vegetables, as amended;(35) 21 Code of Federal Regulations Part 156, Vegetable Juices, as amended;(36) 21 Code of Federal Regulations Part 158, Frozen Vegetables, as amended;(37) 21 Code of Federal Regulations Part 160, Eggs and Egg Products, as amended;(38) 21 Code of Federal Regulations Part 161, Fish and Shellfish, as amended;(39) 21 Code of Federal Regulations Part 163, Cacao Products, as amended;(40) 21 Code of Federal Regulations Part 164, Tree Nut and Peanut Products, as amended;(41) 21 Code of Federal Regulations Part 165, Beverages, as amended;(42) 21 Code of Federal Regulations Part 166, Margarine, as amended;(43) 21 Code of Federal Regulations Part 168, Sweeteners and Table Syrups, as amended;(44) 21 Code of Federal Regulations Part 169, Food Dressings and Flavorings, as amended;(45) 21 Code of Federal Regulations Part 170, Food Additives, as amended;(46) 21 Code of Federal Regulations Part 172, Food Additives Permitted For Direct Addition To Food For Human Consumption, as amended;(47) 21 Code of Federal Regulations Part 173, Secondary Direct Food Additives Permitted in food For Human Consumption, as amended;(48) 21 Code of Federal Regulations Part 174, Indirect Food Additives General, as amended;(49) 21 Code of Federal Regulations Part 175, Indirect Food Additives Adhesives and Components of Coatings, as amended;(50) 21 Code of Federal Regulations Part 176, Indirect Food Additives Paper and Paperboard Components, as amended;(51) 21 Code of Federal Regulations Part 177, Indirect Food Additives Polymers, as amended;(52) 21 Code of Federal Regulations Part 178, Indirect Food Additives Adjuvants, Production Aids, and Sanitizers, as amended;(53) 21 Code of Federal Regulations Part 180, Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study, as amended;(54) 21 Code of Federal Regulations Part 181, Prior-Sanctions Food Ingredients, as amended;(55) 21 Code of Federal Regulations Part 182, Substances Generally Recognized as Safe, as amended;(56) 21 Code of Federal Regulations Part 184, Direct Food Substances Affirmed as Generally Recognized as Safe, as amended;(57) 21 Code of Federal Regulations Part 186, Indirect Food Substances Affirmed as Generally Recognized as Safe, as amended; and(58) 21 Code of Federal Regulations Part 189, Substances Prohibited From Use in Human Food, as amended. Source Note: The provisions of this §229.210 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.210 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185006&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185006 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185006&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185006 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise. Those definitions and interpretations of terms of the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431, are also applicable when used in this subchapter.(1) Acid foods or acidified foods--Foods that have an equilibrium pH of 4.6 or below.(2) Act--Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431.(3) Adequate--That which is needed to accomplish the intended purpose in keeping with good public health practice.(4) Adulterated --Has the meaning as defined in the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431.(5) Affiliate--Any facility that controls, is controlled by, or is under common control with another facility.(6) Allergen cross-contact--The unintentional incorporation of a food allergen into a food.(7) Approved source--A supplier of food that complies with applicable state and federal laws and is licensed, if required, and inspected by the regulatory authority having jurisdiction over the processing and distribution of food.(8) Audit--The systematic, independent, and documented examination (through observation, investigation, records review, discussions with employees of the audited entity, and, as appropriate, sampling and laboratory analysis) to assess a supplier's food safety processes and procedures.(9) Batter--A semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.(10) Blanching (except for tree nuts and peanuts)--A prepackaging heat treatment of foodstuffs for an adequate time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.(11) Calendar day--Every day shown on the calendar.(12) Cleaning--Physical removal of dirt (soil) from surfaces which includes the use of clean water and detergent.(13) Conventional handwashing--The washing of hands that relies on hot running water of at least 100 degrees Fahrenheit and a hand cleaning agent to cleanse the hands.(14) Conventional handwashing sink--A lavatory, trough basin, or vessel for washing, a wash basin, or plumbing fixture especially placed for use in personal hygiene and designed only for washing hands that relies on hot running water of at least 100 degrees Fahrenheit and a hand cleaning agent to cleanse the hands.(15) Correction--An action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce).(16) Corrosion Resistant Material--A material that maintains acceptable surface cleanability characteristics under prolonged influence of a food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.(17) Critical control point--A point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.(18) Defect action level--A level of a non-hazardous, naturally occurring, unavoidable defect at which a food product may be regarded as "adulterated" and subject to enforcement action under Texas Health and Safety Code, §431.081(a)(3).(19) Environmental pathogen--A pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens for the purposes of this subchapter include Listeria monocytogenes and Salmonella spp. But do not include the spores of pathogenic sporeforming bacteria.(20) Facility--(A) A person who manufactures, wholesales, or otherwise holds food and is subject to the requirements of Texas Health and Safety Code, Chapter 431.(B) A domestic facility or a foreign facility that is required to register under the Federal Food, Drug, and Cosmetic Act, §415 in accordance with the requirements of 21 Code of Federal Regulations Part 1, Subpart H.(21) Farm--Means:(A) Primary production farm. A primary production farm is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term "farm" includes operations that, in addition to these activities:(i) Pack or hold raw agricultural commodities;(ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in clause (iii)(II)(-a-) of this subparagraph; and(iii) Manufacture/process food, provided that:(I) All food used in such activities is consumed on that farm or another farm under the same management; or(II) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:(-a-) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);(-b-) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and(-c-) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or(B) Secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described in subparagraph (A)(ii) and (iii) of this paragraph.(22) FDA--The Food and Drug Administration.(23) Food--A raw, cooked, or processed edible substance, ice, beverage, chewing gum or ingredient used or intended for use or for sale in whole or in part for human consumption, including raw materials.(24) Food allergen--A major food allergen is:(A) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.(B) A food ingredient that contains protein derived from a food specified in subparagraph (A) of this paragraph, except the following.(i) Any highly refined oil derived from a food specified in subparagraph (A) of this paragraph, and any ingredient derived from such highly refined oil.(ii) A food ingredient that is exempt under United States Code Title 21 Chapter 9, Subchapter IV, §343(w)(6) and (7).(25) Food-contact surfaces--Those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. "Food-contact surfaces" includes utensils and food-contact surfaces of equipment.(26) Full-time equivalent employee--Is a term used to represent the number of employees of a business entity for the purpose of determining whether the business qualifies for the small business exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a whole number, round down to the next lowest whole number.(27) Harvesting--Applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, removing stems and husks from, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.(28) Hazard--Any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.(29) Hazard requiring a preventive control--A known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's food safety system.(30) Holding--Storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallet loads), but does not include activities that transform a raw agricultural commodity into a processed food. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.(31) Known or reasonably foreseeable hazard--A biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.(32) Lot--Food produced during a period of time and identified by an establishment's specific code. (33) Manufacturing/processing--Making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.(34) Microorganisms--Yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens.(35) Mixed-type facility--An establishment that engages in both activities that are exempt from registration under Federal Food, Drug, and Cosmetic Act, §415 and activities that require the establishment to be registered. An example of such a facility is a "farm mixed-type facility," which is an establishment that is a farm, but also conducts activities outside the farm definition that require the establishment to be registered.(36) Modified atmosphere packaging--A method of packaging food in which the atmosphere of a package of food is modified so that its composition is different from air, which contains 21% oxygen, but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes: reduction in the proportion of oxygen, total replacement of oxygen, removal of air, or an increase in the proportion of other gases such as carbon dioxide or nitrogen.(37) Monitor--To conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.(38) Non-Time/Temperature Control for Safety (TCS) food (NTCS)--(formerly non-Potentially Hazardous Food (non-PHF)) An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonella. A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution. A food that because of its pH or aw value, or interaction of a w and pH values, is designated as a NTCS food in Tables A and B in §229.211(69). A food that is not designated as a NTCS food in Tables A and B in §229.211(69) and for which there is scientific and technical evidence that a control measure or combination of control measures, when properly implemented, effectively controls the identified hazards in such a manner that growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food, is precluded due to either:(A) intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;(B) extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use; (C) a combination of intrinsic and extrinsic factors; or(D) a food that does not support the growth of or toxin formation of pathogenic microorganisms in accordance with one or more of the conditions above in this definition even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.(39) Nonprofit food establishment--A charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans in the United States. The term includes central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment must meet the terms of the U.S. Internal Revenue Code (26 United States Code §501(c)(3)).(40) Packaging--(when used as a verb) Placing food into a container that directly contacts the food and that the consumer receives.(41) Packing--Placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing), but does not include activities that transform a raw agricultural commodity into a processed food.(42) Pathogen--A microorganism of public health significance. (43) Pests--Any objectionable animal or insect including, but not limited to, birds, rodents, flies, and larvae. (44) Plant--The building or structure, or parts thereof, used for or in connection with the manufacturing, processing, packaging, labeling, or holding of human food.(45) pH--(Potential of Hydrogen) A measure of the degree of the acidity or the alkalinity of a solution.(46) Preventive controls--Those risk-based, procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.(47) Preventive controls individual--An individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.(48) Processed food--Any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as but not limited to, canning, cooking, freezing, dehydration, or milling.(49) Processing--Including, but not limited, to the preparing, blending, filtering, preserving, treating, changing into different market forms, manufacturing, packing, repacking, or labeling of food ingredients and or products.(50) Qualified auditor--A person who is an individual as defined in this part and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function as required by 21 Code of Federal Regulations §117.180(c)(2). Examples of potential qualified auditors include:(A) a government employee, including a foreign government employee; and(B) an audit agent of a certification body that is accredited in accordance with regulations in 21 CFR, Part 1, Subpart M.(51) Qualified end-user--With respect to a food, the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in this) section that:(A) is located:(i) in the same State or the same Indian reservation as the qualified facility that sold the food to such restaurant or establishment; or(ii) not more than 275 miles from such facility; and(B) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.(52) Qualified facility--(When including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility to which both of the following apply:(A) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this section) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and(B) the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.(53) Qualified facility exemption--An exemption applicable to a qualified facility under 21 Code of Federal Regulations §117.5(a). (54) Qualified individual--A person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.(55) Quality control operation--A planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.(56) Raw agricultural commodity--Any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.(57) Ready-to-eat food (RTE food)--Any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.(58) Receiving facility--A facility that is subject to 21 Code of Federal Regulations Part 117 Subparts C and G and that manufactures/processes a raw material or other ingredient that it receives from a supplier.(59) Restaurant--A facility that prepares and sells food directly to consumers for immediate consumption. "Restaurant" does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers. Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants.(60) Retail food establishment--An establishment that sells food products directly to consumers as its primary function. The term "retail food establishment" includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term "consumers" does not include businesses. A "retail food establishment" includes grocery stores, convenience stores, and vending machine locations. A "retail food establishment" also includes certain farm-operated businesses selling food directly to consumers as their primary function.(A) Sale of food directly to consumers from an establishment located on a farm includes sales by that establishment directly to consumers:(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.(B) Sale of food directly to consumers by a farm-operated business includes the sale of food by that farm-operated business directly to consumers:(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.(C) For the purposes of this definition, "farm-operated business" means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s).(61) Rework--Clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.(62) Safe-moisture level--A level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for a food is related to its water activity (aw ). An (aw ) will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given (aw ) will not support the growth of undesirable microorganisms.(63) Sanitize--Following cleaning, a process to treat a clean surface that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.(64) Significantly minimize--To reduce to an acceptable level, including to eliminate.(65) Small business--For purposes of this subchapter, a business employing fewer than 500 full-time equivalent employees.(66) Subsidiary--Any company which is owned or controlled directly or indirectly by another company.(67) Supplier--The establishment that manufactures/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.(68) Supply-chain-applied control--A preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. (69) Time/Temperature Control for Safety (TCS) food--(formerly Potentially Hazardous Food (PHF)), A food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation. An animal based food that is raw or heat-treated. A plant based food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixture of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation. Except as specified in Tables A and B of this paragraph, a food that because of the interaction of aw and pH values is designated as requiring scientific and technical evidence that a control measure or combination of control measures, when properly implemented, effectively controls the identified hazards:(A) Table A.Attached Graphic(B) Table B.Attached Graphic(70) Undesirable microorganisms--Includes those microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.(71) Unexposed packaged food--Packaged food that is not exposed to the environment.(72) Validation--Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.(73) Verification--The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.(74) Very small business--For purposes of this subchapter, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).(75) Water activity (aw )--A measure of the free moisture in a food. The quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.(76) Written procedures for receiving raw materials and other ingredients--Written procedures to ensure that raw materials and other ingredients are received only from suppliers approved by the receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use).(77) You--For purposes of this subchapter, the owner, operator, or agent in charge of a facility. Source Note: The provisions of this §229.211 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.211 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185007&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185007 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185007&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185007 03/11/2026 (a) Applicability.(1) The management of an establishment must ensure that all individuals who manufacture, process, pack, or hold food subject to 21 Code of Federal Regulations Part 117 Subparts B and F are qualified to perform their assigned duties.(2) The owner, operator, or agent in charge of a facility must ensure that all individuals who manufacture, process, pack, or hold food subject to 21 Code of Federal Regulations Part 117 Subparts C, D, E, F, or G are qualified to perform their assigned duties.(b) Qualifications of all individuals engaged in manufacturing, processing, packing, or holding food. Each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must:(1) Be a qualified individual as that term is defined in §229.211 of this title (relating to Definitions)-i.e., have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties; and(2) Receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties.(c) Additional qualifications of supervisory personnel. Responsibility for ensuring compliance by individuals with the requirements of this subchapter must be clearly assigned to supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe food.(d) Records. Records that document training required by subsection (b)(2) of this section must be established and maintained. Source Note: The provisions of this §229.212 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.212 Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185008&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185008 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185008&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185008 03/11/2026 (a) Except as provided by 21 Code of Federal Regulations Part 117 Subparts E, C and G does not apply to a qualified facility. Qualified facilities are subject to the modified requirements in 21 Code of Federal Regulations, §117.201.(b) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to activities that are subject to 21 Code of Federal Regulations Part 123, Fish and Fishery Products, at a facility if you are required to comply with, and are in compliance with, Part 123 with respect to such activities.(c) 21 Code of Federal Regulations Part 117 Subparts C and G of this part do not apply with respect to activities that are subject to 21 Code of Federal Regulations Part 120, Hazard Analysis and Critical Control Point (HACCP) Systems, at a facility if you are required to comply with, and are in compliance with, Part 120 with respect to such activities.(d) Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.(1) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to activities that are subject to 21 Code of Federal Regulations Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, at a facility if you are required to comply with, and are in compliance with 21 Code of Federal Regulations Part 113 with respect to such activities.(2) The exemption in paragraph (1) of this subsection is applicable only with respect to the microbiological hazards that are regulated under 21 Code of Federal Regulations Part 113.(e) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to any facility with regard to the manufacturing, processing, packaging, or holding of a dietary supplement that is in compliance with the requirements of 21 Code of Federal Regulations Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, and the Federal Food, Drug, and Cosmetic Act, §761, Serious Adverse Event Reporting for Dietary Supplements.(f) 21 Code of Federal Regulations Part 117 Subparts C and G of do not apply to activities of a facility that are subject to the Federal Food, Drug, and Cosmetic Act, §419, Standards for Produce Safety.(g) Low Risk packing or holding activity/food combinations.(1) The exemption in paragraph (3) of this subsection applies to packing or holding of processed foods on a farm mixed-type facility, except for processed foods produced by drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), the packing and holding of which are within the "farm" definition in §229.211 of this title (relating to Definitions). Activities that are within the "farm" definition, when conducted on a farm mixed-type facility, are not subject to the requirements of 21 Code of Federal Regulations Part 117 Subparts C and G and therefore, do not need to be specified in the exemption.(2) For the purposes of paragraph (3) of this subsection and subsection (h)(3) of this section, the following terms describe the foods associated with the activity/food combinations. Several foods that are fruits or vegetables are separately considered for the purposes of these activity/food combinations (i.e., coffee beans, cocoa beans, fresh herbs, peanuts, sugarcane, sugar beets, tree nuts, seeds for direct consumption) to appropriately address specific hazards associated with these foods and/or processing activities conducted on these foods.(A) Dried/dehydrated fruit and vegetable products includes only those processed food products such as raisins and dried legumes made without additional manufacturing/processing beyond drying/dehydrating, packaging, and/or labeling.(B) Other fruit and vegetable products includes those processed food products that have undergone one or more of the following processes: acidification, boiling, canning, coating with things other than wax/oil/resin, cooking, cutting, chopping, grinding, peeling, shredding, slicing, or trimming. Examples include flours made from legumes (such as chickpea flour), pickles, and snack chips made from potatoes or plantains. Examples also include dried fruit and vegetable products made with additional manufacturing/processing (such as dried apple slices; pitted, dried plums, cherries, and apricots; and sulfited raisins). This category does not include dried/dehydrated fruit and vegetable products made without additional manufacturing/processing as described in subparagraph (A) of this paragraph. This category also does not include products that require time/temperature control for safety (such as fresh-cut fruits and vegetables).(C) Peanut and tree nut products includes processed food products such as roasted peanuts and tree nuts, seasoned peanuts and tree nuts, and peanut and tree nut flours.(D) Processed seeds for direct consumption include processed food products such as roasted pumpkin seeds, roasted sunflower seeds, and roasted flax seeds.(E) Dried/dehydrated herb and spice products includes only processed food products such as dried intact herbs made without additional manufacturing/processing beyond drying/dehydrating, packaging, and/or labeling.(F) Other herb and spice products includes those processed food products such as chopped fresh herbs, chopped or ground dried herbs (including tea), herbal extracts (e.g., essential oils, extracts containing more than 20 percent ethanol, extracts containing more than 35 percent glycerin), dried herb- or spice-infused honey, and dried herb or spice-infused oils and/or vinegars. This category does not include dried/dehydrated herb and spice products made without additional manufacturing/processing beyond drying/dehydrating, packaging, and/or labeling as described in subparagraph (E) of this paragraph. This category also does not include products that require time/temperature control for safety, such as fresh herb-infused oils.(G) Grains include barley, dent or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for oil extraction (such as cotton seed, flax seed, rapeseed, soybeans, and sunflower seed).(H) Milled grain products include processed food products such as flour, bran, and corn meal.(I) Baked goods include processed food products such as breads, brownies, cakes, cookies, and crackers. This category does not include products that require time/temperature control for safety, such as cream-filled pastries.(J) Other grain products include processed food products such as dried cereal, dried pasta, oat flakes, and popcorn. This category does not include milled grain products as described in subparagraph (H) of this paragraph or baked goods as described in subparagraph (I) of this paragraph.(3) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to on-farm packing or holding of food by a small or very small business, and 21 Code of Federal Regulations §117.201 does not apply to on-farm packing or holding of food by a very small business, if the only packing and holding activities subject to the Federal Food, Drug, and Cosmetic Act, §418 that the business conducts are the following low-risk packing or holding activity/food combinations-i.e., packing (or re-packing) (including weighing or conveying incidental to packing or re-packing); sorting, culling, or grading incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of:(A) baked goods (e.g., bread and cookies);(B) candy (e.g., hard candy, fudge, maple candy, maple cream, nut brittles, taffy, and toffee);(C) cocoa beans (roasted);(D) cocoa products;(E) coffee beans (roasted);(F) game meat jerky;(G) gums, latexes, and resins that are processed foods;(H) honey (pasteurized);(I) jams, jellies, and preserves;(J) milled grain products (e.g., flour, bran, and corn meal);(K) molasses and treacle;(L) oils (e.g., olive oil and sunflower seed oil);(M) other fruit and vegetable products (e.g., flours made from legumes; pitted, dried fruits; sliced, dried apples; snack chips);(N) other grain products (e.g., dried pasta, oat flakes, and popcorn);(O) other herb and spice products (e.g., chopped or ground dried herbs, herbal extracts);(P) peanut and tree nut products (e.g., roasted peanuts and tree nut flours);(Q) processed seeds for direct consumption (e.g., roasted pumpkin seeds);(R) soft drinks and carbonated water;(S) sugar;(T) syrups (e.g., maple syrup and agave syrup);(U) trail mix and granola;(V) vinegar; and(W) any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form).(h) Low risk manufacturing/processing activity/food combinations.(1) The exemption in paragraph (3) of this subsection applies to manufacturing/processing of foods on a farm mixed-type facility, except for manufacturing/processing that is within the "farm" definition. Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), are within the "farm" definition. In addition, treatment to manipulate ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling the treated raw agricultural commodities, without additional manufacturing/processing, is within the "farm" definition. In addition, coating intact fruits and vegetables with wax, oil, or resin used for the purpose of storage or transportation is within the "farm" definition. Activities that are within the "farm" definition, when conducted on a farm mixed-type facility, are not subject to the requirements of 21 Code of Federal Regulations Part 117 Subparts C and G and therefore, do not need to be specified in the exemption.(2) The terms in subsection (g)(2) of this section describe certain foods associated with the activity/food combinations in paragraph (3) of this subsection.(3) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to on-farm manufacturing/processing activities conducted by a small or very small business for distribution into commerce, and 21 Code of Federal Regulations §117.201 does not apply to on-farm manufacturing/processing activities conducted by a very small business for distribution into commerce, if the only manufacturing/processing activities subject to the Federal Food, Drug, and Cosmetic Act, §418 that the business conducts are the following low-risk manufacturing/processing activity/food combinations:(A) boiling gums, latexes, and resins;(B) chopping, coring, cutting, peeling, pitting, shredding, and slicing acid fruits and vegetables that have a pH less than 4.2 (e.g., cutting lemons and limes), baked goods (e.g., slicing bread), dried/dehydrated fruit and vegetable products (e.g., pitting dried plums), dried herbs and other spices (e.g., chopping intact, dried basil), game meat jerky, gums/latexes/resins, other grain products (e.g., shredding dried cereal), peanuts and tree nuts, and peanut and tree nut products (e.g., chopping roasted peanuts);(C) coating dried/dehydrated fruit and vegetable products (e.g., coating raisins with chocolate), other fruit and vegetable products except for non-dried, non-intact fruits and vegetables (e.g., coating dried plum pieces, dried pitted cherries, and dried pitted apricots with chocolate are low-risk activity/food combinations but coating apples on a stick with caramel is not a low-risk activity/food combination), other grain products (e.g., adding caramel to popcorn or adding seasonings to popcorn provided that the seasonings have been treated to significantly minimize pathogens, peanuts and tree nuts (e.g., adding seasonings provided that the seasonings have been treated to significantly minimize pathogens), and peanut and tree nut products (e.g., adding seasonings provided that the seasonings have been treated to significantly minimize pathogens);(D) drying/dehydrating (that includes additional manufacturing or is performed on processed foods) other fruit and vegetable products with pH less than 4.2 (e.g., drying cut fruit and vegetables with pH less than 4.2), and other herb and spice products (e.g., drying chopped fresh herbs, including tea);(E) extracting (including by pressing, by distilling, and by solvent extraction) from dried/dehydrated herb and spice products (e.g., dried mint), fresh herbs (e.g., fresh mint), fruits and vegetables (e.g., olives, avocados), grains (e.g., oilseeds), and other herb and spice products (e.g., chopped fresh mint, chopped dried mint);(F) freezing acid fruits and vegetables with pH less than 4.2 and other fruit and vegetable products with pH less than 4.2 (e.g., cut fruits and vegetables);(G) grinding/cracking/crushing/milling baked goods (e.g., crackers), cocoa beans (roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., raisins and dried legumes), dried/dehydrated herb and spice products (e.g., intact dried basil), grains (e.g., oats, rice, rye, wheat), other fruit and vegetable products (e.g., dried, pitted dates), other grain products (e.g., dried cereal), other herb and spice products (e.g., chopped dried herbs), peanuts and tree nuts, and peanut and tree nut products (e.g., roasted peanuts);(H) labeling baked goods that do not contain food allergens, candy that does not contain food allergens, cocoa beans (roasted), cocoa products that do not contain food allergens), coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, honey (pasteurized), jams/jellies/preserves, milled grain products that do not contain food allergens (e.g., corn meal) or that are single-ingredient foods (e.g., wheat flour, wheat bran), molasses and treacle, oils, other fruit and vegetable products that do not contain food allergens (e.g., snack chips made from potatoes or plantains), other grain products that do not contain food allergens (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), peanut or tree nut products, (provided that they are single-ingredient, or are in forms in which the consumer can reasonably be expected to recognize the food allergen(s) without label declaration, or both (e.g., roasted or seasoned whole nuts, single-ingredient peanut or tree nut flours)), processed seeds for direct consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola (other than those containing milk chocolate and provided that peanuts and/or tree nuts are in forms in which the consumer can reasonably be expected to recognize the food allergen(s) without label declaration), vinegar, and any other processed food that does not require time/temperature control for safety and that does not contain food allergens (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form);(I) making baked goods from milled grain products (e.g., breads and cookies);(J) making candy from peanuts and tree nuts (e.g., nut brittles), sugar/syrups (e.g., taffy, toffee), and saps (e.g., maple candy, maple cream);(K) making cocoa products from roasted cocoa beans;(L) making dried pasta from grains;(M) making jams, jellies, and preserves from acid fruits and vegetables with a pH of 4.6 or below;(N) making molasses and treacle from sugar beets and sugarcane;(O) making oat flakes from grains;(P) making popcorn from grains;(Q) making snack chips from fruits and vegetables (e.g., making plantain and potato chips);(R) making soft drinks and carbonated water from sugar, syrups, and water;(S) making sugars and syrups from fruits and vegetables (e.g., dates), grains (e.g., rice, sorghum), other grain products (e.g., malted grains such as barley), saps (e.g., agave, birch, maple, palm), sugar beets, and sugarcane;(T) making trail mix and granola from cocoa products (e.g., chocolate), dried/dehydrated fruit and vegetable products (e.g., raisins), other fruit and vegetable products (e.g., chopped dried fruits), other grain products (e.g., oat flakes), peanut and tree nut products, and processed seeds for direct consumption, provided that peanuts, tree nuts, and processed seeds are treated to significantly minimize pathogens;(U) making vinegar from fruits and vegetables, other fruit and vegetable products (e.g., fruit wines, apple cider), and other grain products (e.g., malt);(V) mixing baked goods (e.g., types of cookies), candy (e.g., varieties of taffy), cocoa beans (roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., dried blueberries, dried currants, and raisins), dried/dehydrated herb and spice products (e.g., dried, intact basil and dried, intact oregano), honey (pasteurized), milled grain products (e.g., flour, bran, and corn meal), other fruit and vegetable products (e.g., dried, sliced apples and dried, sliced peaches), other grain products (e.g., different types of dried pasta), other herb and spice products (e.g., chopped or ground dried herbs, dried herb- or spice-infused honey, and dried herb- or spice-infused oils and/or vinegars), peanut and tree nut products, sugar, syrups, vinegar, and any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form);(W) packaging baked goods (e.g., bread and cookies), candy, cocoa beans (roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, honey (pasteurized), jams/jellies/preserves, milled grain products (e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit and vegetable products (e.g., pitted, dried fruits; sliced, dried apples; snack chips), other grain products (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), peanut and tree nut products, processed seeds for direct consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola, vinegar, and any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form);(X) pasteurizing honey;(Y) roasting and toasting baked goods (e.g., toasting bread for croutons);(Z) salting other grain products (e.g., soy nuts), peanut and tree nut products, and processed seeds for direct consumption; and(AA) sifting milled grain products (e.g., flour, bran, corn meal), other fruit and vegetable products (e.g., chickpea flour), and peanut and tree nut products (e.g., peanut flour, almond flour).(i) Alcoholic beverages.(1) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to alcoholic beverages at a facility that meets the following two conditions:(A) Under the Federal Alcohol Administration Act (27 United States Code 201 et seq.) or Chapter 51 of Subtitle E of the Internal Revenue Code of 1986 (26 United States Code 5001 et seq.) the facility is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States, or is a foreign facility of a type that would require such a permit, registration, or approval if it were a domestic facility; and(B) Under the Federal Food, Drug, and Cosmetic Act, §415, the facility is required to register as a facility because it is engaged in manufacturing, processing, packing, or holding one or more alcoholic beverages.(2) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to food that is not an alcoholic beverage at a facility described in paragraph (1) of this subsection, provided such food:(A) is in prepackaged form that prevents any direct human contact with such food; and(B) constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.(j) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.(k) Exemptions to Subchapter N.(1) Except as provided by paragraph (2) of this subsection, Subchapter N of this chapter does not apply to any of the following:(A) "farms;"(B) fishing vessels that are not subject to the registration requirements of 21 Code of Federal Regulations Part 1, Subpart H in accordance with 21 Code of Federal Regulations §1.226(f);(C) establishments solely engaged in the holding and/or transportation of one or more raw agricultural commodities;(D) activities of "farm mixed-type facilities" as defined under mixed-type facility in §229.211 of this title that fall within the definition of "farm;" or(E) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts except in the case where the nut is cracked and/or shelled and is intended to be consumed raw (without additional manufacturing/processing, such as roasting nuts).(2) If a "farm" or "farm mixed-type facility" dries/dehydrates raw agricultural commodities that are produce as defined in 21 Code of Federal Regulations Part 112, to create a distinct commodity, Subchapter N of this chapter applies to the packaging, packing, and holding of the dried commodities. Compliance with this requirement may be achieved by complying with Subchapter N of this chapter or with the applicable requirements for packing and holding in 21 Code of Federal Regulations Part 112. Source Note: The provisions of this §229.213 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.213 Exemptions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185009&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185009 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185009&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185009 03/11/2026 (a) Applicability of 21 Code of Federal Regulations Part 117 Subparts C and G. 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to a facility solely engaged in the storage of unexposed packaged food.(b) Applicability of 21 Code of Federal Regulations Part 117 Subpart D. A facility solely engaged in the storage of unexposed packaged food, including unexposed packaged time/temperature controlled for safety (TCS) food is subject to the modified requirements in 21 Code of Federal Regulations §117.206 for any unexposed packaged TCS food. Source Note: The provisions of this §229.214 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.214 Applicability of 21 Code of Federal Regulations Part 117 Subparts C, D, and G to a Facility Solely Engaged in the Storage of Unexposed Packaged Food https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185010&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185010 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185010&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185010 03/11/2026 Subchapter N of this chapter applies to the off-farm packaging, packing, and holding of raw agricultural commodities. Compliance with this requirement for raw agricultural commodities that are produce as defined in 21 Code of Federal Regulations Part 112 may be achieved by complying with Subchapter N of this chapter or with the applicable requirements for packing and holding in Part 112. Source Note: The provisions of this §229.215 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.215 Applicability of Subchapter N to the Off-farm Packing and Holding of Raw Agricultural Commodities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185011&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185011 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185011&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185011 03/11/2026 (a) Records that document training required by §229.212(b)(2) of this title (relating to Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food) must be established and maintained.(b) The records that must be established and maintained are subject to the requirements of 21 Code of Federal Regulations Part 117 Subpart F. Source Note: The provisions of this §229.216 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.216 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185012 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185012 03/11/2026 The management of the establishment must take all reasonable measures and precautions to ensure the following.(1) Disease control and employee health. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness; open lesion, including boils, sores, or infected wounds; or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, must be excluded from any operations which may be expected to result in such contamination until the condition is corrected, unless conditions such as open lesions, boils, and infected wounds are adequately covered (e.g. by an impermeable cover). Personnel must be instructed to report such health conditions to their supervisors.(2) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food. The methods for maintaining cleanliness include:(A) wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of food, food-contact surfaces, or food-packaging materials;(B) maintaining adequate personal cleanliness;(C) washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility that meets the provisions of §229.220 of this title (relating to Sanitary Facilities and Controls), before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated;(D) removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials;(E) maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition;(F) wearing, where appropriate and in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints;(G) storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed;(H) confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco; and(I) taking any other precautions to protect against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. Source Note: The provisions of this §229.217 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.217 Personnel https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185013&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185013 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185013&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185013 03/11/2026 (a) Grounds. The grounds about a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds must include:(1) properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests;(2) maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed;(3) adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests;(4) operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed; and(5) if the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraphs (1) through (4) of this subsection, care must be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.(b) Plant construction and design. The plant must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-production purposes (i.e. manufacturing, processing, packing, and holding). The plant must:(1) provide adequate space for such placement of equipment and storage of materials as is necessary for maintenance, sanitary operations, and the production of safe food;(2) permit the taking of adequate precautions to reduce the potential for allergen cross-contact and for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous material. The potential for allergen cross-contact and for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which allergen cross contact and contamination are likely to occur, by one of the following means: location, time, partition, air flow systems, dust control systems, enclosed systems, or other effective means;(3) permit the taking of adequate precautions to protect food in installed outdoor bulk fermentation vessels by any effective means, including:(A) using protective coverings;(B) controlling areas over and around the vessels to eliminate harborages for pests;(C) checking on a regular basis for pests and pest infestation; and(D) skimming the fermentation vessels, as necessary;(4) be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact;(5) provide adequate lighting in:(A) hand-washing areas, dressing and locker rooms, and toilet rooms of at least 10 foot candles (greater than or equal to 108 lux);(B) all areas where food is held and where equipment or utensils are cleaned of at least 20 foot candles (greater than or equal to 220 lux); and(C) all areas where food is examined, manufactured, processed, or packed of at least 50 foot candles (greater than or equal to 540 lux).(6) provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage;(7) provide adequate ventilation or control equipment to minimize dust, odors and vapors (including steam and noxious fumes) in areas where they may cause allergen cross-contact or contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for allergen cross contact and for contaminating food, food-packaging materials, and food-contact surfaces; and(8) provide, where necessary, adequate screening or other protection against pests. Source Note: The provisions of this §229.218 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.218 Plant and Grounds https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185014 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185014 03/11/2026 (a) General maintenance. Buildings, fixtures, and other physical facilities of the plant must be maintained in a clean and sanitary condition and must be kept in repair to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials.(b) Substances used in cleaning and sanitizing; storage of toxic materials.(1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures must be free from undesirable microorganisms and must be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier's guarantee or certification, or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant in areas where food is processed or exposed:(A) those required to maintain clean and sanitary conditions;(B) those necessary for use in laboratory testing procedures;(C) those necessary for plant and equipment maintenance and operation; and;(D) those necessary for use in the plant's operations.(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.(c) Pest control.(1) All areas of the food plant must be kept free of rodents, insects, birds, and other pests which may contaminate food. Guard, guide, or pest detecting dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests. This exclusion of pests includes:(A) no evidence of pest activity in non-food areas;(B) no evidence of pest activity in food storage or food preparation areas; and;(C) no evidence of pest activity in or on food products, food packaging or food preparation utensils, equipment, or devices.(2) Only pesticides approved by the Environmental Protection Agency (EPA) for use in a food processing facility may be used. Pesticides must be used according to label directions. Rodenticides must be placed inside enclosed bait boxes or other approved receptacles. Only a licensed pesticide applicator may apply restricted use pesticides.(3) The use of pesticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.(d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as necessary to protect against allergen cross contact and against contamination of food.(1) Food-contact surfaces used for manufacturing/processing, packing, or holding low-moisture food must be in a clean, dry, sanitary condition before use. When the surfaces are wet-cleaned, they must, when necessary, be sanitized and thoroughly dried before subsequent use.(2) In wet processing, when cleaning is necessary to protect against allergen cross-contact or the introduction of microorganisms into food, all food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment must be cleaned and sanitized as necessary.(3) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) must be stored in appropriate containers and must be handled, dispensed, used, and disposed of in a manner that protects against allergen cross-contact and against contamination of food or food-contact surfaces.(e) Sanitation of non-food-contact surfaces. Non-food-contact surfaces of equipment used in the operation of a food plant must be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials.(f) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils must be stored in a location and manner that protects food-contact surfaces from allergen cross-contact and from contamination. Source Note: The provisions of this §229.219 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.219 Sanitary Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185015 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185015 03/11/2026 Each plant must be equipped with adequate sanitary facilities and accommodations including, but not limited to:(1) Water supply. The water supply must be adequate for the operations intended and must be derived from an approved source.(A) Requirements for approved source. Sources in Texas must comply with the following requirements.(i) Public water systems. Sources in Texas which are public water systems must comply with the Texas Health and Safety Code, Chapter 341, Subchapter C, drinking water standards and rules adopted by the Texas Commission on Environmental Quality, 30 Texas Administrative Code (TAC) Chapter 290.(ii) Other sources. Any other sources in Texas must comply with 30 TAC Chapter 290, Subchapter F, concerning drinking water standards.(B) Sampling requirements.(i) Approved community public water systems as defined by 30 TAC Chapter 290 Subchapter D (relating to Definitions). No additional source water sampling is required.(ii) Source water obtained from other than a community public water system must be sampled and analyzed in accordance with the requirements found in 30 TAC, Chapter 290 Subchapter F pertaining to transient noncommunity water systems.(C) Any water that is used for hand washing or contacts food, food-contact surfaces, or food packaging materials must be safe and of adequate sanitary quality for its intended use. Hot and cold running water at a suitable temperature, and under pressure as needed, must be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. Hot water generation and distribution systems must be adequate to meet peak hot water demands throughout the facility.(2) Plumbing. Plumbing must be of adequate size and design and adequately installed and maintained to:(A) carry adequate quantities of water to required locations throughout the plant;(B) properly convey sewage and liquid disposable waste from the plant;(C) avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition;(D) provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and(E) provide that there is no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing.(3) Sewage disposal. Sewage disposal must be made into an approved sewerage system in accordance with applicable state regulations and local ordinances.(4) Toilet facilities. Each plant must provide its employees with adequate and readily accessible toilet facilities. Toilet facilities must be kept clean and must be constructed and maintained in a manner as to not be a potential source of contamination of food, food-contact surfaces, or food-packaging materials. If the toilet facility opens directly into a manufacturing area the facility must have self-closing doors or an alternate means to protect against contamination.(5) Hand-washing facilities. Each plant must provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. Facilities that utilize conventional hand washing must provide a conventional handwashing sink, hot running water of at least 100 degrees Fahrenheit, hand cleaning agent, and individual disposable towels, continuous towel system that supplies a user with a clean towel, or an air drying device.(6) Rubbish and Offal. Rubbish and Offal must be so conveyed, stored, and disposed of as to minimize the development of odor; minimize the potential for the waste becoming an attractant and harborage or breeding place for pests; and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces, except as allowed in paragraph (7) of this section.(7) Food waste. Bread, nonmeat pastry products, and produce that have been completely removed from all packaging may be disposed of by alternate means according to any applicable requirements of 30 TAC Chapters 330, 332, and 335 or 4 TAC Chapter 55. Source Note: The provisions of this §229.220 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.220 Sanitary Facilities and Controls https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185016 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185016 03/11/2026 (a) Design and Construction.(1) All plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed and of such material and workmanship as to be cleanable, and must be maintained to protect against allergen cross-contact and contamination.(2) Equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration or contamination of food.(3) Equipment must be installed so as to permit the cleaning and maintenance of the equipment and of adjacent spaces.(4) Food-contact surfaces must be corrosion-resistant.(5) Food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, cleaning compounds, sanitizing agents, and cleaning procedures.(6) Food-contact surfaces must be maintained to protect food from allergen cross-contact and from being contaminated by any source.(b) Seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and allergen cross contact.(c) Equipment that is in areas where food is manufactured, processed, packed, or held and that does not come into contact with food must be constructed so that it can be kept in a clean and sanitary condition.(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, must be designed and constructed so as to be maintained in a appropriate clean and sanitary condition.(e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device installed to accurately show the temperature accurately within the compartment.(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food must be accurate and precise and adequately maintained, and adequate in number for their designated uses.(g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives. Source Note: The provisions of this §229.221 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.221 Equipment and Utensils https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185017 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185017 03/11/2026 (a) General.(1) All operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspections, transporting, and segregating) must be conducted in accordance with adequate sanitation principles.(2) Quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable.(3) Overall sanitation of the plant must be under the supervision of one or more competent individuals assigned responsibility for this function.(4) Adequate precautions must be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.(5) Chemical, microbial, or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible allergen cross-contact and food contamination.(6) All food that has become contaminated to the extent that it is adulterated must be rejected, treated or processed to eliminate the contamination.(b) Raw materials and other ingredients.(1) Food, including raw ingredients and finished product, must be obtained from an approved source.(2) Raw materials and other ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and must be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Raw materials must be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food must be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not cause allergen cross-contact or increase the level of contamination of the food.(3) Raw materials and other ingredients must either: not contain levels of microorganisms that may render the food injurious to the health of humans; or they must be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.(4) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins must comply with current Food and Drug Administration regulations for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food.(5) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material must comply with applicable Food and Drug Administration regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food.(6) Raw materials, other ingredients, and rework must be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination and must be held at a temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such.(7) Frozen raw materials and other frozen ingredients must be kept frozen. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.(8) Liquid or dry raw materials and other ingredients received and stored in bulk form must be held in a manner that protects allergen cross-contact and against contamination.(9) Raw materials and other ingredients that are food allergens, and rework that contains food allergens, must be identified and held in a manner that prevents allergen cross-contact.(c) Manufacturing operations.(1) Equipment and utensils and finished food containers must be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. In so far as necessary, equipment must be taken apart for thorough cleaning.(2) All food manufacturing, processing, packaging, packing and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food.(3) Food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding.(A) Time/temperature controlled for safety foods must be maintained at an internal temperature of 41 degrees Fahrenheit or below.(B) Frozen foods must be kept frozen at all times.(C) Shell eggs, after initial packing, must be transported and stored at the lower of 45 degrees Fahrenheit or as required by The United States Department of Agriculture.(D) The temperature of molluscan shellfish from the harvester through the original shellfish dealer must be maintained in accordance with 25 TAC §§241.57- 241.60 of this title (relating to Molluscan Shellfish). Raw molluscan shellfish must be adequately iced or refrigerated at 45 degrees Fahrenheit or less during all subsequent distribution, storage, processing, and sale.(E) Hot foods must be maintained at an internal temperature of 135 degrees Fahrenheit (60 degrees Celsius) or above.(F) Seafood intended for wholesale distribution must comply with temperature requirements specified in 21 Code of Federal Regulations Part 123.(G) Milk received directly from a facility under the jurisdiction of the Pasteurized Milk Ordinance must be received at an internal temperature of 45 degrees F or below. Further storage and transportation of the milk must be maintained at an internal 41 degrees or below.(4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms must be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated.(5) Work-in-process and rework must be handled in a manner that protects against allergen cross-contact, contamination, and the growth of undesirable microorganisms.(6) Effective measures must be taken to protect finished food from allergen cross-contact and from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contaminated food. Food transported by conveyor must be protected against contamination.(7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or other food must be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact and against contamination.(8) Adequate measures must be taken to protect against the inclusion of metal or other extraneous material in food.(9) Food, raw materials, and other ingredients that are adulterated:(A) Must be disposed of in a manner that protects against the contamination of other food; or(B) If the adulterated food is capable of being reconditioned, it must be:(i) reconditioned using a method that has been proven to be effective; or(ii) reconditioned and reexamined and subsequently found not to be adulterated before being incorporated into other food.(10) Steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming must be performed so as to protect food against allergen cross-contact and against contamination. Food must be protected from contaminants that may drip, drain, or be drawn into the food.(11) Heat blanching, when required in the preparation of food capable of supporting microbial growth, must be affected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers must be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing.(12) Batters, breading, sauces, gravies, dressings, dipping solutions, and other similar preparations that are held and used repeatedly over time must be treated or maintained in such a manner that they are protected against allergen cross-contact and against contamination, and minimizing the potential for the growth of undesirable microorganisms.(13) Filling, assembling, packaging, and other operations must be performed in such a way that the food is protected against allergen cross-contact, contamination, and the growth of undesirable microorganisms.(14) Food such as, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms must be processed to and maintained at a safe moisture level.(15) Food such as acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms, must be monitored and maintained at a pH of 4.6 or below. Acid or acidified foods must be heat treated to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.(16) Modified Atmosphere Packaging. Manufacturers using Modified Atmosphere Packaging:(A) Except for a facility that is subject to 21 Code of Federal Regulations Part 117, Subchapter C Hazard Analysis and Risk-Based Preventive Controls or the product being produced is subject to 21 Code of Federal Regulations Part 123, Fish and Fishery Products, a facility that packages a Time/Temperature Control for Safety (TCS) food using a modified atmosphere packaging method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes. (B) a facility that packages TCS food using a modified atmosphere packaging method must implement a food safety plan that contains the information specified under 21 Code of Federal Regulations §117.135 a(1)-c(3) and that:(i) identifies the food to be packaged;(ii) except as specified under subparagraphs (C) and (D) of this paragraph, requires that the packaged food shall be maintained at 5 degrees Celsius (41 degrees Fahrenheit) or less and meet at least one of the following criteria:(I) has an aw of 0.91 or less; (II) has a pH of 4.6 or less; (III) is a meat or poultry product cured at a food processing plant regulated by the USDA or the department using substances specified in 9 Code of Federal Regulations §424.21, use of food ingredients and sources of radiation, and is received in an intact package; or(IV) is a food with a high level of competing organisms such as raw meat, raw poultry, or raw vegetables;(iii) describes how the packages shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:(I) maintain the food at 5 degrees Celsius (41 degrees Fahrenheit) or below; and(II) discard the food if within 30 calendar days of its packaging it is not served for on-premises consumption, or consumed if served or sold for off-premises consumption;(iv) limits the refrigerated shelf life to no more than 30 calendar days from packaging to consumption, except the time the product is maintained frozen, or the original manufacturer's "sell by" or "use by" date, whichever occurs first;(C) a facility that packages TCS food using a modified atmosphere packaging method must ensure individuals performing modified atmosphere packaging have the appropriate training and documentation as required by §229.212 of this title (relating to Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food).(D) Except for fish that is frozen before, during, and after packaging, a facility may not package fish using a modified atmosphere packaging method unless the product is subject to 21 Code of Federal Regulations Part 123, Fish and Fishery Products;(E) Cheese. A facility that packages cheese using a Modified Atmosphere Packaging method must:(i) limit the cheeses packaged to those that are commercially manufactured in a food processing plant with no ingredients added in a facility other than the original food processing plant and that meet the Standards of Identity as specified in 21 Code of Federal Regulations §133.150, Hard cheeses, 21 Code of Federal Regulations §133.169 Pasteurized process cheese or 21 Code of Federal Regulations §133.187 Semisoft cheeses;(ii) have a food safety plan that contains the information specified under 21 Code of Federal Regulations §117.135 a(1)-c(3); and(iii) label the package on the principal display panel with a "use by" date that does not exceed 30 days from its packaging or the original manufacturer's sell by date, or "use by" date, whichever occurs first.(F) A facility using a Modified Atmosphere Packaging method for TCS Foods, intended to be frozen after packaging other than those specified in subparagraph (B)(ii)(I)-(IV) of this paragraph must:(i) implement a food safety plan that contains the information specified under 21 Code of Federal Regulations §117.135 a(1)-c(3);(ii) immediately freeze the product following packaging:(iii) label the product Keep Frozen; and(iv) provide instructions for safe handling after thawing. (G) Foods other than those specified in subparagraphs (B)(ii), (D), (E) (F) of this paragraph may be packaged utilizing modified atmosphere packaging if the facility complies with 21 Code of Federal Regulations Part 117, Subchapter C, Hazard Analysis and Risk Based Preventive Controls.(17) Unshelled pecans intended to be consumed raw must be thoroughly cleaned to remove foreign matter before cracking. After cleaning, unshelled pecans must be sanitized.(18) When ice is used in contact with food, it must be made from water that is safe and of adequate sanitary quality in accordance with §229.220 of this title (relating to Sanitary Facilities and Controls) and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this subchapter. Source Note: The provisions of this §229.222 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.222 Production and Process Controls https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185018&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185018 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185018&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185018 03/11/2026 (a) Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The United States Food and Drug Administration establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action.(b) Compliance with defect action levels does not excuse violation of the requirement in the Texas Health and Safety Code, §431.081(a)(3) that food not be prepared, packed, or held under unsanitary conditions or the requirements in this section that food manufacturers, distributors, and holders must observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.(c) The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated regardless of the defect level of the final food.(d) A compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from foods.regulatory@dshs.state.tx.us or Texas Department of State Health Services Foods Group, P.O. Box 149347, Mail Code 1987, Austin, Texas 78714-9347. Source Note: The provisions of this §229.223 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.223 Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185019 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185019 03/11/2026 (a) Plant and grounds.(1) Storage and transportation of food must be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container.(2) Food storage facilities must be properly constructed and maintained. All walls, ceilings, and floors must be intact to preclude entry of vermin and environmental contaminants.(3) Doors and loading docks must be tight-fitting and kept closed at all times when not in use, or adequately screened during normal operating hours to prevent entry of rodents, birds, or other pests.(4) Outer premises, including trash receptacles, and non food storage areas must be kept clean and free of odors, debris, high weeds, or standing water which could harbor or attract vermin.(5) Adequate lighting of at least 108 lux (10 foot candles) must be provided to facilitate cleaning and inspection of food storage areas.(b) Sanitary facilities.(1) Toilet Facilities. Each warehouse facility must provide employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and in good repair. Toilet facilities must be equipped with a hand washing sink with running water of at least 100 degrees Fahrenheit, hand cleaning agent, and single service towels or an air drying device.(2) Handwashing Facilities:(A) For warehouse facilities that have direct hand contact with food, the facility must provide hand-washing facilities separate from the toilet facilties designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. Facilities that utilize conventional handwashing must provide a conventional handwashing sink, hot running water of at least 100 degrees Fahrenheit, hand cleaning agent, and individual disposable towels, continuous towel system that supplies a user with a clean towel, or an air drying device.(B) For warehouse facilities with no direct hand contact with food, hand-washing facilities separate from toilet facilities are not required.(C) Wastewater must be disposed of in a manner approved by the regulatory authority.(c) Sanitary operations.(1) Food including raw ingredients and finished food products must be obtained from an approved source.(2) All foods, including refrigerated and frozen foods, must be stored to prevent direct contact with the floor and away from walls to help prevent contamination by vermin (rodents and insects for example) and moisture, and to facilitate cleaning and inspection.(3) All food packaging material that are intended to come in direct contact with food must be stored to prevent direct contact with the floor.(4) Food storage facilities and transportation vehicles must be kept free of rodents, insects, birds, and other pests which may contaminate food which includes:(A) no evidence of pest activity in non-food areas;(B) no evidence of pest activity in food storage areas; and(C) no evidence of pest activity in or on food products, food packaging or food preparation utensils, equipment or devices.(5) Damaged, distressed, and infested foods and food packaging material must be stored in a designated "morgue area", adequately separated from undamaged foods and must be disposed of in a timely manner to preclude further contamination.(6) Food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding.(A) Time/temperature controlled for safety foods must be maintained at an internal temperature of 41 degrees Fahrenheit or below.(B) Frozen foods must be kept frozen at all times.(C) Shell eggs, after initial packing, must be transported and stored at the lower of 45 degrees Fahrenheit or as required by The United States Department of Agriculture.(D) The temperature of molluscan shellfish from the harvester through the original shellfish dealer must be maintained in accordance with 25 TAC §§241.57 - 241.60 of this title (relating to Molluscan Shellfish). Raw molluscan shellfish must be adequately iced or refrigerated at 45 degrees Fahrenheit or less during all subsequent distribution, storage, processing, and sale.(E) Seafood intended for wholesale distribution must comply with temperature requirements specified 21 Code of Federal Regulations Part 123, Seafood Safety.(F) Milk received directly from a facility under the jurisdiction of the PMO must be received at an internal temperature of 45 degrees F or below. Further storage and transportation of the milk must be maintained at an internal 41 degrees or below.(7) During warehousing and transporting, all chemicals must be properly stored and physically separated from foods to preclude contamination.(8) Food storage facilities and transportation vehicles operated under the control of the facility must be kept clean and free of excessive dust, dirt, spillage, and other debris, including excess moisture.(9) Food transport vehicles must be operated in compliance with federal regulations pertaining to back-hauling.(10) Each incoming lot must be examined at the time of receipt and contaminated or adulterated foods must not be accepted.(11) Swollen, leaking, and/or severely dented containers of food must be segregated and promptly placed in the "morgue area" and further contamination, attraction of vermin, or sale prior to reconditioning must be prevented.(12) Only pesticides approved by the Environmental Protection Agency (EPA) for use in a food warehouse and/or food processing facility may be used. Pesticides must be used only according to label directions. Rodenticides must be placed inside enclosed bait boxes or other approved receptacles. Only a licensed pesticide applicator may apply restricted use pesticides.(d) Other provisions.(1) Distressed foods salvaged by the facility must be salvaged in accordance with §§229.541 - 229.555, 229.571 - 229.584, 229.601 - 229.614, and 229.631 - 229.644 of this title (relating to Regulation of Food, Drug, Device, and Cosmetic Salvage Establishments and Brokers).(2) Food wholesalers engaged in the receipt and distribution of over-the-counter or prescription drugs must comply with §229.251 of this title (relating to Minimum Standards for Licensure).(3) The facility must keep accurate distribution records so that any foods found to be unfit for human consumption may be recalled expeditiously. Source Note: The provisions of this §229.224 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.224 Good Warehousing Practice https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185020&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185020 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=185020&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 185020 03/11/2026 (a) Criminal penalties as provided in Texas Health and Safety Code, §431.059 may be assessed for violations of these sections.(b) Civil penalties as provided in Texas Health and Safety Code, §431.0585 may be assessed for violations of these sections.(c) Administrative penalties as provided in Texas Health and Safety Code, §431.054, §431.055, §431.056, §431.057, §431.058, and in §229.261 of this title (relating to Assessment of Administrative Penalties), may be assessed for violation of these sections. If the person charged with the violation does not request a hearing, the Commissioner of the Department of State Health Services (Commissioner) or the Commissioner's designee may assess a penalty after determining that a violation has occurred and the amount of the penalty.(d) Emergency orders as provided in Texas Health and Safety Code, §431.045 may be issued by the Commissioner or the Commissioner's designee. Source Note: The provisions of this §229.225 adopted to be effective August 2, 2017, 42 TexReg 3789. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG N CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD §229.225 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220591&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220591 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220591&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220591 03/11/2026 This subchapter provides the minimum licensing standards necessary to ensure the safety and efficacy of nonprescription drugs offered for sale by wholesale distributors. Source Note: The provisions of this §229.241 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.241 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220592&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220592 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220592&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220592 03/11/2026 (a) The department adopts by reference the following laws and regulations:(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §301, et seq., as amended;(2) 9 Code of Federal Regulations (CFR) Part 113, Standard Requirements, as amended;(3) 21 CFR Part 70, Color Additives, as amended;(4) 21 CFR Part 71, Color Additive Petitions, as amended;(5) 21 CFR Part 73, Listing of Color Additives Exempt From Certification, as amended;(6) 21 CFR Part 74, Listing of Color Additives Subject to Certification, as amended;(7) 21 CFR Part 80, Color Additive Certification, as amended;(8) 21 CFR Part 81, General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;(9) 21 CFR Part 82, Listing of Certified Provisionally Listed Colors and Specifications, as amended;(10) 21 CFR Part 201, Labeling, as amended;(11) 21 CFR Part 206, Imprinting of Solid Oral Dosage Form Drug Products for Human Use, as amended;(12) 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code, as amended;(13) 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;(14) 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, as amended;(15) 21 CFR Part 225, Current Good Manufacturing Practice for Medicated Feeds, as amended;(16) 21 CFR Part 226, Current Good Manufacturing Practice for Type A Medicated Articles, as amended;(17) 21 CFR Part 250, Special Requirements for Specific Human Drugs, as amended;(18) 21 CFR Part 299, Drugs; Official Names and Established Names, as amended;(19) 21 CFR Part 300, General, as amended;(20) 21 CFR Part 310, New Drugs, as amended;(21) 21 CFR Part 312, Investigational New Drug Application, as amended;(22) 21 CFR Part 314, Applications for FDA Approval to Market a New Drug, as amended;(23) 21 CFR Part 316, Orphan Drugs, as amended;(24) 21 CFR Part 320, Bioavailability and Bioequivalence Requirements, as amended;(25) 21 CFR Part 328, Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol, as amended;(26) 21 CFR Part 330, Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded, as amended;(27) 21 CFR Part 331, Antacid Products for Over-the-Counter (OTC) Human Use, as amended;(28) 21 CFR Part 332, Antiflatulent Products for Over-the-Counter Human Use, as amended;(29) 21 CFR Part 333, Topical Antimicrobial Drug Products for Over-the-Counter Human Use, as amended;(30) 21 CFR Part 335, Antidiarrheal Drug Products for Over-the-Counter Human Use, as amended;(31) 21 CFR Part 336, Antiemetic Drug Products for Over-the-Counter Human Use, as amended;(32) 21 CFR Part 338, Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use, as amended;(33) 21 CFR Part 340, Stimulant Drug Products for Over-the-Counter Human Use, as amended;(34) 21 CFR Part 341, Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter Human Use, as amended;(35) 21 CFR Part 343, Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter Human Use, as amended;(36) 21 CFR Part 344, Topical Otic Drug Products for Over-the-Counter Human Use, as amended;(37) 21 CFR Part 346, Anorectal Drug Products for Over-the-Counter Human Use, as amended;(38) 21 CFR Part 347, Skin Protectant Drug Products for Over-the-Counter Human Use, as amended;(39) 21 CFR Part 348, External Analgesic Drug Products for Over-the-Counter Human Use, as amended;(40) 21 CFR Part 349, Ophthalmic Drug Products for Over-the-Counter Human Use, as amended;(41) 21 CFR Part 350, Antiperspirant Drug Products for Over-the-Counter Human Use, as amended;(42) 21 CFR Part 352, Sunscreen Drug Products for Over-the-Counter Human Use (Stayed Indefinitely), as amended;(43) 21 CFR Part 355, Anticaries Drug Products for Over-the-Counter Human Use, as amended;(44) 21 CFR Part 357, Miscellaneous Internal Drug Products for Over-the-Counter Human Use, as amended;(45) 21 CFR Part 358, Miscellaneous External Drug Products for Over-the-Counter Human Use, as amended;(46) 21 CFR Part 369, Interpretive Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale, as amended;(47) 21 CFR Part 700, General, as amended;(48) 21 CFR Part 701, Cosmetic Labeling, as amended; and(49) 21 CFR Part 740, Cosmetic Product Warning Statements, as amended.(b) Electronic copies of these laws and regulations are available online at www.dshs.texas.gov.(c) Nothing in this subchapter relieves any person of the responsibility for compliance with other applicable Texas and federal laws and regulations. Source Note: The provisions of this §229.242 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.242 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220593&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220593 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220593&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220593 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431.(2) Adulterated drug--Has the meaning specified in the Act at §431.111.(3) Authorized agent--An employee of the department who is designated by the commissioner to enforce the provisions of the Act.(4) Broker--A person engaged in offering or contracting for wholesale distribution sale or transfer of a nonprescription drug into, within, or out of Texas and who does not take title to or physical possession of the nonprescription drug.(5) Change of ownership--A sole proprietor who transfers all or part of the facility's ownership to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a facility owned by a partnership; a corporate sale, transfer, reorganization, or merger of the corporation which owns the facility if sale, transfer, reorganization, or merger causes a change in the facility's ownership to another person or persons; or if any other type of association, the removal, addition, or substitution of a person or persons as a principal of such association.(6) Commissioner--Commissioner of the Texas Department of State Health Services.(7) Component--Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.(8) Cosmetic--Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleaning, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of those articles. The term does not include soap.(9) Department--The Texas Department of State Health Services.(10) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or other animals; or(C) intended to affect the structure or any function of the body of humans or other animals and does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.(11) Drug--Articles recognized in the official United States Pharmacopoeia National Formulary, or any supplement to it; articles designated or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; articles, other than food, intended to affect the structure or any function of the body of humans or other animals; and articles intended for use as a component of any such article. The term does not include devices or their components, parts, or accessories. A food for which a claim is made in accordance with the Federal Act, §403(r), 21 USC §343, and for which the claim is approved by the United States Food and Drug Administration (FDA) is not a drug solely because the label or labeling contains such a claim.(12) Federal Act--Federal Food, Drug, and Cosmetic Act, 21 USC §301, et seq., as amended.(13) Flea market--A location at which booths or similar spaces are rented or otherwise made available temporarily to two or more persons and at which the persons offer tangible personal property for sale.(14) Inactive ingredient--Any component other than an active ingredient, including any excipient, flavor, fragrance, and color.(15) Labeling--All labels and other written, printed, or graphic matter:(A) upon any drug or any of its containers or wrappers; or(B) accompanying such drug.(16) Manufacturer--A person who manufactures, prepares, propagates, compounds, processes, packages, or repackages nonprescription drugs, or a person who changes the container, wrapper, or labeling of any nonprescription drug package.(17) Misbranded drug--Has the meaning specified in the Act at §431.112.(18) Nonprescription drug--Any drug that is not a prescription drug, including the terms Over-the-Counter Drug and Non-legend Drug.(19) Nonprescription drug product--A finished dosage form, for example, tablet, capsule, solution, etc., containing an active nonprescription ingredient. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. Any nonprescription drug product that is also a cosmetic or device or component thereof is also subject to the applicable requirements of the Federal Act, Chapters V and VI, and Subchapters E and F; and Subchapter D of this chapter (relating to Regulation of Cosmetics) and Subchapter X of this chapter (relating to Licensing of Device Distributors and Manufacturers).(20) Over-the-Counter (OTC) drugs--Drugs that are safe and effective for use by the general public without seeking treatment by a health professional.(21) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity.(22) Place of business--Each location at which a nonprescription drug for wholesale distribution is located.(23) Prescription drug--Any drug (including any biological product, except for blood and blood components intended for transfusion or biological products that are also medical devices) required by federal law (including federal regulation) to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to the Federal Act at §503(b).(24) Wholesale distribution--Distribution to a person other than a consumer or patient, including distribution to any person by a manufacturer, repackager, own label distributor, broker, jobber, warehouse, or wholesaler. This term does not include:(A) intracompany sales of nonprescription drugs, which means transactions or transfers of nonprescription drugs between a division, subsidiary, parent, or affiliated or related company under common ownership and control or any transaction or transfer between co-license holders of a co-licensed product;(B) the distribution of nonprescription drug samples by a representative of a manufacturer or wholesale drug distributor;(C) the delivery of, or offer to deliver, a nonprescription drug by a common carrier solely in the common carrier's usual course of business of transporting nonprescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the nonprescription drug; and(D) the sale or transfer from a purchaser, other than a consumer, seller, or warehouser, of expired, damaged, returned, or recalled nonprescription drugs to the original manufacturer or to a reverse logistics provider. Source Note: The provisions of this §229.243 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.243 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220594&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220594 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220594&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220594 03/11/2026 Any reference in this subchapter to the sale of nonprescription drugs includes:(1) manufacturing, packaging, exposing, offering, possessing, or holding any nonprescription drug for sale;(2) selling, dispensing, or providing any nonprescription drug; and(3) supplying or applying any nonprescription drug in the operation of any nonprescription drug place of business. Source Note: The provisions of this §229.244 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.244 Sale of Nonprescription Drugs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220595&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220595 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220595&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220595 03/11/2026 (a) A person is exempt from licensing a place of business in accordance with §229.246 of this subchapter (relating to Licensure Requirements) if the person holds a license for the place of business issued by the department under Subchapter W of this chapter (relating to Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices).(b) An exemption from the licensing requirement granted in subsection (a) of this section does not constitute an exemption from other applicable requirements for nonprescription drugs in this subchapter or under the Act. Source Note: The provisions of this §229.245 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.245 Exemption https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220596&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220596 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220596&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220596 03/11/2026 (a) General. Except as provided by §229.245 of this subchapter (relating to Exemption), a person may not engage in the wholesale distribution of nonprescription drugs in Texas unless the person has a valid license from the department for each place of business.(b) Out-of-state place of business. Except as provided by §229.245 of this subchapter, a person who engages in the wholesale distribution of nonprescription drugs from outside this state may only engage in the wholesale distribution of nonprescription drugs within this state if the person holds a license as required under subsection (a) of this section.(c) Combination product. If the United States Food and Drug Administration determines, with respect to a product that is a combination of a nonprescription drug and a device, that the primary mode of action of the product is as a nonprescription drug, the wholesale distributor must obtain a license as described in this section.(d) Proof of licensure. The license holder must show proof of licensure in a format readily available at each place of business.(e) New place of business. Each person acquiring or establishing a place of business for wholesale distribution of nonprescription drugs after the effective date of this subchapter must obtain a license before beginning operation.(f) Two or more places of business. A wholesale distributor of nonprescription drugs must obtain a license for each place of business.(g) Pre-licensing inspection. The applicant must cooperate with any pre-licensing inspection by the department of the applicant's place of business. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with the minimum standards in this subchapter for applicants located out-of-state.(h) Issuance of license. In accordance with §229.281 of this chapter (relating to Processing License/Permit Applications Relating to Food and Drug Operations), the department may license a wholesale distributor of nonprescription drugs who meets the requirements in this subchapter and pays all license fees under §229.249 of this subchapter (relating to Licensure Fees).(i) Transfer of license. Licenses are not transferable.(j) License term. Unless the license is amended as provided in subsection (k) of this section, or suspended or revoked as provided in §229.250 of this subchapter (relating to Refusal, Cancellation, Suspension, or Revocation of a License), the license is valid for two years.(k) Amendment of license. A license that is amended, including a change of name or a notification of a change in the location of a licensed place of business requires submission of an application as outlined in §229.247 of this subchapter (relating to Licensing Procedures) and submission of fees as outlined in §229.249 of this subchapter.(l) Renewal of license.(1) The license application as outlined in §229.247 of this subchapter and nonrefundable licensing fees as outlined in §229.249 of this subchapter for each place of business must be submitted to the department before the expiration date of the current license.(2) A person who files a renewal application after the expiration date must pay an additional $100 delinquency fee.(3) A person who fails to submit a renewal application before the current license expires and continues operations is subject to enforcement and penalty provisions in §229.252 of this subchapter (relating to Enforcement and Penalties), and the refusal, cancellation, suspension, and revocation provisions in §229.250 of this subchapter.(4) A renewal license must only be issued when all past due administrative penalties, license fees, and delinquency fees are paid. Source Note: The provisions of this §229.246 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.246 Licensure Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220597&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220597 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220597&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220597 03/11/2026 (a) License application forms. License application forms may be obtained from the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756, or online at www.dshs.texas.gov.(b) Contents of license application. The application for licensure as a wholesale distributor of nonprescription drugs must be signed and verified, submitted on a license application form furnished by the department, and contain the following information:(1) the name of the legal entity to be licensed, including the name under which the business is conducted;(2) the address of each place of business to be licensed;(3) if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state and corporation charter number; or if any other type of association, the names of the principals of such association;(4) the name and valid driver license number for each individual in an actual administrative capacity which, in the case of proprietorship, must be the managing proprietor; partnership, the managing partner; corporation, the officers and directors; or those in a managerial capacity in any other type of association;(5) for each place of business, the residence address of the individual in charge;(6) a list of categories which must be marked and adhered to in the determination and payment of the fee as described in §229.249 of this subchapter (relating to Licensure Fees); and(7) a statement verified by the applicant's signature acknowledging the applicant read, understood, and agrees to abide by the provisions of this subchapter and those of the Act.(c) Renewal license application. The renewal application for licensure as a wholesale distributor of nonprescription drugs must be made on a license application form furnished by the department. Source Note: The provisions of this §229.247 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.247 Licensing Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220598&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220598 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220598&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220598 03/11/2026 (a) Change in the content of a license application. The license holder must notify the department of any change in the information on the license application in writing within 10 days of the change. Failure to inform the department within 10 days of a change in the information required in the application for a license may result in an enforcement action, including suspension or revocation of the license.(b) Change in location of place of business. The license holder must notify the department at least 30 days in advance of an intended change of address of the licensed place of business. The notice must include the address of the new location and the name of the individual in charge of the business at the new location. Within 10 days of beginning operations at the new location, the license holder must notify the department in writing to confirm the move and provide verification or correction of the information provided on the notice of intent. The license holder must simultaneously return the original license to the department. The notice and confirmation required by this subsection will be deemed adequate if the license holder submits the notices by certified mail, return receipt requested, to the Texas Department of State Health Services at 1100 West 49th Street, Austin, Texas 78756, or submits notices electronically through www.texas.gov. Source Note: The provisions of this §229.248 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.248 Report of Changes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220599&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220599 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220599&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220599 03/11/2026 (a) License fee. Except as provided by §229.245 of this subchapter (relating to Exemption), no person may operate or conduct business as a wholesale distributor of nonprescription drugs without first obtaining a license from the department. All applicants for an initial wholesale distributor of nonprescription drugs license or a renewal license must pay a licensing fee unless otherwise exempt as provided by subsection (c) of this section. All fees are nonrefundable. Licenses are issued for two-year terms. A license shall only be issued when all past due administrative penalties, license fees, and delinquency fees are paid.(1) In-state wholesale distributors of nonprescription drugs who are not manufacturers must pay a two-year license fee based on the gross annual sales of all nonprescription drugs.(A) For a wholesale distributor with gross annual nonprescription drug sales of $0 - $199,999.99, the fees are:(i) $1,040 for a two-year license;(ii) $1,040 for a two-year license issued due to a change of ownership; and(iii) $520 for a license issued during the current licensure period due to minor changes.(B) For a wholesale distributor with gross annual nonprescription drug sales of $200,000 - $19,999,999.99, the fees are:(i) $1,690 for a two-year license;(ii) $1,690 for a two-year license issued due to a change of ownership; and(iii) $845 for a license issued during the current licensure period due to minor changes.(C) For a wholesale distributor with gross annual nonprescription drug sales greater than or equal to $20 million, the fees are:(i) $2,210 for a two-year license;(ii) $2,210 for a two-year license issued due to a change of ownership; and(iii) $1,105 for a license issued during the current licensure period due to minor changes.(2) In-state wholesale distributors of nonprescription drugs who are not manufacturers and who also are required to be licensed as a device distributor under §229.439(a) of this chapter (relating to Licensure Fees) or as a wholesale food distributor under §229.182(a)(3) of this chapter (relating to Licensing/Registration Fee and Procedures) must pay a combined two-year license fee for each place of business. License fees are based on the combined gross annual sales of these regulated products (foods, drugs, and devices).(A) For each place of business having combined gross annual sales of $0 - $199,999.99, the fees are:(i) $520 for a two-year license;(ii) $520 for a two-year license issued due to a change of ownership; and(iii) $260 for a license amended during the current licensure period due to minor changes.(B) For each place of business having combined gross annual sales of $200,000 - $499,999.99, the fees are:(i) $780 for a two-year license;(ii) $780 for a two-year license issued due to a change of ownership; and(iii) $390 for a license amended during the current licensure period due to minor changes.(C) For each place of business having combined gross annual sales of $500,000 - $999,999.99, the fees are:(i) $1,040 for a two-year license;(ii) $1,040 for a two-year license issued due to a change of ownership; and(iii) $520 for a license amended during the current licensure period due to minor changes.(D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99, the fees are:(i) $1,300 for a two-year license;(ii) $1,300 for a two-year license issued due to a change of ownership; and(iii) $650 for a license amended during the current licensure period due to minor changes.(E) For each place of business having combined gross annual sales greater than or equal to $10 million, the fees are:(i) $1,950 for a two-year license;(ii) $1,950 for a two-year license issued due to a change of ownership; and(iii) $975 for a license amended during the current licensure period due to minor changes.(3) In-state wholesale distributors of nonprescription drugs who are manufacturers must pay a two-year license fee based on the gross annual sales of all nonprescription drugs.(A) For a wholesale distributor with gross annual nonprescription drug sales of $0 - $199,999.99, the fees are:(i) $1,040 for a two-year license;(ii) $1,040 for a two-year license issued due to a change of ownership; and(iii) $520 for a license amended during the current licensure period due to minor changes.(B) For a wholesale distributor with gross annual nonprescription drug sales of $200,000 - $1,999,999.99, the fees are:(i) $1,235 for a two-year license;(ii) $1,235 for a two-year license issued due to a change of ownership; and(iii) $620 for a license amended during the current licensure period due to minor changes.(C) For a wholesale distributor with gross annual nonprescription drug sales of $2 million to $9,999,999.99, the fees are:(i) $1,560 for a two-year license;(ii) $1,560 for a two-year license issued due to a change of ownership; and(iii) $780 for a license amended during the current licensure period due to minor changes.(D) For a wholesale distributor with gross annual nonprescription drug sales of $10 million to $19,999,999.99, the fees are:(i) $1,885 for a two-year license;(ii) $1,885 for a two-year license issued due to a change of ownership; and(iii) $940 for a license amended during the current licensure period due to minor changes.(E) For a wholesale distributor with gross annual nonprescription drug sales greater than or equal to $20 million, the fees are:(i) $2,210 for a two-year license;(ii) $2,210 for a two-year license issued due to a change of ownership; and(iii) $1,105 for a license amended during the current licensure period due to minor changes.(4) Out-of-state wholesale distributors of nonprescription drugs must pay a two-year license fee based on all gross annual sales of nonprescription drugs delivered into Texas.(A) For each wholesale distributor with gross annual nonprescription drug sales of $0 - $19,999,999.99, the fees are:(i) $1,300 for a two-year license;(ii) $1,300 for a two-year license issued due to a change of ownership; and(iii) $650 for a license amended during the current licensure period due to minor changes.(B) For each wholesale distributor with gross annual nonprescription drug sales of greater than or equal to $20 million, the fees are:(i) $1,950 for a two-year license;(ii) $1,950 for a two-year license issued due to a change of ownership; and(iii) $975 for a license amended during the current licensure period due to minor changes.(b) Proration of license fees. A person having more than one place of business may request a one-time proration of the license fees when applying for a license for each new place of business. Upon approval by the department, the license for the new place of business will have a renewal date the same as the firm's other licensed places of business.(c) Exemption from license fees. A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 26 USC §501(c)(3), or a nonprofit affiliate of the organization, to the extent otherwise permitted by law. Source Note: The provisions of this §229.249 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective November 14, 2019, 44 TexReg 6897; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.249 Licensure Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220600&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220600 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220600&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220600 03/11/2026 (a) The department may refuse an application for a wholesale distributor of nonprescription drugs license or may suspend or revoke such a license if the applicant or license holder:(1) has been convicted of a felony or misdemeanor involving moral turpitude;(2) is an association, partnership, or corporation and the managing officer or any officer or director of the corporation has been convicted of a felony or misdemeanor involving moral turpitude;(3) is an association, partnership, or corporation and the managing officer or any officer or director of the corporation has been convicted of a felony or misdemeanor involving the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;(4) has violated any of the provisions of the Texas, Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431 (Act), or this subchapter.(5) has violated the Texas Health and Safety Code §431.021(l)(3), concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;(6) has violated the Controlled Substance Act, Texas Health and Safety Code Chapter 481, or the Dangerous Drug Act, Texas Health and Safety Code Chapter 483 ;(7) has violated the rules of the director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or license holder maintain;(8) has failed to complete a license application or submits an application containing false, misleading, or incorrect information, or information that cannot be verified by the department;(9) has failed to pay a license fee or a renewal fee for a license; or(10) has obtained or attempted to obtain a license by fraud or deception.(b) The department may, after providing opportunity for hearing, refuse to license a wholesale distributor of nonprescription drugs, or may suspend or revoke a license for violations of the requirements in this subchapter or for any of the reasons described in the Act.(c) Any hearings for the refusal, suspension, or revocation of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(d) If the department suspends a license, the suspension must remain in effect until the department determines the reason for the suspension no longer exists. If the suspension overlaps a renewal date, the suspended license holder must comply with the renewal procedures in §229.247 of this subchapter (relating to Licensing Procedures); however, the department may choose not to renew the license until the department determines the reason for suspension no longer exists.(e) If the department revokes or does not renew a license, a person may reapply for a license by complying with the requirements and procedures in §229.247 of this subchapter at the time of reapplication. The department may refuse to issue a license if the reason for revocation or non-renewal continues to exist.(f) A license issued under this subchapter must be returned to the department if the person's place of business:(1) ceases business or otherwise ceases operation on a permanent basis;(2) relocates; or(3) changes name or ownership. For a corporation, an ownership change is deemed to have occurred, requiring return of the license to the department, when 5.0 percent or more of the share of stock of a corporation is transferred from one person to another. Source Note: The provisions of this §229.250 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.250 Refusal, Cancellation, Suspension or Revocation of License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220601&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220601 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220601&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220601 03/11/2026 (a) General requirements.(1) All persons engaged in the wholesale distribution of nonprescription drugs must comply with the applicable minimum standards in this section, in addition to the statutory requirements contained in the Act and in §229.242 of this subchapter (relating to Applicable Laws and Regulations).(2) For the purpose of this section, the policies that apply to nonprescription drugs as described in the United States Food and Drug Administration's (FDA) Compliance Policy Guides are the policies of the department.(3) Nonprescription drug wholesalers must not purchase or receive drugs in this state other than from drug distributors licensed by the department.(b) Federal establishment registration and drug listing.(1) All persons who operate as nonprescription drug manufacturers in Texas must meet the requirements in 21 Code of Federal Regulations (CFR) Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code.(2) New nonprescription drugs offered for sale by wholesale distributors must have met, if applicable, the requirements of 21 CFR Part 314, Applications for FDA Approval to Market a New Drug.(c) Good manufacturing practices. Manufacturers of nonprescription drug products must comply with the applicable requirements in:(1) 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;(2) 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, as amended;(3) 21 CFR Part 225, Current Good Manufacturing Practice for Medicated Feeds, as amended(4) 21 CFR Part 226, Current Good Manufacturing Practice for Type A Medicated Articles, as amended; and(5) the regulations in this subsection governing the methods used in, and the facilities or controls used for, the manufacture, processing, packing, or holding of a drug to ensure each drug meets the requirements of the Federal Food, Drug, and Cosmetic Act, 21 USC §301, et seq., as amended, (Federal Act) as to safety, and has the identity and strength meeting the quality and purity characteristics it purports or is represented to possess.(d) Buildings and facilities.(1) All manufacturing, processing, packing, or holding of drugs by nonprescription drug manufacturers must take place in buildings and facilities described in subsection (c) of this section.(2) Manufacturing, processing, packing, or holding of nonprescription drugs must not be conducted in any personal residence.(3) Sale of nonprescription drugs must not be conducted in any flea market.(4) Any place of business used by a wholesale distributor of nonprescription drugs who is not a manufacturer to store, warehouse, hold, offer, transport, or display drugs must:(A) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;(B) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;(C) be maintained in a clean and orderly condition and in good repair, including the walls, ceilings, windows, doors, and floors of the premises;(D) be free from infestation by insects, rodents, birds, or vermin of any kind; and(E) utilize a quarantine area for storage of drugs that are outdated, damaged, deteriorated, returned, recalled, misbranded, or adulterated, that is clearly designated and separated from other sections where drugs are stored so drugs in this subchapter are not confused with usable drugs.(e) Storage of nonprescription drugs. All nonprescription drugs stored by wholesale distributors must be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs and the standards set forth in the latest edition of the United States Pharmacopeia/National Formulary (USP/NF). If no storage requirements are established for a nonprescription drug, the nonprescription drug may be held at controlled room temperature, as defined in the USP/NF, to help ensure that its identity, strength, quality, and purity are not adversely affected. Prior to storage in inventory, a wholesale distributor must:(1) upon receipt, visually examine each outside shipping container for identity and to prevent the acceptance of contaminated drugs otherwise unfit for distribution; and(2) carefully inspect each outgoing shipment for identity of the drug and to prevent delivery of drugs that have been damaged in storage, including drugs held under improper conditions.(f) Operating procedures for wholesale distributors who are not manufacturers. Written procedures describing the holding of nonprescription drug products by wholesale distributors of nonprescription drugs who are not manufacturers must be established and followed and include:(1) a procedure for identifying and retrieving nonprescription drug products subject to a recall; and(2) a quarantine procedure for nonprescription drug products that have expired; are subject to recall; or are otherwise determined to be adulterated or misbranded, for the return, destruction, or other disposal of those items.(g) Nonprescription drug labeling. Nonprescription drugs sold by wholesale distributors must meet the labeling requirements of the Act and 21 CFR Part 201, Labeling.(h) Nonprescription drugs that are combination products. Any nonprescription drug that is a combination product as described in §229.246(c) of this title (relating to Licensure Requirements) is also subject to the applicable requirements in Subchapter X of this chapter (relating to Licensing of Device Distributors and Manufacturers).(i) Nonprescription drugs that are also cosmetics. Any nonprescription drug that is also a cosmetic or component thereof is also subject to the applicable requirements of Subchapter D of this chapter (relating to Regulation of Cosmetics). Source Note: The provisions of this §229.251 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.251 Minimum Standards for Licensure https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220602&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220602 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220602&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220602 03/11/2026 (a) Inspection. To enforce this subchapter or the Act, the commissioner, an authorized agent, or a health authority, may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:(1) enter at reasonable times a place of business, including a factory or warehouse, in which a nonprescription drug is manufactured, packed, or held for introduction into commerce or held after the introduction;(2) enter a vehicle being used to transport or hold a nonprescription drug in commerce; or(3) inspect at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item, and obtain samples necessary for the enforcement of this subchapter or the Act.(b) Receipt for samples. An authorized agent or health authority who inspects a place of business, including a factory or warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, must give the owner, operator, or the owner's or operator's agent a receipt describing the sample.(c) Access to records.(1) A person who is required to maintain records referenced in this subchapter or under the Act, or Federal Food, Drug, and Cosmetic Act (Federal Act), Chapter V, or a person who is in charge or custody of those records, must, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times access to records for verification and copying.(2) A person, including a carrier engaged in commerce, or other person receiving a nonprescription drug in commerce or holding a nonprescription drug received in commerce must, at the request of an authorized agent, permit the authorized agent at all reasonable times to have access to and to copy and verify all records showing:(A) the movement in commerce of any nonprescription drug;(B) the holding of any nonprescription drug after movement in commerce; and(C) the quantity, shipper, and consignee of any nonprescription drug.(d) Retention of records. Records required by this subchapter must be maintained at the place of business or other location that is reasonably accessible for a period of at least three years following disposition of the nonprescription drug unless a greater period of time is required by §229.242 of this subchapter (relating to Applicable Laws and Regulations).(e) Adulterated and misbranded nonprescription drug. If the department identifies an adulterated or misbranded nonprescription drug, the department may impose the applicable provisions of Subchapter C of the Act, including detention, emergency order, recall, and administrative penalties. Administrative penalties will be assessed using the Severity Levels contained in §229.261 of this chapter (relating to Assessment of Administrative Penalties). The department may request the attorney general or local law enforcement institute an action for criminal penalties, collection of civil penalties, condemnation, destruction, and injunction under the Act. Source Note: The provisions of this §229.252 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG O LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.252 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207478&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207478 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=207478&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 207478 03/11/2026 (a) Proposals for assessment of administrative penalties. The department shall propose to assess administrative penalties in accordance with the requirements of the Texas Health and Safety Code, Chapter 146 concerning Tattoo and Certain Body Piercing Studios; Chapter 431 concerning Texas Food, Drug, and Cosmetic Act; Chapter 432 concerning Texas Food, Drug, Device, and Cosmetic Salvage Act; and Chapter 437 concerning Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, and Roadside Food Vendors.(b) Assessment of administrative penalties and conduct of hearings. The department shall assess administrative penalties and conduct hearings pursuant to those administrative penalties in accordance with the appropriate statute in subsection (a) of this section and rules adopted under it; the Administrative Procedure Act, Texas Government Code, Chapter 2001; and the department's formal hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(c) Criteria for the assessment of administrative penalties. The department shall assess administrative penalties based upon one or more of the following criteria:(1) history of previous violations;(2) seriousness of the violation;(3) hazard to the health and safety of the public;(4) demonstrated good faith efforts to correct;(5) economic harm to property or the environment;(6) amounts necessary to deter future violations;(7) enforcement costs relating to the violation; and(8) any other matter justice may require.(d) Severity levels. The violations shall be categorized by one of the following severity levels.(1) Severity Level I covers violations that are most significant and may have a significant negative impact on the public health and safety.(2) Severity Level II covers violations that are very significant and may have a negative impact on the public health and safety.(3) Severity Level III covers violations that are significant and, if not corrected, could threaten the public health and safety.(4) Severity Level IV covers violations that are of more than minor significance, but if left uncorrected, could lead to more serious circumstances.(5) Severity Level V covers violations that are of minor health or safety significance.(e) Levels of penalties. Except as provided for in subsection (f) of this section relating to retail food establishments and subsection (g) of this section relating to tattoo studios, the department will impose different levels of penalties per day, per violation, for the following severity level violations:(1) Level I--Up to $25,000;(2) Level II--Up to $15,000;(3) Level III--Up to $10,000;(4) Level IV--Up to $5,000; and(5) Level V--Up to $2,500.(f) Levels of penalties for retail food establishments. As to retail food establishments permitted under Texas Health and Safety Code, Chapter 437, the department will impose different levels of penalties per day, per violation, for the following severity level violations:(1) Level I--Up to $10,000;(2) Level II--Up to $7,500;(3) Level III--Up to $5,000;(4) Level IV--Up to $2,500; and(5) Level V--Up to $1,250.(g) Levels of penalties for tattoo and body-piercing studios. As to certain tattoo and body-piercing studios licensed under Texas Health and Safety Code, Chapter 146, the department will impose different levels of penalties per day, per violation, for the following severity level violations:(1) Level I--Up to $5,000;(2) Level II--Up to $4,000;(3) Level III--Up to $3,000;(4) Level IV--Up to $2,000; and(5) Level V--Up to $1,000.(h) Adjustments to penalties. The department may adjust the penalties listed in subsections (e), (f), or (g) of this section for any one of the following factors.(1) Previous violations. The department may consider previous violations. The penalty may be reduced or increased for past performance. Past performance involves the consideration of the following factors:(A) whether the previous violation was identical or similar to the current violation;(B) how recent was the previous violation;(C) the number of previous violations; and(D) the violator's response to previous violations in regard to correction of the problem.(2) Demonstrated good faith. The department may consider good faith efforts of the violator to correct the violations and demonstrate compliance with the department's rules and regulations as a basis to reduce the proposed penalty. The penalty may be reduced if good faith efforts to correct a violation have been, or are being made. Good faith effort is determined by the department on a case-by-case basis. All good faith efforts to comply with the department's rules and regulations must be fully documented by the violator to merit consideration from the department as to whether to reduce the proposed penalty.(3) Hazard to the health and safety of the public. The department may consider the hazard to the health and safety of the public. The penalty may be increased when a direct hazard to the health and safety of the public is involved. The department shall take into account, but need not be limited to, the following factors:(A) whether any deaths, diseases, or injuries have occurred from the violation;(B) whether any existing conditions contribute to a situation that could expose humans to a health hazard;(C) the impact that the hazard has on various segments of the population such as children, surgical patients, and the elderly; and(D) whether the consequences would be of an immediate or long-range hazard. Source Note: The provisions of this §229.261 adopted to be effective April 24, 2003, 28 TexReg 3337; amended to be effective December 26, 2021, 46 TexReg 9037. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG P ASSESSMENT OF ADMINISTRATIVE PENALTIES §229.261 Assessment of Administrative Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98181&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98181 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=98181&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 98181 03/11/2026 (a) Definition. For purposes of this section, license means a license, permit, registration, or certificate issued by the Texas Department of Health (department) for a food wholesaler and manufacturer, wholesale drug manufacturer and distributor, device manufacturer and distributor, tanning facility, tattoo studio, body piercing studio, salvage broker, salvage establishment, retail food establishment, or narcotic treatment program. This subchapter is not applicable to food manager certification.(b) General. Time periods for processing and issuing a license.(1) The date a license application is received by the Bureau of Food and Drug Safety, Texas Department of Health, is the date the original application reaches the department.(2) An application for a license is complete when the department has received, reviewed, and found acceptable the application information and fee required by the appropriate sections of this title (25 Texas Administrative Code (TAC), Chapter 229, Food and Drug, relating to Licensing Fees, Procedures, Requirements).(3) An application for an annual renewal of a license is complete when the department has received, reviewed and found acceptable the application information and fee required by the appropriate section of this title (25 TAC, Chapter 229, Food and Drug, relating to Licensing Fees, Procedures, Requirements).(4) An application for an amendment of a license is complete when the department has received, reviewed, and found acceptable the application information and fee required by the appropriate section of this title (25 TAC, Chapter 229, Food and Drug relating to Licensing Fees, Procedures, Requirements).(c) Time Periods. An application for a license shall be processed in accordance with the following time periods.(1) The first time period is 45 calendar days, which begins on the date the department receives the application and ends on the date the license is issued. If an incomplete application is received, the period ends on the date the facility is issued a written notice that the application is incomplete. The written notice shall describe the specific information or fee that is required before the application is considered complete.(2) The second time period is 45 calendar days, which begins on the date the last item (information or fee) necessary to complete the application is received by the department and ends on the date the license is issued, or the facility is issued a written notice that the application is being proposed for denial.(3) If the applicant fails to submit the requested information and/or fee within 135 days of the date the department issued the written notice to the applicant as described in paragraph (1) of this subsection, that the application is incomplete and/or additional fees are owed, the application is considered withdrawn. Fees paid are not refundable. There will be no refund of the fee except as provided by subsections (d) and (f) of this section. A new application and fee must be submitted to the department.(d) Reimbursement of fees.(1) In the event the application is not processed within the time periods stated in subsection (c) of this section, the applicant has the right to make a written request within 30 days of the end of the second period that the department reimburse in full the fee paid in that particular application process.(2) If the department finds that good cause existed for exceeding the established periods, the request will be denied. The department will notify the applicant in writing of the denial of the reimbursement within 30 days of the department's receipt of the request for reimbursement.(e) Good cause for exceeding the period established is considered to exist if:(1) the number of applications for licenses to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year;(2) another public or private entity utilized in the application process caused the delay;(3) conditions in violation of the rules exist which are noted in recent investigations or inspections;(4) the application is being held pending completion of an investigation, inspection, or enforcement action;(5) the application is incomplete in information, signature, and/or fee amount submitted; or(6) other conditions existed giving good cause for exceeding the established periods.(f) Appeal. If the request for reimbursement as authorized by subsection (d)(1) of this section is denied, the applicant may, within 30 days of being notified of the denial, appeal to the Commissioner of Health (commissioner) for a resolution of the dispute. The applicant shall give written notice to the commissioner requesting reimbursement of the fee paid because the application was not processed within the established time period. Within 30 days of receiving the appeal, the Bureau of Food and Drug Safety shall submit a written report to the commissioner of the facts related to the processing of the application and describing the good cause for exceeding the established time periods. The commissioner then has 30 days to make the final decision and provide written notification of the decision to the applicant and the Bureau of Food and Drug Safety.(g) Hearings shall be conducted under the provision of contested case hearings pursuant to the department's formal hearing procedures in Chapter 1 of this title (relating to the Texas Board of Health) and the Administrative Procedure Act, Government Code, Chapter 2001. Source Note: The provisions of this §229.281 adopted to be effective December 15, 2002, 27 TexReg 11549. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Q LICENSE/PERMIT APPLICATIONS §229.281 Processing License/Permit Applications Relating to Food and Drug Operations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148341&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148341 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148341&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148341 03/11/2026 These sections set out the requirements for the Department of State Health Services (department) to issue a certificate of free sale and sanitation and/or a certificate of origin and sanitation. Certificates are issued only to Texas licensed manufacturers and/or distributors with product physically present in Texas (and therefore available for inspection by the department) for the purpose of exporting products from the United States into other countries. Products shall be manufactured in Texas and/or distributed, warehoused, and sold from Texas. Certificates for cosmetics can only be issued after the department has inspected the Texas manufacturing and/or warehousing facility. Certificates for meat and poultry products can only be issued by the United States Department of Agriculture (USDA). Source Note: The provisions of this §229.301 adopted to be effective March 15, 2001, 26 TexReg 2031; amended to be effective October 1, 2010, 35 TexReg 8500. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG R ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION §229.301 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148342&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148342 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148342&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148342 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Certificate of free sale and sanitation--A certificate issued by the department, which certifies that the distributor of the food, drugs, cosmetics, medical device products, dietary supplements, milk and dairy products, or molluscan shellfish products listed in the document is duly authorized to distribute the products and that the products can be sold freely to the public in Texas, and that the distributor is in substantial compliance with Texas Health and Safety Code, Chapters 431, 435, 436, or 440, depending on the product (the Acts), and with 25 Texas Administrative Code, Chapters 217, 229, or 241 (the Rules), as determined by the department.(2) Certificate of origin and sanitation--A certificate issued by the department, which certifies that the product(s) listed in the document originate from, are manufactured in, produced in or grown in the State of Texas and can only be issued to a Texas manufacturer.(3) Common or usual name--The common or usual name of a food shall accurately identify or describe in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The "common or usual name" shall comply with all state and federal regulations, including Title 21, Code of Federal Regulations (CFR), §102.5.(4) Current inspection--An official inspection of an establishment conducted within the time specified in §229.303(b) of this title (relating to Minimum Requirements), or immediately preceding a request for certificate of free sale and sanitation and/or a certificate of origin and sanitation.(5) Currently licensed--Establishments regulated by the department under the Texas Health and Safety Code (Texas Food, Drug, and Cosmetic Act, Texas Dairy Products Act, Texas Aquatic Life Act, and Frozen Desserts Manufacturer Licensing Act,) which possess a current, valid license.(6) Custom certificate--A certificate of free sale and sanitation or certificate of origin and sanitation with additional verbiage requested by the applicant. The verbiage may be specific to the requirements of the receiving country and/or specific information about the product(s) listed on the certificate(s).(7) Department--The Department of State Health Services.(8) Private Labeler--A firm that distributes a product under a custom label, trade name, private label, or its own label, and assumes full responsibility for compliance with all applicable laws and regulations, and the product is manufactured and labeled by another licensee and/or registered establishment. For purposes of this regulation, regardless of license type issued, a private labeler can only be issued a certificate of free sale and sanitation.(9) Properly labeled--Products in compliance with applicable state and federal statutes and regulations as listed in subparagraphs (A) - (D) of this paragraph and in accordance with the Texas Food, Drug and Cosmetic Act, Texas Health and Safety Code, Chapter 431.(A) Title 21, CFR, Part 101, Food labeling (relating to labeling of food, beverages, and dietary supplements).(B) Title 21, CFR, Part 201, Labeling (relating to labeling of drugs), and Title 21, CFR, Parts 310 and 328 - 369 (relating to monograph labeling requirements).(C) Title 21, CFR, Parts 701 and 740, Cosmetic labeling.(D) Title 21, CFR, Part 801, Labeling (relating to labeling of medical devices). Source Note: The provisions of this §229.302 adopted to be effective March 15, 2001, 26 TexReg 2031; amended to be effective October 1, 2010, 35 TexReg 8500. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG R ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION §229.302 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148343&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148343 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148343&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148343 03/11/2026 (a) Current license. All establishments, except those exempt from licensing by law, shall be currently licensed by the department and shall be in substantial compliance with the Acts and the Rules as they apply to each specific type of operation.(b) Current compliant inspection. All establishments shall have a current compliant inspection as follows:(1) distributors or wholesalers of foods, drugs, or medical devices, within 24 months of application;(2) manufacturers of foods, drugs, or medical devices, within 12 months of application;(3) manufacturers, distributors, or wholesalers of cosmetic products, within 24 months of application;(4) producers, processors, and distributors of milk or dairy products, within 3 months of application; and(5) producers or distributors of molluscan shellfish, within 3 months of application.(c) Private Labelers. Private Labelers can only apply for and receive a certificate of free sale and sanitation in the name of the private labeler. Private labelers are responsible for purity and labeling of products and for compliance with all applicable laws and regulations. For purposes of this regulation, regardless of license type issued, a private labeler can only be issued a certificate of free sale and sanitation.(d) Product requirements. Products shall be manufactured in Texas, and/or warehoused, distributed, and sold from Texas. Products shall be available for inspection at the licensed location.(e) Rule or Act violations. A certificate of free sale and sanitation and/or certificate of origin and sanitation shall not be issued if substantive violations of the applicable Acts or Rules exist as determined by the department. Applicants whose application for a certificate is denied may appeal the decision pursuant to the provisions of §229.307 of this title (relating to Appeal Procedures). Source Note: The provisions of this §229.303 adopted to be effective March 15, 2001, 26 TexReg 2031; amended to be effective October 1, 2010, 35 TexReg 8500. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG R ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION §229.303 Minimum Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148344&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148344 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148344&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148344 03/11/2026 (a) Application form. Application forms may be obtained from the Department of State Health Services, or at the website, www.dshs.state.tx.us/fdlicense.(b) Application information. The application shall be signed and verified, shall be made on an application form authorized by the department, and shall contain the following information:(1) the name under which the business is conducted and/or licensed;(2) the address where the business is conducted;(3) the type of operation conducted by the requesting establishment;(4) the type of certificate requested; and(5) the product(s) specified on the application to include the full, common or usual name of the product, the name of the manufacturer and the size of the product. Each product size shall be submitted as a separate product. Products on the certificate will be listed exactly as submitted.(c) Complete application. Applications shall be completely filled out and shall be accompanied by the appropriate fee. An application is not considered complete unless all information including the correct fee and any supplemental information is submitted and meets all regulatory requirements.(d) Supplemental information. The labeling information, promotional information, website information, master formulas, marketing clearance letters, distribution records, and advertising affixed to, accompanying, or relating to the products may be required to be submitted for each product upon request by the department. If labeling is in a foreign language, applicant shall provide English translation. Labeling information shall be in final format. Label prototypes and drafts will not be accepted.(e) Information listed. The certificate will list the product name, the manufacturer's name, and the product size, if applicable. Source Note: The provisions of this §229.304 adopted to be effective March 15, 2001, 26 TexReg 2031; amended to be effective October 1, 2010, 35 TexReg 8500. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG R ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION §229.304 Application for Certificate https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148345&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148345 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148345&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148345 03/11/2026 (a) Time frames for issuing a certificate. The time frames for issuing a certificate shall be as follows.(1) No later than 15 business days of receipt of a completed application, the department shall issue a certificate, deny a certificate, schedule an inspection, and/or request supplemental information. Time frames are suspended any time the applicant is requested to submit additional information, the applicant submits additional information, or the applicant requests a custom certificate.(2) No later than 45 business days of receipt of a completed application, the department shall inspect an establishment needing a current compliant inspection, and shall issue the certificate if there is no substantive violation of the Acts or the Rules. If substantive violations exist, the department shall notify the applicant. Time frames are suspended any time substantive violations exist.(3) No later than 30 business days of receipt of requested supplemental information or acceptable documentation of correction of substantive violations, the department shall review all information for compliance with state and federal regulations. If the information meets the requirements of the state and federal law, the establishment has a current compliant inspection, and all fees have been received, the department shall issue the certificate. Time frames are suspended any time the applicant is requested to submit supplemental information.(4) If any time frame is suspended for 60 business days or more with no response from the applicant, the application is considered withdrawn.(b) Expiration dates.(1) Certificates are valid for the lesser of the term of the license or the inspection interval. Expiration dates are applied on the certificates by the department.(2) Certificates are invalid immediately upon notice by the department that the facility is not in substantial compliance with all applicable rules and regulations. Source Note: The provisions of this §229.305 adopted to be effective March 15, 2001, 26 TexReg 2031; amended to be effective October 1, 2010, 35 TexReg 8500. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG R ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION §229.305 Time Frames https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148346&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148346 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148346&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148346 03/11/2026 (a) Original certificate. All applicants for certificates shall pay a nonrefundable fee as follows.(1) $50 for 1 - 50 products; $5 for each additional identical certificate.(2) $60 for 51 - 200 products; $6 for each additional identical certificate.(3) $75 for 201 - 500 products; $8 for each additional identical certificate.(4) $100 for 501 - 1000 products; $10 for each additional identical certificate.(5) $150 for 1001+ products; $15 for each additional identical certificate.(b) Non-licensed establishments. For any establishments not required to be licensed by the department, and that do not have a current compliant inspection, a nonrefundable fee of $400 for an inspection conducted by department staff will be required in addition to costs outlined in subsection (a) of this section.(c) Single service container. For single service container establishments regulated by the department, a non-refundable fee will be required as outlined in subsection (a) of this section.(d) Supplemental information review. For supplemental information review, a separate invoice shall be mailed or sent via facsimile to the applicant. In addition to the fees outlined in subsection (a) of this section, nonrefundable fees of $72 per hour of review time will be charged with a one-half hour minimum. These fees shall be paid prior to the certificate being issued. Failure to pay the review fee will result in denial of the certificate.(e) Custom certificates. For a custom certificate, a separate invoice shall be mailed or sent via facsimile to the applicant. In addition to the fees outlined in subsection (a) of this section, a nonrefundable fee of $72 per hour of review time will be charged with a one-half hour minimum. All applicable fees shall be paid prior to the certificate being issued. Failure to pay all applicable custom certificate fees will result in denial of the certificate.(f) No transfers. Certificates shall not be transferred from one person to another or from one establishment to another. The forging (by altering, making or reproducing) or tampering with a certificate of free sale and sanitation and/or a certificate of origin and sanitation is prohibited by law. Such conduct is a felony punishable under the Texas Penal Code, §32.21 and §37.10.(g) Delivery by mail. Certificates issued will be delivered by first class mail through the United States Postal Service. Applicants will be responsible for all costs associated with other means of mailing. Source Note: The provisions of this §229.306 adopted to be effective March 15, 2001, 26 TexReg 2031; amended to be effective October 1, 2010, 35 TexReg 8500. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG R ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION §229.306 Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148347&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148347 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=148347&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 148347 03/11/2026 Upon denial of a certificate, the applicant will receive a written response outlining the reasons for denial. If the reason for denial is failure to be in substantial compliance with the applicable Acts or Rules, the applicant will receive a notice of violation or other notification from the department. Appeals based on noncompliance issues shall be handled in accordance with the instructions in the notice. An applicant may request in writing a de novo review of the decision to deny a certificate from a representative of the department when the denial is based on any other grounds. Source Note: The provisions of this §229.307 adopted to be effective October 1, 2010, 35 TexReg 8500. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG R ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION §229.307 Appeal Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=81697&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 81697 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=81697&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 81697 03/11/2026 (a) The Texas Department of Health adopts by reference a memorandum of understanding (MOU) covering the positive results of testing conducted for pesticide in food. The MOU is entered into between the Texas Department of Health, Texas Department of Agriculture, Southwest Region of the United States Food and Drug Administration, and the Office of the Texas State Chemist of the Texas Agricultural Experiment Station.(b) Copies of the MOU are available on the Bureau of Food and Drug Safety website, http://www.tdh.state.tx.us/bfds/bfds-hom.htm. Copies are also filed in the office of the Bureau of Food and Drug Safety, Texas Department of Health, 2201 Donley Drive, Suite 200, Austin, Texas 78758, and may be reviewed during regular business hours. Source Note: The provisions of this §229.334 adopted to be effective September 5, 1989, 14 TexReg 4240; amended to be effective October 1, 2000, 25 TexReg 9474. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG S PESTICIDES IN FOOD §229.334 Memorandum of Understanding Covering the Testing for Pesticides in Food https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218037&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218037 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218037&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218037 03/11/2026 The purpose of this subchapter is to implement Texas Health and Safety Code Chapter 437, which requires the department to establish a permitting system for the regulation of food establishments and to ensure uniform requirements for retail food operations. Source Note: The provisions of this §229.370 adopted to be effective March 19, 2000, 25 TexReg 2076; amended to be effective January 1, 2005, 29 TexReg 11982; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG U PERMITTING RETAIL FOOD ESTABLISHMENTS §229.370 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218038&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218038 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218038&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218038 03/11/2026 All definitions found in §228.2 of this title (relating to Definitions) are applicable to this subchapter. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Food--A raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.(2) Food establishment--(A) A food establishment is an operation that:(i) stores, prepares, packages, serves, or vends food directly to the consumer, or otherwise provides food for human consumption, such as:(I) a restaurant;(II) a retail food store;(III) a satellite or catered feeding location;(IV) a catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people;(V) a market;(VI) a vending machine location;(VII) a self-service food market;(VIII) a conveyance used to transport people;(IX) an institution; or(X) a food bank; and(ii) relinquishes possession of food to a consumer directly, or indirectly through a delivery service, such as home delivery of grocery orders or restaurant takeout orders, or delivery service provided by common carriers.(B) A food establishment includes:(i) an element of the operation, such as a transportation vehicle or a central preparation facility supplying a vending machine location or satellite feeding location unless the vending machine or feeding location is permitted by the regulatory authority; and(ii) an operation conducted in a mobile, stationary, temporary, or permanent facility or location and where consumption is on or off the premises regardless if there is a charge for the food.(C) A food establishment does not include:(i) an establishment offering only prepackaged foods that are not time and temperature control for safety (TCS) foods;(ii) a produce stand only offering whole, uncut fresh fruits and vegetables;(iii) a food processing plant, including one located on the premises of a food establishment;(iv) a cottage food production operation;(v) a bed and breakfast limited as defined in §228.2(5) of this title (relating to Definitions); or(vi) a private home receiving catered or home-delivered food.(3) Food Service Establishment--A food establishment as defined in these rules.(4) Nonprofit organization--A civic or fraternal organization, charity, lodge, association, proprietorship, or corporation possessing a 501(c) exemption under the Internal Revenue Code; or a religious organization.(5) Permit holder--The person legally responsible for the operation of the food establishment such as the owner, the owner's agent, or other person; and who possesses a valid permit to operate a food establishment.(6) Retail food store--A food establishment or section of an establishment where food and food products are offered to the consumer and intended for off-premises consumption. The term includes delicatessens offering prepared food in bulk quantities only. The term does not include establishments which handle only prepackaged, non-TCS food products; roadside markets offering only unprocessed fresh fruits and fresh vegetables; or farmers markets; except, for the purposes of obtaining a permit and payment of fees only, the term "retail food store" does not include establishments permitted and inspected under authority granted to municipalities.(7) School food establishment--A food service establishment where food is prepared and intended for service primarily to students in public and private schools, including kindergarten, preschool and elementary schools, junior high schools, high schools, colleges, and universities. A school food establishment is a food establishment and may include concession stands located on the school premises or other school-sponsored venues. School food establishments are managed and operated under the supervision of school district employees.(8) Temporary food establishment--A food establishment operating for a period of no more than 14 consecutive days in conjunction with a single event or celebration.(9) Time and temperature control for safety food (TCS food)--A food requiring time and temperature control for safety to limit pathogen growth or toxin production. The term includes a food that must be held under proper temperature controls, such as refrigeration, to prevent the growth of bacteria that may cause human illness. A TCS food may include a food containing protein and moisture and that is neutral or slightly acidic, such as meat, poultry, fish, and shellfish products; pasteurized and unpasteurized milk and dairy products; raw seed sprouts; baked goods that require refrigeration, including cream or custard pies or cakes; and ice products. The term does not include a food using TCS food as ingredients if the final food product does not require time or temperature control for safety to limit pathogen growth or toxin production. Source Note: The provisions of this §229.371 adopted to be effective March 19, 2000, 25 TexReg 2076; amended to be effective January 1, 2005, 29 TexReg 11982; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG U PERMITTING RETAIL FOOD ESTABLISHMENTS §229.371 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218039 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218039 03/11/2026 (a) Permitting fees.(1) A person who operates a food establishment shall obtain a permit from the department and pay a permit fee for each establishment unless specifically exempted under subsection (b) or (c) of this section. All permit fees are nonrefundable. Permits are issued for a two-year term. The fees are based on gross annual volume of sales as follows:(A) for an establishment with gross annual volume of food sales of $0 - $49,999.99, the fee is $250;(B) for an establishment with gross annual volume of food sales of $50,000 - $149,999.99, the fee is $500; or(C) for an establishment with gross annual volume of food sales of $150,000 or more, the fee is $750.(2) A person who contracts with a school to provide food services on a for-profit basis shall obtain a permit and pay a permit fee for each school where food services are provided. Permits are issued for a two-year term. The permit fee is $250.(3) A person who operates a mobile food unit shall obtain a permit from the department for each mobile food unit operated.(A) Each mobile food unit shall be inspected and comply with §228.221 of this title (relating to Mobile Food Units) and pay a nonrefundable permit fee before a permit is issued. If a request for inspection is not received or if the mobile food unit does not meet the minimum standards contained in §228.221 of this title within two years of paying the permit fee, a new fee shall be paid.(B) Mobile food unit permits are issued for a two-year term. The permit fee is $250.(4) Each roadside food vendor shall obtain a permit and pay a fee. All fees are nonrefundable. A permit will be issued for a two-year term. The permit fee is $250.(5) For all initial and renewal applications submitted through Texas.gov, the department is authorized to collect fees in amounts determined by the Department of Information Resources to recover costs associated with using Texas.gov.(6) If the license or permit category changes during the license or permit period, the license or permit shall be renewed in the proper category at the time of the renewal.(7) An establishment required to be licensed as a food manufacturer under Texas Health and Safety Code Chapter 431, and also required to be permitted under this subchapter, will be issued only one license or permit. The license or permit fee to be paid will be the higher fee of the two applicable fees.(b) Exemptions from permit and fees.(1) Food establishments permitted and inspected by a county or public health district under Texas Health and Safety Code Chapter 437, provided inspections are based on the requirements of §229.373 of this subchapter (relating to Minimum Standards for Permitting and Operation), are exempted from obtaining a permit and paying a fee to the department.(2) The following meet the definition of "food establishment" in §229.371 of this subchapter (relating to Definitions), but are not required to pay a fee or obtain a Retail Food Establishment permit under this subchapter:(A) food establishments permitted and under the inspection authority granted to municipal health departments;(B) food establishments on federal property under federal inspection authority;(C) food establishments under the inspection authority of state college or university personnel in accordance with the requirements of §229.373 of this subchapter;(D) food establishments licensed under Texas Health and Safety Code Chapter 431, as manufacturers of food, provided the fee for licensure exceeds the permit fee required under this section;(E) food establishments under the inspection authority of the Texas Health and Human Services Commission (HHSC) Regulatory Services Division;(F) facilities under the inspection authority of the HHSC Regulatory Services Division;(G) hospitals under the inspection authority of the HHSC Regulatory Services Division and that do not serve food to the general public;(H) correctional facilities under the inspection authority of the Texas Department of Criminal Justice;(I) nonprofit organizations as defined in §229.371(3) of this subchapter; (Nonprofit organizations which meet the definition of "manufacturers of food" under Texas Health and Safety Code Chapter 431, or the definition of "food salvage establishments" under Texas Health and Safety Code Chapter 432, are not exempt from licensure in those categories.)(J) food and beverage vending machines; and(K) mobile food units permitted and inspected under the authority granted to municipalities and which operate only within their respective jurisdictions. (Except for units which handle only pre-packaged, non-TCS foods, a mobile food unit is classified as a food establishment, regardless of whether food preparation occurs on the unit.)(c) Nonprofit fee exemption. Nonprofit organizations as defined in §229.371(3) of this subchapter (relating to Definitions) are exempt from payment of the permit fee. Nonprofit organizations shall comply with the requirements of §229.373 of this subchapter. The department shall provide guidelines for the safe handling of foods prepared by nonprofit organizations. Any civic or fraternal organization, charity, lodge, association, proprietorship, corporation, or church not meeting the definition of "nonprofit organization" shall obtain a permit, pay the required fee, and comply with the requirements.(d) Application for permit. The permit application shall be on a form furnished by the department and shall contain the following information:(1) the name under which the establishment operates;(2) the mailing address and street address of the establishment;(3) if a sole proprietorship, the name of the proprietor; if a partnership, the names of all partners; if a corporation, the date and place of incorporation and the name and address of its registered agent in the State; or if any other type of association, the names of the principals of such association;(4) the names of those individuals in an actual administrative capacity which, in the case of a sole proprietorship, shall be the managing proprietor; in a partnership, the managing partner; in a corporation, the officers and directors; in any other association, those in a managerial capacity;(5) the signature of the owner, operator, or other authorized person; and(6) any other information the department may require issuing a permit.(e) Temporary food establishments. An organizer of an event at which a temporary food establishment operates shall obtain a permit for each temporary food establishment. In the absence of an event organizer, each temporary event operator shall obtain a permit. The application and permit fee for a temporary food establishment must be submitted to the department at least 30 days before the event. The permit fees are as follows.(1) Single-event permit. The permit fee is $50 and is valid for the duration of a single event not to exceed 14 consecutive days from the initial effective date specified in the permit application. The fee is non-refundable.(2) Multiple-event permit. A multiple-event permit is issued for a two-year term and the permit fee is $200. The fee is non-refundable.(f) Two or more establishments. Each establishment shall submit an application even if it is owned by the same person.(g) Pre-permit inspection. The department may conduct a pre-permit inspection to determine compliance with this subchapter.(h) Issuance of a permit. The department may issue a permit or a renewal permit for an establishment based on compliance with Chapter 228 of this title (relating to Retail Food Establishments), and payment of all fees. Copies of the permit application are available by sending a request to the department at 1100 West 49th Street, Austin, Texas 78756-3182 or by downloading online at: https://www.dshs.texas.gov/retail-food-establishments/permitting-information-retail-food-establishments.(1) The permit or proof of permit shall be posted in a location in the food establishment conspicuous to consumers.(2) Permits for mobile food units, including pushcarts and roadside food vendors, shall be displayed on the unit at all times.(3) A permit shall only be issued when all past due and delinquency fees are paid. This applies to any delinquent penalties due under an order issued by the department.(i) Renewal of a permit.(1) The permit holder shall submit a renewal application and permit fees before the expiration date of the permit. A person filing a renewal application after the expiration date shall pay an additional $100 as a delinquency fee.(2) The department may renew a permit if the applicant is compliant with Chapter 228 of this title, and all fees are paid.(3) Failure to submit a renewal application and permit fee before the expiration date, while continuing to operate, is a violation of Texas Health and Safety Code Chapter 437, and is subject to enforcement proceedings under that chapter, and §229.374 of this subchapter (relating to Refusal, Revocation, or Suspension of a Permit; Administrative Penalties).(j) Amendment of permit.(1) Fee. For a permit amendment, including a change of name or physical location of a food establishment requiring a permit under Texas Health and Safety Code §437.0125, the permit holder shall pay as follows:(A) for an establishment with gross annual volume of food sales of $0 - $49,999.99, the fee is $125;(B) for an establishment with gross annual volume of food sales of $50,000.00 - $149,999.99, the fee is $250;(C) for an establishment with gross annual volume of food sales of $150,000.00 or more, the fee is $375; or(D) for each mobile food unit, roadside vendor, school food establishment, or central preparation facility, the fee is $125.(2) Change of location. A permit is not transferrable to another location for any non-mobile food establishment except in the case of a permit amendment as described in paragraph (1) of this subsection. Source Note: The provisions of this §229.372 adopted to be effective March 19, 2000, 25 TexReg 2076; amended to be effective January 1, 2005, 29 TexReg 11982; amended to be effective February 1, 2006, 31 TexReg 501; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG U PERMITTING RETAIL FOOD ESTABLISHMENTS §229.372 Permitting Fees and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218040&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218040 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218040&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218040 03/11/2026 All food establishments shall be operated in accordance with the requirements specified in Chapter 228 of this title (relating to Retail Food Establishments). Copies may be downloaded from: https://www.dshs.texas.gov/retail-food-establishments/statutes-laws-retail-food-establishments. Source Note: The provisions of this §229.373 adopted to be effective March 19, 2000, 25 TexReg 2076; amended to be effective January 1, 2005, 29 TexReg 11982; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG U PERMITTING RETAIL FOOD ESTABLISHMENTS §229.373 Minimum Standards for Permitting and Operation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218041&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218041 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218041&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218041 03/11/2026 (a) Basis. The department may refuse an application for a permit or may revoke or suspend a permit for violations of §229.372 of this subchapter (relating to Permitting Fees and Procedures) or §229.373 of this subchapter (relating to Minimum Standards for Permitting and Operation), or for interference with a department representative in the performance of their duties under this subchapter.(b) Hearings. Any hearings for the refusal, revocation, or suspension of a permit are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures) or under the provisions of the Texas Government Code Chapter 2001, Administrative Procedure Act.(c) Reinstatement. A former permit holder may apply for reinstatement of a suspended permit by demonstrating corrections and controls are implemented to prevent future violations. The department may reinstate the permit after the department has determined the food establishment no longer poses a risk to public health and safety. The department may also require employees of a food establishment to successfully complete a department-accredited training course on food safety principles before reinstatement of the permit.(d) Administrative penalties. Administrative penalties in Texas Health and Safety Code §437.018, and in §229.261 of this chapter (relating to Assessment of Administrative Penalties), may be assessed for violations of this subchapter. Source Note: The provisions of this §229.374 adopted to be effective March 19, 2000, 25 TexReg 2076; amended to be effective January 1, 2005, 29 TexReg 11982; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG U PERMITTING RETAIL FOOD ESTABLISHMENTS §229.374 Refusal, Revocation, or Suspension of a Permit; Administrative Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118478&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118478 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118478&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118478 03/11/2026 (a) These sections provide rules for the licensing and regulation of tattoo and certain body piercing studios and temporary locations.(b) The "Tattoo and Certain Body Piercing Studio Act," Texas Health and Safety Code, Chapter 146.(c) No person may cause, suffer or allow the operation, management, or maintenance of a tattoo and certain body piercing studio and temporary location without a license issued in accordance with these sections.(d) All tattoo and certain body piercing studios and temporary locations shall comply with the minimum standards specified in these sections in addition to the existing standards contained in the Tattoo and Certain Body Piercing Studio Act and the Health and Safety Code, Chapter 431, the Texas Food, Drug, and Cosmetic Act, relating to drugs, devices, and cosmetics, including adulteration and misbranding.(e) All tattoo and certain body piercing studios and temporary locations should comply with applicable provisions of the Americans With Disabilities Act. Source Note: The provisions of this §229.401 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.401 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118479&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118479 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118479&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118479 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Tattoo and Certain Body Piercing Studio Act, Texas Health and Safety Code, Chapter 146.(2) Antiseptic--An agent that kills disease-causing microorganisms on human skin or mucosa.(3) Artist--A person who performs tattooing, permanent cosmetics, and or certain body piercing, and who is responsible for complying with the provisions of these sections.(4) Aseptic technique--A hygienic practice which prevents and hinders the direct transfer of microorganisms, regardless of pathogenicity, from one person or place to another person or place.(5) Authorized agent--An employee of the department designated by the commissioner to enforce the Act.(6) Body piercer--A person who performs body piercing and who is responsible for adherence to the provisions of these sections; hereafter referred to as artist.(7) Body piercing--The creation of an opening in an individual's body, other than in an individual's earlobe, to insert jewelry or another decoration.(8) Body piercing studio--A permanent, nondwelling building or portion of a building, designated by a license holder and located in accordance with applicable local zoning codes where body piercing is performed, completely separated from living quarters; hereafter referred to as studio.(9) Client--A person requesting the application of a tattoo or certain body piercing.(10) Commissioner--Commissioner of Health or his successor.(11) Contaminated waste--Any liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps and pathological and microbiological wastes containing blood and other potentially infectious material, as defined in 29 Code of Federal Regulations, Part 1910.1030, known as "Occupational Exposure to Bloodborne Pathogens". Copies of this provision are indexed and filed at the department, located at 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours.(12) Cosmetic--An article or substance intended to be rubbed, poured, sprinkled, or sprayed on or introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearances; or an article or substance for use as a component of such an article, except that the term does not include soap.(13) Department--The Department of State Health Services.(14) Disinfectant--An agent that kills disease-causing microorganisms on inanimate objects or surfaces.(15) Ear piercing--The creation of an opening in an individual's ear lobe with an ear piercing gun to insert jewelry or other decoration.(16) Ear piercing gun--A device that pierces an individual's ear using a single-use stud and clasp ear piercing system. An ear piercing gun shall not be used to pierce any other part of the body besides the ear.(17) Germicidal Solution--An agent that kills disease-causing microorganisms on hard surfaces; a disinfectant or sanitizer registered with the Environmental Protection Agency and/or a 1:100 dilution of 5.25% sodium hypochlorite (household chlorine bleach) and water, made fresh daily, dispensed from a spray bottle, and used to decontaminate inanimate objects and surfaces.(18) Germicidal soap--An agent designed for use on the skin that kills disease-causing microorganisms, including but not limited to, products containing povidone-iodine, chloroxylenol, triclosan, and chlorhexidine gluconate.(19) Gloves--Disposable, single use gloves labeled for surgical or examination purposes.(20) Hand washing facility--Sink equipped with hot and cold or tempered running water under pressure, used for washing hands, arms, or other portions of the body.(21) Health care practitioner--A person licensed by the state to practice medicine.(22) Instruments--Hand pieces, needles, needle bars, hemostats, forceps, pliers, and other items that may come in contact with a client's body or possible exposure to bodily fluids during the tattoo and body piercing procedures.(23) Jewelry--Any personal ornament inserted into a pierced area, which must be made of surgical implant grade stainless steel (minimum of 316L or 316LVM), solid 14k or 18k gold, niobium, titanium (minimum of 6A14V), platinum, or a dense, low porosity plastic approved by the manufacturer for use in new piercings, which is free of nicks, scratches, or irregular surfaces and has been properly sterilized prior to use.(24) License holder--A person 18 years or older who owns, operates, or maintains a tattoo studio, tattoo and body piercing studio or temporary location in compliance with these sections.(25) Managing conservator--A person, licensed child-placing agency, or authorized agency designated by a court as having the right to possession of the child, and the right to consent to medical, surgical, dental, and psychological treatment of the child.(26) Sanitize--To treat a clean surface and kill pathogenic microorganisms.(27) Sharps--Any object (sterile or contaminated) that may purposefully or accidentally cut or penetrate the skin or mucosa including, but not limited to, needles, scalpel blades, and razor blades.(28) Sharps container--A puncture-resistant, leak-proof container that can be closed for handling, storage, transportation, and disposal and that is labeled with the International Biohazard Symbol.(29) Single-use--Articles intended for one-time, one-person use and which are to be discarded after such use.(30) Sterilization area--A separate room or area separate from workstations with restricted client access in which tattoo and body piercing instruments and jewelry are cleaned, disinfected, and sterilized.(31) Tattoo/tattooing--The practice of producing an indelible mark or figure on the human body by scarring or inserting a pigment under the skin using needles, scalpels, or other related devices including permanent cosmetics. The term includes the application of permanent cosmetics.(32) Tattoo and body piercing area--The portion of the tattoo or body piercing studio used for applying tattoos or performing body piercing, including surrounding areas which are likely to come into contact with contaminated waste.(33) Tattooist--A person who performs tattooing or applies permanent cosmetics and who is responsible for adherence to the provisions of these sections; hereafter referred to as artist.(34) Tattoo Studio--A permanent, nondwelling building or portion of a building, designated by a license holder and located in accordance with applicable zoning codes where tattooing or permanent cosmetic application is performed, completely separated from living quarters; hereafter referred to as studio.(35) Temporary location--A location at which tattooing or body piercing is performed for a specified length of time of not more than seven days in conjunction with a single event.(36) Tongue splitting--Cutting of a human tongue into two or more parts.(37) Universal precautions--A method of infection control in which employees treat all blood and body fluids as to contain all bloodborne pathogens and taking proper precautions to prevent the spread of any bloodborne pathogens. Precautions include hand washing, gloving, personal protective equipment, injury prevention, and proper handling and disposal of needles, other sharp instruments, and blood and body fluid contaminated products.(38) Waterless hand sanitizers--Sanitizers, approved by the United States Food and Drug Administration, approved for use on the hands to kill microorganisms that do not require the addition of water to be effective. Source Note: The provisions of this §229.402 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.402 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118475&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118475 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118475&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118475 03/11/2026 (a) License fees. All applicants for a tattoo and body piercing studio license or a renewal license shall pay a nonrefundable license fee for each place of business operated. The license fees are as follows:(1) $450 per tattoo only studio or temporary location license for a specified length of time not to exceed seven days;(2) $600 for a tattoo and body piercing studio or temporary location license for a specified length of time not to exceed seven days, (allocated $450 for the tattoo portion; and $150 for the body piercing portion);(3) $200 per body piercing only studio or temporary license for a specified length of time not to exceed seven days;(4) $900 for a tattoo only studio for a two-year license;(5) $1,200 for a tattoo and body piercing studio, (allocated $900 for the tattoo portion; and $300 for the body piercing portion) for a two-year license; and(6) $400 per body piercing only studio for a two-year license.(b) License forms. License and renewal license forms may be obtained from the department, located at 1100 West 49th Street, Austin, Texas 78756-3182 or via the Internet at http://www.dshs.state.tx.us/license.shtm.(c) License application. An application shall be submitted for each tattoo studio and a separate application shall be submitted for each body piercing studio. The initial license application for each studio or temporary location shall be signed and verified, shall be made on the license application furnished by the department, and shall contain the following information:(1) the full or legal name under which the studio or temporary location is conducted;(2) the address of the studio or temporary location that is to be licensed. Sufficient descriptive information must be included if the studio or temporary location is located in a portion of the building with other license holders;(3) if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state; or if any other type of association, then the names of the principals of such association;(4) for each studio or temporary location, the name(s) and residence address(es) of the responsible individual(s) thereof;(5) the name(s) of the studio's or temporary location's artist(s);(6) the usual days and hours of operation of each studio or temporary location; and(7) a description of all services to be provided at the studio or temporary location.(d) Issuance and term of license.(1) The department may issue a license to the owner of a studio or temporary location who meets all the requirements of these sections, is in compliance with other applicable statutes, rules, and zoning codes, and pays all fees in compliance with this section.(2) Unless the license is amended under this section or revoked or suspended under §229.412 of this title, a license or renewal license may be issued for one or two years, as determined by the department. A license for a temporary location will be valid for the specified period of time, not to exceed seven days.(3) The license shall be displayed at all times in a prominent place in the studio or temporary location.(e) Renewal of studio licenses.(1) The license holder shall renew a license in accordance with the requirements of this section.(2) The license holder shall renew the license by filing an application for renewal on the form prescribed by the department accompanied by the required licensure fee. A licensee must file for renewal before the expiration date of the current license. A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee.(3) A license holder that fails to submit the renewal application as prescribed in this section and continues to operate the studio is subject to the enforcement provisions of the Tattoo and Certain Body Piercing Studio Act and §229.413 of this title (relating to Refusal, Revocation, or Suspension of License, Emergency Orders, and Enforcement).(A) Amendment of license. A license must be amended when the name, ownership, or location of the licensed studio is changed. Such changes require submission of the fees as outlined in subsection (a) of this section.(B) Notification of change of location of studio.(i) Not fewer than 30 days in advance of the change, the licensee shall notify the commissioner or the commissioner's designee in writing of the licensee's intent to change the location of a licensed studio. The notice shall include the address of the new location, and the name and residence address of the individual in charge of the studio at the new location.(ii) Notice will be deemed adequate if the licensee provides the intent and verification notices to the commissioner or the commissioner's designee within the established time frames of clause (i) of this subparagraph by certified mail, return receipt requested, mailed to the department, 1100 West 49th Street, Austin, Texas 78756.(iii) Not later than the tenth day after the change of location is complete, the license holder shall notify the department in writing and shall verify the information submitted under clause (i) of this subparagraph.(f) Exemption from licensure. Persons who engage only in the following are exempt from the licensing requirements of this section:(1) a studio or temporary location located within a medical facility which is licensed under other law, or an office or clinic of a person licensed by the Texas State Board of Medical Examiners;(2) a person who performs only ear piercing; or(3) a facility in which only ear piercing is performed.(g) Texas Online. Applicants may submit applications and renewal applications for a license under these sections electronically by the Internet through Texas Online at www.texasonline.state.tx.us. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.(h) A current license shall only be issued when all past due fees and late fees are paid. Source Note: The provisions of this §229.403 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.403 Licensing Fees, Procedures, and Exemptions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118476&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118476 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118476&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118476 03/11/2026 (a) A studio must be in a permanent, nondwelling building or portion of a building which must be in a location which is permissible under local zoning codes, if any. The studio shall be separated from living quarters by complete floor to ceiling partitioning and shall contain no access to living quarters.(b) The studio or temporary location shall be maintained in a sanitary condition.(1) Work surfaces shall be cleaned and sanitized with a germicide solution.(2) Other environmental surfaces shall be cleaned with an all-purpose detergent disinfectant.(c) The walls, ceilings, and floors shall be kept in good repair. The tattoo and body piercing area shall be constructed of smooth, hard, surfaces that are non-porous, free of open holes or cracks, and easily cleaned.(d) Studios or temporary locations shall have adequate lighting of at least 50 foot candles of illumination in the tattooing, body piercing, and sterilization area.(e) Adequate mechanical ventilation shall be provided in the studio.(f) Each studio or temporary location shall be equipped with hand-washing facilities for its personnel with unobstructed access to the tattoo and body piercing area such that artists can return to the area without having to touch anything with their hands. Hand-washing facilities shall be equipped with hot and cold or tempered running water under pressure; liquid germicidal soap; single-use towels or other approved hand-drying devices; and a covered refuse container. Such facilities shall be kept clean and in good repair.(g) Animals are not permitted in the studios or temporary locations, except for guide or service animals accompanying persons with disabilities, or non-mammalian animals in enclosed glass containers such as fish aquariums, which shall be outside the tattooing, body piercing, and sterilization area.(h) Use of tobacco products shall be prohibited in the tattoo, body piercing, and sterilization area. Consumption of alcoholic beverages shall be prohibited in the studio or temporary location.(i) The studio or temporary location shall be kept free of rodents and vermin and protected from infestation by insects.(j) If tattooing or body piercing is performed where other non-tattooing or non-body piercing services are provided, it shall be provided in an area that is physically separate, and with protection from other activities to avoid the transfer of disease-causing microorganisms or other irritant particles into to the artist's workstation or sterilization area. Source Note: The provisions of this §229.404 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.404 Physical Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118477&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118477 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118477&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118477 03/11/2026 (a) All artists while tattooing or body piercing shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty.(b) All artists shall wash their hands thoroughly using hot or tempered water with a liquid germicidal soap before and after tattooing or body piercing and as often as necessary to remove contaminants.(c) All artists shall wear single-use gloves while assembling tattooing and body piercing instruments and while tattooing and body piercing.(d) When a session is interrupted or immediately after gloves are torn or perforated:(1) gloves shall be removed and discarded; and(2) hands shall be washed and a fresh pair of gloves used.(e) Artists shall use universal precautions while tattooing or body piercing. An artist diagnosed with a communicable disease shall provide to the department a written statement from a health care practitioner that the artist's condition no longer poses a threat to public health.(f) The area of the client's skin to be tattooed shall be cleaned with an approved germicidal soap according to label directions.(g) The external skin of the client to be pierced shall be cleaned with an approved germicidal soap according to label directions. In the case of oral piercings, the operator shall provide the individual with antiseptic mouthwash in a single-use cup and shall ensure that the individual utilizes the mouthwash provided. In the case of a lip, labret, or cheek piercing, procedures described in this paragraph for both skin and oral piercings shall be followed.(h) If shaving is required, razors shall be single-use. The razor or razor's head must be placed in a biohazard container after use.(i) Each artist performing any tattoo or body piercing procedure in the studio or temporary location, shall have the education, training and experience, or any combination thereof, to practice aseptic technique and prevent the transmission of bloodborne pathogens. All procedures shall be performed using aseptic technique. Source Note: The provisions of this §229.405 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.405 Personnel Responsibilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118487&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118487 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118487&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118487 03/11/2026 (a) Except as permitted in subsections (d) and (e) of this section, a client must be a minimum of 18 years of age and shall present at the time of tattooing or body piercing a valid, government issued, positive identification card including, but not limited to, a driver's license, passport, or military identification. The identification must contain a photograph of the individual and a printed date of birth.(b) The artist shall verify and document in the permanent client record the client's age, date of birth, and the type of identification provided.(c) An artist may not tattoo a person younger than 18 years of age except as permitted in subsection (d) of this section.(d) With the consent of a minor's parent or guardian, who determines it to be in the best interest of the minor child to cover an existing tattoo, a person under the age of 18 may be tattooed under the following conditions:(1) The existing tattoo must contain:(A) obscene or offensive language or symbols;(B) gang-related names, symbols, or markings;(C) drug-related names, symbols, or pictures; or(D) some other type of words, symbols or markings that the parent, guardian, or a court considers would be in the best interest of the minor to cover.(2) The consent required by subsection (d) can be satisfied by the minor's parent or guardian:(A) being physically present at the time the tattooing is being performed;(B) executing an affidavit stating that the person is the parent or guardian of the individual on whom the tattooing is being performed;(C) presenting evidence of the minor's identity to the artist;(D) presenting evidence of the status as parent or guardian of the individual who will receive the tattoo to the artist;(E) supplying the studio with a written detailed description or photograph of the tattoo to be covered to be kept with the studio's permanent records; and(F) the full name, address, and telephone number of the parent or guardian.(e) An artist may not perform body piercing on a person younger than 18 years of age without the consent of a parent or guardian of the individual. The consent can be satisfied by:(1) completion of client and parental approval records that include the following information: a written and notarized consent by the individual's parent, managing conservator, or guardian which shall contain:(A) the full name, address, and telephone number of the client;(B) the full name, address, and telephone number of the parent, managing conservator, or guardian;(C) the location on the body that may be pierced; and(D) the signatures of the minor and parent, managing conservator, or guardian; and(2) the individual's parent, managing conservator, or guardian being physically present at the time the body piercing is being performed; and(A) executing an affidavit stating that the person is the parent, managing conservator, or guardian of the individual on whom the body piercing is being performed;(B) presenting evidence of the minor's identity to the artist; and;(C) presenting evidence of the status as parent, managing conservator, or guardian of the individual who will receive the body piercing to the artist.(f) No person may be tattooed or body pierced who appears to be under the influence of alcohol or drugs.(g) Tattooing and body piercing shall not be performed on any skin surface which manifests any evidence of unhealthy conditions such as rashes, boils, infections, or abrasions.(h) Before receiving a tattoo, each client (and if applicable, the parent, managing conservator, or guardian) shall be informed verbally and in writing about the possible risk and dangers associated with the application of each tattoo. These shall include, but are not limited to, at least the following: the possibility of discomfort or pain; the permanence of the markings; the risk of infection; and the possibility of allergic reaction to the pigments or other materials used.(i) Before receiving a body piercing, each client (and if applicable, the parent, managing conservator, or guardian) shall be informed verbally and in writing about the possible risks and dangers associated with receiving a body piercing. These shall include, but are not limited to, at least the following: the possibility of discomfort or pain; the possibility of scarring; the possibility of bleeding; the possibility of swelling; the risk of infection; the possibility of nerve damage; and the increased risk for adolescents during certain stages of development.(j) The studio or temporary location shall maintain proper records of each client. The information shall be permanently recorded and made available for examination by the authorized agent. Records shall be maintained at the studio for at least two years following the date of the last entry. The temporary location client records shall be maintained by the license holder. These permanent records shall include the following:(1) the name, address, and telephone number of the client;(2) the date tattooing or body piercing was performed;(3) the client's age, date of birth, and type of positive identification provided to the artist (this information is to be recorded by the artist as described in subsection (b) of this section);(4) the specific color or colors of the tattoo or type of jewelry used for the piercing and, when available, the manufacturer's catalogue or identification number of each color or type of jewelry used;(5) the location on the body where the tattoo or body piercing was performed;(6) the name of the artist;(7) a statement that the client has received a copy of applicable written care instructions, and that the client has read and understands the instructions; and(8) the signature of the client.(k) A person who is required to maintain records under this section or a person who is in charge or custody of those records shall, at the request of an authorized agent or health care authority, permit the authorized agent or the health authority at all reasonable times access to and copying of the records for verification.(l) A person younger than 18 years of age commits an offense if the person falsely states that the person is 18 years of age or older or presents any document that indicates that the person is 18 years of age or older to a person engaged in the operation of a tattoo or body piercing studio. An offense under this subsection is a Class B misdemeanor. Source Note: The provisions of this §229.406 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.406 Client Qualifications, Disclosure, and Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118480&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118480 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118480&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118480 03/11/2026 (a) A studio or temporary location is required to utilize instruments that have been prepared as described in §229.409(a)-(e) of this title (relating to Tattooing and Body Piercing Instruments and Jewelry). The studio or temporary location shall use sterilization equipment that is approved by the United States Food and Drug Administration for the purpose of sterilization, and adequate in size to accommodate necessary utensils and instruments. A copy of the manufacturer's recommended procedures for operation of the sterilization unit(s) must be available for inspection by an authorized agent at the time of inspection.(b) Each person responsible for the sterilization of instruments and jewelry shall be able to demonstrate to the department's authorized agent the correct sterilization procedures and the proper operation of autoclave and/or dry heat sterilization equipment.(c) After each use, the reusable instruments and jewelry shall be cleansed to remove blood and tissue residue before sterilization as described in §229.409(n) of this title.(d) Instruments and jewelry requiring sterilization shall be packed in packages approved for the sterilization unit. Instruments and jewelry shall be packed individually, or as a set provided such set is intended to be used for a single procedure. Each package shall be labeled with the date of sterilization and the initials of the person sterilizing the instruments. Packaged sterilized instruments shall be kept in a sterile condition and stored in a clean dust-tight container when not in use. Instruments and jewelry may be sterilized immediately before tattooing or body piercing without the use of sterilization packages as provided by the sterilization unit's manual. The studio must keep records in accordance with subsection (g) of this section.(e) Each package of instruments and jewelry sterilized shall be monitored for sterilization by the use of chemical/heat sensitive indicators.(f) Each sterilization unit used by the studio to sterilize instruments and jewelry must have a spore test performed each calendar month by an approved laboratory, and the test results be made available for inspection.(g) Each studio or temporary location shall maintain sterilization records. The information shall be permanently recorded and made available for examination by an authorized agent in the studio for at least two years from the date of the last entry. These permanent records shall be maintained at the studio and shall include the following:(1) date of sterilization;(2) quantity and type of instruments to be sterilized; and(3) name or initials of the individual sterilizing the instruments.(h) Sterilized instruments and jewelry stored in accordance with the sterilization unit owner's manual and stored in accordance with the sterilization packet manufacturer's labeling or letter provided by the manufacturer of the sterilization packets will be considered sterile for the length of time set out in the sterilization unit owner's manual or packet labeling or supporting documentation. If the studio personnel cannot provide a manual for the sterilization equipment at the time of inspection or if no length of time is set out by the sterilization unit's manual, the equipment must be stored in an approved manner and the instruments and jewelry not used within 60 days after sterilization shall no longer be considered sterile. If presterilized instruments are used, the artist shall obtain documentation from the manufacturer that describes the method of sterilization utilized by the manufacturer and the manufacturer's recommendations for storage and maintenance of sterility. This documentation shall be available for inspection by an authorized agent. The artist shall follow the manufacturer's instructions for storage and maintenance of sterility.(i) One of the following methods of sterilization shall be used.(1) Autoclave--steam under pressure:(A) 121 degrees Celsius (250 degrees Fahrenheit) and a pressure of at least 15 pounds per square inch for not less than 30 minutes after the chamber of the autoclave has reached the required temperature and pressure; or(B) as specified in the manufacturer's operator's manual.(2) Dry heat sterilization:(A) 160 degrees Celsius (320 degrees Fahrenheit) for not less than one hour under atmospheric pressure after the sterilizer has reached the required temperature; or(B) as specified in the manufacturer's operator's manual. Source Note: The provisions of this §229.407 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.407 Sterilization https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118481&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118481 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118481&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118481 03/11/2026 (a) Each time tattooing or body piercing is performed the client (and if applicable, the parent, managing conservator, or guardian) shall receive oral and written instructions on the care of the area tattooed or pierced. The client shall sign a written statement in the permanent client record acknowledging that the client has received a copy of the written care instructions, and that the client has read and understands the instructions.(b) The written care instructions for tattooing shall contain at least the following items:(1) for at least two weeks, the need to minimize exposure to the sun, and to discourage swimming;(2) the need to properly cleanse the tattooed area;(3) the need to apply antibiotic ointment or cream;(4) the need to use sterile bandage(s) or other sterile dressing(s) when necessary;(5) the name of the artist, and the name, address, and telephone number of the studio or temporary location; and(6) the instructions for the client to consult a health care practitioner at the first sign of infection or an allergic reaction, and to report any diagnosed infection, allergic reaction, or adverse reaction resulting from the application of the tattoo to the artist and to the department at 1-888-839-6676.(c) The written care instructions for body piercing shall contain at least the following items:(1) the need to properly cleanse the pierced area by using antibacterial or antimicrobial soap for the external skin or an antiseptic or salt water mouthwash for the oral cavity;(2) for at least the first six weeks, minimize exposure to filth;(3) the need to use sterile bandage(s) or other sterile dressing(s) when necessary;(4) the name of the artist, and the name, address, and telephone number of the studio or temporary location; and(5) the instructions for the client to consult a health care practitioner at the first sign of infection or an allergic reaction, and to report any diagnosed infection, allergic reaction, or adverse reaction resulting from the body piercing to the artist and to the department, at 1-888-839-6676. Source Note: The provisions of this §229.408 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.408 Care of the New Tattoo and/or Body Piercing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118482&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118482 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118482&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118482 03/11/2026 (a) Instruments and jewelry used during tattooing and piercing procedures which may contact blood or other bodily fluids, or which come in direct contact with skin which is not intact shall be sterilized after each use or disposed of. These devices include, but are not limited to, bars, tubes, forceps, receiving tubes, and tapers. This does not include ear piercing guns or tattoo machines/devices.(b) Instruments and jewelry used during tattooing and body piercing which do not come in contact with broken skin but may come in contact with mucous membranes and oral tissue should be sterilized after each use. If, however, sterilization is not feasible because the instrument or jewelry will be damaged, the instrument or jewelry shall be treated with a germicidal solution prior to use. These devices include, but are not limited to, calipers and gauge wheels.(c) Instruments that come into contact only with intact skin shall be treated with a germicidal solution prior to use. These devices include, but are not limited to, hand mirrors.(d) Reusable instruments shall be constructed in a manner that permits easy cleaning and sterilization.(e) Needles and razors or razors' heads used to perform body piercing and tattooing shall be single-use and disposed of in a sharps container.(f) Single-use disposable instruments shall be maintained in clean condition and dispensed in a manner to prevent contamination to the unused instruments. These devices include, but are not limited to, cups, cotton swabs, corks, rubber bands, and toothpicks.(g) Use of styptic pens or alum solids to control blood flow is prohibited.(h) All dyes or pigments used in tattooing and piercing shall be non-toxic, free from adulteration, and made from materials generally regarded as safe. Marking instruments shall be single-use or sanitized by design, such as alcohol based ink pens, and shall be used only on intact skin that has been treated with a germicidal soap. Any marking instrument that comes in contact with mucous membranes or broken skin shall be single-use.(i) Only single-use pigment or dye containers shall be used for each client. Pigments and dyes shall be dispensed from containers in a manner to prevent contamination to the unused portion. Individual containers of dye or pigment shall be discarded after use.(j) In order to minimize transmission of body fluids and disease, single-use plastic covers shall be used to cover spray bottles or other reusable accessories for multiple client use that are handled by the artist during tattooing and body piercing.(k) All stencils shall be single-use. Petroleum jellies, soaps, and other products used in the application of stencils shall be dispensed and applied using aseptic technique and in a manner to prevent contamination of the original container and its contents. The applicator shall be single-use.(l) Contaminated reusable instruments shall be placed in a labeled covered container which may contain a disinfectant solution such as 2.0% alkaline glutaraldehyde (not to be construed as all inclusive) until it can be cleaned and sterilized.(m) All containers holding contaminated instruments and container lids shall be emptied of contaminated solution and cleaned and sanitized daily or more often if needed.(n) Reusable instruments shall be cleaned by gloved personnel prior to sterilization by one of the following methods:(1) mechanically pre-clean the items by using a clean cotton ball or swab moistened with a solution of low-residue detergent and cool water, with care taken to ensure the removal of any pigment or body substances not visible to the eye, thoroughly rinse with warm water and then drain, and clean by soaking in a protein dissolving detergent-enzyme cleaner used according to manufacturer's instructions; or(2) clean the items in an ultrasonic cleaning unit used according to manufacturer's instruction. A copy of the manufacturers recommended procedures for operation of the ultrasonic cleaning unit must be available for inspection by an authorized agent; and(3) rinse and dry the items prior to packaging for sterilization. Source Note: The provisions of this §229.409 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.409 Tattooing and Body Piercing Instruments and Jewelry https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118483&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118483 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118483&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118483 03/11/2026 (a) The studio shall provide a written report of any infection or allergic reaction resulting from a body piercing or the application of a tattoo to the department within five working days of its occurrence or knowledge thereof. The report shall include:(1) the name of the affected client;(2) the name and address of the studio or temporary location where the tattoo or body piercing was performed;(3) the complete legal name of the artist;(4) the date the tattoo or piercing was performed;(5) the specific color or colors of the tattoo or type of jewelry used for the piercing and, when available, the manufacturer's catalogue or identification number of each color or type of jewelry used;(6) the location of the infection and the location on the body where the tattoo or piercing was applied;(7) the name and address of the health care practitioner, if any; and(8) any other information considered relevant to the situation.(b) The department shall use these reports in their efforts to identify the source of the adverse reaction(s) and to take action to prevent its recurrence. Source Note: The provisions of this §229.410 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.410 Report of Infection or Allergic Reactions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118484&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118484 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118484&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118484 03/11/2026 (a) Sharps shall be subjected to the methods of treatment and disposal as described in Chapter 1, Subchapter K, §1.136 of this title (relating to Approved Methods of Treatment and Disposition) and Title 30, Texas Administrative Code, Chapter 330, Subchapter Y.(b) Other studio waste generated during the tattooing and body piercing process, i.e., cotton balls, cotton tip applicators, corks, toothpicks, tissues, paper towels, gloves, single use plastic covering, and pigment containers (not to be construed as all-inclusive) shall be disposed of in accordance with Chapter 1, Subchapter K, §1.136(a)(2) of this title or Title 30, Texas Administrative Code, Chapter 330. Copies of these provisions are indexed and filed in the office of the department, located at 1100 West 49th Street, Austin, Texas 78756, 1-888-839-6676, and are available weekdays for inspection between the hours of 8:00 a.m. and 5:00 p.m. Source Note: The provisions of this §229.411 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.411 Disposal of Infectious Waste https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118485&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118485 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118485&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118485 03/11/2026 (a) Basis. The department may, after providing notice and opportunity for hearing, refuse to license a studio or temporary location, or may revoke or suspend the license for violations of the requirements in these sections or for any reasons described in the Tattoo and Certain Body Piercing Studio Act, or in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(b) Hearing. All hearings for the refusal, revocation or suspension of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(c) Enforcement and penalties.(1) Administrative penalty. The department may, after providing notice and opportunity for hearing, assess an administrative penalty as provided in §146.019 of the Tattoo and Certain Body Piercing Studio Act, the Health and Safety Code, Chapter 431, and §229.261 of this title (relating to Assessment of Administrative), for violations of these sections. All hearings for the assessment of an administrative penalty are governed by the State Office of Administrative Hearings.(2) Civil penalty; Injunction. If it appears that a person has violated or is violating Health and Safety Code, Chapter 146, or an order issued or a rule adopted under Health and Safety Code, Chapter 146, the commissioner may request the attorney general or the district attorney, county attorney, or municipal attorney in the jurisdiction where the violation is alleged to have occurred, is occurring, or may occur to institute a civil suit for:(A) an order enjoining the violation;(B) a permanent or temporary injunction, a temporary restraining order, or other appropriate remedy, if the department shows that the person has engaged in or is engaging in a violation;(C) the assessment and recovery of a civil penalty; or(D) both injunctive relief and a civil penalty.(3) Criminal penalty. A person commits an offense if the person violates the Act or rules adopted under the Act. An offense under the Act or rules is a Class A misdemeanor except as indicated in §229.406(l) of this title (relating to Client Qualifications, Disclosure, and Records).(4) Re-issuance of a license. If a license issued under these sections has been revoked or denied for violation of these rules, the license holder named in the revocation or denial is not eligible for licensing under these sections for a period of two years.(5) Revocation or Suspension of License.(A) License holder includes sole proprietors, each member of a partnership or association and, with respect to a corporation, each officer and the owner or owners of a majority of the corporate stock.(B) The department may suspend for not more than 60 days or revoke an original or renewal tattoo studio or body piercing studio license if it is found, after notice and hearing, that any of the following is true:(i) the license holder has been convicted of violating this chapter or a rule adopted under this chapter;(ii) the license holder violated a provision of this chapter or a rule adopted or order issued under this chapter;(iii) the license holder made a false or misleading statement in connection with the original or renewal application, either in the formal application itself or in any other written instrument relating to the application submitted to the department;(iv) the license holder is indebted to the state for fees or payment of penalties imposed by this chapter or by a rule of the department adopted under this chapter;(v) the license holder knowingly misrepresented to a customer or the public any tattoo or body piercing jewelry sold by the license holder; or(vi) the license holder was intoxicated on the licensed premises.(C) The department may refuse to renew or, after notice and hearing, suspend for not more than 60 days or revoke a tattoo studio or body piercing studio license if the department finds that the license holder is shown on the records of the comptroller as being subject to a final determination of taxes due and payable under Chapter 151, Tax Code, or is shown on the records of the comptroller as being subject to a final determination of taxes due and payable under Chapter 321, Tax Code.(D) If a license holder cannot be located for any notice required under this section, the department shall provide notice by posting a copy of the order on the front door of the licensed premises.(6) Refusal of License. The department may refuse to issue an original or renewal tattoo studio or body piercing studio license if it has reasonable grounds to believe and finds that any of the following circumstances exist:(A) the applicant has been convicted of a violation of this chapter during the two years immediately preceding the filing of the application;(B) three years have not elapsed since the termination, by pardon or otherwise, of a sentence imposed on the applicant for a conviction associated with tattooing or body piercing;(C) the applicant violated or caused to be violated a provision of this chapter or a rule of the department adopted under this chapter involving moral turpitude during the six months immediately preceding the filing of the application;(D) the applicant failed to answer or falsely or incorrectly answered a question in an original or renewal application;(E) the applicant is indebted to the state for a fee or penalty imposed by this chapter or by rule of the department adopted under this chapter;(F) the applicant is a minor; or(G) the applicant does not provide an adequate building available at the address for which the license is sought before conducting any activity authorized by the license.(7) The department may refuse to issue or renew, for a period of one year from the date of application for the initial or renewal license, a tattoo studio or body piercing studio license for a premises where a shooting, stabbing, or other violent act or an offense involving drugs occurred that involved a license applicant, license holder, or registrant under this chapter or a patron or employee of the studio.(d) Emergency Orders. The commissioner may, with or without notice or hearing, issue an emergency order relating to regulation under this chapter of a tattooist or body piercer, or to the operation of a tattoo studio or body piercing studio, if the commissioner finds that:(1) the operation of the tattoo studio or body piercing studio or the performance of tattooing or body piercing by the tattooist or body piercer presents an immediate and serious threat to human health; or(2) a shooting, stabbing, or other violent act or an offense involving drugs:(A) occurred at the tattoo studio or body piercing studio; or(B) involved the tattooist or body piercer; or(3) other procedures available to the department to remedy or prevent the threat will result in an unreasonable delay.(e) If the commissioner issues an emergency order under this section without a hearing, the department shall set a hearing under Chapter 2001, Government Code, to affirm, modify, or set aside the emergency order.(f) If the license or registration holder cannot be located for a notice required under this section, the department shall provide notice by posting a copy of the order on the front door of the premises of the license holder or the premises where the registration holder is employed. Source Note: The provisions of this §229.412 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.412 Enforcement, Administrative Penalties, Refusal, Revocation, or Suspension of License, and Emergency Orders https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118486&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118486 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118486&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118486 03/11/2026 A person may not perform tongue splitting in a tattoo or body piercing studio, or at a temporary location. Source Note: The provisions of this §229.413 adopted to be effective January 1, 2005, 29 TexReg 11982. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG V MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS §229.413 Tongue Splitting https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220603&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220603 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220603&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220603 03/11/2026 This subchapter provides the minimum licensing requirements necessary to ensure the safety and efficacy of prescription drugs offered for sale by wholesale distributors. Source Note: The provisions of this §229.419 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.419 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220604 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220604 03/11/2026 (a) The department adopts by reference the following laws and regulations:(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §301 et seq., as amended;(2) 9 Code of Federal Regulations (CFR) Part 113, Standard Requirements, as amended;(3) 21 CFR Part 70, Color Additives, as amended;(4) 21 CFR Part 71, Color Additive Petitions, as amended;(5) 21 CFR Part 73, Listing of Color Additives Exempt From Certification, as amended;(6) 21 CFR Part 74, Listing of Color Additives Subject to Certification, as amended;(7) 21 CFR Part 80, Color Additive Certification, as amended;(8) 21 CFR Part 81, General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;(9) 21 CFR Part 82, Listing of Certified Provisionally Listed Colors and Specifications, as amended;(10) 21 CFR Part 200, General, as amended;(11) 21 CFR Part 201, Labeling, as amended;(12) 21 CFR Part 202, Prescription Drug Advertising, as amended;(13) 21 CFR Part 203, Prescription Drug Marketing, as amended;(14) 21 CFR Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors, as amended;(15) 21 CFR Part 206, Imprinting of Solid Oral Dosage Form Drug Products for Human Use, as amended;(16) 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code, as amended;(17) 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;(18) 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, as amended;(19) 21 CFR Part 212, Current Good Manufacturing Practice for Positron Emission Tomography Drugs, as amended;(20) 21 CFR Part 216, Human Drug Compounding, as amended;(21) 21 CFR Part 225, Current Good Manufacturing Practice for Medicated Feeds, as amended;(22) 21 CFR Part 226, Current Good Manufacturing Practice for Type A Medicated Articles, as amended;(23) 21 CFR Part 250, Special Requirements For Specific Human Drugs, as amended;(24) 21 CFR Part 251, §804, Importation Program, as amended;(25) 21 CFR Part 290, Controlled Drugs, as amended;(26) 21 CFR Part 299, Drugs; Official Names and Established Names, as amended;(27) 21 CFR Part 300, General, as amended;(28) 21 CFR Part 310, New Drugs, as amended;(29) 21 CFR Part 312, Investigational New Drug Application, as amended;(30) 21 CFR Part 314, Applications for FDA Approval to Market a New Drug, as amended;(31) 21 CFR Part 315, Diagnostic Radiopharmaceuticals, as amended;(32) 21 CFR Part 316, Orphan Drugs, as amended;(33) 21 CFR Part 320, Bioavailability and Bioequivalence Requirements, as amended;(34) 21 CFR Part 361, Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research, as amended;(35) 21 CFR Part 500, General, as amended;(36) 21 CFR Part 510, New Animal Drugs, as amended;(37) 21 CFR Part 511, New Animal Drugs for Investigational Use, as amended;(38) 21 CFR Part 514, New Animal Drug Applications, as amended;(39) 21 CFR Part 515, Medicated Feed Mill License, as amended;(40) 21 CFR Part 516, New Animal Drugs for Minor Use and Minor Species, as amended;(41) 21 CFR Part 520, Oral Dosage Form New Animal Drugs, as amended;(42) 21 CFR Part 522, Implantation or Injectable Dosage Form New Animal Drugs, as amended;(43) 21 CFR Part 524, Ophthalmic and Topical Dosage Form New Animal Drugs, as amended;(44) 21 CFR Part 526, Intramammary Dosage Form New Animal Drugs, as amended;(45) 21 CFR Part 528, New Animal Drugs in Genetically Engineered Animals, as amended;(46) 21 CFR Part 529, Certain Other Dosage Form New Animal Drugs, as amended;(47) 21 CFR Part 530, Extralabel Drug Use in Animals, as amended;(48) 21 CFR Part 556, Tolerances for Residues of New Animal Drugs in Food, as amended;(49) 21 CFR Part 558, New Animal Drugs for Use in Animal Feeds, as amended;(50) 21 CFR Part 589, Substances Prohibited From Use in Animal Food or Feed, as amended;(51) 21 CFR Part 600, Biological Products: General, as amended;(52) 21 CFR Part 601, Licensing, as amended;(53) 21 CFR Part 610, General Biological Products Standards, as amended;(54) 21 CFR Part 660, Additional Standards for Diagnostic Substances for Laboratory Tests, as amended;(55) 21 CFR Part 680, Additional Standards for Miscellaneous Products, as amended;(56) 21 CFR Part 700, General, as amended;(57) 21 CFR Part 701, Cosmetic Labeling, as amended;(58) 21 CFR Part 740, Cosmetic Product Warning Statements, as amended;(59) 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products, as amended;(60) 21 CFR Part 1300, Definitions, as amended;(61) 21 CFR Part 1301, Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances, as amended;(62) 21 CFR Part 1302, Labeling and Packaging Requirements For Controlled Substances, as amended;(63) 21 CFR Part 1304, Records and Reports of Registrants, as amended;(64) 21 CFR Part 1305, Orders for Schedule I and Schedule II Controlled Substances, as amended;(65) 21 CFR Part 1306, Prescriptions, as amended;(66) 21 CFR Part 1307, Miscellaneous; and(67) 21 CFR Part 1317, Disposal, as amended.(b) Copies of these laws and regulations are indexed and filed at the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at www.dshs.texas.gov.(c) Nothing in this subchapter relieves any person of the responsibility for complying with other applicable Texas and federal laws and regulations. Source Note: The provisions of this §229.420 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.420 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220605&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220605 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220605&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220605 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431.(2) Adulterated drug--Has the meaning specified in the Act.(3) Authorized agent--An employee of the department who is designated by the commissioner to enforce the provisions of the Act.(4) Broker--A person engaged in the offering or contracting for wholesale distribution; sale or transfer of a prescription drug into, within, or out of Texas; and, who does not take title to or physical possession of the prescription drug.(5) Change of ownership--A sole proprietor who transfers all or part of the facility's ownership to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a facility owned by a partnership; a corporate sale, transfer, reorganization, or merger of the corporation which owns the facility if sale, transfer, reorganization, or merger causes a change in the facility's ownership to another person or persons; or if any other type of association, the removal, addition, or substitution of a person or persons as a principal of such association.(6) Co-licensed product partner--One of two or more parties having the right to engage in the manufacturing or marketing of a prescription drug consistent with the United States Food and Drug Administration's (FDA) regulations and guidance implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293).(7) Commissioner--Commissioner of the Texas Department of State Health Services.(8) Component--Any ingredient intended for use in the manufacture of a drug product, including those that might not appear in such drug product.(9) Department--The Texas Department of State Health Services.(10) Device--An instrument apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or other animals; or(C) intended to affect the structure or any function of the body of humans or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.(11) Drop shipment--The sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug, or by the manufacturer's co-licensed product partner, third-party logistics provider, or exclusive distributor, in which:(A) the wholesale distributor takes title but not physical possession of the prescription drug;(B) the wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer the drug to a patient; and(C) the pharmacy, pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer or the manufacturer's third-party logistics provider or exclusive distributor.(12) Drug--Articles recognized in the official United States Pharmacopoeia National Formulary, or any supplement to it; articles designated or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; articles, other than food, intended to affect the structure or any function of the body of humans or other animals; and articles intended for use as a component of any such article. The term does not include devices or their components, parts, or accessories. A food for which a claim is made in accordance with the Federal Food, Drug, and Cosmetic Act, §403(r) and 21 United States Code (USC) §301, et seq., and for which the claim is approved by the FDA, is not a drug solely because the label or labeling contains such a claim.(13) Emergency medical reasons--Includes transfers of a prescription drug between a wholesale distributor or pharmacy to alleviate a temporary shortage of a prescription drug arising from delays in or interruption of regular distribution schedules; sales to nearby emergency medical services, i.e., ambulance companies and firefighting organizations in the same state or same marketing or service area, or nearby licensed practitioners of drugs for use in the treatment of acutely ill or injured persons; provision of minimal emergency supplies of drugs to nearby nursing homes for use in emergencies or during hours of the day when necessary drugs cannot be obtained; and transfers of prescription drugs by a retail pharmacy to alleviate a temporary shortage.(14) Federal Act--Federal Food, Drug, and Cosmetic Act, 21 USC, §301, et seq., as amended.(15) Flea market--A location at which booths or similar spaces are rented or otherwise made available temporarily to two or more persons and at which the persons offer tangible personal property for sale.(16) Inactive ingredient--Any component, other than an active ingredient, including excipient, flavor, fragrance, and color.(17) Labeling--All labels and other written, printed, or graphic matter:(A) upon any drug or any of its containers or wrappers; or(B) accompanying such drug.(18) Manufacturer--A person who manufactures, prepares, propagates, compounds, processes, packages, or repackages prescription drugs, or a person who changes the container, wrapper, or labeling of any prescription drug package. A person licensed or approved by the FDA to engage in the manufacture of drugs or devices, consistent with the federal agency's definition of manufacturer under the agency's regulations and guidance implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293). The term does not include a pharmacist engaged in compounding done within the practice of pharmacy and pursuant to a prescription drug order or initiative from a practitioner for a patient or prepackaging done in accordance with Texas Occupations Code §562.154.(19) Manufacturer's exclusive distributor--A person who holds a wholesale distributor license under this subchapter, who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, and who takes title to, but does not have general responsibility to direct the sale or disposition of, the manufacturer's prescription drug. A manufacturer's exclusive distributor must be an authorized distributor of record to be considered part of the normal distribution channel.(20) Misbranded drug--Has the meaning specified in the Act at §431.112.(21) Nonprescription drug--Any drug that is not a prescription drug, including the terms Over-the-Counter Drug and Non-legend Drug.(22) Normal distribution channel--A chain of custody for a prescription drug, either directly or by drop shipment, from the manufacturer of the prescription drug, the manufacturer to the manufacturer's co-licensed product partner, the manufacturer to the manufacturer's third-party logistics provider, or the manufacturer to the manufacturer's exclusive distributor, to:(A) a pharmacy to:(i) a patient; or(ii) another designated person authorized by law to dispense or administer the drug to a patient;(B) an authorized distributor of record to:(i) a pharmacy to a patient; or(ii) another designated person authorized by law to dispense or administer the drug to a patient;(C) an authorized distributor of record to a wholesale distributor licensed under this subchapter to another designated person authorized by law to administer the drug to a patient;(D) an authorized distributor of record to a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy;(E) a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy or another designated person authorized by law to dispense or administer the drug to a patient;(F) a person authorized by law to prescribe a prescription drug that by law may be administered only under the supervision of the prescriber; or(G) an authorized distributor of record to one other authorized distributor of record to a licensed practitioner for office use.(23) Person--An individual, corporation, business trust, estate, trust, partnership, association, or any other public or private legal entity.(24) Pharmacy warehouse--A location for which a person holds a wholesale drug distribution license under this subchapter, serving as a central warehouse for drugs or devices, and from which intracompany sales or transfers of drugs or devices are made to a group of pharmacies under common ownership and control.(25) Prescription drug--Any drug (including any biological product, except for blood and blood components intended for transfusion or biological products that are also medical devices) required by federal law (including federal regulation) to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to the Federal Act, §503(b).(26) Repackage--Repackaging or otherwise changing the container, wrapper, or labeling of a drug to further the distribution of a prescription drug. The term does not include repackaging by a pharmacist to dispense a drug to a patient or prepackaging in accordance with Texas Occupations Code §562.154.(27) Repackager--A person who engages in repackaging.(28) Third-party logistics provider--A person who holds a wholesale distributor license under this subchapter, who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, and who does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition. A third-party logistics provider must be an authorized distributor of record to be considered part of the normal distribution channel.(29) Verification--A person who is engaged in the wholesale distribution of a prescription drug, and who is in possession of a pedigree for a prescription drug must , before distributing the prescription drug, authenticate and certify, in accordance with the Act at Texas Food, Drug, and Cosmetic Act, Health and Safety Code §431.412 and §431.413, and §229.429(f)(3)(G) of this subchapter (relating to Minimum Standards of Licensure), each transaction listed on the pedigree has occurred.(30) Wholesale distribution--Distribution of prescription drugs to a person other than a consumer or patient. The term does not include:(A) intracompany sales of prescription drugs, which means transactions or transfers of prescription drugs between a division, subsidiary, parent, or affiliated or related company under common ownership and control or any transaction or transfer between co-license holders of a co-licensed product;(B) the sale, purchase, trade, or transfer of prescription drugs or the offer to sell, purchase, trade, or transfer a prescription drug for emergency medical reasons including a transfer of a prescription drug by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;(C) the distribution of prescription drug samples by a representative of a manufacturer;(D) the return of drugs by a hospital, health care entity, or charitable institution in accordance with 21 Code of Federal Regulations (CFR) §203.23;(E) the sale of reasonable quantities by a retail pharmacy of a prescription drug to a licensed practitioner for office use;(F) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug under a prescription;(G) the sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets;(H) the delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the prescription drug;(I) the sale or transfer from a retail pharmacy or pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original manufacturer or to a third-party returns processor in accordance with the procedures set out in 21 CFR §203.23(a)(1) - (5) for other returns;(J) the purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of such organizations;(K) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in the Internal Revenue Code of 1986, 26 USC §501(c)(3), to a nonprofit affiliate of the organization to the extent otherwise permitted by law;(L) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities under common control; for purposes of this subchapter, common control means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise; or(M) the sale, purchase, or trade of blood and blood components intended for transfusion.(31) Wholesale distributor--A person engaged in the wholesale distribution of prescription drugs, including a manufacturer, repackager, own-label distributor, private-label distributor, jobber, broker, manufacturer warehouse, distributor warehouse, or other warehouse, manufacturer's exclusive distributor, authorized distributor of record, drug wholesaler or distributor, independent wholesale drug trader, specialty wholesale distributor, third-party logistics provider, retail pharmacy that conducts wholesale distribution, and pharmacy warehouse that conducts wholesale distribution. Source Note: The provisions of this §229.421 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.421 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220606&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220606 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220606&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220606 03/11/2026 Any reference in this subchapter to the sale of a prescription drug must be considered to include the manufacture, packaging, exposure, offer, possession, and holding of any prescription drug for sale; the sale, dispensing, and providing of any prescription drug; and supplying or applying of any prescription drug in the operation of any prescription drug place of business. Source Note: The provisions of this §229.422 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.422 Sale of a Prescription Drug https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220607&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220607 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220607&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220607 03/11/2026 (a) General. A person who engages in the wholesale distribution of prescription drugs in this state for use in humans is exempt from this subchapter if the person is exempt under:(1) the Prescription Drug Marketing Act of 1987 (PDMA Act), (21 United States Code (USC) §353(c)(3)(B));(2) the regulations adopted by the secretary to administer and enforce the PDMA Act;(3) the interpretations of the PDMA Act set forth in the compliance policy manual of the United States Food and Drug Administration; or(4) the Texas Occupations Code §562.154.(b) Exemptions from licensing. Persons who engage in the following types of distribution of prescription drugs are exempt from the licensing requirements of this subchapter, to the extent it does not violate provisions of the Texas Controlled Substances Act, Texas Health and Safety Code Chapter 481, or the Texas Dangerous Drug Act, Texas Health and Safety Code Chapter 483:(1) intracompany sales of prescription drugs, which means transactions or transfers of prescription drugs between a division, subsidiary, parent, or affiliated or related company under common ownership and control, or any transaction or transfer between co-license holders of a co-licensed product;(2) the sale, purchase, trade, or transfer of prescription drugs or the offer to sell, purchase, trade, or transfer a prescription drug for emergency medical reasons; including a transfer of a prescription drug by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;(3) the distribution of prescription drug samples by a representative of a manufacturer;(4) the return of drugs by a hospital, health care entity, or charitable institution in accordance with Title 21, Code of Federal Regulations (CFR) §203.23;(5) the sale of reasonable quantities by a retail pharmacy of a prescription drug to a licensed practitioner for office use;(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug under a prescription;(7) the sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets;(8) the delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the prescription drug;(9) the sale or transfer from a retail pharmacy or pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original manufacturer or to a third-party returns processor in accordance with procedures set out in 21 CFR §203.23(a)(1) - (5) for returns;(10) the purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of such organizations;(11) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in the Internal Revenue Code of 1986, 26 USC §501(c)(3), to a nonprofit affiliate of the organization to the extent otherwise permitted by law;(12) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities that are under common control; for purposes of this subchapter, common control means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise; or(13) the sale, purchase, or trade of blood and blood components intended for transfusion.(c) Applicability of other requirements. An exemption from the licensing requirements granted in subsection (b) of this section does not constitute an exemption from other applicable requirements for prescription drugs under this subchapter or under the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(d) Exemption from certain requirements for certain wholesale distributors.(1) A wholesale distributor that distributes only prescription drugs that are medical gases is exempt from the following requirements: §229.424(d) of this subchapter (relating to Licensure Requirements), §229.425(b)(4) - (5), (c) and (d) of this subchapter (relating to Licensing Procedures); and §229.424(n) and §229.425(h) of this subchapter concerning bonds.(2) A wholesale distributor that is a manufacturer or a third-party logistics provider on behalf of a manufacturer is exempt from the following requirements: §229.424(d) of this title; §229.425(b)(4) - (5), (c) and (d) of this subchapter; and §229.424(n) and §229.425(h) of this subchapter concerning bonds.(3) A state agency or a political subdivision of this state that distributes prescription drugs using federal or state funding to nonprofit health care facilities or local intellectual and developmental disability authorities, referred to as local mental health or mental retardation authorities, for distribution to a pharmacy, practitioner, or patient is exempt from §229.424(d) and (n) and §229.425(d) and (h) of this subchapter concerning bonds, and §229.429(f) of this subchapter (relating to Minimum Standards of Licensure) concerning pedigree.(4) The executive commissioner of the Texas Health and Human Services Commission by rule may exempt specific purchases of prescription drugs by state agencies and political subdivisions of this state if the executive commissioner determines the requirements of this subchapter would result in a substantial cost to the state or a political subdivision of the state. Source Note: The provisions of this §229.423 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.423 Exemptions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220608&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220608 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220608&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220608 03/11/2026 (a) General. Except as provided in §229.423 of this subchapter (relating to Exemptions), a person may not engage in the wholesale distribution of prescription drugs in Texas, as defined in §229.421(30) - (31) of this subchapter (relating to Definitions), unless the person has a valid license from the commissioner of the department for each place of business.(b) Out-of-state place of business.(1) Except as provided by §229.423 of this subchapter, a person who engages in the wholesale distribution of prescription drugs from outside this state may only engage in the wholesale distribution of prescription drugs in this state if the person holds a license as required in subsection (a) of this section.(2) The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 and this subchapter.(3) The department may issue a license to a person who engages in the wholesale distribution of prescription drugs outside this state to engage in the wholesale distribution of prescription drugs in this state if, after an examination of the reports of the person's compliance history and current compliance record, the department determines the person is in compliance with the Act and this subchapter.(4) The department considers each license application and any related documents or reports filed by or in connection with a person who wishes to engage in the wholesale distribution of prescription drugs in this state on an individual basis.(c) Combination product. If the United States Food and Drug Administration determines, with respect to a product that is a combination of a prescription drug and a device, the primary mode of action of the product is as a prescription drug, a wholesale distributor of such a product is subject to licensure as described in this section.(d) Applicant qualifications. To qualify for the issuance or renewal of a wholesale distributor license under this subchapter, the designated representative of an applicant or license holder must:(1) be at least 21 years of age;(2) have been employed full-time for at least three years by a pharmacy or a wholesale distributor in a capacity related to the dispensing or distributing of prescription drugs, including recordkeeping for the dispensing or distributing of prescription drugs;(3) be employed by the applicant full-time in a managerial-level position;(4) be actively involved in and aware of the actual daily operation of the wholesale distributor;(5) be physically present at the applicant's place of business during regular business hours, except when the absence of the designated representative is authorized, including sick leave and vacation leave;(6) serve as a designated representative for only one applicant at any one time, except in a circumstance, as the department determines reasonable, in which more than one licensed wholesale distributor is co-located in the same place of business at the same address and the wholesale distributors are members of an affiliated group, as defined by the Internal Revenue Code of 1986, 26 USC §1504;(7) not have been convicted of a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or the distribution of controlled substances; and(8) not have been convicted of a felony under a federal, state, or local law.(e) Proof of licensure. The license holder must show proof of licensure in a format readily available to the public and at each place of business.(f) New place of business. Each person acquiring or establishing a place of business for the purpose of wholesale distribution of prescription drugs must apply to the department for a license of such business before beginning operation.(g) Two or more places of business. If the wholesale distributor of prescription drugs operates more than one place of business, the wholesale distributor of prescription drugs must license each place of business separately.(h) Pre-licensing inspection. The applicant must cooperate with any pre-licensing inspection by the department of the applicant's place of business.(i) Issuance of license. In accordance with §229.281 of this chapter (relating to Processing License/Permit Applications Relating to Food and Drug Operations), the department may license a wholesale distributor of prescription drugs who meets the requirements of this subchapter and pays all license fees under §229.427 of this subchapter (relating to Licensure Fees).(j) Transfer of license. Licenses are not transferable from one person to another or from one place of business to another.(k) License term. Unless the license is amended as provided in subsection (l) of this section or suspended or revoked as provided in §229.428 of this subchapter (relating to Refusal, Cancellation, Suspension, or Revocation of License), the license is valid for two years.(l) Amendment of license. A license that is amended, including a change of name, or a notification of a change in the location of a licensed place of business will require submission of an application as outlined in §229.425 of this subchapter (relating to Licensing Procedures) and submission of fees as outlined in §229.427 of this subchapter.(m) Renewal of license.(1) The license application as outlined in §229.425 of this subchapter and nonrefundable licensing fees as outlined in §229.427 of this subchapter for each place of business must be submitted to the department not later than the 30th day after the date the wholesale distributor receives a renewal notification form from the department. A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee.(2) A license holder who fails to submit a renewal application before the current licensure expiration date and continues operations may be subject to the enforcement and penalty provisions in §229.430 of this subchapter (relating to Enforcement and Penalties), and the refusal, cancellation, suspension, and revocation provisions in §229.428 of this subchapter.(3) A renewal license is only issued when all past due license fees and delinquency fees are paid.(n) Bond.(1) A wholesale distributor applying for or renewing a license must submit, payable to this state, a bond or other equivalent security acceptable to the department, including an irrevocable letter of credit or a deposit in a trust account or financial institution, in the amount of $100,000.(2) The bond or equivalent security submitted under paragraph (1) of this subsection must secure payment of any fines or penalties imposed by the department or imposed in connection with an enforcement action by the attorney general, any fees or other enforcement costs, including attorney's fees payable to the attorney general, and any other fees and costs incurred by this state related to that license holder, authorized under the laws of this state and not paid by the license holder before the 30th day after the date a fine, penalty, fee, or cost is assessed.(3) The department or this state may make a claim against a bond or security submitted under paragraph (1) of this subsection before the first anniversary of the date a license expires or is revoked under this subchapter.(4) The department must deposit the bonds and equivalent securities received under this section in a separate account.(5) A pharmacy warehouse not engaged in wholesale distribution is exempt from the bond requirement under paragraph (1) of this subsection.(6) A single bond is sufficient to cover all places of business operated by a wholesale distributor in this state. Source Note: The provisions of this §229.424 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.424 Licensure Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220609&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220609 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220609&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220609 03/11/2026 (a) License application forms. License application forms may be obtained from the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756, or online at www.dshs.texas.gov.(b) Contents of license application. The application for licensure as a wholesale distributor of prescription drugs must be signed and verified, submitted on a license application form furnished by the department, and contain the following information:(1) the name, full business address, and telephone number of the applicant;(2) all trade or business names under which the business is conducted;(3) the address, telephone number, and name of a contact person for each of the applicant's places of business;(4) the type of business entity:(A) if a person, the name of the person;(B) if the business is a sole proprietorship, the name of the proprietor;(C) if the business is a partnership, the name of the partnership and each of the partners; or(D) if the business is a corporation, the name of the corporation, the place of incorporation, and the name and title of each corporate office and director;(5) the name, date of birth, residence address, telephone number, and any information necessary to complete a criminal history record check on a designated representative of each place of business;(6) a list of all licenses and permits issued to the applicant by any other state under which the applicant is permitted to purchase or possess prescription drugs;(7) the name of the manager, if different from the designated representative, for each place of business;(8) a list of categories which must be marked and adhered to in the determination and paying of the fee; and(9) a statement verified by the applicant's signature acknowledging the applicant read, understood, and agrees to abide by the provisions of this subchapter and those of the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431.(c) Designated representatives.(1) For each person who is a designated representative of each place of business, the applicant must provide the following to the department:(A) the person's places of residence for the past seven years;(B) the person's date and place of birth;(C) the person's occupations, positions of employment, and offices held during the past seven years;(D) the business name and address of any business, corporation, or other organization in which the person held an office under subsection (b)(4) of this section or in which the person conducted an occupation or held a position of employment;(E) a statement of whether, during the preceding seven years, the person was the subject of a proceeding to revoke a license or a criminal proceeding and the nature and disposition of the proceeding;(F) a statement of whether, during the preceding seven years, the person has been enjoined, either temporarily or permanently, by a court from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, including the details concerning the event;(G) a written description of any involvement by the person as an officer or director with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past seven years, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which the businesses were named as a party;(H) a description of any misdemeanor or felony offense for which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere;(I) a description of any criminal conviction of the person under appeal, a copy of the notice of appeal for that criminal offense, and a copy of the final written order of an appeal not later than the 15th day after the date of the appeal's disposition; and(J) a photograph of the person taken not earlier than 180 days before the date the application was submitted.(2) The information submitted under paragraph (1) of this subsection must be attested to under oath.(d) Criminal history. The department will obtain an applicant's criminal history record information and may forward the fingerprints to the Federal Bureau of Investigation for a federal criminal history check.(e) Renewal license application. The renewal application for licensure as a wholesale distributor of prescription drugs must be made on a license application form furnished by the department. Not later than the 30th day after the date the wholesale distributor receives the form, the wholesale distributor must identify and state under oath to the department any change in or correction to the information.(f) Replacement license. In the event a current and valid license is lost, stolen, or destroyed, the license holder must request a replacement license from the department by submitting an application and non-refundable fee as outlined in §229.427 of this subchapter (relating to Licensing Fees). A replacement license is only issued if the lost, stolen, or destroyed license was current and valid at the time of the request, and no changes in business name, location, or ownership have occurred.(g) Texas.gov. Applicants may submit initial and renewal license applications under this subchapter electronically through texas.gov. The department is authorized to collect fees, in amounts determined by §229.427(a) of this subchapter to recover costs associated with application and renewal application processing through texas.gov.(h) Bond. Applicants will submit a bond in a manner prescribed by the department. Source Note: The provisions of this §229.425 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.425 Licensing Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220610&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220610 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220610&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220610 03/11/2026 (a) Change in the content of a license application. The license holder must notify the department in writing within 10 days of any change which would render the information contained in the application for the license, reported pursuant to §229.425 of this subchapter (relating to Licensing Procedures), no longer accurate. Failure to inform the department no later than 10 days of a change in the information required in the application for a license may result in an enforcement action, including suspension or revocation of the license.(b) Change in location of place of business. The license holder must notify the department at least 30 days in advance of an intended change of address of the licensed place of business. The notice must include the address of the new location and the name of the individual in charge of the business at the new location. Within 10 days of beginning operations at the new location, the license holder must notify the department in writing to confirm the move, and provide verification or correction of the information provided on the notice of intent. The notice and confirmation required by this subchapter will be deemed adequate if the license holder submits the notices by certified mail, return receipt requested, to the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756, or electronically through texas.gov. Source Note: The provisions of this §229.426 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.426 Report of Changes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220611&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220611 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220611&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220611 03/11/2026 (a) License fee. Except as provided by §229.423 of this subchapter (relating to Exemptions), no person may operate or conduct business as a wholesale distributor of prescription drugs without first obtaining a license from the department. All applicants for an initial wholesale distributor of prescription drugs license or a renewal license must pay a licensing fee unless otherwise exempt as provided by subsection (c) of this section. All fees are nonrefundable. Licenses are issued for two-year terms. A license shall only be issued when all past due license fees and delinquency fees are paid.(1) In-state and out-of-state wholesale distributors of prescription drugs who are not manufacturers must pay a two-year license fee based on the gross annual sales of all drugs.(A) For a wholesale distributor of only medical gases, the fees are:(i) $675 for a two-year license;(ii) $675 for a two-year license issued to a change of ownership; and(iii) $337 for a license amended during the current licensure period due to minor changes.(B) For a wholesale distributor with gross annual drug sales of $0 - $199,999.99, the fees are:(i) $1,080 for a two-year license;(ii) $1,080 for a two-year license issued due to a change of ownership; and(iii) $540 for a license amended during the current licensure period due to minor changes.(C) For a wholesale distributor with gross annual drug sales of $200,000 - $19,999,999.99, the fees are:(i) $1,755 for a two-year license;(ii) $1,755 for a two-year license issued due to a change of ownership; and(iii) $877 for a license amended during the current licensure period due to minor changes.(D) For a wholesale distributor with gross annual drug sales greater than or equal to $20 million, the fees are:(i) $2,295 for a two-year license;(ii) $2,295 for a two-year license issued due to a change of ownership; and(iii) $1,147 for a license amended during the current licensure period due to minor changes.(2) In-state and out-of-state wholesale distributors of medical gases who are not manufacturers and who also are required to be licensed as a device distributor under §229.439(a) of this chapter (relating to Licensure Fees) or as a wholesale food distributor under §229.182(a)(3) of this chapter (relating to Licensing/Registration Fee and Procedures) must pay a combined two-year license fee for each place of business. License fees are based on the combined gross annual sales of these regulated products (medical gases, foods, drugs, and devices) as follows:(A) For combined gross annual sales of $0 - $199,999.99, the fees are:(i) $540 for a two-year license;(ii) $540 for a two-year license issued due to a change of ownership; and(iii) $270 for a license amended during the current licensure period due to minor changes.(B) For combined gross annual sales of $200,000 - $499,999.99, the fees are:(i) $810 for a two-year license;(ii) $810 for a two-year license issued due to a change of ownership; and(iii) $405 for a license amended during the current licensure period due to minor changes.(C) For combined gross annual sales of $500,000 - $999,999.99, the fees are:(i) $1,080 for a two-year license;(ii) $1,080 for a two-year license issued due to a change of ownership; and(iii) $540 for a license amended during the current licensure period due to minor changes.(D) For combined gross annual sales of $1 million - $9,999,999.99, the fees are:(i) $1,350 for a two-year license;(ii) $1,350 for a two-year license issued due to a change of ownership; and(iii) $675 for a license issued during the current licensure period due to minor changes.(E) For combined gross annual sales greater than or equal to $10 million, the fees are:(i) $2,025 for a two-year license;(ii) $2,025 for a two-year license issued due to a change of ownership; and(iii) $1,012 for a license amended during the current licensure period due to minor changes.(3) In-state and out-of-state manufacturers of only medical gases must pay a two-year license fee based on the gross annual sales of all prescription drugs as follows.(A) For gross annual drug sales of $0 - $199,999.99, the fees are:(i) $1,080 for a two-year license;(ii) $1,080 for a two-year license issued due to a change of ownership; and(iii) $540 for a license amended during the current licensure period due to minor changes.(B) For gross annual drug sales of $200,000 - $19,999,999.99, the fees are:(i) $1,755 for a two-year license;(ii) $1,755 for a two-year license issued due to a change of ownership; and(iii) $877 for a license amended during the current licensure period due to minor changes.(C) For gross annual drug sales greater than or equal to $20 million, the fees are:(i) $2,295 for a two-year license;(ii) $2,295 for a two-year license issued due to a change of ownership; and(iii) $1,147 for a license amended during the current licensure period due to minor changes.(4) In-state and out-of-state manufacturers of prescription drugs must pay a two-year license fee based on the gross annual sales of all drugs as follows.(A) For gross annual drug sales of $0 - $199,999.99, the fees are:(i) $1,080 for a two-year license;(ii) $1,080 for a two-year license issued due to a change of ownership; and(iii) $540 for a license amended during the current licensure period due to minor changes.(B) For gross annual drug sales of $200,000 - $1,999,999.99, the fees are:(i) $1,350 for a two-year license;(ii) $1,350 for a two-year license issued due to a change of ownership; and(iii) $697 for a license amended during the current licensure period due to minor changes.(C) For gross annual drug sales of $2 million - $9,999,999.99, the fees are:(i) $1,620 for a two-year license;(ii) $1,620 for a two-year license issued due to a change of ownership; and(iii) $847 for a license amended during the current licensure period due to minor changes.(D) For gross annual drug sales of $10 million to $19,999,999.99, the fees are:(i) $1,890 for a two-year license;(ii) $1,890 for a two-year license issued due to a change of ownership; and(iii) $997 for a license amended during the current licensure period due to minor changes.(E) For gross annual drug sales greater than or equal to $20 million, the fees are:(i) $2,295 for a two-year license;(ii) $2,295 for a two-year license issued due to a change of ownership; and(iii) $1,147 for a license amended during the current licensure period due to minor changes.(b) Replacement license fee. The replacement license fee is $100.(c) Proration of license fees. A person having more than one place of business may request a one-time proration of the license fees when applying for a license for each new place of business. Upon approval by the department, the license for the new place of business will have a renewal date the same as the firm's other licensed places of business.(d) Exemption from license fees. A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 26 USC §501(c)(3), or a nonprofit affiliate of the organization, to the extent otherwise permitted by law. Source Note: The provisions of this §229.427 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective November 14, 2019, 44 TexReg 6897; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.427 Licensure Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220612&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220612 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220612&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220612 03/11/2026 (a) The commissioner may refuse an application for a wholesale distributor of prescription drugs license or may suspend or revoke such a license if the applicant or license holder:(1) has been convicted of a felony or misdemeanor involving moral turpitude;(2) is an association, partnership, or corporation and the managing officer or any officer or director of a corporation has been convicted of a felony or misdemeanor involving moral turpitude;(3) is an association, partnership, or corporation and the managing officer or any officer or director of a corporation has been convicted of a felony or misdemeanor involving the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;(4) has violated any of the provisions of the Texas, Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431 (Act) or this subchapter;(5) has violated the Texas Health and Safety Code §431.021(l)(3), (jj), and (kk), concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;(6) has violated the Texas Controlled Substances Act, Texas Health and Safety Code Chapter 481, or the Texas Dangerous Drug Act, Texas Health and Safety Code Chapter 483;(7) has violated the rules of the director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or license holder to maintain;(8) fails to complete a license application or submits an application containing false, misleading, or incorrect information or containing information not verifiable by the department;(9) has furnished false or fraudulent information in any application made in connection with drug manufacturing or distribution;(10) has failed to pay a license fee or a renewal fee for a license; or(11) has obtained or attempted to obtain a license by fraud or deception.(b) The department may, after providing opportunity for hearing, refuse to license a wholesale distributor of prescription drugs, or may suspend or revoke a license for violations of the requirements in this subchapter or for any of the reasons described in the Act.(c) Any hearings for the refusal, suspension, or revocation of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(d) If the department suspends a license, the suspension remains in effect until the department determines the reason for the suspension no longer exists. If the suspension overlaps a renewal date, the suspended license holder must comply with the renewal procedures in §229.425 of this subchapter (relating to Licensing Procedures); however, the department may choose not to renew the license until the department determines the reason for suspension no longer exists.(e) If the department revokes or does not renew a license, a person may reapply for a license by complying with the requirements and procedures in §229.425 of this subchapter at the time of reapplication. The department may refuse to issue a license if the reason for revocation or non-renewal continues to exist.(f) A license issued under this subchapter must be returned to the department if the person's place of business:(1) ceases business or otherwise ceases operation on a permanent basis;(2) relocates; or(3) changes name or ownership. For a corporation, an ownership change is deemed to have occurred, resulting in the necessity to return the license to the department, when 5.0 percent or more of the share of stock of a corporation is transferred from one person to another.(g) The commissioner may suspend or revoke a license if the license holder no longer meets the qualification for obtaining a license under Texas Health and Safety Code §431.405. Source Note: The provisions of this §229.428 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.428 Refusal, Cancellation, Suspension or Revocation of License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220613&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220613 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220613&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220613 03/11/2026 (a) General requirements.(1) All persons engaged in the wholesale distribution of prescription drugs must comply with the applicable minimum standards in this section, in addition to the statutory requirements contained in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code Chapter 431 (Act) and the requirements in §229.420 of this subchapter (relating to Applicable Laws and Regulations).(2) For the purpose of this section, the policies described in the United States Food and Drug Administration (FDA) Compliance Policy Guides as they apply to prescription drugs are the policies of the department.(3) Prescription drug wholesalers must not purchase or receive drugs in this state other than from drug distributors licensed by the department.(b) Federal establishment registration and drug listing. All persons who operate as prescription drug manufacturers in Texas must meet the requirements in 21 Code of Federal Regulations (CFR) Part 207, titled Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code. New prescription drugs offered for sale by wholesale distributors must meet, if applicable, the requirements of 21 CFR Part 314, Applications for FDA Approval to Market a New Drug.(c) Good manufacturing practices. Manufacturers of prescription drug products must comply with the applicable requirements in:(1) 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General;(2) 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals;(3) 21 CFR Part 225, Current Good Manufacturing Practice for Medicated Feeds;(4) 21 CFR Part 226, Current Good Manufacturing Practice for Type A Medicated Articles; and(5) the regulations in this subsection governing the methods used in, and the facilities or controls used for, the manufacture, processing, packing, or holding of a drug to ensure each drug meets the requirements of the Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §301, et seq., as amended, (Federal Act) as to safety, and has the identity and strength and meets the quality and purity characteristics it purports or is represented to possess.(d) Buildings and facilities.(1) All manufacturing, processing, packing, or holding of drugs by prescription drug manufacturers must take place in buildings and facilities described in subsection (c) of this section.(2) Manufacturing, processing, packing, or holding of prescription drugs must not be conducted in any personal residence.(3) Sale of prescription drugs must not be conducted in any flea market.(4) Any place of business used by a wholesale distributor of prescription drugs who is not a manufacturer to store, warehouse, hold, offer, transport, or display drugs must:(A) comply with §229.420(a)(14) of this subchapter;(B) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;(C) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;(D) be maintained in a clean and orderly condition;(E) be free from infestation by insects, rodents, birds, or vermin of any kind; and(F) have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded, or adulterated.(e) Storage of prescription drugs. All prescription drugs stored by wholesale distributors must be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs.(f) Minimum restrictions on transactions.(1) Returns.(A) A wholesale distributor must receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse in accordance with the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse. An expired, damaged, recalled, or otherwise nonsalable prescription drug returned to the wholesale distributor may be distributed by the wholesale distributor only to either the original manufacturer or a third party returns processor. The returns or exchanges, salable or otherwise, received by the wholesale distributor as provided by this subsection, including any redistribution of returns or exchanges by the wholesale distributor, are not subject to the pedigree requirement under Texas Health and Safety Code §431.412, if the returns or exchanges are exempt from pedigree under:(i) §503, Prescription Drug Marketing Act of 1987 (21 USC §353(c)(3)(B));(ii) the regulations adopted by the Secretary of the U.S. Department of Health and Human Services to administer and enforce the Act in clause (i) of this subsection; or(iii) the interpretations of the Act in clause (i) of this subsection, set out in the compliance policy guide of the FDA.(B) Each wholesale distributor and pharmacy must administer the process of drug returns and exchanges to ensure the process is secure and does not permit the entry of adulterated or counterfeit drugs into the distribution channel.(C) Notwithstanding any provision of state or federal law to the contrary, a person not otherwise required to obtain a wholesale license under this subchapter and that is a pharmacy engaging in the sale or transfer of expired, damaged, returned, or recalled prescription drugs to the originating wholesale distributor or manufacturer and pursuant to federal statute, rules, and regulations, including the FDA applicable guidance implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293), is exempt from wholesale licensure requirements under this subchapter.(D) All other returns must comply with the requirements of 21 CFR §203.23(a)(1) - (5).(2) Distributions. A manufacturer or wholesale distributor may distribute prescription drugs only to a person licensed under this subchapter, or the appropriate state licensing authorities, if an out-of-state wholesaler or retailer, or to a person authorized by federal law to receive the drug. Before furnishing prescription drugs to a person not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor must verify the person is legally authorized by the department or the appropriate state licensing authority to receive the prescription drugs or is authorized by federal law to receive the drugs. Wholesale distributors physically located and conducting operations in another state must verify, before purchasing or receiving product, the suppliers of drugs are licensed under this subchapter and physically located in Texas; and must notify the department of unlicensed wholesale distributors.(3) Pedigree.(A) A person, who is engaged in the wholesale distribution of a prescription drug, including a repackager but excluding the original manufacturer, must provide a pedigree for each prescription drug for human consumption that leaves or at any time left the normal distribution channel and is sold, traded, or transferred to any other person.(B) A retail pharmacy or pharmacy warehouse is required to comply with this section only if the pharmacy or warehouse engages in the wholesale distribution of a prescription drug.(C) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager, but excluding the original manufacturer of the finished form of a prescription drug, and who is in possession of a pedigree for a prescription drug must verify before distributing the prescription drug that each transaction listed on the pedigree has occurred.(D) A pedigree must include all necessary identifying information concerning each sale in the product's chain of distribution from the manufacturer, through acquisition and sale by a wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug. At a minimum, the chain of distribution information must include:(i) the name, address, telephone number, and, if available, the e-mail address of each person who owns the prescription drug and each wholesale distributor of the prescription drug;(ii) the name and address of each location from which the product was shipped, if different from the owner's name and address;(iii) the transaction dates; and(iv) certification that each recipient has authenticated the pedigree.(E) The pedigree must include, at a minimum, the:(i) name of the prescription drug;(ii) dosage form and strength of the prescription drug;(iii) size of the container;(iv) number of containers;(v) lot number of the prescription drug; and(vi) name of the manufacturer of the finished dosage form.(F) Each pedigree statement must be:(i) maintained by the purchaser and the wholesale distributor for at least three years; and(ii) available for inspection and duplication not later than the second business day after the date a request is submitted by the department or a peace officer in this state.(G) Verification procedures.(i) Each transaction listed on the pedigree must be affirmatively authenticated before any wholesale distribution of a prescription drug.(ii) A person who is engaged in the wholesale distribution of a prescription drug, and who is in possession of a pedigree for a prescription drug must certify, using the following methods, each transaction listed on the pedigree has occurred.(I) Invoice confirmation. Receipt of an invoice (or shipping document) from the seller to the purchaser, which may have the prices redacted. Documentation requirements include, at a minimum, a copy of the invoice or shipping document. If this method is used to authenticate a pedigree, the wholesaler must review the document received for signs of tampering, incompleteness, or inconsistency with other invoices or shipping documents from that manufacturer or wholesaler, and must randomly verify the authenticity of the invoice or shipping document with the seller or shipping point reflected on that document using one of the methods in the subsections below. Each wholesaler must establish policies and procedures for the random verification of the authenticity of the invoices or shipping documents according to statistically sound standards. Each wholesaler must establish policies and procedures for verification with those wholesalers in the distribution chain with which the wholesaler performing the authentication does not have an established prescription drug vendor relationship.(II) Telephonic confirmation. Documentation requirements include a signed statement by the person placing the telephone call identifying the person's name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and the quantity of prescription drugs involved in the transaction.(III) Electronic mail confirmation. Documentation requirements include a copy of the e-mail identifying the person's name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and quantity of prescription drugs involved in the transaction.(IV) Electronic web-based confirmation. Verification of the transaction per a web-based system established by the seller or an independent person secure from intentional or unintentional tampering or manipulation to conceal an accurate and complete history of the prescription drug transactions. Documentation requirements include a written representation from the seller or independent person that the seller or independent person, as applicable, is responsible for the information included on the website and has adequate security on the information posted to prevent unauthorized tampering, manipulation, or modification of the information and a copy of the dated website page confirming the sales transaction between the parties, including the date of the transaction and quantity of prescription drugs involved in the transaction.(V) Notarized copy confirmation. Receipt of a legible and unaltered copy of a previous transaction's pedigree paper signed under oath at the time of the previous transaction to support the transaction to which the pedigree paper relates. If this method is used to authenticate a pedigree, the wholesaler must review the document received for signs of tampering, incompleteness, or inconsistency, and must randomly verify the authenticity of pedigrees using one of the methods in this subparagraph. Each wholesaler must establish policies and procedures for the random verification of the authenticity of these copies of pedigree according to statistically sound standards.(VI) Exclusive purchasing. A wholesale distributor may use a written agreement between the wholesale distributor and an authorized distributor of record requiring all prescription drugs distributed to the wholesale distributor by the authorized distributor of record, be purchased by the authorized distributor of record from the manufacturer. If this method is used to authenticate a pedigree, the wholesale distributor must establish policies and procedures for the random verification of the authenticity of the pedigrees that disclose the authorized distributor of record purchased the prescription drug from the manufacturer according to statistically sound standards.(VII) Other methods. Any other method approved by the department.(4) Premises. Prescription drugs distributed by a manufacturer or wholesale distributor may be delivered only to the premises listed on the license, except as listed in paragraph (5) of this subsection. A manufacturer or wholesale distributor may distribute prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if:(A) the identity and authorization of the recipient is properly established; and(B) delivery is made only to meet the immediate needs of a particular patient of the authorized person.(5) Delivery to hospital pharmacies. Prescription drugs may be distributed to a hospital pharmacy receiving area if a pharmacist or an authorized receiving person signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the receipt and the type and quantity of the prescription drug actually received must be reported to the delivering manufacturer or wholesale distributor not later than the next business day after the date of delivery to the pharmacy receiving area.(g) Prescription drug labeling. Prescription drugs sold by wholesale distributors must meet the labeling requirements of the Act and those adopted in §229.420(a) of this subchapter.(h) Prescription drugs that are combination products. Any prescription drug that is a combination product as described in §229.424(c) of this subchapter (relating to Licensure Requirements) is also subject to the applicable requirements in Subchapter X of this chapter (relating to Licensing of Device Distributors and Manufacturers).(i) Prescription drugs that are also cosmetics. Any prescription drug that is also a cosmetic or component thereof is also subject to the applicable requirements of Subchapter D of this chapter (relating to Regulation of Cosmetics).(j) Nonprescription drugs. Nonprescription drugs offered for sale by wholesale distributors of prescription drugs must comply with the applicable requirements of Subchapter O of this chapter (relating to Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices). Source Note: The provisions of this §229.429 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.429 Minimum Standards for Licensure https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220614&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220614 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220614&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220614 03/11/2026 (a) Inspection.(1) To enforce this subchapter or the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431 (Act), the commissioner, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:(A) enter at reasonable times a place of business, including a factory or warehouse, in which a prescription drug is manufactured, packed, or held for introduction into commerce or held after the introduction;(B) enter a vehicle being used to transport or hold a prescription drug in commerce; or(C) inspect at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of this subchapter or the Act.(2) The inspection of a place of business, including a factory, warehouse, or consulting laboratory, in which a prescription drug is manufactured, processed, packed, or held for introduction into commerce extends to any place or thing, including a record, file, paper, process, control, or facility, to determine whether the drug:(A) is adulterated or misbranded;(B) may not be manufactured, introduced into commerce, sold, or offered for sale under the Act; or(C) is otherwise in violation of this subchapter or the Act.(3) An inspection under paragraph (2) of this subsection does not extend to:(A) financial data;(B) sales data other than shipment data;(C) pricing data;(D) personnel data other than data relating to the qualifications of technical and professional personnel performing functions under the Act;(E) research data other than data:(i) relating to new drugs and antibiotic drugs; and(ii) subject to reporting and inspection under regulations issued under §505(i) or (j) of the Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §301, et seq., as amended, (Federal Act); or(F) data relating to other drugs, in the case of a new drug, subject to reporting or inspection under regulations issued under §505(j) of the Federal Act.(4) An inspection under paragraph (2) of this subsection must be started and completed with reasonable promptness.(b) Receipt for samples. An authorized agent or health authority who inspects a place of business, including a factory or warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, must give the owner, operator, or the owner's or operator's agent a receipt describing the sample.(c) Access to records.(1) A person required to maintain records referenced in this subchapter or under the Act or Chapter V of the Federal Act or a person in charge or custody of those records must, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times, access to and to copy and verify the records.(2) A person, including a carrier engaged in commerce, or other person receiving a prescription drug in commerce or holding a prescription drug received in commerce must, at the request of an authorized agent, permit the authorized agent at all reasonable times to have access to and to copy and verify all records showing:(A) the movement in commerce of any prescription drug;(B) the holding of any prescription drug after movement in commerce; and(C) the quantity, shipper, and consignee of any prescription drug.(d) Retention of records. Records required by this subchapter must be maintained at the place of business or other location reasonably accessible for a period of at least three years following disposition of the prescription drug unless a greater period of time is required by §229.420 of this subchapter (relating to Applicable Laws and Regulations).(e) Adulterated or misbranded prescription drug. If the department identifies an adulterated or misbranded prescription drug, the department may impose the applicable enforcement provisions of Subchapter C of the Act including detention, emergency order, recall, and administrative penalties. The department may request the attorney general or local law enforcement institute an action for criminal penalties, collection of civil penalties, condemnation, destruction, and injunction under the Act.(f) Order to cease distribution.(1) The commissioner must issue an order requiring a person, including a manufacturer, distributor, or retailer of a prescription drug, to immediately cease distribution of the drug if the commissioner determines there is a reasonable probability:(A) a wholesale distributor has:(i) violated this subchapter or the Act; or(ii) sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use that could cause serious adverse health consequences or death; and(B) other procedures would result in unreasonable delay.(2) An order under this subsection must provide the person subject to the order an opportunity for an informal hearing on the actions required by the order to be held not later than the 10th day after issuance of the order.(3) If, after providing an opportunity for a hearing, the commissioner determines inadequate grounds exist to support the actions required by the order, the commissioner must vacate the order. Source Note: The provisions of this §229.430 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755; amended to be effective September 18, 2024, 49 TexReg 7327. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG W LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES §229.430 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118429&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118429 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118429&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118429 03/11/2026 These sections provide for the minimum licensing standards necessary to ensure the safety and efficacy of devices distributed by device distributors and manufacturers. Source Note: The provisions of this §229.431 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective January 1, 2005, 29 TexReg 11983. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.431 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227288&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227288 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227288&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227288 03/11/2026 (a) The department adopts by reference the following laws and regulations:(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code, et seq., as amended;(2) 21 Code of Federal Regulations (CFR) Part 801, Labeling, as amended;(3) 21 CFR Part 803, Medical Device Reporting, as amended; (4) 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, as amended;(5) 21 CFR Part 814, Premarket Approval of Medical Devices, as amended;(6) 21 CFR Part 820, Quality Management System Regulation, as amended; and(7) 21 CFR Subchapter J--Radiological Health, as amended.(b) Copies of these laws and regulations are indexed and filed at the department, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at https://www.dshs.texas.gov.(c) Nothing in these sections relieves any person of the responsibility for compliance with other applicable Texas and federal laws and regulations. Source Note: The provisions of this §229.432 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective December 13, 1998, 23 TexReg 12353; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.432 Applicable Laws and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227289&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227289 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227289&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227289 03/11/2026 The following words and terms, when used in these sections, have the following meanings, unless the context clearly indicates otherwise.(1) Act--The Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code (HSC) Chapter 431.(2) Adulterated Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, HSC §431.111.(3) Advertising--All representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.(4) Authorized agent--An employee of the department who is designated by the commissioner to enforce the provisions of this chapter.(5) Commissioner--The commissioner of the Department of State Health Services, or the commissioner's successor or designee.(6) Counterfeit device--A device which, or the container, packaging or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.(7) Department--The Department of State Health Services.(8) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes. The term "device" does not include software functions excluded by the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360j.(9) Distributor--A person who furthers the marketing of a finished domestic or imported device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user. The term includes an importer or an own-label distributor. The term does not include a person who repackages a finished device or who otherwise changes the container, wrapper, or labeling of the finished device or the finished device package.(10) Electronic product radiation--Any ionizing or nonionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.(11) Finished device--A device, or any accessory to a device, that is suitable for use, whether or not packaged or labeled for commercial distribution.(12) Health authority--A physician designated to administer state and local laws relating to public health.(13) Importer--Any person who initially distributes a device imported into the United States.(14) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles.(15) Labeling--All labels and other written, printed, or graphic matter:(A) upon any article or any of its containers or wrappers; or(B) accompanying such article.(16) Manufacture--The making by chemical, physical, biological, or other procedures of any article that meets the definition of device. The term includes the following activities:(A) repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;(B) initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications; or (C) sterilization, including contract sterilization services of a device for another establishment's devices.(17) Manufacturer--A person who manufactures, fabricates, assembles, or processes a finished device. The term includes a person who repackages or relabels a finished device. The term does not include a person who only distributes a finished device.(18) Misbranded Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, HSC §431.112.(19) Person--Includes individual, partnership, corporation, and association.(20) Place of business--Each location at which a device is manufactured or held for distribution.(21) Practitioner--As defined in HSC §483.001(12).(22) Prescription device--A restricted device that, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which adequate directions for use cannot be prepared.(23) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.(24) Radioactive material--Any material (solid, liquid, or gas) that emits radiation spontaneously.(25) Reconditioning--Any appropriate process or procedure by which distressed merchandise can be brought into compliance with departmental standards as specified in the Texas Food, Drug, Device, and Cosmetic Salvage Act, HSC §432.003, as defined in the rules in §229.603 of this chapter (relating to Definitions).(26) Restricted device--A device subject to certain controls related to sale, distribution, or use as specified in the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360j. Source Note: The provisions of this §229.433 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective December 13, 1998, 23 TexReg 12353; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.433 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227290&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227290 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227290&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227290 03/11/2026 (a) A person is exempt from licensing under §229.435 of this subchapter (relating to Licensure Requirements) if the person engages only in the following types of device distribution:(1) intracompany sales;(2) distribution from a place of business located outside the State of Texas; or(3) the sale, purchase, or trade of a distressed or reconditioned device by a salvage broker or a salvage operator licensed under §229.605 of this chapter (relating to Licensing Requirements and Procedures).(b) A person is exempt from licensing under §229.435 of this subchapter if the person holds a registration certificate issued under Texas Occupations Code Chapter 266 and engages only in conduct within the scope of that registration.(c) A person is exempt from licensing under §229.435 of this subchapter if the person is exempted from licensing under Texas Occupations Code §605.2515 and engages only in conduct within the scope of that exemption.(d) This section does not exempt a person from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, HSC Chapter 431; the Texas Dangerous Drug Act, HSC Chapter 483; or the rules adopted to administer and enforce those chapters. Source Note: The provisions of this §229.434 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective November 23, 2014, 39 TexReg 9018; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.434 Exemptions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227291&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227291 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227291&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227291 03/11/2026 (a) General. A person may not distribute or manufacture devices in Texas unless the person has a valid license from the commissioner for each place of business, unless exempted by §229.434 of this subchapter (relating to Exemptions).(b) Proof of licensure. The license holder must show proof of licensure in a format readily available to the public.(c) Existing place of business. Each person distributing or manufacturing devices in Texas on the effective date of these sections must apply for a device distributor or manufacturer license no later than 60 days following the effective date.(d) New place of business. Each person who acquires or establishes a place of business to distribute or manufacture devices must apply to the department for a license before beginning operations.(e) Two or more places of business. If the device distributor or manufacturer operates more than one place of business, the device distributor or manufacturer must license each place of business separately. (f) Issuance of license. Under §229.281 of this chapter (relating to Processing License/Permit Applications Relating to Food and Drug Operations), the department may issue a license to a device distributor or manufacturer who meets all applicable requirements and pays all fees as required by §229.439 of this subchapter (relating to Licensure Fees).(g) Transfer of license. A person may not transfer a license to another person or to a different place of business.(h) License term. A license remains valid for two years unless it is amended under subsection (j) of this section or revoked or suspended under §229.440 of this subchapter (relating to Refusal, Cancellation, Suspension, or Revocation of License.(i) Renewal of license.(1) A person must submit the license application outlined in §229.436(b) of this subchapter (relating to Licensing Procedures) and must pay the nonrefundable license fee for each place of business as outlined in §229.439 of this subchapter before the current license expires. A person who submits a renewal application after the expiration date must pay a $100 delinquency fee.(2) A licensee who fails to submit a renewal application before the license expiration date and continues to operate may be subject to enforcement and penalties under §229.443 of this subchapter (relating to Enforcement and Penalties) and to revocation or suspension of the license under §229.440 of this subchapter.(3) The department must issue a renewal license only after receiving all past due fees.(j) Amendment of license. To amend a license, including a name change, or a change in the location of a licensed business, a person must submit an application as outlined in §229.436 of this subchapter and pay the applicable fees as outlined in §229.439 of this subchapter.(k) Notification of change of location of place of business.(1) At least 30 days before changing the location of place of business, the licensee must notify the commissioner or the commissioner's designee in writing of their intent to change locations of place of business. The notice must include address of new business location; name of person in charge of business at new location; and residence address of person in charge of business at new location.(2) Within 10 days of completing the move, the licensee must notify the commissioner or the commissioner's designee by submitting an application to verify: change of location; specific date of move; new location; new location's address; name of person in charge of new business location; and residence address of person in charge of new business location.(3) If the licensee provides the intent and application to the commissioner or commissioner's designee by certified mail (with return receipt requested), the notice will be deemed adequate. The intent and verification notice should be mailed to the department at 1100 West 49th Street, Austin, Texas 78756.(l) Combination products. If the United States Food and Drug Administration determines that a combination product's primary mode of action is that of a device, a distributor or manufacturer of the product is subject to licensure as described in this section.(m) Texas.gov. Applicants may submit initial and renewal license applications electronically at www.texas.gov. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs of processing applications and renewals through the website. Source Note: The provisions of this §229.435 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.435 Licensure Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227292&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227292 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227292&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227292 03/11/2026 (a) License application forms. Applicants may obtain application forms online at www.texas.gov or from the department at 1100 West 49th Street, Austin, Texas, 78756.(b) Contents of license application. The applicant must complete and submit a license application form provided by the department. The application must be signed, verified, and include:(1) the name of the legal entity being licensed, including the name under which the business operates;(2) the address of each licensed place of business;(3) the ownership details:(A) if a proprietorship, the name and residence address of the proprietor;(B) if a partnership, the names and residence addresses of all partners;(C) if a corporation, the date and place of incorporation and name and address of its registered agent in the state and corporation charter number; or(D) if any other type of association, then the names of the principals of such association;(4) the individual details, including the name, residence address, and valid driver license number for each individual in an administrative role:(A) for proprietorships, the managing proprietor;(B) for partnerships, the managing partner;(C) for corporations, the officers and directors; or(D) for any other type of association, those in a managerial capacity;(5) the residence address of the individual in charge at each place of business;(6) selection of categories for calculation and payment of fee; and(7) a signature of verification by the applicant that acknowledges the applicant has read, understood, and agrees to abide by the provisions of these sections and those of the Texas Food, Drug, and Cosmetic Act, HSC Chapter 431.(c) Renewal license application. The renewal application for licensure as a device distributor or manufacturer must be made on a license application form furnished by the department. Source Note: The provisions of this §229.436 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.436 Licensing Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227293&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227293 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227293&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227293 03/11/2026 The license holder must notify the department in writing within 10 days of any change that would render the information contained in the application for the license, as outlined in §229.436 of this subchapter (relating to Licensing Procedures), no longer accurate. Failure to notify the department within 10 days may result in administrative penalties. Source Note: The provisions of this §229.437 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.437 Report of Changes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227294&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227294 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227294&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227294 03/11/2026 (a) License fee.(1) A person must obtain a license from the department before operating or conducting business as a device distributor. All applicants for a device distributor license or a renewal license must pay a non-refundable licensing fee. The department issues licenses for two-year terms and will only issue a license when all past due fees are paid. License fees are based on gross annual device sales.(A) For a distributor with gross annual device sales of $0 - $499,999.99, the fees are:(i) $552 for a two-year license;(ii) $552 for a two-year license for a change of ownership; and(iii) $276 for a license amended during the current licensure period for minor changes.(B) For a distributor with gross annual device sales of $500,000 - $9,999,999.99, the fees are:(i) $1,296 for a two-year license;(ii) $1,296 for a two-year license for a change of ownership; and(iii) $648 for a license amended during the current licensure period for minor changes.(C) For a distributor with gross annual device sales greater than or equal to $10 million, the fees are:(i) $2,016 for a two-year license;(ii) $2,016 for a two-year license for a change of ownership; and(iii) $1,008 for a license amended during the current licensure period for minor changes.(2) If a person who is required to be licensed as a device distributor under this section is also required to be licensed as a wholesale drug distributor under §229.246(a) of this chapter (relating to Licensure Requirements) or a wholesale food distributor under §229.182(a)(3) of this chapter (relating to Licensing/Registration Fee and Procedures), the person must pay a combined non-refundable fee for each place of business. The department issues licenses for two-year terms and will only issue a license when all past due fees are paid. License fees are based on gross annual device sales.(A) For each place of business having combined gross annual sales of $0 - $199,999.99, the fees are:(i) $598 for a two-year license;(ii) $598 for a two-year license for a change of ownership; and(iii) $299 for a license amended during the current licensure period for minor changes.(B) For each place of business having combined gross annual sales of $200,000 - $499,999.99, the fees are:(i) $897 for a two-year license;(ii) $897 for a two-year license for a change of ownership; and(iii) $449 for a license amended during the current licensure period for minor changes.(C) For each place of business having combined gross annual sales of $500,000 - $999,999.99, the fees are:(i) $1,248 for a two-year license;(ii) $1,248 for a two-year license for a change of ownership; and(iii) $624 for a license amended during the current licensure period for minor changes.(D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99, the fees are:(i) $1,560 for a two-year license;(ii) $1,560 for a two-year license for a change of ownership; and(iii) $780 for a license amended during the current licensure period for minor changes.(E) For each place of business having combined gross annual sales greater than or equal to $10 million, the fees are:(i) $2,340 for a two-year license;(ii) $2,340 for a two-year license for a change of ownership; and(iii) $1,170 for a license amended during the current licensure period for minor changes.(3) A person must first obtain a license from the department to operate and conduct business as a device manufacturer in Texas. All applicants for a device manufacturer license or renewal license must pay a nonrefundable licensing fee. The department issues licenses for two-year terms and will only issue a license when all past due fees are paid. License fees are based on gross annual device sales.(A) For a manufacturer with gross annual device sales of $0 - $499,999.99, the fees are:(i) $552 for a two-year license;(ii) $552 for a two-year license for a change of ownership; and(iii) $276 for a license amended during the current licensure period for minor changes.(B) For a manufacturer with gross annual device sales of $500,000 - $9,999,999.99, the fees are:(i) $2,592 for a two-year license;(ii) $2,592 for a two-year license for a change of ownership; and(iii) $1,296 for a license amended during the current licensure period for minor changes.(C) For a manufacturer with gross annual device sales greater than or equal to $10 million, the fees are:(i) $4,320 for a two-year license;(ii) $4,320 for a two-year license for a change of ownership; and(iii) $2,160 for a license amended during the current licensure period for minor changes.(b) Texas.gov. Applicants may submit initial and renewal license applications electronically through www.texas.gov. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs of processing applications and renewals through the website.(c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person:(1) is licensed under §289.252 of this title (relating to Licensing of Radioactive Material) or registered under §289.226 of this title (relating to Registration of Radiation Machine Use and Services) and engages only in the following activities:(A) manufacturing or distributing of radiation machines that are devices; or(B) manufacturing or distributing of devices that contain radioactive materials; or(2) is a charitable organization, as described in the Internal Revenue Code of 1986 §501(c)(3), or a nonprofit affiliate of one, where permitted by law.(d) Sale of food, drugs, or devices. This section includes the manufacture, production, processing, packaging, exposure, offer, possession, and holding of any of the regulated articles for sale; the sale, dispensing, and giving of any regulated article; and supplying or applying of any regulated articles in the operation of any food, drug, or device place of business. Source Note: The provisions of this §229.439 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective March 12, 1997, 22 TexReg 2438; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective February 1, 2006, 31 TexReg 501; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.439 Licensure Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227295 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227295 03/11/2026 (a) The commissioner may refuse an application or may suspend or revoke a license if the applicant or licensee:(1) has a conviction of a misdemeanor that involves moral turpitude or a felony; (2) is an association, partnership, or corporation and the managing officer has a conviction of a misdemeanor that involves moral turpitude or a felony; (3) has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;(4) is an association, partnership, or corporation and the managing officer has been convicted in state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;(5) has violated any of the provisions of the Texas Food, Drug, and Cosmetic Act, HSC Chapter 431 (Act) or these sections;(6) has failed to pay any fees for licensing or renewal;(7) has failed to pay administrative penalties in full more than 30 days after the decision or order assessing the penalty is final, and has not filed a petition for judicial review of the order assessing the penalty; or(8) has obtained or attempted to obtain a license by fraud or deception.(b) The commissioner may refuse an application for a license or may suspend or revoke a license if the commissioner determines from evidence presented during a hearing that the applicant or licensee:(1) has violated HSC §431.021(l)(3), concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;(2) has violated HSC Chapter 481 (Texas Controlled Substances Act), or HSC Chapter 483 (Texas Dangerous Drug Act); or(3) has violated rules established by the director of the Department of Public Safety, including being responsible for a significant discrepancy in records the applicant or licensee is required to maintain under state law.(c) After providing an opportunity for a hearing, the department may refuse, suspend, or revoke a license for a device distributor or manufacturer if the applicant violates any requirements in these sections or for any reasons described in the Act.(d) Any hearings for the refusal, revocation, or suspension of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(e) A license issued under these sections must be returned to the department if the device distributor's or manufacturer's place of business:(1) ceases business or otherwise ceases operation on a permanent basis;(2) relocates; or(3) changes name or ownership. A corporation transferring 5.0% or more of the share of stock from one person to another is considered to have had an ownership change and must return the license to the department. Source Note: The provisions of this §229.440 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.440 Refusal, Cancellation, Suspension, or Revocation of License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227296&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227296 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227296&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227296 03/11/2026 (a) Minimum requirements. All device distributors or manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, and servicing of devices must comply with the minimum standards of this section, in addition to the statutory requirements contained in the Texas Food, Drug, and Cosmetic Act, HSC Chapter 431 (Act). For the purpose of this section, the department adopts the policies described in the United States Food and Drug Administration's (FDA's) Compliance Policy Guides relating to devices.(b) Federal establishment registration and device listing. All persons who operate as device distributors or manufacturers in Texas must meet the applicable requirements in 21 Code of Federal Regulations (CFR) Part 807, relating to Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Devices distributed by device distributors or manufacturers must have met, if applicable, the premarket notification requirements of 21 CFR Part 807 or the premarket approval provisions of 21 CFR Part 814, relating to Premarket Approval of Medical Devices.(c) Good manufacturing practices. Device distributors or manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices must comply with the applicable requirements of 21 CFR Part 820, relating to Quality Management System Regulation. The requirements in this part govern the methods, facilities, and controls used to design, manufacture, package, label, store, install, and service all finished devices intended for human use.(d) Buildings and facilities.(1) Manufacturers must conduct all manufacturing, assembling, packaging, packing, holding, testing, or labeling of devices in buildings and facilities described in 21 CFR §820.45, relating to Device Labeling and Packaging Controls.(2) Manufacturers and distributors must not conduct any manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of devices in any personal residence or any room used as a living area. Manufacturers and distributors must not manufacture or hold devices in any room used as living or sleeping quarters. All device manufacturing and storage must be completely separated from any living or sleeping quarters by a full partition.(3) Any place of business used by a distributor to store, warehouse, hold, offer, transport, or display devices must:(A) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;(B) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;(C) have a designated quarantine area, physically separate from other devices, for storing outdated, damaged, deteriorated, misbranded, or adulterated devices until the quarantined devices are destroyed or returned to the supplier;(D) be maintained in a clean and orderly condition, including keeping walls, ceilings, windows, doors, and floors clean, in good repair, and properly maintained; and(E) be free from infestation by insects, rodents, birds, or vermin of any kind.(e) Storage of devices. All devices stored by distributors must be in-date, not damaged, and held at appropriate temperatures and in appropriate conditions under any labeling requirements of such devices.(f) Device labeling. Devices distributed by device distributors or manufacturers must meet the labeling requirements of the Act and 21 CFR Part 801, relating to Labeling.(g) Device labeling exemptions. Exemptions of labeling or packaging of devices adopted under the Federal Food, Drug, and Cosmetic Act must apply to devices in Texas, unless modified or rejected by rules of the executive commissioner of the Health and Human Services Commission.(h) Reconditioned devices. Reconditioned devices must comply with the provisions of the Act and these sections and are subject to the provisions of the Texas Food, Drug, Device, and Cosmetic Salvage Act, HSC Chapter 432.(i) Medical device reporting. Device distributors or manufacturers must meet the applicable medical device reporting requirements of 21 CFR Part 803, relating to Medical Device Reporting.(j) Radiation emitting devices. Device distributors or manufacturers that distribute devices emitting electronic product radiation must meet the applicable requirements of the Act and 21 CFR Subchapter J, relating to Radiological Health.(k) Distribution of prescription devices.(1) A prescription device in the possession of a device distributor or manufacturer licensed under these sections of this subchapter is exempt from HSC §431.112(e)(1), relating to labeling bearing adequate directions for use, providing it meets the requirements of 21 CFR §801.109, Prescription Devices, and §801.110, Retail Exemption for Prescription Devices.(2) Each device distributor or manufacturer who distributes prescription devices must maintain a record for every prescription device. The records kept must include the identity of the device, the quantity received or manufactured, and the disposition of each device.(3) Each device distributor or manufacturer who delivers a prescription device to the ultimate user must maintain a record of any prescription.(l) Sale of contact lenses at flea markets. Contact lenses may not be sold by persons at flea markets unless:(1) the person selling the contact lenses has complied with the requirements of Texas Business and Commerce Code §35.55; and(2) the person selling the contact lenses has complied with the requirements of the Texas Occupations Code Chapter 353.(m) Distribution of nonprescription devices. Records must include the identity of each device, the quantity received or manufactured, and the final disposition of each device. Source Note: The provisions of this §229.441 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective December 13, 1998, 23 TexReg 12353; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.441 Minimum Standards for Licensure https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227297&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227297 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227297&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227297 03/11/2026 (a) An advertisement of a device is deemed false if it is false or misleading in any way.(b) An advertisement of a device is false if the advertisement represents that the device affects:(1) infectious and parasitic diseases;(2) neoplasms;(3) endocrine, nutritional, and metabolic diseases and immunity disorders;(4) diseases of blood and blood-forming organs;(5) mental disorders;(6) diseases of the nervous system and sense organs;(7) diseases of the circulatory system;(8) diseases of the respiratory system;(9) diseases of the digestive system;(10) diseases of the genitourinary system;(11) complications of pregnancy, childbirth, and the puerperium;(12) diseases of the skin and subcutaneous tissue;(13) diseases of the musculoskeletal system and connective tissue;(14) congenital anomalies;(15) certain conditions originating in the perinatal period;(16) symptoms, signs, and ill-defined conditions; or(17) injury and poisoning.(c) Subsection (b) of this section does not apply to an advertisement of a device if the advertisement does not violate the Act §431.182(a), and is disseminated:(1) to the public for self-medication and is consistent with the labeling claims permitted by the United States Food and Drug Administration (FDA);(2) only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or(3) only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the device.(d) This section does not indicate that self-medication for a disease, other than a disease listed under subsection (b) of this section, is safe and effective. Source Note: The provisions of this §229.442 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.442 Advertising https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227298 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227298 03/11/2026 (a) General enforcement actions. The department may take enforcement action for the following:(1) failing to comply with Texas Food, Drug, and Cosmetic Act, HSC Chapter 431 (Act) or these sections;(2) falsifying information provided in an application for a license, or making a false or misleading statement in connection with the initial or renewal application, either in the formal application itself or in any other instrument relating to the application submitted to the department;(3) refusing to allow the department to conduct an inspection or collect samples;(4) interfering with the department in the performance of its duties;(5) removing or disposing a detained device;(6) misrepresenting any regulated product sold to the public; or(7) receiving a conviction of a misdemeanor that involves moral turpitude or a felony. (b) Administrative penalty. If a person, whether licensed or unlicensed by the department, violates these sections or an order adopted or license issued under the Act, the commissioner may assess an administrative penalty against the person.(1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.(2) Violations subject to this subsection must be categorized into severity levels as determined in §229.261 of this chapter (relating to Assessment of Administrative Penalties).(3) An administrative penalty may be assessed only after the person charged with a violation is given an opportunity for a hearing.(4) If the person charged with the violation does not request a hearing, or defaults, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.(5) After making a determination under this subsection that a penalty is to be assessed, the commissioner must issue an order requiring that the person pay the penalty.(6) Not later than the 30th calendar day after the date of issuance of an order finding that a violation has occurred, the commissioner must inform the person against whom the order is issued of the amount of the penalty.(c) Emergency orders.(1) The commissioner or a person designated by the commissioner may issue a mandatory or prohibitory emergency order, without notice, in relation to the manufacture or distribution of a food, drug, device, or cosmetic upon determination that: the manufacture or distribution creates or poses an immediate and serious threat to human life or health, and other procedures available to the department to remedy or prevent the occurrence of the situation will result in unreasonable delay.(2) If an emergency order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, must propose a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing must be held under departmental formal hearing rules governed by §§1.21, 1.23, 1.25, and 1.27 of this title.(3) The department must transmit the order in person or by electronic mail or by registered or certified mail to the license or registration holder. If the license or registration holder cannot be located for a notice required under this section, the department must provide notice by posting a copy of the order on the front door of the premises of the license or registration holder.(d) Inspection.(1) To enforce these sections or the Act, the department or authorized agent may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:(A) enter, at reasonable times, a place of business, including a factory or warehouse, where a device is manufactured, assembled, packed, or held for introduction into commerce or held after the introduction;(B) enter a vehicle being used to transport or hold a device in commerce; or(C) inspect, at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicle, including all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.(2) The inspection of a place of business, including a factory, warehouse, or consulting laboratory, where a restricted device is manufactured, assembled, packed, or held for introduction into commerce may include any place or item, such as a record, file, paper, process, control, or facility, needed to determine whether the device:(A) is adulterated or misbranded;(B) is prohibited from being manufactured, introduced into commerce, sold, or offered for sale under the Act; or(C) is in violation of these sections or the Act.(3) An inspection under paragraph (2) of this subsection may not extend to:(A) financial data;(B) sales data, except for shipment data;(C) pricing data;(D) personnel data, except for data relating to the qualifications of technical and professional personnel performing functions under the Act; or(E) research data, except data that:(i) relates to devices; and(ii) is subject to reporting and inspection under regulations issued under the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360i or §360j, as amended.(4) An inspection under paragraph (2) of this subsection must be started and completed with reasonable promptness.(e) Receipt for samples. An authorized agent or health authority who inspects a place of business, including a factory or warehouse, and obtains a sample during the inspection must give to the owner, operator, or the owner's or operator's agent a receipt describing the sample before leaving the place of business.(f) Access to records.(1) A person who is required to maintain records referenced in these sections, the Act, or the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360i, or a person who is in charge or custody of those records must, upon request by an authorized agent or health authority, provide access to the records, at all reasonable times, for copying and verification of the records.(2) A person who is subject to licensure under these sections of this subchapter must, at the request of an authorized agent or health authority, provide access to the records, at all reasonable times, for copying and verification of all records showing:(A) the movement in commerce of any device;(B) the holding of any device after movement in commerce; and(C) the quantity, shipper, and consignee of any device.(g) Retention of records. Records required by this subchapter must be maintained at the place of business or another reasonably accessible location for a period of at least two years following disposition of the device, unless a longer retention period is required by laws and regulations adopted in §229.432 of this subchapter (relating to Applicable Laws and Regulations).(h) Adulterated and misbranded device. If the department identifies an adulterated or misbranded device, the department may impose the applicable provisions of Subchapter C of the Act, including detention, emergency order, recall, condemnation, destruction, injunction, civil penalties, criminal penalties, and administrative and civil penalties. Administrative penalties will be assessed using the severity levels contained in §229.261 of this chapter (relating to Assessment of Administrative Penalties). Source Note: The provisions of this §229.443 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective December 13, 1998, 23 TexReg 12353; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG X LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS §229.443 Enforcement and Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=151220&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 151220 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=151220&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 151220 03/11/2026 The sale or distribution of any dietary supplement containing ephedrine group alkaloids is prohibited. Source Note: The provisions of this §229.461 adopted to be effective November 1, 1999, 24 TexReg 4564; amended to be effective March 31, 2011, 36 TexReg 1984. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Y REGULATIONS TO PROHIBIT THE SALE OF DIETARY SUPPLEMENTS CONTAINING EPHEDRINE GROUP ALKALOIDS; AND TO RESTRICT THE SALE AND DISTRIBUTION OF CERTAIN PRODUCTS CONTAINING EPHEDRINE §229.461 Regulations to Prohibit the Sale and Distribution of Dietary Supplements Containing Ephedrine Group Alkaloids https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=151221&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 151221 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=151221&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 151221 03/11/2026 (a) Drug products containing single ingredient ephedrine, its salts, optical isomers or salts of optical isomers, are dangerous drugs as defined in the Health and Safety Code, Chapter 483, relating to Dangerous Drugs. (b) Drug products that contain pseudoephedrine are exempt from the designation as dangerous drugs if the drug product is labeled in accordance with the U.S. Food and Drug Administration's final monograph. (c) Any drug product containing ephedrine, its salts, optical isomers or salts of optical isomers shall not be sold, distributed, introduced into commerce, manufactured, produced, packaged, exposed, offered, possessed or held for sale, dispensed or given away in this state except as dispensed upon the prescription of a licensed practitioner. (d) The following formulations are exempt from the designation as dangerous drugs under subsection (a) of this section, and the dispensing restrictions under subsection (c) of this section: (1) solid dosage forms that combine active ingredients must be in the following ranges for each recommended dose: ephedrine, its salts, optical isomers or salts of optical isomers not to exceed 12.5 milligrams (mg) combined with at least 200 mg guiafenesin; ephedrine, its salts, optical isomers or salts of optical isomers not to exceed 25 mg combined with at least 400 mg guiafenesin; (2) liquid oral dosage forms that combine active ingredients in the following ranges for each 5 milliliter (ml) dose: dextromethorphan HBr (not more than 10 mg), chlorpheniramine maleate (not more than 2 mg), ephedrine HCl (not more than 5 mg), phenylephrine (not more than 5 mg), ammonium chloride (not more than 40 mg), ipecac fluidextract (not more than 0.005 ml); (3) anorectal preparations containing less than 5.0% ephedrine;(4) nasal decongestant preparations containing 0.5% or less ephedrine; and(5) any ephedrine-containing drug product that is marketed pursuant to an approved new drug application under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§301, et seq. Source Note: The provisions of this §229.464 adopted to be effective November 1, 1999, 24 TexReg 4564; amended to be effective March 31, 2011, 36 TexReg 1981. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Y REGULATIONS TO PROHIBIT THE SALE OF DIETARY SUPPLEMENTS CONTAINING EPHEDRINE GROUP ALKALOIDS; AND TO RESTRICT THE SALE AND DISTRIBUTION OF CERTAIN PRODUCTS CONTAINING EPHEDRINE §229.464 Regulations to Restrict the Sale and Distribution of Certain Drug Products Containing Ephedrine https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218042&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218042 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218042&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218042 03/11/2026 The purpose of this subchapter is to implement Texas Health and Safety Code Chapter 437, which authorizes the department to collect fees and to conduct inspections requested or required by certain food establishments when exempt from permitting by the department. Source Note: The provisions of this §229.470 adopted to be effective September 1, 2007, 32 TexReg 5376; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Z INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS §229.470 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218046&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218046 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218046&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218046 03/11/2026 All definitions found in §228.2 of this title (relating to Definitions) are applicable to this subchapter. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Food--A raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.(2) Food employee--An individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.(3) Food establishment--(A) A food establishment is an operation that:(i) stores, prepares, packages, serves, or vends food directly to the consumer, or otherwise provides food for human consumption, such as:(I) a restaurant;(II) a retail food store;(III) a satellite or catered feeding location;(IV) a catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people;(V) a market;(VI) a vending machine location;(VII) a self-service food market;(VIII) a conveyance used to transport people;(IX) an institution; or(X) a food bank; and(ii) relinquishes possession of food to a consumer directly, or indirectly through a delivery service, such as home delivery of grocery orders or restaurant takeout orders, or delivery service provided by common carriers.(B) A food establishment includes:(i) an element of the operation, such as a transportation vehicle or a central preparation facility supplying a vending machine location or satellite feeding location unless the vending machine or feeding location is permitted by the regulatory authority; and(ii) an operation conducted in a mobile, stationary, temporary, or permanent facility or location and where consumption is on or off the premises regardless if there is a charge for the food.(C) A food establishment does not include:(i) an establishment offering only prepackaged foods that are not time and temperature control for safety (TCS) foods;(ii) a produce stand only offering whole, uncut fresh fruits and vegetables;(iii) a food processing plant, including one located on the premises of a food establishment;(iv) a cottage food production operation;(v) a bed and breakfast limited as defined in §228.2(5) of this title (relating to Definitions); or(vi) a private home receiving catered or home-delivered food.(4) Food service establishment--A food establishment as defined in these rules.(5) Group residence--A private or public housing corporation or institutional facility providing living quarters and meals. The term includes a domicile for unrelated persons such as a retirement home, correctional facility, or a long-term care facility.(6) Nonprofit organization--A civic or fraternal organization, charity, lodge, association, proprietorship, or corporation possessing a 501(c) exemption under the Internal Revenue Code; or a religious organization. Nonprofit organizations are exempt from obtaining a permit as specified in §229.372(c) of this chapter (relating to Permitting Fees and Procedures). Nonprofit organizations are not exempt from the payment of an inspection fee as required under §229.472 of this subchapter (relating to Inspection Fees and Procedures).(7) School food establishment--A food service establishment where food is prepared or served and intended for service primarily to students in public and private schools, including kindergarten, preschool and elementary schools, junior high schools, high schools, colleges, and universities. A school food establishment is a food establishment and may include concession stands located on the school premises or other school-sponsored venues. School food establishments are managed and operated under the supervision of school district employees.(8) Temporary food establishment--A food establishment operating for a period of no more than 14 consecutive days in conjunction with a single event or celebration.(9) Time and temperature control for safety food (TCS food)--A food requiring time and temperature control for safety to limit pathogen growth or toxin production. The term includes a food that must be held under proper temperature controls, such as refrigeration, to prevent the growth of bacteria that may cause human illness. A TCS food may include a food containing protein and moisture and that is neutral or slightly acidic, such as meat, poultry, fish, and shellfish products; pasteurized and unpasteurized milk and dairy products; raw seed sprouts; baked goods requiring refrigeration, including cream or custard pies or cakes; and ice products. The term does not include a food using TCS food as ingredients if the final food product does not require time or temperature control for safety to limit pathogen growth or toxin production. Source Note: The provisions of this §229.471 adopted to be effective September 1, 2007, 32 TexReg 5376; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Z INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS §229.471 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218043&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218043 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218043&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218043 03/11/2026 (a) Inspection fees. A person operating a non-permitted food establishment, who requests an inspection be conducted by the department, shall pay an inspection fee for each inspection of the establishment. All inspection fees are nonrefundable.(1) A school food establishment requesting two inspections per year shall pay for both inspections before the first inspection is conducted by the department. The school food establishment fee is $300 for two inspections. The fee is non-refundable.(2) A person operating a non-permitted food establishment that is not a school food establishment shall pay an inspection fee for each inspection of the establishment.(A) The inspection fee is $150 per inspection.(B) An application and inspection fee must be submitted to the department at least 6 weeks before the earliest desired inspection date.(b) Non-permitted food establishments, other than schools, inspection fee requirement. Non-permitted food establishments, that are nonprofit organizations as defined in §229.471(7) of this subchapter (relating to Definitions), are not exempt from paying an inspection fee as required under subsection (a) of this section. Nonprofit organizations are exempt from obtaining a permit as specified in §229.372(c) of this chapter (relating to Permitting Fees and Procedures). Nonprofit organizations shall comply with §229.473 of this subchapter (relating to Minimum Standards for Permitting and Operation). Any civic or fraternal organization, charity, lodge, association, proprietorship, corporation, or church not meeting the definition of "nonprofit organization" shall obtain a permit, pay the required fee, and comply with the requirements for permitted food establishments. Internal Revenue Service documentation of nonprofit status shall be provided, if requested by the department.(c) Food establishments under the jurisdiction of county health departments or public health districts. The department shall not inspect or collect an inspection fee from food establishments permitted or inspected by a county or public health district under Texas Health and Safety Code Chapter 437, or food establishments permitted or inspected under authority granted to municipalities.(d) Exemptions from fees. The following meet the definition of "food establishment" in §229.471 of this subchapter, but are not required to pay a fee to the department or obtain a Retail Food Establishment inspection under this subchapter:(1) food establishments permitted and inspected under authority granted to municipalities;(2) food establishments inspected by state college or university personnel in accordance with the requirements of §229.373 of this chapter (relating to Minimum Standards for Permitting and Operation);(3) food establishments licensed under Texas Health and Safety Code Chapter 431, as manufacturers of food, provided the fee for licensure exceeds the permit fee required under §229.372 of this chapter;(4) food establishments under the inspection authority of the Texas Health and Human Services Commission (HHSC) Regulatory Services Division;(5) facilities under the inspection authority of the HHSC Regulatory Services Division;(6) hospitals under the inspection authority of the HHSC Regulatory Services Division and that do not serve food to the general public;(7) federally inspected food establishments on federal property;(8) correctional facilities under the inspection authority of the Texas Department of Criminal Justice; and(9) mobile food units permitted and inspected under the authority granted to municipalities and which operate only within their respective jurisdictions. (Except for units which handle only pre-packaged, non-TCS foods, a mobile food unit is classified as a food establishment, regardless of whether food preparation occurs on the unit.)(e) Application for inspection request. The inspection request shall be submitted on an application form furnished by the department and shall contain the following information:(1) the name under which an establishment is operated;(2) the mailing address and street address of the establishment; and(3) the signature of the owner, operator, or other authorized person.(f) Two or more establishments. If a person owns or operates two or more establishments, each establishment shall request inspections separately by listing the name and address of each establishment on separate application forms. A school district may submit a single application and attach a listing of each school food establishment requesting inspection.(g) Application form. Copies of the application for inspection request form may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756-3182, or online at https://www.dshs.texas.gov/retail-food-establishments/permitting-information-retail-food-establishments. Source Note: The provisions of this §229.472 adopted to be effective September 1, 2007, 32 TexReg 5376; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Z INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS §229.472 Inspection Fees and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218044&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218044 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218044&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218044 03/11/2026 All food establishments shall be operated in accordance with the requirements of Chapter 228 of this title (relating to Retail Food Establishments). Copies may be downloaded from: https://www.dshs.texas.gov/retail-food-establishments/statutes-laws-retail-food-establishments. Source Note: The provisions of this §229.473 adopted to be effective September 1, 2007, 32 TexReg 5376; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Z INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS §229.473 Minimum Standards for Permitting and Operation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218045&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218045 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218045&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218045 03/11/2026 (a) Basis. The department may refuse an application for an inspection if there are outstanding violations of the requirements of §229.472 of this subchapter (relating to Inspection Fees and Procedures) or §229.473 of this subchapter (relating to Minimum Standards for Permitting and Operation), or for interference with a department representative in the performance of their duties under this subchapter.(b) Hearings. Hearings for the refusal of an inspection are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures) or under the provisions of the Texas Government Code Chapter 2001, Administrative Procedure Act.(c) Administrative penalties. Administrative penalties in Texas Health and Safety Code §437.018, and in §229.261 of this chapter (relating to Assessment of Administrative Penalties), may be assessed for violations of this subchapter or of Chapter 228 of this title (relating to Retail Food Establishments). Source Note: The provisions of this §229.474 adopted to be effective September 1, 2007, 32 TexReg 5376; amended to be effective February 18, 2018, 43 TexReg 578; amended to be effective May 13, 2024, 49 TexReg 3288. 1 DEPARTMENT OF STATE HEALTH SERVICES 229 FOOD AND DRUG Z INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS §229.474 Refusal of Inspection Request; Administrative Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118446&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118446 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125098&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125098 03/11/2026 (a) Definitions. The following words and terms when used in this chapter shall have the following meanings. (1) Actual price--The weighted median invoice price at which a wholesale distributor sells a prescription drug to Texas retail pharmacies from the first day of the month through the last day of the calendar month prior to the date of the request. (2) Average manufacture price--The average price paid to the manufacturer for a prescription drug in the United States by wholesalers for prescription drugs distributed to the retail pharmacy class of trade, after deducting customary prompt pay discounts, calculated for the most recent required quarterly report to the Secretary of Health and Human Services. (3) BFDS--The Bureau of Food and Drug Safety within the Texas Department of Health. (4) Council--The Interagency Council on Pharmaceuticals Bulk Purchasing. (5) Department--The Texas Department of Health. (6) Drug manufacturer--A person licensed by Chapter 229 of this title who manufactures, prepares, propagates, compounds, processes, packages, repackages, or changes the container, wrapper, or labeling of any drug product. (7) Prescription Drug--Any drug as defined by the Health and Safety Code, §431.002(14) that is further described in 21 U.S.C. §503(b)(1) and is a finished pharmaceutical. (8) Retail pharmacy, for the purpose of actual price--Any Class A pharmacy or community pharmacy authorized to dispense a drug or device to the public under a prescription drug order. It does not, however, include long-term care pharmacies, physicians' offices, closed-door pharmacies, or outpatient pharmacies affiliated with health systems. (9) Wholesale drug distributor--A person licensed by Chapter 229 of this title to engage in the wholesale distribution of prescription drugs to retail pharmacies in Texas including, but not limited to: manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions. (b) Exemptions. The following entities, upon furnishing affirmative proof, are exempted from the reporting requirements of this section. (1) Manufacturers or wholesale drug distributors of only: (A) veterinary drugs or medical equipment; (B) durable medical equipment; (C) medical gasses; (D) salvaged drugs or devices; (E) dental anesthetics or equipment; (F) cosmetics; and/or (G) any substance that may be lawfully sold over the counter without a prescription under the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, et seq. (2) Manufacturers or wholesale drug distributors who are: (A) health care clinics; (B) hospitals or hospital districts; (C) university health care systems and/or pharmacy schools; (D) blood and tissue centers; (E) other non-profit health care systems; (F) repackers; (G) contract manufacturers; (H) reverse distributors; or (I) kit manufacturers. (c) Reporting procedures. (1) Requests. No later than the 25th day of each month, the council's designee(s) shall submit a list of prescription drugs about which pricing information is desired, to the BFDS. The list from the council will be in a standardized format, which identifies each drug by the National Drug Code (NDC) for the drug, the name of the drug, the manufacturer of the drug, the form size, the unit dosage and the count, and the name of the manufacturer. The BFDS will then submit the request electronically to all manufacturers and wholesale drug distributors by the 5th day of the next month. Attached Graphic(2) Reports. Every manufacturer and wholesale distributor shall report to BFDS on a standardized electronic format no later than the 30th day after receipt of the request. The manufacturer shall report the most recent average manufacturer price that was required to be reported to the Secretary of Health and Human Services under 42 U.S.C., §1396r-8(k), as amended, and the manufacturer national rebate agreement, and the wholesale drug distributor shall report the actual price for the prescription drug. (A) Report of Actual Price Information from a Wholesale Drug Distributor.Attached Graphic(B) Report of Average Manufacturer Price Information from a Manufacturer. Attached Graphic(3) The BFDS will provide all reports to the council designee(s). BFDS will provide the council with a monthly report of those manufacturers and wholesale drug distributors not filing the required report. (d) Confidentiality. Information provided by a manufacturer and a wholesale drug distributor pursuant to these rules and the Health and Safety Code, Chapter 110, may only be disclosed pursuant to the Health and Safety Code, Chapter 110, and the procedures of the council. (e) Enforcement. (1) The BFDS will provide electronic notice of a failure to report to a manufacturer or wholesale drug distributor from whom the council did not receive a requested report. The manufacturer or wholesale drug distributor must submit the report within 15 days after receipt of the notice of failure to report. (2) If the council disputes the accuracy of the information on a particular NDC or NDCs provided by the manufacturer or wholesale drug distributor, then a confidential settlement conference on only those particular NDC or NDCs with the manufacturer or wholesale drug distributor, a member of the council, and BFDS will be offered. (3) If a manufacturer or wholesale drug distributor fails to file the requested report after being provided the 15-day opportunity to cure, or if the accuracy of the report cannot be reconciled, BFDS shall consider the manufacturer's or wholesale drug distributor's demonstration of good faith prior to any referral to the Office of the Attorney General for investigation and/or action. Source Note: The provisions of this §230.1 adopted to be effective July 1, 2003, 27 TexReg 11919. 1 DEPARTMENT OF STATE HEALTH SERVICES 230 SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS A AVERAGE MANUFACTURE PRICE AND PURCHASE PRICE REPORTING FOR PHARMACEUTICALS §230.1 Average Manufacture Price and Purchase Price Reporting for Pharmaceuticals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191183&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191183 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191183&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191183 03/11/2026 (a) Purpose and applicability. The purpose of this subchapter is to implement the duties of the Department of State Health Services (department) under the Health and Safety Code (HSC), Chapter 486, relating to over-the-counter sales of ephedrine, pseudoephedrine, and norpseudoephedrine.(b) Definitions. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Business establishment--A retail distributor such as a grocery store; general merchandise store; drug store; or other entity or person, other than a licensed pharmacy, that engages in direct sales to end-user consumers. A distributor who engages in greater than 5% of gross annual sales of regulated products to other than end-user consumers must obtain a license as a wholesaler under HSC, Chapter 431, Subchapter I or Subchapter N.(2) Department--The Department of State Health Services.(3) Pharmacy--A person holding a current license to operate a pharmacy issued by the Texas State Board of Pharmacy (Board of Pharmacy) under Occupations Code, Chapter 560.(4) Record of sale--The paper or electronic documentation prepared and maintained in compliance with §230.15 of this title (relating to Records).(5) Regulated products--Any compound, mixture, or preparation containing any detectable amount of ephedrine, pseudoephedrine, or norpseudoephedrine, including its salts, optical isomers, and salts of optical isomers.(6) Over-the-counter sale--The sale within any calendar day of no more than 3.6 grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances; and within any 30-day period, no more than nine grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances to an individual.(7) "Real-time electronic logging system"--A system intended to be used by law enforcement agencies and pharmacies or other business establishments that:(A) is installed, operated, and maintained free of any one-time or recurring charge to the business establishment or to the state;(B) is able to communicate in real-time with similar systems operated in other states and similar systems containing information submitted by more than one state;(C) complies with the security policy of the Criminal Justice Information Services division of the Federal Bureau of Investigation;(D) complies with information exchange standards adopted by the National Information Exchange Model;(E) uses a mechanism to prevent the completion of a sale of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine that would violate state or federal law regarding the purchase of a product containing those substances; and(F) is equipped with an override of the mechanism described in subparagraph (E) of this paragraph that:(i) may be activated by an employee of a business establishment; and(ii) creates a record of each activation of the override.(c) Persons who sell or distribute ephedrine, pseudoephedrine, norpseudoephedrine or phenylpropanolamine may be subject to additional federal statutes and regulations adopted thereunder. Source Note: The provisions of this §230.11 adopted to be effective June 19, 2006, 31 TexReg 4863; amended to be effective October 11, 2012, 37 TexReg 8032; amended to be effective June 7, 2018, 43 TexReg 3594. 1 DEPARTMENT OF STATE HEALTH SERVICES 230 SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS B LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE §230.11 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158929 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158929&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158929 03/11/2026 (a) Before completing a sale of a regulated product, an employee with authority to access regulated products must:(1) require the person making the purchase to:(A) display a driver's license or other form of government-issued identification containing the person's photograph and indicating that the person is 16 years of age or older; and(B) sign for the purchase;(2) make a record of the sale, using a format approved or provided by the department for this purpose, that includes the name and date of birth of the person making the purchase, the address of the purchaser, the date and time of the purchase, the type of identification displayed by the person and the identification number, the product name for the item purchased, and the number of grams purchased; and(3) transmit the record of sales as required by §230.16 of this title (relating to Real-Time Electronic Logging System).(b) A business establishment may not sell to a person who makes over-the-counter purchases of one or more products containing ephedrine, pseudoephedrine, or norpseudoephedrine:(1) within any calendar day, more than 3.6 grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances; and(2) within any 30-day period, more than 9 grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances.(c) Except as provided by subsection (d) of this section, a business establishment shall maintain each record made under subsection (a)(2) of this section until at least the second anniversary of the date the record is made and shall make each record available on request by the department or any local, state, or federal law enforcement agency, including the United States Drug Enforcement Administration.(d) Subsection (c) of this section does not apply to a business establishment that has used a real-time electronic logging system for longer than two years.(e) A business establishment that has used a real-time electronic logging system for longer than two years shall destroy all paper records maintained under this section unless the destruction is otherwise prohibited by law. Source Note: The provisions of this §230.15 adopted to be effective June 19, 2006, 31 TexReg 4863; amended to be effective October 11, 2012, 37 TexReg 8032. 1 DEPARTMENT OF STATE HEALTH SERVICES 230 SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS B LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE §230.15 Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191184&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191184 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191184&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191184 03/11/2026 (a) Before completing an over-the-counter sale of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine, a business establishment that engages in those sales shall transmit the information in the record made under §230.15(a)(2) of this title (relating to Records) to a real-time electronic logging system.(b) Except as provided by subsection (c) of this section, a business establishment may not complete an over-the-counter sale of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine if the real-time electronic logging system returns a report that the completion of the sale would result in the person obtaining an amount of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances greater than the amount described by §230.15(b) of this title, regardless of whether all or some of the products previously obtained by the buyer were sold at the establishment or another business establishment.(c) An employee of a business establishment may complete a sale prohibited by subsection (b) of this section by using the override mechanism described by §230.11(b)(7)(F) of this title (relating to General Provisions) only if the employee has a reasonable fear of imminent bodily injury or death from the person attempting to obtain ephedrine, pseudoephedrine, or norpseudoephedrine.(d) On request of the Department of Public Safety, the administrators of a real-time electronic logging system shall make available to the Department of Public Safety a copy of each record of an over-the-counter sale of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine that is submitted by a business establishment located in this state.(e) On application by a business establishment that engages in over-the-counter sales of products containing ephedrine, pseudoephedrine, or norpseudoephedrine in accordance with this subchapter, the department may grant that business establishment a temporary exemption, not to exceed 180 days, from the requirement of using a real-time electronic logging system under this subchapter.(f) A business establishment granted a temporary exemption under this section must keep records of sales in the same manner required under subsection (h) of this section for a business establishment that experiences a mechanical or electronic failure of the real-time electronic logging system.(g) An exemption granted under this section does not relieve a business establishment of any duty under this subchapter other than the duty to use a real-time electronic logging system.(h) If a business establishment that engages in over-the-counter sales of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine experiences a mechanical or electronic failure of the real-time electronic logging system, the business shall:(1) maintain a written record or an electronic record made by any means that satisfies the requirements of §230.15(a)(2) of this title; and(2) enter the information in the real-time electronic logging system as soon as practicable after the system becomes operational.(i) The administrators of a real-time electronic logging system must comply with Health and Safety Code, §486.0144 (relating to Online Portal), which requires providing real-time access to the information in the system to the Department of Public Safety if the Department of Public Safety executes a memorandum of understanding with the administrators. Source Note: The provisions of this §230.16 adopted to be effective October 11, 2012, 37 TexReg 8032; amended to be effective June 7, 2018, 43 TexReg 3594. 1 DEPARTMENT OF STATE HEALTH SERVICES 230 SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS B LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE §230.16 Real-Time Electronic Logging System https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158931&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158931 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158931&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158931 03/11/2026 (a) The department may impose an administrative penalty for a violation of the Health and Safety Code (HSC), Chapter 486, or this subchapter.(b) The amount of the administrative penalty may not exceed $1,000 per violation. Each day a violation continues or occurs is a separate violation for purposes of imposing a penalty. The total amount of the penalty assessed for a violation continuing or occurring on separate days may not exceed $20,000.(c) The amount of the penalty shall be based on:(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;(2) the threat to health or safety caused by the violation;(3) the history of previous violations;(4) the amount necessary to deter a future violation;(5) whether the violator demonstrated good faith, including good faith efforts to correct the violation; and(6) any other matter that justice may require.(d) If the department initially determines that a violation has occurred, the department will provide notice of the violation in writing to the person. The person may respond to the notice in writing not later than the 20th day after the date the person receives the notice, informing the department that the person:(1) accepts the determination and recommended penalty; or(2) requests a hearing on the occurrence of the violation, the amount of the penalty, or both.(e) If a person does not respond to the department's notice within 20 calendar days after receiving the notice, the department will issue an order approving the determination by default.(f) Hearings will be held at the State Office of Administrative Hearings and will be conducted under Government Code, Chapter 2001. Source Note: The provisions of this §230.17 adopted to be effective October 11, 2012, 37 TexReg 8032. 1 DEPARTMENT OF STATE HEALTH SERVICES 230 SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS B LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE §230.17 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158932&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158932 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=158932&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 158932 03/11/2026 (a) The privacy protections provided an individual under Title 21, Code of Federal Regulations, §1314.45, apply to information entered or stored in a real-time electronic logging system.(b) A business establishment that engages in over-the-counter sales of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine may disclose information entered or stored in a real-time electronic logging system only to the United States Drug Enforcement Administration and other federal, state, and local law enforcement agencies.(c) A business establishment that engages in over-the-counter sales of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine may not use information entered or stored in a real-time electronic logging system for any purpose other than for a disclosure authorized by subsection (b) of this section or to comply with the requirements of this subchapter. Source Note: The provisions of this §230.18 adopted to be effective October 11, 2012, 37 TexReg 8032. 1 DEPARTMENT OF STATE HEALTH SERVICES 230 SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS B LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE §230.18 Privacy Protections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191185&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191185 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=191185&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 191185 03/11/2026 (a) The department may inspect a business establishment under this subchapter in order to implement and enforce this chapter.(b) The department shall collect fees for an inspection conducted to enforce Health and Safety Code, Chapter 486 and this subchapter.(c) A nonrefundable fee of $400.00 for inspections of pharmacies and non-pharmacy retailers conducted by the department will be required. Source Note: The provisions of this §230.19 adopted to be June 7, 2018, 43 TexReg 3594. 1 DEPARTMENT OF STATE HEALTH SERVICES 230 SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS B LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE §230.19 Inspection https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167858&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167858 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167858&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167858 03/11/2026 The purpose of this chapter is to implement Health and Safety Code, Chapter 438, Subchapter H, relating to information on food regulation. Source Note: The provisions of this §231.1 adopted to be effective July 13, 2014, 39 TexReg 5180. 1 DEPARTMENT OF STATE HEALTH SERVICES 231 REQUESTS FOR INFORMATION OR OFFICIAL DETERMINATION ON FOOD REGULATION §231.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167859&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167859 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167859&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167859 03/11/2026 Unless otherwise prohibited by state or federal law, on receipt of a written request for information pertaining to the regulation of food under Health and Safety Code, Chapters 431 - 441, the Department of State Health Services (department) will provide a reasonable and substantial response to the request not later than the 30th day after the date the department receives the request. Source Note: The provisions of this §231.2 adopted to be effective July 13, 2014, 39 TexReg 5180. 1 DEPARTMENT OF STATE HEALTH SERVICES 231 REQUESTS FOR INFORMATION OR OFFICIAL DETERMINATION ON FOOD REGULATION §231.2 Request for Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167860&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167860 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167860&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167860 03/11/2026 (a) On receipt of a written request regarding the applicability to a specific circumstance of a rule or the requirements for compliance with the rule, the Department of State Health Services (department) will provide an official written determination regarding the applicability of the rule or the requirements for compliance with the rule to the requestor not later than the 30th day after the date the department receives the request.(b) An official determination made under this section is valid until the rule that is the subject of the determination is amended by statute or department rule.(c) In order to ensure the accuracy and applicability of the determination, all written requests for official determination should be submitted on a form available from the department and should be completed in its entirety. The form is available from the department's website at http://www.dshs.state.tx.us/. Source Note: The provisions of this §231.3 adopted to be effective July 13, 2014, 39 TexReg 5180. 1 DEPARTMENT OF STATE HEALTH SERVICES 231 REQUESTS FOR INFORMATION OR OFFICIAL DETERMINATION ON FOOD REGULATION §231.3 Request for Official Determination https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167861&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167861 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=167861&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 167861 03/11/2026 An inspector may not issue to a person a citation for a violation of a food rule adopted under Health and Safety Code, Chapters 431 - 441, if the person provides the inspector with an official determination made under §231.3 of this title (relating to Request for Official Determination) that contradicts the opinion of the inspector. Source Note: The provisions of this §231.4 adopted to be effective July 13, 2014, 39 TexReg 5180. 1 DEPARTMENT OF STATE HEALTH SERVICES 231 REQUESTS FOR INFORMATION OR OFFICIAL DETERMINATION ON FOOD REGULATION §231.4 Effect of Official Determination https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101027&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101027 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101027&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101027 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings unless the context clearly indicates otherwise.(1) Authorized agent--An employee of the Texas Department of Health who is designated by the commissioner of health to enforce the provisions of these sections.(2) Act--The Texas Health and Safety Code, Chapter 436, Aquatic Life.(3) Commissioner--The commissioner of health for the State of Texas.(4) Compliance schedule--A written schedule that provides a time period to correct critical, key and other deficiencies.(5) Container--The physical material in contact with or immediately surrounding the crabmeat that confines it into a single unit.(6) Cook lot--All of the crabmeat product cooked in one day at one location.(7) Crabmeat--The edible meat of steamed or cooked crabs that has not been processed other than by picking, packing, and chilling.(8) Critical Control Point (CCP)--A point, step or procedure in a food process at which control can be applied, and as a result a food safety hazard can be prevented, eliminated or reduced to acceptable levels.(9) Critical deficiency--A condition or practice which:(A) results in the production of a product that is adulterated, decomposed, misbranded or unwholesome; or(B) presents a threat to the health or safety of the consumer.(10) Critical limit--The maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.(11) Dealer--A person to whom a license is issued for the activities of crabmeat picking and packing or crabmeat picking, packing, and pasteurization.(12) Department--The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, or its successor state agency, having the responsibility for the enforcement of laws concerning the safety of the food supply including regulating the processing, picking, packing, pasteurization, and/or shipping of crabmeat.(13) Food safety hazard--Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.(14) HACCP--Hazard Analysis Critical Control Point, a systematic, science-based approach used in food production as a means to assure food safety. The concept is built upon the seven principles identified by the National Advisory Committee on Microbiological Criteria for Foods (1992).(15) HACCP Plan--A written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in Title 21, Code of Federal Regulations (CFR), §123.6.(16) Key deficiency--A condition or practice that may result in adulterated, decomposed, misbranded or unwholesome product.(17) Label--Any written, printed or graphic matter affixed to or appearing upon any package containing crabmeat.(18) License--A numbered document issued by the department that authorizes a dealer to process crabmeat for sale.(19) License number--The unique identification number issued by the department to each dealer for each location. Each license number shall consist of a one to five-digit Arabic number preceded by the two-letter state abbreviation and followed by a one or two-letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with the following terms:(A) crabmeat picking and packing (C); or(B) crabmeat picking, packing, and pasteurization (CP).(20) Licensed location--A plant or place of business that has been inspected by the Seafood Safety Division of the department and for which a crabmeat processing license has been issued.(21) Other deficiency--A condition or practice that is not defined as critical or key, but is of a public health significance and, if left uncorrected, could result in a key or critical violation.(22) Packing--The placing of crabmeat into containers for off-premise consumption.(23) Pasteurization plant--A place where crabmeat is heat-treated, without complete sterilization, to improve keeping qualities of the meat.(24) Pasteurized crabmeat--The meat of crabs cooked, picked, and packed for off-premise consumption which has been heat treated, without complete sterilization, to improve keeping qualities of the meat.(25) Person--Any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, government, or governmental subdivision or agency, partnership, association, corporation or other legal entity.(26) Pick(ing)--The removal of crabmeat from the crab shell.(27) Picking plant--A place where crabs are cooked and edible meat is picked therefrom.(28) Principal display panel--The part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of retail sale.(29) Sanitation control record--Records that document the monitoring of sanitation practices and conditions.(30) Sewer--An artificial, usually subterranean, conduit to carry off sewage and/or surface water.(31) SSD--The Seafood Safety Division of the Texas Department of Health, to which responsibility for regulating the processing, picking, packing, pasteurization, and/or shipping of crabmeat is delegated. Source Note: The provisions of this §241.1 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101028&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101028 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101028&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101028 03/11/2026 (a) No crabmeat may be offered for sale for food in the State of Texas unless the crabmeat has been processed and packaged in compliance with §§241.1 - 241.9 of this title (relating to Texas Crabmeat). If obtained from sources outside of the state, the crabmeat shall originate from a source acceptable to the department. These sources must be licensed and inspected by the appropriate state or other government authority.(b) For sources outside the United States to be approved, documentation must be provided by a foreign governmental authority(s) that verifies the licensing and inspection and states that the processes involved comply with §§241.1 - 241.9 of this title, including the HACCP requirements described in §241.6 of this title (relating to General HACCP Requirements).(c) Crabmeat from sources other than those outlined in this section shall not be sold, offered for sale, or held for sale in the State of Texas. Source Note: The provisions of this §241.2 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.2 Sources of Crabmeat https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101029&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101029 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101029&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101029 03/11/2026 (a) No person shall engage in any activity requiring a license under §§241.1 - 241.9 of this title (relating to Texas Crabmeat) without having applied for and obtained an annual numbered license pertaining to the particular activity from the commissioner. No license will be issued without a HACCP plan, in accordance with §241.6 of this title (relating to General HACCP Requirements), that is acceptable to the SSD.(b) Dealer Licensing.(1) Picker-Packer. Any person who cooks crabs and picks and packs the crabmeat shall be licensed as a picker-packer.(2) Pasteurizer. Any person who cooks crabs, picks, packs, and pasteurizes the crabmeat, or pasteurizes crabmeat picked and packed in another location shall be licensed as a pasteurizer.(c) Time Period for Processing and Issuing a License.(1) The date a license application is received is the date the original application reaches the department.(2) The period for processing an application begins on the date the SSD receives a compliance memo from an authorized agent of the state, which states the facility is in compliance with all applicable rules, including the HACCP requirements described in §241.6 of this title.(3) An application for a license is complete when:(A) the SSD has received, reviewed, and found acceptable the application information required by §§241.1 - 241.9 of this title.(B) the SSD receives a compliance memo from an authorized agent of the state, which states the facility is in compliance with all applicable rules, including the HACCP requirements described in §241.6 of this title.(4) A license is valid from March 1 through the last day of February each year, or part thereof.(d) Prior to beginning construction of a new crabmeat plant or major remodeling of an existing crabmeat plant (which includes, but is not limited to: any process new to that particular plant; any change of product flow; or any enlarging of the plant structure), complete, legible plans showing the floor plan of the building with dimensions drawn to scale, location of equipment, doors, floor drains, etc., and written, complete operational procedures for all phases of the activity, including flow of the product, shall be submitted to SSD for review and written approval. Additional plans of the entire premises may be required showing all structures, as well as all water wells and septic systems, with related distances and a statement of specifications as to type, sizes, design, date installed, etc. Plans shall be submitted to the SSD no less than 30 days prior to initiating a new process or beginning construction. No operations shall be conducted while any construction or related activity, that has the potential to contaminate the product, is occurring inside the plant.(e) A legibly written or typed application on forms provided by the department must be filed with the SSD each year.(f) If the applicant proposes to use a date other than an open date, the application for a license must be accompanied by a written statement of the procedure the applicant will use to determine the date to be included on the label for crabmeat packed or pasteurized and shipped from the location listed in the application.(g) A license and unique number shall be issued by the commissioner only after an inspection of the plant by an authorized agent has revealed that the plant and practices are in compliance with these sections. A license and unique number shall be issued to a dealer for each location at which crabmeat operations are to be conducted and a license is required.(h) The inspection of a previously licensed plant which has exhibited operational problems, violations of operational requirements of these sections, or has had a license revoked shall not be conducted until written, complete operational procedures for all phases of the activity, including flow of the product, are submitted to the SSD for review and approval. An application may be refused and a license denied based on a history of failure to comply with the requirements of these sections in accordance with §241.5 of this title (relating to Enforcement).(i) Crabmeat operations by the dealer shall not begin until the commissioner has issued the crabmeat processing license for that location. Each license shall expire automatically at 11:59 p.m. the last day of February following the date of issue. Licenses shall not be transferable. Source Note: The provisions of this §241.3 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.3 Licensing Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101030&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101030 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101030&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101030 03/11/2026 (a) After a license is issued, unannounced inspections may be conducted at any time the SSD has reasonable belief that the business may be in operation or that crabmeat may be stored on the premises. Inspections may be made at such frequency as may be necessary to assure that adequate operational and sanitary conditions are maintained, and the license holder is in compliance with these rules.(b) All crabmeat at a licensed location shall be the responsibility of the dealer at that location for the purposes of these sections.(c) A copy of the completed inspection form listing written descriptions of the violations observed, along with any necessary explanation, shall be provided by an authorized agent of the department to the most responsible individual present at the firm at the conclusion of the inspection. If a responsible individual is not present, the form will be mailed.(d) Any violations of the same rule or regulation found on any two consecutive inspections may result in license suspension in accordance with §241.5(a) of this title (relating to Enforcement).(1) When an inspection detects a critical deficiency, the violation shall be immediately corrected during that inspection or the plant must immediately cease production affected by the violation. If production affected by the violation does not voluntarily cease, all crabmeat handled or processed while the violation exists or existed shall be detained. Further enforcement action may be taken as authorized under this chapter.(2) When an inspection detects four or more key deficiencies, the dealer shall establish a correction schedule acceptable to the SSD. The follow-up inspection shall determine if the violations have been corrected or are being corrected in accordance with the scheduled correction dates noted on the previous inspection report.(3) When a routine inspection detects other deficiencies or three or fewer key deficiencies, the deficiencies shall be corrected prior to the next routine inspection. Source Note: The provisions of this §241.4 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.4 Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101031&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101031 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101031&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101031 03/11/2026 (a) The department may refuse to license, suspend or revoke a license if the applicant or licensee:(1) fails to comply with any provision of the statute;(2) fails to comply with any provision of this chapter;(3) commits fraud, misrepresentation, or concealment of a material fact on any documents required to be submitted to the department or required to be maintained by the facility pursuant to this chapter;(4) aids, abets, or permits the commission of an illegal act;(5) fails to comply with an order of the commissioner of health or another enforcement procedure under the statute;(6) the license holder or representative refuses to allow an inspection or otherwise interferes with the authorized department agent in the performance of his or her duties;(7) fails to have a HACCP plan, has a HACCP plan unacceptable to the SSD, or fails to comply with a HACCP plan that is acceptable to the SSD;(8) fails to provide the required application;(9) has any critical violations identified during the license inspection; or(10) has more than two key deficiencies and three other deficiencies identified during the license inspection.(b) If the department proposes to refuse to license, proposes to suspend, or proposes to revoke a license, the department shall notify the applicant or license holder of the reasons for the proposed action and offer the person an opportunity for a hearing. Notice may be sent by certified mail or first class mail.(1) If the facility chooses to request a hearing, it shall do so within 20 calendar days of receipt of the notice. Receipt of the notice is presumed to occur on the fifth calendar day after the notice is mailed to the last address known to the department unless another receipt date is reflected on a United States Postal Service return receipt.(2) The request for a hearing shall be in writing and submitted to the Director, SSD, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199.(3) A hearing shall be conducted pursuant to the Administrative Procedure Act, Texas Government Code, Chapter 2001, and the department's formal hearing procedures in Chapter 1 of this title (relating to Texas Board of Health).(4) If the facility does not request a hearing in writing within 20 calendar days of receipt of the notice, the facility is deemed to have waived the opportunity for a hearing and the proposed action shall be taken.(5) If the person fails to appear or be represented at the scheduled hearing, the person has waived the right to a hearing and the proposed action shall be taken.(c) If the department suspends a license, the suspension shall remain in effect until the department determines that the reason for suspension no longer exists. An authorized representative of the department shall investigate prior to making a determination. During the time of suspension, the suspended license holder shall return the license to the department and shall not process crabmeat.(d) If the department revokes a license, a person may reapply for a license 180 days after the date of signing of the final order of revocation. The department may refuse to issue a license if the reason for revocation or non-renewal continues to exist, or the applicant does not meet the requirements for a license.(e) Upon revocation a license holder shall return the license to the department. A dealer whose license has been revoked may not be issued a new license for 180 days or before the next licensing period, whichever is longer, after the date of signing of the final order of revocation.(f) Pursuant to Health and Safety Code, §§436.034 - 436.037, the department may assess an administrative penalty against a person who violates §436.011 of the statute or an order issued under this chapter.(1) The penalty may not exceed $25,000 for each violation. Each day of a continuing violation constitutes a separate violation.(2) In determining the amount of an administrative penalty assessed under this section, the department shall consider:(A) the seriousness of the violation;(B) the person's previous violations;(C) the hazard to the health and safety of the public;(D) the person's demonstrated good faith; and(E) any other matters that justice may require.(3) All proceedings for the assessment of an administrative penalty are subject to the Administrative Procedure Act, Government Code, Chapter 2001.(4) If, after investigation of an alleged violation and the facts surrounding that alleged violation, the department determines that a violation has occurred, the department shall give written notice of the violation to the person alleged to have committed the violation. The notice shall include:(A) a brief summary of the alleged violation including the statute and/or rules violated;(B) a statement of the amount of the proposed penalty, based on the factors listed in paragraph (2) of this subsection; and(C) a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.(5) The seriousness of violations for which administrative penalties are assessed may be categorized by one of the following severity levels.(A) Severity Level I covers violations that are most significant and may have a significant negative impact on public health and safety.(B) Severity Level II covers violations that are very significant and may have a negative impact on the public health and safety.(C) Severity Level III covers violations that are significant, and if not corrected, could threaten public health and safety.(D) Severity Level IV covers violations that are of more than minor public health and safety significance, but if left uncorrected could lead to more serious circumstances.(E) Severity Level V covers violations that are of minor public health and safety significance.(6) Not later than the 20th calendar day after the date the notice is received, the person notified may accept the determination of the department made under this section, including the recommended penalty, or make a written request for a hearing on that determination.(7) If the person notified of the violation accepts the determination of the department, or fails to request a hearing, the department shall issue an order approving the determination that a violation occurred and ordering that person to pay the recommended penalty.(8) If a hearing is requested, the department shall refer the matter to the State Office of Administrative Hearings for a hearing.(9) The provisions of §§436.035 and 436.036 of the Act shall be followed in assessing and paying an administrative penalty. Source Note: The provisions of this §241.5 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.5 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101032&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101032 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101032&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101032 03/11/2026 (a) The department hereby adopts by reference Title 21, Code of Federal Regulations (CFR), §123.6 (Hazard Analysis and Hazard Analysis Critical Point (HACCP Plan), as amended. If the requirements of this chapter are more stringent than the requirements of other adopted requirements, then this chapter's requirements prevail and must be complied with.(b) Those dealers required to be licensed under this subchapter shall comply with all the requirements of this section, the Texas Aquatic Life Act, Health and Safety Code, Chapter 436, and the requirements of Title 21, CFR, §123.6, as amended.(c) Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of crabmeat product processed by that dealer and to identify the preventive measures that the dealer can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment and can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent dealer would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that the hazard will occur in the particular type of crabmeat product being processed in the absence of those controls.(d) Every dealer shall have, implement, and comply with a written HACCP plan that is acceptable to the SSD. A copy of the plan shall be provided to the SSD upon request. A HACCP plan shall be specific to:(1) each location where crabmeat products are processed by that dealer; and(2) each kind of crabmeat product processed by the dealer. The plan may group kinds of crabmeat products together, or group kinds of production methods together if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in this section are identical for all crabmeat products so grouped or for all production methods so grouped.(e) The HACCP plan shall, at a minimum:(1) list the food safety hazards that are reasonably likely to occur, as identified in accordance with subsection (c) of this section and that must be controlled for each crabmeat product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:(A) natural toxins;(B) microbiological contamination;(C) chemical contamination;(D) pesticides;(E) drug residues;(F) unapproved use of direct or indirect food or color additives; and(G) physical hazards;(2) list the critical control points for each of the identified food safety hazards, including as appropriate:(A) critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest; and(B) critical control points designed to control food safety hazards that could be introduced in the processing plant environment;(3) list the critical limits that must be met at each of the critical control points;(4) list the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;(5) include any written corrective action plans that have been developed in accordance with this section to be followed in response to deviations from critical limits at critical control points;(6) list the verification procedures, and frequency thereof, that the dealer will use in accordance with this section; and(7) provide for a record keeping system that documents the monitoring of critical control points. The records shall contain the actual values and observations obtained during monitoring.(f) The HACCP plan shall be signed and dated by the most responsible individual on site at the processing facility or by a higher level official of the dealer:(1) upon initial acceptance;(2) upon any modification; and(3) upon verification of the plan in accordance with subsection (i)(1)(A) of this section.(g) Sanitation controls may be included in the HACCP plan, however they must be monitored in accordance with §241.7 of this title (relating to General Sanitation Requirements).(h) Corrective actions.(1) Whenever a deviation from a critical limit occurs, a dealer shall take corrective action either by:(A) following a corrective action plan that is appropriate for the particular deviation; or(B) following the procedures in paragraph (2) of this subsection.(2) Dealers may develop written corrective action plans, which become part of their HACCP plans in accordance with subsection (e)(5) of this section, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps to ensure that:(A) no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and(B) the cause of the deviation is corrected.(3) When a deviation from a critical limit occurs and the dealer does not have a corrective action plan that is appropriate for that deviation, the dealer shall:(A) segregate and hold the affected product, at least until the requirements of subparagraphs (B) and (C) of this paragraph are met;(B) perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review;(C) take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;(D) take corrective action, when necessary, to correct the cause of the deviation; and(E) perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with this section to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.(4) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with subsection (i) of this section and the record keeping requirements of subsection (j) of this section.(i) Verification.(1) Every dealer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur and that the plan is being effectively implemented. Verification shall include, at a minimum:(A) a reassessment of the adequacy of the HACCP plan at least annually or whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way. The reassessment shall be performed by an individual or individuals who have been trained in accordance with subsection (k) of this section. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of subsection (e) of this section. These changes may include:(i) raw materials or source of raw materials;(ii) product formulation;(iii) processing methods or systems;(iv) finished product distribution systems; or(v) the intended use or consumers of the finished product;(B) ongoing verification activities including:(i) a review of any consumer complaints that have been received by the dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;(ii) the calibration of process-monitoring instruments; and(iii) at the option of the dealer, the performing of periodic end-product or in-process testing; and(C) a review, including signing and dating, by an individual who has been trained in accordance with subsection (k) of this section, of the records that document:(i) the monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;(ii) the taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with subsection (h) of this section. This review shall occur within one week of the day that the records are made; and(iii) the calibrating of any process monitoring instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the dealer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the dealer's written procedures as specified in the HACCP plan. These reviews shall occur within a reasonable time period after the records are made.(2) Dealers shall immediately follow the procedures in subsection (h) of this section whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.(3) The calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing, in accordance with paragraph (1)(B)(ii) and (iii) of this subsection shall be documented in records that are subject to the record keeping requirements of subsection (j) of this section.(j) Records.(1) All records required shall include:(A) the name and location of the dealer;(B) the date and time of the activity that the record reflects;(C) the signature or initials of the person performing the operation; and(D) where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.(2) All records required shall be retained at the processing facility for at least one year after the date they were prepared in the case of refrigerated products and for at least two years after the date they were prepared in the case of frozen products.(3) Records that relate to the general adequacy of equipment or processes being used by a dealer, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least two years from the date that product is first produced using the applicable equipment or processes.(4) If the processing facility is closed for a prolonged period between seasonal operations or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal operations, but shall be immediately producible for official review upon request by the department.(5) All records required by subsection (j) of this section and HACCP plans required by subsections (d) and (e) of this section shall be available for official review and copying upon request by the department.(6) The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.(k) Training.(1) At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to crabmeat processing at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration (FDA) or who is otherwise qualified through job experience to perform these functions:(A) developing a HACCP plan, which could include adopting a model or generic-type HACCP plan that is appropriate for a specific processor, in order to meet the requirements of subsection (e) of this section;(B) reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in subsection (h)(3)(E) of this section, and the HACCP plan in accordance with the verification activities specified in subsection (i)(1)(B) of this section; and(C) performing the record review required by subsection (i)(1)(C) of this section.(2) Job experience will qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum as determined by the SSD.(3) The trained individual need not be an employee of the dealer. Source Note: The provisions of this §241.6 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.6 General HACCP Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101033&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101033 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101033&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101033 03/11/2026 (a) Each dealer shall monitor conditions and practices that are both appropriate to the plant and the food being processed with sufficient frequency to ensure, at a minimum, conformance with the requirements specified in §§229.211 - 229.219 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food). The requirements specified in §§229.211 - 229.219 of this title relate to the following sanitation items:(1) safety of water for processing and ice production;(2) condition and cleanliness of food contact surfaces;(3) prevention of cross contamination;(4) maintenance of hand washing, hand sanitizing and toilet facilities;(5) protection from adulterants;(6) proper labeling, storage, or use of toxic compounds;(7) control of employees with adverse health conditions; and(8) exclusion of pests.(b) Each dealer shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by subsection (a) of this section. These records are subject to the requirements of §241.6(j) of this title (relating to General HACCP Requirements).(c) Sanitation controls may be included in the HACCP plan, as required by §241.6(d) of this title. However, to the extent that they are monitored in accordance with subsection (a) of this section, they need not be included in the HACCP plan. Source Note: The provisions of this §241.7 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.7 General Sanitation Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101034&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101034 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101034&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101034 03/11/2026 (a) All containers of fresh or fresh frozen crabmeat shall have permanently recorded on the principal display panel, so as to be easily visible, the following information:(1) the dealer or distributor's name;(2) the dealer's or distributor's address, including at least the city and state;(3) the license number for the licensed location where the crabmeat was packed or pasteurized; and(4) where the name and address of a distributor is used, it shall be preceded by the words "PACKED FOR" or "DISTRIBUTED BY", or followed by the word "DISTRIBUTOR."(b) The principal display panel on each container of fresh or fresh frozen crabmeat shall contain a date. The date shall be the date of packing unless a "SELL BY" date is established and used in accordance with subsection (c) of this section.(c) The date shall be as follows:(1) if it is an open date, it shall be the calendar date as follows: the abbreviation for the month, the numerical day of the month, and the year;(2) if it is a code date, the proposed method must be submitted in writing to the SSD and approved by the SSD before it is used; and(3) if it is a "SELL BY" date, it shall be based on the date the crabmeat was packed and the proposed method must be submitted in writing to the SSD and approved by the SSD before it is used.(d) The presence of any chemical, if any is allowed, and the net weight of the contents shall be permanently recorded on the container. The proper designation of the contents of the container (lump, special, claw, finger, etc.) is required and shall be recorded either on the container sidewall or the lid.(e) Frozen crabmeat shall be labeled as "FROZEN", "INDIVIDUALLY QUICK FROZEN", or "IQF", in print of similar prominence adjacent to the words "CRABMEAT." Containers shall be marked as frozen prior to freezing.(f) All required information shall be provided in a legible and indelible form and shall be either:(1) on the sidewall of the container unless the cover becomes an integral part of the container during a sealing process; or(2) sealed into an area where it remains legible and visible as the principal display panel until all product from the container has been used or disposed of.(g) Adhesive labels shall be durable and waterproof and shall not be used without prior approval from the SSD. The request for use of adhesive labels must be submitted in writing to the SSD.(h) Use of rubber stamps is not allowed except for dating.(i) All labeling is subject to review and approval by the SSD.(j) Reusable containers for in-plant use during picking and packing are exempt from labeling requirements. These containers may be used only for temporary holding of crabmeat during picking and packing activities. Crabmeat may not be stored in unlabeled containers.(k) The label on pasteurized crabmeat shall meet all of the requirements established for fresh or fresh frozen crabmeat in this section.(l) The label on pasteurized crabmeat shall clearly identify the contents of the container as pasteurized crabmeat. Where the term "CRABMEAT" (or its equivalent) appears on the label of pasteurized crabmeat, the word "PASTEURIZED" shall be used in conjunction with it and in print of similar prominence.(m) Each container of pasteurized crabmeat shall be permanently and legibly identified with a code indicating the batch and the day of processing.(n) The words "PERISHABLE--KEEP UNDER REFRIGERATION" or their equivalent shall be prominently displayed on the label of pasteurized crabmeat.(o) When packing and pasteurization of crabmeat by one dealer for another is practiced, the label shall clearly state the license number of the packer/pasteurizer.(p) When crabmeat is packed in one licensed crabmeat picking plant and pasteurized in another licensed crabmeat pasteurization plant, the label shall clearly state the name and license number of both dealers. Source Note: The provisions of this §241.8 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.8 Crabmeat Identification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101035 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101035&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101035 03/11/2026 (a) Complete, accurate, and legible records in a form approved by the SSD shall be maintained by each dealer. The records shall be sufficient to document the dates of purchases of live crabs and the dates of purchases or shipments of crabmeat so that a container of crabmeat can be traced to the specific cook lot in which it was processed.(b) Records covering purchases of live crabs and shipments of fresh crabmeat, pasteurized crabmeat, or frozen crabmeat shall be retained for a minimum of two years, or for a period of time that exceeds the shelf life of the product if that is longer than two years.(c) Records shall be made available for inspection, review, or copying upon request of any authorized agent of the department at any reasonable time.(d) All brand names or trade names used on packages or containers holding crabmeat shall be registered with the SSD prior to being used. Source Note: The provisions of this §241.9 adopted to be effective March 20, 2003, 28 TexReg 2345. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION A TEXAS CRABMEAT §241.9 Crabmeat Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101060&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101060 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101060&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101060 03/11/2026 The following words and terms, when used in this subchapter of this title, relating to molluscan shellfish, shall have the following meanings unless the context clearly indicates otherwise.(1) Act--The Texas Health and Safety Code, Chapter 436, Aquatic Life.(2) Air gap--The unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet supplying water to a tank, plumbing fixture or other device, and the flood level rim of that receptacle.(3) Application process--The filing of an application for certification with the Texas Department of Health followed by an inspection by an authorized agent confirming compliance with the rules.(4) Approved area--A classification used to identify a harvest area where harvest for direct marketing is allowed.(5) Approved source--A source of molluscan shellfish acceptable to the director (commissioner of health).(6) Aquaculture--The cultivation of seed in natural or artificial growing or harvest areas, or the cultivation of molluscan shellstock other than seed in harvest areas.(7) Assure--To make certain.(8) Authorized agent--An employee of the Texas Department of Health who is designated by the commissioner to enforce provisions of these sections.(9) Backflow--The flow of water or other liquids, mixtures or substances into the distribution pipes of a potable water supply from any source or sources other than the intended source.(10) Back siphonage--The flowing back of used, contaminated or polluted water from a plumbing fixture, vessel or other source into potable water supply pipes because of negative pressure in the water supply pipes.(11) Blower--A receptacle for washing shucked molluscan shellfish that uses forced air as a means of agitation.(12) Certificate (molluscan shellfish certificate of compliance)--A numbered document issued by the commissioner which authorizes a dealer to process molluscan shellfish for sale.(13) Certification or certify--The issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:(A) permission from the department to conduct the activity; and(B) initial compliance with the requirements of §§241.50 - 241.71 of this title (relating to Molluscan Shellfish).(14) Certification number--The unique identification number issued by the commissioner to each dealer for each location. Each certification number shall consist of a one to five-digit Arabic number preceded by the two-letter state abbreviation and followed by a two-letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with the following terms:(A) shellstock shipper (SS);(B) shucker/packer (SP);(C) repacker (RP); and(D) depuration processor (DP).(15) Certified location--A plant or place of business that has been inspected by the Seafood Safety Division of the department and for which a molluscan shellfish certificate of compliance has been issued.(16) Coliform group--All of the aerobic and facultative anaerobic, gram negative, non spore-forming, rod-shaped bacilli which ferment lactose broth with gas formation within 48 hours at 95 degrees Fahrenheit (35 degrees plus or minus 0.5 degrees Centigrade).(17) Commingle or commingling--The act of combining different lots of molluscan shell stock or shucked molluscan shellfish.(18) Commissioner--The commissioner of health for the State of Texas and the executive head of the department.(19) Compliance schedule--A written schedule that provides a specific time period to correct critical, key and other deficiencies.(20) Conditionally approved area--A classification used to identify a harvest area which meets the criteria for the approved classification except under certain conditions described in a management plan established by the SSD.(21) Conditionally restricted area--A classification used to identify a harvest area which meets the criteria for the restricted classification except under certain conditions described in a management plan established by the SSD.(22) Container--The physical material in contact with or immediately surrounding molluscan shellfish that confines it into a single unit.(23) Corrosion resistant materials--Materials that maintain their original surface characteristics under normal exposure to the foods being contacted, normal use of cleaning compounds and bactericidal solutions, and other conditions of use.(24) Critical Control Point (CCP)--A point, step or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated or reduced to acceptable levels.(25) Critical deficiency--A condition or practice which:(A) results in the production of a product that is adulterated, decomposed, misbranded or unwholesome; or(B) presents a threat to the health or safety of the consumer.(26) Critical limit--The maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.(27) Cross connection--An unprotected actual or potential connection between a potable water system and any source or system containing unapproved water or a substance that is not or cannot be approved as safe and potable. Examples include bypass arrangements, jumper connection, removable sections, swivel or change over devices, or other devices through which backflow could occur.(28) Cull--To remove dead or unsafe molluscan shell stock from a lot of molluscan shell stock.(29) Dealer--A person to whom certification is issued for the activities of molluscan shell stock shipper, shucker-packer, repacker, or depuration processor.(30) Deficiency--A condition or practice that is a violation of the Act or rules.(31) Department--The Texas Department of Health (TDH), 1100 West 49th Street, Austin, Texas 78756, or its successor state agency, having the responsibility for the enforcement of laws concerning the safety of the food supply, including molluscan shellfish growing area classification and certification of molluscan shellfish dealers.(32) Depletion--The removal, under the direct control of the Texas Parks and Wildlife Department, of all existing commercial quantities of market-size molluscan shellfish from a harvest area classified as prohibited.(33) Depuration or depurate--The process of reducing the level of bacteria and viruses that may be present in molluscan shellfish by using a controlled aquatic environment as the treatment process.(34) Depuration plant--A place where depuration of molluscan shellfish occurs.(35) Depuration Processor (DP)--A person who harvests or receives molluscan shell stock from harvest areas in the approved or conditionally approved, restricted, or conditionally restricted classification and submits such molluscan shell stock to an approved depuration process.(36) Direct marketing--The sale for human consumption of molluscan shellfish which:(A) does not require depuration or relaying prior to sale; or(B) have been subjected to depuration or relaying activities.(37) Director--The executive head (commissioner of health) of the Texas Department of Health.(38) Dry storage--The storage of molluscan shell stock out of water.(39) Durable material--Material with the ability to exist for several years without significant deterioration and able to withstand normal daily use associated with molluscan shellfish operations.(40) Easily cleanable--A surface which is:(A) readily accessible; and(B) is made of such materials, has a finish, and is so fabricated that residues may be effectively removed by normal cleaning methods.(41) Facility--A structure.(42) FDA--The United States Food and Drug Administration or its successor agency, the federal agency in which regulation of foods, including the Cooperative Shellfish Program, is vested.(43) Food contact surface--An equipment surface or utensil that normally comes into direct or indirect contact with shucked molluscan shellfish.(44) Food safety hazard--Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.(45) Gatherer--Person who takes molluscan shellfish by any means from a growing area designated by the commissioner for delivery to a depuration plant.(46) GLO--The Texas General Land Office, 1700 North Congress, Austin, Texas 78701, or its successor agency, the state agency having the responsibility for the enforcement of laws concerning all state lands, including leasing of wetland bottom for private oyster leases.(47) Growing area--Any site that supports or could support the propagation of molluscan shell stock by natural or artificial means.(48) HACCP--Hazard Analysis Critical Control Point, a systematic, science-based approach used in food production as a means to assure food safety. The concept is built upon the seven principles identified by the National Advisory Committee on Microbiological Criteria for Foods (1992).(49) HACCP Plan--A written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in Title 21, Code of Federal Regulations (CFR), §123.6.(50) Harvest--The act of removing molluscan shell stock from growing or harvest areas and its placement on or in a manmade conveyance or other means of transport.(51) Harvest area--An area that contains commercial quantities of molluscan shell stock and may include aquaculture sites and facilities.(52) Harvester--A person who takes molluscan shell stock by any means from a harvest area.(53) Heat shock--The process of subjecting molluscan shell stock to any form of heat treatment prior to shucking, including steam, hot water or dry heat, to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the molluscan shellfish.(54) ISSC--The Interstate Shellfish Sanitation Conference. The ISSC consists of agencies from molluscan shellfish producing and receiving states, FDA, the molluscan shellfish industry, and the National Marine Fisheries Service of the U.S. Department of Commerce.(55) Key deficiency--A condition or practice that may result in adulterated, decomposed, misbranded or unwholesome product.(56) Label--Any written, printed or graphic matter affixed to or appearing upon any package containing molluscan shellfish.(57) License--The document issued by the Texas Parks and Wildlife Department, under the Texas Parks and Wildlife Code, Chapter 47 or Chapter 76, which authorizes a person to harvest or transport molluscan shell stock for commercial sale.(58) Lot of molluscan shell stock--A single type of bulk molluscan shell stock or containers of molluscan shell stock of no more than one day's harvest from a single defined harvest area gathered by one or more harvesters.(59) Lot of molluscan shell stock for depuration--Molluscan shell stock harvested from a particular area during a single day's harvest and delivered to one depuration plant.(60) Lot of shucked molluscan shellfish--A collection of containers of no more than one day's shucked molluscan shellfish product produced under conditions as uniform as possible, and designated by a common container code or marking.(61) Marina--Any water area with a structure (docks, basin, floating docks, etc.) which is:(A) used for docking or otherwise mooring vessels; and(B) constructed to provide temporary or permanent docking space for more than ten boats.(62) Marine biotoxin--Any poisonous compound produced by marine microorganisms and accumulated by molluscan shell stock. Examples of toxin producing marine microorganisms include Alexandrium spp. (Proto gonyaulax species) and Karenia breves.(63) Market shellfish--Molluscan shellfish which are, may be, or have been harvested and/or prepared for sale for human consumption as a fresh or frozen product.(64) Molluscan shellfish--All species of:(A) oysters, clams or mussels, whether:(i) shucked or in the shell;(ii) fresh or frozen; and(iii) whole or in part.(B) scallops in any form, except when the final product form is the adductor muscle only.(65) Monoculture--The culture of a single molluscan shellfish species.(66) MPN--Most probable number.(67) Nursery products--Molluscan shellfish which do not exceed 10% of the market weight or that are six months or more growing time from market size.(68) Open area--A molluscan shellfish growing area where the harvesting for sale, harvesting for transplant, or gathering for depuration of molluscan shellfish is allowed. An open area status may be placed on any one of the classified area designations except for a prohibited area.(69) Open water aquaculture--The cultivation of molluscan shellfish in natural molluscan shellfish harvest areas.(70) Other deficiency--A condition or practice that is not defined as critical or key, but is of a public health significance and, if left uncorrected, could result in a key or critical deficiency.(71) Pack (packing)--All activities involved in placing molluscan shellfish in containers.(72) Person--Any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, government or governmental subdivision or agency, partnership, association, corporation or other legal entity.(73) Poisonous or deleterious substance--A toxic substance occurring naturally or added to the environment for which a regulatory tolerance limit or action level has been established in molluscan shellfish to protect public health.(74) Polyculture--The cultivation of:(A) two or more species of molluscan shellfish; or(B) molluscan shellfish with other species in a common environment.(75) Potable water--A water supply that is suitable for human consumption.(76) Principal display panel--The part of a label that is most likely to be displayed, presented, shown or examined under customary conditions of retail sale.(77) Process batch--A quantity of molluscan shell stock used to fill each separate tank or a series of tanks supplied by a single process water system for a specified depuration cycle in a depuration activity.(78) Process water--The water used in the scheduled depuration process.(79) Prohibited area--A classification used to identify a harvest area where the harvest of molluscan shell stock for any purpose, except depletion or gathering of seed for aquaculture, is not permitted.(80) Records--Written documents required to be maintained under this chapter.(81) Relaying--Transferring of shellstock from a growing area classified as restricted or conditionally restricted to a growing area classified as approved or conditionally approved for the purpose of reducing pathogens, as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the shellstock, by using the ambient environment as the treatment process.(82) Repacker (RP)--A dealer who buys, repacks and sells molluscan shellfish. Repackers are not authorized to shuck shellfish.(83) Repacking molluscan shellstock--The practice of removing molluscan shell stock from containers and placing it into other containers.(84) Restricted area--A classification used to identify a harvest area where harvesting shall be by special license and the molluscan shell stock, following harvest, is subjected to a suitable and effective treatment process through transplanting or gathering for depuration.(85) Safe materials--Articles manufactured from or composed of materials that may not reasonably be expected to, directly or indirectly, become a component of or otherwise adversely affect the characteristics of any food.(86) Sanitation control record--Records that document the monitoring of sanitation practices and conditions.(87) Sanitize--To adequately treat food contact surfaces by a process that is effective in:(A) destroying vegetative cells of microorganisms of public health significance;(B) substantially reducing the numbers of other undesirable microorganisms; and(C) not adversely affecting the product or its safety for the consumer.(88) Seed--Molluscan shell stock which is less than market size.(89) Sewage--Refuse liquids or waste matter, including hand sink drainage.(90) Sewer--An artificial, usually subterranean, conduit to carry off sewage and/or surface water.(91) Sewerage--The removal and disposal of sewage and surface water by sewers.(92) Shell stock--Live molluscan shellfish in the shell.(93) Shell stock packing--The process of placing molluscan shell stock into containers for introduction into commerce.(94) Shellstock Shipper (SS)--A dealer who grows, harvests, buys, or repacks and sells molluscan shell stock. They are not authorized to shuck molluscan shellfish or to repack shucked molluscan shellfish. A shellstock shipper may also ship shucked molluscan shellfish.(95) Shucked shellfish--Molluscan shellfish, whole or in part, from which one or both shells have been removed.(96) Shucker/Packer (SP)--A person who shucks and packs molluscan shellfish. A shucker-packer may act as a shellstock shipper or may repack molluscan shellfish originating from other certified dealers.(97) SSD--The Seafood Safety Division of the Texas Department of Health to which responsibility to classify molluscan shellfish growing areas and to regulate harvesting, processing, and/or shipping of molluscan shellfish is delegated.(98) Take--Catch, hook, net, snare, trap, kill, or capture by any means, including the attempt to take.(99) Temperature Control--The management of the environmental temperature of shellstock by means of ice, mechanical refrigeration or other approved means that is capable of lowering the temperature of the shellstock and maintaining it at 45 degrees Fahrenheit (7.2 degrees Centigrade) or less.(100) TDA--The Texas Department of Agriculture, 1700 North Congress, Austin, Texas 78701, or its successor state agency having responsibility for enforcement of laws concerning licensing of aquaculture.(101) TCEQ--The Texas Commission on Environmental Quality, 12100 Park 35 Circle, Austin, Texas 78753, or its successor state agency having the responsibility for the enforcement of laws concerning water supplies and discharges of water or wastewater in Texas.(102) TPWD--The Texas Parks and Wildlife Department, 4200 Smith School Road, Austin, Texas 78744, or its successor state agency having the responsibility for the enforcement of laws concerning harvesting and depletion of molluscan shellfish resources.(103) Transaction record--The form or forms used to document each purchase or sale of molluscan shellfish at the wholesale level, including molluscan shellfish harvest and sales records, ledgers, purchase records, invoices and bills of lading.(104) Transplant (transplanting)--To transfer molluscan shell stock from a harvest area classified as restricted or conditionally restricted or from a conditionally approved area in the closed status to a harvest area classified as approved or conditionally approved for the purpose of reducing pathogens, as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the molluscan shell stock, by using the ambient environment as the treatment process.(105) Water closet--A toilet bowl and its accessories surrounded by walls or partitions.(106) Wet storage--The temporary storage, by a dealer, of molluscan shell stock from harvest areas in the approved classification or in the open status of the conditionally approved classification in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater. Source Note: The provisions of this §241.50 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.50 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101061&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101061 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101061&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101061 03/11/2026 (a) The department hereby adopts by reference the National Shellfish Sanitation Program Model Ordinance, as amended. If the requirements of this chapter are more stringent than the requirements of other adopted requirements, then this chapter's requirements prevail and must be complied with.(b) Those persons required to obtain a certificate from the department under this chapter shall comply with all of the requirements of this chapter, the Texas Aquatic Life Act, Health and Safety Code, Chapter 436, and the requirements of the National Shellfish Sanitation Program Model Ordinance, as amended. Source Note: The provisions of this §241.51 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.51 Adoption of National Shellfish Sanitation Program (NSSP) Model Ordinance https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101062&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101062 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101062&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101062 03/11/2026 The authority conferred on the commissioner by the Health and Safety Code, §436.101 is hereby delegated pursuant to Health and Safety Code §436.003(a) to the bureau chief of the Bureau of Food and Drug Safety, or his/her designee, under the provisions of this section. The bureau chief shall:(1) designate coastal water (as defined in the rules of the Texas Parks and Wildlife Department, 31 TAC, Chapter 51) for the purposes of taking molluscan shellfish as:(A) an approved area;(B) a conditionally approved area;(C) a restricted area;(D) a conditionally restricted area; or(E) a prohibited area.(2) designate classified growing areas as open areas or closed areas. Source Note: The provisions of this §241.52 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.52 Growing Area Classification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101063&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101063 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101063&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101063 03/11/2026 (a) Any person who wants to transplant molluscan shell stock from a harvest area classified as conditionally approved, restricted, or conditionally restricted shall make application to the TPWD for a permit to transplant molluscan shell stock.(b) No person may transplant molluscan shell stock without a valid transplant permit from the TPWD.(c) Each person who transplants molluscan shell stock shall provide the following information to the department:(1) the source of the molluscan shell stock;(2) the quantity of molluscan shell stock;(3) the destination private oyster lease of the molluscan shell stock; and(4) the date the transplant permit expired or was canceled.(d) No person shall harvest transplanted molluscan shell stock until the molluscan shell stock has been in waters meeting the approved area criteria for a minimum period of 14 consecutive days.(e) Any person, firm, or corporation engaging wholly or part-time in the business of gathering molluscan shellfish from areas designated by the department for delivery to a controlled depuration plant shall be required to hold a current permit issued specifically for this purpose by the TPWD, with a copy in the files of the department.(f) Permits for gathering for depuration shall be granted subject to the following conditions:(1) all gathering and transporting of molluscan shellfish for depuration must be accomplished between the designated times for sunrise and sunset as set by the National Weather Service for that locale;(2) all boats and vehicles used to gather or transport molluscan shellfish for depuration shall be conspicuously marked in a manner established by the TPWD. All boats or vehicles so marked shall be thoroughly cleaned and sanitized and the marking removed prior to use for harvesting or transporting treated molluscan shellfish or other molluscan shellfish approved for harvest or sale;(3) molluscan shellfish gathered for depuration shall not be containerized in any manner resembling normal sales of molluscan shell stock from approved harvest areas. Containers used for normal sales of molluscan shell stock from approved areas shall not be stored on any boat or vehicle used to gather or transport molluscan shellfish for depuration. Containers of untreated molluscan shell stock shall be tagged or labeled as "NOT FOR HUMAN CONSUMPTION";(4) a copy of the TPWD permit shall be kept on board the vessel at all times during gathering and transporting of molluscan shell stock for depuration;(5) all gathering and transporting of molluscan shellfish for depuration shall be conducted under the immediate surveillance of a commissioned officer of the TPWD, or other commissioned officer as provided by law. The responsibility for obtaining this surveillance rests with the depuration plant owner or operator. A commissioned officer shall be present for every ten gatherers or gathering boats or for any portion of ten gatherers or boats working for any single depuration plant. An officer shall not concurrently serve as surveillance officer for more than one depuration plant. Separate surveillance officers shall be present for gatherers from the same plant working concurrently in more than one geographic area. The surveillance officer shall have all molluscan shell stock under his or her control at all times during transport from the gathering area to the depuration plant. The surveillance officer shall prepare a written report stating the gathering area(s), species, and quantity of molluscan shellfish gathered each day by each gatherer under his or her surveillance. One copy of the report shall accompany the molluscan shell stock to the depuration plant and be maintained in the plant files for not less than one year from the actual date of gathering. One copy of the report shall be forwarded to the Texas Department of Health, Seafood Safety Division, 1100 West 49th Street, Austin, Texas 78756;(6) all molluscan shellfish gathered under authority of a depuration permit shall be delivered only to the depuration plant specified in the permit, on the day gathered, and shall be depurated or disposed of as waste; and(7) molluscan shellfish gathered for depuration shall be protected at all times during gathering and transporting to prevent contamination and undue stress.(g) Vessels and all other equipment coming in contact with molluscan shell stock during handling or transport for transplant or depuration shall be thoroughly cleaned before the vessels or equipment are used to transport or handle molluscan shellfish for direct marketing. Source Note: The provisions of this §241.53 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.53 Shell Stock Transplanting and Gathering for Depuration https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101064&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101064 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101064&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101064 03/11/2026 (a) The following activities are exempted from the requirements in this section:(1) hatcheries;(2) nursery products which do not exceed 10% of the market weight; and(3) nursery products that are six months or more growing time from market size.(b) Aquaculture encompasses both open water and land based monoculture and polyculture.(c) Any person who performs open water aquaculture or operates an aquaculture facility to raise molluscan shellfish for human consumption shall obtain:(1) a permit(s) or authorization from the department, GLO, TPWD, TDA, and/or TCEQ for the activity or for construction and functioning of his/her facility;(2) a harvester's license; and(3) certification as a dealer, where necessary.(d) Molluscan shellfish aquaculture shall be practiced only in strict compliance with the provisions of the authorization issued by the department for the aquaculture activity. Authorization shall be based on the aquaculturist's written operational plan.(e) Prior to beginning any activity, a department approved aquaculturist shall obtain the written permission of the department for use of the site and any construction.(f) Water quality at any site used for open water or land based aquaculture shall meet the criteria for the approved, conditionally approved, restricted or conditionally restricted classification.(g) Molluscan shellfish cultured in any open water or land based system meeting the criteria for the approved classification in the open status or the open status of the conditionally approved classification of a harvest area throughout the culture period may be immediately marketed.(h) Any molluscan shellfish raised in aquaculture shall be subjected to relaying or depuration prior to direct marketing if the culture area or facility is located in or using water that is in:(1) the closed status of the conditionally approved classification;(2) the restricted classification; or(3) the open status of the conditionally restricted classification.(i) Only drugs sanctioned by the FDA shall be used for molluscan shellfish treatment.(j) Harvesting, processing, storage, and shipping requirements for molluscan shellfish raised in aquaculture shall be the same as the requirements for wild molluscan shellfish specified in this subchapter of this title (relating to Molluscan Shellfish).(k) Complete and accurate written records shall be maintained for at least two years by the aquaculturist and shall include the:(1) source of molluscan shellfish, including seed if the seed is from harvest areas that are not in the approved classification;(2) dates of transplanting and harvest; and(3) water source, its treatment method, if necessary, and its quality in land based systems.(l) Seed may come from any growing area, or from any harvest area in any classification, provided that:(1) the source of the seed is approved by the department;(2) seed from growing areas or harvest areas in the restricted or prohibited classification has acceptable levels of poisonous or deleterious substances; and(3) seed from growing areas or harvest areas in the prohibited classification is cultured for a minimum of six months. Source Note: The provisions of this §241.54 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.54 Molluscan Shellfish Aquaculture https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101065&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101065 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101065&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101065 03/11/2026 (a) Operational plan. Each land based aquaculture facility shall have a written operational plan. The plan shall be approved in writing by the department prior to its implementation and shall include:(1) a description of the design and activities of the culture facility;(2) the specific site and boundaries in which molluscan shellfish culture activities will be conducted;(3) the types and locations of any structures, including rafts, pens, cages, nets, tanks, ponds, or floats which will be placed in the waters;(4) the species of molluscan shellfish to be cultured and harvested;(5) if appropriate, the source and species of other organisms to be cultured in any polyculture systems;(6) procedures to assure that no poisonous or deleterious substances are introduced into the activities;(7) a program of sanitation, maintenance, and supervision to prevent contamination of the final molluscan shellfish products;(8) a description of the water source, including the details of any water treatment process or method, if necessary;(9) a program to maintain water quality, which includes collection of microbial water samples and their method of analysis and routine temperature and salinity monitoring. The bacterial indicator monitored shall be the same as used for monitoring harvest areas;(10) collection of information on the microbial and chemical quality of molluscan shellfish harvested from the aquaculture site;(11) collection of data concerning the quality of food production (algae or other) used in the artificial harvest system;(12) maintenance of the required records; and(13) how molluscan shell stock will be harvested, processed if applicable, and sold.(b) Water systems.(1) If the aquaculture system is of a continuous flow through design, water from a harvest area classified as approved in the open status, or in the open status of the conditionally approved classification may be used without treatment at all times molluscan shellfish are held.(2) Water used in land-based aquaculture incorporating a closed or recirculating system shall:(A) not contaminate molluscan shellfish with residues that would render the product adulterated;(B) come from a source meeting the restricted classification criteria at a minimum;(C) be maintained, at a minimum, at the bacteriological quality of the restricted classification; and(D) be measured at least five times per year.(3) If the water in the closed or recirculating system meets the criteria for the conditionally approved classification, the operational plan, prior to molluscan shell stock harvest, shall require, at a minimum:(A) collection of three water samples from the tank at least three days apart over a 14-day period; and(B) a fecal coliform density of less than 14 MPN per 100 ml in each water sample collected from the holding tank.(c) Molluscan shell stock quality.(1) Molluscan shell stock cultured in any system using water meeting the criteria for the approved classification in the open status throughout the culture period may be used in direct marketing.(2) If the water in a closed or recirculating system is classified as conditionally approved and in the open status, and if the water quality meets a fecal coliform level of less than 14 MPN per 100 ml. in each sample collected in the 14 days prior to harvest, the molluscan shell stock may be used in direct marketing.(3) Molluscan shell stock cultured in a closed or recirculating system which does not meet the requirements of subsection (b)(3)(A) and (B) of this section shall be relayed or depurated prior to direct marketing. Source Note: The provisions of this §241.55 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.55 Land Based Aquaculture https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101066&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101066 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101066&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101066 03/11/2026 (a) A polyculture system shall:(1) meet all requirements in §241.55 of this title (relating to Land Based Aquaculture); and(2) provide information concerning all sources of and species of all organisms to be cultivated, cultured, and harvested.(b) A polyculture system shall include in its operational plan requirements to:(1) monitor for human pathogens, animal drugs, and/or other poisonous or deleterious substances that might be associated with polyculture activities; and(2) subject all harvested molluscan shell stock to relaying or depuration if human pathogens, animal drugs, and/or other poisonous or deleterious substances exist at levels of public health significance. Source Note: The provisions of this §241.56 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.56 Polyculture Systems https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101067&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101067 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101067&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101067 03/11/2026 (a) Harvesters. Any harvester who engages in molluscan shell stock packing as defined in this subchapter of this title (relating to Molluscan Shellfish) shall:(1) be a dealer; or(2) pack molluscan shell stock for a dealer.(b) Vessels.(1) The dealer shall not accept molluscan shell stock unless all vessels used to harvest and transport molluscan shell stock are properly constructed, operated and maintained to prevent contamination, deterioration and decomposition of the molluscan shell stock.(A) Decks and storage bins shall be constructed and located to prevent bilge water or polluted overboard water from coming into contact with the molluscan shell stock.(B) Bilge pump discharges shall be located so that the discharge shall not come into contact with the molluscan shell stock.(C) Bags or other containers used for storing molluscan shell stock shall be clean and fabricated from safe materials.(D) Boat decks and storage bins used in the harvest or transport of molluscan shell stock for direct marketing shall be:(i) kept clean with potable water or water from a harvest area in the open status of the approved classification or in the open status of the conditionally approved classification; and(ii) constructed so that water does not stand on the deck or in the storage bin.(E) Coverings shall be provided on harvest boats to protect molluscan shell stock from exposure to adverse conditions.(2) Cats, dogs, and other animals shall not be allowed on vessels.(c) Disposal of human sewage from vessels.(1) Human sewage shall not be discharged overboard from a vessel used in the harvesting of molluscan shell stock or from vessels that buy molluscan shell stock, but only into an appropriate sewage disposal system.(2) An approved marine sanitation device (MSD), portable toilet or other sewage disposal receptacle shall be provided on the vessel to contain human sewage.(3) Portable toilets shall:(A) be used only for the purpose intended;(B) be secured while on board and located to prevent contamination of molluscan shell stock by spillage or leakage;(C) be emptied only into an appropriate sewage disposal system;(D) be cleaned and sanitized before being returned to the boat; and(E) be cleaned only with equipment that is not used for washing or processing food.(4) Use of other receptacles for sewage disposal may be approved by the department if the receptacles are:(A) constructed of impervious and cleanable materials; and(B) meet the requirements in subsection (c)(3) of this section.(d) Molluscan shell stock washing.(1) Molluscan shell stock shall be washed reasonably free of bottom sediments as soon after harvesting as practicable.(2) The harvester shall be primarily responsible for washing the molluscan shell stock.(3) If molluscan shell stock washing is not feasible at the time of harvest, the dealer shall assume this responsibility.(4) Water used for molluscan shell stock washing shall be obtained from:(A) a potable water source; or(B) a harvest area in the:(i) open status of the approved classification; or(ii) open status of the conditionally approved classification.(5) If the harvester or dealer elects to use tanks or a water system to wash molluscan shell stock, the molluscan shell stock washing system shall be constructed, operated, and maintained in compliance with an approved HACCP plan in accordance with §241.63 of this title (relating to General HACCP Requirements), and §241.64 of this title (relating to General Sanitation Requirements).(e) Molluscan shell stock identification.(1) Each harvester shall affix a tag to each bag or container of molluscan shell stock that shall be in place while the molluscan shell stock is being transported to a dealer.(2) If the molluscan shell stock is harvested at more than one location, each container shall be tagged at its harvest area.(3) When the harvester is also the dealer, the harvester has the option to tag the molluscan shellfish with a harvester's tag or a dealer's tag meeting all requirements of this section.(4) The harvester's tags shall:(A) be durable, waterproof and approved by the department prior to use; and(B) be at least 2-5/8 by 5-1/4 inches (6.7 by 13.3 cm) in size.(5) The harvester's tag shall contain the following indelible, legible information in the order specified:(A) the commercial oyster boat captain's license number (issued by TPWD), the captain's name, and any one of the following:(i) the oyster boat license number;(ii) the boat state registration number; or(iii) the documented boat name;(B) the date of harvest;(C) the most precise identification of the harvest location as is practicable including the initials of the state of harvest, and any department designation of the harvest area by indexing, administrative or geographic designation;(D) when the molluscan shell stock has been in wet storage in a dealer's operation, the statement: "THIS PRODUCT IS A PRODUCT OF (NAME OF STATE) AND WAS WET STORED AT (FACILITY CERTIFICATION NUMBER) FROM (DATE) TO (DATE)";(E) the type and quantity of molluscan shell stock; and(F) the following statement in bold capitalized type on each tag: "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS."(6) Molluscan shell stock harvested during the period April 1 through October 31 that will not be refrigerated within the Time-To-Refrigeration guidelines required in §241.61 of this title (relating to Molluscan Shell Stock Temperature Control) shall not be harvested before 6:00 a.m. and shall be placed under refrigeration as designated in §241.61 of this title by 8:00 p.m. each day and shall be identified, stored, and processed separately from molluscan shell stock that is refrigerated within these Time-To-Refrigeration guidelines.(7) Molluscan shell stock harvested and held exempt from the Time-To-Refrigeration guidelines in paragraph (6) of this subsection shall:(A) be tagged with a harvester tag meeting all other requirements that shall also be over stamped on both sides with the words "FOR SHUCKING BY A CERTIFIED DEALER" in ink that shall be neon green in color in letters at least one-half inch in height. This special harvester tag shall be placed on each container of molluscan shell stock at the conclusion of harvesting of this exempt molluscan shell stock and before harvesting of any other molluscan shell stock. This special harvester tag shall remain attached to each container until the molluscan shell stock is shucked;(B) not be commingled with any other molluscan shellfish and shall be stored separately on harvest boats and at any certified location; and(C) be shucked and placed in containers bearing the consumer information language adopted by the ISSC, or an equivalent approved in writing by the SSD prior to use, unless the invoice and bill of lading for shipment of this exempt molluscan shell stock to another dealer both contain the following statement: "FOR SHUCKING BY A CERTIFIED DEALER." All dealer tags attached to such molluscan shell stock shall be over stamped identical to the harvester tag.(8) If the molluscan shell stock is removed from the original bag or container, the tag on the new bag or container shall meet all the requirements in subsection (e) of this section.(f) Harvester records.(1) Each harvester who harvests molluscan shell stock during the period April 1-October 31 shall maintain written records for each date molluscan shell stock is harvested that show the time the first molluscan shell stock is harvested, the time harvesting ends, and the time molluscan shell stock is unloaded from the boat.(2) If molluscan shell stock is harvested and held exempt from the Time-To-Refrigeration guidelines in subsection (e)(6), (7), and (8) of this section, the harvester records shall also include the time that harvesting of this exempt molluscan shell stock ends and the time that harvesting of other molluscan shell stock begins.(3) These records shall be provided to the dealer with the molluscan shell stock and shall be maintained as part of the dealer's records.(g) Any molluscan shellfish in the possession of a person holding a valid license issued by TPWD under Texas Parks and Wildlife Code, Chapter 47 or Chapter 76, shall be considered to be harvested for human consumption and offered for sale for food in Texas.(h) Harvesters shall:(1) be responsible for control of their molluscan shell stock until acceptance by a dealer;(2) sell their molluscan shell stock only to a currently certified shellfish dealer;(3) be required to deliver their molluscan shell stock to a dealer the same day the molluscan shell stock is harvested. Delivery of the molluscan shell stock means packing the molluscan shell stock into an approved container, transfer of the molluscan shell stock from the boat to a certified location, and acceptance of the molluscan shell stock by the dealer; and(4) be required to transport molluscan shell stock on ice or at air temperatures of 45 degrees Fahrenheit or less if the time from unloading the boat until the product is accepted by a dealer and placed under refrigeration at a certified location will exceed two hours.(i) If the harvester transports molluscan shell stock other than by boat to a certified location, the harvest boat captain must accompany the molluscan shell stock until acceptance by the dealer.(j) It is illegal for harvesters to sell molluscan shell stock directly to the public. Source Note: The provisions of this §241.57 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.57 Molluscan Shellfish Harvesting and Handling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101068&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101068 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101068&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101068 03/11/2026 (a) No person shall engage in any activity requiring a certificate in §§241.50 - 241.71 of this title (relating to Molluscan Shellfish) without having applied for and obtained an annual numbered certificate of compliance pertaining to the particular activity from the commissioner. No certificate will be issued without a HACCP plan in accordance with §241.63 of this title (relating to General HACCP Requirements) that is acceptable to the SSD.(b) Dealer certification.(1) Shucker/packer. Any person who shucks molluscan shellfish shall be certified as a shucker/packer.(2) Repacker.(A) Any person who repacks shucked molluscan shellfish shall be certified as a shucker/packer or repacker.(B) Any person who repacks molluscan shell stock shall be certified as a shellstock shipper, shucker/packer, or repacker.(C) A repacker shall not shuck molluscan shellfish.(3) Shellstock shipper. Any person who ships and receives molluscan shell stock in interstate commerce shall be certified as a shellstock shipper, repacker, or shucker/packer.(c) Time Period for Processing and Issuing a Certificate of Compliance.(1) The date a certificate of compliance application is received is the date the original application reaches the department.(2) The period for processing an application begins on the date the SSD receives a compliance memo from an authorized agent of the state, which states the facility is in compliance with all applicable rules, including the HACCP requirements described in §241.63 of this title.(3) An application for a certificate of compliance is complete when:(A) the SSD has received, reviewed and found acceptable the application information required by §§241.50 - 241.71 of this title (relating to Molluscan Shellfish); and(B) the SSD receives a compliance memo from an authorized agent of the state, which states the facility is in compliance with all applicable rules, including the HACCP requirements described in §241.63 of this title.(4) A Certificate of Compliance is valid from September 1 - August 31 of each year, or part thereof.(d) Each dealer shall have a Texas business address at which inspections of facilities, activities, equipment, or records can be made.(e) Each dealer shall accept molluscan shellfish only if they are taken from areas approved by the department, or obtained from sources outside the State of Texas that are approved by the department. If obtained from sources outside of the State of Texas, the molluscan shellfish must be from areas approved by the appropriate state or other government authority having jurisdiction and must be obtained from dealers currently certified by the appropriate state or other government authority. Molluscan shellfish obtained from sources other than those outlined in this section shall not be sold, offered for sale, or held for sale in Texas.(f) Prior to beginning construction of a new molluscan shellfish processing plant, or major remodeling of an existing molluscan shellfish processing plant (which includes, but is not limited to: any process new to that particular plant; any change of product flow; or any enlarging of the plant structure), complete, legible plans showing the floor plan of the building, with dimensions drawn to scale, location of equipment, doors, floor drains, etc., and written, complete operational procedures for all phases of the activity, including flow of the product, shall be submitted to the SSD for review and written approval. Additional plans of the entire premises may be required showing all structures, as well as all water wells and septic systems with related distances and a statement of specifications as to type, sizes, design, date installed, etc. Plans shall be submitted to the SSD no less than 30 days prior to initiating a new process or beginning construction. No operations shall be conducted while any construction or related activity that has the potential to contaminate the product is occurring inside the plant.(g) A legibly written or typed application for certification on forms provided by the department must be filed with the SSD each year. The application for a shucker/packer or repacker certificate must be accompanied by a written statement of the procedure the applicant will use to determine the "SELL BY" date for molluscan shellfish packed and shipped from the location listed in the application.(h) A certificate and unique number shall be issued by the commissioner only after an inspection of the plant by an authorized agent has determined that the plant and practices are in compliance with these sections. A certificate and unique number shall be issued to a dealer for each location at which molluscan shellfish operations are to be conducted and a certificate is required.(i) The inspection of a previously certified plant which has had critical, key or other deficiencies cited against it, or had a certificate of compliance revoked, shall not be conducted by the SSD until written, complete operational procedures for all phases of the regulated activity, including flow of the product, are submitted to the SSD for review and written approval. An application may be refused and a certificate of compliance revoked or denied based on a history of failure to comply with the requirements of these sections in accordance with §241.60 of this title (relating to Enforcement).(j) Molluscan shellfish operations by the dealer shall not begin until the department has issued the certificate for that location. Each certificate shall expire automatically at 11:59 p.m. on August 31st following the date of issue. Certificates shall not be transferable. Source Note: The provisions of this §241.58 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.58 Certification Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101069&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101069 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101069&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101069 03/11/2026 (a) After a certificate is issued, unannounced inspections may be conducted at any time the SSD has a reasonable belief that the business may be in operation, or that molluscan shellfish may be stored on the premises. Inspections may be made at such frequency as may be necessary to assure that adequate operational and sanitary conditions are maintained, and the certificate holder is in compliance with the rules.(1) When an inspection finds a critical deficiency, the violation shall be immediately corrected during that inspection or the plant must immediately cease production affected by the violation. If production affected by the violation does not voluntarily cease, all molluscan shellfish handled or processed while the violation exists or existed shall be detained pursuant to Health and Safety Code, §436.028. Further enforcement action may be taken as authorized under this chapter.(2) When an inspection finds four or more key deficiencies, the dealer shall establish a correction schedule acceptable to the SSD. A follow-up inspection shall determine if the violations have been corrected or are being corrected in accordance with the scheduled correction dates noted on the previous inspection report.(3) When an inspection detects other deficiencies or three or fewer key deficiencies, the deficiencies shall be corrected prior to the next routine inspection.(b) All molluscan shellfish at a certified location shall be the responsibility of the dealer at that location, for the purposes of these sections.(c) A copy of the completed inspection form, listing written descriptions of the violations observed along with any necessary explanation, shall be provided by an authorized agent of the department to the most responsible individual present at the firm at the conclusion of the inspection. If a responsible individual is not present, the form will be mailed to the firm.(d) Any violations of the same rule requirement found on any two consecutive inspections may result in certificate suspension in accordance with §241.60(a) of this title (relating to Enforcement).(e) Molluscan shellfish inspections and the SSD inspection forms shall comply with the requirements established in the current National Shellfish Sanitation Program. Source Note: The provisions of this §241.59 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.59 Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101070 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101070 03/11/2026 (a) The department may refuse to certify, suspend or revoke a certificate of compliance if the applicant or certificate holder:(1) fails to comply with any provision of the statute;(2) fails to comply with any provision of this subchapter;(3) commits fraud, misrepresentation, or concealment of a material fact on any documents required to be submitted to the department or required to be maintained by the facility pursuant to this chapter;(4) aids, abets, or permits the commission of an illegal act;(5) fails to comply with an order of the commissioner of health or another enforcement procedure under the statute;(6) the certificate holder or representative refuses to allow an inspection or otherwise interferes with the authorized department agent in the performance of his or her duties;(7) fails to have a HACCP plan, has a HACCP plan unacceptable to the SSD, or fails to comply with a HACCP plan that is acceptable to the SSD;(8) fails to provide the required application information;(9) has any critical violations identified during the certification inspection; or(10) has more than two key deficiencies and 3 other deficiencies identified during the certification inspection.(b) If the department proposes to refuse to certify, proposes to suspend, or proposes to revoke a certificate of compliance, the department shall notify the applicant or certificate holder of the reasons for the proposed action and offer the person an opportunity for a hearing.(1) If the facility chooses to request a hearing, it shall do so within 20 calendar days of receipt of the notice. Receipt of the notice is presumed to occur on the fifth calendar day after the notice is mailed to the last address known to the department unless another receipt date is reflected on a United States Postal Service return receipt.(2) The request for a hearing shall be in writing and submitted to the Director, SSD, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199.(3) A hearing shall be conducted pursuant to the Administrative Procedure Act, Texas Government Code, Chapter 2001, and the department's formal hearing procedures in Chapter 1 of this title (relating to Texas Board of Health).(4) If the facility does not request a hearing in writing within 20 calendar days of receipt of the notice, the facility is deemed to have waived the opportunity for hearing and the proposed action shall be taken.(5) If the person fails to appear or be represented at the scheduled hearing, the person is deemed to have waived the right to a hearing and the proposed action shall be taken.(c) If the department suspends a certificate, the suspension shall remain in effect until the department determines that the reason for suspension no longer exists. An authorized representative of the department shall investigate prior to making a determination during the time of suspension and the suspended certificate holder shall return the certificate of compliance to the department and shall not process molluscan shellfish in Texas.(d) If the department revokes a certificate, a person may reapply for a certificate after 180 days from the date of signing of the final order of revocation. The department may refuse to issue a certificate if the reason for revocation continues to exist, or the applicant does not meet the requirements for a certificate.(e) Upon revocation, a certificate holder shall return the certificate of compliance to the department. A dealer whose certificate has been revoked may not be issued a new certificate for 180 days after the date of signing of the final order of revocation, or before the next certification period, whichever is longer.(f) Pursuant to Health and Safety Code, §§436.034 - 436.037, the department may assess an administrative penalty against a person who violates §436.011 of the statute or an order issued under this chapter.(1) The penalty may not exceed $25,000 a day for each violation. Each day of a continuing violation constitutes a separate violation.(2) In determining the amount of an administrative penalty assessed under this section, the department shall consider:(A) the seriousness of the violation;(B) the person's previous violations;(C) the hazard to the health and safety of the public;(D) the person's demonstrated good faith; and(E) any other matters that justice may require.(3) All proceedings for the assessment of an administrative penalty are subject to the Administrative Procedure Act, Government Code, Chapter 2001.(4) If, after investigation of an alleged violation and the facts surrounding that alleged violation, the department determines that a violation has occurred, the department shall give written notice of the violation to the person alleged to have committed the violation. The notice shall include:(A) a brief summary of the alleged violations including the statute and/or rules violated;(B) a statement of the amount of the proposed penalty, based on the factors listed in paragraph (2) of this subsection; and(C) a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.(5) The seriousness of violations for which administrative penalties are assessed may be categorized by one of the following severity levels.(A) Severity Level I covers violations that are most significant and may have a significant negative impact on public health and safety.(B) Severity Level II covers violations that are very significant and may have a negative impact on the public health and safety.(C) Severity Level III covers violations that are significant, and if not corrected, could threaten public health and safety.(D) Severity Level IV covers violations that are of more than minor public health and safety significance, but if left uncorrected could lead to more serious circumstances.(E) Severity Level V covers violations that are of minor public health and safety significance.(6) Not later than the 20th calendar day after the date the notice is received, the person notified may accept the determination of the department made under this section, including the recommended penalty, or make a written request for a hearing on that determination. Receipt of the notice is presumed to occur on the fifth calendar day after the notice is mailed to the last address known to the department unless another receipt date is reflected on a United States Postal Service return receipt.(7) If the person notified of the violation accepts the determination of the department, or fails to request a hearing within 20 calendar days of the receipt of the notice, the department shall issue an order approving the determination that a violation occurred and ordering that person to pay the recommended penalty.(8) If a hearing is requested, the department shall refer the matter to the State Office of Administrative Hearings for a hearing.(9) The provisions of Health and Safety Code, §§436.035 and 436.036 shall be followed in assessing and paying an administrative penalty. Source Note: The provisions of this §241.60 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.60 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101136&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101136 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101136&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101136 03/11/2026 (a) For the purpose of this section, temperature control is defined as the management of the environmental temperature of shell stock by means of ice, mechanical refrigeration or other approved means which is capable of lowering the temperature of the shell stock and will maintain it at 45 degrees Fahrenheit (10 degrees Centigrade) or less. (b) The department shall establish the water temperature to be applied in Table 1 for each growing area by averaging the previous five years' maximum monthly temperatures. Attached Graphic(c) The time to refrigeration listed in Table 1 shall be based upon the first shell stock harvested. (d) During action levels 2, 3, and 4 listed in Table 1, the product shall be shaded. (e) The department may approve other measures proposed by the industry to provide controls equivalent to the time-temperature requirements in Table 1. Source Note: The provisions of this §241.61 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.61 Molluscan Shell Stock Temperature Control https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101072&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101072 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101072&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101072 03/11/2026 (a) The harvester or dealer who transports molluscan shell stock from the harvester to the first dealer to handle the product shall assure that all trucks used to transport molluscan shell stock are properly constructed, operated, and maintained to prevent contamination, deterioration, and decomposition of the molluscan shell stock.(b) Storage bins on trucks or other vehicles used in the transport of molluscan shell stock for direct marketing shall be:(1) kept clean with potable water or water from an approved area in the open status or conditionally approved area in the open status; and(2) constructed so that water does not stand on the deck or in the storage bin.(c) Molluscan shell stock shall be transported in air temperatures inside the truck or other vehicle of 45 degrees Fahrenheit (7.2 degrees Centigrade) or less.(d) Mechanical refrigeration units shall be:(1) equipped with automatic controls; and(2) capable of maintaining the ambient air temperature in the storage area at temperatures of 45 degrees Fahrenheit (7.2 degrees Centigrade) or less.(e) Any ice used to cool molluscan shell stock during transport shall be produced and handled in compliance with the sanitation standard operating procedures in accordance with 25 TAC, §241.64 of this title (relating to General Sanitation Requirements).(f) Cats, dogs, and other animals shall not be allowed in any part of the truck or other vehicle where molluscan shell stock is stored. Source Note: The provisions of this §241.62 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.62 Trucks and Other Vehicles Used to Transport Molluscan Shell Stock to the Original Dealer https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101073&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101073 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101073&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101073 03/11/2026 (a) Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of molluscan shellfish product processed by that dealer and to identify the preventive measures that the dealer can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent dealer would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that the hazard will occur in the particular type of molluscan shellfish product being processed in the absence of those controls.(b) Every dealer shall have, implement, and comply with a written HACCP plan that is acceptable to the SSD. A copy of the plan shall be provided to the SSD upon request. A HACCP plan shall be specific to:(1) each location where molluscan shellfish products are processed by that dealer; and(2) each kind of molluscan shellfish product processed by the dealer. The plan may group kinds of molluscan shellfish products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in this section are identical for all molluscan shellfish products so grouped or for all production methods so grouped.(c) The HACCP plan shall, at a minimum:(1) list the food safety hazards that are reasonably likely to occur, as identified in accordance with subsection (a) of this section and that must be controlled for each molluscan shellfish product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:(A) natural toxins;(B) microbiological contamination;(C) chemical contamination;(D) pesticides;(E) drug residues;(F) unapproved use of direct or indirect food or color additives; and(G) physical hazards.(2) list the critical control points for each of the identified food safety hazards, including as appropriate:(A) critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest. If the dealer can demonstrate to the department through a hazard analysis that the food safety hazard is not reasonably likely to occur or is otherwise controlled, the critical control point is not required; and(B) critical control points designed to control food safety hazards that could be introduced in the processing plant environment. If the dealer can demonstrate to the department through a hazard analysis that the food safety hazard is not reasonably likely to occur, the critical control point is not required;(3) list the critical limits that must be met at each of the critical control points;(4) list the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;(5) include any written corrective action plans that have been developed in accordance with this section to be followed in response to deviations from critical limits at critical control points;(6) list the verification procedures, and frequency thereof, that the dealer will use in accordance with this section. The records shall contain the actual values and observations obtained during monitoring; and(7) provide for a record keeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.(d) The HACCP plan shall be signed and dated by the most responsible individual on site at the processing facility or by a higher level official of the dealer:(1) upon initial acceptance;(2) upon any modification; and(3) upon verification of the plan in accordance with subsection (g)(1)(A) of this section.(e) Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with §241.64 of this title (relating to General Sanitation Requirements), they need not be included in the HACCP plan.(f) Corrective Actions.(1) Whenever a deviation from a critical limit occurs, a dealer shall take corrective action either by:(A) following a corrective action plan that is appropriate for the particular deviation; or(B) following the procedures in paragraph (2) of this subsection.(2) Dealers may develop written corrective action plans, which become part of their HACCP plans in accordance with subsection (c)(5) of this section, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:(A) no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and(B) the cause of the deviation is corrected.(3) When a deviation from a critical limit occurs and the dealer does not have a corrective action plan that is appropriate for that deviation, the dealer shall:(A) segregate and hold the affected product, at least until the requirements of subparagraphs (B) and (C) of this paragraph are met;(B) perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review;(C) take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;(D) take corrective action, when necessary, to correct the cause of the deviation; and(E) perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with this section to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.(4) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with subsection (g) of this section and the record keeping requirements of subsection (h) of this section.(g) Verification.(1) Every dealer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur and that the plan is being effectively implemented. Verification shall include, at a minimum:(A) a reassessment of the adequacy of the HACCP plan at least annually or whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way. The reassessment shall be performed by an individual or individuals who have been trained in accordance with subsection (i) of this section. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of subsection (c) of this section. These changes may include:(i) raw materials or source of raw materials;(ii) product formulation;(iii) processing methods or systems;(iv) finished product distribution systems; or(v) the intended use or consumers of the finished product.(B) ongoing verification activities including:(i) a review of any consumer complaints that have been received by the dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;(ii) the calibration of process-monitoring instruments; and(iii) at the option of the dealer, the performing of periodic end- product or in-process testing.(C) a review, including signing and dating, by an individual who has been trained in accordance with subsection (i) of this section, of the records that document:(i) the monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;(ii) the taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with subsection (f) of this section. This review shall occur within one week of the day that the records are made; and(iii) the calibrating of any process-monitoring instruments used at critical control points and the performing of any periodic end product or in process testing that is part of the dealer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the dealer's written procedures as specified in the HACCP plan. These reviews shall occur within one week of the day the records are made.(2) Dealers shall immediately follow the procedures in subsection (f) of this section whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.(3) The calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing, in accordance with paragraph (1)(B)(ii) and (iii) of this subsection, shall be documented in records that are subject to the record keeping requirements of subsection (h) of this section.(h) Records.(1) All records required shall include:(A) the name and location of the dealer;(B) the date and time of the activity that the record reflects;(C) the signature or initials of the person performing the operation; and(D) where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.(2) All records required shall be retained at the processing facility for at least one year after the date they were prepared in the case of refrigerated products and for at least two years after the date they were prepared in the case of frozen products.(3) Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least two years from the date that product is first produced using the applicable equipment or processes.(4) If the processing facility is closed for a prolonged period between seasonal operations or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal operations, but shall be immediately producible for official review upon request by the department.(5) All records required by subsection (h) of this section, and HACCP plans required by subsections (b) and (c) of this section shall be available for official review and copying upon request by the department.(6) Tags on containers of molluscan shell stock are not subject to the requirements of this section unless they are used to fulfill the requirements of record keeping.(7) The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.(i) Training.(1) At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to molluscan shellfish processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA or who is otherwise qualified through job experience to perform these functions:(A) developing a HACCP plan, which could include adapting a model or generic-type HACCP plan that is appropriate for a specific processor, in order to meet the requirements of subsection (c) of this section;(B) reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in subsection (f)(3)(E) of this section, and the HACCP plan in accordance with the verification activities specified in subsection (g)(1)(B) of this section; and(C) performing the record review required by subsection (g)(1)(C) of this section.(2) Job experience will qualify an individual to perform these functions if he/she has provided knowledge at least equivalent to that provided through the standardized curriculum as determined by the SSD.(3) The trained individual need not be an employee of the dealer. Source Note: The provisions of this §241.63 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.63 General HACCP Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101074&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101074 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101074&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101074 03/11/2026 (a) Each dealer shall monitor conditions and practices that are both appropriate to the plant and the food being processed with sufficient frequency to ensure, at a minimum, conformance with the requirements specified in §§229.211 - 229.219 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing or Holding Human Food). The requirements specified in §§229.211 - 229.219 of this title relate to the following sanitation items:(1) safety of water for processing and ice production;(2) condition and cleanliness of food contact surfaces;(3) prevention of cross contamination;(4) maintenance of hand washing, hand sanitizing and toilet facilities;(5) protection from adulterants;(6) proper labeling, storage, or use of toxic compounds;(7) control of employees with adverse health conditions; and(8) exclusion of pests.(b) Each dealer shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by subsection (a) of this section. These records are subject to the requirements of §241.63(h) of this title (relating to General HACCP Requirements).(c) Sanitation controls may be included in the HACCP plan, as required by §241.63(b) of this title. However, to the extent that they are monitored in accordance with subsection (a) of this section, they need not be included in the HACCP plan. Source Note: The provisions of this §241.64 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.64 General Sanitation Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101075&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101075 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101075&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101075 03/11/2026 (a) The dealer shall keep the harvester's tag affixed to each container of molluscan shell stock until the bag or container is:(1) shipped; or(2) emptied to wash, grade or pack the molluscan shell stock.(b) Unless the dealer is also the harvester and has already placed a dealer tag on the container, the dealer shall affix his/her tag to each container of molluscan shell stock prior to shipment.(c) The dealer's tags shall:(1) be durable, waterproof and approved by the department prior to use; and(2) be at least 2-5/8 by 5-1/4 inches (6.7 by 13.3 cm) in size.(d) The dealer's tag shall contain the following indelible, legible information in the order specified below:(1) the dealer's name and address;(2) the dealer's certification number as assigned by the department and the original shellstock shipper's certification number;(3) the date of harvest;(4) the most precise identification of the harvest location as is practicable including the initials of the state of harvest, and any department designation of the harvest area by indexing, administrative or geographic designation;(5) when the molluscan shell stock has been in wet storage in a dealer's operation, the tag shall state: "THIS PRODUCT IS A PRODUCT OF (NAME OF STATE) AND WAS WET STORED AT (FACILITY CERTIFICATION NUMBER) FROM (DATE) TO (DATE)";(6) the type and quantity of molluscan shell stock; and(7) the following statements in bold capitalized type on each tag:(A) "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS"; and(B) the consumer information statement adopted by the ISSC or its equivalent as approved by the SSD.(e) When both the dealer and harvester tags appear on the container, the dealer's tag is not required to duplicate the information on the harvester's tag.(f) If the molluscan shell stock is removed from the original container, the tag on the new container shall meet the requirements of this section.(g) When the molluscan shell stock is removed from the original container, the dealer shall:(1) keep the harvester tag for 90 days unless records maintained as part of the HACCP plan provide the necessary information to track product to the original harvest location;(2) track the harvest area and date of harvest for the molluscan shell stock; and(3) maintain the lot identity of all molluscan shell stock during any intermediate stage of processing. Source Note: The provisions of this §241.65 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.65 Dealer Molluscan Shell Stock Identification https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101076&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101076 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101076&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101076 03/11/2026 (a) If the dealer uses reusable containers to hold or transport shucked molluscan shellfish between activities for the purpose of further processing or packing, the reusable containers are exempt from the labeling requirements in this section. When reusable containers are used, the lot shall be accompanied by a record containing:(1) the shucker-packer's name and certification number;(2) the shucking date; and(3) the quantity of molluscan shellfish per container and the total number of containers.(b) If the dealer uses master shipping cartons, the master cartons are exempt from these labeling requirements when the individual containers within the carton are properly labeled.(c) The dealer shall assure that each individual package containing fresh or frozen shucked molluscan shellfish meat is labeled in a legible and indelible form in accordance with applicable federal and state regulations concerning:(1) information on the principal display panel; and(2) the standard of identity.(d) The dealer shall assure that each package containing less than 64 fluid ounces of fresh or frozen molluscan shellfish shall have:(1) the shucker-packer's or repacker's certification number on the label; and(2) a "SELL BY DATE" which provides a reasonable subsequent shelf life or the words "BEST IF USED BY" followed by a date when the product would be expected to reach the end of its shelf life. The date shall consist of the abbreviation for the month and number of the day of the month. For frozen molluscan shellfish, the year will be added to the date.(e) The dealer shall provide a "DATE SHUCKED" on all containers of shucked molluscan shellfish with a capacity of 64 fluid ounces (1873 ml) or more. The "DATE SHUCKED" shall:(1) for fresh molluscan shellfish, consist of the number of the day of the year (Julian date) or the month and the number of the day of the month;(2) for frozen molluscan shellfish, include the year; and(3) appear on the lid and either the sidewall or bottom of durable containers; or(4) appear on the lid or sidewall of disposable containers.(f) The dealer shall label all frozen molluscan shellfish as frozen in type of equal prominence immediately adjacent to the name of the molluscan shellfish.(g) If the dealer thaws and repacks frozen molluscan shellfish, the dealer shall label the molluscan shellfish container as previously frozen.(h) The dealer shall provide all label information in a legible and indelible form.(i) Shucked Molluscan Shellfish. If the dealer elects to repack molluscan shellfish, the dealer shall pack and label all molluscan shellfish in accordance with this section except that the original date of shucking shall be used as the "DATE SHUCKED" or in establishing the "SELL BY DATE." Source Note: The provisions of this §241.66 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.66 Shucked Molluscan Shellfish Labeling https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101077&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101077 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101077&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101077 03/11/2026 (a) If a dealer elects to use a process to reduce the level(s) of one target pathogen, some target pathogens, or all target pathogens of public health concern in shellfish the dealer shall: (1) have a HACCP plan approved by the SSD for the process that ensures that the target pathogen(s) are at safe levels for the at risk population in product that has been subjected to the process: (A) for processes that target Vibrio vulnificus , the level of Vibrio vulnificus in product that has been subjected to the process shall be non-detectable (<3 MPN/gram), to be determined by use of the Vibrio vulnificus FDA approved EIA procedure of Tamplin, et al, as described in the FDA Bacteriological Analytical Manual, 7th Edition, 1992, Chapter 9. (B) for processes that target Vibrio parahaemolyticus , the level of Vibrio parahaemolyticus in product that has been subjected to the process shall be non-detectable (<1 CFU/0.1 gram). (C) for processes that target other pathogens, the level of those pathogens in product that has been subjected to the process shall be below the appropriate FDA action level, or in the absence of such a level, below the appropriate level as determined by the Interstate Shellfish Sanitation Conference. (D) the ability of the process to reliably achieve the appropriate reduction in the target pathogen(s) shall be validated by a study approved by the SSD, with concurrence of FDA. (E) the HACCP Plan shall include: (i) process controls to ensure that the end point criteria are met for every lot; and (ii) a sampling program to periodically verify that the end point criteria are met. (2) package and label all shellfish in accordance with all requirements of §§241.65 - 241.67 of this title. This includes labeling all shellfish which have been subjected to the process but which are not frozen in accordance with applicable shellfish tagging and labeling requirements in §§241.65 - 241.67 of this title; and (3) keep records in accordance with §241.69 of this title (relating to Shipping Documents and Records). (b) A dealer who meets the requirements of this section may label product that has been subjected to the reduction process as: (1) "Processed for added safety," if the process reduces the levels of all pathogens of public health concern to safe levels for the at risk population; (2) "Processed to reduce (name of target pathogen(s)) to non-detectable levels", if the process reduces one or more but not all pathogens of public health concern to safe levels for the at-risk population and if that level is non-detectable; or (3) "Processed to reduce (name of target pathogen(s)) to non-detectable levels for added safety", if the process reduces one or more but not all pathogens of public health concern to safe levels for the at-risk population and if that level is non-detectable; or (4) a term that describes the type of process applied (e.g. "pasteurized", individually quick frozen", "pressure treated") may be substituted for the word "processed" in the options contained in (b)(1), (2) or (3) of this section. (c) For the purpose of refrigeration, if the end product is dead, the product shall be treated as shucked product. If the end product is live, the product shall be treated as shell stock. Source Note: The provisions of this §241.67 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.67 Labeling of Molluscan Shellfish Subjected to Post-Harvest Processing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101078&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101078 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101078&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101078 03/11/2026 The department will implement the requirements of the National Shellfish Sanitation Program's Vibrio vulnificus Risk Management Plan for Oysters. The Texas Vibrio vulnificus Management Plan will be available for viewing at the SSD central office location at 2201 Donley, Suite 200, Austin, Texas 78758. Source Note: The provisions of this §241.68 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.68 Vibrio vulnificus Management Plan for Oysters https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101079 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101079&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101079 03/11/2026 (a) Each molluscan shellfish shipment shall be accompanied by a shipping document that contains:(1) the name, address, and certification number of the shipping dealer;(2) the name and address of the major consignee; and(3) the kind and quantity of the molluscan shellfish product.(b) The receiving dealer shall:(1) maintain in his/her files a copy of the completed shipping document; and(2) make the shipping document available to the department upon request.(c) If the shipment is subdivided to different dealers, each receiving dealer shall maintain records sufficient to trace their portion back to the original shipment.(d) Each dealer shall have a business address at which transaction records are maintained.(e) Each dealer shall maintain complete, accurate and legible records of information required by this chapter.(f) Transaction records shall be sufficient to:(1) document that the molluscan shellfish are from a source authorized under this subchapter of this title (relating to Molluscan Shellfish);(2) permit a container of molluscan shellfish to be traced back to the specific incoming lot of shucked molluscan shellfish from which it was taken; and(3) permit a lot of shucked molluscan shellfish or a lot of molluscan shell stock to be traced back to the harvest area, date of harvest, and if possible, the harvester or group of harvesters.(g) Purchases and sales shall be recorded:(1) in a permanently bound ledger book; or(2) using other recording methods acceptable to and authorized by the department.(h) The transaction records shall be retained:(1) in the case of fresh molluscan shellfish, for a minimum of one year; and(2) in the case of frozen molluscan shellfish, for a minimum of two years or the shelf life of the product, whichever is longer.(i) If computer records are maintained, the department shall approve the format and its use. Source Note: The provisions of this §241.69 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.69 Shipping Documents and Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101080&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101080 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101080&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101080 03/11/2026 All containers of treated molluscan shellfish, before being released from the molluscan shellfish treatment plant, shall be suitably tagged or labeled with a uniform tag or label bearing the following information:(1) the depuration processor's name and address, including at least the city and state;(2) the depuration processor's valid, complete certificate number issued by the SSD;(3) the type of molluscan shellfish;(4) the date on which the molluscan shellfish were released from the depuration plant;(5) the term "DEPURATED" in letters as large as the largest other letters printed on the tag or label; and(6) the lot code of the treatment process batch. Source Note: The provisions of this §241.70 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.70 Tagging of Depurated Molluscan Shellfish https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101081&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101081 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101081&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101081 03/11/2026 (a) Records containing the following information shall be available at the depuration plant at all times for molluscan shellfish presently undergoing the treatment process:(1) name and/or location of gathering area(s);(2) copy of permit(s);(3) date received in plant;(4) quantity of molluscan shellfish received;(5) quantity of molluscan shellfish destroyed;(6) quantity of molluscan shellfish in tank(s); and(7) date and time of initiation of treatment.(b) Records containing the following information shall be available at the depuration plant at all times for each lot of molluscan shellfish for which the treatment process has been completed for a period of one year from the date of treatment:(1) name and/or location of gathering area(s);(2) copy of permit(s);(3) date received in plant;(4) quantity of molluscan shellfish received;(5) quantity of molluscan shellfish destroyed;(6) date and time of initiation of treatment;(7) date and time of termination of treatment;(8) number of hours treated;(9) quantity of molluscan shellfish treated;(10) quantity of molluscan shellfish destroyed after treatment;(11) all laboratory results as specified;(12) date released from plant; and(13) quantity of molluscan shellfish released.(c) The plant supervisor or assistant plant supervisor shall send to the Texas Department of Health, Seafood Safety Division, 1100 West 49th Street, Austin, Texas 78756, on a weekly basis, a copy of the daily records required in this section and the laboratory analysis results of all molluscan shellfish and water samples completed during each weekly period. Source Note: The provisions of this §241.71 adopted to be effective March 20, 2003, 28 TexReg 2346. 1 DEPARTMENT OF STATE HEALTH SERVICES 241 SHELLFISH SANITATION B MOLLUSCAN SHELLFISH §241.71 Depuration Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13714&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13714 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13714&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13714 03/11/2026 (a) Purpose. These sections are promulgated to establish reasonable minimum standards of health and sanitation applicable under conditions of mass gatherings, as defined in the Mass Gatherings Act, and to provide a means for county health officers to make methodical and uniform evaluations of the health and sanitation facilities and practices proposed by a promoter or a mass gathering.(b) Severability. If any section or provision of these rules or the application of that section or provision to any person, situation, or circumstance is for any reason adjudged invalid, the adjudication does not affect any other section or provision of these rules or the application of the adjudicated section or provision to any other person, situation, or circumstance. The Department of Health Resources declared that it would have adopted the valid portions and application of these sections without the invalid part, and to this end the provisions of these sections are declared to be severable.(c) Conflict with other department rules. These rules and regulations are intended to be supplementary to existing statutes and other existing rules and regulations adopted by the Department of Health Resources. If a conflict between these rules and regulations and other existing rules and regulations adopted by the Department of Health Resources exists, the existing rules and regulations shall govern. Source Note: The provisions of this §265.1 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION A HEALTH AND SANITATION FOR MASS GATHERINGS §265.1 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13700&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13700 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13700&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13700 03/11/2026 In addition to the information required for the issuance of a permit under the Mass Gatherings Act, planning material shall be submitted in such detail as to permit a comprehensive review by the county health officer to evaluate the extent of compliance with minimum standards listed in §265.3 of this title (relating to Minimum Standards). Source Note: The provisions of this §265.2 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION A HEALTH AND SANITATION FOR MASS GATHERINGS §265.2 Information Required in Planning Material https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2396&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2396 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2396&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2396 03/11/2026 (a) Water supply.(1) The quality of water to be supplied shall meet the approval of the county health officer, and on his request an evaluation of the supply may be made by the Department of Health Resources.(2) Water shall be provided at the rate of at least one pint per hour for each person present at the site.(3) Water shall be delivered to the dispensing points in such a manner as to preclude the possibility of contamination. All water conveyor facilities shall be cleaned and disinfected prior to being used and any containers used for water delivery shall be covered to prevent the entrance of dust, insects, or other contaminants.(4) A suitable water outlet or water container shall be provided for each 100 persons and be conveniently located for dispensing the water. If containers are utilized for water distribution, the containers shall be properly covered and provisions made for keeping the covers locked. A chlorine residual of at least 0. 2 milligrams per liter shall be maintained at all times at each water distribution point.(5) The use of the common drinking cup is prohibited. At least one dispensable cup shall be provided for each person per hour of attendance.(b) Toilet facilities.(1) Toilet facilities, separate for each sex and plainly marked "Men' and "Women, ' shall be provided at a rate of no more than 50 persons per toilet seat. Such facilities shall be designed to shield the occupants from public view.(2) Privies, if provided, shall be structurally sound and shall be designed to prevent access of flies to deposited excreta.(3) Portable type toilets, if provided, shall have waste therefrom collected at intervals of sufficient frequency to preclude overflow and the wastes therefrom shall be disposed of in a manner that does not create a health hazard or nuisance.(4) Handwashing and drying facilities shall be provided in the vicinity of each toilet building or location. Waste produced from such handwashing facilities shall be collected and disposed of either by holding tanks or subsurface absorption fields.(c) Vector control. Sufficient equipment and chemicals shall be available to control insect vector problems in a manner approved by the county health officer.(d) Minimum area. An area of at least 50 square feet per person shall be provided at the premises.(e) Solid waste facilities.(1) All solid waste shall be stored in suitable containers with tight fitting lids and such containers shall be conveniently located throughout the area.(2) All solid waste shall be collected twice daily or at such more frequent intervals as may be necessary to maintain sanitary conditions at the site and be disposed of in a facility which has been approved by the county health officer.(f) Noise control. Amplifying equipment used shall be designed to control the noise level at the perimeter of the site on which the gathering shall take place and be so operated that at no time more than 70 decibels is registered on the "A' scale at slow response of a standard sound level meter which meets the specifications of the American National Standards Institute.(g) Food sanitation.(1) All food and beverages sold or furnished shall be obtained from approved sources.(2) Foods, while being stored, prepared, or served, shall be protected from contamination.(3) All perishable food shall be stored at such temperatures as will protect against spoilage.(4) All potentially hazardous food which consists in whole or in part of milk or milk products, eggs, meat, poultry, fish, and shellfish shall be maintained at safe temperatures (45 degrees Fahrenheit or below, or 140 degrees Fahrenheit or above).(5) The washing and sanitizing of food equipment and utensils shall be in compliance with the requirements set forth in the State Sterilization Law, Texas Civil Statutes Article 4476-9.(6) All food service personnel shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty. Handwashing facilities shall be provided.(h) Medical and nursing care.(1) At least one emergency aid station for each 10,000 persons or fraction thereof shall be maintained and be clearly identifiable by a prominent sign during the entire time of the mass gathering.(2) Each emergency aid station shall have on duty at all times at least two persons who have had, as a minimum, training in first aid either by the American Red Cross or as a medical corpsman in the armed services. One shall be in charge.(3) Each emergency aid station shall be provided with the following equipment and supplies:(A) a tent or other suitable temporary shelter shall be erected at a convenient location on the grounds of the mass gathering to house the emergency aid station.(B) folding cots-six;(C) blankets-eight;(D) chest or box (for supplies)-one;(E) chairs-two;(F) flashlights-two;(G) pail or plastic wastebasket-two;(H) paper bags for waste-24;(I) paper towels (roll or package)-four;(J) pitcher (with cover)-two;(K) tourniquet (rubber tubing)-three;(L) adhesive bandages (assorted)-four dozen;(M) adhesive tape, three inches and four inches-four rolls each size;(N) bandages, two inches and four inches-12 rolls each size;(O) triangular bandage, 40 inches-six;(P) cotton balls (prepackaged)-400;(Q) alcohol, isopropyl-two pints;(R) scissors, blunt-one pair;(S) snake bite kit-one;(T) splints-six;(U) bag mask resuscitator with oxygen supply-one;(V) stretcher-one;(W) thermometer, oral-two;(X) bandage compress, two inches, three inches, and four inches-six each size;(Y) four inches by four inches cotton gauze squares-100.(4) A written plan for the evacuation of sick or injured persons shall be provided and approved by the county health officer covering the following services and a copy of the plan shall be placed in a conspicuous place in the emergency aid station.(A) name, location, and telephone number(s) of one or more available licensed physicians;(B) name, location, and telephone number(s) of an available ambulance;(C) name, location, and telephone number(s) of an available nearby hospital;(i) Final site cleanup. At the conclusion of a mass gathering, the site shall be inspected by the county health officer for health and sanitation considerations. The landowner, upon notification by the county health officer of the existence of any unsanitary conditions, shall immediately cause such conditions to be corrected. Source Note: The provisions of this §265.3 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION A HEALTH AND SANITATION FOR MASS GATHERINGS §265.3 Minimum Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227385&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227385 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227385&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227385 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the content clearly indicates otherwise.(1) Act--Texas Youth Camp Safety and Health Act, Texas Health and Safety Code Chapter 141.(2) Adult--A person at least 18 years of age or older.(3) Broadband service--Internet service with the capability of providing a:(A) speed of not less than 100 megabits per second for a download;(B) speed of not less than 20 megabits per second for an upload; and(C) network round-trip latency of less than or equal to 100 milliseconds based on the 95th percentile of speed measurements.(4) Cabin--A structure used to provide temporary sleeping quarters for campers.(5) Camper--A minor child, younger than 18 years of age, who is attending a youth camp on either a day or boarding basis.(6) Challenge course--Activity designed for educational purposes or team building, which may offer a variety of challenges, including zip lines, high and low rope courses, rappelling, and climbing walls.(7) Commissioner--The commissioner of the Texas Department of State Health Services.(8) Day camp--A camp that operates during the day or any portion of the day between 7:00 a.m. and 10:00 p.m. for four or more consecutive days and that offers no more than two overnight stays during each camp session. To be eligible to be licensed as a youth camp, the camp's schedule must be structured so that each camper attends for four hours or more per day for four consecutive days. The term does not include a facility that is required to be licensed with the Health and Human Services Commission.(9) Department--Texas Department of State Health Services. (10) Executive commissioner--Executive commissioner of the Health and Human Services Commission.(11) Firearm--Any device designed, made, or adapted to expel a projectile through a barrel by using the energy generated by an explosion or a burning substance, or any device readily convertible to that use.(12) Floodplain--Any area within a 100-year floodplain identified by the Federal Emergency Management Agency (FEMA) under the National Flood Insurance Act of 1968 (42 United States Code (U.S.C.) Section 4001 et seq.). This term includes any area removed from the 100-year floodplain by a letter of map amendment, a letter of map revision based on fill, or a substantially similar administrative process conducted by FEMA.(13) Floodway--An area identified on the most recent flood hazard map published by FEMA under the National Flood Insurance Act of 1968 (42 U.S.C. Section 4001 et seq.) as a regulatory floodway.(14) Governmental entity--This state or a state agency or political subdivision of this state.(15) Municipal water supply--A public water supply owned or operated by or for a city or a corporation having the right of administering local government.(16) Pellet gun--Any device designed, made, or adapted to expel a projectile through a barrel by using compressed air or carbon dioxide. This definition includes air guns, air rifles, BB guns, and paintball guns.(17) Permanent structure--Man-made buildings such as dining halls, dormitories, cabins, or other buildings that are constructed to remain stationary.(18) Person--An individual, partnership, corporation, association, or organization. In rules for this subchapter, a person does not include a government or governmental subdivision.(19) Playground--A designated area designed for campers to play freely on equipment as defined in the U.S. Consumer Product Safety Commission Publication Number 325, "Public Playground Safety Handbook," July 2025 as amended.(20) Primitive camp--A youth camp that does not provide either permanent structures or utilities for camper use.(21) Public water system--A public water system, as defined in 30 Texas Administrative Code (TAC) §290.38 (relating to Definitions) is a system for the provision to the public of water for human consumption through pipes or other constructed conveyances, which includes all uses described under the definition for drinking water in 30 TAC §290.38. Such a system must have at least 15 service connections or serve at least 25 individuals at least 60 days out of the year. This term includes any collection, treatment, storage, and distribution facilities under the control of the operator of such system and used primarily in connection with such system, and any collection or pretreatment storage facilities not under such control that are used primarily in connection with such system. Two or more systems with each having a potential to serve less than 15 connections or less than 25 individuals but owned by the same person, firm, or corporation and located on adjacent land will be considered a public water system when the total potential service connections in the combined systems are 15 or greater or if the total number of individuals served by the combined systems total 25 or greater at least 60 days out of the year. Without excluding other meanings of the terms "individual" or "served," an individual must be deemed to be served by a water system if he lives in, uses as his place of employment, or works in a place to which drinking water is supplied from the system.(22) Resident camp--A camp that for a period of four or more consecutive days continuously provides residential services to each camper, including overnight accommodations for at least three consecutive nights.(23) Supervised--A person is supervised if the person is within sight, except for infrequent momentary periods such as restroom breaks, and within reasonable hearing distance of a camper's outcry, of an adult with an obligation to report inappropriate or dangerous activities or behavior who has been made aware that the obligation is in effect at that time and who has willingly accepted the obligation. This definition is applicable only to rules relating to unsupervised contact with campers.(24) Supervisor/counselor--A person, at least 18 years of age or older, who is responsible for the immediate supervision of campers.(25) Swim test--A formalized test, specific to the body of water utilized, to determine each child's swimming ability. A swim test includes a skill evaluation, or some equivalent method of determining swimming ability, such as the following. (A) A non-swimmer gets into the shallow water, sits down, stands up, and exits the water.(B) An intermediate swimmer jumps feet first into water at least twelve inches deeper than the height of the child, levels off, swims 25 feet, turns around and swims back, then exits the water.(C) A swimmer jumps feet-first into water at least twelve inches deeper than the height of the child and swims 75 yards in a strong stroke on the stomach or side (breaststroke, sidestroke, crawl, trudgen, or any combination); then swims 25 yards on the back (elementary back stroke), floats and rests on the back for one minute, then exits the water.(26) TCEQ--Texas Commission on Environmental Quality.(27) Travel camp--A day or resident camp, lasting for four or more consecutive days, that begins and ends at a fixed location, but may move from location to location on a daily basis.(28) Waterfront--A natural or artificial body of water that includes a lake, ocean, bay, pond, river, swimming pool, or spa, which is the site of any water activity.(29) Waterfront activity--A recreational or instructional activity, occurring in, on, or near a waterfront. Waterfront activity includes swimming, boating, water skiing, scuba diving, rafting, tubing, synchronized swimming, or sailing.(30) Youth camp--A facility or property, other than a facility required to be licensed by the Health and Human Services Commission, that:(A) has the general characteristics of a day camp, resident camp, or travel camp;(B) provides supervision and instruction in recreational, athletic, religious, or educational activities;(C) during a camp session, offers at least two youth camp specialized activities in an outdoor setting;(D) accommodates at least five minors during each camp session who attend or temporarily reside at the camp, apart from parents or guardians, for all or part of at least four consecutive days;(E) operates as a youth camp for four consecutive hours or more per day;(F) operates as a youth camp only during school vacation periods;(G) operates as a youth camp for no more than 120 days each calendar year; and(H) is not a facility or program operated by or on the campus of an institution of higher education or a private or independent institution of higher education as those terms are defined by the Texas Education Code§61.003, that is regularly inspected by one or more local governmental entities for compliance with health and safety standards.(31) Youth camp specialized activity--A camp activity such as waterfront activities, archery, horseback riding, challenge courses, or riflery that requires special technical skills, equipment, or safety regulations, and a high level of adult supervision at all times.(32) Youth camp operator--Any person who owns, operates, controls, or supervises a youth camp, whether or not for profit. Source Note: The provisions of this §265.11 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective February 25, 2019, 44 TexReg 862; amended to be effective June 25, 2020, 45 TexReg 4202; amended to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.11 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199896&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199896 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199896&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199896 03/11/2026 (a) On-site director required. Each youth camp shall be under the on-site direction of a qualified adult with at least two years of experience working with children. The director shall be knowledgeable in camp administrative practices and shall have at least one year of leadership experience with an organized youth camp, school or other youth-serving organization, such as the Boy Scouts of America or Young Men's Christian Association (YMCA).(b) Adult supervisors. Each youth camp shall have at least one adult supervisor who is responsible for the supervision of no more than ten children in the camp. For any youth camp specialized activity, the supervisor(s) shall be in the immediate vicinity (within sight and/or hearing) of the campers. An "all camp" sedentary activity, not requiring physical activity must have at least one adult supervisor to every 25 campers. The camp director shall not be included in the supervisor to camper ratio in camps serving over 50 campers at one time.(c) Supervision of youth camp specialized activity. Youth camp specialized activities shall be conducted by and under the direct supervision of a qualified adult capable of implementing safety standards established by the department or the camp who shall have either documented training or at least two years documented experience in conducting the activity.(d) Written personnel policies and practices. A camp shall have written personnel policies and practices for both campers and staff. Supervisors shall be informed of these policies and practices prior to assuming responsibility for campers.(e) Staff member character and integrity records. The camp management shall ascertain and have on record information, such as a letter of reference, attesting to the character and integrity of each staff member, and information, such as training certificates, attesting to the ability of each staff member to perform the tasks required in his or her position.(f) Criminal conviction and sex offender background check requirements. The camp management shall have on file a record of any criminal conviction and a sex offender registration check for all adult staff members and all adult volunteers working at the camp before the staff member or volunteer has unsupervised contact with children at the camp. A criminal background check and sex offender registration check must be on file for any other adult that will have unsupervised contact with campers, other than their own children. If the records are located off-site, a letter from the national or regional headquarters of the camp organization stating the names of individuals at the camp site for whom background checks have been conducted, shall be available at the camp site. All records of criminal convictions and written evaluations for a camp or camping organization shall be made available to department personnel within two business days upon request. Youth camps are responsible for ensuring that criminal and sex offender background checks have been conducted for international staff obtained through the J-1 visa process, and that documentation of these checks are located with other staff background checks. Records of criminal convictions and sex offender status shall be obtained by:(1) performing an annual criminal background check using a criminal history database for each adult staff member's and each adult volunteer's permanent residence. If the staff member or adult volunteer has a temporary or an educational residence, an annual criminal background check shall include searching under the permanent, temporary and educational address, as applicable. The criminal history database used for the criminal background check is to be based on the individual's residences, and may include state, national or international databases. Documentation of the search results, whether or not the results are positive, shall be maintained with the sex offender background documentation; and(2) performing an annual background check using a sex offender registration database for each adult staff member's and each adult volunteer's permanent residence and educational residence if applicable, such as the TXDPS - Sex Offender Registry, which may be accessed at Texas Department of Public Safety - Crime Records Service. Documentation of the search results, whether or not the results are positive, shall be maintained with the criminal background documentation.(g) Persons whose presence at a youth camp shall be precluded. Youth camps shall not employ paid or unpaid staff members or volunteers at a youth camp, or permit any person to have unsupervised contact with campers other than their own children, if the person has the following types of criminal convictions or deferred adjudications: a misdemeanor or felony under Texas Penal Code, Title 5 (Offenses Against the Person) excluding a Class C misdemeanor under §22.01 (Assault), Title 6 (Offenses Against the Family), Chapter 29 (Robbery) of Title 7, Chapter 43 (Public Indecency) or §42.072 (Stalking) of Title 9, §15.031 (Criminal Solicitation of a Minor) of Title 4, §38.17 (Failure to Stop or Report Aggravated Sexual Assault of Child) of Title 8, or any like offense under the law of another state or under federal law.(h) Persons whose presence at a youth camp may be precluded.(1) Youth camps may preclude a person from being a paid or unpaid staff member or volunteer at a youth camp, or may preclude a person from having unsupervised contact with campers other than the person's own children, if the person has the following types of criminal convictions or deferred adjudications:(A) a Class C misdemeanor committed within the past ten years under §22.01 (Assault) of Title 5 of the Texas Penal Code, or any like offense under the law of another state or under federal law;(B) a misdemeanor or felony committed within the past ten years under §46.13 (Making a Firearm Accessible to a Child) or Chapter 49 (Intoxication and Alcoholic Beverage Offenses) of Title 10 of the Texas Penal Code, or any like offense under the law of another state or under federal law; or(C) any other felony under the Texas Penal Code or any like offense under the law of another state or under federal law that the person committed within the past ten years.(2) Camp management shall have on file a written evaluation by two or more camp executive staff for any staff member or volunteer whose presence at the youth camp may be precluded under this subsection showing that management has determined the person is suitable for a position at the youth camp despite a criminal conviction or deferred adjudication.(i) Sexual abuse and child molestation awareness training and examination program.(1) A youth camp licensee may not employ or accept the volunteer service of an individual for a position involving contact with campers at a youth camp, or permit any person to have unsupervised contact with campers, unless:(A) the individual submits to the licensee or the youth camp has on file documentation that verifies the individual within the preceding two years has successfully completed the training and examination program required by this subsection; or(B) the individual successfully completes the youth camp's training and examination program approved by the department during the individual's first workweek, and prior to any contact with campers unless supervised during the first workweek by an adult who has successfully completed the program.(2) For purposes of this subsection, the term "contact with campers" does not include visitors such as a guest speaker, an entertainer, or a parent who visits for a limited purpose or a limited time if the visitor has no direct and unsupervised contact with campers. A visitor may have direct and unsupervised contact with a camper to whom the visitor is related. A camp may require training and an examination for visitors if it chooses.(3) A youth camp licensee shall retain in the person's personnel record a copy of the documentation required or issued under paragraph (1)(A) and (B) of this subsection for each employee or volunteer until the second anniversary of the examination date.(4) Prior to their use, the department may approve training and examination programs offered by trainers under contract with youth camps, by online training organizations, or programs offered in another format, such as a videotape, authorized by the department.(5) A training and examination program on sexual abuse and child molestation approved by the department shall at a minimum include training and an examination on:(A) the definitions and effects of sexual abuse and child molestation;(B) the typical patterns of behavior and methods of operation of child molesters and sex offenders that put children at risk;(C) the warning signs and symptoms associated with sexual abuse or child molestation, recognition of the signs and symptoms, and the recommended methods of reporting suspected abuse;(D) the recommended rules and procedures for youth camps to implement to address, reduce, prevent, and report suspected sexual abuse or child molestation;(E) the need to minimize unsupervised encounters between adults and minors; and(F) the potential for consensual and nonconsensual sexual activity between campers, steps to prevent sexual activity between campers, and how to respond if sexual activity between campers occurs.(6) The training program shall last for a minimum of one hour and discuss each of the topics described in paragraph (5) of this subsection.(7) The examination shall consist of a minimum of 25 questions which shall cover each of the topics described in paragraph (5) of this subsection.(8) To successfully complete the training program, each employee or volunteer shall achieve a score of 70% or more correct on an individual examination. If the examination is taken on-line, the employee or volunteer shall retain a certificate of completion indicating they successfully completed the course.(9) The department may assess a fee of $125 to each applicant to cover the costs of the department's initial review and each follow-up review of a training and examination program.(10) Applications and fees shall be mailed to the Environmental and Sanitation Licensing Group, Department of State Health Services, Mail Code 2003, P.O. Box 149347, Austin, Texas 78714-9347. Applications may be obtained by calling the Environmental and Sanitation Licensing Group at (512) 834-6600 or may be downloaded from http://www.dshs.state.tx.us/youthcamp/default.shtm.(11) The department, at least every five years from the date of initial approval, shall review each training and examination program approved by the department to ensure the program continues to meet the criteria and guidelines established under this subsection.(j) Supervised contact with campers.(1) A person supervising another person who is prohibited from having unsupervised contact with campers:(A) may include one or more paid or unpaid members of camp staff or management; law enforcement officers; security personnel; lifeguards or other responsible staff at any off-site facility; or parents or other adults;(B) must be charged with responsibility to monitor, oversee, or supervise the person on behalf of the licensee or camp management; and(C) must have the ability and means to summon competent assistance at all times while remaining within sight and hearing distance of the supervised person.(2) A person who is prohibited from having unsupervised contact with campers must be supervised at all times during which that person has or might have any contact with one or more campers, whether intentional or unintentional, and whether part of scheduled camp activities or not. The potential for contact with campers by a person is presumed at all times during which one or more campers are present at the facility at which the person is present unless there is an impassable barrier between them.(k) Records retention. All applications, background check reports, training documentation, and other required personnel documentation required by this subchapter shall be maintained in hard copy or electronic format for a minimum of two years following a person's last day of service. If the youth camp is notified of an investigation or conviction of a camp staff member for an act of sexual abuse, as defined by §21.02 of the Texas Penal Code, which occurred at the camp, the camp shall retain all records related to the investigation or conviction until the department notifies the camp that the record retention is no longer required. Source Note: The provisions of this §265.12 adopted to be effective April 16, 2006, 31 TexReg 3054; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective February 25, 2019, 44 TexReg 862; amended to be effective June 25, 2020, 45 TexReg 4202. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.12 Directors, Supervisors, and Staff https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211947&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211947 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211947&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211947 03/11/2026 (a) Safety of camp facility. The buildings, structures, and grounds shall not present a fire, health, or safety hazard. (b) Accumulation of refuse and debris. The premises of each camp shall be kept free of accumulations of refuse and debris. (c) Compliance with building, plumbing, electrical and life safety codes. All camp buildings shall comply with applicable building, plumbing, electrical, life safety, and similar codes. (d) Permanent living or sleeping structures. All permanent structures used for living or sleeping purposes in the camp shall be provided with walls, floors, and ceilings that shall be kept clean and in good repair. (e) Separate beds, bunks or cots. A separate bed, bunk, or cot shall be required for each person. Beds shall be spaced in a manner that is free of obstruction for entering and exiting. (f) Bunk bed guardrails. In all rooms housing campers, all bunk beds shall have at least two guardrails, one on each side of the bed for each bed having the underside of its foundation more than 30 inches from the floor in accordance with the Code of Federal Regulations (CFR), 16 CFR, Part 1513.3. Bunk beds securely attached to a wall may utilize the wall as one guardrail. (g) Location of sleeping quarters. Sleeping shall not be permitted in kitchens or in rooms used for food preparation, storage, or service. (h) Bedding provided by the camp. All articles of bedding provided by the camp, including mattresses and mattress covers, shall be kept clean and in good repair. Any bedroll provided by the camp and used by campers must be properly cleaned between use by different individuals. (i) Toilets and urinals. The camp shall provide at least one toilet for every 15 females and one toilet for every 15 males. In each male toilet facility, up to 70% of the toilets required may be urinals. In facilities with more than one toilet, some means of privacy must be provided for each toilet. (j) Lavatories. The camp shall provide at least one lavatory adjacent to toilet facilities. In facilities with more than five toilets or urinals in a room, there must be a minimum of two lavatories. (k) Hand cleanser required. Each lavatory shall be equipped with one of the following methods to sanitize hands: (1) lavatories with hot and cold running water shall have soap or hand cleanser available at all times; (2) lavatories with only cold running water shall have hand sanitizer or anti-bacterial soap available at all times; or (3) portable toilet facilities not equipped with lavatories providing water shall have waterless hand sanitizer available at all times. (l) Shower facilities. Resident youth camps shall provide at least one shower for every 15 females and one shower for every 15 males. Each shower shall be equipped with water to meet the needs of the campers. There shall be soap or body cleanser available at all times. (m) Cleanliness and sanitation of toilets, lavatories and bathing facilities. All toilets, lavatories, and bathing facilities shall be maintained in good repair and kept clean at all times. Every shower room floor shall be washed daily with a suitable detergent or sanitizing agent. (n) Availability of toilet tissue. Toilet tissue shall be available at all times for each toilet. (o) Lighting and ventilation in toilet and bathing facilities. All permanent toilets and bathing structures shall be adequately ventilated and properly lighted. (p) Public water supply. If a youth camp water supply meets the definition of a public water system, then all water used for human consumption or which may be used in the preparation of foods or beverages or for the cleaning of any utensil or article used in the course of preparation or consumption of food or beverages for human beings, or which is used for bathing, swimming in a pool or spa, or any other use in which incidental ingestion may occur, shall come from a Texas Commission on Environmental Quality (TCEQ) approved drinking water source that meets all applicable standards of 30 TAC Chapter 290, Subchapter D (relating to Rules and Regulations for Public Water Systems) and Subchapter F (relating to Drinking Water Standards Governing Drinking Water Quality And Reporting Requirements for Public Water Systems), as amended. (q) Private water supply. Youth camps having water supplies that do not meet the definition of a public water system or that are not regulated by the TCEQ shall comply with the following requirements when the camp is open or operational unless otherwise indicated. (1) Water supply. An adequate supply of water shall be available at all times in each camp in accordance with the following table. Attached Graphic(2) Water pressure. The system shall be designed to maintain a minimum pressure of 35 pounds per square inch (psi) at all points within the distribution network at flow rates of at least 1.5 gallons per minute per connection. When the system is intended to provide fire fighting capability, it shall also be designed to maintain a minimum pressure of 20 psi under combined fire and drinking water flow conditions. Minimum distribution pressure shall not be less than 20 psi at any time. (3) Bacteriological properties. (A) Water systems serving camps shall submit a minimum of one water sample for testing for total coliform, fecal coliform, E. coli, or other fecal indicator organisms, for the month prior to camp opening and each month the camp is in operation. (B) Testing for microbial contaminants shall be performed at a laboratory certified by TCEQ. (C) If a routine distribution coliform sample is coliform-positive, then the camp shall issue a written boil water notification to all camp staff and volunteers. The notification shall state, "To ensure destruction of all harmful bacteria and other microbes, water for drinking, cooking, and ice making shall be boiled and cooled prior to consumption. The water shall be brought to a vigorous rolling boil and then boiled for two minutes. In lieu of boiling, purchased bottled water, water obtained from some other suitable source, or ice obtained from an approved source may be used." (D) The boil water notification shall remain in effect until a repeat distribution coliform sample is coliform-negative. (E) Records of all bacteriological tests and of any boil water notification shall be kept on site. (4) Chemical properties. (A) Camps shall submit a water sample obtained from the entry point to the distribution system to a laboratory for chemical analysis at least once every three years. (B) The chemical analysis shall be for secondary constituent levels. (C) Maximum secondary constituent levels are as described in the following table. Attached Graphic(D) Records of all chemical testing shall be kept on site. (5) Minimum residual disinfectant concentrations and maximum residual disinfectant levels (MRDLs). (A) The minimum residual disinfectant concentration in the water entering the distribution system and the water within the distribution system shall be 0.2 milligrams per liter (mg/L) free chlorine or 0.5 mg/L chloramine. (B) The MRDL of chlorine dioxide in the water entering the distribution system shall be 0.8 mg/L. (C) The MRDL of free chlorine or chloramine in the water within the distribution system shall be 4.0 mg/L based on a running annual average. (6) Backflow prevention. The plumbing system shall preclude backflow of a solid, liquid, or gas contaminant into the water supply system at each point of use, including on a hose bib, by: (A) providing an air gap between the water supply inlet and the flood level rim of a plumbing fixture, equipment, or nonfood equipment that is at least twice the diameter of the water supply inlet and not less than 25 mm (1 inch); or (B) installing an approved backflow prevention device that meets the American Society of Sanitary Engineering (ASSE) standards for construction, installation, maintenance, inspection, and testing for that specific application and type of device. (7) Disinfection of new or repaired water system facilities. (A) When repairs are made to existing mains or when new main extensions are installed, they shall be disinfected using such amounts of chlorine compounds as to fill the repaired or new mains and appurtenances with water containing 50 ppm chlorine. (B) After the water containing this amount of chlorine, which is greater than that normally present in drinking water, has been in contact with the pipe and appurtenances for at least 24 hours, the main shall be flushed until the free chlorine or chloramine in the water within the new or repaired distribution system is less than 4.0 mg/L. (C) A sample of water from the new or repaired main shall be submitted to a laboratory certified by TCEQ for bacteriological examination so as to be assured that the disinfection procedure was effective. (8) Calcium hypochlorite. A supply of calcium hypochlorite disinfectant shall be kept on hand for use when making repairs and repairing line breaks. (9) Lead control. Use of pipes and pipe fittings that contain more than 8.0% lead or solders and flux that contain more than 0.2% lead is prohibited for installation or repair of any water supply and for installation or repair of any plumbing in a residential or nonresidential facility providing water for human consumption. This requirement may be waived for lead joints that are necessary for repairs to cast iron pipe. (10) Flushing of water system mains. All dead-end mains should be flushed at monthly intervals or more frequently to maintain water quality. (11) Collection system location. (A) No sanitary sewers or septic tanks shall be allowed within a distance of 50 feet of any well used for drinking water. No cesspool or septic tank open-jointed drain field shall be allowed within a distance of 150 feet of any well used for drinking water. (B) Storm sewers located within specified distances for sanitary sewers shall be constructed so as to prevent leakage from them. (C) Water lines and sanitary sewers shall be installed no closer to each other than nine feet. (12) Well logs. Copies of well material setting data, geological log, sealing information (pressure cementing and surface protection), disinfection information, bacteriological sample results, and a chemical analysis report of a representative sample of water from the well shall be kept on file. (13) Interconnection. No physical connection between the distribution system of a camp water supply and that of any other water supply shall be permitted. (14) Abandoned wells. Abandoned water supply wells owned by the camp shall be plugged with cement according to 16 TAC Chapter 76 (relating to Water Well Drillers and Water Well Pump Installers). Wells that are not in use and are non-deteriorated as defined in those rules shall be tested every five years to demonstrate that they are in a non-deteriorated condition. Deteriorated wells shall be either plugged with cement or repaired to a non-deteriorated condition. (r) Disposal of youth camp wastewater. All camp wastewater shall be disposed of into a community sanitary sewage system or an approved On-site Sewage Facility in accordance with 30 TAC Chapter 285 (relating to On-Site Sewage Facilities). In remote areas, the use of chemical toilets is allowed, if the facilities are built and maintained in accordance with manufacturer designs. (s) Disposal of solid waste. Solid wastes shall be disposed of at a TCEQ approved sanitary landfill or other disposal facility approved by TCEQ under 30 TAC Chapter 330 (relating to Municipal Solid Waste). (t) Permanent food preparation, storage and service areas. Permanent food preparation, storage and service areas shall be maintained in compliance with Chapter 228 of this title (relating to Retail Food). Items inspected may include, but are not limited to: (1) proper cooling for cooked/prepared food; (2) cold hold (41 degrees Fahrenheit/45 degrees Fahrenheit); (3) hot hold (135 degrees Fahrenheit); (4) proper cooking temperatures; (5) rapid reheating (165 degrees Fahrenheit in 2 hours); (6) personnel with infections restricted/excluded; (7) proper/adequate hand washing; (8) good hygienic practices (eating/drinking/smoking/other); (9) approved source/labeling; (10) sound condition - food is not from unapproved sources or in unsound condition; (11) proper handling of ready-to-eat foods; (12) no cross-contamination of raw/cooked foods/other; (13) approved systems (HACCP (Hazard Analysis and Critical Control Points) plans/time as public health control); (14) water supply - approved sources/sufficient capacity/hot and cold water under pressure; (15) equipment adequate to maintain product temperature; (16) hand wash facilities adequate and accessible; (17) hand wash facilities equipped with soap and towels; (18) no evidence of insect contamination; (19) no evidence of rodents/other animals; (20) toxic items properly labeled/stored/used; (21) manual/mechanical ware washing and sanitizing at proper ppm/temperature; (22) manager demonstration of knowledge of safe food handling procedures; (23) approved sewage/wastewater disposal system, proper disposal; (24) thermometers provided/accurate/properly calibrated (±2 degrees Fahrenheit); (25) food contact surfaces of equipment and utensils cleaned/sanitized/good repair; and (26) posting of consumer advisories (abdominal thrust/disclosure/reminder/buffet plate). (u) Playgrounds and equipment. Playgrounds and playground equipment shall meet the standards set forth in the U.S. Consumer Product Safety Commission Publication Number 325, "Public Playground Safety Handbook," November 2010. Equipment that does not meet these standards may not be used by campers. Source Note: The provisions of this §265.13 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective February 18, 2018, 43 TexReg 580; amended to be effective June 25, 2020, 45 TexReg 4202. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.13 Site and Physical Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166537&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166537 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166537&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166537 03/11/2026 (a) Maintenance and operation of primitive campsites. Primitive campsites shall be maintained and operated in a safe and healthful manner.(b) Drinking water at primitive camp, on hikes, or on trips away. Drinking water used at primitive camps and on hikes and trips away from permanent campsites shall be from a source known to be safe or shall be rendered safe.(c) Toilet facilities at primitive campsites. Primitive campsites that are not provided with approved toilet facilities shall have a separate toilet area designated for each sex. Slit trenches or cat holes with a readily available supply of clean earth backfill or other disposal methods approved by the department's Policy, Standards and Quality Assurance Unit, shall be utilized for the disposal of human excreta in these areas. Approval shall be received in writing prior to implementation. Toilet areas shall be located at least 150 feet from a stream, lake, or well, and at least 75 feet from a campsite, tent, or other sleeping or housing facility.(d) Disposal of solid wastes at primitive campsites. Solid wastes that are generated in primitive camps shall be disposed of at a TCEQ approved sanitary landfill or other disposal facility approved by TCEQ under 30 TAC, Chapter 330, Municipal Solid Waste.(e) Food service at primitive campsites. Only foods that can be maintained in a wholesome condition with the equipment available shall be used at primitive camps.(f) Use of hot water and detergent to wash food utensils. Hot water and detergent shall be used to wash all food utensils after each meal at primitive campsites.(g) Supervision of campers at primitive camps. Campers utilizing primitive camps shall be adequately supervised at all times by a responsible adult who is knowledgeable concerning proper wilderness camping techniques. A minimum ratio of one such supervising adult for each ten campers shall be maintained in the immediate vicinity (within sight and/or hearing) of the campers. Source Note: The provisions of this §265.14 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.14 Primitive or Wilderness Camp https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199898 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199898 03/11/2026 (a) Record of an on-call physician required. Documentation shall be kept on file of a physician licensed to practice in Texas who is available to be on call at all times to advise health service personnel on all first aid and nursing services provided by the camp.(b) Emergency transportation. Transportation shall be available at all times to transport any sick or injured camper in an emergency.(c) Medical staffing requirements. A physician, registered nurse, licensed vocational nurse, or a person with an American Red Cross Emergency Response certificate, or its equivalent, shall be in the camp and on call at all times, and will be considered the Camp Health Officer. For camps having documented evidence, such as a letter from the local emergency medical services (EMS), that the camp is located within a 20-minute community EMS response time, a person certified in American Red Cross Community First Aid and Safety, or its equivalent, shall be in the camp and on call at all times, and will be considered the Camp Health Officer.(d) Requirement to report incidents of abuse or neglect of a minor.(1) Requirement to report incidents of abuse or neglect of a minor at a youth camp.(A) If a person, including any member of camp staff, a camp counselor, or camp director has cause to believe that a minor has been or may have been abused or neglected as those terms are defined in the Texas Family Code, Chapter 261, and the abuse or neglect occurred at the youth camp, then that person shall immediately make a report, in accordance with Texas Family Code, §261.101(a) to one of the appropriate agencies designated by Texas Family Code, §261.103. Accordingly, a report shall be made to:(i) any local or state law enforcement agency;(ii) the Department of Family and Protective Services Abuse Hotline, which may be contacted at (800) 252-5400 or through the secure web site http://www.txabusehotline.org/; or(iii) the Department of State Health Services.(B) If a person making a report in accordance with subparagraph (A) of this paragraph has not already notified the Department of State Health Services as part of such a report, the person shall also immediately notify the Department of State Health Services' Policy, Standards, and Quality Assurance Unit by phone at (512) 834-6788, by fax at (512) 834-6707, or by email at PHSCPS@dshs.texas.gov that a minor has been or may have been abused or neglected at a youth camp.(2) Requirement to report incidents of abuse or neglect of a minor other than at a youth camp. If a person, including any member of camp staff, a camp counselor, or camp director has cause to believe that a minor has been or may have been abused or neglected as those terms are defined in the Texas Family Code, Chapter 261, and the abuse or neglect did not occur at the youth camp, then that person shall immediately make a report, in accordance with Texas Family Code, §261.103.(A) Except as provided by subparagraphs (B), (C) and (D) of this paragraph, a report shall be made to:(i) any local or state law enforcement agency;(ii) the Department of Family and Protective Services Abuse Hotline, which may be contacted at (800) 252-5400 or through the secure web site http://www.txabusehotline.org/; or(iii) the agency designated by the court to be responsible for the protection of children.(B) A report may be made to the Texas Juvenile Justice Department instead of the entities listed under subparagraph (A) of this paragraph if the report is based on information provided by a child while under the supervision of the Texas Juvenile Justice Department concerning the child's alleged abuse of another child.(C) Notwithstanding subparagraph (A) of this paragraph, a report, other than a report under subparagraph (D) of this paragraph, shall be made to the Department of Family and Protective Services if the alleged or suspected abuse or neglect involves a person responsible for the care, custody, or welfare of the child.(D) A report of alleged abuse, neglect, or exploitation in any juvenile justice program or facility shall be made to the Texas Juvenile Justice Department and a local law enforcement agency for investigation.(3) The youth camp must develop and maintain a written policy regarding the method for reporting to the Department of State Health Services suspected abuse or neglect of a minor occurring at the camp. This policy must be maintained on-site.(4) The Department of State Health Services, by policy, shall forward a report of alleged abuse of a camper that is received by the Department of State Health Services to the Department of Family and Protective Services or another appropriate agency.(e) Requirement to report camper death or communicable diseases. Camper death or confirmed cases of waterborne or foodborne diseases, such as cholera, dysentery, typhoid, salmonellosis, shigellosis, or infectious hepatitis, shall be reported to the Department of State Health Services' Policy, Standards, and Quality Assurance Unit, within 24 hours of occurrence (or confirmation in the case of disease) by fax at (512) 834-6707, or by email at PHSCPS@dshs.texas.gov.(f) Designation of a first aid area. A first aid area, used exclusively to handle health and emergency cases, shall be designated and suitably equipped. Supplies should be in single use packaging. A first aid kit containing at the minimum the items listed in this subsection shall be available in the first aid area.(1) Sterile adhesive bandages in assorted sizes.(2) Sterile gauze pads in assorted sizes.(3) Hypoallergenic adhesive tape.(4) Triangular bandages.(5) Sterile roller bandages in assorted sizes.(6) Scissors.(7) Tweezers.(8) Moistened towelettes.(9) Antiseptic.(10) Thermometer.(11) Splints.(12) Petroleum jelly or other lubricant.(13) Cleansing agent/soap.(14) Exam quality gloves.(15) Eye wash solution.(g) Isolation of a child with a communicable disease. A child ill with a confirmed or suspected case of a communicable disease shall be isolated to provide safety to other children and quiet to the patient. Any child that is isolated shall be supervised as determined by the Camp Health Officer. A child with a staphylococcal skin infection is not required to be isolated, if the infection is kept completely covered by a bandage.(h) Medical log required. A bound medical log, or other unalterable record keeping system, listing date, name of the patient, ailment, name of the Camp Health Officer, and the treatment prescribed shall be kept in the first aid area for the duration of the camp year for which the license is issued.(i) Camper health records shall be kept on file. The first aid area shall keep a health record on each child with the child's name, allergies, immunizations, parent's name, address, and telephone number, and parent or guardian authorization for emergency medical care.(j) Availability of an emergency telephone. The camp shall have a telephone readily available, preferably in the first aid area, for emergency use.(k) Emergency plans required. A written plan of procedures to be implemented in case of a disaster, serious accident, epidemic, or fatality shall be formulated and posted in the camp's administrative on-site office or location and in each permanent and semi-permanent occupied building. The plan shall include procedures for emergency shelter and for evacuation of each occupied building and the facility. Campers shall be instructed as to their actions in the event of fire, disaster, or the need to evacuate. These procedures shall be reviewed by the staff with specific assignments made to each staff member and counselor. All camp staff and volunteers shall be made aware of this plan during the staff-training program or volunteer briefing. Documentation of this training shall be kept at the camp's administrative on-site office or location.(l) Storing and dispensing prescription medication to campers. If a child is taking a prescription medication when he or she reports to camp, the medication shall be in the original container with the prescription label, and the medical staff shall place that medication, sharps, and related paraphernalia or devices in a lockable cabinet or other secure location that is not accessible to campers. The medication shall be administered by the Camp Health Officer or camp counselor, if authorized in writing by the Camp Health Officer. At no time shall the child be allowed to self-administer the medication without adult supervision. Medications needed for immediate use for life-threatening conditions (e.g., bee-sting medication, inhaler) and limited medications approved for use in first-aid kits may be carried by a camper or staff person. The camp shall have on file a written statement of medical necessity from the prescribing doctor or the written approval of the Camp Health Officer for any camper to carry medication and related paraphernalia or devices.(m) Camp trip first aid kits. First aid kits containing at the minimum the items listed in subsection (f) of this section shall be taken on all out-of-camp trips. Source Note: The provisions of this §265.15 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective February 25, 2019, 44 TexReg 862; amended to be effective June 25, 2020, 45 TexReg 4202. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.15 Medical and Nursing Care https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199899&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199899 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199899&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199899 03/11/2026 (a) Adult waterfront director required at youth camps. An adult waterfront director, who holds a current lifeguard certificate or its equivalent, shall be in charge of all waterfront activities. While waterfront activities are in progress, the waterfront director or an adult certified lifeguard assistant shall be in the immediate vicinity (within sight and/or hearing) of the campers, supervising the program.(b) Responsibilities of the waterfront director. The waterfront director is to be responsible for all waterfront supervision procedures and is responsible for ensuring that the waterfront procedures are strictly enforced. The waterfront staff shall not engage in personal recreational swimming, boating or any other waterfront activity while on waterfront duty. For every 35 campers, or fraction thereof, engaged in waterfront activities, there shall be one certified lifeguard and one additional person (either a certified lifeguard or trained adult lookout) on duty. Camps utilizing natural bodies of water such as rivers, lakes, or creeks may need to increase this ratio.(c) Maintenance and operation of swimming areas.(1) Swimming areas shall be maintained and operated in a safe and clean condition. Youth camp swimming pools are class C pools, and shall be built, operated, and maintained in accordance with 25 Texas Administrative Code (TAC), Chapter 265, General Sanitation, Subchapter L, Standards for Public Pools and Spas.(2) Interactive water features and fountains at youth camps shall be maintained and operated in a safe and clean condition. Interactive water features and fountains at youth camps shall be built, operated, and maintained in accordance with 25 TAC, Chapter 265, General Sanitation, Subchapter M, Interactive Water Features and Fountains.(d) Camper's swimming ability shall be determined in accordance with the camp's written swimming test policy. Camps shall test to determine each child's swimming ability. Children shall then be confined to the limits of swimming skills for which they have been classified. Also, the swimming area shall have areas for non-swimmers, intermediate swimmers, and swimmers clearly marked.(e) Checking campers in and out of the water. A method of checking campers in and out of the water shall be established and enforced.(f) Waterfront lifesaving equipment shall be provided. Lifesaving equipment suitable for the waterfront activity shall be provided at the waterfront activity area and placed so the equipment is immediately available in case of an emergency. All lifesaving equipment shall be kept in good repair and ready condition. At a minimum, this equipment shall include the following.(1) A rescue tube or rescue buoy with strap, or a ring buoy that is approved by the United States Coast Guard that has an outside diameter of 15 to 24 inches attached to a throwing rope that is at least two-thirds the maximum width of the pool with a diameter of 1/4-inch to 3/8-inch.(2) One or more backboards with a minimum of 3 tie down straps and head immobilizer for back and neck injuries.(3) A first aid kit that includes the items listed in §265.15(f) of this title (relating to Medical and Nursing Care).(g) Providing a personal flotation device. A Coast Guard approved Personal Flotation Device (PFD) shall be readily available for each occupant of a watercraft. Each occupant of a watercraft 12 years of age and under shall wear a United States Coast Guard (USCG) approved inherently buoyant Type II PFD, or Near-Shore Buoyancy Vest at all times while in the watercraft. A non-swimmer shall wear a USCG approved inherently buoyant Type II PFD, or Near-Shore Buoyancy Vest and not be permitted in a watercraft unless accompanied by a counselor. A camper shall wear a vest type USCG approved preserver before entering and while in white water or before entering and while on a lake when the water is rough or while waterskiing.(h) Location of swimming areas. Swimming areas shall be used exclusively for swimming while swimming is occurring. A watercraft docking area shall not be allowed in the swimming area and water skiers shall not launch, cross, or stop in the swimming area while swimming is occurring. Source Note: The provisions of this §265.16 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective June 25, 2020, 45 TexReg 4202. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.16 Waterfront Safety https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166530&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166530 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166530&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166530 03/11/2026 (a) Firearm or pellet gun programs at youth camps. A firearm or pellet gun program shall be conducted on a range that meets or exceeds the specifications outlined by the National Rifle Association or its equivalent. Safety procedures shall be enforced whenever the range is in use. The range shall be conspicuously marked and configured to prevent entry of campers onto the range while it is in use.(b) Archery program at youth camps. An archery program shall be conducted on a range that meets or exceeds the specifications outlined by the National Field Archery Association or its equivalent. The archery range shall be conspicuously marked and configured to prevent entry of campers onto the range while it is in use.(c) Program equipment condition and use. Equipment used in all programs shall be kept in good condition and present no hazard as a result of poor condition to the user at any time.(d) Storage of firearms, pellet guns, and archery equipment when not in use. Firearms, pellet guns, ammunition, and archery equipment shall be kept in a secured area when not in use.(e) Safety and maintenance of tools used by campers. All tools, including power tools, used by campers shall be maintained in good repair, shall have the necessary safety guard attached, and shall be used only under supervision.(f) Horseback riding programs.(1) Camps providing horseback riding programs shall require the head instructor or director of the program to follow the camp's riding program and safety procedures outlined in a written document. This document shall include the following:(A) procedures to be followed in the event of an accident;(B) procedures to determine each horse's suitability for safe use;(C) proper care of tack and equipment;(D) proper procedure for mounting;(E) the number of riders per supervisor; and(F) any other information that is specific to the camp's equestrian program or is helpful to the horseback riding director.(2) Camps providing horseback riding programs shall:(A) ensure that horses that are in use are sound and in good physical condition;(B) ensure that the stable area is kept clean and free of all hazards; and(C) require all riders (campers and instructional staff) to wear appropriate protective helmets.(g) Adventure/challenge courses. Camps providing an adventure/challenge program utilizing belaying, spotting, or non-spotting elements must:(1) designate a certified adventure/challenge program manager, who shall be in attendance whenever the adventure/challenge program is operating;(2) ensure that the adventure/challenge program is operated and maintained in a safe manner;(3) develop a set of site-specific policies and procedures, which establish criteria for all adventure/challenge operations, including equipment used and safety precautions;(4) ensure that spotters and belayers are instructed in the proper procedures prior to assuming their duties, and that they are directly supervised until competency is demonstrated;(5) establish a method to control access to the equipment and the activity area in order to prevent use by unauthorized or unsupervised campers;(6) perform safety checks of all equipment and ropes prior to each use and maintain a record of all inspections and maintenance;(7) provide a safety orientation for each camper prior to allowing the camper to engage in adventure/challenge activities;(8) ensure that all campers engaged in adventure/challenge activities are wearing appropriate personal protective equipment; and(9) provide documentation of an annual physical inspection of the adventure/challenge course and equipment by an insured third party inspector. Source Note: The provisions of this §265.17 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective March 13, 2014, 39 TexReg 1713. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.17 Program Safety and Equipment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227386&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227386 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227386&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227386 03/11/2026 (a) Fire and safety codes. Facilities at all youth camps that meet the definition of a campground as defined in Texas Health and Safety Code Section 762.001(2), except those described in subsection (d) of this section, must comply with the National Fire Protection Association 1194, Standard for Recreational Vehicle Parks and Campgrounds, 2021 Edition, other than Sections 1.1.1 and 5.1.1.1. Facilities at all youth camps must meet local fire and safety codes.(b) Fire exits in buildings. All buildings where groups of people live, eat, sleep, or assemble must have ready exits for use in case of fire and these exits must be conspicuously marked.(c) Storage of flammable or explosive materials. Containers of gasoline, flammables, or explosives must be plainly marked and stored in a locked area separate and apart from any permanent and semi-permanent structures used by campers. The presence of flammable or explosive materials must be kept to a minimum.(d) Subsection (a) of this section does not apply to a youth camp owned or controlled by a governmental entity. A governmental entity may adopt a policy, rule, ordinance, or order to regulate environmental health and sanitation, electrical distribution system safety, liquefied petroleum gas storage and dispensing safety, or fire protection only if the policy, rule, ordinance, or order does not impose standards more stringent than the standards described under subsection (a) of this section. Source Note: The provisions of this §265.18 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.18 Fire Prevention https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166532&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166532 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166532&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166532 03/11/2026 (a) Inspection of vehicles used for transportation of campers. Any vehicle used for transporting children on public roadways shall have all current and applicable Department of Public Safety vehicle inspections.(b) First aid kits in vehicles transporting campers or staff. Every vehicle used for transporting staff or campers off site shall be equipped with a first aid kit containing the items listed in §265.15(f) of this title (relating to Medical and Nursing Care) and emergency equipment such as fire extinguishers, tools, and flares.(c) Drivers shall have a valid driver's license. All drivers shall be adults and hold a valid driver's license appropriate for the type of vehicle being driven.(d) Safety belts. In any vehicle used for transportation of campers that is equipped with safety belts or that is required by any law to be equipped with safety belts:(1) the safety belts shall be in good working condition; and(2) all campers shall wear the safety belts provided when the vehicle is in motion. Source Note: The provisions of this §265.19 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.19 Maintenance and Safe Use of Motor Vehicles https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166533&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166533 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166533&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166533 03/11/2026 (a) Location of animals. Horses and other animals maintained at any camp shall be quartered at a reasonable distance from any sleeping, living, eating, or food preparation area.(b) Location of stables or corrals. Stables and corrals shall be located so as to prevent contamination of any water supply. Manure shall be removed from stalls and corrals as often as necessary to prevent a fly problem.(c) Animals in waterfront areas prohibited. Horses, dogs, or other domestic animals or pets shall not be permitted on a beach or in the water near the beach when in use for waterfront activities.(d) Rabies vaccinations of animals. All dogs and cats owned or under the supervision of anyone on the camp premises shall be currently vaccinated against rabies in compliance with Health and Safety Code, §826.021. Evidence of vaccination shall be provided to a department representative upon request. Source Note: The provisions of this §265.20 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.20 Farm and Domestic Animals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124290&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124290 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124290&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124290 03/11/2026 (a) Prevention of insect, rodent or other pest infestations. The camp management shall maintain every building used or intended for human habitation in a manner to keep it free from insects, rodents, and other pests.(b) Storage of chemical control agents. Chemical control agents, insecticides, rodenticides, and other hazardous chemicals shall have the containers plainly marked and be stored in a locked area not accessible to campers. The presence of such chemicals shall be kept to a minimum. Source Note: The provisions of this §265.21 adopted to be effective April 16, 2006, 31 TexReg 3049. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.21 Insect and Rodent Control https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124291&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124291 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124291&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124291 03/11/2026 A youth camp may not allow campers or staff to be nude except when bathing, showering, changing clothing, or receiving medical care. Source Note: The provisions of this §265.22 adopted to be effective April 16, 2006, 31 TexReg 3049. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.22 Nudity Prohibited https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227387&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227387 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227387&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227387 03/11/2026 (a) License required. A person must possess a valid youth camp license prior to operating a youth camp.(1) Submitting an application. A complete application to operate a youth camp must be submitted to and received by the department's Environmental and Sanitation Licensing Branch between January 1 and March 31 of each calendar year, and include:(A) an activity schedule showing dates and detailed information about the activities that are conducted both at the camp and at other locations;(B) an emergency plan, as described in §265.31 of this subchapter (related to Emergency Preparedness and Response);(C) the estimated number of campers attending the camp during the upcoming calendar year;(D) any other requested documents and information; and(E) the license fee, as described in §265.28 of this subchapter (relating to Fees).(2) Applications and fees. Applications and fees may be submitted online to https://vo.ras.dshs.state.tx.us.(3) Qualifying for a youth camp license. Subject to subsection (j) of this section, a facility qualifies for a youth camp license if the facility:(A) meets the definition of a "youth camp," as described in §265.11 of this subchapter (relating to Definitions); and(B) is in compliance, or has demonstrated a plan for compliance, with all provisions of the Act and the rules before operation as determined by:(i) submitting a complete application as described in paragraph (1) of this subsection; and(ii) passing a pre-licensing inspection conducted by the department, using the standard youth camp inspection form that may be found at https://www.dshs.texas.gov/youth-camp-program/applications-forms-youth-camp-program. (b) Processing applications.(1) A complete application must be submitted to the Environmental and Sanitation Licensing Branch at least 90 calendar days before camp operations begin. An application is considered incomplete until all required documentation, information, and fees are received. If the application is incomplete, the department issues a deficiency notice, including identification of deficiencies, a deadline for deficiency corrections, and the need for a pre-licensing inspection.(2) Upon receipt of an application, the department issues the following documents in accordance with policy, as applicable:(A) a license after the date of successfully passing the pre-licensing inspection--within 45 days;(B) a letter of application deficiency--within 45 days; or(C) a letter of pre-licensing inspection deficiency at the conclusion of the pre-licensing inspection.(i) The camp must provide proof of all deficiency corrections, except for corrections to the emergency plan, within 10 days after the inspection or before camp operation, whichever comes first.(ii) The camp must provide proof of all deficiency corrections for the emergency plan. The proof must be provided within 45 days after the camp received the department letter of pre-licensing inspection deficiency.(3) In the event that an application for a new license is not processed within 120 days, and no good cause exists for the delay, the applicant may request reimbursement of all fees paid in that particular application process so long as a complete application was submitted at least 120 calendar days prior to camp operation. Requests for reimbursement must be made in writing to the Environmental and Sanitation Licensing Branch. Good cause for exceeding the time period is considered to exist if the number of applications for licensure exceeds by 15% or more the number of applications processed the same calendar quarter of the preceding year or any other condition exists giving the department good cause for exceeding the time period.(4) If the request for reimbursement as authorized by paragraph (3) of this subsection is denied, the applicant may then appeal to the commissioner for a resolution of the dispute. The applicant must give written notice to the commissioner requesting reimbursement of the fee paid because the application was not processed within the established time period. The department submits a written report of the facts related to the processing of the application and good cause for exceeding the established time periods. The commissioner makes the final decision and provides written notification of the decision to the applicant and to the department.(c) Record availability. All records, except criminal background and sex offender registration database checks (including any written evaluation for any staff member or volunteer with a criminal conviction or deferred adjudication), required by this subchapter must be made available to the department immediately upon request. Criminal background and sex offender registration database checks (including any written evaluation for any staff member or volunteer with a criminal conviction or deferred adjudication) must be made available to the department within two business days upon request.(d) Term of license. The term of a youth camp license is one year, beginning on the date of issuance.(e) License non-transferable. A youth camp license is not transferable and may not be sold, assigned, or otherwise transferred. Any new business entity that acquires the operation of a youth camp through sale, assignment, or other transfer must obtain a new license.(f) Ownership change. A new application, fee, pre-licensing inspection, and license is required if there is a change in ownership.(g) Name change. If a camp changes its name during operation, but does not change location or ownership, then a new license certificate may be issued if requested by email to youthcamps.reg@dshs.texas.gov. A nonrefundable fee of $20 will be assessed.(h) Location change. A new application, fee, pre-licensing inspection, and license is required if there is a change in physical camp location.(i) Duplicate license. A duplicate license may be issued if requested by email to youthcamps.reg@dshs.texas.gov. A nonrefundable fee of $20 will be assessed.(j) Denials.(1) The department may deny an application for licensing to applicants who fail to meet the standards established by the Act and this subchapter. In making this determination, the department considers any violation by the applicant of the Act or this subchapter, including employment of an individual who was convicted of an act of sexual abuse, as defined by Texas Penal Code §21.02, that occurred at the camp. When the department proposes to deny an application, the department gives notice of the proposed action in writing and provides information on how to request an administrative hearing. The applicant must submit a written request for a hearing within 30 days from the date of the department's notice letter. The hearing is conducted in accordance with the Act; Texas Government Code Chapter 2001, the Administrative Procedure Act; and the formal hearing procedures in Chapter 1 of this title (relating to Miscellaneous Provisions).(2) A letter of denial of licensure may be issued within 60 days after the receipt of application if the applicant does not meet the requirements of subsection (a)(3)(A) of this section.(3) A letter of denial of licensure may be issued if the applicant does not meet the requirements of subsection (a)(3)(B) of this section:(A) within 60 days following the first scheduled date of camp operations if a pre-licensing inspection has not been completed; or(B) within 60 days following the first scheduled date of camp operations if the camp does not pass the pre-licensing inspection. (4) A license holder whose license has been revoked may not reapply for a new license for two years from the date of final revocation.(k) Refunds.(1) If the applicant does not meet the requirements of subsection (a)(3)(A) of this section, the application may be denied and the license fee, less a handling fee of $50, may be refunded. If an application is denied because the facility does not meet the requirements of subsection (a)(3)(A) of this section, the applicant should determine if a license from another agency is required.(2) If the applicant does not meet the requirements of subsection (a)(3)(B) of this section, the application may be denied and the license fee may not be refunded. Source Note: The provisions of this §265.23 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective February 25, 2019, 44 TexReg 862; amended to be effective June 25, 2020, 45 TexReg 4202; amended to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.23 Application and Denial of a New License; Non-transferable https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227388&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227388 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227388&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227388 03/11/2026 (a) Renewal of a youth camp license. A youth camp operator holding a license issued under this chapter must submit a complete renewal application to operate a youth camp. A renewal application must be submitted:(1) annually to the department's Environmental and Sanitation Licensing Branch between January 1 and March 31 of each calendar year; and(2) no later than the 30th day after the date the youth camp operator:(A) alters the boundaries of a youth camp;(B) completes construction of one or more new cabins located on the premises; or(C) completes any renovation to one or more existing cabins located on the premises of the camp that:(i) increases or decreases the number of beds in an affected cabin; or(ii) alters the method of ingress or egress to an affected cabin.(b) Renewal notice. At least 60 days before a license expires, the department, as a service to the licensee, may send a renewal notice to the licensee or registrant to the last address provided by the licensee. The licensee is responsible for renewing the license whether the licensee receives the department's notice or not. The renewal notice states:(1) license type requiring renewal;(2) time period allowed for renewal; and(3) the amount of the renewal fee.(c) Renewal requirements. Renewal applications and fees must be received by the department before the license's annual expiration date.(1) Submitting an application. A complete renewal application must be submitted to the department and include:(A) a completed youth camp renewal application;(B) an activity schedule showing dates and detailed information about the activities that are conducted both at the camp and at other locations;(C) an emergency plan, including any updated emergency plan, as described in §265.31 of this subchapter (relating to Emergency Preparedness and Response);(D) the estimated number of campers attending the camp during the upcoming calendar year;(E) any other requested documents and information; and(F) the renewal license fee as described in §265.28 of this subchapter (relating to Fees).(2) Applications and fees. Applications and fees may be submitted online to https://vo.ras.dshs.state.tx.us.(3) Qualifying for renewal of a youth camp license. Subject to subsection (k) of this section, the department issues a renewal license if the facility:(A) meets the definition of a "youth camp," as described in §265.11 of this subchapter (relating to Definitions); and(B) is in compliance with all provisions of the Act and the rules before operation as determined by:(i) submitting a complete renewal application as described in this subsection;(ii) passing a pre-licensing inspection conducted by the department, if required; and(iii) complying with all final orders resulting from any violations of this subchapter before the application for renewal is submitted.(d) Processing renewal applications.(1) A complete application for a license renewal issued under this subchapter must be received by the department's Environmental and Sanitation Licensing Branch before the expiration date of the license or 45 days before camp operation, whichever is earlier.(A) An application is considered incomplete until all required documentation, information, and fees are received.(B) If the application is incomplete, the department issues a deficiency notice, including identification of deficiencies, a deadline for deficiency correction, and the need for a pre-licensing inspection.(C) If a camp is subject to pre-licensing inspection, a renewal license is issued after the inspection is completed and compliance with the Act and this subchapter is confirmed.(2) Upon receipt of an application, the department issues the following documents in accordance with policy, as applicable:(A) a license--within 30 days;(B) a letter of renewal application deficiency--within 30 days; or(C) a letter of pre-licensing inspection deficiency at the conclusion of the pre-licensing inspection.(i) The camp must provide proof of all deficiency corrections, except for corrections to the emergency plan, within 10 days after the inspection or before camp operation, whichever comes first.(ii) The camp must provide proof of all deficiency corrections for the emergency plan. The proof must be provided within 45 days after the camp received the department letter of pre-licensing deficiency.(3) In the event that a timely and complete application for license renewal is not processed within timeframe established in department policy, and no good cause exists for the delay, the applicant has the right to request reimbursement of all fees paid in that particular application process. Requests for reimbursement must be made by email to youthcamps.reg@dshs.texas.gov. Good cause for exceeding the time period is considered to exist if the number of applications for licensure exceeds by 15% or more the number of applications processed the same calendar quarter of the preceding year or any other condition exists giving the department good cause for exceeding the time period.(4) If the request for reimbursement as authorized by paragraph (3) of this subsection is denied, the applicant may then appeal to the commissioner for a resolution of the dispute. The applicant must give written notice to the commissioner requesting reimbursement of the fee paid because the application was not processed within the established time period. The department submits a written report of the facts related to the processing of the application and good cause for exceeding the established time periods. The commissioner makes the final decision and provides written notification of the decision to the applicant and to the department.(e) Late renewal. If a license is not renewed within one year after the expiration date, the license cannot be renewed. A new license may be obtained by submitting a new application in compliance with §265.23 of this subchapter (relating to Application and Denial of a New License; Non-transferable). If the license is renewed after its expiration date, the renewed license expires on the date the license would have expired if the license had been renewed timely.(f) Non-renewal. The department may refuse to renew a license if the applicant has not complied with all final orders resulting from any violations of these sections. Eligibility for license renewal may be reestablished by meeting all conditions of the orders and complying with the requirements of this section. The department may not renew the license of a youth camp that has not corrected deficiencies identified in a final order before the application for renewal is submitted. Corrections must be submitted to and approved by the department's Environmental and Sanitation Licensing Branch before submitting the renewal application.(g) Application determination affecting license expiration. If a license holder submits a timely and complete license renewal application, the existing license does not expire until the application has been finally determined by the department. If a license holder submits a late or incomplete application and the application is denied, the existing license does not expire until the last day to request a review of the agency order or a later date granted by order of the reviewing court.(h) Reapplication for license upon revocation. A license holder whose license has been revoked may not reapply for a new license for two years from the date of final revocation.(i) Opportunity for a hearing. When the department proposes to deny an initial or renewal application, the department gives notice of the proposed action in writing and provides information on how to request an administrative hearing. The applicant must submit a written request for a hearing within 30 days from the date of the notice letter.(j) Pre-licensing inspections. A youth camp applying for a license renewal may be subject to a pre-licensing inspection. Youth camps must be in compliance with all provisions of the Act and the rules before operation.(k) Denials.(1) The department may deny a renewal application for licensing to applicants who fail to meet the standards established by the Act and this subchapter. The department considers any violations by the applicant of the Act or this subchapter, including employment of an individual who was convicted of an act of sexual abuse, as defined by Texas Penal Code §21.02, that occurred at the camp. When the department proposes to deny a renewal application, the department gives notice of the proposed action in writing and provides information on how to request an administrative hearing. The hearing is conducted in accordance with the Act; Texas Government Code Chapter 2001, the Administrative Procedure Act; and the formal hearing procedures in Chapter 1 of this title (relating to Miscellaneous Provisions).(2) A letter of denial of license renewal may be issued within 60 days of the receipt of application if the applicant does not meet the requirements of subsection (c)(3)(A) of this section.(3) A letter of denial of license renewal may be issued within 60 days following the first scheduled date of camp operations if the applicant does not meet the requirements of subsection (c)(3)(B) of this section.(l) Refunds.(1) If the applicant does not meet the requirements of subsection (c)(3)(A) of this section, the renewal application may be denied and the renewal license fee, less a handling fee of $50, may be refunded. If an applicant is denied because the facility does not meet the requirements of subsection (c)(3)(A) of this section, the applicant should determine if a license from another agency is required.(2) If the applicant does not meet the requirements of subsection (c)(3)(B) of this section, the renewal application may be denied and the renewal license fee may not be refunded. Source Note: The provisions of this §265.24 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective March 13, 2014, 39 TexReg 1713; amended to be effective February 25, 2019, 44 TexReg 862; amended to be effective June 25, 2020, 45 TexReg 4202; amended to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.24 Application and Denial of a Renewal License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124294&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124294 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124294&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124294 03/11/2026 (a) Inspections and corrections. An employee or agent of the department may enter any property for which a license is issued in accordance with the Act, property for which a license application to operate a youth camp is pending, or property on which a youth camp is operating without a license to investigate and inspect conditions relating to the health and safety of the campers. An employee or agent of the department who enters a youth camp to investigate and inspect conditions shall:(1) notify the person in charge of the camp of the inspector's presence and shall present proper credentials;(2) notify the person in charge of the camp or the person's designee of any violations as they are discovered; and(3) allow the camp to correct the violations while the investigation and inspection is occurring.(b) Investigation or inspection may not be delayed. An employee or agent of the department may not extend or delay an investigation or inspection in order to allow the youth camp to correct a violation noted during the investigation or inspection.(c) Interference with an inspection. A department representative in pursuance of his/her official duties is not required to seek permission to conduct inspections or investigations. It is a violation of the Act for a person to interfere with, deny, or delay an inspection or investigation conducted by a department representative. Source Note: The provisions of this §265.25 adopted to be effective April 16, 2006, 31 TexReg 3049. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.25 Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124295 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=124295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 124295 03/11/2026 (a) A person violating the Act or a rule or order adopted under the Act is subject to a civil penalty of not less than $50 or more than $1,000 for each act of violation.(b) If it appears that a person has violated, is violating, or is threatening to violate the Act or a rule or order adopted under the Act, the department may bring a civil action in a district court for injunctive relief, a civil penalty, or both.(c) The district court, upon finding that the person is violating the Act, or a rule or order adopted under the Act, shall grant injunctive relief, assess a civil penalty, or both, as warranted by the facts.(d) The department may petition a district court for a temporary restraining order to immediately halt a violation or other action creating an emergency condition if it appears that a person is:(1) violating or threatening to violate the Act or a rule or order adopted under the Act; or(2) taking any other action that creates an emergency condition that constitutes an imminent danger to the health, safety, or welfare of campers, staff or visitors at a youth camp.(e) An action under this section may be brought in the county in which the defendant resides or in which the violation or threat of violation occurs.(f) If an action for injunctive relief under this section is granted by the court, the court may grant any prohibitory or mandatory injunction warranted by the facts, including temporary restraining orders, temporary injunctions, and permanent injunctions. The court shall grant injunctive relief without a bond or other undertaking by the department.(g) An appellate court shall give precedence to an action brought under this section over other cases of a different nature on the docket of the court. Source Note: The provisions of this §265.26 adopted to be effective April 16, 2006, 31 TexReg 3049. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.26 Civil Penalties and Injunctions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199902&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199902 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199902&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199902 03/11/2026 (a) License revocation. (1) If the department finds that a violation of the Act or of a rule has occurred or is occurring at a youth camp for which a license has been issued, the department shall give written notice to the licensee setting forth the nature of the violation and demanding that the violation cease. (2) The department may initiate proceedings to revoke the license if the licensee fails to comply with the notice of violation in the time and manner directed in the notice. (b) Assessment of an administrative penalty. The Commissioner may assess an administrative penalty if a person violates the Act, a rule of the department, or an order of the commissioner issued under the Act or rules. (c) Determination of the penalty amount. In determining the amount of the penalty, the commissioner shall consider: (1) previous compliance history; (2) the seriousness of the violation; (3) any hazard to public health and safety; (4) the person's demonstrated good faith; and (5) any other matters as justice may require. (d) Administrative penalty limits. The administrative penalty may not exceed $1,000 a day for each violation. Each day a violation continues may be considered a separate violation. (e) Opportunity for a hearing. Prior to revoking a license or assessing an administrative penalty, the department shall give the person charged an opportunity for a hearing. The hearing shall be conducted in accordance with the Act, the Administrative Procedures Act, Texas Government Code, Chapter 2001, and the formal hearing procedures of the department at 25 Texas Administrative Code §1.21 et seq. (f) Violation severity levels. Violations shall be categorized into severity levels I, II, and III. Administrative penalties may be imposed for: (1) Critical violations. Severity level I violations have or could have a direct or immediate negative effect on the health, safety, and welfare of campers or the operation and management of a youth camp. These violations are assessed at $750 - $1,000 per violation per day. Examples of severity level I violations include, but are not limited to: (A) operating a youth camp without a current license; (B) failing to report an incident of camper abuse or neglect of a camper as required; (C) providing drinking water from an unapproved source; (D) policies or procedures not being followed in a way that has a direct negative impact on camper health or safety; (E) unqualified or insufficient number of personnel staffing operations or activities; (F) criminal conviction and sex offender records not on file; (G) sexual abuse training and exam records not on file; and (H) interfering with, denying, or delaying an inspection or investigation conducted by a department representative. (2) Serious violations. Severity level II violations are those that could threaten the health, safety, and welfare of campers or the operation and management of a youth camp. These violations are assessed at $500 - $750 per violation per day. Examples of severity level II violations include, but are not limited to: (A) written personnel practices and policies regarding camp and staff are not available as required; (B) staff members not informed regarding personnel and camp practice policies; (C) proper sanitation of all food utensils not achieved; (D) policies or procedures not being followed in a way that could threaten the health, safety, and welfare of campers or the operation and management of a youth camp; (E) swimming areas not maintained in clean condition; or (F) disaster and/or fire evacuation procedures are not posted properly. (3) Significant violations. Severity level III violations are those of concern that if left uncorrected could lead to more serious circumstances. These violations are assessed at $250 - $500 per violation per day. Examples of severity level III violations include, but are not limited to: (A) toilets and bathing facilities not adequately lighted and ventilated; (B) docking and waterskiing permitted in the swimming area; (C) vehicles used to transport staff or campers not equipped with a first aid kit; (D) policies or procedures not being followed in a way that if left uncorrected could lead to more serious circumstances; and (E) unauthorized nudity allowed. Source Note: The provisions of this §265.27 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815; amended to be effective June 25, 2020, 45 TexReg 4202. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.27 Revocation, Administrative Penalties, and Hearings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227389&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227389 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227389&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227389 03/11/2026 (a) All applicable fees must be paid to the department before the department issues a license.(b) For all initial and renewal applications, the department is authorized to collect subscription and convenience fees, to recover costs associated with electronic application and renewal application processing.(c) The annual fees, not including subscription and convenience fees, are as follows:(1) initial license day youth camp:(A) 99 or less campers per year--$950;(B) 100 to 999 campers per year--$1,150;(C) 1,000 to 1,999 campers per year--$2,000;(D) 2,000 to 4,999 campers per year--$2,600; and(E) 5,000 or more campers per year--$4,000;(2) renewal license day youth camp:(A) 99 or less campers per year--$750;(B) 100 to 999 campers per year--$950;(C) 1,000 to 1,999 campers per year--$1,750;(D) 2,000 to 4,999 campers per year--$2,250; and(E) 5,000 or more campers per year--$3,500;(3) initial license residential youth camp:(A) 99 or less campers per year--$2,150;(B) 100 to 499 campers per year--$2,500;(C) 500 to 999 campers per year--$6,500;(D) 1,000 to 1,999 campers per year--$12,000;(E) 2,000 to 4,999 campers per year--$15,000;(F) 5,000 to 9,999 campers per year--$18,000; and(G) 10,000 or more campers per year--$21,000;(4) renewal license residential youth camp:(A) 99 or less campers per year--$1,900;(B) 100 to 499 campers per year--$2,250;(C) 500 to 999 campers per year--$5,500;(D) 1,000 to 1,999 campers per year--$10,000;(E) 2,000 to 4,999 campers per year--$13,500;(F) 5,000 to 9,999 campers per year--$16,500; and(G) 10,000 or more campers per year--$19,500.(d) Miscellaneous fees are as follows:(1) duplicate license fee--$20;(2) camp name change during operation--$20; and(3) non-sufficient fund fee--$20.(e) Late fees will be assessed for applications received after March 31 as follows:(1) initial late fee--$500; and(2) renewal late fee--$250.(f) An applicant or licensee whose license fee payment is returned for any reason, including insufficient funds, account closed, or payment stopped, must pay the department the amount of the license fee within 30 days after the date of the department's notice. An application is incomplete until the fee is received and cleared through the appropriate financial institution.(g) The department may notify the applicant or the license holder that the person has failed to comply with this section and that any license issued is invalid.(h) Initial application or renewal fees are refunded only if the fee amounts paid exceed the correct fee amount or if there is a double payment. The department does not refund fees if the applicant fails to respond to a written request from the department within 90 days.(i) All fees must be submitted online at https://vo.ras.dshs.state.tx.us. Source Note: The provisions of this §265.28 adopted to be effective April 16, 2006, 31 TexReg 3049; amended to be effective May 16, 2010, 35 TexReg 3815 ; amended to be effective June 25, 2020, 45 TexReg 4202; amended to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.28 Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227390&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227390 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227390&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227390 03/11/2026 (a) The Youth Camp Safety Multidisciplinary Team (YCSMT) is composed of at least one representative from:(1) the department;(2) the Texas Division of Emergency Management (TDEM);(3) the Texas Department of Insurance (TDI), State Fire Marshal's Office;(4) the Texas Parks and Wildlife Department (TPWD);(5) the Texas Water Development Board (TWDB);(6) the Texas A&M Forest Service (TAMFS); and(7) the Texas Department of Public Safety (DPS).(b) The commissioner or the commissioner's designee serves as the chair of the team.(c) The YCSMT meets regularly to develop proposed minimum standards for youth camps. The YCSMT presents the proposed minimum standards to the executive commissioner as recommendations for adoption. Source Note: The provisions of this §265.29 adopted to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.29 Youth Camp Safety Multidisciplinary Team https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227391&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227391 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227391&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227391 03/11/2026 (a) The department may grant a waiver from the requirements of this chapter to a program that meets the conditions described in Texas Health and Safety Code (HSC), §141.0025(a). The program seeking the waiver must provide proof to the department that the program meets the conditions described in HSC §141.0025(a) before the department may grant a waiver. To ensure the program continues to be eligible for a waiver, the department may require the program to resubmit proof of meeting the conditions described in HSC §141.0025(a) no more frequently than one time per calendar year or as part of an investigation described in subsection (c) of this section.(b) A waiver granted by the department under subsection (a) of this section is valid until the waiver is revoked for cause by the department. Examples of cause for revocation include:(1) the failure to ensure the health, safety, or welfare of persons at the program; or(2) the failure to report abuse or neglect occurring at the program as required by Texas Family Code Chapter 261.(c) The department may conduct an investigation in response to an allegation that there is cause to revoke a program's waiver or that a program no longer meets the conditions described in HSC §141.0025(a).(d) A person who operates a program for which an application for a waiver under this section has been denied or for which a waiver under this section has been revoked may appeal the action in the manner provided for appeal of contested cases under Texas Government Code Chapter 2001. When the department proposes to deny or revoke a waiver granted under this section, it must give notice of the proposed action in writing and must provide information on how to request an administrative hearing. The program must make a written request for a hearing within 30 days from the date on the notice letter sent by the department.(e) The department will not grant a waiver from the requirements provided in HSC §141.0091 or HSC Chapter 762. Source Note: The provisions of this §265.30 adopted to be effective March 21, 2018, 43 TexReg 1635; amended to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.30 Waiver; Appeal https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227392&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227392 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227392&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227392 03/11/2026 (a) A youth camp operator must develop an emergency plan that:(1) specifies areas where campers and camp staff are to gather in an emergency event that requires evacuation from any location within the premises of the camp;(2) establishes procedures for responding to an emergency event, including:(A) a lost camper;(B) a fire on the premises;(C) a severe injury, severe illness, serious accident, or death of one or more campers, visitors, camp staff, or camp volunteers that occurs:(i) on camp premises; or(ii) while under the supervision of camp staff;(D) an aquatic emergency if the camp borders a watercourse, lake, pond, or any other body of water;(E) an epidemic;(F) an unauthorized or unknown individual present on the camp's premises;(G) a transportation emergency; and(H) any other applicable natural disaster, including flood, hurricane, tornado or wildfire; or emergency event;(3) establishes procedures to identify and account for each camper affected by the emergency event;(4) establishes procedures to notify and communicate with:(A) local emergency management services, including the designated emergency management director or coordinator by the political subdivision where the camp is located;(B) camp administrative and medical services staff; and(C) the parents or legal guardians of each camper identified under paragraph (3) of this subsection; and(5) designates a camp emergency preparedness coordinator.(b) A youth camp operator must develop an emergency evacuation plan for:(1) evacuating campers who are at a camp within a floodplain on issuance of a flash flood or flood warning;(2) evacuating campers on issuance of an evacuation order by the emergency management director or coordinator for the county or, if applicable, the municipality in which the camp is located, due to wildfire, hurricane, or other disaster; and(3) sheltering campers in place on issuance of:(A) a tornado warning; or(B) an order to shelter in place issued by the emergency management director or coordinator for the county or, if applicable, the municipality in which the camp is located.(c) A youth camp operator must:(1) implement the emergency evacuation plan developed under subsection (b)(1) of this section on issuance by the National Weather Service (NWS) of a flash flood or flood warning for an area of the camp; and(2) implement the emergency evacuation plan developed under subsection (b)(3) of this section on issuance by the NWS of a tornado warning for an area of the camp.(d) A youth camp operator must send a copy of an emergency evacuation plan developed under subsection (b) of this section to:(1) the emergency management director or coordinator for the municipality (for camps located in a municipality); and(2) the emergency management director or coordinator for the county.(e) A youth camp operator must provide a copy of the camp's emergency plan not later than the 10th business day following the date the department approves the emergency plan or, if the department determines the plan is deficient under §265.23 of this subchapter (relating to Application and Denial of a New License; Non-transferable) or §265.24 of this subchapter (relating to Application and Denial of a Renewal License), the youth camp must provide a copy of the camp's revised and approved emergency plan to:(1) the designated emergency management director or coordinator for the municipality (for camps located in a municipality); and(2) the designated emergency management director or coordinator for the county.(f) In developing the youth camp's emergency plan, a youth camp operator may consult with an emergency management director or coordinator described in subsection (d) of this section.(g) A youth camp operator must:(1) provide the most recent version of a youth camp's emergency plan submitted under this section to the parent or legal guardian of:(A) a camper who is participating in a camp session; or(B) a camper who is registered to participate in a future camp session;(2) notify the parent or legal guardian of a camper described by paragraph (1) of this subsection if any area of the camp is located within a floodplain; and(3) ensure the parent or legal guardian signs and submits to the operator a statement acknowledging receipt of the notice required under paragraph (2) of this subsection.(h) A youth camp operator must:(1) maintain an operable radio providing real-time weather alerts issued by the NWS or a similar professional weather service at the camp;(2) install and maintain at the camp an emergency warning system:(A) alerting all campers and camp occupants of an emergency; and(B) including a public address system operable without reliance on an internet connection;(3) monitor safety alerts issued:(A) by the NWS or a similar professional weather service; and(B) by local river authorities, if applicable to the camp, or through other local emergency notification systems; and(4) certify the operator's compliance with this subsection.(i) The youth camp operator or a youth camp staff member must conduct a mandatory safety orientation, not more than 48 hours after each youth camp session begins. The safety orientation:(1) notifies each camper of the camp's boundaries and any hazards present on the camp premises;(2) instructs each camper on behavioral expectations in an emergency event; and(3) provides each camper developmentally appropriate instruction on the appropriate actions and procedures to follow in an emergency event, in accordance with the camp's emergency plan required under this section.(j) At least once a year, a youth camp operator must:(1) provide each youth camp staff member and volunteer a copy of the camp's most recent emergency plan;(2) ensure each staff member and volunteer successfully completes training on the camp's emergency plan in compliance with any minimum standards and required hours established by department rule;(3) instruct each staff member and volunteer on the proper procedures to follow in an emergency under the plan; and(4) maintain written records documenting each staff member's and volunteer's successful completion of the training required under this subsection.(k) A youth camp operator must:(1) post the proper evacuation route described in the youth camp's emergency plan in a conspicuous place in each cabin on the youth camp premises; and(2) ensure each evacuation route on the camp premises is illuminated at night.(l) A youth camp operator must notify the department as described in §265.24 of this subchapter of any modification to:(1) a structure intended to facilitate youth camp activities; or(2) the location of a camp activity on the camp's premises.(m) On receiving notification of a modification described by subsection (l) of this section, the department may require the youth camp operator to update the youth camp's emergency plan.(n) The department must store in a digital database each emergency plan submitted to the department under this section and provide access to that database to:(1) TDEM; and(2) each member of the Youth Camp Safety Multidisciplinary Team (YCSMT) created under §265.29 of this subchapter (relating to Youth Camp Safety Multidisciplinary Team). Source Note: The provisions of this §265.31 adopted to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.31 Emergency Preparedness and Response https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227393&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227393 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227393&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227393 03/11/2026 The minimum camper to counselor ratios for overnight stays at youth camps are as follows.(1) For campers from four to five years of age--one counselor for every five campers.(2) For campers from six to eight years of age--one counselor for every six campers.(3) For campers from nine to 14 years of age--one counselor for every eight campers.(4) For campers from 15 to 17 years of age--one counselor for every 10 campers. Source Note: The provisions of this §265.32 adopted to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.32 Minimum Overnight Camper to Counselor Ratios https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227394&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227394 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227394&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227394 03/11/2026 The department will post, maintain, and update on the department's internet website a list of each youth camp with an active license issued under this subchapter. Source Note: The provisions of this §265.33 adopted to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.33 Online Youth Camp Registry https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227395&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227395 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227395&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227395 03/11/2026 (a) A youth camp operator's public-facing website must include a prominent, clearly marked link to the department's complaint website where campers, parents, camp staff, and volunteers can report noncompliance with the subchapter.(b) The department will investigate each youth camp complaint filed with the department to ensure the youth camp operator is properly implementing the camp's approved emergency plan submitted as required under §265.31 of this subchapter (relating to Emergency Preparedness and Response).(c) A department investigation under this section must include an inspection to ensure the youth camp's compliance with this subchapter. The inspection will be performed in the same manner as a compliance inspection, as described in §265.25 of this subchapter (relating to Inspections). Source Note: The provisions of this §265.34 adopted to be effective February 2, 2026, 51 TexReg 571. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.34 Additional Inspection Required; Parental Complaints https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227396&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227396 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227396&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227396 03/11/2026 (a) A youth camp must not operate a cabin located within a Federal Emergency Management Agency (FEMA) identified 100-year floodplain, unless:(1) each cabin located within a floodplain is a result of the cabin's proximity to a lake, pond, or other still body of water that:(A) is not connected to a stream, river, or other watercourse; or(B) is dammed; or(2) each cabin is at least 1,000 feet from a floodway.(b) A youth camp that operates a cabin within the floodplain as described in subsection (a) of this section must install and maintain an emergency ladder capable of providing access to the cabin's roof. Source Note: The provisions of this §265.36 adopted to be effective February 2, 2026, 51 TexReg 589. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.36 Prohibited Operation of Cabins within Floodplains. https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227397&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227397 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=227397&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 227397 03/11/2026 A youth camp operator must provide and maintain for a youth camp:(1) internet services through a broadband service that connects to the internet using end-to-end fiber optic facilities; and(2) a secondary internet connection through a broadband service distinct from the service described under paragraph (1) of this section. Source Note: The provisions of this §265.37 adopted to be effective February 2, 2026, 51 TexReg 591. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION B TEXAS YOUTH CAMPS SAFETY AND HEALTH §265.37 Redundant Internet Connections Required. https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212227&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212227 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=212227&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 212227 03/11/2026 The camp shall be so located as to promote at all times the health, safety, and well-being of persons accommodated.(1) Housing site.(A) All campsites shall be well drained and free from depressions in which water may stand. Natural sinkholes, pools, swamps, or other surface collectors of water within 200 feet of the periphery of the camp shall be either drained or filled to remove the still surface water. Mosquito breeding shall be prevented in such area containing water not subject to such drainage or filling.(B) Housing shall not be subject to or in proximity to conditions that create or are likely to create offensive odors, flies, noise, traffic, or any similar hazards.(C) Grounds within the housing site shall be free from debris, noxious plants (poison ivy, etc.) and uncontrolled weeds or brush.(D) The housing site shall provide a space for recreation reasonably related to the size of the facility and the type of occupancy.(2) Water supply.(A) When drinking water supply system is to be established for a camp, plans are to be submitted to the Texas State Department of Health for review and approval prior to construction thereof. All water systems serving camps are to be constructed in conformance to the Board of Health's current "Rules and Regulations for Public Water Systems' and maintained and operated in accordance with the following minimum acceptable operating standards, which are based upon state statutes, regulations, and good operating practices.(B) The use of a common drinking cup shall not be permitted.(C) The camp shall be connected to an acceptable existing public water supply system if at all possible. Should a camp have its own source of water supply, then the following requirements are to be met:(i) Water systems serving camps shall submit a minimum of four water samples each month the camp is in operation to the Texas State Department of Health or one of its regional laboratories for bacteriological analysis (be sure to check with the laboratory to see what days of the week they will accept these samples).(ii) Annually every camp shall submit a one-half gallon water sample for chemical analysis and, in addition, an eight-ounce sample collected in a glass bottle for iron and manganese determination.(iii) A minimum chlorine residual of 0.2 ppm must be maintained throughout the distribution system at all times. In this connection, a chlorine test kit should be obtained so the chlorine residuals can be checked. Test results should be recorded.(iv) When repairs are made to existing mains or when new main extensions are provided, they must be disinfected by water department personnel using such amounts of chlorine or chlorine compounds as to fill the repaired or new mains and appurtenances with water containing 50 ppm chlorine. After the water containing this amount of chlorine, which is greater than that normally present in drinking water, has been in contact with the pipe and appurtenances at least 24 hours, the water shall be replaced with water to be transported normally, and samples of water from the new or repaired main submitted to laboratories for bacteriological examination so as to be assured that the disinfection procedure was effective. When it is necessary to return repaired mains to service as rapidly as possible, doses may be increased to 500 ppm and the contact time reduced to 1/2 hour.(v) A supply of calcium hypochlorite disinfectant shall be kept on hand for use when making repairs and repairing line breaks.(vi) Continuous efforts shall be made by camp personnel to locate possible interconnections between privately owned water systems and the camp water system. As these undesirable interconnections are located, they shall be eliminated so as to prevent possible contamination of the water supplied by the camp water facilities. Water lines and sanitary sewers shall be installed no closer to each other than nine feet, nor closer than 10 feet to septic tank drainfields.(vii) All dead-end mains should be flushed at monthly intervals or more frequently if necessary to maintain water quality.(viii) No tile or concrete sanitary sewers or septic tanks shall be allowed within a distance of 50 feet, and no cesspool or septic tank open-jointed drainfields shall be allowed within a distance of 150 feet of the well.(ix) Copies of well material setting data, geological log, sealing information (pressure cementing and surface protection), disinfection information, bacteriological sample results, and a chemical analysis report of a representative sample of water from the well shall be kept on file.(x) No physical connection between the distribution system of a camp water supply and that of any other supply shall be permitted unless such other water is of safe sanitary quality and the interconnection is approved by the State Department of Health.(3) Excreta and liquid waste disposal.(A) Adequate and safe sewerage facilities with flush toilets shall be provided if water supply is available. Raw or treated liquid waste shall not be discharged or allowed to accumulate on the ground surface.(B) Where public sewer systems are available, all facilities for disposal of sewage or wastewater shall be connected thereto.(C) Where public sewers are not available, a subsurface septic tank-seepage system or other type of liquid waste treatment and disposal system shall be provided. If wastewater plant is to be utilized and discharge is to occur, a waste control order must be secured from the Texas Water Quality Board.(D) Where water supply is not available, sanitary-type privies or portable toilets shall be provided. All such facilities shall be constructed as required by the Texas State Department of Health. Privies, if provided, shall be constructed according to standards set forth in the department's "Texas Community Sanitation Handbook," and maintained so to prevent access of flies and animals to the contents therein, to prevent fly breeding, and to prevent contamination of water supply.(E) All facilities provided for excreta and liquid waste disposal shall be maintained and operated in a sanitary manner to eliminate possible health or pollution hazards.(4) Housing.(A) Housing shall be structurally sound, in good repair, maintained in a sanitary condition, and shall provide protection to the occupants against the elements.(B) Housing shall have flooring constructed of rigid materials, smooth finished, readily cleanable, and so located as to prevent the entrance of ground and surface water.(C) Each habitable room shall be adequately ventilated.(D) Therapeutic camps shall have an annual pressure test for all gas pipes, to be performed by the local gas company or a licensed plumber.(E) A balcony, upper story, attic, or loft is not recommended for sleeping or group assembly and can only be used when recommended minimum safety requirements for emergency exits are met (two or more exits remote from each other; exits to ground level by stairs, not ladders; one or more exits by outside stairs; walls with well-secured handrails or guards on both sides of stairs, minimum width of 36 inches for stairs; minimum width of 34 inches for doorways giving access to stairs; doors that swing open in direction exit travel; a landing, at least as wide and as long as the door width, between door and stairs).(5) Screening.(A) All outside openings shall be protected with screening of 16 mesh or less.(B) All screen doors shall be tight, in good repair and equipped with self-closing devices.(6) Heating.(A) All living quarters and service rooms shall be provided with properly installed, operable heating equipment capable of maintaining a temperature of at least 68° F if during the period of normal occupancy the temperature in such quarters falls below 68° F.(B) Any stoves or other sources of heat utilizing combustible fuel shall be installed and vented in such a manner as to prevent fire hazards and a dangerous concentration of gases. No portable heaters other than those operated by electricity shall be provided. If a solid or liquid fuel stove is used in a room with wooden or other combustible flooring, there shall be a concrete slab, insulated metal sheet, or other fireproof materials on the floor under each stove, extending at least 18 inches beyond the perimeter of the base of the stove.(C) Any wall or ceiling within 18 inches of a solid or liquid fuel stove or a stovepipe shall be of fireproof material. A vented metal collar shall be installed around a stovepipe, or vent passing through a wall, ceiling, floor, or roof. Such vent or chimney shall extend above the peak of the roof.(D) When a heating system has automatic controls, the controls shall be of the type which cut off the fuel supply upon the failure or interruption of the flame or ignition, or whenever a predetermined safe temperature or pressure is exceeded. All steam and hot water systems shall be provided with safety devices arranged to prevent hazardous pressures and excessive temperatures.(E) All heating equipment shall be maintained and operated in a safe manner to eliminate possibilities of fire.(7) Electricity and lighting.(A) All housing sites shall be provided with electric services when available.(B) When available, each habitable room and all common use rooms, and areas such as laundry rooms, toilets, privies, hallways, stairways, etc., shall contain adequate ceiling or wall-type light fixtures. At least one wall-type electrical convenience outlet shall be provided in each individual living room.(C) When available, adequate lighting shall be provided for the yard area, and pathways to common use facilities.(D) All wiring and lighting fixtures shall be installed and maintained in a safe condition.(8) Toilet facilities.(A) Toilets shall be constructed, located, and maintained so as to prevent any nuisance or public health hazard.(B) Privies shall be located at least 150 feet from a stream, lake, or well and at least 75 feet from a sleeping or housing facility.(C) Water closets or privy seats for each sex shall be in ratio of not less than one such unit for each 15 occupants, with a minimum of one unit for each sex in common use facilities.(D) Separate toilet accommodations for men and women shall be provided. If toilet facilities for men and women are in the same building, they shall be separated by a solid wall from floor to ceiling. Toilets shall be distinctly marked "Men' and "Women.'(E) Urinals, constructed of nonabsorbent materials, may be substituted for men's toilet seats on basis of one urinal or 24 inches of trough-type urinal for one toilet seat up to a maximum of 1/3 of the required toilet seats. The wall and floor or space to a point of one foot in front of the urinal lip and four feet above the front and at least one foot to each side of the urinal shall be faced with nonabsorbent material. Privy structures and pits shall be flyproof. Privy pits shall have adequate capacity for the required seats.(F) Common use toilet facilities and privies shall be well lighted and ventilated and shall be clean and sanitary.(G) An adequate supply of toilet paper shall be provided.(9) Washrooms, bathrooms, and laundry rooms.(A) Bathing and handwashing facilities, supplied with hot and cold water under pressure, shall be provided for the use of all occupants. These facilities shall be clean and sanitary and maintained in good repair.(B) There shall be a minimum of one showerhead per 15 persons. Showerheads shall be spaced at least three feet apart, with a minimum of nine square feet of floor space per unit. Adequate dry dressing space shall be provided in common use facilities. Shower floors shall be constructed of nonabsorbent, nonskid materials and sloped to properly constructed floor drains. Separate shower facilities shall be provided for each sex. When common use shower facilities for both sexes are in the same building, they shall be separated by a solid nonabsorbent wall extending from the floor to ceiling or roof, and shall be plainly designated "Men' or "Women.'(C) Lavatories or equivalent units shall be provided in a ratio of one per 15 persons.(D) If laundry service is not otherwise provided, laundry facilities supplied with hot and cold water under pressure shall be provided for the use of all occupants. Laundry trays or tubs shall be provided in the ratio of one per 25 persons. Mechanical washers may be provided in the ratio of one per 50 persons in lieu of laundry trays, although a minimum of one laundry tray per 100 persons shall be provided in addition to the mechanical washers.(10) Swimming pools. New swimming pools shall be constructed in accordance with Texas State Department of Health design standards and all pools shall be maintained and operated as required by local regulations and the standards of the Texas State Department of Health for swimming pools. (See "Texas Sanitation & Health Protection Law") and "A Training Course in Swimming Pool Operation" available from the Texas State Department of Health.)(A) There shall be one unit of water safety equipment for each 2000 square feet of water surface area.(B) The outdoor swimming pool shall have a fence. All entrances and exits to outdoor and indoor pools shall be closed and locked when not in use. Machinery rooms shall be locked to prevent children from entering.(11) Sleeping facilities.(A) Bedding provided by the operator shall be clean and sanitary. All bedding shall be laundered or otherwise sanitized between assignment to different employees.(B) Linens shall be changed as often as required for cleanliness and sanitation, but not less frequently than once a week.(C) Bedwetters shall have their linens changed as often as they are wet.(D) Clean mattresses and mattress covers shall be provided.(E) Adequate personal storage area shall be available for each child to separate his clothing from other children's personal belongings.(F) Boys and girls shall not share the same sleeping unit.(G) The operator shall insure that a separate bed, bunk, or cot is available for each person. Double-deck beds are permissible, but triple-deck beds are prohibited. Beds shall be spaced in a manner which will provide a walk space on at least one side and at least one end of each bed.(12) Food sanitation.(A) Food shall be from approved sources and shall be properly identified.(B) Milk products shall be pasteurized.(C) Food shall be protected from contamination.(D) Thermometers shall be placed in refrigeration facilities.(E) Potentially hazardous foods shall be stored at proper temperatures.(i) Refrigerated food shall be stored at 45° F or below.(ii) Frozen food shall be stored at 0° Fahrenheit or below.(iii) Hot foods shall be held at 140° F or above.(F) The handling of food shall be minimized through the use of utensils.(G) Fruits and vegetables shall be properly washed prior to use.(H) Food and food containers shall be covered and stored off the floor and on clean surfaces. Refrigerated food shall also be covered.(I) Sugar shall be served in closed dispensers or packaged.(J) Poisonous and toxic materials shall be properly identified, stored separately from food, and properly used. Poisonous polishes shall not be used on eating and cooking utensils.(K) Persons with wounds or communicable diseases shall be prohibited from handling food.(L) Food handlers shall practice good hygienic practices.(M) Food handling equipment shall be properly designed, installed, and maintained.(N) Tableware and kitchenware shall be clean to sight and touch.(O) Eating and cooking ware shall be washed and sanitized in accordance with the "State Sterilization Law.' Where the chlorine method of sanitizing is used, a three compartment vat is required.(P) Food contact surfaces shall be clean.(Q) All eating and cooking ware shall be properly stored. Single service articles shall be properly stored, handled, and used only once.(R) Toilet facilities for the kitchen area shall be properly equipped and maintained.(S) Flies, rats, roaches, and other pests shall be controlled.(T) Floors, walls, and ceilings shall be kept clean and in good repair.(U) Adequate lighting shall be provided and shall be properly protected from breakage.(V) The kitchen area and cooking equipment shall be properly vented.(W) Pets shall not be allowed in the food storage, preparation, or dining area.(13) Garbage and other refuse.(A) Durable, clean containers of adequate size and tight fitting lids shall be conveniently located to each housing unit for storage of garbage and other refuse. When mechanical equipment is available, bulk type containers may be used. When containers of 32 gallon capacity are used, a minimum ratio of one container per 15 persons is required.(B) Provisions shall be made for collection of refuse at least twice a week, or more often if necessary. The disposal of refuse, which includes garbage, shall be in accordance with requirements of the Texas State Department of Health.(C) Storage facilities and areas shall be maintained in a sanitary condition.(14) Insect and rodent control.(A) A vector control program shall be maintained to insure effective control of all insects and rodents in buildings and on the premises.(B) If chemical control is needed to supplement good sanitation practices, proper pesticides should be used in strict accordance with label instructions.(15) Farm and domestic animals.(A) Horses and other animals maintained in any camp shall be quartered at a reasonable distance from any sleeping, living, eating, or food preparation area.(B) Stables and corrals shall be located as to prevent contamination of any water supply. Manure shall be removed from stalls and corrals as often as necessary to prevent a fly problem.(C) Horses, dogs, or other domestic animals or pets shall not be permitted on a bathing beach or in the water in the area used for waterfront activities.(D) All dogs, cats, and other warm-blooded pets owned or under the supervision of an occupant of any camp shall be currently vaccinated against rabies in compliance with the law of Texas.(i) Written records shall be kept on the type of vaccinations and the date of vaccinations.(ii) The premises shall be kept free of stray domestic animals.(E) Dogs and other small animal pets and their quarters shall be kept clean and free of ectoparasites. Pens should be cleaned daily but not less than each 24 hours and droppings properly disposed of. Source Note: The provisions of this §265.71 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION E MINIMUM STANDARDS OF ENVIRONMENTAL HEALTH FOR STATE DEPARTMENT OF PUBLIC WELFARE LICENSED THERAPEUTIC CAMPS §265.71 Permanent Camps https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13743&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13743 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13743&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13743 03/11/2026 Primitive campsites shall be maintained and operated in a safe and healthful manner.(1) Drinking water used at primitive camps and on hikes and trips away from permanent campsites shall be from a source known to be safe (free of coliform organisms) or shall be rendered safe before used in a manner approved by the Texas State Department of Health. An adequate supply of water, under pressure where possible, shall be provided at the cooking area for hand washing, dish washing, food preparation, drinking, etc.(2) Primitive campsites which are not provided with approved toilet facilities shall have a separate toilet area designated for each sex at a minimum ratio of one toilet seat per 15 persons. Slit trenches or cat holes with a readily available supply of clean earth backfill or other disposal methods approved in writing by the Texas State Department of Health shall be utilized for the disposal of human excreta in these area. Toilet areas shall be located at least 150 feet from a stream, lake or well and at least 75 feet from a campsite, tent, or other sleeping or housing facility.(3) Solid wastes which are generated in primitive camps should be disposed of at an approved sanitary landfill or similar disposal facility. Where such facilities are not available, solid wastes shall be disposed of daily by burial under at least two feet of compacted earth cover in a location which is not subject to inundation by flooding. Burning is not recommended.(4) All food and drink shall be of safe quality and stored in such a way as to prevent spoilage. Only the foods which can be maintained in a wholesome condition with the equipment available shall be used at primitive camps. Perishable foods shall be refrigerated where possible. Where ice and ice chests are used, adequate ice shall be provided, meats and other highly perishable foods shall not be stored over 24 hours, and ice chests shall be drained to prevent accumulation of water from melted ice.(5) Hot water and detergent shall be used to wash all food utensils after each meal at primitive campsites. Where group dishwashing is practiced, all utensils shall be immersed for at least two minutes in a lukewarm chlorine bath containing at least 50 ppm of available chlorine at all times. Where chlorine is used, a three compartment vat or three containers are required for washing, rinsing, and immersion.(6) No dish, receptacle, or utensil used in handling food for human consumption shall be used or kept for use if chipped, cracked, broken, damaged, or constructed in such a manner as to prevent proper cleaning sanitizing.(7) Disposable or single use dishes, receptacles, or utensils used in handling food shall be discarded after one use.(8) Eating utensils shall not be stored with foods or other materials and substances and shall be stored in clean dry containers.(9) Persons who handle food or eating utensils or both for the group shall maintain personal cleanliness, shall keep hands clean at all times and shall thoroughly wash the hands with soap and water after each visit to the toilet. They shall be free of local infection commonly transmitted through the handling of food or drink and free of communicable disease.(10) Food shall be stored in clean and dry containers that provide protection from insects, rodents, and wildlife. Hazardous substances, medicines, etc., shall not be stored in containers with food. Source Note: The provisions of this §265.72 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION E MINIMUM STANDARDS OF ENVIRONMENTAL HEALTH FOR STATE DEPARTMENT OF PUBLIC WELFARE LICENSED THERAPEUTIC CAMPS §265.72 Primitive or Wilderness Camps (Therapeutic) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13739&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13739 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13739&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13739 03/11/2026 (a) Applicability of standards. These minimum standards shall be considered as minimum requirements within the State of Texas and shall in no way affect the authority of municipalities to enact more stringent regulatory ordinances nor counties to pass an order establishing more stringent regulations governing the use of private sewage facilities in the county as authorized under Texas Water Code §21.084. Proposed county regulations must be approved by the Texas Water Quality Board prior to enactment.(b) Preparation of plans.(1) Plans required. When a proposal for a mobile home development includes the establishment of a drinking water supply or sewage treatment facility or both, plans therefor shall be submitted pursuant to Texas Civil Statutes Article 4477-1, §12(a), and in accordance with the Texas Department of Health Resources' "Rules and Regulations for Public Water Systems" and "Design Criteria for Sewerage Systems," respectively.(2) Information required. Planning material shall be submitted in such detail as to permit a comprehensive review to assure compliance with the department's "Rules and Regulations for Public Water Systems' and "Design Criteria for Sewerage Systems.' In addition, plans for the mobile home development should include the address or description of the location of the tract, dimensions of the tract of land, drainage information, the number, location, and size of all mobile home lots, location and width of roadways and parking facilities, location and size of recreation areas, location and floor plan of service building including plumbing, and construction details of the mobile home stands.(c) Definitions. The following are defined for the purpose of these minimum standards:(1) Accessory structure-Any structural addition to the mobile home which includes awnings, cabanas, carports, Florida rooms, porches, ramadas, storage cabinets, and similar appurtenant structures.(2) Mobile home-A movable or portable dwelling constructed to be towed on its own chassis by a motor vehicle over Texas roads and highways under special permit, connected to utilities, and designed without a permanent foundation, for year-round living. It may consist of two or more units which are separately towable but designed to be joined into one integral unit. It does not mean a travel trailer, which is designed to provide temporary living quarters for recreational, camping, or travel use, and is of such a size as not to require a special highway movement permit.(3) "Mobile home development' contiguous parcel of land which has been planned and improved for the placement of mobile homes for nontransient occupancy.(4) Mobile home stand-That part of an individual lot which has been reserved for the placement of mobile homes for nontransient use.(5) Sewer connection-The connection consisting of all pipes, fittings, and appurtenances from the drain outlet of the mobile home to the inlet or the corresponding sewer riser pipe of the sewerage system serving the mobile home stand.(6) Sewer riser pipe-The pipe connected to the sewer lateral extending vertically from the lateral to the surface of the ground.(7) Shall-Indicates that which is required.(8) Should-Indicates that which is recommended but not required.(9) Water connection-The connection consisting of all pipes, fittings, and appurtenances from the water riser pipe to the water inlet pipe of the distribution system within the mobile home. Source Note: The provisions of this §265.81 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION F MINIMUM STANDARDS FOR MOBILE HOME DEVELOPMENTS §265.81 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2403&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2403 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2403&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2403 03/11/2026 (a) Water supply.(1) Quality and source. Whenever possible, the source of water supply to serve the mobile home development should be from an existing public drinking water system. When an existing public water system is not available, the source and development of the water supply system shall be planned, installed, and operated in accordance with the Texas Department of Health Resources' "Rules and Regulations for Public Water Systems' and applicable state statutes. In either case and at all times, an adequate supply of water under pressure which meets the bacteriological, chemical, and physical requirements of the Texas Department of Health Resources regarding drinking water shall be provided in each mobile home development.(2) Location of mains. Water lines shall not be installed closer than 10 feet to septic tank open-jointed drainfields nor closer than nine feet to sanitary sewers. Where drainage is toward the water line or where the soil has rapid percolation, e.g., sand, or lateral fissures, consideration should be given to increasing the minimum separation distance from septic tank open-jointed drainfields. Where the nine feet minimum distance between a water line and a sanitary sewer cannot be obtained, the sanitary sewer shall be constructed of pressure type cast iron pipe or the equivalent of 150 psi pressure pipe with water-tight joints used in water main construction for the nine-foot clearance.(b) Service connections.(1) Individual water riser pipes should be located within the confined area of the mobile home stand at a point where the water connection will approximate a vertical position.(2) Water riser pipes should extend at least four inches above the ground elevations. The pipe should be at least 3/4 inch in diameter. The pipe shall be capped when a mobile home does not occupy the lot.(3) Adequate provisions should be made to prevent freezing of service lines, valves, and riser pipes. Adequate protection of riser pipes against freezing is especially important where septic tanks are used because the practice of leaving a small stream of water running during freezing weather will result in more effluent in the drainfield than the soil can absorb. Surface drainage should be diverted from the location of the riser pipe.(4) A shutoff valve should be provided on the water riser pipe for each mobile home.(5) Underground stop and waste valves should not be installed on any water service.(6) All water piping fixtures should be installed and maintained in accordance with current National Plumbing Code or equivalent.(c) Sewage disposal.(1) General. A properly designated and constructed sewerage system shall be provided in all mobile home developments for conveying and disposing of sewage or wastewater from mobile homes and other facilities such as laundry rooms, bath houses, etc. If feasible, the mobile home development sewage system should be connected to a public sewerage system. If public sewers are not available within a reasonable distance of the mobile home development, adequate treatment facilities meeting the standards of the Texas Department of Health Resources and approved by the local health department or licensing authority shall be installed to dispose of the sewage. In the absence of public sewers, two acceptable alternatives should be considered. The first is a sewage collection system and central treatment plant, and the second is individual septic tank systems. A sewage collection system and central treatment plant, in general, will provide more satisfactory service than septic tanks, which are subject to more operational difficulties.(2) Sewage systems. Plans for sewage collection systems and central treatment plants must be prepared under the direction of a registered professional engineer and submitted to the Texas Department of Health Resources for approval. Possession by the treatment plant owner of a waste control order from the Texas Water Quality Board prior to discharging plant effluent into a stream or drainageway is also mandatory.(3) Septic tanks. Any septic tank system should be designed and constructed in accordance with the Texas Department of Health Resources' publication "A Guide to the Disposal of Household Sewage.' The system shall also comply with local ordinances or with orders issued by local licensing authorities. The local health department or other licensing authority should be contacted further information. The tendency to design mobile home parks for a high density of units is frequently not compatible with septic tank systems. Adequate ground area and percolation for the drainfield, without undue encroachment upon neighboring facilities, is essential. Another basic difficulty with septic tanks in mobile home parks has resulted from the failure to design septic tank systems with adequate capacities. An individual system for each mobile home, built by the same design criteria as for conventional housing, is strongly recommended. A septic tank should not be considered if the lot size is under 15,000 square feet. If a drinking water system is on the property, the minimum lot size for a septic tank consideration is 20,000 square feet provided percolation is satisfactory.(4) Individual sewer connections.(A) Each mobile home stand should be provided with at least a four-inch diameter sewer riser pipe. The sewer riser pipe should be so located on each stand that the sewer connection to the mobile home drain outlet will approximate a vertical position.(B) The sewer connection should have an inside diameter of at least three inches, and the slope of any portion thereof should be at least 1/4 inch per foot. The sewer connection should consist of one pipe only without any branch fittings. All joints should be watertight.(C) All materials used for sewer connections should be semirigid, corrosion resistant, nonabsorbent, and durable. The inner surface of pipes and fittings should be smooth.(D) Provision shall be made for plugging or capping the sewer riser pipe when a mobile home does not occupy the lot. Surface drainage should be diverted away from the riser. The rim of the riser pipe should extend at least four inches above ground elevation.(d) Electrical distribution system. If any electrical wiring system is provided, the complete electrical system and all parts thereof should comply with local codes and ordinances. In the absence of local codes and ordinances, installations should comply with appropriate provisions of the American National Standards Institute standard for mobile homes and the current edition of the National Electric Code.(e) Solid waste disposal. The storage, collection, and disposal of solid waste shall be performed in accordance with applicable State statutes and the "Municipal Solid Waste Regulations' of the Texas Department of Health Resources. The regulations generally provide that the storage, collection, and disposal of solid waste shall be so conducted as to create no environmental health hazard, rodent harborage, insect breeding area, or safety or fire hazard. Safeguards required by the above regulations in regard to disposal are more stringent for heavily populated areas and for areas within 300 yards of a public highway than for unurbanized areas.(f) Insect and rodent control. No standing water shall be allowed in a mobile home development and the premises shall be kept free of refuse and debris which may provide harborage for rodents or contribute to mosquito or fly breeding. When rats or other rodents are known to be on the premises, the owner or operator shall take definite action for their eradication.(g) Restriction of animals. No owner or person in charge of a dog, cat, or other pet animal should permit said animal to run at large or cause any nuisance within the limits of any mobile home development. Kennels, pens, or other facilities provided for such pets should be maintained in a sanitary condition at all times.(h) Site location. Sites hereinafter selected for mobile home developments should be well drained and free from topographical or other conditions unfavorable to a proper residential environment.(i) Streets and parking facilities.(1) Accessibility. All mobile home developments hereinafter constructed should be provided with safe and convenient vehicular access from abutting public streets or roads to each mobile home stand. The street system should provide convenient circulation by means of minor streets and properly located collector streets.(2) Widths. Pavement should be of adequate widths to accommodate the contemplated parking and traffic load in accordance with the type of street, with 10 feet minimum moving lanes for minor streets, seven feet minimum lane for parallel parking, and should also meet the following minimum requirements:(A) Collector streets with guest parking allowances-34 feet.(B) Collector streets and all other streets except minor streets without parking allowances-24 feet.(C) Minor streets serving less than 40 mobile home stands (no parking)-18 feet.(D) One-way minor streets serving less than 20 mobile home stands (no parking) -14 feet.(3) Off-street parking. Off-street parking in the form of parking bays or individual parking spaces on each lot should be provided within 200 feet of each mobile home stand. Exposed ground surfaces in all parts of every parking area should be paved or covered in such a manner as to prevent soil erosion and objectionable dust.(j) Separation between structures. Mobile homes in mobile home developments hereafter constructed should be separated from each other and from other structures, except their own accessory structures, by at least 10 feet, and should be located at least 25 feet from any mobile home development property line abutting upon a public street or highway, 10 feet from all other property lines, and 10 feet from any area such as a mobile home development street or a common parking area. Where individual water wells or septic tank systems or both are to be installed, special care in site planning will be needed to allow the incorporation of recommended minimum separation distances into the design of each individual water and sewerage system.(k) Outdoor living area. Each mobile home lot or space should be provided with an outdoor living and service area. Such area should be improved as necessary to assure reasonable privacy and comfort. The minimum area should be not less than 300 square feet with a least dimension of 15 feet.(l) Recreation areas. Mobile home developments hereinafter constructed which accommodate 25 or more mobile homes should be provided with at least one easily accessible outdoor or indoor recreation area except that recreation areas may not be needed in a mobile home development if each mobile home lot therein contains 5,000 or more square feet of area. Recreation areas should otherwise be provided in a ratio of not less than 100 square feet of space per mobile home stand. Each outdoor recreation area should contain at least 2,500 square feet of area to assure adequate space for all activities. Swimming pools which comply with Texas Department of Health Resources design standards for swimming pools, recreation buildings, and child play areas can be considered as fulfilling part of the total requirement for recreation areas.(m) Mobile home stand. Stand construction and anchorage requirements are under the jurisdiction of the Texas Department of Labor and Standards, Austin, Texas. Source Note: The provisions of this §265.82 adopted to be effective January 1, 1976. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION F MINIMUM STANDARDS FOR MOBILE HOME DEVELOPMENTS §265.82 Minimum Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13748&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13748 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13748&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13748 03/11/2026 The following term shall have the meaning indicated: Filling station--Any facility which:(1) sells motor fuels;(2) provides one or more attendants who dispense fuel into tanks of motor vehicles; and(3) offers one or more of the following services:(A) tire repair;(B) oil change;(C) battery charge; or(D) car repair. Source Note: The provisions of this §265.111 adopted to be effective January 4, 1984, 8 TexReg 5411. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION H FILLING STATIONS §265.111 Definition of Filling Station https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13749&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13749 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13749&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13749 03/11/2026 (a) Scope. These sections apply to facilities where the public congregates. This includes sports and entertainment arenas, stadiums, community and convention halls, specialty event centers, and amusement facilities.(b) Exclusion. The term "facilities where the public congregates" does not include hotels, churches, restaurants, bowling centers, public or private elementary or secondary schools, or historic buildings. If local standards or regulations are at least as or more stringent than these standards, these rules do not apply.(c) Purpose. The purpose of these sections is to prescribe minimum standards for the availability of sufficient temporary or permanent restrooms to meet the needs of the public at peak hours at publicly- and privately-owned facilities where the public congregates.(d) Penalty and enforcement. The statutory penalty and enforcement provisions covering violations of Chapter 341 and these sections are contained in the Health and Safety Code, Chapter 341, §341.091 and §341.092.(e) Applicability date. These sections apply to facilities on which construction is started on or after January 1, 1994, or on which structural alterations, repairs, or improvements exceeding 50% of the entire facility are undertaken on or after January 1, 1994. Source Note: The provisions of this §265.121 adopted to be effective July 21, 1994, 19 TexReg 5355. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION I STANDARDS FOR PUBLIC RESTROOM FACILITIES §265.121 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13757&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13757 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13757&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13757 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.(1) Approved--Approved by the Texas Department of Health, the local health authority, or the local building code enforcement officer, whichever shall maintain jurisdiction.(2) Chemical toilets--A toilet facility in which human waste is collected in a container charged with a chemical for the purpose of disinfecting and deodorizing prior to disposal.(3) Construction--The actual, physical initiation of the building process such as the clearing of land, moving of dirt or preparation of a building to begin work.(4) Exceeding 50% of the entire facility--Structural alterations, repairs, or improvements with a cost exceeding 50% of the worth of the facility, as determined by the taxing authority maintaining jurisdiction.(5) Facilities where the public congregates--Sports and entertainment arenas, stadiums, community and convention halls, specialty event centers, and amusement facilities. The term does not include hotels, churches, restaurants, bowling centers, public or private elementary or secondary schools, or historic buildings.(6) Historic buildings--Buildings listed as historic by the Texas Historical Commission.(7) May--Used to denote authorized alternatives to mandatory provisions of this regulation.(8) Restroom--Toilet, chemical toilet, or water closet.(9) Sanitary condition--That condition of good order and cleanliness which precludes the probability of disease transmission.(10) Shall (or must)--Used to denote mandatory provisions of these sections.(11) Should--Indicates provisions which are not mandatory, but which are recommended as good practice.(12) Standards--Methods, practices, processes or operations necessary or appropriate to establish healthful conditions as determined by the authority having jurisdiction.(13) Temporary toilet facilities--Mobile trailers or prefabricated, skid-mounted, or otherwise portable structures.(14) Toilet or toilet facility--A plumbing device for the purpose of defecation or urination, or both, including water closets and biological or chemical toilets, and urinals.(15) Toilet room--An enclosed area containing one or more toilet facilities and offering personal privacy. Toilet rooms may be either permanently located (fixed) or portable.(16) Urinal--A water-flushed fixture connected with a sewer, maintained within a toilet room for the sole purpose of urination.(17) Water closet--A toilet facility which is connected to a sewer and flushed with water. Source Note: The provisions of this §265.122 adopted to be effective July 21, 1994, 19 TexReg 5355. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION I STANDARDS FOR PUBLIC RESTROOM FACILITIES §265.122 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83215 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83215&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83215 03/11/2026 (a) General standards.(1) Toilet facilities shall be provided in separate toilet rooms for both sexes in all facilities where the public congregates. They shall be readily accessible to all users. (2) Toilet facilities shall be either water-actuated, chemical, or biological toilets. Other systems may be used only upon specific permission of the health authority having local jurisdiction.(3) If the use of restrooms is designated by gender, toilet facilities shall be provided for each sex at a ratio of not less than 2:1 women's to men's or according to the following table.Attached Graphic(4) Toilet rooms and facilities shall be maintained in a sanitary condition, free of objectionable odors during all hours the facility is open to the public. The floors, walls, ceilings, partitions and doors of all toilet rooms shall be of a finish that can be easily cleaned. Floors shall have a smooth, hard, nonabsorbent surface such as portland cement, concrete, ceramic tile or other approved material which extends upward onto the walls at least five inches. Materials used in such walls shall be of a type not adversely affected by moisture. Walls within two feet of the front and sides of a urinal and water closets shall have a smooth, hard, nonabsorbent surface of portland cement, concrete, ceramic tile or other smooth, hard, nonabsorbent surface to a height of four feet. An adequate supply of toilet paper in a suitable holder shall be maintained for each toilet. Covered waste receptacles shall be provided in all toilet rooms used by women.(b) Specifications for toilet facilities and rooms at fixed locations.(1) Each toilet facility (water closet) at a fixed (permanent) location shall occupy a separate compartment equipped with a door and latch. Walls within two feet of the front and sides of a urinal and water closet shall have a smooth, hard, nonabsorbent surface of portland cement, concrete, ceramic tile or other smooth, nonabsorbent surface to a height of four feet. Walls or partitions between fixtures shall be sufficiently high to assure privacy. Urinals do not need to occupy separate compartments.(2) Each toilet facility shall be so installed that the space around it can be easily cleaned. Walls within two feet of the front and sides of a urinal and water closet shall have a smooth, hard, nonabsorbent surface of portland cement, concrete, ceramic tile or other smooth, nonabsorbent surface to a height of four feet. This provision does not prohibit the use of wall-hung toilet stools or urinals.(3) Each toilet seat shall have a seat made of substantial material having a nonabsorbent finish.(4) Toilet rooms at fixed locations that are not ventilated by mechanical means shall be provided with screened ventilation with openings of not less than 1/20th of the floor area. (c) Specifications for temporary toilet facilities and rooms. (1) Temporary toilet facilities shall be so constructed as to be readily accessible. (2) Buildings housing temporary toilet rooms may be mobile trailers or prefabricated, skid-mounted, or otherwise portable structures. If they contain more than one facility, each shall occupy a separate compartment with a door and a latch. Walls or partitions between toilets shall be sufficiently high to assure privacy. Urinals need not occupy separate compartments.(3) If the structure contains a tank in which waste is stored, the tank shall be vented to the outside of the structure.(4) Temporary toilet rooms that are not ventilated by mechanical means shall be provided with an adequate screened ventilation opening. Source Note: The provisions of this §265.123 adopted to be effective July 21, 1994, 19 TexReg 5355. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION I STANDARDS FOR PUBLIC RESTROOM FACILITIES §265.123 Standards for Toilet Facilities and Toilet Rooms https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198370&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198370 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198370&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198370 03/11/2026 (a) Scope and purpose. This subchapter addresses minimum standards for the design and construction of artificial swimming lagoons. The rules in this subchapter establish minimum operating standards for artificial swimming lagoons to ensure proper filtration, chemical balance, and maintenance of the water for the safety of users, and to reduce to a practical minimum the possibility of drowning or injury to users. This subchapter implements Texas Health and Safety Code, §341.064(g) authorized by Texas Health and Safety Code, §341.002, and the rules are considered good public health engineering practices.(b) Application of the rules. This subchapter applies to all artificial swimming lagoons, regardless of the date of construction, unless otherwise specified.(c) Date of construction. The date of construction of the artificial swimming lagoon is the date that a building permit for construction is issued or, if no building permit is required, the date that excavation or electrical service begins, whichever is earlier, in which case the artificial swimming lagoon owner or operator must produce adequate written documentation of that fact.(d) Local regulatory authority. A local regulatory authority that has jurisdiction for the regulation of the artificial swimming lagoon may adopt standards equivalent to or more stringent than this subchapter, with the exception of a department-approved alternate method of disinfectant, that are in accordance with good public health engineering and safety practices.(e) Effective date. The effective date of this subchapter is March 1, 2020. Source Note: The provisions of this §265.151 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.151 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198371&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198371 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198371&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198371 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) AED--Automated External Defibrillator. A device that automatically diagnoses the life-threatening cardiac arrhythmias of ventricular fibrillation and pulseless ventricular tachycardia, and is able to treat those conditions by application of electricity which stops the arrhythmia, allowing the heart to re-establish an effective rhythm.(2) Alternative communication system--Devices that alert multiple on-site staff when activated, such as pager systems, radios, or walkie-talkie communication systems. Used to notify either on-site emergency medical services (EMS), on-site medical staff, or on-site certified staff such as lifeguards, or a commercial emergency monitoring service.(3) Alternative method of disinfectant--A method of disinfection required to be approved by the department.(4) ANSI--American National Standards Institute.(5) APSP--Association of Pool and Spa Professionals.(6) ARC--American Red Cross.(7) Artificial swimming lagoon (lagoon)--An artificial body of water used for recreational purposes with more than 20,000 square feet of surface area, an artificial liner, and a method of disinfectant. The term does not include a body of water open to the public that continuously recirculates water from a spring or a pool. The term "lagoon" used in this subchapter means "artificial swimming lagoon."(8) Artificial swimming lagoon yard--An area that has an enclosure that contains the lagoon.(9) ASME--American Society of Mechanical Engineers.(10) ASPSA--American Swimming Pool and Spa Association.(11) Australian standard AS 4663-2013--A method to measure the slip resistance of pedestrian surfaces.(12) Backflow prevention device--A device designed to prevent a physical connection between a potable water system and a non-potable source such as the lagoon, or a physical connection between the lagoon and a sanitary sewer or wastewater disposal system.(13) Bonded--Permanent joining of metallic parts to form an electrically conductive path that ensures electrical continuity and the capacity to conduct safely any current likely to be imposed to minimize the risk of electrocution.(14) Broken stripe--A horizontal stripe that is at least 1-inch wide with uniform breaks in the stripe, with the breaks totaling not more than 75% of the length of the stripe and stripe breaks.(15) BVM--Bag-Valve Mask. A handheld device used to provide positive pressure ventilation to persons who are not breathing adequately. Also known by its proprietary name, Ambu bag.(16) Chemical feeder--A mechanical or electronic device for applying chemicals into the lagoon.(17) Circulation equipment--Mechanical components that are part of a circulation system on the lagoon. Circulation equipment includes pumps, hair and lint strainers, filters, valves, gauges, meters, heaters, surface skimmers, inlet/outlet fittings, and chemical feeding devices.(18) Cross-connection control device--A device that is designed to prevent a physical connection between a potable water system and a non-potable source such as the lagoon, or a physical connection between the lagoon and a sanitary sewer or wastewater disposal system. (See paragraph (12) of this section "Backflow prevention device.")(19) DCOF--Dynamic coefficient of friction. A measurement of frictional resistance of a surface one pushes against when already in motion.(20) DCOF AcuTest--A test used to evaluate the slip resistance or DCOF of a tile surface under known conditions using a standardized sensor prepared according to a specific protocol.(21) Deck--An area immediately adjacent to or attached to the lagoon that is specifically constructed or installed for sitting, standing, or walking and may include the coping. The term does not include a sandy beach area adjacent to a zero-entry access area.(22) Deep area--A water level in the lagoon that is over five feet in depth.(23) Department--The Texas Department of State Health Services.(24) Depth--Vertical distance measured at three feet from the lagoon wall or barrier from the bottom of the lagoon to the design water level.(25) Design water level--(A) For a skimmer system, the midpoint of the operating range of the skimmers.(B) For a gutter or overflow system, the top of the overflow rim of the gutter or overflow system.(26) Disinfectant--Energy, chemicals, or a combination of both used to kill undesirable or pathogenic (disease causing) organisms and having a measurable residual or level adequate to make the desired kill.(27) Diving board--A recreational mechanism for entering the lagoon, consisting of a semi-rigid board that derives its elasticity through the use of a fulcrum mounted below the board.(28) DPD--A chemical testing reagent (N, N-Diethyl-P-Phenylenediamine). It is used to measure the levels of free chlorine or bromine in water by yielding a series of colors ranging from light pink to dark red.(29) Facility--The lagoon and restrooms, dressing rooms, equipment rooms, decks or walkways, beach entries, enclosure and other appurtenances directly serving the lagoon.(30) Filter--A device that removes undissolved particles from water by recirculating the water through a porous substance (filter media or element).(31) Filter media--A finely graded material (for example, sand, diatomaceous earth, polyester fabric, or anthracite) that removes filterable particles from the water.(32) FINA--Fédération Internationale de Natation. The organization that administers international competition in aquatic sports.(33) Licensed engineer--A person licensed to engage in the practice of engineering in the State of Texas in accordance with the Texas Engineering Practice Act, Texas Occupations Code, Chapter 1001, and related rules.(34) Licensed master electrician--An individual, licensed as a master electrician, who on behalf of an electrical contractor, electrical sign contractor, or employing governmental entity, performs electrical work in accordance with the Texas Electrical Safety and Licensing Act, Texas Occupations Code, Chapter 1305, and related rules.(35) Lifeguard--An expert swimmer who supervises the safety and rescue of swimmers, surfers, and other water sports participants and who has successfully completed and holds a current ARC certificate or the equivalent certification from an aquatic safety organization, which includes training in cardiopulmonary resuscitation for adults, infants, and children, use of an AED, use of a BVM, and first aid.(36) Local regulatory authority--A county, municipality, or other political subdivision of the state.(37) Motorboat--Any vessel propelled or designed to be propelled by machinery, whether or not the machinery is permanently or temporarily affixed or is the principal source of propulsion. (See paragraph (64) of this section "Vessel.")(38) Non-swimming area--A section of a lagoon used by vessels or motorboats, or for other aquatic activities such as surfing and wakeboarding.(39) NSF--NSF International.(40) NSF 50 or NSF/ANSI Standard 50--Standard establishing minimum requirements for materials, design, construction, and performance of equipment commonly included in the water circulation systems of residential and public swimming pools, spas, or hot tubs.(41) NSF 60 or NSF/ANSI Standard 60--Standard covering drinking water treatment chemicals and establishing criteria for promoting sanitation and protection of public health in relation to drinking water.(42) ORP--Oxidation Reduction Potential. The potential level of oxidation-reduction produced by strong oxidizing (sanitizing) agents in a water solution. Oxidation level is measured in millivolts by an ORP meter.(43) Overflow system--Overflows, surface skimmers, and surface water collection systems of various design and manufacture for removal of surface water from the lagoon.(44) pH--A value expressing the relative acidic or basic tendencies of a substance such as water on a scale from 0 to 14 with 7.0 being neutral, values less than 7.0 being acidic, and values greater than 7.0 being basic.(45) PHTA--Pool and Hot Tub Alliance, formally APSP and National Swimming Pool Foundation.(46) Pump--A mechanical device that causes hydraulic flow and pressure for filtration, heating, and circulation of the water in the lagoon.(47) Regulatory authority--A federal or state agency or a local regulatory authority.(48) Rescue tube--A piece of lifesaving equipment that is an essential part of the equipment that must be carried by lifeguards and that is used to make water rescue easier by helping support the victim's and rescuer's weight.(49) Return inlet or inlet--Aperture or fitting through which the water under positive pressure returns into the lagoon.(50) Ring buoy--A ring-shaped floating buoy capable of supporting a user.(51) Rope and float line--A continuous line that is not less than 1/4-inch in diameter and that is supported by buoys and attached to sides of the lagoon to separate swimming areas from non-swimming areas of the lagoon.(52) Secchi disk--An eight-inch diameter disk with alternating black and white quadrants that is lowered in the water column and is used to measure water turbidity and clarity.(53) Self-closing and self-latching device--A mechanism on a gate that enables a gate to automatically fully close and latch without human or electrical power.(54) Service animal--A canine that is specially trained or equipped to help a person with a disability and that is used by a person with a disability in accordance with the Texas Human Resources Code, Chapter 121. An animal of any other species, whether wild or domestic, trained or untrained, is not considered a service animal.(55) Slide--A recreational feature with a flow of water and an inclined flume or channel by which a rider is conveyed downward into the lagoon.(56) Slip resistant--A surface that has been treated or constructed to significantly reduce the chance of slipping.(57) Steps, recessed steps, ladders, and recessed treads--A lagoon entry and exit that may be used separately or in conjunction with one another.(58) Suction outlet--A fitting, fitting assembly, cover or grate, and related components that provide a localized low-pressure area for the transfer of water from the lagoon.(59) Surf lagoon--A lagoon in which waves are generated and dedicated to the activity of surfing on a surfboard or analogous surfing device commonly used in the ocean and intended for sport as opposed to general play intent for wave lagoons.(60) Swimming area--A section of a lagoon used for swimming, wading, or other activities involving contact with or immersion in water.(61) TCEQ--Texas Commission on Environmental Quality.(62) UL--An independent testing laboratory (formerly Underwriters Laboratories).(63) User load--The number of persons in the swimming areas of the lagoon at any given moment or during any stated period of time.(64) Vessel--Any watercraft, including surfboards, paddleboards, and wakeboards, other than a seaplane on water, used or capable of being used for transportation on water. (See paragraph (37) of this section "Motorboat.")(65) VGBA--The Virginia Graeme Baker Pool and Spa Safety Act. A federal law that requires all public pools and spas to be fitted with suction outlets that meet the ASME/ANSI A112.19.8 standard.(66) Wading only areas--Wading only areas of the lagoon that are intended for use by non-swimmers or for non-swimming activities.(67) Wastewater disposal system--A plumbing system used to dispose of backwash or other water from the lagoon or from dressing rooms and other facilities associated with the lagoon.(68) Water lounge or shelf--A horizontal area of the lagoon that adjoins the lagoon wall at a depth of 2 inches to 10 inches and is used for seating and play. Source Note: The provisions of this §265.152 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.152 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198372&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198372 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198372&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198372 03/11/2026 (a) Licensed Engineer required. Lagoons constructed on or after the effective date of this subchapter shall be planned and designed by a licensed engineer. The licensed engineer shall provide necessary observation of construction work to certify that the project was completed in accordance with engineering documents.(b) Plans and permits. The department may review plans for the lagoon to ensure compliance with the rules in this subchapter. The lagoon shall comply with any regulatory authority permit requirements. Regardless of whether a regulatory authority requires plans or permits, the lagoon shall be designed, constructed, and operated in compliance with this subchapter.(c) Operational instructions. Upon completion of construction, the owner shall obtain complete written operational instructions for the lagoon that include procedures for filtration, backwash, cleaning, operation of all chemical feed devices, and general maintenance. In addition, the builder shall label all valves and exposed piping, including normal operating pressures and pressure differential that indicate the need for cleaning. Source Note: The provisions of this §265.153 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.153 Plans, Permits, and Instructions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198373&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198373 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198373&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198373 03/11/2026 (a) Non-toxic and sound materials. Lagoons and all appurtenances shall be constructed of materials that:(1) are nontoxic to humans and the environment;(2) are impervious and enduring;(3) will withstand design stresses; and(4) will provide a watertight structure with a smooth, easily cleanable surface without cracks or joints that are not watertight and easily cleanable.(b) NSF 50. For lagoons constructed on or after the effective date of this subchapter, pumps, filters, skimmers, chemical feeders, and other equipment that falls within NSF/ANSI Standard 50 shall meet the standard as confirmed by a testing laboratory. Conformity with the NSF 50 shall be evidenced by the listing or labeling of such equipment by such a laboratory or by separate documentation.(c) Prohibition of earth material.(1) Earth shall not be permitted as an interior finish in the lagoon. Clean sand or similar material if used in a beach environment:(A) shall only be used over an impervious surface;(B) shall be designed to perform in such an environment; and(C) shall be controlled so as not to adversely affect the proper circulation, filtration, treatment system, maintenance, safety, sanitation, and operation of the lagoon.(2) If sand or similar material is used in the lagoon, positive upflow circulation through the sand or other systems shall be provided as necessary to ensure that sanitary conditions are maintained at all times.(d) Interior color. The color of the interior of the lagoon shall be white or a light enough color so that objects and users in the water shall be easily seen. The finish shall be at least 6.5 on the Munsell color value scale. An eight-inch black disk or a Secchi disk at the deepest point of the floor in a swimming area of the lagoon shall be clearly and immediately seen by an observer.(e) Materials to withstand freezing temperatures. The lagoon liner or shell and appurtenances, piping, filter system, pump and motor, and other components shall be designed and constructed to facilitate protection from damage due to freezing.(f) Surface water. The lagoon shall be designed such that surface water does not enter the lagoon.(g) Interior surface footing. The surfaces within the lagoon intended to provide footing for users shall be slip-resistant to help reduce the chance for a fall. The roughness or irregularity of such surfaces shall not cause injury to feet during normal use.(h) General shape. This subchapter is not intended to regulate the perimeter shape of the lagoon. It is the responsibility of the licensed engineer to take into account the effect a given shape of the lagoon will have on the health and safety of the users.(i) Entanglement or entrapment avoidance. There shall be no protrusions, extensions, means of entanglement, or other obstructions in the lagoon that are likely to cause entrapment or injury of the user.(j) Maximum users in swimming areas. Maximum user loading in a swimming area shall comply with the following:(1) In an area of water depth 4 feet or less, the user load shall not exceed one user per 15 square feet of water surface.(2) In an area of water depth greater than 4 feet, the user load shall not exceed one user per 25 square feet of water surface.(3) The owner or operator shall be responsible for restricting usage so that the maximum capacity is not exceeded.(k) Maximum users in non-swimming areas. The owner or operator shall determine the maximum user loading in a non-swimming area by considering the type of use in the non-swimming area and the presence of motorboats and vessels and shall post signs indicating the maximum number of users.(l) Floor slopes. For the lagoon constructed on or after the effective date of this subchapter, floor slope in a swimming area shall comply with the following:(1) For depths up to five feet, the slope shall be uniform and not exceed 1:10.(2) For depths over five feet, the slope shall be uniform and not exceed 1:3.(3) The slope may vary in limited areas where access for persons with disabilities has been provided.(m) Underwater seat benches. An underwater seat bench shall:(1) be constructed with slip-resistant materials;(2) have a maximum seating width of 18 inches projecting from the wall at a depth not to exceed 20 inches below the design water level;(3) be located fully outside of the required minimum diving water envelope if the lagoon is used for diving;(4) be visually set apart and provided with a solid or broken stripe at least 1-inch wide on the top surface along the front leading edge of the bench; and(A) the stripe shall be plainly visible to persons on the ground above the bench; and(B) the stripe shall be a contrasting color to the background on which it is applied, and the color shall be permanent; and(5) not be used as a required entry or exit access unless used in conjunction with steps.(n) Water lounges. A water lounge shall:(1) be a minimum of 20 inches wide and provide a minimum of 10 square feet of horizontal surface adjoining on the edge of the lagoon over a distance of not less than 3 feet;(2) be horizontal and at a depth of 2 inches to 10 inches below the water surface;(3) be visually set apart with a horizontal solid or broken stripe at least 1-inch wide on the top surface along the leading edge of horizontal surfaces of all edges not adjoining the lagoon wall; and(A) the stripe shall be plainly visible to persons on the deck; and(B) the stripe shall be contrasting color to the background on which it is applied, and the color shall be permanent;(4) be located fully outside of the required minimum diving water envelope if the lagoon is intended for use with diving equipment;(5) have a slip-resistant surface; and(6) be located in water depth of 4 feet or less.(o) Construction tolerances. For lagoons constructed on or after the effective date of this subchapter, construction tolerances shall be in accordance with the construction plan submitted by the licensed engineer. Source Note: The provisions of this §265.154 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.154 General Construction and Design https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198374&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198374 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198374&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198374 03/11/2026 (a) Access. Entrances and exits, including hand and grab rails, walkways, and docks, shall comply with applicable requirements for access to recreation facilities and the elements for persons with disabilities under federal, state, and local fair housing and disability access laws.(b) Decks for lagoons. The following is required where decks are provided for lagoons:(1) Each deck shall be at least five feet wide.(2) A deck shall be provided at each entry or exit into the swimming areas.(3) An unobstructed deck area at least four feet wide shall be provided for access around:(A) diving equipment;(B) special feature stairways, such as for a waterslide;(C) lifeguard stands;(D) diving boards;(E) similar deck equipment; and(F) structural columns.(4) In a swimming area or in a surf lagoon where perimeter deck is non-contiguous and the clearance is not at least four feet, locations for lifeguards to safely access the edge of the lagoon are required.(5) A deck shall slope away from the lagoon so that water drains into deck drains or to perimeter areas.(6) A deck drain shall not drain to the lagoon, lagoon gutter, or recirculation systems.(7) Loose plant material or bedding shall not be permitted within a perimeter deck.(8) Carpet, wood, and artificial turf are prohibited as perimeter deck materials.(9) Concrete that is used as a deck material shall be installed in accordance with the American Concrete Institute ACI Standard 302.1R-15, "Guide for Concrete Floor and Slab Construction" or in accordance with the requirements established by the licensed engineer, and in accordance with local building codes.(10) All decks shall have slip resistant, textured finishes that have a minimum dynamic coefficient of friction at least equal to the requirements of ANSI A137.1-2012 for that installation as measured by the DCOF AcuTest or by the Australian Standard AS 4663-2013.(11) Continuous watertight expansion joint material shall be provided between perimeter decks and lagoon coping.(12) Open joints or gaps larger than 3/16-inch or vertical elevations exceeding 1/4-inch in the deck shall be corrected using appropriate fillers.(c) Acceptable means of entry or exit. Acceptable means of entry or exit include stairs, recessed steps, ladders, ramps, swimouts, lifts, and beach (zero-depth) entry or exit. Access to a surf lagoon shall be at the shallow or beach entry end with the exception of an allowable Americans with Disabilities Act (ADA) designated entry point.(d) Number of entry or exit points. A minimum of two entry or exit points are required in each swimming area. A single set of entry or exit steps or a single beach entry extending a minimum of 75% around the perimeter of the swimming area meets the minimum entry or exit requirements.(e) Beach entry slope. Beach entry slopes shall not exceed 1:10.(f) Slip resistant surfaces. Steps, ladders, and recessed treads shall have slip resistant surfaces.(g) Steps. For a lagoon constructed on or after the effective date of this subchapter, steps shall comply with the following:(1) Steps shall conform with the most recent edition of the Centers for Disease Control and Prevention Model Aquatic Health Code (MAHC) in MAHC Sections 4.5.4.5, MAHC Table 4.5.4.5, MAHC Figure 4.5.4.5.1, Figure 4.5.4.5.2, and Figure 4.5.4.5.2.(2) The bottom riser height may be allowed to taper to zero.(3) Underwater steps shall be provided with a horizontal solid or broken stripe at least one-inch wide on the top surface along the front leading edge of each step. This stripe shall be plainly visible to persons standing above the steps. The stripe shall be a contrasting color to the background on which it is applied, and the color shall be permanent in nature and shall be a slip resistant surface.(h) Handrails. A lagoon shall comply with applicable federal, state, and local requirements for access by persons with disabilities.(1) Handrails, if removable, shall be installed in such a way that they cannot be removed without the use of tools.(2) Handrails shall be provided for each set of stairs provided in a lagoon constructed on or after the effective date of this subchapter and shall be constructed of corrosion-resistant materials, bonded in accordance with the National Electrical Code, and anchored securely.(3) The upper railing surface of handrails shall extend above the deck or at the interface of the water and beach.(4) Dimensions of handrails not for use by persons with disabilities shall conform to requirements in the most current edition of the Centers for Disease Control and Prevention Model Aquatic Health Code (MAHC) in MAHC Table 4.5.5.7 and MAHC Figure 4.5.5.7.1.(i) Floating platforms.(1) A floating swim platform or floating dive platform shall:(A) be constructed of a non-slip and splinter-resistant material that can be easily cleaned;(B) have at least one ladder with handles and steps that extend at least 30 inches below water level;(C) be anchored or secured to keep it in its designated area if a floating platform; and(D) minimize the risk of entrapment by being constructed with:(i) all braces and struts designed to prevent entrapment of users; and either(ii) a visible minimum 12-inch air space under maximum load; or(iii) a smooth solid bottom that extends at least 2 feet below the water.(2) A floating platform with a perimeter greater than 75 feet shall have a minimum of two ladders with handles and steps that extend at least 30 inches below the water level.(3) A floating dive platform less than 20 inches above the water level shall have a minimum of 9 feet of water depth for 16 feet horizontal distance beyond the diving platform.(4) A floating dive platform greater than 20 inches above the water level shall be designed and constructed according to minimum dimensions specified by the FINA Facilities Rules, 2017-2021.(j) Slides and other aquatic play features.(1) A slide or other aquatic play feature, such as a climbing wall, floating amusement island, or zip line, shall be installed according to manufacturer's instructions or in accordance with the licensed engineer's specifications.(2) An aquatic play feature that meets the definition of "Amusement Ride" in Texas Occupations Code, Chapter 2151 (the Amusement Ride Safety Inspection and Insurance Act) shall comply with that chapter.(3) A feature that meets the definition of a "slide" in the Consumer Product Safety Commission's Standard for Swimming Pool Slides as published in Title 16 Code of Federal Regulations, Part 1207, shall comply with those standards.(k) Diving platforms or boards. A diving platform or diving board shall be designed and constructed according to standards specified by the FINA Rules, 2017-2021. Source Note: The provisions of this §265.155 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.155 Decks, Entrances and Exits, Diving Facilities, Slides, and Other Aquatic Play Features https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198375&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198375 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198375&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198375 03/11/2026 (a) Licensed Engineer. The circulation system of a lagoon constructed on or after the effective date of this subchapter shall be designed by a licensed engineer.(b) Circulation. The circulation system shall provide complete and uniform circulation of the water necessary to maintain the water quality requirements in this subchapter, unless an alternate method of disinfectant has been approved by the department.(c) Access for inspection or repair. Circulation system components shall be accessible for inspection, servicing, repair, or replacement and shall be installed in accordance with manufacturer's specifications.(d) Non-toxic materials. The circulation system piping and fittings shall be non-toxic, and shall be of materials able to withstand operating pressures and conditions. Polyvinyl chloride pipe shall bear the NSF seal for potable water and be schedule 40 or stronger.(e) Operation and maintenance instructions. Circulation system operation and maintenance instructions shall be provided to the operator of the lagoon. A copy of the instructions shall be kept in the building housing the circulation system.(f) Gauges and meters. For a lagoon constructed on or after the effective date of this subchapter, the circulation system shall be equipped with:(1) a filter inlet pressure gauge on each filter;(2) a filter outlet gauge on each filter; and(3) a flow meter installed according to manufacturer's instructions and located to show the rate of flow through each filter in gallons per minute and that is represented by the manufacturer to be accurate within 10% of the true flow rate.(g) Labeling of exposed piping. Exposed piping shall be labeled to identify the piping function and direction of flow. The name of the liquid or gas and arrows indicating direction of flow shall be permanently indicated on the pipe in a legible manner through use of labeling, writing, or other means. Source Note: The provisions of this §265.156 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.156 General Requirements for Circulation Systems https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198376&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198376 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198376&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198376 03/11/2026 (a) NSF/ANSI standards. Filters shall be listed and labeled to NSF/ANSI Standard 50 or NSF/ANSI Standard 60, unless the lagoon was constructed before the effective date of this subchapter and it uses filters that are not replaced.(b) Filters cleanable. For lagoons constructed on or after the effective date of this subchapter, filters shall be designed so that after cleaning according to manufacturer's instructions, the system provides the required water clarity.(c) Observable waste discharge. For a lagoon constructed on or after the effective date of this subchapter, filters shall have a readily observable free fall or sight glass installed on the waste discharge line in order that the filter washing progress may be observed. Sight glasses shall be readily removable for cleaning.(d) Filters accessible. Filters shall be installed so that filtration surfaces are accessible for inspection and service in accordance with manufacturer's instructions.(e) Operation and maintenance instructions. Filters and separation tanks shall have operation and maintenance instructions permanently installed on the filter or separation tank. Maintenance instructions shall be unobstructed and clearly visible. Source Note: The provisions of this §265.157 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.157 Filters https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198377&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198377 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198377&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198377 03/11/2026 (a) Safe pump operation. The installation of a pump and component parts shall provide safe operation in accordance with manufacturer's instructions.(b) UL and NEMA requirements. A pump shall comply with UL or National Electrical Manufacturers Association requirements. Motors shall comply with UL requirements for motors and shall be constructed electrically and mechanically to perform satisfactorily and safely under the conditions of load and environment normally encountered in lagoon installations.(c) Backflow prevention. A priming device for a pump receiving piped water from a public water supply providing potable water shall be isolated from the potable supply by means of a cross-connection control device (backflow prevention device) approved by the TCEQ or local regulatory authority.(d) Backflow prevention assembly testing. A backflow prevention assembly shall be tested upon installation and certified to be operating within specifications by a licensed backflow prevention assembly tester. A backflow prevention assembly shall be tested and certified to be operating within specifications at least annually by a licensed backflow prevention assembly tester. Documentation of testing and certification shall be kept for at least three years and shall be provided during an inspection.(e) Pumps and motors. A pump or motor provided for circulation of water shall meet the filter design range of flow required for filtering and cleaning the filters against the total dynamic head developed by the complete system and to meet required water clarity.(f) Cleanable strainer or screen. For a lagoon constructed on or after the effective date of this subchapter, a pump, except a pump with a vacuum filter, shall have a cleanable strainer or screen upstream of the circulation pump to remove waste that shall be readily accessible and cleaned as per manufacturer's instructions.(g) Motors. A motor shall:(1) be capable of operating the pump under full load with a voltage variation of plus or minus 10% from the nameplate rating;(2) have thermal or current overload protection, either built in or in the line starter, to provide locked rotor and running protection; and(3) comply with UL requirements.(h) Emergency shutoff switch. An emergency shutoff switch shall be provided for service personnel to disconnect all power to circulation and jet system pumps. An emergency shut-off switch shall be readily accessible to operators and located within sight of the lagoon and not more than 50 feet from the lagoon. Source Note: The provisions of this §265.158 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.158 General Requirements for Pumps and Motors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198378&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198378 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198378&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198378 03/11/2026 (a) Skimmer. For this section, a skimmer is not considered to be a suction outlet.(b) Licensed Engineer. A suction outlet system, gravity flow system, or return system constructed on or after the effective date of this subchapter shall be planned and designed by a licensed engineer.(c) Submerged suction outlets. Fully submerged suction outlets (main drains) are not required.(d) Entrapment protection. A suction outlet system shall be designed to protect against suction entrapment, evisceration, and hair entanglement/entrapment hazards in accordance with ANSI/APSP-16, American National Standard for Suction Entrapment Avoidance in Swimming Pools, Wading Pools, Spas, Hot Tubs and Catch Basins.(e) Suction outlets. Suction outlets shall comply with the following:(1) Covers, grates, and fittings shall be compliant with the VGBA.(2) At least two hydraulically balanced VGBA-compliant suction outlets shall be provided per pump suction line.(3) Suction outlets installed in water 4 feet deep or less shall be unblockable such that its perforated (open) area cannot be shadowed by the area of the 18-inch x 23-inch Body Blocking Element as described in ANSI/APSP-16, American National Standard for Suction Entrapment Avoidance in Swimming Pools, Wading Pools, Spas, Hot Tubs and Catch Basins.(4) The distance between hydraulically balanced VGBA-compliant suction outlets, as measured from center to center of the suction outlet cover or grate shall be no less than three feet.(5) The flow rating of balanced suction outlets, including the cover or grate, shall be in compliance with the ANSI/APSP/ICC-7 in effect at the time of construction or replacement of any component of a suction outlet.(6) No means of isolating hydraulically balanced suction outlets is permitted that could allow one suction outlet to serve as the sole source of water to a pump.(7) A single pipe to a pump suction inlet that serves two or more suction outlets may have a valve to shut off the flow to the pump.(f) Flow rate through suction fittings. The flow rate through a fitting, cover, or grate shall not exceed the approved flow rate for that fitting, cover, or grate when one suction fitting in a suction outlet system is blocked.(g) Closure when cover broken, missing, or loose. If the cover or grate on a suction outlet including a vacuum outlet is missing, broken, or loose, the swimming area of the lagoon shall be closed immediately and remain closed until a proper repair is made or replacement is installed.(h) Return inlets. A return inlet shall be designed so as not to constitute a hazard to the user.(i) Automatic cleaners. An automatic bottom or side cleaner that could provide a means of entanglement or entrapment shall not be operated in a swimming area of the lagoon when the swimming area is occupied by users. Source Note: The provisions of this §265.159 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.159 Suction Outlets, Gravity Flow Systems, and Return Inlets https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198379&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198379 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198379&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198379 03/11/2026 (a) Licensed engineer. A surface skimming system or perimeter overflow (gutter) system constructed on or after the effective date of this subchapter shall be planned and designed by a licensed engineer.(b) Surface skimming design. A surface skimming system or perimeter overflow system shall be planned and designed as required in §265.159 of this subchapter (relating to Suction Outlets, Gravity Flow Systems, and Return Inlets) and shall be capable of providing 100% of the design system flow, unless the department has approved an alternate method of disinfectant.(c) Safe design of surface skimming and perimeter overflow systems. A surface skimmer or perimeter overflow system shall be designed and installed to prevent body and limb entrapment.(d) Effective skimming action maintained. Surface skimmers shall be located to maintain effective skimming action throughout the lagoon.(e) Hydraulic capacity of perimeter overflow system. The hydraulic capacity of a perimeter overflow (gutter) surface skimming system shall be capable of handling 100% of the circulation flow, unless the department has approved an alternate method of disinfectant. Source Note: The provisions of this §265.160 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.160 Surface Skimming and Perimeter Overflow (Gutter) Systems https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198380&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198380 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198380&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198380 03/11/2026 (a) Licensed designer. An electrical system installed on or after the effective date of this subchapter shall be planned and designed by a licensed engineer or licensed master electrician.(b) Compliance with National Electrical Code (NEC). All electrical equipment and lines shall comply with applicable provisions in the current NEC in effect on the date of installation.(c) Testing laboratory approval. Electrical equipment shall be approved by a nationally recognized electrical testing laboratory, such as UL, at the time of installation as evidenced by the listing or labeling on the equipment.(d) Grounding and bonding. Equipment, as required, shall be bonded and grounded in accordance with the NEC in effect at the time of installation. Pumps shall be both internally and externally grounded and bonded in accordance with the NEC.(e) Manufacturer's instructions. Electrical equipment and related electrical components shall comply with manufacturer's installation instructions.(f) Line clearances. Electrical line clearances shall comply with the National Electrical Safety Code or NEC in effect at the time of construction.(g) Inspections required. For a lagoon constructed on or after the effective date of this subchapter, a licensed electrician shall conduct at least two inspections, one during construction and one after construction, to ensure that all electrical facilities are constructed in compliance with this section.(h) Shut-off switch for service personnel. A shut-off switch shall be provided for service personnel to disconnect all power to circulation and jet system pumps.(i) Surf lagoon emergency shut-off switches required. A minimum of two emergency shut-off switches capable of immediately stopping wave generation shall be provided, shall be clearly marked as emergency shut-offs, and shall be readily accessible to lifeguards. Source Note: The provisions of this §265.161 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.161 Electrical Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198381&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198381 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198381&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198381 03/11/2026 (a) Water Supply. For a lagoon constructed on or after the effective date of this subchapter, the initial fill water and make-up water shall come from a public water system as defined by 30 TAC §290.38 (relating to Definitions) or from a well that complies with the requirements of subsection (c) of this section.(b) Water distribution system. All portions of the water distribution system shall be protected against backflow and back siphonage using a high hazard preventer such as a reduced-pressure-principle backflow preventer meeting the requirements of the American Society of Sanitary Engineering Standard 1013 2013, as amended, and approved for use in potable water systems possibly subjected to back siphonage or high back pressure or an air gap designed to ASME Standard A112.1.2.(c) Private water supply. If the water supply providing water to the lagoon does not meet the definition of a public water system, that water supply shall comply with the following requirements.(1) Water supply system. The water supply system shall:(A) be designed to maintain a minimum pressure of 35 pounds per square inch (psi) at all points within the distribution network at flow rates of at least 1.5 gallons per minute per connection;(B) be designed to maintain a minimum pressure of 20 psi under combined fire and drinking water flow conditions when the system is intended to provide firefighting capability; and(C) maintain a minimum distribution pressure not be less than 20 psi at any time.(2) Bacteriological properties. Coliform testing of the well water shall be performed each month the lagoon is open for use. Records of bacteriological tests of the well water shall be kept on-site for three years and made available during inspection.(3) Chemical properties.(A) Water samples for chemical analysis obtained from the entry point to the distribution system shall be submitted to a laboratory certified by TCEQ once every three years.(B) The chemical analysis shall be for secondary constituent levels as set out by 30 TAC §290.118 (relating to Secondary Constituent Levels) excluding, for saline lagoons, Total Dissolved Solids.(C) Records of all chemical testing shall be kept on site for three years and made available during inspection.(d) Hose bibs. Hose bibs shall be protected with a vacuum breaker. Source Note: The provisions of this §265.162 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.162 Water Supply https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198382&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198382 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198382&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198382 03/11/2026 (a) Drinking water. Drinking water shall be available to users at all areas of the lagoon.(b) Location of water lines. Location of water lines in relation to wastewater lines shall be in compliance with 30 TAC §290.44 (relating to Water Distribution).(c) Food and beverages. Food and beverages may be consumed in the lagoon only if it is privately owned and operated. Consumption of food and beverages in a lagoon that is not privately owned and operated is prohibited.(d) Non-breakable containers. Food and beverages shall be served only in non-breakable containers. Glass containers shall not be allowed on a deck, in the lagoon, or anywhere within the enclosure.(e) Trash containers. Covered trash containers shall be provided where food and beverages are allowed or served. Source Note: The provisions of this §265.163 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.163 Drinking Water, Food, Beverages, and Containers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198383&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198383 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198383&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198383 03/11/2026 (a) Discharge or disposal. Filter backwash water and drainage water that is not reused in a lagoon shall be discharged or disposed of in accordance with the requirements of TCEQ or local regulatory authority.(b) No direct connection. No direct mechanical (hard) connection shall be made between the lagoon, the lagoon drain, the chemical treatment equipment, or the system of piping and the sanitary sewer system, septic system, or other wastewater disposal system.(c) Backwash water. Backwash water and lagoon draining water shall be discharged through an air gap formed by positioning the discharge pipe opening at least two pipe diameters above the overflow level of any barriers that could cause flooding and submergence of the discharge opening or by other means in accordance with TCEQ requirements. Splash screening barriers are permitted as long as the barriers do not destroy air gap effectiveness.(d) On-site sewage facility wastewater disposal lines. On-site sewage facility wastewater disposal lines shall be located in compliance with 30 TAC §285.31 (relating to Selection Criteria for Treatment and Disposal Systems) or local regulatory requirements.(e) Other wastewater or drainage water disposal facilities or lines. The location of other wastewater disposal facilities or lines shall meet applicable standards of 30 TAC, Chapter 307, Texas Surface Water Quality Standards, Chapter 308, Criteria and Standards for the National Pollutant Discharge Elimination System, Chapter 311, Watershed Protection, and Chapter 315, Pretreatment Regulations for Existing and New Sources of Pollution, or local regulatory authority. Source Note: The provisions of this §265.164 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.164 Wastewater Disposal https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198384&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198384 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198384&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198384 03/11/2026 (a) Design requirement. Disinfectant equipment and systems constructed on or after the effective date of this subchapter shall be planned and designed by a licensed engineer.(b) Disinfectant agent. Lagoon water shall be continuously disinfected by a disinfectant agent with a residual that can be easily measured by simple and accurate field tests, unless the department has approved an alternate method of disinfectant.(c) Training and protection. Personnel responsible for the operation of the disinfectant agent and other potentially hazardous chemicals shall be properly trained and provided with appropriate protective equipment and clothing, including rubber gloves and goggles, safety information, and safety data sheets. Safety data sheets covering all chemicals for which personnel are responsible shall be kept on site and readily available.(d) Monitoring controllers. Automated, manual, or remotely managed controllers shall be installed for monitoring and turning on or off chemical feeders used for pH and disinfectants.(e) Instructions. Operation manuals or other instructions that give clear directions for cleaning and calibrating automated controller probes and sensors shall be kept in close proximity to the automated controller.(f) Storage.(1) Disinfectant agents and other chemicals and feed equipment shall be stored so that users do not have access.(2) Dry chemicals shall be stored off the floor in a dry, above-ground-level room and protected against flooding or wetting from floors, walls, and ceiling.(3) Chlorine compounds shall not be stored in the same storage room or storage area as petroleum products.(g) Labeling. All chemical bulk and day tanks shall be clearly labeled to indicate the tank's contents.(h) Chlorine gas prohibited. Use of compressed chlorine gas is prohibited. Source Note: The provisions of this §265.165 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.165 Disinfectant Equipment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198385&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198385 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198385&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198385 03/11/2026 (a) Environmental Protection Agency (EPA) registration. A sanitizer, disinfectant, or other chemical used to treat the water shall be EPA-registered under the Federal Insecticide, Fungicide, and Rodenticide Act if it is a pesticide as defined by the EPA.(b) NSF/ANSI listing. A non-pesticide chemical used to treat the water shall be listed and labeled to NSF/ANSI Standard 50 or NSF/ANSI Standard 60.(c) Manufacturer's instructions. Chemicals shall be used according to the manufacturer's instructions. (d) Required water quality. Unless the department has approved an alternate form of disinfectant, water quality shall meet the following criteria at all times the lagoon is open.Attached Graphic(e) Water clarity. Water clarity shall be sufficient such that an eight-inch black disk or Secchi Disk on the floor at the deepest part of the swimming areas of the lagoon can be clearly and immediately seen by an observer on the water surface above the disk or by someone standing on the shore closest to the disk. (f) Swimming area testing frequency.(1) When a swimming area of a lagoon is open, tests for sanitizer levels (free available chlorine or bromine) and pH shall be made in each swimming area at least three times a day. One of the tests for sanitizer levels and pH shall be made before opening.(2) Test samples in a swimming area shall be taken where the water is a minimum of three feet in depth.(3) Alkalinity and calcium hardness testing frequency. Unless the department has approved an alternate method of disinfectant when a lagoon is open, tests for alkalinity shall be performed weekly and tests for calcium hardness shall be performed monthly in all swimming areas of the lagoon.(g) Non-swimming area testing and frequency.(1) Unless the department has approved an alternate method of disinfectant when a non-swimming area of a lagoon is open, tests for sanitizer levels (free available chlorine, bromine) and pH shall be performed at least three times a day. One of the tests for sanitizer levels and pH shall be performed before opening.(2) Test samples in a non-swimming area of the lagoon shall be taken at a minimum of two locations located on opposite sides of the lagoon.(3) Alkalinity testing frequency. Unless the department has approved an alternate method of disinfectant when a lagoon is open, tests for alkalinity shall be performed weekly and tests for calcium hardness shall be performed monthly.(h) ORP reading frequency. Readings shall be recorded at the same time sanitizer and pH tests are performed where in-line ORP meters are used.(i) Reliable testing methods. A reliable means of testing for pH, free available chlorine, combined chlorine, cyanuric acid (if used), bromine, alkalinity, and calcium hardness, shall be maintained for the lagoon. The test method shall be capable of measuring chemical ranges as detailed in subsection (d) of this section.(j) DPD chemical test. Free available chlorine levels shall be determined by the use of the DPD method or its equivalent.(k) Storage of test kits and reagents. Test kits and reagents shall be stored according to the manufacturer's instructions and protected from extreme heat and cold and from exposure to water, chemicals, petroleum products or any other element or environment that could adversely affect the efficacy of water quality test results.(l) Testing reagents. Testing reagents shall be changed at frequencies recommended by the manufacturer to ensure accuracy of the tests.(m) Chemical balance. Unless an alternate method of disinfectant has been approved by the department, water in a lagoon shall be chemically balanced. Testing methods to determine the chemical balance of the water in the lagoon, such as the Langelier Saturation Index, shall be conducted once a week at a minimum. (n) Operation record retention. Operational records, including results of required chemical testing under this section, shall be kept for three years and be made available during an inspection. (o) Off-season chemical levels. When a lagoon is not in use for at least 30 days (such as off-season), clarity shall be maintained, and algae growth shall be prevented, however, other water quality parameters as required in this section need not be maintained. Source Note: The provisions of this §265.166 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.166 Water Quality https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198386&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198386 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198386&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198386 03/11/2026 (a) Application. Pursuant to Texas Health and Safety Code, §341.064(b), an owner or operator may apply to use an alternate method of disinfectant.(b) Submission. A completed application for use of an alternate method of disinfectant must be submitted to the department, Consumer Safety Section, no later than 180 days before the opening of the lagoon. The application shall include:(1) the type and level of primary disinfectant;(2) the type and level, where applicable, of any supplemental method of water treatment;(3) the method for and equipment used for storing, delivering, and measuring primary disinfectant levels and supplemental water treatment levels;(4) data supporting the effectiveness of the primary disinfectant and supplemental method of water treatment in maintaining required water quality;(5) descriptions of any specialized equipment, application methods, or other water treatment methods that may differ from the requirements in §265.166 of this subchapter (relating to Water Quality);(6) a proposed testing schedule for determining levels of biological and chemical levels as specified by the department to ensure the health and safety of the public;(7) a detailed drawing or map of the lagoon that indicates swimming areas and non-swimming areas; and(8) any additional information the department requires to make its decision.(c) Decision. The department shall approve or reject a request to use an alternate method of disinfectant no later than 90 days after the completed application is submitted.(d) Additional information. If the department requires additional information to make its decision, the application is not considered completed for purposes of subsections (b) and (c) of this section until the department receives the additional information as requested.(e) An alternate method of disinfectant for a particular lagoon approved before the effective date of this subchapter by the department remains in effect for that lagoon. Source Note: The provisions of this §265.167 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.167 Request for Alternate Method of Disinfectant https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198387&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198387 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198387&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198387 03/11/2026 (a) Enclosure required. The lagoon facility shall be enclosed by a fence, wall, or barrier that meets the requirements in this section.(b) Minimum height. The enclosure, including doors and gates, shall have a minimum perpendicular height of at least six feet as measured from the ground surface on the outside of the fence.(c) Openings. The enclosure shall have no openings in it, through it, or under it, which would allow a four-inch diameter sphere to pass.(d) An enclosure constructed with horizontal and vertical members with the distance between the tops of the horizontal members less than 48 inches, shall have openings that shall not allow a sphere 1-3/4 inches in diameter to pass through the enclosure.(e) The enclosure shall be designed and constructed so that it cannot be readily climbed. Structures, light poles, trees, or any other object that could make the enclosure easy to climb shall be a minimum of three horizontal feet from the exterior of the fence.(f) Entry gates, doors and windows.(1) Entry doors, gates, and windows in the enclosure shall be directly and continuously supervised by staff during hours of operation or locked to prevent unauthorized entry.(2) All entry gates and doors shall open outward away from the lagoon and shall:(A) have hand-activated opening hardware; and(B) have hardware enabling the doors and gates to be locked by a padlock or built-in lock.(g) Latching devices. Entry doors and gates shall be equipped with self-closing and self-latching devices that keep the gate or door securely closed and within its range of operation. A gate latch shall be installed on entry gates and doors so that it is at least 60 inches above the ground, except that it may be installed lower if:(1) the latch is installed on the lagoon side of the gate only; and(2) the gate or enclosure has no openings greater than 1/2-inch in any direction within 18 inches from the latch, including the space between the gate and the gate post to which the gate latches; or(3) a gate latch may be located 42 inches or higher above the ground if the gate cannot be opened except by key, card, or combination from either side of the gate.(h) Building. A building that serves as part of the enclosure shall have doors or gates that access the yard of the lagoon constructed on or after the effective date of this subchapter only if:(1) any doors or gates between the building and the lagoon yard are for entry into a storage room, restroom, shower room, dressing room, or mechanical room adjacent to the lagoon; and(2) the room does not have any door or gate openings to the outside of the enclosure. Source Note: The provisions of this §265.168 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.168 Enclosures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198388&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198388 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198388&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198388 03/11/2026 (a) Safety equipment. Safety equipment shall have its function plainly marked and shall be kept in ready condition at all times a lagoon is open for use.(b) Boundaries. Boundaries shall be designated as follows.(1) Boundaries for swimming areas of the lagoon shall be marked by a buoy line with floats.(A) The buoy line floats or buoys shall be at regular intervals, no further than 25 feet apart and where the lines are joined.(B) Buoy lines with floats shall be located where the depth of the water is five feet and at the boundary of the swimming and non-swimming areas of the lagoon if the swimming area is deeper than five feet.(2) Areas of the lagoon intended for wading only or for use by non-swimmers shall not exceed three feet in depth and shall:(A) have the boundary marked by a buoy line with floats; and(B) have the buoy line floats or buoys be at regular intervals, no further than 25 feet apart and where lines are joined.(3) Safety rope and float lines required at the shallow to deep water transition areas of the lagoon shall not apply to surf lagoons.(c) Surf lagoon float lines and caisson barriers. Surf lagoons shall be fitted with a float line located to restrict access to the caisson wall if required by the surf lagoon equipment manufacturer. Caisson barriers shall be provided for all surf lagoon wave generating caissons which would not allow passage of a 4-inch sphere. Surf lagoons using forced air to generate waves shall not be required to have caisson barriers unless recommended by the manufacturer.(d) Vessel and motorboat safety.(1) Ignitable fuel. Motorboats using any ignitable propellant or fuel such as gasoline, kerosene, propane, or alcohol are prohibited in the swimming areas, but may be permitted in other areas for specific events, subject to any safety plan approved by a local regulatory authority.(2) Personal floatation devices.(A) Each vessel or motorboat passenger under 13 years of age shall be required to wear a United State Coast Guard (USCG)-approved personal floatation device while the vessel or motorboat is underway. A life belt, floaties, or a ring buoy does not satisfy this requirement.(B) An adult operator of a vessel or motorboat shall not permit a person under 13 years of age to be on board the vessel or motorboat while the vessel or motorboat is under way if the person is not wearing a USCG-approved personal floatation device.(C) No person shall be prohibited from the use of a USCG-approved personal floatation device.(3) Activities. Activities such as snorkeling, scuba diving, or any other activity that allows immersion of users in the non-swimming areas of the lagoon are prohibited when vessels or motorboats are in use unless a rope and float line, as described in subsection (b)(1) of this section, or warning buoys separate the immersion activity area from the area with vessel or motorboat use.(e) Safety requirements for surfers. No surfer shall enter the surf lagoon unless:(1) tethered to the surf board; or(2) wearing a USCG-approved personal floatation device; or(3) a lifeguard is in the surf lagoon directly supervising surfing activity.(f) Non-surfing user safety. Non-surfing users shall not be allowed to enter the wave areas of the surf lagoon while waves are being generated unless they are wearing a USCG-approved personal floatation device.(g) Safety signs. Lagoon safety signs shall comply with the following:(1) Signs shall be securely mounted.(2) Signs shall be easily readable from all areas of the lagoon and have a minimum letter, symbol, and number height of three inches.(3) All letters, numbers, and symbols on the signs shall be in contrasting color to the background and easily read.(4) Required signs in the swimming area:(A) days and hours of operation;(B) "Non-Service Animals Prohibited;"(C) "Glass Containers Prohibited;"(D) "Entering the Lagoon if Ill with Diarrhea is Prohibited;"(E) "Changing Diapers Within 6 Feet of the Lagoon is Prohibited;"(F) "In Case of Emergency Dial 911;"(G) "No Swimmers Allowed Outside the Swimming Area;"(H) "No Diving" and the international symbol for no diving where water depths are less than nine feet; and(I) maximum user load.(5) Required signs in the non-swimming area:(A) days and hours of operation;(B) "Non-Service Animals Prohibited;"(C) "Glass Containers Prohibited;"(D) "Entering the Lagoon if Ill with Diarrhea is Prohibited;"(E) "Changing Diapers Within 6 Feet of the Lagoon is Prohibited;"(F) "In Case of Emergency Dial 911;"(G) "Motorboats and Vessels Are Prohibited in Swimming Area" at lagoons where vessels or motorboats are allowed;(H) "No Diving" and the international symbol for no diving where water depths are less than nine feet; and(I) maximum user load.(6) If lifeguards are not provided or are not required to be present, the following signs are required:(A) "Warning - No Lifeguard on Duty;" and(B) "No Diving" and the international symbol for no diving.(7) The required notifications may be mounted on individual signs or combined on one sign.(h) Night swimming prohibited. Night swimming, from one-half hour before sunset to one-half hour after sunrise, shall be prohibited unless lighting is provided as required in subsection (f) of this section.(i) Lighting Requirements. If the lagoon is open for night swimming or during periods of low illumination, the lagoon surface lighting shall:(1) Maintain lagoon surface lighting levels at a minimum of 15 horizontal foot candles (161 lux).(2) Illuminate all parts of the lagoon open for use, including the swimming areas, depth markers, signs, entrances, restrooms, safety equipment, deck areas, walkways, and any area occupied or in use.(3) Underwater lighting shall not be less than eight-initial rated lumens per linear foot of the lagoon perimeter where underwater lighting is provided. Underwater lighting is not required for lagoons.(4) Lighting levels of the lagoon may be reduced for scheduled special events such as movies, holiday events, or similar activities.(j) Ring buoy, throw rope, and reaching pole. A lagoon shall have at least one ring buoy with throwing rope and a reaching pole at each swimming area and at each area that provides access to motorboats or vessels.(1) The reaching pole shall be in the immediate vicinity of the water and accessible to users.(2) The reaching pole shall be light, strong, non-telescoping, and at least 12 feet long. The pole shall be constructed of fiberglass or other material that does not conduct electricity and shall have a body hook or shepherd's crook with blunted ends attached.(3) The throwing rope shall be 1/4-inch to 3/8-inch diameter, with a length at least two-thirds of the width of the swimming area. A USCG-approved ring buoy with an outside diameter of at least 20 inches shall be attached to the throwing rope.(k) Safety equipment. Safety equipment, including ring buoys and rope, floating lines with buoys, emergency communication equipment, backboards with tie-downs and head supports, first aid kits, and required signs, shall be maintained in good condition and in good working order.(l) Emergency telephone. The lagoon shall have a minimum of two emergency telephones, commercial emergency contact devices, or alternative communication systems that are capable of immediately summoning emergency services and that are readily accessible, within 200 feet of the water, and are functioning at all times the lagoon is open. Clear operating instructions for the emergency telephone shall be provided.(1) A fixed location telephone, commercial emergency contact device, or alternative communication system shall be visible, have no obstruction to access, and have some method of identification that enables the telephone or other device or system to be easily identified by users.(2) A telephone or emergency contact device shall not be answered by an on-site office. The alternative communication system shall not be answered by an on-site office unless the alternative communication system complies with paragraph (5) of this subsection.(3) A telephone shall be capable of making outside calls to 911 dispatch or emergency medical services.(4) A commercial emergency contact device, when activated, shall directly connect to a 24-hour monitoring service, or directly to 911 dispatch or to emergency medical services.(5) An alternative communication system that contacts an on-site office may be used if the lagoon is in a remote area with limited or delayed emergency medical services response times, and it has employees on-site that are trained and certified or licensed to perform emergency medical intervention when the lagoon is open.(6) At least one emergency telephone, commercial emergency contact device, or alternative communication system device shall be located within 200 feet of a swimming area. Source Note: The provisions of this §265.169 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.169 Safety Features https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198389&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198389 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198389&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198389 03/11/2026 (a) Waterfront supervision. A waterfront manager or director who holds a current lifeguard certificate or its equivalent shall be required to manage and direct all water-related activities in the non-swimming and swimming areas.(b) Lifeguards required. A lagoon shall provide lifeguards if:(1) alcohol is sold, served, or allowed to be brought in;(2) motorboats are used or allowed;(3) the lagoon is open to the general public;(4) the lagoon is used for the recreation of youth groups, including youth camps, childcare, or school groups;(5) unsupervised children under the age of 14 years are allowed; or(6) users enter the water from any height above the deck or wall, including from diving boards, drop slides, starting platforms, or climbing walls.(c) Minimum number. A minimum of two lifeguards shall be provided for each swimming area. In the non-swimming area of the lagoon, the owner or operator shall have a lifeguard safety plan in place that defines the number of lifeguards for non-swimming areas when open.(1) The number of lifeguards shall be sufficient to provide adequate supervision and close observation of all users at all times.(2) The number of lifeguards shall be sufficient to allow for alternation of tasks such that no lifeguard conducts surveillance activities for more than 60 continuous minutes.(d) Surveillance. Each lifeguard shall be given an assigned surveillance area commensurate with ability and training.(e) Other assigned duties shall not distract. Lifeguards conducting surveillance of users shall not be assigned duties that would distract the lifeguard's attention from proper observation of the users, or that would prevent immediate assistance to persons in the water.(f) In-service training. Lifeguards shall be provided with alertness and response drills and other training, including:(1) a pre-season training program to refresh skills;(2) review of the Centers for Disease Control and Prevention standards for responding to formed-stool contamination, diarrheal-stool contamination, vomit contamination and contamination involving blood;(3) a continual "in-service" training program totaling a minimum 60 minutes each week for each lifeguard; and(4) performance audits as recommended by the ARC, Young Men's Christian Association, or equivalent aquatic safety organization.(g) Records kept on-site. Records of each lifeguard's certification, including expiration dates, and in-service training records, shall be kept on-site for at least three years.(h) Emergency action plan. An Emergency Action Plan shall be developed for the lifeguards and shall contain at a minimum:(1) a list of emergency telephone numbers;(2) the location of the first-aid kit and other rescue equipment such as the AED, BVM, and the backboard;(3) a response plan for inclement weather such as thunderstorms, lightning, or high winds, including evacuation areas; and(4) a plan following Centers for Disease Control and Prevention standards for responding to formed-stool contamination, diarrheal-stool contamination, vomit contamination, and contamination involving blood.(i) Safety equipment. Lifeguards shall have access to safety equipment, including:(1) An Occupational Safety and Health Administration (OSHA)-compliant 24-unit first aid kit housed in a durable weather-resistant container and kept filled and ready for use. The kit shall include disease transmission barriers and cleaning kits meeting OSHA standards.(2) A number of backboards equipped with a head immobilizer and sufficient straps to immobilize a person to the backboard, in locations sufficient to affect a two-minute response time to an incident.(3) At least one portable AED and one BVM kept in a secure location that can be easily and quickly accessed by lifeguards or other trained personnel.(4) Platforms or stands are required where water surface area is greater than 2,000 square feet or where the depth of the water is greater than 5 feet and shall include a protective umbrella or sunshade high enough to give lifeguards a complete and unobstructed view of the area of responsibility for the lifeguards.(j) Personal equipment. Each lifeguard shall be provided:(1) uniform attire that readily identifies the lifeguard as a staff member and a lifeguard;(2) a rescue tube with a strap;(3) personal protective devices, including a resuscitation mask with one-way valve and non-latex, non-powdered, one-use disposable gloves worn as a hip pack or attached to the rescue tube; and(4) a whistle or other signaling device for communicating to users, other lifeguards, or staff.(k) Equipment for lifeguards for surf lagoons. In addition to the requirements for lifeguards in this section, lifeguards for surf lagoons shall be provided with any equipment necessary to reach the deepest area of the surf lagoon during an emergency. The equipment shall be accessible to all lifeguards, clearly labeled as "For Lifeguard Use Only" and shall be available at all times the surf lagoon is open and used for surfing. Source Note: The provisions of this §265.170 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.170 Lifeguard Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198390&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198390 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198390&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198390 03/11/2026 (a) Required certification. The lagoon shall be maintained under the supervision and direction of a properly trained and certified operator who is responsible for the sanitation, safety, proper maintenance of the lagoon, and for maintaining all physical and mechanical equipment and records. Training and certification can be obtained by completion of one of the following courses or their equivalent:(1) the National Recreation and Parks Association, "Aquatic Facility Operator;"(2) the PHTA, "Certified Pool Operator;" or(3) the American Swimming Pool and Spa Association, "Licensed Aquatic Facility Technician."(b) Water clarity. The lagoon shall be opened for use only when the bottom at the deepest point of the swimming areas of the lagoon are clearly visible. Visual occlusion by sediment or other matter shall be checked before opening and periodically, as necessary, while the lagoon is in use. Clarity shall be observed between one and five minutes after users have exited. Sediment shall be removed as needed before allowing re-entry by users into the lagoon.(c) Closure signs. When the lagoon is closed for the season or for any other reason other than during normal operating periods, a "Lagoon Closed" sign in letters at least one-inch in height shall be posted on the exterior of each entrance.(d) Off-season water clarity. When the lagoon is not in use for at least 30 days (such as off-season), clarity shall be maintained, and algae growth shall be prevented, however, other water quality parameters required by §265.166 of this subchapter (relating to Water Quality) need not be maintained.(e) Off-season safety. When a lagoon is not in use after seasonal operation, while under construction or renovation, or for any other reason, the lagoon shall not be allowed to give off objectionable odors, become a breeding site for pests, or create any other nuisance condition or hazard.(f) Domestic animals prohibited. Domestic animals and other pets shall not be allowed within the enclosure, except that service animals shall be allowed within the enclosure, but not in the lagoon.(g) Floatation devices. No person shall be prohibited from the use of a USCG-approved personal floatation device.(h) Protection from chemical exposure. Personnel in charge of maintaining the lagoon shall be properly trained in accordance with §265.165 of this subchapter (relating to Disinfectant Equipment).(i) Use of chemicals. Use of chemicals shall be according to the chemical manufacturer's directions. No chemical shall be used in a way that violates the manufacturer's instructions for the chemical feed system or the NSF/ANSI 50 or NSF/ANSI 60 certification of the chemical feed system.(j) Use of registered products. Only chemicals registered and labeled for use in pools, spas, drinking water, and other recreational water aquatic facilities shall be used. Source Note: The provisions of this §265.171 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.171 Operation and Management https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198391&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198391 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198391&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198391 03/11/2026 (a) Fixture design. Fixtures at dressing and sanitary facilities shall be designed so that the fixtures are readily cleanable.(b) Fixture installation. Fixtures at dressing and sanitary facilities shall be installed in accordance with local plumbing codes and shall be properly protected by backflow connection prevention devices.(c) Cleaning. Dressing and sanitary facilities shall be cleaned as necessary to maintain sanitary conditions at all times. (d) Ventilation. Adequate ventilation shall be provided in dressing and sanitary facilities to prevent objectionable odors.(e) Dressing and sanitary facilities at lagoons open to the general public.(1) Separate men's and women's dressing and sanitary facilities shall be provided. The rooms shall be well lit, drained, ventilated, and of good construction, using impervious materials. The facilities shall be developed and planned so that good sanitation will be maintained throughout the building at all times. An appropriate number of dressing rooms that can accommodate a family are allowed.(2) Partitions between portions of the dressing room area, screen partitions, shower, toilet, and dressing room booths shall be of durable material not subject to damage by water and shall be designed so that a waterway is provided between partitions and floor to permit thorough cleaning of the walls and floor areas with hoses and brooms.(3) Floors shall have slip-resistant surfaces and shall be sufficiently smooth to ensure ease in cleaning. Floor drains shall be provided, and floors shall be sloped a minimum of 1/4-inch per foot toward the drains to ensure positive drainage.(4) An adequate number of hose bibs and a hose of adequate length shall be provided for washing down all areas of the dressing facility interior. Adequate cross-connection control devices, approved by TCEQ or the local regulatory authority, shall be provided. When not in use, hoses shall be stored in such a manner to prevent a trip hazard.(f) Lavatories, showers, and toilets at lagoons open to the general public constructed on or after the effective date of this subchapter shall comply with the following. (1) Lavatory, shower, and toilet facilities shall be located to encourage use of the sanitary facilities by users of the lagoon as follows:(A) at points of main entry into the enclosure; (B) within 200 feet of entry or exit into the swimming area; and(C) no more than 500 feet from entry or exit into the non-swimming area.(2) The required fixture schedule for lagoons open to the general public is contained in the following table: Attached Graphic(3) Cleansing showers and lavatories shall be provided with hot and cold running water. (4) The number of total fixtures required at the lagoon can be distributed between required sanitary facilities within the enclosure of the lagoon.(g) Lavatories, showers, and toilets at lagoons serving apartments, Home Owners Associations (HOAs), condominiums, hotels or motels, or other mixed-use, privately owned developments shall comply with the following. (1) Lavatories, showers, and toilets shall be located to encourage use of the sanitary facilities by users of the lagoon as follows:(A) within 200 feet of entry or exit into the swimming areas of the lagoon; and(B) no more than 500 feet from entry or exit into the non-swimming areas of the lagoon.(2) The required fixture schedule for lagoons at apartments, HOAs, condominiums, hotels or motels, or other mixed-use privately owned developments are contained in the following table: Attached Graphic(3) Lavatories, showers, and toilets in apartments, HOAs, condominiums, hotels or motels, or other mixed-use privately owned developments sharing use or ownership of the lagoon may count their public-use sanitary facilities toward the required number of fixtures if in compliance with paragraph (2) of this subsection.(4) When sanitary facilities are located within an apartment, HOA, condominium, hotel or motel, or other mixed-use privately owned development sharing use or ownership of the lagoon, a sign shall be posted at each entry or exit in letters at least three inches in height stating the location of the nearest available restroom facility.(h) Additional requirements for all sanitary facilities:(1) Soap dispensers with liquid or powdered soap shall be provided at each lavatory. The dispenser shall be metal or plastic, with no glass permitted.(2) When provided, mirrors shall be shatter resistant.(3) Toilet paper holders and toilet paper shall be provided at each toilet.(4) Covered waste receptacles shall be provided in toilet or dressing room areas.(5) Single-use hand drying towels or hand drying devices shall be provided near the lavatory. Source Note: The provisions of this §265.172 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.172 Dressing and Sanitary Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198392&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198392 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198392&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198392 03/11/2026 (a) A department or local regulatory authority shall have the right to enter at all reasonable times any area or environment, including the lagoon facility, building, storage, equipment room, bathhouse, or office to inspect and investigate for compliance with this subchapter to review records, to question any person, or to locate, identify, and assess the condition of the lagoon.(b) Advance notice or permission for entry is not required.(c) A department or local regulatory authority shall not be impeded or refused entry during his official duties by reason of any company policy.(d) It is a violation of this subchapter for a person to interfere, deny, or delay an inspection or investigation conducted by a department or a local regulatory authority. Source Note: The provisions of this §265.173 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.173 Compliance, Inspections, and Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198393&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198393 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=198393&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 198393 03/11/2026 (a) If a person violates Texas Health and Safety Code, §341.064, or this subchapter, the department or local regulatory authority may, in accordance with Texas Health and Safety Code, §341.092, institute a civil suit in district court for the assessment of civil penalties, injunctive relief, or both.(b) A person who violates Texas Health and Safety Code, §341.064, or this subchapter may also be subject to a criminal penalty under Texas Health and Safety Code, §341.091.(c) If the lagoon closes, either voluntarily or by court order, public access to the lagoon shall be restricted and a notice posted notifying the public that the lagoon is closed until further notice. Source Note: The provisions of this §265.174 adopted to be effective March 1, 2020, 45 TexReg 1024. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION K ARTIFICIAL SWIMMING LAGOONS §265.174 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211618&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211618 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211618&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211618 03/11/2026 (a) Scope and purpose. The purpose of this subchapter is to implement Texas Health and Safety Code, §341.064, Swimming Pools, Artificial Swimming Lagoons and Bathhouses, and §341.0645, Pool Safety.(b) Adoption by reference. Department of State Health Services (DSHS) adopts by reference the 2021 International Swimming Pool and Spa Code (ISPSC) regarding construction, alteration, renovation, enlargement, and repair of commercial swimming pools and spas; the ANSI/APSP-16 American National Standard for Suction Outlet Fitting Assemblies (SOFA) for use in Pools Spas and Hot Tubs; and the ANSI/PHTA/ICC-7 American National Standard for Suction Entrapment Avoidance in Swimming Pools, Wading Pools, Spas, Hot Tubs, and Catch Basins as specified in subsection (c) of this section.(c) ISPSC sections adopted. DSHS adopts by reference the following chapters and sections from the ISPSC, except as provided in subsection (d) of this section: Section 102 in Chapter 1, Scope and Administration; Chapter 2, Definitions; Chapter 3, General Compliance, only as these sections and chapters relate to the construction, alteration, renovation, enlargement, and repair of commercial swimming pools and spas; Chapter 4, Public Swimming Pools; Chapter 5, Public Spas and Public Exercise Spas; and Chapter 6, Aquatic Recreation Facilities.(d) ISPSC sections not adopted. DSHS does not adopt by reference the following chapters and sections from the 2021 ISPSC: Sections 102.7.1, 103, 104, 105, 106, 107, 108, 109.2, 109.3, 110, 111, 112, 113, and 114 in Chapter 1, Scope and Administration; Definitions in Section 202 in Chapter 2: Code Official, Deep Area, Design Professional, and Jurisdiction; Section 412.2 in Chapter 4, Public Swimming Pools; Section 508.3 in Chapter 5, Public Spas and Public Exercise Spas; Section 603.3 in Chapter 6, Aquatic Recreation Facilities; Chapter 7, Onground Storable Residential Swimming Pools; Chapter 8, Permanent Inground Residential Swimming Pools; Chapter 9, Permanent Residential Spas and Permanent Residential Exercise Spas; and Chapter 10, Portable Residential Spas and Portable Residential Exercise Spas.(e) Application of the rules. The rules in this subchapter establish minimum standards for swimming pools and spas concerning pool operation and management, water quality, safety standards unrelated to design and construction, signage, enclosures, and safety features intended to reduce to a practical minimum the possibility of drowning or injury to users.(f) Date of construction. The date of construction of a pool, spa, or a bathhouse is the date that a building permit for construction is issued. If no building permit is required, the date that excavation or electrical service begins, whichever is earlier, is the date of construction. In the case of the latter, the owner or operator must produce adequate written documentation of the date of excavation or the beginning date of electrical service.(g) Regulations not in the ISPSC. Regarding regulations in this subchapter not addressed by the ISPSC, local regulatory authorities may, with the exception of DSHS-approved alternate methods of disinfection set forth in §265.196 of this subchapter (relating to Request for Alternate Method of Disinfectant), adopt standards that vary from the standards in this subchapter; however, such standards must be equivalent to or more stringent than the standards in this subchapter.(h) References to public swimming pools and public spas. The rules specify whether a particular provision concerns pool operation and management, water quality, safety standards unrelated to design and construction, signage, enclosures, and safety features applies to pools and spas constructed on or after the effective date of this subchapter or whether it applies to all public swimming pools and public spas regardless of the date of construction. Source Note: The provisions of this §265.181 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.181 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211619&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211619 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211619&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211619 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) AED--Automated External Defibrillator. A device that automatically diagnoses the life-threatening cardiac arrhythmias of ventricular fibrillation and pulseless ventricular tachycardia and can treat those conditions by application of electricity which stops the arrhythmia, allowing the heart to re-establish an effective rhythm.(2) Alternate method of disinfectant--A method of disinfectant for a pool or spa requiring approval by DSHS.(3) Alternative communication system--Devices that alert multiple on-site staff when activated, such as pager systems, radios, or walkie-talkie communication systems. Used to notify on-site EMS, on-site medical staff, on-site certified staff such as lifeguards, or a commercial emergency monitoring service.(4) ANSI--American National Standards Institute.(5) APSP--Association of Pool and Spa Professionals now known as the Pool and Hot Tub Alliance (PHTA).(6) ARC--American Red Cross.(7) Artificial swimming lagoon--An artificial body of water used for recreational purposes with more than 20,000 square feet of surface area, an artificial liner, and a disinfectant method. The term does not include a body of water open to the public that continuously recirculates water from a spring or a pool.(8) ASPSA--American Swimming Pool and Spa Association.(9) ASTM International--American Society of Testing Materials International.(10) ASTM F2376--Standard Practice For Classification, Design, Manufacture, Construction, And Operation Of Water Slide Systems.(11) Backflow prevention device--A device designed to prevent a physical connection between a potable water system and a non-potable source, such as a pool or spa, or a physical connection between a pool or spa and a sanitary sewer or wastewater disposal system.(12) Breakpoint chlorination--The addition of enough of the chlorination compound to water to destroy chlorine demand compounds, chloramines, and any combined chlorine that is present. The amount added is normally 10 times the combined chlorine concentration. Breakpoint chlorination, also called "superchlorination," results in a decrease in eye irritation potential and "chlorine odors." (13) BVM--Bag-Valve Mask. A handheld device used to provide positive pressure ventilation to persons who are not breathing adequately. Also known by its proprietary name, Ambu bag.(14) Chlorine--An element that at room temperature and pressure is a heavy green-yellow gas that is used to sanitize water. Chlorine, when mixed with water, forms hypochlorous acid, which is the disinfecting agent, and hydrochloric acid. (15) Cleansing shower--A shower with hot and cold running water and soap for the purpose of removing dead skin, sweat, dirt, and waste material from users.(16) Combined chlorine--Also known as "chloramine(s)." Formed when free chlorine combines with nitrogen-containing compounds such as perspiration and ammonia. Combined chlorine, or chloramines, can cause eye and skin irritation, strong and unpleasant "chlorine" odors, and is not as effective as a sanitizer or disinfectant.(17) Commercial pool and spa--A public swimming pool and spa as defined in paragraph (51) of this section, referring to public pool and in paragraph (54) of this section, referring to public spa.(18) Cross-connection control device--A backflow prevention device as defined in this section.(19) Cryptosporidium parvum --A microscopic parasite that is highly tolerant to chlorine disinfection and that causes the diarrheal disease cryptosporidiosis. It is commonly referred to as Crypto.(20) Day camp--A day camp as described in the Texas Youth Camps Safety and Health rules, §265.11 of this chapter (relating to Definitions). (21) Disinfectant--Energy, chemicals, or a combination of both used to kill or irreversibly inactivate microorganisms such as bacteria, viruses, and parasites. (22) DPD--A chemical testing reagent (N, N-Diethyl-P-Phenylenediamine) used to measure the levels of free chlorine or bromine in water by yielding a series of colors ranging from light pink to dark red.(23) DSHS--Texas Department of State Health Services.(24) EMS--Emergency medical services.(25) Emergency monitoring service--A service that provides an emergency summoning device at pools and spas that is monitored 24 hours a day off-site by personnel trained to identify pool and spa related emergencies, such as drownings. A service capable of contacting local EMS, providing a precise location of the emergency call to local EMS, and that has personnel trained to offer the caller instructions for assisting when possible. (26) Exercise spa or swim spa--For purposes of the rules in this subchapter related to safety, operation and management, signage, and enclosures, exercise spas or swim spas are a variant of a spa in which the design and construction includes specific features and equipment to produce a water flow intended to allow recreational physical activity including swimming in place. (27) Facility--A pool, spa, public interactive water feature or fountain, and restrooms, dressing rooms, equipment rooms, deck or walkways, beach entries, enclosure, and other appurtenances directly serving the pool or spa.(28) FIFRA--The Federal Insecticide, Fungicide, and Rodenticide Act.(29) Filter media--A finely graded material (for example, sand, diatomaceous earth, or polyester fabric) that removes filterable particles from the water.(30) FINA--Fédération Internationale de Natation. The organization that administers international competition in aquatic sports. (31) Floatation system--A combination of a float solution holding vessel and treatment system for the immersion and floatation of a person or persons in a temperature-controlled environment. Also known as a flotation system, sensory deprivation system or floatation chamber. For purposes of this subchapter, a floatation system is not considered a pool or spa. (32) Free available chlorine or free chlorine residual--That portion of the total chlorine remaining in chlorinated water that is not combined with ammonia or nitrogen compounds and that will react chemically with bacteria or other pathogenic organisms in the water of a pool, spa, or lagoon.(33) Gpm--Gallons per minute.(34) Hyperchlorination--The intentional and specific raising of chlorine levels for a prolonged period-of-time to inactivate pathogens following a diarrheal release in a pool or spa as per the Centers for Disease Control and Prevention's guidance titled "Healthy Swimming: Fecal Incident Response Recommendations for Aquatic Staff". (35) Island--A structure inside a pool where the perimeter is surrounded by the water in the pool and the top is above the surface of the pool. (36) Langelier Saturation Index--A number indicating the degree of saturation in water related to calcium carbonate solubility. The number represents the ability of water to deposit calcium carbonate, or dissolve metal, concrete, or grout.(37) Licensed design professional--A person licensed to engage in the practice of design in the state of Texas in accordance with relevant licensing laws, including an architect, electrician, and engineer. (38) Licensed architect--A person licensed to engage in the practice of architecture in the State of Texas in accordance with the Texas Occupations Code, Chapter 1051, and related rules.(39) Licensed electrician--A person licensed to perform electrical work on pools and spas in accordance with the Texas Electrical Safety and Licensing Act, Texas Occupations Code, Chapter 1305, and related rules.(40) Licensed engineer--A person licensed to engage in the practice of engineering in the State of Texas in accordance with the Texas Engineering Practice Act, Texas Occupations Code, Chapter 1001, and related rules.(41) Lifeguard--A person who supervises the safety and rescue of swimmers, surfers, and other water sports participants and who has successfully completed and holds a current ARC, Young Men's Christian Association, or equivalent Lifeguard Certificate from an aquatic safety organization, a current First Aid Certificate, and a current cardiopulmonary resuscitation (CPR) certificate received for training in CPR for adults, infants, and children and the use of an AED and BVM.(42) Local regulatory authority--A county, municipality, or other political subdivision of the state having jurisdiction over pools and spas and associated facilities. (43) mV--Millivolt.(44) NCAA--National Collegiate Athletic Association.(45) NRPA--National Recreation and Parks Association.(46) ORP--Oxidation Reduction Potential. The measure of the oxidation-reduction potential of chemicals in water or the tendency for a solution to either gain or lose electrons. It is generally measured in millivolts (mV) by means of an electronic meter and depends upon types and concentrations of oxidizing and reducing chemicals in water.(47) pH--A value expressing the relative acidic or basic tendencies of liquids, such as water, on a scale from 0 to 14 with 7.0 being neutral, values less than 7.0 being acidic, and values greater than 7.0 being basic.(48) PHTA--Pool and Hot Tub Alliance. Formerly APSP.(49) PIWF--Public interactive water feature and fountain. A PIWF includes any indoor or outdoor installation maintained for public recreation that includes water sprays, dancing water jets, waterfalls, dumping buckets, or shooting water cannons in various arrays for the purpose of wetting the persons playing in the spray streams. It may be a stand-alone PIWF, also known as a splash pad, spray pad, or wet deck, or may share a water supply, disinfection system, filtration system, circulation system, or other treatment system that allows water to co-mingle with a pool. (50) Pool yard or spa yard--An area that has an enclosure containing a pool or spa.(51) Public pool--For purposes of the rules in this subchapter related to safety, operation and management, signage and enclosures, pools are classified and referred to as follows: any man-made permanently installed or non-portable structure, basin, chamber, or tank containing an artificial body of water that is maintained or used expressly for public recreation, swimming, diving, aquatic sports, or other aquatic activity. Public pools include but are not limited to activity pools, catch pools, lazy or leisure river pools, wave action pools, vortex pools, therapy pools, and wading pools. A public pool may be publicly or privately owned and may be operated by an owner, lessee, operator, licensee, or concessionaire. A fee for use may or not be charged. The term does not include a residential pool, artificial swimming lagoon, floatation system or chamber, or a body of water that continuously recirculates water from a spring. (A) Class A pool--Any pool maintained or used, with or without a fee, for accredited competitive events such as FINA, United States Swimming, United States Diving, NCAA, or National Federation of State High School Association events. A Class A pool may also be used for recreational swimming.(B) Class B pool--Any pool maintained or used for public recreation and open to the general public with or without a fee.(C) Class C pool--Any pool that is not a Class A or B pool that is limited to occupants, members, or students and their guests, but not to the general public. It is a pool operated for and in conjunction with: (i) lodging, such as hotels, motels, apartments, condominiums, RV parks, or mobile home parks; (ii) youth camps, property owner associations, private organizations, or clubs; or(iii) schools, colleges, or universities while operated for academic or continuing education classes. (52) Pools and Spas--Public swimming pools and public spas are referred to as pools and spas throughout this subchapter.(53) Ppm--Parts per million.(54) Public spa--A body of water intended for the immersion of persons in either hot or cold water circulated in a closed system and not intended to be drained and refilled after each use. A spa can include a filter, heater, a pump or pumps, blowers, and water sanitizing equipment. The term includes a swim spa or exercise spa. For purposes of the rules in this subchapter related to safety, operation and management, signage, and enclosures, spas are classified and referred to as follows: (A) Class A spa--Any spa maintained or used, with or without a fee, for accredited competitive events such as FINA, United States Swimming, United States Diving, NCAA, and National Federation of State High School Association events.(B) Class B spa--Any spa maintained or used for public recreation and open to the general public with or without a fee.(C) Class C spa--A spa that is not a Class A or Class B spa that is open to occupants, members, or students and their guests, but not to the general public. It is a spa that is operated for and in conjunction with: (i) lodging, such as hotels, motels, apartments, condominiums, RV parks, or mobile home parks; (ii) youth camps, property owner associations, private organizations, or clubs; or(iii) schools, colleges, or universities while operated for academic or continuing education classes, or hospitals or medical centers. (55) Regulatory authority--A federal or state agency or local regulatory authority having jurisdiction over pools and spas, and associated facilities.(56) Rescue tube--A piece of lifesaving equipment that is a part of the equipment used by lifeguards to make water rescue easier by helping support the victim's and rescuer's weight.(57) Resident youth camp--A resident youth camp as described in the Texas Youth Camps Safety and Health rules, §265.11 of this chapter. (58) Residential pool or spa--A pool or spa that is located on private property under the control of the property owner or the owner's tenant and that is intended for use by not more than two resident families and their guests. It includes a pool or a spa serving only a single-family home or duplex. (59) Rinsing shower--A shower located on the pool or spa deck for the purpose of removing sand, dirt, sweat, and user hygiene products without the use of hot water or soap. (60) Secchi disk--An 8-inch diameter disk with alternating black and white quadrants that is lowered in the pool and spa and is used to measure water turbidity and clarity.(61) Secondary disinfection system--A process or system installed in addition to the standard disinfection system required on all pools and spas.(62) Self-closing and self-latching device--A device or mechanism that causes a gate to automatically close without human or electrical power after it has been opened and to automatically latch without human or electrical power when the gate closes.(63) Slide--A recreational feature with a flow of water and an inclined flume or channel by which a user is conveyed downward into a pool. (A) Drop slide--A slide that drops users into the water from an elevated height into water.(B) Pool slide--A slide having a configuration as defined in the Code of Federal Regulations, Chapter II, Title 16, Part 1207 by United States Consumer Product Safety Commission or is similar in construction to a playground slide that allows users to slide from an elevated height to a pool. This includes children's (tot) slides.(C) Waterslide--A slide that runs into a landing pool or runout through a fabricated channel with flowing water. (64) Supplemental treatment system--A system, process, or water treatment which is not required on a public pool or spa for health and safety reasons that may be used to enhance overall system performance and improve water quality.(65) Surf pool--A pool with less than 20,000 square feet of water surface area in which waves are generated and dedicated to the activity of surfing on a surfboard or analogous surfing device commonly used in the ocean and intended for sport. A surf pool is intended for the sport of surfing as opposed to general play activities in wave pools.(66) Superchlorination--See paragraph (12) of this section, Breakpoint chlorination. (67) TCEQ--Texas Commission on Environmental Quality.(68) TDLR--Texas Department of Licensing and Regulation.(69) Therapeutic pool or spa--A pool or spa that is operated exclusively for therapeutic purposes, such as physical therapy, and is under the direct supervision and control of licensed or certified medical personnel.(70) Total alkalinity--A measure of the ability or capacity of water to resist change in pH, also known as the buffering capacity of water. Total alkalinity is measured with a test kit and expressed as parts per million (ppm) and consists mainly of carbonates, bicarbonates and hydroxides. (71) Total chlorine--The sum of both the free available chlorine and combined chlorine (chloramines). (72) UL--An independent testing laboratory (formerly Underwriters Laboratories).(73) USCG--United States Coast Guard.(74) User--A person using a pool, spa, or lagoon or adjoining deck.(75) VGBA--The Virginia Graeme Baker Pool and Spa Safety Act. A federal law that requires drain covers to comply with entrapment protection requirements specified by the American National Standards Institute (ANSI) ANSI/APSP 16 performance standard or any successor standard, and ANSI/PHTA/ICC-7 American National Standard for Suction Entrapment Avoidance in Swimming Pools, Wading Pools, Spas, Hot Tubs, and Catch Basins. (76) Wading pool--A pool with a maximum water depth that is no greater than 18 inches. A wading pool may contain a PIWF. (77) Wave pool--A pool, with less than 20,000 square feet of water surface area, designed to simulate breaking or cyclic waves for purposes of general play. A wave pool is intended for general play as opposed to a surf pool that is intended for sport.(78) Written instructions--Written communication that provides directions for carrying out a procedure or performing a task. Written instructions can include manuals, journals, lists, printed materials, computer-generated materials, and handwritten materials. Written instructions may be maintained in electronic form so long as electronic use and transmission of the electronic materials does not present a risk to the health and safety of individuals accessing the electronic materials. Source Note: The provisions of this §265.182 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.182 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211620&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211620 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211620&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211620 03/11/2026 (a) Plans for new construction of pools and spas. DSHS may review plans for pools and spas to ensure compliance with construction requirements. If DSHS intends to review plans, DSHS will notify the owner or operator in writing.(b) Additions, alterations, renovations, or repairs authorized. A minor addition, alteration, renovation, or repair to an existing pool or spa and related mechanical, electrical, and plumbing systems may be performed in accordance with the construction standard that was in place when the pool and spa was constructed.(c) Accepted practice for pools and spas. The structural design and materials for pools and spas constructed before the effective date of this subchapter must be in accordance with accepted industry engineering practices and methods prevailing at the time of original construction unless otherwise stated in this subchapter. Source Note: The provisions of this §265.183 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.183 Plans and Instructions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211621&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211621 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211621&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211621 03/11/2026 (a) Proper installation of a slide or other aquatic play feature. A slide or other aquatic play feature, such as a climbing wall, floating amusement island, zip line, or anchored floats, must be installed according to manufacturer's instructions or in accordance with the specifications established by a licensed engineer or licensed architect.(b) Amusement ride. An aquatic play feature or slide that meets the definition of "Amusement Ride" in Texas Occupations Code, Chapter 2151 (the Amusement Ride Safety Inspection and Insurance Act) must comply with that chapter.(c) Jumping rocks or ledges. Pools with diving or jumping rocks or ledges must be designed by a licensed engineer or licensed architect. Source Note: The provisions of this §265.184 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.184 Slides and other Aquatic Play Features https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211622&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211622 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211622&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211622 03/11/2026 A pump for a pool or spa must not be operated if the owner or operator of the pool or spa knows or should know in the exercise of ordinary care that the drain grate, suction outlet, or any suction outlet cover is missing, broken, or loose. If such a condition exists, the pool or spa must be closed and remain closed until corrected. Source Note: The provisions of this §265.185 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.185 Pumps and Motors for Pools and Spas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211623&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211623 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211623&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211623 03/11/2026 (a) Licensed electrician required. The electrical system of a pool or spa and structures in the pool yard or spa yard must be installed, maintained, repaired, or replaced by a licensed electrician in accordance with the Texas Electrical Safety and Licensing Act, Texas Occupations Code, Chapter 1305 and related rules.(b) Extension cords. Temporary extension cords and power connectors must not be used as a substitute for permanent wiring.(1) All parts of an extension cord must be restrained at a minimum of 6 feet as measured along the shortest possible path from a pool or spa during times when the pool or spa is open for use.(2) An extension cord may be used within 6 feet of the nearest edge of a pool or spa if a permanent wall exists between the pool or spa and the extension cord.(3) The circuit supplying power to an extension cord must be protected by a ground fault circuit interrupter, commonly referred to as GFCI, when the extension cord is to be used within 6 feet of a pool or spa. Source Note: The provisions of this §265.186 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.186 Electrical Requirements for Pools and Spas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211624&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211624 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211624&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211624 03/11/2026 (a) Water supply. For all pools and spas, the initial fill water and make-up water used to maintain the water level and water used as a vehicle for sanitizers or other chemicals for pump priming or for other additions must be from a public water system, as defined by 30 TAC §290.38 (relating to Definitions), or from a water well that complies with the requirements of subsection (c) of this section.(b) Water distribution system. All portions of the water distribution system must be protected against backflow and back siphonage using a high hazard preventer such as a reduced-pressure-principle backflow preventer meeting the requirements of the American Society of Sanitary Engineering Standard 1013, as amended, and approved for use in potable water systems possibly subjected to back siphonage or high back pressure or an air gap designed to ASME Standard A112.1.2.(c) Private water supply. If the water supply providing water to the pool or spa does not meet the definition of a public water system, as defined in subsection (a) of this section, that water supply must comply with the following requirements.(1) Water pressure system must be designed to:(A) maintain a minimum pressure of 35 pounds per square inch (psi) at all points within the distribution network at flow rates of at least 1.5 gallons per minute per connection;(B) maintain a minimum pressure of 20 psi under combined fire and drinking water flow conditions when the system is intended to provide firefighting capability; and(C) maintain a minimum distribution pressure not less than 20 psi at any time.(2) Coliform testing of the well water must be performed each month the pool or spa is open for use. Records of any bacteriological tests must be kept on-site for three years and made available during inspection.(3) Chemical analysis must be for the secondary constituent levels set out by 30 TAC §290.118 (relating to Secondary Constituent Levels).(A) Water samples for chemical analysis obtained from the entry point to the distribution system must be submitted once every three years to a laboratory certified by the TCEQ.(B) Records of all chemical testing must be kept on-site for three years and made available during inspection.(d) Drinking water provided. At least one drinking water fountain or other source of drinking water, such as bottled water, must be provided and available for pool and spa users at all pools and spas constructed on or after October 1, 1999, and must be available at all times the pool or spa is open for use. A faucet, spigot, or sink does not satisfy the requirements for providing drinking water. Glass containers must not be allowed on a deck, in the pool or spa, or anywhere within the pool yard or spa yard.(1) The drinking water is not required to be chilled.(2) The drinking water is not required to be in the pool or spa yard.(3) When the drinking water is not located in the pool yard or spa yard, a sign with letters a minimum of 1 inch in height is required. The sign must be posted so that it is visible to users that informs the users of the location of the drinking water.(e) Hose bibs. Hose bibs in the pool yard or spa yard must be protected with a vacuum breaker. Source Note: The provisions of this §265.187 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.187 Pool or Spa Water Supply and Drinking Water for All Pools and Spas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211625&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211625 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211625&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211625 03/11/2026 (a) Filter backwash wastewater disposal. Filter backwash, cartridge wash water, and drainage water that is not reused in the pool or spa must be discharged or disposed of in accordance with the requirements of the TCEQ or local regulatory authority.(b) No direct connection. No direct mechanical (hard) connection may be made between the pool or spa, the drains, the chemical treatment equipment, or the system of piping and the sanitary sewer system, septic system, or other wastewater disposal system.(c) Pool and spa backwash. Backwash water and draining water must be discharged through an air gap formed by positioning the discharge pipe opening at least two pipe diameters above the overflow level of any barriers that could cause flooding and submergence of the discharge opening or by other means in accordance with TCEQ requirements. Splash screening barriers are permitted, as long as the barriers do not destroy air gap effectiveness.(d) Wastewater post treatment. Filter backwash water and circulation system drainage water must be treated either chemically or through use of settling tanks to eliminate or neutralize chemicals, diatomaceous earth, and other contaminants in the water that exceed discharge limits set by TCEQ or the local regulatory authority.(e) Other wastewater or drainage water disposal facilities or lines. The location of other wastewater disposal facilities or lines must meet applicable standards of 30 TAC Chapter 307, Texas Surface Water Quality Standards, Chapter 308, Criteria and Standards for the National Pollutant Discharge Elimination System, Chapter 311, Watershed Protection, and Chapter 315, Pretreatment Regulations for Existing and New Sources of Pollution, or the local regulatory authority. Source Note: The provisions of this §265.188 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.188 Wastewater Disposal for Pools and Spas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211626&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211626 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211626&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211626 03/11/2026 (a) Disinfectant agent. Pool and spa water must be continuously disinfected by a chlorine or bromine disinfectant agent that can be easily measured by simple and accurate field tests. (b) Supplemental treatment systems. Supplemental treatment systems may be installed and used on pools and spas.(1) Supplemental treatment systems used only to treat water in a pool or spa and not a public interactive water feature or fountain (PIWF) are not required to meet the minimum 3-log or 2-log inactivation of Cryptosporidium parvum. (2) Supplemental treatment systems used to treat water in a PIWF must comply with the requirements in §265.306(g) of this chapter (relating to Water Quality at Public Interactive Water Features and Fountains) referring to supplemental water treatment systems for PIWFs.(3) Supplemental treatment systems must meet NSF Standard 50 or NSF Standard 60, have an Environmental Protection Agency (EPA) or FIFRA registration, and be used in accordance with the manufacturer's instructions.(c) Secondary disinfection systems. Secondary disinfection systems may be installed and used on a pool or spa and must be certified, listed, and labeled to NSF Standard 50.(1) Secondary disinfection systems must achieve a minimum 2-log (99%) reduction in the number of infective Cryptosporidium parvum oocysts per pass though the treatment system; and(2) must be located in the treatment system so that the 2-log reduction is obtained.(3) Validation records, as applicable, and operation records must be maintained for any secondary disinfection system or treatment, and must be maintained on-site, or made available to the inspector within five business days upon request if kept off-site.(d) Water treatment chemicals. Treatment chemicals must be certified, listed, and labeled to either NSF Standard 50 or NSF Standard 60 or have an EPA FIFRA registration and be used only in accordance with the manufacturer's instructions.(e) Chlorine gas prohibited. Use of compressed chlorine gas is prohibited in pools and spas constructed on or after January 1, 2021.(f) Training and protection. Personnel responsible for the operation of the disinfectant agent and other potentially hazardous chemicals, whether it is the trained and certified operator, or someone assigned to maintain a pool or spa when the trained and certified operator is not on-site, must be properly trained and provided with appropriate protective equipment and clothing, including rubber gloves and goggles, safety information, and safety data sheets. Safety data sheets covering all chemicals for which personnel are responsible must be kept on-site and be readily available.(g) Application of disinfectant in a pool or spa. (1) Automatic distribution of chemicals. If using automatic feeders, automated controllers that adjust chemical feed based on demand or manually, or remotely managed controllers for pool and spa disinfection and pH control, must be installed. Automatic feeders must meet NSF Standard 50 for use in public pools and spas and must operate in a manner that does not invalidate the NSF rating for the system and equipment.(A) Controllers that adjust chemical feed either manually or automatically are required.(B) Disinfection equipment must be selected and monitored so that continuous and effective disinfection can be achieved under all conditions. (C) Disinfectant feed systems must have the capacity to maintain up to 5 parts per million (ppm) chlorine (or equivalent bromine level) in outdoor pools and spas and up to 3 ppm chlorine (or equivalent bromine level) in indoor pools and spas under all conditions of intended use.(D) Skimmer baskets or floating dispensers may not be used to dispense disinfectant, chemicals that adjust pH, or algaecides. (2) Hand distribution of chemicals. Hand distribution of disinfectant chemicals, chemicals used to adjust pH, or algaecides is prohibited when users are in the pool or spa. Before users reenter the pool or spa following hand distribution of disinfectant chemicals, chemicals used to adjust pH, or algaecides, the following applies:(A) tests of disinfectant levels and pH must be performed 30 minutes after hand distribution; and(B) no one may reenter the pool or spa until the disinfectant levels and pH are checked and are found to be within the required range.(h) Bulk chemical tanks. All chemical bulk and day tanks must be clearly labeled to indicate the tank's contents. (i) Chemical storage areas. (1) Disinfectant agents, other chemicals, and feed equipment must be stored so that pool and spa users and other unauthorized persons do not have access.(2) Dry chemicals must be stored off the floor or in waterproof containers in a dry room and protected against flooding or wetting from floors, walls and ceiling.(3) Chlorine compounds must not be stored in the same storage room or storage area as petroleum products. Source Note: The provisions of this §265.189 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.189 Disinfectant Equipment and Chemical Feeders https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=217947&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 217947 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=217947&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 217947 03/11/2026 (a) Safety rope and float lines and floor markings.(1) Class A pools not being used for competitive events or lap swimming must have a rope and float line.(A) A rope and float line must be located between 1 and 2 feet from the 5-foot depth location, toward the shallow end of the pool. Floats must be spaced at no more than 7-foot intervals and secured so they do not slide or bunch. The size of the stretched rope and float line must provide a good handhold and be strong enough to support the load normally imposed by users.(B) A rope and float line must be fastened securely to a wall or deck anchor made of corrosion-resistant material that is recessed or removable and does not create a hazardous projection when the line is removed.(2) Class B pools over 5 feet deep must have:(A) a permanent method to mark the transition point of the pool floor from the shallow area to the deep area using a color contrasting with the bottom of the pool, such as a 4-inch minimum width row of floor tile;(B) a rope and float line located between 1 and 2 feet from the 5-foot depth location, toward the shallow end of the pool and floats must be spaced at no more than 7-foot intervals and secured so they do not slide or bunch; and(i) the size of the stretched rope and float line must provide a good handhold and be strong enough to support the load normally imposed by users; and(ii) the rope and float line may be removed when the pool is used for lap swimming or competitive events; and(C) the rope and float line is securely fastened to a wall or deck anchor made of corrosion-resistant material that is recessed or removable and does not create a hazardous projection when the line is removed.(3) Class C pools over 5 feet deep must have a permanent method to mark the transition point of the pool floor from the shallow area to the deep areas using a color contrasting with the bottom of the pool, such as a 4-inch minimum width row of floor tile.(A) A rope and float line may be used in addition to the transition line and must be located between 1 and 2 feet from the 5-foot depth location, toward the shallow end of the pool. Floats must be spaced at no more than 7-foot intervals and secured so they do not slide or bunch. The size of the stretched rope and float line must provide a good handhold and be strong enough to support the load normally imposed by users.(B) Rope and float lines must be securely fastened to a wall or deck anchor made of corrosion-resistant material that is recessed or removable and does not create a hazardous projection when the line is removed.(4) Wave pools, surf pools, and waterslide landing pools are not required to provide a safety rope on the shallow side of the change in floor slope.(b) Depth markers. (1) Depth markers must be placed in the top 4-1/2 inches of the pool or spa wall just under the coping and be positioned to be read by a user while in the pool or spa.(2) There must be no less than two depth markers for each pool or spa, regardless of size and shape.(3) Depth markers must be permanent with numbers and letters no less than 4 inches in height and be clearly marked in a color contrasting the background of the deck and vertical wall of the pool or spa.(4) Depth markers must be spaced uniformly around the perimeter of the pool or spa in intervals of no more than 25 feet.(5) Deck depth markers must be slip-resistant and positioned to be read while standing on the deck of the pool or spa.(6) Depth markers must have units of measurement that either spell out "feet" or "inches" or abbreviate "FT," "IN," or fractions of a foot.(c) Deck "NO DIVING" marker and symbol. Where a diving marker and symbol are required in pools, the marker and symbol must comply with the requirements in the International Swimming Pool and Spa Code (ISPSC) and:(1) The no diving marker and symbol must not be less than 4 inches in height. The no diving symbol must consist of a diver's profile in a circle with a 45-degree slash through the diver.(2) The color of the letters and symbol must be permanent and contrast with the background.(3) The no diving marker and symbol on the deck must be slip resistant.(4) The no diving marker and symbol on the deck must be within 18 inches of the water's edge and positioned to be read while standing on the deck facing the water.(5) If a permanent structure above the pool deck is within 5 feet of the water's surface, the 4-inch no diving marker and symbol must be on the structure so the warning is visible to persons attempting to use the structure for diving. The no diving marker and symbol are not required on diving boards or diving platforms, Americans with Disabilities Act-compliant chair lifts, slide flumes, lifeguard stands, or bridges over the water.(6) The no diving marker and symbol are not required on the interior tile line of a pool or spa.(d) Starting platforms. Starting platforms must be used during official competition only or when there is direct supervision by the team coach, a qualified instructor, or a lifeguard. Starting platforms must be removed or secured to prevent use without direct supervision.(e) Certain safety requirements for pools. In addition to safety signs required in the ISPSC, the following pool safety signs and operational procedures are required.(1) Signs must be securely mounted as applicable, readily visible to the pool user, and be posted within the pool yard unless otherwise stated within this subchapter.(2) Sign panels and lettering must be durable for the weather conditions.(3) Branding or artwork applied to signs must not distract from the message panel, and signs must have a distinct border.(4) Safety signs can be combined on one sign or posted individually.(5) Safety signs for pools constructed on or after the effective date of this section or safety signs replaced at pools constructed before the effective date of this section, must comply with Figure: 25 TAC §265.190(e)(5).Attached Graphic(6) In areas of Texas where most residents are non-English speakers, signs and other written warnings or information required by this subchapter may be posted in the predominant language, in addition to English.(7) Variations of the language of the required safety signs in Figure: 25 TAC §265.190(e)(5) are allowed if the language of the safety signs is substantially equivalent to the language in Figure: 25 TAC §265.190(e)(5) and local swimming pool and spa regulatory officials approve the variation before the sign is posted in the pool yard.(f) Rescue equipment. A pool must have at least one ring buoy with throwing rope and a reaching pole for every 2000 square feet of pool surface area up to 6000 square feet. A pool with more than 6000 square feet of surface area must have an additional ring buoy, throw rope, and reaching pole for each additional 4000 square feet of surface area or fraction thereof. Reaching poles and ring buoys with rope must be visible and readily accessible from all areas of the pool yard.(1) The reaching pole must be light, strong, non-telescoping, and at least 12 feet long. The pole must be constructed of fiberglass or other material that does not conduct electricity and must have a body hook or shepherd's crook with blunted ends attached.(2) The throwing rope must be 1/4-inch to 3/8-inch in diameter and at least two-thirds the maximum width of the pool in length. A USCG-approved ring buoy must be attached to the throwing rope.(g) Certain safety requirements for spas.(1) Safety signs, for spas constructed on or after the effective date of this section or safety signs replaced at spas constructed before the effective date of this section, must be securely mounted, readily visible to spa users, and inside the spa enclosure, as required in Figure: 25 TAC §265.190(g)(1).Attached Graphic(2) Safety signs can be combined on one sign or posted individually.(3) Variations of the language of the required safety signs in Figure: 25 TAC §265.190(g)(1) are allowed if the language of the safety signs is substantially equivalent to the language in Figure: 25 TAC §265.190(g)(1) and local swimming pool and spa regulatory officials approve the variation before the sign is posted in the pool yard or spa yard.(4) Safety signs for spas constructed on or after the effective date of this section, or safety signs replaced at spas constructed before the effective date of this section, must comply with Figure: 25 TAC §265.190(g)(1).(h) Emergency summoning device. A pool or spa must have a minimum of one emergency telephone, emergency monitoring contact device, or alternative communication system that is capable of immediately summoning emergency services and that is readily accessible, within 200 feet of the water, and functioning when the pool or spa is open for use. An emergency summoning device for a pool or spa with a seasonal operation schedule must function 24 hours a day during the season the pool or spa is in use. Clear operating instructions for the emergency summoning device must be posted.(1) The fixed-location telephone, emergency monitoring device, or alternative communication system must be visible, easily identified by users, and have no obstruction to access.(2) The telephone or emergency monitoring device must not be answered by an on-site office. An alternative communication system may be answered by an on-site office if the system complies with paragraph (5) of this subsection.(3) The telephone must be capable of making calls to 911 dispatch or to an emergency service.(4) When activated, the emergency monitoring contact device must directly connect to a 24-hour monitoring service, 911 dispatch, or emergency medical services.(5) An alternative communication system contacting an on-site office may be used if the pool or spa is in a remote area with limited or delayed emergency medical services response times and employees on-site are trained and certified or licensed to perform emergency medical intervention when the pool or spa is open for use.(6) A cell phone dedicated for use at the pool or spa, mounted in the pool yard or spa yard for public use, and labeled as the emergency phone may be used if the cell phone is activated by a service provider, has a permanent power supply, and can reach the emergency service provider or 911 emergency services.(7) A sign must be posted above the emergency summoning with the precise location of the pool or spa, such as an address, building number, Global Positioning System (GPS) location, or other location identifying information in letters a minimum of 1-inch in height.(i) Lighting at pools and spas. A pool or spa operating at night must have lighting providing visibility to all areas of the pool or spa while standing on the deck at the water's edge. Source Note: The provisions of this §265.190 adopted to be effective January 1, 2023, 47 TexReg 8668; amended to be effective May 2, 2024, 49 TexReg 2695. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.190 Safety Features for Pools and Spas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211628&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211628 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211628&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211628 03/11/2026 (a) Lifeguards required. Pools and spas are required to meet the operational standard that is most applicable to their respective use. For example, a pool or spa that is normally operated as a Class C pool or spa but is occasionally made available to the public, with or without a fee, must meet Class B lifeguard standards when the pool is open to the general public, with or without a fee. A minimum of two lifeguards must be provided at:(1) Class A pools during competitive events;(2) Class B pools whenever the Class B pool is open;(3) any pool where a user enters the water from any height above the deck or wall, including from diving boards, diving platforms, drop slides, waterslides, starting platforms, zip lines, or climbing walls that are open for use;(4) any wave or surf pool; or(5) any pool while it is being used for the recreation of youth groups, including youth camps, visiting childcare groups, or visiting school groups, and a minimum of two lifeguards must be provided by either the aquatic facility or by the youth group using the aquatic facility.(b) Closing diving boards, diving platforms, drop slides, waterslides, starting platforms, zip line, or climbing wall. A diving board, diving platform, drop slide, waterslide, starting platform, zip line, climbing wall, or any other structure that allows entry from any height above the deck will be considered open unless there is a lock, chain, or other method used to prevent access to these structures, and a sign is posted on the entry to these structures stating that they are closed.(c) Lifeguards at spas. Lifeguards are not required at spas.(d) Lifeguard staffing plan required. A staffing plan specifying the number of on-duty lifeguards must be prepared by the pool operator, lifeguard supervisor, or pool owner, and must provide adequate supervision and close observation of all users at all times. A copy of the plan must be available on-site and be provided to a DSHS or local regulatory authority inspector upon request.(e) Surveillance area. Each lifeguard must be given an assigned surveillance area commensurate with ability and training. The lifeguard must be able to view the entire assigned surveillance area.(f) Other duties must not distract. Lifeguards conducting surveillance of users must not be assigned duties that would distract the lifeguard's attention from proper observation of the users or that would prevent immediate assistance to persons in the water.(g) Lifeguard rotation required. When lifeguards are provided or required, a rotation procedure for lifeguards is required. Lifeguards must have break time from guarding activities as recommended by ARC or equivalent aquatic safety organization.(h) Lifeguard training and drills. When lifeguards are provided or required, alertness and response drills and any other training is required, including:(1) a pre-season training program;(2) a continual "in-service" program of at least a minimum of 60 minutes for every 40 hours of employment by the lifeguard or other aquatic safety personnel;(3) a review of the Centers for Disease Control and Prevention standards for responding to formed-stool contamination, diarrheal-stool contamination, vomit contamination, and contamination involving blood;(4) performance audits as recommended by the ARC, Young Men's Christian Association, or by an equivalent aquatic safety organization; and(5) a facility emergency action plan for an event, such as submersion, suspected spinal injury, medical emergency, thunderstorm, missing person, bad weather, or chemical exposure.(i) Emergency action plan. Any pool or spa emergency action plan must contain the following:(1) a list of emergency phone numbers and contacts, including the trained and certified operator;(2) the location of the first-aid kit and other rescue equipment such as the AED, BVM, and backboard;(3) a response plan for inclement weather such as a thunderstorm, lightning, or high wind, including evacuation areas; and(4) a plan following the Centers for Disease Control and Prevention standards for responding to formed-stool contamination, diarrheal-stool contamination, vomit contamination, and contamination involving blood.(j) Lifeguard records. All training must be kept current. Records confirming the status of training must be made available upon request. If records are not kept on-site, records must be provided to DSHS or local regulatory authority within five business days of the request. The following records pertaining to lifeguards must be kept three years:(1) each lifeguard's certification, including the expiration date; and(2) records of the most current training, including date, length of training, training topic, trainer name, and attendee.(k) Lifeguard access to safety equipment. Lifeguards must have access to safety equipment including:(1) an Occupational Safety and Health Administration (OSHA) compliant, minimum 24-unit first aid kit housed in a durable weather-resistant container that is fully stocked and ready for use. The kit must include disease transmission barriers and cleaning kits meeting OSHA standards;(2) at least one backboard equipped with a head immobilizer and sufficient straps to immobilize a person to the backboard located close enough to a pool or spa to enable a two-minute response time to an incident in a pool or spa.(3) at least one portable AED and one BVM kept in a secure location that can be easily and quickly accessed by lifeguards or other trained personnel.(l) Lifeguard stands. OSHA-compliant lifeguard stands with platforms for lifeguards are required where water depth is greater than 5 feet and must have a protective umbrella or sunshade high enough to give lifeguards a complete and unobstructed view of the assigned area of surveillance for the lifeguards. Lifeguard stands and platforms must be located such that there are no hazards such as electrical wires directly overhead.(m) Personal lifeguard equipment. Each lifeguard must be provided with the following personal equipment:(1) uniform attire that readily identifies the lifeguard as a staff member and a lifeguard;(2) a rescue tube with attached rope or strap;(3) personal protective devices including a resuscitation mask with one-way valve and non-latex, non-powdered, single use disposable gloves worn in a hip pack or attached to the rescue tube; and(4) a whistle or other signaling device for communicating to users, other lifeguards, or staff.(n) Minimum lifeguard standards. The standards in this subsection are considered minimum standards. Pool owners or operators may require additional and more stringent lifeguard policies, procedures, staffing requirements, training requirements, and performance audits. Source Note: The provisions of this §265.191 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.191 Lifeguard Personnel Requirements and Standards at Pools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211629 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211629 03/11/2026 (a) Fence or barrier required. All pool yards and spa yards must be completely enclosed by a fence, wall, or equivalent barrier that is durable and is not easily climbed. An enclosure can surround multiple pools and spas within an aquatic facility.(1) Planters, light poles, and other structures and site furnishings must not be permitted within 36 inches, as measured horizontally, outside of the enclosure.(2) Planters, light poles, and other structures and site furnishings inside the pool or spa enclosure must be constructed and placed such that the fence is not made easily climbable from outside the pool or spa enclosure.(3) Tree limbs must be kept trimmed to prevent a tree or the limbs of the tree from being used by children to climb over the enclosure.(4) Solid barriers that do not have openings must be smooth and not have any indentations or protrusions that could be used as a handhold or foothold except for normal construction tolerances and tooled masonry joints on the side away from the pool or spa.(b) Enclosures for Class A and Class B pools and spas and resident youth camp pools and spas. Enclosures for Class A and Class B pools and spas and resident youth camp pools and spas must meet the following requirements.(1) Class A and B pools and spas and pools and spas at resident youth camps must have an enclosure consisting of a fence, portion of a building, wall or other durable enclosure, or an equivalent structure. Chain link material with a maximum opening of 1-3/4 inch mesh may be used for fencing at Class A, Class B, and residential youth camp pools and spas.(2) A building that serves as part of the enclosure must have doors or gates that open into the pool or spa yard only if:(A) any doors or gates between the building and the pool or spa yard are for entry into a storage room, restroom, shower room, dressing room, or mechanical room adjacent to the pool or spa; and(B) the room does not have any door or gate openings to the outside of the pool yard or spa yard enclosure.(3) The enclosure, including doors and gates, must be designed and constructed so that it cannot be easily climbed and:(A) have a minimum effective perpendicular height of at least 6 feet as measured from the ground surface on the outside of the enclosure;(B) have no openings in the enclosure, either through or under it, which would allow passage of a 4-inch sphere;(C) have no horizontal mid-rail and be designed and constructed so that it cannot be readily climbed;(D) have all doors and gates in the enclosure directly and continuously supervised by staff at the pool during hours of operation or locked to prevent unauthorized entry; and(E) have no windows in the enclosure lower than 6 feet from the ground as measured from outside of the enclosure that can be opened.(4) Gates and doors of Class A, Class B, and resident youth camp pool and spa enclosures must open outward away from the pool or spa, be capable of being locked, and must be locked if the pool or spa is not open for use. The gate or door must be locked if the pool or spa is closed for repairs, hazards, weather related hazards, adding chemicals by hand, or any other condition that warrants closure of the pool or spa.(c) Enclosures for pools and spas subject to Texas Health and Safety Code, Chapter 757. A pool or spa that is in a multiunit rental complex or owned, controlled, or maintained by a property owners association and subject to Texas Health and Safety Code, Chapter 757, must have an enclosure as required in Chapter 757.(d) Enclosures for all other Class C and day camp pools and spas. A Class C or day camp pool or spa not subject to Texas Health and Safety Code, Chapter 757 must have an enclosure that complies with this subsection and, if applicable, subsection (h) of this section.(1) The pool yard or spa yard enclosure must consist of one or a combination of a fence, portion of a building, wall, or other durable enclosure that meets the requirements of this section. The enclosure must comply with the following:(A) The enclosure must have a minimum perpendicular height of at least 48 inches as measured from the ground surface on the outside of the enclosure.(B) An enclosure with horizontal and vertical members constructed or replaced on or after January 1, 2021, must have no horizontal mid-rail and be constructed so that it cannot be easily climbed. The distance between horizontal members of the fence that is 48 inches in height must not be less than 45 inches.(C) Openings in, under, or through all enclosures at Class C and day camp pools and spas must not allow the passage of a 4-inch diameter sphere.(D) Chain link fencing material is prohibited for Class C pools and spas constructed on or after October 1, 1999. Pool and spa fences at Class C pools and spas constructed before October 1, 1999, that replace a chain link fence are prohibited from using chain link fencing material.(E) Windows that are capable of being opened are not allowed as a part of a pool or spa enclosure unless those windows are above the required enclosure height as measured from the ground level outside of the pool enclosure, and have a maximum opening of 4 inches, or are provided with a non-removable screen.(F) Doors or gates of a building that are capable of being opened are not allowed as part of an enclosure unless:(i) the doors or gates between the building and pool yard or spa yard are for entry into a storage room, restroom, shower room, dressing room, or mechanical room adjacent to the pool or spa;(ii) the room does not have any door or gate openings to the outside of the pool yard or spa yard enclosure; or(iii) the pool yard or spa yard is indoor and complies with the requirements of subsection (h) of this section.(2) Gates and doors of a pool or spa enclosure subject to this subsection must:(A) be equipped with self-closing and self-latching devices meeting the definition in §265.182(62) of this subchapter (relating to Definitions);(B) be designed to close and to keep the gate or door securely closed and latched whenever the gate or door is not in use;(C) open outward away from the pool or spa;(D) be capable of being locked and be locked if the pool or spa is not open for use; and(E) be locked if the pool or spa is closed for repairs, hazards, weather-related hazards, adding chemicals by hand, or any other condition that warrants closure of the pool or spa.(3) Self-closing and self-latching devices on gates and doors of a pool or spa constructed on or after January 1, 2021, must:(A) have hand-activated door- or gate-opening hardware located at least 3-1/2 feet above the deck or walkway; or(B) have hand-activated door- or gate-opening hardware located on the pool yard side of the gate that is at least 3 inches below the top of the gate;(C) have a gate or enclosure with no opening greater than 1/2 inch in any direction within 18 inches from the latch including the space between the gate and the gate post to which the gate latches; and(D) have a gate latch that may be located 42 inches or higher above the ground if the gate cannot be opened except by key, card, or combination on both sides of the gate.(e) Entry into pool yard or spa yard. Pool yard and spa yard enclosures must be constructed so that all persons will be required to pass through an enclosure gate or door to gain access to the pool or spa. All gates and doors exiting a pool or spa yard must open into a public area or walkway accessible by all users of the pool or spa.(f) Propping open gates prohibited. No gate or door into a pool yard or spa yard may be propped open or remain propped open unless an agent, employee, or contractor of the owner is present and doing construction, maintenance, or repair work in the pool yard or spa yard or on its enclosure that reasonably requires the gate to be propped open.(g) Service gates or doors. Service gates or doors at a Class A, Class B, or Class C facility used only by service personnel are not required to be self-closing and self-latching. Service gates and doors must not be used as a user entry or exit and must be kept securely closed and locked when not in actual use by service personnel entering or exiting the pool or spa yard. A service gate or door may include:(1) a gate or door used by chemical delivery services, facility maintenance services, and lawn and landscaping services; or(2) a door or service window used solely by food service staff from a food preparation area, bar, or snack bar.(h) Enclosures for pools and spas in a building. For pools and spas that are in a building, the interior or exterior building walls may be designated as the enclosure.(1) Entry and exit gates or doors into the pool or spa located in a building must comply with the requirements for entry and exit gates and doors for Class A, Class B, or Class C pool and spa gates and doors in subsections (b), (c), and (d) of this section, as applicable.(2) Elevator doors are not to be used as an entry or exit into the pool yard or spa yard when the pool or spa is inside a building or accessed from the interior of a building.(3) Where separate indoor and outdoor pools and spas are located at the same site, a door or gate may be provided between them if they comply with all the requirements in subsections (b), (c), and (d) of this section for Class A, Class B, and Class C pool and spa gates and doors, as applicable, except that if the gate or door between the indoor and outdoor pool or spa does not provide an exit from the pool or spa yard, that gate or door may open inward into the outdoor pool or spa yard. Source Note: The provisions of this §265.192 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.192 Pool Yard and Spa Yard Enclosures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211630 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211630 03/11/2026 (a) Environmental Protection Agency (EPA) registration. A sanitizer, disinfectant, or other chemical used to disinfect or sanitize the pool or spa water must be EPA-registered for use in pools and spas under the Federal Insecticide, Fungicide, and Rodenticide Act. (b) Algae. Pools and spas must be treated to eliminate algae in order to prevent creation of a slip hazard, to prevent the water from becoming cloudy reducing visibility in the pool or spa, and to prevent uncontrolled growth of algae that could harbor pathogens.(c) Required chemical levels. Water quality for a pool or spa must meet the following criteria when the pool or spa is open for use. The water quality parameters in Figure: 25 TAC §265.193(c) apply to both pools and spas unless otherwise indicated. Attached Graphic(d) Cyanuric acid. Cyanuric acid and stabilized chlorine such as dichlor, must not be used in any indoor pool or spa or in therapy pools. (e) Water clarity. Water clarity must be sufficient such that an 8-inch black disk or Secchi disk on the floor at the deepest part of the pool can be clearly and immediately seen by an observer on the water surface above the disk or by someone standing on the deck closest to the disk. (f) Reliable means of water testing required. A reliable means of testing for pH, free and total (combined) chlorine, bromine, cyanuric acid, alkalinity, and calcium hardness to minimum and maximum levels and levels in between, must be provided and available for the pool operator at the pool or spa when the pool or spa is open for use.(g) DPD chemical test. Free available chlorine levels and bromine levels must be determined using the DPD testing method.(h) ORP reading frequency. ORP readings must be recorded at the same time required sanitizer and pH tests are performed where in-line ORP meters are used. The date and the mV level must be recorded in the required pool or spa logs required in this section.(i) Storage of test kits and reagents. Test kits and reagents must be stored according to the manufacturer's instructions and protected from extreme heat and cold and from exposure to water, chemicals, petroleum products, or any other element or environment that could adversely affect the efficacy of water quality test results. (j) Accuracy of test reagents. Testing reagents must be changed at frequencies recommended by the manufacturer to ensure accuracy of the tests.(k) Chemical balance. Water in the pool or spa must be chemically balanced. Testing methods to determine the chemical balance of the water in the pool or spa, such as the Langelier Saturation Index, must be conducted at least once every 10 days while the pool or spa is open. The date of the test and the results of the testing and any adjustments made to the pool or spa to correct water quality must be recorded in the required pool or spa logs required in this section. Logs must be made available upon request. If logs are not kept on-site, logs must be provided to DSHS or local regulatory authority within five business days of the request.(l) Water monitoring records of public pools and spas. A record of all pool and spa water chemical testing must be recorded in a pool or spa log, either electronically or manually in a logbook, and must be made available upon request. If logs are not kept on-site, logs must be provided to DSHS or local regulatory authority within five business days of the request. Records shall be maintained for a minimum of three years and must include: (1) if multiple pools or spas on-site, identification of the pool or spa tested;(2) date and time of testing;(3) chemical levels as required in Figure: 25 TAC §265.193(c) in accordance with the testing schedule requirements in subsection (o) of this section; (4) mV of ORP meter where applicable; and(5) any action taken to correct chemical readings including addition of sanitizer, algaecide, or chemical to correct pH and tests to ensure chemical levels return to required levels, closure of the pool or spa, formed stool or diarrhea in a pool or spa and remedial actions taken as a result, or any other significant action taken which impacts pool and spa water quality.(m) Skimmers. Skimmers must not be used for dispensing chemicals into the pool or spa.(n) Off-season circulation system operation. When an outdoor pool or spa is not in use for an extended period of time (such as off-season), clarity must be maintained. Circulation rates must provide acceptable water clarity as required in this section. (o) Testing frequency and record keeping when pools and spas are open for use.(1) When Class A and Class B pools and spas are open for use:(A) Tests for disinfectant levels and pH must be made and recorded in pool or spa logs every two hours.(B) If a system is used to automatically control disinfectant and pH, tests for disinfectant level and pH must be performed and the results recorded in the pool or spa logs at least three times per day and a reading of the automatic control device must also be made and recorded in the pool or spa logs. (C) Where cyanuric acid is used either in stabilized chlorine or used as needed, tests for cyanuric acid levels must be performed once each week and the results recorded in the pool or spa log.(2) Class C pools and spas that have on-site staff primarily responsible for pool and spa operations, such as lifeguards, must be tested for disinfectant levels and pH a minimum of three times a day. Results of the testing must be recorded in pool or spa logs. (A) If a system is used to automatically control disinfectant and pH, testing for disinfectant level and pH must be performed and the results recorded a minimum of once a day and a reading of the automatic control device must also be made and the results recorded in the pool or spa log.(B) Where cyanuric acid is used either in stabilized chlorine or as needed, tests for levels of cyanuric acid must be performed once each week and the results recorded in the pool or spa log.(3) Class C pools and spas that do not have on-site staff primarily responsible for pool and spa operations, such as lifeguards, must be tested for disinfectant levels and pH a minimum of one time a day and the results must be recorded in the pool or spa log. (A) If a system is used to control disinfectant and pH electronically, and the system has the ability to record and transmit the mV level or free chlorine level and pH to the trained and certified operator once a day, sanitizer level and pH must be measured once each week using a test kit and recorded in the pool or spa log. (B) A reading of the automatic control device must also be recorded at the same time the sanitizer level and pH are measured using the test kit and recorded in the pool or spa log. (C) Where cyanuric acid is used either in stabilized chlorine or as needed, tests for levels of cyanuric acid must also be performed once each week and the results recorded in the pool or spa log.(4) Other required tests for pools and spas. Tests for alkalinity, calcium hardness, and chemical balance must be performed at least once every 10 days, or more often, if necessary, to maintain required water quality parameters in subsection (c) of this section and water clarity requirements in subsection (e) of this section. Results of the tests must be recorded in the pool or spa log. (5) Records of all testing of the pool and spa water must be maintained for at least three years and be available or made available upon request by DSHS or local regulatory authority. If records are stored off-site, they must be provided within five business days.(p) Cyanuric acid levels must not exceed 100 ppm. Whenever cyanuric acid levels exceed 100 ppm the following is required.(1) Sanitizer level must be raised to 2.0 ppm free available chlorine and maintained at that level until the cyanuric acid level drops to less than 100 ppm. (2) Sanitizer level, pH, and cyanuric acid levels must be measured and recorded at least once a day in the pool or spa log until the cyanuric acid level drops below 100 ppm. (3) Records of cyanuric acid levels exceeding 100 ppm and actions taken to return those levels to at or below the allowable maximum must be recorded in the pool or spa log.(q) Clarifiers, flocculants, and defoamers.(1) Clarifiers, flocculants, and defoamers must be used per manufacturer's instructions and must not create a hazardous condition, compromise disinfectant efficacy, or interfere with other water quality measures in Figure: 25 TAC §265.193(c).(2) Clarifiers, flocculants, defoamers, and any other chemical used in a pool or spa must be certified, listed, and labeled to either NSF Standard 50 or NSF Standard 60.(r) Chemical feed equipment. All chemical feed equipment must be maintained in good working condition at all times. Source Note: The provisions of this §265.193 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.193 Water Quality at Pools and Spas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211631&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211631 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211631&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211631 03/11/2026 (a) Operational standard for all pools and spas. Pools and spas must be required to meet the operational standard that is most applicable to their respective use. For example, a pool or spa that is being operated as a Class C pool or spa but is generally or for specific occasions made available to the public, with or without a fee, must meet Class B operational standards.(b) Required operator certification. All Class A, Class B, and Class C pools and spas must be maintained under the supervision and direction of a properly trained and certified operator.(1) The operator is not required to be on-site when the pool or spa is open.(2) The operator may be responsible for multiple pools and spas.(3) The trained and certified operator's name and contact information must be made available to on-site staff, such as lifeguards, and to property management companies or property managers, and must be made available at the request of DSHS or a local regulatory authority.(c) Operator responsibilities. The trained operator must ensure that the staff is properly trained in day-to-day operations of the pool and spa circulation system, as defined in the International Swimming Pool and Spa Code, and that the circulation system is being maintained in good operating condition in accordance with manufacturer's instructions.(d) Operator training and certification. Operator training and certification can be obtained by completion of one of the following courses or the equivalent:(1) the NRPA, "Aquatic Facility Operator;"(2) the PHTA, "Certified Pool Operator;"(3) the ASPSA, "Licensed Aquatic Facility Technician;" or(4) an equivalent course which requires testing and provides certification and that is approved by the local regulatory authority.(e) Documentation required for pools and spas.(1) Documentation for all pool and spa suction outlets confirming compliance with ANSI/APSP-16 or any successor standard, whether the suction outlet is manufactured or field fabricated, must be kept on-site at all times the pool or spa is open for use or must be made available within five business days upon request by a regulatory official.(2) Documentation of compliance with ASME/ANSI A112.19.17, ASTM F 2387, or any successor United States Consumer Product Safety Commission approved standard for manufactured pool and spa Safety Vacuum Release Systems and Automatic pump shut-off systems must be kept on-site at all times the pool or spa is open for use or must be made available within five business days upon request by a regulatory official.(f) Proper use and protection from chemicals in pools and spas. Personnel in charge of maintaining a pool or spa, whether it is the trained and certified operator or someone assigned to maintain a pool or spa when the trained and certified operator is not on-site, must be properly trained in accordance with §265.193 of this subchapter (relating to Water Quality at Pools and Spas).(1) The use of chemicals at pools and spas must be according to the chemical manufacturer's directions.(2) No chemical may be used in a way that violates the manufacturer's instructions for the chemical feed system or NSF 50 certification of that chemical feed system.(g) Pool and spa equipment access. Pool and spa circulation equipment, mechanical spaces, and chemical storage spaces, whether indoors or out-of-doors, must be inaccessible to pool and spa users or other unauthorized persons. A warning sign against unauthorized entry must be posted on the entry door or gate to the pool and spa equipment room, building, or area.(h) Water clarity standards for pools and spas. When the pool or spa is open and available for use the water must be of sufficient clarity that the bottom of the pool or spa is clearly visible while the water is static. Visual occlusion by sediment or other matter must be checked before opening and periodically, as necessary, while the pool or spa is in use. The pool or spa must be open for use only if the bottom and the submerged suction outlets, when present, are clearly visible.(i) Off-season water quality. When an outdoor pool or spa is not in use for an extended period of time, such as off-season, clarity must be maintained, and algae growth must be prevented; however, other water quality parameters as required in §265.193 of this subchapter do not need to be maintained. Other methods may be used to maintain pools and spas during extended periods of non-use if approved by local regulatory officials in writing and water clarity is maintained.(j) Pool and spa closure. When a pool or spa is not in use, such as after seasonal operation, while under construction, renovation, or for any reason, entry to the pool yard or spa yard by users or other unauthorized persons must not be allowed. A sign must be posted on the entry gates indicating the pool and spa are closed. The pool and spa and facility, when closed, must not give off objectionable odors, become a breeding site for insects, or create any other nuisance conditions or hazards.(k) Domestic animals prohibited at pools and spas. Domestic animals and other pets must not be allowed within a pool or spa enclosure area or in the pool or spa except as required by 28 CFR §36.302(c) and, if applicable, 24 CFR §100.204. Animals permitted under 28 CFR §36.302(c) and 24 CFR §100.204 must be allowed on the deck and within the pool and spa yard, but not in the pool or spa.(l) Wave pools constructed or renovated on or after the effective date of this subchapter. The wave pools must have a minimum of two emergency shutoff switches capable of immediately stopping wave generation, one on each side of the wave pool, clearly marked as emergency shutoffs and readily accessible to lifeguards.(m) Surf pools constructed or renovated on or after the effective date of this subchapter. The surf pools must have a minimum of two emergency shutoff switches capable of immediately stopping wave generation, one on each side of the surf pool, clearly marked as emergency shutoffs and readily accessible to lifeguards.(n) Actual water level at pools and spas. The actual water level in pools and spas must be maintained within the designed operating water level range of the rim, gutter, or skimmer system. When the water level is below the operating water level range of the pool or spa rim, gutter, or skimmer system, the pool or spa must be closed.(o) Use of personal floatation devices (PFD). No person may be prohibited from the use of a USCG-approved PFD in a pool or spa.(p) Food and beverages. Food and beverages may be consumed in the pool or spa only if it is privately owned and operated. Consumption of food and beverages in a pool or spa that is not privately owned and operated is prohibited.(q) Glass containers prohibited. Food and beverages in the pool or spa or in the pool yard or spa yard must be in non-breakable containers. Glass containers and glass furniture must not be allowed on a deck, in the pool or spa, or anywhere within the pool yard or spa yard.(r) Covered trash receptacles required. Covered trash receptacles must be provided where food and beverages are allowed or served.(s) Standing water on decks. Decks must not have standing water and deck drains must be cleaned and maintained to prevent water accumulating on a pool or spa deck.(t) Slime and biofilm. Slime and biofilm layers must be removed from all accessible pool and spa surfaces including steps and ladders, sidewall tile, depth markers, and from all aquatic features such as slides, climbing walls, and diving boards. Source Note: The provisions of this §265.194 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.194 Operation and Management of Pools and Spas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211632&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211632 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211632&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211632 03/11/2026 (a) Slide flumes. Slide flumes constructed on or after the effective date of this subchapter must be easily cleanable, have proper drainage in all valleys and dips, and have safety measures that ensure a rider cannot fall or be ejected from the flume.(b) Wave pools.(1) Wave pools must be fitted with a rope and float line located to restrict access to the caisson wall if required by the wave pool equipment manufacturer. Safety rope and float lines typically required at the shallow to deep water transition do not apply to wave pools.(2) A minimum of two emergency shutoff switches to disable the wave action must be provided, one on each side of the wave pool.(3) Caisson barriers must have no openings that would allow passage of a 4-inch sphere and must be provided for all wave pools. Wave pools using forced air to generate waves must not be required to have caisson barriers unless recommended by the manufacturer.(4) Safety rope and float lines required at the shallow to deep water transition do not apply to surf pools.(c) Leisure rivers. Leisure rivers constructed on or after the effective date of this subchapter must comply with the following:(1) Obstructions such as landscaping, walls, or bridges are allowed provided they do not impact lifeguarding, sight lines, or rescue operations.(2) Depth markers at leisure rivers are required on the sidewalls on both sides of all entry and exits, but if the depth is consistent, they are not required in the landscape, where there is no deck, or on the sidewalls in the main channel of the leisure river.(d) Movable floor pools.(1) The use of starting platforms in the area of a movable floor is prohibited when the water depth is shallower than 5 feet.(2) Use of the moveable floor portion of the pool must not be open to users when the floor is being raised or lowered.(3) Pools or spas with movable floors must have a sign indicating movable floor and varied water depth. The posted water depth must be the water level to the floor of the pool or spa measured vertically 3 feet from the wall of the pool or spa.(4) A sign must be posted to inform the user that the pool or spa has a varied depth and refer to the sign showing the current depth.(e) Surf pools.(1) Surf pools must be fitted with a float line located to restrict access to the caisson wall if required by the surf pool equipment manufacturer.(2) Wave caisson barriers must be provided for all surf pools and may not have an opening that would allow passage of a 4-inch sphere. Surf pools using forced air to generate waves may not have caisson barriers unless recommended by the manufacturer.(3) Safety rope and float lines required at the shallow to deep water transition do not apply to surf pools.(4) In addition to the requirements for lifeguards in §265.191 of this subchapter (relating to Lifeguard Personnel Requirements and Standards at Pools), lifeguards must be provided with any equipment necessary to reach the deepest area of the surf pool during an emergency. The equipment must be accessible to all lifeguards, clearly labeled "For Lifeguard Use Only," and be available when the surf pool is open and used for surfing.(5) No surfer may enter the surf pool unless:(A) tethered to the surfboard;(B) wearing a USCG-approved PFD; or(C) a lifeguard is in the surf pool in the surfing area directly supervising surfing activity.(6) Non-surfing users may not be allowed to enter the wave areas of the surf pool over 5 feet of depth while waves are being generated unless they are wearing a USCG-approved PFD.(f) Islands in Pools and Spas Constructed on or After the Effective Date of This Subchapter.(1) An island not designed or intended for walking on by pool or spa users must have signs stating "No Entry" in letters a minimum of 2 inches in height.(2) An island must have a demarcation tile line on the perimeter of the island that is a minimum of 4 inches in height and must be positioned in the top 4-1/2 inches of the island wall just under the coping. Source Note: The provisions of this §265.195 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.195 Additional Requirements for Aquatic Activity Devices and Specific Pools https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211633&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211633 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211633&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211633 03/11/2026 (a) Application. Pursuant to Texas Health and Safety Code, §341.064(b-1), an owner or operator may apply to use an alternate method of disinfectant.(b) Submission. A completed application for use of an alternate method of disinfectant must be submitted to DSHS's Consumer Protection Division at least 180 days before the opening of the pool or spa. The application must include:(1) the type and level of primary disinfectant;(2) the type and level, where applicable, of any supplemental method of water treatment;(3) the method and equipment used for storing, delivering, and measuring primary disinfectant levels and supplemental water treatment levels;(4) data supporting the effectiveness of the primary disinfectant and supplemental method of water treatment in maintaining required water quality;(5) descriptions of any specialized equipment, application methods, or other water treatment methods that may differ from the requirements in §265.193 of this subchapter (relating to Water Quality at Pools and Spas);(6) a proposed testing schedule for determining levels of biological and chemical levels as specified by DSHS to ensure the health and safety of the public;(7) a detailed drawing or map of the pool that indicates swimming areas and non-swimming areas; and(8) any additional information DSHS requires to make its decision.(c) Decision. DSHS approves or rejects a request to use an alternate method of disinfectant no later than 90 days after the completed application is submitted.(d) Additional information. If DSHS requires additional information to make its decision, the application is not considered complete for purposes of subsections (b) and (c) of this section until DSHS receives the additional information as requested. Source Note: The provisions of this §265.196 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.196 Request for Alternate Method of Disinfectant https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211634&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211634 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211634&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211634 03/11/2026 (a) DSHS or the local regulatory authority has the right to enter at all reasonable times any area or environment, including a building, storage, equipment room, bathhouse, or office to inspect and investigate for compliance with this subchapter, to review records, to question any person, or to locate, identify, and assess the condition of the pool or spa.(b) Advance notice or permission for entry is not required.(c) DSHS or the local regulatory authority must not be impeded or refused entry during its official duties by reason of any company policy.(d) It is a violation of this subchapter for a person to interfere with, deny, or delay an inspection or investigation conducted by DSHS or a local regulatory authority. Source Note: The provisions of this §265.197 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.197 Compliance, Inspections, and Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211635&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211635 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211635&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211635 03/11/2026 (a) If a person violates Texas Health and Safety Code, §341.064 or §341.0645 or this subchapter, DSHS or the local regulatory authority may, in accordance with Texas Health and Safety Code, §341.092, institute a civil suit in district court for the assessment of civil penalties, injunctive relief, or both.(b) A person who violates Texas Health Safety Code, §341.064 or §341.0645, or this subchapter may also be subject to a criminal penalty under Texas Health and Safety Code, §341.091.(c) If a pool or spa closes, either voluntarily or by court order, public access to the pool or spa must be restricted and a notice posted on the entry gates or doors. Source Note: The provisions of this §265.198 adopted to be effective January 1, 2023, 47 TexReg 8668. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION L PUBLIC SWIMMING POOLS AND SPAS §265.198 Enforcement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145628&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145628 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145628&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145628 03/11/2026 (a) Purpose of the rules. These rules implement Texas Health and Safety Code, §341.0695.(b) Scope of rules. These rules address minimum sanitation requirements for public interactive water features and fountains (PIWFs). These standards are based in part on the American National Standards Institute and International Aquatic Foundation Standards for Aquatic Recreation Facilities (ANSI/IAF-9 2005) as amended, the National Swimming Pool Foundation's 2008 "Aquatic Play Feature Handbook" as amended, the Centers for Disease Control and Prevention "Designing Public Swimming Facilities Guidelines," and the Centers for Disease Control and Prevention "Operating Public Swimming Pools Guidelines" both available at http://www.cdc.gov/healthyswimming/.(1) These rules apply to all PIWFs whether the PIWF shares or does not share a water supply, disinfection system, filtration system, circulation system, or any other treatment system that allows water to co-mingle with any other water feature or a pool.(2) A PIWF that is supplied entirely by drinking water that is not recirculated is not subject to §265.303(d) and §265.303(f) of this title (relating to Operation and Maintenance of Public Interactive Water Features and Fountains); §265.305 (relating to Circulation and Disinfectant Systems for Public Interactive Water Features and Fountains), and §265.306 of this title (relating to Water Quality at Public Interactive Water Features and Fountains).(3) These rules do not apply to a PIWF that uses freshwater originating from a natural watercourse for recreational purposes and that releases the freshwater back into the same natural water course.(4) A PIWF with water reservoirs or basins that are accessible to users may be subject to the suction device requirements of Chapter 265, Subchapter L of this title (relating to Standards for Public Swimming Pools and Spas).(c) PIWF standards. Where a local regulatory authority has jurisdiction for the regulation of PIWFs, such authorities may adopt standards that vary from these standards; however, such standards shall be the same as, equivalent to, or more stringent than these standards. Source Note: The provisions of this §265.301 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.301 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145629 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145629 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. (1) Act--Refers to Health and Safety Code, §341.0695, relating to Interactive Water Features and Fountains.(2) American Society of Sanitary Engineering (ASSE)--International Office, 901 Canterbury, Suite A, Westlake, Ohio 44145, telephone (440) 835-3040, website: www.asse-plumbing.org.(3) ANSI--American National Standards Institute, 25 West 43rd Street (4th Floor), New York, New York 10036, telephone (212) 642-4900, website: www.ansi.org.(4) ANSI/IAF-9 2005--American National Standards Institute and International Aquatic Foundation Standards for Aquatic Recreation Facilities.(5) AquaTech--Starfish Aquatics Institute, Human Kinetics Aquatic Education Center, P.O. Box 5076, Champaign, Illinois, 61825-5076, telephone (800) 747-4457, website: www.aquaticeducationcenter.com.(6) APSP--Association of Pool and Spa Professionals, 2111 Eisenhower Avenue, Suite 500, Alexandria, Virginia 22314-4695, telephone (703) 838-0083, website: www.apsp.org.(7) ASPSA--American Swimming Pool and Spa Association, 1108 Little River Drive, Elizabeth City, North Carolina 27909, telephone (252) 331-2301, website: www.swimmingpooloperator.com.(8) Automatic chemical feeder--An automatic device for adding chemical to water in a public interactive water feature or fountain (PIWF). An automatic chemical feeder has valves controlled by electronic equipment that use pumps to dispense chemicals based on signals from probes continuously monitoring the water's properties.(9) Available chlorine--Rating of chlorine-containing products for total oxidizing power (See definition number (30) "Free available chlorine.")(10) Backflow prevention device--A device that is designed to prevent a physical connection between a potable water system and a non-potable source such as a pool, spa, or PIWF, or to prevent a physical connection between a pool, spa, or PIWF and a sanitary sewer or wastewater disposal system. (See definition number (20) "Cross-connection control device.")(11) Bacteria--Single-celled microorganisms of various forms, some of which cause infections or disease.(12) Bromine--A chemical element (Br 2) that exists as a liquid in its elemental form or as part of a chemical compound that is a biocide agent used to disinfect water in a pool, spa, or PIWF.(13) CDC--Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, Georgia 30333, telephone (800) 232-4636, website: www.cdc.gov.(14) Chlorine--A chemical element (Cl 2) that exists as a gas in its elemental form or as part of a chemical compound that is an oxidant. Chlorine is a biocide agent used to disinfect water in a pool, spa, or PIWF.(15) Chloramine--A compound formed when chlorine combines with nitrogen or ammonia that, when found in significant amounts in the water of a PIWF, may cause eye and skin irritation and may have an objectionable odor.(16) Circulation equipment--The components that are part of a circulation system for a PIWF. Circulation equipment may include but is not limited to, categories of pumps; treatment tanks; hair and lint strainers; filters; valves; gauges; meters; heaters; inlet/outlet fittings; and chemical feeding devices. The components have separate functions, but when connected to each other by piping, perform as a coordinated system for purposes of maintaining PIWF water in a clear, sanitary, and desirable condition for use.(17) Circulation system--An arrangement of equipment or components, connected by piping to a PIWF in a closed circuit. The function of a circulation system is to direct water from the PIWF, causing it to flow through the various system components for purposes of clarifying, heating, purifying, and returning the water back to the PIWF.(18) Coliform bacteria--Bacteria found in the intestines and fecal matter of warm-blooded animals.(19) Combined chlorine--The portion of total chlorine in a water-chemical combination with ammonia, nitrogen, and/or organic compounds, mostly comprised of chloramines. Combined chlorine plus free available chlorine equals total chlorine.(20) Cross-connection control device--A device that is designed to prevent a physical connection between a potable water system and a non-potable source such as a pool, spa, or PIWF, or to prevent a physical connection between a pool, spa, or PIWF and a sanitary sewer or wastewater disposal system. (See definition number (10) "Backflow prevention device.")(21) Cryptosporidiosis--A diarrheal disease caused by microscopic parasites of the genus Cryptosporidium. Water is the most common method of transmission and Cryptosporidium is one of the most frequent causes of waterborne illness among humans in the United States.(22) Cyanuric acid--A chemical that reduces the loss of chlorine in water due to the ultraviolet rays of the sun. Also known by the names stabilizer, isocyanuric acid, conditioner and triazinetrione. (23) Date of construction--The date a building permit for construction of a PIWF is issued by a municipality or county. If no building permit is required, the date excavation or electrical service to the PIWF begins, whichever is first.(24) Department--Department of State Health Services, Environmental and Consumer Safety Unit, Policy, Standards, and Quality Assurance, P.O. Box 149347, MC 1987, Austin, Texas 78714-9347, telephone (512) 834-6788, website: www.dshs.state.tx.us.(25) Disinfectant--Energy or chemicals used to kill undesirable or pathogenic (disease causing) organisms at a level adequate to make the desired kill.(26) Disinfection equipment--Equipment designed to apply or deliver a disinfectant (such as chlorine) at a controlled rate.(27) DPD--A chemical testing reagent (N,N-Diethyl-P-Phenylenediamine) used to measure the levels of available chlorine or bromine in water by yielding a series of colors ranging from light pink to dark red.(28) Extensively remodeled--Replacement of facility components or modification of the PIWF so that the design, configuration, capacity, or operation is 20% or more different from the original design, configuration, capacity, or operation. This term does not include the normal maintenance and repair of a PIWF or a water circulation system or the partial replacement of circulation system equipment if the size, type, or operation of the equipment is not substantially different from the original equipment. Replacement of 30% or more of the circulation system shall fall within the meaning of extensively remodeled.(29) Filter--A device that removes undissolved particles from water by recirculating the water through a porous substance (filter media or element).(30) Free available chlorine--That portion of the total chlorine remaining in the chlorinated water that is not combined with ammonia or nitrogen compounds and that will react chemically with undesirable or pathogenic organisms. Free chlorine is also known as free available chlorine. Combined chlorine plus free available chlorine equals total chlorine.(31) Free residual chlorine--For purposes of this rule free residual chlorine means free available chlorine. (See definition number (30) "Free available chlorine.")(32) Incidental water contact--Contact with water that is accidental and/or that occurs merely by chance. For purposes of this subchapter, incidental water contact at a water feature or attraction is contact that occurs primarily when users do not expect to become completely wetted, immersed, or submerged in water and the water feature or attraction is not designed to completely wet users or to allow for immersion or submersion in water, and is not used by users who become completely wetted, immersed, or submerged in water when using the water feature or attraction.(33) Labeled--Equipment or material to which has been attached a label, symbol, or other identifying mark of an organization that is acceptable to the authority having jurisdiction and concerned with product evaluation that maintains periodic inspection of production of labeled equipment or materials and by whose labeling the manufacturer indicates compliance with appropriate standards of performance in a specified manner.(34) Local regulatory authority--The local enforcement body or authorized representative having jurisdiction over PIWFs and associated facilities.(35) mJ--Millijoule, a unit of work or energy.(36) mJ/cm2 --Millijoules per centimeter squared.(37) NRPA--National Recreation and Parks Association, 22377 Belmont Ridge Road, Ashburn, Virginia 20148-4501, telephone 1-800-626-6772, website: www.nrpa.org.(38) NSF--National Sanitation Foundation International, P.O. Box 130140, 789 N. Dixboro Drive, Ann Arbor, Michigan 48113-0140, telephone (800) 673-6275, website www.nsf.org.(39) NSF/ANSI-50 Standard--National Sanitation Foundation International/American National Standard Institute Standard 50, Equipment for Swimming Pools, Spas, Hot Tubs and other Recreational Water Facilities. (40) NSPF--National Swimming Pool Foundation, 4775 Granby Circle, Colorado Springs, Colorado 80919-3131, telephone (719) 540-9119, website: www.nspf.com.(41) ONPG-MUG--Ortho-nitrophenyl-beta-D-galactopyranoside-4-methylumbelli-feryl-beta-D-glucuronide, an enzyme substrate assay used for measuring total coliform and E. coli in water as described in the Code of Federal Regulations, Title 40, Part 141.(42) Owner or operator--The owner of the property upon which the PIWF is located, or the operator, business manager, complex manager, property owners association manager, rental agent, lessee, licensee, concessionaire, or other individual who is in charge of the day to day operations or maintenance of the property. The owner or operator is responsible to ensure that the PIWF complies with state and local standards.(43) Ozone (O3 )--A gas composed of oxygen that is generated on site and used to oxidize organic matter in water.(44) Ozone generator--A device that produces ozone, usually by exposing air or oxygen to a corona discharge or ultraviolet light.(45) Parts per million (ppm)--A unit measurement in chemical testing that indicates the parts by weight in relation to one million parts by weight of water. For the purposes of PIWF water chemistry, ppm is considered to be essentially identical to the term milligrams per liter (mg/L).(46) pH--A value expressing the relative acidic or basic tendencies of a substance, such as water, as indicated by the hydrogen ion concentration. The pH is expressed as a number on the scale of zero to 14, less than one being most acidic, 1 to 6.9 being acidic, 7 being neutral, 7.1 to 14 being basic, and 14 being most basic.(47) Pool--For purposes of this subchapter, the term shall have the meaning assigned to it in Subchapter L, §265.182 of this title (relating to Definitions).(48) Potable water--Water that meets all applicable standards for an approved drinking water source of the Texas Commission on Environmental Quality (TCEQ), 30 Texas Administrative Code (TAC), Chapter 290, Public Drinking Water, Subchapter D, Rules and Regulations for Public Water Systems, as amended, and 30 TAC Chapter 290, Public Drinking Water, Subchapter F, Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems, as amended, or the equivalent.(49) Public interactive water feature and fountain (PIWF)--Any indoor or outdoor installation maintained for public recreation that includes water sprays, dancing water jets, waterfalls, dumping buckets, or shooting water cannons in various arrays for the purpose of wetting the persons playing in the spray streams. PIWFs:(A) may be stand-alone PIWFs or may share a water supply, disinfection system, filtration system, circulation system, or other treatment system that allows water to co-mingle with a pool;(B) may be publicly or privately owned;(C) may be operated by an owner, lessee, operator, licensee, or concessionaire, regardless of whether a fee is charged for use;(D) include, but are not limited to, interactive water features or fountains that are open exclusively to members of an organization and their guests, residents of a multi-unit apartment building or apartment complex, residential real estate development, or other multi-family residential area, schools, day care facilities, youth camp, or hotel or other public accommodations facility;(E) do not include interactive water features or fountains located on private property under the control of the property owner or the owner's tenant serving a single-family residence or duplex and that are intended for use by not more than two resident families and their guests; and(F) are not fountains, installations, amusement rides, or other attractions, whether decorative or interactive, in which only incidental water contact occurs.(50) Pump--A mechanical device, usually powered by an electric motor that causes hydraulic flow and pressure for the purpose of filtration, heating, and circulation of the PIWF water.(51) Recreational water park--A property or any portion thereof upon which one or more PIWFs are located.(52) Regulatory authority--Any federal, state, or local enforcement body or authorized representative having jurisdiction over PIWFs.(53) Shall--Indicator of the mandatory provisions of these rules.(54) Stabilizer--A chemical that reduces the loss of chlorine in water due to the ultraviolet rays of the sun. Also known by the names cyanuric acid, isocyanuric acid, conditioner, and triazinetrione. (55) Stand-alone PIWF--A PIWF that does not share a water supply, disinfection system, filtration system, circulation system, or any other treatment system that allows water to co-mingle with a pool as defined in Subchapter L, §265.182 of this title. This does include a PIWF that shares a water supply, disinfection system, filtration system, circulation system, or any other treatment system that allows water to co-mingle with any other water feature other than a pool as defined in Subchapter L, §265.182 of this title.(56) TCEQ--Texas Commission on Environmental Quality, P.O. Box 13087, Austin, Texas 78711-3087, telephone (512) 239-1000, website: www.tceq.state.tx.us.(57) Total chlorine--The sum of both the free available chlorine and combined chlorine.(58) Treatment tank--The vessel, chamber, or tank used to collect the water that has been sprayed, dumped, or otherwise used at the PIWF and returned through the drains.(59) Turnover rate--The period of time (usually in hours) required to circulate a volume of water equal to the total pool and PIWF water volume, or in the case of a stand-alone PIWF, the PIWF water volume, through the filtration equipment.(60) Ultraviolet light (UV)--Electromagnetic radiation that is invisible to the human eye with wavelengths on the border of x-rays, about 4 nanometers, to just beyond violet in the visible spectrum, about 380 nanometers.(61) United States Environmental Protection Agency (EPA)--Ariel Rios Building, 12000 Pennsylvania Avenue, N.W., Washington, DC 20450, telephone (202) 272-0167, website: www.epa.gov.(62) Water quality testing device or kit--A product designed to measure the level of a specific chemical in the water of a PIWF. A water quality testing device or kit includes a method to provide a visual indication of chemical level, and may include one or more testing reagents and accessory items. Source Note: The provisions of this §265.302 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.302 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145630 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145630&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145630 03/11/2026 (a) Public interactive water feature and fountain (PIWF) operation requirements. PIWFs shall be operated and maintained under the supervision and direction of a properly trained and certified operator who is responsible for sanitation and proper maintenance of the PIWF, and who is responsible for maintaining all physical and mechanical equipment and records. Training and certification shall be obtained by completion of one of the following courses or its equivalent: (1) the NRPA, "Aquatic Facility Operator" (A.F.O.);(2) the NSPF, "Certified Pool Operator" (C.P.O.);(3) the ASPSA, "Licensed Aquatic Facility Technician" (L.A.F.T.); or(4) AquaTech Pool and Aquatic Facility Operator.(b) Operator credentials. The operator of the PIWF who is responsible for the sanitation and proper maintenance of the PIWF shall provide evidence of current certification as specified in subsection (a) of this section during inspection by the regulatory authority.(c) Sanitation of PIWFs. The owner, manager, operator, or other attendant in charge of a PIWF shall maintain the water feature or fountain in a sanitary condition.(1) The PIWF treatment tank shall be completely drained and cleaned at a frequency necessary to maintain water quality and sanitary conditions.(2) Any dirt, trash, refuse, animal waste, or debris on the surface of a zero depth PIWF shall be removed from the surface and the surfaces shall be flushed and sanitized with a United States Environmental Protection Agency approved disinfectant as often as is needed to prevent contamination of the water in the PIWF.(3) The surfaces of zero depth PIWFs and the decks of all PIWFs shall be kept clean and free of pooled water to prevent the growth of algae and bacteria.(d) Signs for PIWFs. Warning and notification signs shall be posted at the entrance of all PIWFs, or where the signs are clearly visible to users entering the PIWF area before contact with PIWF water occurs, when the PIWF is open or in use. Signs shall be securely mounted, clearly visible, and easily read with letters in a contrasting color to the background. The required signage can be combined into a single sign. The signage shall provide the following notifications and warnings in letters at least 2 inches in height:(1) "Non-Service Animals Prohibited;"(2) "Changing Diapers Within 6 Feet Of The Water Feature is Prohibited;"(3) "Use Of The Water Feature If Ill With A Contagious Disease is Prohibited;"(4) "Do Not Drink Water From The Water Feature;" and(5) "Use Of The Water Feature When Ill With Diarrhea is Prohibited."(e) PIWFs without an on-site owner or operator. At PIWFs without an on-site owner or operator a sign shall be posted that provides a contact number to be used in the event of a malfunction, unsanitary condition, or any other non-emergency problem requiring correction at the PIWF. Letters and numbers on the posted sign shall be a minimum of 2 inches in height and the sign shall be clearly visible. (f) Records for PIWFs. The following records pertaining to the operation, maintenance, cleaning, sanitation, and chemical levels shall be kept for a minimum of 2 years and, when kept on site, shall be made available during inspection by the regulatory authority. If the records are kept in a separate location off site they shall be provided to the regulatory authority within 5 working days following the inspection:(1) daily chemical log;(2) chlorine, bromine, cyanuric acid, and pH test results; (3) routine maintenance schedule and activities;(4) preventative maintenance schedule and activities;(5) documentation that circulation equipment meets the NSF/ANSI-50 Standard, if applicable;(6) copy of manufacturer's instructions for operation of the disinfection equipment, chemical control equipment, and chemical feed system;(7) documentation of the facility's method for determining turnover rates as described in §265.305(c) of this title (relating to Circulation and Disinfectant Systems for Public Interactive Water Features and Fountains);(8) documentation that the turnover rates meet the requirements as described in §265.305(c) of this title;(9) documentation of any Cryptosporidium testing required by this subchapter;(10) documentation of supplemental water treatment conducted as required in §265.308(f) of this title (relating to Closure of a Public Interactive Water Feature and Fountain); and(11) documentation of the date of construction of the PIWF. Source Note: The provisions of this §265.303 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.303 Operation and Maintenance of Public Interactive Water Features and Fountains https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145631&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145631 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145631&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145631 03/11/2026 (a) Water supply. The initial water supply of a public interactive water feature or fountain (PIWF) shall be potable water.(b) Water distribution system. All portions of the water distribution system serving a PIWF shall be protected against backflow and back siphonage. For purposes of these rules, this means a high hazard preventer such as a reduced-pressure-principle blackflow preventer meeting the requirements of American Society of Sanitary Engineering ASSE Standard 1013 2009, as amended, and approved for use in potable water systems possibly subjected to backsiphonage or high backpressure. An air-gap designed to ASME Standard A112.1.2 is an acceptable high-hazard backflow preventer. No direct mechanical connection shall be made between the chlorinating equipment or system of piping for the PIWF and a sanitary sewer system, septic system, or other wastewater disposal system.(c) Hose bibs. Hose bibs shall be protected with a vacuum beaker.(d) Backwash water. Filter backwash water or drainage water from a PIWF shall be discharged or disposed of as wastewater in accordance with the requirements of the Texas Commission on Environmental Quality or local regulatory authority. Source Note: The provisions of this §265.304 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.304 Water Supply and Wastewater Disposal https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145632&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145632 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145632&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145632 03/11/2026 (a) General circulation requirements. The circulation system consisting of pumps, piping, filters, return inlets, water conditioning equipment, disinfection equipment, surge chamber, treatment tank and other ancillary equipment shall provide adequate circulation of water and be designed to accommodate 100% of the turnover flow rate and maintain the distribution of disinfectant through all parts of the public interactive water feature or fountain (PIWF).(b) Circulation equipment. Where circulation equipment falls within the scope of NSF and ANSI Standard 50 (NSF/ANSI-50 Standard), such equipment shall meet the standard. Conformity with NSF/ANSI-50 as evidenced by the listing or labeling of such equipment by a testing laboratory or by separate documentation is required.(c) Turnover rate. The turnover rate for the circulation of water in a PIWF that is combined or circulated with water from a pool shall be the same as the pool. The turnover rate for circulation of water in a stand-alone PIWF shall meet the following requirements.(1) If the PIWF was constructed prior to May 1, 2010, the turnover rate shall meet the minimum design turnover rate for that PIWF.(2) If the PIWF is constructed or extensively remodeled on or after May 1, 2010 the minimum turnover rate shall be at least once every hour.(d) Treatment tank. The treatment tank shall:(1) be designed to provide ready access for cleaning and inspections, and be capable of complete draining;(2) have an automatic water level controller; and(3) have any makeup water introduced into the treatment tank through an air gap or by another method which will prevent back flow and back-siphonage. Source Note: The provisions of this §265.305 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.305 Circulation and Disinfectant Systems for Public Interactive Water Features and Fountains https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145633&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145633 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145633&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145633 03/11/2026 (a) Public interactive water features and fountains (PIWF) constructed prior to May 1, 2010, shall be equipped with equipment capable of maintaining chemical levels as required in subsection (c) of this section, referring to disinfection and cyanuric acid levels, and subsection (d) of this section, referring to pH, at all times the PIWF is open.(b) PIWFs constructed or extensively remodeled on or after May 1, 2010, shall be equipped with automatic disinfectant and pH feed equipment that provides continuous and effective disinfection and maintains the required pH at all times the PIWF is open. Disinfection, pH, and any other chemical control equipment shall:(1) be capable of automatically adjusting chemical feed based on demand;(2) be installed, maintained, operated, and repaired in accordance with manufacturer's instructions;(3) be provided with make-up water supply lines to chemical feeder solution containers that have an air gap or other acceptable cross-connection control;(4) be designed to prevent siphoning from the recirculation system to the solution container and to prevent siphoning of the chemical solution into the PIWF; and(5) incorporate failure-proof features so that the chemical cannot feed into the PIWF, the piping system, or the water supply system if equipment or power fails, or if there is not adequate return flow to properly disperse the chemical.(c) Disinfectant and cyanuric acid levels shall meet the following criteria at any time a PIWF is open or in use:Attached Graphic(d) The pH shall meet the following criteria at any time a PIWF is open or in use:Attached Graphic(e) Forms of chlorine containing stabilizer (cyanuric acid) shall not be used in indoor PIWFs.(f) Chemicals used in a PIWF shall:(1) be registered and labeled for use in recreational aquatic facilities, such as pools and spas, by the United States Environmental Protection Agency (EPA);(2) be used according to the chemical manufacturer's instructions for the chemical feed system in use; and(3) comply with the NSF/ANSI-50 Standard certification for the chemical feed system.(g) In addition to maintaining sanitizer, cyanuric acid, and pH levels as required in this section, and except as provided in subsections (j) and (l) of this section, PIWFs shall be equipped with a supplemental water treatment system that will protect the public against infection by the parasite, Cryptosporidium. (1) Supplemental water treatment systems for a PIWF include:(A) UV light disinfection installed after filtration;(B) ozone;(C) a NSF/ANSI-50 product, combination of products, or process to control Cryptosporidium; (D) weekly hyperchlorination following the Center for Disease Control's Recommendations for Aquatics Operators of Treated Venues "Hyperchlorination to Kill Cryptosporidium" available on the CDC's website: www.cdc.gov/healthyswimming/; or(E) an equivalent product, process, or system approved by the department.(2) Except as provided in subsections (j) and (l) of this section, water from a PIWF shall not be combined or circulated with water of other water features or pools unless:(A) all of the water either into or from the PIWF is treated with a supplemental water treatment system prior to combining or circulating with water from other water features or pools; or(B) all of the water in the other water features or pools that is combined or circulated with water from the PIWF is treated with a supplemental water treatment system.(h) UV light disinfection systems shall:(1) conform to the NSF/ANSI-50 Standard relating to Equipment for Pools, Spas, Hot Tubs, and Other Recreational Water Facilities;(2) provide a validated dosage confirmed by a third party validation which results in a 3 log kill of Cryptosporidium; (3) provide a validated dosage equivalent to 40mJ/cm2 or greater at the end of lamp life;(4) include an automatic audible alarm to warn of a UV light disinfection unit malfunction or impending shutdown;(5) be equipped with an automatic mechanism for shutting off the power to the UV light source whenever the protective UV unit cover is removed; and(6) be installed in an enclosure designed to protect the operator against electrical shock or excessive radiation and that provides protection from UV exposure.(i) Ozone disinfection systems shall meet the standards in the EPA Guidance Manual for Alternative Disinfectants and Oxidants, EPA Publication 815-R-99-014, April 1999, as amended, available at: http://www.epa.gov/safewater/mdbp/alternative_disinfectants_guidance.pdf. (j) Operators of stand-alone PIWFs constructed prior to May 1, 2010, in addition to maintaining sanitizer, cyanuric acid, and pH levels as required in this section shall:(1) implement a supplemental water treatment system that will protect the public against infection by the parasite, Cryptosporidium; or(2) test the water of the PIWF for Cryptosporidium every 14 days during operation. (k) Operators of stand-alone PIWFs constructed or extensively remodeled after May 1, 2010 shall, in addition to maintaining sanitizer, cyanuric acid, and pH levels as required in this section, implement a supplemental water treatment system that will protect the public against infection by the parasite, Cryptosporidium. (l) Operators of all PIWFs constructed prior to May 1, 2010, and that share a water supply, disinfection system, filtration system, circulation system or any other treatment system that allows water to co-mingle with a pool, in addition to maintaining sanitizer, cyanuric acid, and pH levels as required in this section shall:(1) implement a supplemental water treatment system that will protect the public against infection by the parasite, Cryptosporidium; or(2) test the water of the PIWF for Cryptosporidium every 30 days during operation. (m) Operators of all PIWFs constructed or extensively remodeled after May 1, 2010, and that share a water supply, disinfection system, filtration system, circulation system, or any other treatment system that allows water to co-mingle with a pool, shall in addition to maintaining sanitizer, cyanuric acid, and pH levels as required in this section implement a supplemental water treatment system that will protect the public against infection by the parasite, Cryptosporidium. (n) A water quality testing device or kit capable of accurately testing for and measuring pH, free and total chlorine, bromine, and cyanuric acid within the chemical ranges as required in this section shall be provided by the PIWF owner or operator.(1) Free available chlorine and bromine levels shall be determined by use of the DPD method or its equivalent.(2) Test reagents shall be properly stored and replaced at frequencies recommended by the manufacturer to assure accuracy of the tests.(3) The water quality testing device or kit shall conform to the NSF/ANSI-50 Standard relating to Equipment for Pools, Spas, Hot Tubs, and Other Recreational Water Facilities.(o) When a PIWF is open for use, tests for chlorine or bromine levels and pH shall be conducted to comply with the following: (1) If the PIWF is equipped with automatic disinfectant and pH feed equipment that provides continuous and effective disinfection and maintains the required pH, and that system continually monitors and automatically controls chlorine or bromine levels and pH, testing for chlorine or bromine and pH of the PIWF water shall be conducted at least once during each day the PIWF is in operation.(2) If the PIWF is not equipped with automatic disinfectant and pH feed equipment that provides continuous and effective disinfection and maintains the required pH and that continually monitors and automatically controls chlorine or bromine levels and pH, testing for chlorine or bromine and pH of the PIWF water shall be conducted at least twice a day, once immediately prior to opening the PIWF and once midway through the period of time it is open for use, during each day the PIWF is in operation.(3) Tests for cyanuric acid levels shall be conducted at least once every 7 days of operation when chlorine containing stabilizer is in use.(p) Records of all testing performed at a PIWF shall be kept for 2 years and, if kept on site, shall be made available during inspection by the regulatory authority. If the records are kept in a separate location off site they shall be provided to the regulatory authority within 5 working days following the inspection.(q) If the water of a PIWF is sampled and tested for bacterial content the sample shall not:(1) exceed 200 bacteria per milliliter as determined by heterotrophic plate count; or(2) indicate the presence of total coliform organisms in a 100 milliliter sample by any of the following methods:(A) multiple tube;(B) membrane filter; or(C) the Minimal Medium ONPG-MUG test described in the Code of Federal Regulations, Title 40, Part 141. Source Note: The provisions of this §265.306 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.306 Water Quality at Public Interactive Water Features and Fountains https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145634&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145634 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145634&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145634 03/11/2026 (a) A county, municipality, or the department may:(1) require that the owner or operator of a public interactive water feature or fountain (PIWF) obtain a permit for operation of the water feature or fountain;(2) inspect a PIWF for compliance with this subchapter; and(3) require that the PIWF is tested for Cryptosporidium when the illness Cryptosporidiosis is diagnosed in an individual that has used that PIWF.(b) A department or local regulatory representative, upon presenting credentials, shall have the right to enter at all reasonable times any area or environment, including but not limited to the PIWF facility, building, storage area, equipment room, or office area to investigate for compliance with these sections, to review records, to question any person, or to locate, to identify, and to assess the condition of the PIWF facility.(c) Advance notice or permission for inspections or investigations by the department or local regulatory authority is not required.(d) A department or local regulatory representative shall not be impeded or refused entry in the course of the representative's official duties by reason of any state or federal law or company policy. It is a violation of the Act for a person to interfere with, deny, or delay an inspection or investigation conducted by a department or local regulatory representative.(e) A county, municipality or the department may impose and collect a reasonable fee in connection with a permit or inspection requirement.(f) If a county or municipality imposes and collects a fee for a permit or inspection of a PIWF the following conditions shall be met:(1) the auditor for the county or municipality shall review the program every 2 years to ensure that the fees imposed do not exceed the cost of the program; and(2) the county or municipality shall refund the permit holders any revenue determined by the auditor to exceed the cost of the program. Source Note: The provisions of this §265.307 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.307 Inspections and Permitting of Public Interactive Water Features and Fountains https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145635&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145635 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=145635&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 145635 03/11/2026 (a) A county, a municipality, or the department may by order close, for the period specified in the order, a public interactive water feature or fountain (PIWF), if:(1) the operation of the PIWF violates this subchapter;(2) the operation of the PIWF violates a permitting or inspection requirement imposed under the Act, this subchapter, or as authorized by the Act or this subchapter; or(3) the water in the PIWF tests positive for the presence of Cryptosporidium. (b) The closure order is effective immediately with or without notice and without a hearing to the PIWF owner or operator.(c) If the order is issued under this section without a hearing, the department shall conduct a hearing no later than the 10th calendar day after the closure order to affirm, modify, or set aside the order.(d) The hearing and appeal are governed by the department's rules in 25 Texas Administrative Code, Chapter 1, Subchapter B, regarding Formal Hearing Procedures, and Government Code, Chapter 2001.(e) A PIWF shall be considered closed when the following conditions are met:(1) a notice is posted at the public entrance of the PIWF notifying the public that the PIWF is closed; and(2) water is shut off to all features of the PIWF.(f) When water from a PIWF tests positive for the presence of Cryptosporidium the owner or operator shall close the PIWF and notify the appropriate regulatory authority. The PIWF shall not reopen until:(1) the PIWF is hyperchlorinated following the Center for Disease Control's (CDC) Recommendations for Aquatics Operators of Treated Venues "Hyperchlorination to Kill Cryptosporidium" available on the CDC's website: www.cdc.gov/healthyswimming/; and(2) documentation verifying that proper hyperchlorination procedure was followed by methodology the same as or equivalent to the CDC's "Water Contamination Response Log" available at: www.cdc.gov/healthyswimming/ is supplied to the appropriate regulatory authority. Source Note: The provisions of this §265.308 adopted to be effective May 20, 2010, 35 TexReg 3828. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION M INTERACTIVE WATER FEATURES AND FOUNTAINS §265.308 Closure of a Public Interactive Water Feature and Fountain https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157440&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157440 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157440&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157440 03/11/2026 Scope and purpose of rules. The purpose of this subchapter is to establish requirements relating to sexual abuse and child molestation training and examination for employees of certain programs for minors operated by or held on the campus of an institution of higher education or a private or independent institution of higher education, and to provide penalties. This subchapter implements Texas Education Code, Chapter 51, Subchapter Z, §51.976, Training and Examination Program for Employees of Campus Programs for Minors on Warning Signs of Sexual Abuse and Child Molestation. Source Note: The provisions of this §265.401 adopted to be effective July 22, 2012, 37 TexReg 5280. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION N CAMPUS PROGRAMS FOR MINORS §265.401 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157436&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157436 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157436&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157436 03/11/2026 The following words and terms shall have the following meaning when used in this subchapter, unless the context indicates otherwise.(1) Act--Texas Education Code, Chapter 51, Subchapter Z, §51.976, Training And Examination Program For Employees of Campus Programs For Minors on Warning Signs Of Sexual Abuse and Child Molestation.(2) Camper--A minor, under the age of 18 years, who is attending a campus program for minors.(3) Campus program for minors--A program that:(A) is operated by or on the campus of an institution of higher education or a private or independent institution of higher education;(B) offers recreational, athletic, religious, or educational activities for at least 20 campers who:(i) are not enrolled at the institution;(ii) attend or temporarily reside at the camp for all or part of at least four days; and(C) is not a day camp or youth camp as defined by Texas Health and Safety Code, §141.002, or a facility or program required to be licensed by the Department of Family and Protective Services.(4) Department--Department of State Health Services.(5) Employee--A person of any age who receives compensation for work or service at a campus program for minors.(6) Institution of higher education--Has the meaning assigned by Texas Education Code, §61.003.(7) Person--Includes corporation, organization, government or governmental subdivision or agency, business trust, estate, trust, partnership, association, and any other legal entity.(8) Private or independent institution of higher education--Has the meaning assigned by Texas Education Code, §61.003.(9) Program operator--A person who owns, operates, or supervises a campus program for minors, regardless of whether it is operated on a for-profit or non-profit basis.(10) Training and examination program on sexual abuse and child molestation--A program approved by the department under §265.404 of this title (relating to Training and Examination Program on Sexual Abuse and Child Molestation). Source Note: The provisions of this §265.402 adopted to be effective July 22, 2012, 37 TexReg 5280. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION N CAMPUS PROGRAMS FOR MINORS §265.402 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157437&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157437 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157437&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157437 03/11/2026 (a) A program operator may not employ an individual in a position involving contact with campers at a campus program for minors unless:(1) the individual submits to the program operator or the campus program for minors has on file documentation verifying that within the preceding two years of the beginning date of employment, the individual successfully completed the required training and examination program on sexual abuse and child molestation; or(2) the individual successfully completes during the individual's first five days of employment the required training and examination program on sexual abuse and child molestation.(b) For purposes of this section, the term "contact with campers" does not include an employee acting as a guest speaker, an entertainer, or fulfilling any other role whose attendance at the campus program for minors is for a limited purpose or a limited time if the employee has no direct and unsupervised interaction with campers. A program operator may require training and an examination for visitors, including parents, if it chooses.(c) Subsection (a) of this section does not apply to an individual who is a student enrolled at the institution of higher education or private or independent institution of higher education that operates the campus program for minors or at which the campus program is conducted and whose contact with campers is limited to a single class of short duration. The training and examination requirement in subsection (a) of this section does not apply if:(1) employees of the institution of higher education or private or independent institution of higher education are not employees of the campus program for minors; or(2) the institution of higher education or private or independent institution of higher education is the operator of the campus program for minors and its employees, agents, or contractors have only limited or incidental contact with campers.(d) A program operator must:(1) submit to the department on the form provided by the department and within five days of the start of the campus program for minors verification that each employee of the campus program for minors has complied with the requirements of this section; and(2) retain in the operator's records an electronic or paper copy of the documentation required or issued in subsection (a) of this section for each employee until the second anniversary of the examination date.(e) A person applying for or holding an employee position involving contact with campers at a campus program for minors must successfully complete the training and examination program on sexual abuse and child molestation during the applicable period prescribed in subsection (a) of this section. Source Note: The provisions of this §265.403 adopted to be effective July 22, 2012, 37 TexReg 5280. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION N CAMPUS PROGRAMS FOR MINORS §265.403 Program Operators https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157438&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157438 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157438&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157438 03/11/2026 (a) A training and examination program on sexual abuse and child molestation must be approved by the department prior to being offered and shall at a minimum include training and an examination on:(1) the definitions and effects of sexual abuse and child molestation;(2) the typical patterns of behavior and methods of operation of child molesters and sex offenders that put children at risk;(3) the warning signs and symptoms associated with sexual abuse or child molestation, recognition of the signs and symptoms, and the recommended methods of reporting suspected abuse;(4) the recommended rules and procedures to implement to address, reduce, prevent, and report suspected sexual abuse or child molestation;(5) the need to minimize one-on-one isolated encounters between an adult and a minor; and(6) the risk of sexual activity between campers, steps to prevent sexual activity between campers, and how to respond if sexual activity between campers occurs.(b) The training program shall last for a minimum of one hour and discuss each of the topics described in subsection (a) of this section.(c) The examination shall consist of a minimum of 25 questions that cover each of the topics described in subsection (a) of this section.(d) To successfully complete the training program, each employee must achieve a score of 70% or more correct on an individual examination. If the examination is taken on-line, the employee shall retain a certificate of completion indicating successful completion of the course.(e) Training and examination program providers shall issue a certificate or similar record indicating successful completion of the program training to individuals who have successfully completed a campus program for minors training and examination program on sexual abuse and child molestation. For individuals employed by campus programs overseen, managed, operated or run by different institutions of higher education, such certificate, or similar record, shall be presumptive proof that the named individual has successfully completed the training required under these rules.(f) Applicants for a training and examination program required to be approved in subsection (a) of this section shall pay a fee of $125 to cover the costs of the department's initial review and an additional $125 fee for each follow-up review of a training and examination program.(g) Applications shall be made on forms provided by the department and fees shall be mailed to the Environmental and Sanitation Licensing Group, Department of State Health Services, Mail Code 2003, P.O. Box 149347, Austin, Texas 78714-9347. Application forms may be obtained by calling the Environmental and Sanitation Licensing Group at (512) 834-6600 or may be downloaded from http://www.dshs.state.tx.us/youthcamp/default.shtm.(h) The department, at least every five years from the date of initial approval, shall review each training and examination program approved by the department to ensure the program continues to meet the criteria and guidelines established under this section.(i) A program operator shall consider the costs of compliance with this section in determining any charges or fees imposed and collected for participation in the campus program for minors. Source Note: The provisions of this §265.404 adopted to be effective July 22, 2012, 37 TexReg 5280. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION N CAMPUS PROGRAMS FOR MINORS §265.404 Training and Examination Program on Sexual Abuse and Child Molestation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157439&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157439 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=157439&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 157439 03/11/2026 (a) The department may investigate a person the department suspects of violating the Act, a rule, or an order adopted under the Act.(b) A person violating the Act, a rule, or an order adopted under the Act is subject to a civil penalty of not less than $50 or more than $1,000 for each act of violation.(c) If it appears that a person has violated, is violating, or is threatening to violate the Act or a rule or order adopted under the Act, the department may bring a civil action in a district court for injunctive relief, a civil penalty, or both.(d) The district court, upon finding that the person is violating the Act, a rule, or an order adopted under the Act, shall grant injunctive relief, assess a civil penalty, or both, as warranted by the facts.(e) The department may petition a district court for a temporary restraining order to immediately halt a violation or other action creating an emergency condition if it appears that a person is:(1) violating or threatening to violate the Act, a rule, or an order adopted under the Act; or(2) taking any other action that creates an emergency condition that constitutes an imminent danger to the health, safety, or welfare of campers at a campus program for minors.(f) An action under this section may be brought in the county in which the defendant resides or in which the violation or threat of violation occurs.(g) If an action for injunctive relief under this section is granted by the court, the court may grant any prohibitory or mandatory injunction warranted by the facts, including temporary restraining orders, temporary injunctions, and permanent injunctions. The court shall grant injunctive relief without a bond or other undertaking by the department.(h) An appellate court shall give precedence to an action brought under this section over other cases of a different nature on the docket of the court.(i) The program operator and the institution that operate the campus program for minors or at which the campus program is conducted are immune from civil or criminal liability for any act or omission of an employee for which the employee is immune under Texas Family Code, §261.106. Source Note: The provisions of this §265.405 adopted to be effective July 22, 2012, 37 TexReg 5280. 1 DEPARTMENT OF STATE HEALTH SERVICES 265 GENERAL SANITATION N CAMPUS PROGRAMS FOR MINORS §265.405 Civil Penalty; Injunction https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168974&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168974 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168974&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168974 03/11/2026 (a) Purpose. The purpose of this Memorandum of Understanding (MOU) between the Department of State Health Services (DSHS) and the Texas Commission on Environmental Quality (TCEQ) regarding the regulation of sources of radiation is to acknowledge each agency's respective jurisdiction and duties under Health and Safety Code (HSC), Chapter 401. Pursuant to HSC, §401.414, the separate areas of each agency's jurisdiction are articulated; and the duties and responsibilities of and between the two agencies are clarified. This MOU is adopted between DSHS and TCEQ to ensure that regulation of radiation sources is consistent with HSC, Chapter 401; avoids duplication of effort; and results in a well-coordinated, consistent regulatory scheme.(b) Definitions. The words and terms used in this section shall have the same meaning as defined in the HSC, §401.003, unless the context clearly indicates otherwise.(c) Jurisdiction.(1) DSHS is the Texas Radiation Control Agency. DSHS has jurisdiction over activities and substances regulated under HSC, Chapter 401, except as provided by HSC, §401.011(b) and Subchapters E, F, G, and K of Chapter 401.(2) TCEQ has jurisdiction to regulate and license:(A) the disposal of radioactive substances;(B) the processing or storage of low-level radioactive waste or naturally occurring radioactive material (NORM) waste received from other persons, except oil and gas NORM;(C) the recovery or processing of source material in accordance with HSC, Chapter 401, Subchapter G;(D) the processing of by-product material as defined by HSC, §401.003(3)(B); and(E) sites for the disposal of:(i) low-level radioactive waste;(ii) by-product material; or(iii) NORM waste.(d) Responsibility over specific activities.(1) The receipt, storage, or processing of radioactive substances received by a TCEQ licensee for the activity covered by the TCEQ license shall be regulated by TCEQ. All other uses of radioactive material (e.g., well logging, industrial radiography, gauging devices, etc.) at a TCEQ-licensed facility shall be regulated by DSHS.(2) Radioactive waste produced at DSHS-licensed facilities remains under DSHS jurisdiction until it is transferred to a licensed waste broker, waste processor, or a low-level radioactive waste disposal site.(3) DSHS has jurisdiction over the possession, processing, and/or use of NORM except for its disposal. TCEQ has jurisdiction over the commercial or third party waste processing and/or disposal of non-oil and gas NORM waste.(e) Radioactive materials and water quality.(1) TCEQ has the responsibility for issuance of licenses, permits, and for enforcement of the terms and conditions of licenses, permits, rules, and/or orders that concern the treatment and discharge of radioactive material within the meaning of pollutant as defined in the Water Code, Chapter 26.(2) TCEQ's jurisdiction regarding discharge of radioactive material is not exclusive as certain wastes are regulated by the Railroad Commission of Texas and DSHS regulates radioactive materials discharged to sanitary sewers. No separate license from TCEQ shall be required to authorize discharge of radioactive wastewaters into a sanitary sewer by DSHS licensees.(3) TCEQ and DSHS shall notify each other in the event that radioactive materials impact water quality, including safe drinking water standards.(f) Coordination of regulatory activities. DSHS and TCEQ shall coordinate with each other in the following activities.(1) DSHS and TCEQ each agree to work together to ensure that complete regulation is maintained for sources, uses, and users of radiation. As appropriate, DSHS and TCEQ each agree to coordinate rulemaking activities between the two agencies and the Texas Radiation Advisory Board (TRAB) to ensure consistency of regulation in accordance with HSC, §401.020. In addition, TCEQ agrees to coordinate with DSHS in the preparation of the annual evaluation and report to the Legislative Budget Board as required under the Government Code, §2110.006 and §2110.007. DSHS and TCEQ each agree to seek and consider advice from TRAB on issues that involve the development, use, or regulation of sources of radiation.(2) DSHS and TCEQ each agree to coordinate rulemaking activities that pertain to the requirements of the Agreement between the State of Texas and the United States Nuclear Regulatory Commission (NRC), as amended, and to ensure the compatibility of rules and guidelines with federal regulatory programs. Each agency agrees to coordinate on providing information on any proposed legislation relating to the regulation of radioactive substances.(g) Incident response. Incidents concerning radioactive material will be investigated as follows.(1) Response to unidentified radioactive material discovered at municipal landfills will be investigated by TCEQ. If the investigation reveals that the waste is not acceptable for the municipal landfill and is determined to be generated by a DSHS licensee, TCEQ will refer the matter to DSHS.(2) Each agency will investigate incidents and allegations concerning radioactive material within each agency's jurisdiction and make required notifications to the NRC.(h) Emergency preparedness. Emergency preparedness for response to radiological emergencies shall be as follows.(1) The State of Texas is required by federal laws and regulations to have trained personnel always available for emergency response training, drills, exercises, and actual emergency response. DSHS is assigned the lead role for the state response to radiological emergencies.(2) DSHS shall provide training to emergency responders along low-level radioactive waste shipping routes with funds collected from shippers of low-level radioactive waste.(3) DSHS shall collect an annual fee from the operators of fixed nuclear facilities in the state for expenses arising from emergency response activities, including training.(4) DSHS and TCEQ will coordinate personnel availability for emergency preparedness and response activities.(5) DSHS will inform TCEQ in a timely manner of all required exercises, drills, and training. All DSHS and TCEQ technical personnel who work in the radiation program and are assigned to the emergency response team shall attend appropriate emergency response training coordinated by DSHS. TCEQ shall notify DSHS of changes in the employment status of all TCEQ radiation personnel assigned to the emergency response team. In the event of an emergency, the appropriate DSHS and TCEQ radiation staff will be available for emergency response under the direction of DSHS staff and in accordance with Annex D of the State of Texas Emergency Management Plan.(i) Mutual assistance. Each agency may request from the other agency short-term assistance of personnel or resources when there is need for such assistance, such as for performing close-out surveys, training, incident/emergency response and recovery operations, environmental monitoring, technical reviews, financial security information, and technical support at contested hearings or other project information. Each agency will provide the requested assistance to the extent possible without disrupting its own required activities, in accordance with an approved interagency contract when applicable.(j) Financial security for decontamination, decommissioning, reclamation, corrective action, and disposal of radioactive material.(1) When required, TCEQ and DSHS will ensure that financial security is provided for each entity under each agency's jurisdiction.(2) For entities licensed by both agencies:(A) each agency will ensure that separate financial security instruments are maintained;(B) the agencies shall coordinate the allocation of financial security provided to each agency and determine an equitable division of financial assurance to avoid duplication;(C) each agency will review, evaluate, and collect sufficient financial security instruments required for decontamination, decommissioning, reclamation, and disposal of radioactive material pursuant to each agency's rules for each entity under their respective jurisdictions; and(D) in the event that either agency cannot determine that decontamination, decommissioning, reclamation, or disposal of radioactive material activities fall under the exclusive jurisdiction of either agency, then both agencies will coordinate and share efforts to address the situation in a prompt manner.(k) Miscellaneous.(1) DSHS and TCEQ shall revise their respective rules and procedures as needed to implement this MOU.(2) If any provision of this MOU is held to be invalid, the invalid provision will be severed and the remaining provisions shall not be affected.(l) Effective date. This MOU will take effect after approval by both agencies and 20 days after the date on which it is filed in the Office of the Secretary of State in accordance with the provisions of Government Code, §2001.036. Source Note: The provisions of this §289.101 adopted to be effective September 7, 2014, 39 TexReg 6860. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL C TEXAS REGULATIONS FOR CONTROL OF RADIATION §289.101 Memorandum of Understanding Between the Department of State Health Services and the Texas Commission on Environmental Quality Regarding Radiation Control Functions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154625&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154625 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154625&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154625 03/11/2026 (a) Purpose. The purpose of this Memorandum of Understanding (MOU) is to delineate areas of respective jurisdiction and to coordinate the respective responsibilities and duties of the Department of State Health Services (DSHS) and the Railroad Commission of Texas (RRC) in the regulation of sources of radiation in accordance with Health and Safety Code, §401.414, in order to provide a consistent approach and to avoid duplication. Nothing in this MOU shall be construed to reduce the statutory authority of either agency.(b) Definitions. The words and terms used in this section shall have the same meaning as defined in the Health and Safety Code, §401.003, unless the context clearly indicates otherwise. Oil and gas naturally occurring radioactive material (NORM) waste is defined in the Health and Safety Code, §401.003(27), as solid, liquid, or gaseous material or combination of materials, excluding source material, special nuclear material, and by-product material, that:(1) in its natural physical state spontaneously emits radiation;(2) is discarded or unwanted;(3) is not exempt by DSHS rule adopted under Health and Safety Code, §401.106; and(4) constitutes, is contained in, or has contaminated oil and gas waste as that term is defined in the Natural Resources Code, §91.1011.(c) General agency jurisdiction. The jurisdictional authority for each agency is as follows.(1) RRC jurisdiction. In accordance with the Health and Safety Code, §401.415 (relating to Oil and Gas NORM Waste), the RRC has sole authority to:(A) regulate and issue licenses, permits and orders for the disposal of oil and gas NORM waste; and(B) in order to protect public health and safety and the environment, require the owner or operator of oil and gas equipment used in exploration, production, or disposal to determine whether the equipment contains or is contaminated with oil and gas NORM waste and identify any equipment determined to contain or be contaminated with oil and gas NORM.(2) DSHS jurisdiction. The DSHS has jurisdiction to regulate and license the possession, receipt, use, handling, transfer, transport, and storage of all radioactive material in accordance with Health and Safety Code, §401.003(3)(A). The DSHS has sole jurisdiction to regulate and register or license the use or service of electronic products as defined in the Health and Safety Code, §401.003(9). The Health and Safety Code, §401.106, gives the DSHS the authority, through rulemaking by the Executive Commissioner of the Texas Health and Human Services Commission, to exempt a source of radiation or a kind of use or user from licensing or registration requirements.(d) Jurisdiction over specific activities and wastes. Each agency has the following responsibilities.(1) Disposal activities. The RRC has jurisdiction over the disposal of oil and gas NORM waste. For purposes of this MOU, disposal is defined in 16 TAC §4.603(3) (relating to Definitions) as "engaging in the act of discharging, depositing, injecting, dumping, spilling, leaking, or placing of any oil and gas NORM waste into or on any land or water, or causing or allowing any such act, so that such waste, or any constituent thereof, may enter the environment or be emitted into the air or discharged into any waters, including subsurface waters. For purposes of this subchapter, disposal of oil and gas NORM waste includes its management at the site (e.g., lease, unit, or facility) where disposal will occur when undertaken for the explicit purpose of facilitating disposal at that site. The term does not include decontamination activities, except for in-place mixing of oil and gas NORM waste to remedy historical contamination of the land surface and decontamination of equipment and facilities that become contaminated solely through disposal operations. In addition, the term does not include activities, including processing or treatment, that occurs at a location other than the disposal site."(2) Decontamination activities. The DSHS has jurisdiction over decontamination activities, except for in-place mixing of oil and gas NORM waste to remedy historical contamination of the land surface and decontamination of equipment and facilities that become contaminated solely through disposal operations.(3) Transportation activities. The DSHS has jurisdiction over the transportation of oil and gas NORM waste.(4) Radioactive logging tools. The DSHS has jurisdiction over radioactive logging tools used during normal operations by the licensee. The RRC and the DSHS have jurisdiction over radioactive logging tools that are abandoned down hole.(5) Radioactive tracers. The DSHS has jurisdiction over radioactive tracers used in normal operations by the licensee. The RRC has jurisdiction over Class II injection wells into which well logging screen out wastes (well returns) may be disposed in accordance with §289.253(u)(3) of this title (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies).(6) NORM-contaminated equipment. The DSHS has jurisdiction over NORM-contaminated equipment, except as stated in subsection (c)(1) of this section, and with respect to the RRC requirements for identification of equipment contaminated with oil and gas NORM in 16 TAC §4.605 (relating to Identification of Equipment Contaminated with NORM).(7) Recycling/Scrap yards. The RRC has jurisdiction over the disposal of NORM-contaminated scale from oil and gas equipment that is managed at a pipe yard, scrap yard, or recycling facility. However, the decontamination of NORM-contaminated pipe and other equipment at any facility is under the jurisdiction of the DSHS. A DSHS-specific licensee would be required to perform the removal of NORM-contaminated scale on the ground at a pipe yard, scrap yard, or recycling facility in accordance with §289.259(i) of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)). The removed NORM waste would require disposal in accordance with RRC regulations.(e) Coordination of regulatory activities. The DSHS and the RRC shall coordinate with each other in the following activities.(1) The DSHS and the RRC each agree to work together to ensure that complete regulation is maintained for radioactive materials and other sources of radiation associated with oil and gas exploration, development, and production operations. The DSHS and the RRC each agree to coordinate rulemaking activities between the two agencies and the Texas Radiation Advisory Board (TRAB) to ensure consistency of regulation in accordance with the Health and Safety Code, §401.020. In addition, the RRC agrees to coordinate with the DSHS in the preparation of the annual evaluation and report to the Legislative Budget Board as required under the Government Code, §2110.006 and §2110.007. The DSHS and the RRC each agree to seek, and consider, advice from the TRAB on issues that involve management or disposal of NORM waste generated in connection with oil or gas exploration, development, or production operations.(2) The DSHS and the RRC each agree to coordinate rulemaking activities that pertain to the requirements of the agreement between the State of Texas and the United States Nuclear Regulatory Commission, as amended, and to ensure that rules and guidelines are compatible with federal regulatory programs. Each agency agrees to coordinate with the other by providing information on any proposed legislation relating to the regulation of radioactive substances.(3) The DSHS and the RRC each agree to meet as needed to discuss possible changes in this MOU and to encourage increased communication between the agencies.(4) The DSHS and the RRC each agree to coordinate with the other agency with respect to activities involving radioactive sources that are lodged, abandoned, or lost down hole. Prior to approving abandonment procedures, tool recovery, well re-entry, and corrective action when a radioactive source has been breached or radiation otherwise escapes the source, RRC will assure coordination with DSHS to obtain concurrence.(f) Coordination of enforcement and incident response activities. The DSHS has responsibility for enforcement of the conditions of its licenses and rules. The RRC has jurisdiction for enforcement of the conditions of its permits and rules. Each agency will refer to the other agency any complaints received that are the responsibility of the other agency. When deemed appropriate by both agencies, the RRC and the DSHS may jointly enforce permit and license terms and conditions, make joint inspections and incident investigations, and cooperate on enforcement actions. Each agency shall retain the authority to undertake separate enforcement or legal actions.(g) Mutual assistance. The DSHS and the RRC may each request from the other agency short-term assistance of personnel or resources when there is need for such assistance, such as for performing training, environmental or public health or safety monitoring, or technical reviews. Each agency will provide the requested assistance to the extent possible without disrupting its own required activities.(h) Miscellaneous.(1) The RRC and the DSHS agree to revise their respective rules and procedures as needed to implement this MOU.(2) If any provision of this MOU is held to be invalid, the remaining provisions shall not be affected thereby.(i) Effective date. This MOU will take effect after approval by both agencies and 20 days after the date on which it is filed in the office of the secretary of state in accordance with the provisions of Government Code, §2001.036. This MOU will remain in effect until rescinded by either agency. Source Note: The provisions of this §289.102 adopted to be effective January 2, 2012, 36 TexReg 9331. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL C TEXAS REGULATIONS FOR CONTROL OF RADIATION §289.102 Memorandum of Understanding between the Department of State Health Services and the Railroad Commission of Texas Regarding Radiation Control Functions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224007&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224007 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224007&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224007 03/11/2026 (a) Statutory authority. The Radiation Advisory Board (board) is established under Texas Health and Safety Code §401.015 and is subject to Texas Government Code Chapter 2110, concerning State Agency Advisory Committees.(b) Purpose. The board advises the Executive Commissioner, the Texas Department of State Health Services (DSHS), the Railroad Commission of Texas (RRC), the Texas Commission on Environmental Quality (TCEQ), and other state agencies concerning state radiation policies and programs.(c) Tasks. The board:(1) reviews and evaluates state radiation policies and programs;(2) makes recommendations and furnishes technical advice to DSHS, RRC, TCEQ, and other state agencies relating to development, use, and regulation of radiation sources;(3) reviews proposed rules and guidelines of any state agency related to the regulation of sources of radiation and recommends changes in proposed or existing rules and guidelines relating to those matters;(4) develops and implements policies that provide the public with a reasonable opportunity to appear before the board and to speak on any issue under the jurisdiction of the board; and(5) adopts bylaws to guide its operation.(d) Reporting Requirements. By December 31 of each year, the board files an annual written report with the Executive Commissioner covering the meetings and activities in the preceding fiscal year. The report includes:(1) a list of the meeting dates;(2) the members' attendance records;(3) a brief description of actions taken by the board;(4) a description of how the board accomplished its tasks;(5) a description of activities the board anticipates undertaking in the next fiscal year;(6) recommended amendments to this section; and(7) the costs related to the board, including the cost of DSHS staff time spent supporting the board's activities and the source of funds used to support the board's activities.(e) Meetings.(1) Open meetings. The board is not a "governmental body" as defined in the Open Meetings Act. However, to promote public participation, each board meeting is announced and conducted per the Open Meetings Act, Texas Government Code Chapter 551, except provisions allowing executive sessions.(2) Frequency. The board meets quarterly on dates set by the board.(A) A special meeting may be called by the chairperson or at least five members.(B) Meetings are arranged and supported by DSHS staff.(C) Members of the board will be given timely notice of each board meeting.(3) Quorum. A simple majority of all members constitutes a quorum to transact official business. The board is authorized to transact official business only when in a legally constituted meeting with a quorum present.(4) Public comment. The agenda for each board meeting includes an item titled Public Comment, under which any person will be allowed to address the board on matters relating to board business. The chairperson may establish procedures for public comment, including a time limit on each comment.(5) Documentation. A record must be kept of each board meeting.(f) Membership.(1) The board includes 19 members appointed by the Governor:(A) one representative from industry who is trained in nuclear physics, science, or nuclear engineering;(B) one representative from labor;(C) one representative from agriculture;(D) one representative from the insurance industry;(E) one individual who is engaged in the use and application of nuclear physics in medicine and is certified by the American Board of Radiology or licensed by the Texas Medical Board under Chapter 602, Texas Occupations Code;(F) one hospital administrator;(G) one individual licensed by the Texas Medical Board who specializes in nuclear medicine;(H) one individual licensed by the Texas Medical Board who specializes in pathology;(I) one individual licensed by the Texas Medical Board who specializes in radiology;(J) one representative from the nuclear utility industry;(K) one representative from the radioactive waste industry; (L) one representative from the petroleum industry;(M) one health physicist certified by the American Board of Health Physics;(N) one individual licensed by the State Board of Dental Examiners;(O) one representative from the uranium mining industry;(P) one individual licensed by the State Board of Veterinary Medical Examiners; and(Q) three representatives of the public.(2) Members are appointed for staggered terms so the terms of an equal or almost equal number of members will expire at the end of each term. Regardless of the term limit, a member serves until a replacement has been appointed. This ensures sufficient, appropriate representation.(A) If a vacancy occurs, the Governor will appoint an individual to serve the unexpired portion of the term.(B) The term of each member is six years, except the term may be less than six years as necessary to stagger terms. A member may apply to serve one additional term.(C) An individual is not eligible to be appointed as a representative of the public on the advisory board if that individual or individual's spouse is:(i) engaged in an occupation in the health care field; or(ii) employed by, participates in the management of, or has a financial interest, other than as a consumer, in part of the nuclear utility industry or in a business entity or other organization that is licensed under Subchapter F or Subchapter G of this chapter.(g) Officers. The Governor designates a member of the board as the chairperson to serve at the will of the Governor. The board elects from its members a vice-chairperson and secretary.(1) The chairperson serves until the first quarterly meeting of the fiscal year of each even-numbered year. The vice-chairperson serves until the first quarterly meeting of the fiscal year of each odd-numbered year.(2) A member serves no more than two consecutive terms as chairperson or vice-chairperson.(3) The chairperson presides over all board meetings, calls meetings as specified in this section, appoints subcommittees of the board as necessary, and ensures accurate reports are made to the board. The chairperson may serve as an ex-officio member of any subcommittee of the board.(4) The vice-chairperson performs the duties of the chairperson in the event of an absence or the disability of the chairperson. If the position of the chairperson becomes vacant, the vice-chairperson will serve until a successor is appointed to complete the unexpired portion of the chairperson's term.(5) A vacancy in the office of vice-chairperson or secretary is filled at the next board meeting.(h) Attendance. Members must attend board meetings as scheduled. Members must attend and participate in meetings of subcommittees to which the members are assigned.(1) A member must notify the chairperson or appropriate DSHS staff if the member is unable to attend a scheduled meeting.(2) A member may be removed from the board if the member cannot discharge duties for a substantial part of the appointed term because of illness or disability or if absent from more than half of the board meetings during a calendar year without an excuse approved by a majority vote of the board.(3) The validity of a board action is not affected by the fact that it is taken when grounds for removal of a member exist.(i) Procedures. Robert's Rules of Order, Newly Revised, is the basis of parliamentary decisions except where otherwise provided by law or rule.(1) Any action taken by the board must be approved by a majority vote of the members present once a quorum is established.(2) Each member may vote once during any call for votes.(3) A member may not authorize another individual to represent the member by proxy.(4) The board makes decisions in discharging duties without discrimination based on any individual's race, creed, sex, religion, national origin, age, physical condition, or economic status.(5) Minutes of each board meeting will be taken by DSHS staff. A summary of the meeting is provided to each board member before the next meeting.(j) Subcommittees. The board may establish subcommittees to assist the board in carrying out its duties.(1) The chairperson may appoint members to serve on subcommittees and to act as subcommittee chairpersons. The chairperson may also appoint nonmembers of the board to serve on subcommittees as the need for additional expertise arises.(2) Subcommittees must meet when called by the subcommittee chairperson or when directed by the board.(3) The subcommittee chairperson makes regular reports to the board at each board meeting or in interim written reports, as needed. The reports include an executive summary or minutes of each subcommittee meeting.(k) Statement by members.(1) The Executive Commissioner, DSHS, and the board are not bound in any way by any statement or action on the part of any member except when a statement or action is in pursuit of specific instructions from the Executive Commissioner, DSHS, or board.(2) The board and its members may participate in legislative activity in the name of the Executive Commissioner or DSHS with approval through the DSHS legislative process. Members may represent the board's decisions, themselves, or other entities in the legislative process.(3) A member must not accept or solicit any benefit that might reasonably influence the member in the discharge of the member's official duties.(4) A member must not disclose confidential information acquired through board membership.(5) A member should not knowingly solicit, accept, or agree to accept any benefit for exercising the member's official powers or duties in favor of another person.(6) A member with a personal or private interest in a matter pending before the board must publicly disclose the fact in a board meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the member has a direct financial interest in the matter but does not include the member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.(l) Reimbursement for expenses. A member may receive reimbursement for the member's expenses incurred for each day the member engages in official board business as specified in Texas Government Code Chapter 2110.(1) Compensatory per diem is not paid to members unless required by law, but members are reimbursed for travel, meals, lodging, and incidental expenses to the extent permitted by the current General Appropriations Act. A member may be reimbursed for their travel to and from meetings if funds are appropriated and available and in accordance with the DSHS Travel Policy.(2) A member who is an employee of a state agency, other than DSHS, may not receive reimbursement for expenses from DSHS if the member is reimbursed by that state agency.(3) A nonmember of the board who is appointed to serve on a subcommittee may not receive reimbursement for expenses from DSHS.(4) Each member to be reimbursed for expenses must submit to staff the member's receipts for expenses and any required official forms within 14 days after each board meeting.(5) Requests for reimbursement of expenses must be made on official state travel vouchers prepared by DSHS staff. Source Note: The provisions of this §289.130 adopted to be effective November 1, 1995, 20 TexReg 7839; amended to be effective August 15, 1999, 24 TexReg 6088; amended to be effective August 28, 2003, 28 TexReg 6875; amended to be effective December 27, 2007, 32 TexReg 9633; amended to be effective February 19, 2025, 50 TexReg 861. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL C TEXAS REGULATIONS FOR CONTROL OF RADIATION §289.130 Radiation Advisory Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221101&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221101 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221101&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221101 03/11/2026 (a) Scope. Except as otherwise specifically provided, this section applies to all persons who receive, possess, use, transfer, or acquire any radioactive material unless the person is subject to regulation by the United States Nuclear Regulatory Commission (NRC). This section does not apply to radioactive material in the possession of federal agencies. State regulation of source material, byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of the agreement between the state and NRC and to Part 150 of NRC regulations (10 Code of Federal Regulations (CFR) Part 150). A person who receives, possesses, uses, owns, transfers, or acquires radioactive material before receiving a license is subject to the requirements of this chapter. (b) Definitions. The following words and terms when used in this chapter have the following meanings unless the context clearly indicates otherwise. (1) Absorbed dose--The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad. (2) Accelerator-produced material--Any material made radioactive by exposing it to the radiation from a particle accelerator. (3) Access control--A system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access. (4) Act--Texas Radiation Control Act, Texas Health and Safety Code (HSC) Chapter 401. (5) Activity--The rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci). (6) Adult--An individual 18 or more years of age. (7) Aggregated--Accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a category 2 quantity of radioactive material. (8) Agreement state--Any state with which NRC has entered into an effective agreement under Section 274 of the Atomic Energy Act of 1954, as amended. (9) Airborne radioactive material--Any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases. (10) Airborne radioactivity area--A room, enclosure, or area in which airborne radioactive materials exist in concentrations: (A) over the derived air concentrations (DACs) specified in Table I, Column 3 of §289.202(ggg)(2)(F) of this subchapter (relating to Standards for Protection Against Radiation from Radioactive Materials); or (B) to such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 derived air concentration-hours (DAC-hours). (11) Approved individual--An individual whom the licensee has determined to be trustworthy and reliable for unescorted access as specified in §289.252(ii)(2)-(8) of this chapter (relating to Licensing of Radioactive Material) and who has completed the training required by §289.252(ii)(10)(C) of this chapter. (12) As low as is reasonably achievable (ALARA)--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of ionizing radiation and licensed sources of radiation in the public interest. (13) Background investigation--The investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability. (14) Background radiation--Radiation from cosmic sources; non-technologically enhanced, naturally occurring radioactive material, including radon, except as a decay product of source or special nuclear material; and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents, such as Chernobyl, contributing to background radiation and not under the control of the licensee. "Background radiation" does not include radiation from sources of radiation regulated by the department. (15) Becquerel (Bq)--The International System of Units (SI) unit of activity. One becquerel is equal to one disintegration or transformation per second (dps or tps). Commonly used multiples of the becquerel are the kBq (kilobecquerel, 103 Bq), MBq (megabecquerel, 106 Bq), GBq (gigabecquerel, 109 Bq), and TBq (terabecquerel, 1012 Bq). 1 Ci = 37 GBq. (16) Bioassay--The determination of kinds, quantities, or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of this chapter, "radiobioassay" is an equivalent term. (17) Brachytherapy--A method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application. (18) Byproduct material--Byproduct material is defined as: (A) any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material; (B) the tailings or wastes produced by or resulting from the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition; (C) any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity;(D) any material that has been made radioactive by use of a particle accelerator; and is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or (E) any discrete source of naturally occurring radioactive material, other than source material, that is extracted or converted after extraction before, on, or after August 8, 2005, for use in a commercial, medical, or research activity and that the United States NRC, in consultation with the Administrator of the United States Environmental Protection Agency (EPA), the United States Secretary of Energy, the United States Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security. (19) Category 1 quantity of radioactive material--A quantity of radioactive material meeting or exceeding the category 1 threshold in §289.252(jj)(9) of this chapter. This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. (20) Category 2 quantity of radioactive material--A quantity of radioactive material meeting or exceeding the category 2 threshold but less than the category 1 threshold in §289.252(jj)(9) of this chapter. This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. (21) Certificate of registration--A form of permission to engage in regulated activities given by the department to an applicant who has met the requirements for registration or mammography system certification set out in the Act and this chapter. (22) Certification of mammography systems (state certification)--A form of permission to engage in regulated activities given by the department to an applicant who has met the requirements for mammography system certification set out in the Act and this chapter. (23) Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation. (24) Commercial--Having financial profit as the primary aim. (25) Committed dose equivalent (HT,50 ) --The dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake. (26) Committed effective dose equivalent (HE,50 )--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = &SgrWT HT,50 ). (27) Consortium--An association of medical use licensees and a Positron Emission Tomography (PET) radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance costs of the PET radionuclide production facility. The PET radionuclide production facility produces radionuclides for production and noncommercial distribution of radioactive drugs among consortium members for medical use and is located at an educational institution or a medical facility. (28) Constraint (dose constraint)--A value above which specified licensee actions are required. (29) Critical group--The group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances. (30) Curie (Ci)--A unit of measurement of radioactivity. One curie (Ci) is the quantity of radioactive material that decays at the rate of 3.7 x 1010 disintegrations per second (dps). Commonly used submultiples of the curie are the millicurie (mCi) and the microcurie (µCi). One mCi = 1 x 10-3 Ci = 3.7 x 107 dps. One µCi = 1 x 10-6 Ci = 3.7 x 104 dps. One nanocurie (nCi) = 1 x 10-9 Ci = 3.7 x 101 dps. One picocurie (pCi) = 1 x 10-12 Ci = 3.7 x 10-2 dps. (31) Decommission--To remove a facility or site safely from service and reduce residual radioactivity to a level that permits the following: (A) release of the property for unrestricted use or termination of license; or (B) release of the property under alternate requirements for license termination. (32) Deep dose equivalent (Hd ), that applies to external whole body exposure--The dose equivalent at a tissue depth of 1 centimeter (cm) (1,000 milligrams per square centimeter (mg/cm2 )). (33) Department--The Department of State Health Services. (34) Depleted uranium--The source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material. (35) Discrete source--A radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities. (36) Distinguishable from background--The detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site, or, in the case of structures or equipment, in similar materials using adequate measurement technology, survey, and statistical techniques. (37) Distribution--The physical conveyance and authorized transfer of commodities from producers to consumers and any intermediate persons involved in that conveyance. (38) Diversion--The unauthorized movement of radioactive material subject to §289.252(ii) of this chapter to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored. (39) Dose--A generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of this chapter, "radiation dose" is an equivalent term. (40) Dose equivalent (HT )--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem. (41) Dose limits--The permissible upper bounds of radiation doses established as specified in this chapter. For purposes of this chapter, "limits" is an equivalent term.(42) Effective dose equivalent (HE )--The sum of the products of the dose equivalent to each organ or tissue (HT ) and the weighting factor (WT ) applicable to each of the body organs or tissues that are irradiated (HE = &SgrWT HT ). (43) Embryo/fetus--The developing human organism from conception until the time of birth. (44) Entrance or access point--Any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed sources of radiation. This includes portals of sufficient size to permit human access, irrespective of their intended use. (45) Escorted access--Accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance, at all times over an individual who is not approved for unescorted access.(46) Exposure--The quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exposure is the coulomb per kilogram (C/kg). The roentgen is the special unit of exposure. For purposes of this chapter, this term is used as a noun.(47) Exposure rate--The exposure per unit of time.(48) External dose--That portion of the dose equivalent received from any source of radiation outside the body.(49) Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the knee. The arm above the elbow and the leg above the knee are considered part of the whole body.(50) Fingerprint orders--The orders issued by the NRC or the legally binding requirements issued by agreement states that require fingerprints and criminal history records checks for individuals with unescorted access to category 1 and category 2 quantities of radioactive material or Safeguards Information-Modified Handling files. (51) Generally applicable environmental radiation standards--Standards issued by the EPA under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material. (52) Gray (Gy)--The SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (J/kg) or 100 rad. (53) High radiation area--An area, accessible to individuals, in which radiation levels from sources of radiation external to the body could result in an individual receiving a dose equivalent more than 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm from any source of radiation or from any surface that the radiation penetrates. (54) Human use--The internal or external administration of radiation or radioactive material to human beings for healing arts purposes or research and development specifically authorized by the department. (55) Individual--Any human being. (56) Individual monitoring--The assessment of: (A) dose equivalent to an individual using individual monitoring devices; or (B) committed effective dose equivalent to an individual by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. (See the definition for DAC-hours in §289.202(c) of this subchapter ); or (C) dose equivalent to an individual using survey data. (57) Individual monitoring device--Device designed to be worn by a single individual (such as a film badge, thermoluminescent dosimeter (TLD), optically stimulated luminescence dosimeter (OSL), or digital output personnel dosimeter) used for the assessment of dose equivalent. For purposes of this chapter, "personnel dosimeter" and "dosimeter" are equivalent terms. (58) Inspection--An official examination or observation, including records, tests, surveys, and monitoring to determine compliance with the Act and rules, orders, requirements, and conditions of the department. (59) Internal dose--That portion of the dose equivalent received from radioactive material taken into the body. (60) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, and other nuclear particles. (61) Land disposal facility--The land, buildings, and equipment that are intended to be used for the disposal of low-level radioactive waste (LLRW) into the subsurface of the land. (62) Lens dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm2 ). (63) License--A form of permission to engage in regulated activities given by the department to an applicant who has met the requirements for licensing set out in the Act and this chapter. (64) Licensed material--Radioactive material received, possessed, used, or transferred under a general or specific license issued by the department. (65) Licensee--Any person who is licensed by the department as specified in the Act and this chapter. (66) Local law enforcement agency (LLEA)--A public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed category 1 or category 2 quantity of radioactive material is used, stored, or transported. (67) Lost or missing radioactive material--Radioactive material whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system. (68) Low-level radioactive waste (LLRW)--Radioactive material that meets the following criteria: (A) LLRW includes: (i) discarded or unwanted radioactive material not exempt by rule adopted under the Texas Radiation Control Act (Act), specifically, HSC, §401.106; (ii) waste, as that term is defined in 10 CFR §61.2; and (iii) radioactive material subject to: (I) concentration limits established in 10 CFR §61.55, or compatible rules adopted by the department or the Texas Commission on Environmental Quality (TCEQ), as applicable; and (II) disposal criteria established in Title 10 of the CFR or established by the department or TCEQ, as applicable. (B) LLRW does not include: (i) high-level radioactive waste as defined by 10 CFR §60.2; (ii) spent nuclear fuel as defined by 10 CFR §72.3; (iii) byproduct material defined in HSC §401.003(3)(B); (iv) naturally occurring radioactive material (NORM) waste that is not oil and gas NORM waste; (v) oil and gas NORM waste; or (vi) transuranics greater than 100 nanocuries per gram. (69) Manufacture--To fabricate or mechanically produce. (70) Member of the public--Any individual, except when that individual is receiving an occupational dose. (71) Minor--An individual less than 18 years of age. (72) Mobile device--A piece of equipment containing licensed radioactive material that either is mounted on a permanent base with wheels or casters, or otherwise equipped for moving while completely assembled and without dismounting; or is a portable device. Mobile devices do not include stationary equipment installed in a fixed location. (73) Monitoring--The measurement of radiation, radioactive material concentrations, surface area activities, or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this chapter, "radiation monitoring" and "radiation protection monitoring" are equivalent terms. (74) Movement control center--An operations center remote from the transport activity that maintains position information on the movement of radioactive material, receives reports of attempted attacks or thefts, provides a means for reporting these and other problems to appropriate agencies, and can request and coordinate appropriate aid. (75) Naturally occurring or accelerator-produced radioactive material (NARM)--Any naturally occurring or accelerator-produced radioactive material except source material or special nuclear material. (76) Natural radioactivity--Radioactivity of naturally occurring nuclides whose location and chemical and physical form have not been altered by man. (77) No-later-than arrival time--The date and time that the shipping licensee and receiving licensee have established as the time at which an investigation will be initiated if the shipment has not arrived at the receiving facility. The no-later-than arrival time may not be more than six hours after the estimated arrival time for shipments of category 2 quantities of radioactive material. (78) NRC--The United States Nuclear Regulatory Commission or its duly authorized representatives. (79) Occupational dose--The dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to sources of radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released as specified in this chapter, from voluntary participation in medical research programs, or as a member of the public. (80) Particle accelerator--Any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and designed to discharge the resultant particulate or other associated radiation at energies usually greater than 1 million electron volts (MeV). (81) Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing, other than NRC, and other than federal government agencies licensed or exempted by NRC. (82) Personnel monitoring equipment (See definition for individual monitoring devices.) (83) Pharmacist--An individual licensed by the Texas State Board of Pharmacy to compound and dispense drugs, prescriptions, and poisons. (84) Physician--An individual licensed by the Texas Medical Board to practice medicine under Texas Occupations Code Chapter 155.(85) Pocket dosimeter--A small ionization detection instrument or electronic personal dosimeter that indicates ionizing radiation exposure directly. An auxiliary charging device may be necessary. (86) Portable device--A piece of equipment containing licensed radioactive material that is designed by the manufacturer to be hand carried during use. (87) Positron emission tomography (PET) radionuclide production facility--A facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides. (88) Principal activities--Activities authorized by the license that are essential to achieving the purposes for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities. (89) Public dose--The dose received by a member of the public from exposure to sources of radiation released by a licensee, or to any other source of radiation under the control of a licensee/registrant. It does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released as specified in this chapter, or from voluntary participation in medical research programs. (90) Quality factor (Q)--The modifying factor listed in subsection (m)(1) and (2) of this section that is used to derive dose equivalent from absorbed dose. (91) Quarter (calendar quarter)--A period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters. (92) Rad--The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01 Gy). (93) Radiation--One or more of the following: (A) gamma and x rays; alpha and beta particles and other atomic or nuclear particles or rays; (B) emission of radiation from any electronic device to such energy density levels as to reasonably cause bodily harm; or (C) sonic, ultrasonic, or infrasonic waves from any electronic device or resulting from the operation of an electronic circuit in an electronic device in the energy range to reasonably cause detectable bodily harm. (94) Radiation area--Any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent more than 0.005 rem (0.05 mSv) in one hour at 30 cm from the source of radiation or from any surface that the radiation penetrates. (95) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation. (96) Radiation safety officer (RSO)--An individual who has the knowledge, authority, and responsibility to apply appropriate radiation protection rules, standards, and practices, who is specifically authorized on a radioactive material license, and who is the primary contact with the department. Specific training and responsibilities for an RSO are listed in §289.252 of this chapter, §289.253 of this chapter (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies), §289.255 of this chapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), and §289.256 of this chapter (relating to Medical and Veterinary Use of Radioactive Material). (97) Radioactive material--Any material (solid, liquid, or gas) that emits radiation spontaneously. (98) Radioactive waste--For purposes of this chapter, this term is equivalent to LLRW. (99) Radioactivity--The disintegration of unstable atomic nuclei with the emission of radiation. (100) Radiobioassay--See definition for bioassay.(101) Registrant--Any person issued a certificate of registration by the department as specified in the Act and this chapter.(102) Regulation--See definition for rule.(103) Regulations of the United States Department of Transportation (DOT)--The federal requirements in 49 CFR Parts 100 - 189. (104) Rem--The special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 sievert (Sv)). (105) Research and development--Research and development is defined as: (A) theoretical analysis, exploration, or experimentation; or (B) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. (106) Residential location--Any area where a structure or structures are located in which people live, and the grounds on which these structures are located, including houses, apartments, condominiums, and garages. (107) Residual radioactivity--The radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made as specified in 10 CFR Part 20. (108) Restricted area--An area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area. (109) Reviewing official--The individual who makes the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the category 1 or category 2 quantities of radioactive materials in the possession of the licensee. (110) Roentgen (R)--The special unit of exposure. One roentgen (R) equals 2.58 x 10-4 C/kg of air. (See definition for exposure.) (111) Rule (as defined in the Texas Government Code Chapter 2001)--Any agency statement of general applicability that implements, interprets, or prescribes law or policy, or describes the procedure or practice requirements of an agency. The term includes the amendment or repeal of a prior rule and does not include a statement regarding only the internal management or organization of a state agency and not affecting private rights or procedures. The word "rule" was formerly referred to as "regulation." (112) Sabotage--The deliberate damage, with malevolent intent, to a category 1 or category 2 quantity of radioactive material, a device that contains a category 1 or category 2 quantity of radioactive material, or the components of the security system protecting those materials. (113) Safe haven--A readily recognizable and readily accessible site at which security is present or from which, in the event of an emergency, the transport crew can notify and wait for local law enforcement authorities. (114) Sealed source--Any radioactive or byproduct material that is encased in a capsule designed to prevent leakage or escape of the material. (115) Security zone--Any temporary or permanent area determined and established by the licensee for the physical protection of category 1 or category 2 quantities of radioactive material. (116) Shallow dose equivalent (Hs ) (that applies to the external exposure of the skin of the whole body or the skin of an extremity)--The dose equivalent at a tissue depth of 0.007 cm (7 mg/cm2 ). (117) SI--The abbreviation for the International System of Units. (118) Sievert--The SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem). (119) Site boundary--That line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee. (120) Source material--Source material is defined as: (A) uranium or thorium, or any combination thereof, in any physical or chemical form; or (B) ores that contain by weight 0.05 percent or more of uranium, thorium, or any combination thereof; and (C) does not include special nuclear material. (121) Source of radiation--Any radioactive material, or any device or equipment emitting or capable of producing radiation. (122) Special form radioactive material--Radioactive material satisfying the following conditions: (A) either a single solid piece or contained in a sealed capsule only opened by destroying the capsule; (B) the piece or capsule has at least one dimension not less than 5 millimeters (mm) (0.2 inch); and (C) satisfies the requirements specified by NRC. A special form encapsulation designed as specified in NRC requirements in effect on June 30, 1983, and constructed before July 1, 1985, may continue to be used. A special form encapsulation designed as specified in NRC requirements in effect on March 31, 1996, and constructed before April 1, 1998, may continue to be used. A special form encapsulation either designed or constructed after April 1, 1998, must meet the requirements of this definition applicable at the time of its design or construction. (123) Special nuclear material--Special nuclear material is defined as: (A) plutonium (Pu), uranium-233 (U-233), uranium enriched in the isotope 233 or in the isotope 235, and any other material that NRC, as specified in the provisions of the Atomic Energy Act of 1954, §51 as amended, determines to be special nuclear material, but does not include source material; or (B) any material artificially enriched by any of the foregoing, but does not include source material. (124) Special nuclear material in quantities not sufficient to form a critical mass--Uranium enriched in the isotope 235 in quantities not exceeding 350 grams (g) of contained uranium-235; uranium-233 in quantities not exceeding 200 g; plutonium in quantities not exceeding 200 g; or any combination of them as specified in the following formula. (A) For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all kinds of special nuclear material in combination must not exceed "1" (i.e., unity). (B) For example, the following quantities in combination would not exceed the limitation and are within the formula. Attached Graphic(125) Special units--The conventional units historically used by licensees, for example, curie (activity), rad (absorbed dose), and rem (dose equivalent). (126) Stationary device--A piece of equipment containing licensed radioactive material that is installed in a fixed location. (127) Survey--An evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such survey includes tests, physical examination of location of materials and equipment, measurements of levels of radiation or concentration of radioactive material present, and evaluation of administrative and engineered controls. (128) Telemetric position monitoring system--A data transfer system that captures information by instrumentation or measuring devices about the location and status of a transport vehicle or package between the departure and destination locations.(129) Temporary job site--A location where licensed or registered sources of radiation are used or stored other than the specific use location or locations listed on a license or certificate of registration. (130) Termination--A release by the department of the obligations and authorizations of the licensee under the terms of the license. It does not relieve a person of duties and responsibilities imposed by law. (131) Test--A method of determining the characteristics or condition of sources of radiation or components thereof. (132) Texas Regulations for Control of Radiation (TRCR)--All sections of 25 Texas Administrative Code (TAC) Chapter 289. (133) Total effective dose equivalent (TEDE)--The sum of the effective dose equivalent for external exposures and the committed effective dose equivalent for internal exposures. (134) Total organ dose equivalent (TODE)--The sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in §289.202(rr)(1)(F) of this chapter. (135) Transport index--The dimensionless number (rounded up to the next tenth) placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is determined as follows: (A) For non-fissile material packages, the number determined by multiplying the maximum radiation level in millisievert per hour (mSv/hr) at 1 meter (m) (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour (mrem/hr) at 1 m (3.3 feet).(B) For fissile material packages, the number determined by multiplying the maximum radiation level in mSv/hr at 1 m (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in mrem/hr at 1 m (3.3 feet)), or, for criticality control purposes, the number obtained as described in 10 CFR §71.59, whichever is larger. (136) Trustworthiness and reliability--Characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to category 1 or category 2 quantities of radioactive material by that individual does not constitute an unreasonable risk to the public health and safety or security. A determination of trustworthiness and reliability for this purpose is based upon the results from a background investigation. (137) Type A quantity--A quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material or A2 for normal form radioactive material, where A1 and A2 are given in §289.257(ee) of this chapter (relating to Packaging and Transportation of Radioactive Material) or may be determined by procedures described in §289.257(ee) of this chapter. (138) Type B quantity--A quantity of radioactive material greater than a type A quantity. (139) Unescorted access--Solitary access to an aggregated category 1 or category 2 quantity of radioactive material or the devices that contain the material. (140) Unrefined and unprocessed ore--Ore in its natural form before any processing, such as grinding, roasting or beneficiating, or refining. Processing does not include sieving or encapsulation of ore or preparation of samples for laboratory analysis. (141) Unrestricted area (uncontrolled area)--An area, or access to, which is neither limited nor controlled by the licensee. For purposes of this chapter, "uncontrolled area" is an equivalent term. (142) Very high radiation area--An area, accessible to individuals, in which radiation levels from sources of radiation external to the body could result in an individual receiving an absorbed dose more than 500 rads (5 Gy in one hour at 1 m) from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, Sv, and rem. (143) Veterinarian--An individual licensed by the Texas State Board of Veterinary Medical Examiners to practice veterinary medicine under Texas Occupations Code Chapter 801. (144) Waste--Low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (18)(B) - (E) of this subsection. (145) Week--Seven consecutive days starting on Sunday. (146) Whole body--For purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee. (147) Worker--An individual engaged in work under a license or certificate of registration issued by the department and controlled by a licensee or registrant but does not include the licensee or registrant. (148) Working level (WL)--Any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy. The short-lived radon daughters are--for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212. (149) Working level month (WLM)--An exposure to one working level for 170 hours--2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month. (150) Year--The period of time beginning in January used to determine compliance with the provisions of this chapter. The licensee may change the starting date of the year used to determine compliance by the licensee if the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years. (c) Exemptions. (1) General provision. The department may, upon application or its own initiative, exempt a source of radiation or a kind of use or user from the requirements of this chapter if the department determines that the exemption is not prohibited by law and will not result in a significant risk to public health and safety, and the environment. In determining such exemptions, the department considers: (A) state of technology; (B) economic considerations in relation to benefits to the public health and safety; and (C) other societal, socioeconomic, or public health and safety considerations. (2) United States Department of Energy (DOE) contractors and NRC contractors. Any DOE contractor or subcontractor and any NRC contractor or subcontractor of the following categories, operating within Texas, is exempt from this chapter, except §289.204 of this subchapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), to the extent that such contractor or subcontractor under that individual's contract, receives, possesses, uses, transfers, or acquires sources of radiation: (A) prime contractors performing work for DOE at United States government-owned or controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation; (B) prime contractors of DOE performing research in, or development, manufacture, storage, testing, or transportation of atomic weapons or components of atomic weapons; (C) prime contractors of DOE using or operating nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel; and (D) any other prime contractor or subcontractor of DOE or of NRC when Texas and NRC jointly determine that: (i) the exemption of the prime contractor or subcontractor is authorized by law; and (ii) as specified in the terms of the contract or subcontract, there is adequate assurance that the work can be accomplished without undue risk to the public health and safety and the environment. (d) Records. (1) Each licensee must maintain records showing the receipt, transfer, and disposal of all non-exempt sources of radiation. (A) Records of receipt, transfer, and disposal of sources of radiation must include, as a minimum: (i) a unique identification of each source of radiation, including: (I) manufacturer's name; (II) isotope; (III) activity; and (IV) if available, sealed source serial number; (ii) the date of receipt, transfer, or disposal of each source of radiation; (iii) for the licensee transferring the source of radiation, the name of the transferee, the number of the transferee's radioactive material license authorizing possession of the material, and the regulatory agency issuing the license to the transferee; and (iv) for the licensee receiving the source of radiation, the name of the transferor, the number of the transferor's radioactive material license authorizing possession of the material, and the regulatory agency issuing the license to the transferor. (B) Records of receipt and transfer of radioactive material must be retained by the licensee until disposal of the records is authorized by the department. Records of radioactive material disposal must be retained by the licensee until termination of the license.(2) Additional record requirements and retention periods are specified elsewhere in this chapter. (3) All records required by this chapter must be accurate and factual. (4) Records are only valid if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated. (5) Each record required by this chapter must include all pertinent information and be stored in a legible and reproducible format throughout the retention period specified by the department. The licensee must maintain adequate safeguards against tampering with and loss of records. (e) Inspections. (1) The department may enter public or private property at reasonable times to determine whether, in a matter under the department's jurisdiction, there is compliance with the Act, the department's rules, license conditions, and orders issued by the department. (2) Each licensee must afford the department, at all reasonable times, opportunity to inspect sources of radiation and the premises and facilities where sources of radiation are used or stored. (3) Each licensee must make available to the department for inspection, upon reasonable notice, records maintained as specified in this chapter. (f) Tests. (1) Each licensee must perform, upon instructions from the department, or must permit the department to perform, reasonable tests the department deems appropriate or necessary, including tests of: (A) sources of radiation; (B) facilities where sources of radiation are used or stored; (C) radiation detection and monitoring instruments; and (D) other equipment and devices used in connection with utilization or storage of licensed sources of radiation. (2) Each licensee is required to accept from the department, samples collected from its facility or from areas that are radioactive resulting from its licensed activities. (g) Tests for leakage or contamination of sealed sources. (1) The licensee possessing any sealed source must assure that: (A) each sealed source, except as specified in paragraph (2) of this subsection and §289.253(j) of this chapter, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee has a certificate from the transferor indicating that the sealed source was tested within six months before transfer to the licensee; (B) each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed six months or at alternative intervals approved by the department, the NRC, or any agreement state after evaluation of information specified in §289.252(v) of this chapter or equivalent regulations of the NRC or any agreement state; (C) each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed three months or at alternative intervals approved by the department, the NRC, or any agreement state after evaluation of information specified in §289.252(v) of this chapter, or equivalent regulations of the NRC, or any agreement state; (D) for each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the sealed source is tested for leakage or contamination before further use; (E) tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, are capable of detecting the presence of 0.005 µCi (185 Bq) of radioactive material on a test sample. Test samples must be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted and at the nearest accessible point to the sealed source where contamination might accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the "off" position; (F) the test for leakage for brachytherapy sources manufactured to contain radium are capable of detecting an absolute leakage rate of 0.001 µCi (37 Bq) of radon-222 in a 24-hour period when the collection efficiency for radon-222 and its daughters has been determined with respect to collection method, volume, and time; (G) tests for contamination from radium daughters are taken on the interior surface of brachytherapy source storage containers and are capable of detecting the presence of 0.005 µCi (185 Bq) of a radium daughter that has a half-life greater than four days; and (H) tests for leakage or contamination are performed using a leak test kit or method approved by the department, the NRC, or any agreement state. (2) A licensee need not perform tests for leakage or contamination on the following: (A) sealed sources containing only radioactive material with a half-life of less than 30 days; (B) sealed sources containing only radioactive material as a gas; (C) sealed sources containing 100 µCi (3.7 MBq) or less of beta or gamma-emitting material or 10 µCi (370 kBq) or less of alpha or neutron-emitting material; (D) sealed sources containing only hydrogen-3 (tritium); (E) seeds of iridium-192 encased in nylon ribbon; and (F) sealed sources, except teletherapy and brachytherapy sources, that are stored, not being used, and identified as in storage. However, the licensee must test each sealed source for leakage or contamination and receive the test results before any use or transfer, unless it has been tested for leakage or contamination in the six months before the date of use or transfer. (3) Analysis of tests for leakage or contamination from sealed sources must be performed by persons specifically authorized by the department, the NRC, or any agreement state to perform such services. (4) Test results must be kept in units of microcurie or becquerel and maintained for inspection by the department. (5) The following is considered evidence that a sealed source is leaking: (A) the presence of 0.005 µCi (185 Bq) or more of removable contamination on any test sample; (B) leakage of 0.001 µCi (37 Bq) of radon-222 per 24 hours for brachytherapy sources manufactured to contain radium; or (C) the presence of removable contamination resulting from the decay of 0.005 µCi (185 Bq) or more of radium. (6) The licensee must immediately withdraw a leaking sealed source from use and must take action to prevent the spread of contamination. Within two years of the determination that a sealed source is leaking, the leaking sealed source must be repaired or transferred for disposal as specified in §289.202 of this subchapter. The licensee must check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of as specified in §289.202 of this subchapter. (7) Reports of test results for leaking or contaminated sealed sources must be made as specified in §289.202(bbb) of this subchapter. (h) Additional requirements. The department may, by rule, order, or condition of license or general license acknowledgment, impose upon any licensee such requirements in addition to those established in this chapter as it deems appropriate or necessary to minimize danger to public health and safety or property or the environment. (i) Violations. An injunction or other court order may be obtained prohibiting any violation of any provision of the Act or any rule or order issued thereunder. Any person who willfully violates any provision of the Act or any rule or order issued thereunder may be guilty of a misdemeanor and upon conviction, may be punished by fine or imprisonment or both, as provided by law. (j) Impounding. Sources of radiation are subject to impounding as specified in §401.068 of the Act and §289.205 of this subchapter (relating to Hearing and Enforcement Procedures). (k) Communications. (1) Except where otherwise specified, all communications and reports concerning this chapter and applications filed under them should be addressed to Radiation Control, Department of State Health Services, P.O. Box 149347, Austin, Texas, 78714-9347. Communications, reports, and applications may be delivered in person to the department's office located at 1100 West 49th Street, Austin, Texas. (2) Documents transmitted to the department will be deemed submitted on the date of the postmark or other electronic media transmission. (l) Interpretations. Except as specifically authorized by the department in writing, no interpretation of the meaning of this chapter by any officer or employee of the department other than a written interpretation by the Office of General Counsel, Department of State Health Services, will be considered binding upon the department. (m) Mean quality factors and absorbed dose equivalencies. (1) As used in this chapter, the quality factors for converting absorbed dose to dose equivalent are shown in the following table: Attached Graphic(2) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in paragraph (1) of this subsection, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of this section, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value from the following table to convert a measured tissue dose in rad (gray) to dose equivalent in rem (Sv). Attached Graphic(n) Units of activity. For purposes of this chapter, activity is expressed in the special unit of curie (Ci), becquerel (Bq), or its multiples, or disintegrations or transformations per second (dps or tps). (1) 1 Ci = 3.7 x 1010 dps or tps = 3.7 x 1010 Bq = 2.22 x 1012 disintegrations or transformations per minute (dpm or tpm). (2) 1 Bq = 1 dps or tps. Source Note: The provisions of this §289.201 adopted to be effective October 1, 1995, 20 TexReg 6454; amended to be effective May 20, 1996, 21 TexReg 4051; amended to be effective March 1, 1998, 23 TexReg 1045; amended to be effective October 1, 2000, 25 TexReg 4825; amended to be effective April 29, 2003, 28 TexReg 3498; amended to be effective February 22, 2009, 34 TexReg 1065; amended to be effective February 18, 2010, 35 TexReg 1223; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective March 1, 2016, 41 TexReg 1444; amended to be effective October 23, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL D GENERAL §289.201 General Provisions for Radioactive Material https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221102&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221102 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221102&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221102 03/11/2026 (a) Purpose. (1) This section establishes standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the department. (2) The requirements in this section are designed to control the receipt, possession, use, and transfer of sources of radiation by any licensee so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this section. However, nothing in this section may be construed as limiting actions that are necessary to protect health and safety in an emergency. (b) Scope. (1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer sources of radiation, unless otherwise exempted. No person may use, manufacture, produce, transport, transfer, receive, acquire, own, possess, process, or dispose of sources of radiation unless that person has a license or exemption from the department. The dose limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released as specified in this chapter, or to voluntary participation in medical research programs. No radiation may be deliberately applied to human beings except by or under the supervision of an individual authorized by and licensed as specified in Texas' statutes to engage in the healing arts. (2) Licensees who are also registered by the department to receive, possess, use, and transfer radiation machines must also comply with the requirements of §289.231 of this chapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (c) Definitions. The following words and terms when used in this section have the following meaning unless the context clearly indicates otherwise. (1) Air-purifying respirator--A respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element. (2) Annual limit on intake (ALI)--The derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by Reference Man that would result in a committed effective dose equivalent of 5 rem (0.05 sievert (Sv)) or a committed dose equivalent of 50 rem (0.5 Sv) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Columns 1 and 2 of Table I of subsection (ggg)(2) of this section. (3) Assigned protection factor (APF)--The expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF. (4) Atmosphere-supplying respirator--A respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units. (5) Class--A classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which apply to a range of clearance half-times: for Class D, Days, of less than 10 days; for Class W, Weeks, from 10 to 100 days, and for Class Y, Years, of greater than 100 days. For purposes of this section, lung class and inhalation class are equivalent terms. (6) Debris--The remains of something destroyed, disintegrated, or decayed. Debris does not include soils, sludges, liquids, gases, naturally occurring radioactive material regulated as specified in §289.259 of this chapter (relating to Licensing of Naturally Occurring Radioactive Material (NORM)), or low-level radioactive waste (LLRW) received from other persons. (7) Declared pregnant woman--A woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman voluntarily withdraws the declaration in writing or is no longer pregnant. (8) Demand respirator--An atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation. (9) Derived air concentration (DAC)--The concentration of a given radionuclide in air that, if breathed by Reference Man for a working year of 2,000 hours under conditions of light work, results in an intake of 1 ALI. For purposes of this section, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in Column 3 of Table I of subsection (ggg)(2) of this section. (10) Derived air concentration-hour (DAC-hour)--The product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to represent ALI, equivalent to a committed effective dose equivalent of 5 rem (0.05 Sv). (11) Disposable respirator--A respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus. (12) Dosimetry processor--A person that processes and evaluates personnel monitoring devices to determine the radiation dose delivered to the monitoring devices. (13) Filtering facepiece (dust mask)--A negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps. (14) Fit factor--A quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn. (15) Fit test--The use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual. (16) Helmet--A rigid respiratory inlet covering that also provides head protection against impact and penetration. (17) Hood--A respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso. (18) Inhalation class (see definition for Class). (19) Loose-fitting facepiece--A respiratory inlet covering that is designed to form a partial seal with the face. (20) Lung class (see definition for Class). (21) Nationally tracked source--A sealed source containing a quantity equal to or greater than category 1 or category 2 levels of any radioactive material listed in subsection (hhh)(2) of this section. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form, and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the category 2 threshold but less than the category 1 threshold. (22) Negative pressure respirator (tight fitting)--A respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator. (23) Non-stochastic effect--A health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a non-stochastic effect. For purposes of this section, deterministic effect is an equivalent term. (24) Planned special exposure--An infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits. (25) Positive pressure respirator--A respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator. (26) Powered air-purifying respirator--An air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering. (27) Pressure demand respirator--A positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation. (28) Qualitative fit test--A pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent. (29) Quantitative fit test--An assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator. (30) Quarter--A period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters. (31) Reference man--A hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health employees to standardize results of experiments and to relate biological insult to a common base. A description of Reference Man is contained in the International Commission on Radiological Protection Report, ICRP Publication 23, "Report of the Task Group on Reference Man." (32) Respiratory protective equipment--An apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials. (33) Sanitary sewerage--A system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant. (34) Self-contained breathing apparatus--An atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user. (35) Stochastic effect--A health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of this section probabilistic effect is an equivalent term. (36) Supplied-air respirator or airline respirator--An atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user. (37) Tight-fitting facepiece--A respiratory inlet covering that forms a complete seal with the face. (38) User seal check (fit check)--An action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check. (39) Weighting factor wT for an organ or tissue (T)--The proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of wT are: Attached Graphic(d) Implementation. (1) Any existing license condition that is more restrictive than this section remains in force until there is an amendment or renewal of the license that modifies or removes this condition. (2) If a license condition exempts a licensee from a provision of this section in effect on or before January 1, 1994, it also exempts the licensee from the corresponding provision of this section. (3) If a license condition cites provisions of this section in effect before January 1, 1994, that do not correspond to any provisions of this section, the license condition remains in force until there is an amendment or renewal of the license that modifies or removes this condition. (e) Radiation protection programs. (1) Each licensee must develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of this section. See subsection (mm) of this section for recordkeeping requirements relating to these programs. Documentation of the radiation protection program may be incorporated in the licensee's operating, safety, and emergency procedures. (2) The licensee must use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable (ALARA). (3) The licensee must, at intervals not to exceed 12 months, ensure the radiation protection program content and implementation is reviewed. The review must include a reevaluation of the assessments made to determine monitoring is not required, as specified in subsection (q)(1) and (3) of this section in conjunction with the licensee's current operating conditions. (4) To implement the ALARA requirement in paragraph (2) of this subsection and notwithstanding the requirements in subsection (n) of this section, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its daughters, must be established by licensees such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent (TEDE) more than 10 millirem (mrem) (0.1 millisievert (mSv)) per year, from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee must report the exceedance as required in subsection (yy) of this section and promptly take appropriate corrective action to ensure against recurrence. (5) If monitoring is not required as specified in subsection (q)(1) and (3) of this section, the licensee must document assessments made to determine the requirements of subsection (q)(1) and (3) of this section are not applicable. The licensee must maintain the documentation as specified in subsection (rr)(5) of this section. (f) Occupational dose limits for adults. (1) The licensee must control the occupational dose to individuals, except for planned special exposures as specified in subsection (k) of this section, to the following dose limits. (A) An annual limit that is the lesser of: (i) the total effective dose equivalent being equal to 5 rem (0.05 Sv); or (ii) the sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue, other than the lens of the eye, being equal to 50 rem (0.5 Sv). (B) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities are: (i) a lens dose equivalent of 15 rem (0.15 Sv); and (ii) a shallow dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity. (2) Doses received over the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See subsection (k)(6)(A) and (B) of this section. (3) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the department. The assigned deep dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent must be the dose averaged over the contiguous 10 square centimeters (cm2 ) of skin receiving the highest exposure. (4) The deep dose equivalent, lens dose equivalent, and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable. (5) DAC and ALI values are specified in Table I of subsection (ggg)(2) of this section and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See subsection (rr) of this section. (6) Notwithstanding the annual dose limits, the licensee must limit the soluble uranium intake by an individual to 10 milligrams (mg) in a week, in consideration of chemical toxicity. See footnote 3 of subsection (ggg)(2) of this section. (7) The licensee must reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person. See subsection (j)(4) of this section. (g) Compliance with requirements for summation of external and internal doses. (1) If the licensee is required to monitor as specified in subsection (q)(1) and (3) of this section, the licensee must demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only as specified in subsection (q)(1) of this section or only as specified in subsection (q)(3) of this section, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses as specified in paragraphs (2) - (4) of this subsection. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits. (2) If the only intake of radionuclides is by inhalation, the TEDE limit is not exceeded if the sum of the deep dose equivalent divided by the TEDE limit, and one of the following, does not exceed unity: (A) the sum of the fractions of the inhalation ALI for each radionuclide; or (B) the total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000; or (C) the sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, wT , and the committed dose equivalent, HT,50 , per unit intake is greater than 10 percent of the maximum weighted value of HT,50 , that is, wT HT,50 , per unit intake for any organ or tissue. (3) If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee must account for this intake and include it in demonstrating compliance with the limits. (4) The licensee must evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated or accounted for as specified in this paragraph. (h) Determination of external dose from airborne radioactive material. (1) Licensees must, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, eye dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See footnotes 1 and 2 of subsection (ggg)(2) of this section. (2) Airborne radioactivity measurements and DAC values should not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based on measurements using instruments or individual monitoring devices. (i) Determination of internal exposure. (1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee must, when required as specified in subsection (q) of this section, take suitable and timely measurements of: (A) concentrations of radioactive materials in air in work areas; (B) quantities of radionuclides in the body; (C) quantities of radionuclides excreted from the body; or (D) combinations of these measurements. (2) Unless respiratory protective equipment is used, as provided in subsection (x) of this section, or the assessment of intake is based on bioassays, the licensee must assume that an individual inhales radioactive material at the airborne concentration in which the individual is present. (3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may: (A) use that information to calculate the committed effective dose equivalent, and, if used, the licensee must document that information in the individual's record; (B) upon prior approval from the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and (C) separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See subsection (ggg)(2) of this section. (4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (1)(A) or (B) of this subsection, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by subsections (xx) or (yy) of this section. This delay permits the licensee to make additional measurements basic to the assessments. (5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours must be either: (A) the sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from subsection (ggg)(2) of this section for each radionuclide in the mixture; or (B) the ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture. (6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is unknown, the DAC for the mixture must be the most restrictive DAC of any radionuclide in the mixture. (7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if: (A) the licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in subsection (f) of this section and in complying with the monitoring requirements in subsection (q)(3) of this section; (B) the concentration of any radionuclide disregarded is less than 10 percent of its DAC; and (C) the sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent. (8) When determining the committed effective dose equivalent, the following information may be considered. (A) To calculate the committed effective dose equivalent, the licensee may assume that the inhalation of 1 ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 5 rem (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent. (B) For an ALI and the associated DAC determined by the non-stochastic organ dose limit of 50 rem (0.5 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rem (0.05 Sv), that is, the stochastic ALI, is listed in parentheses in Table I of subsection (ggg)(2) of this section. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee must demonstrate that the limit in subsection (f)(1)(A)(ii) of this section is met. (j) Determination of occupational dose for the current year. (1) For each individual who is likely to receive, in a year, an occupational dose requiring monitoring as specified in subsection (q) of this section, the licensee must determine the occupational radiation dose received during the current year. (2) In complying with the requirements of paragraph (1) of this subsection, a licensee may: (A) accept, as a record of the occupational dose that the individual received during the current year, RC Form 202-2 from previous or other current employers, or other clear and legible records, of all information required on that form and indicating any periods of time for which data are not available; or (B) accept, as a record of the occupational dose that the individual received during the current year, a written, signed statement from the individual, or from the individual's previous or other current employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; or (C) obtain reports of the individual's dose equivalent from previous or other current employers for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee, by telephone, letter, or other electronic media transmission. The licensee must request a written verification of the dose data if the authenticity of the transmitted report cannot be established. (3) The licensee must record the exposure data for the current year, as required by paragraph (1) of this subsection, on RC Form 202-3, or other clear and legible record, of all the information required on that form. (4) If the licensee is unable to obtain a complete record of an individual's current occupational dose while employed by any other licensee, the licensee must assume in establishing administrative controls as specified in subsection (f)(7) of this section for the current year, the allowable dose limit for the individual is reduced by 1.25 rem (12.5 mSv) for each quarter; or 416 mrem (4.16 mSv) for each month for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure. (5) If an individual has incomplete (e.g., a lost or damaged personnel monitoring device) current occupational dose data for the current year and that individual is employed solely by the licensee during the current year, the licensee must: (A) assume the allowable dose limit for the individual is reduced by 1.25 rem (12.5 mSv) for each quarter; (B) assume the allowable dose limit for the individual is reduced by 416 mrem (4.16 mSv) for each month; or (C) assess an occupational dose for the individual during the period of missing data using surveys, radiation measurements, or other comparable data for the purpose of demonstrating compliance with the occupational dose limits. (6) Administrative controls established as specified in paragraph (4) of this subsection must be documented and maintained for inspection by the department. Occupational dose assessments made as specified in paragraph (5) of this subsection and records of data used to make the assessment must be maintained for inspection by the department. The licensee must retain the records as specified in subsection (rr) of this section. (k) Planned special exposures. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in subsection (f) of this section, if each of the following conditions is satisfied. (1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the doses estimated to result from the planned special exposure are unavailable or impractical. (2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs. (3) Before a planned special exposure, the licensee ensures that each individual involved is: (A) informed of the purpose of the planned operation; (B) informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and (C) instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present. (4) Before permitting an individual to participate in a planned special exposure, the licensee must determine: (A) the internal and external doses from all previous planned special exposures; (B) all doses over the limits, including doses received during accidents and emergencies, received during the lifetime of the individual; and (C) all lifetime cumulative occupational radiation doses. (5) In complying with the requirements of paragraph (4)(C) of this subsection, a licensee may: (A) accept, as the record of lifetime cumulative radiation dose, an up-to-date RC Form 202-2 or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee; and (B) obtain reports of the individual's dose equivalent from previous employers for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee, by telephone, letter, or other electronic media transmission. The licensee must request a written verification of the dose data if the authenticity of the transmitted report cannot be established. (6) Subject to subsection (f)(2) of this section, the licensee must not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses over the limits to exceed: (A) the numerical values of any of the dose limits in subsection (f)(1) of this section in any year; and (B) five times the annual dose limits in subsection (f)(1) of this section during the individual's lifetime. (7) The licensee maintains records of the conduct of a planned special exposure as specified in subsection (qq) of this section and submits a written report to the department as specified in subsection (zz) of this section. (8) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days of the date of the planned special exposure. The dose from planned special exposures are not considered in controlling future occupational dose of the individual as specified in subsection (f)(1) of this section but must be included in evaluations required by paragraphs (4) and (6) of this subsection. (9) The licensee must record the exposure history, as required by paragraph (4) of this subsection, on RC Form 202-2, or other clear and legible record, of all the information required on that form. The form or record must show each period in which the individual received occupational exposure to radiation or radioactive material and must be signed by the individual who received the exposure. For each period for which the licensee obtains reports, the licensee must use the dose shown in the report in preparing RC Form 202-2, or equivalent. (l) Occupational dose limits for minors. The annual occupational dose limits for minors are 10 percent of the annual occupational dose limits specified for adult workers in subsection (f) of this section. (m) Dose equivalent to an embryo/fetus. (1) If a woman declares her pregnancy, the licensee must ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure, does not exceed 0.5 rem (5 mSv). If a woman chooses not to declare pregnancy, the occupational dose limits specified in subsection (f)(1) of this section are applicable to the woman. See subsection (rr) of this section for recordkeeping requirements. (2) The licensee must make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman to satisfy the limit in paragraph (1) of this subsection. The National Council on Radiation Protection and Measurements (NCRP) recommended in NCRP Report No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June 1, 1987), that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received in any one month. (3) The dose equivalent to an embryo/fetus is taken as: (A) the dose equivalent to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman; and (B) the dose equivalent that is most representative of the dose equivalent to the embryo/fetus from external radiation, that is, in the mother's lower torso region. (i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman is the dose equivalent to the embryo/fetus. (ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device that is most representative of the dose equivalent to the embryo/fetus is the dose equivalent to the embryo/fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo/fetus is not required unless that dose equivalent is also the most representative deep dose equivalent for the region of the embryo/fetus. (4) If by the time the woman declares pregnancy to the licensee, the dose equivalent to the embryo/fetus has exceeded 0.45 rem (4.5 mSv), the licensee will be deemed compliant with paragraph (1) of this subsection, if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy. (n) Dose limits for individual members of the public. (1) Each licensee must conduct operations and ensure: (A) the TEDE to individual members of the public from the licensed and registered operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contribution from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released as specified in §289.256 of this chapter (relating to Medical and Veterinary Use of Radioactive Material), from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage as specified in subsection (gg) of this section; and (B) the dose in any unrestricted area from licensed and registered external sources, exclusive of the dose contributions from patients administered radioactive material and released as specified in §289.256 of this chapter, does not exceed 0.002 rem (0.02 mSv) in any one hour. (2) If the licensee permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals. (3) A licensee or an applicant for a license may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). This application must include: (A) a demonstration of the need for and the expected duration of operations over the limit in paragraph (1) of this subsection; (B) the licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and (C) the procedures to maintain the dose ALARA. (4) In addition to the requirements of this section, a licensee subject to the provisions of the United States Environmental Protection Agency's (EPA) generally applicable environmental radiation standards in 40 Code of Federal Regulations (CFR) §190, must also comply with those requirements. (5) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents to restrict the collective dose. (6) Notwithstanding paragraph (1)(A) of this subsection, a licensee may permit visitors to an individual who cannot be released, as specified in §289.256 of this chapter, to receive a radiation dose greater than 0.1 rem (1 mSv) if: (A) the radiation dose received does not exceed 0.5 rem (5 mSv); and (B) the authorized user, as defined in §289.256 of this chapter, has determined before the visit that it is appropriate. (o) Compliance with dose limits for individual members of the public. (1) The licensee must make, or cause to be made, surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public as required in subsection (n) of this section. (2) A licensee must show compliance with the annual dose limit in subsection (n) of this section by: (A) demonstrating by measurement or calculation that the TEDE to the individual likely to receive the highest dose from the licensed or registered operation, does not exceed the annual dose limit; or (B) demonstrating that: (i) the annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table II of subsection (ggg)(2) of this section; and (ii) if an individual were continuously present in an unrestricted area, the dose from external sources of radiation would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year. (3) Upon approval from the department, the licensee may adjust the effluent concentration values in Table II, of subsection (ggg)(2) of this section, for members of the public, to consider the actual physical and chemical characteristics of the effluents, such as, aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form. (p) General surveys and monitoring. (1) Each licensee must make, or cause to be made, surveys of areas, including the subsurface that: (A) are necessary for the licensee to comply with this chapter; and (B) are necessary under the circumstances to evaluate: (i) the magnitude and extent of radiation levels; (ii) concentrations or quantities of residual radioactivity; and (iii) the potential radiological hazards of the radiation levels and residual radioactivity detected. (2) In addition to subsection (nn) of this section, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be maintained and retained as specified in §289.252(gg) of this chapter (relating to Licensing of Radioactive Material). (3) The licensee must ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are operable and calibrated: (A) by a person licensed or registered by the department, the United States Nuclear Regulatory Commission (NRC), or any agreement state to perform such service; (B) at intervals not to exceed 12 months unless a different time interval is specified in another section of this chapter; (C) after each instrument or equipment repair; (D) for the types of radiation used and at energies appropriate for use; and (E) at an accuracy within 20 percent of the true radiation level. (4) All individual monitoring devices requiring processing to determine the radiation dose, except for those individual monitoring devices used to measure the dose to any extremity, and that are used by licensees to comply with subsection (f) of this section, with other applicable provisions of this chapter, or with conditions specified in a license, must be processed and evaluated by a dosimetry processor: (A) holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and (B) approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored. (5) All individual monitoring devices must be appropriate for the environment in which they are used. (q) Conditions requiring individual monitoring of external and internal occupational dose. Each licensee must monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this section. As a minimum: (1) each licensee must monitor occupational exposure to radiation and must supply and require the use of individual monitoring devices by: (A) adults likely to receive, in one year from sources of radiation external to the body, a dose more than 10 percent of the limits in subsection (f)(1) of this section; (B) minors likely to receive, in one year from sources of radiation external to the body, a deep dose equivalent more than 0.1 rem (1 mSv), a lens dose equivalent more than 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities more than 0.5 rem (5 mSv); (C) declared pregnant women likely to receive, during the entire pregnancy, from sources of radiation external to the body, a deep dose equivalent more than 0.1 rem (1 mSv); and (D) individuals entering a high or very high radiation area; (2) notwithstanding paragraph (1)(C) of this subsection, a licensee is exempt from supplying individual monitoring devices to healthcare personnel who may enter a high radiation area while providing patient care if: (A) the personnel are not likely to receive, in one year from sources external to the body, a dose more than 10 percent of the limits in subsection (f)(1) of this section; and (B) the licensee complies with the requirements of subsection (e)(2) of this section; and (3) each licensee must monitor, to determine compliance with subsection (i) of this section, the occupational intake of radioactive material by and assess the committed effective dose equivalent to: (A) adults likely to receive, in one year, an intake more than 10 percent of the applicable ALI in Columns 1 and 2 of Table I of subsection (ggg)(2) of this section; (B) minors likely to receive, in one year, a committed effective dose equivalent more than 0.1 rem (1 mSv); and (C) declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent more than 0.1 rem (1 mSv). (r) Location and use of individual monitoring devices. (1) Each licensee must ensure that individuals who are required to monitor occupational doses as specified in subsection (q)(1) of this section wear and use individual monitoring devices as follows. (A) An individual monitoring device used for monitoring the dose to the whole body is worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar). (B) If an additional individual monitoring device is used for monitoring the dose to an embryo/fetus of a declared pregnant woman, as specified in subsection (m)(1) of this section, it is located at the waist under any protective apron being worn by the woman. (C) An individual monitoring device used for monitoring the lens dose equivalent, to demonstrate compliance with subsection (f)(1)(B)(i) of this section, is located at the neck (collar) or at a location closer to the eye, outside any protective apron being worn by the monitored individual. (D) An individual monitoring device used for monitoring the dose to the skin of the extremities, to demonstrate compliance with subsection (f)(1)(B)(ii) of this section, is worn on the skin of the extremity likely to receive the highest exposure. Each individual monitoring device, to the extent practicable, is oriented to measure the highest dose to the skin of the extremity being monitored. (E) An individual monitoring device is assigned to and worn by only one individual. (F) An individual monitoring device that requires processing is worn for the period of time authorized by the dosimetry processor or for no longer than three months, whichever is earlier. (G) All individual monitoring devices are processed or evaluated at least quarterly or promptly after replacement, whichever is more frequent.(2) Each licensee must ensure that individual monitoring devices are returned to the dosimetry processor for proper processing, as applicable. (3) Each licensee must ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device. (s) Control of access to high radiation areas. (1) The licensee must ensure that each entrance or access point to a high radiation area has one or more of the following features: (A) a control device that, upon entry into the area, causes the level of radiation to be reduced below the level at which an individual might receive a deep dose equivalent of 0.1 rem (1 mSv) in one hour at 30 centimeters (cm), from the source of radiation, from any surface that the radiation penetrates; (B) a control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or (C) entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry. (2) In place of the controls required by paragraph (1) of this subsection for a high radiation area, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry. (3) The licensee may apply to the department for approval of alternative methods for controlling access to high radiation areas. (4) The licensee must establish controls required by paragraphs (1) and (3) of this subsection in a way that does not prevent individuals from leaving a high radiation area. (5) The licensee is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled as specified in the regulations of the United States Department of Transportation (DOT) if: (A) the packages do not remain in the area longer than three days; and (B) the dose rate at 1 meter (m) from the external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour. (6) The licensee is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, if there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to sources of radiation over the established limits in this section and who operate within the ALARA provisions of the licensee's radiation protection program. (t) Control of access to very high radiation areas. In addition to the requirements in subsection (s) of this section, the licensee must institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas where radiation levels could be encountered at 500 rads (5 gray (Gy)) or more in one hour at 1 m from a source of radiation or any surface through which the radiation penetrates at this level. (u) Control of access to very high radiation areas for irradiators. (1) This subsection applies to licensees with sources of radiation in non-self-shielded irradiators. This subsection does not apply to sources of radiation that are used in teletherapy, industrial radiography, or completely self-shielded irradiators where the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual. (2) Each area in which there may exist radiation levels more than 500 rads (5 Gy) in one hour at 1 m from a source of radiation that is used to irradiate materials must meet the following requirements. (A) Each entrance or access point is equipped with entry control devices that: (i) function automatically to prevent any individual from inadvertently entering a very high radiation area; (ii) permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent more than 0.1 rem (1 mSv) in one hour; and (iii) prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual more than 0.1 rem (1 mSv) in one hour. (B) Additional control devices are provided so that, upon failure of the entry control devices to function as required by subparagraph (A) of this paragraph: (i) the radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent more than 0.1 rem (1 mSv) in one hour; and (ii) conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices. (C) The licensee provides control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container: (i) the radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent more than 0.1 rem (1 mSv) in one hour; and (ii) conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, is aware of the failure or removal of the physical barrier. (D) When the shield for stored sealed sources is a liquid, the licensee provides means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding. (E) Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances, are not required to comply with subparagraphs (C) and (D) of this paragraph. (F) Each area is equipped with devices that automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, installed in the area that can prevent the source of radiation from being put into operation. (G) Each area is controlled by use of administrative procedures and devices necessary to ensure that the area is cleared of personnel before each use of the source of radiation. (H) Each area is checked by a radiation measurement to ensure that, before the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent more than 0.1 rem (1 mSv) in one hour. (I) The entry control devices required in subparagraph (A) of this paragraph are tested for proper functioning. See subsection (uu) of this section for recordkeeping requirements. (i) Testing must be conducted before initial operation of the source of radiation on any day unless operations were continued uninterrupted from the previous day. (ii) Testing must be conducted before resumption of operation of the source of radiation after any unintentional interruption. (iii) The licensee must submit and adhere to a schedule for periodic tests of the entry control and warning systems. (J) The licensee does not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly. (K) Entry and exit portals used to transport materials to and from the irradiation area, and not intended for use by individuals, are controlled by such devices and administrative procedures as necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials are equipped to automatically detect and signal the presence of any loose radioactive material that is carried toward such an exit to prevent loose radioactive material from being carried out of the area. (3) Licensees or applicants for licenses for sources of radiation under paragraph (2) of this subsection used in a variety of positions or in locations, such as open fields or forests, making it impracticable to comply with certain requirements of paragraph (2) of this subsection, such as those for the automatic control of radiation levels, may apply to the department for approval of alternative safety measures. Alternative safety measures must provide personnel protection at least equivalent to those specified in paragraph (2) of this subsection. At least one of the alternative measures must include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual enters an area where sources of radiation are used. (4) The entry control devices required by paragraphs (2) and (3) of this subsection must be established so no individual is prevented from leaving the area. (v) Use of process or other engineering controls. The licensee must use, to the extent practicable, process or other engineering controls, such as containment, decontamination, or ventilation, to control the concentrations of radioactive material in air. (w) Use of other controls. (1) When it is not practicable to apply process or other engineering controls to ensure concentrations of radioactive material in air values are below those that define an airborne radioactivity area, the licensee must, consistent with maintaining the TEDE ALARA, increase monitoring and limit intakes by one or more of the following means: (A) control of access; (B) limitation of exposure times; (C) use of respiratory protection equipment; or (D) other controls. (2) If the licensee performs an ALARA analysis to determine whether respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee must consider the impact of respirator use on workers' industrial health and safety. (x) Use of individual respiratory protection equipment. (1) If the licensee uses respiratory protection equipment to limit intakes of radioactive material as specified in subsection (w) of this section, the licensee must:(A) use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH), except as provided in subparagraph (B) of this paragraph. (B) submit an application to the department for authorized use of equipment, including a demonstration by testing, or a demonstration on the basis of test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use, if the licensee wishes to use equipment that has not been tested or certified by the NIOSH, or for which there is no schedule for testing or certification. (C) implement and maintain a respiratory protection program that includes: (i) air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses; (ii) surveys and bioassays, as appropriate, to evaluate actual intakes; (iii) testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately before each use; (iv) written procedures regarding the following: (I) monitoring, including air sampling and bioassays; (II) supervision and training of respirator users; (III) fit testing; (IV) respirator selection; (V) breathing air quality; (VI) inventory and control; (VII) storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment; (VIII) recordkeeping; and (IX) limitations on periods of respirator use and relief from respirator use; (v) determination by a physician before initial fitting of a face-sealing respirator and the first field use of non-face-sealing respirators, and either, every 12 months thereafter or periodically at a frequency determined by a physician, the individual user is medically fit to use the respiratory protection equipment; and (vi) fit testing, with fit factor >10 times the APF for negative pressure devices, and a fit factor >500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one year. Fit testing must be performed with the facepiece operating in the negative pressure mode. (D) advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require relief. (E) use respiratory protection equipment within the equipment manufacturer's expressed limitations for type and mode of use and provide for vision correction, adequate communication, low-temperature work environment, and the concurrent use of other safety or radiological protection equipment. The licensee must use equipment so that it does not interfere with the proper operation of the respirator. (F) ensure standby rescue persons are positioned to render aid whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual may have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons must observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and provide effective emergency rescue, if needed. (G) ensure atmosphere-supplying respirators are supplied with respirable air of grade D quality, or better, as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration (29 CFR §1910.134(i)(1)(ii)(A) - (E)). Grade D quality air criteria include: (i) oxygen content (volume/volume) of 19.5 - 23.5 percent; (ii) hydrocarbon (condensed) content of 5 mg per cubic meter of air or less; (iii) carbon monoxide (CO) content of 10 parts per million (ppm) or less; (iv) carbon dioxide content of 1,000 ppm or less; and (v) lack of noticeable odor. (H) ensure no objects, materials, or substances, such as facial hair, or any conditions interfering with the facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece. (I) when estimating the dose to individuals from intake of airborne radioactive materials, initially assume the concentration of radioactive material in the air, inhaled when respirators are worn, is the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used. (2) The department may impose restrictions in addition to those in paragraph (1) of this subsection, subsection (w) of this section, and subsection (ggg)(1) of this section, to: (A) ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining TEDE ALARA; and (B) limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls. (3) The licensee must obtain authorization from the department before assigning respiratory protection factors exceeding those specified in subsection (ggg)(1) of this section. The department may authorize a licensee to use higher protection factors on receipt of an application that: (A) describes the situation for which a need exists for higher protection factors; and (B) demonstrates that the respiratory protection equipment provides higher protection factors under the proposed conditions of use. (y) Security and control of licensed sources of radiation. (1) The licensee must secure radioactive material from unauthorized removal or access. (2) The licensee must maintain constant surveillance, using devices or administrative procedures to prevent unauthorized access to use of radioactive material in an unrestricted area and not in storage. (3) Each portable gauge licensee must use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee. (4) Utilization records must be maintained for portable and mobile devices containing radioactive material transported from a licensed site temporarily for use by the licensee and then returned to the licensed site of origin. The information required by subparagraphs (A) - (D) of this paragraph must be recorded when a device is removed from the licensed site. The information in subparagraph (E) of this paragraph must be recorded when a device is returned to the licensed site: (A) the manufacturer, model, and serial number of the device; (B) the names of personnel transporting and using the device; (C) the locations where each device is used; (D) the date each device is removed from storage; and (E) the date each device is returned to storage. (5) Utilization records must be maintained at the licensed site where the devices are stored for inspection by the department as specified in subsection (ggg)(5) of this section. (z) Caution signs. (1) Unless otherwise authorized by the department, the standard radiation symbol prescribed must use the colors magenta, or purple, or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows: Attached Graphic(A) the cross-hatched area of the symbol is magenta, or purple, or black; and (B) the background of the symbol is yellow. (2) Notwithstanding the requirements of paragraph (1) of this subsection, licensees are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement. (aa) Posting requirements. (1) The licensee must post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA." (2) The licensee must post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA." (3) The licensee must post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA." If the very high radiation area involves medical treatment of patients, the licensee may omit the word "GRAVE" from the sign or signs. (4) The licensee must post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA." (5) The licensee must post each area or room where there is used or stored amounts of licensed material exceeding 10 times the quantity of such material specified in subsection (ggg)(3) of this section, with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)." (bb) Exceptions to posting requirements. (1) A licensee is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than eight hours, if each of the following conditions are met: (A) the sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation over the limits established in this section; and (B) the area or room is subject to the licensee's control. (2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs as specified in subsection (aa) of this section if the patient could be released from licensee control as specified in this chapter. (3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source if the radiation level at 30 cm from the surface of the sealed source container or housing does not exceed 0.005 rem (0.05 mSv) per hour. (4) Rooms in medical facilities used for teletherapy are exempt from the requirement to post caution signs as specified in subsection (aa) of this section if the following conditions are met. (A) Access to the room is controlled as specified in this chapter; and (B) Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation over the limits established in this section. (cc) Labeling containers. (1) The licensee must ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label must also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures. (2) Each licensee must, before removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials. (dd) Exemptions to labeling requirements. A licensee is not required to label: (1) containers holding licensed material in quantities less than the quantities listed in subsection (ggg)(3) of this section; (2) containers holding licensed material in concentrations less than those specified in Table III of subsection (ggg)(2) of this section; (3) containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals over the limits established by this section; (4) containers when they are in transport and packaged and labeled as specified in the rules of the DOT (labeling of packages containing radioactive materials is required by the DOT if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by DOT regulations 49 CFR §173.403(m) and (w) and §173.424); (5) containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record must be retained while the containers are in use for the purpose indicated on the record; or (6) installed manufacturing or process equipment, such as piping and tanks. (ee) Procedures for receiving and opening packages. (1) Each licensee who expects to receive a package containing quantities of radioactive material more than a Type A quantity, as defined in §289.201(b) of this subchapter (relating to General Provisions for Radioactive Material) and specified in §289.257(ee) of this chapter (relating to Packaging and Transportation of Radioactive Material), must make arrangements to receive: (A) the package when the carrier offers it for delivery; or (B) the notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously. (2) Each licensee must: (A) monitor the external surfaces of a labeled package, labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations 49 CFR §§172.403 and 172.436 - 172.440, for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in §289.201(b) of this subchapter; (B) monitor the external surfaces of a labeled package, labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations 49 CFR §§172.403 and 172.436 - 172.440, for radiation levels, unless the package contains quantities of radioactive material less than or equal to the Type A quantity, as defined in §289.201(b) of this subchapter and specified in §289.257(ee) of this chapter; and (C) monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged. (3) The licensee must perform the monitoring required by paragraph (2) of this subsection as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours. If a package is received after working hours, the package must be monitored no later than three hours from the beginning of the next working day. If the licensee discovers there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged, the package must be surveyed immediately. (4) The licensee must immediately notify the final delivery carrier and, by telephone or other electronic media transmission, the department when removable radioactive surface contamination or external radiation levels exceed the limits established in subparagraphs (A) and (B) of this paragraph. (A) Limits for removable radioactive surface contamination levels. (i) The level of removable radioactive contamination on the external surfaces of each package offered for shipment must be ALARA. The level of removable radioactive contamination may be determined by wiping an area of 300 square centimeters (cm2 ) of the surface concerned with an absorbent material, using moderate pressure, and measuring the activity on the wiping material. Sufficient measurements must be taken in the most appropriate locations to yield a representative assessment of the removable contamination levels. Except as provided in clause (iii) of this subparagraph, the amount of radioactivity measured on any single wiping material, when averaged over the surface wiped must not be more than the limits given in clause (ii) of this subparagraph at any time during transport. If other methods are used, the detection efficiency of the method used must be considered and the removable contamination on the external surfaces of the package must not be more than 10 times the limits listed in clause (ii) of this subparagraph. (ii) Removable external radioactive contamination wipe limits are as follows. Attached Graphic(iii) In the case of packages transported as exclusive use shipments by rail or highway only, the removable radioactive contamination at any time during transport must not exceed 10 times the levels prescribed in clause (ii) of this subparagraph. The levels at the beginning of transport must not exceed the levels in clause (ii) of this subparagraph. (B) Limits for external radiation levels. (i) External radiation levels around the package and around the vehicle, if applicable, must not be more than 200 millirem per hour (mrem/hr) (2 millisieverts per hour (mSv/hr)) at any point on the external surface of the package at any time during transportation. The transport index must not be more than 10. (ii) For a package transported in exclusive use by rail, highway, or water, radiation levels external to the package may exceed the limits specified in clause (i) of this subparagraph but must not be more than any of the following: (I) 200 mrem/hr (2 mSv/hr) on the accessible external surface of the package unless the following conditions are met, in which case the limit is 1,000 mrem/hr (10 mSv/hr): (-a-) the shipment is made in a closed transport vehicle; (-b-) provisions are made to secure the package so that its position within the vehicle remains fixed during transportation; and (-c-) there are no loading or unloading operations between the beginning and end of the transportation; (II) 200 mrem/hr (2 mSv/hr) at any point on the outer surface of the vehicle, including the upper and lower surfaces, or, in the case of a flat-bed style vehicle, with a personnel barrier, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load (or enclosure, if used), and on the lower external surface of the vehicle (a flat-bed style vehicle with a personnel barrier must have radiation levels determined at vertical planes. If no personnel barrier, the package cannot exceed 200 mrem/hr (2 mSv/hr) at the surface.); (III) 10 mrem/hr (0.1 mSv/hr) at any point 2 m from the vertical planes represented by the outer lateral surfaces of the vehicle, or, in the case of a flat-bed style vehicle, at any point 2 m from the vertical planes projected from the outer edges of the vehicle; and (IV) 2 mrem/hr (0.02 mSv/hr) in any normally occupied positions of the vehicle, except that this provision does not apply to private motor carriers when persons occupying these positions are provided with special health supervision, personnel radiation exposure monitoring devices, and training as specified in §289.203(c) of this subchapter (relating to Notices, Instructions, and Reports to Workers; Inspections). (5) Each licensee must: (A) establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and (B) ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened. (6) Licensees transferring special form sources in vehicles owned or operated by the licensee to and from a work site are exempt from the contamination monitoring requirements of paragraph (2) of this subsection, but are not exempt from the monitoring requirement in paragraph (2) of this subsection for measuring radiation levels ensuring the source is still properly lodged in its shield. (ff) General requirements for waste management. (1) Unless otherwise exempted, a licensee may discharge, treat, or decay licensed material or transfer waste for disposal only: (A) by transfer to an authorized recipient as provided in subsection (jj) of this section, §289.252 of this chapter, §289.257 of this chapter, §289.259 of this chapter, or to the United States Department of Energy (DOE); (B) by decay in storage with prior approval from the department, except as authorized in §289.256(ee) of this chapter; (C) by release in effluents within the limits in subsection (n) of this section as specified in the applicable requirements of the Texas Commission on Environmental Quality (TCEQ) or the Railroad Commission of Texas; (D) as authorized in paragraph (2) of this subsection, and subsections (gg), (hh), and (fff) of this section; (E) by transfer of residual radiopharmaceutical waste for decay in storage only to persons who manufactured, compounded, and supplied the radiopharmaceutical and who otherwise meet the requirements for exemption under 30 Texas Administrative Code (TAC) §336.1209 (relating to Exemptions); or (F) by procedures reviewed and authorized by the department following approval of an application that includes: (i) a description of the waste-containing licensed material to be disposed, including the physical and chemical properties important to risk evaluation, and the proposed manner and conditions of waste disposal;(ii) an analysis and evaluation of pertinent information on the nature of the environment;(iii) the nature and location of other potentially affected licensed and unlicensed facilities; and (iv) analyses and procedures to ensure doses are maintained ALARA and within the dose limits in this chapter. (2) Upon approval from the department, emission control dust and other material from electric arc furnaces or foundries contaminated because of inadvertent melting of cesium-137 or americium-241 sources may be transferred for disposal to a hazardous waste disposal facility authorized by TCEQ or its successor, another state's regulatory agency with jurisdiction to regulate hazardous waste as classified under Subtitle C of the Resource Conservation and Recovery Act (RCRA), or the EPA. The material may be transferred for disposal without regard to its radioactivity if the following conditions are met. (A) Contaminated material described in paragraph (2) of this subsection, whether packaged or unpackaged (i.e., bulk), must be treated through stabilization to comply with all waste treatment requirements of the appropriate state or federal regulatory agency as listed in this paragraph. The treatment operations must be undertaken by either of the following: (i) the owner/operator of the electric arc furnace or foundry licensed to possess, treat, or transfer cesium-137 or americium-241 contaminated incident-related material; or (ii) a service contractor licensed by the department, NRC, or an agreement state to possess, treat, or transfer cesium-137 or americium-241 contaminated incident-related material. (B) The emission control dust and other incident-related materials have been stored (if applicable) and transferred as specified in operating and emergency procedures approved by the department. (C) The total cesium-137 or americium-241 activity contained in emission control dust and other incident-related materials to be transferred to a hazardous waste disposal facility has been specifically approved by NRC or the appropriate agreement state or states and does not exceed the total activity associated with the inadvertent melting incident. (D) The hazardous waste disposal facility operator is notified, in writing, of the impending transfer of the incident-related materials and has agreed, in writing, to receive and dispose of the packaged or unpackaged materials. Copies of the notification and agreement must be submitted to the department. (E) The licensee, as listed in subparagraph (A)(i) or (ii) of this paragraph, notifies the NRC or agreement state or states where the transferor and transferee are located, in writing, of the impending transfer, at least 30 days before the transfer. (F) The packaged stabilized material has been packaged for transportation and disposal in non-bulk steel packaging as defined in DOT regulations at 49 CFR §173.213. (G) The emission control dust and other incident-related materials that have been stabilized and packaged as described in subparagraph (F) of this paragraph contain pretreatment average concentrations of cesium-137 that do not exceed 130 picocuries per gram (pCi/g) of material, above background, or pretreatment average concentrations of americium-241 that do not exceed 3 pCi/g of material, above background. (H) The dose rate at 3.28 feet (1 m) from the surface of any package containing stabilized waste does not exceed 20 microrem (µrem) per hour or 0.20 microsieverts (µSv) per hour, above background. (I) The unpackaged stabilized material contains pretreatment average concentrations of cesium-137 that do not exceed 100 pCi/g of material, above background, or pretreatment average concentrations of americium-241 that do not exceed 3 pCi/g of material, above background. (J) The licensee transferring the cesium-137 or americium-241 contaminated incident-related material must consult with the department, TCEQ or its successor, another state's regulatory agency with jurisdiction to regulate hazardous waste as classified under RCRA, or the EPA and other authorized parties, including state and local governments, and obtain all necessary approvals, in addition to those of the NRC or any agreement state, for the transfers described in paragraph (2) of this subsection. (K) Nothing in this subsection is intended to be construed as a waiver of any RCRA permit condition or term, of any state or local statute or regulation, or of any RCRA regulation. (L) The total incident-related cesium-137 activity described in paragraph (2) of this subsection received by a facility over its operating life, is not more than 1 curie (Ci) (37 gigabequerels (GBq)). The total incident-related americium-241 activity described in paragraph (2) of this subsection received by a facility over its operating life, is not more than 30 millicuries (mCi) (1.11 GBq). The department maintains a record of the total incident-related cesium-137 or americium-241 activity shipped by a person licensed by the department. Upon consultation with TCEQ, the department determines if the total incident-related activity received by a hazardous waste disposal facility over its operating life has reached 1 Ci (37 GBq) of cesium-137 or 30 mCi (1.11 GBq) of americium-241. The department does not approve shipments of cesium-137 or americium-241 contaminated incident-related material that will cause this limit to be exceeded. (3) Radioactive waste exempted by TCEQ for disposal in a hazardous waste disposal facility holding a TCEQ permit issued under Subtitle C of the RCRA may be transferred for disposal as authorized by TCEQ. (4) A person must be specifically licensed to receive waste containing licensed material from other persons for: (A) treatment before disposal; (B) treatment by incineration; (C) decay in storage; (D) disposal at an authorized land disposal facility; or (E) storage until transferred to a storage or disposal facility authorized to receive the waste. (5) Byproduct material as defined in §289.201(b)(18)(C) - (E) of this subchapter may be disposed of as specified in 10 CFR Part 61, even though it is not defined as low-level radioactive waste. Any byproduct material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed under 10 CFR Part 61, must meet the requirements of this chapter. (6) A licensee may dispose of byproduct material, as defined in §289.201(b)(18)(C) - (E) of this subchapter, at a disposal facility authorized to dispose of such material with any federal or state solid or hazardous waste law. (7) Any licensee shipping byproduct material as defined in §289.201(b)(18)(C) - (E) of this subchapter intended for ultimate disposal at a land disposal facility licensed under 10 CFR Part 61 must document the information required on the NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee as specified in §289.257(gg) of this chapter. (gg) Discharge by release into sanitary sewerage. (1) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied: (A) the material is readily soluble, or is readily dispersible biological material, in water; (B) the quantity of licensed radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee is not more than the concentration listed in Table III of subsection (ggg)(2) of this section; and (C) if more than one radionuclide is released, the following additional conditions must also be satisfied: (i) the fraction of the limit in Table III of subsection (ggg)(2) of this section represented by discharges into sanitary sewerage determined by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table III of subsection (ggg)(2) of this section; and (ii) the sum of the fractions for each radionuclide required by clause (i) of this subparagraph is not more than unity; and (D) the total quantity of licensed radioactive material that the licensee releases into the sanitary sewerage in a year is not more than 5 Ci (185 GBq) of hydrogen-3, 1 Ci (37 GBq) of carbon-14, and 1 Ci (37 GBq) of all other radioactive materials combined. (2) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (1) of this subsection. (hh) Treatment by incineration. A licensee may treat licensed material by incineration only in the form and concentration specified in subsection (fff)(1) of this section or as authorized by the department. (ii) Discharge by release into septic tanks. Licensees must not discharge radioactive material into a septic tank system except as specifically approved by the department. (jj) Transfer for disposal and manifests. (1) The control of transfers of LLRW intended for disposal at a licensed low-level radioactive waste disposal facility, the establishment of a manifest tracking system, and additional requirements concerning transfers and recordkeeping for those wastes are found in §289.257(ff) of this chapter. (2) Each person involved in the transfer of waste for disposal, including the waste generator, waste collector, and waste processor, must comply with the requirements specified in §289.257(ff) of this chapter. (kk) Compliance with environmental and health protection regulations. Nothing in subsections (ff), (gg), (hh), or (jj) of this section relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of as specified in subsections (ff), (gg), (hh), or (jj) of this section. (ll) General provisions for records. (1) Each licensee must use the International System of Units (SI) units becquerel, gray, sievert, and coulomb per kilogram, or the special units curie, rad, rem, and roentgen, including multiples and subdivisions, and must clearly indicate the units of all quantities on records required by this section. Disintegrations per minute may be indicated on records of surveys performed to determine compliance with subsections (ee)(4) and (ggg)(6) of this section. To ensure compatibility with international transportation standards, all limits in this section are given in terms of dual units: The SI units followed or preceded by United States (U.S.) standard or customary units. The U.S. customary units are not exact equivalents, but are rounded to a convenient value, providing a functionally equivalent unit. For the purpose of this section, either unit may be used. (2) Notwithstanding the requirements of paragraph (1) of this subsection, when recording information on shipment manifests, as required in §289.257 of this chapter, information must be recorded in SI units or in SI and units as specified in paragraph (1) of this subsection. (3) The licensee must make a clear distinction among the quantities entered on the records required by this section, such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent. (4) Records required as specified in §289.201(d) of this subchapter, and subsections (mm) - (oo) and (ss) - (uu) of this section, must include the date and the identification of personnel making the record, and, as applicable, a unique identification of survey instruments used, and an exact description of the location of the survey. Records of receipt, transfer, and disposal of sources of radiation must uniquely identify the source of radiation. (5) Copies of records required as specified in §289.201(d) of this subchapter, and subsections (mm) - (uu) of this section, and by license condition that are relevant to operations at an additional authorized use/storage site must be maintained at that site in addition to the main site specified on a license. (mm) Records of radiation protection programs. (1) Each licensee must maintain records of the radiation protection program, including: (A) the provisions of the program; and (B) audits and other reviews of program content and implementation. (2) The licensee must make, maintain, and retain the records required by paragraphs (1)(A) and (1)(B) of this subsection for inspection by the department as specified in subsection (ggg)(5) of this section. (nn) Records of surveys. (1) Each licensee must make, maintain, and retain records documenting the results of surveys and calibrations required by subsections (p) and (ee)(2) of this section and include a unique identification of survey instruments. The licensee must maintain these records for inspection by the department as specified in subsection (ggg)(5) of this section. (2) Record of the calibration must include: (A) the manufacturer's name, model, and serial number of each calibrated source or device; (B) the complete date of the calibration; and (C) the name of the individual recording the information. (3) The licensee must make, maintain, and retain each of the following records for inspection by the department as specified in subsection (ggg)(5) of this section: (A) the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents; (B) the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose; (C) the results of air sampling, surveys, and bioassays required as specified in subsection (x)(1)(C)(i) and (ii) of this section; and (D) the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment. (oo) Records of tests for leakage or contamination of sealed sources. Records of tests for leakage or contamination of sealed sources required by §289.201(g) of this subchapter must be kept in units of becquerel or microcurie and maintained and retained for inspection by the department as specified in subsection (ggg)(5) of this section. (pp) Records of lifetime cumulative occupational radiation dose. The licensee must make, maintain, and retain the records of lifetime cumulative occupational radiation dose as specified in subsection (k) of this section on RC Form 202-2, or equivalent, and the records used in preparing RC Form 202-2, or equivalent, for inspection by the department as specified in subsection (ggg)(5) of this section. (qq) Records of planned special exposures. (1) For each use of the provisions of subsection (k) of this section for planned special exposures, the licensee must maintain records that describe: (A) the exceptional circumstances requiring the use of a planned special exposure; (B) the name of the management official who authorized the planned special exposure and a copy of the signed authorization; (C) what actions were necessary; (D) why the actions were necessary; (E) what precautions were taken to assure that doses were maintained ALARA; (F) what individual and collective doses were expected to result; and (G) the doses actually received in the planned special exposure. (2) The licensee must retain the records until the department terminates each pertinent license requiring these records. (rr) Records of individual monitoring results. (1) Each licensee must maintain records of doses received by all individuals for whom monitoring was required as specified in subsection (q) of this section, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before January 1, 1994, need not be changed. These records must include, when applicable: (A) the deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities; (B) the estimated intake of radionuclides. See subsection (g) of this section; (C) the committed effective dose equivalent assigned to the intake of radionuclides; (D) the specific information used to calculate the committed effective dose equivalent as specified in subsection (i)(1) and (3) of this section and when required by subsection (q)(1) of this section; (E) the TEDE when required by subsection (g) of this section; (F) the total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose; and (G) the data used to make occupational dose assessments as specified in subsection (j)(5) of this section. (2) The licensee must make entries of the records specified in paragraph (1) of this subsection at intervals not more than one year and not later than April 30 of the following year. (3) The licensee must maintain the records specified in paragraph (1) of this subsection on RC Form 202-3, as specified in the instructions for RC Form 202-3, or in clear and legible records containing all the information required by RC Form 202-3. (4) The licensee must maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, must also be kept on file, but may be maintained separately from the dose records. (5) The licensee must retain each required form or record until the department terminates each pertinent license requiring the record. The licensee must retain records used in preparing RC Form 202-3 or equivalent for three years after the record is made. (ss) Records of dose to individual members of the public. (1) Each licensee must maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See subsection (n) of this section. (2) The licensee must retain the records required by paragraph (1) of this subsection until the department terminates each pertinent license requiring the record. (tt) Records of discharge, treatment, or transfer for disposal. (1) Each licensee must maintain records of the discharge or treatment of licensed materials made as specified in subsection (gg) and (hh) of this section and of transfers for disposal made as specified in subsection (jj) of this section and §289.257 of this chapter. (2) The licensee must retain the records required by paragraph (1) of this subsection until the department terminates each pertinent license requiring the record. (uu) Records of testing entry control devices for very high radiation areas. (1) Each licensee must maintain records of tests made as specified in subsection (u)(2)(I) of this section on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function. (2) The licensee must retain the records required by paragraph (1) of this subsection for three years after the record is made. (vv) Form of records. Each record required by this chapter must include all pertinent information and be stored in a legible and reproducible format throughout the specified retention period. The licensee must maintain adequate safeguards against tampering with and loss of records. (ww) Reports of stolen, lost, or missing licensed sources of radiation. (1) Each licensee must report to the department by telephone as follows: (A) immediately after its occurrence becomes known to the licensee, stolen, lost, or missing licensed radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in subsection (ggg)(3) of this section, if it appears to the licensee an exposure could result to individuals in unrestricted areas; or (B) within 30 days after the licensee knows lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than 10 times the quantity specified in subsection (ggg)(3) of this section is still missing. (2) Each licensee required to make a report as specified in paragraph (1) of this subsection must, within 30 days after making the telephone report, make a written report to the department, including: (A) a description of the licensed source of radiation involved, including, for radioactive material, the kind, quantity, chemical and physical form, source or device manufacturer, model number, and serial number; (B) a description of the circumstances under which the loss or theft occurred; (C) a statement of disposition, or probable disposition, of the licensed source of radiation involved; (D) exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible TEDE to persons in unrestricted areas; (E) actions taken, or to be taken, to recover the source of radiation; and (F) procedures or measures adopted, or to be adopted, ensuring against a recurrence of the loss or theft of licensed sources of radiation. (3) Subsequent to filing the written report, the licensee must also report additional substantive information on the loss or theft within 30 days after the licensee learns of such information. (4) The licensee must prepare any report filed with the department as specified in this subsection so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report. (xx) Notification of incidents. (1) Notwithstanding other requirements for notification, each licensee must immediately report each event involving a source of radiation possessed by the licensee that may have caused or threatens to cause: (A) an individual, except a patient administered radiation for purposes of medical diagnosis or therapy, to receive: (i) a TEDE of 25 rem (0.25 Sv) or more; (ii) a lens dose equivalent of 75 rem (0.75 Sv) or more; or (iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 250 rads (2.5 Gy) or more; or (B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures. (2) Each licensee must, within 24 hours of discovery of the event, report to the department each event involving loss of control of a licensed source of radiation possessed by the licensee that may have caused, or threatens to cause: (A) an individual to receive, in a period of 24 hours: (i) a TEDE exceeding 5 rem (0.05 Sv); (ii) a lens dose equivalent exceeding 15 rem (0.15 Sv); or (iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rem (0.5 Sv); or (B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake more than one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures. (3) Licensees must make the initial notification reports required by paragraphs (1) and (2) of this subsection by telephone to the department and must confirm the initial notification report within 24 hours by other electronic media transmission to the department. (4) The licensee must prepare each report filed with the department as specified in this section so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report. (5) The provisions of this section do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported as specified in subsection (zz) of this section. (6) Each licensee must notify the department as soon as possible, but not later than four hours after the discovery, of an event that prevents immediate protective actions necessary to avoid exposures to radioactive materials that could exceed regulatory limits, or releases of radioactive materials that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). (7) Each licensee must notify the department within 24 hours after the discovery of any of the following events involving radioactive material: (A) an unplanned contamination event: (i) requiring access to the contaminated area to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area; (ii) involving a quantity of material greater than five times the lowest annual limit on intake specified in subsection (ggg)(2) of this section for the material; and (iii) restricting access to the area for a reason other than to allow isotopes with a half-life of less than 24 hours to decay before decontamination; (B) an event in which equipment is disabled or fails to function as designed when: (i) the equipment is required by rule or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; (ii) the equipment is required to be available and operable when it is disabled or fails to function; and (iii) no redundant equipment is available and operable to perform the required safety function; (C) an event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body; or (D) an unplanned fire or explosion damaging any radioactive material or any device, container, or equipment containing radioactive material when: (i) the quantity of material involved is greater than five times the lowest annual limit on intake specified in subsection (ggg)(2) of this section for the material; and (ii) the damage affects the integrity of the radioactive material or its container. (8) Preparation and submission of reports. Reports made by licensees in response to the requirements of paragraphs (6) and (7) of this subsection must be made as follows. (A) Licensees must make reports required by paragraphs (6) and (7) of this subsection by telephone to the department. To the extent that the information is available at the time of notification, the information provided in these reports must include: (i) the caller's name and call back telephone number; (ii) a description of the event, including date and time; (iii) the exact location of the event; (iv) the isotopes, quantities, and chemical and physical form of the radioactive material involved; (v) any personnel radiation exposure data available; and (vi) the source or device manufacturer, model, and serial number. (B) Each licensee who makes a report required by paragraphs (6) and (7) of this subsection must submit to the department a written follow-up report within 30 days of the initial report. Written reports prepared as specified in other requirements of this chapter may be submitted to fulfill this requirement if the reports contain all necessary information and the appropriate distribution is made. The reports must include: (i) a description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; (ii) the exact location of the event; (iii) the isotopes, quantities, chemical and physical form of the radioactive material involved, and the source or device manufacturer, model number, and serial number; (iv) date and time of the event; (v) corrective actions taken or planned and the results of any evaluations or assessments; and (vi) the extent of exposure of individuals to radioactive materials without identification of individuals by name. (yy) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits. (1) In addition to the notification required by subsection (xx) of this section, each licensee must submit a written report within 30 days after becoming aware of: (A) incidents for which notification is required by subsection (xx) of this section; (B) doses exceeding: (i) the occupational dose limits for adults in subsection (f) of this section; (ii) the occupational dose limits for a minor in subsection (l) of this section; (iii) the limits for an embryo/fetus of a declared pregnant woman in subsection (m) of this section; (iv) the limits for an individual member of the public in subsection (n) of this section; (v) any applicable limit in the license; or (vi) the ALARA constraints for air emissions as required by subsection (e)(4) of this section; (C) levels of radiation or concentrations of radioactive material in: (i) a restricted area exceeding applicable limits in the license; or (ii) an unrestricted area more than 10 times the applicable limit set forth in this section or in the license, whether or not involving exposure of any individual over the limits in subsection (n) of this section; or (D) for licensees subject to the provisions of the EPA's generally applicable environmental radiation standards in 40 CFR §190, levels of radiation or releases of radioactive material exceeding those standards, or of license conditions related to those requirements. (2) Each report required by paragraph (1) of this subsection must describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate: (A) estimates of each individual's dose; (B) the levels of radiation, dose limit exceeded, concentrations of radioactive material involved, and the source or device manufacturer, model number, and serial number; (C) the cause of the elevated exposures, dose rates, or concentrations; and (D) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license conditions. (3) Each report filed as specified in paragraph (1) of this subsection must include for each individual exposed: the name, identification number, and date of birth. With respect to the limit for the embryo/fetus in subsection (m) of this section, the identifiers should be those of the declared pregnant woman. The report must be prepared so that this information is stated in a separate and detachable portion of the report. (4) All licensees who make reports as specified in paragraph (1) of this subsection must submit the report in writing to the department. (zz) Reports of planned special exposures. The licensee must submit a written report to the department within 30 days following any planned special exposure conducted as specified in subsection (k) of this section, informing the department a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by subsection (qq) of this section. (aaa) Notifications and reports to individuals. (1) Requirements for notification and reports to individuals of exposure to sources of radiation are specified in §289.203 of this subchapter. (2) When a licensee is required as specified in subsection (yy) or (zz) of this section to report to the department any exposure of an identified occupationally exposed individual, or an identified member of the public, to sources of radiation, the licensee must also notify the individual and provide a copy of the report submitted to the department to the individual. Such notice must be transmitted not later than the transmittal to the department and must comply with the provisions of §289.203(d)(1) of this subchapter. (bbb) Reports of leaking or contaminated sealed sources. The licensee must immediately notify the department if the test for leakage or contamination required as specified in §289.201(g) of this subchapter indicates a sealed source is leaking or contaminated. A written report of a leaking or contaminated source must be submitted to the department within five days. The report must include the equipment involved, including the device manufacturer, model and serial number; the test results; the date of the test; model and serial number, if assigned, of the leaking source; the radionuclide and its estimated activity; and the corrective action taken. (ccc) Vacating premises. (1) Each licensee or person possessing non-exempt sources of radiation must notify the department, in writing, at least 30 days before vacating and relinquishing possession or control of premises. (2) The licensee or person possessing non-exempt radioactive material must decommission the premises to a degree consistent with subsequent use as an unrestricted area and as specified in the requirements of subsection (ddd) of this section. (ddd) Radiological requirements for license termination. (1) General provisions and scope. (A) The requirements in this section apply to the decommissioning of facilities licensed as specified in §289.252 of this chapter, §289.253 of this chapter (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies), §289.255 of this chapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), §289.258 of this chapter (relating to Licensing and Radiation Safety Requirements for Irradiators), and §289.259 of this chapter (relating to Licensing of Naturally Occurring Radioactive Material (NORM)). (B) The requirements in this section do not apply to: (i) sites that have been decommissioned before October 1, 2000, as specified in requirements identified in this section and in §289.252 of this chapter; or (ii) sites that have previously submitted and received approval on a decommissioning plan before October 1, 2000. (C) After a site has been decommissioned and the license terminated as specified in the requirements in this subsection, the department requires additional cleanup when it determines that the requirements of this subsection were not met and residual radioactivity remaining at the site could result in significant threat to public health and safety. (D) When calculating TEDE to the average member of the critical group, the licensee must determine the peak annual TEDE dose expected within the first 1,000 years after decommissioning. (2) Radiological requirements for unrestricted use. A site will be considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that is not more than 25 mrem (0.25 mSv) per year, including from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are ALARA. Determination of ALARA levels must take into consideration any detriments, such as deaths from transportation accidents, that could result from decontamination and waste disposal. (3) Criteria for license termination under restricted conditions. A site will be considered acceptable for license termination under restricted conditions if: (A) the licensee demonstrates further reductions in residual radioactivity necessary to comply with the requirements of paragraph (2) of this subsection would result in net public or environmental harm or were not being made because the residual levels associated with restricted conditions are ALARA. Determination of ALARA levels must take into consideration any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal; (B) the licensee has made provisions for legally enforceable institutional controls providing reasonable assurance the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is not more than 25 mrem (0.25 mSv) per year; (C) the licensee has provided sufficient financial assurance enabling an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. Acceptable financial assurance mechanisms include: (i) funds placed into a trust segregated from the licensee's assets and outside the licensee's administrative control, and in which the adequacy of the trust funds is assessed based on an assumed annual 1 percent real rate of return on investment; (ii) a statement of intent in the case of federal, state, or local government licensees, as described in §289.252(gg) of this chapter; or (iii) when a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity. (D) the licensee has submitted a decommissioning plan or License Termination Plan (LTP) to the department indicating the licensee's intent to decommission as specified in §289.252(y) of this chapter, and specifying that the licensee intends to decommission by restricting use of the site. The licensee must document in the LTP or decommissioning plan how the input of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that input. (i) Licensees proposing to decommission by restricting use of the site must seek input from affected parties regarding the following concerning the proposed decommissioning: (I) whether provisions for institutional controls proposed by the licensee; (-a-) provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) TEDE per year; (-b-) are enforceable; and (-c-) do not impose undue burdens on the local community or other affected parties; and (II) whether the licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. (ii) In seeking input on the issues identified in clause (i) of this subparagraph, the licensee must provide for: (I) participation by representatives of a broad cross section of community interests who may be affected by the decommissioning; (II) an opportunity for a comprehensive, collective discussion on the issues by the participants represented; and (III) a publicly available summary of the results of all discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues; and (E) residual radioactivity at the site has been reduced so that, if the institutional controls were no longer in effect, there is reasonable assurance the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is ALARA and would not exceed either: (i) 100 mrem (1 mSv) per year; or (ii) 500 mrem (5 mSv) per year provided the licensee: (I) demonstrates that further reductions in residual radioactivity necessary to comply with the 1 mSv per year (100 mrem per year) value of clause (i) of this subparagraph are not technically achievable, are prohibitively expensive, or result in net public or environmental harm; (II) makes provisions for durable institutional controls; and (III) provides sufficient financial assurance to enable a responsible government entity or independent third party, including a governmental custodian of a site, to carry out periodic rechecks of the site no less frequently than every five years to assure that the institutional controls remain in place as necessary to meet the criteria of paragraph (2) of this subsection, and to assume and carry out responsibilities for any necessary control and maintenance of those controls. Acceptable financial assurance mechanisms are those in subparagraph (C) of this paragraph. (4) Alternate requirements for license termination. (A) The department may terminate a license using alternate requirements greater than the dose requirements specified in paragraph (2) of this subsection if the licensee: (i) provides assurance that public health and safety would continue to be protected, and it is unlikely the dose from all man-made sources combined, other than medical, would be more than the 1 mSv per year (100 mrem per year) limit specified in subsection (o) of this section, by submitting an analysis of possible sources of exposure; (ii) reduces doses to ALARA levels, taking into consideration any detriments such as traffic accidents that could result from decontamination and waste disposal; (iii) submits a decommissioning plan to the department indicating the licensee's intent to decommission as specified in the requirements in §289.252(y) of this chapter, and specifying that the licensee proposes to decommission by use of alternate requirements. The licensee must document in the decommissioning plan how the input of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that input. In seeking input, the licensee must provide for: (I) participation by representatives of a broad cross section of community interests who may be affected by the decommissioning; (II) an opportunity for a comprehensive, collective discussion on the issues by the participants represented; and (III) a publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues; and (iv) has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. (B) The use of alternate requirements to terminate a license requires the approval of the department after consideration of the department's recommendations addressing any comments provided by the EPA and any public comments submitted as specified in paragraph (5) of this subsection. (5) Public notification and public participation. Upon receipt of a decommissioning plan from the licensee, or a proposal from the licensee for release of a site pursuant to paragraphs (3) and (4) of this subsection, or whenever the department deems such notice to be in the public interest, the department: (A) notifies and solicits comments from: (i) local and state governments in the vicinity of the site and any Indian Nation or other indigenous people having treaty or statutory rights that could be affected by the decommissioning; and (ii) the EPA, for cases where the licensee proposes to release a site as specified in paragraph (4) of this subsection; and (B) publishes a notice in the Texas Register and a forum, such as local newspapers, letters to state or local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties. (6) Minimization of contamination. (A) Applicants for licenses, other than renewals, after October 1, 2000, must describe in the application how facility design and procedures for operation minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of LLRW. (B) Licensees must conduct operations, to the extent practical, to minimize the introduction of residual radioactivity into the site, including the subsurface, as specified in the existing radiation protection requirements and radiological criteria for license termination in this subsection. (eee) Limits for contamination of soil, surfaces of facilities and equipment, and vegetation. (1) Licensees must not possess, receive, use, or transfer radioactive material in a manner causing contamination of surfaces of facilities or equipment in unrestricted areas to the extent that the contamination is more than the limits specified in subsection (ggg)(6) of this section. (2) Licensees must not possess, receive, use, or transfer radioactive material in a manner causing contamination of soil in unrestricted areas, to the extent that the contamination is more than, on a dry weight basis, the concentration limits specified in: (A) subsection (ddd) of this section; or (B) the effluent concentrations in Table II, Column 2 of subsection (ggg)(2)(F) of this section, with the units changed from microcuries per milliliter to microcuries per gram, for radionuclides not specified in paragraph (4) of this subsection. (3) Where combinations of radionuclides are involved, the sum of the ratios between the concentrations present and the limits specified in paragraph (2) of this subsection must not exceed one. (4) Notwithstanding the limits specified in paragraph (2) of this subsection, licensees must not cause the concentration of radium-226 or radium-228 in soil in unrestricted areas, averaged over any 100 square meters (m2 ), to exceed the background level by more than: (A) 5 pCi/g (0.185 becquerel per gram (Bq/g)), averaged over the first 15 cm of soil below the surface; and (B) 15 pCi/g (0.555 Bq/g), averaged over 15 cm thick layers of soil more than 15 cm below the surface. (5) Licensees must not possess, receive, use, or transfer radioactive material in a manner causing contamination of vegetation in unrestricted areas to be more than 5 pCi/g (0.185 Bq/g), based on dry weight, for radium-226 or radium-228. (6) Notwithstanding the limits specified in paragraph (2) of this subsection, licensees must not cause the concentration of natural uranium with no daughters present, based on dry weight and averaged over any 100 m2 of area, to exceed the following limits: (A) 30 pCi/g (1.11 Bq/g), averaged over the top 15 cm of soil below the surface; and (B) 150 pCi/g (5.55 Bq/g), average concentration at depths greater than 15 cm below the surface so that no individual member of the public will receive an effective dose equivalent more than 100 mrem (1 mSv) per year. (fff) Exemption of specific wastes. (1) A licensee may discard the following licensed material without regard to its radioactivity: (A) 0.05 microcurie (µCi) (1.85 kilobecquerels (kBq)), or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; and (B) 0.05 µCi (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of animal tissue averaged over the weight of the entire animal. (2) A licensee must not discard tissue as specified in paragraph (1)(B) of this subsection in a manner permitting its use either as food for humans or as animal feed. (3) The licensee must maintain records as specified in subsection (tt) of this section. (4) Any licensee may, upon approval from the department of procedures required in paragraph (6) of this subsection, discard licensed material included in subsection (ggg)(7) of this section, if it does not exceed the concentration and total curie limits contained therein, in a Type I municipal solid waste site as defined in the Municipal Solid Waste Regulations of the authorized regulatory agency (30 TAC Chapter 330 (relating to Municipal Solid Waste), unless such licensed material also contains hazardous waste, as defined in §361.003(12) of the Solid Waste Disposal Act, Texas Health and Safety Code Chapter 361. Any licensed material included in subsection (ggg)(7) of this section and which is a hazardous waste as defined in the Solid Waste Disposal Act, may be discarded at a facility authorized to manage hazardous waste by the authorized regulatory agency. (5) Each licensee discarding material described in paragraphs (1) or (4) of this subsection must: (A) make surveys adequate to assure that the limits of paragraphs (1) or (4) of this subsection are not exceeded; and (B) remove or otherwise obliterate or obscure all labels, tags, or other markings that would indicate that the material or its contents is radioactive. (6) Before authorizations as specified in paragraph (4) of this subsection, a licensee must submit procedures to the department for: (A) the physical delivery of the material to the disposal site; (B) surveys to be performed for compliance with paragraph (5)(A) of this subsection; (C) maintaining secure packaging during transportation to the site; and (D) maintaining records of any discards made under paragraph (4) of this subsection. (7) Nothing in this section relieves the licensee of maintaining records showing the receipt, transfer, and discard of such radioactive material as specified in §289.201(d) of this subchapter. (8) Nothing in this section relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous property of these materials. (9) Licensed material discarded under this section is exempt from the requirements of §289.252(ff) of this chapter. (ggg) Appendices. (1) Assigned protection factors for respirators. The following table contains assigned protection factors for respiratorsa : Attached Graphic(2) ALI and DAC of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage. (A) Introduction. (i) For each radionuclide, Table I of subparagraph (F) of this paragraph indicates the chemical form to be used for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 micron, and for three classes (D, W, Y) of radioactive material, which refer to their retention (approximately days, weeks, or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times for D if less than 10 days, for W from 10 to 100 days, and for Y greater than 100 days. Table II of subparagraph (F) of this paragraph provides concentration limits for airborne and liquid effluents released to the general environment. Table III of subparagraph (F) of this paragraph provides concentration limits for discharges to sanitary sewerage. (ii) The values in Tables I, II, and III of subparagraph (F) of this paragraph are presented in the computer "E" notation. In this notation a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6 x 102 or 600, and 6E+0 represents 6 x 100 or 6. (B) Occupational values. (i) Note that the columns in Table I of subparagraph (F) of this paragraph captioned "Oral Ingestion ALI," "Inhalation ALI," and "DAC," are applicable to occupational exposure to radioactive material. (ii) The ALIs in subparagraph (F) of this paragraph are the annual intakes of given radionuclide by Reference Man that would result in either a committed effective dose equivalent of 5 rem (0.05 Sv), stochastic ALI, or a committed dose equivalent of 50 rem (0.5 Sv) to an organ or tissue, non-stochastic ALI. The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 5 rem (0.05 Sv). The derivation includes multiplying the committed dose equivalent to an organ or tissue by a weighting factor, wT . This weighting factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of wT are listed under the definition of "weighting factor" in subsection (c) of this section. The non-stochastic ALIs were derived to avoid non-stochastic effects, such as prompt damage to tissue or reduction in organ function. (iii) A value of wT = 0.06 is applicable to each of the five organs or tissues in the "remainder" category receiving the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. These portions of the gastrointestinal (GI) tract are treated as four separate organs: stomach, small intestine, upper large intestine, and lower large intestine. (iv) The dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. (v) When an ALI is defined by the stochastic dose limit, this value alone is given. When an ALI is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. Abbreviated organ or tissue designations are used as follows: (I) LLI wall = lower large intestine wall; (II) St. wall = stomach wall; (III) Blad wall = bladder wall; and (IV) Bone surf = bone surface. (vi) The use of the ALIs listed first, the more limiting of the stochastic and non-stochastic ALIs, will ensure non-stochastic effects are avoided and risk of stochastic effects is limited to an acceptably low value. If, in a particular situation involving a radionuclide for which the non-stochastic ALI is limiting, use of that non-stochastic ALI is considered unduly conservative, the licensee may use the stochastic ALI to determine the committed effective dose equivalent. The licensee must also ensure the 50 rem (0.5 Sv) dose equivalent limit for any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the internal committed dose equivalent to that organ, not the effective dose. For the case where there is no external dose contribution, this is demonstrated if the sum of the fractions of the non-stochastic ALIs (ALIns ) contributing to the committed dose equivalent to the organ receiving the highest dose does not exceed unity, that is, &Sgr (intake in µCi of each radionuclide/ALIns ) < 1.0. If there is an external deep dose equivalent contribution (Hd ), then this sum must be less than 1 - (Hd /50), instead of < 1.0.(vii) The DAC values are derived limits intended to control chronic occupational exposures. The relationship between the DAC and the ALI is given by: Attached Graphic(viii) The DAC values relate to one of two modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. DACs based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately. (ix) The ALI and DAC values include contributions to exposure by the single radionuclide named and any in-growth of daughter radionuclides produced in the body by decay of the parent. Intakes that include both the parent and daughter radionuclides are treated by the general method appropriate for mixtures. (x) The values of ALI and DAC do not apply directly when the individual both ingests and inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external irradiation. See subsection (g) of this section. When an individual is exposed to radioactive materials falling under several of the translocation classifications of the same radionuclide, such as, Class D, W, or Y, the exposure may be evaluated as if it were a mixture of different radionuclides. (xi) It should be noted that the classification of a compound as Class D, W, or Y is based on the chemical form of the compound and does not consider the radiological half-life of different radionuclides. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionuclides. (C) Effluent concentrations. (i) The columns in Table II of subparagraph (F) of this paragraph captioned "Effluents," "Air," and "Water" are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of subsection (o) of this section. The concentration values given in Columns 1 and 2 of Table II of subparagraph (F) of this paragraph are equivalent to the radionuclide concentrations that, if inhaled or ingested continuously over the course of a year, would produce a TEDE of 0.05 rem (0.5 mSv). (ii) Consideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at or below the dose levels established for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was used in deriving the corresponding airborne effluent limit in Table II of subparagraph (F) of this paragraph. For this reason, the DAC and airborne effluent limits are not always proportional as they were in the previous radiation protection standards. (iii) The air concentration values listed in Column I of Table II of subparagraph (F) of this paragraph were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by 2.4 x 109 , relating the inhalation ALI to the DAC, as explained in subparagraph (B)(viii) of this paragraph, and then divided by a factor of 300. The factor of 300 includes the following components: (I) a factor of 50 to relate the 5 rem (0.05 Sv) annual occupational dose limit to the 0.1 rem limit for members of the public; (II) a factor of 3 to adjust for the difference in exposure time and the inhalation rate for a worker and members of the public; and (III) a factor of 2 to adjust the occupational values, derived for adults, so that they are applicable to other age groups. (iv) For those radionuclides for which submersion, that is external dose, is limiting, the occupational DAC in Column 3 of Table I of subparagraph (F) of this paragraph was divided by 219. The factor of 219 is composed of a factor of 50, as described in clause (iii) of this subparagraph, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full-time exposure (8,760 hours per year). Note that an additional factor of two for age considerations is not warranted in the submersion case. (v) The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 107 . The factor of 7.3 x 107 milliliters (mL) includes the following components: (I) the factors of 50 and two described in clause (iii) of this subparagraph; and (II) a factor of 7.3 x 105 mL which is the annual water intake of Reference Man.(vi) Note 2 of subparagraph (F) of this paragraph provides groupings of radionuclides that are applicable to unknown mixtures of radionuclides. These groupings, including occupational inhalation ALIs and DACs, air and water effluent concentrations, and releases to sewer, require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitively excluded as being present either from knowledge of the radionuclide composition of the source or from actual measurements. (D) Releases to sewers. The monthly average concentrations for release to sanitary sewerage are applicable to the provisions in subsection (gg) of this section. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 106 mL. The factor of 7.3 x 106 ml is composed of a factor of 7.3 x 105 mL, the annual water intake by Reference Man, and a factor of 10, such that the concentrations, if the sewage released by the licensee is the only source of water ingested by a Reference Man during a year, results in a committed effective dose equivalent of 0.5 rem. (E) List of elements. Attached Graphic(F) Tables--Values for annual limits. The following tables contain values for ALI and DAC of radionuclides for occupational exposure, effluent concentrations, and concentrations for release to sanitary sewerage: Attached Graphic(3) Quantities of licensed material requiring labeling. The following tables contain quantities of licensed material requiring labeling: Attached Graphic(4) Classification and characteristics of LLRW. (A) Classification of radioactive waste for land disposal. (i) Considerations. Determination of the classification of LLRW involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard persists long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective. (ii) Classes of waste. (I) Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in subparagraph (B)(i) of this paragraph. If Class A waste also meets the stability requirements set forth in subparagraph (B)(ii) of this paragraph, it is not necessary to segregate the waste for disposal. (II) Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in subparagraph (B) of this paragraph. (III) Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in subparagraph (B) of this paragraph. (iii) Classification determined by long-lived radionuclides. If the radioactive waste contains only radionuclides listed in subclause (V) of this clause, classification must be determined as follows. (I) If the concentration does not exceed 0.1 times the value in subclause (V) of this clause, the waste is Class A. (II) If the concentration exceeds 0.1 times the value in Table I, but does not exceed the value in subclause (V) of this clause, the waste is Class C. (III) If the concentration exceeds the value in subclause (V) of this clause, the waste is not generally acceptable for land disposal. (IV) For wastes containing mixtures of radionuclides listed in subclause (V) of this clause, the total concentration must be determined by the sum of fractions rule described in clause (vii) of this subparagraph. (V) Classification table for long-lived radionuclides. Attached Graphic(iv) Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in clause (iii)(V) of this subparagraph, classification must be determined based on the concentrations shown in subclause (VI) of this clause. As specified in clause (vi) of this subparagraph, if radioactive waste does not contain any nuclides listed in either clause (iii)(V) of this subparagraph or subclause (VI) of this clause, it is Class A. (I) If the concentration does not exceed the value in Column 1 of subclause (VI) of this clause, the waste is Class A. (II) If the concentration exceeds the value in Column 1 of subclause (VI) of this clause but does not exceed the value in Column 2 of subclause (VI) of this clause, the waste is Class B. (III) If the concentration exceeds the value in Column 2 of subclause (VI) of this clause but does not exceed the value in Column 3 of subclause (VI) of this clause, the waste is Class C. (IV) If the concentration exceeds the value in Column 3 of subclause (VI) of this clause, the waste is not generally acceptable for near-surface disposal. (V) For wastes containing mixtures of the radionuclides listed in subclause (VI) of this clause, the total concentration must be determined by the sum of fractions rule described in clause (vii) of this subparagraph. (VI) Classification table for short-lived radionuclides. Attached Graphic(v) Classification determined by both long and short-lived radionuclides. If the radioactive waste contains a mixture of radionuclides, some of which are listed in clause (iii)(V) of this subparagraph and some of which are listed in clause (iv)(VI) of this subparagraph, classification must be determined as follows. (I) If the concentration of a radionuclide listed in clause (iii)(V) of this subparagraph is less than 0.1 times the value listed in clause (iii)(V) of this subparagraph, the class must be that determined by the concentration of radionuclides listed in clause (iv)(VI) of this subparagraph. (II) If the concentration of a radionuclide listed in clause (iii)(V) of this subparagraph exceeds 0.1 times the value listed in clause (iii)(V) of this subparagraph, but does not exceed the value listed in clause (iii)(V) of this subparagraph, the waste is Class C, provided the concentration of radionuclides listed in clause (iv)(VI) of this subparagraph does not exceed the value shown in Column 3 of clause (iv)(VI) of this subparagraph. (vi) Classification of wastes with radionuclides other than those listed in clauses (iii)(V) and (iv)(VI) of this subparagraph. If the waste does not contain any radionuclides listed in either clause (iii)(V) or (iv)(VI) of this subparagraph, it is Class A. (vii) The sum of the fractions rule for mixtures of radionuclides. When determining classification for waste containing a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains strontium-90 (Sr-90) in a concentration of 50 curies per cubic meter (Ci/m3 (1.85 terabecquerels per cubic meter (TBq/m3 )) and cesium-137 (Cs-137) in a concentration of 22 Ci/m3 (814 gigabecquerels per cubic meter (GBq/m3 )). Since the concentrations both exceed the values in Column 1 of clause (iv)(VI) of this subparagraph, they must be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33, for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B. (viii) Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors, which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as nanocurie (becquerel) per gram. (B) Radioactive waste characteristics. (i) The following are minimum requirements for all classes of waste and are intended to facilitate handling and provide health and safety protections of personnel at the disposal site. (I) Wastes must be packaged in conformance with the conditions of the license issued to the site operator where the waste will be shipped. Where the conditions of the site license are more restrictive than the provisions of this section, the site license conditions govern. (II) Wastes must not be packaged for disposal in cardboard or fiberboard boxes. (III) Liquid waste must be packaged in sufficient absorbent material to absorb twice the volume of the liquid. (IV) Solid waste containing liquid must contain as little free-standing and non-corrosive liquid as is reasonably achievable. The liquid must not exceed 1 percent of the volume. (V) Waste must not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water. (VI) Waste must not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged as specified in subclause (VIII) of this clause. (VII) Waste must not be pyrophoric. Pyrophoric materials contained in wastes must be treated, prepared, and packaged to be nonflammable. (VIII) Wastes in a gaseous form must be packaged at an absolute pressure that does not exceed 1.5 atmospheres at 20 degrees Celsius. Total activity must not exceed 100 Ci (3.7 TBq) per container. (IX) Wastes containing hazardous, biological, pathogenic, or infectious material must be treated to reduce, to the maximum extent practicable, the potential hazard from the non-radiological materials. (ii) The following requirements are intended to provide stability of the waste. Stability is intended to ensure that the waste does not degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder since it provides a recognizable and non-dispersible waste. (I) Waste must have structural stability. A structurally stable waste form generally maintains its physical dimensions and its form under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal. (II) Notwithstanding the provisions in clause (i)(III) and (IV) of this subparagraph, liquid wastes, or wastes containing liquid, must be converted into a form that contains as little free-standing and non-corrosive liquid as is reasonably achievable. The liquid must not exceed 1 percent of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5 percent of the volume of the waste for waste processed to a stable form. (III) Void spaces within the waste and between the waste and its package must be reduced to the extent practicable. (C) Labeling. Each package of waste must be clearly labeled to identify whether it is Class A, Class B, or Class C waste, as specified in subparagraph (A) of this paragraph. (5) Time requirements for record keeping. Attached Graphic(6) Acceptable surface contamination levels (per 100 cm2 ). Attached Graphic(7) Concentration and activity limits of nuclides for disposal in a Type I municipal solid waste site or a hazardous waste facility (for use in subsection (fff) of this section). The following table contains concentration and activity limits of nuclides for disposal in a Type I municipal solid waste site or a hazardous waste facility. Attached Graphic(8) Cumulative occupational exposure form. RC Form 202-2, found in the attached graphic, Figure: 25 TAC §289.202(ggg)(8), or other equivalent clear and legible record of all the required information, must be used to document cumulative occupational exposure history: Attached Graphic(9) Occupational exposure form. RC Form 202-3, found in the attached graphic, Figure: 25 TAC §289.202(ggg)(9), or other equivalent clear and legible record of all the required information, must be used to document occupational exposure record for a monitoring period: Attached Graphic(hhh) Requirements for nationally tracked sources. (1) Reports of transactions involving nationally tracked sources. Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source must complete and submit to NRC a National Source Tracking Transaction Report as specified in the following subparagraphs for each type of transaction. (A) Each licensee who manufactures a nationally tracked source must complete and submit to NRC a National Source Tracking Transaction Report. The report must include: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the manufacturer, model, and serial number of the source; (iv) the radioactive material in the source; (v) the initial source strength in curies (becquerels) at the time of manufacture; and (vi) the manufacture date of the source. (B) Each licensee that transfers a nationally tracked source to another person must complete and submit to NRC a National Source Tracking Transaction Report. A source transfer transaction does not include transfers to a temporary domestic job site. Domestic transactions in which the nationally tracked source remains in the possession of the licensee do not require a report to the National Source Tracking System. The report must include: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the name and license number of the recipient facility and the shipping address; (iv) the manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (v) the radioactive material in the source; (vi) the initial or current source strength in curies (becquerels); (vii) the date for which the source strength is reported; (viii) the shipping date; (ix) the estimated arrival date; and (x) for nationally tracked sources transferred as waste under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification. (C) Each licensee that receives a nationally tracked source must complete and submit to NRC a National Source Tracking Transaction Report. The report must include:(i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the name, address, and license number of the person that provided the source; (iv) the manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (v) the radioactive material in the source; (vi) the initial or current source strength in curies (becquerels); (vii) the date for which the source strength is reported; (viii) the date of receipt; and (ix) for material received under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification. (D) Each licensee that disassembles a nationally tracked source must complete and submit to NRC a National Source Tracking Transaction Report. The report must include: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (iv) the radioactive material in the source; (v) the initial or current source strength in curies (becquerels); (vi) the date for which the source strength is reported; and (vii) the disassemble date of the source. (E) Each licensee disposing a nationally tracked source must complete and submit to NRC a National Source Tracking Transaction Report. The report must include: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the waste manifest number; (iv) the container identification; (v) the date of disposal; and (vi) the method of disposal. (F) The reports discussed in subparagraphs (A) - (E) of this paragraph must be submitted to NRC by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports must be submitted to the National Source Tracking System by using the following: (i) the on-line National Source Tracking System; (ii) electronically, using a computer-readable format; (iii) by other electronic media transmission; (iv) by mail to the address on the National Source Tracking Transaction Report Form (NRC Form 748); or (v) by telephone with follow-up by other electronic media transmission or mail. (G) Each licensee must correct any error in previously filed reports or file a new report for any missed transaction within five business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee must reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the National Source Tracking System. The reconciliation must be conducted during the month of January each year. The reconciliation process must include resolving any discrepancies between the National Source Tracking System and the actual inventory by filing the reports identified by subparagraphs (A) - (E) of this paragraph. By January 31 of each year, each licensee must submit to the National Source Tracking System confirmation the data in the National Source Tracking System is correct. (2) Nationally tracked source thresholds. The TBq values are the regulatory standards. The Ci values specified are obtained by converting from the TBq value. The Ci values are provided for practical usefulness only and are rounded after conversion. Attached Graphic(3) Serialization of nationally tracked sources. Each licensee who manufactures a nationally tracked source after February 6, 2007 must assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters. Source Note: The provisions of this §289.202 adopted to be effective May 20, 1996, 21 TexReg 4026; amended to be effective March 1, 1998, 23 TexReg 1045; amended to be effective July 12, 1998, 23 TexReg 6960; amended to be effective October 1, 2000, 25 TexReg 4834; amended to be effective April 1, 2002, 27 TexReg 2019; amended to be effective March 29, 2006, 31 TexReg 2456; amended to be effective December 27, 2007, 32 TexReg 9657; amended to be effective February 22, 2009, 34 TexReg 1065; amended to be effective October 1, 2011, 36 TexReg 5851; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective March1,2016, 41 TexReg 1444; amended to be effective October 23, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL D GENERAL §289.202 Standards for Protection Against Radiation from Radioactive Materials https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152913&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152913 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152913&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152913 03/11/2026 (a) Scope and purpose. This section establishes requirements for notices, instructions, and reports by licensees or registrants to individuals engaged in activities under a license or certificate of registration, and options available to such individuals in connection with agency inspections of licensees or registrants to ascertain compliance with the provisions of the Texas Radiation Control Act (Act), Health and Safety Code, Chapter 401, and rules, orders, licenses, and certificates of registration issued thereunder regarding radiological working conditions. The requirements in this section apply to all persons who receive, possess, use, or transfer sources of radiation licensed by or registered with the agency in accordance with this chapter.(b) Posting of notices to workers.(1) Each licensee or registrant shall post current copies of the following documents:(A) the requirements in this section and in §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Materials) or §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation), as applicable;(B) the license, certificate of registration, conditions or documents incorporated into the license or certificate of registration by reference, and amendments thereto;(C) the operating procedures applicable to work under the license or certificate of registration; and(D) any notice of violation involving radiological working conditions or order that has:(i) been issued in accordance with §289.201 of this title (relating to General Provisions for Radioactive Material), §289.205 of this title (relating to Hearing and Enforcement Procedures), and §289.231 of this title; and(ii) not been labeled "withhold from public disclosure under Government Code, §552.101," or equivalent phrase, in accordance with §289.252(ii) of this title (relating to Licensing of Radioactive Material).(2) If posting of a document specified in paragraph (1) of this subsection is not practicable, the licensee or registrant shall post a notice that describes the document and states where it may be examined.(3) Each licensee or registrant shall post RC Form 203-1, "Notice to Employees," as contained in subsection (i) of this section, or an equivalent document containing at least the same wording as RC Form 203-1.(4) Documents, notices, or forms posted in accordance with this subsection shall:(A) appear in a sufficient number of places to permit individuals engaged in work under the license or certificate of registration to observe them on the way to or from any particular work location to which the document applies;(B) shall be conspicuous; and(C) shall be replaced if defaced or altered.(c) Instructions to workers.(1) All individuals likely to receive in a year an occupational dose in excess of 100 millirem (1 millisievert) shall be:(A) kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;(B) instructed in the health protection problems associated with exposure to sources of radiation, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;(C) instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of agency requirements, licenses, and certificates of registration, for the protection of personnel from exposures to sources of radiation occurring in such areas;(D) instructed of their responsibility to report promptly to the licensee or registrant any condition that may constitute, lead to, or cause a violation of agency requirements, license conditions, or certificate of registration conditions, or unnecessary exposure to sources of radiation;(E) instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to sources of radiation; and(F) advised as to the radiation exposure reports that workers may request in accordance with subsection (d) of this section.(2) The extent of these instructions shall be commensurate with potential radiological health protection problems associated with the source(s) of radiation in the workplace.(d) Notifications and reports to individuals.(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be made available to the individual as specified in this section. The information reported shall include data and results obtained in accordance with agency requirements, orders, license or certificate of registration conditions, as shown in records maintained by the licensee or registrant in accordance with §289.202 or §289.231 of this title, as applicable. Each notification and report shall:(A) be in writing;(B) include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number;(C) include the individual's exposure information; and(D) contain the following statement: "This report is furnished to you under the provisions of the Texas Regulations for Control of Radiation, 25 Texas Administrative Code §289.203. You should preserve this report for further reference."(2) Each licensee or registrant shall provide an annual written report to advise each worker of the worker's dose, received in that monitoring year, as shown in records maintained by the licensee or registrant in accordance with §289.202(q), §289.202(rr) or §289.231(dd) of this title, as applicable, if:(A) the individual's occupational dose exceeds 100 mrem (1 mSv) total effective dose equivalent or 100 mrem (1 mSv) to any individual organ or tissue; or(B) the individual requests his or her annual dose report in writing.(3) At the written request of a worker formerly engaged in activities controlled by the licensee or registrant, each licensee or registrant shall furnish a written report of the worker's exposure to sources of radiation. The report shall include the dose record for each year the worker was required to be monitored in accordance with §289.202(q) or §289.231(n) of this title, as applicable. Such report shall be furnished within 30 days from the date of the request, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and the dates and locations of work under the license or certificate of registration in which the worker participated during this period.(4) When a licensee or registrant is required in accordance with §289.202(xx), (yy), and (zz) or §289.231(hh) and (ii) of this title, as applicable, to report to the agency any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report of that individual's exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the agency.(5) At the written request of a worker who is terminating employment with the licensee or registrant in work involving exposure to sources of radiation during the current year, each licensee or registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate. When the final individual monitoring results are available, those written results shall be provided to the worker or the worker's designee.(e) Presence of representatives of licensees or registrants and workers during inspection.(1) Each licensee or registrant shall afford to the agency at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records in accordance with this chapter.(2) During an inspection, agency inspectors may consult privately with workers as specified in subsection (f) of this section. The licensee or registrant may accompany agency inspectors during other phases of an inspection.(3) If, at the time of inspection, an individual has been authorized by the workers to represent them during agency inspections, the licensee or registrant shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.(4) Each workers' representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in subsection (c) of this section.(5) Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors.(6) With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany agency inspectors during the inspection of physical working conditions.(7) Notwithstanding the other provisions of this section, agency inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.(f) Consultation with workers during inspections.(1) Agency inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of agency regulations and licenses and/or certificates of registration to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.(2) During the course of an inspection any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which that individual has reason to believe may have contributed to or caused any violation of the Act, the requirements in this chapter, license or certificate of registration conditions, or any unnecessary exposure of an individual to radiation from any source of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements of subsection (g)(1) of this section.(3) The provisions of paragraph (2) of this subsection shall not be interpreted as authorization to disregard instructions in accordance with subsection (c) of this section.(g) Requests by workers for inspections.(1) Any worker or representative of workers who believes that a violation of the Act, the requirements of this chapter, or license or certificate of registration conditions exists or has occurred in work under a license or certificate of registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the agency. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the agency no later than at the time of inspection except that, upon the request of the worker giving such notice, the worker's name and the name(s) of individual(s) referred to therein shall not appear in such copy or on any record published, released, or made available by the agency, except for good cause shown.(2) If, upon receipt of such notice, the agency determines that the request meets the requirements set forth in paragraph (1) of this subsection, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspections in accordance with this section need not be limited to matters referred to in the request.(3) No licensee or registrant, contractor or subcontractor of a licensee or registrant shall discharge or in any manner discriminate against any worker because of the following:(A) such worker has filed any request or instituted or caused to be instituted any proceeding under this chapter;(B) such worker has testified or is about to testify in any such proceeding; or(C) because of the exercise by such worker on behalf of that individual or others of any option afforded by this section.(h) Inspections not warranted.(1) If the agency determines, with respect to a request under subsection (g) of this section, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the agency shall notify the requestor in writing of such determination. The requestor may obtain review of such determination in accordance with the provisions of the Act and the Government Code, Chapters 2001 and 2002.(2) If the agency determines that an inspection is not warranted because the requirements of subsection (g)(1) of this section have not been met, the agency shall notify the requestor in writing of such determination. Such determination shall be without prejudice to the filing of a new request meeting the requirements of subsection (g)(1) of this section.(i) Notice to employees. The following form, RC Form 203-1, or an equivalent as stated in subsection (b)(3) of this section, shall be posted.Attached Graphic Source Note: The provisions of this §289.203 adopted to be effective June 7, 1998, 23 TexReg 5968; amended to be effective February 7, 2002, 27 TexReg 912; amended to be effective February 18, 2010, 35 TexReg 1223; amended to be effective October 1, 2011, 36 TexReg 5851. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL D GENERAL §289.203 Notices, Instructions, and Reports to Workers; Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168975&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168975 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=168975&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 168975 03/11/2026 (a) Purpose. The requirements in this section establish fees for licensing, registration, emergency planning and implementation, and other regulatory services, and provide for their payment. (b) Scope. Except as otherwise specifically provided, the requirements in this section apply to any person who is the following: (1) an applicant for, or holder of: (A) a radioactive material license issued in accordance with §289.252 of this title (relating to Licensing of Radioactive Material), or §289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)); or (B) a general license acknowledgment issued in accordance with §289.251 of this title (relating to Exemptions, General Licenses, and General License Acknowledgments); or (C) a certificate of registration for radiation machines and/or services, or sources of laser radiation, issued in accordance with §289.226 of this title (relating to Registration of Radiation Machine Use and Services), §289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography), a certificate of registration for dental radiation machines in accordance with §289.232 of this title (relating to Radiation Control Regulations for Dental Radiation Machines), a certificate of registration for radiation machines used in veterinary medicine in accordance with §289.233 of this title (relating to Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine), §289.234 of this title (relating to Mammography Accreditation), or §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices); or (2) the holder of a fixed nuclear facility construction permit or operating license issued by the United States Nuclear Regulatory Commission (NRC) in accordance with Title 10, Code of Federal Regulations, Part 50; or (3) the operator of any other fixed nuclear facility. (c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise. (1) Contiguous properties--Those locations adjacent to an existing licensed or permitted area. (2) Decontamination services--Providing deliberate operations to reduce or remove residual radioactivity from equipment, facilities, and land owned, possessed, or controlled by other persons to a level that permits release of equipment, facilities, and land for unrestricted use and/or termination of a license. (3) Emergency planning and implementation--The development and application of those capabilities necessary for the protection of the public and the environment from the effects of an accidental or uncontrolled release of radioactive materials, including the equipping, training and periodic retraining of response personnel. (4) Fixed nuclear facility--The following are considered fixed nuclear facilities: (A) any nuclear reactor(s) at a single site; (B) any facility designed or used for the assembly or disassembly of nuclear weapons; or (C) any other facility using special nuclear material for which the agency conducts off-site environmental surveillance and/or emergency planning and implementation to protect the public health and safety or the environment. (5) Limited manufacturer--A manufacturer/distributor of radioactive material that is not required to submit a decommissioning funding plan or an emergency plan in accordance with §289.252 of this title. (6) Processor of radioactive material--A manufacturer/distributor who converts normal form radioactive material into special form or a manufacturer/distributor of radioactive sealed sources. (d) Payment of fees. (1) Each application for a specific license, general license acknowledgement, or certificate of registration for which a fee is prescribed in subsection (e), (g), or (j) of this section shall be accompanied by a nonrefundable fee equal to the appropriate fee. Each request for evaluation of a sealed source and/or device shall be accompanied by a nonrefundable fee prescribed in subsection (f) of this section. Each application for accreditation of a mammography facility shall be accompanied by a nonrefundable fee prescribed in subsection (h) of this section. Each application for an industrial radiographer certification and an industrial radiographer examination shall be accompanied by a nonrefundable and non-transferable fee prescribed in subsection (i) of this section. (A) An application for a license covering more than one category of specific license shall be accompanied by the prescribed fee for the highest category and 25% of the applicable prescribed fee for each additional requested category. (B) An application for a certificate of registration covering more than one category shall be accompanied by the prescribed fee for the highest category. (C) No application will be accepted for filing or processed prior to payment of the full amount specified. (2) A nonrefundable fee, in accordance with subsection (e) of this section shall be paid for each radioactive material license and/or for each general license acknowledgement. The fee shall be paid every two years based on the month listed as the expiration month on the license or general license acknowledgement and shall be paid in full on or before the last day of the expiration month. In the case of a single license that authorizes more than one category of use, the fee shall be the prescribed fee for the highest license category plus 25% of the applicable prescribed fee for each additional license category authorized. (3) A nonrefundable fee, in accordance with subsection (j) of this section, shall be paid for each certificate of registration for radiation machines and/or services, or sources of laser radiation. The fee shall be paid every two years based on the month listed as the expiration month on the certificate of registration and shall be paid in full on or before the last day of the expiration month. For certificates of registration with no specified expiration date, payment shall be paid in full on or before the due date stated on the invoice. (4) In the case of a single certificate of registration that authorizes more than one category of machine/type of use, the category listed in subsection (j) of this section and assigned the higher fee will be used. (5) An additional nonrefundable fee equal to 5% of the total fee for each specific license shall be paid with the specified fee by each holder of a specific license, excluding licensees that are authorized only for diagnostic nuclear medicine. (A) The fees collected by the agency in accordance with this paragraph shall be deposited to the credit of the agency's Radiation and Perpetual Care Account. (B) The agency shall collect the fees in accordance with this paragraph so long as the sum of the balances of the perpetual care accounts specified under Health and Safety Code, §401.307, does not exceed $100 million; and if the sum of such balances subsequently is reduced to $50 million or less, the agency shall reinstitute assessment of the fee until the sum of such balances reaches $100 million. (6) Each application for reciprocal recognition of an out-of-state license in accordance with §289.252(s) of this title, an out-of-state registration in accordance with §289.226 of this title, or an out-of-state laser registration in accordance with §289.301 of this title, shall be accompanied by the applicable fee, provided that no such fee has been submitted within 24 months of the date of commencement of the proposed activity. (7) Each holder of a fixed nuclear facility construction permit or operating license or an operator of any other fixed nuclear facility shall submit an annual fee for services received. This fee shall recover for the State of Texas the actual expenses arising from environmental surveillance and emergency planning and implementation activities. Payment shall be made within 90 days following the date of invoice. (8) Fee payments shall be in cash or by check or money order made payable to the Department of State Health Services. The payments may be made by personal delivery to the central office, Radiation Control, Department of State Health Services, 1100 West 49th Street, Austin, Texas, or mailed to Radiation Control, Department of State Health Services, P.O. Box 149347, MC 2003, Austin, Texas, 78714-9347. (9) Any applicant requesting authorization for any of the categories in subsection (e) of this section for veterinary use will be assessed the fee for the corresponding category. (e) Schedule of fees for radioactive material licenses. The following schedule contains the fees for radioactive material licenses: Attached Graphic(f) Fee for evaluation of a sealed source and/or device. (1) Each time a manufacturer submits a request for evaluation of a unique sealed source, one of the following fees shall be paid: (A) for an initial evaluation, a fee of $5,320; or (B) for an amendment requiring re-evaluation, a fee of $2,660. (2) Each time a manufacturer submits a request for evaluation of a unique device, one of the following fees shall be paid: (A) for an initial evaluation, a fee of $10,650; or (B) for an amendment requiring re-evaluation, a fee of $5,330. (3) A manufacturer shall pay a $1,000 record maintenance fee, beginning one year after initial sealed source and device authorization listing and every two years thereafter. (4) No request for evaluation will be processed prior to payment of the full amount specified. (g) Fees for certification of mammography systems and mammography machines used for interventional breast radiography. No application will be accepted for filing or processed prior to payment of the full amount specified in paragraph (1) of this subsection. (1) An application for certification of mammography systems shall be accompanied by a nonrefundable fee of $2,010. Additional mammography systems that have not been assigned a separate United States Food and Drug Administration (FDA) identification number shall be authorized on the same certification. A nonrefundable fee of $240 for each additional mammography system on the same certification shall be included in the nonrefundable application fee. (2) The annual fee for mammography systems is $2,010. A fee of $240 for each additional mammography system on the same certification shall be included in the annual fee. (3) Fees for mammography machines used for interventional breast radiography shall be as follows: (A) An application for certification of machines used for interventional breast radiography shall be accompanied by a nonrefundable fee of $490. A nonrefundable fee of $240 for each machine used for interventional breast radiography on the same certification shall be included in the nonrefundable application fee. (B) The annual fee for machines used for interventional breast radiography is $490. A fee of $240 for each additional machine used for interventional breast radiography on the same certification shall be included in the annual fee. (h) Fees for accreditation of mammography facilities. (1) Each application for accreditation or re-accreditation of a mammography facility shall be accompanied by a nonrefundable fee. No application will be accepted for filing or processed prior to payment of the full amount specified in paragraph (2) of this subsection. (2) Fees for accreditation of mammography facilities are as follows. (A) The accreditation fee for the first mammography machine is $1,025. (B) The accreditation fee for each additional mammography machine is $610. (C) The fee for re-evaluation of clinical images due to failure during the accreditation process is $330 per mammography machine. (D) The fee for re-evaluation of phantom images due to failure during the accreditation process is $300 per machine. (E) The fee for an additional mammography review will be based on the number of clinical image sets reviewed and the type of review. (F) The fee for reinstatement of a mammography machine is $610. (G) Each facility for which a targeted clinical image review is required will be charged for actual expenses to the agency arising from the visit. (H) The fee for the review of clinical images for dual modality mammography machines, if utilized, is $330 for the alternative modality. (I) Each facility for which an on-site visit due to three denials of accreditation is required will be charged for actual expenses to the agency arising from such visit. (J) Payment of the fees in subparagraphs (G) and (I) of this paragraph shall be made within 60 days following the date of invoice. (i) Fees for industrial radiographer certification and for radiographer certification examinations. (1) The nonrefundable and non-transferable application fee for examination shall be $120 and shall be submitted to the agency with the application for examination. (2) The nonrefundable application fee for radiographer certification shall be $110 and shall be submitted to the agency with the application for radiographer certification. (j) Schedule of fees for certificates of registration for radiation machines, lasers, and services. The following schedule contains the fees for certificates of registration for radiation machines, lasers, and services. As of January 1, 2012, the fees for the dental radiographic only category and the veterinary category, as specified in the following schedule, are the applicable fees for those categories. Attached Graphic(k) Annual fees for environmental surveillance and emergency planning and implementation. Fees shall be set annually by the agency for each facility. Fees for fixed nuclear facilities shall be the actual expenses for environmental surveillance and emergency planning and implementation activities. Costs of activities benefiting more than one facility shall be prorated. (l) Failure to pay prescribed fees. (1) In any case where the agency finds that an applicant for a license or certificate of registration has failed to pay the fee prescribed in this section, the agency will not process that application until such fee is paid. (2) In any case where the agency finds that a licensee or registrant has failed to pay a fee prescribed by this section by the due date, the agency may implement compliance procedures as provided in §289.205 of this title (relating to Hearing and Enforcement Procedures). (3) In any case where the agency finds that a fixed nuclear facility has failed to pay fees for environmental surveillance or emergency planning and implementation within 90 days following date of invoice, the agency may issue an order to show cause why those services should not be terminated. (m) Electronic fee payments. Renewal payments may be processed through texas.gov or another electronic payment system specified by the agency. For all types of electronic fee payments, the agency will collect additional fees, in amounts determined by texas.gov to recover costs associated with electronic payment processing. Source Note: The provisions of this §289.204 adopted to be effective February 10, 1998, 23 TexReg 1045; amended to be effective September 1, 1998, 23 TexReg 5971; amended to be effective July 1, 2000, 25 TexReg 5348; amended to be effective May 1, 2002, 27 TexReg 3180; amended to be effective September 1, 2004, 29 TexReg 7308; amended to be effective February 1, 2006, 31 TexReg 509; amended to be effective April 30, 2007, 32 TexReg 2362; amended to be effective October 12, 2008, 33 TexReg 8326; amended to be effective January 1, 2012, 36 TexReg 8829; amended to be effective September 7, 2014, 39 TexReg 6861. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL D GENERAL §289.204 Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=134327&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 134327 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=134327&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 134327 03/11/2026 (a) Purpose. This section governs the following in accordance with the Texas Radiation Control Act (Act), the Texas Administrative Procedure Act, Texas Government Code, Chapter 2001, and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title (relating to the Texas Board of Health): (1) proceedings for the granting, denying, renewing, transferring, amending, suspending, revoking, or annulling of a: (A) license or certificate of registration; (B) accreditation of a mammography facility; or (C) industrial radiographer certification; (2) determining compliance with or granting of exemptions from the requirements of this chapter, order, or condition of the license or certificate of registration; (3) assessing administrative penalties; and (4) determining propriety of other agency orders. (b) Definitions. The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise. (1) Administrative penalty--A monetary penalty assessed by the agency in accordance with the Texas Radiation Control Act (Act), §401.384, to emphasize the need for lasting remedial action and to deter future violations. (2) Administrative Law Judge (ALJ)--Administrative law judge from the State Office of Administrative Hearings. (3) Applicant--A person seeking a license, certificate of registration, accreditation of mammography facility, or industrial radiographer certification, issued in accordance with the provisions of the Act and the requirements in this chapter. (4) Certified industrial radiographer--An individual who meets the definition of radiographer as stated in §289.255(c) of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography). (5) Commissioner--The commissioner of the Texas Department of State Health Services. (6) Contested case--A proceeding in which the agency determines the legal rights, duties, or privileges of a party after an opportunity for adjudicative hearing. (7) Director--The director of the radiation control program in accordance with the agency's jurisdiction. (8) Hearing--A proceeding to examine an application or other matter before the agency in order to adjudicate rights, duties, or privileges. (9) Informal Conference--A meeting held by the department with a person to discuss the following: (A) safety, safeguards, or environmental problems; (B) compliance with regulatory, license condition, or registration condition requirements; (C) proposed corrective measures including, but not limited to, schedules for implementation; and (D) enforcement options available to the department. (10) Interested person--A person who participates in a hearing concerning a contested case but who is not admitted as a party by the ALJ. (11) Major amendment--An amendment to a license issued in accordance with the requirements of §289.260 of this title (relating to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities) that: (A) reflects a transfer of ownership of the licensed facility; (B) authorizes enlargement of the licensed area beyond the boundaries of the existing license; (C) authorizes a change of the method specified in the license for disposal of byproduct material as defined in the Act, §401.003(3)(B); or (D) grants an exemption from any provision of §289.260 of this title. (12) Notice of violation--A written statement prepared by the department of one or more alleged infringements of a legally binding requirement. (13) Order--A specific directive contained in a legal document issued by the agency. (14) Party--A person designated as such by the ALJ. A party may consist of the following: (A) the agency; (B) an applicant, licensee, registrant, accredited mammography facility, or certified industrial radiographer; and (C) any person affected. (15) Person affected--A person who demonstrates that the person has suffered or will suffer actual injury or economic damage and, if the person is not a local government, is: (A) a resident of a county, or a county adjacent to the county, in which radioactive material is or will be located; or (B) doing business or has a legal interest in land in the county or adjacent county. (16) Preliminary report--A document prepared by the agency containing the following: (A) a statement of facts on which the agency bases the conclusion that a violation has occurred; (B) recommendations that an administrative penalty be imposed on the person charged; (C) recommendations for the amount of that proposed penalty; and (D) a statement that the person charged has a right to a hearing on the occurrence of the violation, the amount of the penalty, or both. (17) Radiation and Perpetual Care Account--An account established for the purposes described in the Act, §401.305. (18) Requestor--A person claiming party status as a person affected. (19) Severity level--A classification of violations based on relative seriousness of each violation and the significance of the effect of the violation on the occupational or public health or safety or the environment. (20) Violation--An infringement of any rule, license or registration condition, order of the agency, or any provision of the Act. (c) Procedures for licensing actions in accordance with the Act, §401.054. (1) Except as provided in subsections (d) - (f) of this section, when the agency grants, renews, denies, transfers, or amends any specific license for the possession of radioactive materials, or grants exemptions from requirements of this chapter, orders, or licenses in accordance with the Act, the agency shall, no later than 30 days following the end of the month in which the action was taken, submit notice of the action for publication in the Texas Register. The action taken will remain in full force and effect unless and until modified by subsequent action of the agency. (2) Any person who considers himself/herself a person affected by an agency action described in paragraph (1) of this subsection or any applicant/licensee may request a hearing by submitting a written request to the director within 30 days after the notice is published in the Texas Register. (A) The request for a hearing must contain the following: (i) name and address of the person/applicant/licensee who considers himself/herself affected by agency action; (ii) identification of the subject license; (iii) reasons why the person/applicant/licensee considers himself/herself affected; (iv) relief sought; and (v) name and address of the attorney if the applicant/licensee or requestor is represented by an attorney. (B) Failure to submit a written request for a hearing within 30 days could result in denial of party status and render the agency action final. (3) Either the applicant/licensee or the agency may contest the standing of a requestor as a person affected by motion filed with the ALJ no later than ten days prior to the hearing. The requestor has the burden of proof in a hearing to determine whether the requestor is a person affected. (4) The ALJ may designate parties at the commencement of the hearing on the merits. (5) A hearing may be scheduled by the agency regardless of whether a request for a hearing has been received. (d) Special procedures for issuing, renewing, or amending byproduct material licenses in accordance with §289.260 of this title. (1) When the agency determines that the issuance or renewal, in accordance with §289.260 of this title, of a license to process materials resulting in byproduct material or to dispose of byproduct materials as defined in the Act, §401.003(3)(B), will have a significant impact on the human environment, the agency shall prepare or secure a written analysis of the impact and make it available to the public for written comment at least 30 days before a public hearing, if any, on the issuance or renewal of the license. (2) At least 30 days prior to the issuance of a new license, renewal, or major amendment, a notice of such action will be published in the following: (A) Texas Register; and (B) a newspaper published in each county in which the proposed facility is located or, in which the proposed facility will be located. The applicant/licensee shall do the following: (i) cause notice of the proposed action to be published and pay for the publication of the newspaper notice(s); and (ii) file proof of publication required in this subparagraph with the agency within 30 days of publication. An affidavit by the publisher accompanied by a printed copy of the notice as published shall be conclusive evidence of publication. (3) The notice referenced in paragraph (2) of this subsection shall contain at least the following: (A) statement identifying the location of the proposed facility and a summary of the proposed actions; (B) availability of an environmental analysis for the proposed facility; and (C) offer of an opportunity for a hearing to any person affected. (4) When a hearing is requested in writing within 30 days after publication of the notice described in paragraph (2) of this subsection, the procedures described in subsection (c)(3) and (4) of this section and Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title apply. Failure to submit a written request for a hearing in the form specified by subsection (c)(2) of this section within 30 days may result in no hearing being held and the proposed agency action being taken. (5) A hearing may be scheduled by the agency regardless of whether a request for a hearing has been received. (e) Special procedures for issuing or renewing licenses to process or store radioactive waste from other persons in accordance with §289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities). (1) At least 30 days prior to issuance or renewal of a license to process or store radioactive waste from other persons, in accordance with §289.254 of this title, a notice of such action will be published in the following: (A) Texas Register; and (B) a newspaper published in each county in which the proposed facility is located or, in which the proposed facility will be located. The applicant/licensee shall do the following: (i) cause notice to be published and pay for the publication of the newspaper notice(s); and (ii) file proof of publication of the notice required in paragraph (1)(B) of this subsection with the agency within 30 days of publication. An affidavit by the publisher accompanied by a printed copy of the notice as published shall be conclusive evidence of publication. (2) The notice specified in paragraph (1) of this subsection shall contain at least the following: (A) the agency's intent to issue or renew a license in accordance with §289.254 of this title; (B) location of the proposed facility; (C) in the case of a Category III storage or processing facility, the availability of an environmental analysis for each proposed activity the agency determines has a significant impact on the human environment; and (D) opportunity for a person affected to request a hearing. (3) A hearing will be held only when requested, unless scheduled by the agency on its own motion. When a hearing is requested in writing by the date stated in the notice described in paragraph (1) of this subsection, the procedures described in subsection (c)(3) and (4) of this section and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title apply. Failure to submit a written request for a hearing in the form prescribed in subsection (c)(2) of this section on or before the stated date could result in denial of party status and in issuance or renewal of the license by the commissioner. (A) Notice of the hearing shall be published in the following: (i) Texas Register; and (ii) a newspaper published in each county in which the proposed facility is located or, in which the proposed facility will be located. (B) Notice of the hearing shall contain the subject, time, date, and location of the hearing. (C) The applicant/licensee shall cause notice to be published and pay for the publication of the newspaper notice(s). (D) The applicant/licensee shall file proof of publication of the notice required in subparagraph (A)(ii) of this paragraph with the agency at least ten days before the hearing. An affidavit by the publisher accompanied by a printed copy of the notice as published shall be conclusive evidence of publication. (E) If no newspaper is published in the county or counties in which the proposed facility is to be located, a written copy of the notice of hearing shall be posted at the courthouse door and five other public places in the immediate locality to be affected for at least 30 days prior to the beginning of the hearing. (F) The return of service by the sheriff or constable, or the affidavit of any credible person made on a written copy of the notice so posted showing the fact of the posting and filed with the agency at least ten days prior to the hearing date shall be conclusive evidence of posting. (G) The applicant/licensee shall give written notice of the hearing by certified mail, addressed to the last known address, to persons shown on the current county tax records as owning property adjacent to the proposed site. The written notice shall contain the same information described in subparagraph (B) of this paragraph. (i) The applicant/licensee shall furnish the agency with a list of names and addresses of the adjacent property owners no later than ten days before the hearing. (ii) The list of names and addresses will be deemed accurate and valid if obtained from the current county tax records of the county where the adjacent property is located as of the mailing date of the notice of hearing. The information shall be certified by an appropriate county official. (iii) The applicant/licensee shall certify to the mailing of the notice of hearing by certified mail, and proof of mailing to the proper address or the receipt shall be accepted at the hearing as conclusive evidence of the fact of the mailing. (H) Failure to comply with the provisions of subparagraphs (A)(ii), (E), and (G) of this paragraph may result in denial of the license. (f) Special procedures for amending waste licenses in accordance with §289.254 of this title. (1) If the agency amends a license to process or store radioactive waste, in accordance with §289.254 of this title, the amendment will take effect immediately. (2) Notice of amendment shall be published one time in the following: (A) Texas Register; (B) a newspaper of general circulation in the county or counties in which the licensed activity is located. The licensee shall file with the agency, within 30 days of publication, proof of publication of the notice. (3) The licensee shall cause notice to be published and pay for publication of the newspaper notice(s). (4) An affidavit from the publisher accompanied by a printed copy of the notice as published shall be conclusive evidence of publication. (5) The notice shall contain the following: (A) identity of the licensee and the license amended; (B) a concise statement of the substance of the amendment; and (C) opportunity for a person affected to request a hearing. (6) The agency shall notify any person who has submitted an advance, written request to be notified of any proposed amendment to the license. Proof of mailing to the proper address shall be conclusive evidence of the agency's compliance. (7) A person who considers himself/herself a person affected may request the agency to hold a hearing by writing the director, in the manner provided by subsection (c)(2) of this section, no later than 30 days after the notice is published. Failure to submit a written request for a hearing within 30 days could result in denial of party status and render the agency action final. (8) Upon receipt of a request for hearing, the agency or the licensee may follow the procedures set out in subsection (c)(3) and (4) of this section to contest standing. (9) Notice of a hearing on the merits shall be given in accordance with appropriate provisions of subsection (e)(3) of this section. (g) Revocation of accreditation of mammography facilities. (1) An accreditation of a mammography facility may be revoked, for any of the following: (A) any material false statement in the application or any statement of fact required in accordance with the Act; (B) conditions revealed by such application or statement of fact or any report, record, inspection, or other means that would warrant the agency to refuse to grant an accreditation of mammography facility on an original application; or (C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or order of the agency. (2) Before the agency revokes an accreditation of mammography facility, the agency shall give notice by personal service or by certified mail, addressed to the last known address, of the facts or conduct alleged to warrant the revocation by complaint, and order the accredited mammography facility to show cause why the mammography facility accreditation should not be revoked. The accredited mammography facility shall be given an opportunity to request a hearing on the matter no later than 30 days after service of the notice. (3) Any accredited mammography facility against whom the agency contemplates an action described in paragraph (1) of this subsection may request a hearing by submitting a written request to the director within 30 days of service of the notice. (A) The written request for a hearing must contain the following: (i) statement requesting a hearing; (ii) name, address, and identification number of the accredited mammography facility against whom the action is being taken. (B) Failure to submit a written request for a hearing within 30 days will render the agency action final. (h) Denial of an application for a license, certificate of registration, accreditation of a mammography facility, or industrial radiographer certification. (1) When the agency contemplates denial of an application for a license, certificate of registration, accreditation of a mammography facility, or industrial radiographer certification, the licensee, registrant, mammography facility seeking accreditation, or certified industrial radiographer shall be afforded the opportunity for a hearing. Notice of the denial shall be delivered by personal service or certified mail, addressed to the last known address, to the licensee, registrant, mammography facility seeking accreditation, or certified industrial radiographer. (2) Any applicant, licensee, registrant, mammography facility seeking accreditation, or certified industrial radiographer against whom the agency contemplates an action described in paragraph (1) of this subsection may request a hearing by submitting a written request to the director within 30 days of service of the notice. (A) The written request for a hearing must contain the following: (i) statement requesting a hearing; and (ii) name and address of the applicant, licensee, registrant, mammography facility seeking accreditation, or certified industrial radiographer; (B) Failure to submit a written request for a hearing within 30 days will render the agency action final. (i) Compliance procedures for licensees, registrants, certified industrial radiographers, and other persons. (1) A licensee, registrant, certified industrial radiographer, or other person who commits a violation(s) will be issued a notice of violation. The person receiving the notice shall provide the agency with a written statement and supporting documentation by the date stated in the notice describing the following: (A) steps taken by the person and the results achieved; (B) corrective steps to be taken to prevent recurrence; and (C) the date when full compliance was or is expected to be achieved. The agency may require responses to notices of violation to be under oath. (2) The terms and conditions of all licenses and certificates of registration shall be subject to amendment or modification. A license, certificate of registration, or industrial radiographer certification may be modified, suspended, or revoked by reason of amendments to the Act, or for violation of the Act, the requirements of this chapter, a condition of the license, certificate of registration, or an order of the agency. (3) Any license, certificate of registration, or industrial radiographer certification may be modified, suspended, or revoked in whole or in part, for any of the following: (A) any material false statement in the application or any statement of fact required in accordance with provisions of the Act; (B) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a license, certificate of registration, or industrial radiographer certification on an original application; or (C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or of the license, certificate of registration, or industrial radiographer certification or order of the agency; or (D) existing conditions that constitute a substantial threat to the public health or safety or the environment. (4) If another state or federal entity takes an action such as modification, revocation, or suspension of the license, certificate of registration, or industrial radiographer certification, the agency may take a similar action against the licensee, registrant, or certified industrial radiographer. (5) When the agency determines that the action provided for in paragraph (8) of this subsection or subsection (j) of this section is not to be taken immediately, the agency may offer the licensee, registrant, or certified industrial radiographer an opportunity to attend an informal conference to discuss the following with the agency: (A) methods and schedules for correcting the violation(s); or (B) methods and schedules for showing compliance with applicable provisions of the Act, the rules, license or registration conditions, or any orders of the agency. (6) Notice of any informal conference shall be delivered by personal service, or certified mail, addressed to the last known address. An informal conference is not a prerequisite for the action to be taken in accordance with paragraph (8) of this subsection or subsection (j) of this section. (7) Except in cases in which the occupational and public health, or safety requires otherwise, no license, certificate of registration, or industrial radiographer certification shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the licensee, registrant, or certified industrial radiographer in writing, and the licensee, registrant, or certified industrial radiographer shall have been afforded an opportunity to demonstrate compliance with all lawful requirements. (8) When the agency contemplates modification, suspension, or revocation of the license, certificate of registration, or industrial radiographer certification, the licensee, registrant, or certified industrial radiographer shall be afforded the opportunity for a hearing. Notice of the contemplated action, along with a complaint, shall be given to the licensee, registrant, or certified industrial radiographer by personal service or certified mail, addressed to the last known address. (9) Any applicant, licensee, registrant, or certified industrial radiographer against whom the agency contemplates an action described in paragraph (8) of this subsection may request a hearing by submitting a written request to the director within 30 days of service of the notice. (A) The written request for a hearing must contain the following: (i) statement requesting a hearing; (ii) name, address, and identification number of the licensee, registrant, or certified industrial radiographer against whom the action is being taken. (B) Failure to submit a written request for a hearing within 30 days will render the agency action final. (j) Assessment of administrative penalties. (1) When the agency determines that monetary penalties are appropriate, proposals for assessment of and hearings on administrative penalties shall be made in accordance with the Act, §401.384, and applicable sections of the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title. (2) Assessment of administrative penalties shall be based on the following criteria: (A) the seriousness of the violation(s); (B) previous compliance history; (C) the amount necessary to deter future violations; (D) efforts to correct the violation; and (E) any other mitigating or enhancing factors. (3) Application of administrative penalties. The agency may impose differing levels of penalties for different severity level violations and different classes of users as follows. (A) Administrative penalties may be imposed for severity level I and II violations. Administrative penalties may be imposed for severity level III, IV, and V violations when they are combined with those of higher severity level(s) or for repeated violations. (B) The following Tables IA and IB show the base administrative penalties. Attached Graphic(C) Adjustments to the percentages of base amounts in Table IB may be made for the presence or absence of the following factors: (i) prompt identification and reporting; (ii) corrective action to prevent recurrence; (iii) compliance history; (iv) prior notice of similar event; (v) multiple occurrences; and (vi) negligence that resulted in or increased adverse effects. (D) The penalty for each violation may be in an amount not to exceed $10,000 a day for a person who violates the Act or a rule, order, license or registration issued in accordance with the Act. Each day a violation continues may be considered a separate violation for purposes of penalty assessment. (4) The department may conduct settlement negotiations. (k) Severity levels of violations for licensees, registrants, certified industrial radiographers, or other persons. (1) Violations for licensees, registrants, certified industrial radiographers, or other persons shall be categorized by one of the following severity levels. (A) Severity level I are violations that are most significant and may have a significant negative impact on occupational and/or public health and safety or on the environment. Severity level I violations are most significant and may have a significant negative impact by increasing the risk of unauthorized use of radioactive material that would be detrimental to public health and safety. (B) Severity level II are violations that are very significant and may have a negative impact on occupational and/or public health and safety or on the environment. Severity level II violations are very significant and may have a negative impact by increasing the risk of unauthorized use of radioactive material that would be detrimental to public health and safety. (C) Severity level III are violations that are significant and which, if not corrected, could threaten occupational and/or public health and safety or the environment. Severity level III are significant and, if not corrected, could increase the risk of unauthorized use of radioactive material that would be detrimental to public health and safety. (D) Severity level IV are violations that are of more than minor significance, but if left uncorrected, could lead to more serious circumstances. (E) Severity level V are violations that are of minor safety or environmental significance. (2) Additional violations for mammography registrants. Violations for mammography registrants shall be categorized by one of the following severity levels. (A) Severity level I violations indicate a serious noncompliance that may adversely affect image quality or that may compromise the quality of mammography services. (B) Severity level II violations indicate key quality system requirements are being met, but there is a failure to meet one or more quality standards that may lead to a compromise of the quality of mammography services. (C) Severity level III violations indicate that the quality system requirements are being met, but minor corrective actions are required for compliance with the quality standards. (D) Severity level IV violations indicate that the quality system requirements and standards are being met, but minor corrective actions are required for compliance. (3) Criteria to elevate or reduce severity levels. (A) Severity levels may be elevated to a higher severity level for the following reasons: (i) more than one violation resulted from the same underlying cause; (ii) a violation contributed to or was the consequence of the underlying cause, such as a management breakdown or breakdown in the control of licensed or registered activities; (iii) a violation occurred multiple times between inspections; (iv) a violation was willful or grossly negligent; (v) compliance history; or (vi) other mitigating factors. (B) Severity levels may be reduced to a lower level for the following reasons: (i) the licensee/registrant identified and corrected the violation prior to the agency inspection; (ii) the licensee/registrant's actions corrected the violation and prevented recurrence; or (iii) other mitigating factors. (4) Examples of severity levels. Examples of severity levels are available upon request to the agency. (l) Impoundment of sources of radiation. (1) In the event of an emergency, the agency shall have the authority to impound or order the impounding of sources of radiation possessed by any person not equipped to observe or failing to observe the provisions of the Act, or any rules, license or registration conditions, or orders issued by the agency. The agency shall submit notice of the action to be published in the Texas Register no later than 30 days following the end of the month in which the action was taken. (2) At the agency's discretion, the impounded sources of radiation may be disposed of by: (A) returning the source of radiation to a properly licensed or registered owner, upon proof of ownership, who did not cause the emergency; (B) releasing the source of radiation as evidence to police or courts; (C) returning the source of radiation to a licensee or registrant after the emergency is over and settlement of any compliance action; or (D) sale, destruction or other disposition within the agency's discretion. (3) If agency action is necessary to protect the public health and safety, no prior notice need be given the owner or possessor. If agency action is not necessary to protect the public health and safety, the agency will give written notice to the owner and/or the possessor of the impounded source of radiation of the intention to dispose of the source of radiation. Notice shall be the same as provided in subsection (i)(8) of this section. The owner or possessor shall have 30 days from the date of personal service or mailing to request a hearing in accordance with 1 TAC, Chapter 155, and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title, and in accordance with subsection (i)(9) of this section, concerning the intention of the agency. If no hearing is requested within that period of time, the agency may take the contemplated action, and such action is final. (4) Upon agency disposition of a source of radiation, the agency may notify the owner and/or possessor of any expense the agency may have incurred during the impoundment and/or disposition and request reimbursement. If the amount is not paid within 60 days from the date of notice, the agency may request the Attorney General to file suit against the owner/possessor for the amount requested. (5) If the agency determines from the facts available to the agency that an impounded source of radiation is abandoned, with no reasonable evidence showing its owner or possessor, the agency may make such disposition of the source of radiation as it sees fit. (m) Emergency orders. (1) When an emergency exists requiring immediate action to protect the public health or safety or the environment, the agency may, without notice or hearing, issue an order citing the existence of such emergency and require that certain actions be taken as it shall direct to meet the emergency. The agency shall, no later than 30 days following the end of the month in which the action was taken, submit notice of the action for publication in the Texas Register. The action taken will remain in full force and effect unless and until modified by subsequent action of the agency. (2) In addition to the requirements of paragraph (1) of this subsection, the agency shall issue an order directing any action and corrective measure needed to remedy or neutralize the following emergency situations: (A) when the agency determines that byproduct material as defined in the Act, §401.003(3)(B), or the operation generating the byproduct material, or that radioactive waste threatens the public health or safety or the environment; and (B) if the person managing the byproduct material, or the operation generating the byproduct material or the radioactive waste, is unable to correct or neutralize the threat. (3) An emergency order takes effect immediately upon service. (4) Any person receiving an emergency order shall comply immediately. (5) The agency shall use any security provided by a licensee in accordance with the Act to pay toward the costs of such actions and corrective measures taken. If the cost of actions and corrective measures require more funds than the security has provided, the agency shall request the Attorney General to seek reimbursement from the licensee or person causing the threat. (A) The agency may send a copy of its order specified in this subsection to the Comptroller of Public Accounts together with necessary documents authorizing the Comptroller of Public Accounts to enforce security supplied by the licensee, convert the necessary amount of security into cash, and disburse from this security in the fund the amount necessary to pay costs of the agency actions and corrective measures. The agency shall direct the comptroller as to the amounts and recipients of the funds. (B) The agency may request the Attorney General to file suit for reimbursement if the agency uses security from the Radiation and Perpetual Care Account to pay for actions or corrective measures to remedy spills or contamination by radioactive material resulting from a violation of the Act or requirements of this chapter, license, or order of the agency. (6) The person receiving the order shall be afforded the opportunity for a hearing on an emergency order. Notice of the action, along with a complaint, shall be given to the person by personal service or certified mail, addressed to the last known address. A hearing shall be held on an emergency order if the person receiving the order submits a written request to the director within 30 days of the date of the order. (A) The hearing shall be held not less than 10 days nor more than 20 days after receipt of the written application for hearing. (B) At the conclusion of the hearing and after the proposal for decision is made as provided in the Texas Administrative Procedure Act, Texas Government Code, Chapter 2001, the commissioner shall take one of the following actions: (i) determine that no further action is warranted; (ii) amend the license or certificate of registration; (iii) revoke or suspend the license, certificate of registration, or industrial radiographer certification; (iv) rescind the emergency order; or (v) issue such other order as is appropriate. (C) The application and hearing shall not delay compliance with the emergency order. (n) Miscellaneous provisions. (1) Computation of time. A time period established by the requirements of this chapter shall begin on the first day after the event that invokes the time period. When the last day of the period falls on a Saturday, Sunday, or state or federal holiday, the period shall end on the next day that is not a Saturday, Sunday, or state or federal holiday. The time period shall expire at 5:00 p.m. of the last day of the computed period. (2) Interested person. (A) An interested person may: (i) make sworn or unsworn statements; (ii) attend a hearing and may present evidence after the presentation of evidence by the parties; or (iii) be represented by an attorney. (B) An interested person may not: (i) cross-examine the witnesses of the parties; (ii) object to evidence presented by the parties; or (iii) appeal a decision rendered by the agency. (C) An interested person is not responsible for sharing the costs of the transcription of the hearing, but may purchase a transcript. (D) The parties may cross-examine witnesses presented by an interested person. (E) At the discretion of the ALJ an interested person may make an unsworn statement. Such statement shall not be made a part of the record. (3) Hearing location. Hearings will be held at the offices of the State Office of Administrative Hearings in Austin unless the ALJ specifies another location. (4) Prepared testimony. The following shall apply to written testimony of a witness: (A) the testimony of a witness may be reduced to writing and offered into evidence as an exhibit, provided: (i) the witness is present and has been sworn; (ii) the witness identifies and adopts the written testimony as his/her own; and (iii) all parties receive a copy of the testimony at least ten days before its submission at the hearing. (B) written testimony shall be subject to objection and may be stricken by the ALJ. The witness shall be subject to cross-examination. (5) Prior testimony. Testimony and evidence presented in the hearing to determine standing have the same weight at the hearing on the merits if a tape recording or written transcript of the standing hearing is available. (6) Non-party witness and mileage fees. (A) A witness or deponent who is not a party (or an employee, agent, or representative of a party) and who is subpoenaed or otherwise compelled to attend an agency hearing or a proceeding to give a deposition, or to produce books, records, papers, accounts, documents, or other objects necessary and proper for the purposes of the hearing or proceeding may receive reimbursement for transportation and other costs at rates established by the current Appropriations Act for state employees. (B) The person requesting the attendance of the witness or deponent must deposit with the agency the funds estimated to accrue in accordance with subparagraph (A) of this paragraph when filing a motion for the issuance of a subpoena or a commission to take a deposition. (7) Service. A return of service by the person who performed personal service, postal return receipt, or proof of mailing to the last known address shall be conclusive evidence of service. Source Note: The provisions of this §289.205 adopted to be effective April 11, 1999, 24 TexReg 2668; amended to be effective December 28, 2003, 28 TexReg 11285; amended to be effective December 27, 2007, 32 TexReg 9633. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL D GENERAL §289.205 Hearing and Enforcement Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205604 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205604 03/11/2026 (a) Purpose. (1) This section provides for the registration of persons using radiation machines and persons who are in the business of providing radiation machine services. (2) Requirements for the registration of persons using radiation machines. (A) No person shall use radiation machines except as authorized in a certificate of registration issued by the Department of State Health Services (department) per the requirements of this section. (B) A person who receives, possesses, uses, owns, or acquires radiation machines before receiving a certificate of registration is subject to the requirements of this chapter.(b) Scope. (1) In addition to the requirements of this section, all registrants are subject to the requirements of:(A) §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections); (B) §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services); (C) §289.205 of this title (relating to Hearing and Enforcement Procedures); and (D) §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (2) Registrants using radiation machines in the healing arts are also subject to the requirements of §289.227 of this title (relating to Use of Radiation Machines in the Healing Arts). Morgues, educational facilities, and forensic medicine or investigations utilizing radiation machines for non-human use are subject to the specific requirements of §289.227 of this title. (3) Registrants using analytical and other industrial radiation machines, such as x-ray equipment used for cathodoluminescence, ion implantation, gauging, or electron beam welding, are subject to the requirements of §289.228 of this title (relating to Radiation Safety Requirements for Industrial Radiation Machines). (4) Registrants using accelerators, therapeutic radiation machines, simulators, and electronic brachytherapy devices are also subject to the requirements of §289.229 of this title (relating to Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices). (5) Registrants using mammography radiation machines are also subject to the requirements of §289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography) and §289.234 of this title (relating to Mammography Accreditation). (6) Registrants using radiation machines in industrial radiographic operations are also subject to the requirements of §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography). (7) Registrants using radiation machines in dental medicine are subject to the requirements of §289.232 of this title (relating to Radiation Control Regulations for Dental Radiation Machines). (8) Registrants using radiation machines in veterinary medicine are subject to the requirements of §289.233 of this title (relating to Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine). (9) Registrants using laser radiation machines are subject to the requirements of §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices). (10) To determine compliance with the requirements in this chapter for radiation machines, all radiation air kerma rate or dose measurements for fluoroscopy or computed tomography radiation machines shall be performed by a licensed medical physicist with a specialty in diagnostic medical physics. (11) For purposes of this section, radiation services include: (A) measurement of air kerma rate or dose measurements on radiation machines that are not for human use; (B) measurement of air kerma for human-use, general radiographic and special purpose radiation machines, as defined in §289.227 and §289.229 of this title, by or under the supervision of a licensed medical physicist;(C) performance of services specified in paragraph (10) of this subsection or services requiring a licensed medical physicist as specified in §289.227(e) and §289.229 of this title on radiation machines for human use;(D) demonstration and sale of radiation machines or imaging acquisition systems that require the individual to operate a radiation machine or cause a radiation machine to be energized; (E) assembly, installation or repair of a radiation machine to ensure it is operating according to manufacturer's specifications; (F) completion of equipment performance evaluations (EPE) on dental radiation machines and machines used in veterinary medicine; and (G) provision of radiation machines to a facility for limited periods. (12) For purposes of this section, a person providing the services described in paragraph (11)(G) of this subsection is a provider of equipment. (13) For purposes of this section, a practitioner of the healing arts is a person licensed to practice healing arts by either the Texas Medical Board as a physician, the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatric Medical Examiners. (14) For purposes of this section, a physician is an individual licensed by the Texas Medical Board. (15) For purposes of this section, a certified physician is a physician licensed by the Texas Medical Board and certified in radiation oncology or therapeutic radiology. (16) For purposes of this section, veterinary-use is the use of a radiation machine for the practice of veterinary medicine as defined by Texas Occupations Code Chapter 801. Animal research is not considered veterinary-use.(17) This section does not apply to an entity under the jurisdiction of the federal government. (c) Prohibitions. (1) No person shall cause the operation of a radiation machine that results in exposure of an individual to the useful beam for training, demonstration, or other non-healing arts purposes.(2) No person shall use radiation machines or perform radiation machine services except as authorized in a certificate of registration issued by the department per the requirements of this section.(3) Radiation machines shall be designated for human-use or veterinary-use but shall not be designated for both unless one of the following conditions are met:(A) the machine use is for human research conducted per subsection (u) of this section; or(B) the facility has applied for and received written authorization from the department.(d) Exemptions. (1) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this section, provided that the dose equivalent rate averaged over an area of 10 square centimeters (cm2 ) does not exceed 0.5 millirem per hour (mrem/hr)(0.005 mSv per hour (mSv/hr)) at 5 centimeters (cm) from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt. (2) Radiation machines in transit or storage incident to transit are exempt from the requirements of this section. This exemption does not apply to the providers of radiation machines for mobile services. (3) Facilities that have placed all radiation machines in storage, including on-site storage secured from unauthorized use or removal, and have notified the department in writing, are exempt from the requirements of this section. This exemption is void if any radiation machine is energized resulting in the production of radiation. Before resuming use of the machine(s) for human use, the machine shall meet all requirements of this section. (4) Inoperable radiation machines are exempt from the requirements of this section. For this section, an inoperable radiation machine means a radiation machine that cannot be energized when connected to a power supply without repair or modification. (5) Domestic television receivers, video display terminals, transmission microscopes, and electron microscopes, including the servicing of such devices, are exempt from the requirements of this section. (6) A person that takes possession of a radiation machine as the result of foreclosure, bankruptcy, or other default of payment may possess the machine without registering it. If the machine is energized, it shall be under the supervision of a person registered per this section and shall be energized only to demonstrate that the machine is operable for sale, lease, or transfer purposes. (7) Facilities, including academic institutions and research or development facilities, registered for the use of radiation machines are exempt from the registration requirements of subsection (j) of this section, regarding radiation services, to the extent that their personnel perform radiation services only for the registrant by whom they are employed. (8) Bone densitometry machines used by, or under the supervision of, a licensed physician, are exempt from equipment performance evaluations.(e) General requirements for application for registration. (1) Application for registration shall be completed on forms prescribed by the department and shall contain all the information required by the form and accompanying instructions. For initial registrations with multiple use locations, a separate application RC Form 226-2 shall be completed for each use location under the registration. (2) A radiation safety officer (RSO) shall be designated on each application form. The qualifications of that individual shall be submitted to the department with the application. The RSO shall meet the applicable qualifications specified in paragraph (3) of this subsection and carry out the responsibilities of subsection (n) of this section. (3) Qualifications for RSOs for registrants. (A) All RSOs shall meet the following general qualifications in addition to qualifications in specific categories: (i) knowledge of potential radiation hazards and emergency precautions; and (ii) completed educational courses related to ionizing radiation safety or a radiation safety officer course; or (iii) experience in the use and familiarity of the type of equipment used. (B) Specific qualifications for RSOs by the facility type are as follows. (i) RSOs for healing arts facilities shall meet the following qualifications: (I) practitioner RSOs shall submit documentation of their licensing board number;(II) qualifications for a non-practitioner RSO with radiation machine-related credentials, and the following credentials will be accepted for an RSO who is not a practitioner: (-a-) evidence of a valid general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and at least two years of supervised radiation safety experience or supervised use of radiation machines; (-b-) evidence of a valid limited certificate issued under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and at least four years of supervised radiation safety experience or supervised use of radiation machines; (-c-) evidence of registry by the American Registry of Radiologic Technologists (ARRT) or the American Registry of Clinical Radiologic Technologists (ARCRT) and at least two years of supervised radiation safety experience or supervised use of radiation machines; (-d-) evidence of associate degree in radiologic technology, health physics, or nuclear technology, and at least two years of supervised radiation safety experience or supervised use of radiation machines; (-e-) for radiation therapy facilities, evidence of registry by the ARRT or ARCRT and at least four years of supervised radiation-related experience or supervised use of radiation therapy machines; or(-f-) evidence of a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in one or more of the following appropriate specialties: (-1-) medical health physics, diagnostic medical physics, or nuclear medical physics for diagnostic x-ray facilities; or (-2-) medical health physics or therapeutic medical physics for radiation therapy facilities; or(III) qualification for a non-practitioner RSO without radiation machine-related credentials, and an RSO who is not a practitioner and who does not have radiation machine-related credentials must meet the following criteria: (-a-) credentials:(-1-) evidence of registration with the Texas Board of Nursing as a registered nurse and at least two years of supervised experience in the use of radiation machines in their respective specialty; (-2-) evidence of registration with the Texas Physician Assistant Board and at least two years of supervised experience in the use of radiation machines in their respective specialty; or(-3-) evidence of bachelor's or higher degree in radiologic technology, health physics, or nuclear technology and at least two years of supervised experience in the use of radiation machines; and(-b-) additional documentation for a non-practitioner RSO without radiation machine-related credentials, and the following documentation must be provided to be qualified:(-1-) an attestation by a physician or qualified department director describing the radiation safety experience and performance of the RSO responsibilities listed in subsection (n) of this section, as applicable, and attestation must include that the RSO has achieved a level of radiation safety knowledge sufficient to function independently as RSO for the medical use for which they are applying; and(-2-) documentation of an accredited radiation safety or radiation machine course completion, and the course must be at least 24 credit hours and include the principles of image processing, radiation protections, dose optimization and reduction; biological effects of ionizing radiation; radiology quality control and improvement; and review of Texas Regulations related to radiation as applicable.(ii) Academic institutions or research and development facilities shall have RSOs who are faculty or staff members with a bachelor's degree or higher in a radiation-related field and at least two years of supervised experience in the use of radiation machines and the following documentation is also required:(I) an attestation by a physician or qualified department director describing the radiation safety experience and performance of the RSO responsibilities listed in subsection (n) of this section, as applicable, and attestation must include that the RSO has achieved a level of radiation safety knowledge sufficient to function independently as RSO for the medical use for which they are applying.(II) documentation that the individual has satisfactorily completed 40 hours of education related to safe use of radiation machines from an accredited institution.(iii) Industrial radiography operations shall have an RSO who meets the requirements of §289.255(e)(4)(B) of this title.(C) The RSO identified on a certificate of registration issued before September 1, 1993, need not comply with the training requirements in this subsection. (D) The RSO for an application for registration of an electronic brachytherapy device shall meet the qualifications of this subsection and shall carry out the responsibilities of subsection (n) of this section. (E) The department may determine that a person who otherwise meets the RSO qualifications specified in this section is unqualified to be named as the RSO, based on the person's history with ensuring a facility's compliance with the Act and rules of this chapter.(4) Any time after the filing of the original application, the department may require additional information to determine if the certificate of registration should be issued or denied. (5) An application for a certificate of registration may include a request for a certificate of registration authorizing one or more activities or use locations. Applications for certification of mammography systems shall be made separately. (6) Applications and documents submitted to the department may be made available for public inspection except that the department may withhold any document or part thereof from public inspection per §289.231(aa) of this title. (7) Each application for a certificate of registration shall be accompanied by the fee prescribed in §289.204 of this title.(8) Each application shall be accompanied by a completed RC Form 226-1 (Business Information Form) that shall contain the legal name of the entity or business. Unless exempt per the Business and Commerce Code, Chapter 71, the applicant shall: (A) be authorized to conduct business in the State of Texas as listed on the Texas Secretary of State (SOS) website; and (B) file an assumed name certificate with the Texas SOS if using an assumed name in their application. (f) Application for registration for human use of radiation machines. (1) In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following. (A) Each person having a radiation machine used in the healing arts shall apply for registration with the department within 30 days after beginning use of the radiation machine, except for mobile services that shall be registered per subsection (g) of this section, and healing arts screening that shall be approved per subsection (h) of this section. (B) Each person having an accelerator, therapeutic radiation machine, or electronic brachytherapy device shall apply for and receive a certificate of registration from the department before using the accelerator. A person may energize the accelerator for purposes of installation and acceptance testing before receiving a certificate of registration from the department. (2) The applicant shall ensure that radiation machines are operated by individuals qualified by training and experience to use the radiation machines for the purpose requested per this section in such a manner as to minimize danger to occupational and public health and safety. (3) An application for healing arts shall be signed by a licensed practitioner. The signature of the administrator, president, or chief executive officer will be accepted instead of a licensed practitioner's signature if the facility has more than one licensed practitioner who may direct the operation of radiation machines. The application shall also be signed by the RSO. (4) An application for accelerators or therapeutic radiation machines, including electronic brachytherapy devices, for human use, shall be signed by a physician licensed by the Texas Medical Board. The signature of the administrator, president, or chief executive officer will be accepted instead of a physician's signature if the facility has more than one physician who may direct the operation of radiation machines. The application shall also be signed by the RSO. (5) Each applicant for accelerators, therapeutic radiation machines, and electronic brachytherapy devices, shall submit: (A) operating and safety procedures as described in §289.229(h)(1)(G) of this title; (B) credentials:(i) units operating above 1 MeV and electronic brachytherapy devices shall submit credentials for a Board-Certified Radiation Oncologist; or(ii) units under 1 MeV shall submit credentials for a Board-Certified Dermatologist or Board-Certified Radiation Oncologist;(C) a copy of the most current record of surveys, calculations, and quality assurance checks on each device; and(D) a floor plan of the physical facility.(g) Application for registration of mobile service operations. (1) In addition to the requirements of subsections (e) and (f) of this section or §289.230 of this title, as applicable, each applicant shall apply for and receive authorization from the department before beginning mobile service operations. (2) The following shall be submitted: (A) an established main location where the machine(s), records, etc. will be maintained for inspection. This shall be a street address, not a post office box number; (B) a sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed machine inside, furnish the floor plan indicating protective shielding and the operator's position; and (C) a current copy of the applicant's operating and safety procedures regarding radiological practices for the protection of patients, operators, employees, and the general public. (h) Application for registration of healing arts screening. (1) In addition to the requirements of subsections (e) and (f) of this section, each applicant shall apply for and receive authorization for healing arts screening before initiating a screening program. (2) Persons requesting approval from the department for healing arts screening programs shall submit: (A) name and address of the applicant; (B) diseases or conditions for which the x-ray examinations are to be used in diagnoses; (C) a detailed description of the x-ray examinations proposed in the screening program; (D) a description of the population to be examined in the screening program, for example, age, sex, physical condition, and other appropriate information; (E) for mobile screening operations, location(s) where radiation machines are maintained; (F) operating and safety procedures as follows: (i) for all radiation machines (except bone densitometers) to include: (I) an evaluation of the radiation machines to be used in the screening program; (II) documentation that the evaluation was performed by a licensed medical physicist with a specialty in diagnostic medical physics; (III) the evaluation shall show that the machines satisfy all requirements of this chapter; (ii) for bone densitometers, the manufacturer's evaluation of the radiation machine(s) to be used in the screening program; (G) documentation for verification of the following procedures: (i) a method of recommending a means of selecting a physician for patients who do not have a physician; (ii) a description of the procedures to be used in advising the individuals screened and their physicians of the results of the screening procedure and any further medical needs indicated; and (iii) a description of the procedures for the retention or disposition of the radiographs and other records about the x-ray examinations.(3) Screening standards/procedures shall meet national standards such as the American College of Radiology or other national standards. (i) Application for registration of radiation machines for non-human use, including use in morgues, forensic medicine or investigations, and educational facilities. (1) In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following. (A) Each person having an accelerator for non-human use shall apply for and receive a certificate of registration from the department before beginning the use of the accelerator. A person may energize the accelerator for purposes of installation and testing before receiving a certificate of registration from the department. (B) Each person having an accelerator for non-human use shall submit: (i) operating and safety procedures as described in §289.229(f)(3)(B) of this title; and (ii) a description of the applicant's proposed facilities per §289.229(f)(2) and (f)(3)(A), (D) and (E) of this title. (2) Each person having a radiation machine for non-human use, other than those specified in paragraph (1)(A) of this subsection and those used for industrial radiographic operations as defined in §289.255 of this title, shall apply for registration with the department within 30 days after beginning use of the machine. (3) Each applicant for use of radiation machines in industrial radiographic operations shall submit the information required in §289.255(t)(1) of this title and receive a certificate of registration from the department before beginning use of the machine(s). (4) An application for the uses specified in this subsection shall be signed by the applicant, registrant, or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO. (j) Application for registration of radiation machine services. (1) In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following. (A) Each person who intends to provide radiation services described in subsection (b)(11) of this section shall apply for and receive a certificate of registration from the department before providing the service. (B) An application for radiation services shall be signed by the applicant or registrant or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO. (2) The applicant shall document the qualifications of the specific training and experience that qualifies each individual to perform the service as follows: (A) for individuals performing assembly, installation, or repair of radiation machines in subsection (b)(11)(E) of this section, document the qualifications listed in paragraph (5) of this subsection; (B) for individuals performing the services specified in subsection (b)(10) and (11)(C) of this section, obtain a copy of the individual's license from the Texas Board of Licensure for Professional Medical Physicists; and (C) for all other services, document the qualifications listed in paragraph (5) of this subsection. (3) No person shall provide services specified in subsection (b)(10) and (11) of this section that are not specifically authorized by the department. (4) No person shall provide radiation machine services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the department except for: (A) services specified in subsection (b)(11)(B), (C) and (D) of this section; or (B) the initial installation of the first machine(s) for a new certificate of registration. (5) The minimum education and training for persons performing radiation machine assembly, installation, or repair are as follows. (A) All persons performing radiation machine assembly, installation, or repair shall meet one of the following requirements: (i) one year of formal training (may be satisfied by factory school, military technical training school, or other courses in radiation machine assembly, installation or repair techniques) or an associate degree in biomedical equipment repair; (ii) a bachelor's degree in electrical engineering with specialized training in radiation producing devices; or (iii) a combination of training and experience totaling one year to include: (I) experience or education providing familiarity with the type(s) of equipment to be serviced, to include radiation safety; (II) knowledge of protective measures to reduce potentially hazardous conditions; and (III) six months of supervised assembly and repair of the type(s) of equipment to be serviced. (B) A registrant holding a valid certificate of registration who has hired individuals to perform services before September 1, 1993, need not comply with the education and training requirements in this paragraph. Individuals hired on or after September 1, 1993, shall comply with the education and training requirements in this paragraph. (6) Each applicant for providers of equipment shall also submit: (A) the address of an established main location where the radiation machines, records, etc., will be maintained for inspection. This shall be a street address, not a post office box number; and (B) a current copy of the applicant's operating and safety procedures. This is required when the applicant's personnel are provided to operate the equipment for their client.(7) A record documenting the qualifications of each individual that performs the service shall be made and maintained for inspection by the department per subsection (v) of this section. (k) Issuance of certificates of registration. (1) A certificate of registration application will be approved if the department determines that an application meets the requirements of the Act and the requirements of this chapter. The certificate of registration authorizes the proposed activity in the form and contains the conditions and limitations as the department deems appropriate or necessary. (2) The department may incorporate in the certificate of registration at the time of issuance, or thereafter by amendment, additional requirements and conditions concerning the registrant's possession, use, and transfer of radiation machines subject to this chapter as it deems appropriate or necessary to: (A) minimize danger to occupational and public health and safety; (B) require additional reports and the keeping of additional records as may be appropriate or necessary; and (C) prevent loss or theft of radiation machines subject to this section. (3) The department may request, and the registrant shall provide, additional information after the certificate of registration has been issued to enable the department to determine whether the certificate of registration should be modified per subsection (s) of this section. (l) Terms and conditions of certificates of registration. (1) Each certificate of registration issued per this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable rules and orders of the department. (2) No certificate of registration issued or granted under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the department authorizes the transfer in writing. (3) Each person registered by the department for radiation machine use per this section shall confine use and possession of the radiation machine registered to the locations and purposes authorized in the certificate of registration. (4) In deciding whether to grant, deny, amend, renew, revoke, suspend, or restrict a certificate of registration, the department may consider the technical competence and compliance history of an applicant or holder of a certificate of registration. After an opportunity for a hearing, the department shall deny an application for a certificate of registration, an amendment to a certificate of registration, or renewal of a certificate of registration if the applicant's compliance history reveals that at least three department actions have been issued against the applicant, within the previous 6 years, that assess administrative or civil penalties against the applicant, or that revoke or suspend the certificate of registration. (m) Responsibilities of the registrant. (1) The registrant is responsible for complying with this chapter and the conditions of the certificate of registration. (2) The registrant shall designate an individual qualified per subsection (e)(3) of this section as the radiation safety officer and shall ensure the individual continually performs the responsibilities of the radiation safety officer as identified in subsection (n) of this section. (3) Persons using radiation machines per subsection (f)(1)(B) of this section (concerning radiation accelerator or therapeutic radiation machines or electronic brachytherapy devices for human use), subsection (g) of this section (concerning an application for mobile service operations), subsection (i)(1)(A) of this section (concerning persons having an accelerator for non-human use), and subsection (i)(3) of this section (concerning radiation machines in industrial radiographic operations) shall have a valid certificate of registration issued by the department before use. (4) Other than the initial installation of the first machines(s) for a new certificate of registration, no person shall use radiation machines unless they have applied for registration within 30 days of beginning use of the machines per subsection (f)(1)(A) of this section. (5) No registrant shall engage any person for services described in subsection (b)(11) of this section until the person provides to the registrant evidence of registration with the department. (6) No person shall provide radiation machine services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the department except for: (A) the initial installation of the first machines(s) for a new certificate of registration; and (B) the registrant authorized for demonstration and sale may demonstrate a radiation machine per paragraph (13) of this subsection. (7) The registrant shall notify the department of any changes that would render the information contained in the application for registration or the certificate of registration inaccurate. The notification shall be in writing and signed by an authorized representative. (A) Notification is required within 30 days after the following changes: (i) name or mailing address; (ii) street address where machine will be used; (iii) additional use location; (iv) RSO; or (v) name and registration number of the contracted provider of equipment, registered per this section. (B) The registrant shall notify the department within 30 days after changes in the radiation machines that include: (i) any change in the category(ies) of machine type or type of use as specified in §289.231(ll) of this title and as authorized in the certificate of registration; or (ii) any increase in the number of machines authorized by the certificate of registration in any machine type or type of use category. (8) The registrant, or the parent company, shall notify the department in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy. This notification shall include: (A) the bankruptcy court in which the petition for bankruptcy was filed; and (B) the case name and number, and date of filing the petition. (9) The registrant shall inventory all radiation machines in the registrant's possession at an interval not to exceed one year. (A) The inventory shall include: (i) manufacturer's name; (ii) model and serial number of the control panel; and (iii) location of radiation machine(s) (for example, room number). (B) Records of the inventory shall be made and maintained for inspection by the department per subsection (v) of this section. (10) The registrant shall maintain records of receipt, transfer, and disposal of radiation machines. (A) The records shall include: (i) manufacturer's name; (ii) model and serial number from the control panel; (iii) date of the receipt, transfer, and disposal; (iv) name and address of person machine(s) received from, transferred to, or disposed of; and (v) name of the individual recording the information. (B) Records of the receipt, transfer, or disposal of the machine(s) shall be made and maintained for inspection by the department per subsection (v) of this section. (11) The persons using loaner radiation machines shall comply with the following. (A) For persons having a valid certificate of registration, loaner radiation machines may be used for up to 30 days. Within the following 30 days, the registrant shall: (i) notify the department of a change in the category(ies) of machine type or type of use as specified in §289.231(ll) of this title and as authorized in the certificate of registration; or (ii) notify the department of any increase in the number of machines authorized by the certificate of registration in any machine type or type of use category; and (iii) perform an equipment performance evaluation on the radiation machine(s) per §289.227(o) of this title. (B) For persons who do not hold a valid certificate of registration, loaner radiation machines may be used for human use up to 30 days, by or under the direction of a practitioner, before applying for a certificate of registration per subsection (e) of this section. This does not include: (i) accelerators for human use as described in subsection (f)(1)(B) of this section; (ii) mobile services as described in subsection (g) of this section; (iii) healing arts screening as described in subsection (h) of this section; (iv) accelerators for non-human use as described in subsection (i)(1)(A) of this section; and (v) industrial radiography as described in subsection (i)(3) of this section. (12) Persons authorized to provide radiation machines shall comply with the following. (A) Providers of equipment shall: (i) ensure that all radiation machines used on humans for healing arts purposes meet the requirements of §289.227(o) of this title; and (ii) provide radiation machines only to facilities holding a valid certificate of registration. (B) Providers of equipment shall keep a log of radiation machines provided in Texas. The record shall list the following current information: (i) date machine is provided; (ii) name of customer; and (iii) customer's certificate of registration number. (C) Records of machines provided shall be made and maintained for inspection by the department per subsection (v) of this section. (13) Persons authorized to perform demonstration and sale of radiation machines in Texas shall comply with the following. (A) A daily log shall be maintained and shall include: (i) date of all demonstrations and sales of radiation machines performed in Texas; (ii) name and address of the customer; and (iii) customer's certificate of registration number unless the service provided is an initial installation as described in paragraph (6) of this subsection. (B) Records of all demonstrations and sales shall be made and maintained for inspection by the department per subsection (v) of this section. (C) Individuals must not be exposed to the useful beam except for healing arts purposes and unless such exposure has been specifically and individually ordered by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes: (i) exposure of an individual for training or demonstration; (ii) QA/QC testing; or(iii) other non-healing arts purposes.(D) Demonstration of radiation machines performed by the service provider shall be on phantoms only. (E) The registrant authorized for demonstration and sale of radiation machines is responsible for performing and documenting all tests required by §289.227 of this title when demonstration of a radiation machine involves exposure specifically and individually ordered by a licensed practitioner of the healing arts.(n) Responsibilities of RSOs. (1) Duties of the RSO include: (A) establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable (ALARA); (i) review them at intervals not to exceed 12 months to ensure that the procedures are current and conform with this chapter; and(ii) review and ensure that all actions required in this chapter are performed at the respective intervals to maintain compliance;(B) ensuring that individual monitoring devices are properly used by occupationally-exposed personnel, records are kept of the monitoring results, and timely notifications are made as required by §289.203 of this title; (C) investigating and reporting to the department each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this chapter; (D) assuming control and having the authority to institute corrective actions including the shut-down of operations when necessary in an emergency or unsafe conditions; (E) ensuring that corrective actions for violations issued by the department are implemented to avoid a repeat violation; and(F) maintaining records as required by this chapter. (2) The RSO shall ensure that personnel are adequately trained and complying with this chapter, the conditions of the certificate of registration, and the operating and safety procedures of the registrant. (3) The RSO shall make entries of the records in paragraph (1) of this subsection at intervals not to exceed 30 days after receipt of a monitoring report.(o) Responsibilities of assemblers and installers. (1) No person shall provide radiation machine services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the department except for the initial installation of the first machine(s) for a new certificate of registration. (2) Persons who assemble or install radiation machines shall notify the department of the following information within 30 days after assembly or installation: (A) the name, address, and certificate of registration number, except in the case of initial machine installation, of persons who have received the machines; (B) the type of radiation machine, the manufacturer's name, model number, and control panel serial number of each radiation machine; and (C) the date of transfer or disposal of each radiation machine. (3) Persons who assemble, install, or repair radiation machines, or components of the machines, shall ensure the radiation machines meet the applicable requirement of this chapter when the machines are placed in operation. (4) Persons assembling, installing, and repairing radiation machines shall keep a daily log to include the following information: (A) date of service; (B) name of customer; (C) customer's certificate of registration number unless the installation is an initial installation described in paragraph (1) of this subsection; and (D) records of assembling, installing and repairing of the machines shall be made and maintained for inspection by the department per subsection (v) of this section. (5) Equipment performance evaluations shall be performed as follows: (A) on all medical, chiropractic or podiatric radiation machines within 30 days after the initial installation, re-installation, and after repair of a machine component that would affect the radiation output that includes but is not limited to the timer, tube, and power supply, per §289.227(o)(2) of this title; and (B) on all dental radiation machines and radiation machines used in veterinary medicine within 30 days after the initial installation, re-installation, and after repair of a machine component that would affect the radiation output that includes the timer, tube, and power supply, per §289.232(j)(5)(J)(i) and §289.233(j)(5)(N)(i)(I) - (III) of this title, as applicable. (6) Radiation air kerma rate or dose measurements for fluoroscopy and computed tomography (CT) radiation machines, as required by §289.227 and §289.233 of this title shall be performed by a licensed medical physicist with a specialty in diagnostic medical physics. (7) Radiation entrance exposure data required during EPEs on general radiographic and special purpose radiation machines, as defined in §289.227(e) and §289.233(d) of this title, shall be performed by or under the supervision of a licensed medical physicist with a specialty in diagnostic medical physics. The physicist shall: (A) establish written procedures for non-physicists that document entrance exposure data; (B) calculate the entrance exposure; (C) verify the entrance exposure meets compliance with §289.227(j) of this title;(D) retest the machine, by measuring entrance exposure, at the facility's specified technique after repair or adjustment by a service technician;(E) submit any test or EPE results to the facility within 30 days after completion of testing. Documentation shall include:(i) name of the facility;(ii) address of facility; if satellite facility, address of where the radiation machine is located;(iii) business email address;(iv) registration number of the facility;(v) make, model, and serial number from the machine control panel;(vi) registration number of physicist and service company performing EPE;(vii) mailing/business address of physicist performing EPE;(viii) date of the last calibration of testing equipment;(ix) signature of physicist that performed the EPE;(F) retain documentation of subparagraph (E) of this paragraph according to subsection (v) of this section; and (G) maintain a calibrated dosimetry system available for use: (i) The system shall be calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). (ii) The calibration shall be performed within the previous 24 months and after any servicing that may have affected system calibration. (p) Expiration of certificates of registration. (1) Except as provided by subsection (r) of this section, each certificate of registration expires at the end of the day, in the month and year stated in the certificate of registration. (2) If a registrant does not submit an application for renewal of the certificate of registration per subsection (r) of this section, as applicable, on or before the expiration date specified in the certificate of registration, the registrant shall: (A) terminate use of all radiation machines and terminate radiation machine servicing or radiation services as applicable; and (B) pay any outstanding fees per §289.204 of this title. (3) The expiration of the certificate of registration does not relieve the registrant of the requirements of this chapter. (q) Termination of certificates of registration. (1) When a registrant decides to terminate all activities involving radiation machines or services authorized under the certificate of registration, the registrant shall immediately: (A) request termination of the certificate of registration in writing signed by the RSO, owner, or an individual authorized to act on behalf of the registrant; and (B) submit to the department a record of the disposition of the radiation machines, if applicable; and if transferred, to whom they are transferred. (2) The registrant shall pay any outstanding fees per §289.204 of this title. (r) Renewal of certificates of registration. (1) An application for renewal of a certificate of registration shall be filed per subsection (e) of this section and applicable paragraphs of subsections (f) - (j) of this section. (2) If a registrant applies for renewal in proper form before the existing certificate of registration expires, such certificate of registration shall not expire until the application status has been determined by the department. (s) Modification, suspension, and revocation of certificates of registration. (1) The terms and conditions of all certificates of registration shall be subject to revision or modification. A certificate of registration may be suspended or revoked because of amendments to the Act, because of amendments to the rules in this chapter, or orders issued by the department. (2) Any certificate of registration may be revoked, suspended, or modified, in whole or in part, for: (A) any material false statement in the application or any statement of fact required under provisions of the Act; (B) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the department to refuse to grant a certificate of registration on an original application; (C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, the certificate of registration, or order of the department; or (D) existing conditions that constitute a substantial threat to public health or safety or the environment. (3) Each certificate of registration revoked by the department ends at the end of the day on the date of the department's final determination to revoke the certificate of registration, or on the revocation date stated in the determination, or as otherwise provided by the department order. (4) Except in cases in which the occupational and public health or safety requires otherwise, no certificate of registration shall be suspended or revoked unless, before the institution of proceedings, therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been allowed to demonstrate compliance with all lawful requirements. (t) Reciprocal recognition of out-of-state certificates of registration. (1) Whenever any radiation machine is to be brought into the state for any temporary use, the person proposing to bring the machine into the state shall apply for and receive a notice from the department granting reciprocal recognition before beginning operations. The request for reciprocity shall include a: (A) completed RC Form 226-1 (Business Information Form); (B) completed RC Form 226-3 (Application for Registration of Industrial Radiation Machines); (C) RSO qualifications per subsection (e)(3) of this section. (D) completed RC Form 252-3 (Notice of Intent to Work in Texas Under Reciprocity); (E) completed qualification forms (RC Forms 255-E, 255-T or 255-OS) for each radiographer who will be working in Texas if the reciprocity request is for industrial radiography; (F) copy of the applicant's current certificate of registration or equivalent document; (G) copy of the applicant's current operating and safety procedures pertinent to the proposed use; and(H) the fee as specified in §289.204(d) of this title. (2) Upon a determination that the request for reciprocity meets the requirements of the department, the department may issue a notice granting reciprocal recognition authorizing the proposed use. (3) Once reciprocity is granted, the out-of-state registrant shall file a RC Form 252-3 with the department before each entry into the state. This form shall be filed at least three working days before the radiation machine is to be used in the state. If, for a specific case, the three-day period would impose an undue hardship, the out-of-state registrant may, at the determination of the department, obtain permission to proceed sooner. (4) When radiation machines are used as authorized under reciprocity, the out-of-state registrant shall have the following in its possession at all times for inspection by the department: (A) completed RC Form 252-3; (B) copy of the notice from the department granting reciprocity; (C) copy of the out-of-state registrants operating and safety procedures; and (D) copy of the applicable rules as specified in the notice granting reciprocity. (5) If the state from which the radiation machine is proposed to be brought does not issue certificates of registration or equivalent documents, a certificate of registration shall be obtained from the department per the requirements of this section. (6) The department may withdraw, limit, or qualify its acceptance of any certificate of registration or equivalent document issued by another department upon determining that the action is necessary to prevent an undue hazard to occupational and public health and safety or property. (7) Reciprocal recognition will expire two years from the date it is granted. A new request for reciprocity shall be submitted to the department every two years. Reciprocity requests made after the initial request shall include the following: (A) completed RC Form 226-1 (Business Information Form); (B) completed RC Form 226-3 (Application for Registration of Industrial Radiation Machines); (C) RSO qualifications in accordance with subsection (e)(3) of this section.(D) completed RC Form 252-3 (Notice of Intent to Work in Texas Under Reciprocity); (E) completed qualification forms RC Forms 255-E, 255-T or 255-OS for each radiographer who will be working in Texas if the reciprocity request is for industrial radiography; (F) copy of the applicant's current certificate of registration or equivalent document;(G) copy of the applicant's current operating and safety procedures pertinent to the proposed use; and(H) the fee as specified in §289.204(d) of this title. (8) Radiation services provided by a person from out-of-state will not be granted reciprocity. Whenever radiation services are to be provided by a person from out-of-state, that person shall apply for and receive a certificate of registration from the department before providing radiation services. The application shall be filed per subsections (e), (i), and (j) of this section, as applicable. (u) Medical research and investigational devices. (1) Any research using radiation machines on humans shall be approved by an Investigational Review Board (IRB) as required by Title 45, Code of Federal Regulations (CFR), Part 46 and Title 21, CFR, Part 56. The IRB shall include at least one physician to direct any use of radiation per §289.231(b) of this title. (2) Facilities with radiation machines with investigational device exemptions that are involved in clinical studies shall comply with primary regulations that govern the conduct of clinical studies and that apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. These regulations include: (A) 21 CFR, Part 812, Investigational Device Exemptions; (B) 21 CFR, Part 50, Protection of Human Subjects; (C) 21 CFR, Part 56, Institutional Review Boards; (D) 21 CFR, Part 54, Financial Disclosure by Clinical Investigators; and (E) 21 CFR, Part 820, Subpart C, Design Controls of the Quality System Regulation. (v) Record/document retention requirements for registration of radiation machines. (1) Each registrant shall maintain the following records/documents at each site, including authorized records sites for mobile services, at the time intervals specified for inspection by the department. Attached Graphic(2) Records listed in paragraph (1) of this subsection may be maintained in electronic format. Source Note: The provisions of this §289.226 adopted to be effective December 17, 2013, 38 TexReg 9051; amended to be effective July 18, 2021, 46 TexReg 4302. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.226 Registration of Radiation Machine Use and Services https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=160898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 160898 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=160898&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 160898 03/11/2026 (a) Purpose. This section establishes requirements for the use of radiation machines in the healing arts. (b) Scope. (1) The registrant shall be responsible for directing the operation of the radiation machines under the administrative control of the registrant. The registrant shall assure that the requirements of this section are met in the operation of such radiation machines. All usage of such machines under this section shall be made by or under the supervision of a practitioner of the healing arts. (2) In addition to the requirements of this section, all registrants, unless otherwise specified, are subject to the requirements of §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.226 of this title (relating to Registration of Radiation Machine Use and Services), and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (3) The use of mammography radiation machines is subject to the requirements in §289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography), and §289.234 of this title (relating to Mammography Accreditation). The use of dental radiation machines is subject to the requirements in §289.232 of this title (relating to Radiation Control Regulations for Dental Radiation Machines). However, dental radiation machines located in a facility that also has other healing arts radiation machines will be inspected at the intervals specified in §289.231(ll)(2) of this title, and equipment performance evaluations performed at the interval specified for a medical facility in subsection (o)(1) of this section. The use of radiation machines for veterinary medicine is subject to the requirements in §289.233 of this title (relating to Radiation Control Regulations for Radiation Machines in Veterinary Medicine). (4) An entity that is a "covered entity" as that term is defined in HIPAA (the Health Insurance Portability and Accountability Act of 1996, 45 Code of Federal Regulations, Parts 160 and 164) may be subject to privacy standards governing how information that identifies a patient can be used and disclosed. Failure to follow HIPAA requirements may result in the department making a referral of a potential violation to the U.S. Department of Health and Human Services. (c) Prohibitions. (1) The agency may prohibit use of radiation machines that pose significant threat or endanger occupational and public health and safety, in accordance with §289.205 of this title and §289.231 of this title. (2) Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits intentional exposure for the following purposes: (A) exposure of an individual for training, demonstration, or other non-healing arts purposes; (B) exposure of an individual for the purpose of healing arts screening, except as authorized by §289.226(h) of this title; and (C) exposure of an individual for the purpose of research, except as authorized by §289.226(t)(1) of this title. (3) Non-image-intensified fluoroscopic systems shall not be used. (d) Exemptions. (1) Portable x-ray systems designed to be hand-held are exempt from the requirements of subsection (i)(11) of this section. The portable radiation machine shall be held by the tube housing support or handle. (2) Individuals who are sole practitioners and sole operators and the only occupationally exposed individual are exempt from the following requirements: (A) §289.203(b) of this title, "Posting of notices to workers;" (B) §289.203(c) of this title, "Instructions to workers;" and (C) operating and safety procedures in accordance with subsection (i)(2) of this section. (3) Registrants are exempt from the posting of the radiation area requirements in §289.231(x)(1) of this title provided that the operator has continuous surveillance and access control of the radiation area. (e) Definitions. The following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise. (1) Accessible surface--The external surface of the enclosure or housing provided by the manufacturer. (2) Air kerma--The kinetic energy released in air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy). For purposes of this section, when exposure in air measured in roentgen (R) is to be converted to dose in air measured in gray (Gy), a nationally recognized standard air conversion factor shall be used. (3) Aluminum equivalent--The thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. The nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper. (4) Attenuate--To reduce the exposure rate upon passage of radiation through matter. (5) Attenuation block--A block or stack, having dimensions 20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper. (6) Automatic exposure control (AEC)--A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation at preselected locations (See definition for phototimer). (7) Automatic exposure rate control (AERC)--A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation per unit time at preselected locations. (8) Barrier (See definition for protective barrier). (9) Beam axis--A line from the source through the centers of the x-ray fields. (10) Beam-limiting device--A device that provides a means to restrict the dimensions of the x-ray field. (11) Beam quality (diagnostic x-ray)--A term that describes the penetrating power of the x-ray beam. This is identified numerically by half-value layer and is influenced by kilovolt peak (kVp) and filtration. (12) Bone densitometer--A device intended for medical purposes to measure bone density and mineral content by x-ray transmission measurements through the bone and adjacent tissues. (13) Calibration of instruments--The comparative response or reading of an instrument relative to a series of known radiation values over the range of the instrument. (14) Category 1 continuing medical education units (CMEU)--Educational activities designated as Category I and approved by the Accreditation Council for Continuing Medical Education, the American Osteopathic Association, a state medical society, or an equivalent organization. (15) Central axis of the beam--A line passing through the virtual source and the center of the plane figure formed by the edge of the first beam-limiting device. (16) Certified x-ray systems--X-ray systems that have been certified in accordance with Title 21, Code of Federal Regulations (CFR). (17) Certified radiologist--A physician certified by the American Board of Radiology, the American Osteopathic Board of Radiology, the Royal College of Physicians and Surgeons of Canada, or Le College des Medecins du Quebec. (18) Coefficient of variation or C--The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation: Attached Graphic(19) Collimator--A device or mechanism by which the x-ray beam is restricted in size. (20) Computed tomography (CT)--The production of a tomogram by the acquisition and computer processing of x-ray transmission data. (21) Computed tomography dose index (CTDI)--CTDI represents the average absorbed dose along the z-axis from a series of contiguous irradiations. CTDI approximates the average central dose values associated with a spatially complex dose distribution in a reference acrylic phantom for one particular set of exam techniques. CTDI is defined exclusively for axial scanning. (22) Control panel--The part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors. (23) CT conditions of operation--All selectable parameters governing the operation of a CT system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in this subsection. (24) CT gantry--The tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames that hold these components. (25) Cumulative air kerma (CAK)--The air kerma accumulated at a specific point in space relative to the fluoroscopic gantry during a procedure. CAK does not include tissue backscatter and is measured in Gy. Some manufacturers identify CAK as cumulative dose (CD). (26) Diagnostic source assembly--The tube housing assembly with a beam-limiting device attached. (27) Diagnostic x-ray system--An x-ray system designed for irradiation of any part of the human body for the purpose of diagnosis or visualization. (28) Dose-area product (DAP)--Dose-area product is the integral of air kerma (absorbed dose to air) across the entire x-ray beam emitted from the x-ray tube. DAP is a surrogate measurement for the entire amount of energy delivered to the patient by the beam. DAP is measured in R x cm2 (cGy x cm2 ). (29) Dose-length product (DLP)--DLP is the CTDIvol multiplied by the scan length (slice thickness x number of slices) in centimeters. It reflects the total energy absorbed attributable to the complete scan acquisition but is independent of what is actually scanned. (30) Entrance exposure (Entrance air kerma)--The entrance exposure in air expressed in roentgens (R) or the entrance dose in air (air kerma) expressed in gray (Gy), measured at the point where the center of the useful beam enters the patient. (31) Entrance exposure rate (air kerma rate)--The exposure (air kerma) per unit time at the point where the center of the useful beam enters the patient. (32) Field emission equipment--Equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field. (33) Field size--The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the normal treatment or examination source-to-image distance and defined by the intersection of the major axes and the 50% isodose line. (34) Filter--Material placed in the useful beam to preferentially absorb selected radiations. (35) Fluoroscopic system--A system in which x-ray photons produce a fluoroscopic image. It includes the image receptors such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly. (36) Fluoroscopically-Guided Interventional (FGI) Procedures--An interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy. FGI procedures may include but not be limited to: (A) TIPS creation (transjugular intrahepatic portosystemic shunt); (B) Embolization (any location, any lesion); (C) Stroke therapy; (D) Biliary drainage; (E) Angioplasty with or without stent placement; (F) Stent-graft placement; (G) Chemoembolization; (H) Angiography and intervention for gastrointestinal hemorrhage; (I) Carotid stent placement; (J) RF (radiofrequency) cardiac ablation; (K) Complex placement of cardiac EP (electrophysiology) devices; and (L) PCI (percutaneous coronary intervention) (single or multiple vessel). (37) Focal spot--The area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates. (38) General purpose x-ray system--Any x-ray system that is not limited by design to radiographic examinations of specific anatomical regions. (39) Gonadal shield--A protective barrier for the testes or ovaries. (40) Half-value layer (HVL)--The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate (air kerma rate) is reduced to one-half of its original value. (41) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition. (42) Healing arts screening--The testing of asymptomatic human beings using radiation machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment. (43) High level control for fluoroscopy--Any selected mode having an entrance exposure rate (air kerma rate) above 10 roentgens per minute (R/min) or (100 mGy/min). This mode shall meet the high level requirements in subsection (m)(3)(A)(i)(II), (ii)(II), or (iii)(II) of this section. (44) Image intensifier--A device, installed in its housing that instantaneously converts an x-ray pattern into a corresponding light or digital image. (45) Image receptor--Any device, such as a fluorescent screen or radiographic film that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations. (46) Irradiation--The exposure of matter to ionizing radiation. (47) kV--Kilovolt. (48) kVp--Kilovolt peak (See definition for peak tube potential). (49) kWs--Kilowatt-second. It is equivalent to 10 E 3 watt-second, where 1 watt-second = 1 kV x 1 milliampere (mA) x 1 second. (50) Lead equivalent--The thickness of lead affording the same attenuation, under specified conditions, as the material in question. (51) Leakage radiation--Radiation emanating from the diagnostic source assembly except for the useful beam and radiation produced when the exposure switch or timer is not activated. (52) Leakage technique factors--The technique factors associated with the diagnostic source assembly that is used in measuring leakage radiation. They are defined as follows: (A) for diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs (10 milliampere-second (mAs)) or the minimum obtainable from the unit, whichever is larger; (B) for diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; or (C) for all other diagnostic source assemblies, the maximum-rated peak tube potential and the continuous tube current for the maximum-rated peak tube potential. (53) Licensed medical physicist--An individual holding a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, with a specialty in diagnostic medical physics. (54) mA--Milliampere. (55) mAs--Milliampere-second. (56) Medical research--The investigation of various health risks and diseases. (57) Mobile service operation--The provision of x-ray systems and personnel at temporary sites for limited time periods. The x-ray systems may be fixed inside a motorized vehicle or may be a radiation machine that may be removed from the vehicle and taken into a facility for use. (58) Multiple slice tomogram system--A computed tomography x-ray system that obtain x-ray transmission data simultaneously during a single scan to produce more than one tomogram. (59) Nominal tomographic section thickness--The full-width at half-maximum of the sensitivity profile taken at the center of the cross sectional volume over which x-ray transmission data are collected. (60) Non-certified x-ray systems--X-ray systems manufactured and assembled prior to certification requirements of Title 21, CFR, effective as specified in Title 21, CFR, Part 1020.30(a). (61) Patient--An individual subjected to healing arts examination, diagnosis, or treatment. (62) Peak tube potential--The maximum value of the potential difference in kilovolts across the x-ray tube during an exposure. (63) Phantom--A volume of material behaving in a manner that can be related to tissue with respect to the attenuation and scattering of radiation. (64) Phototimer--A method for controlling exposures to image receptors by the amount of radiation that reaches a radiation detection device. The radiation detection device is part of an electronic circuit that controls the duration of time the tube is activated (See definition for automatic exposure control). (65) Physician--An individual licensed by the Texas Medical Board. (66) Portable x-ray systems--X-ray systems that are mounted on a permanent base with wheels and/or casters for moving while completely assembled. Portable x-ray systems may also include x-ray systems designed to be hand-carried. (67) Practitioner of the healing arts (practitioner)--A person licensed to practice healing arts by either the Texas Medical Board as a physician, the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatric Medical Examiners. (68) Primary protective barrier--(See definition for protective barrier). (69) Protective apron--An apron made of radiation attenuating materials used to reduce radiation exposure. (70) Protective barrier--A barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows: (A) primary protective barrier--A barrier sufficient to attenuate the useful beam to the required degree. (B) secondary protective barrier--A barrier sufficient to attenuate the stray radiation to the required degree. (71) Protective glove--A glove made of radiation attenuating materials used to reduce radiation exposure. (72) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation. (73) Radiation oncologist--A physician with a specialty in radiation therapy. (74) Radiograph--An image receptor on which the image is created directly or indirectly by an x-ray exposure and results in a permanent record. (75) Radiologist--A physician with a specialty in using ionizing and non-ionizing radiation for medical imaging and interpretation for diagnostic and treatment purposes. (76) Reference level--The suggested levels at which a facility should review its methods and determine if acceptable image quality can be achieved at a lower radiation output level as determined by measurements taken from a selected phantom. The specific purpose of the reference level is to provide a benchmark for comparison of imaging equipment performance under prescribed conditions and is not intended to define a maximum or minimum exposure limit for any patient. (77) Reference plane--A plane that is displaced from and parallel to the tomographic plane. (78) Roentgen (R)--The special unit of exposure. One roentgen (R) equals 2.58 x 10-4 C/kg of air. (79) Scan--The complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms. (80) Scan increment--The amount of relative displacement of the patient with respect to the CT system between successive scans measured along the direction of such displacement. (81) Scan sequence--A preselected set of 2 or more scans performed consecutively under preselected CT conditions of operation. (82) Scan time--The period of time between the beginning and end of x-ray transmission data accumulation for a single scan. (83) Scattered radiation--Radiation that has been deviated in direction during passage through matter. (84) Secondary protective barrier (See definition for protective barrier). (85) Shutter--A device attached to the tube housing assembly that can totally intercept the useful beam and that has a lead equivalency not less than that of the tube housing assembly. (86) Single tomogram system--CT system that obtains x-ray transmission data during a scan to produce a single tomogram. (87) Source--The focal spot of the x-ray tube. (88) Source-to-image receptor distance--The distance from the source to the center of the input surface of the image receptor. (89) Source-to-skin distance (SSD)--The distance from the source to the skin of the patient. (90) Special purpose x-ray system--Any x-ray system that is limited by design to radiographic examinations of specific anatomical regions. Special purpose x-ray systems include, but are not limited to, dedicated chest units, cystography units, and head and skull units. (91) Special procedures--The application of special x-ray systems and specialized techniques to obtain required diagnostic information. Special procedures include, but are not limited to, angiography, cardiac catheterization, myelography, and surgery. (92) Spot film--A radiograph that is made during a fluoroscopic examination to permanently record conditions that exist during that fluoroscopic procedure. (93) Spot film device--A device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph. (94) Stationary x-ray system--A stationary x-ray system that is installed in a fixed location. (95) Stray radiation--The sum of leakage and scattered radiation. (96) Supervision--The delegating, by the practitioner, of the task of applying radiation to persons who perform tasks under the practitioner's control and who are certified under the Medical Radiologic Technologist Act, Texas Occupations Code, Chapter 601. The practitioner assumes full responsibility for these tasks and shall assure that the tasks will be administered correctly. (97) Target--The part of a radiation machine head that by design intercepts a beam of accelerated particles with subsequent emission of other radiation. (98) Technique chart--A chart that provides technical factors, anatomical examination, patient thickness for examination being performed, and source-to-image distance needed to make clinical radiographs when the radiographic system is in manual mode. (99) Technique factors--The conditions of operation that are specified as follows: (A) for capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs. (B) for field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses; (C) for CT systems designed for pulsed operations, peak tube potential in kV, scan time in seconds, and either tube current in mA, x-ray pulse width in seconds, and the number of x-ray pulses per scan or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs; (D) for CT systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds or the product of tube current and exposure time in mAs when the scan time and exposure time are equivalent; and (E) for all other x-ray systems, peak tube potential in kV and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs. (100) Tomogram--The depiction of the x-ray attenuation properties of a section through the body. (101) Tomographic plane--The geometric plane that is identified as corresponding to the output. (102) Tomographic section--The volume of an object whose x-ray attenuation properties are imaged in a tomogram. (103) Traceable to a national standard--This indicates that a quantity or a measurement has been compared to a national standard, for example, the National Institute of Standards and Technology, directly or indirectly through one or more intermediate steps and that all comparisons have been documented. (104) Tube--An x-ray tube, unless otherwise specified. (105) Tube housing assembly--The tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing. (106) Useful beam--Radiation that passes through the window, aperture, cone, or other collimating device of the source housing. Also referred to as the primary beam. (107) X-ray control panel--A device that controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices that control the technique factors of an x-ray exposure. (108) X-ray field--That area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate (air kerma rate) is 1/4th of the maximum in the intersection. (109) X-ray high-voltage generator--A device that transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tubes, high-voltage switches, electrical protective devices, and other appropriate elements. (110) X-ray system--An assemblage of components for the controlled production of x-rays and include a radiation machine. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system. (111) X-ray tube--Any electron tube that is designed to be used primarily for the production of x rays. (f) Morgues, forensic medicine, and educational facilities. (1) Morgues shall comply with the following requirements: (A) subsection (b)(1) and (2) of this section concerning scope; (B) subsection (c) of this section concerning prohibitions; (C) subsection (e) of this section concerning definitions, as applicable; (D) subsection (i)(2) of this section concerning operating and safety procedures; (E) subsection (i)(4) of this section concerning protective devices; (F) subsection (i)(11) of this section concerning holding of tube; (G) subsection (k)(1) of this section concerning warning labels; (H) subsection (m)(1)(A) of this section concerning fluoroscopy; and (I) subsection (s)(1)(A) - (I), and (R) of this section concerning records. (2) Facilities conducting training using non-humans shall comply with all the requirements of this section except for the following: (A) subsection (i)(5) of this section concerning operator credentialing; (B) subsection (j) of this section concerning radiographic entrance exposure (air kerma) limits; (C) subsections (p), (q) and (r) of this section concerning film processing; and (D) subsection (o) of this section concerning equipment performance evaluation. (g) Requirements for bone densitometers. Bone densitometers shall be exempt from this chapter except for the following: (1) §289.203 of this title, §289.204 of this title, §289.205 of this title, §289.226 of this title, and §289.231 of this title; (2) healing arts screening and medical research in accordance with §289.226(h) and (t) of this title; (3) purpose and scope in accordance with subsections (a) and (b) of this section; (4) prohibitions in accordance with subsection (c)(1) and (2) of this section; (5) definitions in accordance with subsection (e) of this section, as applicable; (6) operating and safety procedures in accordance with subsection (i)(2) of this section; (7) operator training in accordance with §140.521 of this title (relating to Bone Densitometry Training); (8) gonadal shielding in accordance with subsection (i)(13) of this section; (9) warning labels in accordance with §289.231(z) of this title. (10) record requirements for authorized use locations and authorized records locations for mobile services in accordance with subsection (s)(1)(A) - (D), (G), (J), (R), and (s)(2) of this section; and (11) record requirements for mobile services in accordance with subsection (s)(1)(A), (D), (H), and (J) of this section. These records shall be maintained with the bone densitometer authorized to be used for mobile services. (h) Certified x-ray systems. In addition to the requirements of this chapter, the registrant shall not make, nor cause to be made, any modification of components or installations of components certified in accordance with the United States Food and Drug Administration (FDA) Title 21, CFR, Part 1020, "Performance Standards for Ionizing Radiation Emitting Products," as amended, in any manner that could cause the installations or the components to fail to meet the requirements of the applicable parts of the standards specified in Title 21, CFR, Part 1020, except where a variance has been granted by the Director, Center for Devices and Radiological Health, FDA. A copy of the variance shall be maintained by the registrant in accordance with subsection (s)(1) of this section for inspection by the agency. (i) General operating requirements. (1) Technique chart. A technique chart relevant to the particular radiation machine shall be provided or electronically displayed in the vicinity of the control panel and used by all operators. (2) Operating and safety procedures. (A) Each registrant shall have and implement written operating and safety procedures. The procedures shall include, but are not limited to, the following as applicable: (i) posting notices to workers in accordance with §289.203(b) of this title; (ii) instructions to workers in accordance with §289.203(c) of this title; (iii) notifications and reports to individuals in accordance with §289.203(d) of this title; (iv) ordering x-ray exams in accordance with §289.231(b)(1) of this title; (v) occupational dose requirements in accordance with §289.231(m) of this title; (vi) personnel monitoring requirements in accordance with §289.231(n), (q), and (s) of this title; (vii) posting of a radiation area in accordance with §289.231(x) of this title; (viii) use of a technique chart in accordance with paragraph (1) of this subsection; (ix) use of protective devices in accordance with paragraph (4) of this subsection; (x) credentialing requirements for individuals operating radiation machines in accordance with paragraph (5) of this subsection; (xi) exposure of individuals other than the patient in accordance with paragraph (7) of this subsection; (xii) holding of patients or image receptors in accordance with the following; (I) a list of circumstances in which mechanical holding devices cannot be routinely utilized; and (II) a procedure used for selecting an individual to hold or support the patient or image receptor. (xiii) gonadal shielding in accordance with paragraph (13) of this subsection; (xiv) control of scattered radiation in accordance with subsection (m)(8) of this section; and (xv) film processing program or digital image processing protocols in accordance with subsections (p), (q), and (r) of this section. (B) The registrant shall maintain the operating and safety procedures in accordance with subsection (s)(1) of this section for inspection by the agency. (C) The procedures shall be made available to each individual operating a radiation machine, including any restrictions of the operating technique required for the safe operation of the particular x-ray system. (D) The registrant shall document that each individual operating a radiation machine has read the operating and safety procedures at least annually and shall maintain this documentation for inspection by the agency. The documentation shall include the following: (i) name and signature of individual; (ii) date individual read the operating and safety procedures; and (iii) initials of the RSO. (3) Occupational dose limits and personnel monitoring. Except as otherwise exempted, all individuals who are associated with the operation of a radiation machine are subject to the occupational dose limits of §289.231(m) of this title regarding dose limits to individuals, and the personnel monitoring requirements of §289.231(n) of this title. (4) Protective devices. Protective devices shall be utilized when required, as in paragraphs (8)(B) and (C), (10), and (13) of this subsection, and subsection (m)(8) of this section. (A) Protective devices shall be of no less than 0.25 millimeter (mm) lead equivalent material except as specified in paragraph (13) of this subsection and subsection (m)(8)(B)(i) of this section. (B) Protective devices, including aprons, gloves, and shields shall be checked annually for defects such as holes, cracks, and tears. These checks may be performed by the registrant by visual or tactile means, or x-ray imaging. If a defect is found, protective devices shall be replaced or removed from service until repaired. A record of this test shall be made and maintained by the registrant in accordance with subsection (s)(1) of this section for inspection by the agency. (5) Operator credentialing. Individuals who operate radiation machines for human use shall meet the appropriate credentialing requirements of rules issued in accordance with the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601. Copies of the credentialing document shall be maintained at the location(s) where the individual is working. (6) Practice of medical physics. Surveys, tests, or evaluations required by this section may constitute the practice of medical physics and, therefore, require a license from the Texas Board of Licensure for Professional Medical Physicists in accordance with the Medical Physics Practice Act, Texas Occupations Code, Chapter 602. (7) Exposure of individuals other than the patient. No individual other than a patient, operator, and ancillary personnel shall be in the x-ray room or area while exposures are being made unless such individual's assistance is required. (8) Holding of patient or image receptor. (A) When a patient or image receptor must be held in position during radiography, mechanical supporting or restraining devices shall be used when the exam permits. (B) If a patient or image receptor must be held by an individual during an exposure, that individual shall be protected with appropriate shielding devices described in paragraph (4) of this subsection. (C) In those cases where the patient must hold the image receptor, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.25 mm lead equivalent material. (9) Viewing system and contact with patient. (A) Windows, mirrors, closed circuit television, or another method shall be provided to permit the operator to continuously observe the patient during irradiation. (B) The operator shall be able to maintain verbal, visual, and aural contact with the patient. (10) Operator position. The operator position during the exposure shall be such that the operator's exposure is as low as reasonably achievable (ALARA) and the operator is a minimum of 6 feet from the source of radiation or protected by an apron, gloves, or other shielding having a minimum of 0.25 mm lead equivalent material. (11) Holding of tube. In no case shall an individual hold the tube or tube housing assembly supports during any radiographic exposure. (12) Patient protection. Notwithstanding the provisions of paragraph (7) of this subsection, other patients who are in line with the primary beam and who cannot be removed from the room shall be protected by whole body protective barriers of a minimum of 0.25 mm lead equivalent material or so positioned that the nearest portion of their body is at least 6 feet from both the tube head and the nearest edge of the image receptor. (13) Gonadal shielding. Gonadal shielding shall be used on patients when the gonads are in or within 5 cm of the useful beam. This requirement does not apply if the shielding will interfere with the diagnostic procedure. Gonadal shielding shall be of at least 0.5 mm lead equivalent material. (14) Measurements of the radiation output for x-ray, fluoroscopic, and CT systems. Measurements of the radiation output of x-ray, fluoroscopic, and CT systems shall be performed with a calibrated dosimetry system in accordance with the following. (A) The dosimetry system calibration shall be traceable to a national standard. (B) Dosimetry systems shall be calibrated within 24 months from the date of the prior calibration. (C) Measurements of radiation output shall be performed with a dosimetry system that has been calibrated within the 24 months preceding the date of the measurement. (D) Record of the dosimetry system calibration shall include: (i) manufacturer's name, model and serial number of each calibrated instrument; (ii) date of the calibration; and (iii) name of the individual recording the information. (E) The registrant shall record the dosimetry system calibration information specified in subparagraph (D)(i) - (iii) of this paragraph and maintain that record in accordance with subsection (s)(1) of this section for inspection by the agency. (j) Radiographic entrance exposure (air kerma) limits. The in-air exposure (air kerma) determined for the technique used by the registrant for the specified average human adult patient thickness for medical radiography shall not exceed the entrance exposure (air kerma) limits in the following Table I. Attached Graphic(k) Machine requirements for general x-ray and fluoroscopic systems. (1) Warning label. The warning label will meet the requirements of §289.231(z) of this title. (2) Mechanical support of tube head. The tube housing assembly shall be adjusted to remain stable during an exposure unless tube housing movement is a designed function of the x-ray system. (3) Battery charge indicator. On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation. (4) Beam quality. The following requirements apply to beam quality. (A) Half-value layer. (i) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in the following Table II. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table II, linear interpolation may be made. Attached Graphic(ii) For capacitor energy storage equipment, compliance with the requirements of this paragraph shall be determined with the maximum quantity of charge per exposure. (B) Filtration controls. (i) For x-ray systems that have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filters and shall prevent an exposure unless the minimum amount of filtration required by subparagraph (A) of this paragraph is in the useful beam for the given kVp that has been selected. (ii) Any other system having removable filters shall be required to have the minimum amount of filtration as required by subparagraph (A)(i) of this paragraph permanently located in the useful beam during each exposure. (5) Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly that has been selected. (6) Technique and exposure indicators. (A) The technique factors to be used during an exposure shall be indicated before the exposure begins except when automatic exposure controls are used, in which case the technique factors that are set prior to the exposure shall be indicated. (B) On x-ray systems having fixed technique factors, the requirement of subparagraph (A) of this paragraph may be met by permanent markings. (C) The x-ray control panel shall provide visual indication of the production of x-rays. (D) The indicated technique factors shall be accurate to meet manufacturer's specifications. If these specifications are not available from the manufacturer, the factors shall be accurate to within plus or minus 10% of the indicated setting. (7) X-ray control. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for an exposure of 0.5 seconds or less or during serial radiography when means shall be provided to permit completion of any single exposure of the series in process. (l) Additional machine requirements for x-ray systems. This subsection does not apply to fluoroscopic or CT systems. (1) Beam limitation. Beam limitation shall be as follows. (A) Stationary general purpose x-ray systems. (i) Beam-limiting devices shall restrict the useful beam to the area of clinical interest as follows: (I) the misalignment of the x-ray field for a manual rectangular collimator shall be within plus or minus 2.0% of the SID for the length or width of the image receptor; (II) the x-ray field for a circular or polygon collimator shall not exceed the diagonal of the image receptor by more than 2.0% of the SID; or (III) the misalignment of the x-ray field for an automatic or semi-automatic collimator shall be within plus or minus 3.0% of the SID for the length and width of the image receptor and shall be within plus or minus 4.0% of the SID, without regard to the sign, of the sum of the difference of the length and width of the image receptor. (ii) If the area of clinical interest is smaller than the image receptor, the operator of the x-ray system shall use all beam limiting devices necessary to restrict the useful beam to the clinical area of interest. (iii) A method shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field with the respective edges, either the length or width, of the x-ray field shall not exceed 2.0% of the SID. (iv) A numerical SID indicator shall be present and shall be accurate to within plus or minus 2.0% of the SID. (v) The system shall indicate when the axis of the x-ray field is perpendicular to the plane of the image receptor. (vi) The center of the x-ray field, when perpendicular to the image receptor, shall be accurate to within plus or minus 2.0% of the SID with respect to the center of the image receptor. (vii) The beam-limiting device shall numerically indicate the field size in the plane of the image receptor. (viii) Indication of field size dimensions and SIDs shall be specified in inches and/or centimeters. (ix) The field size indicated on the beam-limiting device shall be within plus or minus 2.0% of the SID along the width and length, separately, of the actual x-ray field size. (B) Portable x-ray systems. Portable x-ray systems shall comply with the requirements in subparagraph (A) of this paragraph, as applicable, based on manufacturer's design. (C) X-ray systems designed for one image receptor size. X-ray systems designed for only one image receptor size at a fixed SID shall provide a means to do the following: (i) limit the x-ray field to no greater than the dimensions of the image receptor at the SID, and to align the center of the x-ray field with the center of the image receptor to within plus or minus 2.0% of the SID center; or (ii) align the x-ray field such that the x-ray field does not extend beyond any edge of the image receptor at the SID. (D) Special purpose x-ray systems. (i) When the x-ray beam is perpendicular to the plane of the image receptor, a means shall be provided to do the following: (I) limit the x-ray field such that the x-ray field does not exceed each dimension of the image receptor by more than 2.0% of the SID; and (II) align the center of the x-ray field with the center of the image receptor to within plus or minus 2.0% of the SID. (ii) The requirements of clause (i) of this subparagraph may be met with a system that meets the requirements for a general purpose x-ray system as specified in subparagraph (A)(i) - (iv) of this paragraph or, when alignment means are also provided, may be met with either of the following: (I) an assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or (II) a beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the radiation machine is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use. (2) Radiation exposure control devices. Radiation exposure control devices shall include the following: (A) Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided. (B) AEC. When AEC is provided, the following shall occur. (i) Indication shall be made on the control panel when AEC mode of operation is selected. (ii) If the x-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to 2 pulses. (iii) The minimum exposure time for all x-ray systems other than that specified in clause (ii) of this subparagraph shall be equal to or less than 0.0167 second or a time interval required to deliver 5 mAs, whichever is greater. (iv) A visible and/or audible signal shall indicate when an exposure has been terminated. (C) Exposure interval reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure interval for both manual and AEC systems shall not exceed 0.05. This requirement applies to clinically used techniques. (3) SSD. All portable x-ray systems shall be provided with means to limit the SSD to equal to or greater than 30 cm. (4) Exposure reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure for both manual and AEC systems shall not exceed 0.05. This requirement applies to clinically used techniques. (5) Linearity. The average ratios of exposure (air kerma) mR/mGy to the indicated mAs product obtained at any 2 consecutive mA or mAs settings shall not differ by more than 0.10 times their sum, where X1 and X2 are the average mR/mAs (mGy/mAs) values obtained at each of 2 consecutive tube current settings: Attached Graphic(6) Radiation from capacitor. Radiation from capacitor energy storage equipment in standby status. Radiation emitted from the x-ray tube when the exposure switch or timer is not activated shall not exceed a rate of 2 milliroentgens per hour (mR/hr) or 0.02 milligray per hour (mGy/hr) at 5 cm from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open. (7) X-ray systems needing correction or repair. In order to achieve compliance with this chapter, the correction or repair shall begin within 30 days following the failure and shall be performed according to a plan designated by the registrant. Correction or repair shall be completed no longer than 90 days from discovery unless authorized by the agency. (8) Records of an x-ray system corrections or repairs. The registrant shall maintain records of corrections or repairs and any tests, measurements or numerical readings listed in subsection (o)(6) of this section in accordance with subsection (s)(1) of this section for inspection by the agency. (m) Fluoroscopic systems and spot-film devices for all facilities. (1) Limitation of the useful beam. Limitation of the useful beam shall be as follows. (A) Primary barrier. (i) The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID. (ii) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the useful beam and the imaging device is in place and operable. (iii) The exposure rate (air kerma rate) due to transmission through the barrier with the attenuation block in the useful beam, combined with radiation through the image intensifier if provided, shall not exceed 3.34 x 10-3 % of the entrance exposure rate (air kerma rate) at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. (B) Measuring compliance of barrier transmission. (i) The exposure rate (air kerma rate) due to transmission through the primary protective barrier combined with radiation through the image intensifier shall be determined by measurements averaged over an area of 100 cm2 with no linear dimension greater than 20 cm. (ii) If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. (iii) If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. (iv) Movable grids and compression devices shall be removed from the useful beam during the measurement. (v) The attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance exposure rate (air kerma rate) and between this point and the input surface of the fluoroscopic imaging assembly. (vi) The collimator shall be fully open when the measurement is made. (C) X-ray field. (i) Compliance with clauses (ii) - (vi) of this subparagraph shall be determined with the beam axis perpendicular to the plane of the image receptor. (ii) Fluoroscopic systems with a fixed SID and the capability of a visible area of no greater than 300 cm2 shall be provided with either stepless adjustment of the x-ray field or a means to further limit the x-ray field at the image receptor to 125 cm2 or less. If the equipment is provided with stepless adjustment, the minimum x-ray field size at the maximum SID shall be less than or equal to 5 cm by 5 cm at the image receptor. (iii) Fluoroscopic systems with a variable SID or a fixed SID with the capability of a visible area of greater than 300 cm2 shall be provided with stepless adjustment of the field size. The minimum x-ray field size at the maximum SID shall be less than or equal to 5 cm by 5 cm at the image receptor. (iv) Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID. (v) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor. (vi) For fluoroscopic systems with only a manual mode of collimation, the x-ray field produced shall be limited to the area of the spot-film cassette at 16 inches above tabletop. Additionally, during fluoroscopy, the beam shall be restricted to the area of the input phosphor. (vii) Spot-film devices shall meet the following additional requirements. (I) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film that has been selected on the spot-film selector. (-a-) Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. (-b-) The total misalignment of the edges of the x-ray field with the respective edges of the selected portion of the image receptor along the length or width dimensions of the x-ray field in the plane of the image receptor shall not exceed 3.0% of the SID when adjusted for full coverage of the selected portion of the image receptor. (-c-) The sum, without regard to sign of the misalignment along any two orthogonal dimensions, shall not exceed 4.0% of the SID. (II) The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within plus or minus 2.0% of the SID. (2) Activation of the fluoroscopic tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the fluoroscopist for the entire time of the exposure (continuous pressure type switch). When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposures at any time, but means may be provided to permit completion of any single exposure of the series in process. (3) Entrance exposure rate (air kerma rate) allowable limits for fluoroscopic systems. (A) The following requirements apply to fluoroscopic systems manufactured prior to May 19, 1995. (i) Fluoroscopic systems with AERC. Fluoroscopic systems that are provided with AERC shall not be operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) in excess of 2.58 x 10-3 coulomb per kilogram per minute (C/kg/min) (10 roentgens per minute (10 R/min) or (100 mGy/min) at the point where the center of the useful beam enters the patient, except: (I) during recording of fluoroscopic images, excluding last image hold; or (II) when an optional high-level control is provided. When so provided, the fluoroscopic system shall not be operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) in excess of 1.29 x 10-3 C/kg/min (5 R/min or 50 mGy/min) at the point where the center of the useful beam enters the patient, unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed. (ii) Fluoroscopic systems without AERC (manual mode). Fluoroscopic systems that are not provided with AERC shall not be operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) in excess of 1.29 x 10-3 C/kg/min (5 R/min or 50 mGy/min) at the point where the center of the useful beam enters the patient, except: (I) during recording of fluoroscopic images, excluding last image hold; or (II) when an optional high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed. (iii) Fluoroscopic systems with both an AERC mode and a manual mode. Fluoroscopic systems that are provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) in excess of 2.58 x 10-3 C/kg/min (10 R/min or 100 mGy/min) in either mode at the point where the center of the useful beam enters the patient except: (I) during recording of fluoroscopic images, excluding last image hold; or (II) when the mode or modes have an optional high-level control, in which case that mode or modes shall not be operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) in excess of 1.29 x 10-3 C/kg/min (5 R/min or 50 mGy/min) at the point where the center of the useful beam enters the patient, unless the high level control is activated. Special means of activation of high-level control shall be required. The high level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level is being employed. (iv) Measuring compliance. Compliance of entrance exposure rate (air-kerma rate) for fluoroscopic systems shall be determined as follows. (I) If the source is below the x-ray table, the exposure rate (air kerma rate) shall be measured at 1 cm above the tabletop or cradle. (II) If the source is above the x-ray table, the exposure rate (air kerma rate) shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. (III) In a C-arm fluoroscopic system, the exposure rate (air kerma rate) shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly. The applicable limit shall not be exceeded at any available SID. (IV) In a lateral (horizontal) fluoroscopic system, the exposure rate (air kerma rate) shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the table top is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table. (B) The following requirements apply to fluoroscopic systems manufactured on or after May 19, 1995. (i) Fluoroscopic systems operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) greater than 1.29 x 10-3 C/kg/min (5 R/min or 50 mGy/min) at the point where the center of the useful beam enters the patient shall be equipped with AERC. Provision for manual selection of technique factors may be provided. (ii) Fluoroscopic systems shall not be operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) in excess of 2.58 x 10-3 C/kg/min (10 R/min or 100 mGy/min) at the point where the center of the useful beam enters the patient except: (I) for fluoroscopic systems manufactured prior to June 10, 2006, during the recording of images from an x-ray image-intensifier tube using photographic film or a video camera when the x-ray source is operated in a pulsed mode; (II) for fluoroscopic systems manufactured on and after June 10, 2006, during the recording of images from the x-ray image-intensifier to provide the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded; and (III) when the high-level control is activated, the fluoroscopic system shall not be operable at any combination of tube potential and current that will result in an exposure rate (air kerma rate) in excess of 5.16 x 10-3 C/kg/min (20 R/min or 200 mGy/min) at the point where the center of the useful beam enters the patient. Special means of activation of high-level controls shall be required. The high-level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed. (iii) Measuring compliance of entrance exposure rate (air-kerma rate) for fluoroscopic systems shall be determined as follows. (I) If the source is below the x-ray table, the exposure rate (air kerma rate) shall be measured at 1 cm above the tabletop or cradle. (II) If the source is above the x-ray table, the exposure rate (air kerma rate) shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. (III) In a C-arm fluoroscopic system, the exposure rate (air kerma rate) shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly. The applicable limit shall not be exceeded at any available SID. (IV) In a lateral (horizontal) fluoroscopic system, the exposure rate (air kerma rate) shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the table top is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table. (C) For hand-held fluoroscopic systems, the exposure rate (air kerma rate) shall be measured at the point closest to the source. (D) Periodic measurement of entrance exposure rate (air kerma rate) for fluoroscopic systems shall be performed as follows by a licensed medical physicist. (i) Such measurements shall be made within 30 days of installation and within 30 days after any maintenance of the system that might affect the exposure rate. Thereafter, the measurements shall be made annually or at intervals not to exceed 14 months from the date of the prior measurements. (ii) Results of these measurements shall be posted where any fluoroscopist may have ready access to such results while using the fluoroscopic system and maintained in accordance with subsection (s)(1) of this section for inspection by the agency. The measurement results shall be stated in R/min or mGy/min and include the technique factors used in determining such results. The name of the person performing the measurements and the date the measurements were performed shall be included in the results. (iii) Conditions of periodic measurement of entrance exposure rate (air kerma rate) are as follows. (I) The measurement shall be made in accordance with subparagraph (A)(iv) or (B)(iii) of this paragraph, as applicable. (II) Fluoroscopic systems that do not incorporate an AERC shall utilize a milliamperage and kVp typical of the clinical use of the fluoroscopic system. Materials should be placed in the useful beam between the detection and imaging systems when conducting these periodic measurements to protect the imaging system. (III) Fluoroscopic systems that do incorporate an AERC shall have sufficient material placed in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system. (4) Measurements of the output rate for fluoroscopic systems. Measurements of the output rate of the fluoroscopic system shall be performed with a calibrated dosimetry system in accordance with subsection (i)(14) of this section. (5) Indication of potential and current. During fluoroscopy and cinefluorography, the kV and the mA shall be continuously indicated at the control panel and/or the fluoroscopist's position. (6) Source-to-skin distance (SSD). (A) Means shall be provided to limit the SSD to the following: (i) not less than 38 cm on stationary fluoroscopic systems; and (ii) not less than 30 cm on portable fluoroscopic systems. (B) For image-intensified fluoroscopic systems intended for specific surgical application that would be prohibited at the SSDs specified in subparagraph (A) of this paragraph, provisions may be made for operation at shorter SSDs, but in no case less than 20 cm. (C) For stationary or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-to-image receptor distance of less than 45 cm, the following requirements shall be met. (i) Means shall be provided to limit the SSD to not less than 19 cm. (ii) Such systems will be labeled and used for extremity use only. (iii) For those systems intended for specific surgical applications that would be prohibited at the SSD specified in clause (i) of this subparagraph, provisions may be made for operation at a shorter SSD, but in no case less than 10 cm. (D) The registrant's written operating and safety procedures shall provide precautionary measures to be adhered to during the use of the shorter SSD, in accordance with manufacturer's precautions, if provided. (E) The SSD shall not be less than the FDA approved variance for a specific manufacturer of a hand-held fluoroscope. (7) Fluoroscopic system timer and display. (A) Fluoroscopic systems manufactured prior to June 10, 2006 shall comply with the following requirements. (i) Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting. (ii) A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while x rays are produced until the timing device is reset. In lieu of such signal, the timer shall terminate the beam after the preset cumulative on-time is completed. (B) Fluoroscopic systems manufactured on or after June 10, 2006 shall meet the following requirements. (i) A display of the irradiation time visible to the fluoroscopist shall meet the following requirements. (I) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least every 6 seconds. (II) The fluoroscopic irradiation time shall also be displayed within 6 seconds of termination of an exposure, and remain displayed until reset. (ii) Means shall be provided to display the last-image-hold (LIH) image following the termination of the fluoroscopic exposure. (iii) A display of the exposure rate (air kerma rate) as well as the cumulative exposure (cumulative air kerma) shall be displayed at the fluoroscopist's working position and shall meet the following requirements. (I) The display of the exposure rate (air kerma rate) shall be clearly distinguishable from the cumulative exposure (cumulative air kerma). (II) Means shall be provided to reset to zero the display of cumulative exposure (cumulative air kerma) prior to the beginning of a new examination or procedure. (iv) A signal audible to the fluoroscopist shall sound for each passage of 5 minutes of irradiation time during an examination or procedure. The signal shall sound until manually reset, or if automatically reset, for at least 2 seconds. (8) Control of scattered radiation. (A) Fluoroscopic system configuration, including fluoroscopic table designs, shall not permit any portion of any individual's body, except the head, neck, and extremities, to be exposed to scattered radiation emanating from above or below the tabletop unless the radiation has passed through not less than a total of 0.25 mm lead equivalent material. The material may be, but is not limited to, drapes, self-supporting curtains, or viewing shields, in addition to any lead equivalency provided by a protective apron. (B) Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met. (i) All persons, except the patient, in the room where fluoroscopy is performed shall wear protective aprons that provide a shielding equivalent of 0.35 mm of lead. (ii) The fluoroscopic field size shall be reduced to the absolute minimum required for the procedure being performed (area of clinical interest). (iii) Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or nonuse of the protective drapes. (C) For image-intensified fluoroscopic systems with only a manual mode of collimation, the x-ray field produced shall be limited to the area of the spot-film cassette at 16 inches above tabletop. Additionally, during fluoroscopy, the beam shall be restricted to the area of the input phosphor. (9) Radiation protocol committee (RPC) for fluoroscopically-guided interventional (FGI) procedures. (A) Development of a RPC. (i) Each registrant utilizing FGI procedures shall develop a RPC in accordance with the following. (I) The registrant may establish a system-wide committee if the registrant has more than one site. (II) One or more registrant may form a cooperative RPC as long as each facility has a representative on the committee. (III) If the registrant has already established a radiation safety committee, the requirements of this subsection may be delegated to that committee if the members meet the requirements of subparagraph (B) of this paragraph. (IV) The committee shall meet as often as necessary to conduct business but no less than once every 14 months. (V) Interim meetings may be conducted by electronic means. (ii) The registrant shall make a record of each RPC meeting to include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. The registrant shall maintain the record in accordance with subsection (s)(1) of this section for inspection by the agency. (B) Members required for the RPC. Members shall include but not be limited to the following individuals: (i) a licensed physician of the healing arts who meets the requirements in subparagraph (E) of this paragraph; (ii) a licensed medical physicist; (iii) the RSO; and (iv) other individuals as deemed necessary by the registrant. (C) Establish and implement FGI procedure protocols. (i) The RPC shall establish and implement written protocols, or protocols documented in an electronic report system, that include but are not limited to the following. (I) A restriction of the use of fluoroscopic systems for interventional purposes to radiologists, radiation oncologists, physicians, as well as individuals to whom a physician has delegated authority pursuant to the Occupations Code, Chapter 601, and the applicable rules of the Texas Medical Board, who have completed the radiation safety awareness training as required in subparagraph (E) of this paragraph. (II) A method to be used to monitor the radiation exposure. (III) A recommended reference level for FGI procedures performed. (IV) Actions to be taken for cases when the reference level was exceeded which may include patient follow-up. (V) A review of the established protocol at an interval not to exceed 14 months. (ii) The registrant shall make and maintain a record of each RPC protocol in accordance with subsection (s)(1) of this section for inspection by the agency. If the RPC revises a protocol, the registrant shall maintain the previous documentation after the revision in accordance with subsection (s)(1) of this section for inspection by the agency. (D) Procedures for maintaining records. (i) The registrant shall make and maintain a record of radiation output information so the radiation dose to the skin may be estimated in accordance with established protocols. The record shall include the following: (I) patient identification; (II) type and date of examination; (III) identification of the fluoroscopic system used; and (IV) cumulative air kerma or dose area product used if the information is available on the fluoroscopic system. (ii) If the cumulative air kerma or dose area product are not displayed on the fluoroscopic system, records shall include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following as necessary: (I) fluoroscopic mode, such as, high-level or pulsed mode of operation; (II) cumulative fluoroscopic exposure time; and (III) number of films or recorded exposures. (iii) The registrant shall maintain records required by this subparagraph in accordance with record retention policies of the facility. (E) Radiation safety awareness training. Physicians, other than radiologists and radiation oncologists, as well as individuals to whom a physician has delegated authority pursuant to the Occupations Code, Chapter 601, and the applicable rules of the Texas Medical Board, shall complete a minimum of 8 hours of Category 1 CMEU in radiation safety awareness training prior to performing FGI procedures. (i) The radiation safety awareness training shall include, but not be limited to the following topics: (I) principles of radiation protection; (II) biological effects of x-ray radiation; (III) principles of fluoroscopic systems; (IV) operation of fluoroscopic systems used for interventional purposes; (V) fluoroscopic exposure (air kerma) outputs; (VI) high level control options; (VII) dose reduction techniques; and (VIII) procedures for recording pertinent data specified in subparagraph (D) of this paragraph. (ii) In addition to the 8-hour Category 1 CMEU as required in this subparagraph, the radiation safety awareness training shall: (I) include a minimum of 1 hour fluoroscopic machine training demonstrating application of clause (i)(I), and (IV) - (VII) of this subparagraph; and (II) be provided by a radiologist, licensed medical physicist, or a physician that meets the requirements of this subparagraph. (iii) The registrant shall ensure that radiation safety awareness training be completed within 2 years from the effective date of this rule for each physician, "as well as individuals to whom a physician has delegated authority pursuant to the Occupations Code, Chapter 601, and the applicable rules of the Texas Medical Board," performing FGI procedures. (iv) Two years after the effective date of this rule, the registrant shall ensure that prior to performing FGI procedures each physician, "as well as individuals to whom a physician has delegated authority pursuant to the Occupations Code, Chapter 601, and the applicable rules of the Texas Medical Board," shall complete the radiation safety awareness training. (v) The 8 hours of Category 1 CMEU in radiation safety awareness training required by this subsection may be obtained by web-based online training. (vi) The registrant shall maintain radiation safety awareness training records for the 8 hours Category 1 CMEU and the 1 hour fluoroscopic machine training required in this subparagraph in accordance with subsection (s)(1) of this section for inspection by the agency. (n) CT systems. (1) CT system requirements shall include the following. (A) Warning label. The warning label will meet the requirements of §289.231(z) of this title. (B) Visual indication. The CT control panel shall provide visual indication of the production of x-rays. (C) Indicated technique factors. The indicated technique factors shall be accurate to meet manufacturer's specifications. If these specifications are not available from the manufacturer, the factors shall be accurate to within plus or minus 10% of the indicated setting. (D) Tomographic plane indication and alignment. (i) For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane. (ii) For any multiple slice tomogram system, means shall be provided to permit visual determination of the location of a reference plane. The reference plane can be offset from the location of the tomographic planes. (iii) If a device using a light source is used to satisfy the requirements of clause (i) or (ii) of this subparagraph, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux. (E) Indication of CT conditions of operation. The CT system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence are indicated prior to the initiation of a scan or a scan sequence. On CT systems having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible. (F) Initiation of operation. (i) The CT control panel and gantry shall provide visual indication whenever x rays are produced and, if applicable, whether the shutter is open or closed. (ii) Means shall be provided to require operator initiation of each individual scan or series of scans. (iii) All emergency buttons/switches shall be clearly labeled as to their functions. (G) Termination of exposure. (i) Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110% of its preset value through the use of either a backup timer or devices that monitor equipment function. (ii) A signal visible to the operator shall indicate when the x-ray exposure has been terminated through the means required by clause (i) of this subparagraph. (iii) The operator shall be able to terminate the x-ray exposure at any time during a scan or series of scans under CT system control, of greater than 0.5 seconds duration. Termination of the x-ray exposure shall necessitate resetting of the CT conditions of operation prior to initiation of another scan. (H) Additional requirements applicable to CT systems. Additional requirements applicable to CT systems containing a gantry manufactured after September 3, 1985, are as follows. (i) The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 mm. (ii) If the x-ray production period is less than 0.5 seconds, the indication of x-ray production shall be actuated for at least 0.5 seconds. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible. (iii) The deviation of indicated scan increment versus actual increment shall not exceed plus or minus 1 mm with any mass from 0 to 100 kilograms (kg) resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 cm, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment can be taken anywhere along this travel. (2) Facility design requirements shall include the following. (A) Provision shall be made for two-way aural communication between the patient and the operator at the control panel. (B) Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel. (i) Should the viewing system described in subparagraph (B) of this paragraph fail or be inoperative, treatment shall not be performed with the unit until the system is restored. (ii) In a facility that has a primary viewing system by electronic means and an alternate viewing system, should the viewing system described in subparagraph (B) of this paragraph fail or be inoperative, treatment shall not be performed with the unit until one of the systems is restored. (3) Measurements of the radiation output of the CT system, using the computed tomography dose index (CTDI) as recommended by the American Association of Physicists in Medicine (AAPM) and the International Council on Radiation Protection (ICRP), shall be performed by a licensed medical physicist. (A) Performance of the radiation output measurements shall be: (i) within 30 days after initial installation; (ii) thereafter annually or at intervals not to exceed 14 months from the date of the prior radiation output measurements; (iii) within 30 days of any major maintenance, that could affect radiation output; and (iv) within 30 days of any major change in equipment operation for example, introduction of a new software package. (B) The registrant shall ensure that radiation output measurements of a CT system are performed with a calibrated dosimetry system in accordance with subsection (i)(14) of this section. (4) A maintenance schedule shall be developed and followed. This schedule shall be in writing or documented in an electronic reporting system and shall be included in the registrant's operating and safety procedures. The maintenance schedule shall include but not be limited to the following: (A) radiation output measurements required by paragraph (3)(A) of this subsection; (B) acquisition of images by a licensed medical physicist obtained with phantoms and using the same processing mode and CT conditions of operation as are used to perform radiation output measurements required by paragraph (3)(A) of this subsection; and (C) acquisition of images by the registrant for quality control purposes obtained with phantoms and using protocol and intervals recommended by the manufacturer or the licensed medical physicist. (5) The registrant shall maintain the images specified in paragraph (4)(B) and (C) of this subsection in accordance with subsection (s)(1) of this section for inspection by the agency. The images may be maintained by either of the following methods: (A) photographic copies of the images obtained from the image display device; or (B) images stored in digital form. (6) Radiation protocol committee (RPC) for CT systems. (A) Development of a RPC. (i) Each registrant utilizing CT systems shall develop a RPC in accordance with the following: (I) The registrant may establish a system-wide committee if the registrant has more than one site. (II) One or more registrants may form a cooperative RPC as long as each facility has a representative on the committee. (III) If the registrant has already established a radiation safety committee, the requirements of this subsection may be delegated to that committee if the members meet the requirements of subparagraph (B) of this paragraph. (IV) The committee shall meet as often as necessary to conduct business but no less than once every 14 months. (V) Interim meetings may be conducted by electronic means. (ii) The registrant shall make a record of each RPC meeting to include the date, names of individuals in attendance, minutes of the meeting, and any action taken. The registrant shall maintain the record in accordance with subsection (s)(1) of this section for inspection by the agency. (B) Members required for the RPC. Members shall include but not be limited to the following individuals: (i) a radiologist or radiation oncologist; (ii) a licensed medical physicist; (iii) the RSO; and (iv) other individuals as deemed necessary by the registrant. (C) Establish and implement CT system protocols. (i) The RPC shall establish and implement written protocols, or protocols documented in an electronic reporting system, that include but are not limited to the following. (I) A method to be used to monitor the radiation output. (II) A recommended reference level for CT procedures performed. (III) Actions to be taken for cases when the reference level was exceeded which may include patient follow-up. (IV) A review of the established protocols at an interval not to exceed 14 months. (ii) The registrant shall make and maintain a record of each RPC protocol in accordance with subsection (s)(1) of this section for inspection by the agency. If the RPC revises a protocol, the registrant shall maintain the previous documentation after the revision in accordance with subsection (s)(1) of this section for inspection by the agency. (D) Procedures for maintaining records. (i) The registrant shall make and maintain a record of radiation output information so the radiation dose to the skin may be estimated in accordance with established protocols. The record shall include the following: (I) patient identification; (II) type and date of examination; (III) identification of the CT system used; and (IV) if the CT system is capable of calculating and displaying these values: (-a-) CTDI vol ; (-b-) DLP; or (-c-) recommendations as identified in "Comprehensive Methodology for the Evaluation of Radiation Dose in X-ray Computed Tomography. Report of American Association of Physicists in Medicine, Task Group 111; The Future of CT Dosimetry, February 2010," may be used to meet compliance with this subsection. (ii) The registrant shall maintain records required by this subparagraph in accordance with record retention policies of the facility. (o) Equipment performance evaluation (EPE). (1) Frequency of EPE. For x-ray, fluoroscopic, and CT systems, an EPE shall be performed at the frequency listed in the following table. Attached Graphic(2) Performance of EPE. For all x-ray systems an EPE shall be performed by or under the supervision of a licensed medical physicist: (A) within 30 days after initial installation of new machines; (B) within 30 days after reinstallation of a machine; or (C) within 30 days after repair of a machine component that would effect the radiation output that includes but is not limited to the timer, tube, and power supply. (3) Records of EPE results. Records of the test results shall include: (A) measurements and numerical readings; (B) indicate a pass or fail for each test; and (C) be reviewed and signed by the licensed medical physicist. (4) Correction of EPE results. (A) Any items not meeting the specifications of the EPE shall be corrected or repaired. The correction or repair shall begin within 30 days following the EPE and shall be performed according to a plan designated by the registrant. Correction or repair shall be completed no longer than 90 days from discovery unless authorized by the agency. (B) The registrant shall make and maintain records of corrections or repairs in accordance with subsection (s)(1) of this section for inspection by the agency. (5) Calibrated dosimetry system. The registrant shall ensure that measurements of the radiation output of an x-ray system are performed with a calibrated dosimetry system in accordance with subsection (i)(14) of this section. (6) EPE for x-ray systems. (A) Timer. The accuracy of the timer shall meet the manufacturer's specifications. If the manufacturer's specifications are not obtainable, the timer accuracy shall be plus or minus 10% of the indicated time with testing performed at 0.5 second. (B) Exposure reproducibility. Exposure reproducibility shall meet the requirements of subsection (l)(4) of this section. (C) Linearity. mR/mAs (mGy/mAs) stations shall meet the requirements of subsection (l)(5) of this section. (D) kVp. If the registrant possesses documentation of the appropriate manufacturer's kVp specifications, the radiation machine shall meet those specifications. If the registrant does not possess documentation of the appropriate manufacturer's kVp specifications, the indicated kVp shall be accurate to within plus or minus 10% of the indicated setting at no less than 3 points over the usual operating range of the machine. (E) Tube stability. The x-ray tube shall remain physically stable during exposures. In cases where tubes are designed to move during exposure, the registrant shall assure proper and free movement of the unit. (F) Collimation. The following items shall meet the requirements of subsection (l)(1) of this section: (i) numerical indicators of x-ray field size; (ii) light field versus x-ray field congruence; (iii) automatic and semi-automatic collimators unless disabled; and (iv) center of x-ray field alignment with center of image receptor. (G) Entrance exposure (air kerma) limits. Entrance exposure (air kerma) limits shall meet the requirements specified in subsection (j) of this section and shall be determined for all examinations specified in Table I of subsection (j) of this section, that are performed by the registrant. (7) EPE for fluoroscopic systems and spot film devices. Fluoroscopic systems shall meet the requirements of subsections (i)(14) and (m)(1)(C) and (3) of this section. (8) EPE for CT systems. CT systems shall meet the requirements of subsections (i)(14) and (n)(1)(H) of this section. (p) Automatic and manual film processing for facilities and mobile services. (1) Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer. The specified developer temperature for automatic processing and the time-temperature chart for manual processing shall be posted near the film processing area. If the registrant determines an alternate time-temperature relationship is more appropriate for a specific facility, that time-temperature relationship shall be documented and posted. (2) Chemicals shall be replaced according to the chemical manufacturer's or supplier's recommendations or at an interval not to exceed 3 months. (3) Darkroom light leak tests shall be performed at intervals not to exceed 6 months. (4) Lighting in the film processing/loading area shall be maintained with the filter, bulb wattage, and distances recommended by the film manufacturer for that film emulsion or with products that provide an equivalent level of protection against fogging. (5) Corrections or repairs of the light leaks or other deficiencies in paragraphs (2) - (4) of this subsection shall be initiated within 72 hours of discovery and completed no longer than 15 days from detection of the deficiency unless a longer time is authorized by the agency. The registrant shall make a record of the correction or repairs to include the date and initials of the individual performing these functions. The records shall be maintained in accordance with subsection (s)(1) of this section for inspection by the agency. (6) Documentation of the items in paragraphs (2), (3), and (5) of this subsection shall include the date and initials of the individual completing these items. The registrant shall maintain these records at the site where performed in accordance with subsection (s)(1) of this section for inspection by the agency. (q) Alternative processing systems. Users of daylight processing systems, laser processors, self-processing film units, or other alternative processing systems shall follow manufacturer's recommendations for image processing. Documentation that the registrant is following manufacturer's recommendations shall include the date and initials of the individual completing the document and shall be maintained at the site where performed in accordance with subsection (s)(1) of this section for inspection by the agency. (r) Digital imaging acquisition systems. Users of digital imaging acquisition systems shall follow quality assurance/quality control protocol for image processing established by the manufacturer or, if no manufacturer's protocol is available, by the registrant. The registrant shall include the protocols, whether established by the registrant or the manufacturer, in its operating and safety procedures. The registrant shall document the frequency at which the quality assurance/quality control protocol is performed. Documentation shall include the date and initials of the individual completing the document and shall be maintained at the site where performed in accordance with subsection (s)(1) of this section for inspection by the agency. (s) Record/document requirements for mobile services and authorized use locations. (1) Each registrant shall maintain the following records/documents at each site, including authorized records sites for mobile services at the time intervals specified, for inspection by the agency. The records may be maintained in electronic format. Attached Graphic(2) Records required in item F of the table in paragraph (1) of this subsection shall include the following: (A) manufacturer's name, model and serial number; (B) unique identification of the calibrated dosimetry system; and (C) name of the individual recording the information. (3) Copies of the records/documents in items (A) - (D), (H), (J), and (N) - (Q) of the table in paragraph (1) of this subsection shall be kept with radiation machines authorized to be used for mobile services. Mobile services with on-board film processors shall maintain the records in items (O) - (Q) of the table in paragraph (1) of this subsection, as applicable, with the processor or system for a period of no less than 1 year. Source Note: The provisions of this §289.227 adopted to be effective May 1, 2013, 38 TexReg 1185. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.227 Use of Radiation Machines in the Healing Arts https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=136344&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 136344 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=136344&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 136344 03/11/2026 (a) Purpose. This section establishes requirements for the use of industrial radiation machines not otherwise covered by this chapter. For purposes of this section, industrial radiation machines include, but are not limited to, portable/handheld fluorescence x-ray (open beam), fluoroscopy hand held intensified, fluoroscopy x-ray, industrial accelerator, spectrography x-ray, flash x-ray, flash x-ray for bomb detection, educational facility (x-ray for non-human or not live animal use), diffraction x-ray, uncertified cabinet x-ray, and minimal threat radiation machines.(b) Scope.(1) The requirements of this section are in addition to and not in substitution for other applicable requirements of this chapter.(2) In addition to the requirements of this section, all registrants, unless otherwise specified, are subject to the requirements of §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.226 of this title (relating to Registration of Radiation Machine Use and Services), and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation).(3) Radiation safety requirements and registration procedures for industrial radiography are specified in §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography).(c) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.(1) Fail-safe characteristics--Design features that cause beam port shutters to close, or otherwise prevent emergence of the primary beam, upon the failure of a safety or warning device.(2) Local components--Parts of an x-ray system that include areas that are struck by x rays, such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.(3) Minimal threat radiation machines--Minimal threat radiation machines include, but are not limited to, fluorescence x-ray (closed beam), gauges x-ray, certified cabinet x-ray, package x-ray, electron beam welding, particle size analyzer, ion-implant, and cathodoluminescence. In addition, minimal threat radiation machines are those radiation machines capable of generating or emitting fields of radiation that, during the operation of which:(A) no deliberate exposure of an individual occurs;(B) the radiation is not emitted in an open beam configuration; and(C) no known physical injury to an individual has occurred.(4) Open-beam configuration--A radiation machine in which an individual could accidently place some part of his/her body in the primary beam path during normal operation.(5) Primary beam--Ionizing radiation that passes through an aperture of the source housing by a direct path from the x-ray tube located in the radiation source housing.(6) Safety device--A device that prevents the entry of any portion of an individual's body into the primary x-ray beam path or that causes the beam to be shut off upon entry into its path.(7) X-ray system--A group of components utilizing x rays to determine the elemental composition or to examine the microstructure of materials.(d) Exemptions.(1) Uses of minimal threat radiation machines as specified in §289.231(ll)(3) of this title, are exempt from the requirements of subsections (e)(2)(B) and (C), (f)(3), and (g)(1) of this section.(2) Uses of certified and certifiable cabinet x-ray systems are exempt from the requirements of subsection (f)(1) and (2) of this section. This exemption will apply only to those radiation machines that do not allow a person or body part to be exposed to the radiation beam.(3) Uses of portable/handheld fluorescence x-ray (open beam) devices that are manufactured without safety devices are exempt from the requirements of subsection (e)(1)(A) of this section.(e) Equipment requirements.(1) Safety devices.(A) A safety device shall be provided on all open-beam configurations.(B) A registrant may apply to the agency for an exemption from the requirement of a safety device in accordance with §289.231 of this title. Any such request shall include:(i) a description of the various safety devices that have been evaluated;(ii) the reason each of these devices cannot be used; and(iii) a description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.(2) Warning devices.(A) Open-beam configurations shall be provided with a visible indication of:(i) x-ray tube status (ON-OFF) located near the radiation source housing, if the primary beam is controlled in this manner; and/or(ii) shutter status (OPEN-CLOSED) located near each port on the radiation source housing, if the primary beam is controlled in this manner.(B) The x-ray control shall provide visual indication whenever x rays are produced.(C) Warning devices shall be labeled so that their purpose is easily identified and shall have fail-safe characteristics.(3) Ports. Unused ports on radiation machine source housings shall be secured in the closed position in a manner that will prevent inadvertent opening.(4) Labeling. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner to caution individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit. If the radiation machine is not visible from the control unit, the radiation machine shall have a visible indication that it is energized.(5) Shutters. On open-beam configurations, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.(6) Radiation source housing. Each x-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled.(7) Generator cabinet. Each x-ray generator shall be supplied with a protective cabinet that limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is not capable of producing a dose in excess of 0.5 millirem (5.0 microsieverts (µSv)) in any one hour.(8) Certified and certifiable cabinet x-ray systems. Certified and certifiable cabinet x-ray systems, including those designed to allow admittance of individuals, shall:(A) be maintained in compliance with Title 21, Code of Federal Regulations (CFR), §1020.40 and no modification shall be made to the system unless prior agency approval has been granted in accordance with §289.231(d) of this title; and(B) comply with the following requirements.(i) No registrant shall permit any individual to operate a cabinet x-ray system until the individual has received a copy of and instruction in the operating procedures for the unit.(ii) Tests for proper operation of interlocks shall be conducted and recorded at intervals not to exceed 12 months.(iii) The registrant shall perform an evaluation to determinate compliance with §289.231(o)(1) - (3) of this title and Title 21, CFR, §1020.40 at intervals not to exceed one year. The registrant shall ensure that radiation emitted 5 centimeters from the external surface of the cabinet x-ray system does not exceed 0.5 millirem (5.0 µSv) in any one hour.(iv) Documentation of the requirements in clauses (i) - (iii) of this subparagraph shall be maintained by the registrant for 10 years for inspection by the agency.(9) Package x-ray systems.(A) The registrant shall perform an annual evaluation to ensure radiation emitted 5 centimeters from the external surface of the package x-ray system does not exceed 0.5 millirem (5.0 µSv) in any one hour.(B) Tests for proper operation of interlocks shall be conducted and recorded at intervals not to exceed 12 months.(C) Documentation of the requirements in subparagraphs (A) and (B) of this paragraph shall be maintained by the registrant for 10 years for inspection by the agency.(f) Area requirements.(1) Radiation levels. The local components of an x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group that could result in a dose to an individual present in the area in excess of the dose limits specified in §289.231 of this title.(2) Surveys.(A) Radiation surveys, as required by §289.231 of this title, of all radiation machines and x-ray systems sufficient to show compliance with paragraph (1) of this subsection shall be performed:(i) upon installation of the equipment;(ii) following any change in the initial arrangement, number, or type of local components in the system;(iii) following any maintenance requiring the disassembly or removal of a local component in the system;(iv) during the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed;(v) any time a visual inspection of the local components in the system reveals an abnormal condition; or(vi) whenever individual monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the radiation dose limits.(B) Radiation survey measurements shall not be required if a registrant can demonstrate, to the satisfaction of the agency, compliance with paragraph (1) of this subsection in some other manner.(3) Posting. Each area or room containing radiation machines shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words "CAUTION - X-RAY EQUIPMENT," or words having a similar intent.(g) Operating requirements.(1) Procedures. Operating and safety procedures shall be written and made available to all radiation machine operators. No person shall be permitted to operate radiation machines in any manner other than that specified in the procedures unless that person has obtained written approval of the radiation safety officer.(2) Bypassing. No person shall bypass a safety device unless that person has obtained the approval of the radiation safety officer. When a safety device has been bypassed, a visible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing.(3) Repair or modification of radiation machines. Except as specified in paragraph (2) of this subsection, no operation involving removal of covers, shielding materials, or tube housings, or modifications to shutters, collimators, or beam stops shall be performed without ensuring that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.(h) Personnel requirements.(1) Instructions. No person shall be permitted to operate or maintain radiation machines unless such person has received instruction in and demonstrated competence in the following:(A) identification of radiation hazards associated with the use of the radiation machine;(B) radiation warning and safety devices incorporated into the radiation machine, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;(C) operating and safety procedures for the radiation machine; and(D) proper procedures for reporting an actual or suspected exposure in excess of the limits specified in §289.231 of this title.(2) Instructions for bomb detection radiation machines. All personnel operating bomb detection radiation machines shall be trained in the set-up and operation of the radiation machine and in establishing a restricted area.(3) Individual monitoring. In addition to the requirements of §289.231(n)(1)(A) of this title, finger dosimetric devices shall be provided to and shall be used by:(A) radiation machine workers using systems having an open-beam configuration and not equipped with a safety device; and(B) personnel maintaining radiation machines if the maintenance procedures require the presence of a primary x-ray beam when any local component in the x-ray system is disassembled or removed.(4) Records and documentation. Documentation of the requirements in paragraphs (1) - (3) of this subsection shall be maintained by the registrant for 10 years for inspection by the agency. In addition to complying with the requirements of this paragraph, records of individual monitoring results shall be maintained by the registrant in accordance with §289.231(dd) of this title. Source Note: The provisions of this §289.228 adopted to be effective July 1, 2000, 25 TexReg 5346; amended to be effective May 1, 2008, 33 TexReg 3417. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.228 Radiation Safety Requirements for Industrial Radiation Machines https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220839&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220839 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220839&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220839 03/11/2026 (a) Purpose. This section establishes the following requirements for using accelerators, therapeutic radiation machines, radiation therapy simulation systems, and electronic brachytherapy (EBT) devices.(1) Requirements for the registration of a person using radiation machines used in healing arts.(A) A person must not use radiation machines except as authorized in a certificate of registration issued by the Department of State Health Services (department) as specified in the requirements of this section.(B) A person who receives, possesses, uses, owns, or acquires radiation machines before receiving a certificate of registration is subject to the requirements of this chapter.(2) Requirements are intended to control receipt, possession, use, and transfer of radiation machines by any person so the total radiation dose to an individual, excluding background radiation, does not exceed the standards for protection against radiation prescribed in this section. This section does not limit actions necessary to protect public health and safety during an emergency.(3) Requirements for specific record keeping and general provisions of records and reports.(b) Scope.(1) This section applies to a person who receives, possesses, uses, acquires, or transfers an accelerator used in industrial operations and research and development, therapeutic radiation machines, radiation therapy simulation systems, and EBT devices used in the healing arts. The registrant is responsible for the administrative control and for directing the use of the accelerators, other therapeutic radiation machines, radiation therapy simulation systems, and EBT devices.(2) The requirements of this section are in addition to and not in substitution for other applicable requirements of:(A) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(B) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);(C) §289.205 of this chapter (relating to Hearing and Enforcement Procedures);(D) §289.226 of this chapter (relating to Registration of Radiation Machine Use and Services);(E) §289.227 of this chapter (relating to Use of Radiation Machines in the Healing Arts); and(F) §289.231 of this chapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (3) Registrants engaged in industrial radiographic operations are subject to the requirements of §289.255 of this chapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography).(4) Registrants engaged in veterinary accelerator operations are subject to the requirements of §289.233 of this chapter (relating to Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine).(5) An entity, defined in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as a "covered entity" under 45 Code of Federal Regulations (CFR) Parts 160 and 164 may be subject to privacy standards governing how information identifying a patient can be used and disclosed. Failure to follow HIPAA requirements may result in the department referring a potential violation to the United States Department of Health and Human Services.(c) Prohibitions.(1) The department prohibits the use of accelerators, therapeutic radiation machines, radiation therapy simulation systems, or EBT devices posing a significant threat or danger to occupational and public health and safety, as specified in §289.205 and §289.231 of this chapter.(2) An individual must not be exposed to the useful beam of accelerators, therapeutic radiation machines, radiation therapy simulation systems, or EBT devices except for healing arts purposes and unless a physician of the healing arts has authorized such exposure. This provision specifically prohibits the deliberate exposure of an individual for training, demonstration, or other non-healing arts purposes.(3) Research and development using radiation machines on humans is prohibited unless approved by an Institutional Review Board (IRB) as required by 45 CFR Part 46 and 21 CFR Part 56. The IRB must include at least one physician of the healing arts to direct any use of radiation as specified in §289.231(b) of this chapter.(4) Remote operation of radiation machines on humans is prohibited.(5) Use of therapeutic radiation machines in the healing arts without the supervision of a physician of the healing arts is prohibited.(6) Use of EBT devices in the healing arts without the supervision of a certified physician, as defined in subsection (e)(12) of this section, is prohibited.(d) Exemptions. An individual who is a sole physician, sole operator, and the only occupationally exposed individual is exempt from the following requirements:(1) §289.203(b) and (c) of this chapter; and(2) subsection (h)(1)(G) of this section.(e) Definitions. When used in this section, the following words and terms have the following meaning unless the context indicates otherwise.(1) Absorbed dose (D)--The mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to the mass dM. The System International (SI) unit of absorbed dose is joule per kilogram and the special name of the unit of absorbed dose is gray (Gy). The previously used special unit of absorbed dose (rad) is replaced by gray.(2) Absorbed dose rate--Absorbed dose per unit time for machines with timers, or dose monitor unit per unit time for linear accelerators.(3) Accelerator beam quality--The type and penetrating power of the ionizing radiation produced for certain machine settings.(4) Air kerma--The kinetic energy released in air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is Gy.(5) Barrier--See definition for protective barrier.(6) Beam axis--The axis of rotation of the beam limiting device.(7) Beam-flattening filter--See definition for field-flattening filter.(8) Beam-limiting device--A field-defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam.(9) Beam monitoring system--A system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.(10) Beam quality--The penetrating power of the x-ray beam identified numerically by the half-value layer and influenced by kilovolt peak (kVp) and filtration.(11) Central axis of the beam--An imaginary line passing through the center of the useful beam and the center of the plane figure formed by the edge of the first beam-limiting device.(12) Certified physician--A physician licensed by the Texas Medical Board and certified in radiation oncology or therapeutic radiology.(13) Coefficient of variation or C--The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:Attached Graphic(14) Collimator--A device or mechanism by which the x-ray beam is restricted in size.(15) Computed tomography (CT)--The production of a tomogram by the acquisition and computer processing of x-ray transmission data.(16) Continuous pressure type switch--A switch that can only power a device when the operator maintains continuous pressure on the switch.(17) Control panel--The part of the radiation machine where the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors are located. For purposes of this section, console is an equivalent term.(18) Conventional radiation therapy simulator--A radiation machine with radiographic or fluoroscopic capabilities uniquely designed for the direct purpose of simulating radiation therapy treatment ports.(19) CT conditions of operation--All selectable parameters governing the operation of a CT x-ray system, including nominal tomographic section thickness, filtration, and the technique factors as defined in this subsection.(20) CT radiation therapy simulator--CTs that interface with radiation therapy linear accelerators.(21) Diaphragm--A device or mechanism by which the x-ray beam is restricted in size.(22) Dose monitor unit (DMU)--A unit response from the beam monitoring system from which the absorbed dose can be calculated. (23) Dosimetry system--An ion chamber used as a dosimeter for measurement of clinical photon and electron beams with calibration coefficients determined either in air or in water and traceable to a national primary standards dosimetry laboratory.(24) Electronic brachytherapy--A method of radiation therapy using electrically generated x-rays to deliver a radiation dose at a distance of up to a few centimeters by intracavitary, intraluminal, or interstitial application, or by applications with the source in contact with the body surface or very close to the body surface.(25) Electronic brachytherapy (EBT) device--The system used to produce and deliver therapeutic radiation, including the x-ray tube, the control mechanism, the cooling system, and the power source.(26) External beam radiation therapy--Therapeutic irradiation in which the source of radiation is at a distance from the body.(27) Field-flattening filter--A filter used to homogenize the absorbed dose rate over the radiation field.(28) Field size--The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the nominal treatment or examination source-to-image distance and defined by the intersection of the major axes and the 50 percent isodose line.(29) Focal spot--The area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.(30) Gantry--The part of the radiation therapy system that supports and allows possible movements of the radiation head about the center of rotation.(31) Gray (Gy)--The SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is replaced by the gray (1 Gy = 100 rad).(32) Half-value layer (HVL)--The thickness of a specified material that attenuates x-radiation or gamma radiation to the extent the exposure rate (air kerma rate) or absorbed dose rate is reduced to one-half of the value measured without the material at the same point.(33) Healing arts--Any treatment, operation, diagnosis, prescription, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.(34) Image receptor--Any device that transforms incident x-ray photons either into a visible image or into another form made into a visible image by further transformations.(35) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct a periodic review of biomedical research involving human subjects.(36) Image-Guided Radiation Therapy (IGRT)--Radiation therapy employing advanced imaging to maximize accuracy and precision throughout the entire process of treatment delivery with the goal of optimizing the accuracy and reliability of radiation therapy to the target while minimizing dose to normal tissues.(37) Intensity-Modulated Radiation Therapy (IMRT)--A technology for delivering highly conformal external beam radiation to a well-defined treatment volume with radiation beams whose intensity varies across the beam.(38) Interlock--A device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.(39) Interruption of irradiation--The stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.(40) Irradiation--The exposure of a living being or matter to ionizing radiation.(41) Irradiation filter (filter)--Radiation absorbers or beam-modifying devices placed in the useful high-energy beam to shape the beam and optimize the target volume dose distribution in therapeutic radiation machines subject to subsection (h) of this section. Irradiation filter types are defined as follows.(A) Dynamic or virtual wedge--A wedge produced by computer-controlled movement of one or more collimator jaws. The wedge generates a spatial dose distribution similar to a physical wedge. The wedge-shaped graduated attenuation across the radiation beam can produce symmetric or asymmetric radiation fields.(B) Multileaf collimator (MLC) wedge filter--A beam-limiting device made of individual "leaves" of a high atomic numbered material, usually tungsten, that can move independently in and out of the path of a radiotherapy beam to shape and vary its intensity.(C) Physical wedge filter--Physical wedges are made of metallic material and are manually placed in the useful radiation beam. The wedges are shaped in such a way as to produce graduated attenuation across the radiation field.(D) Stereotactic radiosurgery (SRS) filter--A precise form of target localization delivering radiation through narrow circular cones or circular collimator tubes with lenses or computer leaf-driven systems enabling more precise beam filtering or shaping for complex radiation fields.(42) Isocenter--The center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.(43) Kilovolt (kV) (kilo electron volt (keV))--The energy given to a particle with one electron charge when passing through a potential difference of one thousand volts in a vacuum. (Note: current convention is to use kV for photons and keV for electrons.)(44) Kilovolt peak (kVp)--See definition for peak tube potential.(45) Lead equivalent--The thickness of lead affording the same attenuation, under specified conditions, as the material in question.(46) Leakage radiation--Radiation emanating from the source assembly except for the useful beam and radiation produced when the exposure switch or timer is not activated.(47) Leakage technique factors--The technique factors associated with the source assembly used when measuring leakage radiation. (48) Licensed medical physicist--An individual holding a current Texas license under the Medical Physics Practice Act, Texas Occupations Code Chapter 602.(49) Light field--The area illuminated by light, simulating the radiation field.(50) Medical event--An event meeting the criteria specified in subsection (i) of this section.(51) Megavolt (MV) (megaelectron volt (MeV))--The energy given to a particle with one electron charge when passing through a potential difference of one million volts in a vacuum.(52) Mobile EBT device--An EBT device transported from one address to be used at another address.(53) Moving beam radiation therapy--Radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation, and rotational therapy.(54) Nominal treatment distance--The following nominal treatment distances apply.(A) For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam, as specified by the manufacturer.(B) For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam to the isocenter. For non-isocentric equipment, this distance is specified by the manufacturer.(55) Output--The exposure rate (air kerma rate), dose rate, or a quantity related to these rates from a therapeutic radiation machine.(56) Peak tube potential--The maximum value of the potential difference in kilovolts across the x-ray tube during exposure.(57) Phantom--An object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.(58) Physician--An individual licensed by the Texas Medical Board to practice medicine under Texas Occupations Code Chapter 155.(59) Port film--An x-ray exposure made with a radiation therapy system to visualize a patient's treatment area using radiographic film.(60) Portable shielding--Moveable shielding placed in the primary or secondary beam to reduce radiation exposure to the patient, occupational worker, or a member of the public. The shielding can be easily moved to position using mobility devices or by hand.(61) Prescribed dose--The total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic machine using clinically acceptable and historically consistent assumptions for the treatment technique and calculations previously used for patients treated with the same clinical technique.(62) Primary dose monitoring system--A system monitoring the useful beam during irradiation and terminating irradiation when a preselected number of monitor units are delivered.(63) Protective apron--An apron made of radiation-absorbing materials used to reduce radiation exposure.(64) Protective barrier--A barrier of radiation-absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows.(A) Primary protective barrier. A barrier sufficient to attenuate the useful beam to the required degree.(B) Secondary protective barrier. A barrier sufficient to attenuate the scatter radiation to the required degree.(65) Protective glove--A glove made of radiation-absorbing materials used to reduce radiation exposure.(66) Quality assurance (QA) check--A test or analysis performed at a specified interval to verify the consistent output of radiation equipment.(67) Radiation detector--A device providing, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.(68) Radiation field--See definition for useful beam.(69) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.(70) Radiation therapy simulation system --An x-ray system intended for localizing and confirming the volume to be irradiated during radiation treatment and confirming the position and size of the therapeutic irradiation field.(71) Radiation therapy system--A system utilizing machine-produced, prescribed doses of ionizing radiation for treatment.(72) Radiation treatment head--The structure from which the useful beam emerges.(73) Scan--The complete process of collecting x-ray transmission data to produce one or more tomograms.(74) Scan increment--The amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.(75) Scan sequence--A preselected set of two or more scans performed consecutively under preselected CT conditions of operation. (76) Scan time--The period between the beginning and end of x-ray transmission data accumulation for a single scan.(77) Scattered radiation--Secondary radiation occurring when the beam intercepts an object causing the x-rays to be scattered.(78) Secondary dose monitoring system--A system terminating irradiation in the event of failure of the primary dose monitoring system.(79) Shutter--A device attached to the tube housing assembly capable of completely intercepting the useful beam and with a lead equivalency greater than or equal to the tube housing assembly.(80) Source-to-skin distance (SSD)--The distance from the source to the skin of the patient.(81) Stationary beam therapy--Radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.(82) Supervision--Delegating the task of applying radiation to a person by a physician. The physician can only delegate tasks to an individual certified under the Medical Radiologic Technologist Act, Texas Occupations Code Chapter 601. The physician assumes full responsibility for these tasks and ensures the tasks are administered correctly.(83) Target--The part of an x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation.(84) Termination of irradiation--The stopping of irradiation in a fashion not permitting the continuation of irradiation without resetting operating conditions at the control panel.(85) Therapeutic radiation machine--X-ray, particle, or electron-producing equipment designed and used for external beam radiation therapy.(86) Traceable to a national standard--This indicates a quantity or a measurement has been compared to a national standard, for example the National Institute of Standards and Technology, directly or indirectly through one or more intermediate steps and that all comparisons have been documented.(87) Tube housing assembly--The tube housing with tube installed.(88) Useful beam--Radiation passing through the window, aperture, cone, or other collimating device of the source housing. Also referred to as the primary beam.(89) Virtual simulation--A process using the import, manipulation, display, and storage of electronic patient images to create linear accelerator treatment ports.(90) Virtual source--A point from which radiation appears to originate.(91) Wedge transmission factor--The ratio of doses, with and without the wedge, at a point along the central axis of the useful beam that compensates for the decrease in dose produced by the filter.(92) Written directive--An order in writing for the administration of radiation to a specific patient as specified in subsection (h)(1)(F)(ii) of this section.(f) Accelerators used for research and development or industrial operations.(1) Registration. Each person possessing an accelerator for non-human use must apply for and receive a certificate of registration from the department before beginning use of the accelerator. A person may energize the accelerator for purposes of installation and acceptance testing before receiving a certificate of registration from the department as specified in §289.226(i)(1) of this chapter.(2) Facility requirements.(A) Each accelerator facility must be provided with primary and secondary barriers necessary to assure compliance with §289.231(m) and (o) of this chapter.(B) A radiation survey must be conducted when the accelerator is registered and capable of producing radiation to determine compliance with §289.231(m) and (o) of this chapter.(C) The registrant must maintain a copy of the initial and all subsequent vault survey reports for inspection by the department as specified in subsection (l) of this section. Vault surveys must be performed:(i) on all new and existing facilities not previously surveyed by, or under the direction of, the registrant; and(ii) upon installation, replacement, or upgrade to a higher energy accelerator.(D) The registrant must maintain a copy of the initial survey report for inspection by the agency in accordance with subsection (l) of this section. A completed survey report must include:(i) a diagram of the facility detailing building structures and the position of the accelerator, control panel, and associated equipment;(ii) a description of the accelerator, including the manufacturer, model and serial number, beam type, and beam energy;(iii) a description of the instrumentation used to determine radiation measurements, including the date and source of the most recent calibration for each instrument used;(iv) conditions under which radiation measurements were taken;(v) survey data including:(I) projected annual total effective dose equivalent (TEDE) in areas adjacent to the accelerator; and(II) a description of workload, use, and occupancy factors employed in determining the projected annual TEDE; and(vi) documentation of all instances where the facility violates this chapter's applicable requirements. Any deficiencies detected during the survey must be corrected before using the accelerator. (3) Safety requirements.(A) Interlock systems, including inherent, add-on, and aftermarket devices attaching to the accelerator, must comply with the following requirements.(i) Instrumentation, readouts, and controls in the accelerator console are clearly identified.(ii) Each entrance into a target room or other high radiation area is provided with a safety interlock terminating the useful beam under conditions of barrier penetration.(iii) When the production of radiation has been interrupted, it is only possible to resume operation of the accelerator by manually resetting the interlock at the console.(iv) Each safety interlock is on an electrical circuit allowing the interlock to operate independently of all other safety interlocks.(v) All safety interlocks are designed so any defect or component failure in the interlock system prevents operating the accelerator.(vi) A scram button or other emergency power cut-off switch is labeled. The scram button or cut-off switch includes a manual reset so the accelerator cannot be restarted from the accelerator console without resetting the cut-off switch.(vii) The safety interlock system includes a visible or audible alarm indicating when any interlock has been activated.(viii) All interlocks and visible or audible alarms are tested for proper operation at intervals meeting or exceeding nationally recognized, published guidelines from a professional body with expertise in accelerator radiation technologies, or manufacturer recommendations.(ix) If an interlock or alarm is operating improperly, it is immediately labeled as defective and repaired within seven calendar days.(x) Records of tests and repairs required by this paragraph are made and maintained as specified in subsection (l) of this section for inspection by the department.(B) Each registrant must develop, implement, and maintain written operating and safety procedures (OSP) as specified in subsection (h)(1)(G) of this section.(C) The registrant must ensure radiation measurements are performed with a calibrated dosimetry system. The dosimetry system calibration must be traceable to a national standard. Instruments and equipment must be calibrated at an interval not to exceed 24 months. Each accelerator facility must have appropriate portable monitoring equipment available that is operable and calibrated for the radiation produced at the facility.(D) A radiation protection survey must be performed and the results recorded when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.(E) For portable or mobile accelerators, such as neutron generators used at temporary job sites where permanent shielding is not available, radiation protection must be provided by temporary shielding or by providing an adequate exclusion area around the accelerator while it is in use.(F) Records of calibration and survey results made as specified in subparagraphs (C) and (D) of this paragraph must be maintained according to subsection (l) of this section.(G) The registrant must perform radiation surveys and contamination smears before the transfer or disposal of an accelerator operating at or above 10 MeV. The survey must be documented and maintained by the registrant for inspection by the department as specified in subsection (l) of this section.(H) The registrant must retain records of receipt, transfer, and disposal of all radiation machines specific to each authorized use location. The records must be maintained by the registrant for inspection by the department as specified in subsection (l) of this section. The records must include the:(i) date;(ii) manufacturer name;(iii) model;(iv) serial number from the control panel or console of the radiation machine; and(v) name of the individual making the record.(4) Training requirements for operators.(A) An individual must not operate an accelerator unless the individual has received instruction in and demonstrated competence with the following:(i) OSP as specified in paragraph (3)(B) of this subsection; (ii) radiation warning and safety devices incorporated into the equipment and in the room;(iii) identification of radiation hazards associated with the use of the equipment; and(iv) procedures for reporting a medical event or an actual or suspected exposure to the operator.(B) Records of the training specified in subparagraph (A) of this paragraph must be made and maintained for department inspection as specified in subsection (l) of this section.(g) Requirements for an accelerator used in industrial radiography. In addition to the requirements in subsections (f)(1), (f)(2), and (f)(3)(C) - (H) of this section, accelerators used for industrial radiography must meet the applicable requirements of §289.255 of this chapter.(h) Requirements for therapeutic radiation machines, radiation therapy simulation systems used in the healing arts, and EBT devices.(1) General requirements.(A) Each person possessing a therapeutic radiation machine capable of operating at or above 1 MeV or an EBT device must apply for and receive a certificate of registration from the department before using the accelerator for human use. A person may energize the accelerator for purposes of installation and acceptance testing before receiving a certificate of registration from the department.(B) A person possessing a radiation therapy simulation system or a therapeutic radiation machine capable of operating below 1 MeV must apply for a certificate of registration within 30 days after energizing the equipment.(C) An individual who operates a radiation machine for human use must meet the appropriate credentialing requirements as specified in the Medical Radiologic Technologist Certification Act, Texas Occupations Code Chapter 601. Copies of the credentialing document must be maintained at the location where the individual is working. A copy of the credentialing document must be maintained by the registrant for inspection by the department as specified in subsection (l) of this section.(D) The EBT registration requires the physician to be:(i) licensed by the Texas Medical Board; and(ii) certified in:(I) radiation oncology or therapeutic radiology by the American Board of Radiology; or(II) radiation oncology by the American Osteopathic Board of Radiology.(E) The registrant must ensure an operator of an EBT device completes device-specific training and maintains a record of each individual's training as specified in subsection (l) of this section. The device-specific training must include:(i) completing a training program provided by the manufacturer; or(ii) training substantially equivalent to the manufacturer's training program from a certified physician or a licensed medical physicist trained to use the device.(F) Each facility must develop a written QA program or an electronic reporting system. The QA program must be implemented to minimize deviations from facility procedures and to document preventative measures taken before serious patient injury or therapeutic misadministration. (i) The QA program must include the following topics:(I) treatment planning and patient simulation;(II) charting and documenting treatment field parameters;(III) dose calculation and review procedures;(IV) review of daily treatment records; and(V) for EBT devices, verification of catheter placement and device exchange procedures.(ii) A written directive must be prepared before administration of a therapeutic radiation dose except where a delay in providing a written directive would jeopardize the patient's health. If an oral directive must be made, the information contained in the oral directive must be documented immediately in the patient's record. A written directive must be prepared within 24 hours of the oral directive.(iii) A written directive changing an existing written directive for any therapeutic radiation procedure is only acceptable if the revision is dated and signed by a certified physician before the administration of the therapeutic dose, or the next fractional dose.(iv) Deviations from the prescribed treatment, from the facility's QA program, or from the OSP must be investigated and brought to the attention of the certified physician or licensed medical physicist, and the radiation safety officer (RSO).(v) The patient's identity must be verified by more than one method as the individual named in the written directive before administration.(vi) The discovery of each medical event must be reported as specified in subsections (i) and (j) of this section.(vii) The review of the QA program must include all the deviations from the prescribed treatment and must be conducted at intervals not to exceed 14 months. A signed record of each dated review must be maintained for inspection by the department as specified in subsection (l) of this section and must include evaluations and findings of the review.(G) Written OSP must be developed by a licensed medical physicist with a specialty in therapeutic radiological physics and must include any restrictions required for the safe operation of each therapeutic radiation machine. These procedures must be available in the control area of the therapeutic radiation machine, radiation therapy simulation system, or EBT device. The registrant must maintain records of OSP as specified in subsection (l) of this section for inspection by the department. The operator must be able to demonstrate familiarity with these procedures. The OSP must address the following requirements:(i) therapeutic radiation machines must not be used for irradiation of a patient unless full calibration measurements and QA checks have been completed;(ii) therapeutic radiation machines must not be used in the administration of radiation therapy if a QA check indicates a significant change in the operating characteristics of a system as specified in the written procedures;(iii) therapeutic radiation machines must not be left unattended unless secured by a locking device, or computerized password system, preventing unauthorized use;(iv) mechanical supporting or restraining devices must be used when there is a need to immobilize a patient or port film for radiation therapy;(v) no individual, other than the patient, is allowed in the treatment room during exposures from therapeutic radiation machines operating above 150 kV;(vi) at energies less than or equal to 150 kV, any individual in the treatment room, other than the patient, must be protected by a barrier sufficient to meet the requirements of §289.231(m) and (o) of this chapter;(vii) a technique chart for radiation therapy simulation systems must be used as specified in paragraph (5)(A)(i) of this subsection; (viii) occupational and public radiation dose must be controlled as specified in §289.231(m) and (o) of this chapter;(ix) occupational dose must be monitored as specified in §289.231(n) of this chapter;(x) protective devices must be used for radiation therapy simulation systems as specified in paragraph (5)(A)(iii) of this subsection; (xi) operators of radiation machines must be credentialled as specified in subparagraph (C) of this paragraph;(xii) film processing program for conventional radiation therapy simulation systems must be performed as specified in paragraph (5)(E)(i) of this subsection;(xiii) procedures for restriction and alignment of the beam for conventional radiation therapy simulation systems as specified in paragraph (5)(F)(iii) of this subsection;(xiv) methods utilized for testing interlocks, entrance controls, and alarm systems;(xv) notifications and reports must be provided to individuals as specified in §289.203(d) of this chapter; and(xvi) notices to workers must be posted as specified in §289.203(b) of this chapter.(H) A registrant with equipment granted variances by the United States Food and Drug Administration (FDA) to 21 CFR Part 1020 must maintain copies of those variances at authorized use locations as specified in subsection (l) of this section.(I) The registrant must perform radiation surveys and contamination smears before the transfer or disposal of an accelerator operating at or above 10 MeV. Surveys must be documented and maintained by the registrant for inspection by the department as specified in subsection (l) of this section.(J) Where applicable, the licensed medical physicist must perform acceptance testing on the treatment planning system of therapy-related computer systems as specified in protocols accepted by nationally recognized, published guidelines, from a professional body with expertise in the use of therapeutic radiation technologies. In the absence of such a published protocol, the manufacturer's current protocol must be followed.(2) Therapeutic radiation machines capable of operating at energies below 1 MeV.(A) Equipment requirements.(i) When the tube is operated at its leakage technique factors, the leakage radiation must not exceed the values specified at the distance stated for the classification of the radiation machine system shown in the following Table I. The leakage technique factors are the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.Attached Graphic(ii) Permanent fixed diaphragms or cones used for limiting the useful beam must provide the same or a higher degree of protection as required for the tube housing assembly.(iii) Removable and adjustable beam-limiting devices must meet the following requirements.(I) Removable beam-limiting devices must, for the portion of the useful beam to be blocked by these devices, transmit not more than 1 percent of the useful beam at the maximum kVp and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the x-ray field to shape the useful beam to the individual patient.(II) Adjustable beam-limiting devices must, for the portion of the x-ray beam to be blocked by these devices, transmit not more than 5 percent of the useful beam at the maximum kVp and maximum treatment filter.(III) Adjustable beam-limiting devices must meet the requirements of subclause (I) of this clause.(iv) The filter system must be designed so:(I) the filters cannot be accidentally displaced at any possible tube orientation;(II) an interlock system prevents irradiation if the proper filter is not in place;(III) the air kerma rate escaping from the filter slot must not exceed 1 centigray/hour (cGy/hr) at 1 meter (m) under any operating conditions; and(IV) each filter is marked as to its material of construction and its thickness. For wedge filters, the wedge angle must appear on the wedge or wedge tray.(v) The tube housing assembly must be capable of being immobilized for stationary treatments.(vi) The tube housing assembly must be marked so it is possible to determine the location of the focal spot to within 5 millimeters (mm), and such marking must be readily accessible for use during calibration procedures.(vii) The contact therapy tube housing assembly must have a removable shield of at least 0.5 mm lead equivalency at 100 kVp capable of being positioned over the entire useful beam exit port during periods when the beam is not in use.(viii) The timer must:(I) have a display provided at the treatment control panel and a pre-set time selector;(II) activate with the production of radiation and retain its reading after irradiation is interrupted;(III) be reset to zero after irradiation is terminated and before irradiation can be re-initiated;(IV) terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;(V) permit selection of exposure times as short as 1 second;(VI) not permit exposure if set at zero;(VII) not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer factor to compensate for mechanical lag; and(VIII) be accurate to within 1 percent of the selected value or 1 second, whichever is greater.(ix) The control panel, in addition to the displays required in clause (viii)(I) of this subparagraph, must have the following: (I) an indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;(II) an indication of whether x-rays are being produced;(III) means for indicating x-ray tube potential and current;(IV) means for terminating an exposure at any time;(V) a locking device preventing unauthorized use of the therapeutic radiation system (a computerized password system also constitutes a locking device);(VI) a positive display of specific filters in the beam; and(VII) emergency buttons or switches clearly labeled as to their functions.(x) There must be a means of initially determining the SSD to within 1 centimeter (cm) and of reproducing this measurement to within 2 mm.(xi) Unless it is possible to bring the radiation output to the prescribed exposure parameters within 5 seconds, the beam must be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. After the unit is at operating parameters, the shutter must be controlled electrically by the operator from the control panel. An indication of shutter position must appear at the control panel.(xii) Each therapeutic radiation system equipped with a beryllium or other low-filtration window must be clearly labeled on the tube housing assembly and at the control panel.(B) Facility requirements for therapeutic radiation systems capable of operating above 50 kVp.(i) Provision must be made for continuous two-way aural communication between the patient and the operator at the control panel.(ii) Windows, mirrors, closed-circuit television, or an equivalent system must be provided to permit continuous observation of the patient during irradiation and be located so the operator can observe the patient from the control panel.(I) If the viewing system described in clause (ii) of this subparagraph fails or is inoperative, treatment must not be performed with the unit until the system is restored.(II) If a facility has a primary viewing system by electronic means and an alternate viewing system, and both viewing systems described in clause (ii) of this subparagraph fail or are inoperative, treatment must not be performed with the unit until one of the systems is restored.(C) Additional facility requirements for therapeutic radiation systems capable of operation above 150 kVp.(i) Each installation must be provided with primary and secondary barriers as necessary to assure compliance with §289.231(m) and (o) of this chapter. All protective barriers must be fixed except for entrance doors or beam interceptors.(ii) The control panel must be located outside the treatment room or in an enclosed booth inside the room.(iii) Interlocks must be provided to ensure all entrance doors are closed, including doors to any interior booths, before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it must not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel. When any door is opened while the x-ray tube is activated, the exposure at a distance of 1 m from the source must be reduced to less than 1 milligray per hour (mGy/hr) (100 millirad per hour (mrad/hr)).(D) Surveys, calibrations, and QA checks.(i) Surveys must be performed as follows.(I) All new and existing facilities not previously surveyed must have an initial shielding survey made by a licensed medical physicist, as authorized by 22 Texas Administrative Code (TAC) §160.17 (relating to Medical Physicist Scope of Practice), who must provide a written report of the survey to the registrant. Additional surveys must be done after any change in the facility, facility design, or equipment that might cause a significant increase in radiation hazard.(II) The registrant must maintain a copy of the initial survey report and all subsequent survey reports required by subclause (I) of this clause as specified in subsection (l) of this section for inspection by the department.(III) The survey report must indicate all instances where the installation violates this chapter's applicable requirements.(ii) Full calibrations must be performed as follows.(I) The calibration of a therapeutic radiation system must be performed at intervals not to exceed 12 months and after any change or replacement of components that could cause a change in the radiation output. The calibrations must ensure the dose at a reference point in a water or plastic phantom can be calculated to within an uncertainty of 5 percent.(II) The calibration of the radiation output of the therapeutic radiation system is performed by a licensed medical physicist with a specialty in therapeutic radiological physics, physically present at the facility during such calibration.(III) The calibration of the therapeutic radiation system includes:(-a-) verification the radiation therapy system is operating in compliance with the design specifications;(-b-) HVL for each kV setting and filter combination used;(-c-) the exposure rates (air kerma rates) as a function of field size, technique factors, filter, and treatment distance used; and(-d-) the degree of congruence between the radiation field and the field indicated by the localizing device, if such device is present, which must be within 5 mm for any field edge.(IV) Calibration measurements of the radiation output of a therapeutic radiation system must be performed with a calibrated dosimetry system. Calibration of the dosimetry system must be performed and completed at intervals not to exceed 24 months and traceable to a national standard.(V) Records of calibration measurements specified in this clause must be maintained by the registrant as specified in subsection (l) of this section for inspection by the department.(VI) A copy of the latest calibrated absorbed dose rate measured on a particular therapeutic radiation system must be available at a designated area within the therapy facility housing the therapeutic radiation system.(iii) QA checks must be performed on therapeutic radiation systems capable of operation at greater than 150 kVp. Such measurements must meet the following requirements.(I) The QA check procedures must be in writing or documented in an electronic reporting system, and must have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics.(II) If a licensed medical physicist does not perform the QA check measurements, the results of the QA check measurements must be reviewed by a licensed medical physicist with a specialty in therapeutic radiological physics within five treatment days and a record made of the review. If the output varies by more than 5 percent from the expected value, a licensed medical physicist with a specialty in therapeutic radiological physics must be notified immediately.(III) The written QA check procedures must specify the testing or measurement frequency and state that the QA check must be performed during the calibration specified in clause (ii) of this subparagraph. The acceptable tolerance for each parameter measured when compared to the value for that parameter determined in the calibration specified in clause (ii) of this subparagraph must be stated.(IV) The written QA check procedures must include special operating instructions required to be carried out whenever a parameter in subclause (III) of this clause exceeds an acceptable tolerance.(V) Whenever a QA check indicates a significant change in the operating characteristics of a system, as specified in the procedures, the system must be recalibrated, as required in clause (ii) of this subparagraph.(VI) Records of written QA checks and any necessary corrective actions must be maintained by the registrant as specified in subsection (l) of this section for inspection by the department. A copy of the most recent QA check must be available at a designated area within the therapy facility housing the therapeutic radiation system.(VII) QA checks must be obtained using a system satisfying the requirements of clause (ii)(IV) of this subparagraph.(iv) All testing reports must meet or exceed nationally recognized, published guidelines from a professional body with expertise in the use of therapeutic radiation technologies or manufacturer recommendations. (3) Therapeutic radiation machines capable of operating at energies of 1 MeV and above.(A) Equipment requirements.(i) For operating conditions producing maximum leakage radiation, the absorbed dose in rads (mGy) due to leakage radiation (including x-rays, electrons, and neutrons) must not exceed 0.1 percent of the maximum absorbed dose in rads (mGy) of the unattenuated useful beam. The absorbed dose for this leakage radiation requirement must be measured at any point in a circular plane of 2 m radius centered on and perpendicular to the central axis of the beam at the isocenter or nominal treatment distance and outside the maximum useful beam size. The unattenuated useful beam must be measured at the point of intersection of the central axis of the beam and the plane surface.(I) Measurements excluding those for neutrons must be averaged over an area up to, but not exceeding, 100 square centimeters (cm2 ) at the positions specified.(II) Measurements of the portion of the leakage radiation dose contributed by neutrons must be averaged over an area up to, but not exceeding, 200 cm2 .(III) For each system, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified for the specified operating conditions.(IV) Records on leakage radiation measurements must be maintained as specified in subsection (l) of this section for inspection by the department.(ii) Irradiation filters.(I) Dynamic or virtual wedge filter.(-a-) An interlock system must be provided to prevent irradiation if any virtual or dynamic wedge selected in the treatment room does not agree with the virtual or dynamic wedge selection and operation carried out at the treatment console.(-b-) The dose distribution selected must include:(-1-) beam energy;(-2-) field size; and(-3-) wedge angle.(-c-) A virtual wedge transmission factor must be established and utilized.(II) Multileaf collimator (MLC) filter.(-a-) An interlock system must be provided to prevent irradiation if the spatial dose distribution selected in the treatment room does not agree with the filter selection and operation carried out at the treatment console.(-b-) The distribution selected must include:(-1-) beam energy; and(-2-) MLC selection.(III) Stereotactic radiosurgery (SRS) filter.(-a-) An interlock system must be provided to prevent irradiation if the spatial dose distribution selected in the treatment room does not agree with the filter selection and operation carried out at the treatment console.(-b-) The distribution selected must include:(-1-) beam energy;(-2-) SRS cone; or(-3-) MLC selection.(-c-) A virtual wedge transmission factor must be established and utilized.(IV) Physical wedge filter.(-a-) Each wedge filter removable from the system must be marked with an identification number.(-b-) Documentation must be available at the console containing a description of the filter.(-c-) The wedge angle must appear on the wedge or wedge tray (if permanently mounted to the tray).(-d-) If the wedge or wedge tray is damaged, the wedge must be removed from clinical service.(-e-) Irradiation must not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment console, either manually or automatically.(-f-) A display must be provided at the treatment console showing the accelerator beam quality in use.(-g-) An interlock system must be provided to prevent irradiation if any filter selection operation carried out in the treatment room does not agree with the filter selection and operation carried out at the treatment console.(iii) Beam Quality. The registrant must determine data sufficient to assure the following beam quality requirements in tissue equivalent material are met.(I) The absorbed dose resulting from x-rays in a useful electron beam at a point on the central axis of the beam 10 cm greater than the practical range of the electrons must not exceed the values stated in Table II. Linear interpolation must be used for values not stated.Attached Graphic(II) Compliance with subclause (I) of this clause must be determined using:(-a-) a measurement within a tissue equivalent phantom with the incident surface of the phantom at the nominal treatment distance and normal to the central axis of the beam;(-b-) a field size of 10 cm by 10 cm; and(-c-) a phantom whose cross-sectional dimensions exceed the measurement radiation field by at least 5 cm and whose depth is sufficient to perform the required measurement.(III) The absorbed dose at a surface located at the nominal treatment distance, at the point of intersection of that surface with the central axis of the useful beam during x-ray irradiation, must not exceed the limits stated in the following Table III. Linear interpolation must be used for values not stated.Attached Graphic(IV) Compliance with subclause (III) of this clause must be determined by measurements:(-a-) within a tissue equivalent phantom using an instrument allowing extrapolation to the surface absorbed dose;(-b-) using a phantom whose size and placement meet the requirements of subclause (II) of this clause;(-c-) after removal of all beam-modifying devices capable of being removed without the use of tools, except for beam-scattering or beam-flattening filters; and(-d-) using the largest field size available not exceeding 15 cm by 15 cm.(iv) All therapeutic radiation systems must be provided with radiation detectors in the gantry head. These must include the following, as appropriate.(I) At least two independent radiation detectors must be used. The detectors must be incorporated into two independent dose monitoring systems.(II) The incorporated detector and monitoring system must meet the following requirements.(-a-) Each detector must be removable only with tools and must be interlocked to prevent incorrect positioning.(-b-) Each detector must form part of a dose monitoring system from whose readings in dose monitor units the absorbed dose at a reference point in the treatment volume can be calculated.(-c-) Each dose monitoring system must be capable of independently monitoring, interrupting, and terminating irradiation.(-d-) The design of the dose monitoring systems must assure the malfunctioning of one system does not affect the correct functioning of the secondary system; and failure of any element common to both systems affecting the correct function of both systems must terminate irradiation.(-e-) Each dose monitoring system must have a legible display at the treatment console. Each display must:(-1-) maintain a reading until intentionally reset to zero;(-2-) have only one scale and no scale multiplying factors;(-3-) utilize a design so increasing dose is displayed by increasing numbers and if there is an overdosage of radiation, the absorbed dose may be accurately determined; and(-4-) retain the dose monitoring information in at least one system for 15 minutes in the event of a power failure.(v) For equipment inherently capable of producing useful beams with unintentional asymmetry exceeding 5 percent, the asymmetry of the radiation beam in two orthogonal directions must be monitored before the beam passes through the beam-limiting device. If the difference in dose rate between one region and another region symmetrically displaced from the central axis of the beam exceeds 5 percent of the central axis dose rate, an indication of this condition must be displayed at the console; and if this difference exceeds 10 percent of the central axis dose rate, the irradiation must be terminated.(vi) Selection and display of dose monitor units must meet the following requirements.(I) Irradiation must not be possible until a selection of dose monitor units has been made at the treatment console.(II) The preselected number of dose monitor units must be displayed at the treatment console until reset manually for the next irradiation.(III) After termination of irradiation, it must be necessary to reset the dosimeter display to zero before subsequent treatment can be initiated.(IV) After termination of irradiation, the preselected dose monitor units must be reset manually before irradiation can be initiated.(vii) Termination of irradiation by the dose monitoring system or systems during stationary beam therapy must meet the following requirements.(I) Each primary system must terminate irradiation when the preselected number of dose monitor units has been detected by the system.(II) A secondary dose monitoring system must be present. The system must be capable of terminating irradiation when not more than 10 percent or 25 dose monitoring units, whichever is smaller, above the preselected number of dose monitor units set at the console has been detected by the secondary dose monitoring system.(III) An indicator on the console must show which dose monitoring system has terminated irradiation.(viii) A locking device must be provided in the system to prevent unauthorized use of the x-ray system. A computerized password system would also constitute a locking device.(ix) It must be possible to interrupt irradiation and equipment movements at any time from the operator's position at the treatment console. Following an interruption, it must be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a preselected value during an interruption, irradiation and equipment movements must be automatically terminated.(x) It must be possible to terminate irradiation and equipment movements or go from an interruption condition to termination conditions at any time from the operator's position at the treatment console.(xi) Timers must meet the following requirements.(I) A timer with a display is provided at the treatment console. The timer has a preset time selector and an elapsed time indicator.(II) The timer is a cumulative timer activating with the production of radiation and retaining its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it is necessary to reset the elapsed time indicator to zero.(III) After termination of irradiation and before irradiation can be reinitiated, the preset time selector is reset manually.(IV) The timer terminates irradiation when a preselected time has elapsed if the dose monitoring systems have not previously terminated irradiation.(xii) Equipment capable of producing more than one radiation type must meet the following additional requirements.(I) Irradiation is not possible until a selection of radiation type has been made at the treatment console.(II) An interlock system is provided to:(-a-) ensure the equipment can emit only the radiation type selected;(-b-) prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment console;(-c-) prevent irradiation with x-rays except to obtain a port film when electron applicators are fitted; and(-d-) prevent irradiation with electrons when accessories specific for x-ray therapy are fitted.(III) The radiation type selected is displayed at the treatment console before and during irradiation.(xiii) Equipment capable of generating radiation beams of different energies must meet the following requirements.(I) Irradiation is not possible until a selection of energy has been made at the treatment console.(II) An interlock system is provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment console.(III) The nominal energy value selected is displayed at the treatment console before and during irradiation.(xiv) Equipment capable of both stationary beam therapy and moving beam therapy must meet the following requirements.(I) Irradiation is not possible until a selection of stationary beam therapy or moving beam therapy has been made at the treatment console.(II) An interlock system is provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment console.(III) The selection of stationary or moving beam is displayed at the treatment console. An interlock system must be provided to ensure the equipment can only operate in the selected mode.(IV) An interlock system is provided to terminate irradiation if movement of the gantry occurs during stationary beam therapy or stops during moving beam therapy unless such stoppage is a preplanned function.(V) Moving beam therapy is controlled to obtain the selected relationships between incremental dose monitor units and incremental angle of movement.(-a-) An interlock system must be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of arc differs by more than 20 percent from the selected value.(-b-) Where gantry angle terminates the irradiation in arc therapy, the dose monitor units must be within 5 percent from the value calculated from the absorbed dose per unit angle relationship.(VI) Where the dose monitor system terminates the irradiation in moving beam therapy, the termination of irradiation must meet the requirements of clause (vii) of this subparagraph.(xv) A system must be provided from whose readings the absorbed dose rate at a reference point in the treatment volume can be calculated. The radiation detectors specified in clause (iv) of this subparagraph may form part of this system. In addition, the dose monitor unit rate must be displayed at the treatment console. If the equipment can deliver, under any conditions, an absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer for any machine parameters utilized, a device must be provided to terminate irradiation when the absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated must be in a record maintained by the registrant as specified in subsection (l) of this section for department inspection.(xvi) The registrant must determine, or obtain from the manufacturer, the location with reference to an accessible point on the gantry, of the x-ray target, or the virtual source of x-rays and the electron window, or the virtual source of electrons if the system has electron beam capabilities.(xvii) Capabilities must be provided so all radiation safety interlocks can be checked for correct operation.(B) Facility and shielding requirements.(i) Each installation must be provided with primary and secondary barriers as are necessary to assure compliance with §289.231(m) and (o) of this chapter.(ii) All protective barriers must be fixed except for entrance doors or beam interceptors.(iii) The console must be located outside the treatment room and all emergency buttons or switches must be clearly labeled as to their functions.(iv) Windows, mirrors, closed-circuit television, or an equivalent system must be provided to permit continuous observation of the patient following positioning and during irradiation and must be located so the operator can see the patient from the console.(I) If the viewing system described in clause (iv) of this subparagraph fails or is inoperable, treatment must not be performed with the unit until the system is restored.(II) In a facility with a primary viewing system by electronic means and an alternate viewing system, if both viewing systems described in clause (iv) of this subparagraph fail or are inoperative, treatment must not be performed with the unit until one of the systems is restored.(v) Provision must be made for continuous two-way aural communication between the patient and the operator at the console independent of the accelerator. However, where excessive noise levels or treatment requirements make aural communication impractical, other methods of communication must be used. When this is the case, a description of the alternate method must be submitted to and approved by the department. (vi) Treatment room entrances must be provided with a warning light in a readily observable position near the outside of all access doors to indicate when the useful beam is "on."(vii) Interlocks must be provided to ensure all entrance doors are closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it must not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the console.(C) Surveys, dose calibrations, QA checks, and operational requirements.(i) Surveys must be performed as follows.(I) All new and existing facilities not previously surveyed must have an initial shielding survey made by a licensed medical physicist as authorized by 22 TAC §160.17 who must provide a written report of the survey to the registrant. The physicist who performs the survey must be an individual who:(-a-) did not consult in the design of the therapeutic radiation machine installation and;(-b-) is not employed by or within any corporation or partnership with the person who consulted in the design of the installation.(II) The survey report must include:(-a-) a diagram of the facility detailing building structures and the position of the console, therapeutic radiation machine, and associated equipment;(-b-) a description of the therapeutic radiation system, including the manufacturer, model and serial number, beam type, and beam energy;(-c-) a description of the instrumentation used to determine radiation measurements, including the date and source of the most recent calibration for each instrument used;(-d-) conditions under which radiation measurements were taken; and(-e-) survey data including:(-1-) projected annual TEDE in areas adjacent to the therapy room; and(-2-) a description of workload, use, and occupancy factors employed in determining the projected annual TEDE.(III) The registrant must maintain a copy of the survey report, and a copy of the survey report must be provided to the department within 30 days of completion of the survey. Records of the survey report must be maintained as specified in subsection (l) of this section for inspection by the department.(IV) The survey report must include documentation of all instances where the installation is in violation of applicable regulations. Any deficiencies detected during the survey must be corrected before using the machine.(V) In addition, such surveys must be done after any change in the facility or equipment that might cause a significant increase in radiation hazard.(ii) Dose calibrations. Records of calibration measurements specified in subclause (I) of this clause and dosimetry system calibrations specified in subclause (III) of this clause must be maintained by the registrant as specified in subsection (l) of this section for inspection by the department. A copy of the latest calibrated absorbed dose rate measured as specified in subclause (I) of this clause must be available at a designated area within the facility housing the radiation therapy system. Calibrations of therapeutic systems must be performed as follows.(I) The calibration of systems subject to this subsection are performed as specified in an established calibration protocol before the system is first used for irradiation of a patient and then at intervals not exceeding 12 months and after any change significantly altering the calibration, spatial distribution, or other characteristics of the therapy beam.(-a-) The calibration procedures must be in writing, or documented in an electronic reporting system, and must have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics.(-b-) Acceptance testing, commissioning, and dose calibration must be performed as specified in current published recommendations from a nationally recognized professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a national professional association, the manufacturer's protocol, or equivalent quality, safety, and security protocols, must be followed.(-c-) At a minimum, the calibration protocol must include all items in subclauses (III) - (V) of this clause.(II) The calibration is performed by a licensed medical physicist with a specialty in therapeutic radiological physics who is physically present at the facility during the calibration.(III) Calibration radiation measurements required by subclause (I) of this clause are performed using a dosimetry system:(-a-) having a calibration factor for cobalt-60 gamma rays traceable to a national standard;(-b-) traceable to a national standard and at an interval not to exceed 24 months;(-c-) calibrated to the extent an uncertainty can be stated for the radiation quantities monitored by the system; and(-d-) having constancy checks performed as specified by the licensed medical physicist with a specialty in therapeutic radiological physics.(IV) Calibrations must be in sufficient detail to ensure the dose at a reference point in a tissue equivalent phantom can be calculated to within an uncertainty of 5 percent.(V) The calibration of the therapy unit must include the following determinations.(-a-) Verification that the equipment is operating in compliance with the design specifications concerning the light field, patient positioning lasers, and back-pointer lights with the isocenter when applicable; variation in the axis of rotation for the table, gantry, and collimator system; and beam flatness and symmetry at the specified depth.(-b-) Verification of the accuracy of the absorbed dose rate at various depths in a tissue equivalent phantom for the range of field sizes and effective energies used in all therapy procedures. (-c-) Uniformity of the radiation field to include symmetry, flatness, and dependence on the gantry angle.(-d-) Verification that existing isodose charts applicable to the specific machine continue to be valid or are updated to existing machine conditions.(-e-) Verification of transmission factors for all accessories such as wedges, block trays, and universal and custom-made beam modifying devices.(VI) Calibration of therapeutic systems containing asymmetric jaws, multileaf collimation, or dynamic or virtual wedges must be performed with an established protocol. The procedures must be developed by a licensed medical physicist with a specialty in therapeutic radiological physics and must be in writing or documented in an electronic reporting system.(iii) QA checks must be performed on systems subject to this paragraph during calibrations and then at weekly intervals with the period between QA checks not to exceed five treatment days. Such radiation output measurements must meet the following requirements.(I) The QA check procedures must be performed as specified in established protocol, be in writing or documented in an electronic reporting system, and be developed by a licensed medical physicist with a specialty in therapeutic radiological physics. The protocol must meet or exceed nationally recognized, published guidelines from a professional body with expertise in the use of therapeutic radiation technologies or manufacturer recommendations. At a minimum, the QA check protocol must include all items in subclauses (III) - (VI) of this clause.(II) If a licensed medical physicist does not perform the QA check measurements, the results of the QA check measurements must be reviewed by a licensed medical physicist at a frequency not to exceed five treatment days and a record kept of the review. If the output varies by more than 3 percent from the expected value, a licensed medical physicist must be notified immediately.(III) The written QA check procedures must specify the frequency at which tests or measurements are performed and the acceptable tolerance for each parameter measured in the QA check when compared to the value for that parameter determined in the calibration.(IV) Where a system has built-in devices providing a measurement of any parameter during irradiation, such measurement must not be utilized as a QA check measurement.(V) A parameter exceeding a tolerance set by a licensed medical physicist must be corrected before the system is used for patient irradiation.(VI) Whenever a QA check indicates a significant change in the operating characteristics of a system, as specified in a licensed medical physicist's written procedures, the system must be recalibrated.(VII) Records of QA check measurements and any necessary corrective actions must be maintained by the registrant as specified in subsection (l) of this section for inspection by the department.(VIII) QA checks must be completed using a system satisfying the requirements of clause (ii)(III) of this subparagraph.(iv) Facilities with therapeutic radiation machines with energies of 1 MeV and above must procure the services of a licensed medical physicist with a specialty in therapeutic radiological physics.(I) The physicist must be responsible for:(-a-) dose calibration of radiation machines;(-b-) supervision and review of beam and clinical dosimetry; (-c-) measurement, analysis, and tabulation of beam data;(-d-) establishment of QA procedures and performance of QA check review; and(-e-) review of absorbed doses delivered to patients.(II) The licensed medical physicist described in subclause (I) of this clause must also be available and responsive to immediate problems or emergencies.(4) Requirements for EBT devices. In addition to the requirements in paragraph (1) of this subsection, EBT devices must meet the requirements in this paragraph.(A) Technical requirements for EBT devices.(i) The timer must:(I) have a display provided at the treatment control panel and a pre-set time selector;(II) activate with the production of radiation and retain its reading after irradiation is interrupted;(III) be reset to zero after irradiation is terminated and before irradiation can be re-initiated;(IV) terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;(V) permit selection of exposure times as short as 1 second;(VI) not permit an exposure if set at zero; and(VII) be accurate to within 1 percent of the selected value or 1 second, whichever is greater.(ii) The control panel, in addition to the displays required in subparagraph (A)(i) of this paragraph, must have:(I) an indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;(II) means for indicating x-rays are being produced;(III) means for indicating x-ray tube potential and current; and(IV) means for terminating an exposure at any time.(iii) All emergency buttons or switches must be clearly labeled as to their functions.(B) Surveys, calibrations, and QA checks.(i) Survey procedures.(I) All new and existing facilities with an EBT device must have an initial shielding survey made by a licensed medical physicist, as authorized by 22 TAC §160.17, who must provide a written survey report to the registrant. Additional surveys must be done when:(-a-) making any change in the portable shielding; and(-b-) relocating the electronic therapy device.(II) The registrant must maintain a copy of the initial survey report and all subsequent survey reports as specified in subsection (l) of this section for inspection by the department.(III) The survey report must indicate all instances where the installation is in violation of the applicable requirements of this chapter.(ii) Calibrations procedures. Records of calibration measurements must be maintained by the registrant as specified in subsection (l) of this section for inspection by the department. A copy of the latest calibrated absorbed dose rate measured on the EBT device must be available at a designated area within the therapy facility housing the EBT device.(I) Calibration procedures must be in writing, or documented in an electronic reporting system, and must have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics.(II) The registrant must make calibration measurements required by this section as specified in any current recommendations from a recognized national professional association (such as the American Association of Physicists in Medicine Report Number 152) for an EBT device, when available. Equivalent alternative methods are acceptable. In the absence of a protocol by a national professional association, a published protocol included in the device manufacturer operator's manual must be followed.(III) The calibration of the EBT device must be performed after changing the x-ray tube or replacing components that could cause a change in the radiation output. The calibration must ensure the dose at a reference point in a water or plastic phantom can be calculated to within an uncertainty of 5 percent.(IV) The calibration of the radiation output of the EBT device must be performed by a licensed medical physicist with a specialty in therapeutic radiological physics who is physically present at the facility during such calibration.(V) The calibration of the therapeutic EBT device must include verification that the EBT device is operating in compliance with the design specifications.(VI) Calibration of the radiation output of the EBT device must be performed with a calibrated dosimetry system. The dosimetry calibration must be traceable to a national standard. The calibration interval must not exceed 24 months.(iii) QA check. Records of the written QA checks and any necessary corrective actions must be maintained by the registrant as specified in subsection (l) of this section for inspection by the department. A copy of the most recent QA check must be available at a designated area within the therapy facility housing the therapeutic radiation system.(I) QA check procedures must be in writing, or documented in an electronic reporting system, and must have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics.(II) If a licensed medical physicist does not perform the QA check measurements, the results of the QA check measurements must be reviewed by a licensed medical physicist with a specialty in therapeutic radiological physics within two treatment days, and a record made of the review.(III) The written QA check procedures must specify the operating instructions required to be carried out whenever a parameter exceeds an acceptable tolerance as established by the licensed medical physicist.(IV) The certified physician or licensed medical physicist must prevent the clinical use of a malfunctioning device until the malfunction identified in the QA check has been evaluated and corrected or, if necessary, the equipment repaired.(V) QA checks must be completed using a dosimetry system satisfying the requirements of clause (ii)(VI) of this subparagraph.(5) Radiation therapy simulation systems.(A) General requirements. In addition to the requirements in paragraph (1)(B), (C), (F), and (H) of this subsection, radiation therapy simulation systems must comply with the following:(i) Technique chart. A technique chart relevant to the radiation machine is provided or electronically displayed in the vicinity of the console and used by all operators.(ii) Operating and safety procedures. Each registrant develops, implements, and maintains written OSP as specified in paragraph (1)(G) of this subsection and §289.227(i)(2)(A) of this chapter.(iii) Protective devices. When utilized, protective devices meet the following requirements.(I) Protective devices must be made of no less than 0.25 mm lead equivalent material.(II) Protective devices, including aprons, gloves, and shields, are checked annually for defects, such as holes, cracks, and tears. The registrant must perform these checks by visual, tactile, or x-ray imaging. If a defect is found, equipment must be replaced or removed from service until repaired. A record of this test is made and maintained by the registrant as specified in subsection (l) of this section for inspection by the department.(iv) Viewing system. Windows, mirrors, closed circuit television, or an equivalent system is provided to permit the operator to continuously observe the patient during irradiation. The operator is able to maintain continuous verbal, visual, and aural contact with the patient.(v) Operator position. The operator's position during the exposure ensures the operator's exposure is as low as reasonably achievable (ALARA). The operator is a minimum of 6 feet from the source of radiation or protected by an apron, gloves, or other shielding having a minimum of 0.25 mm lead equivalent material.(vi) Holding of the tube. An individual does not hold the tube or tube housing assembly supports during any radiographic exposure.(vii) No individuals other than the patient and the operator are allowed in the treatment room during the operation of the simulator.(B) Facility design requirements.(i) Provision must be made for two-way aural communication between the patient and the operator at the control panel.(ii) Windows, mirrors, closed-circuit television, or an equivalent must be provided to permit continuous patient observation during irradiation and be located so the operator can see the patient from the console. If the viewing system described in this clause fails or is inoperable, the unit must not be used until the system is restored. (iii) In a facility with a primary viewing system by electronic means and an alternate viewing system, and both viewing systems described in this clause fail or are inoperative, the unit must not be used until one of the systems is restored.(C) Requirements for radiation therapy simulation systems utilizing standard CT systems.(i) Equipment requirements.(I) Tomographic systems must meet the following requirements. (-a-) For any single tomogram system, means must be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.(-b-) For any multiple tomogram system, means must be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.(-c-) If a device using a light source is used to satisfy the requirements of item (-a-) or (-b-) of this subclause, the light source must provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.(II) The CT system must be designed so the CT conditions of operation to be used during a scan or a scan sequence are indicated before the initiation of a scan or a scan sequence. For equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions must be visible from any position from which scan initiation is possible.(III) The CT control and gantry must provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.(IV) Means must be provided to require operator initiation of each individual scan or series of scans.(V) All emergency buttons or switches must be clearly labeled as to their functions.(VI) Termination of exposure must meet the following requirements.(-a-) Means must be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination must occur within an interval limiting the total scan time to no more than 110 percent of its preset value using either a backup timer or a device that monitors equipment function. (-b-) A signal visible to the operator must indicate when the x-ray exposure has been terminated through the means required by item (-a-) of this subclause.(-c-) The operator must be able to terminate the x-ray exposure at any time during a scan or series of scans under CT system control of greater than 0.5 second duration. Termination of the x-ray exposure must necessitate resetting the CT conditions of operation before initiation of another scan.(VII) CT systems containing a gantry must meet the following requirements.(-a-) The total error in the indicated location of the tomographic plane or reference plane must not exceed 5 mm.(-b-) If the x-ray production period is less than 0.5 seconds, the indication of x-ray production must be actuated for at least 0.5 seconds. Indicators at or near the gantry must be discernible from any point external to the patient opening, where insertion of any part of the human body into the primary beam is possible.(-c-) The deviation of indicated scan increment versus actual increment must not exceed plus or minus 1 mm with any mass from 0 to 100 kilograms (kg) resting on the support device. The patient support device must be incremented from a typical starting position to the maximum incremented distance or 30 cm, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment can be taken anywhere along this travel.(ii) Additional requirements for CT systems integrated with virtual simulation features and linear accelerator capabilities (e.g., 3-D cone beam or modulation).(I) QA procedures for the CT simulation system must be performed with an established protocol meeting or exceeding nationally recognized, published guidelines from a professional body with expertise in the use of therapeutic radiation technologies or manufacturer recommendations. (II) QA procedures for the CT simulation system must be in writing, or documented in an electronic reporting system, by a licensed medical physicist with a specialty in therapeutic radiological physics.(III) The electronic transfer of the treatment delivery parameters to the delivery system must be verified at the treatment location. The CT simulation treatment planning and the linear accelerator must interface accurately.(iii) QA for CT simulation software.(I) QA procedures for CT simulation software systems must be in writing, or documented in an electronic reporting system, by a licensed medical physicist with a specialty in therapeutic radiological physics.(II) The protocol established must meet or exceed nationally recognized, published guidelines from a professional body with expertise in the use of therapeutic radiation technologies or manufacturer recommendations. (III) The CT QA procedures must include:(-a-) spatial/geometry accuracy tests;(-b-) evaluation of digitally reconstructed radiographs; and(-c-) periodic QA testing.(IV) The electronic transfer of the treatment delivery parameters to the delivery system must be verified at the treatment location. The software for the CT simulation treatment planning computer and the linear accelerator must interface accurately.(iv) Dose measurements of the radiation output of the CT system.(I) Dose measurements must be completed as specified in §289.227(n)(3) of this chapter.(II) Equipment performance evaluations (EPEs) must be completed as specified in §289.227(o) of this chapter.(III) Records of dose measurements and EPEs specified in subclause (I) and (II) of this clause must be maintained by the registrant as specified in subsection (l) of this section for inspection by the department.(D) A maintenance schedule must be developed as specified by the manufacturer. The schedule must include:(i) dose measurements required by subparagraph (C)(iv) of this paragraph; and(ii) acquisition of images obtained with phantoms using the same processing mode and CT conditions of operation as are used to perform dose measurements required by subparagraph (F) of this paragraph. The registrant must maintain either of the following as specified in subsection (l) of this section for inspection by the department:(I) copies of the images obtained from the image display device; or(II) images stored in digital form.(E) Conventional radiation therapy simulation systems designed with x-ray or fluoroscopic capabilities.(i) Film processing.(I) Films must be developed according to the time-temperature relationships recommended by the film manufacturer. The specified developer temperature for automatic processing and the time-temperature chart for manual processing must be posted in the darkroom. If the registrant determines an alternate time-temperature relationship is more appropriate for a specific facility, the time-temperature relationship must be documented and posted.(II) Chemicals must be replaced according to the chemical manufacturer's or supplier's recommendations or at an interval not to exceed three months.(III) Darkroom light leak tests must be performed and any light leaks corrected at intervals not to exceed six months.(IV) Lighting in the film processing and loading area must be maintained with the filter, bulb wattage, and distances recommended by the film manufacturer for that film emulsion or with products providing an equivalent level of protection against fogging.(V) Corrections or repairs of the light leaks or other deficiencies in subclauses (II), (III), and (IV) of this clause must be initiated within 72 hours of discovery and completed no longer than 15 days from detection of the deficiency unless a longer time is authorized by the department. Records of the correction or repairs must include the date and initials of the individual performing these functions and must be maintained as specified in subsection (l) of this section for inspection by the department.(VI) Documentation of the items in subclauses (II), (III), and (V) of this clause must be maintained at the site where performed and must include the date and initials of the individual completing these items. These records must be kept as specified in subsection (l) of this section for inspection by the department.(ii) Alternative processing systems. Users of daylight processing systems, laser processors, self-processing film units, or other alternative processing systems must follow the manufacturer's recommendations for image processing. Documentation that the registrant is following the manufacturer's recommendations must include the date and initials of the individual completing the document and must be maintained at the site where performed as specified in subsection (l) of this section for inspection by the department.(iii) Digital imaging acquisition systems. Users of digital imaging acquisition systems must follow the QA protocol for image processing established by the manufacturer or, if no manufacturer's protocol is available, by the registrant. The registrant must include the protocol, whether established by the registrant or the manufacturer, in its OSP. The registrant must document the frequency at which the QA protocol is performed. Documentation must include the date and initials of the individual completing the document and must be maintained at the site where performed as specified in subsection (l) of this section for inspection by the department.(F) Additional requirements for conventional radiation therapy simulation systems used in the general radiographic mode of operation for radiation therapy port documentation.(i) Beam quality. The half-value layer of the useful beam for a given x-ray tube potential must not be less than the values shown in Table IV. If it is necessary to determine such half-value layer at an x-ray tube potential not listed in Table IV, linear interpolation may be made.Attached Graphic(ii) Technique and exposure indicators.(I) The technique factors to be used during an exposure must be indicated before the exposure begins except when automatic exposure controls are used, in which case the technique factors set before the exposure must be indicated.(II) The indicated technique factors must meet the manufacturer's specifications. If these specifications are not available from the manufacturer, the factors must be accurate to within plus or minus 10 percent of the indicated setting.(iii) Beam limitation.(I) The beam limiting device (collimator) must restrict the useful beam to the area of clinical interest.(II) A method must be provided to visually define the center (cross-hair centering) of the x-ray field to within a 2 mm diameter.(III) A method must be provided to accurately indicate the distance to within 2 mm.(IV) The delineator wires must be accurate with the indicated setting within 2 mm.(V) The x-ray field must be congruent with the light field within 2 mm.(iv) Timers. Means must be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it must not be possible to make an exposure when the timer is set to a "zero" or "off" position and a visual and audible signal must indicate when an exposure has been terminated.(v) Automatic exposure control (AEC). When an AEC is provided, an indication must be made on the control panel when this mode of operation is selected.(vi) Timer reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure interval for both manual and AEC systems must not exceed 0.05. This requirement applies to clinically used techniques.(vii) Exposure reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure for both manual and AEC systems must not exceed 0.05. This requirement applies to clinically used techniques.(viii) Linearity.Attached Graphic(G) Additional requirements for radiation therapy simulation systems utilizing fluoroscopic capabilities.(i) X-ray production in the fluoroscopic mode must be controlled by a device requiring continuous pressure by the fluoroscopist for the entire time of the exposure (continuous pressure type switch).(ii) During fluoroscopy and cinefluorography, the kV and the Milliampere (mA) must be continuously indicated at the control panel and the fluoroscopist's position.(iii) The SSD must not be less than 20 cm for image-intensified fluoroscopes used for examinations as specified in the registrant's OSP. The written OSP must provide precautionary measures to be adhered to during the use of this device. The procedures must provide information on the means to restore the unit to a 30 cm SSD when the unit is returned to general service.(iv) Fluoroscopic timers must meet the following requirements. (I) Means must be provided to preset the cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device must not exceed five minutes without resetting.(II) A signal audible to the fluoroscopist must indicate the completion of any preset cumulative on-time. The signal must continue to sound while x-rays are produced until the timing device is reset. In lieu of such a signal, the timer must terminate the beam after the preset cumulative on-time is completed.(v) The exposure foot switch must be permanently mounted in the control booth to ensure the operator cannot enter the simulator room while the fluoroscope is activated.(vi) Radiation therapy simulation systems must duplicate the geometric conditions of the radiation therapy equipment plan, and therefore measurements regarding geometric conditions must be performed as specified in subsection (h)(3)(C)(iii)(I) of this section.(vii) If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment-delivery parameters to the treatment-delivery unit must be verified at the treatment location.(i) Medical events.(1) Medical events involving equipment operating at energies below 1 MeV and EBT devices must be reported when:(A) the event involves the wrong individual, or the wrong treatment site;(B) the treatment consists of three or fewer fractions, and the calculated total administered dose differs from the total prescribed dose by more than 10 percent; or(C) the calculated total administered dose differs from the total prescribed dose by more than 20 percent.(2) Medical events involving equipment operating with energies of 1 MeV and above must be reported when:(A) the event involves the wrong individual, wrong type of radiation, wrong energy, or wrong treatment site;(B) the treatment consists of three or fewer fractions, and the calculated total administered dose differs from the total prescribed dose by more than 10 percent;(C) the calculated total administered dose differs from the total prescribed dose by more than 20 percent; or(D) the combination of external beam radiation therapy and radioactive material therapy causes over-radiation of a patient resulting in physical injury or death.(j) Reports of medical events.(1) For a medical event, a registrant must do the following: (A) notify the department by telephone no later than 24 hours after the discovery of the event;(B) notify the referring physician and the patient of the event no later than 24 hours after its discovery, unless the referring physician personally informs the registrant that either the referring physician will inform the patient or that based on medical judgment, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the registrant must notify the patient as soon as possible. The registrant may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the event, because of any delay in notification;(C) submit a written report to the department within 15 days after the discovery of the event. The report must not include the patient's name or other information that could lead to the identification of the patient. The written report must include the following:(i) registrant's name and certificate of registration number;(ii) prescribing physician's name;(iii) a brief description of the event;(iv) why the event occurred;(v) the effect on the patient;(vi) what improvements are needed to prevent recurrence;(vii) actions taken to prevent recurrence;(viii) whether the registrant notified the patient, or the patient's responsible relative or guardian (this person will be subsequently referred to as "the patient"); and if not, why not; and(ix) if the patient was notified, what information was provided to the patient; and(D) furnish the following to the patient within 15 days after discovery of the event if the patient was notified:(i) a copy of the report that was submitted to the department; or(ii) a brief description of both the event and the consequences, as they may affect the patient, provided a statement is included that the report submitted to the department can be obtained from the registrant.(2) Each registrant must retain a record of each event as specified in subsection (l) of this section for inspection by the department. The record must contain the following:(A) the names of all involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician);(B) the patient's identification number;(C) a brief description of the event;(D) why it occurred;(E) the effect on the patient;(F) what improvements are needed to prevent recurrence; and(G) the actions taken to prevent a recurrence.(3) Aside from the notification requirement, nothing in subsection (i) of this section and paragraphs (1) and (2) of this subsection affects any rights or duties of registrants, and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.(k) Emerging and future technologies.(1) Each registrant must develop, implement, and maintain a dedicated quality management program to control the process of administering therapeutic radiation with newly acquired FDA-cleared emerging technologies or previously unused features of a future technology system.(2) Implementation and ongoing clinical use of the technology dated before the technology arrives at the facility or the new features are used must include:(A) an explicit strategy to ensure the quality of processes and patient safety; and(B) an approval from facility management and the radiation oncology safety team before the technology arrives or new features are used.(3) The radiation oncology safety team must develop the quality management program.(4) The quality management program must address, at a minimum:(A) education and training about the new technology and features;(B) a system and timeline for ongoing competency assessment; (C) a system for real-time recording of ongoing issues related to the technology and clinical use of the new technology or features;(D) a strategy for timely investigation and adjudication of accidents and process deviations that may be captured in the system developed in paragraph (2) of this subsection;(E) a strategy for routine review at intervals not to exceed 12 months of the clinical use of the new technology and features, which includes an assessment of the current use compared to paragraph (2) of this subsection and plan to either update the clinical use plan or steps to bring the clinical use back into alignment with paragraph (2) of this subsection;(F) a strategy to ensure the quality of equipment functions; and(G) an explicit strategy for ensuring quality after hardware and software updates and after equipment repair.(5) The quality management program must follow current published recommendations from a recognized national professional association with expertise in therapeutic radiation technologies. In the absence of a protocol published by a national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocol must be followed.(6) New technology issues must be reported to the manufacturer and the department, and be reviewed and addressed via the registrant's reporting system.(l) Records for department inspection. The registrant must maintain the following records at the time intervals specified, for inspection by the department. The records may be maintained in electronic format.Attached Graphic Source Note: The provisions of this §289.229 adopted to be effective October 1, 2000, 25 TexReg 9474; amended to be effective December 29, 2011, 36 TexReg 8835; amended to be effective September 30, 2024, 49 TexReg 7910. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.229 Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Radiation Therapy Simulation Systems, and Electronic Brachytherapy Devices https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225282&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225282 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225282&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225282 03/11/2026 (a) Purpose. This section establishes the requirements for using mammography systems and x-ray machines for interventional breast radiography.(1) Requirements for the registration of a person using radiation machines for mammography.(A) A person must not use radiation machines except as authorized in a certificate of registration issued by the Department of State Health Services (department) as specified in the requirements of this section.(B) A person who receives, possesses, uses, owns, or acquires radiation machines before receiving a certificate of registration is subject to the requirements of this chapter.(2) Mammography machines certified under this section must be used under the supervision of a physician licensed by the Texas Medical Board.(3) Requirements for specific record keeping and general provisions for records and reports.(b) Scope.(1) This section applies to a person who receives, possesses, uses, or transfers radiation machines in mammography facilities. The facility is responsible for the administrative control and oversight of the mammography systems or x-ray machines used for interventional breast radiography.(2) In addition to the requirements of this section, all facilities are subject to the requirements of:(A) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(B) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);(C) §289.205 of this chapter (relating to Hearing and Enforcement Procedures);(D) §289.226 of this subchapter (relating to Registration of Radiation Machine Use and Services);(E) §289.231 of this subchapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation); and(F) 21 Code of Federal Regulations (CFR) Part 900, except for facilities subject to subsection (w) of this section.(3) The procedures as specified in §289.205 of this chapter relating to modifications, suspensions, revocations, denials, and hearings regarding certificates of registration are applicable to certifications issued by the department.(4) This section does not apply to an entity under the jurisdiction of the federal government.(5) An entity, defined in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as a "covered entity" under 45 CFR Parts 160 and 164, may be subject to privacy standards governing how information identifying a patient can be used and disclosed. Failure to follow HIPAA requirements may result in the department referring a potential violation to the United States Department of Health and Human Services.(c) Prohibitions.(1) The department prohibits the use of radiographic equipment designed for general purpose or special non-mammography procedures for mammographic imaging. This includes systems that have been modified or equipped with special attachments for mammography.(2) The department prohibits the use of mammography machines posing a significant threat or danger to occupational and public health and safety, as specified in §289.205 and §289.231 of this chapter.(3) The department prohibits exposing an individual to the useful beam, except for healing arts imaging ordered by a practitioner. This provision specifically prohibits intentional exposure of an individual for:(A) training, demonstration, or other non-healing arts purposes;(B) healing arts screening, or self-referral mammography except as authorized by subsection (r) of this section; and(C) research, except as authorized by subsection (s) of this section.(4) The department prohibits remote operation of radiation machines.(d) Exemptions.(1) Mammography machines or cabinet x-ray machines used exclusively for examination of breast biopsy specimens are exempt from the requirements of this section. These machines are required to meet applicable provisions of §289.226 and §289.228 of this subchapter (relating to Radiation Safety Requirements for Industrial Radiation Machines).(2) Machines used exclusively for interventional breast radiography are exempt from the requirements of this section except for those listed in subsection (w) of this section. These machines are not required to be accredited by a United States Food and Drug Administration (FDA)-approved accreditation body (AB).(3) Loaner machines as described in subsection (g)(6) of this section are exempt from the inspection requirements in subsection (v)(1) of this section. These machines are not required to be accredited by an AB.(4) Mammography machines with investigational device exemptions as described in subsection (s) of this section and used in clinical studies are exempt from the requirements of this chapter. These machines are not required to be accredited by an AB.(5) All mammography and interventional breast radiography facilities are exempt from the posting of radiation area requirements of §289.231 of this subchapter if the operator has continuous surveillance and controls access to the radiation area.(e) Definitions. The following words and terms, when used in this section, have the following meanings unless the context indicates otherwise.(1) Accreditation--The approved use of a mammography machine by an AB.(2) Act--Texas Radiation Control Act, Health and Safety Code Chapter 401.(3) Action limit--The minimum or maximum value of a quality assurance (QA) measurement representing acceptable performance. Values less than the minimum or greater than the maximum action limit indicate corrective action must be taken by the facility.(4) Additional mammography review (AMR)--A review of clinical images and other relevant facility information necessary to assess compliance with accreditation standards.(5) Adverse event--An undesirable experience associated with mammography activities. Adverse events include:(A) poor image quality;(B) failure to send mammography reports within 30 days to the referring physician or in a timely manner to the self-referred patient; and(C) use of personnel who do not meet the applicable requirements of subsection (h) of this section.(6) Air kerma--The kinetic energy released in air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The System International (SI) unit of air kerma is joule per kilogram, and the special name for the unit of kerma is gray (Gy).(7) American Registry of Radiologic Technologists - Radiography (ARRT(R))--the credential issued by the American Registry of Radiologic Technologists in radiography.(8) Automatic exposure control (AEC)--A device automatically controlling one or more technique factors to obtain the required quantity of radiation at preselected locations.(9) Average glandular dose--The average absorbed dose to the glandular tissue of the breast.(10) Beam-limiting device--A device providing a means to restrict the dimensions of the x-ray field.(11) Breast implant--A prosthetic device implanted in the breast.(12) Calendar quarter--Any one of the following time periods during a given year: January 1 - March 31, April 1 - June 30, July 1 - September 30, or October 1 - December 31.(13) Calibration of instruments--The comparative response or reading of an instrument relative to a series of known radiation values over the range of the instrument.(14) Category I continuing medical education units (CMEU)--Educational activities designated as Category I and approved by the Accreditation Council for Continuing Medical Education, the American Osteopathic Association, a state medical society, or an equivalent organization.(15) Certification--An authorization for the use of a mammography system for mammography or x-ray machines used for interventional breast radiography.(16) Clinical image--See the definition for mammogram.(17) Contact hour--An hour of training received through direct instruction.(18) Continuing education unit (CEU)--One contact hour of training.(19) Control panel--The part of the radiation machine control upon which are mounted the hardware necessary for setting the technique factors.(20) Direct instruction--Instruction, including:(A) interaction between an instructor and student, such as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or(B) administration and correction of student examinations by an instructor with subsequent feedback to the student.(21) Direct supervision--Oversight of operations, including the following.(A) During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the interpretation of the physician being supervised and signs the report before it is entered into the patient's record.(B) During performance of a mammography examination, the supervising medical radiologic technologist (MRT) is present to observe and correct, as needed, the individual performing the examination. (C) During performance of a survey of the facility's equipment and QA program, the supervising medical physicist is present to observe, and correct, as needed, the individual conducting the survey.(22) Facility--A hospital, outpatient department, clinic, radiology practice, mobile unit, an office of a physician, or other person conducting breast cancer screening or diagnosis through mammography activities, including:(A) operating equipment to produce a mammogram;(B) processing film or digital images;(C) interpreting the mammogram; or(D) maintaining the viewing conditions for interpretation. (23) FDA-approved accreditation body (AB)--An entity approved by the FDA under 21 CFR §900.3(d) to accredit mammography facilities.(24) Final assessment categories--The overall final assessment of findings in a report of a mammography examination classified in subsection (j)(3)(E) of this section.(25) First allowable time--The earliest time a resident physician is eligible to take the diagnostic radiology boards from an FDA-designated certifying body.(26) Formal training--Attendance and participation in direct instruction. This does not include self-study programs.(27) Half-value layer (HVL)--The thickness of a specified material attenuating the beam of radiation to the extent the exposure rate is reduced to one-half of its original value.(28) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.(29) Healthcare provider--A doctor of medicine or osteopathy, podiatrist, dentist, chiropractor, clinical psychologist, optometrist, physician assistant, or nurse practitioner authorized to practice by the state of Texas and performing within the scope of their practice as defined by state law.(30) Image receptor--Any device that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.(31) Institutional review board (IRB)--Any board, committee, or other group created under 45 CFR Part 46 and 21 CFR Part 56, and formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.(32) Interpreting physician (IP)--A licensed physician who interprets mammographic images and who meets the requirements of subsection (h)(1) of this section.(33) Interventional breast radiography--Imaging of a breast during invasive interventions for localization or biopsy procedures.(34) Investigational device exemption--An exemption allowing an investigational device to be used in a clinical study to collect safety and effectiveness data required to support a Premarket Approval application or a 510(k) Premarket Notification submission to FDA.(35) Kerma--The sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.(36) Laterality--The designation of either the right or left breast.(37) Lead interpreting physician (LIP)--The interpreting physician assigned the general responsibility for ensuring a facility's QA program meets all requirements of subsections (k), (l), and (m) of this section.(38) Mammogram--A radiographic image produced through mammography.(39) Mammographic modality--A technology, within the scope of 42 United States Code (U.S.C.) §263b, for radiography of the breast. Examples are screen-film mammography, full-field digital mammography, and digital breast tomosynthesis (DBT).(40) Mammography--The use of x-rays to produce an image of the breast that may be used to detect the presence of pathological conditions of the breast. Mammography does not include radiography of the breast performed:(A) during invasive interventions for localization or biopsy procedures, except as specified in subsection (w) of this section; or(B) using an investigational mammography device as part of a scientific study conducted under the FDA's investigational device exemption regulations.(41) Mammography machine--An assemblage of components for mammography. This includes an x-ray high-voltage generator, x-ray control, tube housing assembly, beam-limiting device, and the necessary supporting structures. Additional components functioning with the machine are considered integral parts of the system.(42) Mammography medical outcomes audit--A systematic collection of mammography results and the comparison of those results with outcomes data.(43) Mammography system--A system, including:(A) an x-ray machine used as a source of radiation in producing images of breast tissue;(B) an imaging system used for the formation of a latent image of breast tissue;(C) an imaging-processing device for changing a latent image of breast tissue to a visual image that can be used for diagnostic purposes;(D) a device used for viewing and evaluating an image of breast tissue;(E) an MRT who meets the qualifications specified in subsection (h)(2) of this section and performs mammography; and(F) a physician who interprets mammography and meets the requirements specified in subsection (h)(1) of this section.(44) Mandatory training--Additional training required by the department or AB for IPs, MRTs, or medical physicists as the result of a required corrective action.(45) Medical physicist--An individual who performs surveys and evaluations of mammographic equipment and facility QA programs as specified in this section and who meets the qualifications in subsection (h)(3) of this section.(46) Medical radiologic technologist (MRT)--An individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations, who performs mammography examinations as specified in this section and who meets the qualifications in subsection (h)(2) of this section.(47) Mobile service operation--The provision of mammography machines and personnel at temporary sites to perform mammography for limited time periods.(48) Multi-reading--Two or more physicians interpreting the same mammogram. At least one physician must be qualified as an IP.(49) Operator--An individual who performs interventional breast mammography examinations.(50) Optical density (OD)--A measure of the fraction of incident light transmitted through a developed film and defined by the equation:Attached Graphic(51) Patient--Any individual who undergoes a mammography examination in a facility, regardless of whether the individual is referred by a physician or is self-referred.(52) Phantom--A test object used to simulate radiographic characteristics of compressed breast tissue and containing components modeling aspects of breast disease and cancer in a radiograph.(53) Phantom image--A radiographic image of a phantom.(54) Physical science--This includes physics, chemistry, radiation science (including medical physics and health physics), and engineering.(55) Physician--An individual licensed by the Texas Medical Board to practice medicine under Texas Occupations Code Chapter 155.(56) Positive mammogram--A mammogram with an overall assessment of findings that are either "suspicious" or "highly suggestive of malignancy."(57) Provisional certification--A certification category enabling a facility to perform mammography and obtain the clinical images needed to complete the accreditation process.(58) Qualified instructor--An individual whose training and experience prepares the qualified instructor to carry out specified training assignments. IPs, MRTs, or medical physicists who meet the requirements of subsection (h) of this section are considered qualified instructors in their respective areas of mammography. Other examples of an individual who may be a qualified instructor for the purpose of providing training to meet the requirements of this section include instructors in a post-high school training institution and manufacturers' representatives.(59) Quality control (QC) technologist--An individual meeting the requirements of subsection (h)(2) of this section who is responsible for those QA responsibilities not assigned to the LIP or to the medical physicist.(60) Radiation machine--see definition for mammography machine.(61) Self-referral mammography--The use of x-ray to test asymptomatic women for the detection of diseases of the breasts when such tests are not specifically and individually ordered by a licensed physician.(62) Serious adverse event--An adverse event that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner.(63) Serious complaint--A report of a serious adverse event.(64) Source-to-image receptor distance (SID)--The distance from the source to the center of the input surface of the image receptor. (65) Standard breast--A 4.2 cm thick compressed breast consisting of 50 percent glandular tissue and 50 percent adipose tissue.(66) Survey--An on-site physics consultation and evaluation of a facility QA program performed as specified in subsection (l)(5) of this section by a medical physicist meeting the requirements of subsection (h)(3) of this section.(67) Technique chart--A chart providing all necessary generator control settings and geometry needed to make clinical radiographs. (68) Traceable to a national standard--Calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory participating in a proficiency program with NIST at least once every two years. The results of the proficiency test conducted within 24 months of calibration must show agreement within plus or minus 3.0 percent of the national standard in the mammography energy range.(f) Mammography systems certification.(1) Requirements for certification.(A) A facility must meet the quality standards in subsections (h) - (q) of this section and be accredited by an AB. To qualify for certification, a new facility must apply to the department and receive acceptance of an accreditation application by an AB.(B) A person who receives, possesses, uses, owns, or acquires a mammography machine must apply for certification as specified in §289.226(e) of this subchapter, relating to general requirements for application for registration, and receive certification from the department before using a mammography machine on humans.(C) An application for certification must be signed by the:(i) LIP;(ii) applicant; and(iii) radiation safety officer (RSO).(D) Each applicant must submit documentation of:(i) personnel qualifications, including dates of licensure or certification, as specified in subsection (h) of this section;(ii) manufacturer, model name, and serial number of each mammography machine control panel;(iii) evidence that a medical physicist has:(I) determined each machine meets the equipment standards in subsection (i) of this section;(II) performed a survey and a mammography equipment evaluation as specified in subsection (l)(5) and (6) of this section; and(III) determined the average glandular dose for one craniocaudal view for each machine is less than the value in subsection (i)(11)(D) of this section;(iv) self-referral program information as specified in subsection (r) of this section, if the facility offers self-referral mammography;(v) items required for authorization of a mobile service operation as specified in §289.226(g) of this subchapter, relating to application for registration of mobile service operations, if the facility provides a mobile service; and(vi) proof of current accreditation.(2) Issuance of certification. A certification will be issued if the department determines the application meets the requirements of the Act and this chapter. The certification authorizes the proposed operations and includes conditions and limitations deemed necessary by the department.(A) The certification may include:(i) mammography systems and facilities certification, following approval of accreditation by an AB; or(ii) certification of interventional breast radiography machines.(B) Conditions. The department may incorporate in the certification at the time of issuance, or by amendment, additional requirements and conditions to:(i) minimize danger to occupational and public health and safety;(ii) require additional reporting and record keeping; and(iii) prevent loss or theft of radiation machines subject to this section.(C) Additional information. The department may request additional information after the certification has been issued to enable the department to determine whether the certification should be modified as specified in §289.226(r) of this subchapter, relating to renewal of certificates of registration.(3) Provisional certification.(A) To apply for and receive a provisional certification, a new facility must meet the requirements of this chapter and submit the necessary information to an AB.(B) Following the department's receipt of the accreditation body's decision that a facility has submitted the required information, the department may issue a provisional certification to a facility if the facility has satisfied the requirements of the Act and this chapter.(i) A provisional certification is effective for up to six months as noted on the certificate.(ii) A provisional certification cannot be renewed, but a facility may apply for a 90-day extension of the provisional certification.(C) To apply for a 90-day extension to a provisional certification, a facility must submit to the AB who issued the original certificate, a statement of actions taken to obtain certification and evidence that there would be a significant adverse impact on access to mammography in the geographic area served if the facility did not obtain an extension.(i) The department may issue a 90-day extension for a provisional certification if the extension meets the criteria in paragraph (3) of this subsection.(ii) Renewal of a provisional certification beyond the 90-day extension is prohibited.(4) Reinstatement.(A) A previously certified facility that has allowed its certification to expire, been refused a renewal of its certification by the department, or had its certification suspended or revoked by the department, may reapply to have the certification reinstated so the facility may be considered a new facility and thereby be eligible for a provisional certification.(B) Unless prohibited from reinstatement as specified in subsection (f)(5) of this section, a facility applying for reinstatement must:(i) contact an AB for reapplication of accreditation;(ii) provide documentation of its history as a previously provisionally certified or certified mammography facility, and include the:(I) name and address of the facility under which it was previously provisionally certified or certified;(II) name of previous owner or lessor;(III) facility identification number assigned to the facility under its previous certification by the FDA or the department; and(IV) expiration date of the most recent FDA or department provisional certification; and(iii) justify application for reinstatement of accreditation by submitting to an AB a corrective action plan detailing how the facility has corrected deficiencies contributing to the lapse, denial of renewal, or revocation of its certification.(C) The department may issue a provisional certification to the facility if the department determines the facility has:(i) adequately corrected, or is in the process of correcting, pertinent deficiencies; and(ii) taken sufficient corrective action since the lapse, denial of renewal, or revocation of its previous certification.(D) After receiving the provisional certification, the facility may lawfully perform mammography while completing the requirements for accreditation and certification.(5) Suspension or revocation of certification.(A) Except as provided in subparagraph (B) of this paragraph, the department may suspend or revoke a certification issued by the department if it finds, after providing the owner or facility representative with notice and an opportunity for a hearing as specified in §289.205 of this chapter, that the owner, facility representative, or any employee of the facility has:(i) misrepresented documentation to obtain the certification; (ii) failed to comply with the requirements of this chapter;(iii) failed to comply with requests of the department or an AB for records, information, reports, or materials necessary to determine the continued eligibility of the facility for a certification or continued compliance with the requirements of this chapter;(iv) refused a request of a duly designated FDA inspector, state inspector, or an AB representative for permission to inspect the facility or the operations and pertinent records of the facility;(v) violated or aided and abetted in the violation of any provision of or regulation promulgated pursuant to the requirements of the Act and the requirements of this chapter; or(vi) failed to comply with prior sanctions imposed by the department as specified in §289.205 of this chapter.(B) The department may suspend a certification of a facility before holding a hearing if it makes a finding described in subparagraph (A) of this paragraph and determines that:(i) the failure to comply with requirements presents a serious risk to human health;(ii) the refusal to permit inspection makes immediate suspension necessary; or(iii) there is reason to believe the violation or aiding and abetting of the violation was intentional or associated with fraud.(C) If the department suspends a certification as specified in subparagraph (B) of this paragraph:(i) the department will provide the facility with an opportunity to request a hearing as specified in §289.205 of this chapter; and(ii) the suspension will remain in effect until it is determined by the department that the:(I) allegations of violations or misconduct were not substantiated;(II) violations of requirements have been corrected to the department's satisfaction; or(III) certification is revoked as specified in subparagraph (D) of this paragraph.(D) After providing a hearing as specified in §289.205 of this chapter, the department may revoke the certification if it is determined by the department that the facility:(i) is unwilling or unable to correct violations that were the basis for suspension; or(ii) has engaged in fraudulent activity to obtain or continue certification.(E) If a facility's certification was revoked based on an act described in §289.205 of this chapter, a person who owned or operated that facility at the time the act occurred is prohibited from owning a mammography facility for two years following the revocation date.(6) Appeal of adverse accreditation or reaccreditation decisions preventing certification or recertification.(A) The appeal process described in this paragraph is only available for adverse accreditation or reaccreditation decisions preventing certification by the department. If the department suspends or revokes a certificate already in effect, it will be handled as specified in subsection (f)(5) of this section.(B) If a facility has failed to become accredited or reaccredited, the department will notify the facility that the department is unable to certify the facility without proof of accreditation.(C) A facility that has been denied accreditation or reaccreditation and cannot achieve satisfactory resolution of an adverse accreditation decision through the AB's appeal process is entitled to further appeal to the FDA.(D) A facility cannot perform mammography services while an adverse accreditation decision is being appealed.(7) Denial of certification.(A) The department may deny the application if the department has reason to believe that:(i) the facility will not be operated as specified in the provisions of subsections (h) - (q) of this section;(ii) the facility will not permit inspections or provide access to records or information timely;(iii) made a materially false statement in the application or any statement of fact required under provision of the Act;(iv) conditions revealed by such application or statement of fact or any report, record, inspection, or other means that would warrant the department to refuse to grant a certification of mammography facility on an original application; or(v) the facility failed to observe any of the terms and conditions of the Act, this chapter, or order of the department.(B) Before the department denies an application for certification, the department must give notice of the denial, the facts warranting the denial, and afford the applicant an opportunity for a hearing in accordance with §289.205(h) of this chapter. If no request for a hearing is received by the director of the Radiation Control Program within 30 days of date of receipt of the notice, the department may proceed to deny. The applicant must bear the burden of proof showing cause why the application should not be denied.(C) If the department denies an application for certification from a facility that has received accreditation from an AB, the department will provide the facility with a written statement of the grounds on which the denial is based.(8) Appeals of a certification denial.(A) The appeals procedures described in this paragraph are available only to facilities that are denied certification by the department after they have been accredited by an AB.(B) A facility that has been denied certification may request reconsideration and appeal the department's determination as specified in the applicable provisions of §289.205(h) of this chapter.(9) Modification of certification. Modification of a certification will follow the requirements in §289.226(s) of this subchapter, relating to modification, suspension, and revocation of certificates of registration.(10) Specific terms and conditions of certification. Specific terms and conditions of certification will be as specified in §289.226(l) of this subchapter, relating to terms and conditions of certificates of registration.(11) Renewal of certification.(A) A certification for a mammography system is valid for three years from the date of issuance unless the certification of the facility is suspended or revoked before such deadlines.(B) A mammography facility filing an application for renewal of their certification must meet the quality standards in subsections (h) - (q) of this section and be accredited by an AB. The renewal must include a list of all IPs, MRTs, and medical physicists practicing at the facility and must be filed as specified in:(i) §289.226(r) of this subchapter, relating to renewal of certificates of registration;(ii) §289.204(d) and (g) of this chapter, relating to payment of fees;(iii) subsection (f)(1)(C) of this section; and(iv) subsection (f)(1)(D)(i) of this section.(C) A mammography facility filing an application for renewal before the existing certification expires may continue to perform mammography until the application status has been determined by the department.(D) A facility with mammography machines used for interventional breast radiography must apply for renewal as specified in subsection (w)(5) of this section and pay the fee specified in §289.204(d) of this chapter.(12) Expiration of certification.(A) Each certification expires at the end of the day on the expiration date listed on the mammography certificate unless the certificate is suspended or revoked before the expiration date. Expiration of the certification does not relieve the facility of the requirements of this chapter.(B) If a facility does not apply for renewal of the certification as specified in paragraph (11) of this subsection, as applicable, the facility must:(i) terminate use of all mammography machines;(ii) notify the department in writing of the storage location of mammography images and address how the requirements of subsection (j)(7)(E) of this section will be met;(iii) pay any outstanding fees specified in §289.204 of this chapter; and(iv) submit a record of the disposition of the mammography machine to the department.(13) Termination of certification. When a facility decides to terminate all activities involving mammography machines authorized under the certification, the facility must:(A) notify the department and the AB within 30 days;(B) request termination of the certification in writing;(C) pay any outstanding fees specified in §289.204 of this chapter;(D) notify the department, in writing, of the storage location of mammography images and address how the requirements of subsection (j)(7)(E) of this section will be met; and(E) submit a record of the disposition of the mammography machine to the department.(g) Responsibilities of the facility.(1) In addition to the requirements of §289.226(m)(3) - (7) of this subchapter, relating to responsibilities of the registrant, the facility must notify the department in writing, within 30 days, of any changes rendering the information contained in the application or the certification inaccurate, including the:(A) name of the facility;(B) mailing address;(C) street address where the machine is used;(D) addition or removal of any mammography machine; or(E) name and qualifications of the RSO or LIP.(2) Before employing an individual listed in subparagraphs (A) - (E) of this paragraph, the facility is required to verify and maintain a copy of the qualifications of the:(A) RSO;(B) LIP;(C) IP;(D) MRT; or(E) medical physicist.(3) A facility utilizing an IP or MRT from a temporary staffing service must verify and maintain copies of the qualifications of these individuals for inspection by the department.(4) For accreditation, a facility adding or replacing a mammography machine must have a current accreditation or apply to the AB, unless exempted by subsection (d) of this section.(5) For certification, a facility with an existing certificate may begin using a new or replacement machine before receiving an updated certificate if the facility submits to the department and AB an application with a medical physicist report as specified in subsection (l)(5) and (6) of this section.(6) Loaner mammography machines may be used on patients for 60 days without adding the mammography machine to the certification. A medical physicist's report verifying compliance of the loaner mammography machine with this section must be completed before use on patients. The results of the survey must be submitted to the department with a cover letter indicating period of use. If the use period will exceed 60 days, the facility must add the mammography machine to its certification and a fee will be assessed.(7) Records of training and experience and all other records required by this section must be maintained for review as specified in subsection (x) of this section.(h) Personnel qualifications. The following requirements apply to all personnel involved in any aspect of mammography, including the production and interpretation of mammograms.(1) Interpreting physician. Each physician interpreting mammograms must hold a current Texas license issued by the Texas Medical Board and meet the following qualifications.(A) Initial qualifications. Before interpreting mammograms independently, the physician must:(i) be certified by the American Board of Radiology, the American Osteopathic Board of Radiology, or one of the other bodies approved by the FDA to certify IPs or have at least three months of documented formal training in the interpretation of mammograms and in topics related to mammography as specified in subparagraph (B) of this paragraph;(ii) have completed a minimum of 60 hours of documented category I CMEUs in mammography and at least 15 of the 60 hours must have been acquired within three years immediately before the date the physician became qualified as an IP (hours spent in residency specifically devoted to mammography will be equivalent to category I CMEUs and accepted if documented in writing by the appropriate representative of the training institution); and(iii) have interpreted or multi-read, under the direct supervision of an IP, at least 240 mammographic examinations within the six-month period immediately before the date that the physician qualifies as an IP. The supervising interpreting physician's presence is not required when the physician being supervised makes the initial interpretation. However, the supervising physician must review and, if necessary, correct the final interpretation before it is given to the patient.(B) Subjects to be included in mammography training for interpreting physicians must include:(i) radiation physics, including radiation physics specific to mammography;(ii) radiation effects;(iii) radiation protection; and(iv) interpretation of mammograms. This must be under the direct supervision of a physician who meets the requirements of paragraph (1) of this subsection.(C) Exemptions.(i) A physician qualified as an IP as specified in the requirements of §289.230 that were in effect before April 28, 1999, or any other equivalent state or federal requirements in effect before April 28, 1999, is considered to have met the initial requirements of subparagraph (A) of this paragraph.(ii) Physicians who have interpreted or multi-read at least 240 mammographic examinations under the direct supervision of an IP in any six-month period during the last two years of a diagnostic radiology residency and who became board certified at the first allowable time, are exempt from subparagraph (A)(iii) of this paragraph.(D) Continuing education.(i) Each IP must maintain continuing education by completing at least 15 category I mammography CMEUs, in a rolling 36-month period, by participating in or teaching mammography courses. CMEUs earned through teaching a specific course can only be counted once during the 36-month period.(I) The period for the initial continuing education begins when a physician completes the requirements in subparagraph (A) of this paragraph.(II) The facility chooses one of the dates in subclause (III) of this clause to determine the start of the subsequent 36-month continuing education period.(III) Continuing education must be completed in the 36 months immediately preceding:(-a-) the date of the facility's inspection;(-b-) the last day of the calendar quarter preceding the inspection; or(-c-) any date in between the two.(ii) Each IP must complete at least eight hours of training in any mammography modality in which the IP has not been previously trained, before independently using the new modality.(E) Continuing experience.(i) Each IP must maintain continuing experience by interpreting or multi-reading at least 960 mammographic examinations.(ii) The period for the initial continuing experience begins when a physician completed the requirements in subparagraph (A) of this paragraph.(iii) The facility chooses one of the dates in clause (iv) of this subparagraph to determine the start of the subsequent 24-month continuing experience period.(iv) Continuing experience must be completed in the 24 months immediately preceding:(I) the date of the facility's inspection;(II) the last day of the calendar quarter preceding the inspection; or(III) any date in between the two.(F) Re-establishing qualifications. Before resuming independent interpretation of mammograms, an IP failing to maintain the required continuing education or experience must re-establish their qualifications by completing one or both of the following requirements, as applicable:(i) obtain additional category I CMEUs to bring the total up to 15 category I CMEU credits required in the previous 36 months;(ii) within the six months immediately before resuming independent interpretation and under the direct supervision of a physician qualified as an IP, interpret or multi-read one of the following, whichever is less:(I) at least 240 mammographic examinations; or(II) additional mammographic examinations to bring the total up to 960 examinations for the prior 24 months.(G) Additional mandatory training. Additional mandatory training may be required by the department based on the recommendations of an AB, the department, or the FDA. Training is developed on a case-by-case basis.(i) The department may require pre-approval of any additional mandatory training.(ii) Documentation of the additional mandatory training must be submitted for review by the date specified by the department.(iii) Records of all additional mandatory training must be maintained by the facility for inspection by the department as specified in subsection (x)(3) of this section.(2) Medical radiologic technologists (MRTs). Each individual performing mammographic examinations must maintain current credentials as an ARRT(R) and MRT as specified in the Medical Radiologic Technologist Certification Act, Texas Occupations Code Chapter 601, and must meet the following qualifications.(A) Initial requirements. Before performing mammographic examinations, the MRT must:(i) complete a minimum of 40 contact hours of training as specified in subparagraph (B) of this paragraph by a qualified instructor; and(ii) perform a minimum of 25 mammographic examinations under the direct supervision of an individual qualified as specified in this paragraph. The 25 mammographic examinations may be obtained concurrently with the 40 contact hours of training specified in clause (i) of this subparagraph but must not exceed 16 hours of the 40 contact hours.(B) Subjects to be included in mammography training for an MRT must include the following:(i) breast anatomy and physiology;(ii) positioning and compression;(iii) QA/QC techniques;(iv) imaging of patients with breast implants; and(v) at least eight hours of training in each mammography modality to be used by the MRT in performing mammography examinations.(C) Exemptions. MRTs qualified to perform mammography as specified in the requirements of §289.230 that were in effect before April 28, 1999, and any other federal requirements in effect before April 28, 1999, are considered to have met the initial requirements of subparagraph (A) of this paragraph.(D) Continuing education.(i) Each MRT must maintain continuing education by completing at least 15 mammography CEUs, in a rolling 36-month period, by participating in or teaching mammography courses. CEUs earned through teaching a specific course can only be counted once during the 36-month period.(I) The period for the initial continuing education begins when an MRT completes the requirements in subparagraph (A) of this paragraph, or April 28, 1999, whichever is later.(II) The facility chooses one of the dates in subclause (III) of this clause to determine the start of the subsequent 36-month continuing education period.(III) Continuing education must be completed in the 36 months immediately preceding:(-a-) the date of the facility's inspection;(-b-) the last day of the calendar quarter preceding the inspection; or(-c-) any date in between the two.(ii) Each MRT must complete at least eight hours of CEUs in any mammography modality in which the MRT has not been previously trained, before independently using the new modality.(E) Continuing experience.(i) Each MRT must maintain continuing experience by completing 200 mammographic examinations.(ii) The period for the initial continuing experience begins when an MRT completes the requirements in subparagraph (A) of this paragraph.(iii) The facility chooses one of the dates in clause (iv) of this subparagraph to determine the start of the subsequent 24-month continuing experience period.(iv) Continuing experience must be completed in the 24 months immediately preceding:(I) the date of the facility's inspection;(II) the last day of the calendar quarter preceding the inspection; or(III) any date in between the two.(F) Requalification. Before resuming independent performance of mammograms, MRTs who fail to maintain the continuing education or experience requirements must re-establish their qualifications by completing one or both of the following requirements, as applicable:(i) obtain additional CEUs to bring the total up to 15 CEU credits required in the previous 36 months;(ii) perform a minimum of 25 mammographic examinations under the direct supervision of a qualified MRT.(G) Additional mandatory training. Additional mandatory training may be required by the department based on the recommendations of an AB, the department, or the FDA. Training is developed on a case-by-case basis.(i) The department may require pre-approval of any additional mandatory training.(ii) Documentation of the additional mandatory training must be submitted for review by the date specified by the department.(iii) Records of all additional mandatory training must be maintained by the facility for inspection by the department as specified in subsection (x)(3) of this section.(3) Medical physicist. Each medical physicist performing mammographic surveys, evaluating mammographic equipment, or providing oversight of the facility QA program as specified in subsection (k) of this section must hold a current Texas license under the Medical Physics Practice Act, Texas Occupations Code Chapter 602, in diagnostic radiological physics. The medical physicist must be registered with the department or employed by an entity registered with the department, as specified in §289.226(j) of this subchapter and the Act, unless exempted by §289.226(d)(7) of this subchapter. Each medical physicist must meet the following qualifications.(A) Initial qualifications. Before performing surveys and evaluating mammographic equipment independently, the medical physicist must have:(i) a master's degree or higher in a physical science from an accredited institution, with no less than 20 semester hours, 30 quarter hours, or equivalent of college undergraduate or graduate level physics;(ii) 20 contact hours of documented specialized training in conducting surveys of mammography facilities; and(iii) experience conducting surveys of at least one mammography facility and a total of at least 10 mammography machines. Experience conducting surveys must be acquired under the direct supervision of a medical physicist who meets the requirements of subparagraphs (A), (C), and (D) of this paragraph. No more than one survey of a specific machine within a period of 60 days can be counted towards the total mammography machine survey requirement.(B) Alternative initial qualifications. Individuals who qualified as a medical physicist as specified in the requirements of this section that were in effect before April 28, 1999, or any other equivalent state or federal requirements in effect before April 28, 1999, and have met the following additional qualifications before April 28, 1999, are determined to have met the initial qualifications of subparagraph (A) of this paragraph:(i) a bachelor's degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics;(ii) 40 contact hours of documented specialized training in conducting surveys of mammography facilities; and(iii) experience conducting surveys of at least one mammography facility and a total of at least 20 mammography machines. No more than one survey of a specific machine within a period of 60 days can be counted towards the total mammography machine survey requirement. The training and experience requirements must be met after fulfilling the degree requirements.(C) Continuing education.(i) Each medical physicist must maintain continuing education by completing at least 15 mammography CEUs, in a rolling 36-month period, by participating in or teaching mammography courses. CEUs earned through teaching a specific course can only be counted once during the 36-month period.(I) The period for the initial continuing education begins when a medical physicist completes the requirements in subparagraph (A) of this paragraph, or April 28, 1999, whichever is later.(II) The facility chooses one of the dates in subclause (III) of this clause to determine the start of the subsequent 36-month continuing education period.(III) Continuing education must be completed in the 36 months immediately preceding:(-a-) the date of the facility's inspection;(-b-) the last day of the calendar quarter preceding the inspection; or(-c-) any date in between the two.(ii) Each medical physicist must also complete at least eight hours of training in any mammography modality in which the medical physicist has not been previously trained, before independently using the new modality.(D) Continuing experience.(i) Each medical physicist must perform a survey of two mammography facilities and at least six mammography machines. No more than one survey of a specific facility within a 10-month period or a specific machine within 60 days can be counted toward the total mammography machine survey requirement.(ii) The period for the initial continuing experience begins when a medical physicist completes the requirements in subparagraph (A) of this paragraph.(iii) The facility chooses one of the dates in clause (iv) of this subparagraph to determine the start of the subsequent 24-month continuing experience period.(iv) Continuing experience must be completed in the 24 months immediately preceding:(I) the date of the facility's inspection;(II) the last day of the calendar quarter preceding the inspection; or(III) any date in between the two.(E) Re-establishing qualifications. Before resuming independent performance of surveys and equipment evaluations, medical physicists who fail to maintain the continuing education or experience requirements must reestablish their qualifications by completing one or both of the following requirements, as applicable:(i) obtain additional CEUs to bring the total up to the 15 CEU credits required in the previous 36 months;(ii) perform surveys, under the direct supervision of a qualified medical physicist, to bring their total up to two mammography facilities and a total of at least six mammography machines for the prior 24 months. No more than one survey of a specific machine within a period of 60 days may be counted towards the total mammography machine survey requirement.(4) Retention of personnel records.(A) Facilities must maintain records of training and experience relevant to their qualifications, as specified in subsection (h)(1) - (3) of this section, for personnel who work or have worked at the facility as IPs, MRTs, or medical physicists for review by the department.(B) Records of personnel no longer employed by the facility must be maintained for at least 24 months from the date of the departure of the employee, and these records must be available for review at the time of any inspection occurring during those 24 months. Personnel records must be maintained by the facility for inspection by the department as specified in subsection (x) of this section.(i) The facility must provide copies of these personnel records to current IPs, MRTs, and medical physicists upon their request.(ii) The facility must provide personnel records to a former employee if the former employee communicates their request within 24 months of the date of their departure.(I) If it has been greater than 24 months and the facility has maintained those records, the facility must provide those records to former employees upon request.(II) If a facility closes or stops providing mammography services, it must arrange for current and former personnel to access their personnel qualification records before closing. Access may be provided by a permanent transfer of records to the personnel or the transfer of the records to a facility or other entity that will provide access to these records for at least 24 months from the date of facility closure of mammography services.(i) Machine Requirements. Mammographic machines must meet the following requirements.(1) System design. The equipment must be specifically designed and manufactured for mammography and as required by 21 CFR §§1010.2, 1020.30, and 1020.31.(2) A mammography machine converted from one mammographic modality to another is considered a new machine at the facility under this subsection.(A) Before clinical use, the mammography machine must undergo a mammography equipment evaluation and demonstrate compliance with applicable requirements.(B) The facility must also follow the accreditation body's procedures for applying for accreditation of the unit.(3) Screen-film mammography systems must meet the requirements of 21 CFR Part 900.(4) Motion of tube-image receptor assembly. The x-ray tube must remain physically stable during exposures. In cases where tubes are designed to move during exposure, the facility must ensure proper and free movement of the unit. In the event of power interruption, this mechanism must not fail.(5) Magnification. Systems used to perform diagnostic procedures must have radiographic magnification capability available for use with at least one magnification value within the range of 1.4 to 2.0.(6) Focal spot and target material selection. Selection of the focal spot or target material must be as follows.(A) When more than one focal spot is provided, the system must indicate, before exposure, which focal spot is selected.(B) When more than one target material is provided, the system must indicate, before exposure, the preselected target material.(C) When the target material and focal spot are selected by a system algorithm based on the exposure, after the exposure, the system must display the target material and focal spot used during the exposure.(7) Compression. All mammography systems must incorporate a compression device.(A) Application of compression. Each system must provide the following features operable from both sides of the patient:(i) an initial power-driven compression activated by hands-free controls; and(ii) fine adjustment compression controls.(B) Compression paddle.(i) Systems must be equipped with different sized compression paddles matching the sizes of all full-field image receptors provided for the system.(ii) Compression paddles for special purposes, including those smaller than the full size of the image receptor (for example, spot compression) may be provided. Such paddles are not subject to the requirements of clauses (v) and (vi) of this subparagraph.(iii) Except as provided in clause (iv) of this subparagraph, the compression paddle must be flat and parallel to the breast support table and must not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.(iv) Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression must meet the manufacturer's design specifications and maintenance requirements.(v) The chest wall edge of the compression paddle must be straight and parallel to the edge of the image receptor.(vi) The chest wall edge may be bent upward to allow for patient comfort, but must not appear on the image.(8) Technique factor selection and display. Technique factor selection and display must be as follows.(A) Manual selection of milliampere seconds (mAs) or at least one of its component parts, milliampere (mA) or time, must be available.(B) The technique factors (kVp and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) used during an exposure must be indicated before the exposure begins, except when AEC is used, in which case the technique factors that are set before the exposure must be indicated. (C) When the AEC mode is used, the system must indicate the actual kVp and mAs used during the exposure. The mAs may be displayed as mA and time.(9) Automatic exposure control. Each system must provide an AEC mode operable in all combinations of equipment configuration provided, for example, various image receptor sizes.(A) The positioning or selection of the detector must permit flexibility in the placement of the detector under the target tissue.(i) The size and available positions of the detector must be clearly indicated at the x-ray input surface of the breast compression paddle.(ii) The selected position of the detector must be clearly indicated.(B) The system must provide means to vary the selected optical density from the normal, or zero, setting.(10) Equipment variances. Facilities with mammography equipment with variances issued by the FDA as specified in 21 CFR §§1020.2, 1020.30, 1020.31, or have an alternative to a quality standard for equipment approved by the FDA as required by 21 CFR §900.18, must maintain copies of those variances or alternative standards.(11) Each mammography machine must meet the following technical specifications.(A) Kilovoltage peak accuracy and reproducibility. At the most used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp must be equal to or less than 0.02. The kVp must be accurate to within plus or minus 5.0 percent of the indicated or selected kVp at the following:(i) the lowest clinical kVp that can be measured by a kVp test device;(ii) the most used clinical kVp; and(iii) the highest available clinical kVp.(B) Beam quality and half-value layer (HVL). The HVL must meet the specifications of 21 CFR §1020.30(m)(1) for the minimum HVL. These values, extrapolated to the mammographic range, are shown as follows. This test is performed using the clinical kVp on the standard breast. Values not shown in Table I may be determined by linear interpolation or extrapolation.Attached Graphic(C) Breast entrance air kerma and AEC reproducibility. The coefficient of variation for both air kerma and mAs must not exceed 0.05.(D) Dosimetry. The average glandular dose delivered during a single view or DBT exposure of an FDA-accepted phantom simulating a standard breast must not exceed 3.0 milligray (mGy) (0.3 rad) per exposure.(E) X-ray field, light field, image receptor, and compression paddle alignment. All systems must meet the following.(i) Beam-limiting devices that allow the entire chest wall edge of the x-ray field to extend to the chest wall edge of the image receptor must provide means to ensure the x-ray field does not extend beyond any edge of the image receptor by more than 2.0 percent of the SID.(ii) The light field passing through the x-ray beam limitation device must be aligned with the x-ray field so the total of any misalignment of the edges, along the length or the width of the visually defined field at the plane of the breast support surface, does not exceed 2.0 percent of the SID.(iii) When tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness, the chest wall edge of the compression paddle does not extend beyond the edge of the image receptor by greater than 1.0 percent of the SID. The shadow of the vertical edge of the compression paddle must not be visible in the image.(12) Light fields. For any mammography system with a light beam that passes through the x-ray beam-limiting device, the light must provide an average illumination of not less than 160 lux (15 foot candles) at 100 cm or the maximum SID, whichever is less.(j) Medical records and mammography reports.(1) Contents and terminology. Each facility must prepare a written report of the results of each mammographic examination performed. (2) The mammographic examination presented for interpretation must be in the original mammographic modality in which it was performed and must not consist of digital images produced through copying or digitizing hardcopy original images.(3) The mammography report must include the:(A) patient name and an additional patient identifier;(B) examination date;(C) facility name and location, including the city, state, zip code, and telephone number of the facility;(D) name and signature of the IP who interpreted the mammogram (electronic signatures are acceptable);(E) overall final assessment of findings using the final assessment categories as defined in clauses (i) - (vii) of this subparagraph, and classified in one of the following categories with the assessment statement, including only the word or phrase within the quotation marks:(i) "Negative" indicates nothing to comment upon (if the IP is aware of clinical findings of symptoms, despite the negative assessment, these must be documented and addressed);(ii) "Benign" indicates a normal result, with benign findings present, but no evidence of malignancy (if the IP is aware of clinical findings or symptoms, despite the benign assessment, these must be documented and addressed);(iii) "Probably Benign" indicates a finding that has a high probability of being benign;(iv) "Suspicious" indicates a finding without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;(v) "Highly suggestive of malignancy" indicates a finding that has a high probability of being malignant;(vi) "Known biopsy proven malignancy" is reserved for known malignancies being mammographically evaluated for definitive therapy; or(vii) "Post procedure mammogram for marker placement" indicates a mammogram to confirm the deployment and position of a breast tissue marker; or(F) in cases where the final assessment category cannot be assigned due to incomplete work-up, the IP must assign one of the following classification statements and reasons why the final assessment cannot be made:(i) "Incomplete: Need additional imaging evaluation" is reserved for examinations where additional imaging needs to be performed before an assessment category identified in subparagraph (E)(i)-(vii) of this paragraph can be given; or(ii) "Incomplete: Need prior mammograms for comparison" is reserved for examinations where comparison with prior mammograms should be performed before an assessment category identified in subparagraph (E) of this paragraph can be given; if this assessment category is used, a follow-up report with an assessment category identified in subparagraph (E)(i)-(v) of this paragraph must be issued within 30 calendar days of the initial report whether or not comparison views can be obtained;(G) overall assessment of breast density, classified in one of the following categories:(i) "The breasts are almost entirely fatty";(ii) "There are scattered areas of fibroglandular density"; (iii) "The breasts are heterogeneously dense, which may obscure small masses"; or(iv) "The breasts are extremely dense, which lowers the sensitivity of mammography"; and(H) recommendations made to the healthcare provider about what additional actions, if any, should be taken. All clinical questions raised by the referring healthcare provider must be addressed in the report to the extent possible, even if the assessment is negative or benign.(4) Communication of mammography results to the patient and healthcare providers, as applicable.(A) Each facility must send a mammography report to referring healthcare providers, or patients who do not name a healthcare provider to receive the mammography report, the report described in subsection (j)(3) of this section within 30 days of the mammography examination. If the assessment of the mammography report is "Suspicious" or "Highly suggestive of malignancy," the facility must send this report within seven calendar days of the mammography examination.(B) Each facility must send a mammography report summary, written in plain language, to patients advising them of the results of the mammography examination and any further medical needs within 30 days of the mammography examination. If the assessment of the mammography report is "Suspicious" or "Highly suggestive of malignancy," the facility must send this report summary within seven calendar days of the final interpretation of the mammogram.(5) A summary of the report written in plain language must be provided within 30 days of interpretation and include:(A) patient name;(B) name, address, and telephone number of the facility performing the mammographic examination; and(C) assessment of breast density as described in subsection (j)(3)(G) of this section, as applicable.(i) If the mammography report identifies the patient's breast density as "The breasts are almost entirely fatty" or "There are scattered areas of fibroglandular density," the summary must include the statement, "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation."(ii) If the mammography report identifies the breast density as "The breasts are heterogeneously dense, which may obscure small masses" or "The breasts are extremely dense, which lowers the sensitivity of mammography," the summary must include the statement, "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation."(6) Follow-up with patients and healthcare provider. Each facility must follow-up to confirm if:(A) patients with positive findings and patients needing repeat examinations have received proper notification; and(B) healthcare providers have received proper notification of patients with positive findings or needing repeat examinations.(7) Retention of clinical images for a current, closed, or terminated facility.(A) A facility must implement policies and procedures to minimize the possibility of loss of these records. The original mammograms must be retained, in retrievable form in the mammographic modality in which they were produced, for a minimum of five years. Original mammograms cannot be produced by copying or digitizing hardcopy originals. If additional mammograms of the patient are not performed at the facility, the images and reports must be maintained for a minimum of 10 years as specified in subsection (x) of this section.(B) Each facility performing mammograms must, within 15 calendar days of request by or on behalf of the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, a physician, or to the patient directly.(i) Transferred mammograms must be in the mammographic modality in which they were produced and cannot be produced by copying or digitizing hardcopy originals.(ii) For digital mammograms or DBT, if the examination is being transferred for final interpretation purposes, the facility must be able to provide the recipient with original digital images electronically.(C) If the medical records are permanently forwarded, the receiving institution or physician must maintain and become responsible for the original images until the fifth or tenth anniversary, as specified in subparagraph (A) of this paragraph.(D) Any fee charged to a patient for providing the services in subparagraphs (B) - (C) of this paragraph must not exceed the documented costs associated with this service.(E) Closure or termination.(i) The facility must maintain the mammography images for five years.(ii) Within 180 days of closing, the facility must notify each patient or patient's representative with instructions on how to access or authorize disposal of the patient's records.(I) Access may be provided by the permanent transfer of mammographic records to the patient, the patient's healthcare provider, or a facility or other entity that will provide access to patients and healthcare providers. Access to the records must be provided by the facility or other entity for the remainder of the time periods specified in subparagraph (A) of this paragraph.(II) If a facility ceases to perform mammography but continues to operate as a medical entity and is able to satisfy the record keeping requirements of subparagraph (A) of this paragraph, it may choose to continue to retain the medical records rather than transfer them to another facility, unless a transfer is requested by, or on behalf of, the patient. The facility must notify the AB and department in writing of the arrangements it has made and must make reasonable efforts to notify all affected patients.(iii) Within 60 days of closing, the facility must publish a notice in at least one newspaper, or publicly available media, covering the geographical area served by the closing facility. The notice must include:(I) contact information for retrieving patient records; and(II) information that the records will be destroyed if not retrieved by the patient or the patient's representative within five years.(iv) If records have not been retrieved by the patient or the patient's representative during the five-year period after closing, the registrant may destroy the records.(8) Mammographic image identification. Each mammographic image must include the following information indicated on it in a permanent, legible manner and placed so it does not obscure anatomic structures:(A) patient name and date of birth;(B) date of examination;(C) view and laterality, placed on the image in a position near the axilla;(D) facility name and location, including city, state, and zip code;(E) MRT identification;(F) cassette identification, if applicable;(G) mammography machine identification, if there is more than one machine in the facility;(H) compressed breast thickness or degree of compression; and(I) kVp.(k) Quality assurance - general. Each facility must establish and maintain a written quality assurance program to ensure the safety, reliability, clarity, and accuracy of mammography services performed at the mammography facility, including corrective actions taken if images are of poor quality.(1) Responsible individuals. Responsibility for the QA program and each of its elements must be assigned to individuals who are qualified for their assignments and allowed adequate time to perform these duties.(A) Lead interpreting physician. The facility must identify a LIP who is responsible for:(i) ensuring the QA program meets all requirements of this subsection and subsections (l) and (m) of this section;(ii) reviewing and documenting, with date and signature, the MRTs' QC test results at least every three months or more frequently if consistency has not yet been achieved;(iii) reviewing and documenting, with date and signature, the physicists' results within 60 days of the receipt of the results or more frequently when needed; and(iv) assigning the individual and evaluating their qualifications to perform the QA tasks in subparagraphs (B) - (D) of this paragraph.(B) Interpreting physicians. All physicians interpreting mammograms for a facility must:(i) follow the facility's procedures for corrective action when the images they are asked to interpret are of poor quality; these procedures must be included in the facility's operating and safety procedures (OSP); and(ii) participate in the medical outcomes audit program.(C) Medical physicist. Each facility must use the services of a licensed medical physicist to survey mammography equipment and oversee the equipment-related QA practices of the facility. At a minimum, the medical physicist is responsible for performing the surveys, performing mammography equipment evaluations, and providing the facility with the reports described in subsection (l)(5) and (6) of this section.(D) Quality control technologist. The QC technologist, designated by the LIP, must ensure performance of the items designated in subsection (l)(1) - (4), (7), and (9) of this section. If other personnel are assigned the QA tasks in accordance with subparagraph (A)(iv) of this paragraph, the QC technologist must ensure the requirements of subsection (l)(1) - (4), (7), and (9) of this section are met.(2) Quality assurance records.(A) The LIP, QC technologist, and medical physicist must ensure records concerning mammography technique and procedures, QC (include monitoring data, corrective actions, and the effectiveness of the corrective actions), safety, protection, and employee qualifications related to assigned QA tasks are properly maintained and updated.(B) The QC records must be kept for each test specified in subsections (l) and (m) of this section, as specified in subsection (x) of this section.(l) Quality assurance - equipment.(1) Facilities with screen-film systems must perform QC tests as specified in 21 CFR Part 900.(2) Systems with image receptor modalities, other than screen-film, must follow a QA program that is substantially the same as the one recommended by the image receptor manufacturer.(3) Mobile service operation.(A) The mobile facility must verify mammography machines used to produce mammograms at more than one location meet the requirements in paragraphs (1) and (2) of this subsection.(B) At each examination location, before any examinations are conducted, the facility must verify satisfactory performance of the mammography machines by using a testing method, as required by the manufacturer, establishing the adequacy of the image quality produced by the machine.(C) Processor performance testing must be completed as required by 21 CFR Part 900.(4) Use of test results. After completion of the tests specified in paragraphs (1) and (2) of this subsection, the following must occur.(A) The facility must compare the test results to the manufacturer's recommended action limits.(B) If components of the mammography system fail QA tests, the facility must follow corrective actions required by 21 CFR Part 900, or the QA program recommended by the image receptor manufacturer.(C) Documentation of the tests and the corrective actions described in subparagraph (B) of this paragraph must be maintained as specified in subsection (x) of this section.(5) Surveys. Annually, not to exceed 14 months from the date of the previous survey, each mammography system must undergo a survey by a medical physicist, or an individual under the direct supervision of a medical physicist, as specified in paragraphs (1) - (3) of this subsection.(A) The medical physicist must provide a written survey report to the facility within 30 days of the date of the survey. The report must include a summary of the test performed, all test conditions, specifications, results, and recommendations for corrective actions.(B) If any deficiencies require immediate corrective action as specified in paragraphs (1) - (3) of this subsection, the physicist must give a preliminary written report to the facility within 72 hours of the survey.(C) The survey report must include the:(i) date, name, and signature of the medical physicist performing or supervising the survey;(ii) name and signature of each individual under the direct supervision of the medical physicist performing any part of the survey, as applicable;(iii) name of the facility;(iv) address of facility;(v) registration number of the facility;(vi) make, model, and serial number from the machine control panel;(vii) registration number of the service provider performing the survey;(viii) service provider email address;(ix) business mailing address of the service provider performing the survey; and(x) date of the last calibration of testing equipment.(D) The facility must maintain the survey report as specified in subsection (x) of this section.(6) Mammography equipment evaluations. Additional evaluations of mammography machines must follow manufacturer specifications. Screen-film mammography machines must follow applicable requirements in 21 CFR Part 900. The mammography equipment evaluation and dosimetry must be performed by a medical physicist or an individual under the direct supervision of a medical physicist.(7) Each diagnostic review workstation (RWS) used to interpret images must follow manufacturer specifications for display conditions and quality control. If the RWS manufacturer does not specify QC procedures, then a QA program that is substantially the same as the QA program recommended by the image receptor manufacturer must be established and followed.(8) Calibration of air kerma measuring instruments. Instruments used by medical physicists in their annual survey and mammography equipment evaluation to measure the air kerma or air kerma rate from a mammography machine must be calibrated at least once every two years and each time the instrument is repaired. The instrument calibration must be traceable to a national standard and calibrated with an accuracy of plus or minus six percent, or 95 percent confidence level, in the mammography energy range.(9) Infection control. Facilities must establish and comply with a system specifying procedures for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system must specify the methods for documenting facility compliance with the infection control procedures established and must:(A) comply with all applicable federal, state, and local regulations pertaining to infection control; and(B) comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or(C) if adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available.(m) Quality assurance - mammography medical outcomes audit. Each registrant must establish and maintain a mammography medical outcomes audit program to followup positive mammographic assessments and to correlate pathology results with the IP's findings. The program must be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms.(1) General requirements.(A) Each facility must establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the IP's mammography report.(B) For cases of breast cancer among patients imaged at the facility that become known to the facility, the facility must initiate a follow-up on surgical and pathology results and a review of the mammographic examinations taken before the diagnosis of a malignancy. (C) The outcome data must be made individually and collectively for all IPs at the facility and include determinations of the following.(i) Positive predictive value. The percent of patients with positive mammograms who are diagnosed with breast cancer within one year of the date of the mammographic examination.(ii) Cancer detection rate. Of the patients initially examined with screening mammograms who receive an assessment of "Incomplete: Need additional imaging evaluation," "Suspicious," or "Highly Suggestive of Malignancy" on the screening mammogram or on a subsequent diagnostic mammogram, the number of patients who are diagnosed with breast cancer within one year of the date of the initial screening mammogram, expressed as a ratio per 1,000 patients.(iii) Recall rate. The percentage of screening mammograms given an assessment of "Incomplete: Need additional imaging evaluation."(2) Frequency of audit analysis. The facility's first audit analysis must begin within 12 months of the facility becoming certified, and completed within the following 12 months to permit completion of diagnostic procedures and data collection.(A) Subsequent audit analyses will be conducted at least once every 12 months.(B) The facility must maintain the audit analysis as specified in subsection (x) of this section.(3) Reviewing interpreting physician. Each LIP or an interpreting physician designated by the LIP must review the medical outcomes audit data at least annually, not to exceed 12 months following the data collection period. This individual must analyze the results of the audit and is responsible for the following:(A) recording the dates of the audit period;(B) documenting the results;(C) notifying other IPs of their results and the facility's collective results;(D) documenting any follow up actions and the nature of the follow up; and(E) recording the audit completion by providing a signature and date on the audit.(n) Mammographic procedure and techniques for mammography of patients with breast implants. Each registrant must have a procedure to inquire if the patient has breast implants before the mammographic exam. Except where contraindicated, or unless modified by a physician's directions, patients with breast implants must have mammographic views to maximize the visualization of breast tissue.(o) Complaints. Each accredited facility must do the following:(1) establish a written procedure for collecting and resolving consumer complaints;(2) maintain a record of each serious complaint received by the facility as specified in subsection (x) of this section;(3) provide the consumer with adequate directions for filing serious complaints with the facility's AB if the facility is unable to resolve a serious complaint to the consumer's satisfaction; and(4) report unresolved serious complaints to the facility's AB within 30 days of receiving the complaint.(p) Clinical image quality. Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by the facility's AB.(q) Additional mammography review, targeted clinical reviews, and patient notification.(1) If the department believes the mammography quality at a facility is compromised and presents a serious risk to human health, the facility must provide clinical images and other relevant information, as specified by the department, for review by the AB. The additional mammography review will assist the department with determining:(A) the facility's compliance with this section; and(B) if there is a need to notify affected patients, their healthcare provider, or the public that the reliability, clarity, and accuracy of the interpretation of mammograms has been compromised.(2) If the department determines the mammography quality at a facility has been compromised and presents a serious risk to human health, the facility must provide clinical images and other relevant information, as specified by the department, for review by the AB. The department may require such facility to notify patients who received mammograms and their referring healthcare provider. The notification must occur within a time frame and in a manner specified by the department. The notification must:(A) inform the patient the mammography system failed to satisfy the department and AB's standards;(B) recommend the patient consult with the patient's healthcare provider regarding the need for another mammogram;(C) list three non-affiliated facilities closest to the original testing facility that have a certified mammography system; and(D) include the deficiencies presenting such risk, the potential consequences to the patient, appropriate remedial measures, and other relevant information required by the department.(3) If the facility is unable or unwilling to perform such notification, the department may notify patients and their referring physicians or other healthcare providers individually or through the mass media.(4) The department, the AB, or the FDA may request a targeted clinical image review.(r) Self-referral mammography. Any person proposing to conduct a self-referral mammography program must not initiate such a program without prior approval from the department. When requesting such approval, the person must submit the following information:(1) the number and type of views (or projections);(2) the age of the population to be examined and the frequency of the exam following established, nationally recognized criteria, such as those of the American Cancer Society, American College of Radiology (ACR), or the National Council on Radiation Protection and Measurements;(3) written procedures to include methods of:(A) advising a patient and healthcare provider of the results of the mammography examination as specified in subsection (j)(4) of this section;(B) follow-up with patients and healthcare provider as specified in subsection (j)(6) of this section; and(C) recommending a healthcare provider to patients who do not have a healthcare provider when clinically indicated, to include when a patient's mammogram assessment is probably benign, suspicious, or highly suggestive of malignancy; and(4) methods for educating mammography patients in breast self-examination techniques and on the necessity for follow-up by a physician.(s) Medical research and investigational devices.(1) Any research using radiation producing devices on humans must be approved by an IRB as required by 45 CFR Part 46 and 21 CFR Part 56. The IRB must include at least one licensed physician to direct any use of radiation as specified in §289.231(b) of this subchapter.(2) Facilities with mammography machines with investigational device exemptions involved in clinical studies must comply with primary regulations governing the conduct of clinical studies and that apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. These regulations include:(A) 21 CFR Part 50, Protection of Human Subjects;(B) 21 CFR Part 54, Financial Disclosure by Clinical Investigators;(C) 21 CFR Part 56, Institutional Review Boards;(D) 21 CFR Part 812, Investigational Device Exemptions; and(E) 21 CFR Part 820, Subpart C, Design Controls.(t) Operating and safety procedures (OSP).(1) Each facility must implement and maintain written OSP.(2) The OSP must be available to each individual operating x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular system.(3) The facility's OSP must address the following requirements, as applicable:(A) §289.203(b) of this chapter, related to posting notices to workers;(B) §289.203(c) of this chapter, related to instructions to workers;(C) §289.203(d) of this chapter, related to notifications and reports to individuals;(D) §289.231(b) of this subchapter, related to ordering x-ray examinations;(E) §289.231(m) of this subchapter, related to occupational dose requirements;(F) §289.231(n) and (q) of this subchapter, related to personnel monitoring requirements;(G) §289.231(x) and (y) of this subchapter, related to posting of a radiation area;(H) subsection (h) of this section, related to credentialing requirements for LIPs, IPs, MRTs, and medical physicists;(I) subsection (j)(7) of this section, related to retention of clinical images;(J) subsections (k) - (m) of this section, related to quality assurance program;(K) subsection (k)(1)(B)(i) of this section, related to image quality and corrective action for images of poor quality;(L) subsection (l)(1) - (3) of this section, related to repeat analysis;(M) subsection (n) of this section, related to procedures and techniques for mammography patients with breast implants;(N) subsection (o) of this section, related to the procedure to handle complaints;(O) subsection (r) of this section, related to self-referral mammography;(P) subsection (u)(2) of this section, related to the use of a technique chart;(Q) subsection (u)(5) of this section, related to exposure of individuals other than the patient;(R) subsection (u)(6) of this section, related to use of protective devices; and(S) subsection (u)(7) of this section, related to holding of patients or image receptors.(u) Other operating procedures.(1) Phantom image scoring protocol must be performed as specified in (l)(1) - (3).(2) Technique chart. A technique chart or manual must be provided and followed. It must be displayed in the vicinity of the control panel of each machine that specifies technique factors used for a patient's anatomical size.(3) Receipt, transfer, and disposal of mammography machines. Each registrant must maintain records showing the receipt, transfer, and disposal of mammographic machines. These records must include the date of receipt, transfer, and disposal; the name and signature of the person making the record; and the manufacturer's model name and serial number from the control panel of the mammographic machine. Records must be maintained as specified in subsection (x) of this section for inspection by the department.(4) Viewing system. Windows, mirrors, closed circuit television, or an equivalent system must be provided to permit the operator to continuously observe the patient during irradiation. The operator must be able to maintain verbal, visual, and aural contact with the patient.(5) Exposure of an individual other than the patient. Only the staff and ancillary personnel required for the medical procedure or training may be in the room during the radiation exposure unless such individual's assistance is required.(6) Protective devices. Protective devices must be utilized when required, as in paragraph (7) of this subsection.(A) Protective devices must be of no less than 0.25 millimeter (mm) lead equivalent material.(B) Protective devices, including aprons, gloves, and shields must be checked annually for defects such as holes, cracks, and tears. These checks may be performed by the registrant by visual or tactile means, or x-ray imaging. If a defect is found, protective devices must be replaced or removed from service until repaired. A record of this test must be made and maintained by the registrant as specified in subsection (x) of this section for inspection by the department.(7) Holding of patient or image receptor.(A) When a patient or image receptor must be held in position during radiography, mechanical supporting or restraining devices must be used when the exam permits.(B) If a patient or image receptor must be held by an individual during an exposure, the individual must be protected with appropriate shielding devices described in paragraph (6) of this subsection.(C) The facility's written OSP specified in subsection (t) of this section must include the following:(i) a list of circumstances in which mechanical holding devices cannot be routinely utilized; and(ii) a procedure used for selecting an individual to hold or support the patient or image receptor.(D) In those cases where the patient must hold the image receptor, any portion of the body other than the area of clinical interest struck by the useful beam must be protected by not less than 0.25 mm lead equivalent material.(8) Calibration, maintenance, and modifications. Each registrant must maintain records showing calibrations, maintenance, and modifications performed on each mammographic machine. These records must include the date of the calibration, maintenance, or modification performed; the name of the individual making the record; and the manufacture's model name and serial number of the control panel of the mammographic machine. These records must be maintained as specified in subsection (x) of this section.(v) Inspections. In addition to the requirements of §289.231(kk) of this subchapter, the following applies to inspections of mammography systems.(1) The department may inspect each mammography system that receives a certification as specified in this chapter no later than the 60th day after the date the certification is issued.(2) The department may inspect, at least once annually, each mammography system that receives a certification.(3) To protect the public health, the department may conduct more frequent inspections than required by this subsection.(4) The department may make reasonable attempts to coordinate inspections in this section with other inspections required as specified in this chapter for the facility where the mammography system is used.(5) After each satisfactory inspection, the department issues a certificate of inspection for each mammography system inspected. The certificate of inspection must be posted at a conspicuous place on or near the place where the mammography system is used. The certificate of inspection includes the:(A) specific identification of the mammography system inspected;(B) name and address of the facility where the mammography system was used at the time of the inspection; and(C) date of the inspection.(6) Any severity level I violation involving a mammography system, determined by the department, as specified in §289.205 of this chapter, constitutes grounds for posting notice of failure of the mammography system to satisfy department requirements.(A) Notification of such failure must be posted:(i) on the mammography machine at a conspicuous place if the violation is machine-related; or(ii) near the place where the mammography system practices if the violation is personnel-related; and(iii) in a sufficient number of places to permit the patient to observe the notice.(B) The notice of failure must remain posted until the facility is authorized to remove it by the department. A facility may post documentation of corrections of the violations submitted to the department along with the notice of failure until approval to remove the notice of failure is received from the department.(7) Facilities that receive a severity level I violation and are deemed a serious risk to human health must notify patients as specified in (q)(2) of this section.(8) In addition to the requirements of paragraph (7) of this subsection, the department may require a facility to notify a patient of any other failure of the facility's mammography system to meet the department's certification standards.(9) The patient notification must include the following:(A) an explanation of the mammography system failure to the patient; and(B) the potential consequences to the mammography patient. (10) The facility must make a record of the mammography patients notified as specified in paragraphs (7) and (8) of this subsection for inspection by the department.(A) The record must include the name and address of each mammography patient notified, date of notification, and a copy of the text sent to the individual.(B) The record must be maintained as specified in subsection (x) of this section.(w) Requirements for interventional breast radiography machines.(1) Interventional breast radiography machine certificate of registration (COR).(A) A person who receives, possesses, uses, owns, or acquires an interventional breast radiography machine must apply for a certificate of registration as specified in §289.226(e) of this subchapter, relating to general requirements for application and registration, and must receive a COR from the department before using an interventional breast radiography machine on humans.(B) An application for a COR must be signed by:(i) a licensed physician, and(ii) the RSO.(C) An application for a COR may contain information on multiple interventional breast radiography machines. Each machine must be identified by referring to the machine's manufacturer, model name, and serial number located on the control panel.(D) Each applicant must submit documentation of a survey performed by a medical physicist, as specified in paragraph (11) of this subsection.(2) Issuance of a certificate of registration.(A) A COR for interventional breast radiography machines will be issued if the department determines the application meets the requirements of the Act and this chapter. The COR authorizes the proposed operations and includes conditions and limitations the department deems necessary.(B) Conditions. The department may incorporate in the COR at the time of issuance, or by amendment, additional requirements and conditions for the facility's possession, use, and transfer of radiation machines necessary to:(i) minimize danger to occupational and public health and safety;(ii) require additional reports and maintain additional records as necessary; and(iii) prevent loss or theft of radiation machines subject to this section.(C) Additional information. The department may request additional information after the certification has been issued to enable the department to determine whether the certification should be modified as specified in §289.226(r) of this subchapter relating to renewal of a certificate of registration.(3) Modification, suspension, or revocation of the certificate of registration. Modification, suspension, or revocation of the COR must occur as specified in §289.226(s) of this subchapter. (4) Specific terms and conditions of the certificate of registration. Specific terms and conditions of the COR, as specified in §289.226 of this subchapter, must be followed.(5) Renewal of certification. The registrant must file an application for renewal of the COR as follows.(A) A person who receives, possesses, uses, owns, or acquires an interventional breast radiography machine must apply for renewal as specified in §289.226(e)(1) - (3), (5), and (7) of this subchapter.(B) An application for renewal must be signed by a licensed physician and the RSO.(C) An application for renewal must include a medical physicist's survey as specified in paragraph (11) of this subsection. (D) If a registrant files an application for renewal in proper form at least 30 days before the existing certification expires, the existing certification does not expire until the application status has been determined by the department.(6) Expiration of the certificate of registration.(A) COR of an interventional breast radiography machine expires at the end of the day in the month and year stated on the certificate. Expiration of the COR does not relieve the registrant of the requirements of this chapter.(B) If a registrant does not apply for renewal of the certification under paragraph (8) of this subsection, as applicable, the registrant must:(i) terminate use of all interventional breast radiography machines;(ii) pay any outstanding fees as specified in §289.204 of this chapter; and(iii) submit a record of the disposition of the interventional breast radiography machine to the department. If the machine was transferred, include to whom it was transferred.(7) Termination of certification. When a registrant decides to terminate all activities involving an interventional breast radiography machine authorized under the COR, the registrant must notify the department immediately and:(A) request termination of the COR in writing signed by the RSO, owner, or a person authorized to act on behalf of the registrant;(B) pay any outstanding fees as specified in §289.204 of this chapter; and(C) submit a record of the disposition of the interventional breast radiography machine to the department. If the machine was transferred, include to whom it was transferred.(8) Responsibilities of registrant.(A) In addition to the requirements of §289.226(m)(3) - (7) of this subchapter, a facility must notify the department in writing before any changes rendering the information in the application or the COR inaccurate, including the:(i) name and mailing address;(ii) street address where the interventional breast radiography machine will be used; and(iii) addition or removal of any interventional breast radiography machine.(B) If a facility makes a change in the RSO, the qualifications of the RSO must be submitted to the department within 30 days of such change.(C) A facility with an existing certification may begin using a new or replacement interventional breast radiography machine before receiving an updated certification if the registrant submits to the department the required documentation with a medical physicist's report as specified in paragraph (11) of this subsection, verifying compliance of the new interventional breast radiography machine with this section. The medical physicist's report is required before using the interventional breast radiography machine on patients.(D) Loaner interventional breast radiography machines may be used on patients for 60 days without adding the interventional breast radiography machine to the COR. A medical physicist's report verifying compliance of the loaner interventional breast radiography machine with this section must be completed before use on patients. If the use period exceeds 60 days, the facility must add the interventional breast radiography machine to its certification and a fee will be assessed.(9) Personnel requirements.(A) An operator must maintain a current general certificate as required by the Medical Radiologic Technologist Certification Act, Texas Occupations Code Chapter 601.(B) A medical physicist must maintain a current Texas license as required by the Medical Physics Practice Act, Texas Occupations Code Chapter 602, in diagnostic radiological physics and be registered with the department or employed by an entity registered with the department, as specified in §289.226(j) of this subchapter, relating to application for registration of radiation machine services, and the Act, unless exempted by §289.226(d)(7) of this subchapter, relating to exemptions. (10) Requirements to have a written quality assurance program. Requirements to have a written QA program as described by the manufacturer or the medical physicist to ensure the safety, reliability, clarity, and accuracy of services performed at the facility must comply with the following.(A) If any failures are noted, corrective actions must be taken within the time frame established by the manufacturer or medical physicist. If a time frame is not indicated, corrective action must be completed within 30 days of the failure.(B) If any component tested fails the dosimetry test, the corrective action must be taken before any further interventional breast radiography examinations are performed.(11) Interventional breast radiography machine evaluations and annual survey.(A) Interventional breast radiography machines are required to have a medical physicist perform a survey:(i) whenever a new interventional breast radiography machine is installed, or disassembled and reassembled, at the same or a new location;(ii) whenever major components of an interventional breast radiography machine are changed or repaired; and(iii) annually or at intervals not to exceed 14 months from the date of the previous survey.(B) Annual survey. Annual surveys for interventional mammography machines must be conducted as specified, or substantially the same as specified, in the machine's QA program recommended by the manufacturer.(C) The medical physicist must provide the facility with a preliminary written report of deficiencies within 72 hours of the survey if it involves dosimetry.(D) The medical physicist must prepare a written report for the facility within 30 days of the date of the survey. The survey report must include a summary of the tests performed, all test conditions, specifications, results, and recommendations for corrective actions and:(i) date, name, and signature of the medical physicist performing or supervising the survey;(ii) name and signature of each individual under the direct supervision of the medical physicist performing any part of the survey, as applicable;(iii) name of the facility;(iv) address of facility;(v) registration number of the facility;(vi) make, model, and serial number from the machine control panel;(vii) registration number of physicist and service company performing the survey;(viii) service provider email address;(ix) mailing or business address of the service provider performing the survey; and(x) date of the last calibration of testing equipment.(12) Operating and safety procedures (OSP). Each facility must have and implement written OSP that must be made available to each individual operating the x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular system. These procedures must address the following requirements: (A) §289.203(b) of this chapter, related to posting notices to workers;(B) §289.203(c) of this chapter, related to instructions to workers;(C) §289.203(d) of this chapter, related to notifications and reports to individuals;(D) §289.231(b) of this subchapter, related to ordering x-ray examinations;(E) §289.231(m) of this subchapter, related to occupational dose requirements;(F) §289.231(n) and (q) of this subchapter, related to personnel monitoring requirements;(G) paragraph (9) of this subsection, related to credentialing requirements for operators and medical physicists;(H) paragraph (19) of this subsection, related to use of a technique chart;(I) paragraph (16) of this subsection, related to exposure of individuals other than the patient; and(J) subsection (u)(7) of this section, related to holding of patients or image receptors.(13) Receipt, transfer, and disposal of interventional breast radiography machines. Each facility must maintain records showing the receipt, transfer, and disposal of interventional breast radiography machines. These records must be maintained as specified in subsection (x) of this section for inspection by the department and include the:(A) date of receipt, transfer, or disposal;(B) name and signature of the individual making the record; and(C) manufacturer's model name and serial number on the control panel.(14) Calibration, maintenance, and modifications. Each facility must maintain records showing calibrations, maintenance, and modifications performed on each interventional breast radiography machine. These records must be maintained as specified in subsection (x) of this section for inspection by the department and include the:(A) date of the calibration, maintenance, or modification performed;(B) name of the individual making the record; and(C) manufacturer's model name and serial number on the control panel.(15) Viewing system. Windows, mirrors, closed circuit television, or an equivalent system must be provided to permit the operator to continuously observe the patient during irradiation. The operator must maintain verbal, visual, and aural contact with the patient.(16) Exposure of individuals other than the patient. Only the staff and ancillary personnel required for the medical procedure or training are allowed in the room during the radiation exposure unless such individual's assistance is required.(17) Inspection requirements. Inspections of interventional breast radiography machines are specified in subsection (v)(2) - (4) of this section.(18) Equipment requirements. Interventional breast radiography machines must meet the equipment requirements specified in §289.227(h) of this subchapter, relating to certified x-ray systems.(19) Technique chart. A chart or manual must be provided or electronically displayed in the vicinity of the control panel of each interventional breast radiography machine that specifies technique factors used for a patient's anatomical size. The technique chart must be used by all operators.(x) Record requirements. Records specified in this section must be maintained for inspection by the department as specified in paragraph (3) of this subsection. Records may be maintained electronically as specified in §289.231(ff)(3) of this subchapter.(1) Records for mammography machines authorized for mobile service operations.(A) Copies of the following must be kept with mammography machines authorized for mobile services:(i) OSP as specified in subsection (t)(1) of this section; (ii) operator's credentials;(iii) current quality control records for at least the last 90 calendar days for on-board processors as specified in subsection (l)(1) of this section;(iv) current copies of §289.203, §289.226, §289.230, and §289.231 of this chapter;(v) copy of certification;(vi) certification of inspection as specified in subsection (v)(5) of this section;(vii) notice of failure from last inspection as specified in subsection (v)(6) of this section, if applicable; and(viii) copy of mammography accreditation.(B) Copies of all other records specified in this section must be maintained at a specified location.(2) Records required at separate authorized use locations. Copies of the following must be kept at each separate authorized use location:(A) credentialing, continuing education, and continuing experience records for IPs, MRTs, and medical physicists operating at the location specified in subsection (h) of this section;(B) mandatory training records for IPs and medical physicists operating at the location specified in subsection (h) of this section, if applicable;(C) current physicist annual survey of the mammography system;(D) current copies of §289.203, §289.226, §289.230, and §289.231 of this chapter;(E) copy of certification;(F) QA program as specified in subsections (k), (l), and (m) of this section;(G) quality control records as specified in subsection (k)(2) of this section;(H) OSP as specified in subsection (t)(1) of this section; (I) records of receipts, transfers, and disposal as specified in subsection (u)(3) of this section;(J) calibration, maintenance, and modification records as specified in subsection (t)(8) of this section;(K) certification of inspection as specified in subsection (v)(5) of this section;(L) notification of failure as specified in subsection (v)(6), if applicable;(M) records of notification of patients as specified in subsection (v)(10) this section; and(N) copy of mammography accreditation.(3) Retention requirements for record keeping. Time requirements for record keeping must be according to the following chart.Attached Graphic Source Note: The provisions of this §289.230 adopted to be effective April 1, 2007, 31 TexReg 9455; amended to be effective April 29, 2012, 37 TexReg 2874; amended to be effective June 8, 2025, 50 TexReg 3459. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.230 Certification of Mammography Systems and X-Ray Machines Used for Interventional Breast Radiography https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154251&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154251 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154251&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154251 03/11/2026 (a) Purpose. (1) This section establishes standards for protection against ionizing radiation resulting from the use of radiation machines. (2) The requirements in this section are designed to control the receipt, possession, use, and transfer of radiation machines by any person so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this section. However, nothing in this section shall be construed as limiting actions that may be necessary to protect health and safety in an emergency. A person who receives, possesses, uses, owns, or acquires radiation machines prior to receiving a certificate of registration is subject to the requirements of this chapter. (b) Scope. (1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer radiation machines. The dose limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with this chapter, or to voluntary participation in medical research programs. However, no radiation may be deliberately applied to human beings except by or under the supervision of an individual authorized by and licensed in accordance with Texas' statutes to engage in the healing arts. (2) Registrants who are also licensed by the agency to receive, possess, use, and transfer radioactive materials must also comply with the requirements of §289.201 of this title (relating to General Provisions for Radioactive Material) and §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Material). (c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise. (1) Absorbed dose--The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad. (2) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401. (3) Adult--An individual 18 or more years of age. (4) Agency--The Department of State Health Services. (5) Agreement State--Any state with which the United States Nuclear Regulatory Commission (NRC) has entered into an effective agreement under §274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689). (6) As low as is reasonably achievable (ALARA)--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in this chapter as is practical, consistent with the purpose for which the registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of ionizing radiation and radiation machines in the public interest. (7) Background radiation--Radiation from cosmic sources; non-technologically enhanced naturally occurring radioactive material, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents, such as Chernobyl, that contribute to background radiation and are not under the control of the registrant. "Background radiation" does not include radiation from sources of radiation regulated by the agency. (8) Certificate of registration--A form of permission given by the agency to an applicant who has met the requirements for registration or mammography system certification set out in the Texas Radiation Control Act (Act) and this chapter. (9) Certification of mammography systems (state certification)--A form of permission given by the agency to an applicant who has met the requirements for mammography system certification set out in the Act and this chapter. (10) Chiropractor--An individual licensed by the Texas Board of Chiropractic Examiners. (11) Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation. (12) Declared pregnant woman--A woman who has voluntarily informed the registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman voluntarily withdraws the declaration in writing or is no longer pregnant. (13) Deep dose equivalent (DDE), that applies to external whole body exposure--The dose equivalent (DE) at a tissue depth of 1 centimeter (cm) (1,000 milligrams per square centimeter (mg/cm 2 )). (14) Dentist--An individual licensed by the Texas State Board of Dental Examiners. (15) Dose--For external exposure to x-ray radiation from radiation machines, a generic term that means absorbed dose, DE, or total effective dose equivalent. For purposes of this chapter, "radiation dose" is an equivalent term. (16) Dose equivalent (DE)--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of DE are the sievert (Sv) and rem. (17) Dose limits--The permissible upper bounds of radiation doses established in accordance with this chapter. For purposes of this chapter, "limits" is an equivalent term. (18) Dosimetry processor--A person that processes and evaluates personnel monitoring devices in order to determine the radiation dose delivered to the monitoring devices. (19) Embryo/fetus--The developing human organism from conception until the time of birth. (20) Entrance or access point--Any opening through which an individual or extremity of an individual could gain access to radiation areas or to radiation machines. This includes portals of sufficient size to permit human access, irrespective of their intended use. (21) Exposure--The quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The International System of Units (SI) unit of exposure is the coulomb per kilogram (C/kg). The roentgen is the special unit of exposure. For purposes of this chapter, this term is used as a noun. (22) Exposure rate (air kerma rate)--The exposure per unit of time. (23) External dose--That portion of the DE received from any source of radiation outside the body. (24) Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the knee. The arm above the elbow and the leg above the knee are considered part of the whole body. (25) Gray (Gy)--The SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (J/kg) or 100 rad. (26) High radiation area--An area, accessible to individuals, in which radiation levels from sources of radiation external to the body could result in an individual receiving a DE in excess of 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm from any source of radiation or from any surface that the radiation penetrates. (27) Human use--For exposure to x-ray radiation from radiation machines, the external administration of radiation to human beings for healing arts purposes or research and/or development specifically authorized by the agency. (28) Individual--Any human being. (29) Individual monitoring--The assessment of DE to an individual by the use of: (A) individual monitoring devices; or (B) survey data. (30) Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of DE. For purposes of this chapter, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices include, but are not limited to, film badges, thermoluminescence dosimeters (TLDs), optically stimulated luminescence dosimeters (OSLs), pocket ionization chambers (pocket dosimeters), and electronic personal dosimeters. (31) Inspection--An official examination and/or observation including, but not limited to, records, tests, surveys, and monitoring to determine compliance with the Act and rules, orders, requirements, and conditions of the agency. (32) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles. (33) Lens dose equivalent (LDE)--The external DE to the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm2 ). (34) License--A form of permission given by the agency to an applicant who has met the requirements for licensing set out in the Act and this chapter. (35) Licensed material--Radioactive material received, possessed, used, or transferred under a general or specific license issued by the agency. (36) Licensee--Any person who is licensed by the agency in accordance with the Act and this chapter. (37) Licensing state--Any state with rules equivalent to the Suggested State Regulations for Control of Radiation relating to, and having an effective program for, the regulatory control of naturally occurring or accelerator-produced radioactive material (NARM) and has been designated as such by the Conference of Radiation Control Program Directors, Inc. (38) Lost or missing radiation machine(s)--A radiation machine(s) whose location is unknown. (39) Machine-produced radiation--A stimulated emission of radiation from a manufactured product or device or component part of a manufactured product or device that has an electronic circuit that during operation can generate or emit a physical field of radiation. (40) Manufacture--To fabricate or mechanically produce. (41) Member of the public--Any individual, except when that individual is receiving an occupational dose. (42) Minimal threat radiation machines--Those radiation machines capable of generating or emitting fields of radiation that, during the operation of which: (A) no deliberate exposure of an individual occurs; (B) the radiation is not emitted in an open beam configuration; and (C) no physical injury to an individual has occurred and is known by the agency. (43) Minor--An individual less than 18 years of age. (44) Monitoring--The measurement of radiation and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this chapter, "radiation monitoring" and "radiation protection monitoring" are equivalent terms. (45) Occupational dose--The dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to sources of radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this chapter, from voluntary participation in medical research programs, or as a member of the public. (46) Particle accelerator--Any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and designed to discharge the resultant particulate or other associated radiation at energies usually in excess of 1 MeV. (47) Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing, other than the NRC, and other than federal government agencies licensed or exempted by the NRC. (48) Personnel monitoring equipment--(See definition for individual monitoring devices.) (49) Physician--An individual licensed by the Texas Medical Board. (50) Podiatrist--An individual licensed by the Texas State Board of Podiatric Medical Examiners. (51) Public dose--The dose received by a member of the public from exposure to sources of radiation released by a licensee, or to any other source of radiation under the control of a licensee/registrant. It does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this chapter, or from voluntary participation in medical research programs. (52) Quarter--A period of time equal to one-fourth of the year observed by the registrant, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters. (53) Rad--The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01 gray). (54) Radiation--One or more of the following: (A) gamma and x-ray; alpha and beta particles and other atomic or nuclear particles or rays; (B) radiation emitted to energy density levels that could reasonably cause bodily harm from an electronic device; or (C) sonic, ultrasonic, or infrasonic waves from any electronic device or resulting from the operation of an electronic circuit in an electronic device in the energy range to reasonably cause detectable bodily harm. (55) Radiation area--Any area, accessible to individuals, in which radiation levels could result in an individual receiving a DE in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 cm from the radiation machine or from any surface that the radiation penetrates. (56) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation. (57) Radiation safety officer (RSO)--An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who must be specifically authorized on a certificate of registration, and who is the primary contact with the agency. (58) Registrant--Any person issued a certificate of registration by the agency in accordance with the Act and this chapter. (59) Regulation (See definition for rule.) (60) Rem--The special unit of any of the quantities expressed as DE. The DE in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 sievert (Sv)). (61) Remote inspection--An examination by the agency of information submitted by the registrant on a form provided by the agency. (62) Research and development--Research and development is defined as: (A) theoretical analysis, exploration, or experimentation; or (B) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. (63) Restricted area--An area, access to which is limited by the registrant for the purpose of protecting individuals against undue risks from exposure to radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area. (64) Roentgen (R)--The special unit of exposure. One roentgen (R) equals 2.58 x 10-4 C/kg of air. (See definition for exposure.) (65) Rule (as defined in the Government Code, Chapters 2001 and 2002, as amended)--Any agency statement of general applicability that implements, interprets, or prescribes law or policy, or describes the procedure or practice requirements of an agency. The term includes the amendment or repeal of a prior section but does not include statements concerning only the internal management or organization of any agency and not affecting private rights or procedures. The word "rule" was formerly referred to as "regulation." (66) Shallow dose equivalent (Hs ) (that applies to the external exposure of the skin of the whole body or the skin of an extremity)--The dose equivalent at a tissue depth of 0.007 cm (7 mg/cm2 ). For purposes of this chapter, the acronym SDE has the same meaning as the term shallow dose equivalent. (67) SI--The abbreviation for the International System of Units. (68) Sievert (Sv)--The SI unit of any of the quantities expressed as DE. The DE in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem). (69) Site boundary--That line beyond which the land or property is not owned, leased, or otherwise controlled by the registrant. (70) Source of radiation--Any radioactive material, or any device or equipment emitting or capable of producing radiation. (71) Special units--The conventional units historically used by registrants, for example, rad (absorbed dose), and rem (DE). (72) Survey--An evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, disposal, and/or presence of sources of radiation. When appropriate, such survey includes, but is not limited to, tests, physical examination of location of equipment, measurements of levels of radiation present, and evaluation of administrative and/or engineered controls. (73) Termination--A release by the agency of the obligations and authorizations of the registrant under the terms of the certificate of registration. It does not relieve a person of duties and responsibilities imposed by law. (74) Texas Regulations for Control of Radiation (TRCR)--All sections of Title 25 Texas Administrative Code (TAC), Chapter 289. (75) Total effective dose equivalent (TEDE)--For external exposures only to x-ray radiation from radiation machines, the TEDE is equal to the DDE. If an individual receives an occupational dose from both radiation machines and radioactive materials, the TEDE is the sum of the DDE for external exposures and the committed effective dose equivalent for internal exposures as defined in §289.201(b) of this title. (76) Unrestricted area (uncontrolled area)--An area, access to which is neither limited nor controlled by the registrant. For purposes of this chapter, "uncontrolled area" is an equivalent term. (77) Very high radiation area--An area, accessible to individuals, in which radiation levels from sources of radiation external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter (m) from a radiation machine or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of DE, Sv and rem. (78) Veterinarian--An individual licensed by the Texas Board of Veterinary Medical Examiners. (79) Week--Seven consecutive days starting on Sunday. (80) Whole body--For purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee. (81) Worker--An individual engaged in work under a certificate of registration issued by the agency and controlled by a registrant, but does not include the registrant. (82) Year--The period of time beginning in January used to determine compliance with the provisions of this chapter. The registrant may change the starting date of the year used to determine compliance by the registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years. (d) Exemptions. The agency may, upon application therefore or upon its own initiative, exempt a source of radiation or a kind of use or user from the requirements of this chapter if the agency determines that the exemption is not prohibited by law and will not result in a significant risk to public health and safety and the environment. In determining such exemptions, the agency will consider: (1) state of technology; (2) economic considerations in relation to benefits to the public health and safety; and (3) other societal, socioeconomic, or public health and safety considerations. (e) Prohibited uses. (1) A hand-held fluoroscopic screen shall not be used unless accepted for certification by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health. (2) A shoe-fitting fluoroscopic device shall not be used. (f) Additional requirements. The agency may, by rule, order, or condition of certificate of registration, impose upon any registrant such requirements in addition to those established in this chapter as it deems appropriate or necessary to minimize danger to public health and safety or property or the environment. (g) Violations. A court injunction or agency order may be issued prohibiting any violation of any provision of the Act or any rule or order issued thereunder. Any person who willfully violates any provision of the Act or any rule or order issued thereunder may be subject to civil and/or administrative penalties. Such person may also be guilty of a misdemeanor and upon conviction, may be punished by fine or imprisonment or both, as provided by law. (h) Impounding. Radiation machines shall be subject to impounding in accordance with §401.068 of the Act and §289.205 of this title (relating to Hearing and Enforcement Procedures). (i) Communications. (1) Except where otherwise specified, all communications and reports concerning this chapter and applications filed under them should be addressed to the Radiation Control Program, Department of State Health Services, P.O. Box 149347, Mail Code 1987, Austin, Texas, 78714-9347. Communications, reports, and applications may be delivered in person to the agency's office located at 8407 Wall Street, Austin, Texas. (2) Documents transmitted to the agency will be deemed submitted on the date of the postmark, telegram, telefacsimile, or electronic media transmission. (j) Interpretations. Except as specifically authorized by the agency in writing, no interpretation of the meaning of this chapter by any officer or employee of the agency other than a written legal interpretation by the agency, will be considered binding upon the agency. (k) Mean quality factors and absorbed dose equivalencies. (1) As used in this chapter, the quality factors for converting absorbed dose to DE are shown in the following table: Attached Graphic(2) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in paragraph (1) of this subsection, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of this section, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit DE or the appropriate Q value from the following table to convert a measured tissue dose in rad (gray) to DE in rem (Sv). Attached Graphic(l) As low as reasonably achievable (ALARA). The registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are ALARA.(m) Occupational dose limits. (1) The registrant shall control the occupational dose to individuals to the following dose limits. (A) An annual limit shall be the TEDE being equal to 5 rems (0.05 Sv). (B) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities shall be: (i) an LDE of 15 rems (0.15 Sv); and (ii) an SDE of 50 rems (0.5 Sv) to the skin of the whole body, or to the skin of any extremity. (C) The annual limits for a minor shall be 10% of the annual occupational dose limits specified in subparagraphs (A) and (B) of this paragraph. (D) If a woman declares her pregnancy, the registrant shall ensure that the DE to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). If a woman chooses not to declare pregnancy, the occupational dose limits specified in paragraph (1)(A) and (B) of this subsection are applicable to the woman. (i) The registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate (air kerma rate) to a declared pregnant woman so as to satisfy the limit in paragraph (1) of this subsection. The National Council on Radiation Protection and Measurements recommended in NCRP Report No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June 1, 1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received in any 1 month. (ii) If by the time the woman declares pregnancy to the registrant, the DE to the embryo/fetus has exceeded 0.45 rem (4.5 mSv), the registrant shall be deemed to be in compliance with paragraph (1) of this subsection, if the additional DE to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy. (iii) The DE to an embryo/fetus shall be taken as the DE that is most representative of the DE to the embryo/fetus from external radiation, that is, in the mother's lower torso region. (iv) If multiple measurements have been made, assignment of the DDE for the declared pregnant woman from the individual monitoring device that is most representative of the DE to the embryo/fetus shall be the DE to the embryo/fetus. Assignment of the highest DDE for the declared pregnant woman to the embryo/fetus is not required unless that dose is also the most representative DDE for the region of the embryo/fetus. (v) If multiple measurements have not been made, assignment of the highest DDE for the declared pregnant woman shall be the DE to the embryo/fetus. (2) The assigned DDE shall be for the portion of the body receiving the highest exposure. The assigned SDE shall be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. (3) When a protective apron is worn while working with fluoroscopic equipment used for clinical diagnostic or research purposes, the effective dose equivalent (EDE) for external radiation shall be determined as follows. (A) When only 1 individual monitoring device is used and it is located at the neck (collar) outside the protective apron, the reported DDE shall be the EDE for external radiation; or (B) When only 1 individual monitoring device is used and it is located at the neck (collar) outside the protective apron, and the reported dose exceeds 25% of the limit specified in paragraph (1) of this subsection, the reported DDE value multiplied by 0.3 shall be the EDE for external radiation; or (C) When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck (collar), the EDE for external radiation shall be assigned the value of the sum of the DDE reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the DDE reported for the individual monitoring device located at the neck (collar) outside the protective apron multiplied by 0.04. (4) The EDE determined by paragraph (3) of this subsection shall be recorded as part of an individual's dose record and will contribute to that individual's annual TEDE. (5) The DDE, LDE, and SDE may be assessed from surveys or radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable. (6) The registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received from radiation machines or radioactive materials while employed by any other person. See subsection (r)(4) of this section. (n) Conditions requiring individual monitoring of occupational dose. (1) Each registrant shall monitor exposures from radiation machines at levels sufficient to demonstrate compliance with the occupational dose limits of this section. As a minimum, each registrant shall monitor occupational exposure to radiation from radiation machines and shall supply and require the use of individual monitoring devices by: (A) adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the limits in subsection (m)(1) of this section; (B) minors likely to receive, in 1 year from sources of radiation external to the body, a DDE in excess of 0.1 rem (1 mSv), an LDE in excess of 0.15 rem (1.5 mSv), or an SDE to the skin or to the extremities in excess of 0.5 rem (5 mSv); (C) declared pregnant women likely to receive during the entire pregnancy, from sources of radiation external to the body, a DDE in excess of 0.1 rem (1 mSv); and (D) individuals entering a high or very high radiation area. (2) Notwithstanding the requirements of paragraph (1)(A) of this subsection, no personnel monitoring shall be required for personnel operating only minimal threat radiation machines as specified in subsection (ll)(3) of this section. (o) Dose limits for individual members of the public. (1) Each registrant shall conduct operations so that: (A) the TEDE to individual members of the public from exposure to radiation from radiation machines does not exceed 0.5 rem (5 mSv) in a year, exclusive of the dose contribution from background radiation, exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs; and (B) the dose in any unrestricted area from registered external sources does not exceed 0.002 rem (0.02 mSv) in any 1 hour. (2) If the registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals. (3) The agency may impose additional restrictions on radiation levels in unrestricted areas in order to restrict the collective dose. (4) The registrant shall ensure that in facilities utilizing both radiation producing machines and radioactive materials, the TEDE to an individual member of the public shall not exceed 0.1 rem (1 mSv) in 1 year. (p) Compliance with dose limits for individual members of the public. (1) The registrant shall make or cause to be made surveys of radiation levels in unrestricted areas to demonstrate compliance with the dose limits for individual members of the public as required in subsection (o) of this section. (2) A registrant shall show compliance with the annual dose limit in subsection (o) of this section by demonstrating by measurement or calculation that the TEDE to the individual likely to receive the highest dose from the registered operation does not exceed the annual dose limit. (3) Registrants exempt from individual monitoring requirements in accordance with subsection (n)(2) of this section are exempt from the requirements of paragraphs (1) and (2) of this subsection. (q) Location and use of individual monitoring devices. (1) Each registrant shall ensure that individuals who are required to monitor occupational doses in accordance with subsection (n)(l) of this section wear and use individual monitoring devices as follows. (A) An individual monitoring device shall be assigned to and worn by only one individual. (B) An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar). (C) If an additional individual monitoring device is used for monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance with subsection (n)(1)(C) of this section, it shall be located at the waist under any protective apron being worn by the woman. (D) An individual monitoring device used for monitoring the LDE, to demonstrate compliance with subsection (m)(1)(B)(i) of this section, shall be located at the neck (collar) or at a location closer to the eye, outside any protective apron being worn by the monitored individual. (E) An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with subsection (m)(1)(B)(ii) of this section, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device, to the extent practicable, shall be oriented to measure the highest dose to the extremity being monitored. (2) Each registrant shall ensure that individual monitoring devices are returned to the dosimetry processor for proper processing. (3) Each registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device. (r) Determination of occupational dose for the current year. (1) For each individual who is likely to receive, in a year, an occupational dose requiring monitoring in accordance with subsection (n) of this section, the registrant shall determine the occupational radiation dose received during the current year. Occupational dose includes doses received from exposure to registered/licensed or unregistered/unlicensed sources of radiation as defined in subsection (c) of this section. (2) In complying with the requirements of paragraph (1) of this subsection, a registrant may: (A) accept, as a record of the occupational dose that the individual received during the current year, RC Form 231-3 from prior or other current employers, or other clear and legible record, of all information required on that form and indicating any periods of time for which data are not available; or (B) accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's prior or other current employer(s) for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; or (C) obtain reports of the individual's DE from prior or other current employer(s) for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the registrant, by telephone, telegram, facsimile, or letter. The registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established. (3) The registrant shall record the exposure data for the current year, as required by paragraph (1) of this subsection, on RC Form 231-3, or other clear and legible record, of all the information required on RC Form 231-3. (4) If the registrant is unable to obtain a complete record of an individual's current occupational dose while employed by any other registrant or licensee, the registrant shall assume in establishing administrative controls in accordance with subsection (m)(6) of this section for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 millisieverts (mSv)) for each quarter; or 416 millirems (mrem) (4.16 mSv) for each month for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure. (5) If an individual has incomplete (for example, a lost or damaged personnel monitoring device) current occupational dose data for the current year and that individual is employed solely by the registrant during the current year, the registrant shall: (A) assume that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each quarter; (B) assume that the allowable dose limit for the individual is reduced by 416 mrem (4.16 mSv) for each month; or (C) assess an occupational dose for the individual during the period of missing data using surveys, radiation measurements, or other comparable data for the purpose of demonstrating compliance with the occupational dose limits. (6) Administrative controls established in accordance with paragraph (4) of this subsection shall be documented and maintained for inspection by the agency. Occupational dose assessments made in accordance with paragraph (5) of this subsection and records of data used to make the assessment shall be maintained for inspection by the agency. The registrant shall retain the records in accordance with subsection (ll)(6) of this section. (s) General surveys and monitoring. (1) Each registrant shall make, or cause to be made, surveys that: (A) are necessary for the registrant to comply with this section; and (B) are necessary under the circumstances to evaluate: (i) the magnitude and extent of radiation levels; and (ii) the potential radiological hazards. (2) The registrant shall ensure that instruments and equipment used for qualitative and quantitative radiation measurements, for example, dose rate, are operable and calibrated: (A) by a person licensed or registered by the agency, another agreement state, a licensing state, or the NRC to perform such service; (B) at intervals not to exceed 12 months unless a different time interval is specified in another section of this chapter; (C) after each instrument or equipment repair; (D) for the types of radiation used and at energies appropriate for use; and (E) at an accuracy within 20% of the true radiation level. (3) All individual monitoring devices, except for direct and indirect reading pocket dosimeters, electronic personal dosimeters, and those individual monitoring devices used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by registrants to comply with subsection (m) of this section, with other applicable provisions of this chapter, shall be processed and evaluated by a dosimetry processor: (A) holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and (B) approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored. (t) Control of access to high radiation areas. (1) The registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features: (A) a control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a DDE of 0.1 rem (1 mSv) in one hour at 30 cm from the source of radiation from any surface that the radiation penetrates; (B) a control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or (C) entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry. (2) In place of the controls required by paragraph (1) of this subsection for a high radiation area, the registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry. (3) The registrant may apply to the agency for approval of alternative methods for controlling access to high radiation areas. (4) The registrant shall establish the controls required by paragraphs (1) and (3) of this subsection in a way that does not prevent individuals from leaving a high radiation area. (5) The registrant is not required to control entrance or access to rooms or other areas containing radiation machines capable of producing a high radiation area as described in this subsection if the registrant has met all the specific requirements for access and control specified in other applicable sections of this chapter, such as §289.227 of this title (relating to Use of Radiation Machines in the Healing Arts), §289.229 of this title (relating to Radiation Safety for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices), and §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography). (u) Control of access to very high radiation areas. (1) In addition to the requirements in subsection (t) of this section, the registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 grays) or more in 1 hour at 1 m from a radiation machine or any surface through which the radiation penetrates at this level. (2) The registrant is not required to control entrance or access to rooms or other areas containing radiation machines capable of producing a very high radiation area as described in paragraph (1) of this subsection if the registrant has met all the specific requirements for access and control specified in other applicable sections of this chapter, such as §289.227 of this title, §289.229 of this title, and §289.255 of this title. (3) The entry control devices required by paragraphs (1) and (2) of this subsection shall be established in such a way that no individual will be prevented from leaving the area. (v) Security and control of radiation machines. (1) The registrant shall secure radiation machines from unauthorized removal. (2) The registrant shall use devices and/or administrative procedures to prevent unauthorized use of radiation machines. (w) Caution signs. Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors magenta, or purple, or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows: Attached Graphic(1) the cross-hatched area of the symbol is to be magenta, purple, or black; and (2) the background of the symbol is to be yellow. (x) Posting requirements. (1) The registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA." (2) The registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA." (3) The registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA." If the very high radiation area involves medical treatment of patients, the registrant may omit the word "GRAVE" from the sign or signs. (y) Exceptions to posting requirements. A registrant is not required to post caution signs in areas or rooms containing radiation machines for periods of less than 8 hours, if each of the following conditions is met: (1) the radiation machines are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation in excess of the limits established in this section; and (2) the area or room is subject to the registrant's control. (z) Labeling radiation machines. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit. (aa) Open records. (1) Subject to the limitations provided in the Texas Public Information Act, Government Code, Chapter 552, all information and data collected, assembled, or maintained by the agency are public records open to inspection and copying during regular office hours. (2) Any person who submits written information or data to the agency and requests that the information be considered confidential, privileged, or otherwise not available to the public under the Texas Public Information Act, shall justify such request in writing, including statutes and cases where applicable, addressed to the agency. (A) Documents containing information that is claimed to fall within an exception to the Texas Public Information Act shall be marked to indicate that fact. Markings shall be placed on the document on origination or submission. (i) The words "NOT AN OPEN RECORD" shall be placed conspicuously at the top and bottom of each page containing information claimed to fall within one of the exceptions. (ii) The following wording shall be placed at the bottom of the front cover and title page, or first page of text if there is no front cover or title page: Attached Graphic(B) The agency requests, whenever possible, that all information submitted under the claim of an exception to the Texas Public Information Act be extracted from the main body of the application and submitted as a separate annex or appendix to the application. (C) Failure to comply with any of the procedures described in subparagraphs (A) and (B) of this paragraph may result in all information in the agency file being disclosed upon an open records request. (3) The agency will determine whether information falls within one of the exceptions to the Texas Public Information Act. The agency will determine whether or not there has been a previous determination that the information falls within one of the exceptions to the Texas Public Information Act. If there has been no previous determination and the agency believes that the information falls within one of the exceptions, an opinion of the Attorney General will be requested. If the agency agrees in writing to the request, the information shall not be open for public inspection unless the Attorney General's office subsequently determines that it does not fall within an exception. (4) Requests for information. (A) All requests for open records information must be in writing and refer to documents currently in possession of the agency. (B) The agency will ascertain whether the information may be released or whether it falls within an exception to the Texas Public Information Act. (i) The agency may take a reasonable period of time to determine whether information falls within one of the exceptions to the Texas Public Information Act. (ii) If the information is determined to be public, it will be presented for inspection and/or copies of documents will be furnished within a reasonable period of time. A fee will be charged to recover agency costs for copies. (C) Original copies of public records may not be removed from the agency. Under no circumstances shall material be removed from existing records. (bb) General provisions for records. (1) All records required by this chapter shall be accurate and factual. These records shall be maintained by the registrant in accordance with subsection (ll)(6) of this section. Additional record requirements are specified elsewhere in this chapter. (2) Records are only valid if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated. (3) Each registrant shall use the SI units gray, sievert, and coulomb per kilogram, or the special units rad, rem, and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. (4) The registrant shall make a clear distinction among the quantities entered on the records required by this section, such as TEDE, SDE, LDE, or DDE. (5) Records required in accordance with subsections (cc) - (ee) of this section shall include the date and the identification of individual(s) making the record, and, as applicable, a unique identification of survey instrument(s) used, and an exact description of the location of the survey. (6) Copies of records required in accordance with subsections (cc) - (ee) of this section, and by certificate of registration conditions that are relevant to operations at an additional authorized use/storage site shall be maintained at that site in addition to the main site specified on a certificate of registration in accordance with subsection (ll)(6) of this section. (cc) Records of surveys. (1) Each registrant shall make and maintain records showing the results of surveys and calibrations required by subsection (s) of this section. The registrant shall retain these records in accordance with subsection (ll)(6) of this section. (2) The registrant shall retain the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual DEs in accordance with subsection (ll)(6) of this section. (dd) Records of individual monitoring results. (1) Each registrant shall make and maintain records in accordance with subsection (r) of this section of the doses received by all individuals for whom monitoring was required in accordance with subsection (n) of this section, and records of doses received during accidents, and emergency conditions. Assessments of DE and records made using units in effect before January 1, 1994, need not be changed. These records shall include, when applicable: (A) the DDE to the whole body, LDE, SDE to the skin of the whole body, and SDE to the skin of any extremities; and (B) the data used to make occupational dose assessments in accordance with subsection (r)(5) of this section. (2) The registrant shall make entries of the records specified in paragraph (1) of this subsection at intervals not to exceed 1 year and within 90 days of the end of the year. (3) The registrant shall maintain the records specified in paragraph (1) of this subsection on RC Form 231-3, in accordance with the instructions for RC Form 231-3, or in clear and legible records containing all the information required by RC Form 231-3. (4) The registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records. (5) The registrant shall retain each required form or record required by this subsection and records used in preparing RC Form 231-3 or equivalent in accordance with subsection (ll)(6) of this section. (ee) Records of dose to individual members of the public. (1) Each registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See subsections (o) and (p) of this section. (2) The registrant shall retain the records required by paragraph (1) of this subsection in accordance with subsection (ll)(6) of this section. (ff) Form of records. (1) Each record required by this chapter shall be legible throughout the specified retention period. (2) The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. (3) The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. (4) Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. (5) The registrant shall maintain adequate safeguards against tampering with and loss of records. (gg) Reports of stolen, lost, or missing radiation machines. (1) Each registrant shall report to the agency by telephone a stolen, lost, or missing radiation machine immediately after its occurrence becomes known to the registrant. (2) Each registrant required to make a report in accordance with paragraph (1) of this subsection shall, within 30 days after making the telephone report, make a written report to the agency that includes the following information: (A) a description of the radiation machine involved, including, the manufacturer, model and serial number; (B) a description of the circumstances under which the loss or theft occurred; (C) exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible TEDE to persons in unrestricted areas; (D) actions that have been taken, or will be taken, to recover the radiation machine; and (E) procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of radiation machines. (3) Subsequent to filing the written report, the registrant shall also report additional substantive information on the loss or theft within 30 days after the registrant learns of such information. (4) The registrant shall prepare any report filed with the agency in accordance with this subsection so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report. (hh) Notification of incidents. (1) Notwithstanding other requirements for notification, each registrant shall immediately report each event involving a radiation machine possessed by the registrant that may have caused or threatens to cause an individual, except a patient administered radiation for the purpose of medical diagnosis or therapy, to receive: (A) a TEDE of 25 rems (0.25 Sv) or more; (B) an LDE of 75 rems (0.75 Sv) or more; or (C) an SDE to the skin of the whole body or to the skin of the extremities of 250 rads (2.5 grays) or more. (2) Each registrant shall, within 24 hours of discovery of the event, report to the agency each event involving loss of control of a radiation machine possessed by the registrant that may have caused, or threatens to cause an individual to receive, in a period of 24 hours: (A) a TEDE exceeding 5 rems (0.05 Sv); (B) an LDE exceeding 15 rems (0.15 Sv); or (C) an SDE to the skin of the whole body or to the skin of the extremities exceeding 50 rems (0.5 Sv). (3) Registrants shall make the initial notification reports required by paragraphs (1) and (2) of this subsection by telephone to the agency and shall confirm the initial notification report within 24 hours by telegram, mailgram, or facsimile to the agency. (4) The registrant shall prepare each report filed with the agency in accordance with this section so that names of individuals who have received exposure to radiation are stated in a separate and detachable portion of the report. (ii) Reports of exposures and radiation levels exceeding the limits. (1) In addition to the notification required by subsection (hh) of this section, each registrant shall submit a written report within 30 days after learning of any of the following occurrences: (A) incidents for which notification is required by subsection (hh) of this section; (B) doses in excess of any of the following: (i) the occupational dose limits for adults in subsection (m)(1)(A) and (B) of this section; (ii) the occupational dose limits for a minor in subsection (m)(1)(C) of this section; (iii) the limits for an embryo/fetus of a declared pregnant woman in subsection (m)(1)(D) of this section; (iv) the limits for an individual member of the public in subsection (o) of this section; or (v) any applicable limit in the registration; (C) levels of radiation in: (i) a restricted area in excess of applicable limits in the certificate of registration; or (ii) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the registration, whether or not involving exposure of any individual in excess of the limits in subsection (o) of this section. (2) Each report required by paragraph (1) of this subsection shall describe the extent of exposure of individuals to radiation, including, as appropriate: (A) estimates of each individual's dose; (B) the levels of radiation involved; (C) the cause of the elevated exposures, dose rates; and (D) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, and associated registration conditions. (3) Each report filed in accordance with paragraph (1) of this subsection shall include for each individual exposed: the name, social security number, and date of birth. With respect to the limit for the embryo/fetus in subsection (m)(1)(D) of this section, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report. (4) All registrants who make reports in accordance with paragraph (1) of this subsection shall submit the report in writing to the agency. (jj) Notifications and reports to individuals. (1) Requirements for notification and reports to individuals of exposure to radiation are specified in §289.203 of this title (relating to Notices, Instructions and Reports to Workers; Inspections). (2) When a registrant is required in accordance with subsection (ii) of this section to report to the agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation, the registrant shall also notify the individual and provide a copy of the report submitted to the agency, to the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency, and shall comply with the provisions of §289.203 of this title. (kk) Inspections. (1) The agency may enter public or private property at reasonable times to determine whether, in a matter under the agency's jurisdiction, there is compliance with the Act, the agency's rules, certificate of registration conditions, and orders issued by the agency. (2) Each registrant shall afford the agency, at all reasonable times, opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored. (3) Each registrant shall make available to the agency for inspection, upon reasonable notice, records made and maintained in accordance with this chapter. (4) Inspection of radiation machines and services. (A) Routine inspections by agency personnel will be made no more frequently than the intervals specified in subsection (ll)(2) of this section. Registrants having certificates of registration authorizing multiple uses will be inspected at the most frequent interval specified for the uses authorized. (B) Notwithstanding the inspection intervals specified in this section, the agency may inspect registrants more frequently due to: (i) the persistence or severity of violations found during an inspection; (ii) investigation of an incident or complaint concerning the facility; (iii) a request for an inspection by a worker(s) in accordance with §289.203 of this title; (iv) any change in a facility or equipment that might cause a significant increase in radiation output or hazard; or (v) a mutual agreement between the agency and registrant. (C) On-site routine inspections and remote inspections may be alternated as determined by the agency. (D) For remote inspection of radiation machines, each registrant shall respond to a request from the agency for a remote inspection by performing the following: (i) completing the remote inspection forms in accordance with the instructions included with the forms; and (ii) returning to the agency the completed remote inspection forms with documentation of the most recent equipment performance evaluation performed in accordance with §289.227(o) of this title and an inventory in accordance with §289.226(m)(1)(B) of this title, by the deadline indicated on the form. (E) The agency will conduct inspections of radiation machines or lasers in a manner designed to cause as little disruption of a healing arts practice as is practicable. (5) A person who inspects medical radiation machines or lasers will have training in the design and uses of the machines and will receive training specified in subsection (ll)(4) and/or (5) of this section. (6) Each registrant shall perform, upon instructions from the agency, or shall permit the agency to perform such reasonable surveys as the agency deems appropriate or necessary including, but not limited to, surveys of: (A) radiation machines; (B) facilities where radiation machines are used or stored; (C) radiation detection and monitoring instruments; and (D) other equipment and devices used in connection with utilization or storage of radiation machines. (ll) Appendices. (1) Definitions of machine types and types of use. For the purposes of this section, the listed machine types and types of use have the following meanings: (A) CT--computerized tomography machines used for medical purposes; (B) fluoroscopy--fluoroscopic machines used for medical purposes; (C) accelerators, simulators other therapeutic machines, and electronic brachytherapy devices, used for medical purposes; (D) radiographic only--facilities possessing and using only radiographic machines for medical purposes, including but not limited to, tomography, chiropractic machines, and bone densitometers; (E) podiatric radiographic only--facilities possessing and using only radiographic machines for podiatry. This category may also include bone densitometers; (F) minimal threat only--facilities possessing and using only machines defined as minimal threat machines; (G) industrial radiography only--facilities possessing and using radiographic machines for industrial radiography, including accelerators. This category includes machines used at permanent and temporary job sites; (H) other industrial--facilities possessing and using radiation machines for other industrial purposes (non-human use), including diffraction, hand-held light intensifying imaging devices, flash radiography, accelerators, CT, and fluoroscopy; (I) services--persons providing the services listed in §289.226(b)(10) of this title; (J) laser (human use/research/academic)--lasers used for medical and/or research or academic purposes, including veterinary use; and (K) laser other (industrial/entertainment/services)--lasers used for industrial purposes, for demonstration/sales, and for stationary/mobile entertainment light shows. This category also includes facilities that provide calibration/repair services for lasers and that provide lasers to facilities for short periods of time. (2) Inspection intervals for registrants. Attached Graphic(3) Minimal threat radiation machines. Minimal threat radiation machines include, but are not limited to, the following: (A) x-ray fluorescence (machine); (B) x-ray gauges; (C) particle size analyzer (x-ray); (D) electron beam welding; (E) ion implantation devices; (F) cathodoluminescence devices; (G) package x-ray; and (H) certified cabinet x-ray. (4) Training for agency inspectors of radiation machines for human use. (A) Objectives. Training of agency individuals performing inspections of radiation machines for human use will be conducted by the agency. Upon completion of training, the inspector will be able to: (i) select and operate the necessary testing equipment used to perform an inspection of radiation machines; (ii) utilize radiation protection principles; (iii) operate radiation detection instruments; (iv) define basic regulatory terminology; (v) apply this section regarding radiation machines; (vi) perform routine agency inspections of radiation machines; (vii) complete agency inspection documentation; (viii) demonstrate knowledge of agency ethics, professional, and technical policies; and (ix) successfully achieve the objectives in this subparagraph. (B) Initial training program. (i) Initial training will be conducted during a six-month period. (ii) All training evaluation instruments will be developed by the agency. (iii) Instruments to be used in determining a proficiency level are as follows: (I) evaluation of each inspector's training needs prior to initial training; (II) evaluation of knowledge obtained and verification of tasks performed by each inspector subsequent to training received by the agency; and (III) evaluation of each inspector's task performance by the agency. (C) Continuing education. (i) The agency inspector of radiation machines for human use will accumulate 24 hours of continuing education regarding radiation machines for human use, at intervals not to exceed 24 months. These hours of continuing education may be acquired as follows: (I) documented continuing education earned in an agency-accepted training format; and (II) agency staff meetings. (ii) Failure to obtain 24 hours of continuing education within each 24-month interval may result in a reassessment by the agency of an agency inspector's proficiency level. (iii) After the initial training period, each inspector of radiation machines for human use will be evaluated by the agency, at intervals not to exceed 12 months. (D) Agency proficiency standards. The agency proficiency standards for agency inspectors of radiation machines for human use are as follows. (i) Level I. The agency inspector has not successfully achieved the objectives in subparagraph (A) of this paragraph after the initial training period. Additional training is required. Unsupervised inspections will not be performed. (ii) Level II. The agency inspector has partially achieved the objectives in subparagraph (A) of this paragraph, but has not achieved the objective in subparagraph (A)(ix) of this paragraph after the initial training period. Additional training is required. Unsupervised inspections are not permitted for the type of radiation machines for human use for which the objectives of subparagraph (A)(ix) of this paragraph have not been achieved. Unsupervised inspections may be performed for the type of radiation machines for human use for which the objectives in subparagraph (A)(ix) of this paragraph have been successfully achieved. (iii) Level III. The agency inspector has successfully achieved the objectives in subparagraph (A) of this paragraph. Supervision is not required for routine inspections. (5) Training for agency inspectors of lasers. Initial training will include an introduction to the requirements in this chapter and inspection forms. Inspections of 2 medical and 2 entertainment lasers, conducted by an inspector having completed the requirements of this paragraph, shall be observed before unsupervised inspection of lasers is permitted. (6) Time requirements for record keeping. The following are time requirements for record keeping. Attached Graphic(7) Occupational exposure form. The following, RC Form 231-3 is to be used to document occupational exposure record for a monitoring period. Attached Graphic Source Note: The provisions of this §289.231 adopted to be effective October 1, 2000, 25 TexReg 4855; amended to be effective September 1, 2004, 29 TexReg 7334; amended to be effective December 29, 2011, 36 TexReg 8835. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.231 General Provisions and Standards for Protection Against Machine-Produced Radiation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=195609&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 195609 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=195609&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 195609 03/11/2026 (a) Purpose. This section establishes the requirements for the use of dental radiation machines.(1) Fees for certificates of registration for dental facilities and provisions for their payment will be processed in accordance with subsection (h) of this section or §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), as amended. (2) Requirements of persons using radiation machines are as follows. (A) No person shall use radiation machines except as authorized in a certificate of registration issued by the agency in accordance with the requirements of this section. (B) A person who receives, possesses, uses, owns, or acquires radiation machines before receiving a certificate of registration is subject to the requirements of this chapter.(3) Requirements intended to control the receipt, possession, use, and transfer of radiation machines by any person so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter. However, nothing in this section shall be construed as limiting actions that may be necessary to protect health and safety in an emergency.(4) Requirements for the use of radiation machines include that the registrant shall ensure the requirements of this section are met in the operation of such radiation machines and only persons who have received proper instructions in the safe use of radiation machines shall be permitted to operate the radiation machines.(5) Requirements for specific record keeping and general provisions for records and reports are included in this section.(6) Requirements for providing notices to employees and instructions and options available to such individuals in connection with agency inspections of registrants to determine compliance with the provisions of the Texas Radiation Control Act, Health and Safety Code, Chapter 401, and requirements of this section, orders, and certificates of registration issued thereunder regarding radiological working conditions. (7) Governing of the following in accordance with the Texas Radiation Control Act, Health and Safety Code, Chapter 401; the Texas Administrative Procedure Act, Texas Government Code, Chapter 2001; Title 1, Texas Administrative Code, Chapter 155; and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title:(A) proceedings for the granting, denying, renewing, transferring, amending, suspending, revoking, or annulling of a certificate of registration; (B) determining compliance with or granting of exemptions from requirements of this section, an order, or a condition of the certificate of registration; (C) assessing administrative penalties; and (D) determining propriety of other agency orders.(b) Scope.(1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer dental radiation machines. (A) The dose limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for dental diagnosis, to exposure from individuals administered radioactive material and released in accordance with this chapter, or to voluntary participation in medical research programs. (B) No radiation may be deliberately applied to human beings except by or under the supervision of a dentist licensed by the Texas State Board of Dental Examiners.(2) Registrants who are also registered by the agency to receive, possess, acquire, transfer, or use class IIIb and class IV lasers in dentistry shall also comply with the requirements of §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices).(3) Dental radiation machines located in a facility that also has other healing arts radiation machines will be inspected at the intervals specified in §289.231(ll)(2) of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (4) The agency may, by requirements in this chapter, an order, or a condition of the certificate of registration, impose upon any registrant such requirements in addition to those established in this section as it deems appropriate or necessary to minimize danger to public health and safety or the environment.(5) Registrants who are also specifically licensed by the agency to receive, possess, use, and transfer radioactive materials shall also comply with the applicable requirements of §289.201 of this title (relating to General Provisions for Radioactive Material), §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Materials), §289.203 of this title (relating to Notice, Instructions, and Reports to Workers; Inspections), §289.204 of this title, §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.252 of this title (relating to Licensing of Radioactive Material), §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material), and §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).(c) Prohibitions.(1) The agency may prohibit use of radiation machines that pose significant threat or endanger occupational and public health and safety, in accordance with subsections (a) - (g) and (l)(3) of this section.(2) Individuals shall not be exposed to the useful beam except for healing arts purposes authorized by a dentist. This provision specifically prohibits deliberate exposure for the following purposes:(A) exposure of an individual for training, demonstration, or other non-healing arts purposes; or(B) exposure of an individual for research except as authorized by subsection (j)(6) of this section.(3) No person shall cause the operation of a radiation machine that results in exposure of an individual to the useful beam for training, demonstration, or other non-healing arts purposes. (4) In no case shall an individual hold the tube or tube housing assembly support during any radiographic exposure. Hand-held radiation machines shall be held only in the manner specified by manufacturer recommendation.(d) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.(1) Absorbed dose--The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad. (2) Accessible surface--The external surface of the enclosure or housing provided by the manufacturer.(3) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401.(4) Administrative law judge (ALJ)--A judge employed by the State Office of Administrative Hearings.(5) Administrative penalty--A monetary penalty assessed by the agency in accordance with Health and Safety Code, §401.384, to emphasize the need for lasting remedial action and to deter future violations.(6) Adult--An individual 18 or more years of age.(7) Agency--The Department of State Health Services or its successor.(8) Agreement State--Any state with which the United States Nuclear Regulatory Commission (NRC) has entered into an effective agreement under §274b of the Atomic Energy Act of 1954 (42 United States Code et seq.), as amended (73 Stat. 689).(9) Air kerma--The kinetic energy released in air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray. For purposes of this section, when exposure in air measured in roentgen (R) is to be converted to dose in air measured in gray, a nationally recognized standard air conversion factor shall be used. (10) Applicant--A person seeking a certificate of registration issued in accordance with the provisions of the Act and the requirements in this section.(11) As low as is reasonably achievable (ALARA)--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in this section as is practical, consistent with the purpose for which the registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of ionizing radiation and radiation machines in the public interest.(12) Attenuate--To reduce the exposure rate (air kerma rate) upon passage of radiation through matter.(13) Automatic exposure control--A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation at preselected locations (See definition for phototimer). (14) Background radiation--Radiation from cosmic sources; non-technologically enhanced naturally occurring radioactive material, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents, such as Chernobyl, that contribute to background radiation and are not under the control of the registrant. "Background radiation" does not include radiation from sources of radiation regulated by the agency.(15) Barrier--(See definition for protective barrier.)(16) Beam-limiting device--A device that provides a means to restrict the dimensions of the x-ray field.(17) Beam quality (diagnostic x-ray)--A term that describes the penetrating power of the x-ray beam. This is identified numerically by half-value layer and is influenced by kilovolt peak (kVp) and filtration. (18) Certificate of registration--A form of permission given by the agency to an applicant who has met the requirements for registration set out in the Act and this chapter.(19) Certified radiation machines--Radiation machines that have been certified in accordance with Title 21, Code of Federal Regulations (CFR).(20) Coefficient of variation or C--The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:Attached Graphic(21) Collective dose--The sum of the individual doses received in a given period by a specified population from exposure to a specified source of radiation.(22) Commissioner--The Commissioner of the Department of State Health Services.(23) Committed effective dose equivalent (HE,50 )--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (HE,50 = ΣWT HT.50 ).(24) Contested case--A proceeding in which the agency determines the legal rights, duties, or privileges of a party after an opportunity for adjudicative hearing.(25) Continuous pressure type switch--A switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.(26) Consultant--An individual who is not routinely engaged in work under the registrant who provides advice related to compliance with this chapter.(27) Control panel--The part of the radiation machine where the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors are located.(28) Declared pregnant woman--A woman who has voluntarily informed the registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman voluntarily withdraws the declaration in writing or is no longer pregnant.(29) Deep dose equivalent (Hd ), that applies to external whole body exposure--The dose equivalent at a tissue depth of 1 centimeter (1000 milligrams per square centimeter). (30) Dentist--An individual licensed to practice dentistry by the Texas State Board of Dental Examiners.(31) Diagnostic source assembly--The tube housing assembly with a beam-limiting device attached.(32) Director--The director of the radiation control program under the agency's jurisdiction.(33) Dose--A generic term that means absorbed dose, dose equivalent, or total effective dose equivalent. For purposes of this section, "radiation dose" is an equivalent term.(34) Dose equivalent (Ht )--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.(35) Dose limits--The permissible upper bounds of radiation doses established in accordance with this chapter. For purposes of this section, "limits" is an equivalent term.(36) Effective dose equivalent (HE )--The sum of the products of the dose equivalent to the organ or tissue (HT ) and the weighting factors (WT ) applicable to each of the body organs or tissues that are irradiated (HE = ΣWT HT ).(37) Embryo/fetus--The developing human organism from conception until the time of birth.(38) Entrance exposure (Entrance air kerma)--The entrance exposure in air expressed in roentgens or the entrance dose in air (air kerma) expressed in gray, measured at the point where the center of the useful beam enters the patient.(39) Equipment performance evaluations (EPE)--Required testing performed by a registered service provider at a specified interval to ensure radiation machines operate in compliance with this chapter. (40) Exposure--The quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The International System of Units (SI) unit of exposure is the coulomb per kilogram. The roentgen is the special unit of exposure. For purposes of this section, this term is used as a noun.(41) Exposure rate (air kerma rate)--The exposure per unit of time. For purposes of this section, "air kerma rate" is an equivalent term.(42) External dose--That portion of the dose equivalent received from any source of radiation outside the body.(43) Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the knee. The arm above the elbow and the leg above the knee are considered part of the whole body.(44) Field emission equipment--Equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.(45) Filter--Material placed in the useful beam to absorb selected radiations preferentially.(46) Gray (Gy)--The SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram or 100 rad.(47) Half-value layer (HVL)--The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate (air kerma rate) is reduced to one-half of its original value.(48) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.(49) Hearing--A proceeding to examine an application or other matter before the agency in order to adjudicate rights, duties, or privileges.(50) Human use--For exposure to x-ray radiation from radiation machines, the external administration of radiation to human beings for healing arts purposes or research or development specifically authorized by the agency.(51) Image receptor--Any device, such as a fluorescent screen, radiographic film, or digital sensor that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.(52) Individual--Any human being.(53) Individual monitoring--The assessment of dose equivalent to an individual by the use of:(A) individual monitoring devices; or(B) survey data.(54) Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this section, "personnel dosimeter," "dosimeter," and "personnel monitoring equipment" are equivalent terms. Examples of individual monitoring devices include, but are not limited to, film badges, thermoluminescence dosimeters, optically stimulated luminescence dosimeters, pocket ionization chambers (pocket dosimeters), and electronic personal dosimeters.(55) Informal conference--A meeting held by the agency with a person to discuss the following:(A) safety, safeguards, or environmental problems;(B) compliance with regulatory or registration condition requirements;(C) proposed corrective measures, including, but not limited to, schedules for implementation; and(D) enforcement options available to the agency.(56) Inspection--An official thorough examination or observation, including, but not limited to, records, tests, surveys, and monitoring to effectively determine compliance with the Act and requirements of this section, orders, and conditions of the agency.(57) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.(58) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, and other nuclear particles. (59) kV--Kilovolt. (60) kVp--Kilovolt peak (See definition for peak tube potential). (61) kWs--Kilowatt-second. It is equivalent to 10 E 3 watt-second, where 1 watt-second =1 kilovolt x 1 milliampere x 1 second. (62) Lead equivalent--The thickness of lead affording the same attenuation, under specified conditions, as the material in question.(63) Leakage radiation--Radiation emanating from the diagnostic assembly except for the useful beam and radiation produced when the exposure switch or timer is not activated.(64) Lens dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeters (300 milligrams per square centimeter).(65) License--A form of permission given by the agency to an applicant who has met the requirements for licensing set out in the Act and this chapter. (66) Licensed material--Radioactive material received, possessed, used, or transferred under a general or specific license issued by the agency. (67) Licensee--Any person who is licensed by the agency in accordance with the Act and this chapter. (68) mA--Milliampere. (69) mAs--Milliampere-second.(70) Medical research--The investigation of various health risks and diseases.(71) Member of the public--Any individual, except when that individual is receiving an occupational dose. (72) Minor--An individual less than 18 years of age.(73) Mobile service operation--The provision of radiation machines and personnel at temporary locations for limited time periods.(74) Monitoring--The measurement of radiation and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this section, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.(75) Notice of violation--A written statement prepared by the agency of one or more alleged infringements of a legally binding requirement.(76) Occupational dose--The dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this section, from voluntary participation in medical research programs, or as a member of the public.(77) Order--A specific directive contained in a legal document issued by the agency.(78) Party--A person designated as such by the ALJ. A party may consist of the following:(A) the agency; (B) an applicant, licensee, registrant, accredited mammography facility, or certified industrial radiographer; and (C) any person affected.(79) Patient--An individual subjected to dental examination, diagnosis, or treatment.(80) Peak tube potential--The maximum value of the potential difference in kilovolts across the x-ray tube during an exposure.(81) Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing, other than the United States Nuclear Regulatory Commission, and other than federal government agencies licensed or exempted by the United States Nuclear Regulatory Commission.(82) Personnel monitoring equipment--(See definition for individual monitoring devices).(83) Phototimer--A method for controlling radiation exposures to image receptors by the amount of radiation that reaches a radiation detection device. The radiation detection device is part of an electronic circuit that controls the duration of time the tube is activated (See definition for automatic exposure control).(84) Primary protective barrier--(See definition for protective barrier).(85) Protective barrier--A barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows:(A) primary protective barrier--A barrier sufficient to attenuate the useful beam to the required degree; or (B) secondary protective barrier--A barrier sufficient to attenuate the stray radiation to the required degree.(86) Public dose--The dose received by a member of the public from exposure to radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. It does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this section, or from voluntary participation in medical research programs, or as a member of the public.(87) Rad--The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 Gy).(88) Radiation--One or more of the following:(A) gamma and x-rays, alpha and beta particles, and other atomic or nuclear particles or rays;(B) radiation emitted to energy density levels that could reasonably cause bodily harm from an electronic device; or(C) sonic, ultrasonic, or infrasonic waves from any electronic device or resulting from the operation of an electronic circuit in an electronic device in the energy range to reasonably cause detectable bodily harm.(89) Radiation area--Any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 millisievert) in one hour at 30 centimeters from the radiation machine or from any surface that the radiation penetrates.(90) Radiation machine--An x-ray system, subsystem, or component capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation. For purposes of this section, "radiation machine," "x-ray equipment," "x-ray system," and "x-ray unit" are equivalent terms. Types of radiation machines include, but are not limited to:(A) Stationary radiation machine--A radiation machine that is installed in a fixed location.(B) Hand-held radiation machine--A radiation machine that is designed to be hand-held during operation.(C) Portable radiation machine--A radiation machine that is mounted on a permanent base with wheels or casters for moving while completely assembled, including a hand-carried radiation machine that is designed to be mounted on a support while operating.(D) Mobile radiation machine--A radiation machine that is transported in a vehicle to be used at various temporary locations.(91) Radiation safety officer (RSO)--An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who shall be specifically authorized on a certificate of registration, and who is the primary contact with the agency.(92) Radiograph--An image receptor on which the image is created directly or indirectly by an x-ray exposure and results in a permanent record.(93) Registrant--Any person issued a certificate of registration by the agency in accordance with the Act and this chapter.(94) Regulation--(See definition for rule).(95) Rem--The special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem sievert (Sv) is equal to the absorbed dose in rad or gray multiplied by the quality factor (1 rem = 0.01 Sv).(96) Remote inspection--An examination by the agency of information submitted by the registrant on a form provided by the agency.(97) Research and development--Research and development is defined as:(A) theoretical analysis, exploration, or experimentation; or(B) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, radiation machines, materials, and processes.(98) Restricted area--An area, access to which is limited by the registrant for protecting individuals against undue risks from exposure to radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.(99) Roentgen (R)--The special unit of exposure. One roentgen (R) equals 2.58 x 10‑4 coulombs per kilogram of air. (See definition for exposure.)(100) Rule--Any agency statement of general applicability that implements, interprets, or prescribes law or policy, or describes the procedure or practice requirements of an agency. The term includes the amendment or repeal of a section but does not include statements concerning the internal management or organization of any agency and does not affect private rights or procedures. The word "rule" was formerly referred to as "regulation."(101) Scattered radiation--Radiation that has been deviated in direction during passage through matter.(102) Secondary protective barrier--(See definition for protective barrier).(103) Severity level--A classification of violations based on relative seriousness of each violation and the significance of the effect of the violation on the occupational or public health or safety or the environment.(104) Shallow dose equivalent (Hs ) (that applies to the external exposure of the skin of the whole body or the skin of an extremity)--The dose equivalent at a tissue depth of 0.007 centimeters (7 milligrams per square centimeter).(105) SI--The abbreviation for the International System of Units.(106) Sievert--The SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 sievert = 100 rem).(107) Source of radiation--Any radioactive material or device that is capable of emitting or producing ionizing radiation.(108) Source-to-image receptor distance--The distance from the source to the center of the input surface of the image receptor. (109) Source-to-skin distance--The distance from the source to the skin of the patient.(110) Special units--The conventional units historically used by registrants, i.e., rad (absorbed dose), and rem (dose equivalent). (111) Stray radiation--The sum of leakage and scattered radiation.(112) Supervision--The delegating of the task of applying radiation in accordance with this section to persons not licensed in dentistry, who perform tasks under the dentist's control. The dentist assumes full responsibility for these tasks and shall assure that the tasks will be administered correctly.(113) Survey--An evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, and disposal of radiation machines. When appropriate, such survey includes, but is not limited to, tests, physical examination of location of equipment or radiation machines, and measurements of levels of radiation present, and evaluation of administrative and engineered controls.(114) Technique chart--A chart that provides technical factors, anatomical examination, and patient size for examination being performed needed to make clinical radiographs when the radiation machine is in manual mode. (115) Technique factors--The conditions of operation that are specified as follows:(A) for capacitor energy storage equipment, peak tube potential in kilovolt and quantity of charge in milliampere-second;(B) for field emission equipment rated for pulsed operation, peak tube potential in kilovolt and number of x-ray pulses; and(C) for all other radiation machines, peak tube potential in kilovolt and either tube current in milliamperes and exposure time in seconds or the product of tube current and exposure time in milliampere-second. (116) Termination--A release by the agency of the obligations and authorizations of the registrant under the terms of the certificate of registration. It does not relieve a person of duties and responsibilities imposed by law or rule.(117) Texas Regulations for Control of Radiation --All sections of Chapter 289 of this title.(118) Total effective dose equivalent--The sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). (119) Traceable to a national standard--This indicates that a quantity or a measurement has been compared to a national standard, for example, the National Institute of Standards and Technology, directly or indirectly through one or more intermediate steps and that all comparisons have been documented.(120) Tube--An x-ray tube, unless otherwise specified.(121) Tube housing assembly--The tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.(122) Unrestricted area (uncontrolled area)--An area, access to which is neither limited nor controlled by the registrant. For purposes of this section, "uncontrolled area" is an equivalent term.(123) Useful beam--Radiation that passes through the window, aperture, core, or other collimating device of the source housing. Also referred to as the primary x-ray beam.(124) Violation--An infringement of any rule, license or registration condition, order of the agency, or any provision of the Act.(125) Whole body--For purposes of external exposure, head, trunk, including male gonads, arms above the elbow, or legs above the knee.(126) Worker--An individual engaged in work under the certificate of registration issued by the agency. (127) X-ray control panel--A device that controls input power to the x-ray high-voltage generator or the x-ray tube. It includes components such as timers, phototimers, automatic brightness stabilizers, and similar devices that control the technique factors of an x-ray exposure.(128) X-ray field--That area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate (air kerma rate) is one-fourth of the maximum in the intersection.(129) X-ray high-voltage generator--A device that transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tubes, high-voltage switches, electrical protective devices, and other appropriate elements.(130) X-ray system--An assemblage of components for the controlled production of x-rays. It includes, minimally, an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system.(131) X-ray subsystem--Any combination of two or more components of an x-ray system.(132) X-ray tube--Any electron tube that is designed to be used primarily for the production of x-rays.(133) Year--The period of time beginning in January used to determine compliance with the provisions of this chapter. The registrant may change the starting date of the year used to determine compliance by the registrant if the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.(e) Exemptions. (1) The agency may, upon application or upon its own initiative, exempt a source of radiation or a kind of use or user from the requirements of this section if the agency determines that the law does not prohibit the exemption and it will not result in a significant risk to public health or safety or the environment. In determining such exemptions, the agency will consider: (A) state of technology; (B) economic considerations in relation to benefits to the public health and safety; and(C) other societal, socioeconomic, or public health and safety considerations. (2) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this section, if the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 millirem (5 microsieverts) per hour at 5 centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt. (3) Radiation machines in transit or in storage incident to transit are exempt from the requirements of this section. This exemption does not apply to the providers of radiation machines for mobile services. (4) Facilities that have placed all radiation machines in storage, including on-site storage secured from unauthorized use or removal, and have notified the agency in writing, are exempt from the requirements of this section. This exemption is void if any radiation machine is energized resulting in the production of radiation. Before resuming use of the radiation machine for human use, the radiation machine shall meet all requirements of this section.(5) Inoperable radiation machines are exempt from the requirements of this section. For the purposes of this section, an inoperable radiation machine means a radiation machine that cannot be energized when connected to a power supply without repair or modification. (6) A person who takes possession of a radiation machine as the result of foreclosure, bankruptcy, or other default of payment may possess the radiation machine without registering it. If the radiation machine is energized, it shall be in accordance with this chapter.(7) No individual monitoring shall be required for personnel operating only dental radiation machines for dental diagnostic purposes. (8) Portable radiation machines designed to be hand-held are exempt from the requirements of subsections (c)(4) and (j)(5)(C) of this section. The portable radiation machines shall be held according to manufacturer's specifications. (9) Individuals who are sole practitioners and sole operators, and the only occupationally exposed individual are exempt from the following requirements: (A) operating and safety procedures specified in subsection (j)(2) of this section; (B) instruction to workers specified in subsection (j)(3)(D) of this section; and (C) posting of notices to workers specified in subsection (j)(4)(B) and (C) of this section. (10) In accordance with Texas Occupations Code, §258.054, dental practices are exempt from the Medical Physics Practice Act, Texas Occupations Code, Chapter 602. Registrants required to have EPE tests performed in accordance with subsection (j)(5)(J) of this section may select any qualified person authorized by registration through the Department of State Health Services, Radiation Control.(f) Communications. (1) Except where otherwise specified, all communications and reports concerning this chapter and applications filed under the communications and reports should be mailed by postal service to Radiation Control, Department of State Health Services, P.O. Box 149347, MC 2003, Austin, Texas, 78714-9347. Communications, reports, and applications may be delivered in person to the agency's office located at 8407 Wall Street, Austin, Texas, 78754. (2) Documents received by the agency will be deemed to have been received on the date of the postmark, facsimile, or other electronic media transmission.(g) Interpretations. Except as specifically authorized by the agency in writing, no interpretation of the meaning of this chapter by any officer or employee of the agency other than a written legal interpretation by the agency, will be considered binding upon the agency.(h) Fees for certificates of registration for dental facilities.(1) Payment of fees.(A) Each application for a certificate of registration shall be accompanied by a nonrefundable fee specified in §289.204 of this title, as amended. No application will be accepted for filing or processed before payment of the full amount specified. (B) A nonrefundable fee specified in §289.204 of this title, as amended, shall be paid for each certificate of registration for radiation machines used in dentistry. The fee shall be paid every two years and shall be paid in full and on or before the due date stated on the invoice. (i) For each additional use location where radiation machines or services are authorized under the same registration, there will be an additional charge of 30% of the applicable fee.(ii) In the case of a single certificate of registration that authorizes more than one category of radiation machine use, the category listed in §289.204 of this title that is assigned the higher fee will be used. (C) Each application for reciprocal recognition of an out-of-state registration in accordance with subsection (i)(8) of this section shall be accompanied by the non-refundable fee specified in §289.204 of this title, as amended, provided that no such fee has been submitted within 24 months of the date of commencement of the proposed activity.(D) Fee payments shall be in cash or by check or money order made payable to the Department of State Health Services. The payments may be made by personal delivery to the central office, Radiation Control, Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756-3199 or mailed to Radiation Control, Department of State Health Services, P.O. Box 149347, MC 2003, Austin, Texas, 78714-9347.(2) Failure to pay prescribed fees.(A) In any case where the agency finds that an applicant for a certificate of registration has failed to pay the non-refundable fee prescribed in §289.204 of this title, as amended, the agency will not process that application until such fee is paid. (B) In any case where the agency finds that a registrant has failed to pay a fee prescribed by §289.204 of this title, as amended, by the due date, the agency may implement compliance procedures as provided in subsection (l)(3)(C) of this section.(3) Electronic fee payments. Renewal payments may be processed through www.texas.gov or another electronic payment system specified by the agency. For all types of electronic fee payments, the agency will collect additional fees, in amounts determined by www.texas.gov to recover costs associated with electronic payment processing. (i) Registration of radiation machine use.(1) Application for registration of radiation machines. (A) Application for registration shall be completed on forms prescribed by the agency and shall contain all the information required by the form and accompanying instructions. For initial registrations with multiple radiation machine use locations, a separate application shall be completed for each use location under the registration.(B) Each person having a radiation machine used in dentistry shall apply for registration with the agency within 30 days after beginning use of the radiation machine, except for mobile services that shall be registered in accordance with paragraph (2) of this subsection and clinical trial evaluations that shall be registered in accordance with paragraph (5)(K) of this subsection.(C) If the application is incomplete 60 days after submission, the agency may abandon the application and return the original application. The applicant will cease use of all radiation machines once the application has been abandoned.(D) The applicant shall ensure that radiation machines will be operated by individuals qualified by reason of training and experience to use the radiation machines for the purpose requested in accordance with this section in such a manner as to minimize danger to occupational and public health and safety. (E) A radiation safety officer shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application. The radiation safety officer shall meet the applicable qualifications of clause (i) of this subparagraph and carry out the responsibilities specified in clause (v) of this subparagraph.(i) The radiation safety officer shall have the following qualifications:(I) knowledge of potential hazards and emergency precautions; and(II) educational courses completed that relate to ionizing radiation safety or a radiation safety officer course; or(III) experience in the use and familiarity of the type of radiation machine used; and(ii) In addition to the qualifications in clause (i) of this subparagraph, documentation of the following shall be submitted to the agency:(I) for dentist radiation safety officers, a dental licensing board number and their signature on the application;(II) for a practitioner radiation safety officer, documentation of a licensing board number; or (III) for non-practitioner radiation safety officers, any one of the following:(-a-) evidence of a valid general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and at least two years of supervised experience or supervised use of radiation machines;(-b-) evidence of a valid limited general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and at least four years of supervised experience or supervised use of radiation machines;(-c-) evidence of registry by the American Registry of Radiologic Technologists and at least two years of supervised experience or supervised use of radiation machines;(-d-) evidence of associate degree in radiologic technology, health physics, or nuclear technology, and at least two years of supervised experience or supervised use of radiation machines;(-e-) evidence of registration with the Texas Board of Nursing as a Registered Nurse and at least two years of supervised experience or supervised use of radiation machines in the respective specialty;(-f-) evidence of registration with the Texas Physician Assistant Board, and at least two years of supervised use of radiation machines in the respective specialty;(-g-) evidence of:(-1-) registration with the Texas State Board of Dental Examiners to perform radiologic procedures under a dentist's instruction and direction or evidence of a valid certificate as a registered dental hygienist; and(-2-) at least four years of supervised use of radiation machines in the respective dentist's specialty;(-h-) evidence of bachelor's (or higher) degree in a natural or physical science, health physics, radiological science, nuclear medicine, or nuclear engineering; or(-i-) evidence of a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in medical health physics, diagnostic medical physics, or nuclear medical physics for diagnostic x-ray facilities.(iii) Academic institutions and research and development facilities shall have radiation safety officers who are faculty or staff members in radiation protection, radiation engineering, or related disciplines. (This individual may also serve as the radiation safety officer over the dental section of the facility.)(iv) The radiation safety officer identified on a certificate of registration for use of dental radiation machines issued before September 1, 1993, need not comply with the qualification requirements in this subsection.(v) Specific duties of the radiation safety officer include, but are not limited to, the following: (I) establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable, and reviewing the procedures at intervals not to exceed 12 months to ensure that the procedures are current and conform with this section; (II) investigating and reporting to the agency each:(-a-) known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this section; and (-b-) theft or loss of radiation machines, determining the cause, and taking steps to prevent its recurrence; (III) assuming control and having the authority to institute corrective actions, including shutdown of operations when necessary in emergencies or unsafe conditions; (IV) making and maintaining records as required by this section; and (V) ensuring that personnel are adequately trained and complying with this section, the conditions of the certificate of registration, and the operating and safety procedures of the registrant. (F) At any time after the filing of the original application, the agency may require additional information to determine whether the certificate of registration is issued or denied. (G) An application for a certificate of registration may include a request for a certificate of registration authorizing one or more activities or radiation machine use locations. If an application includes a request for an additional authorization other than use of a dental radiation machine, compliance with other applicable sections of this chapter will be required.(H) Each application for a certificate of registration shall be accompanied by the fee prescribed in §289.204 of this title, as amended. No application will be accepted for filing or processed before payment of the full amount specified. (I) Each application shall be accompanied by a completed RC Form 226-1, Business Information Form that shall contain the legal name of the entity or business. The form can be found at http://dshs.texas.gov/radiation/x-ray/medical-faq.aspx. Unless exempt in accordance with the Business and Commerce Code, Chapter 71, the applicant shall: (i) be authorized to conduct business in the State of Texas as listed on the Texas Secretary of State (SOS) website; and (ii) file an assumed name certificate with the Texas SOS if using an assumed name in their application or the office of the county clerk in the county where the business is located.(J) An application for use of a dental radiation machine shall be signed by a licensed dentist. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed dentist's signature if the facility has more than one licensed dentist who may direct the operation of radiation machines. The application shall also be signed by the radiation safety officer.(K) Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with subsection (k)(1)(J) and (K) of this section. (2) Application for registration of mobile service operation used in dentistry. In addition to the requirements of paragraph (1) of this subsection, each applicant shall apply for and receive authorization from the agency for mobile service operation before beginning mobile service operation. The following shall be submitted:(A) An established main location where the radiation machines and related compliance documents and records will be maintained for inspection. This shall be a street address, not a post office box number. (B) A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed radiation machine inside, furnish the floor plan indicating protective shielding and the operator's position.(C) A current copy of the applicant's operating and safety procedures regarding radiological practices for protection of patients, operators, employees, and the public.(3) Issuance of certificate of registration.(A) A certificate of registration will be approved if the agency determines that an application meets the requirements of the Act and the requirements of this chapter. The certificate of registration authorizes the proposed activity and contains the conditions and limitations, as the agency deems appropriate or necessary. (B) The agency may incorporate in the certificate of registration at the time of issuance, or thereafter by amendment, additional requirements and conditions concerning the registrant's possession, use, and transfer of radiation machines subject to this chapter, as it deems appropriate or necessary in order to: (i) minimize danger to occupational and public health and safety; (ii) require additional records and the keeping of additional records as may be appropriate or necessary; and (iii) prevent loss or theft of radiation machines subject to this chapter.(C) The agency may request, and the registrant shall provide, additional information after the certificate of registration has been issued to enable the agency to determine whether the certificate of registration should be modified in accordance with paragraph (7) of this subsection.(4) Terms and conditions of certificates of registration.(A) Each certificate of registration issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable requirements of this chapter and orders of the agency.(B) No certificate of registration issued or granted under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the agency authorizes the transfer in writing. (C) Each person registered by the agency for radiation machine use in accordance with this section shall confine use and possession of the radiation machine registered to the locations and purposes authorized in the certificate of registration. (D) In making a determination whether to grant, deny, amend, revoke, suspend, or restrict a certificate of registration, the agency may consider the technical competence and compliance history of an applicant or holder of a certificate of registration. After an opportunity for a hearing, the agency shall deny an application for a certificate of registration or an amendment to a certificate of registration if the applicant's compliance history reveals that at least three agency actions have been issued against the applicant, within the previous six years, that assess administrative or civil penalties against the applicant, or that revoke or suspend the certificate of registration. (5) Responsibilities of the registrant.(A) The registrant is responsible for complying with this section and the conditions of the certificate of registration. (B) The registrant shall designate an individual qualified in accordance with paragraph (1)(E)(i) of this subsection as the radiation safety officer and shall ensure the individual continually performs the duties of the radiation safety officer as identified in paragraph (1)(E)(v) of this subsection.(C) Persons using radiation machines in accordance with subsection (i)(2) of this section, concerning application for mobile services, shall have a valid certificate of registration issued by the agency before initiation of the mobile services. (D) No person shall use a radiation machine unless the person has applied for registration within 30 days after beginning use of the radiation machine in accordance with subsection (i)(1)(B) of this section. (E) No registrant shall engage any person for services described in §289.226(b)(11) of this title (relating to Registration of Radiation Machine Use and Services) until such person provides to the registrant evidence of registration with the agency. (F) No person shall provide radiation machine services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the agency except for:(i) the initial installation of the first radiation machine for a new certificate of registration; and(ii) the registrant authorized for demonstration and sale may demonstrate a radiation machine in accordance with paragraph (5)(D) of this subsection, except as prohibited by subsection (c) of this section.(G) The registrant shall notify the agency in writing of any changes that would render the information contained in the application for registration or the certificate of registration inaccurate. The notification shall be in writing and signed by an authorized representative. (i) Notification is required within 30 days after the following changes:(I) legal business name;(II) mailing address;(III) street address where radiation machine will be used;(IV) additional radiation machine location;(V) radiation safety officer; or(VI) name and registration number of the contracted "provider of equipment," registered in accordance with §289.226 of this title.(ii) The registrant shall notify the agency within 30 days after changes in the radiation machines that include: (I) any change in the category of radiation machine type or type of use as authorized in the certificate of registration (for example, addition of a computerized tomography radiation machine); or (II) any increase in the number of radiation machines authorized by the certificate of registration in any radiation machine type or type of use category.(H) The registrant, or the parent company, shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy. This notification shall include: (i) the bankruptcy court in which the petition for bankruptcy was filed; and(ii) the case name and number, and date of filing the petition.(I) The registrant shall inventory all radiation machines in the registrant's possession at an interval not to exceed one year. (i) The inventory shall include:(I) manufacturer's name;(II) model and serial number of the control panel; and(III) location of all radiation machines, for example, room number.(ii) Records of the inventory shall be made and maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(J) Receipt, transfer, and disposal of radiation machines. (i) The registrant shall make and maintain records of receipt, transfer, and disposal of radiation machines. The records shall include the following: (I) manufacturer's name and model and serial number from the control panel; (II) date of the receipt, transfer, and disposal; (III) name and address of person the radiation machines received from, transferred to, or disposed of; and(IV) name of the individual recording the information.(ii) Records of receipt, transfer, and disposal of radiation machines shall be made and maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(K) The following criteria applies to loaner radiation machines. (i) For persons having a valid certificate of registration, loaner radiation machines may be used for up to 30 days. If the loaner radiation machine is used for more than 30 days, the registrant is required, within the next 30 days, to complete the following:(I) notify the agency of any change in the category of radiation machine type or type of use as authorized in the certificate of registration (for example, addition of a computerized tomography radiation machine); or (II) notify the agency of any increase in the number of radiation machines authorized by the certificate of registration in any radiation machine type or type of use category; and(III) perform an EPE on the radiation machines in accordance with subsection (j)(5)(J) of this section.(ii) For persons who do not hold a valid certificate of registration, loaner radiation machines may be used for human use up to 30 days, by or under the supervision of a dentist licensed by Texas State Board of Dental Examiners, before applying for a certificate of registration in accordance with this section. (6) Termination of certificates of registration. When a registrant decides to terminate all activities involving radiation machines authorized under the certificate of registration, the registrant shall notify the agency immediately and:(A) request termination of the certificate of registration in writing. The request shall be signed by the radiation safety officer, owner, or an individual authorized to act on behalf of the registrant;(B) submit to the agency a record of the disposition of the radiation machines and, if transferred, to whom transferred; and(C) pay any outstanding fees in accordance with subsection (h) of this section.(7) Modification, suspension, and revocation of certificates of registration. (A) The terms and conditions of all certificates of registration shall be subject to revision or modification. A certificate of registration may be suspended or revoked by reason of amendments to the Act, by reason of requirements of this chapter or orders issued by the agency.(B) Any certificate of registration may be revoked, suspended, or modified, in whole or in part in accordance with subsection (l)(3)(C)(iii) of this section. (C) Each certificate of registration revoked by the agency ends at the end of the day on the date of the agency's final determination to revoke the certificate of registration, or on the revocation date stated in the determination, or as otherwise provided by the agency order.(D) Except in cases in which the occupational and public health or safety requires otherwise, no certificate of registration shall be suspended or revoked unless, before the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been afforded an opportunity to demonstrate compliance with all lawful requirements.(8) Reciprocal recognition of out-of-state certificates of registration. (A) Whenever any radiation machine is to be brought into the State of Texas for any temporary use, the person proposing to bring the radiation machine into the state shall apply for and receive a notice from the agency granting reciprocal recognition before beginning operations. The request for reciprocity shall include the following:(i) completed RC Form 226-1 (Business Information Form);(ii) completed RC Form 252-3 (Notice of Intent to Work in Texas Under Reciprocity);(iii) name and Texas licensing board number of the dentist if the radiation machines are used on humans; (iv) copy of the applicant's current state certificate of registration or equivalent document;(v) copy of the applicant's current operating and safety procedures pertinent to the proposed use; (vi) fee as specified in subsection (h)(1) of this section; and(vii) qualifications of personnel who will be operating the radiation machines.(B) Upon a determination that the request for reciprocity meets the requirements of the agency, the agency may issue a notice granting reciprocal recognition authorizing the proposed radiation machine use.(C) Once reciprocity is granted, the out-of-state registrant shall file a RC Form 252-3 with the agency before each entry into the state. This form shall be filed at least three working days before the radiation machine is used in the state. At determination of the agency, the out-of-state registrant may, for a specific case, obtain permission to proceed sooner if the three-day period would impose an undue hardship.(D) When radiation machines are used as authorized under reciprocity, the out-of-state registrant shall have the following in its possession at all times for inspection by the agency:(i) completed RC Form 252-3; (ii) copy of the notice from the agency granting reciprocity; (iii) copy of the out-of-state registrant's operating and safety procedures; and(iv) copy of the applicable rules as specified in the notice granting reciprocity.(E) If the state from which the radiation machine is proposed to be brought does not issue certificates of registration or equivalent documents, a certificate of registration shall be obtained from the agency in accordance with the requirements of this section. (F) The agency may withdraw, limit, or qualify its acceptance of any certificate of registration or equivalent document issued by another agency upon determining that such action is necessary in order to prevent undue hazard to occupational and public health and safety or property or environment.(G) Reciprocal recognition will expire two years from the date it is granted. A new request for reciprocity shall be submitted to the agency every two years and the items in subparagraph (A) of this paragraph shall be included. (H) Radiation services provided by a person from out-of-state will not be granted reciprocity. Whenever radiation services are to be provided by a person from out-of-state, that person shall apply for and receive a certificate of registration from the agency before providing radiation services. The application shall be filed in accordance with this subsection, as applicable.(j) Use of radiation machines.(1) As low as reasonably achievable. Persons shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as reasonably achievable. (2) Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures. These procedures shall be read by and accessible to each individual before operating a radiation machine, including any restrictions of the operating technique required for the safe operation of the particular radiation machine. (A) The registrant shall ensure and document that each individual has read the operating and safety procedures before operating a radiation machine and reviewed the procedures annually not to exceed 12 months. This documentation shall be maintained in accordance with subsection (k)(2) of this section for inspection by the agency. The documentation shall include the following:(i) name and signature of individual;(ii) date individual read the operating and safety procedures; and(iii) initials of the radiation safety officer. (B) The operating and safety procedures shall include, but are not limited to, the following procedures as applicable:(i) ordering x-ray exams in accordance with subsection (b)(1)(A) and (B) of this section; (ii) providing radiation dose requirements in accordance with paragraph (3)(A) of this subsection;(iii) instructing workers in accordance with paragraph (3)(D) of this subsection;(iv) posting notices to workers in accordance with paragraph (4)(B) of this subsection;(v) posting of a radiation area in accordance with paragraph (4)(C) and (D) of this subsection; (vi) using a technique chart in accordance with paragraph (5)(A) of this subsection;(vii) holding of patients or film in accordance with paragraph (11)(A) and (B) of this subsection and subsection (c)(4) of this section;(viii) following film for processing program or digital imaging acquisition system protocols in accordance with paragraphs (12) - (14) of this subsection; (ix) notifying and reporting to individuals in accordance with subsection (k)(2) and (3) of this section; and(x) ensuring security and control of radiation machines in accordance with paragraph (4)(E)(i) of this subsection.(3) Personnel requirements. (A) Occupational dose limits.(i) The registrant shall control the occupational dose to individuals, to the following dose limits.(I) An annual limit shall be the total effective dose equivalent being equal to 5 rems (0.05 sievert).(II) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of any extremities shall be:(-a-) a lens dose equivalent of 15 rems (0.15 sievert); and(-b-) a shallow dose equivalent of 50 rems (0.5 sievert) to the skin of the whole body or to the skin of any extremity.(III) The annual limits for a minor shall be 10% of the annual occupational dose limits specified in subclauses (I) and (II) of this clause.(IV) If a woman declares her pregnancy, the registrant shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 millisievert). If a woman chooses not to declare pregnancy, the occupational dose limits specified in subclauses (I) and (II) of this clause are applicable to the woman.(V) The registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate (air kerma rate) to a declared pregnant woman to satisfy the limit in clause (i) of this subparagraph. The National Council on Radiation Protection and Measurements recommended in NCRP Report No. 116 "Limitation of Exposure to Radiation" (March 31, 1993) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received in any one month.(ii) The assigned deep dose equivalent shall be for the portion of the body receiving the highest exposure. The assigned shallow dose equivalent shall be the dose averaged over the contiguous 10 cm2 of the skin receiving the highest exposure.(iii) The deep dose equivalent, lens dose equivalent, and shallow dose equivalent may be assessed from surveys or radiation measurements for demonstrating compliance with the occupational dose limits.(iv) The registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received from radiation machines or radioactive materials while employed by any other person.(v) The agency may impose additional requirements for controlling occupational exposure to restrict or assess the collective dose. (B) Dose limits for individual members of the public.(i) Each registrant shall conduct operations so that:(I) the total effective dose equivalent to individual members of the public from exposure to radiation from radiation machines does not exceed 0.5 rem (5 millisieverts) in a year, exclusive of the dose contribution from background radiation, exposure of patients to radiation for medical diagnosis or therapy, or to voluntary participation in medical research programs; and(II) the dose in any unrestricted area from external sources does not exceed 0.002 rem (0.02 millisieverts) in any one hour.(ii) If the registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals.(iii) The agency may impose additional restrictions on radiation levels in unrestricted areas in order to restrict the collective dose.(C) Occupational doses from other sources of radiation. Individuals who receive occupational doses from sources of radiation other than dental radiation machines may be required to comply with the requirements of §289.231(n) and (q) - (s) of this title. (D) Instructions to workers. The registrant shall provide instructions to radiation workers before beginning initial work in restricted areas. These instructions shall include the following: (i) precautions or procedures to minimize exposure;(ii) the applicable provisions of agency requirements and certificates of registration for the protection of personnel from exposures to radiation occurring in such areas; and(iii) the radiation worker's responsibility to report promptly to the registrant any condition that may constitute, lead to, or cause a violation of agency requirements or certificate of registration conditions, or unnecessary exposure to radiation.(4) Facility requirements.(A) Caution signs. Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors magenta, purple or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows:Attached Graphic(i) the cross-hatched area of the symbol is to be magenta, purple, or black; and (ii) the background of the symbol is to be yellow.(B) Posting of notices to workers.(i) Each registrant shall post current copies of the following documents: (I) RC Form 232-1, "Notice to Employees," or an equivalent document containing at least the same wording as RC Form 232-1; andAttached Graphic(II) a notice that describes the following documents and states where the documents may be examined:(-a-) a copy of this section; (-b-) the certificate of registration and conditions or documents incorporated into the certificate of registration by reference and amendments thereto;(-c-) the operating procedures applicable to work under the certificate of registration; and(-d-) any notice of violation, if applicable, involving radiological working conditions, or order issued in accordance with subsections (b) and (l)(3) of this section and documentation of the corrections of any violations. (ii) Documents, notices, or forms posted in accordance with this subsection shall: (I) appear in an area visible to all workers to permit individuals engaged in work under the certificate of registration to observe the documents on the way to or from any particular work location to which the document applies;(II) be conspicuous; and(III) be replaced if defaced or altered. (C) Posting requirements. The registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA." (D) Exceptions to posting requirements. Registrants are exempt from the posting of the radiation area requirements in subparagraph (C) of this paragraph if the operator has continuous surveillance and access control of the radiation area.(E) Security and control of radiation machines.(i) The registrant shall establish a protocol to ensure radiation machines are secure from unauthorized removal.(ii) The registrant shall use devices and administrative procedures to prevent unauthorized use of radiation machines.(iii) Any person using hand-held dental radiation machines shall ensure proper storage of the unit to include:(I) securing the unit against theft or unauthorized use; and(II) storing the unit in locked cabinets, storage rooms or work areas when not under immediate supervision of authorized users.(5) Radiation machine requirements.(A) Technique chart. (i) A technique chart relevant to the particular radiation machine shall be provided or electronically displayed near the control panel and used by all operators. (ii) Technique and exposure indicators. (I) The technique factors to be used during an exposure shall be indicated before the exposure begins except: (-a-) when automatic exposure controls are used, in which case the technique factors that are set before the exposure shall be indicated; or (-b-) unless prevented by the design of the certified radiation machine.(II) On radiation machines having fixed technique factors, the requirement of subclause (I) of this clause may be met by permanent markings. (III) The x-ray control shall provide visual indication of the production of x-rays. In addition, a signal audible to the operator shall indicate that the exposure has terminated.(IV) The indicated technique factors shall be accurate to within manufacturer's specifications. If these specifications are not available from the manufacturer, the factors shall be accurate to within plus or minus 10% of the indicated setting. (B) Labeling radiation machines. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the radiation machine. (C) Mechanical support of tube head. The tube housing assembly shall be adjusted to remain stable during an exposure unless tube housing movement is a designed function of the radiation machine. (D) Battery charge indicator. On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.(E) Beam quality. The following requirements apply to beam quality.(i) Half-value layer.(I) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in the following table. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in the table, linear interpolation may be made.Attached Graphic(II) For capacitor energy storage equipment, compliance with the requirements of this subparagraph shall be determined with the maximum quantity of charge per exposure.(ii) Filtration controls. (I) For radiation machines that have variable kilovolt peak and variable filtration for the useful beam, a device shall link the kilovolt peak selector with the filters and shall prevent an exposure unless the minimum amount of filtration required by clause (i) of this subparagraph is in the useful beam for the given kilovolt peak that has been selected.(II) Any other radiation machine having removable filters shall be required to have the minimum amount of filtration as required by clause (i)(I) of this subparagraph permanently located in the useful beam during each exposure.(F) Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated before initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly that has been selected.(G) X-ray control. An x-ray control shall be incorporated into each radiation machine such that an exposure can be terminated by the operator at any time, except for exposures of 0.5 second or less. The exposure switch shall be of the continuous pressure type.(H) Radiation machines needing correction or repair. The correction or repair shall begin within 30 days following the failure and the registrant shall perform or cause to be performed the correction or repair according to a designated plan. Correction or repair shall be completed no longer than 90 days from discovery unless authorized in writing by the agency.(I) Records of radiation machine corrections or repairs. The registrant shall maintain records of corrections or repairs and any tests, measurements or numerical readings listed in subparagraph (J) of this paragraph in accordance with subsection (k)(2) of this section for inspection by the agency. (J) Equipment performance evaluations (EPE). (i) For all dental radiation machines, the registrant shall perform, or cause to be performed, EPE tests for each item specified in clauses (v) - (xi) of this subparagraph as follows: (I) within 30 days after initial installation of radiation machines:(II) within 30 days after reinstallation of a radiation machine; and(III) within 30 days after repair of a radiation machine component that would affect the radiation output that includes, but is not limited to, the timer, tube, and power supply. (ii) Frequency of EPE. For x-ray and CT systems, an EPE shall be performed at the frequency listed in the following table.Attached Graphic(iii) Records of the EPE results shall be available for inspection by the agency and shall include the following:(I) measurements and numerical readings;(II) indication of pass or fail for each test; and(III) maintenance by the registrant in accordance with subsection (k)(2) of this section for inspection by the agency.(iv) Radiation machines needing correction or repair. If a radiation machine requires correction or repair following an EPE, the correction or repair shall begin within 30 days following the failure and the registrant shall perform or cause to be performed the correction or repair according to a designated plan. Correction or repair shall be completed no longer than 90 days from discovery unless authorized in writing by the agency.(v) Timer.(I) The accuracy of the timer shall meet the manufacturer's specifications. If the manufacturer's specifications are not obtainable, the timer accuracy shall be plus or minus 10% of the indicated time with testing performed at 0.5 second.(II) Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided. (vi) Exposure reproducibility. When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed 0.05. This requirement applies to clinically used techniques.(vii) Kilovolt peak. If the registrant possesses documentation of the appropriate manufacturer's kilovolt peak specifications, the radiation machine shall meet those specifications. If the registrant does not possess documentation of the appropriate manufacturer's kilovolt peak specifications, the indicated kilovolt peak shall be accurate to within plus or minus 10% of the indicated settings. For radiation machines with fewer than three fixed kilovolt peak settings, the radiation machine shall be checked at those settings.(viii) Tube stability. The x-ray tube shall remain physically stable during exposures. In cases where tubes are designed to move during exposure, the registrant shall assure proper and free movement of the radiation machine.(ix) Collimation. Field limitation shall meet the requirements of paragraphs (9) and (10) of this subsection.(x) Entrance exposure limits (air kerma limits) for dental facilities. The in-air exposure (entrance air kerma) for an adult bite wing view shall be determined from the exposure technique used by the registrant for the average adult patient. The in-air exposure (entrance air kerma) for intraoral (bite wing) dental radiography shall not exceed the following entrance exposure limits (air kerma limits):Attached Graphic(xi) Measurements of the radiation output for a radiation machine. Measurements of the radiation output for a radiation machine shall be performed with a calibrated dosimetry system in accordance with the following. (I) The dosimetry system calibration shall be traceable to a national standard.(II) Dosimetry systems shall be calibrated within 24 months from the date of the prior calibration.(xii) Record of dosimetry system calibration. The registrant shall verify all dosimetry equipment meets the requirements of clause (xi) of this subparagraph. (6) Dental research. (A) Any research using radiation machines on humans shall be approved by an Investigational Review Board (IRB) as required by Title 45, CFR, Part 46, and Title 21, CFR, Part 56. The IRB shall include at least one licensed dentist to direct any use of radiation in accordance with this section. (B) Facilities with radiation machines with investigational device exemptions that are involved in clinical studies shall comply with primary regulations that govern the conduct of clinical studies and that apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. These regulations include the following:(i) 21 CFR, Part 812, Investigational Device Exemptions;(ii) 21 CFR, Part 50, Protection of Human Subjects;(iii) 21 CFR, Part 56, Institutional Review Boards;(iv) 21 CFR, Part 54, Financial Disclosure by Clinical Investigators; and(v) 21 CFR, Part 820, Subpart C, Design Controls of the Quality System Regulation.(7) Educational facilities. Facilities conducting training using non-humans are held to all the requirements of this section except for paragraph (5)(J) of this subsection concerning EPE and for paragraphs (12) and (13) of this subsection concerning image processing. (8) Certified radiation machines for dental facilities. The registrant shall not make, nor cause to be made, any modification of components or installations of components certified in accordance with the United States Food and Drug Administration Title 21, CFR, Part 1020, "Performance Standards for Ionizing Radiation Emitting Products," as amended, in any manner that could cause the installations or the components to fail to meet the requirements of the applicable parts of the standards specified in Title 21, CFR, Part 1020, except where a variance has been granted by the Director, Center for Devices and Radiological Health, United States Food and Drug Administration. A copy of the variance shall be maintained by the registrant in accordance with subsection (k)(2) of this section for inspection by the agency. All modifications of components or installation of components must be approved by the manufacturer.(9) Additional requirements for dental intraoral radiation machines. (A) Source-to-skin distance. Radiation machines designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than: (i) 18 centimeters if operable above 50 kilovolt peak; or (ii) 10 centimeters if not operable above 50 kilovolt peak. (B) Field limitation. Radiation machines designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that: (i) if the minimum source-to-skin distance is 18 centimeters or more, the x-ray field at the minimum source-to-skin distance shall be restricted to a dimension of no more than seven centimeters; and (ii) if the minimum source-to-skin distance is less than 18 centimeters, the x-ray field at the minimum source-to-skin distance shall be restricted to a dimension of no more than six centimeters. (10) Additional requirements for dental extraoral radiation machines. (A) Dental panoramic radiation machines shall be provided with means to restrict the x-ray beam to the following: (i) the imaging slit in the transverse axis; and (ii) no more than a total of 0.5 inches larger than the imaging slit in the vertical axis. (B) All other dental extraoral radiation machines (e.g., cephalometric) shall be provided with means to restrict the x-ray field to the image receptor. The x-ray field shall not exceed the image receptor by more than: (i) 2.0% of the source-to-image receptor distance for the length or width of the image receptor for rectangular collimation; or(ii) 2.0% of the source-to-image receptor distance for the diagonal of the image receptor for circular or polygon collimation. (11) Additional operational controls.(A) When a patient or image receptor must be held in position during radiography, mechanical supporting or restraining devices shall be used when the exam permits except in individual cases in which the registrant has determined that the holding devices are contraindicated. (B) The registrant's written operating and safety procedures required by paragraph (2) of this subsection shall include the following: (i) a list of circumstances in which mechanical holding devices cannot be routinely utilized; and(ii) a procedure used for selecting an individual to hold or support the patient or image receptor. (C) The operator position during the exposure shall be such that the operator's exposure is as low as reasonably achievable and the operator is a minimum of six feet from the useful beam or behind a protective barrier. The operator shall maintain verbal, aural, and visual contact with the patient.(12) Automatic and manual film processing for dental facilities and mobile dental services.(A) Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer. The specified developer temperature for automatic processing and the time-temperature chart for manual processing shall be posted in the processing area. If the registrant determines an alternate time-temperature relationship is more appropriate for a specific facility, that time-temperature relationship shall be documented and posted. (B) Chemicals shall be replaced according to the chemical manufacturer or supplier's recommendations or at an interval not to exceed three months. (C) Darkroom light leak tests shall be performed at intervals not to exceed six months. (D) Lighting in the film processing/loading area shall be maintained with the filter, bulb wattage, and distances recommended by the film manufacturer for that film emulsion or with products that provide an equivalent level of protection against fogging.(E) Corrections or repairs of the light leaks or other deficiencies in subparagraphs (B) - (D) of this paragraph shall be initiated within 72 hours after discovery and completed no longer than 15 days from detection of the deficiency unless a longer time is authorized by the agency. Records of the corrections or repairs shall include the date and initials of the individual performing these functions and the registrant shall maintain the records in accordance with subsection (k)(2) of this section for inspection by the agency.(F) Documentation of the items in subparagraphs (B), (C), and (E) of this paragraph shall be maintained at the site where performed and shall include the date and initials of the individual completing these items. These records shall be made and maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(13) Alternative processing systems. Users of daylight processing systems, laser processors, self-processing film systems, or other alternative processing systems shall follow manufacturer's recommendations for image processing. Documentation that the registrant is following manufacturer's recommendations shall include the date and initials of the individual completing the document and shall be made and maintained at the authorized use location where performed in accordance with subsection (k)(2) of this section for inspection by the agency.(14) Digital imaging acquisition systems. (A) Users of digital imaging acquisition systems shall follow quality assurance/quality control (QA/QC) protocol for digital imaging established by the manufacturer. (i) The registrant shall include the protocols established in paragraph (2) of this subsection in its operating and safety procedures. (ii) The registrant shall document the frequency at which the quality assurance/quality control protocol is performed. Documentation shall:(I) include the date and initials of the individual completing the document and the images acquired; and(II) be maintained and available at the authorized use location where performed in accordance with subsection (k)(2) of this section for inspection by the agency.(B) If a protocol cannot be established by the manufacturer, it shall be developed and implemented by the registrant. (i) The QA/QC protocol, as developed and implemented by the registrant, shall include image quality testing for, but not limited to, spatial resolution, noise, artifacts and contrast by using a commercially purchased testing tool or an inanimate object of at least three varying densities. (I) Images shall be acquired with each x-ray image receptor at an interval not to exceed three months. (II) Test images shall be compared to previous test images to assess degradation of image quality. (III) If a radiation machine or components of the digital imaging acquisition system require correction or repair following a quality test, the correction or repair shall begin within 30 days following the failure and the registrant shall perform or cause to be performed the correction or repair according to a designated plan. Correction or repair shall be completed no longer than 90 days from discovery unless authorized in writing by the agency.(ii) The registrant shall include the protocols established in paragraph (2) of this subsection in its operating and safety procedures. (iii) The registrant shall document the frequency at which the quality assurance/quality control protocol is performed. Documentation shall:(I) include the date and initials of the individual completing the document and the images acquired; and(II) be maintained and available at the authorized use location where performed in accordance with subsection (k)(2) of this section for inspection by the agency.(k) Records and reports.(1) General provisions for records and reports.(A) Each registrant shall maintain records at each site, including sites authorized by the certificate of registration, conditions, and records sites for mobile services. The records shall include those specified in paragraph (2) of this subsection and shall be maintained at the time interval indicated for inspection by the agency. These records may be maintained in electronic format. These records shall be accessible to radiation machine operators during working hours.(B) All records required by this section shall be accurate and factual. (C) Each registrant shall use the SI units gray, sievert, and coulomb per kilogram, or the special units rad, rem, and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this section. (D) The registrant shall make a clear distinction among the quantities entered on the records required by this section, such as, total effective dose equivalent, shallow dose equivalent, lens dose equivalent, and deep dose equivalent. (E) Each record required by this section shall be legible throughout the specified retention period. (F) The record shall be the original, a reproduced copy, or a microform, if the authorized personnel authenticate the copy or microform and that the microform is capable of producing a clear copy throughout the required retention period. (G) The record may also be stored in electronic format with the capability for producing legible, accurate, and complete records during the required retention period.(H) The registrant shall maintain adequate safeguards against tampering with and loss of records.(I) Copies of records required in subsections (i)(5)(I) and (J), (j)(5)(J), and (j)(12)(F) of this section and by certificate of registration condition that are relevant to operations at an additional authorized use location shall be maintained at that location in addition to the main site specified on a certificate of registration in accordance with subsection (k)(2) of this section.(J) Subject to the limitations provided in the Texas Public Information Act, Government Code, Chapter 552, all information and data collected, assembled, or maintained by the agency are public records open to inspection and copying during regular office hours.(K) Any person who submits written information or data to the agency and requests that the information be considered confidential, privileged, or otherwise not available to the public under the Texas Public Information Act, shall justify such request in writing, including statutes and cases where applicable, addressed to the agency.(i) Documents containing information that is claimed to fall within an exception to the Texas Public Information Act shall be marked to indicate that fact. Markings shall be placed on the document on origination or submission.(I) The words "NOT AN OPEN RECORD" shall be placed conspicuously at the top and bottom of each page containing information claimed to fall within one of the exceptions.(II) The following wording shall be placed at the bottom of the front cover and title page, or first page of text if there is no front cover or title page:Attached Graphic(ii) The agency requests, whenever possible, that all information submitted under the claim of an exception to the Texas Public Information Act be extracted from the main body of the application and submitted as a separate annex or appendix to the application.(iii) Failure to comply with any of the procedures that are described in clauses (i) and (ii) of this subparagraph may result in all information in the agency file being disclosed upon an open records request.(L) The agency will determine whether information falls within one of the exceptions to the Texas Public Information Act. The agency will determine whether there has been a previous determination that the information falls within one of the exceptions to the Texas Public Information Act. If there has been no previous determination and the agency believes that the information falls within one of the exceptions, an opinion of the Attorney General will be requested. If the agency agrees in writing to the request, the information shall not be open for public inspection unless the Attorney General's office subsequently determines that it is not an exception.(M) Requests for information.(i) All requests for open records information shall be in writing and refer to documents currently in possession of the agency.(ii) The agency will determine whether the information may be released or whether it falls within an exception to the Texas Public Information Act.(I) The agency may take a reasonable period to determine whether information falls within one of the exceptions to the Texas Public Information Act.(II) If the information is determined to be public, it will be presented for inspection and copies of documents will be furnished within a reasonable period. A fee will be charged to recover agency costs for copies.(iii) Original copies of public records may not be removed from the agency. Under no circumstances shall material be removed from existing records.(2) Records requirements. (A) Each registrant shall maintain the following records at each site, including authorized records sites for mobile services, at the time intervals specified and make available to the agency for inspection. The records may be maintained in electronic format.Attached Graphic(B) For radiation machines authorized for mobile service, copies of the records specified in the table in subparagraph (A)(iii)-(v) of this paragraph shall be maintained with the radiation machine in accordance with subparagraph (A) of this paragraph for inspection by the agency. If on-board processors are utilized, image processing records shall also be made on board in accordance with subsection (j)(12), (13), and (14) of this section and maintained in accordance with subparagraph (A) of this paragraph for inspection by the agency. (C) For authorized records sites for mobile services, copies of the records specified in subparagraph (A)(ii) and (vi)-(xii) of this paragraph shall be maintained in accordance with subparagraph (A) of this paragraph for inspection by the agency. (3) Reports.(A) Reports of stolen, lost, or missing radiation machines. (i) Each registrant shall report to the agency by telephone a stolen, lost, or missing radiation machine immediately after its occurrence becomes known to the registrant. (ii) Within 30 days after making the telephone report, each registrant required to make a report according to clause (i) of this subparagraph shall make a written report to the agency that includes the following information: (I) a description of the radiation machine involved, including the manufacturer name, model and serial number; (II) a description of the circumstances under which the loss or theft occurred; (III) actions that have been taken, or will be taken, to recover the radiation machine; and (IV) procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of radiation machines. (iii) Subsequent to filing the written report, the registrant shall also report additional information pertaining to the loss or theft within 30 days after the registrant learns of such information. (iv) The registrant shall prepare any report filed with the agency in accordance with this subsection so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.(B) Reports of incidents.(i) Notwithstanding other requirements for notification, each registrant shall immediately report each event involving a radiation machine possessed by the registrant that may have caused or threatens to cause an individual, except radiation administered for healing arts purposes, to receive:(I) a total effective dose equivalent of 25 rems (0.25 sievert) or more; (II) a lens dose equivalent of 75 rems (0.75 sievert) or more; or(III) a shallow dose equivalent to the skin of the whole body or to the skin of any extremities of 250 rads (2.5 grays) or more.(ii) Within 24 hours of discovery of the event, each registrant shall report to the agency each event involving loss of control of a radiation machine possessed by the registrant that may have caused, or threatens to cause an individual to receive, in a period of 24 hours:(I) a total effective dose equivalent exceeding 5 rems (0.05 sievert); (II) a lens dose equivalent exceeding 15 rems (0.15 sievert); or(III) a shallow dose equivalent to the skin of the whole body or to the skin of any extremities exceeding 50 rems (0.5 sievert).(iii) Registrants shall make the initial notification reports required by clauses (i) and (ii) of this subparagraph by telephone to the agency and shall confirm the initial notification report within 24 hours by facsimile or other electronic media to the agency. (iv) The registrant shall prepare each report filed with the agency in accordance with this section so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.(C) Reports of exposures and radiation levels exceeding the limits. (i) In addition to the notification required by subparagraph (B) of this paragraph, each registrant shall submit a written report within 30 days after learning of any of the following occurrences: (I) incidents for which notification are required by subparagraph (B) of this paragraph; (II) doses in excess of any of the following: (-a-) the occupational dose limits for adults in subsection (j)(3)(A)(i) of this section; (-b-) the occupational dose limits for a minor in subsection (j)(3)(A)(i)(III) of this section; (-c-) the limits for an embryo/fetus of a declared pregnant woman in subsection (j)(3)(A)(i)(IV) and (V) of this section; (-d-) the limits for an individual member of the public in subsection (j)(3)(B) of this section; or (-e-) any applicable limit in the certificate of registration; (III) levels of radiation in: (-a-) a restricted area in excess of applicable limits in the certificate of registration; or(-b-) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the certificate of registration conditions, whether or not involving exposure of any individual in excess of the limits in subsection (j)(3)(B) of this section. (ii) Each report required by clause (i) of this subparagraph shall describe the extent of exposure of individuals to radiation, including, as appropriate: (I) estimates of each individual's dose; (II) the levels of radiation involved; (III) the cause of the elevated exposures, dose rates; and (IV) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, and associated registration conditions. (iii) Each report filed in accordance with clause (i) of this subparagraph shall include, for each individual exposed, the name, a unique identification number, and date of birth. With respect to the limit for the embryo/fetus in subsection (j)(3)(A)(i)(IV) and (V) of this section, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report. (D) Reports to individuals of exposures. (i) If applicable, radiation exposure data for an individual shall be reported to the individual as specified in this paragraph. The information reported shall include data and results obtained in accordance with requirements of this section, orders, certificate of registration conditions, as shown in records made and maintained by the registrant in accordance with this subsection. Each notification and report shall: (I) be in writing; (II) include appropriate identifying data such as the name of the registrant, the name of the individual, and the individual's identification number; (III) include the individual's exposure information; and (IV) contain the following statement: "This report is furnished to you under the provisions of the Texas Regulations for Control of Radiation, 25 Texas Administrative Code §289.232(j)(3)(A) - (C). You should preserve this report for further reference." (ii) If applicable, each registrant shall provide an annual written report to advise each worker of the worker's estimated dose, received in that monitoring year, as shown in records made and maintained by the registrant in accordance with subparagraph (C) of this paragraph if: (I) the individual's occupational dose exceeds 100 mrem (1 mSv) total effective dose equivalent or 100 mrem (1 mSv) to any individual organ or tissue; or(II) the individual requests his or her annual dose report in writing.(iii) When a registrant is required in accordance with subparagraphs (B) and (C) of this paragraph to report to the agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation, the registrant shall also notify the individual and provide the individual with a copy of the report submitted to the agency, including the information required by clause (i) of this subparagraph. Such reports shall be transmitted no later than the transmittal to the agency.(l) Compliance and hearing procedures.(1) Inspections. The agency may enter public or private property at reasonable times to determine whether, in a matter under the agency's jurisdiction, there is compliance with the Act, the requirements of this section, certificate of registration conditions, and orders issued by the agency. (A) Each registrant shall perform, upon instructions from the agency, or shall permit the agency to perform such reasonable surveys, as the agency deems appropriate or necessary, including, but not limited to, surveys of: (i) radiation machines;(ii) facilities where radiation machines are used; and(iii) other radiation machines and devices used in connection with utilization of radiation machines.(B) The routine inspection interval for dental facilities is four years. On-site inspections and remote inspections may be alternated as determined by the agency. The inspection interval specified is based upon the average number of health-related violations per inspection, as determined from compliance history data. Registrant's having certificates of registration authorizing multiple radiation machine use categories will be inspected on-site at the most frequent interval specified for the radiation machine uses authorized. (i) Notwithstanding the inspection interval specified in this subparagraph, the agency may inspect registrants more frequently due to: (I) the persistence or severity of violations found during an inspection; (II) investigation of an incident or complaint concerning the facility; (III) a request for an inspection by a worker in accordance with paragraph (2) of this subsection; (IV) any change in a facility or radiation machine that might cause a significant increase in radiation output or hazard; or (V) a mutual agreement between the agency and registrant. (ii) The agency will conduct inspections of dental radiation machines in a manner designed to cause as little disruption of a dental practice as is practicable.(C) On-site Inspections.(i) Each registrant shall afford to the agency at all reasonable times opportunity to inspect materials, radiation machines, activities, facilities, premises, and records in accordance with this section. (ii) During an inspection, agency inspectors may obtain and retain paper or electronic copies of requested documentation in accordance with this section. (iii) Each registrant shall make available to the agency for inspection records made and maintained in accordance with this section.(iv) Agency inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of agency regulations and certificates of registration to the extent the inspectors deem necessary for the conduct of an inspection. (v) An employee who routinely is engaged in work under control of the registrant, operating the radiation machines for healing arts purposes, shall be made available to operate the radiation machines at the time of the inspection and engage in the inspection process.(vi) Notwithstanding the other provisions of this section, agency inspectors are authorized to refuse to permit accompaniment by any individual who interferes, delays, or causes to be delayed an inspection. (D) For remote inspection of dental radiation machines, each registrant shall:(i) respond to a request from the agency for a remote inspection; (ii) complete the remote inspection forms in accordance with the instructions included with the forms; and(iii) return to the agency the completed remote inspection forms, including documentation of the most recent EPE performed in accordance with subsection (j)(5)(J) of this section and an inventory in accordance with subsection (i)(5)(I) of this section by the deadline indicated on the forms.(E) During the course of an inspection, any worker may privately inform the inspectors, either verbally or in writing, any past or present condition which that individual has reason to believe may have contributed to or caused any violation of the Act, the requirements in this section, certificate of registration conditions, or any unnecessary exposure of an individual to radiation from any radiation machine source of radiation under the registrant's control. Any such notice in writing shall comply with the requirements of paragraph (2) of this subsection. (F) The provisions of subparagraph (E) of this paragraph shall not be interpreted as authorization to disregard instructions in accordance with subsection (j)(3)(D) of this section. (2) Complaints. Any worker or representative of a worker who believes that a violation of the Act, the requirements of this section, or certificate of registration conditions exists or has occurred in work under a certificate of registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the agency. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and the worker or representative of the worker shall sign the notice. A copy shall be provided to the registrant by the agency no later than at the time of inspection except that, upon the request of the worker giving such notice, the worker's name and the name of individual referred to therein shall not appear in such copy or on any record published, released, or made available by the agency, except for good cause shown. (A) If, upon receipt of such notice, the agency determines that the request meets the requirements set forth in this paragraph, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspections in accordance with this section need not be limited to matters referred in the request. (B) No registrant, contractor or subcontractor of a registrant shall discharge or in any manner discriminate against any worker because of the following: (i) such worker has filed any request or instituted or caused to be instituted any proceeding under this section; (ii) such worker has testified or is about to testify in any such proceeding; or (iii) because of the exercise by such worker on behalf of that individual or others of any option afforded by this section. (C) Inspections not warranted. (i) If the agency determines, with respect to a request under subparagraphs (A) and (B) of this paragraph, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the agency shall notify the requestor in writing of such determination. The requestor may obtain review of such determination in accordance with the provisions of the Act and the Government Code, Chapters 2001 and 2002. (ii) If the agency determines that an inspection is not warranted because the requirements of this paragraph have not been met, the agency shall notify the requestor in writing of such determination. Such determination shall be without prejudice to the filing of a new request meeting the requirements of this paragraph. (D) Agency inspectors are required to have special training in the design and uses of medical x-ray equipment. Inspector training requirements and standards will be detailed in the Radiation Control Program policies and procedures manual.(3) Hearing and enforcement procedures.(A) Violations. (i) A court injunction or agency order may be issued prohibiting any violation of any provision of the Act or any requirement of this section or order issued thereunder.(ii) Any person who violates any provision of the Act or any requirement of this section or order issued thereunder may be subject to civil or administrative penalties. (iii) Such person may also be guilty of a misdemeanor and upon conviction, may be punished by fine or imprisonment or both, as provided by law. (B) Denial of an application for a certificate of registration. (i) When the agency contemplates denial of an application for certificate of registration as outlined in subparagraph (A)(i) of this paragraph, the registrant shall be afforded the opportunity for a hearing. Notice of the denial shall be delivered to the registrant by mail, addressed to the last known address of the registrant. (ii) Any applicant or registrant against whom the agency contemplates denial of an application may request a hearing by submitting a written request to the director within 30 days after service of the notice or date of mailing. (I) The written request for a hearing shall contain the following: (-a-) statement requesting a hearing; and (-b-) name and address of the applicant or registrant. (II) Failure to submit a written request for a hearing within 30 days after notice is sent will render the agency action final.(C) Compliance procedures for registrants and other persons.(i) A registrant or other person who commits a violation will be issued a notice of violation. The person receiving the notice shall provide the agency with a written statement and supporting documentation by the date stated in the notice describing the following:(I) steps taken by the person and the results achieved;(II) corrective steps to be taken to prevent recurrence; and (III) the date when full compliance was or is expected to be achieved. The agency may require responses to notices of violation to be under oath.(ii) The terms and conditions of all certificates of registration shall be subject to amendment or modification. A certificate of registration may be modified, suspended, or revoked by reason of amendments to the Act, or for violation of the Act, the requirements of this section, a condition of the certificate of registration, or an order of the agency.(iii) Any certificate of registration may be modified, suspended, or revoked in whole or in part, for any of the following:(I) any material false statement in the application or any statement of fact required in accordance with provisions of the Act;(II) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a certificate of registration on an original application; (III) violation of, or failure to observe any of the applicable terms and conditions of the Act, this section, or of the certificate of registration, or order of the agency; or (IV) existing conditions that constitute a substantial threat to the public health or safety or the environment.(iv) If another state or federal entity takes an action such as modification, revocation, or suspension of the certificate of registration, the agency may take a similar action against the registrant. (v) When the agency determines that the action provided for in clause (viii) of this subparagraph or subparagraph (D) of this paragraph is not to be taken immediately, the agency may offer the registrant an opportunity to attend an informal conference to discuss the following with the agency: (I) methods and schedules for correcting the violations; or (II) methods and schedules for showing compliance with applicable provisions of the Act, the requirements of this section, certificate of registration conditions, or any orders of the agency. (vi) Notice of any informal conference shall be delivered by personal service, or certified mail, addressed to the last known address. An informal conference is not a prerequisite for the action to be taken in accordance with clause (viii) of this subparagraph or subparagraph (D) of this paragraph.(vii) Except in cases in which the occupational and public health or safety requires otherwise, no certificate of registration shall be suspended or revoked unless, before the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing, and the registrant shall have been afforded an opportunity to demonstrate compliance with all lawful requirements.(viii) When the agency contemplates modification, suspension, or revocation of the certificate of registration, the registrant shall be afforded the opportunity for a hearing. Notice of the contemplated action, along with a complaint, shall be given to the registrant by personal service or certified mail, addressed to the last known address.(ix) Any applicant or registrant against whom the agency contemplates an action described in clause (viii) of this subparagraph may request a hearing by submitting a written request to the director within 30 days after service of the notice. (I) The written request for a hearing shall contain the following: (-a-) statement requesting a hearing; (-b-) name, address, and identification number of the registrant against whom the action is being taken. (II) Failure to submit a written request for a hearing within 30 days after notice is sent will render the agency action final.(D) Assessment of administrative penalties.(i) When the agency determines that monetary penalties are appropriate, proposals for assessment of and hearings on administrative penalties shall be made in accordance with Health and Safety Code, §401.384; Title 1, Texas Administrative Code, Chapter 155; and applicable sections of the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title.(ii) Assessment of administrative penalties shall be based on the following criteria: (I) the seriousness of the violations; (II) previous compliance history; (III) the amount necessary to deter future violations; (IV) efforts to correct the violations; and (V) any other mitigating or enhancing factors.(iii) Application of administrative penalties. The agency may impose differing levels of penalties for different severity level violations and different classes of users as follows.(I) Administrative penalties may be imposed for severity level I and II violations. Administrative penalties may be imposed for severity level III, IV, and V violations when the violations are combined with those of higher severity levels or for repeated violations. (II) The following Tables A and B show the base administrative penalties. Attached Graphic(III) Adjustments to the percentages of base amounts in Table B may be made for the presence or absence of the following factors: (-a-) prompt identification and reporting; (-b-) corrective action to prevent recurrence; (-c-) compliance history; (-d-) prior notice of similar event; (-e-) multiple occurrences; and (-f-) negligence that resulted in or increased adverse effects. (IV) The penalty for each violation may be in an amount not to exceed $10,000 a day for a person who violates the Act or requirements of this section, order, or certificate of registration issued in accordance with the Act. Each day a violation continues may be considered a separate violation for purposes of penalty assessment.(iv) The agency may conduct settlement negotiations.(E) Severity levels of violations for registrants or other persons.(i) Violations for registrants or other persons shall be categorized by one of the following severity levels.(I) Severity level I are violations that are most significant and may have a significant negative impact on occupational or public health and safety or on the environment. (II) Severity level II are violations that are very significant and may have a negative impact on occupational or public health and safety or on the environment. (III) Severity level III are violations that are significant and which, if not corrected, could threaten occupational or public health and safety or the environment. (IV) Severity level IV are violations that are of more than minor significance, but if left uncorrected, could lead to more serious circumstances. (V) Severity level V are violations that are of minor safety or environmental significance.(ii) Criteria to elevate or reduce severity levels. (I) Severity levels may be elevated to a higher severity level for the following reasons: (-a-) more than one violation resulted from the same underlying cause; (-b-) a violation contributed to or was the consequence of the underlying cause, such as a management breakdown or breakdown in the control of registered activities; (-c-) a violation occurred multiple times between inspections; (-d-) a violation was willful or grossly negligent;(-e-) compliance history; or (-f-) other mitigating factors.(II) Severity levels may be reduced to a lower level for the following reasons: (-a-) the registrant identified and corrected the violation before the agency inspection; (-b-) the registrant's actions corrected the violation and prevented recurrence; or(-c-) other mitigating factors.(iii) Examples of severity levels. Examples of severity levels are available upon request to the agency.(F) Impoundment of radiation machines. Radiation machines shall be subject to impounding in accordance with Health and Safety Code, §401.068 and this paragraph.(i) In the event of an emergency, the agency shall have the authority to impound or order the impounding of radiation machines possessed by any person not equipped to observe or failing to observe the provisions of the Act, or any requirements of this section, certificate of registration conditions, or orders issued by the agency. The agency shall submit notice of the action to be published in the Texas Register no later than 30 days following the end of the month in which the action was taken. (ii) At the agency's discretion, the impounded radiation machines may be disposed of by: (I) returning the radiation machine to a properly registered owner, upon proof of ownership, who did not cause the emergency;(II) releasing the radiation machine as evidence to police or courts; (III) returning the radiation machine to a registrant after the emergency is over and settlement of any compliance action; or (IV) selling, destroying or other disposition within the agency's discretion.(iii) If agency action is necessary to protect the public health and safety, no prior notice need be given the owner or possessor. If agency action is not necessary to protect the public health and safety, the agency will give written notice to the owner or the possessor of the impounded radiation machine of the intention to dispose of the radiation machine. Notice shall be the same as provided in subparagraph (C)(viii) of this paragraph. The owner or possessor shall have 30 days from the date of personal service or mailing to request a hearing under Title 1, Texas Administrative Code, Chapter 155, and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title, and in accordance with subparagraph (C)(ix) of this paragraph, concerning the intention of the agency. If no hearing is requested within that period, the agency may take the contemplated action, and such action is final.(iv) Upon agency disposition of a radiation machine, the agency may notify the owner or possessor of any expense the agency may have incurred during the impoundment or disposition and request reimbursement. If the amount is not paid within 60 days from the date of notice, the agency may request the Attorney General to file suit against the owner or possessor for the amount requested.(v) If the agency determines from the facts available that an impounded radiation machine is abandoned, with no reasonable evidence showing its owner or possessor, the agency may make such disposition of the radiation machine as it sees fit.(G) Emergency orders.(i) When an emergency exists requiring immediate action to protect the public health or safety or the environment, the agency may, without notice or hearing, issue an order citing the existence of such emergency and require that certain actions be taken as the agency directs to meet the emergency. No later than 30 days following the end of the month in which the action was taken, the agency shall submit notice of the action for publication in the Texas Register. The action taken will remain in full force and effect unless and until modified by subsequent action of the agency.(ii) An emergency order takes effect immediately upon service. (iii) Any person receiving an emergency order shall comply immediately.(iv) The person receiving the order shall be afforded the opportunity for a hearing on an emergency order. Notice of the action, along with a complaint, shall be given to the person by personal service or certified mail, addressed to the last known address. A hearing shall be held on an emergency order if the person receiving the order submits a written request to the director within 30 days after the date of the order.(I) The hearing shall be held not less than 10 days nor more than 20 days after receipt of the written application for hearing. (II) At the conclusion of the hearing and after the proposal for decision is made as provided in the Texas Administrative Procedure Act, Texas Government Code, Chapter 2001, the commissioner shall take one of the following actions: (-a-) determine that no further action is warranted; (-b-) amend the certificate of registration; (-c-) revoke or suspend the certificate of registration; (-d-) rescind the emergency order; or (-e-) issue such other order as is appropriate. (III) The application and hearing shall not delay compliance with the emergency order.(H) Miscellaneous provisions.(i) Computation of time. A time established by the requirements of this section shall begin on the first day after the event that invokes the time. When the last day of the period falls on a Saturday, Sunday, or state or federal holiday, the time shall end on the next day that is not a Saturday, Sunday, or state or federal holiday. The time shall expire at 5:00 p.m. of the last day of the computed time.(ii) Hearing location. Hearings will be held at the offices of the State Office of Administrative Hearings in Austin unless the administrative law judge specifies another location.(iii) Non-party witness and mileage fees.(I) A witness or deponent who is not a party (or an employee, agent, or representative of a party) and who is subpoenaed or otherwise compelled to attend an agency hearing or a proceeding to give a deposition, or to produce books, records, papers, accounts, documents, or other objects necessary and proper for the purposes of the hearing or proceeding may receive reimbursement for transportation and other costs at rates established by the current Appropriations Act for state employees.(II) The person requesting the attendance of the witness or deponent shall deposit with the agency the funds estimated to accrue in accordance with subclause (I) of this clause when filing a motion for the issuance of a subpoena or a commission to take a deposition.(iv) Service. A return of service by the person who performed personal service, postal return receipt, or proof of mailing to the last known address shall be conclusive evidence of service. Source Note: The provisions of this §289.232 adopted to be effective June 25, 2019, 44 TexReg 3105. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.232 Radiation Control Regulations for Dental Radiation Machines https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=204523&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 204523 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=204523&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 204523 03/11/2026 (a) Purpose. This section establishes the following requirements for radiation machines used in veterinary medicine.(1) Fees for certificates of registration for veterinary facilities and provisions for payment will be processed in accordance with §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), as amended.(2) Requirements for the registration of persons using radiation machines used in veterinary medicine. (3) Requirements that are intended to control the receipt, possession, use, and transfer of radiation machines by any person so the total dose to an individual, including doses resulting from all radiation machines other than background radiation, does not exceed the standards for protection against radiation prescribed in this section. However, nothing in this section shall be construed as limiting actions that may be necessary to protect public health and safety during an emergency.(4) Requirements for the use of radiation machines including that the registrant shall ensure the requirements of this section are met in the operation of such radiation machines and only persons who have received proper instructions in the safe use of radiation machines shall be permitted to operate the radiation machines.(5) Requirements for specific record keeping and general provisions for records and reports.(6) Requirements for providing notices to employees and instructions and options available to such individuals in connection with agency inspections of registrants to determine compliance with the provisions of the Texas Radiation Control Act (Act), Texas Health and Safety Code, Chapter 401, and requirements of this section, orders, and certificates of registration issued thereunder regarding radiological working conditions.(7) In accordance with the Act, Texas Health and Safety Code, Chapter 401; the Administrative Procedure Act, Texas Government Code, Chapter 2001; 1 TAC Chapter 155; and §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures) governing of:(A) proceedings for the granting, denying, renewing, transferring, amending, suspending, revoking, or annulling of a certificate of registration;(B) determining compliance with or granting of exemptions from requirements of this section, an order, or a condition of certificate of registration;(C) assessing administrative penalties; and(D) determining propriety of other agency orders.(b) Scope.(1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer radiation machines used in veterinary medicine.(A) The dose limits in this section do not apply to doses received from background radiation or voluntary participation in medical research programs. (B) Facilities conducting animal research must register under §289.228 of this title (relating to Radiation Safety Requirements for Industrial Radiation Machines). (C) No radiation may be deliberately applied to animals except by or under the supervision of a veterinarian authorized by the Texas Board of Veterinary Medical Examiners to engage in veterinary medicine. (2) A person who receives, possesses, uses, owns, or acquires radiation machines before receiving a certificate of registration is subject to the requirements of this chapter. (3) Registrants who are also registered by the agency to receive, possess, acquire, transfer, or use Class IIIb and Class IV lasers in veterinary medicine shall also comply with the requirements of §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices).(4) The agency may, by requirements in this chapter, an order, or a condition of certificate of registration, impose upon any registrant such requirements in addition to those established in this section as it deems appropriate or necessary to minimize danger to public health and safety, property, or the environment.(5) Registrants who are also specifically licensed by the agency to receive, possess, use, and transfer radioactive materials must also comply with the applicable requirements of:(A) §289.201 of this title (relating to General Provisions for Radioactive Material);(B) §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Materials);(C) §289.252 of this title (relating to Licensing of Radioactive Material);(D) §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material); and(E) §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).(6) In addition to this section, the veterinary registrant must meet the requirements in:(A) §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections);(B) §289.204 of this title;(C) §289.205 of this title (relating to Hearing and Enforcement Procedures); (D) §289.226 of this title (relating to Registration of Machine Use and Services); and(E) §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (c) Prohibitions.(1) The agency may prohibit use of radiation machines that pose significant threat or endanger occupational and public health and safety, in accordance with this subsection and subsections (a), (b), and (d) - (g) of this section.(2) Individuals shall not be exposed to the useful beam.(3) In no case shall an individual hold the tube or tube housing assembly support during any radiographic exposure. Hand-held radiation machines shall be held only in the manner specified by the manufacturer.(d) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.(1) Absorbed dose--The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.(2) Accessible surface--The external surface of the enclosure or housing provided by the manufacturer.(3) Act--Texas Radiation Control Act, Texas Health and Safety Code, Chapter 401.(4) Adult--An individual who is 18 years or older.(5) Agency--The Department of State Health Services.(6) Agreement state--Any state with which the United States Nuclear Regulatory Commission (NRC) has entered into an effective agreement under Section 274b of the Atomic Energy Act of 1954, as amended (73 Stat. 689).(7) Air kerma--The kinetic energy released in air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is Gy. For purposes of this section, when exposure in air measured in roentgen (R) is to be converted to dose in air measured in Gy, a nationally recognized standard air conversion factor shall be used. (8) Applicant--A person seeking a certificate of registration issued in accordance with the provisions of the Act and the requirements in this section.(9) As low as is reasonably achievable (ALARA)--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in this section as is practical, consistent with the purpose for which the registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of ionizing radiation and radiation machines in the public interest.(10) Attenuate--To reduce the air kerma rate upon passage of radiation through matter.(11) Attenuation block--A block or stack, having dimensions 20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 1100 aluminum alloy is 99 percent minimum aluminum, 0.12 percent copper.(12) Automatic exposure control--A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation at preselected locations (See definition for phototimer).(13) Background radiation--Radiation from cosmic sources; non‑technologically enhanced naturally occurring radioactive material, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents, such as Chernobyl, that contribute to background radiation and are not under the control of the registrant. "Background radiation" does not include radiation from radiation machines regulated by the agency.(14) Barrier--See definition for protective barrier.(15) Beam axis--A line from the source through the centers of the x-ray fields.(16) Beam-limiting device--A device that provides a means to restrict the dimensions of the x-ray field.(17) Beam quality (diagnostic x-ray)--A term that describes the penetrating power of the x-ray beam. This is identified numerically by half-value layer and is influenced by kilovolt peak (kVp) and filtration. (18) Central axis of the beam--A line passing through the virtual source and the center of the plane figure formed by the edge of the first beam‑limiting device.(19) Certificate of registration--A form of permission given by the agency to an applicant who has met the requirements for registration set out in the Act and this chapter.(20) Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.(21) Commissioner--The Commissioner of the Department of State Health Services.(22) Committed Effective Dose Equivalent (HE,50 )--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (HE,50 = ΣWT HT.50 ).(23) Computed tomography (CT)--The production of a tomogram by the acquisition and computer processing of x-ray transmission data.(24) Control panel--The part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors.(25) CT conditions of operation--All selectable parameters governing the operation of a CT system including, nominal tomographic section thickness, filtration, and the technique factors as defined in this subsection.(26) CT gantry--The tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames that hold these components.(27) Declared pregnant woman--A woman who has voluntarily informed the registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman voluntarily withdraws the declaration in writing or is no longer pregnant.(28) Deep dose equivalent (Hd ) that applies to external whole-body exposure--The dose equivalent at a tissue depth of 1 cm (1,000 milligrams per square centimeter (mg/cm2 )).(29) Diagnostic source assembly--The tube housing assembly with a beam-limiting device attached.(30) Dose--A generic term that means absorbed dose, dose equivalent, or total effective dose equivalent. For purposes of this section, "radiation dose" is an equivalent term.(31) Dose equivalent (Ht )--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.(32) Dose limits--The permissible upper bounds of radiation doses established in accordance with this chapter. For purposes of this section, "limits" is an equivalent term.(33) Effective dose equivalent (HE )--The sum of the products of the dose equivalent to the organ or tissue (HT ) and the weighting factors (WT ) applicable to each of the body organs or tissues that are irradiated (HE = ΣWT HT ).(34) Embryo/fetus--The developing human organism from conception until the time of birth.(35) Entrance exposure (Entrance air kerma)--The exposure in air expressed in roentgens (R) or the dose in air (air kerma) expressed in Gy, measured at the point where the center of the useful beam enters the animal.(36) Equipment performance evaluations (EPE)--Required testing performed by a registered service provider at a specified interval to ensure radiation machines operate in compliance with this chapter.(37) Exposure--The quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exposure is the coulomb per kilogram (C/kg). The roentgen is the special unit of exposure. For purposes of this section, this term is used as a noun.(38) Exposure rate (air kerma rate)--The exposure per unit of time. For purposes of this section "air kerma rate" is an equivalent term.(39) External dose--That portion of the dose equivalent received from any source of radiation outside the body.(40) Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the knee. The arm above the elbow and the leg above the knee are considered part of the whole body.(41) Field emission equipment--Equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.(42) Field size--The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the normal treatment or examination source to image distance and defined by the intersection of the major axes and the 50 percent isodose line.(43) Filter--Material placed in the useful beam to preferentially absorb selected radiation.(44) Fluoroscopic imaging assembly--A subsystem in which x-ray photons produce a fluoroscopic image. It includes the image receptors, such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.(45) Focal spot--The area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.(46) Gray (Gy)--The SI unit of absorbed dose. One Gy is equal to an absorbed dose of 1 joule per kilogram (J/kg) or 100 rad.(47) Half-value layer--The thickness of a specified material that attenuates the beam of radiation to an extent such that the air kerma rate is reduced to one-half of its original value.(48) High radiation area--An area, accessible to individuals, in which radiation levels external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm from any source of radiation or from any surface that the radiation penetrates.(49) Image intensifier--A device, installed in its housing, that instantaneously converts an x-ray pattern into a corresponding light image of higher energy density.(50) Image receptor--Any device, such as a fluorescent screen, radiographic film, or digital sensor that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.(51) Individual--A human being.(52) Individual monitoring--The assessment of dose equivalent to an individual by the use of:(A) individual monitoring devices; or(B) survey data.(53) Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this section, "personnel dosimeter," "dosimeter," and "personnel monitoring equipment" are equivalent terms. Examples of individual monitoring devices include film badges, thermoluminescence dosimeters, optically stimulated luminescence dosimeters, pocket ionization chambers (pocket dosimeters), and electronic personal dosimeters.(54) Inspection--An examination or observation, including records, tests, surveys, and monitoring to determine compliance with the Act and requirements of this section, orders, and conditions of the agency.(55) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles.(56) Irradiation--The exposure of matter to ionizing radiation.(57) kV--Kilovolt.(58) kVp--Kilovolt peak (See definition for peak tube potential).(59) Lead equivalent--The thickness of lead affording the same attenuation, under specified conditions, as the material in question.(60) Lens dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm2 ).(61) Licensing state--Any state with rules equivalent to the Suggested State Regulations for Control of Radiation relating to, and having an effective program for, the regulatory control of naturally occurring or accelerator-produced radioactive material.(62) mA--Milliampere.(63) mAs--Milliampere-second.(64) Medical research--The investigation of various health risks and diseases as it pertains to veterinary practices.(65) Member of the public--Any individual, except when that individual is receiving an occupational dose.(66) Minor--An individual who is under 18 years of age.(67) Mobile service operation--The provision of radiation machines and personnel at temporary sites for limited time periods. The radiation machines may be fixed inside a motorized vehicle or may be a portable radiation machine that may be removed from the vehicle and taken into a facility for use.(68) Monitoring--The measurement of radiation and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this section, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.(69) Occupational dose--The dose received by an individual during the course of employment in which the individual's assigned duties involve exposure to sources of radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this section, from voluntary participation in medical research programs, or as a member of the public.(70) Peak tube potential--The maximum value of the potential difference in kilovolts across the x-ray tube during an exposure.(71) Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing, other than the NRC and other federal government agencies licensed or exempted by the NRC. (72) Personnel monitoring equipment--See definition for individual monitoring devices.(73) Phototimer--A method for controlling exposures to image receptors by the amount of radiation that reaches a radiation detection device. The radiation detection device is part of an electronic circuit that controls the duration of time the tube is activated (See definition for automatic exposure control). (74) Primary protective barrier--See definition for protective barrier.(75) Protective apron--An apron made of radiation absorbing materials used to reduce radiation exposure.(76) Protective barrier--A barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows:(A) primary protective barrier, which is a barrier sufficient to attenuate the useful beam to the required degree; or(B) secondary protective barrier, which is a barrier sufficient to attenuate the stray radiation to the required degree.(77) Public dose--The dose received by a member of the public from exposure to radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. It does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this section, or from voluntary participation in medical research programs, or as a member of the public.(78) Rad--The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01 Gy).(79) Radiation (ionizing radiation)--Any alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. Radiation, as used in this part, does not include non-ionizing radiation, such as radio- or microwaves, or visible, infrared, or ultraviolet light.(80) Radiation area--Any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 cm from the radiation machine or from any surface that the radiation penetrates.(81) Radiation machine--An x-ray system, subsystem, or component capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation. For purposes of this section, "radiation machine," "x-ray equipment," "x-ray system," and "x-ray unit" are equivalent terms. Types of radiation machines include: (A) A stationary radiation machine, which is a radiation machine that is installed in a fixed location. (B) A hand-held radiation machine, which is a radiation machine that is designed to be hand-held during operation.(C) A portable radiation machine, which is a radiation machine that is mounted on a permanent base with wheels or casters for moving while completely assembled, including a hand-carried radiation machine that is designed to be mounted on a support while operating. (D) A mobile radiation machine, which is a radiation machine that is transported in a vehicle to be used at various temporary locations.(82) Radiation safety officer (RSO)--An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who shall be specifically authorized on a certificate of registration, and who is the primary contact with the agency.(83) Radiograph--An image receptor on which the image is created directly or indirectly by an x-ray exposure and results in a permanent record.(84) Registrant--Any person issued a certificate of registration by the agency in accordance with the Act and this chapter.(85) Regulation--See definition for rule.(86) Rem--The special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem Sv is equal to the absorbed dose in rad or Gy multiplied by the quality factor (1 rem = 0.01 Sv).(87) Remote inspection--An examination by the agency of information submitted by the registrant on a form provided by the agency. (88) Research and development--Research and development is defined as:(A) theoretical analysis, exploration, or experimentation; or(B) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, radiation machines, equipment, materials, and processes.(89) Restricted area--An area, access to which is limited by the registrant for the purpose of protecting individuals against undue risks from exposure to radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.(90) Roentgen (R)--The special unit of exposure. One R equals 2.58 x 10‑4 C/kg of air (See definition for exposure).(91) Rule--Any agency statement of general applicability that implements, interprets, or prescribes law or policy, or describes the procedure or practice requirements of an agency. The term includes the amendment or repeal of a prior section but does not include statements concerning only the internal management or organization of any agency and not affecting private rights or procedures. The word "rule" was formerly referred to as "regulation."(92) Scan--The complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.(93) Scan time--The period of time between the beginning and end of x-ray transmission data accumulation for a single scan.(94) Scattered radiation--Radiation that has been deviated in direction during passage through matter.(95) Secondary protective barrier--See definition for protective barrier.(96) Shallow dose equivalent (Hs ) (that applies to the external exposure of the skin of the whole body or the skin of an extremity)--The dose equivalent at a tissue depth of 0.007 cm (7 milligrams per square centimeter).(97) Shutter--A device attached to the tube housing assembly that can totally intercept the useful beam and that has a lead equivalency not less than that of the tube housing assembly.(98) SI--The abbreviation for the International System of Units.(99) Sievert (Sv)--The SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in Sv is equal to the absorbed dose in Gy multiplied by the quality factor (1 Sv = 100 rem.)(100) Source-to-image receptor distance (SID)--The distance from the source to the center of the input surface of the image receptor.(101) Source-to-skin distance (SSD)--The distance from the source to the skin of the animal.(102) Special units--The conventional units historically used by registrants, i.e. rad (absorbed dose), and rem (dose equivalent). (103) Spot film--A radiograph that is made during a fluoroscopic examination to permanently record conditions that exist during that fluoroscopic procedure.(104) Stray radiation--The sum of leakage and scattered radiation.(105) Supervision--The delegating of the task of applying radiation in accordance with this section to persons not licensed in veterinary medicine, who perform tasks under the veterinarian's control. The veterinarian assumes full responsibility for these tasks and shall assure that the tasks will be administered correctly.(106) Survey--An evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, disposal, and presence of radiation machines. When appropriate, such survey includes, tests, physical examination of location of radiation machines, measurements of levels of radiation present, and evaluation of administrative and engineered controls.(107) Technique chart--A chart that provides technical factors, anatomical examination, and animal size for examination being performed needed to make clinical radiographs when the radiation machine is in manual mode.(108) Technique factors--The conditions of operation that are specified as follows:(A) for capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;(B) for field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses;(C) for CT systems designed for pulsed operations, peak tube potential in kV, scan time in seconds, and either tube current in mA, x-ray pulse width in seconds, and the number of x-ray pulses per scan or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;(D) for CT systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds or the product of tube current and exposure time in mAs when the scan time and exposure time are equivalent; and(E) for all other x-ray systems, peak tube potential in kV and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs. (109) Termination--A release by the agency of the obligations and authorizations of the registrant under the terms of the certificate of registration. It does not relieve a person of duties and responsibilities imposed by law or rule.(110) Texas Regulations for Control of Radiation--All sections of Chapter 289 of this title.(111) Total effective dose equivalent--The sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). (112) Traceable to a national standard--This indicates that a quantity or a measurement has been compared to a national standard, for example, the National Institute of Standards and Technology, directly or indirectly through one or more intermediate steps and that all comparisons have been documented.(113) Tube--An x-ray tube, unless otherwise specified.(114) Tube housing assembly--The tube housing with tube installed. It includes high-voltage and filament transformers and other appropriate elements when such are contained within the tube housing.(115) Unrestricted area--An area, access to which is neither limited nor controlled by the registrant. For purposes of this section, "uncontrolled area" is an equivalent term.(116) Useful beam--Radiation that passes through the window, aperture, cone, or other collimating device of the source housing. Also referred to as the primary x-ray beam.(117) Veterinarian--An individual licensed by the Texas Board of Veterinary Medical Examiners.(118) Veterinary medicine--The term when used in this chapter has the same meaning as found in Texas Occupations Code, Chapter 801.(119) Very high radiation area--An area, accessible to individuals, in which radiation levels from radiation machines external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in one hour at 1 meter from a radiation machine or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, Gy and rad, are appropriate, rather than units of dose equivalent, Sv and rem.(120) Violation--An infringement of any rule, license or registration condition, order of the agency, or any provision of the Act.(121) Whole body--For purposes of external exposure, head and trunk, including male gonads, arms above the elbow, or legs above the knee.(122) Worker--An individual engaged in work under a certificate of registration issued by the agency and controlled by a registrant but does not include the registrant.(123) X-ray control panel--A device that controls input power to the x-ray high-voltage generator or the x-ray tube. It includes equipment, such as timers, phototimers, automatic brightness stabilizers, and similar devices that control the technique factors of an x-ray exposure.(124) X-ray field--That area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the air kerma rate is one-fourth of the maximum in the intersection. (125) X-ray system--An assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system.(126) X-ray tube--Any electron tube that is designed to be used primarily for the production of x-rays.(127) Year--The period of time beginning in January used to determine compliance with the provisions of this chapter. The registrant may change the starting date of the year used to determine compliance by the registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.(e) Exemptions.(1) The agency may, upon application or upon its own initiative, exempt a source of radiation or a kind of use or user from the requirements of this section if the agency determines that the law does not prohibit the exemption and it will not result in a significant risk to public health or safety or the environment. In determining such exemptions, the agency will consider:(A) state of technology;(B) economic considerations in relation to benefits to the public health and safety; and(C) other societal, socioeconomic, or public health and safety considerations.(2) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this section, if the dose equivalent rate averaged over an area of 10 square cm does not exceed 0.5 millirem (5 microsieverts) per hour at 5 cm from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.(3) Radiation machines in transit or in storage incident to transit are exempt from the requirements of this section. This exemption does not apply to the providers of radiation machines for mobile services. (4) Facilities that have placed all radiation machines in storage, including on-site storage secured from unauthorized use or removal, and have notified the agency in writing, are exempt from the requirements of this section. This exemption is void if any radiation machine is energized resulting in the production of radiation. Before resuming use of the radiation machine, the radiation machine shall meet all requirements of this section.(5) Inoperable radiation machines are exempt from the requirements of this section. For the purposes of this section, an inoperable radiation machine means a radiation machine that cannot be energized when connected to a power supply without repair or modification. (6) A person that takes possession of a radiation machine as the result of foreclosure, bankruptcy, or other default of payment may possess the radiation machine without registering it. If the radiation machine is energized, it shall be under the supervision of a person registered in accordance with this section and shall be energized in accordance with this chapter and shall be energized only to demonstrate that the radiation machine is operable for sale, lease, or transfer purposes. (7) Portable radiation machines designed to be hand-held are exempt from the requirements of subsection (i)(5)(I) of this section. The portable radiation machines shall be held according to manufacturer's specifications. (8) Individuals who are sole veterinarians, sole operators, and the only occupationally exposed individual are exempt from the following requirements:(A) operating and safety procedures specified in subsection (j)(2) of this section;(B) instructions to workers specified in subsection (j)(3)(G) of this section; and(C) posting of notices to workers specified in subsection (j)(4)(B) of this section. (f) Communications.(1) Except where otherwise specified, all communications and reports concerning this chapter and applications filed under the communications and reports should be faxed, emailed, or mailed by postal service to Radiation Control, Department of State Health Services, P.O. Box 149347, MC 2003, Austin, Texas, 78714-9347. Communications, reports, and applications may be delivered in person to the agency's office located at 8407 Wall Street, Austin, Texas, 78754. (2) Documents received by the agency will be deemed to have been received on the date of the postmark, fax, or other electronic media transmission.(g) Interpretations. Except as specifically authorized by the agency in writing, no interpretation of the meaning of this chapter by any officer or employee of the agency other than a written legal interpretation by the agency, will be considered binding upon the agency.(h) Fees for certificates of registration for veterinary facilities.(1) Payment of fees.(A) Each application for a certificate of registration for radiation machines used in veterinary medicine shall be accompanied by a nonrefundable fee specified in §289.204 of this title, as amended. No application will be accepted for filing or processed before payment of the full amount specified.(B) A nonrefundable fee specified in §289.204 of this title, as amended, shall be paid for each certificate of registration for radiation machines in veterinary medicine.(C) Each application for reciprocal recognition of an out-of-state registration shall be accompanied by the nonrefundable fee specified in §289.204 of this title, as amended, provided that no such fee has been submitted within 24 months of the date of commencement of the proposed activity.(2) Failure to pay prescribed fees.(A) In any case where the agency finds that an applicant for a certificate of registration has failed to pay the fee prescribed in §289.204 of this title, as amended, the agency will not process that application until such fee is paid. (B) In any case where the agency finds that a registrant has failed to pay a fee prescribed in §289.204 of this title, as amended, by the due date, the agency may implement compliance procedures as provided in §289.205 of this title, as amended.(3) Electronic fee payments. Renewal payments may be processed through www.texas.gov or another electronic payment system specified by the agency. For all types of electronic fee payments, the agency will collect additional fees, in amounts determined by www.texas.gov to recover costs associated with electronic payment processing. (i) Registration of radiation machine use. (1) Requirements for application for registration of radiation machines used for veterinary medicine. (A) Application for registration shall be completed on forms prescribed by the agency and shall contain all the information required by the form and accompanying instructions. For initial registrations with multiple radiation machine use locations, a separate application shall be completed for each radiation machine location under the registration. (B) Each person having a radiation machine used in veterinary medicine shall apply for registration with the agency within 30 days after beginning use of the radiation machine, except for mobile services that shall be registered in accordance with paragraph (2) of this subsection.(C) If the application is incomplete 60 days after submission, the agency may abandon the application and return the original application. The applicant shall cease use of all radiation machines once the application has been abandoned.(D) The applicant shall ensure that radiation machines will be operated by individuals qualified by reason of training and experience to use the radiation machine for the purpose requested in accordance with this section in such a manner as to minimize danger to occupational and public health and safety.(E) An RSO shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application. The RSO shall meet the applicable qualifications of clause (i) of this subparagraph and carry out the duties specified in clause (iv) of this subparagraph. (i) The RSO shall have the following qualifications:(I) knowledge of potential hazards and emergency precautions; and(II) completed educational courses related to ionizing radiation safety or a radiation safety officer course; or(III) experience in the use and familiarity of the type of radiation machine used.(ii) In addition to the qualifications in clause (i) of this subparagraph, documentation of the following shall be submitted to the agency:(I) for a veterinarian RSO, the veterinary license board number;(II) for a non-veterinarian RSO, at least two years of supervised experience in the use of veterinary radiation machines under the supervision of a licensed veterinarian.(iii) Academic institutions and research and development facilities shall have RSOs who are faculty or staff members in radiation protection, radiation engineering, or related disciplines. This individual may also serve as the RSO over the veterinary section of the facility. (iv) Specific duties of the RSO include the following:(I) establishing and overseeing operating and safety procedures that maintain radiation exposures ALARA, and reviewing the procedures at intervals not to exceed 12 months to ensure that the procedures are current and conform with this section;(II) ensuring that individual monitoring devices:(-a-) are properly used by occupationally exposed personnel; (-b-) that records are kept of the monitoring results; and(-c-) that timely notifications are made as required by subsections (j)(4)(B) and (C) and (k)(3)(B) - (D) of this section;(III) investigating and reporting to the agency:(-a-) each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this section; and (-b-) each theft or loss of radiation machines, determining the cause, and taking steps to prevent its recurrence; (IV) having a thorough knowledge of management policies and administrative procedures of the registrant and keeping management informed on a periodic basis of the performance of the registrant's radiation protection program, if applicable.(V) assuming control and having the authority to institute corrective actions, including shutdown of operations when necessary in emergency situations or unsafe conditions;(VI) making and maintaining records as required by this section; and(VII) ensuring that personnel are adequately trained, complying with this section, the conditions of the certificate of registration, the operating and safety procedures of the registrant, and records maintained in accordance with subsection (k)(2) of this section.(F) The agency may, at any time after the filing of the original application, require further statements in order to enable the agency to determine whether the certificate of registration should be issued or denied.(G) An application for a certificate of registration may include a request for a certificate of registration authorizing one or more activities or radiation machine use locations. If an application includes a request for an additional authorization other than use of a veterinary radiation machine, compliance with other applicable sections of this chapter will be required. (H) Each application for a certificate of registration shall be accompanied by the fee specified in §289.204 of this title, as amended. No application will be accepted for filing or processed before payment of the full amount specified.(I) Each application shall be accompanied by a completed RC Form 226-1, Business Information Form that shall contain the legal name of the entity or business. Unless exempt in accordance with the Business and Commerce Code, Chapter 71, the applicant shall: (i) be authorized to conduct business in the State of Texas as listed on the Texas Secretary of State (SOS) website; and(ii) file an assumed name certificate with the Texas SOS if using an assumed name in their application.(J) An application for use of radiation machines for veterinary medicine shall be signed by a licensed veterinarian. The application shall also be signed by the RSO if the RSO is someone other than the veterinarian.(K) Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with §289.231(aa) of this title.(L) The applicant's proposed radiation machines, facilities, and operating and safety procedures shall be adequate to minimize danger to occupational and public health and safety.(M) Each person possessing a therapeutic radiation machine capable of operating at or above 1 million electron volts (1 MeV) shall apply for and receive a certificate of registration from the agency before using the accelerator for veterinary use. A person may energize the accelerator for purposes of installation and acceptance testing before receiving a certificate of registration from the agency. (N) Each person possessing a simulator or a therapeutic radiation machine capable of operating below 1 MeV shall apply for a certificate of registration within 30 days after energizing the radiation machine. (2) Application for registration of mobile service operation used in veterinary medicine. In addition to the requirements of paragraph (1) of this subsection, each applicant shall apply for and receive authorization from the agency for mobile service operation before beginning mobile service operation. The following shall be submitted:(A) An established main location where the radiation machines and related compliance documents and records will be maintained for inspection. This shall be a street address, not a post office box number.(B) A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's position during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's position. (C) A current copy of the applicant's operating and safety procedures regarding radiological practices for protection of operators, employees, and the general public.(3) Issuance of certificate of registration.(A) A certificate of registration will be approved if the agency determines that an application meets the requirements of the Act and the requirements of this chapter. The certificate of registration authorizes proposed activities and contains the conditions and limitations as the agency deems appropriate or necessary.(B) The agency may incorporate in the certificate of registration at the time of issuance, or thereafter by amendment, additional requirements and conditions concerning the registrant's possession, use, and transfer of radiation machines subject to this chapter as it deems appropriate or necessary in order to:(i) minimize danger to occupational and public health and safety;(ii) require additional reports and the keeping of additional records as may be appropriate or necessary; and(iii) prevent loss or theft of radiation machines subject to this chapter.(C) The agency may request, and the registrant shall provide, additional information after the certificate of registration has been issued to enable the agency to determine whether the certificate of registration should be modified in accordance with paragraph (7) of this subsection.(4) Terms and conditions of certificates of registration.(A) Each certificate of registration issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable requirements of this chapter and orders of the agency.(B) No certificate of registration issued or granted under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the agency authorizes the transfer in writing.(C) Each person registered by the agency for radiation machine use in accordance with this section shall confine use and possession of the radiation machine registered to the locations and purposes authorized in the certificate of registration.(D) In making a determination whether to grant, deny, amend, renew, revoke, suspend, or restrict a certificate of registration, the agency may consider the technical competence and compliance history of an applicant or holder of a certificate of registration. After an opportunity for a hearing, the agency shall deny an application for a certificate of registration, an amendment to a certificate of registration, or renewal of a certificate of registration if the applicant's compliance history reveals that at least three agency actions have been issued against the applicant, within the previous six years, that assess administrative or civil penalties against the applicant, or that revoke or suspend the certificate of registration.(5) Responsibilities of the registrant.(A) The registrant is responsible for complying with this section and the conditions of the certificate of registration. (B) The registrant shall designate an individual qualified in accordance with subsection (i)(1)(E) of this section as the RSO and shall ensure the individual continually performs the responsibilities of the RSO as identified in subsection (i)(1)(E)(iv) of this section.(C) Persons using radiation machines in accordance with subsection (i)(2) of this section, concerning application for mobile services, shall have a valid certificate of registration issued by the agency before initiation of the mobile services. (D) No person shall use a radiation machine unless the person has applied for registration within 30 days after beginning use of the radiation machine in accordance with subsection (i)(1)(A) of this section. (E) No registrant shall engage any person for services described in §289.226(b)(11) of this title until such person provides to the registrant evidence of registration with the agency.(F) No person shall provide radiation machine services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the agency except for:(i) the initial installation of the first radiation machine for a new certificate of registration; or (ii) the registrant authorized for demonstration and sale may demonstrate a radiation machine in accordance with subparagraph (K) of this paragraph.(G) The registrant shall notify the agency in writing of any changes that would render the information contained in the application for registration or the certificate of registration inaccurate. The notification shall be in writing and signed by an authorized representative. Notification is required within 30 days of the following changes:(i) name of business; (ii) mailing address;(iii) street address where radiation machine will be used;(iv) additional radiation machine site/location;(v) RSO;(vi) name and registration number of the entity contracted for "provider of equipment," registered in accordance with §289.226 of this title; or(vii) an increase in the number of radiation machines authorized by the certificate of registration in any radiation machine type or type of use category.(H) The registrant, or the parent company, shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy. This notification shall include: (i) the bankruptcy court in which the petition for bankruptcy was filed; and(ii) the case name, number, and date of filing the petition.(I) The registrant shall inventory all radiation machines in the registrant's possession at an interval not to exceed 12 months. (i) The inventory shall include:(I) manufacturer's name;(II) model and serial number of the control panel; and(III) location of radiation machine, for example, room number.(ii) Records of the inventory shall be made and maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(J) The registrant shall make and maintain records of receipt, transfer, and disposal of radiation machines. (i) The records shall include the following:(I) manufacturer's name, model, and serial number from the control panel; (II) date of the receipt, transfer, and disposal; (III) name and address of person the radiation machine received from, transferred to, or disposed of; and(IV) name of the individual recording the information.(ii) Records of receipt, transfer, and disposal of radiation machines shall be made and maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(K) The following criteria applies to loaner or demonstration radiation machines.(i) For persons having a valid certificate of registration, radiation machines used for loaner or demonstration radiation machines may be used for up to 30 days. After 30 days, the registrant shall:(I) notify the agency of an increase in the number of radiation machine authorized by the certificate of registration in any radiation machine type or type of use category; and(II) perform an equipment performance evaluation on the radiation machine in accordance with subsection (j)(5)(N) of this section.(ii) For persons who do not hold a valid certificate of registration, a loaner radiation machine may be used up to 30 days, by or under the direction of a veterinarian licensed by the Texas Board of Veterinary Medical Examiners in accordance with this section.(6) Termination of certificates of registration. When a registrant decides to terminate all activities involving radiation machines authorized under the certificate of registration, the registrant shall notify the agency immediately and do the following:(A) request termination of the certificate of registration in writing to be signed by the RSO, owner, or an individual authorized to act on behalf of the registrant;(B) submit to the agency a record of the disposition of the radiation machines and if transferred, to whom transferred; and(C) pay any outstanding fees in accordance with §289.204 of this title, as amended. (7) The agency shall take actions for modification, suspension, and revocation of certificates of registration, shall be taken in accordance with §289.205 of this title.(j) Use of radiation machines for veterinary medicine.(1) ALARA. Persons shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are ALARA.(2) Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures. These procedures shall be made available to each individual operating a radiation machine, including any restrictions of the operating technique required for the safe operation of the particular radiation machine. (A) The registrant shall document that each individual operating a radiation machine has read the operating and safety procedures annually not to exceed 12 months. This documentation shall be maintained in accordance with subsection (k)(2) of this section for inspection by the agency. The documentation shall include the following:(i) name and signature of individual;(ii) date individual read the operating and safety procedures; and(iii) initials of the RSO.(B) The operating and safety procedures shall include the following procedures as applicable:(i) posting notices to workers in accordance with paragraph (4)(B) of this subsection; (ii) instructions to workers in accordance with paragraph (3)(G) of this subsection; (iii) notifications and reports to individuals in accordance with paragraph (4)(B) and (C) of this subsection and subsection (k)(3)(B) - (D) of this section; (iv) ordering x-ray exams in accordance with subsection (b)(1) of this section; (v) occupational dose requirements in accordance with paragraph (3)(A) of this subsection;(vi) personnel monitoring requirements in accordance with paragraphs (3)(B), (D), and (E) of this subsection;(vii) controlling a radiation area in accordance with paragraph (4)(C) and (D) of this subsection;(viii) use of a technique chart in accordance with paragraph (5)(A) of this subsection;(ix) use of protective devices in accordance with paragraph (3)(H) of this subsection;(x) exposure of individuals in accordance with paragraph (3)(I) of this subsection;(xi) holding of animals or image receptors in accordance with the following: (I) a list of circumstances in which mechanical holding devices cannot be routinely utilized; and (II) a procedure used for selecting an individual to hold or support the animal or image receptor;(xii) control of scattered radiation in accordance with paragraph (6)(C) of this subsection; and(xiii) film processing program or digital image processing in accordance with paragraphs (10) - (12) of this subsection.(3) Personnel requirements. (A) Occupational dose limits. Except as otherwise exempted, all individuals who are associated with the operation of a radiation machine are subject to the occupational dose limits of this subparagraph regarding dose limits to individuals, and the personnel monitoring requirements of subparagraph (B) of this paragraph.(i) The registrant shall control the occupational dose to individuals to the following dose limits.(I) An annual limit shall be the total effective dose equivalent (TEDE) being equal to 5 rems (0.05 Sv).(II) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities shall be:(-a-) a lens dose equivalent (LDE) of 15 rems (0.15 Sv); and (-b-) a shallow dose equivalent (SDE) of 50 rems (0.5 Sv) to the skin of the whole body or to the skin of any extremity.(III) The annual limits for a minor shall be 10 percent of the annual occupational dose limits specified in subclauses (I) and (II) of this clause.(IV) If a woman declares her pregnancy, the registrant shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). If a woman chooses not to declare pregnancy, the occupational dose limits specified in subclauses (I) and (II) of this clause are applicable to the woman.(-a-) The registrant shall make efforts to avoid substantial variation above a uniform monthly air kerma to a declared pregnant woman so as to satisfy the limit in clause (i) of this subparagraph. The National Council on Radiation Protection and Measurements recommended in NCRP Report No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June 1, 1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received in any one month.(-b-) If by the time the woman declares pregnancy to the registrant, the dose equivalent to the embryo/fetus has exceeded 0.45 rem (4.5 mSv), the registrant shall be deemed to be in compliance with clause (i) of this subparagraph, if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.(-c-) The dose equivalent to an embryo/fetus shall be taken as the dose equivalent that is most representative of the dose equivalent to the embryo/fetus from external radiation, that is, in the mother's lower torso region.(-d-) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device that is most representative of the dose equivalent to the embryo/fetus shall be the dose equivalent to the embryo/fetus. Assignment of the highest dose equivalent for the declared pregnant woman to the embryo/fetus is not required unless that dose is also the most representative dose equivalent for the region of the embryo/fetus.(-e-) If multiple measurements have not been made, assignment of the highest dose equivalent for the declared pregnant woman shall be the to the embryo/fetus.(ii) The assigned dose equivalent shall be for the portion of the body receiving the highest exposure. The assigned shallow dose equivalent shall be the dose averaged over the contiguous 10 cm2 of skin receiving the highest exposure.(iii) When a protective apron is worn while working with fluoroscopic radiation machines used for clinical diagnostic or research purposes, the effective dose equivalent for external radiation shall be determined as follows:(I) when only one individual monitoring device is used, and it is located at the neck (collar) outside the protective apron, the reported deep dose equivalent shall be the effective dose equivalent (EDE) for external radiation; or(II) when only one individual monitoring device is used, and it is located at the neck (collar) outside the protective apron, and the reported dose exceeds 25 percent of the limit specified in clause (i) of this subparagraph, the reported deep dose equivalent value multiplied by 0.3 shall be the EDE for external radiation; or(III) when individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck (collar), the EDE for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck (collar) outside the protective apron multiplied by 0.04.(iv) The deep dose equivalent, lens dose equivalent, and shallow dose equivalent may be assessed from surveys or radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.(v) The registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received from radiation machines or radioactive materials while employed by any other person. See subparagraph (F)(iv) of this paragraph. (B) Conditions requiring individual monitoring of occupational dose. Each registrant shall monitor exposures from radiation machines at levels sufficient to demonstrate compliance with the occupational dose limits of this section. As a minimum, each registrant shall monitor occupational exposure to radiation from radiation machines and shall supply and require the use of individual monitoring devices by:(i) adults likely to receive, in one year from sources external to the body, a dose in excess of 10 percent of the limits in subparagraph (A)(i) of this paragraph;(ii) minors likely to receive, in one year from radiation machines external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin of the whole body or to the skin of any extremities in excess of 0.5 rem (5 mSv);(iii) declared pregnant women likely to receive during the entire pregnancy, from radiation machines external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv); and(iv) individuals entering a high or very high radiation area.(C) Dose limits for individual members of the public.(i) Each registrant shall conduct operations so that:(I) the TEDE to individual members of the public from exposure to radiation from radiation machines does not exceed 0.5 rem (5 mSv) in a year, exclusive of the dose contribution from background radiation, exposure of animals to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs; and(II) the dose in any unrestricted area from registered external sources does not exceed 0.002 rem (0.02 mSv) in any one hour.(ii) If the registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals.(iii) The agency may impose additional restrictions on radiation levels in unrestricted areas in order to restrict the collective dose.(iv) The registrant shall ensure that in facilities utilizing both radiation producing machines and radioactive materials, the TEDE to an individual member of the public shall not exceed 0.1 rem (1 mSv) in one year.(D) Compliance with dose limits for individual members of the public.(i) The registrant shall make or cause to be made surveys of radiation levels in unrestricted areas to demonstrate compliance with the dose limits for individual members of the public as required in subparagraph (C) of this paragraph.(ii) A registrant shall show compliance with the annual dose limit in subparagraph (C) of this paragraph by demonstrating by measurement or calculation that the TEDE to the individual likely to receive the highest dose from the registered operation does not exceed the annual dose limit.(iii) Registrants exempt from individual monitoring requirements in accordance with subparagraph (B) of this paragraph are exempt from the requirements of clauses (i) and (ii) of this subparagraph. (E) Location and use of individual monitoring devices.(i) Each registrant shall ensure that individuals who are required to monitor occupational doses in accordance with subparagraph (B) of this paragraph wear and use individual monitoring devices as follows.(I) An individual monitoring device shall be assigned to and worn by only one individual.(II) An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device shall be worn outside of the protective apron.(III) If an additional individual monitoring device is used for monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance with subparagraph (B)(iii) of this paragraph, it shall be located at the waist under any protective apron being worn by the woman.(IV) An individual monitoring device used for monitoring the lens dose equivalent, to demonstrate compliance with subparagraph (A)(i)(II)(-a-) of this paragraph, shall be located at the neck (collar) or at a location closer to the eye, outside any protective apron being worn by the monitored individual.(V) An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with subparagraph (A)(i)(II)(-b-) of this paragraph, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device, to the extent practicable, shall be oriented to measure the highest dose to the extremity being monitored.(ii) Each registrant shall ensure that individual monitoring devices are returned to the dosimetry processor for proper processing.(iii) Each registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.(F) Determination of occupational dose for the current year.(i) For each individual who is likely to receive, in a year, an occupational dose requiring monitoring in accordance with subparagraph (B) of this paragraph, the registrant shall determine the occupational radiation dose received during the current year. Occupational dose includes doses received from exposure to registered/licensed or unregistered/unlicensed sources of radiation as defined in subsection (d) of this section.(ii) In complying with the requirements of clause (i) of this subparagraph, a registrant may:(I) accept, as a record of the occupational dose that the individual received during the current year RC Form 233-1 (Occupational Exposure Record for a Monitoring Period) from prior or other current employers, or other clear and legible record, of all information required on that form and indicating any periods of time for which data are not available; (II) accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's prior or other current employers for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; or(III) obtain reports of the individual's dose equivalent from prior or other current employers for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the registrant, by telephone, telegram, fax, letter, or email. The registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.(iii) The registrant shall record the exposure data for the current year, as required by clause (i) of this subparagraph, on RC Form 233-1, or other clear and legible record, of all the information required on RC Form 233-1.(iv) If the registrant is unable to obtain a complete record of an individual's current occupational dose while employed by any other registrant or licensee, the registrant shall assume in establishing administrative controls in accordance with subsection (j)(3)(A)(iv) of this section for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each quarter; or 416 millirems (mrem) (4.16 mSv) for each month for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure. (v) If an individual has incomplete (for example, a lost or damaged personnel monitoring device) current occupational dose data for the current year and that individual is employed solely by the registrant during the current year, the registrant shall:(I) assume that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each quarter;(II) assume that the allowable dose limit for the individual is reduced by 416 mrem (4.16 mSv) for each month; or(III) assess an occupational dose for the individual during the period of missing data using surveys, radiation measurements, or other comparable data for the purpose of demonstrating compliance with the occupational dose limits.(vi) Administrative controls established in accordance with clause (iv) of this subparagraph shall be documented and maintained for inspection by the agency. Occupational dose assessments made in accordance with clause (v) of this subparagraph and records of data used to make the assessment shall be made and maintained for inspection by the agency. The registrant shall retain the records in accordance with subsection (k)(2) of this section.(G) Instructions to workers.(i) All individuals likely to receive in a year an occupational dose in excess of 100 millirem (1 mSv) shall be: (I) kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace; (II) instructed in the health protection problems associated with exposure to sources of radiation, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;(III) instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of agency requirements and certificates of registration, for the protection of personnel from exposures to sources of radiation occurring in such areas; (IV) instructed of their responsibility to report promptly to the registrant any condition that may constitute, lead to, or cause a violation of agency requirements or certificate of registration conditions, or unnecessary exposure to sources of radiation;(V) instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to sources of radiation; and(VI) advised as to the radiation exposure reports that workers may request in accordance with subsection (k)(3)(D)(i) and (ii) of this section.(ii) The extent of these instructions shall be commensurate with potential radiological health protection problems associated with the sources of radiation in the workplace.(H) Protective devices. Protective devices shall be utilized when required, as in subparagraphs (J)(i) and (ii) and (K) of this paragraph and paragraph (6)(C) of this subsection.(i) Protective devices shall be of no less than 0.25 millimeter (mm) lead equivalent material except as specified in paragraph (6)(C)(ii)(I) of this subsection.(ii) Protective devices, including aprons, gloves, and shields shall be checked annually for defects, such as holes, cracks, and tears. These checks may be performed by the registrant by visual or tactile means, or x-ray imaging. If a defect is found, protective devices shall be replaced or removed from service until repaired. A record of this test shall be made and maintained by the registrant in accordance with subsection (k)(2) of this section for inspection by the agency.(I) Exposure of individuals. No individual other than the animal, operator, and ancillary personnel shall be in the x-ray room or area while exposures are being made unless such individual's assistance is required.(J) Holding of animal or image receptor.(i) When an animal or image receptor must be held in position during an exposure, mechanical supporting or restraining devices shall be used when the exam permits.(ii) If an animal or image receptor must be held by an individual during an exposure, that individual shall be protected with appropriate shielding devices described in subparagraph (H) of this paragraph.(iii) The registrant's written operating and safety procedures required by paragraph (2) of this subsection shall include the following:(I) a list of circumstances in which mechanical holding devices cannot be routinely utilized; and(II) a procedure used for selecting an individual to hold or support the animal or image receptor.(K) Operator position. The operator position during the exposure shall be such that the operator's exposure is ALARA and the operator is a minimum of six feet from the radiation machine or protected by an apron, gloves, or other shielding having a minimum of 0.25 mm lead equivalent material.(L) Holding of tube. In no case shall an individual hold the tube or tube housing assembly support during any radiographic exposure. Hand-held radiation machines shall be held only in the manner specified by the manufacturer.(4) Facility requirements.(A) Caution signs. Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors magenta, purple, or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows:Attached Graphic(i) the cross-hatched area of the symbol is to be magenta, purple, or black; and (ii) the background of the symbol is to be yellow. (B) Posting of notices to workers.(i) Each registrant shall post current copies of the following documents: (I) this section, §289.233; (II) the certificate of registration and conditions or documents incorporated into the certificate of registration by reference and amendments thereto; (III) the operating procedures applicable to work under the certificate of registration; and (IV) any notice of violation, if applicable, involving radiological working conditions, or order issued in accordance with subsection (a) of this section and §289.205 of this title, and documentation of the corrections of any violations.(ii) RC Form 233-2 Notice to Employees, or an equivalent document containing at least the same wording as RC Form 233-2. (iii) If posting of a document specified in clause (i) of this subparagraph is not practicable, the registrant shall post a notice that describes the document and states where it may be examined.(iv) Documents, notices, or forms posted in accordance with this section shall: (I) appear in a sufficient number of places to permit individuals engaged in work under the certificate of registration to observe them on the way to or from any particular work location to which the document applies; (II) be conspicuous; and(III) be replaced if defaced or altered.(C) Posting requirements.(i) The registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."(ii) The registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."(iii) The registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA."(D) Exceptions to posting requirements. A registrant is not required to post caution signs in areas or rooms containing radiation machines for periods of less than eight hours, if each of the following conditions is met:(i) the radiation machines are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation in excess of the limits established in this section; and(ii) the area or room is subject to the registrant's control. (E) General surveys and monitoring.(i) Each registrant shall make, or cause to be made, surveys that:(I) are necessary for the registrant to comply with this section; and(II) are necessary under the circumstances to evaluate: (-a-) the magnitude and extent of radiation levels; and(-b-) the potential radiological hazards.(ii) The registrant shall ensure that instruments and equipment used for qualitative and quantitative radiation measurements, for example, dose rate, are operable and calibrated:(I) by a person licensed or registered by the agency, another agreement state, a licensing state, or the United States Nuclear Regulatory Commission to perform such service;(II) at intervals not to exceed 24 months unless a different time interval is specified in another section of this chapter;(III) after each instrument or equipment repair;(IV) for the types of radiation used and at energies appropriate for use; and(V) at an accuracy within 20 percent of the true radiation level.(iii) Record of the dosimetry system calibration shall include:(I) manufacturer's name, model and serial number of each calibrated instrument; (II) date of the calibration; and(III) name of the individual recording the information.(iv) All individual monitoring devices, except for direct and indirect reading pocket dosimeters, electronic personal dosimeters, and those individual monitoring devices used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by registrants to comply with paragraph (3)(A) of this subsection, with other applicable provisions of this chapter, shall be processed and evaluated by a dosimetry processor:(I) holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and(II) approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored. (F) Control of access to high radiation areas.(i) The registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features:(I) a control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 0.1 rem (1 mSv) in one hour at 30 cm from the source of radiation from any surface that the radiation penetrates;(II) a control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or(III) entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.(ii) In place of the controls required by clause (i) of this subparagraph for a high radiation area, the registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.(iii) The registrant may apply to the agency for approval of alternative methods for controlling access to high radiation areas.(iv) The registrant shall establish the controls required by clauses (i) and (iii) of this subparagraph in a way that does not prevent individuals from leaving a high radiation area.(G) Control of access to very high radiation areas.(i) In addition to the requirements in subparagraph (F) of this paragraph, the registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 grays) or more in one hour at 1 m from a radiation machine or any surface through which the radiation penetrates at this level.(ii) The entry control devices required by clause (i) of this subparagraph shall be established in such a way that no individual will be prevented from leaving the area.(H) Security and control of radiation machines.(i) The registrant shall secure radiation machines from unauthorized removal.(ii) The registrant shall use devices and administrative procedures to prevent unauthorized use of radiation machines.(iii) Any person using hand-held veterinary radiation machines shall ensure proper storage of the unit to include: (I) securing the unit against theft or unauthorized use; and (II) storing the unit in locked cabinets, storage rooms or work areas when not under immediate supervision of authorized users.(5) Radiation machine requirements.(A) Technique chart. (i) A technique chart relevant to the particular radiation machine shall be provided or electronically displayed in the vicinity of the control panel and used by all operators.(ii) Technique and exposure indicators.(I) The technique factors to be used during an exposure shall be indicated before the exposure begins except when automatic exposure controls are used, in which case the technique factors that are set before the exposure shall be indicated.(II) On radiation machines having fixed technique factors, the requirement of this paragraph may be met by permanent markings.(III) The x-ray control shall provide visual or audible indication of the production of x-rays observable at or from the operator's protected position whenever x-rays are produced. (IV) The indicated technique factors shall be accurate to meet manufacturer's specifications. If these specifications are not available from the manufacturer, the factors shall be accurate to within plus or minus 10 percent of the indicated setting.(B) Labeling radiation machines. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit.(C) Mechanical support of tube head. The tube housing assembly shall be adjusted to remain stable during an exposure unless tube housing movement is a designed function of the radiation machine.(D) Battery charge indicator. On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.(E) Beam quality. The following requirements apply to beam quality.(i) Half-value layer.(I) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in the following Table I. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table I, linear interpolation may be made. Attached Graphic(II) For capacitor energy storage equipment, compliance with the requirements of subparagraph (I) of this paragraph shall be determined with the maximum quantity of charge per exposure.(ii) Filtration controls.(I) For radiation machines that have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filters and shall prevent an exposure unless the minimum amount of filtration required by subparagraph (A) of this paragraph is in the useful beam for the given kVp that has been selected. (II) Any other radiation machine having removable filters shall be required to have the minimum amount of filtration as required by subparagraph (E)(i)(I) of this paragraph permanently located in the useful beam during each exposure.(F) Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated before initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly that has been selected.(G) Beam limiting devices.(i) The beam-limiting device shall provide the same degree of protection as is required of the housing.(ii) The numerical SID indicator shall be present and shall be accurate to within 2.0 percent of the SID for the beam-limiting device. (iii) The center of the x-ray field, when perpendicular to the image receptor, shall be accurate to within plus or minus 2.0 percent of the SID with respect to the center of the image receptor.(iv) The beam-limiting device shall numerically indicate the field size in the plane of the image receptor. (v) Indication of field size dimensions and SIDs shall be specified in inches or centimeters. (vi) The field size indicated on the beam-limiting device shall not exceed 2.0 percent of the SID along the width and length, separately, of the actual x-ray field size.(H) Portable x-ray systems. Portable x-ray systems shall comply with the requirements in subparagraph (G) of this paragraph, as applicable, based on manufacturer's design.(I) X-ray control. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for an exposure of 0.5 seconds or less or during serial radiography when means shall be provided to permit completion of any single exposure of the series in process.(J) Stationary or portable radiation machines. All stationary or portable radiation machines used for veterinary x-rays shall be provided with the following:(i) a continuous pressure type exposure switch; and(ii) either a six and one-half foot high protective barrier for operator protection during exposures; or(iii) a means for the operator to be at least six feet from the tube housing assembly.(K) Hand-held portable radiation machines. Operators using portable radiation machines designed to be hand-held are exempt from the requirements of paragraph (3)(K) of this subsection. The hand-held portable radiation machine shall be held only in the manner specified by the manufacturer. The operator shall wear protective devices in accordance with paragraph (3)(H) of this subsection.(L) Portable radiation machines. Portable radiation machines shall comply with the requirements in subparagraph (H) of this paragraph, as applicable, based on manufacturer's design.(M) Radiation machines needing correction or repair. (i) The correction or repair shall begin within 30 days following the failure and shall be performed according to a plan designated by the registrant. (ii) Correction or repair shall be completed no longer than 90 days from discovery unless authorized in writing by the agency.(iii) The registrant shall maintain records of corrections or repairs and any tests, measurements or numerical readings listed in subsection (j)(5) of this section in accordance with subsection (k)(2) of this section for inspection by the agency.(N) Equipment performance evaluations (EPE).(i) For all radiation machines used in veterinary medicine, the registrant shall perform, or cause to be performed, EPE tests for each item specified in clauses (iii) through (vii) of this subparagraph as follows: (I) within 30 days after initial installation of radiation machines:(II) within 30 days after reinstallation of a radiation machine; (III) within 30 days after repair of a radiation machine component that would affect the radiation output that includes the timer, tube, and power supply; and(IV) after initial installation, the EPE tests shall be performed every 5 years.(ii) Records of the EPE results shall include the following: (I) measurements and numerical readings;(II) indication of pass or fail for each test; and(III) maintenance by the registrant in accordance with subsection (k)(2) of this section for inspection by the agency.(iii) Timer.(I) The accuracy of the timer shall meet the manufacturer's specifications. If the manufacturer's specifications are not obtainable, the timer accuracy shall be plus or minus 10 percent of the indicated time with testing performed at 0.5 second.(II) Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided.(iv) Kilovolt peak (kVp). The accuracy of the kVp setting shall meet manufacturer's specifications. If the registrant does not possess documentation of the appropriate manufacturer's kVp specifications, the indicated kVp shall be accurate to within plus or minus 10 percent of the indicated setting(s). For radiation machines with fewer than three fixed kVp settings, the radiation machine shall be checked at those settings.(v) Tube stability. The x-ray tube shall remain physically stable during exposures. In cases where tubes are designed to move during exposure, the registrant shall assure proper and free movement of the radiation machine within manufacturer's specifications.(vi) Collimation. Field limitation shall meet the requirements for beam-limiting devices of subparagraph (G) of this paragraph.(vii) Measurements of the radiation output for a radiographic x-ray, fluoroscopic, CT, therapeutic machine, simulator, and electronic brachytherapy device. Measurements for the radiation output of a radiographic x-ray shall be performed by a registered service provider. Measurements for the radiation output for a fluoroscopic, CT, and therapeutic, simulators and electronic brachytherapy devices shall be performed by licensed medical physicist with a calibrated dosimetry system in accordance with the following. (I) The dosimetry system calibration shall be traceable to a national standard.(II) Dosimetry systems shall be calibrated within 24 months from the date of the prior calibration.(III) Measurements of radiation output shall be performed with a dosimetry system that has been calibrated within the 24 months preceding the date of the measurement.(IV) Record of the dosimetry system calibration shall include:(-a-) manufacturer's name, model and serial number of each calibrated instrument; (-b-) date of the calibration; and(-c-) name of the individual recording the information.(viii) Record of dosimetry system calibration. The registrant shall record the dosimetry system calibration information specified in clause (vii)(I) - (IV) of this subparagraph and maintain that record in accordance with subsection (k)(2) of this section for inspection by the agency.(6) Additional requirements for fluoroscopic radiation machines.(A) Limitation of the useful beam. Limitation of the useful beam shall be as follows.(i) Primary barrier.(I) The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID.(II) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the useful beam and the imaging device is in place and operable.(III) The air kerma rate due to transmission through the barrier with the attenuation block in the useful beam, combined with radiation through the image intensifier if provided, shall not exceed 3.34 x 10-3 percent of the entrance air kerma rate at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor.(ii) Measuring compliance of barrier transmission.(I) The air kerma rate due to transmission through the primary protective barrier combined with radiation through the image intensifier shall be determined by measurements averaged over an area of 100 cm2 with no linear dimension greater than 20 cm.(II) If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop.(III) If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm.(IV) Movable grids and compression devices shall be removed from the useful beam during the measurement.(V) The attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance air kerma rate and between this point and the input surface of the fluoroscopic imaging assembly.(VI) The collimator shall be fully open when the measurement is made.(iii) X-ray field.(I) Compliance with subclauses (II) - (VII) of this clause shall be determined with the beam axis perpendicular to the plane of the image receptor.(II) Fluoroscopic radiation machine with a fixed SID and the capability of a visible area of no greater than 300 cm2 shall be provided with either stepless adjustment of the x-ray field or a means to further limit the x-ray field at the image receptor to 125 cm2 less. If the fluoroscopic radiation machine is provided with stepless adjustment, the minimum x-ray field size at the maximum SID shall be less than or equal to 5 cm by 5 cm at the image receptor.(III) Fluoroscopic radiation machines with a variable SID or a fixed SID with the capability of a visible area of greater than 300 cm2 shall be provided with stepless adjustment of the field size. The minimum x-ray field size at the maximum SID shall be less than or equal to 5 cm by 5 cm at the image receptor.(IV) Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4.0 percent of the SID.(V) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.(VI) For fluoroscopic radiation machines with only a manual mode of collimation, the x-ray field produced shall be limited to the area of the spot-film cassette at 16 inches above tabletop. Additionally, during fluoroscopy, the beam shall be restricted to the area of the input phosphor.(VII) Spot-film devices shall meet the following additional requirements.(-a-) Means shall be provided between the source and the animal for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film that has been selected on the spot-film selector.(-1-) Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film.(-2-) The total misalignment of the edges of the x-ray field with the respective edges of the selected portion of the image receptor along the length or width dimensions of the x-ray field in the plane of the image receptor shall not exceed 3.0 percent of the SID when adjusted for full coverage of the selected portion of the image receptor.(-3-) The sum, without regard to sign of the misalignment along any two orthogonal dimensions, shall not exceed 4.0 percent of the SID.(-b-) The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within 2.0 percent of the SID.(B) Activation of the fluoroscopic tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the fluoroscopist for the entire time of the exposure (continuous pressure type switch). When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposures at any time but means may be provided to permit completion of any single exposure of the series in process.(C) Control of scattered radiation.(i) Fluoroscopic configuration, including fluoroscopic table designs, shall not permit any portion of any individual's body, except the head, neck, and extremities, to be exposed to scattered radiation emanating from above or below the tabletop unless the radiation has passed through not less than a total of 0.25 mm lead equivalent material. The material may be drapes, self-supporting curtains, or viewing shields, in addition to any lead equivalency provided by a protective apron.(ii) Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met.(I) All persons in the room where fluoroscopy is performed shall wear protective aprons that provide a shielding equivalent of 0.35 mm of lead.(II) The fluoroscopic field size shall be reduced to the absolute minimum required for the procedure being performed (area of clinical interest).(III) Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use or nonuse of the protective drapes.(iii) For image-intensified fluoroscopic radiation machines with only a manual mode of collimation, the x-ray field produced shall be limited to the area of the spot-film cassette at 40cm above tabletop. Additionally, during fluoroscopy, the beam shall be restricted to the area of the input phosphor.(7) Additional requirements for CT radiation machines.(A) Warning Label. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit.(B) Indicated technique factors. The indicated technique factors shall be accurate to meet manufacturer's specifications. If these specifications are not available from the manufacturer, the factors shall be accurate to within plus or minus 10 percent of the indicated setting. (C) Tomographic plane indication and alignment. (i) For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane. (ii) For any multiple slice tomogram system, means shall be provided to permit visual determination of the location of a reference plane. The reference plane can be offset from the location of the tomographic planes. (iii) If a device using a light source is used to satisfy the requirements of clause (i) or (ii) of this subparagraph, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.(D) Initiation of operation.(i) The x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.(ii) Means shall be provided to require operator initiation of each individual scan or series of scans.(iii) All emergency buttons/switches shall be clearly labeled as to their functions.(E) Termination of exposure.(i) Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of radiation machine failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110 percent of its preset value through the use of either a backup timer or devices that monitor radiation machine function.(ii) A signal visible to the operator shall indicate when the x-ray exposure has been terminated through the means required by clause (i) of this subparagraph.(iii) The operator shall be able to terminate the x-ray exposure at any time during a scan or series of scans under CT radiation machines control of greater than 0.5 seconds duration. Termination of the x-ray exposure shall necessitate resetting of the CT conditions of operation before initiation of another scan.(8) Additional requirements for therapeutic radiation machines, simulators and electronic brachytherapy devices. (A) General requirements.(i) Each veterinarian possessing a therapeutic radiation machine, a simulator, or an electronic brachytherapy device shall apply for and receive a certificate of registration from the agency before using the device for veterinary use. A person may energize the device for purposes of installation and acceptance testing before receiving a certificate of registration from the agency.(ii) The registrant for veterinary use of a therapeutic radiation machine, a simulator, or an electronic brachytherapy device shall be a veterinarian licensed by the Texas Board of Veterinary Medical Examiners.(iii) Operators of the therapeutic radiation machine, simulator, or electronic brachytherapy device shall: (I) complete device-specific training with a training program provided by the manufacturer; or(II) complete training received that is substantially equivalent to the manufacturer's training program from a licensed medical physicist who is trained to use the device; and(III) retain a record of each individual's device specific training by the registrant in accordance with subsection (k) of this section for inspection by the agency.(iv) Each facility shall develop a quality assurance program in writing or in an electronic reporting system. The quality assurance program shall be implemented as a method of minimizing deviations from facility procedures.(I) The quality assurance program shall include the following topics:(-a-) Occupational and public radiation safety during simulation; and(-b-) Occupational and public radiation safety during treatment.(II) Deviations from the operating and safety procedures shall be investigated and brought to the attention of the veterinarian and the RSO.(III) The review of the quality assurance program shall be conducted at intervals not to exceed 14 months.(v) Written operating and safety procedures shall be developed by a licensed medical physicist with a specialty in therapeutic radiological physics and shall include any restrictions required for the safe operation of the particular therapeutic radiation device. These procedures shall be available in the control area of the therapeutic radiation device. The operators shall be able to demonstrate familiarity with these procedures. These procedures shall include the following:(I) therapeutic radiation machines shall not be left unattended unless secured by a locking device which will prevent unauthorized use (A computerized password system would also constitute a locking device);(II) when there is a need to immobilize an animal or port film for radiation therapy, mechanical supporting or restraining devices shall be used; (III) no individual, other than the animal, shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV;(IV) at energies less than or equal to 150 kV, any individual in the treatment room shall be protected by a barrier sufficient to meet the requirements of §289.231(m) of this title;(V) radiation dose requirements in accordance with §289.231(m) of this title;(VI) personnel monitoring requirements in accordance with §289.231(m) of this title;(VII) use of protective devices for simulators in accordance with paragraph (3)(H) of this subsection;(VIII) procedures for restriction and alignment of beam for simulators in accordance with paragraph (5)(G) of this subsection. (vi) The registrant shall perform radiation surveys and contamination smears before the transfer or disposal of an accelerator operating at or above 10 MeV. Such surveys shall be documented and maintained by the registrant for inspection by the agency in accordance with subsection (k)(2) of this section.(B) Therapeutic radiation machines capable of operating at energies below 1 MeV.(i) Equipment requirements.(I) When the tube is operated at its leakage technique factors, the leakage radiation shall not exceed the values specified at the distance stated for the classification of that radiation machine system shown in the following Table II. The leakage technique factors are the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.Attached Graphic(II) Permanent fixed diaphragms or cones used for limiting the useful beam shall provide the same or a higher degree of protection as required for the tube housing assembly.(III) Removable and adjustable beam-limiting devices shall meet the following requirements.(-a-) Removable beam-limiting devices shall, for the portion of the useful beam to be blocked by these devices, transmit not more than 1.0 percent of the useful beam at the maximum kVp and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the x-ray field to shape the useful beam to the individual animal.(-b-) Adjustable beam-limiting devices installed before March 1, 1989, shall, for the portion of the x-ray beam to be blocked by these devices, transmit not more than 5.0 percent of the useful beam at the maximum kVp and maximum treatment filter.(-c-) Adjustable beam-limiting devices installed after March 1, 1989, shall meet the requirements of subclause (I) of this clause.(IV) The filter system shall be so designed that:(-a-) the filters cannot be accidentally displaced at any possible tube orientation;(-b-) for equipment installed after March 1, 1989, an interlock system prevents irradiation if the proper filter is not in place;(-c-) the radiation at 5 cm from the filter insertion slot opening does not exceed 30 roentgens per hour (R/hr) (300 mGy/hr) under any operating conditions; and(V) The tube housing assembly shall be so marked that it is possible to determine the location of the focal spot to within 5 millimeters (mm), and such marking shall be readily accessible for use during calibration procedures.(VI) Contact therapy tube housing assemblies shall have a removable shield of at least 0.5 mm lead equivalency at 100 kVp that can be positioned over the entire useful beam exit port during periods when the beam is not in use.(VII) The timer shall:(-a-) have a display provided at the treatment control panel and a pre-set time selector; and(-b-) not permit an exposure if set at zero;(VIII) The control panel, in addition to the displays required in subclause (VII)(-a-) of this clause, shall have the following: (-a-) an indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;(-b-) an indication of whether x-rays are being produced; (-c-) means for indicating x-ray tube potential and current;(-d-) means for terminating an exposure at any time;(-e-) a locking device that will prevent unauthorized use of the therapeutic radiation system (a computerized password system would also constitute a locking device); and(-f-) emergency buttons/switches that shall be clearly labeled as to their functions.(IX) There shall be means of determining initially the SSD to within 1 cm.(X) An indication of shutter position, if applicable, shall appear at the control panel.(ii) Facility Requirements(I) Each installation shall be provided with primary and secondary barriers as are necessary to assure compliance with §289.231(m) of this title. All protective barriers shall be fixed except for entrance doors or beam interceptors.(II) For therapeutic radiation systems capable of operation above 150 kVp.(-a-) The control panel shall be located outside the treatment room or in an enclosed booth inside the room.(-b-) Interlocks shall be provided such that all entrance doors shall be closed, including doors to any interior booths, before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.(iii) Surveys, Calibrations and Spot Checks.(I) Surveys shall be performed as follows.(-a-) All new and existing facilities not previously surveyed shall have an initial survey made by a licensed medical physicist with a specialty in therapeutic radiological physics, who shall provide a written report of the survey to the registrant. Additional surveys shall be done after any change in the facility, facility design, or equipment that might cause a significant increase in radiation hazard.(-b-) The registrant shall maintain a copy of the initial survey report and all subsequent survey reports required by this subclause in accordance with subsection (k)(2) of this section for inspection by the agency.(-c-) The survey report shall indicate all instances where the installation is in violation of applicable requirements of this chapter.(II) Calibrations shall be performed as follows.(-a-) The calibration of a therapeutic radiation system shall be performed at intervals not to exceed one year and after any change or replacement of components that could cause a change in the radiation output. (-b-) The calibration of the radiation output of the therapeutic radiation system shall be performed by a licensed medical physicist with a specialty in therapeutic radiological physics who is physically present at the facility during such calibration.(-c-) The calibration of the therapeutic radiation system shall include verification that the radiation therapy system is operating in compliance with the design specifications.(-d-) Calibration of the radiation output of a therapeutic radiation system shall be performed with a calibrated dosimetry system. The dosimetry system calibration shall be traceable to a national standard. The calibration interval for the dosimetry system shall not exceed 24 months.(-e-) Records of calibration measurements specified in clause (ii) of this subparagraph shall be maintained by the registrant in accordance with subsection (k)(2) of this section for inspection by the agency.(-f-) A copy of the latest calibrated absorbed dose rate measured on a particular therapeutic radiation system shall be available at a designated area within the therapy facility housing that therapeutic radiation system.(III) Spot checks shall be performed on therapeutic radiation systems capable of operation at greater than 150 kVp. (-a-) The spot check procedures shall be in writing, or documented in an electronic reporting system, and shall have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics.(-b-) Records of written spot checks and any necessary corrective actions shall be maintained by the registrant in accordance with subsection (k)(2) of this section for inspection by the agency. A copy of the most recent spot check shall be available at a designated area within the therapy facility housing that therapeutic radiation system.(C) Therapeutic radiation machines capable of operating at energies of 1 MeV and above.(i) Equipment requirements.(I) For operating conditions producing maximum leakage radiation, the absorbed dose in rads (mGy) due to leakage radiation, including x-rays, electrons, and neutrons, at any point in a circular plane of 2 m radius centered on and perpendicular to the central axis of the beam at the isocenter or normal treatment distance and outside the maximum useful beam size shall not exceed 0.1 percent of the maximum absorbed dose in rads (mGy) of the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the plane surface. Measurements excluding those for neutrons shall be averaged over an area up to, but not exceeding, 100 square centimeters (cm2 ) at the positions specified. Measurements of the portion of the leakage radiation dose contributed by neutrons shall be averaged over an area up to, but not exceeding, 200 cm2 . For each system, the registrant shall determine or obtain from the manufacturer the leakage radiation existing at the positions specified for the specified operating conditions. Records on leakage radiation measurements shall be maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(II) Each wedge filter that is removable from the system shall be clearly marked with an identification number. Documentation available at the control panel shall contain a description of the filter. The wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge tray is damaged, the wedge transmission factor shall be re-determined. Equipment manufactured after March 1, 1989, shall meet the following requirements.(-a-) Irradiation shall not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment console, either manually or automatically.(-b-) An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position.(-c-) A display shall be provided at the treatment console showing the beam quality in use.(-d-) An interlock shall be provided to prevent irradiation if any filter selection operation carried out in the treatment room does not agree with the filter selection operation carried out at the treatment console. (III) The registrant shall determine data sufficient to assure that the following beam quality requirements in tissue equivalent material are met.(-a-) The absorbed dose resulting from x-rays in a useful electron beam at a point on the central axis of the beam 10 cm greater than the practical range of the electrons shall not exceed the values stated in the following Table III. Linear interpolation shall be used for values not stated.Attached Graphic(-b-) Compliance with subclause (I) of this clause shall be determined using:(-1-) a measurement within a tissue equivalent phantom with the incident surface of the phantom at the normal treatment distance and normal to the central axis of the beam; (-2-) a field size of 10 cm by 10 cm; and (-3-) a phantom whose cross-sectional dimensions exceed the measurement radiation field by at least 5 cm and whose depth is sufficient to perform the required measurement. (-c-) The absorbed dose at a surface located at the normal treatment distance, at the point of intersection of that surface with the central axis of the useful beam during x-ray irradiation, shall not exceed the limits stated in the following Table IV. Linear interpolation shall be used for values not stated.Attached Graphic(-d-) Compliance with subclause (III) of this clause shall be determined by measurements made as follows:(-1-) within a tissue equivalent phantom using an instrument that will allow extrapolation to the surface absorbed dose;(-2-) using a phantom whose size and placement meet the requirements of subclause (II) of this clause;(-3-) after removal of all beam modifying devices that can be removed without the use of tools, except for beam scattering or beam-flattening filters; and(-4-) using the largest field size available that does not exceed 15 cm by 15 cm.(IV) All therapeutic radiation systems shall be provided with radiation detectors in the radiation head. These shall include the following, as appropriate. (-a-) Equipment manufactured after March 1, 1989, shall be provided with at least two independent radiation detectors. The detectors shall be incorporated into two independent dose monitoring systems. (-b-) Equipment manufactured on or before March 1, 1989, shall be provided with at least one radiation detector. This detector shall be incorporated into a primary dose monitoring system. (-c-) The detector and the system into which that detector is incorporated shall meet the following requirements. (-1-) Each detector shall be removable only with tools and shall be interlocked to prevent incorrect positioning.(-2-) Each detector shall form part of a dose monitoring system from whose readings in dose monitor units the absorbed dose at a reference point in the treatment volume can be calculated. (-3-) Each dose monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation.(-4-) For equipment manufactured after March 1, 1989, the design of the dose monitoring systems shall assure that the malfunctioning of one system shall not affect the correct functioning of the secondary system, and failure of any element common to both systems that could affect the correct function of both systems shall terminate irradiation. (-5-) Each dose monitoring system shall have a legible display at the treatment console. For equipment manufactured after March 1, 1989, each display shall maintain a reading until intentionally reset to zero; have only one scale and no scale multiplying factors; utilize a design such that increasing dose is displayed by increasing numbers and shall be so designed that, in the event of an overdosage of radiation, the absorbed dose may be accurately determined; and each display shall retain the dose monitoring information in at least one system for a 15-minute period of time in the event of a power failure. (V) In equipment manufactured after March 1, 1989, inherently capable of producing useful beams with unintentional asymmetry exceeding 5.0 percent, the asymmetry of the radiation beam in two orthogonal directions shall be monitored before the beam passes through the beam-limiting device. If the difference in dose rate between one region and another region symmetrically displaced from the central axis of the beam exceeds 5.0 percent of the central axis dose rate, indication of this condition shall be at the console; and if this difference exceeds 10 percent of the central axis dose rate, the irradiation shall be terminated. (VI) Selection and display of dose monitor units shall meet the following requirements.(-a-) Irradiation shall not be possible until a selection of a number of dose monitor units has been made at the treatment console. (-b-) The preselected number of dose monitor units shall be displayed at the treatment console until reset manually for the next irradiation. (-c-) After termination of irradiation, it shall be necessary to reset the dosimeter display to zero before subsequent treatment can be initiated.(-d-) For equipment manufactured after March 1, 1989, after termination of irradiation, it shall be necessary to manually reset the preselected dose monitor units before irradiation can be initiated.(VII) Termination of irradiation by the dose monitoring system or systems during stationary beam therapy shall meet the following requirements. (-a-) Each primary system shall terminate irradiation when the preselected number of dose monitor units has been detected by the system. (-b-) If original design of the equipment includes a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than 15 percent or 40 dose monitor units, whichever is smaller, above the preselected number of dose monitor units set at the console has been detected by the secondary dose monitoring system.(-c-) For equipment manufactured after March 1, 1989, a secondary dose monitoring system shall be present. That system shall be capable of terminating irradiation when not more than 10 percent or 25 dose monitoring units, whichever is smaller, above the preselected number of dose monitor units set at the console has been detected by the secondary dose monitoring system. (-d-) For equipment manufactured after March 1, 1989, an indicator on the console shall show which dose monitoring system has terminated irradiation. (VIII) A locking device shall be provided in the system to prevent unauthorized use of the x-ray system. A computerized password system would also constitute a locking device. (IX) It shall be possible to interrupt irradiation and equipment movements at any time from the operator's position at the treatment console. Following an interruption, it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a preselected value during an interruption, irradiation and equipment movements shall be automatically terminated.(X) It shall be possible to terminate irradiation and equipment movements or go from an interruption condition to termination conditions at any time from the operator's position at the treatment console. (XI) Timers shall meet the following requirements.(-a-) A timer that has a display shall be provided at the treatment console. The timer shall have a preset time selector and an elapsed time indicator. (-b-) The timer shall be a cumulative timer that activates with the production of radiation and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator to zero. (-c-) For equipment manufactured after March 1, 1989, after termination of irradiation and before irradiation can be reinitiated, it shall be necessary to manually reset the preset time selector. (-d-) The timer shall terminate irradiation when a preselected time has elapsed if the dose monitoring systems have not previously terminated irradiation. (XII) Equipment capable of producing more than one radiation type shall meet the following additional requirements. (-a-) Irradiation shall not be possible until a selection of radiation type has been made at the treatment console. (-b-) An interlock system shall be provided to:(-1-) ensure that the equipment can emit only the radiation type that has been selected; (-2-) prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment console; (-3-) prevent irradiation with x-rays except to obtain a port film when electron applicators are fitted; and (-4-) prevent irradiation with electrons when accessories specific for x-ray therapy are fitted. (-c-) The radiation type selected shall be displayed at the treatment console before and during irradiation. (XIII) Equipment capable of generating radiation beams of different energies shall meet the following requirements. (-a-) Irradiation shall not be possible until a selection of energy has been made at the treatment console. (-b-) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment console. (-c-) The nominal energy value selected shall be displayed at the treatment console before and during irradiation. (XIV) Equipment capable of both stationary beam therapy and moving beam therapy shall meet the following requirements. (-a-) Irradiation shall not be possible until a selection of stationary beam therapy or moving beam therapy has been made at the treatment console. (-b-) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment console. (-c-) The selection of stationary or moving beam shall be displayed at the treatment console. An interlock system shall be provided to ensure that the equipment can only operate in the mode that has been selected. (-d-) For equipment manufactured after March 1, 1989, an interlock system shall be provided to terminate irradiation if movement of the gantry occurs during stationary beam therapy or stops during moving beam therapy unless such stoppage is a preplanned function. (-e-) Moving beam therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental angle of movement. (-1-) For equipment manufactured after March 1, 1989, an interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of arc differs by more than 20 percent from the selected value. (-2-) For equipment manufactured after March 1, 1989, where gantry angle terminates the irradiation in arc therapy, the dose monitor units shall differ by less than 5.0 percent from the value calculated from the absorbed dose per unit angle relationship.(-f-) Where the dose monitor system terminates the irradiation in moving beam therapy, the termination of irradiation shall be as required by subclause (VII) of this clause. (XV) For equipment manufactured after March 1, 1989, a system shall be provided from whose readings the absorbed dose rate at a reference point in the treatment volume can be calculated. The radiation detectors specified in subclause (IV) of this clause may form part of this system. In addition, the dose monitor unit rate shall be displayed at the treatment console. If the equipment can deliver under any conditions an absorbed dose rate at the normal treatment distance more than twice the maximum value specified by the manufacturer for any machine parameters utilized, a device shall be provided that terminates irradiation when the absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be in a record maintained by the registrant in accordance with subsection (k)(2) of this section for agency inspection. (XVI) The registrant shall determine, or obtain from the manufacturer, the location with reference to an accessible point on the radiation head of the x-ray target or the virtual source of x-rays and the electron window or the virtual source of electrons if the system has electron beam capabilities. (XVII) Capabilities shall be provided so that all radiation safety interlocks can be checked for correct operation.(ii) Facility and shielding requirements.(I) Each installation shall be provided with primary and secondary barriers as are necessary to assure compliance with §289.231(m) of this title.(II) All protective barriers shall be fixed except for entrance doors or beam interceptors.(III) The console shall be located outside the treatment room and all emergency buttons/switches shall be clearly labeled as to their functions.(IV) Treatment room entrances shall be provided with a warning light in a readily observable position near the outside of all access doors to indicate when the useful beam is "on."(V) Interlocks shall be provided such that all entrance doors shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the console.(iii) Surveys, calibrations, spot checks, and operational requirements.(I) Surveys shall be performed as follows.(-a-) All new and existing facilities not previously surveyed shall have an initial survey made by a licensed medical physicist with a specialty in therapeutic radiological physics, who shall provide a written report of the survey to the registrant. In addition, such surveys shall be done after any change in the facility or equipment that might cause a significant increase in radiation hazard.(-b-) The survey report shall include the following:(-1-) a diagram of the facility that details building structures and the position of the console, therapeutic radiation machine, and associated equipment;(-2-) a description of the therapeutic radiation system, including the manufacturer, model and serial number, beam type, and beam energy;(-3-) a description of the instrumentation used to determine radiation measurements, including the date and source of the most recent calibration for each instrument used;(-4-) conditions under which radiation measurements were taken; (-5-) projected annual TEDE in areas adjacent to the therapy room; and(-6-) a description of workload, use, and occupancy factors employed in determining the projected annual TEDE.(-c-) The registrant shall maintain a copy of the survey report and a copy of the survey report shall be provided to the agency within 30 days of completion of the survey. Records of the survey report shall be maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(-d-) The survey report shall include documentation of all instances where the installation is in violation of applicable regulations. Any deficiencies detected during the survey shall be corrected before using the machine.(II) Calibrations of therapeutic systems shall be performed as follows.(-a-) The calibration of systems subject to this subsection shall be performed in accordance with an established calibration protocol before the system is first used for irradiation of an animal and thereafter at time intervals that do not exceed 12 months and after any change that might significantly alter the calibration, spatial distribution, or other characteristics of the therapy beam. The calibration procedures shall be in writing, or documented in an electronic reporting system, and shall have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics.(-b-) The calibration shall be performed by a licensed medical physicist with a specialty in therapeutic radiological physics who is physically present at the facility during the calibration.(-c-) The calibration shall include verification that the equipment is operating in compliance with the design specifications concerning the light field, animal positioning lasers, and back-pointer lights with the isocenter when applicable, variation in the axis of rotation for the table, gantry, and collimator system, and beam flatness and symmetry at the specified depth.(-d-) Records of calibration measurements shall be maintained according to subsection (k)(2) of this section for inspection by the agency.(III) The spot check procedures shall be performed in accordance with established protocol, shall be in writing, or documented in an electronic reporting system, and shall have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics.(-a-) The written spot check procedures shall specify the frequency at which tests or measurements are to be performed and the acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the calibration. (-b-) Records of spot check measurements and any necessary corrective actions shall be maintained by the registrant in accordance with subsection (k) of this section for inspection by the agency.(D) General requirements for simulators in radiation therapy.(i) A technique chart relevant to the particular radiation machine shall be provided or electronically displayed in the vicinity of the console and used by all operators.(ii) Each registrant shall have and implement written operating and safety procedures in accordance with paragraph (2) of this subsection.(iii) When utilized, protective devices shall follow the requirements of paragraph (3)(H) of this subsection.(iv) The operator's position during the exposure shall follow the requirements of paragraph (3)(K) of this subsection.(v) No individuals other than the animal and the operators shall be in the treatment room during operation of the simulator.(9) Educational facilities. Facilities conducting training using live animals are held to the requirements of this section except for paragraphs (10) - (12) of this subsection concerning film processing. (10) Automatic and manual film processing for veterinary facilities and mobile veterinary services.(A) Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer. The specified developer temperature for automatic processing and the time-temperature chart for manual processing shall be posted in the processing area. If the registrant determines an alternate time-temperature relationship is more appropriate for a specific facility, that time-temperature relationship shall be documented and posted.(B) Chemicals shall be replaced according to the chemical manufacturer's or supplier's recommendations or at an interval not to exceed three months.(C) Darkroom light leak tests shall be performed at intervals not to exceed six months.(D) Lighting in the film processing/loading area shall be maintained with the filter, bulb wattage, and distances recommended by the film manufacturer for that film emulsion or with products that provide an equivalent level of protection against fogging.(E) Corrections or repairs of the light leaks or other deficiencies in subparagraphs (B) - (D) of this paragraph shall be initiated within 72 hours of discovery and completed no longer than 15 days from detection of the deficiency unless a longer time is authorized by the agency. (F) Documentation of the items in subparagraphs (B), (C), and (E) of this paragraph shall be maintained at the site where performed and shall include the date and initials of the individual completing these items. These records shall be made and maintained in accordance with subsection (k)(2) of this section for inspection by the agency.(11) Alternative processing systems. Users of daylight processing systems, laser processors, self-processing film units, or other alternative processing systems shall follow manufacturer's recommendations for image processing. Documentation that the registrant is following manufacturer's recommendations shall include the date and initials of the individual completing the document and shall be made and maintained at the site where performed in accordance with subsection (k)(2) of this section for inspection by the agency.(12) Digital imaging acquisition systems. (A) Users of digital imaging acquisition systems shall follow quality assurance/quality control (QA/QC) protocol for digital imaging established by the manufacturer.(i) The registrant shall include the protocols established in subparagraph (B) of this paragraph in its operating and safety procedures.(ii) The registrant shall document the frequency at which the QA/QC protocol is performed. Documentation shall:(I) include the date and initials of the individual completing the document and the images acquired; and(II) be maintained and available at the authorized use location where performed in accordance with subsection (k)(2) of this section for inspection by the agency.(B) If a protocol cannot be established by the manufacturer, it shall be developed and implemented by the registrant.(i) The QA/QC protocol, as developed and implemented by the registrant, shall include image quality testing for spatial resolution, noise, artifacts and contrast by using a commercially purchased testing tool or an inanimate object of at least three varying densities.(I) Images shall be acquired with each x-ray image receptor at an interval not to exceed three months.(II) Test images shall be compared to previous test images to assess degradation of image quality.(III) If a radiation machine or components of the digital imaging acquisition system require correction or repair following a quality test, the correction or repair shall begin within 30 days following the failure and the registrant shall perform or cause to be performed the correction or repair according to a designated plan. Correction or repair shall be completed no longer than 90 days from discovery unless authorized in writing by the agency.(ii) The registrant shall include the protocols established in this paragraph in its operating and safety procedures.(iii) The registrant shall document the frequency at which the QA/QC protocol is performed. Documentation shall:(I) include the date and initials of the individual completing the document and the images acquired; and(II) be maintained and available at the authorized use location where performed in accordance with subsection (k)(2) of this section for inspection by the agency.(k) Records and reports.(1) General provisions for records and reports.(A) Each registrant shall maintain records at each site including sites authorized by certificate of registration condition and records sites for mobile services. The records shall include those specified in paragraph (2) of this subsection and shall be maintained at the time interval indicated for inspection by the agency. These records may be maintained in electronic format. These records shall be accessible to radiation machine operators during working hours.(B) All records required by this chapter shall be accurate and factual.(C) Records are only valid if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures.(D) Each registrant shall use the SI units Gy, Sv, and coulomb per kilogram, or the special units rad, rem, and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter.(E) The registrant shall make a clear distinction among the quantities entered on the records required by this section, such as total effective dose equivalent, shallow dose equivalent, lens dose equivalent, or deep dose equivalent.(F) Each record required by this section shall be legible throughout the specified retention period.(G) The record shall be the original or a reproduced copy or a microfilm provided that the copy or microform is authenticated by authorized personnel and that the microfilm is capable of producing a clear copy throughout the required retention period.(H) The record may also be stored in electronic format with the capability for producing legible, accurate, and complete records during the required retention period.(I) The registrant shall maintain adequate safeguards against tampering with and loss of records.(J) Copies of records required in subsections (i)(5)(I) and (J), and (j)(10)(F) of this section and by certificate of registration condition that are relevant to operations at an additional authorized use location shall be maintained at that location in addition to the main site specified on a certificate of registration in accordance with paragraph (2) of this subsection.(K) Records of surveys.(i) Each registrant shall make and maintain records showing the results of surveys required by subsection (j)(4)(E) of this section for inspection by the agency. The registrant shall retain these records in accordance with paragraph (2) of this subsection.(ii) The registrant shall retain the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents in accordance with paragraph (2) of this subsection.(L) Records of individual monitoring results.(i) Each registrant shall make or cause to be made and maintain records in accordance with subsection (j)(3)(F) of this section of the doses received by all individuals for whom monitoring was required in accordance with subsection (j)(3)(F) of this section, and records of doses received during accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before January 1, 1994, need not be changed. These records shall include, when applicable:(I) the deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin of the whole body, and shallow dose equivalent to the skin of any extremities; and(II) the data used to make occupational dose assessments in accordance with subsection (j)(3)(F)(v) of this section.(ii) The registrant shall make entries of the records specified in clause (i) of this subparagraph at intervals not to exceed one year and within 90 days of the end of the year.(iii) The registrant shall make or cause to be made and maintain the records specified in clause (i) of this subparagraph on RC Form 233-1 in accordance with the instructions for RC Form 233-1, or in clear and legible records containing all the information required by RC Form 233-1. (iv) The registrant shall make or cause to be made and maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.(v) The registrant shall retain each required form or record required by this subsection in accordance with paragraph (2) of this subsection for inspection by the agency. The registrant shall retain records used in preparing RC Form 233-1 or equivalent in accordance with paragraph (2) of this subsection.(M) Records of dose to individual members of the public.(i) Each registrant shall make and maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public for inspection by the agency. See subsection (j)(3)(C) and (D) of this section.(ii) The registrant shall retain the records required by clause (i) of this subparagraph in accordance with paragraph (2) of this subsection.(2) Record or document requirements. Each registrant shall maintain the following records at each site, including authorized records sites for mobile services, at the time intervals specified and make available to the agency for inspection.Attached Graphic(3) Reports.(A) Reports of stolen, lost, or missing radiation machines. (i) Each registrant shall report to the agency by telephone a stolen, lost, or missing radiation machine immediately after its occurrence becomes known to the registrant. (ii) Each registrant required to make a report in accordance with clause (i) of this subparagraph shall, within 30 days after making the telephone report, make a written report to the agency that includes the following information:(I) a description of the radiation machine involved, including the manufacturer, model, and serial number;(II) a description of the circumstances under which the loss or theft occurred;(III) exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible TEDE to persons in unrestricted areas;(IV) actions that have been taken, or will be taken, to recover the radiation machine; and(V) procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of radiation machines.(iii) Subsequent to filing the written report, the registrant shall also report additional substantive information on the loss or theft within 30 days after the registrant learns of such information.(iv) The registrant shall prepare any report filed with the agency in accordance with this subsection so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.(B) Reports of incidents.(i) Notwithstanding other requirements for notification, each registrant shall immediately report each event involving a radiation machine possessed by the registrant that may have caused or threatens to cause an individual to receive:(I) a total effective dose equivalent of 25 rems (0.25 Sv) or more;(II) a lens dose equivalent of 75 rems (0.75 Sv) or more; or (III) a shallow dose equivalent to the skin of the whole body or to the skin of any extremities of 250 rads (2.5 grays) or more.(ii) Each registrant shall, within 24 hours of discovery of the event, report to the agency each event involving loss of control of a radiation machine possessed by the registrant that may have caused, or threatens to cause an individual to receive, in a period of 24 hours:(I) total effective dose equivalent exceeding 5 rems (0.05 Sv);(II) lens dose equivalent exceeding 15 rems (0.15 Sv); or(III) a shallow dose equivalent to the skin of the whole body or to the skin of any extremities exceeding 50 rems (0.5 Sv).(iii) Registrants shall make the initial notification reports required by clauses (i) and (ii) of this subparagraph by telephone to the agency shall confirm the initial notification report within 24 hours by facsimile or other electronic media to the agency.(iv) The registrant shall prepare each report filed with the agency in accordance with this section so that names of individuals who have received exposure to radiation are stated in a separate and detachable portion of the report.(C) Reports of exposures and radiation levels exceeding the limits.(i) In addition to the notification required by subparagraph (B) of this paragraph, each registrant shall submit a written report within 30 days after learning of any of the following occurrences:(I) incidents for which notification is required by subparagraph (B) of this paragraph;(II) doses in excess of any of the following:(-a-) the occupational dose limits for adults in subsection (j)(3)(A)(i)(I) of this section;(-b-) the occupational dose limits for a minor in subsection (j)(3)(A)(i)(III) of this section;(-c-) the limits for an embryo/fetus of a declared pregnant woman in subsection (j)(3)(A)(i)(IV) of this section;(-d-) the limits for an individual member of the public in subsection (j)(3)(C) of this section; or(-e-) any applicable limit in the certificate of registration; (III) levels of radiation in:(-a-) a restricted area in excess of applicable limits in the certificate of registration; or(-b-) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the registration, whether or not involving exposure of any individual in excess of the limits in subsection (j)(3)(C) of this section.(ii) Each report required by clause (i) of this subparagraph shall describe the extent of exposure of individuals to radiation, including, as appropriate:(I) estimates of each individual's dose;(II) the levels of radiation involved;(III) the cause of the elevated exposures, dose rates; and(IV) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, and associated registration conditions.(iii) Each report filed in accordance with clause (i) of this subparagraph for each individual exposed shall include the name, a unique identification number, and date of birth. With respect to the limit for the embryo/fetus in subsection (j)(3)(A)(i)(IV) of this section, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.(iv) All registrants who make reports in accordance with clause (i) of this subparagraph shall submit the report in writing to the agency.(D) Reports to individuals of exposures.(i) Radiation exposure data for an individual shall be reported annually to the individual as specified in this section. The information reported shall include data and results obtained in accordance with requirements of this section, orders, certificate of registration conditions, as shown in records made and maintained by the registrant in accordance with this subsection. Each notification and report shall:(I) be in writing; (II) include appropriate identifying data, such as the name of the registrant, the name of the individual, and the individual's identification number;(III) include the individual's exposure information; and (IV) contain the following statement: "This report is furnished to you under the provisions of the Texas Regulations for Control of Radiation, 25 Texas Administrative Code §289.233. You should preserve this report for further reference."(ii) Each registrant shall provide an annual written report to advise each worker of the worker's dose, received in that monitoring year, as shown in records made and maintained by the registrant in accordance with paragraph (1)(M) of this subsection, if:(I) the individual's occupational dose exceeds 0.1 rem (1 mSv) total effective dose equivalent or 0.1 rem (1 mSv) to any individual organ or tissue; or(II) the individual requests the individual's annual dose report in writing.(iii) At the written request of a worker formerly engaged in activities controlled by the registrant, each registrant shall furnish a written report of the worker's exposure to radiation machines. The report shall include the dose record for each year the worker was required to be monitored in accordance with subsection (j)(3)(B) of this section. Such report shall be furnished within 30 days from the date of the request, or within 30 days after the dose of the individual has been determined by the registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to radiation machines and the dates and work sites under the certificate of registration in which the worker participated during this period.(iv) When a registrant is required, in accordance with subparagraphs (B) and (C) of this paragraph, to report to the agency any exposure of an individual to radiation, the registrant shall also notify the individual and provide the individual with a copy of the report submitted to the agency, including the information required by clause (i) of this subparagraph. Such reports shall be transmitted at a time not later than the transmittal to the agency. (v) At the written request of a worker who is terminating employment with the registrant in work involving exposure to radiation machines during the current year, each registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate. When the final individual monitoring results are available, those written results shall be provided to the worker or the worker's designee.(vi) When a registrant is required in accordance with paragraph (3)(C) of this subsection to report to the agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation, the registrant shall also notify the individual and provide a copy of the report submitted to the agency, to the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency and shall comply with the provisions of paragraph (3)(D) of this subsection. Source Note: The provisions of this §289.233 adopted to be effective April 15, 2021, 46 TexReg 2424. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL E REGISTRATION REGULATIONS §289.233 Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=192252&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 192252 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=192252&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 192252 03/11/2026 (a) Purpose. This section provides for exemptions to licensing requirements, general licensing of radioactive material, and acknowledgement of general licenses. (b) Scope. Except as otherwise authorized, no person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a general license or general license acknowledgement issued in accordance with this section, or in a specific license issued in accordance with §289.252 of this title (relating to Licensing of Radioactive Material), §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material), §289.258 of this title (relating to Licensing and Radiation Safety Requirements for Irradiators), or §289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM). (c) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise. (1) General license--An authorization in accordance with this section that grants authority to a person for certain activities involving radioactive material, and is effective without the filing of applications with the agency or the issuance of licensing documents to the particular persons. The general licensee is subject to all other applicable portions of this chapter and any limitations of the general license. (2) General license acknowledgement--A written recognition of a general license issued in accordance with this section. The issuance of a general license acknowledgement requires the submission of an application to the agency. A written acknowledgement of a general license granted in accordance with this section is issued by the agency. The holder of a general license acknowledgement is subject to all other applicable portions of this chapter as well as any conditions specified in the acknowledgement document. (d) Exemptions for source material.(1) Any person is exempt from this section and §289.252 of this title if that person receives, possesses, uses, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1.0% (0.05%) of the mixture, compound, solution, or alloy. (2) Any person is exempt from this section and §289.252 of this title if that person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore. This exemption does not apply to the mining of ore containing source material.(3) Any person is exempt from this section and §289.252 of this title to the extent that such person receives, possesses, uses, or transfers:(A) any quantities of thorium contained in: (i) incandescent gas mantles; (ii) vacuum tubes; (iii) welding rods; (iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams (mg) of thorium; (v) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium; (vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25% by weight thorium, uranium, or any combination of these; or (vii) personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 mg of thorium; (B) source material contained in the following products: (i) glazed ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20% by weight source material; (ii) glassware containing not more than 2% by weight source material or, for glassware manufactured before August 27, 2013, 10% by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; (iii) glass enamel or glass enamel frit containing not more than 10% by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983; or (iv) piezoelectric ceramic containing not more than 2.0% by weight source material; (C) photographic film, negatives, and prints containing uranium or thorium; (D) any finished product or part fabricated of, or containing, metal-thorium alloys, provided that the thorium content of the alloy does not exceed 4% by weight and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part;(E) uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that: (i) each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM" (The requirements specified in this clause need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM," required at that time); (ii) each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED" (The requirements specified in this clause need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM" required at that time); and (iii) the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering; (F) natural or depleted uranium used as shielding constituting part of any shipping container, provided that:(i) the shipping container is conspicuously and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM;" and (ii) the uranium metal is encased in a one-eighth inch minimum wall thickness of mild steel or equally fire resistant material;(G) thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10% by weight of thorium or uranium or, for lenses manufactured before August 27, 2013, 30% by weight of thorium; and that the exemption contained in this subparagraph shall not be deemed to authorize either: (i) the shaping, grinding, or polishing of such lens or mirror or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or (ii) the receipt, possession, use, or transfer of uranium or thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or in other optical instruments; (H) uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie (µCi) (185 becquerels (Bq) of uranium; or (I) thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that: (i) the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and (ii) the thorium content in the nickel-thoria alloy does not exceed 4.0% by weight.(4) The exemptions in subsection (d)(3) of this section do not authorize the manufacture of any of the products described. (5) No person may initially transfer for sale or distribution a product containing source material to persons exempt under subsection (d)(3) of this section, Title 10, CFR, §40.13(c), or equivalent regulations of an agreement state, unless authorized by a license issued under Title 10, CFR, §40.52, to initially transfer such products for sale or distribution. (A) Persons initially distributing source material in products covered by the exemptions in subsection (d)(3) of this section before August 27, 2013, without specific authorization may continue such distribution for 1 year beyond this date. Initial distribution may also be continued until the agency takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than 1 year beyond this date. (B) Persons authorized by the agency, the NRC, or any agreement state to manufacture, process, or produce these materials or products containing source material, and persons who import finished products or parts, for sale or distribution must be authorized by a license issued under Title 10, CFR, §40.52, for distribution only. These persons are exempt from the requirements of §289.202 (relating to Standards for Protection Against Radiation from Radioactive Materials), §289.203 (relating to Notices, Instructions, and Reports to Workers; Inspections), and §289.252(e)(1) and (2) of this title. (e) Exemptions for radioactive material other than source material.(1) Exempt concentrations. (A) Except as provided in subparagraph (B) of this paragraph, any person is exempt from this section and §289.252 of this title if that person receives, possesses, uses, transfers, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in subsection (l)(1) of this section.(B) No person may introduce radioactive material into a product or material, including waste, knowing or having reason to believe that it will be transferred to persons exempt in accordance with subparagraph (A) of this paragraph or equivalent regulations of the NRC or any agreement state, except in accordance with a specific license issued under §289.252(i) of this title.(C) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license, as specified in §289.252 of this title, if the manufacturer, processor, or producer transfers radioactive material contained in a product or material that does not exceed the concentrations specified in subsection (l)(1) of this section, and that has been introduced into the product or material by a licensee holding a specific license issued by the NRC that expressly authorizes such introduction. The exemption specified in this subparagraph does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.(2) Exempt quantities.(A) Except as provided in subparagraphs (C), (D), and (F) of this paragraph, any person is exempt from these rules if that person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities, each of which does not exceed the applicable quantity set forth in subsection (l)(2) of this section. (B) Any person who possesses radioactive material received or acquired, prior to September 25, 1971, in accordance with the general license provided in subsection (f)(4)(A) of this section is exempt from the requirements for a license set forth in §289.252 of this title if that person possesses, uses, transfers, or owns such radioactive material.(C) This paragraph does not authorize the production, packaging, or repackaging or transfer of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.(D) No person may, for purposes of commercial distribution, transfer radioactive material in quantities greater than the individual quantities set forth in subsection (l)(2) of this section, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this paragraph or equivalent regulations of the NRC or any agreement state, except in accordance with a specific license issued by the NRC in accordance with Title 10, CFR, §32.18 or by the agency in accordance with §289.252(j) of this title, which states that the radioactive material may be transferred by the licensee to persons exempt in accordance with this paragraph or the equivalent regulations of the NRC or any agreement state. (E) The schedule of quantities set forth in subsection (l)(2) of this section applies only to radioactive materials distributed as exempt quantities under a specific license issued by the agency, the NRC, or any agreement state. Subsection (l)(2) of this section does not apply to radioactive materials that have decayed from quantities not originally exempt and does not make such material, or the sources or devices in which the material is contained exempt from the licensing requirements in this section or §289.252 of this title. (F) No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in subsection (l)(2) of this section, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the requirements in this title.(3) Exempt items.(A) Certain items containing radioactive material.(i) Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from this chapter if that person receives, possesses, uses, transfers, or acquires the following products:(I) timepieces, hands, or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:(-a-) 25 millicuries (mCi) (925 megabecquerels (MBq)) of tritium per timepiece; (-b-) 5 mCi (185 MBq) of tritium per hand; (-c-) 15 mCi (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial); (-d-) 100 µCi (3.7 MBq) of promethium-147 per watch or 200 µCi (7.4 MBq) of promethium-147 per any other timepiece; (-e-) 20 µCi (0.74 MBq) of promethium-147 per watch hand or 40 µCi (1.48 MBq) of promethium-147 per other timepiece hand; (-f-) 60 µCi (2.22 MBq) of promethium-147 per watch dial or 120 µCi (4.44 MBq) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial); (-g-) the levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter (mg/cm2) of absorber: (-1-) for wrist watches, 0.1 millirad per hour (mrad/hr) at 10 centimeters (cm) from any surface; (-2-) for pocket watches, 0.1 mrad/hr at 1 cm from any surface; and (-3-) for any other timepiece, 0.2 mrad/hr at 10 cm from any surface; or(-h-) 1 µCi (0.037 MBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007;(II) static elimination devices which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 µCi (18.5 MBq) of polonium-210 per device; (III) ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 µCi (18.5 MBq) of polonium-210 per device or of a total of not more than 50 mCi (1.85 gigabecquerels (GBq)) of hydrogen-3 (tritium) per device; (IV) such devices authorized before October 23, 2012, for use under a general license issued under this section or equivalent regulations of the NRC or any agreement state and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the NRC; (V) balances of precision containing not more than 1 mCi (37 MBq) of tritium per balance or not more than 0.5 mCi (18.5 MBq) of tritium per balance part manufactured before December 17, 2007; (VI) marine compasses containing not more than 750 mCi (27.75 MBq) of tritium gas and other marine navigational instruments containing not more than 250 mCi (9.25 GBq) of tritium gas manufactured before December 17, 2007; (VII) electron tubes, provided that each tube does not contain more than one of the following specified quantities of radioactive material and that the levels of radiation from each electron tube containing radioactive material do not exceed 1 mrad/hr at 1 cm from any surface when measured through 7 mg/cm2 of absorber (For purposes of this clause, "electron tubes" include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube designed to control electrical currents): (-a-) 150 mCi (5.55 GBq) of tritium per microwave receiver protector tube or 10 mCi (0.37 GBq) of tritium per any other electron tube; (-b-) 1 µCi (0.037 MBq) of cobalt-60; (-c-) 5 µCi (0.185 GBq) of nickel-63; (-d-) 30 µCi (1.11 GBq) of krypton-85; (-e-) 5 µCi (0.185 GBq) of cesium-137; or (-f-) 30 µCi (1.11 GBq) of promethium-147; (VIII) ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, a source of radioactive material not exceeding: (-a-) the applicable quantity set forth in subsection (l)(2) of this section or 0.05 µCi (1.85 kilobecquerels (kBq)) of americium-241; and (-b-) each instrument contains no more than 10 exempt quantities. For purposes of this subclause, an instrument's source(s) shall contain either one type or different types of radionuclides and an individual exempt quantity shall be composed of fractional parts of one or more of the exempt quantities in accordance with subsection (l)(2) of this section, provided that the sum of such fractions shall not exceed unity. (IX) ionization chamber smoke detectors containing not more than 1 µCi (37 kBq) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.(ii) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, DC 20555. (iii) Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in clause (i) of this subparagraph, or who desires to initially transfer for sale or distribution such products containing radioactive material, shall apply for a specific license issued by the NRC in accordance with Title 10, CFR, §32.14, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to clause (i) of this subparagraph.(B) Self-luminous products containing tritium, krypton-85, or promethium-147.(i) Except for persons who manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in clause (iii) of this subparagraph, any person is exempt from this chapter if that person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the NRC in accordance with Title 10, CFR, §32.22, which authorizes the initial transfer of the product to persons who are exempt from regulatory requirements.(ii) Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under clause (i) of this subparagraph, should apply for:(I) a specific license to be issued by the NRC in accordance with Title 10, CFR, §32.22; and (II) a certificate of registration to be issued by the NRC in accordance with Title 10, CFR, §32.210. (iii) The exemption in clause (i) of this subparagraph does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments. (C) Gas and aerosol detectors containing radioactive material. (i) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property. (I) Detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the NRC in accordance with Title 10, CFR, §32.26. (II) The specific license issued by the NRC in accordance with Title 10, CFR, §32.26, authorizes the initial transfer of the product for use to persons who are exempt from regulatory requirements. (III) This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued in accordance with §289.252 of this title or under comparable provisions to Title 10, CFR, §32.26 authorizing distribution to persons exempt from regulatory requirements. (IV) Any person who desires to manufacture, process, or produce, gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under this clause, shall apply for: (-a-) a specific license to be issued by the NRC in accordance with Title 10, CFR, §32.26; and (-b-) a certificate of registration to be issued by the NRC in accordance with Title 10, CFR, §32.210. (ii) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, DC 20555. (iii) Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by any agreement state shall be considered exempt in accordance with clause (i) of this subparagraph, provided that the devices are labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of §289.252 of this title. (D) Certain industrial devices. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere. (i) Devices containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued under Title 10, CFR, §32.30. (ii) The specific license issued by the NRC in accordance with Title 10, CFR, §32.30, authorizes the initial transfer of the device for use under Title 10, CFR, §32.30. (iii) This exemption does not cover sources not incorporated into a device, such as calibration and reference sources. (iv) Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under this subparagraph, shall apply for: (I) a license to be issued by the NRC under Title 10, CFR, §32.30; and (II) a certificate of registration to be issued by the NRC in accordance with Title 10, CFR, §32.210.(4) Exemption for capsules containing carbon-14 urea for "in vivo" diagnostic use in humans. (A) Except as provided in subparagraphs (B) and (C) of this paragraph, a person is exempt from the requirements of this section and §289.256 of this title provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 1 µCi (37 kBq) or less of carbon-14 urea each (allowing for nominal variation that may occur during the manufacturing process), for "in vivo" diagnostic use in humans. (B) A person desiring to use the capsules for research involving human subjects shall apply for and receive a specific license in accordance with §289.256 of this title. (C) A person desiring to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license in accordance with Title 10, CFR, §32.21. (D) Nothing in this subsection relieves a person from complying with applicable requirements of the United States Food and Drug Administration (FDA) and other federal and state requirements governing the receipt, administration, and use of drugs.(f) General licenses. In addition to the requirements of this section, all general licenses, unless otherwise specified, are subject to the requirements of §289.201 of this title (relating to General Provisions for Radioactive Material), §289.202(ww) and (xx) of this title, §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), and §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).(1) Compliance history. In making a determination whether to revoke, suspend, or restrict a general license, the agency may consider the technical competence and compliance history of a general licensee. After an opportunity for a hearing, the agency may revoke, suspend, or restrict a general license if the general licensee's compliance history reveals that at least 3 agency actions have been issued against the general licensee, within the previous 6 years, that assess administrative or civil penalties against the general licensee, or that revoke or suspend the general license. (2) Modification, suspension, and revocation of a general license. (A) The terms and conditions of all general licenses shall be subject to revision or modification. (B) A general license may be suspended or revoked by reason of amendments to the Texas Radiation Control Act (Act), Health and Safety Code, Chapter 401, by reason of rules in this chapter, or orders issued by the agency. (C) Any general license may be revoked, suspended, or modified, in whole or in part, for any of the following: (i) any material false statement in the application for a general license acknowledgement or any statement of fact required in accordance with provisions of the Act; (ii) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a general license on an original application; (iii) violation of, or failure to observe, any of the terms and conditions of the Act, this chapter, or of the general license, or order of the agency; or (iv) existing conditions that constitute a substantial threat to the public health or safety or the environment. (D) Except in cases in which the occupational and public health, or safety requires otherwise, no general license shall be suspended or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the holder of the general license in writing and the holder of the general license shall have been afforded an opportunity to demonstrate compliance with all lawful requirements. (E) Each general license revoked by the agency expires at the end of the day on the date of the agency's final determination to revoke the general license, or on the revocation date stated in the determination, or as otherwise provided by agency order. (3) General licenses for source material.(A) General license for small quantities of source material.(i) A general license is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions, and federal, state and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities: (I) no more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. (-a-) Any material processed by the general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form. (-b-) A person authorized to possess, use, and transfer source material as specified in this clause may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any 1 calendar year. (-c-) Persons possessing source material in excess of these limits as of August 27, 2013, may continue to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time until the NRC takes final action on any pending application submitted on or before August 27, 2014, for a specific license for such material; and may receive up to 70 kg (154 lb) of uranium or thorium in any one calendar year until the NRC takes final action on a pending application submitted on or before August 27, 2014, for a specific license for such material; and (II) no more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time. (-a-) A person authorized to possess, use, and transfer source material as specified in this clause may not receive more than a total of 70 kg (154 lb) of uranium and thorium in any 1 calendar year. (-b-) A person may not alter the chemical or physical form of the source material possessed as specified in this clause unless it is accounted for in accordance with the limits of clause (i)(I) of this subparagraph; or (III) no more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lb) of uranium from drinking water during a calendar year under this clause; or (IV) no more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material as specified in this clause may not receive more than a total of 70 kg (154 lb) of source material in any 1 calendar year. (ii) Any person who receives, possesses, uses, or transfers source material in accordance with the general license in clause (i) of this subparagraph: (I) is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the agency in a specific license; (II) shall not abandon such source material. Source material may be disposed of as follows: (-a-) a cumulative total of 0.5 kg (1.1 lb) of source material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material in accordance with the general license to persons receiving the material for permanent disposal. The recipient of source material transferred in accordance with this item is exempt from the requirements to obtain a license as specified in subsection (f)(3) of this section to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under §289.252 of this title; or (-b-) in accordance with §289.202(ff) of this title; (III) is subject to the regulations in subsection (f)(2), (h)(2), and (i) of this section and §§289.201(a), (b), (d) - (f), (i), (k), and (l); 289.202 (vv), (xx)(6) - (8) and (vv); 289.203(g)(3); 289.252(a), (w)(2), (x)(1) - (4), and (cc); and 289.257(b)(1) of this title; and (IV) shall not export such source material except in accordance with Title 10, CFR, Part 110. (iii) Any person who receives, possesses, uses, or transfers source material in accordance with clause (i) of this subparagraph shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the agency about such contamination and may consult with the agency as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used in accordance with this general license is not likely to result in exposures that exceed the limits in §289.202(ddd)(2) of this title.(iv) Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in clause (i) of this subparagraph is exempt from the regulations in §§289.201, 289.202, and 289.203 of this title to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the regulations of §289.202(ff) and (ddd)(2)(A) of this title to the extent necessary to meet the requirements of clauses (ii)(II) and (iii) of this subparagraph. However, this exemption does not apply to any person who also holds a specific license issued under §289.252 of this title.(v) No person may initially transfer or distribute source material to persons generally licensed as specified in clause (i)(I) or (II) of this subparagraph, or equivalent regulations of any agreement state, unless authorized by a specific license issued in accordance with §289.252(cc)(6)(A) of this title or equivalent regulations of the NRC or any agreement state. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample. Initial distribution of source material to persons generally licensed by clause (i) of this subparagraph may be continued until the NRC takes final action on a pending application for license or license amendment to specifically authorize distribution submitted on or before August 27, 2014.(B) A general license is issued to own source material without regard to quantity. This general license does not authorize any person to receive, possess, use or transfer source material. (C) A general license is issued to mine, transport, and transfer ores containing source material without regard to quantity. In addition to the provisions of subsection (f) of this section, persons who mine, transport, and transfer ores containing source material in accordance with this section shall comply with the provisions of §289.202(n) and (ff) of this title.(D) A general license is issued to receive, acquire, possess, use, or transfer depleted uranium contained in products or devices for the purpose of providing shielding, including beam shaping and collimation, in accordance with clauses (i) - (iv) of this subparagraph. (i) The general license in this paragraph applies only to products or devices that have been manufactured either in accordance with a specific license issued by the agency to the manufacturer of the products or devices in accordance with §289.252(s) of this title or in accordance with a specific license issued to the manufacturer by another agreement state or the NRC that authorizes manufacture of the products or devices for distribution to persons generally licensed by another agreement state or the NRC. (ii) Persons who receive, acquire, possess, or use depleted uranium in accordance with the general license in this paragraph shall notify the agency within 30 days after the first receipt of acquisition of such depleted uranium. The general licensee shall furnish the following information and such other information as may be required by the agency: (I) name and address of the general licensee; (II) a statement that the general licensee has developed and will maintain procedures designed to establish physical control over the depleted uranium in accordance with this paragraph and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and (III) name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the general licensee in supervising the procedures identified in clause (ii) of this subparagraph. (iii) The general licensee possessing or using depleted uranium in accordance with the general license in this paragraph shall report in writing to the agency any changes in information furnished by the general licensee. The report shall be submitted within 30 days after the effective date of such change. (iv) A person who receives, acquires, possesses, or uses depleted uranium in accordance with the general license in this paragraph: (I) shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium; (II) shall not abandon such depleted uranium; (III) shall transfer or dispose of such depleted uranium only in accordance with the provisions of §289.252(cc) of this title. In the case where the transferee receives the depleted uranium in accordance with the general license in this paragraph or equivalent rule of the NRC or an agreement state, the transferor shall furnish the transferee a copy of this paragraph; (IV) within 30 days of transfer, shall report in writing to the agency the name and address of the person receiving the depleted uranium in accordance with such transfer; and (V) shall not export such depleted uranium except in accordance with a license issued by the NRC in accordance with Title 10, CFR, Part 110. (v) Any person receiving, acquiring, possessing, using, or transferring depleted uranium in accordance with the general license in this paragraph is exempt from the requirements of §289.202 of this title and §289.203 of this title with respect to the depleted uranium covered by that general license. (4) General licenses for radioactive material other than source material.(A) General licenses for static elimination devices and ion generating tubes. A general license is issued to transfer, receive, acquire, possess, and use radioactive material incorporated in the devices or equipment specified in the following clauses (i) and (ii) of this paragraph that have been manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the NRC. In addition to the provisions of subsection (f) of this section, this general license is subject to the provisions of subsection (e)(1)(B) of this section and §289.252(cc) of this title: (i) static elimination devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material totaling not more than 500 µCi (18.5 MBq) of polonium-210 per device; or (ii) ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material totaling not more than 500 µCi (18.5 MBq) of polonium-210 per device or a total of not more than 50 mCi (1.85 GBq) of tritium per device. (B) General license for luminous safety devices for aircraft. (i) A general license is issued to receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided: (I) each device contains not more than 10 curies (Ci) (370 GBq) of tritium or 300 mCi (11.1 GBq) of promethium-147; and (II) each device has been manufactured, assembled, or initially transferred in accordance with a specific license issued by the NRC, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the agency or any agreement state that authorizes the manufacture or assembly of the device to persons generally licensed by the agency or an agreement state. (ii) The general license in clause (i) of this subparagraph does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium-147. (iii) The general license in clause (i) of this subparagraph does not authorize the receipt, acquisition, possession, or use of tritium or promethium-147 contained in instrument dials. (C) General license for ownership of radioactive material. A general license is issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this section, this general license does not authorize the manufacture, production, transfer, receipt, possession, or use of radioactive material.(D) General license for calibration, stabilization, and reference sources. (i) A general license is issued to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of clauses (ii) and (iii) of this subparagraph, americium-241, plutonium, and/or radium-226, in the form of calibration, stabilization, or reference sources to any person who holds a specific license issued by the: (I) agency that authorizes that person to receive, possess, use, and transfer radioactive material; and (II) NRC that authorizes that person to receive, possess, use, and transfer radioactive material. (ii) The general license in clause (i) of this subparagraph applies only to calibration, stabilization, or reference sources that have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the NRC in accordance with Title 10, CFR, §32.57 or Title 10, CFR, §70.39 or that have been manufactured or initially transferred in accordance with the authorizations contained in a specific license issued to the manufacturer by the agency or any agreement state, in accordance with licensing requirements equivalent to those contained in Title 10, CFR, §32.57 or Title 10, CFR, §70.39. (iii) Persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources in accordance with these general licenses: (I) shall not possess at any one time, at any one location of storage or use, more than 5 µCi (185 kBq) each of americium-241, plutonium-238, plutonium-239, and radium-226 in such sources; (II) shall not receive, possess, use, or transfer such source unless the source or the storage container bears a label that includes the following statements, or a substantially similar statement that contains the information in the following statements: (-a-) option 1, as appropriate:Attached Graphic(-b-) option 2, as appropriate: Attached Graphic(III) shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a specific license from the agency, the NRC, or any agreement state to receive the source; (IV) shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium-238, plutonium-239, or radium-226 that might otherwise escape during storage; and (V) shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources. (iv) The general license in subparagraph (A) of this paragraph does not authorize the manufacture of calibration or reference sources containing americium-241, plutonium-238, plutonium-239, or radium-226.(E) General license for ice detection devices. (i) A general license is issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 50 µCi (1.85 MBq) of strontium-90 and each device has been manufactured or initially transferred in accordance with a specific license issued by the NRC or each device has been manufactured in accordance with the authorizations contained in a specific license issued by the agency or any agreement state to the manufacturer of such device in accordance with licensing requirements equivalent to those in Title 10, CFR, §32.61. (ii) Persons who receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices in accordance with the general license in clause (i) of this paragraph shall do the following: (I) upon occurrence of visually observable damage, such as bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license from the NRC or an agreement state to manufacture or service such devices; or dispose of the device by transfer to a person authorized by a specific license from the agency, the NRC, or an agreement state; and (II) assure that all labels affixed to the device at the time of receipt, and which bear a statement prohibiting removal of the labels, are maintained on the device. (iii) The general license in subparagraph (A) of this paragraph does not authorize the manufacture, assembly, disassembly, or repair of strontium-90 in ice detection devices.(F) General license for intrastate transportation of radioactive material. (i) A general license is issued to any common or contract carrier to transport and store radioactive material in the regular course of their carriage for another or storage incident to transport, provided the transportation and storage is in accordance with the applicable requirements of §289.257 of this title insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Any notification of incidents referred to in those requirements shall be filed with the agency and the United States Department of Transportation (DOT). Persons who transport and store radioactive material in accordance with the general license in this paragraph are exempt from the requirements of §289.202 and §289.203 of this title except for §289.202(ww) - (yy) of this title. (ii) A general license is issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements, appropriate to the mode of transport, of the DOT insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Any notification of incidents referred to in those requirements shall be filed with the DOT, and with the agency in accordance with §289.202(ww) - (yy) of this title.(G) General license for the use of radioactive material for certain in vitro clinical or laboratory testing, not to include research and development. (The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.) (i) A general license is issued to any physician, veterinarian, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with clauses (ii) - (iii) of this subparagraph, the following radioactive materials in prepackaged units: (I) iodine-125, in units not exceeding 10 µCi (0.37 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (II) iodine-131, in units not exceeding 10 µCi (0.37 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (III) carbon-14, in units not exceeding 10 µCi (0.37 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (IV) hydrogen-3 (tritium), in units not exceeding 50 µCi (1.85 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (V) iron-59, in units not exceeding 20 µCi (0.74 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (VI) selenium-75, in units not to exceed 10 µCi (0.37 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (VII) mock iodine-125 reference or calibration sources, in units not exceeding 0.05 µCi (1850 Bq) of iodine-129 and 0.005 µCi of americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; or (VIII) cobalt-57, in units not exceeding 10 µCi (0.37 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals.(ii) A person who receives, acquires, possesses, or uses radioactive material in accordance with the general license in clause (i) of this subparagraph shall comply with the following. (I) The general licensee shall not possess at any one time, at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 200 µCi (7.4 MBq). (II) The general licensee shall store the radioactive material in the original shipping container or in a container providing equivalent radiation protection and meeting the requirements of §289.202(cc) of this title until used. (III) The general licensee shall use the radioactive material only for the uses authorized by clause (i) of this subparagraph. (IV) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it in accordance with a specific license issued by the agency, the NRC, or any agreement state, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier. (V) The general licensee shall dispose of the mock iodine-125 reference or calibration sources described in clause (i)(VII) of this subparagraph as required by §289.202(ff) of this title. (iii) The general licensee shall not receive, acquire, possess, or use radioactive material in accordance with the general license in clause (i) of this subparagraph: (I) except as prepackaged units that are labeled in accordance with the provisions of an applicable specific license issued in accordance with §289.252(p) of this title or in accordance with the requirements of a specific license issued by the NRC or any agreement state that authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or mock iodine-125 to general licensees in accordance with this subparagraph or its equivalent; and (II) unless one of the statements in the following figures, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package: (-a-) option 1, as appropriate:Attached Graphic(-b-) option 2, as appropriate: Attached Graphic(iv) No person shall receive, acquire, possess, use, or transfer radioactive material in accordance with the general license in clause (i) of this subparagraph until that person has filed an application for registration on a form prescribed by the agency and has received from the agency a notification of receipt with an assigned registration number. The applicant shall submit the following information and any other information as may be required by the agency: (I) name and address of the physician, veterinarian, clinical laboratory, or hospital; (II) the location of use; and (III) a statement that the physician, veterinarian, clinical laboratory, or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized in accordance with clause (i) of this subparagraph, and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material. (H) General license for certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere.(i) A general license is issued to commercial and industrial firms and to research, educational, and medical institutions, individuals in the conduct of their business, and state or local government agencies to receive, acquire, possess, use, or transfer in accordance with the provisions of clauses (ii) - (iv) of this subparagraph, radioactive material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition or for producing light or an ionized atmosphere.(ii) The general license in clause (i) of this subparagraph applies only to radioactive material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in:(I) a specific license issued by the agency in accordance with §289.252(l) of this title; (II) a specific license issued by the NRC or any agreement state that authorizes distribution of devices to persons generally licensed by the NRC or any agreement state; or(III) an equivalent specific license issued by a state with provisions comparable to §289.252(l) of this title.(iii) The devices must have been received from a specific licensee described in clause (ii) of this subparagraph or through a transfer made in accordance with clause (iv)(XII) of this subparagraph. (iv) Any person who receives, acquires, possesses, uses, or transfers radioactive material in a device in accordance with the general license in this subparagraph shall do the following:(I) assure that all labels, affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained on the device and are clearly visible and legible. The general licensee shall comply with all instructions and precautions provided by such labels;(II) assure that the device is tested for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as specified in the label; however:(-a-) devices containing only krypton need not be tested for leakage of radioactive material; and(-b-) devices containing only tritium or not more than 100 µCi (3.7 MBq) of other beta and/or gamma emitting material or 10 µCi (0.37 MBq) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;(III) assure that the tests required by subclause (II) of this clause and other testing, installation, servicing, and removal from location of installation involving the radioactive materials, its shielding or containment, are performed:(-a-) in accordance with the instructions provided by the labels; (-b-) in accordance with written instructions provided by the manufacturer as specified in §289.252(l)(3) of this title; or (-c-) by a person holding a specific license from the agency, the NRC, or any agreement state to perform such activities;(IV) maintain records for inspection by the agency documenting compliance with the requirements of subclauses (II) and (III) of this clause. The records shall include the test results. The records also shall identify the device tested by manufacturer, model and serial number of the device, serial number of the sealed source, and show the dates of performance of and the names of persons performing testing, installation, servicing, and removal from location of installation, of the radioactive material, its shielding or containment. Retention shall be as follows: (-a-) records for tests for leakage of radioactive material required by subclause (II) of this clause shall be kept for 3 years after the next required leak test is performed or until the sealed source is transferred or disposed of; (-b-) records of the test of the on-off mechanism and indicator required by subclause (II) of this clause shall be kept for 3 years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of; and (-c-) records of the testing, installation (removal of the manufacturer's lock and initial alignment of the radiation beam), servicing, and removal from location of installation involving the radioactive materials, its shielding or containment required by subclause (III) of this clause shall be kept for 3 years from the date of the recorded event or until the device is transferred or disposed of;(V) maintain assignment records (utilization records) for portable or mobile devices for inspection by the agency at the location listed in the general license acknowledgement in accordance with subsection (g) of this section. These records shall include: (-a-) a unique identification (for example, serial number) of each portable or mobile device; (-b-) the location(s) where each portable or mobile device is assigned; and (-c-) the date(s) each portable or mobile device is assigned to the location(s) in accordance with item (-b-) of this subclause; (VI) have a copy of the appropriate operating and instruction manual at each temporary site for agency inspection; (VII) immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the "on-off" mechanism, or indicator, or upon the detection of 185 Bq (0.005 µCi) or more of removable radioactive material. The device shall not be operated until it has been repaired by the manufacturer or other person holding a specific license from the agency, the NRC, or any agreement state to repair such devices. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device. A report, prepared in accordance with §289.202(xx) and (yy) of this title, containing a brief description of the event and the remedial action taken and in the case of detection of 185 Bq (0.005 µCi) or more removable radioactive material or failure of, or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use shall be furnished to the agency within 30 days. Under these circumstances, the requirements in §289.202(ddd) of this title may be applicable, as determined by the agency on a case-by-case basis;(VIII) not abandon the device containing radioactive material; (IX) transfer or dispose of the device containing radioactive material only by export in accordance with Title 10, CFR, Part 110, by transfer to another general licensee as authorized in subclauses (XII) and (XVI) of this clause or to a person authorized to receive the device by a specific license issued by the agency in accordance with §289.252(l) of this title, or an equivalent specific license issued by the NRC or any agreement state, or as otherwise approved under subclause (XI) of this clause; (X) furnish a report to the agency within 30 days after the transfer or export of a device to a specific licensee. The report must contain the following: (-a-) identification of the device by manufacturer's (or initial transferor's) name, model and serial number; (-b-) name, address, and license number of the person receiving the device; and (-c-) date of the transfer; (XI) obtain written agency approval before transferring the device to any other specific licensee not specifically identified in subclause (IX) of this clause; however, a holder of a specific license may transfer a device for possession and use in accordance with its own specific license without prior approval, if, the holder: (-a-) verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use; (-b-) removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by clause (iv)(I) of this subparagraph) so that the device is labeled in compliance with §289.202(cc) of this title; however the manufacturer, model number, and serial number must be retained; (-c-) obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and (-d-) reports the transfer as specified in subclause (X) of this clause;(XII) transfer the device to another general licensee only if: (-a-) the device remains in use at a particular location. In such case, the transferor shall give the transferee a copy of this section and any safety documents identified in the label on the device. Within 30 days of the transfer, the transferor shall report the following to the agency: (-1-) manufacturer's (or initial transferor's) name; (-2-) model and serial number of the device transferred; (-3-) transferee's name and mailing address for the location of use; and (-4-) name, title, and phone number of the responsible individual identified by the transferee in accordance with subclause (XIII) of this clause to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or (-b-) the device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee;(XIII) appoint an individual responsible for having knowledge of the appropriate agency requirements and the authority for taking required actions to comply with appropriate agency requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate agency requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard; (XIV) report changes to the mailing address for the location of use (including change in name of general licensee) to the agency within 30 days of the effective date of the change. If it is a portable device, a report of address change is only required for a change in the device's primary place of storage; (XV) not hold devices that are not in use for longer than 24 months following the last principal activity use. (-a-) If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required by clause (iv) of this subparagraph need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they shall be tested for leakage before use or transfer and the shutter tested before use. (-b-) Devices kept in standby for future use are excluded from the 24-month time limit if the agency approves a plan for future use submitted by the licensee. Licensees shall submit plans at least 30 days prior to the end of the 24 months of nonuse. (-c-) The general licensee shall perform quarterly physical inventories of these devices while they are in standby. The licensee shall make, maintain, and retain for intervals of 5 years, records of the quarterly physical inventories for inspection by the agency; (XVI) not export the device containing radioactive material except in accordance with Title 10, CFR, Part 110; (XVII) comply with the provisions of §289.202(ww) and (xx) of this title for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of §289.202 and §289.203 of this title; (XVIII) respond to written requests from the agency to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency a written justification for the request; and (XIX) assure that the device is used in accordance with information contained in the device safety evaluation.(I) The general license in subparagraph (H) of this paragraph does not authorize the manufacture or import of devices containing radioactive material.(J) The written instructions specified in subparagraph (H)(iv)(III)(-a-) and (-b-) of this paragraph shall be followed while performing the testing and the written instructions in subparagraph (H)(iv)(III)(-b-) of this paragraph shall be maintained for inspection by the agency. (K) General license for certain items and self-luminous products containing radium-226. (i) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer radium-226 contained in the following products manufactured prior to November 30, 2007.(I) Antiquities originally intended for use by the general public. For purposes of this subclause, antiquities are products distributed for use by the general public in the late 19th and early 20th centuries; such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads. (II) Intact timepieces containing greater than 1 µCi (0.037 MBq), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces. (III) Luminous items installed in air, marine, or land vehicles. (IV) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.(V) Small radium sources containing no more than 1 µCi (0.037 MBq) of radium 226. For the purposes of this paragraph, "small radium sources" means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.(ii) Persons who acquire, receive, possess, use, or transfer byproduct material under the general license issued in clause (i) of this subparagraph are exempt from the provisions of §§289.201, 289.202, 289.203, and 289.252 of this title, to the extent that the receipt, possession, use, or transfer of byproduct material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed under §289.252 of this title.(iii) Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with this subparagraph shall do the following.(I) Provide to the agency within 30 days of any indication of possible damage to the product that could result in a loss of the radioactive material. The report should include a brief description of the event, and the remedial action taken.(II) Not abandon products containing radium-226. (-a-) The product, and any radioactive material from the product, may only be disposed of according to §289.202 of this title or as otherwise approved by the agency. (-b-) The product, and any radioactive material from the product, may be transferred to a person authorized by a specific license to receive the radium-226 or as otherwise approved by the agency.(III) The general license in this subparagraph does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired provided that paint containing radium-226 is not applied or removed.(IV) Not export products containing radium-226 except in accordance with or equivalent regulations of the NRC Title 10, CFR, §110.(V) Dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under this section, or under equivalent regulations of the NRC, or any agreement state.(VI) Respond to written requests from the agency, the NRC, or any agreement state to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency, the NRC, or any agreement state a written justification for the request. (g) General license acknowledgements for radioactive material other than source material. In addition to the requirements of this section, all general license acknowledgement holders, unless otherwise specified, are subject to the requirements of §§289.201, 289.202(ww) and (xx), 289.204, 289.205, and 289.257 of this title.(1) Persons possessing a general license for devices in accordance with subsection (f)(4)(H) of this section and being in the possession of radioactive material in devices containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 MBq (0.1 mCi) of radium-226, 37 MBq (1 mCi) of americium-241, or any transuranic (for example, element with atomic number greater than uranium (92)), based on the activity indicated on the label on the device, shall file an application for acknowledgement within 30 days of receipt, acquisition, or possession of such a device. The application shall be on a form prescribed by the agency to include the following information and any other information specifically requested by the agency:(A) name and mailing address of the general licensee; (B) information about each device to include the manufacturer (or initial transferor), model number, and serial number of the device, and the radioisotope and activity (as indicated on the label), and serial number of the source; (C) name, title, and telephone number of the responsible person designated as a representative of the general licensee in accordance with subsection (f)(4)(H)(iv)(XIII) of this section; (D) address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage; (E) certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information; (F) certification by the responsible representative of the general licensee that they are aware of the requirements of this section; and (G) a completed RC Form 252-1, Business Information Form and the applicable fee as required by §289.204 of this title.(2) Persons generally licensed by the agency, the NRC, or any agreement state with respect to devices meeting the criteria in paragraph (1) of this subsection, are not subject to the requirements of paragraph (1) of this subsection if the devices are used in areas subject to agency jurisdiction for a period less than 180 days in any calendar year.(3) Persons possessing a device meeting the criteria of paragraph (1) of this subsection shall respond annually to the General License Acknowledgement Self Evaluation Form provided by the agency. The form shall be completed in accordance with the instructions contained in the form. The completed form shall be submitted to the agency within 30 days of receipt.(4) Each address for a location of use, as described under paragraph (1)(D) of this subsection, represents a separate general licensee and requires a separate registration and fee.(h) Issuance of general license acknowledgements. (1) When the agency determines that an application meets the requirements of the Act and the rules of the agency, the agency may issue a general license acknowledgement recognizing the general license authorizing the activity in such form and containing the conditions and limitations as it deems appropriate or necessary. (2) The agency may incorporate in any general license acknowledgement at the time of issuance, or thereafter by amendment, additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this section as the agency deems appropriate or necessary in order to: (A) minimize danger to occupational and public health and safety or the environment; (B) require reports and the keeping of records, and to provide for inspections of activities in accordance with the license as may be appropriate or necessary; and (C) prevent loss or theft of material subject to this section. (3) The agency may request, and the licensee shall provide, additional information after the general license acknowledgement has been issued to enable the agency to determine whether the general license acknowledgement should be modified in accordance with subsection (k) of this section.(i) Specific terms and conditions. (1) Each general license acknowledgement issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable rules and orders of the agency. (2) Each person holding a general license acknowledgement issued by the agency in accordance with this section shall confine use and possession of the devices and radioactive material identified in the general license acknowledgement to the locations specified in the general license acknowledgement. Radioactive material shall not be used or stored in residential locations unless authorized by the agency. Each person holding a general license acknowledgement issued by the agency shall obtain prior approval from the agency before storing or using radioactive material in an area not previously authorized in the general license acknowledgement. (3) Each holder of a general license acknowledgement shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by the general license acknowledgement holder or its parent company. (4) The notification in paragraph (3) of this subsection shall include: (A) the bankruptcy court in which the petition for bankruptcy was filed; and (B) the date of the filing of the petition. (5) A copy of the "Petition for Bankruptcy" shall be submitted to the agency with the written notification.(j) Termination of general license acknowledgements. (1) Each holder of a general license acknowledgement shall notify the agency immediately, in writing, and request termination of the general license acknowledgement when the holder of the general license acknowledgement decides to terminate all activities involving materials specified in the general license acknowledgement. (2) Each holder of a general license acknowledgement shall, no less than 30 days before vacating or relinquishing possession of control of premises that have been used as a place of storage or use of radioactive material as a result of general licensed activities, notify the agency in writing of intent to vacate and do the following: (A) terminate use of radioactive material; (B) dispose of radioactive material in accordance with this section and/or §289.202(ff) of this title; and (C) pay any outstanding fees in accordance with §289.204 of this title.(k) Amendment of general license acknowledgements. (1) The holder of the general license acknowledgement required by subsection (g)(1) of this section shall report in writing to the agency any changes in information furnished by the holder of the general license acknowledgement. The report shall be submitted within 30 days after the effective date of such change. (2) Applications for amendments of a general license acknowledgement shall be filed in accordance with subsection (g)(1)(A) - (F) of this section, as applicable, and shall specify the respects in which the holder of a general license acknowledgement desires a general license acknowledgement to be amended. (l) Appendices. (1) Exempt concentrations. Attached Graphic(2) Exempt quantities. Attached Graphic Source Note: The provisions of this §289.251 adopted to be effective September 1, 2004, 29 TexReg 7396; amended to be effective May 1, 2008, 33 TexReg 3417; amended to be effective February 18, 2010, 35 TexReg 1223; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective March 1, 2016, 41 TexReg 1444; amended to be effective September 24, 2018, 43 TexReg 6289. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.251 Exemptions, General Licenses, and General License Acknowledgements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221280 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221280&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221280 03/11/2026 (a) Purpose. The intent of this section is as follows.(1) This section provides for the specific licensing of radioactive material.(2) Unless otherwise exempted, no person may manufacture, produce, receive, possess, use, transfer, own, or acquire radioactive material except as authorized by:(A) a specific license issued under this section and any of the following sections:(i) §289.253 of this subchapter (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies);(ii) §289.255 of this subchapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography);(iii) §289.256 of this subchapter (relating to Medical and Veterinary Use of Radioactive Material);(iv) §289.258 of this subchapter (relating to Licensing and Radiation Safety Requirements for Irradiators); or(v) §289.259 of this subchapter (relating to Licensing of Naturally Occurring Radioactive Material (NORM)); or(B) a general license or general license acknowledgment issued under §289.251 of this subchapter (relating to Exemptions, General Licenses, and General License Acknowledgements).(3) A person who manufactures, produces, receives, possesses, uses, transfers, owns, or acquires radioactive materials before receiving a license is subject to the requirements of this chapter.(b) Scope. In addition to the requirements of this section, the following requirements are applicable.(1) All licensees, unless otherwise specified, are subject to the requirements in:(A) §289.201 of this chapter (relating to General Provisions for Radioactive Material);(B) §289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials);(C) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(D) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);(E) §289.205 of this chapter (relating to Hearing and Enforcement Procedures); and(F) §289.257 of this subchapter (relating to Packaging and Transportation of Radioactive Material).(2) Licensees engaged in well logging service operations and tracer studies are subject to the requirements of §289.253 of this subchapter.(3) Licensees engaged in industrial radiographic operations are subject to the requirements of §289.255 of this subchapter.(4) Licensees using radioactive material for medical or veterinary use are subject to the requirements of §289.256 of this subchapter.(5) Licensees using sealed sources in irradiators are subject to the requirements of §289.258 of this subchapter.(6) Licensees possessing or using naturally occurring radioactive material are subject to the requirements of §289.259 of this subchapter.(c) Types of licenses. There are two types of licenses for radioactive materials: general and specific.(1) General licenses provided in §289.251 and §289.259 of this subchapter are effective without the filing of applications with the department or the issuance of licensing documents, although filing an application for acknowledgement with the department may be required for a particular general license. The general licensee is subject to any other applicable portions of this chapter and any conditions or limitations of the general license.(2) Specific licenses require the submission of an application to the department and the issuance of a licensing document by the department. The licensee is subject to all applicable portions of this chapter as well as any conditions or limitations specified in the licensing document.(d) Filing application for specific licenses. The department may request additional information at any time to determine if the application should be granted or denied or if an existing license should be modified or revoked.(1) Applications for specific licenses must be filed in a manner prescribed by the department.(2) Each application must be signed by the chief executive officer or other individual delegated the authority to manage, direct, or administer the licensee's activities.(3) An application for a license may include a request for a license authorizing one or more activities. The department may require the issuance of separate specific licenses for those activities.(4) An application for a license may include a request for more than one use location on the license. The department may require the issuance of a separate license for additional locations more than 30 miles from the main site specified on a license.(5) Each application for a specific license, other than a license exempted from §289.204 of this chapter, must be accompanied by the fee prescribed in §289.204 of this chapter.(6) Each application must be accompanied by a completed RC Form 252-1 (Business Information Form).(7) Each applicant must demonstrate to the department the applicant is financially qualified to conduct the activity requested for licensure, including any required decontamination, decommissioning, reclamation, and disposal before the department issues a license. Each licensee must demonstrate to the department it remains financially qualified to conduct the licensed activity before a license is renewed. Methods for demonstrating financial qualifications are specified in subsection (jj)(8) of this section. Demonstrating financial qualifications is separate from the requirement as specified in subsection (gg) of this section for certain applicants or licensees to provide financial assurance.(8) If facility drawings submitted in conjunction with the license application are prepared by a professional engineer or engineering firm, those drawings must be final and must be signed, sealed, and dated as specified in the requirements of the Texas Board of Professional Engineers and Land Surveyors, 22 Texas Administrative Code (TAC) Chapter 137 (relating to Compliance and Professionalism for Engineers).(9) Applications for licenses must be processed according to the following time periods.(A) The first period is the time from receipt of an application by the department to the date of issuance or denial of the license or a written notice outlining why the application is incomplete or unacceptable. This time period is 60 days.(B) The second period is the time from receipt of the last item necessary to complete the application to the date of issuance or denial of the license. This time period is 30 days.(C) These time periods are exclusive of any time period incident to hearings and post-hearing activities required by the Texas Government Code, Chapter 2001.(10) Except as provided in this paragraph, an application for a specific license to use radioactive material in the form of a sealed source or in a device containing the sealed source must:(A) identify the source or device by manufacturer and model number as registered under subsection (v) of this section or with equivalent regulations of the United States Nuclear Regulatory Commission (NRC) or any agreement state, or for a source or a device containing radium-226 or accelerator-produced radioactive material registered under subsection (v) of this section; or(B) contain the information as specified in subsection (v)(3) - (4) of this section.(11) For sources or devices manufactured before October 23, 2012, that are not registered under subsection (v) of this section or with equivalent regulations of the NRC or any agreement state, and for which the applicant is unable to provide all categories of information as specified in subsection (v)(3) - (4) of this section, the application must include:(A) all available information identified in subsection (v)(3) - (4) of this section concerning the source, and, if applicable, the device; and(B) sufficient additional information to demonstrate there is reasonable assurance the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include:(i) a description of the source or device;(ii) a description of radiation safety features;(iii) the intended use and associated operating experience; and(iv) the results of a recent leak test.(12) For sealed sources and devices allowed to be distributed without registration of safety information as specified in subsection (v)(8)(A) of this section, the applicant must supply the manufacturer, model number, radionuclide, and quantity.(13) If it is not feasible to identify each sealed source and device individually, the applicant must propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, instead of identifying each sealed source and device.(14) Notwithstanding the provisions of §289.204(d)(1) of this chapter, reimbursement of application fees may be granted in the following manner.(A) If the application is not processed within the time periods stated in paragraph (9) of this subsection, the applicant may request a full reimbursement of all application fees paid in that application process from the director of the Radiation Control Program. If the director does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied.(B) Good cause for exceeding the period established is considered to exist if:(i) the number of applications for licenses to be processed exceeds by 15 percent or more the number processed in the same calendar quarter the preceding year;(ii) another public or private entity utilized in the application process caused the delay; or(iii) other conditions existed giving good cause for exceeding the established periods.(C) If the request for full reimbursement authorized by subparagraph (A) of this paragraph is denied, the applicant may then request a hearing by appeal to the Commissioner of Health for a resolution of the dispute. The appeal will be processed according to 1 TAC Chapter 155 (relating to Rules of Procedure), and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title.(15) Applications for licenses may be denied for:(A) any materially false statement in the application or any statement of fact required under provisions of the Texas Radiation Control Act (Act);(B) conditions revealed by the application or statement of fact or any report, record, or inspection, or other means warranting department refusal to grant a license on an application; or(C) failure to clearly demonstrate how the requirements in this chapter are addressed.(16) Action on a specific license application is considered abandoned if the applicant does not respond within 30 days from the date of a request by the department for any information. Abandonment of these actions does not provide an opportunity for a hearing, but the applicant retains the right to resubmit the application as specified in paragraphs (1) - (8) of this subsection.(e) General requirements for the issuance of specific licenses. A license application will be approved if the department determines:(1) the applicant and all personnel who handle the radioactive material are qualified by training and experience to use the material for the purpose requested under this chapter in such a manner as to minimize danger to occupational and public health and safety, life, property, and the environment;(2) the applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to occupational and public health and safety, life, property, and the environment;(3) the issuance of the license will not be harmful to the health and safety of the public;(4) the applicant satisfies any applicable special requirement in this section and other sections as specified in subsection (a)(2)(A) of this section;(5) the radiation safety information submitted for requested sealed sources or devices containing radioactive material complies with subsection (v) of this section;(6) qualifications of the designated radiation safety officer (RSO) as specified in subsection (f) of this section are adequate for the purpose requested in the application;(7) the applicant submitted adequate operating, safety, and emergency procedures;(8) the applicant's permanent facility is located in Texas (if the applicant's permanent facility is not located in Texas, reciprocal recognition must be sought as required by subsection (ee) of this section);(9) the owner of the property is aware radioactive material is stored or used on the property. If the proposed facility is not owned by the applicant, the applicant must provide a written statement from the owner, or from the owner's agent, indicating such. This paragraph does not apply to property owned or held by a government entity or to property on which radioactive material is used under an authorization for temporary job site use;(10) there is no reason to deny the license as specified in subsections (d)(13) or (x)(9) of this section; and(11) the applicant possesses a current registration with the Texas Secretary of State (SOS) to conduct business in the state unless the applicant is exempt. All applicants using an assumed name in their application must file an assumed name certificate as required under Texas Business and Commerce Code, Chapter 71.(f) RSO.(1) An RSO must be designated for every license issued by the department. A single individual may be designated as RSO for more than one license if authorized by the department.(2) The RSO's documented qualifications must include, at a minimum:(A) possession of a high school diploma or a certificate of high school equivalency based on the General Educational Development (GED) test;(B) completion of the training and testing requirements as specified in this chapter for the activities for which the license application is submitted; and(C) training and experience necessary to supervise the radiation safety aspects of the licensed activity.(3) Every licensee must establish in writing the authority, duties, and responsibilities of the RSO and ensure the RSO is provided sufficient authority, organizational freedom, time, resources, and management prerogative to perform the specific duties of the RSO, including:(A) establishing and overseeing operating, safety, emergency, and as low as reasonably achievable (ALARA) procedures, and reviewing them at least annually to ensure the procedures are current and conform with this chapter;(B) overseeing and approving all phases of the training program for operations and personnel so appropriate and effective radiation protection practices are taught;(C) ensuring required radiation surveys and leak tests are performed and documented as specified in this chapter, including any corrective measures when levels of radiation exceed established limits;(D) ensuring individual monitoring devices are used properly by occupationally exposed personnel, records are kept of the monitoring results, and timely notifications are made as specified in §289.203 of this chapter;(E) investigating and causing a report to be submitted to the department for each known or suspected case of radiation exposure to an individual or radiation level detected over the limits established by this chapter, determining the cause or causes, and taking steps to prevent recurrence;(F) investigating and causing a report to be submitted to the department for each theft or loss of radiation sources, determining the cause or causes, and taking steps to prevent recurrence;(G) investigating and causing a report to be submitted to the department for each known or suspected case of release of radioactive material to the environment over the limits established by this chapter;(H) having a thorough knowledge of management policies and administrative procedures of the licensee;(I) assuming control and having the authority to institute corrective actions, including shutdown of operations when necessary in emergency situations or unsafe conditions;(J) ensuring records are maintained as required by this chapter;(K) ensuring the proper storing, labeling, transport, use, and disposal of sources of radiation;(L) ensuring inventories are performed according to the activities for which the license application is submitted;(M) performing a physical inventory of the radioactive sealed sources authorized for use on the license every six months. Written records of the inventory must be made, maintained, and retained as specified in subsection (mm) of this section. Inventory records must include:(i) isotopes;(ii) quantities;(iii) activities;(iv) date inventory is performed;(v) location;(vi) unique identifying number or serial number; and(vii) signature of person performing the inventory;(N) ensuring personnel are complying with this chapter, the conditions of the license, and the operating, safety, and emergency procedures of the licensee;(O) serving as the primary contact with the department; and(P) having knowledge of and ensuring compliance with federal and state security measures for radioactive material.(4) The RSO must ensure the duties listed in paragraph (3)(A) - (P) of this subsection are performed.(5) The RSO must be on site periodically, appropriate to the scope of licensed activities, to satisfy the requirements of paragraphs (3) and (4) of this subsection.(6) The RSO, or a Site RSO designated on the license, must be capable of physically arriving at the licensee's authorized use site or sites within a reasonable time of being notified of an emergency or unsafe condition. A Site RSO must meet the qualifications in paragraph (2) of this subsection.(7) Requirements for an RSO for specific licenses for broad scope authorization for research and development. In addition to the requirements in paragraphs (1) and (3) - (6) of this subsection, the RSO's qualifications for specific licenses for broad scope authorization for research and development must include:(A) a bachelor's degree in health physics, radiological health, physical science, or a biological science with a physical science minor and four years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed; or(B) a master's degree in health physics or radiological health and three years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed; or(C) two years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed and one of the following:(i) doctorate degree in health physics or radiological health;(ii) comprehensive certification by the American Board of Health Physics;(iii) certification by the American Board of Radiology in Nuclear Medical Physics;(iv) certification by the American Board of Science in Nuclear Medicine in Radiation Protection; or(v) certification by the American Board of Medical Physics in Medical Health Physics; or(D) equivalent qualifications as approved by the department. (8) The qualifications in paragraph (7)(A) - (D) do not apply to individuals who have been adequately trained and designated as an RSO on licenses issued before October 1, 2000.(g) Duties and responsibilities of the Radiation Safety Committee (RSC). The duties and responsibilities of the RSC include:(1) meeting as often as necessary to conduct business but no less than three times a year;(2) reviewing summaries of the following information presented by the RSO:(A) over-exposures;(B) significant incidents, including spills, contamination, or medical events; and(C) items of non-compliance following an inspection;(3) reviewing the program for maintaining doses ALARA, and providing any necessary recommendations to ensure doses are ALARA;(4) reviewing the overall compliance status for authorized users;(5) sharing responsibility with the RSO to conduct periodic audits of the radiation safety program;(6) reviewing the audit of the radiation safety program and acting upon the findings;(7) developing criteria to evaluate training and experience of new authorized user applicants;(8) evaluating and approving authorized user applicants who request authorization to use radioactive material at the facility;(9) evaluating new uses of radioactive material;(10) reviewing and approving permitted program and procedural changes before implementation; and(11) having knowledge of and ensuring compliance with federal and state security measures for radioactive material.(h) Specific licenses of broad scope.(1) Types of specific licenses of broad scope.(A) A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license. The quantities specified are usually in the multicurie range.(B) A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material as specified in subsection (jj)(10) of this section.(i) The possession limit for a Type B specific license of broad scope, if only one radionuclide is possessed under such a license, is the quantity specified for that radionuclide in subsection (jj)(10) of this section.(ii) If two or more radionuclides are possessed under such a license, the possession limit for each is determined as follows:(I) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity as specified in subsection (jj)(10) of this section for that radionuclide.(II) The sum of the ratios for all radionuclides possessed under the license must not exceed unity.(C) A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in subsection (jj)(10) of this section.(i) The possession limit for a Type C specific license of broad scope, if only one radionuclide is possessed under such a license, is the quantity specified for that radionuclide in subsection (jj)(10) of this section.(ii) If two or more radionuclides are possessed under such a license, the possession limit is determined for each as follows:(I) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity as specified in subsection (jj)(10) of this section for that radionuclide.(II) The sum of the ratios for all radionuclides possessed under the license must not exceed unity.(2) An application for a Type A specific license of broad scope will be approved if:(A) the applicant satisfies the general requirements as specified in subsection (e) of this section;(B) the applicant has engaged in a reasonable number of activities involving the use of radioactive material; and(C) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:(i) the establishment of an RSC composed of an RSO, a representative of management, and persons trained and experienced in the safe use of radioactive materials to fulfill the duties and responsibilities as specified in subsection (g) of this section;(ii) the appointment of a full-time RSO meeting the requirements of subsection (f)(7) or (8) of this section who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and(iii) the establishment of appropriate administrative procedures to ensure:(I) control of procurement and use of radioactive material; (II) completion of safety evaluations of proposed uses of radioactive material that take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and(III) review, approval, and recording by the RSC of safety evaluations of proposed uses prepared as specified in subclause (II) of this clause before use of the radioactive material.(3) An application for a Type B specific license of broad scope will be approved if:(A) the applicant satisfies the general requirements as specified in subsection (e) of this section; and(B) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:(i) the appointment of an RSO who is qualified by training and experience in radiation protection, and who is available for advice and assistance on safety matters; and(ii) the establishment of appropriate administrative procedures to ensure:(I) control of procurement and use of radioactive material; (II) completion of safety evaluations of proposed uses of radioactive material that take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and(III) review, approval, and recording by the RSO of safety evaluations of proposed uses prepared under subclause (II) of this clause before use of the radioactive material.(4) An application for a Type C specific license of broad scope will be approved if:(A) the applicant satisfies the general requirements as specified in subsection (e) of this section;(B) the applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:(i) a college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and(ii) at least 40 hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and(C) the applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.(5) An application filed pursuant to subsection (e) of this section for a specific license other than one of broad scope is considered by the department as an application for a specific license of broad scope if the applicable requirements of this subsection are satisfied.(6) The following conditions apply to specific licenses of broad scope.(A) Unless specifically authorized by a separate license, a person licensed under this subsection must not:(i) conduct tracer studies in the environment involving direct release of radioactive material;(ii) receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;(iii) conduct activities for which a specific license issued by the department under subsections (i) - (u) of this section and §289.255, §289.256, and §289.259 of this subchapter is required;(iv) add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being; or(v) commercially distribute radioactive materials.(B) Each Type A specific license of broad scope issued under this subsection is subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's RSC.(C) Each Type B specific license of broad scope issued under this subsection is subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's RSO.(D) Each Type C specific license of broad scope issued under this subsection is subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of paragraph (4) of this subsection.(i) Specific licenses for introduction of radioactive material into products in exempt concentrations. A person must not introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to a person exempt under §289.251 of this subchapter except as specified with a license issued by the NRC.(j) Specific licenses for commercial distribution of radioactive material in exempt quantities.(1) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material, byproduct material, or naturally occurring and accelerator-produced radioactive material (NARM) whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission (NRC), Washington, DC 20555 under Title 10 Code of Federal Regulations (10 CFR) §32.18.(2) Licenses issued under this subsection do not authorize: (A) the combining of exempt quantities of radioactive material in a single device;(B) any program advising a person to combine exempt quantity sources and providing devices for them to do so; and(C) the possession and use of combined exempt sources, in a single unregistered device, by a person exempt from licensing under §289.251(e)(2) of this subchapter.(k) Specific licenses for incorporating byproduct material or NARM into gas and aerosol detectors. A specific license authorizing the incorporation of byproduct material or NARM into gas and aerosol detectors to be distributed to a person exempt from this chapter must only be issued by the NRC under 10 CFR §32.26.(l) Specific licenses for the manufacture and commercial distribution of devices to a person generally licensed under §289.251(f)(4)(H) of this subchapter.(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture or commercially distribute devices containing radioactive material to a person generally licensed under §289.251(f)(4)(H) of this subchapter or equivalent requirements of the NRC or any agreement state will be issued if the department approves the following information submitted by the applicant: (A) the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:(i) the device can be safely operated by a person not having training in radiological protection;(ii) under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely any person will receive, in any period of one year, a dose in excess of ten percent of the limits as specified in §289.202(f) of this chapter; and(iii) under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely any person would receive an external radiation dose or dose commitment in excess of the following organ doses:(I) 15 rem to the whole body; head and trunk; active blood-forming organs; gonads; or lens of eye;(II) 200 rem to the hands and forearms; feet and ankles; or localized areas of skin averaged over areas no larger than 1 square centimeter (cm2 ); or(III) 50 rem to other organs;(B) procedures for disposition of unused or unwanted radioactive material;(C) each device bears a durable, legible, clearly visible label or labels approved by the department containing the following in a clearly identified and separate statement:(i) instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);(ii) the requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and(iii) the information in one of the following statements, as appropriate, in the same or substantially similar form:(I) For radioactive materials other than NARM, the following statement is appropriate:Attached Graphic(II) For NARM, the following statement is appropriate:Attached Graphic(III) The model and serial number and name of manufacturer or distributor may be omitted from this label provided they are elsewhere stated in labeling affixed to the device.(D) Each device having a separable source housing providing the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial numbers, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in §289.202(z) of this chapter, and the name of the manufacturer or initial distributor.(E) Each device meeting the criteria of §289.251(g)(1) of this subchapter, bears a permanent (for example, embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, including the words, "Caution-Radioactive Material," and, if practicable, the radiation symbol described in §289.202(z) of this chapter.(F) The device has been registered in the Sealed Source and Device Registry.(2) If the applicant desires the device be tested at intervals longer than six months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material, or for both, the applicant must include in the application sufficient information to demonstrate the longer interval is justified by performance characteristics of the device or similar devices and by design features having a significant bearing on the probability or consequences of radioactive material leakage from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for radioactive material leakage, the department considers information, including:(A) primary containment (sealed source capsule);(B) protection of primary containment;(C) method of sealing containment;(D) containment construction materials;(E) form of contained radioactive material;(F) maximum temperature withstood during prototype tests;(G) maximum pressure withstood during prototype tests;(H) maximum quantity of contained radioactive material;(I) radiotoxicity of contained radioactive material; and(J) operating experience with identical devices or similarly designed and constructed devices.(3) If the applicant desires the general licensee under §289.251(f)(4)(H) of this subchapter or equivalent regulations of the NRC or any agreement state, be authorized to install the device, collect the sample to be analyzed by a specific licensee for radioactive material leakage, service the device (i.e., replace labels, perform rust and corrosion prevention, or perform repair and maintenance of fixed gauge sealed source holder mounting brackets), test the "on-off" mechanism and indicator, or remove the device from installation, the applicant must include in the application written instructions to be followed by the general licensee, estimated annual doses associated with these activities, and bases for the estimates. The submitted information must demonstrate performance of these activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices as authorized by the general license, is unlikely to cause that individual to receive an annual dose in excess of ten percent of the limits as specified in §289.202(f) of this chapter.(4) Before the device may be transferred, each person licensed under this subsection to commercially distribute devices to generally licensed persons must furnish to each person to whom a device is transferred for use under the general license in §289.251(f)(4)(H) of this subchapter or equivalent NRC or agreement state general license:(A) a copy of the general license in §289.251(f)(4)(H) of this subchapter;(B) a copy of the general license in the NRC's or any agreement state's regulation equivalent to §289.251(f)(4)(H) of this subchapter, or alternatively, a copy of the general license in §289.251(f)(4)(H) of this subchapter;(i) if certain requirements of the regulations do not apply to the device, those requirements may be omitted; and(ii) if a copy of the general license in §289.251(f)(4)(H) of this subchapter is furnished to such a person, it must be accompanied by an explanation that use of the device is regulated by the NRC or any agreement state under requirements substantially the same as those in §289.251(f)(4)(H) of this subchapter;(C) a copy of §289.251(g) of this subchapter, if applicable;(D) a list of the services that can only be performed by a specific licensee;(E) information on acceptable disposal options, including estimated costs of disposal;(F) the name or position, address, and phone number of a contact person at the department, the NRC, or any agreement state, from which additional information may be obtained; and(G) a statement that it is the NRC's policy to issue high civil penalties for improper disposal if the device is commercially distributed to a general licensee of the NRC.(5) An alternative approach to informing customers may be submitted by the licensee for approval by the department.(6) In the case of a transfer through an intermediate person, each licensee who commercially distributes radioactive material in a device for use under the general license in §289.251(f)(4)(H) of this subchapter, must furnish the information in paragraph (4) of this subsection to the intended user before the initial transfer to the intermediate person.(7) Each person licensed under this subsection to commercially distribute devices to generally licensed persons must:(A) report to the department all commercial distributions of devices to any person for use under the general license in §289.251(f)(4)(H) of this subchapter and all receipts of devices from general licensees licensed under §289.251(f)(4)(H) of this subchapter.(i) The report must:(I) cover each calendar quarter;(II) be filed within 30 days of the end of each calendar quarter;(III) be submitted on a form prescribed by the department or in a clear and legible report containing all the data required by the form;(IV) clearly indicate the period covered by the report;(V) clearly identify the specific licensee submitting the report and include the license number of the specific licensee;(VI) identify each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee must be submitted along with information on the actual location of use;(VII) identify an individual by name, title, and phone number who has knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;(VIII) identify the type, model and serial number of the device, and serial number of the sealed source commercially distributed; (IX) identify the quantity and type of radioactive material contained in the device; and(X) include the date of transfer.(ii) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must also include the information as specified in paragraph (7)(A)(i) of this subsection for both the intended user and each intermediate person and clearly designate the intermediate person.(iii) If no commercial distributions have been made to a person generally licensed under §289.251(f)(4)(H) of this subchapter during the reporting period, the report must so indicate.(iv) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.(B) report the following to the NRC to include covering each calendar quarter to be filed within 30 days thereafter, clearly indicating the period covered by the report, the identity of the specific licensee submitting the report, and the license number of the specific licensee:(i) all commercial distributions of such devices to a person for use under the NRC general license in 10 CFR §31.5 and all receipts of devices from general licensees in areas under NRC jurisdiction, including:(I) the identity of each general licensee by name and address;(II) the type, model and serial number of the device, and serial number of sealed source commercially distributed;(III) the quantity and type of radioactive material contained in the device; and(IV) the date of transfer; or(ii) if the licensee makes changes to a device possessed under the general license in §289.251(f)(4)(H) of this subchapter, and the label must be changed to update required information, the report must identify the licensee, the device, and the changes to information on the device label;(iii) the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor;(iv) if no commercial distributions were made to the NRC licensees during the reporting period; the report must so indicate;(C) report to the department or any agreement state all transfers of devices manufactured and commercially distributed under this subsection for use under a general license in the state's requirements equivalent to §289.251(f)(4)(H) of this subchapter and all receipts of devices from general licensees.(i) The report must:(I) be submitted within 30 days after the end of each calendar quarter in which the device is commercially distributed to the generally licensed person;(II) clearly indicate the period covered by the report;(III) clearly identify the specific licensee submitting the report and include the license number of the specific licensee;(IV) identify each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use an alternate address for the licensee must be submitted along with the information on the actual location of use;(V) identify an individual by name, position, and phone number who has knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;(VI) include the type, model and serial number of the device, and serial number of the sealed source commercially distributed;(VII) include the quantity and type of radioactive material contained in the device; and(VIII) include the date of receipt.(ii) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must also include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person.(iii) If no commercial distributions have been made to persons in the agreement state during the reporting period, the report shall so indicate.(iv) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor; and(D) make, maintain, and retain records required by this paragraph for inspection by the department as specified in subsection (mm) of this section, including the name, address, and the point of contact for each general licensee to whom the licensee directly or through an intermediate person commercially distributes radioactive material in devices for use under the general license provided in §289.251(f)(4)(H) of this subchapter, or equivalent requirements of the NRC or any agreement state.(i) The records must include:(I) the date of each commercial distribution;(II) the isotope and the quantity of radioactivity in each device commercially distributed;(III) the identity of any intermediate person; and(IV) compliance with the reporting requirements of this subsection.(ii) The records must indicate when no commercial distributions have been made to a person generally licensed under §289.251(f)(4)(H) of this subchapter during the reporting period.(8) If a notification of bankruptcy has been made as specified in subsection (x)(6) of this section or the license is to be terminated, each person licensed under this subsection must provide, upon request, to the NRC and to any appropriate agreement state, records of final disposition required under subsection (y)(16)(A) of this section.(9) Each device transferred after February 19, 2002, must meet the labeling requirements as specified in paragraph (1)(C) - (E) of this subsection.(m) Specific licenses for the manufacture, assembly, repair, or initial transfer of luminous safety devices containing tritium or promethium-147 for use in aircraft for distribution to a person generally licensed under §289.251(f)(4)(B) of this subchapter. In addition to the requirements in subsection (e) of this section, a specific license to manufacture, assemble, repair, or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to a person generally licensed under §289.251(f)(4)(B) of this subchapter, is issued if the department approves the information submitted by the applicant. The information must satisfy the requirements of 10 CFR §§32.53, 32.54, 32.55, and 32.56, or their equivalent.(n) Specific licenses for the manufacture or initial transfer of calibration sources containing americium-241 or radium-226 for commercial distribution to a person generally licensed under §289.251(f)(4)(D) of this subchapter.(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture or initially transfer calibration sources containing americium-241, or radium-226 to a person generally licensed under §289.251(f)(4)(D) of this subchapter will be issued if the department approves the information submitted by the applicant. The information must satisfy the requirements of 10 CFR §§32.57, 32.58, 32.59, and §70.39 or their equivalent. (2) Each person licensed under this subsection must perform a dry wipe test on each source containing more than 0.1 microcurie (µCi) (3.7 kilobecquerels (kBq)) of americium-241 or radium-226 before transferring the source to a general licensee under §289.251(f)(4)(D) of this subchapter or equivalent regulations of the NRC or any agreement state. This test must be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper must be measured by using radiation detection instrumentation capable of detecting 0.005 µCi (0.185 kBq) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.005 µCi (0.185 kBq) of americium-241 or radium-226 by methods described in this paragraph, the source must be rejected and may not be transferred to a general licensee under §289.251(f)(4)(D) of this subchapter or equivalent regulations of the NRC or any agreement state.(o) Specific licenses for the manufacture and commercial distribution of sealed sources or devices containing radioactive material for medical use. In addition to the requirements in subsection (e) of this section, a specific license to manufacture and commercially distribute sealed sources and devices containing radioactive material to a person licensed under §289.256 of this subchapter for use as a calibration, transmission, or reference source or for use of sealed sources listed in §289.256(q), (rr), (bbb), and (ddd) of this subchapter will be issued if the department approves the following information submitted by the applicant:(1) an evaluation of the radiation safety of each type of sealed source or device, including:(A) the radioactive material contained, its chemical and physical form, and amount;(B) details of design and construction of the sealed source or device;(C) procedures for, and results of, prototype tests to demonstrate the sealed source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;(D) for devices containing radioactive material, the radiation profile of a prototype device;(E) details of quality control procedures to assure production sources and devices meet the standards of the design and prototype tests;(F) procedures and standards for calibrating sealed sources and devices;(G) instructions for handling and storing the sealed source or device from the radiation safety standpoint. These instructions are to be included on a durable label attached to the sealed source or device or attached to a permanent storage container for the sealed source or device; instructions too lengthy for the label may be summarized on the label and printed in detail on a brochure referenced on the label; and(H) a legend and methods for labeling sources and devices as to their radioactive content;(2) documentation that the label affixed to the sealed source or device, or to the permanent storage container for the sealed source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the name of the sealed source or device is licensed by the department for commercial distribution to a person licensed for use of sealed sources in the healing arts or by equivalent licenses of the NRC or any agreement state;(3) documentation that in the event the applicant desires that the sealed source or device be tested for radioactive material leakage at intervals longer than six months, the applicant must include in the application sufficient documentation to demonstrate the longer interval is justified by performance characteristics of the sealed source or device or similar sources or devices and by design features having a significant bearing on the probability or consequences of radioactive material leakage from the sealed source;(4) documentation considered in determining the acceptable interval for testing radioactive material leakage, includes:(A) primary containment (sealed source capsule);(B) protection of primary containment;(C) method of sealing containment;(D) containment construction materials;(E) form of contained radioactive material;(F) maximum temperature withstood during prototype tests;(G) maximum pressure withstood during prototype tests;(H) maximum quantity of contained radioactive material;(I) radiotoxicity of contained radioactive material; and(J) operating experience with identical sealed sources or devices or similarly designed and constructed sealed sources or devices; and(5) the source or device has been registered in the national Sealed Source and Device Registry.(p) Specific licenses for the manufacture and commercial distribution of radioactive material for certain in vitro clinical or laboratory testing under the general license. In addition to the requirements in subsection (e) of this section, a specific license to manufacture or commercially distribute radioactive material for use under the general license in §289.251(f)(4)(G) of this subchapter will be issued if the department approves the following information submitted by the applicant:(1) documentation the radioactive material will be prepared for distribution in prepackaged units of:(A) iodine-125 in units not exceeding 10 µCi (0.37 megabecquerel (MBq)) each;(B) iodine-131 in units not exceeding 10 µCi (0.37 MBq) each;(C) carbon-14 in units not exceeding 10 µCi (0.37 MBq) each;(D) hydrogen-3 (tritium) in units not exceeding 50 µCi (1.85 MBq) each;(E) iron-59 in units not exceeding 20 µCi (0.74 MBq) each;(F) cobalt-57 in units not exceeding 10 µCi (0.37 MBq) each;(G) selenium-75 in units not exceeding 10 µCi (0.37 MBq) each; or(H) mock iodine-125 in units not exceeding 0.05 µCi (1.85 kBq) of iodine-129 and 0.005 µCi (0.185 kBq) of americium-241 each;(2) evidence each prepackaged unit will bear a durable, clearly visible label:(A) identifying the radioactive contents as to chemical form and radionuclide, and indicating the amount of radioactivity does not exceed 10 µCi (0.37 MBq) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 µCi (1.85 MBq) of hydrogen-3 (tritium); 20 µCi (0.74 MBq) of iron-59; or mock iodine-125 in units not exceeding 0.05 µCi (1.85 kBq) of iodine-129 and 0.005 µCi (0.185 kBq) of americium-241; and(B) displaying the radiation caution symbol as specified in §289.202(z) of this chapter and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals";(3) one of the following statements, as appropriate, or a substantially similar statement appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure accompanying the package:(A) option 1:Attached Graphic(B) option 2:Attached Graphic(4) the label affixed to the unit, or the leaflet or brochure accompanying the package, contains adequate information as to the precautions to be observed in handling and storing the radioactive material. In the case of a mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements of §289.202(ff) of this chapter.(q) Specific licenses for the manufacture and commercial distribution of ice detection devices. In addition to the requirements of subsection (e) of this section, a specific license to manufacture and commercially distribute ice detection devices to a person generally licensed under §289.251(f)(4)(E) of this subchapter will be issued if the department approves the information submitted by the applicant. This information must satisfy the requirements of 10 CFR §32.61 and §32.62.(r) Specific licenses for the manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing radioactive materials for medical use under §289.256 of this subchapter.(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture, prepare, or transfer for commercial distribution, radioactive drugs containing radioactive material for use by a person authorized under §289.256 of this subchapter will be issued if the department approves the following information submitted by the applicant:(A) evidence the applicant is at least:(i) registered with the United States Food and Drug Administration (FDA) as the owner or operator of a drug establishment engaging in the manufacture, preparation, propagation, compounding, or processing of a drug under Title 21 CFR §207.17(a); or(ii) registered or licensed with a state agency as a drug manufacturer; or(iii) licensed as a pharmacy by the Texas State Board of Pharmacy; or(iv) operating as a nuclear pharmacy within a federal medical institution; or(v) a positron emission tomography (PET) drug production facility registered with a state agency;(B) radionuclide data relating to:(i) chemical and physical form;(ii) maximum activity per vial, syringe, generator, or other container of the radioactive drug; and(iii) shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees;(C) labeling requirements, including:(i) each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution must include:(I) the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL";(II) the name of the radioactive drug or its abbreviation; and(III) the quantity of radioactivity at a specified date and time (the time may be omitted for radioactive drugs with a half-life greater than 100 days); and(ii) each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution must include:(I) radiation symbol and the words, "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; and(II) an identifier ensuring the syringe, vial, or other container can be correlated with the information on the transport radiation shield.(2) A licensee must possess and use instrumentation to measure the radioactivity of radioactive drugs and must have procedures for the use of the instrumentation. The licensee must measure, by direct measurement or by a combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting radioactive drugs before transfer for commercial distribution. In addition, the licensee must:(A) perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary;(B) check each instrument for constancy and proper operation at the beginning of each day of use; and(C) make, maintain, and retain records of the tests and checks required in this paragraph for inspection by the department as specified in subsection (mm) of this section.(3) A licensee described in paragraph (1)(A)(iii) or (iv) of this subsection may prepare radioactive drugs for medical use as defined in §289.256 of this subchapter with the following provisions.(A) Radioactive drugs must be prepared by either an authorized nuclear pharmacist, as specified in subparagraphs (B) and (D) of this paragraph, or an individual under the supervision of an authorized nuclear pharmacist as specified in §289.256(s) of this subchapter.(B) A pharmacist may be allowed to work as an authorized nuclear pharmacist if:(i) the individual qualifies as an authorized nuclear pharmacist as defined in §289.256 of this subchapter;(ii) the individual meets the requirements as specified in §289.256(k)(2) and (m) of this subchapter, and the licensee has received from the department, an approved license amendment identifying the individual as an authorized nuclear pharmacist; or(iii) the individual is designated as an authorized nuclear pharmacist under subparagraph (D) of this paragraph.(C) The actions authorized in subparagraphs (A) and (B) of this paragraph are permitted despite more restrictive language in license conditions.(D) A licensee may designate a pharmacist, as defined in §289.256 of this subchapter, as an authorized nuclear pharmacist if:(i) the individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and(ii) the individual practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC or the department.(E) The licensee must provide the following to the department:(i) a copy of each individual's certification by a specialty board whose certification process has been recognized by the NRC, the department, or an agreement state as specified in §289.256(k)(1) of this subchapter; or(ii) the department, NRC, or another agreement state license; or(iii) NRC master materials licensee permit; or(iv) the permit issued by a broad scope licensee or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or(v) documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC or the department; and(vi) a copy of the Texas State Board of Pharmacy licensure or registration, no later than 30 days after the date the licensee allows, under subparagraph (B)(i) and (iii) of this paragraph, the individual to work as an authorized nuclear pharmacist.(F) The radiopharmaceuticals for human use must be processed and prepared according to instructions furnished by the manufacturer on the label attached to or in the FDA-accepted instructions in the leaflet or brochure accompanying the generator or reagent kit.(G) If the authorized nuclear pharmacist elutes generators or processes radioactive material with the reagent kit in a manner deviating from written instructions furnished by the manufacturer, a complete description of the deviation must be made and maintained for inspection by the department as specified in subsection (mm) of this section.(4) A licensee must satisfy the labeling requirements in subsection (r)(1)(C) of this section.(5) Nothing in this subsection relieves the licensee from complying with applicable FDA, or other federal and state requirements governing radioactive drugs.(s) Specific licenses for the manufacture and commercial distribution of products containing depleted uranium for mass-volume applications.(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture products and devices containing depleted uranium for use under §289.251(f)(3)(D) of this subchapter or equivalent regulations of the NRC or an agreement state, will be issued if the department approves the following information submitted by the applicant:(A) the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the product or device to provide reasonable assurance the possession, use, or commercial distribution of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one year a radiation dose in excess of ten percent of the limits as specified in §289.202(f) of this chapter; and(B) reasonable assurance is provided that unique benefits will accrue to the public because of the usefulness of the product or device.(2) In the case of a product or device whose unique benefits are questionable, the department will issue a specific license under paragraph (1) of this subsection only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.(3) The department may deny any application for a specific license under this subsection if the end use or uses of the product or device cannot be reasonably foreseen.(4) Each person licensed under paragraph (1) of this subsection must:(A) maintain the level of quality control required by the license in the manufacture of the product or device, and in the installation of the depleted uranium into the product or device;(B) label or mark each unit to:(i) identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and(ii) state the receipt, possession, use, and commercial distribution of the product or device are subject to a general license or the equivalent and the requirements of the NRC or of an agreement state;(C) assure that before being installed in each product or device, the depleted uranium has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";(D) furnish a copy of the following:(i) the general license in §289.251(f)(3)(D) of this subchapter to each person to whom the licensee commercially distributes depleted uranium in a product or device for use under the general license in §289.251(f)(3)(D) of this subchapter;(ii) the NRC's or agreement state's requirements equivalent to the general license in §289.251(f)(3)(D) of this subchapter and a copy of the NRC's or agreement state's certificate; or(iii) alternately, a copy of the general license in §289.251(f)(3)(D) of this subchapter to each person to whom the licensee commercially distributes depleted uranium in a product or device for use under the general license of the NRC or an agreement state;(E) report to the department all commercial distributions of products or devices to a person for use under the general license in §289.251(f)(3)(D) of this subchapter.(i) The report must be submitted within 30 days after the end of each calendar quarter in which a product or device is commercially distributed to the generally licensed person and must include the following:(I) the identity of each general licensee by name and address;(II) the identity of an individual by name and position who may constitute a point of contact between the department and the general licensee;(III) the type and model number of devices commercially distributed; and(IV) the quantity of depleted uranium contained in the product or device.(ii) If no commercial distributions have been made to a person generally licensed under §289.251(f)(3)(D) of this subchapter during the reporting period, the report must indicate this;(F) report to the NRC and each responsible agreement state agency all commercial distributions of industrial products or devices to a person for use under the general license in the NRC's or agreement state's equivalent requirements to §289.251(f)(3)(D) of this subchapter. The report must meet the provisions of subparagraph (E)(i) and (ii) of this paragraph; and(G) make, maintain, and retain records, including the name, address, and point of contact for each general licensee to whom the licensee commercially distributes depleted uranium in products or devices for use under the general license provided in §289.251(f)(3)(D) of this subchapter or equivalent requirements of the NRC or any agreement state. The records must be maintained for inspection by the department as specified in subsection (mm) of this section and must include the date of each commercial distribution, the quantity of depleted uranium in each product or device commercially distributed, and compliance with the report requirements of this section.(t) Specific licenses for the processing of loose radioactive material for manufacture and commercial distribution. In addition to the requirements in subsection (e) of this section, a license to process loose radioactive material for manufacture and commercial distribution of radioactive material to a person authorized to possess such radioactive material under this chapter will be issued if the department approves the following information submitted by the applicant: (1) the radionuclides to be used, including the chemical and physical form and the maximum activity of each radionuclide;(2) the intended use of each radionuclide and the sealed sources or other products to be manufactured, including:(A) receipt of radioactive material;(B) chemical or physical preparations;(C) sealed source construction;(D) final assembly or processing;(E) quality assurance testing;(F) quality control program;(G) leak testing;(H) American National Standards Institute (ANSI) testing procedures;(I) transportation containers;(J) shipping procedures; and(K) disposition of unwanted or unused radioactive material; (3) scaled drawings of the facility to include:(A) air filtration;(B) ventilation system;(C) plumbing; and(D) radioactive material handling systems and, when applicable, remote handling hot cells;(4) details of the environmental monitoring program; and(5) documentation of training as specified in subsection (jj)(1) of this section for all personnel who handle radioactive materials. (u) Specific licenses for other manufacture and commercial distribution of radioactive material. In addition to the requirements in subsection (e) of this section, a license to manufacture and commercially distribute radioactive material to a person authorized to possess such radioactive material under these requirements will be issued if the department approves the following information submitted by the applicant:(1) the radionuclides to be used, including the chemical and physical form and the maximum activity of each radionuclide;(2) the intended use of each radionuclide and the sealed sources or other products to be manufactured, including:(A) receipt of radioactive material;(B) chemical or physical preparations;(C) sealed source construction;(D) final assembly or processing;(E) quality assurance testing;(F) quality control program;(G) leak testing;(H) ANSI testing procedures;(I) transportation containers;(J) shipping procedures; and(K) disposition of unwanted or unused radioactive material; (3) scaled drawings of radioactive material handling systems; and(4) documentation of training as specified in subsection (jj)(1) of this section for all personnel who handle radioactive material. (v) Sealed source or device evaluation.(1) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the department for evaluation of radiation safety information about its product and for its registration.(2) The request for review must be sent to the department as specified in §289.201(k) of this chapter and must be submitted in duplicate accompanied by the appropriate fee as specified in §289.204 of this chapter.(3) In order to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property, the request for evaluation of a sealed source or device must include sufficient information about the:(A) design;(B) manufacture;(C) prototype testing;(D) quality control program;(E) labeling;(F) proposed uses; and(G) leak testing.(4) The request for evaluation of a device must also include sufficient information about:(A) installation;(B) service and maintenance;(C) operating and safety instructions; and(D) its potential hazards.(5) The department normally evaluates a sealed source or a device using radiation safety criteria within accepted industry standards. If these standards and criteria do not readily apply to a particular case, the department formulates reasonable standards and criteria with the help of the manufacturer or distributor. The department must use criteria and standards sufficient to ensure the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Section 289.251(e)(1) - (3) of this subchapter includes specific criteria applying to certain exempt products and §289.251(f) of this subchapter includes specific criteria applying to certain generally licensed devices. This section includes specific provisions applying to certain specifically licensed items.(6) After completion of the evaluation, the department issues a sealed source and device (SS & D) certificate of registration to the person making the request. The SS & D certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of SS & D certificate of registration. (7) The person submitting the request for evaluation and SS & D certificate of registration of safety information about the product must manufacture and distribute the product as specified in:(A) the statements and representations, including the quality control program, contained in the request; and(B) the provisions of the SS & D certificate of registration.(8) Authority to manufacture or initially distribute a sealed source or device to specific licensees must be provided in the license without the issuance of a SS & D certificate of registration in the following cases:(A) calibration and reference sources must contain no more than:(i) 1 millicurie (mCi) (37 MBq) for beta or gamma emitting radionuclides; or(ii) 10 µCi (0.37 MBq) for alpha emitting radionuclides; or(B) the intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and(i) the intended recipients are licensed under subsection (h) of this section, §289.256(o) of this subchapter, or equivalent regulations of the NRC or any agreement state; or(ii) the recipients are authorized for research and development; or(iii) the sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 20 curie (Ci) (740 gigabecquerel (GBq)) of tritium or 200 mCi (7.4 GBq) of any other radionuclide.(9) After the SS & D certificate of registration is issued, the department may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the department will complete its evaluation according to criteria specified in this section. The department may request additional information it considers necessary to conduct its review and the SS & D certificate of registration holder must provide the information requested.(10) Inactivation of SS & D certificates of registration. (A) An SS & D certificate of registration holder no longer manufacturing or initially transferring any of the sealed sources or devices covered by a particular SS & D certificate of registration issued by the department must request inactivation of the SS & D certificate of registration. Such a request must be made to the department by an appropriate method under §289.201(k) of this chapter and must be made no later than two years after initial distribution of all of the sources or devices covered by the SS & D certificate of registration have ceased. However, if the SS & D certificate of registration holder determines an initial transfer was in fact the last initial transfer more than two years after that transfer, the SS & D certificate of registration holder must request inactivation of the SS & D certificate of registration within 90 days of this determination and briefly describe the circumstances of the delay.(B) If a distribution license is to be terminated under subsection (y) of this section, the licensee must request inactivation of its SS & D certificate of registration associated with that distribution license before the department will terminate the license. A request for inactivation of the SS & D certificate of registration must indicate the license is being terminated and include the associated specific license number.(C) A specific license to manufacture or initially transfer a source or device covered only by an inactivated SS & D certificate of registration no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must comply with any conditions in the SS & D certificate of registration, including in the case of an inactive SS & D certificate of registration. (w) Issuance of specific licenses.(1) When the department determines an application meets the requirements of the Act and the rules of this chapter, the department issues a specific license authorizing the proposed activity in such form and containing the conditions and limitations as the department deems appropriate or necessary.(2) The department may incorporate in any license at the time of issuance, or by amendment, additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this section as the department deems appropriate or necessary to:(A) minimize danger to occupational and public health and safety and the environment;(B) require reports and the keeping of records, and provide for inspections of activities under the license as may be appropriate or necessary; and(C) prevent loss or theft of radioactive material subject to this chapter.(3) The department may request, and the licensee must provide, additional information after the license has been issued to enable the department to determine whether the license should be modified as specified in subsection (dd) of this section.(x) Specific terms and conditions of licenses.(1) Each license issued under this section is subject to the applicable provisions of the Act and to applicable rules in effect and orders of the department.(2) No license issued or granted under this section and no right to possess or utilize radioactive material granted by any license issued under this section may be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the department, after securing full information, finds the transfer complies with the Act, applicable rules in effect, and orders of the department. The department provides its consent in writing.(3) An application for transfer of license must include:(A) the identity, technical and financial qualifications of the proposed transferee; and(B) financial assurance for decommissioning information required by subsection (gg) of this section.(4) Each person licensed by the department under this section must confine use and possession of the radioactive material licensed to the locations and purposes authorized in the license. Radioactive material must not be used or stored in residential locations unless specifically authorized by the department.(5) The licensee must notify the department in writing within 15 calendar days of any of the following changes:(A) name;(B) mailing address; or(C) RSO.(6) Each licensee must notify the department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by the licensee or its parent company, if the parent company is involved in the bankruptcy.(7) The notification in paragraph six of this subsection must include:(A) the bankruptcy court in which the petition for bankruptcy was filed; and(B) the date of the filing of the petition.(8) A copy of the petition for bankruptcy must be submitted to the department along with the written notification.(9) In deciding whether to grant, deny, amend, renew, revoke, suspend, or restrict a license, the department may consider the technical competence and compliance history of an applicant or holder of a license. After an opportunity for a hearing, the department may deny an application for a license, an amendment to a license, or an application for renewal of a license if the applicant's compliance history reveals three or more disciplinary actions have been issued against the applicant within the previous six years. Disciplinary actions include those assessing administrative or civil penalties against the applicant or revoking or suspending the applicant's license.(10) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators must test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, under §289.256 of this subchapter.(A) The licensee must make, maintain, and retain a record of the results of each test for inspection by the department, as specified in subsection (mm) of this section.(B) The licensee must report the results of any test exceeding the permissible concentration listed in §289.256(ii) of this subchapter at the time of generator elution, as specified in §289.256(www) of this subchapter.(11) Licensees must not hold radioactive waste, sources, or devices not authorized for disposal by decay in storage, and not in use for longer than 24 months following the last principal activity use. Sources and devices kept in standby for future use may be excluded from the 24-month time limit if the department approves a plan for future use. A plan for an alternative disposal timeframe may be submitted by the licensee if the 24-month time limit cannot be met. Licensees must submit plans to the department at least 30 days before the end of the 24 months of nonuse.(y) Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.(1) Except as provided in paragraph (2) of this subsection and subsection (z)(2) of this section, each specific license expires at the end of the day, in the month and year stated in the license.(2) Expiration of the specific license does not relieve the licensee of the requirements of this chapter.(3) All license provisions continue in effect beyond the expiration date, with respect to possession of radioactive material until the department notifies the former licensee in writing the provisions of the license are no longer binding. During this time, the former licensee must:(A) be limited to actions involving radioactive material to those related to decommissioning; and(B) continue to control entry to restricted areas until each location is suitable for release for unrestricted use, as specified in §289.202(ddd) of this chapter.(4) Within 60 days of the occurrence of any of the following, each licensee must provide notification to the department in writing and either begin decommissioning a site, or any separate building or outdoor area containing residual radioactivity, so the building and outdoor area is suitable for release under §289.202(eee) of this chapter, or submit within 12 months of notification a decommissioning plan, if required by paragraph (7) of this subsection, and begin decommissioning upon approval of that plan if:(A) the license has expired or has been revoked, as specified in this subsection or subsection (dd) of this section;(B) the licensee has decided to permanently cease principal activities, as defined in §289.201(b) of this chapter, at the entire site or in any separate building or outdoor area containing residual radioactivity and the building or outdoor area is unsuitable for release, as specified in department requirements;(C) no principal activities at an entire site as specified in the license have been conducted for a period of 24 months; or(D) no principal activities have been conducted for a period of 24 months in any separate building or outdoor area containing residual radioactivity such that the building or outdoor area is unsuitable for release under §289.202(eee) of this chapter.(5) Coincident with the notification required by paragraph (4) of this subsection, the licensee must maintain in effect all decommissioning financial assurances established by the licensee, as specified in subsection (gg) of this section in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be decreased, as appropriate, with department approval, to cover the detailed cost estimate for decommissioning established under paragraph (10)(E) of this subsection.(A) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan must do so as specified in subsection (gg) of this section.(B) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site, with the approval of the department.(6) The department may grant a request to delay or postpone initiation of the decommissioning process if the department determines such relief is not detrimental to the occupational and public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification under paragraph (4) of this subsection. The schedule for decommissioning set forth in paragraph (4) of this subsection must not commence until the department has decided on the request.(7) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the department and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:(A) procedures would involve techniques not applied routinely during cleanup or maintenance operations;(B) workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;(C) procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or(D) procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.(8) The department may approve an alternate schedule for submittal of a decommissioning plan required under paragraph (4) of this subsection if the department determines the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the occupational and public health and safety and is otherwise in the public interest.(9) The procedures listed in paragraph (7) of this subsection must not be carried out before approval of the decommissioning plan.(10) The proposed decommissioning plan for the site or separate building or outdoor area must include the following:(A) a description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;(B) a description of planned decommissioning activities;(C) a description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning; (D) a description of the planned final radiation survey;(E) an updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and(F) for decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay based on the criteria in paragraph (15) of this subsection. (11) The proposed decommissioning plan will be approved by the department if the information in the plan demonstrates the decommissioning will be completed as soon as practicable and the health and safety of workers and the public will be adequately protected.(12) Except as provided in paragraph (14) of this subsection, licensees must complete decommissioning of the site or separate building or outdoor areas as soon as practicable but no later than 24 months following the initiation of decommissioning.(13) Except as provided in paragraph (14) of this subsection, when decommissioning involves the entire site, the licensee must request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.(14) The department may approve a request for an alternate schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the department determines the alternative is warranted by consideration of the following:(A) whether it is technically feasible to complete decommissioning within the allotted 24-month period;(B) whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;(C) whether a significant volume reduction in wastes requiring disposal is achieved by allowing short-lived radionuclides to decay;(D) whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and(E) other site-specific factors the department may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, groundwater treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.(15) As the final step in decommissioning, the licensee must:(A) certify the disposition of all licensed material, including accumulated wastes; and(B) conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey unless the licensee demonstrates the premises are suitable for release according to the radiological requirements for license termination as specified in §289.202(ddd) of this chapter. The licensee must, as appropriate:(i) report the following levels:(I) gamma radiation in units of microroentgen per hour (µR/hr) (millisieverts per hour (mSv/hr)) at 1 meter (m) from surfaces;(II) radioactivity, including alpha and beta, in units of disintegrations per minute (dpm) or microcuries (µCi) (megabecquerels (MBq)) per 100 square centimeters (cm2 ) for surfaces;(III) µCi (MBq) per milliliter for water; and(IV) picocuries (pCi) (becquerels (Bq)) per gram (g) for solids such as soils or concrete; and(ii) specify the manufacturer's name and model and serial number of each survey instrument used and certify each instrument is properly calibrated, as specified in §289.202(p) of this chapter, and tested.(16) The department will provide written notification to specific licensees, including former licensees with provisions continued in effect beyond the expiration date under paragraph (3) of this subsection, that the provisions of the license are no longer binding. The department provides such notification when the department determines:(A) radioactive material has been properly disposed;(B) reasonable effort has been made to eliminate residual radioactive contamination, if present;(C) a radiation survey has been performed demonstrating the premises are suitable for release according to the radiological requirements for license termination as specified in §289.202(ddd) of this chapter, or other information submitted by the licensee is sufficient to demonstrate the premises are suitable for release according to the radiological requirements for license termination as specified in §289.202(ddd) of this chapter; and(D) any outstanding fees under §289.204 of this chapter are paid and any outstanding notices of violations of this chapter or of license conditions are resolved.(17) Each licensee must submit to the department all records required by §289.202(nn)(3) of this chapter before the license is terminated.(z) Renewal of licenses.(1) Requests for renewal of specific licenses must be filed as specified in subsection (d)(1) - (4) and (6) - (8) of this section. In any application for renewal, the applicant may incorporate drawings by clear and specific reference (for example, title, date, and unique number of drawing), if no modifications have been made since previously submitted.(2) In any case in which a licensee, not less than 30 days before expiration of an existing license, has filed a request in proper form for renewal or for a new license authorizing the same activities, the existing license will not expire until the request has been finally determined by the department. In any case in which a licensee, not more than 90 days after the expiration of an existing license, has filed a request in proper form for renewal or for a new license authorizing the same activities, the department may reinstate the license and extend the expiration until the request has been finally determined by the department. The requirements in this subsection are subject to the provisions of Texas Government Code, §2001.054.(3) An application for technical renewal of a license will be approved if the department determines the requirements of subsection (e) of this section are satisfied.(aa) Amendment of licenses at request of licensee.(1) Requests for amendment of a license must be filed as specified in subsection (d)(1) - (4) of this section, must be signed by management or the RSO, and must specify the respects in which the licensee desires a license to be amended and the grounds for the amendment. (2) Requests for amendments to delete a subsite from a license must be filed as specified in subsections (d)(1) and (2) and (y)(13) and (15) of this section.(bb) Department action on requests to renew or amend. In considering a request by a licensee to renew or amend a license, the department applies the criteria in subsection (e) of this section as applicable.(cc) Transfer of material.(1) A licensee must not transfer radioactive material except as authorized under this chapter. This subsection does not include transfer for commercial distribution.(2) Except as otherwise provided in a license and subject to the provisions of paragraphs (3) and (4) of this subsection, any licensee may transfer radioactive material:(A) to the department, only after receiving approval from the department;(B) to the United States Department of Energy (DOE);(C) to any person exempt from this section to the extent permitted, as specified in such exemption;(D) to any person authorized to receive such material under the terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the department, the NRC, or any agreement state, or to any person otherwise authorized to receive such material by the federal government or any agency of the federal government, the department, or any agreement state; or(E) as otherwise authorized by the department in writing.(3) Before transferring radioactive material to a specific licensee of the department, the NRC, or any agreement state, or to a general licensee who is required to register with the department, the NRC, or any agreement state before receipt of the radioactive material, the licensee transferring the material must verify the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.(4) The following methods for the verification required by paragraph (3) of this subsection are acceptable.(A) The transferor possesses and has read a current copy of the transferee's specific license.(B) When a current copy of the transferee's specific license described in subparagraph (A) of this paragraph is not readily available or when a transferor desires to verify the information received is correct or up-to-date, the transferor may obtain and record confirmation from the department, the NRC, or any agreement state the transferee is licensed to receive the radioactive material.(5) Preparation for shipment and transport of radioactive material must be performed as specified in the provisions of subsection (ff) of this section.(6) Requirements for a specific license to initially transfer source material to a person generally licensed under §289.251(f)(3) of this subchapter.(A) An application for a specific license to initially transfer source material for use under §289.251(f)(3) of this subchapter; 10 CFR §40.22; or equivalent regulations of any agreement state, will be approved if:(i) the applicant satisfies the general requirements as specified in subsection (e) of this section; and(ii) the applicant submits adequate information on, and the department approves, the methods to be used for quality control, labeling, and providing safety instructions to recipients.(B) Quality control, labeling, safety instructions, and records and reports. Each person licensed under subparagraph (A) of this paragraph must:(i) label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material";(ii) ensure the quantities and concentrations of source material are as labeled and indicated in any transfer records;(iii) provide the information as specified in this clause to each person to whom source material is transferred for use under §289.251(f)(3) of this subchapter; 10 CFR §40.22; or equivalent regulations of any agreement state. This information must be provided before the source material is transferred for the first time in each calendar year to the recipient. The required information includes:(I) a copy of this subsection, and as applicable, §289.251(f)(3) of this subchapter; 10 CFR §40.22; or the equivalent agreement state regulation; and 10 CFR §40.51; or the equivalent agreement state regulations; and(II) appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material; and(iv) report transfers as follows:(I) File a report with the department and the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The report must include the following information:(-a-) the name, address, and license number of the person who transferred the source material;(-b-) for each general licensee under §289.251(f)(3) of this subchapter; 10 CFR §40.22; or equivalent regulations of any agreement state to whom greater than 50 grams (0.11 pounds (lb)) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and(-c-) the total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.(II) File a report with each responsible agreement state agency that identifies all persons operating under §289.251(f)(3) of this subchapter; 10 CFR §40.22; or equivalent regulations of any agreement state to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report must include the following information specific to those transfers made to the agreement state being reported to:(-a-) the name, address, and license number of the person who transferred the source material; and(-b-) the name and address of the general licensee to whom source material was distributed; a responsible agent, by name or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and(-c-) the total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the agreement state.(III) The following are to be submitted to the department by January 31 of each year:(-a-) each report required by subclauses (I) and (II) of this clause covering all transfers for the previous calendar year;(-b-) if no transfers were made during the current period to a person generally licensed under §289.251(f)(3) of this subchapter; 10 CFR §40.22; or equivalent regulations of any agreement state, a report to the department indicating so; and(-c-) if no transfers have been made to general licensees in a particular agreement state during the reporting period, this information must be reported to the responsible agreement state upon request of that agency.(C) Records.(i) The licensee must maintain all information supporting the reports required by this paragraph concerning each transfer to a general licensee for inspection by the department, as specified in subsection (mm) of this section.(ii) The licensee transferring the material must retain each record of transfer of radioactive material until the department terminates each license authorizing the activity subject to the recordkeeping requirement.(dd) Modification, suspension, and revocation of licenses. (1) The terms and conditions of all licenses are subject to revision or modification. A license may be modified, suspended, or revoked due to amendments to the Act or rules in this chapter, or orders issued by the department or a court.(2) Any license may be revoked, suspended, or modified, in whole or in part, for any of the following:(A) any material false statement in the application or any statement of fact required under provisions of the Act;(B) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means warranting department refusal to grant a license on an original application;(C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, the license, or order of the department or court; or(D) existing conditions constituting a substantial threat to the public health or safety or the environment.(3) Each specific license revoked by the department ends at the end of the day on the date of the department's final determination to revoke the license, or on the revocation date stated in the determination, or as otherwise provided by the department order.(4) Except in cases in which the occupational and public health or safety requires otherwise, no license will be suspended or revoked unless, before the institution of proceedings, facts or conduct warranting such action is called to the attention of the licensee in writing and the licensee has been given an opportunity to demonstrate compliance with all lawful requirements.(ee) Reciprocal recognition of licenses.(1) Subject to this section, any person who holds a specific license from the NRC or any agreement state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity, and at which radiation safety records are normally maintained, is granted a general license to conduct the activities authorized in such licensing document within the State of Texas provided:(A) the licensing document does not limit the activity authorized by such document to specified installations or locations;(B) the out-of-state licensee notifies the department in writing at least three working days before engaging in such activity. If, for a specific case, the three-working-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the department, obtain permission to proceed sooner. The department may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in this subsection. Such notification must include:(i) the exact location, start date, duration, and type of activity to be conducted;(ii) the identification of the radioactive material to be used;(iii) the name and in-state address of each individual performing the activity;(iv) a copy of the applicant's pertinent license;(v) a copy of the licensee's operating, safety, and emergency procedures;(vi) a fee as specified in §289.204 of this chapter; and(vii) a copy of the completed RC Form 252-1 (Business Information Form);(C) the out-of-state licensee complies with all applicable rules of the department and with all the terms and conditions of the licensee's licensing document, except any such terms and conditions inconsistent with applicable rules of the department;(D) the out-of-state licensee supplies such other information as the department may request;(E) the out-of-state licensee must not transfer or dispose of radioactive material possessed or used under the general license provided in this subsection except by transfer to a person:(i) specifically licensed by the department, the NRC, or any agreement state to receive such material, or(ii) exempt from the requirements for a license for such material under §289.251(e)(1) of this subchapter; and(F) the out-of-state licensee must always have the following documents in their possession when conducting work in Texas, and make them available for department review upon request:(i) a copy of the department letter granting the licensee reciprocal recognition of their out-of-state license;(ii) a copy of the licensee's operating and emergency procedures;(iii) a copy of the licensee's radioactive material license;(iv) a copy of all applicable sections of this chapter; and(v) a copy of the completed RC Form 252-3 notifying the department of the licensee's intent to work in Texas.(2) In addition to the provisions of paragraph (1) of this subsection, any person who holds a specific license issued by the NRC or any agreement state authorizing the holder to manufacture, transfer, install, or service the device described in §289.251(f)(4)(H) of this subchapter or in 10 CFR §150.20, within areas subject to the jurisdiction of the licensing body, is granted a general license to install, transfer, demonstrate, or service the device in the State of Texas provided that:(A) the person files a report with the department within 30 days after the end of each calendar quarter in which any device is transferred to or installed in the State of Texas. Each report must identify by name and address, each general licensee to whom the device is transferred, the type of device transferred by manufacturer's name, model and serial number of the device, and serial number of the sealed source, and the quantity and type of radioactive material contained in the device;(B) the device has been manufactured, labeled, installed, and serviced as specified in applicable provisions of the specific license issued to the person by the NRC or any agreement state;(C) the person assures any labels required to be affixed to the device according to requirements of the authority licensing the manufacture of the device, bear a statement that "Removal of this label is prohibited"; and(D) the holder of the specific license furnishes to each general licensee to whom the holder of the specific license transfers the device, or on whose premises the holder of the specific license installs the device, a copy of the general license contained in §289.251(f)(4)(H) of this subchapter.(3) The department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed under the licensing document, upon determining the action is necessary to prevent undue hazard to occupational and public health and safety and the environment.(ff) Preparation of radioactive material for transport. Requirements for the preparation of radioactive material for transport are specified in §289.257 of this subchapter.(gg) Financial assurance and record keeping for decommissioning. (1) The applicant for a specific license or renewal of a specific license, or holder of a specific license, authorizing the possession and use of radioactive material must submit and receive written authorization for a decommissioning funding plan as described in paragraph (4) of this subsection in an amount sufficient to allow the department to engage a third party to decommission each site specified on the license for the following situations:(A) when unsealed radioactive material requested or authorized on the license, with a half-life greater than 120 days, is in quantities exceeding 105 times the applicable quantities set forth in subsection (jj)(2) of this section;(B) when a combination of the unsealed radionuclides requested or authorized on the license, with a half-life greater than 120 days, results in the R of the radionuclides divided by 105 being greater than 1 (unity rule), where R is defined as the sum of the ratios of the quantity of each radionuclide to the applicable value in subsection (jj)(2) of this section;(C) when sealed sources or plated foils requested or authorized on the license, with a half-life greater than 120 days and in quantities exceeding 1012 times the applicable quantities set forth in subsection (jj)(2) of this section (or when a combination of isotopes is involved if R, as defined in this subsection, divided by 1012 is greater than 1), must submit a decommissioning funding plan as described in paragraph (4) of this subsection; or(D) when radioactive material requested or authorized on the license is in quantities more than 100 mCi (3.7 GBq) of source material in a readily dispersible form.(2) The applicant for a specific license or renewal of a specific license or the holder of a specific license authorizing possession and use of radioactive material as specified in paragraph (3) of this subsection must either:(A) submit a decommissioning funding plan as described in paragraph (4) of this subsection in an amount sufficient to allow the department to engage a third party to decommission each site specified on the license; or(B) submit financial assurance for decommissioning in the amount specified in paragraph (3) of this subsection, using one of the methods described in paragraph (6) of this subsection, in an amount sufficient to allow the department to engage a third party to decommission each site specified on the license.(3) The required amount of financial assurance for decommissioning is determined by the quantity of material authorized by the license and is determined as follows:(A) $1,125,000 for quantities of material greater than 104 but less than or equal to 105 times the applicable quantities in subsection (jj)(2) of this section in unsealed form. (For a combination of radionuclides, if R, as defined in paragraph (1) of this subsection, divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1);(B) $225,000 for quantities of material greater than 103 but less than or equal to 104 times the applicable quantities in subsection (jj)(2) of this section in unsealed form. (For a combination of radionuclides, if R, as defined in paragraph (1) of this subsection, divided by 103 is greater than 1 but R divided by 104 if less than or equal to 1);(C) $113,000 for quantities of material greater than 1010 but less than or equal to 1012 times the applicable quantities in subsection (jj)(2) of this section in sealed sources or plated foils. (For a combination of radionuclides, if R, as defined in paragraph (1) of this subsection, divided by 1010 is greater than 1, but R divided by 1012 is less than or equal to 1); or(D) $225,000 for quantities of source material greater than 10 mCi (0.37 GBq) but less than or equal to 100 mCi (3.7 GBq) in a readily dispersible form.(4) Each decommissioning funding plan must:(A) be submitted for review and approval and must contain the following:(i) a detailed cost estimate for decommissioning in an amount reflecting:(I) the cost of an independent contractor to perform all decommissioning activities;(II) the cost of meeting the criteria of §289.202(ddd)(2) of this chapter for unrestricted use provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of §289.202(ddd)(3) of this chapter, then the cost estimate may be based on meeting the criteria of §289.202(ddd)(3) of this chapter;(III) the volume of onsite subsurface material containing residual radioactivity requiring remediation to meet the criteria for license termination; and(IV) an adequate contingency factor;(ii) identification of and justification for using the key assumptions contained in the detailed cost estimate;(iii) a description of the method of assuring funds for decommissioning from paragraph (6) of this subsection, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;(iv) a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and(v) a signed original of the financial instrument obtained to satisfy the requirements of paragraph (6) of this subsection (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning); and(B) be resubmitted at the time of license renewal and at intervals not to exceed three years with adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance is adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:(i) spills of radioactive material producing additional residual radioactivity in onsite subsurface material;(ii) waste inventory increasing above the amount previously estimated;(iii) waste disposal costs increasing above the amount previously estimated;(iv) facility modifications;(v) changes in authorized possession limits;(vi) actual remediation costs exceeding the previous cost estimate;(vii) onsite disposal; and(viii) use of a settling pond.(5) Financial assurance in conjunction with a decommissioning funding plan must be submitted as follows:(A) for an applicant for a specific license, financial assurance as described in paragraph (6) of this subsection, may be obtained after the application has been approved and the license issued by the department, but must be submitted to the department before receipt of licensed material; or(B) for an applicant for renewal of a specific license, or a holder of a specific license, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (6) of this subsection must be submitted with the decommissioning funding plan.(6) Financial assurance for decommissioning must be provided by one or more of the following methods. The financial instrument obtained must be continuous for the term of the license in a form prescribed by the department. The applicant or licensee must obtain written approval of the financial instrument or any amendment to it from the department.(A) Prepayment is the deposit into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.(B) A surety method, insurance, or other guarantee method. These methods guarantee decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in subsection (jj)(3) of this section. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this section. For commercial corporations issuing bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in subsection (jj)(4) of this section. For commercial companies not issuing bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in subsection (jj)(5) of this section. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in subsection (jj)(6) of this section. A guarantee by the applicant or licensee may not be used in combination with any other financial methods to satisfy the requirements of this section or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions.(i) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless 90 days or more before the renewal date, the issuer notifies the department, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide the full face amount be paid to the beneficiary automatically before the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the department within 30 days after receipt of notification of cancellation.(ii) The surety method or insurance must be payable in the State of Texas to the Radiation and Perpetual Care Account.(iii) The surety method or insurance must remain in effect until the department has terminated the license.(C) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must comply with subparagraph (B) of this paragraph.(D) In the case of federal, state, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount as specified in paragraph (3) of this subsection, and indicating funds for decommissioning will be obtained when necessary.(E) When a governmental entity is assuming custody and ownership of a site, there must be an arrangement deemed acceptable by such governmental entity.(7) Each person licensed under this section must make, maintain, and retain records of information important to the safe and effective decommissioning of the facility in an identified location for inspection by the department, as specified in subsection (mm) of this section. If records of relevant information are kept for other purposes, reference to these records and their locations may be used. Information the department considers important to decommissioning consists of the following:(A) records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood contaminants may have spread to inaccessible areas, as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations;(B) as-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee must substitute appropriate records of available information concerning these areas and locations;(C) except for areas containing only sealed sources (provided the sealed sources have not leaked or no contamination remains after any leak) or byproduct materials having only half-lives of less than 65 days, a list contained in a single document and updated every two years of:(i) all areas designated and formerly designated as restricted areas as defined in §289.201(b) of this chapter;(ii) all areas outside of restricted areas requiring documentation under subparagraph (A) of this paragraph; and(iii) all areas outside of restricted areas containing material where, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in §289.202(ddd) of this chapter, or meet the requirements for approval of disposal under §289.202(ff) - (kk) of this chapter; and(D) records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds.(hh) Emergency plan for responding to a release.(1) A new or renewal application for each specific license to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass, in excess of the quantities in subsection (jj)(7) of this section, must contain either:(A) an evaluation showing the maximum dose to a person offsite due to a release of radioactive material would not exceed 1 rem effective dose equivalent or 5 rem to the thyroid; or(B) an emergency plan for responding to a release of radioactive material.(2) One or more of the following factors may be used to support an evaluation submitted under paragraph (1)(A) of this subsection:(A) the radioactive material is physically separated so only a portion could be involved in an accident;(B) all or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;(C) the release fraction in the respirable size range would be lower than the release fraction in subsection (jj)(7) of this section due to the chemical or physical form of the material;(D) the solubility of the radioactive material would reduce the dose received;(E) facility design or engineered safety features in the facility would cause the release fraction to be lower than that in subsection (jj)(7) of this section;(F) operating restrictions or procedures would prevent a release fraction as large as that in subsection (jj)(7) of this section; or(G) other factors appropriate for the specific facility.(3) An emergency plan for responding to a release of radioactive material submitted under paragraph (1)(B) of this subsection must include the following information.(A) Facility description. A brief description of the licensee's facility and area near the site.(B) Types of accidents. Identification of each radioactive materials accident type for which protective actions may be needed.(C) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.(D) Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.(E) Mitigation of consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.(F) Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.(G) Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the department; also, responsibilities for developing, maintaining, and updating the plan.(H) Notification and coordination. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated, injured onsite workers, when appropriate. A control point must be established. The notification and coordination must be planned so unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee must also commit to notify the department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees from complying with the requirements under the Emergency Planning and Community Right-to-Know-Act of 1986, Title III, Publication L. 99-499 or other state or federal reporting requirements.(I) Information to be communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the department.(J) Training. A brief description of the frequency, performance objectives, and plans for the training the licensee will provide workers on how to respond to an emergency, including any special instructions and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training must familiarize personnel with site-specific emergency procedures. Also, the training must comprehensively prepare site personnel to effectively respond to accidents considered as most probable for the specific site and include the use of team training for such events.(K) Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.(L) Exercises. Provisions for conducting quarterly communications checks with offsite response organizations at intervals not to exceed three months and biennial onsite exercises to test response to simulated emergencies. Communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee must invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios must not be known to most exercise participants. The licensee must critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.(M) Hazardous chemicals. A certification the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Publication L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.(4) The licensee must allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the department. The licensee must provide any comments received during the 60 days to the department with the emergency plan.(ii) Physical protection of category 1 and category 2 quantities of radioactive material.(1) Specific exemptions. A licensee possessing radioactive waste containing category 1 or category 2 quantities of radioactive material is exempt from the requirements of paragraphs (2) - (23) of this subsection, except any radioactive waste containing discrete sources, ion-exchange resins, or activated material weighing less than 2,000 kilograms (kg) (4,409 lb) is not exempt from the requirements of this subsection. The licensee must implement the following requirements to secure the radioactive waste:(A) use continuous physical barriers allowing access to the radioactive waste only through established access control points;(B) use a locked door or gate with monitored alarm at the access control point;(C) assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and(D) immediately notify the local law enforcement agency (LLEA) and request an armed response from the LLEA upon determination there was an actual or attempted theft, sabotage, or diversion of the radioactive waste containing category 1 or category 2 quantities of radioactive material.(2) Personnel access authorization requirements for category 1 or category 2 quantities of radioactive material.(A) General.(i) Each licensee possessing an aggregated quantity of radioactive material at or above the category 2 threshold must establish, implement, and maintain its access authorization program, as specified in the requirements of this paragraph and paragraphs (3) - (8) of this subsection.(ii) An applicant for a new license and each licensee that would become subject to the requirements of this paragraph and paragraphs (3) - (8) of this subsection upon application for modification of its license, must implement the requirements of this paragraph and paragraphs (3) - (8) of this subsection, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.(iii) Any licensee that has not previously implemented the security orders or been subject to this paragraph and paragraphs (3) - (8) of this subsection must implement the provisions of these paragraphs before aggregating radioactive material to a quantity equaling or exceeding the category 2 threshold.(B) General performance objective. The licensee's access authorization program must ensure individuals specified in subparagraph (C)(i) of this paragraph are trustworthy and reliable.(C) Applicability.(i) Licensees must subject the following individuals to an access authorization program:(I) any individual whose assigned duties require unescorted access to category 1 or category 2 quantities of radioactive material or to any device containing the radioactive material; and(II) reviewing officials.(ii) Licensees need not subject the categories of individuals listed in paragraph (6)(A)(i) - (xiii) of this subsection to the investigation elements of the access authorization program.(iii) Licensees must approve for unescorted access to category 1 or category 2 quantities of radioactive material only those individuals with job duties requiring unescorted access to category 1 or category 2 quantities of radioactive material.(iv) Licensees may include individuals needing access to safeguards information-modified handling under 10 CFR Part 73, in the access authorization program under this paragraph and paragraphs (3) - (8) of this subsection.(3) Access authorization program requirements.(A) Granting unescorted access authorization.(i) Licensees must implement the requirements of paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection for granting initial or reinstated unescorted access authorization.(ii) Individuals who have been determined to be trustworthy and reliable must also complete the security training required by paragraph (10)(C) of this subsection before being allowed unescorted access to category 1 or category 2 quantities of radioactive material.(B) Reviewing officials.(i) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations allowing individuals to have unescorted access to category 1 or category 2 quantities of radioactive materials possessed by the licensee.(ii) Each licensee must name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee must provide to the department under oath or affirmation, a certification the reviewing official is deemed trustworthy and reliable by the licensee. The fingerprints of the named reviewing official must be taken by a law enforcement agency, federal or state agencies providing fingerprinting services to the public, or commercial fingerprinting services authorized by a state to take fingerprints. The licensee must recertify the reviewing official is deemed trustworthy and reliable every 10 years, as specified in paragraph (4)(C) of this subsection.(iii) Reviewing officials must be permitted to have unescorted access to category 1 or category 2 quantities of radioactive materials or access to safeguards information or safeguards information-modified handling if the licensee possesses safeguards information or safeguards information-modified handling.(iv) Reviewing officials cannot approve other individuals to act as reviewing officials.(v) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:(I) the individual has undergone a background investigation, including fingerprinting and a Federal Bureau of Investigation (FBI) criminal history records check and has been determined to be trustworthy and reliable by the licensee; or(II) the individual is subject to a category listed in paragraph (6)(A) of this subsection.(C) Informed consent.(i) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent must include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee must provide the individual with an opportunity to correct any inaccurate or incomplete information developed during the background investigation. Licensees do not need to obtain signed consent from those individuals meeting the requirements of paragraph (4)(B) of this subsection. A signed consent must be obtained before any reinvestigation. (ii) The subject individual may withdraw his or her consent at any time. Licensees must inform the individual that:(I) if an individual withdraws his or her consent, the licensee may not initiate any elements of the background investigation not in progress at the time the individual withdrew his or her consent; and(II) the withdrawal of consent for the background investigation is sufficient cause for denial or termination of unescorted access authorization.(D) Personal history disclosure. Any individual who is applying for unescorted access authorization must disclose the personal history information required by the licensee's access authorization program for the reviewing official to determine the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection is sufficient cause for denial or termination of unescorted access.(E) Determination basis.(i) The reviewing official must determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all the information collected to meet the requirements of paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection.(ii) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all the information collected to meet the requirements of paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection and determined the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.(iii) The licensee must document the basis for concluding whether there is reasonable assurance an individual is trustworthy and reliable.(iv) The reviewing official may terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual granted unescorted access authorization.(v) Licensees must maintain a list of persons currently approved for unescorted access authorization. When a licensee determines a person no longer requires unescorted access or meets the access authorization requirement, the licensee must:(I) remove the person from the approved list as soon as possible, but no later than seven working days; and(II) take prompt measures to ensure the individual is unable to have unescorted access to the material.(F) Procedures. Licensees must develop, implement, and maintain written procedures for implementing the access authorization program. The procedures must:(i) include provisions for the notification of individuals who are denied unescorted access;(ii) include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization; and(iii) contain a provision to ensure the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.(G) Right to correct and complete information.(i) Before any final adverse determination, licensees must provide each individual subject to paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection with the right to complete, correct, and explain information obtained resulting from the licensee's background investigation. Confirmation of receipt by the individual of this notification must be maintained by the licensee for inspection by the department as specified in subsection (mm) of this section.(ii) If, after reviewing his or her criminal history record, an individual believes it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. These procedures include direct application by the individual challenging the record to the law enforcement agency contributing the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR §§16.30 - 16.34. In the latter case, the FBI will forward the challenge to the agency submitting the data and will request the agency verify or correct the challenged entry. Upon receipt of an official communication directly from the agency contributing the original information, the FBI Identification Division makes any changes necessary according to the information supplied by that agency. Licensees must provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his or her review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.(H) Records. The licensee must make, maintain, and retain the following records/documents for inspection by the department as specified in subsection (mm) of this section. The licensee must maintain superseded versions or portions of the following records/documents for inspection by the department as specified in subsection (mm) of this section:(i) documentation regarding the trustworthiness and reliability of individual employees;(ii) a copy of the current access authorization program procedures; and(iii) the current list of persons approved for unescorted access authorization.(4) Background investigations.(A) Initial investigation. Before allowing an individual unescorted access to category 1 or category 2 quantities of radioactive material or to the devices containing the material, licensees must complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation must encompass at least the seven years preceding the date of the background investigation or since the individual's eighteenth birthday, whichever is shorter. The background investigation must include at a minimum:(i) fingerprinting and an FBI identification and criminal history records check as specified in paragraph (5) of this subsection;(ii) verification of true identity. Licensees must:(I) verify the true identity of the individual who is applying for unescorted access authorization to ensure the applicant is who the individual claims to be;(II) review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information;(III) document the type, expiration, and identification number of the identification document, or maintain a photocopy of identifying documents on file as specified in paragraph (7) of this subsection;(IV) certify in writing the identification was properly reviewed; and(V) maintain the certification and all related documents for inspection by the department as specified in subsection (mm) of this section;(iii) employment history verification. Licensees must:(I) complete an employment history verification, including military history; and(II) verify the individual's employment with each previous employer for the most recent seven years before the date of application;(iv) verification of education. Licensees must verify the individual participated in the education process during the claimed period;(v) character and reputation determination. Licensees must complete reference checks to determine the character and reputation of the individual applying for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks as specified in paragraphs (2) and (3), this paragraph, and paragraphs (5) - (8) of this subsection must be limited to whether the individual has been and continues to be trustworthy and reliable;(vi) the licensee must also, to the extent possible, obtain independent information to corroborate information provided by the individual (e.g., seek references not supplied by the individual); and(vii) if a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide information or indicates an inability or unwillingness to provide information within a time frame deemed appropriate by the licensee, but at least after 10 business days of the request, or if the licensee is unable to reach the entity, the licensee must document the refusal, unwillingness, or inability in the record of investigation and attempt to obtain the information from an alternate source.(B) Grandfathering.(i) Individuals who have been determined to be trustworthy and reliable for unescorted access to category 1 or category 2 quantities of radioactive material as specified in the fingerprint orders may continue to have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. These individuals are subject to the reinvestigation requirement.(ii) Individuals determined to be trustworthy and reliable under 10 CFR Part 73, or the security orders for access to safeguards information, safeguards information-modified handling, or risk-significant material may have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. The licensee must document the individual was determined to be trustworthy and reliable under 10 CFR Part 73, or a security order. Security order, in this context, refers to any order issued by the NRC requiring fingerprints and an FBI criminal history records check for access to safeguards information, safeguards information-modified handling, or risk significant material such as special nuclear material or large quantities of uranium hexafluoride. These individuals are subject to the reinvestigation requirement.(C) Reinvestigations. Licensees must conduct a reinvestigation every 10 years for any individual with unescorted access to category 1 or category 2 quantities of radioactive material. The reinvestigation must consist of fingerprinting and an FBI identification and criminal history records check as specified in paragraph (5) of this subsection. The reinvestigations must be completed within 10 years of the date on which these elements were last completed.(5) Requirements for criminal history records checks of individuals granted unescorted access to category 1 or category 2 quantities of radioactive material.(A) General performance objective and requirements.(i) Except for those individuals listed in paragraph (6) of this subsection and those individuals grandfathered under paragraph (4)(B) of this subsection, each licensee subject to the requirements of paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection must:(I) fingerprint each individual who is to be permitted unescorted access to category 1 or category 2 quantities of radioactive material;(II) transmit all collected fingerprints to the NRC for transmission to the FBI; and(III) use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to category 1 or category 2 quantities of radioactive materials for that individual.(ii) The licensee must notify each affected individual their fingerprints will be used to secure a review of their criminal history record and must inform the individual of the procedures for revising the record or adding explanations to the record.(iii) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to category 1 or category 2 quantities of radioactive materials if:(I) the individual returns to the same facility granting unescorted access authorization within 365 days of the termination of the individual's unescorted access authorization; and(II) the previous access was terminated under favorable conditions.(iv) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to category 1 or category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee, based upon a background investigation conducted under paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection, the fingerprint orders, or 10 CFR Part 73. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access as specified in the requirements of paragraph (7)(C) of this subsection.(v) Licensees must use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to category 1 or category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.(B) Prohibitions.(i) Licensees may not base a final determination to deny an individual unescorted access authorization to category 1 or category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:(I) an arrest more than one year old for which there is no information of the disposition of the case; or(II) an arrest resulting in dismissal of the charge or an acquittal.(ii) Licensees may not use information received from a criminal history records check obtained under paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection in a manner infringing on the rights of any individual under the First Amendment to the Constitution of the United States, nor may licensees use the information in any way discriminating among individuals on the basis of race, religion, national origin, gender, or age.(C) Procedures for processing of fingerprint checks.(i) For the purpose of complying with paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection, licensees must use an appropriate method listed in 10 CFR §37.7, to submit to the U.S. Nuclear Regulatory Commission, Director, Division of Physical and Cyber Security Policy, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-07D04M, 11545 Rockville Pike, Rockville, Maryland 20852, one completed, legible standard fingerprint card (Form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan, or, where practicable, other fingerprint record for each individual requiring unescorted access to category 1 or category 2 quantities of radioactive material. Copies of these forms may be obtained by emailing MAILSVS.Resource@nrc.gov . Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/security/chp.html . (ii) Fees for the processing of fingerprint checks are due upon application. Licensees must submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order, or electronic payment, made payable to "U.S. NRC." (For guidance on making electronic payments, contact the Division of Physical and Cyber Security Policy by emailing Crimhist.Resource@nrc.gov. ) Combined payment for multiple applications is acceptable. The NRC publishes the amount of the fingerprint check application fee on the NRC's public website. (To find the current fee amount, go to the Licensee Criminal History Records Checks & Firearms Background Check information page at https://www.nrc.gov/security/chp.html and see the link for How do I determine how much to pay for the request?).(iii) The NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee's application for criminal history records checks.(6) Relief from fingerprinting, identification, and criminal history records checks and other elements of background investigations for designated categories of individuals permitted unescorted access to certain radioactive materials.(A) Fingerprinting, the identification and criminal history records checks required by Section 149 of the Atomic Energy Act of 1954, as amended, and other elements of the background investigation are not required for the following individuals before granting unescorted access to category 1 or category 2 quantities of radioactive materials:(i) an employee of the NRC or of the Executive Branch of the U.S. Government who has undergone fingerprinting for a prior U.S. Government criminal history records check;(ii) a member of Congress;(iii) an employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. Government criminal history records check;(iv) the governor of a state or his or her designated state employee representative;(v) federal, state, or local law enforcement personnel;(vi) state radiation control program directors and state homeland security advisors or their designated state employee representatives;(vii) agreement state employees conducting security inspections on behalf of the NRC under an agreement executed as specified in section 274.i. of the Atomic Energy Act;(viii) representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC;(ix) emergency response personnel who are responding to an emergency;(x) commercial vehicle drivers for road shipments of category 1 and category 2 quantities of radioactive material;(xi) package handlers at transportation facilities such as freight terminals and railroad yards;(xii) any individual having an active federal security clearance, if the individual makes available the appropriate documentation. Written confirmation from the agency/employer granting the federal security clearance or reviewed the criminal history records check must be provided to the licensee. The licensee must maintain and retain this documentation for inspection by the department as specified in subsection (mm) of this section; and(xiii) any individual employed by a service provider licensee for which the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to category 1 or category 2 quantities of radioactive material. Written verification from the service provider must be provided to the licensee. The licensee must maintain and retain the documentation for inspection by the department as specified in subsection (mm) of this section.(B) Fingerprinting, and the identification and criminal history records checks required by Section 149 of the Atomic Energy Act of 1954, as amended, are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last five years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check, provided the individual makes available the appropriate documentation. Written confirmation from the agency/employer reviewing the criminal history records check must be provided to the licensee. The licensee must maintain and retain this documentation for inspection by the department as specified in subsection (mm) of this section. These programs include:(i) National Agency Check;(ii) Transportation Worker Identification Credentials (TWIC) under 49 CFR Part 1572;(iii) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under 27 CFR Part 555;(iv) Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR Part 73;(v) Hazardous Material security threat assessment for hazardous material endorsement to commercial driver's license under 49 CFR Part 1572; and(vi) Customs and Border Protection's Free and Secure Trade (FAST) Program.(7) Protection of information.(A) Each licensee who obtains background information on an individual under paragraphs (2) - (6), this paragraph, or paragraph (8) of this subsection must establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.(B) The licensee may not disclose the record or personal information collected and maintained to any person other than the subject individual, the individual's representative, or to those having a need to access to the information in performing assigned duties in the process of granting or denying unescorted access to category 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling. No individual authorized to have access to the information may disseminate the information to any other individual who does not have a need to know.(C) The personal information obtained on an individual from a background investigation may be provided to another licensee:(i) upon the individual's written request to the licensee holding the data to disseminate the information contained in his or her file; and(ii) provided the recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.(D) The licensee must make background investigation records obtained under paragraphs (2) - (6), this paragraph, and paragraph (8) of this subsection available for examination by an authorized representative of the department to determine compliance with the regulations and laws.(E) The licensee must retain all fingerprint and criminal history records on an individual (including data indicating no record) received from the FBI, or a copy of these records if the individual's file has been transferred, for inspection by the department as specified in subsection (mm) of this section.(8) Access authorization program review.(A) Each licensee is responsible for the continuing effectiveness of the access authorization program. Each licensee must ensure access authorization programs are reviewed to confirm compliance with the requirements of paragraphs (2) - (7) and this paragraph of this subsection and comprehensive actions are taken to correct any noncompliance identified. The review program must evaluate all program performance objectives and requirements. Each licensee must review the access program content and implementation at least every 12 months.(B) The results of the reviews, along with any recommendations, must be documented. Each review report must identify conditions adverse to the proper performance of the access authorization program, the cause of each condition, and, when appropriate, recommend corrective actions and corrective actions taken. The licensee must review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.(C) Review records must be maintained for inspection by the department as specified in subsection (mm) of this section.(9) Security program.(A) Applicability.(i) Each licensee possessing an aggregated category 1 or category 2 quantity of radioactive material must establish, implement, and maintain a security program complying with the requirements of this paragraph and paragraphs (10) - (17) of this subsection.(ii) An applicant for a new license and each licensee becoming newly subject to the requirements of this paragraph and paragraphs (10) - (17) of this subsection upon application for modification of its license must implement the requirements of this paragraph and paragraphs (10) - (17) of this subsection, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.(iii) Any licensee not previously implementing the security orders or subject to the provisions of this paragraph and paragraphs (10) - (17) of this subsection must provide written notification to the department at least 90 days before aggregating radioactive material to a quantity equaling or exceeding the category 2 threshold.(B) General performance objective. Each licensee must establish, implement, and maintain a security program designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to category 1 or category 2 quantities of radioactive material.(C) Program features. Each licensee's security program must include the program features, as appropriate, described in paragraphs (10) - (16) of this subsection.(10) General security program requirements.(A) Security plan.(i) Each licensee identified in paragraph (9)(A) of this subsection must develop a written security plan specific to its facilities and operations. The purpose of the security plan is to establish the licensee's overall security strategy to ensure the integrated and effective functioning of the security program required by paragraph (9), this paragraph, and paragraphs (11) - (17) of this subsection. The security plan must, at a minimum:(I) describe the measures and strategies used to implement the requirements of paragraph (9), this paragraph, and paragraphs (11) - (17) of this subsection; and(II) identify the security resources, equipment, and technology used to satisfy the requirements of paragraph (9), this paragraph, and paragraphs (11) - (17) of this subsection.(ii) The security plan must be reviewed and approved by the individual with overall responsibility for the security program.(iii) A licensee must revise its security plan as necessary to ensure the effective implementation of department and NRC requirements. The licensee must ensure:(I) the revision has been reviewed and approved by the individual with overall responsibility for the security program; and(II) the affected individuals are instructed on the revised plan before the changes are implemented.(iv) The licensee must maintain a copy of the current security plan as a record for inspection by the department as specified in subsection (mm) of this section. If any portion of the plan is superseded, the licensee must maintain and retain the superseded material for inspection by the department as specified in subsection (mm) of this section.(B) Implementing procedures.(i) The licensee must develop and maintain written procedures documenting how the requirements of paragraph (9), this paragraph, and paragraphs (11) - (17) of this subsection and the security plan are met.(ii) The implementing procedures and revisions to these procedures must be approved in writing by the individual with overall responsibility for the security program.(iii) The licensee must retain a copy of the current procedure as a record for inspection by the department as specified in subsection (mm) of this section. Superseded portions of the procedure must be maintained for inspection by the department as specified in subsection (mm) of this section.(C) Training.(i) Each licensee must conduct training to ensure those individuals implementing the security program possess and maintain the knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. The training must include instruction in:(I) the licensee's security program and procedures to secure category 1 or category 2 quantities of radioactive material, and in the purposes and functions of the security measures employed;(II) the responsibility to report promptly to the licensee any condition causing or potentially causing a violation of the requirements of the department;(III) the responsibility of the licensee to report promptly to the local law enforcement agency and licensee any actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material; and(IV) the appropriate response to security alarms.(ii) In determining those individuals who must be trained on the security program, the licensee must consider each individual's assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion, or sabotage of category 1 or category 2 quantities of radioactive material. The extent of the training must be commensurate with the individual's potential involvement in the security of category 1 or category 2 quantities of radioactive material.(iii) Refresher training must be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. This training must include:(I) review of the training requirements of this subparagraph and any changes made to the security program since the last training;(II) reports on any relevant security issues, problems, and lessons learned;(III) relevant results of inspections by the department; and(IV) relevant results of the licensee's program review and testing and maintenance.(iv) The licensee must maintain records of the initial and refresher training for inspection by the department as specified in subsection (mm) of this section. The training records must include:(I) the dates of the training;(II) the topics covered;(III) a list of licensee personnel in attendance; and(IV) any related information.(D) Protection of information.(i) Licensees authorized to possess category 1 or category 2 quantities of radioactive material must limit access to and unauthorized disclosure of their security plan, implementing procedures, and the list of individuals approved for unescorted access.(ii) Efforts to limit access must include the development, implementation, and maintenance of written policies and procedures for controlling access to and for proper handling and protection against unauthorized disclosure of the security plan, implementing procedures, and the list of individuals approved for unescorted access.(iii) Before granting an individual access to the security plan, implementing procedures, or the list of individuals approved for unescorted access, licensees must:(I) evaluate an individual's need to know the security plan, implementing procedures, or the list of individuals approved for unescorted access; and(II) if the individual has not been authorized for unescorted access to category 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling, the licensee must complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination must be conducted by the reviewing official and must include the background investigation elements contained in paragraph (4)(A)(ii) - (vii) of this subsection.(iv) Licensees need not subject the following individuals to the background investigation elements for protection of information:(I) the categories of individuals listed in paragraph (6)(A)(i) - (xiii) of this subsection; or(II) security service provider employees, provided written verification the employee has been determined to be trustworthy and reliable, by the required background investigation in paragraph (4)(A)(ii) - (vii) of this subsection, has been provided by the security service provider.(v) The licensee must document the basis for concluding an individual is trustworthy and reliable and should be granted access to the security plan, implementing procedures, or the list of individuals approved for unescorted access.(vi) Licensees must maintain a list of persons currently approved for access to the security plan, implementing procedures, or the list of individuals approved for unescorted access. When a licensee determines a person no longer needs access to the security plan, implementing procedures, and the list of individuals approved for unescorted access, or no longer meets the access authorization requirements for access to the information, the licensee must:(I) remove the individual from the approved list as soon as possible, but no later than seven working days; and(II) take prompt measures to ensure the individual is unable to obtain the security plan, implementing procedures, or the list of individuals approved for unescorted access.(vii) When not in use, the licensee must store its security plan, implementing procedures, and the list of individuals approved for unescorted access in a manner to prevent unauthorized access. Information stored in nonremovable electronic form must be password protected.(viii) The licensee must make, maintain, and retain as a record for inspection by the department as specified in subsection (mm) of this section:(I) a copy of the information protection procedures; and(II) the list of individuals approved for access to the security plan, implementing procedures, or the list of individuals approved for unescorted access.(11) LLEA coordination.(A) A licensee subject to paragraphs (9) and (10), this paragraph, and paragraphs (12) - (17) of this subsection must coordinate, to the extent practicable, with an LLEA for responding to threats to the licensee's facility, including any necessary armed response. The information provided to the LLEA must include:(i) a description of the facilities and the category 1 and category 2 quantities of radioactive materials along with a description of the licensee's security measures implemented to comply with paragraphs (9) and (10), this paragraph, and paragraphs (12) - (17) of this subsection; and(ii) a notification the licensee will request a timely armed response by the LLEA to any actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of material.(B) The licensee must notify the department within three business days if:(i) the LLEA has not responded to the request for coordination within 60 days of the coordination request; or(ii) the LLEA notifies the licensee the LLEA does not plan to participate in coordination activities.(C) The licensee must document its efforts to coordinate with the LLEA. The documentation must be kept for inspection by the department as specified in subsection (mm) of this section.(D) The licensee must coordinate with the LLEA at least every 12 months, or when changes to the facility design or operation adversely affect the potential vulnerability of the licensee's material to theft, sabotage, or diversion.(12) Security zones.(A) Licensees must ensure all aggregated category 1 and category 2 quantities of radioactive material are used or stored within licensee-established security zones. Security zones may be permanent or temporary.(B) Temporary security zones must be established as necessary to meet the licensee's transitory or intermittent business activities, such as periods of maintenance, source delivery, and source replacement.(C) Security zones must, at a minimum, allow unescorted access only to approved individuals through:(i) isolation of category 1 and category 2 quantities of radioactive materials using continuous physical barriers allowing access to the security zone only through established access control points. A physical barrier is a natural or man-made structure or formation sufficient for the isolation of the category 1 or category 2 quantities of radioactive material within a security zone; or(ii) direct control of the security zone by approved individuals at all times; or(iii) a combination of continuous physical barriers and direct control.(D) For category 1 quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation, or source removal or exchange, the licensee must, at a minimum, provide sufficient individuals approved for unescorted access to maintain continuous surveillance of sources in temporary security zones and in any security zone in which physical barriers or intrusion detection systems have been disabled to allow such activities. (E) Individuals not approved for unescorted access to category 1 or category 2 quantities of radioactive material must be escorted by an approved individual when in a security zone.(13) Monitoring, detection, and assessment.(A) Monitoring and detection.(i) Licensees must:(I) establish and maintain the capability to continuously monitor and detect without delay all unauthorized entries into its security zones;(II) provide the means to maintain continuous monitoring and detection capability in case of a loss of the primary power source; or(III) provide for an alarm and response in case of a loss of this capability to continuously monitor and detect unauthorized entries.(ii) Monitoring and detection must be performed by:(I) a monitored intrusion detection system linked to an onsite or offsite central monitoring facility;(II) electronic devices for intrusion detection alarms alerting nearby facility personnel;(III) a monitored video surveillance system;(IV) direct visual surveillance by approved individuals located within the security zone; or(V) direct visual surveillance by a licensee designated individual located outside the security zone.(iii) A licensee subject to paragraphs (9) - (12), this paragraph, and paragraphs (14) - (17) of this subsection must also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability must provide:(I) for category 1 quantities of radioactive material, immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. Such immediate detection capability must be provided by:(-a-) electronic sensors linked to an alarm;(-b-) continuous monitored video surveillance; or(-c-) direct visual surveillance; and(II) for category 2 quantities of radioactive material, weekly verification through physical checks, tamper indicating devices, use, or other means to ensure the radioactive material is present.(B) Assessment. Licensees must immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage, or diversion.(C) Personnel communications and data transmission. For personnel and automated or electronic systems supporting the licensee's monitoring, detection, and assessment systems, licensees must:(i) maintain continuous capability for personnel communication and electronic data transmission and processing among site security systems; and(ii) provide an alternative communication capability for personnel, and an alternative data transmission and processing capability, in case of a loss of the primary means of communication or data transmission and processing. Alternative communications and data transmission systems may not be subject to the same failure modes as the primary systems.(D) Response. Licensees must immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material at licensee facilities or temporary job sites. For any unauthorized access involving an actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material, the licensee's response must include requesting, without delay, an armed response from the LLEA.(14) Maintenance and testing.(A) Each licensee subject to paragraphs (9) - (13), this paragraph, and paragraphs (15) - (17) of this subsection must implement a maintenance and testing program to ensure intrusion alarms, associated communication systems, and other physical components of the systems used to secure or detect unauthorized access to radioactive material are maintained in operable condition and are capable of performing their intended function when needed. The equipment relied on to meet the security requirements of this subsection must be inspected and tested for operability and performance at the manufacturer's suggested frequency. If there is no suggested manufacturer's suggested frequency, the testing must be performed at least annually, not to exceed 12 months.(B) The licensee must maintain records on the maintenance and testing activities for inspection by the department as specified in subsection (mm) of this section.(15) Requirements for mobile devices. Each licensee possessing mobile devices containing category 1 or category 2 quantities of radioactive material must:(A) have two independent physical controls forming tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee; and(B) for devices in or on a vehicle or trailer, unless the health and safety requirements for a site prohibit the disabling of the vehicle, the licensee must utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee. Licensees must not rely on the removal of an ignition key to meet this requirement.(16) Security program review.(A) Each licensee is responsible for the continuing effectiveness of the security program. Each licensee must ensure the security program is reviewed to confirm compliance with the requirements of paragraphs (9) - (15), this paragraph, and paragraph (17) of this subsection, and comprehensive actions are taken to correct any noncompliance identified. The review must include the radioactive material security program content and implementation. Each licensee must review the security program content and implementation at least every 12 months.(B) The results of the review, along with any recommendations, must be documented.(i) Each review report must:(I) identify conditions adverse to the proper performance of the security program;(II) identify the cause of each condition; and(III) when applicable, recommend corrective actions, and identify and document any corrective actions taken.(ii) The licensee must review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.(C) The licensee must make, maintain, and retain the documentation of the review required under subparagraph (B) of this paragraph for inspection by the department as specified in subsection (mm) of this section.(17) Reporting of events.(A) The licensee must immediately notify the LLEA after determining an unauthorized entry resulted in an actual or attempted theft, sabotage, or diversion of a category 1 or category 2 quantity of radioactive material. As soon as possible after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee must notify the department at (512) 458-7460. Notification to the department must not be later than four hours after the discovery of any attempted or actual theft, sabotage, or diversion.(B) The licensee must assess any suspicious activity related to possible theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material and notify the LLEA as appropriate. As soon as possible but not later than four hours after notifying the LLEA, the licensee must notify the department at (512) 458-7460.(C) Each initial telephonic notification required by subparagraphs (A) and (B) of this paragraph must be followed by, within a period of 30 days, a written report submitted to the department. The report must include sufficient information for department analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.(18) Additional requirements for transfer of category 1 and category 2 quantities of radioactive material. A licensee transferring a category 1 or category 2 quantity of radioactive material to a licensee of the department, the NRC, or any agreement state must meet the license verification requirements listed below instead of those listed in subsection (cc)(4) of this section.(A) Any licensee transferring category 1 quantities of radioactive material to a licensee of the department, the NRC, or any agreement state, before conducting such transfer, must verify with the NRC's license verification system or the license issuing authority the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred and the licensee is authorized to receive radioactive material at the location requested for delivery. If the verification is conducted by contacting the license issuing authority, the transferor must document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.(B) Any licensee transferring category 2 quantities of radioactive material to a licensee of the department, the NRC, or any agreement state, before conducting such transfer, must verify with the NRC's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. If the verification is conducted by contacting the license issuing authority, the transferor must document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.(C) In an emergency where the licensee cannot reach the license issuing authority and the license verification system is nonfunctional, the licensee may accept a written certification by the transferee that it is authorized by license to receive the type, form, and quantity of radioactive material to be transferred.(i) The certification must include:(I) the license number;(II) the current revision number;(III) the issuing authority;(IV) the expiration date; and(V) for a category 1 shipment, the authorized address.(ii) The licensee must keep a copy of the certification.(iii) The certification must be confirmed by use of the NRC's license verification system or by contacting the license issuing authority by the end of the next business day.(D) The transferor must keep a copy of the verification documentation required under this paragraph as a record for inspection by the department as specified in subsection (mm) of this section.(19) Applicability of physical protection of category 1 and category 2 quantities of radioactive material during transit. The shipping licensee is responsible for meeting the requirements of paragraph (18), this paragraph, and paragraphs (20) - (23) of this subsection unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under this paragraph, and paragraphs (20) - (23) of this subsection.(20) Preplanning and coordination of shipment of category 1 and category 2 quantities of radioactive material.(A) Each licensee planning to transport, or deliver to a carrier for transport, licensed material that is a category 1 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage must:(i) preplan and coordinate shipment arrival and departure times with the receiving licensee;(ii) preplan and coordinate shipment information with the governor or the governor's designee of any state through which the shipment will pass to:(I) discuss the state's intention to provide law enforcement escorts; and(II) identify safe havens; and(iii) document the preplanning and coordination activities. (B) Each licensee planning to transport, or deliver to a carrier for transport, licensed material that is a category 2 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage must coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee must document the coordination activities.(C) Each licensee receiving a shipment of a category 2 quantity of radioactive material must confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee must notify the originator.(D) Each licensee, who transports or plans to transport a shipment of a category 2 quantity of radioactive material and determines the shipment will arrive after the no-later-than arrival time provided pursuant to subparagraph (B) of this paragraph, must promptly notify the receiving licensee of the new no-later-than arrival time.(E) The licensee must make, maintain, and retain a copy of the documentation for preplanning and coordination and any revision thereof, as a record for inspection by the department as specified in subsection (mm) of this section.(21) Advance notification of shipment of category 1 quantities of radioactive material. As specified in subparagraphs (A) and (B) of this paragraph, for shipments initially made by an agreement state licensee, each licensee must provide advance notification to the Texas Department of Public Safety and the governor of the State of Texas, or the governor's designee, of the shipment of licensed material in a category 1 quantity, through or across the boundary of the state, before the transport or delivery to a carrier for transport of the licensed material outside the confines of the licensee's facility or other place of use or storage.(A) Procedures for submitting advance notification.(i) The notification must be made to the Texas Department of Public Safety and to the office of each appropriate governor or governor's designee.(I) The contact information, including telephone and mailing addresses, of governors and governors' designees, is available on the NRC's website at https://scp.nrc.gov/special/designee.pdf. A list of agreement state advance notification contact information is also available upon request from the Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.(II) Notifications to the Texas Department of Public Safety must be to the Director, Texas Department of Public Safety, Office of Homeland Security, P.O. Box 4087, Austin, Texas 78773 or by fax to (512) 424-5708.(ii) A notification delivered by mail must be postmarked at least seven days before transport of the shipment commences at the shipping facility.(iii) A notification delivered by any means other than mail must reach the Texas Department of Public Safety at least four days before the transport of the shipment commences; and(iv) A notification delivered by any means other than mail must reach the office of the governor or the governor's designee at least four days before transport of a shipment within or through the state.(B) Information to be furnished in advance notification of shipment. Each advance notification of shipment of category 1 quantities of radioactive material must contain the following information, if available at the time of notification:(i) the name, address, and telephone number of the shipper, carrier, and receiver of the category 1 radioactive material;(ii) the license numbers of the shipper and receiver;(iii) a description of the radioactive material contained in the shipment, including the radionuclides and quantity;(iv) the point of origin of the shipment and the estimated time and date shipment will commence;(v) the estimated time and date the shipment is expected to enter each state along the route;(vi) the estimated time and date of arrival of the shipment at the destination; and(vii) a point of contact, with a telephone number, for current shipment information.(C) Revision notice.(i) The licensee must provide any information not previously available at the time of the initial notification, as soon as the information becomes available but not later than commencement of the shipment, to the governor of the state or the governor's designee and to the Director, Texas Department of Public Safety, Office of Homeland Security, P.O. Box 4087, Austin, Texas 78773 or by fax to (512) 424-5708.(ii) A licensee must provide notice as follows of any changes to the information provided under subparagraphs (B) and (C)(i) of this paragraph.(I) Promptly notify the governor of the state or the governor's designee.(II) Immediately notify the Director, Texas Department of Public Safety, Office of Homeland Security, P.O. Box 4087, Austin, Texas 78773 or by fax to (512) 424-5708.(D) Cancellation notice.(i) Each licensee who cancels a shipment for which advance notification has been sent must send a cancellation notice to:(I) the governor of each state or to the governor's designee previously notified; and(II) the Director, Texas Department of Public Safety, Office of Homeland Security, P.O. Box 4087, Austin, Texas 78773 or by fax to (512) 424-5708.(ii) The licensee must send the cancellation notice before the shipment would have commenced or as soon thereafter as possible.(iii) The licensee must state in the notice it is a cancellation and identify the advance notification being cancelled.(E) Records. The licensee must make, maintain, and retain a copy of the advance notification and any revision and cancellation notices as a record for inspection by the department as specified in subsection (mm) of this section.(F) Protection of information. State officials, state employees, and other individuals, whether licensees of the department, the NRC, or any agreement state, receiving schedule information of the kind specified in subparagraph (B) of this paragraph must protect that information against unauthorized disclosure as specified in paragraph (10)(D) of this subsection.(22) Requirements for physical protection of category 1 or category 2 quantities of radioactive material during shipment.(A) Shipments by road.(i) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 1 quantity of radioactive material must:(I) ensure movement control centers are established maintaining position information from a remote location. These control centers must monitor shipments 24 hours a day, seven days a week, and have the ability to communicate immediately, in an emergency, with the appropriate law enforcement agencies;(II) ensure redundant communications are established allowing the transport to contact the escort vehicle (when used) and movement control center at all times. Redundant communications may not be subject to the same interference factors as the primary communication; (III) ensure shipments are continuously and actively monitored by a telemetric position monitoring system or an alternative tracking system reporting to a movement control center. A movement control center must provide positive confirmation of the location, status, and control over the shipment. The movement control center must be prepared to promptly implement preplanned procedures in response to deviations from the authorized route or a notification of actual, attempted, or suspicious activities related to the theft, loss, or diversion of a shipment. These procedures will include the identification of and contact information for the appropriate LLEA along the shipment route;(IV) provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number of allowable hours of service in a 24-hour duty day as established by the Department of Transportation Federal Motor Carrier Safety Administration. The accompanying individual may be another driver; and(V) develop written normal and contingency procedures to address:(-a-) notifications to the communication center and law enforcement agencies;(-b-) communication protocols, which must include a strategy for the use of authentication codes and duress codes and provisions for refueling or other stops, detours, and locations where communication is expected to be temporarily lost;(-c-) loss of communications; and(-d-) responses to an actual or attempted theft or diversion of a shipment.(ii) Each licensee who arranges for the shipment of category 1 quantities of radioactive material must ensure drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures.(iii) Each licensee transporting category 2 quantities of radioactive material must maintain constant control or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance.(iv) Each licensee delivering to a carrier for transport, in a single shipment, a category 2 quantity of radioactive material must:(I) use carriers having established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control or surveillance, the package tracking system must allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;(II) use carriers maintaining constant control or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and(III) use carriers having established tracking systems requiring an authorized signature before releasing the package for delivery or return.(B) Shipments by rail.(i) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 1 quantity of radioactive material must:(I) ensure rail shipments are monitored by a telemetric position monitoring system or an alternative tracking system reporting to the licensee, third-party, or railroad communications center. The communications center must provide positive confirmation of the location of the shipment and its status. The communications center must implement preplanned procedures in response to deviations from the authorized route or to a notification of actual, attempted, or suspicious activities related to the theft or diversion of a shipment. These procedures will include the identification of and contact information for the appropriate LLEA along the shipment route; and(II) ensure periodic reports to the communications center are made at preset intervals.(ii) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 2 quantity of radioactive material must:(I) use carriers having established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control or surveillance, the package tracking system must allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;(II) use carriers maintaining constant control or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and(III) use carriers having established tracking systems requiring an authorized signature before releasing the package for delivery or return.(C) Investigations.(i) Each licensee making arrangements for the shipment of category 1 quantities of radioactive material must immediately investigate upon the discovery a category 1 shipment is lost or missing.(ii) Each licensee making arrangements for the shipment of category 2 quantities of radioactive material must immediately investigate, in coordination with the receiving licensee, any shipment not arriving by the designated no-later-than arrival time.(23) Reporting of events during shipment.(A) The shipping licensee must notify the appropriate LLEA and must notify the department at (512) 458-7460 within one hour of its determination a shipment of category 1 quantities of radioactive material is lost or missing. The appropriate LLEA is the law enforcement agency in the area of the shipment's last confirmed location. During the investigation required by paragraph (22)(C) of this subsection, the shipping licensee provides agreed upon updates to the department on the status of the investigation.(B) The shipping licensee must notify the department at (512) 458-7460 within four hours of its determination a shipment of category 2 quantities of radioactive material is lost or missing. If, after 24 hours of its determination the shipment is lost or missing, the radioactive material has not been located and secured, the licensee must immediately notify the department.(C) The shipping licensee must notify the designated LLEA along the shipment route as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment or suspicious activities related to the theft or diversion of a shipment of a category 1 quantity of radioactive material. As soon as possible after notifying the LLEA, the licensee must notify the department at (512) 458-7460 upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment of category 1 radioactive material.(D) The shipping licensee must notify the department at (512) 458-7460 as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of a category 2 quantity of radioactive material. (E) The shipping licensee must notify the department at (512) 458-7460 and the LLEA as soon as possible upon recovery of any lost or missing category 1 quantities of radioactive material.(F) The shipping licensee must notify the department at (512) 458-7460 as soon as possible upon recovery of any lost or missing category 2 quantities of radioactive material.(G) The initial telephonic notification required by subparagraphs (A) - (D) of this paragraph must be followed, within 30 days, by a written report submitted to the department. A written report is not required for notifications on suspicious activities required by subparagraphs (C) and (D) of this paragraph. The report must set forth the following information:(i) a description of the licensed material involved, including kind, quantity, and chemical and physical form;(ii) a description of the circumstances under which the loss or theft occurred;(iii) a statement of disposition, or probable disposition, of the licensed material involved;(iv) actions taken, or to be taken, to recover the material; and(v) procedures or measures adopted, or to be adopted, to ensure against a recurrence of the loss or theft of licensed material. (H) Subsequent to filing the written report, the licensee must also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.(24) Form of records. Each record required by this subsection must include all pertinent information and be stored in a legible and reproducible format throughout the retention period specified in the department's rules. The licensee must maintain adequate safeguards against tampering with and loss of records.(25) Record retention. All records/documents referenced in this subsection must be made and maintained by the licensee for inspection by the department as specified in subsection (mm) of this section. If a retention period is not otherwise specified, these records must be retained until the department terminates the facility's license. All records related to this subsection may be destroyed upon department termination of the facility license.(jj) Appendices.(1) Subjects to be included in training courses:(A) fundamentals of radiation safety:(i) characteristics of radiation;(ii) units of radiation dose (rem) and activity of radioactivity (curie);(iii) significance of radiation dose;(I) radiation protection standards; and(II) biological effects of radiation;(iv) levels of radiation from sources of radiation;(v) methods of controlling radiation dose;(I) time;(II) distance; and(III) shielding;(vi) radiation safety practices, including prevention of contamination and methods of decontamination; and(vii) discussion of internal exposure pathways;(B) radiation detection instrumentation to be used:(i) radiation survey instruments:(I) operation;(II) calibration; and(III) limitations;(ii) survey techniques; and(iii) individual monitoring devices;(C) equipment to be used:(i) handling equipment and remote handling tools;(ii) sources of radiation;(iii) storage, control, disposal, and transport of equipment and sources of radiation;(iv) operation and control of equipment; and(v) maintenance of equipment;(D) the requirements of pertinent federal and state regulations;(E) the licensee's written operating, safety, and emergency procedures; and(F) the licensee's record keeping procedures.(2) Isotope quantities (for use in subsection (gg) of this section).Attached Graphic(3) Criteria relating to use of financial tests and parent company guarantees for providing reasonable assurance of funds for decommissioning.(A) Introduction. An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration the parent company passes a financial test. This paragraph establishes criteria for passing the financial test and for obtaining the parent company guarantee.(B) Financial test.(i) To pass the financial test, the parent company must meet the criteria of either subclause (I) or (II) of this clause.(I) The parent company must have:(-a-) two of the following three ratios:(-1-) a ratio of total liabilities to net worth less than 2.0;(-2-) a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and(-3-) a ratio of current assets to current liabilities greater than 1.5;(-b-) net working capital and tangible net worth each at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used);(-c-) tangible net worth of at least $10 million; and(-d-) assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used.)(II) The parent company must have:(-a-) a current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poor's or Aaa, Aa, A, or Baa as issued by Moody's;(-b-) tangible net worth each at least six times the current decommissioning cost estimate for the total of all facilities or parts thereof (or prescribed amount if a certification is used);(-c-) tangible net worth of at least $10 million; and(-d-) assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if certification is used).(ii) The parent company's independent certified public accountant must have compared the data used by the parent company in the financial test, which is derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee must inform the department within 90 days of any matters coming to the auditor's attention causing the auditor to believe the data specified in the financial test should be adjusted and the company no longer passes the test.(iii) After the initial financial test, the parent company must repeat the passage of the test within 90 days after the close of each succeeding fiscal year.(iv) If the parent company no longer meets the requirements of clause (i) of this subparagraph, the licensee must send notice to the department of intent to establish alternate financial assurance as specified in the department's regulations. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year-end financial data show the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.(C) Parent company guarantee. The terms of a parent company guarantee that an applicant or licensee obtains must provide:(i) the parent company guarantee will remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the department, as evidenced by the return receipts;(ii) if the licensee fails to provide alternate financial assurance as specified in the department's rules within 90 days after receipt by the licensee and the department of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor will provide such alternative financial assurance in the name of the licensee;(iii) the parent company guarantee and financial test provisions must remain in effect until the department has terminated the license; and(iv) if a trust is established for decommissioning costs, the trustee and trust must be acceptable to the department. An acceptable trustee includes an appropriate state or federal government agency or an entity having the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.(4) Criteria relating to use of financial tests and self-guarantees for providing reasonable assurance of funds for decommissioning. (A) Introduction. An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee funds will be available for decommissioning costs and on a demonstration the company passes a financial test of subparagraph (B) of this paragraph. Subparagraph (B) of this paragraph establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee. (B) Financial test.(i) To pass the financial test, a company must meet all of the following criteria:(I) tangible net worth at least 10 times the total current decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor);(II) assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current decommissioning cost estimate (or the current amount required if certification is used for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor); and(III) a current rating for its most recent bond issuance of AAA, AA, A as issued by Standard and Poor's, or Aaa, Aa, A as issued by Moody's.(ii) To pass the financial test, a company must meet all of the following additional criteria:(I) the company must have at least one class of equity securities registered under the Securities Exchange Act of 1934;(II) the company's independent certified public accountant must have compared the data used by the company in the financial test derived from the independently audited year-end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in the financial statement. In connection with that procedure, the licensee must inform the department within 90 days of any matters coming to the auditor's attention causing the auditor to believe the data specified in the financial test should be adjusted and the company no longer passes the test; and(III) after the initial financial test, the company must repeat the passage of the test within 90 days after the close of each succeeding fiscal year.(iii) If the licensee no longer meets the criteria of clause (i) of this subparagraph, the licensee must send immediate notice to the department of its intent to establish alternate financial assurance as specified in the department's rules within 120 days of the notice.(C) Company self-guarantee. The terms of a self-guarantee an applicant or licensee furnishes must provide:(i) the company guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the department, as evidenced by the return receipt.(ii) the licensee must provide alternate financial assurance as specified in the department's rules within 90 days following receipt by the department of a notice of cancellation of the guarantee;(iii) the guarantee and financial test provisions must remain in effect until the department has terminated the license or until another financial assurance method acceptable to the department has been put in effect by the licensee;(iv) the licensee will promptly forward to the department and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission as specified in the requirements of the Securities and Exchange Act of 1934, §13;(v) if, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poor's or Moody's, the licensee will provide notice in writing to the department within 20 days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poor's and Moody's, the licensee no longer meets the criteria of subparagraph (B)(i) of this paragraph; and(vi) the applicant or licensee must provide to the department a written guarantee (a written commitment by a corporate officer) stating the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.(5) Criteria relating to use of financial tests and self-guarantees for providing reasonable assurance of funds for decommissioning by commercial companies having no outstanding rated bonds.(A) Introduction. An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee funds will be available for decommissioning costs and on a demonstration the company passes the financial test of subparagraph (B) of this paragraph. The terms of the self-guarantee are in subparagraph (C) of this paragraph. This paragraph establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.(B) Financial test.(i) To pass the financial test a company must meet the following criteria:(I) tangible net worth greater than $10 million, or at least 10 times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor;(II) assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor; and(III) a ratio of cash flow divided by total liabilities greater than 0.15 and a ratio of total liabilities divided by net worth less than 1.5.(ii) In addition, to pass the financial test, a company must meet all the following requirements.(I) The company's independent certified public accountant must have compared the data used by the company in the financial test, required to be derived from the independently audited year-end financial statement, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in the financial statement. In connection with that procedure, the licensee must inform the department within 90 days of any matters causing the auditor to believe the data specified in the financial test should be adjusted and the company no longer passes the test.(II) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.(III) If the licensee no longer meets the requirements of subparagraph (B)(i) of this paragraph, the licensee must send notice to the department of its intent to establish alternative financial assurance as specified in the department's rules. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year-end financial data show the licensee no longer meets the financial test requirements. The licensee must provide alternative financial assurance within 120 days after the end of such fiscal year.(C) Company self-guarantee. The terms of a self-guarantee an applicant or licensee furnishes must provide the following.(i) The guarantee must remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the department. Cancellation may not occur until an alternative financial assurance mechanism is in place.(ii) The licensee must provide alternative financial assurance as specified in the department's rules within 90 days following receipt by the department of a notice of cancellation of the guarantee.(iii) The guarantee and financial test provisions must remain in effect until the department has terminated the license or until another financial assurance method acceptable to the department has been put in effect by the licensee.(iv) The applicant or licensee must provide to the department a written guarantee (a written commitment by a corporate officer) stating the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.(6) Criteria relating to use of financial tests and self-guarantees for providing reasonable assurance of funds for decommissioning by nonprofit entities, such as colleges, universities, and nonprofit hospitals.(A) Introduction. An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee funds will be available for decommissioning costs and on a demonstration the applicant or licensee passes the financial test of subparagraph (B) of this paragraph. The terms of the self-guarantee are in subparagraph (C) of this paragraph. This paragraph establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.(B) Financial test.(i) To pass the financial test, a college or university must meet the criteria of subclause (I) or (II) of this clause. The college or university must meet one of the following:(I) for applicants or licensees issuing bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poor's or Aaa, Aa, or A as issued by Moody's; or(II) for applicants or licensees not issuing bonds, unrestricted endowment consisting of assets located in the United States of at least $50 million, or at least 30 times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all decommissioning activities for which the college or university is responsible as a self-guaranteeing licensee.(ii) To pass the financial test, a hospital must meet the criteria in subclause (I) or (II) of this clause. The hospital must meet one of the following:(I) for applicants or licensees issuing bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poor's or Aaa, Aa, or A as issued by Moody's; or(II) for applicants or licensees not issuing bonds, all the following tests must be met:(-a-) (total revenues less total expenditures) divided by total revenues must be equal to or greater than 0.04;(-b-) long term debt divided by net fixed assets must be less than or equal to 0.67;(-c-) (current assets and depreciation fund) divided by current liabilities must be greater than or equal to 2.55; and(-d-) operating revenues must be at least 100 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the hospital is responsible as a self-guaranteeing licensee.(iii) In addition, to pass the financial test, a licensee must meet all the following requirements.(I) The licensee's independent certified public accountant must have compared the data used by the licensee in the financial test required to be derived from the independently audited year-end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in the financial statement. In connection with that procedure, the licensee must inform the department within 90 days of any matters coming to the attention of the auditor causing the auditor to believe the data specified in the financial test should be adjusted and the licensee no longer passes the test.(II) After the initial financial test, the licensee must repeat passage of the test within 90 days after the close of each succeeding fiscal year.(III) If the licensee no longer meets the requirements of subparagraph (A) of this paragraph, the licensee must send notice to the department of its intent to establish alternative financial assurance as specified in the department's rules. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year-end financial data show the licensee no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.(C) Self-guarantee. The terms of a self-guarantee an applicant or licensee furnishes must provide:(i) The guarantee must remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the department. Cancellation may not occur unless an alternative financial assurance mechanism is in place.(ii) The licensee must provide alternative financial assurance as specified in the department's regulations within 90 days following receipt by the department of a notice of cancellation of the guarantee.(iii) The guarantee and financial test provisions must remain in effect until the department has terminated the license or until another financial assurance method acceptable to the department has been put in effect by the licensee.(iv) The applicant or licensee must provide to the department a written guarantee (a written commitment by a corporate officer or officer of the institution) stating the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.(v) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poor's or Moody's, the licensee must provide notice in writing of the fact to the department within 20 days after publication of the change by the rating service.(7) Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release. The following table contains quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release.Attached Graphic(8) Requirements for demonstrating financial qualifications. (A) If an applicant or licensee is not required to submit financial assurance as specified in subsection (gg) of this section, that applicant or licensee must demonstrate financial qualification by submitting an attestation the applicant or licensee is financially qualified to conduct the activity requested for licensure, including any required decontamination, decommissioning, reclamation, and disposal before the department issues a license.(B) If an applicant or licensee is required to submit financial assurance as specified in subsection (gg) of this section, the applicant or licensee must:(i) submit one of the following:(I) the bonding company report or equivalent (from which information can be obtained to calculate a ratio in clause (ii) of this subparagraph) used to obtain the financial assurance instrument used to meet the financial assurance requirement as specified in subsection (gg) of this section. However, if the applicant or licensee posted collateral to obtain the financial instrument used to meet the requirement for financial assurance as specified in subsection (gg) of this section, the applicant or licensee must demonstrate financial qualification by one of the methods specified in subclause (II) or (III) of this clause;(II) Securities and Exchange Commission documentation (from which information can be obtained to calculate a ratio as described in clause (ii) of this subparagraph, if the applicant or licensee is a publicly held company); or(III) a self-test (for example, an annual audit report certifying a company's assets and liabilities and resulting ratio as described in clause (ii) of this subparagraph or, in the case of a new company, a business plan specifying expected expenses versus capitalization and anticipated revenues); and(ii) declare its Standard Industry Classification (SIC) code. Several companies publish lists, on an annual basis, of acceptable assets-to-liabilities (assets divided by liabilities) ratio ranges for each type of SIC code. If an applicant or licensee submits documentation of its current assets and current liabilities or, in the case of a new company, a business plan specifying expected expenses versus capitalization and anticipated revenues, and the resulting ratio falls within an acceptable range as published by generally recognized companies (for example, Almanac of Business and Industrial Financial Ratios, Industry NORM and Key Business Ratios, Dun & Bradstreet Industry publications, and Manufacturing USA: Industry Analyses, Statistics, and Leading Companies), the department considers that applicant or licensee financially qualified to conduct the requested or licensed activity.(C) If the applicant or licensee is a state or local government entity, a statement of this will suffice as demonstration the government entity is financially qualified to conduct the requested or licensed activities.(D) The department will consider other types of documentation if the documentation provides an equivalent measure of assurance of the applicant's or licensee's financial qualifications as found in subparagraphs (A) and (B) of this paragraph.(9) Category 1 and category 2 radioactive materials. Licensees must use Figure: 25 TAC §289.252(jj)(9) to determine whether a quantity of radioactive material constitutes a Category 1 or Category 2 quantity of radioactive material.Attached Graphic(10) Broad scope license limits (for use in subsection (h) of this section).Attached Graphic(kk) Requirements for the issuance of specific licenses for a medical facility or educational institution to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium.(1) A license application will be approved if the department determines an application from a medical facility or educational institution to produce PET radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under §289.256 of this subchapter includes:(A) a request for authorization for the production of PET radionuclides or evidence of an existing license issued under this section, the NRC, or another agreement state's requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides;(B) evidence the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in subsection (r)(1)(A) of this section;(C) identification of each individual authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation each individual meets the requirements of an authorized nuclear pharmacist as specified in subsection (r)(3)(B) of this section; and(D) information identified in subsection (r)(1)(B) of this section on the PET drugs to be noncommercially transferred to members of its consortium.(2) Authorization under paragraph (1) of this subsection to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.(3) Each licensee authorized under paragraph (1) of this subsection to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium must:(A) satisfy the labeling requirements in subsection (r)(1)(C) of this section for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium; and(B) possess and use instrumentation meeting the requirements of §289.202(p)(3)(D) of this chapter to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in subsection (r)(2) of this section.(4) A licensee that is a pharmacy authorized under paragraph (1) of this subsection to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium must require any individual preparing PET radioactive drugs to be:(A) an authorized nuclear pharmacist meeting the requirements in subsection (r)(3)(B) of this section; or(B) an individual under the supervision of an authorized nuclear pharmacist as specified in §289.256(s) of this subchapter.(5) A pharmacy, authorized under paragraph (1) of this subsection to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium allowing an individual to work as an authorized nuclear pharmacist, must meet the requirements of subsection (r)(3)(E) of this section.(ll) Specific licenses for installation, repair, or maintenance of devices containing sealed sources of radioactive material. (1) In addition to the requirements in subsection (e) of this section, a specific license authorizing a person to perform installation, repair, or maintenance of devices containing sealed sources, including source exchanges will be issued if the department approves the information submitted by the applicant.(2) Each installation, repair, or maintenance activity must be documented and a record maintained for inspection by the department as specified in subsection (mm) of this section. The record must include the date, description of the service, initial survey results, and the names of each individual who performed the work.(3) Installation, repair, maintenance, or source exchange activities must be performed by a specifically licensed person unless otherwise authorized under subsection (v) of this section.(mm) Records/documents retention. Each licensee must make, maintain, and retain at each authorized use site and for the time period set forth in the table, the records/documents described in the following table and in the referenced rule provision, and must make them available to the department for inspection, upon reasonable notice.Attached Graphic Source Note: The provisions of this §289.252 adopted to be effective October 1, 2000, 25 TexReg 9555; amended to be effective December 26, 2002, 27 TexReg 11927; amended to be effective September 1, 2004, 29 TexReg 7112; amended to be effective May 1, 2008, 33 TexReg 3417; amended to be effective February 18, 2010, 35 TexReg 1223; amended to be effective October 1, 2011, 36 TexReg 5851; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective March 1, 2016, 41 TexReg 1444; amended to be effective September 24, 2018, 43 TexReg 6289; amended to be effective January 5, 2022, 46 TexRg 9309; amended to be effective October 29, 2024, 49 TexReg8585. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.252 Licensing of Radioactive Material https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226001&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226001 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=226001&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 226001 03/11/2026 (a) Purpose. This section establishes radiation safety requirements for persons using sources of radiation for well logging service operations, including radioactive markers, mineral exploration, and tracer studies.(b) Scope.(1) This section applies to all persons who use sources of radiation for well logging service operations, radioactive markers, mineral exploration, and tracer studies.(2) In addition to the requirements of this section, persons are subject to the requirements of:(A) §289.201 of this chapter (relating to General Provisions for Radioactive Material);(B) §289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials);(C) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(D) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);(E) §289.205 of this chapter (relating to Hearing and Enforcement Procedures);(F) §289.226 of this chapter (relating to Registration of Radiation Machine Use and Services);(G) §289.229 of this chapter (relating to Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Radiation Therapy Simulation Systems, and Electronic Brachytherapy Devices);(H) §289.231 of this chapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation); (I) §289.252 of this subchapter (relating to Licensing of Radioactive Material); and(J) §289.257 of this subchapter (relating to Packaging and Transportation of Radioactive Material).(c) Definitions. The following words and terms when used in this section have the following meaning unless the context clearly indicates otherwise.(1) Energy compensation source (ECS)--A small, sealed source with an activity not exceeding 100 microcuries (µCi) (3.7 megabecquerel (MBq)), used within a logging tool or other tool component, to provide a reference standard to maintain the tool's calibration when in use.(2) Field station (additional authorized use/storage location)--A facility where sources of radiation may be stored or used and from which equipment is dispatched to temporary job sites.(3) Injection tool--A device used for subsurface or downhole controlled injection of radioactive tracer material.(4) Logging assistant (equipment operator)--Any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by subsection (bb) of this section.(5) Logging supervisor (field engineer)--The individual who provides personal supervision of the use of sources of radiation at temporary job sites.(6) Logging tool--A device used subsurface to perform well logging.(7) Mineral logging--Any logging performed for the purpose of mineral exploration other than oil or gas.(8) Personal supervision--Guidance and instruction by the supervisor, who is physically present at the job site and in such proximity that visual contact can be maintained and immediate assistance given as required.(9) Radiation safety officer--An individual named by the licensee or registrant and listed on the license or certificate of registration having knowledge of, responsibility for, and authority to enforce appropriate radiation protection rules, standards, and practices on behalf of the licensee or registrant, and who meets the requirements of subsection (s) of this section.(10) Radioactive marker--Radioactive material placed subsurface or upon a structure intended for subsurface use for the purpose of depth determination or direction orientation.(11) Residential location--Any area where a structure or structures are located, in which people live, and the grounds on which these structures are located, including houses, apartments, condominiums, and garages.(12) Screenout--A situation in which radioactive tracer material is reversed out of an oil or gas well (well returns).(13) Service company--Any contracted or subcontracted company that is present at the temporary job site specifically, a company whose equipment is connected to licensee's equipment and exposed to radioactive material.(14) Source holder--A housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source.(15) Storage container--A container used to secure and store radioactive sources.(16) Temporary job site--A location where well logging or tracer studies are performed other than the specific locations listed on a license or certificate of registration.(17) Tracer study--The release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the wellbore, at the wellhead, or adjacent formation.(18) Transport container--A container that meets the requirements of the United States Department of Transportation (DOT) and is designed to provide radiation safety and security when sources of radiation are being transported.(19) Tritium neutron generator target source--A tritium source used within a neutron generator tube to produce neutrons for use in well logging applications.(20) Uranium sinker bar--A weight containing depleted uranium used to aid in the descent of a logging tool down toward the bottom of a wellbore.(21) Wellbore--A drilled hole in which wireline service operations are performed.(22) Well logging--All operations involving the lowering and raising of measuring devices or logging tools (that may or may not contain sources of radiation) into wellbores or cavities for the purpose of obtaining information about the well or adjacent formations.(23) Wireline--An armored steel cable, containing one or more electrical conductors, used to lower and raise logging tools in the wellbore.(24) Wireline service operation--Any mechanical or electronic service that is performed in the wellbore using devices that are lowered into the well on a wireline for purposes of evaluation.(d) Specific licenses for well logging.(1) The applicant must satisfy the general requirements specified in this subsection and in §289.252(e) of this subchapter.(2) The applicant must develop a program for training logging supervisors and logging assistants and submit to the department a description of this program that specifies:(A) initial training;(B) on-the-job training;(C) annual safety reviews provided by the licensee;(D) how the applicant will demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the department's regulations and licensing requirements and the applicant's operating and emergency procedures; and(E) how the applicant will demonstrate the logging assistant's knowledge and understanding of and ability to comply with the applicant's operating and emergency procedures.(3) The applicant must submit to the department written operating and emergency procedures as described in subsection (ee)(4) of this section.(4) The applicant must establish and submit to the department its program for annual inspections of the job performance of each logging supervisor to ensure the department's regulations, license requirements, and the applicant's operating and emergency procedures are followed. Inspection records must be retained for three years after each annual internal inspection.(5) The applicant must submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility.(6) If an applicant wants to perform leak testing of sealed sources, the applicant must identify the manufacturers and the model numbers of the leak test kits used. If the applicant wants to analyze its own wipe samples, the applicant must establish procedures to follow and submit a description of these procedures to the department. The description must include the:(A) instruments used;(B) methods of performing the analysis; and(C) pertinent experience of the person who will analyze the wipe samples.(e) Prohibitions.(1) Licensees must not perform well logging service operations with a sealed source in any well or wellbore unless, before commencement of the operation, the licensee has a written agreement with the well operator, well owner, drilling contractor, or landowner, that specifies who will be responsible for ensuring:(A) a reasonable effort at recovery will be made in the event a sealed source is lost or lodged downhole;(B) a person does not attempt to recover a sealed source in a manner that, in the licensee's opinion, could result in a source rupture;(C) if the environment, any equipment, or personnel are contaminated with radioactive material, decontamination to levels specified in §289.202(f), (n), and (eee) of this chapter are performed; and(D) the requirements of subsection (dd)(4) of this section are met if a decision is made to abandon the sealed source downhole.(2) Licensees must not perform tracer study operations with a substance tagged with radioactive material in any well or wellbore unless, before commencement of the operation, the licensee has a written agreement with the well operator, well owner, drilling contractor, or landowner, and the service company to which the licensee's equipment is connected, as applicable, specifying who is responsible for ensuring:(A) in the event the service company's personnel or equipment are contaminated with radioactive material, they will be decontaminated as specified in §289.202(n) or (ddd) of this chapter before release from the job site or release for unrestricted use, respectively;(B) in the event the well head or job site is contaminated with radioactive material, it will be decontaminated as specified in §289.202(ddd) of this chapter; and(C) in the event radioactive material is reversed from the well or the well screens out, the licensee will have established procedures and equipment or facilities to:(i) reverse material into a preconstructed steel or lined pit that is specifically established in the event of a screen out; or(ii) reverse material into a suitable transport container or containers in the event of a screen out.(3) The licensee must maintain, as specified in subsection (ee)(5) of this section, a copy of the written agreement specified in paragraph (1) or (2) of this subsection.(f) Limits on levels of radiation. Sources of radiation must be used, stored, and transported in such a manner that the requirements of §289.202 of this chapter, §289.231 of this chapter, and §289.257 of this subchapter, as applicable, are met.(g) Storage precautions.(1) Each source of radiation, except accelerators, must be provided with a storage or transport container. Each container must have a lock (or tamper seal for calibration sources) to prevent unauthorized removal of, or exposure to, the source of radiation.(2) Each area or room in which sources of radiation are stored must be posted as specified in §289.202(aa)(5) or §289.231(x) of this chapter, as applicable.(3) Sources of radiation, except accelerators, must be stored downhole or in a bunker to minimize the danger from explosion or fire.(4) Sources of radiation may not be stored in residential locations unless specifically authorized by the department.(5) Sources of radiation in storage must be secured to prevent tampering or removal by unauthorized individuals.(h) Transport precautions. Transport containers must be locked and physically secured to the transporting vehicle to prevent shifting during transport, accidental loss, tampering, or unauthorized removal.(i) Radiation survey instruments.(1) The licensee or registrant must maintain a sufficient number of calibrated and operable radiation survey instruments capable of detecting beta and gamma radiation at each location where sources of radiation are stored or used to make physical radiation surveys, as required by this section and by §289.202(p) or §289.231(s) of this chapter, as applicable. Instrumentation must be capable of measuring 0.1 milliroentgen per hour (mR/hr) (1 microsievert per hour (µSv/hr)) through at least 50 mR/hr (500 µSv/hr). (Instrumentation capable of measuring 0.1 mR/hr (1 µSv/hr) through 50 mR/hr (500 µSv/hr) may not be sufficient to determine compliance with DOT requirements.)(2) A licensee using tracer material must have available at each additional authorized use/storage location and temporary job site, additional calibrated and operable radiation survey instruments sensitive enough to detect the radioactive surface contamination limits specified in §289.202(eee) of this chapter.(3) Each radiation survey instrument required under paragraph (1) of this subsection must be calibrated:(A) by a person specifically licensed or registered by the department, another agreement state, or the United States Nuclear Regulatory Commission (NRC) to perform such service;(B) at intervals not to exceed six months and after each survey instrument repair;(C) for the types of radiation used and at energies appropriate for use; and(D) at an accuracy within plus or minus 20 percent of the true radiation level at each calibration point.(4) The licensee or registrant must maintain calibration records as specified in subsection (ee)(5) of this section.(j) Leak testing of sealed sources.(1) Testing and record keeping. Sealed sources must be tested for leakage and contamination as specified in this section and §289.201(g) of this chapter. The licensee must maintain records of leak tests as specified in subsection (ee)(5) of this section.(2) Each energy compensation source that is not exempt from testing as specified in §289.201(g)(2) of this chapter must be tested at intervals not to exceed three years. In the absence of a certificate from a transferor that a test has been made within the three years before the transfer, the energy compensation source must not be used until tested as specified in §289.201(g) of this chapter.(3) If a sealed source is found to be leaking as specified in §289.201(g) of this chapter, the licensee must check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by persons specifically authorized by the department, the NRC, or an agreement state, to perform such services.(k) Quarterly inventory. Each licensee or registrant must conduct a physical inventory to account for all sources of radiation received or possessed at intervals not to exceed three months. The licensee or registrant must make and maintain records of inventories as specified in subsection (ee)(5) of this section and must include:(1) the quantities and kinds of sources of radiation;(2) the location where sources of radiation are assigned;(3) the unique identification of each source of radiation; (4) the date of the inventory; and(5) the name of the individual conducting the inventory.(l) Utilization records. For each source of radiation, utilization records must be maintained by each licensee or registrant as specified in subsection (ee)(5) of this section and must include:(1) identification of each source of radiation, including: (A) the make and model number or serial number (or if absent, a description) of each sealed source used; or(B) the radionuclide and activity of tracer materials and radioactive markers used at a particular well site and the disposition of any unused tracer materials;(2) the identity of the logging supervisor or individual who is responsible for receiving sources of radiation, to whom assigned; and(3) the locations where used and dates of use.(m) Design and performance criteria for sealed sources used in well logging operations.(1) Each sealed source used in well logging applications must meet the following minimum criteria.(A) The sealed source is of doubly encapsulated construction. (B) The sealed source contains radioactive material with a chemical/physical form as insoluble and non-dispersible as practicable.(C) The sealed source meets one of the following requirements: (i) for a sealed source manufactured on or before July 14, 1989, the requirements from the United States of America Standards Institute (USASI) N5.10-1968, "Classification of Sealed Radioactive Sources," or the requirements in clause (ii) or (iii) of this subparagraph; (ii) for a sealed source manufactured after July 14, 1989, the oil-well logging requirements from the American National Standards Institute/Health Physics Society (ANSI/HPS) N43.6-1997, "Sealed Radioactive Sources-Classification"; or(iii) for a sealed source manufactured after July 14, 1989, the sealed source's prototype has been tested and found to maintain its integrity after each of the following tests.(I) Temperature. The test source must be held at negative 40 degrees Celsius for 20 minutes, 600 degrees Celsius for one hour, and then be subjected to a thermal shock test with a temperature drop from 600 degrees Celsius to 20 degrees Celsius within 15 seconds.(II) Impact. A 5 kilogram (kg) steel hammer, 2.5 centimeters (cm) in diameter, must be dropped from a height of 1 meter (m) onto the test source.(III) Vibration. The test source must be subjected to a vibration from 25 Hertz (Hz) to 500 Hz with a peak amplitude of five times the acceleration of gravity for 30 minutes.(IV) Puncture. A 1 gram (g) hammer and pin, 0.3 cm pin diameter, must be dropped from a height of 1 m onto the test source.(V) Pressure. The test source must be subjected to an external pressure of 24,600 pounds per square inch absolute (1.695 x 107 pascals) without leakage.(2) The requirements in paragraph (1) of this subsection do not apply to sealed sources containing radioactive material in gaseous form.(3) The requirements in this subsection do not apply to energy compensation sources.(n) Labeling.(1) Each source, source holder, or logging tool containing radioactive material in other than an exempt quantity must bear a durable, legible, and clearly visible marking or label, including, at a minimum, the standard radiation caution symbol with no color requirement, and the wording "DANGER (or CAUTION), RADIOACTIVE--DO NOT HANDLE, NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)."(2) The labeling specified in paragraph (1) of this subsection must be on the smallest component, source, source holder, or logging tool that is transported as a separate piece of equipment containing radioactive material.(3) Each transport container must have permanently attached a durable, legible, and clearly visible label having, at a minimum, the standard radiation caution symbol and the wording "DANGER (or CAUTION), RADIOACTIVE, NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)." (4) Each transport container must have attached a durable, legible, and clearly visible label having, at a minimum, the licensee's name, address, and telephone number, the radionuclide, its activity, and assay date.(o) Inspection and maintenance.(1) Each licensee or registrant must conduct, at intervals not to exceed six months, a program of visual inspection and maintenance of source holders (or sealed source, if there is no source holder), logging tools, source handling tools, storage containers, transport containers, and injection tools to assure proper labeling and physical condition. The inspection program may be performed concurrently with routine leak testing of sealed sources. Records of inspection and maintenance must be made and maintained by the licensee or registrant as specified in subsection (ee)(5) of this section.(2) If any inspection conducted as specified in paragraph (1) of this subsection reveals damage to labeling or components critical to radiation safety, the device must be removed from service at the time the damage is discovered and until repairs have been made.(3) Any operation, such as drilling, cutting, or chiseling on a source holder containing a sealed source, must be performed on the source holder only by persons specifically licensed to do so by the department, another agreement state, or the NRC. The provisions of this paragraph do not apply to logging tool recovery (fishing) operations conducted as specified in the provisions of subsection (dd)(4) of this section.(4) The repair, opening, or modification of any sealed source must be performed only by persons specifically licensed to do so by the department, another agreement state, or the NRC.(p) Training requirements.(1) Licensees or registrants must not permit any individual to act as a logging supervisor until such individual has:(A) completed a course including at least 24 hours of formal training in the subjects outlined in subsection (ee)(1) of this section;(B) received copies of and instruction in:(i) the requirements contained in this section and the applicable subsections of §§289.201, 289.202, 289.203, and 289.231 of this chapter or their equivalent;(ii) the conditions of the appropriate license or certificate of registration; and(iii) the licensee's or registrant's operating, safety, and emergency procedures;(C) demonstrated understanding of the requirements in subparagraphs (A) and (B) of this paragraph by successfully completing a written examination administered by the licensee or registrant;(D) completed two months of on-the-job training under the supervision of a logging supervisor; and(E) demonstrated, through a field evaluation, competence in the use of sources of radiation, related handling tools, and the type of radiation survey instruments that will be used in the job assignment.(2) Licensees or registrants must not permit any individual to act as a logging assistant until such individual has:(A) received copies of and instruction in the applicable subsections of §§289.201, 289.202, 289.203, and 289.231 of this chapter or their equivalent, and the licensee's or registrant's operating, safety, and emergency procedures;(B) demonstrated understanding of the requirements in subparagraph (A) of this paragraph by successfully completing a written examination administered by the licensee or registrant; and(C) demonstrated competence to use, under the personal supervision of the logging supervisor, the sources of radiation, related handling tools, and radiation survey instruments used in the job assignment. (3) The licensee or registrant must provide an annual radiation safety review for logging supervisors and logging assistants.(4) Each licensee or registrant must maintain records documenting the requirements of paragraphs (1) - (3) of this subsection are met. Such records must be maintained as specified in subsection (ee)(5) of this section.(q) Operating, safety, and emergency procedures. The licensee or registrant must maintain written operating, safety, and emergency procedures that include descriptions of and directions in at least the items listed in subsection (ee)(4) of this section.(r) Personnel monitoring.(1) In addition to the requirements of §289.202(p)(4) and (q) of this chapter or §289.231(n) and (s)(3) of this chapter, as applicable, no licensee or registrant may permit any individual to act as a logging supervisor or logging assistant unless that individual wears an individual monitoring device at all times during well logging service operations or tracer studies utilizing sources of radiation. Each individual monitoring device must be assigned to and worn by only one individual. Film badges must be replaced at least monthly. Other individual monitoring devices requiring replacement must be replaced at least quarterly. After replacement, each individual monitoring device requiring processing must be returned to the supplier for processing within 14 calendar days or as soon as practicable. All individual monitoring devices must be evaluated at least quarterly or promptly after replacement, whichever is more frequent. Circumstances preventing meeting these time limits must be documented, and those records must be available for review by the department.(2) When necessary to aid in determining the extent of an individual's intake of radioactive material, the department may require a licensee or registrant to make available to the individual, appropriate bioassay services and to furnish a copy of the reports of such services to the department.(3) Personnel monitoring records must be maintained by the licensee or registrant as specified in subsection (ee)(5) of this section.(s) Radiation safety officer.(1) A radiation safety officer (RSO) must be designated for every license and certificate of registration issued by the department. (2) The RSO's documented qualifications must include: (A) possession of a high school diploma or a certificate of high school equivalency based on the General Education Development (GED) test;(B) completion of the training and testing requirements of subsection (p)(1) of this section; and(C) two years of experience as a logging supervisor, including knowledge of well logging service operations and tracer studies.(3) The duties of the RSO include:(A) establishing and overseeing operating, safety, emergency, and as low as reasonably achievable (ALARA) procedures, and reviewing them regularly to ensure the procedures are current and conform with this chapter;(B) overseeing and approving all phases of the training program for well logging service operations and tracer studies personnel so that appropriate and effective radiation protection practices are taught;(C) ensuring required radiation surveys and leak tests are performed and documented as specified in this chapter, including any corrective measures when levels of radiation exceed established limits;(D) ensuring personnel monitoring is used properly by occupationally exposed personnel, records are kept of the monitoring results, and timely notifications are made, as required by §289.203 of this chapter;(E) investigating and reporting to the department each known or suspected case of radiation exposure to an individual or radiation level detected over the limits established by this chapter and each theft or loss of each source of radiation, determining the cause, and taking steps to prevent recurrence;(F) having a thorough knowledge of management policies and administrative procedures of the licensee or registrant;(G) assuming control and having the authority to institute corrective actions, including shutdown of operations, when necessary in emergency situations or unsafe conditions;(H) maintaining records as required by this chapter (see subsection (ee)(5) of this section);(I) ensuring the proper storing, labeling, transport, and use of sources of radiation, storage, and transport containers;(J) ensuring inventories are performed as specified in subsection (k) of this section;(K) ensuring personnel are complying with this chapter, the conditions of the license or the registration, and the operating, safety, and emergency procedures of the licensee or registrant; and(L) serving as the primary contact with the department.(t) Security.(1) A logging supervisor must be physically present at a temporary job site whenever radioactive material is being handled or is not stored and locked in a vehicle or storage place. The logging supervisor may leave the job site to obtain assistance if a sealed source becomes lodged in a well.(2) During well logging, except when sealed sources are below ground or in shipping or storage containers, the logging supervisor or other individual designated by the logging supervisor must maintain direct surveillance of the operation to prevent unauthorized entry into a restricted area, as defined in §289.201(b) of this chapter, or §289.231(c) of this chapter, as applicable.(u) Handling tools. The licensee must provide and require the use of tools that assure remote handling of sealed sources, other than low activity calibration sources.(v) Tracer studies.(1) Appropriate protective clothing and equipment must be used by all personnel handling radioactive tracer material. Precautions must be taken to avoid ingestion or inhalation of radioactive material and to avoid contamination of field stations, temporary job sites, vehicles, associated equipment, and clothing.(2) Licensees may not permit the injection of radioactive material into usable quality groundwater (3,000 parts per million (ppm) total dissolved solids or less) without prior written authorization from the department.(3) The well operator must contact the licensee when a decision is made to reverse the radioactive tracer material out of a well. The licensee must be onsite and present at the well when radioactive tracer material is reversed out of a well.(w) Particle accelerators. Licensees or registrants must not permit above-ground testing of particle accelerators that results in the production of radiation except in areas or facilities controlled or shielded to meet the requirements of §289.202(f) or (n) of this chapter, or §289.231(m) or (o) of this chapter, as applicable.(x) Radioactive markers. The licensee may use radioactive markers in wells only if the individual markers contain quantities of radioactive material not exceeding the quantities specified in §289.251(l)(2) of this subchapter (relating to Exemptions, General Licenses, and General License Acknowledgements). The use of markers is subject only to the provisions of this subsection and subsection (k) of this section.(y) Uranium sinker bars. The licensee may use a depleted uranium sinker bar in well logging service operations only if it is legibly impressed with the wording "DANGER (or CAUTION), RADIOACTIVE-DEPLETED URANIUM, NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY) IF FOUND."(z) Energy compensation source (ECS).(1) The licensee may use an ECS that is contained within a logging tool or other tool components.(2) For well logging applications with a surface casing for protecting freshwater aquifers, use of the ECS is only subject to the requirements of subsections (j), (k), and (l) of this section.(3) For well logging applications without a surface casing for protecting freshwater aquifers, use of the ECS is only subject to the requirements of subsections (e), (j), (k), (l), (dd), and (ee)(4)(A) of this section.(aa) Tritium neutron generator target source.(1) Use of a tritium neutron generator target source, containing quantities not exceeding 30 curies (Ci) (1,110 gigabecquerels (GBq)) and in a well with a surface casing to protect freshwater aquifers, is subject to the requirements of this section, except subsections (e), (m), and (dd) of this section.(2) Use of a tritium neutron generator target source, containing quantities exceeding 30 Ci (1,110 GBq) or in a well without a surface casing to protect freshwater aquifers, is subject to the requirements of this section, except subsection (m) of this section.(bb) Radiation surveys.(1) Radiation surveys (and calculations for neutron sources) must be made and recorded for each area where radioactive materials are stored.(2) Radiation surveys (and calculations for neutron sources) of the radiation levels in occupied positions and on the exterior of each vehicle used to transport radioactive materials must be made and recorded. Such surveys (and calculations for neutron sources) must include all sources of radiation transported in the vehicle.(3) If the sealed source assembly is removed from the logging tool before departing the job site, a survey of the tool to verify that the logging tool is free of contamination must be made and recorded.(4) If the encapsulation of the sealed source has been damaged by an operation or is likely to have been damaged by an operation, the licensee must immediately conduct a radiation survey and make a record of that survey, including a contamination survey, during and after the operation.(5) Radiation surveys must be made and recorded at the job site and well head for each tracer operation except for those utilizing hydrogen-3, carbon-14, sulfur-35, or krypton-85. These surveys must include measurements of radiation levels before and after the operation.(6) Records required as specified in paragraphs (1) - (5) of this subsection must include the dates, the identification of personnel making the survey, the unique identification of survey instruments used, radiation measurements in milliroentgen per hour (mR/hr), calculations in millirem per hour (mrem/hr) or microsievert per hour (µSv/hr), and an exact description of the location of the survey. Each licensee or registrant must make and maintain records of these surveys as specified in subsection (ee)(5) of this section.(cc) Records/documents for inspection by the department.(1) Each licensee or registrant must maintain the records/documents specified in subsection (ee)(5) of this section.(2) Each licensee or registrant maintaining additional authorized use/storage locations from which well logging service operations are conducted must have copies of the records/documents specified in subsection (ee)(5)(C) - (F), (H) - (J), (L), (M), and (Q) of this section that are specific to the site, available at each site.(3) Records/documents required as specified in paragraph (2) of this subsection must be maintained as specified in subsection (ee)(5) of this section.(4) Each licensee or registrant conducting well logging service operations at a temporary job site must have copies of the records/documents specified in subsection (ee)(5)(C), (J), (L), (M), and (P) of this section available at that site.(5) Records/documents required by paragraph (4) of this subsection must be maintained at the temporary job site for the period of operation at that site.(dd) Notification of incidents and lost sources; abandonment procedures for irretrievable sources.(1) Notification of incidents and sources lost in other than downhole well logging operations must be made as specified in appropriate provisions of §289.202 of this chapter, or §289.231 of this chapter, as applicable.(2) Whenever a sealed source or a device containing radioactive material has been ruptured or is likely to have been ruptured, the licensee must notify the department immediately by telephone and submit written notification within 30 days. The written notification must designate:(A) the well or other location;(B) the magnitude and extent of the escape of radioactive material;(C) the consequences of the rupture; and(D) the efforts planned or being taken to mitigate these consequences.(3) Whenever a sealed source is separated from the logging tool and is lost downhole, the licensee must notify the department immediately by telephone before beginning source recovery operations.(4) Whenever a sealed source or device containing radioactive material is lost downhole, the licensee must:(A) consult with the well operator, well owner, drilling contractor, or landowner regarding methods to retrieve the source or device that may reduce the likelihood that the source or device will be damaged or ruptured during logging tool recovery (fishing) operations;(B) continuously monitor the circulating fluids from the well, if any, during logging tool recovery (fishing) operations to check for contamination resulting from damage to the sealed source with an appropriate radiation detection instrument or a logging tool with a radiation detector; and(C) notify the department immediately by telephone and submit written notification within 30 days if radioactive contamination is detected at the surface or if the source appears to be damaged.(5) When efforts to recover the radioactive source are not successful, the licensee must:(A) notify the department by telephone of the circumstances that resulted in the inability to retrieve the source and obtain approval from the department to implement abandonment procedures, or that the licensee implemented abandonment before receiving approval from the department because the licensee believed there was an immediate threat to public health and safety; and(B) advise the well operator of the Railroad Commission of Texas requirements regarding abandonment and an appropriate method of abandonment, that includes:(i) the immobilization and sealing in place of the radioactive source with a cement plug;(ii) a means to prevent inadvertent intrusion on the source, such as the setting of a whipstock or other deflection device, unless the source is not accessible to any subsequent drilling operations; and(iii) the mounting of a permanent identification plaque, containing information required by paragraph (6) of this subsection, at the surface of the well;(C) notify the department by telephone, giving the circumstances of the loss; and(D) file a written report with the department within 30 days of the abandonment, providing:(i) the date of occurrence;(ii) a description of the radioactive source involved, including radionuclide, activity, chemical and physical form, and manufacturer, model number and serial number;(iii) the surface location and identification of the well;(iv) the results of efforts to immobilize and seal the source in place;(v) the depth of the radioactive source;(vi) the depth of the top of the cement plug;(vii) the depth of the well; and(viii) the information contained on the permanent identification plaque.(6) Whenever a sealed source containing radioactive material is abandoned downhole, the licensee must provide a permanent plaque (an example of a suggested plaque is shown in subsection (ee)(3) of this section) for posting on the well or wellbore. This plaque must:(A) be constructed of long-lasting material such as stainless steel, brass, bronze, or monel. The size of the plaque should be convenient for use on active or inactive wells; for example, a 7-inch (17 cm) square. Letter size of the word "CAUTION" should be approximately twice the letter size of the rest of the information; for example, 1/2 inch (1.27 cm) and 1/4 inch (0.63 cm) letter size, respectively; and(B) contain the following engraved information on its face:(i) the word "CAUTION";(ii) the radiation symbol (color not required);(iii) the date of abandonment;(iv) the name of the well operator or well owner;(v) the well name and well identification number or other designation;(vi) radionuclides and activities of the sources;(vii) the source depth and the plug back depth (depth to the top of the plug); and(viii) an appropriate warning, depending on the specific circumstances of each abandonment, such as:(I) "Do not drill below plug back depth";(II) "Do not enlarge casing"; or(III) "Do not re-enter hole before contacting Radiation Control, Texas Department of State Health Services."(7) The licensee must immediately notify the department by telephone and confirming letter if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable water source. Such notice must designate well location and describe the magnitude and extent of loss of radioactive material, consequences of such loss, and efforts taken or planned to mitigate these consequences.(8) In the event of an uncontrolled release of radioactive tracer material to the environment, the licensee must notify the department by telephone within 24 hours and submit written notification within 30 days.(ee) Appendices.(1) Subjects to be included in training courses for well logging service operations and tracer studies are as follows:(A) fundamentals of radiation safety that include:(i) characteristics of radiation;(ii) units of radiation dose (rem) and activity;(iii) significance of radiation dose specifying radiation protection standards and biological effects of radiation;(iv) levels of radiation from sources of radiation;(v) methods of controlling radiation dose specifying time, distance, and shielding;(vi) radiation safety practices, specifying prevention of contamination and methods of decontamination; and(vii) discussion of ingestion and inhalation pathways;(B) radiation detection instrumentation to be used that includes:(i) use of radiation survey instruments specifying operation, calibration, and limitations;(ii) survey techniques; and(iii) use of individual monitoring devices;(C) equipment to be used that specifies:(i) handling equipment and remote handling tools;(ii) sources of radiation;(iii) storage control, disposal, and transport of equipment and sources of radiation;(iv) operation and control of equipment; and(v) maintenance of equipment;(D) pertinent federal and state requirements;(E) the licensee's or registrant's written operating, safety, and emergency procedures;(F) the licensee's or registrant's record keeping procedures; and(G) case histories and potential consequences of accidents in well logging service operations and tracer studies.(2) In addition to the subjects for training courses required in paragraph (1) of this subsection, individuals performing tracer studies must also complete training in the following subjects:(A) sources of contamination;(B) contamination detection and control;(C) decontamination techniques and limits;(D) survey techniques for tracer materials; and(E) packaging requirements for transportation of radioactive materials, especially residual materials from tracer studies.(3) The following is an example of a plaque for identifying wells containing sealed sources of radioactive material abandoned downhole.Attached Graphic(4) The licensee's or registrant's operating, safety, and emergency procedures must include descriptions of and instructions in:(A) the handling and use of sources of radiation in wells without surface casing for protecting freshwater aquifers, if appropriate;(B) the handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation doses over the limits established in §289.202 of this chapter, or §289.231 of this chapter, as applicable; every reasonable effort must be made to keep radiation exposures and releases of radioactive material in soils and effluents to unrestricted areas as low as is reasonably achievable;(C) methods and occasions for conducting radiation surveys;(D) methods and occasions for locking and securing sources of radiation;(E) personnel monitoring, including bioassays, and the use of individual monitoring devices;(F) removing radioactive material from storage, transporting radioactive material to field locations and temporary job sites, including packaging of sources of radiation in the vehicles, placarding of vehicles, securing sources of radiation during transportation, and returning to storage;(G) minimizing exposure of individuals during routine use and in the event of an accident;(H) notifying proper personnel in the event of an accident or well excursion;(I) maintaining records;(J) using, inspecting, and maintaining source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools;(K) actions to be taken if a sealed source is lost or lodged downhole;(L) picking up, receiving, handling, and opening packages containing radioactive material;(M) surveying temporary job sites and equipment, and decontamination of vehicles, associated equipment, and clothing following tracer studies;(N) storing and disposing of radioactive waste;(O) laundering contaminated clothing, if applicable;(P) the licensee's or registrant's management structure;(Q) posting of radiation areas and labeling radioactive material containers;(R) actions to be taken if there is an uncontrolled release of radioactive tracer material to the environment; and(S) actions to be taken if a sealed source is ruptured, including actions preventing the spread of contamination and minimizing inhalation and ingestion of radioactive material, and actions to obtain suitable radiation survey instruments as required by subsection (i) of this section.(5) The following records/documents must be maintained by the licensee or registrant for inspection by the department.Attached Graphic Source Note: The provisions of this §289.253 adopted to be effective April 15, 1997, 22 TexReg 3297; amended to be effective October 1, 2000, 25 TexReg 9580; amended to be effective April 29, 2003, 28 TexReg 3508; amended to be effective March 29, 2006, 31 TexReg 2458; amended to be effective October 1, 2011, 36 TexReg 5851; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective September 24, 2018, 43 TexReg 6289; amended to be effective October 23, 2024, 49 TexReg 8090; amended to be effective September 11, 2025, 50 TexReg 5936. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.253 Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221104&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221104 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221104&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221104 03/11/2026 (a) Purpose. (1) The requirements in this section establish radiation safety requirements and licensing and registration procedures for using sources of radiation for industrial radiography and for certification of industrial radiographers. (2) The requirements in this section apply to licensees and registrants who possess sources of radiation for industrial radiography, including radiation machines, accelerators, and sealed radioactive sources. (3) Each licensee and registrant is responsible for ensuring compliance with this chapter, license and registration conditions, and orders of the department. (4) Each licensee and registrant is responsible for ensuring radiographic personnel performing activities under a license or registration comply with this chapter, license and registration conditions, and orders of the department. (b) Scope. (1) The requirements of this section are in addition to and not in substitution for other applicable requirements of this chapter. (2) The requirements of the following sections of this chapter apply to all licensed industrial radiographic operations: (A) §289.201 of this chapter (relating to General Provisions for Radioactive Material); (B) §289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials); (C) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections); (D) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services); (E) §289.205 of this chapter (relating to Hearing and Enforcement Procedures); (F) §289.251 of this subchapter (relating to Exemptions, General Licenses, and General License Acknowledgements); (G) §289.252 of this subchapter (relating to Licensing of Radioactive Material); and (H) §289.257 of this subchapter (relating to Packaging and Transportation of Radioactive Material). (3) The requirements of the following sections of this chapter apply to all registered industrial radiographic operations: (A) §289.203 of this chapter; (B) §289.204 of this chapter; (C) §289.205 of this chapter; (D) §289.226 of this chapter (relating to Registration of Radiation Machine Use and Services); and (E) §289.231 of this chapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). (4) The requirements of §289.228 of this chapter (relating to Radiation Safety Requirements for Industrial Radiation Machines) apply to persons using analytical and other industrial radiation machines subject to this section. (5) The requirements of §289.229 of this chapter (relating to Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators and Electronic Brachytherapy Devices) apply to persons using accelerators subject to this section. (c) Definitions. The following words and terms when used in this section have the following meaning unless the context clearly indicates otherwise. (1) ANSI--American National Standards Institute. (2) Annual refresher safety training--A review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review may include, as appropriate, the results of internal audits, new procedures or equipment, new or revised regulations, accidents or errors that have been observed, and should also provide opportunities for employees to ask safety questions. (3) Associated equipment--Equipment, used in conjunction with a radiographic exposure device used to make radiographic exposures, that drives, guides, or comes in contact with the source, (such as, guide tube, control tube, control cable (drive cable), removable source stop, "J" tube, and collimator when it is used as an exposure head). (4) Cabinet x-ray system--An x-ray system with the x-ray tube installed in an enclosure independent of existing architectural structures except the floor on which it may be placed. An x-ray tube used within a shielded part of a building, or x-ray equipment that may temporarily or occasionally incorporate portable shielding, is not considered a cabinet x-ray system. The cabinet x-ray system is intended to: (A) contain at least that portion of a material being irradiated; (B) provide radiation attenuation; and (C) exclude personnel from its interior during generation of radiation. (5) Certifiable cabinet x-ray system--An existing uncertified x-ray system modified to meet the certification requirements specified in 21 Code of Federal Regulations (CFR) §1020.40. (6) Certification identification (ID) card--The document issued by the department to individuals who have completed the requirements stated in subsection (e)(2)(A) of this section. (7) Certified cabinet x-ray system--An x-ray system that has been certified as specified in 21 CFR §1010.2 as being manufactured and assembled on or after April 10, 1975, as specified in the provisions of 21 CFR §1020.40. (8) Certifying entity--An entity that is: (A) an independent certifying organization; (B) an Agreement State whose industrial radiographer certification program meets the applicable parts of 10 CFR Part 34, Appendix A, Parts II and III for radioactive material; or (C) a radiation control agency whose x-ray or combination certification requirements are found to be equivalent to criteria established by the Conference of Radiation Control Program Directors, Inc.. (9) Collimator--A radiation shield placed on the end of a guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure. (10) Conference of Radiation Control Program Directors, Inc. (CRCPD)--A 501(c)(3) nonprofit, non-governmental, professional organization dedicated to radiation protection to serve as a common forum for the many governmental radiation protection agencies to communicate with each other and to promote uniform radiation protection regulations and activities. (11) Control cable (drive cable)--The cable connected to the source assembly and used to drive the source from and return it to the shielded position. (12) Control mechanism (drive mechanism)--A device enabling the source assembly to be moved from and returned to the shielded position. A drive mechanism is also known as a crank assembly. (13) Control tube--A protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device. (14) Crank-out device--The control cable, control tube, and drive mechanism used to move the sealed source to and from the shielded position to make an industrial radiographic exposure. (15) Exposure head--A device that locates the gamma radiography sealed source in the selected working position. An exposure head is also known as a source stop. (16) Field station--A facility where licensed material or radiation machines are stored or used and from which equipment is dispatched to temporary job sites. (17) Guide tube--A flexible or rigid tube, such as a "J" tube, for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head. (18) Independent certifying organization--An independent organization meeting the criteria of 10 CFR Part 34, Appendix A, for radioactive material, or comparable standards for x-ray machines. (19) Industrial radiography (radiography)--A non-destructive testing method using ionizing radiation, such as gamma rays or x-rays, to make radiographic images for the purpose of detecting flaws in objects without destroying them. (20) Lay-barge radiography--Industrial radiography performed on any water vessel used for laying pipe. (21) Lock-out survey--A radiation survey performed to determine a sealed source is in its fully shielded position before moving the radiographic exposure device or source changer to a different temporary job site or before securing the radiographic exposure device or source changer against unauthorized removal. (22) Offshore--Within the territorial waters of the State of Texas. The territorial waters of Texas extend to the three marine league line or nine nautical miles from the Texas coast. (23) On-the-job training (hands-on experience)--Experience in all areas considered to be directly involved in the radiography process. The hours of on-the-job training do not include safety meetings, classroom training, travel, darkroom activities, film development and interpretation, or use of a cabinet x-ray unit. (24) Permanent radiographic installation--An enclosed shielded room, cell, or vault, not located at a temporary job site, in which radiography is performed and meets the criteria of subsection (n) of this section. (25) Personal supervision--Guidance and instruction provided to a radiographer trainee by a radiographer trainer present at the site, in visual contact with the trainee while the trainee is using sources of radiation, associated equipment, and survey meters, and in such proximity that immediate assistance can be given, if required. (26) Pipeliners--A directional beam radiographic exposure device. (27) Platform radiography--Industrial radiography performed on an offshore platform or other structure over a body of water. (28) Practical examination--A demonstration through practical application of the safety rules and principles in industrial radiography including use of all appropriate equipment and procedures. (29) Radiation safety officer (RSO)--An individual named by the licensee or registrant and listed on the license or certificate of registration having a knowledge of, responsibility for, and authority to enforce appropriate radiation protection rules, standards, and practices on behalf of the licensee or registrant and who meets the requirements of subsection (e)(4) of this section. (30) Radiographer--Any individual who has successfully completed the requirements of subsection (e)(2)(A) of this section, performs industrial radiographic operations, or provides visual surveillance of industrial radiographic operations while in attendance during transport or at the site where the sealed source or sources are being used, and is responsible to the licensee or registrant for assuring compliance with the requirements of the department's regulations and conditions of the license or certificate of registration. These individuals may be referred to as certified industrial radiographers or certified radiographers.(31) Radiographer certification--Written approval received from a certifying entity stating an individual has satisfactorily met certain established radiation safety, testing, and experience criteria. (32) Radiographer trainee--Any individual who has successfully completed the training and documentation requirements of subsection (e)(1)(A) of this section and uses sources of radiation and associated equipment or radiation survey instruments under the personal supervision of a radiographer trainer. (33) Radiographer trainer--A radiographer who instructs and supervises radiographer trainees during on-the-job training and meets the requirements of subsection (e)(3) of this section. (34) Radiographic exposure device--Any instrument containing a sealed source fastened or contained therein, where the sealed source or shielding may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure (e.g., camera). (35) Radiographic operations--All activities associated with the presence of x-ray machines or radioactive sources in a radiographic exposure device during the use of the machine or device or transport (except when being transported by a common or contract transport). Radiographic operations include surveys to confirm the adequacy of boundaries, setting up equipment, and any activity inside restricted area boundaries. (36) Radiographic personnel--Any radiographer, radiographer trainer, or radiographer trainee. (37) Residential location--Any area where a structure or structures are located, in which people live, and the grounds on which these structures are located, including houses, apartments, condominiums, and garages. (38) S-tube--A tube through which the radioactive source travels when inside a radiographic exposure device. (39) Shielded position--The location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement. (40) Shielded-room radiography--Industrial radiography conducted in a room shielded so radiation levels at every location on the exterior meet the limitations specified in §289.202(n) of this chapter or §289.231(o) of this chapter, as applicable. A shielded room is also known as a bay or bunker. (41) Source assembly (pigtail)--An assembly consisting of the sealed source and a connector that attaches the source to the control cable. The source assembly may also include a ball stop used to secure the source in the shielded position. (42) Source changer--A device designed and used to replace sealed sources in radiographic exposure devices, including those used to transport and store sealed sources. (43) Storage area--Any location, facility, or vehicle used to store and secure a radiation machine, radiographic exposure device, a storage container, or a sealed source when it is not in use. Storage areas are locked or have a physical barrier to prevent accidental exposure, tampering, or unauthorized removal of the machine, device, container, or source. (44) Storage container--A device in which the sealed source is secured and stored. (45) Temporary job site--A location where radiographic operations are conducted and where licensed or registered sources of radiation may be stored other than the specific use location or locations listed on a license or certificate of registration.(46) Trainee status card--The document issued by the department following completion of the requirements of subsection (e)(1)(A) of this section. (47) Transport container--A package that is designed to provide radiation safety and security when sealed sources are transported and meets all applicable requirements of the United States Department of Transportation (DOT). (48) Underwater radiography--Industrial radiography performed when the radiographic exposure device or related equipment are beneath the surface of the water. (d) Exemptions. (1) Uses of certified and certifiable cabinet x-ray systems are exempt from the requirements of this section except for the requirements of subsections (a), (b)(3), (c), and (t)(8) of this section. (2) Industrial uses of hand-held light intensified imaging devices are exempt from the requirements in this section if the exposure rate 18 inches from the source of radiation to any individual does not exceed 2 millirem per hour (mrem/hr) (0.02 millisievert per hour (mSv/hr)). Devices with exposure rates that exceed the 2 mrem/hr (0.02 mSv/hr) level must meet the applicable requirements of this section and §289.252 of this subchapter or §289.226 of this chapter, as applicable. This exemption will apply only to those radiation machines that do not allow a person or body part to be exposed to the radiation beam. (3) Radiation machines determined by the department to constitute a minimal threat to human health and safety as specified in §289.231(ll)(3) of this chapter are exempt from the requirements in this section except for the requirements of paragraph (1) of this subsection. (4) Facilities that utilize radiation machines for industrial radiography only at permanent radiographic installations are exempt from the requirements of this section except for the requirements of subsections (a), (b)(1), (b)(3) - (5), (c), (e), (j), (k), (n), (o), (t)(1), (t)(2), (t)(5), and (t)(7). (e) Requirements for qualifications of radiographic personnel. (1) Radiographer trainee. Licensees or registrants must not permit any individual to act as a radiographer trainee until the individual possesses the original or a copy of a department-issued trainee status card or certification ID card. (A) To obtain a department-issued trainee status card, the licensee, registrant, or the individual must document to the department on RC Form 255-E, or equivalent, that such individual has successfully completed a course of at least 40 hours on the applicable subjects outlined in subsection (x)(1) of this section. (B) The trainee must carry a copy of the completed RC Form 255-E in the interim period after submitting documentation to the department and before receiving a trainee status card. The copy of the completed RC Form 255-E submitted to the department may be used in lieu of the trainee status card for a period of 30 days from the date recorded by the trainee on the documentation. (C) The individual must notify the department, in writing, of the need for a replacement trainee status card. The individual must carry a copy of documentation of the request while performing industrial radiographic operations until a replacement trainee status card is received from the department. (D) Records required by subparagraph (A) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. (E) Each licensee and registrant must maintain, for inspection by the department, clear and legible records demonstrating all the applicable requirements of this paragraph are met. A copy of the trainee status card will satisfy the documentation requirements of this paragraph. (2) Radiographer. Licensees or registrants must not permit any individual to act as a radiographer until the individual possesses a valid radiographer certification. (A) To obtain a radiographer certification, an individual must submit the fee as prescribed in subsection (h)(1) of this section and: (i) complete the requirements of paragraph (1)(A) of this subsection; (ii) document to the department on RC Form 255-R completion of on-the-job training as a radiographer trainee supervised by a radiographer trainer who meets the requirements of subsection (e)(3) of this section; (I) The radiographer trainee must carry a legible trainee status card as specified in paragraph (1) of this subsection while obtaining the on-the-job training specified in subclauses (II) - (VII) of this clause. (II) The on-the-job training must include at least 200 hours of active participation in radioactive materials industrial radiographic operations or 120 hours of active participation in x-ray industrial radiographic operations, as applicable. (III) Individuals performing industrial radiography utilizing radioactive materials and x-ray machines must complete both segments (320 hours) of on-the-job training. (IV) The hours of on-the-job training do not include safety meetings, classroom training, travel, darkroom activities, film development and interpretation, or use of a cabinet x-ray unit. (V) One year of documented experience of on-the-job training as authorized by another agreement state or the United States Nuclear Regulatory Commission (NRC) may be substituted for the requirements of subclauses (II) or (III) of this clause. The documentation must be submitted to the department on RC Form 255-OS or equivalent. (VI) The trainee must be under the personal supervision of a radiographer trainer whenever a radiographer trainee: (-a-) uses radiation machines, radiographic exposure devices, or associated equipment; or (-b-) performs radiation surveys required by: (-1-) subsection (t)(6) of this section to determine the radiation machine has stopped producing radiation; or (-2-) subsection (u)(9) of this section to determine the sealed source has returned to the shielded position after an exposure. (VII) The personal supervision must include:(-a-) the radiographer trainer's physical presence at the site where the sources of radiation are being used; (-b-) the availability of the radiographer trainer to give immediate assistance if required; and (-c-) the radiographer trainer's direct observation of the trainee's performance of the operations referred to in this section. (iii) successfully complete within the last five years the appropriate department-administered examination prescribed in subsection (g)(2) of this section or the appropriate examination of another certifying entity that affords the same or comparable certification standards as those afforded by this clause and clauses (i) and (ii) of this subparagraph; and (iv) possesses a current certification ID card issued as specified in subsection (h)(2) of this section or by another certifying entity affording the same or comparable certification standards as those afforded by this clause or clauses (i) - (iii) of this subparagraph. (B) Reciprocal recognition by the department of an individual radiographer certification may be granted as specified in subsection (h)(5)(A) and (B) of this section. (C) Once an individual has completed the requirements of paragraph (2)(A)(iv) of this subsection, the licensee or registrant is not required to submit the documentation referenced in paragraph (2)(A)(i) and (ii) of this subsection for renewal of a radiographer certification. (D) Records required by subparagraph (A) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. (E) Each licensee and registrant must maintain for inspection by the department, clear and legible records demonstrating the applicable requirements of this paragraph are met for all industrial radiographic personnel. A copy of the certification ID card will satisfy the documentation requirements of this paragraph. (3) Radiographer trainer. (A) Licensees or registrants must not permit any individual to act as a radiographer trainer until: (i) it has been documented to the department on RC Form 255-T or equivalent the individual has: (I) met the radiographer certification requirements of paragraph (2)(A) of this subsection; and (II) documented 2000 hours of direct experience as a certified radiographer. (ii) the individual is in receipt of a valid trainer certification ID card issued by the department and under which the individual is acting as a radiographer trainer; and (iii) determination is made by the department the individual is not currently under order from the department prohibiting the individual from acting as a radiographer trainer. (B) The specific duties of the radiographer trainer include: (i) providing personal supervision to any radiographer trainee at the site where the sources of radiation are being used; and (ii) preventing any unauthorized use of a source of radiation by a radiographer trainee. (4) RSO for industrial radiography. An RSO must be designated on every industrial radiography license and certificate of registration issued by the department. The RSO's qualifications must be submitted to the department. A single individual may be designated as RSO for more than one license or certificate of registration if authorized by the department. (A) The minimum qualifications for industrial radiography RSOs are: (i) completion of requirements for a radiographer trainer of subsection (e)(3)(A) of this section; and (ii) formal training in the establishment and maintenance of a radiation protection program. (B) The department considers alternatives when the RSO has appropriate training and experience in the field of ionizing radiation and has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program. (C) The specific duties of the RSO include: (i) establishing and overseeing operating, safety, emergency, and as low as reasonably achievable (ALARA) procedures, and to review them regularly to ensure that the procedures are current and conform with the requirements of this chapter; (ii) overseeing and approving all phases of the training program for radiographic personnel so that appropriate and effective radiation protection practices are taught; (iii) ensuring required radiation surveys and leak tests are performed and documented as specified in this chapter, including any corrective measures when levels of radiation exceed established limits; (iv) ensuring personnel monitoring devices are calibrated and used properly by occupationally exposed personnel; (v) ensuring timely notifications to employees are made as specified in §289.203 of this chapter; (vi) ensuring timely notifications to the department are made as specified in this section and §289.202 of this chapter or §289.231 of this chapter, as applicable; (vii) ensuring any required interlock switches and warning signals are functioning and radiation signs, ropes, and barriers are properly posted and positioned; (viii) investigating, determining the cause, taking steps to prevent the recurrence, and reporting to the department each: (I) known or suspected case of radiation exposure to an individual or radiation level detected over the limits established by this chapter; and (II) theft or loss of sources of radiation; (ix) having a thorough knowledge of management policies and administrative procedures of the licensee or registrant; (x) assuming control and having the authority to institute corrective actions, including shutdown of operations, when necessary, in emergency situations or unsafe conditions; (xi) maintaining records as specified in subsection (v)(1) of this section; (xii) ensuring the proper storing, labeling, transport, and use of exposure devices and sources of radiation; (xiii) ensuring inventory and inspection and maintenance programs are performed as specified in subsections (k) and (m) of this section; (xiv) ensuring personnel are complying with the requirements of this chapter and the conditions of the license or the certificate of registration; and (xv) ensuring the operating, safety, and emergency procedures of the licensee or registrant are met as specified in subsections (t)(5)(A) - (C) and (G) and (u)(8)(A) - (C) and (I) of this section. (f) Additional requirements. (1) Licensees or registrants must not permit any individual to act as a radiographer trainee, radiographer, radiographer trainer, or RSO until the individual has met the certification requirements as specified in subsection (e) of this section, as applicable, and has: (A) received copies of and demonstrated an understanding of the following by successful completion of a written or oral examination administered by the licensee or registrant covering this material: (i) the requirements contained in this section and the applicable requirements of §289.201 of this chapter, §289.202 of this chapter, §289.203 of this chapter, §289.231 of this chapter, and §289.257 of this subchapter; (ii) the appropriate license and certificate of registration conditions; (iii) the licensee's or registrant's operating, safety, and emergency procedures; and (B) demonstrated competence in the use of sources of radiation, radiographic exposure devices, associated equipment, related handling tools, and radiation survey instruments that may be employed in industrial radiographic assignments by successful completion of a practical examination administered by the licensee or registrant covering such use. (2) A radiographer and radiographer trainer must ensure radiographic operations to which the individual is assigned are conducted as specified in the requirements of this section. (3) Records of the administration of and the examinations required by paragraph (1) of this subsection must be made and maintained as specified in subsection (v)(1) of this section. Records must include: (A) copies of written tests administered by the licensee or registrant; (B) dates of oral and practical examinations and names of individuals conducting and receiving the oral and practical examinations; and (C) a list of items tested and the results of the oral and practical examinations. (g) Application and fee for radiographer certification examinations. (1) Application. (A) An application for taking the examination must be on forms prescribed and furnished by the department. (B) The non-refundable and non-transferable application fee for examination is $120. (C) The appropriate fee must be submitted with the application for examination. (D) The application and the non-refundable and non-transferable fee must be submitted to the department on or before the dates specified by the department. (E) Applicants who fail to appear at a scheduled exam and do not reschedule 48 hours before their assigned exam session must apply for a future exam session and submit the appropriate fee, as specified in subparagraphs (A) - (D) of this paragraph. (2) Examination. The examination must be given for the purpose of determining the qualifications of applicants. (A) The scope of the examination and the methods of procedure, including determination of the passing score, are prescribed by the department. The examination assesses the applicant's knowledge to safely use sources of radiation and related equipment and the applicant's knowledge of this section, and the applicable requirements of §289.201 of this chapter, §289.202 of this chapter, and §289.231 of this chapter. (B) The examination is administered by the department or persons authorized by the department. (C) A candidate failing an examination may apply for re-examination as specified in paragraph (1) of this subsection. A candidate may not retake the same version of the department-administered examination. (D) The examination is normally offered once each month. Times, dates, and locations of the examination are furnished by the department. (E) The examination is in the English language. (F) To take the examination, an individual must present a government-issued photo identification card, such as a driver's license, at the time of the examination. (G) Calculators will be permitted during the examination. Calculators or computers with preprogrammed data or formulas, including exposure calculators, are not permitted during the examination. (H) The examination is a "closed-book" examination. (I) Any individual observed by a department proctor compromising the integrity of the examination will be required to surrender the examination, the answer sheet, and all scratch paper. The individual is not allowed to complete the examination, forfeits the examination fee, and leaves the examination site to avoid disturbing other examinees. The individual must wait 90 days before taking a new examination and must resubmit a new application and a $120 non-refundable and non-transferable examination fee. (J) Examination material must be returned to the department at the end of the examination. No photographic or other copying of examination questions or materials is permitted. Disclosure by any individual of the contents of any examination before its administration is prohibited. (K) The names and scores of individuals taking the examination are a public record. (h) Radiographer certification. (1) An application for radiographer certification must be on RC Form 255-R, RC Form 255-OS, or equivalent. (A) The non-refundable fee for radiographer certification is $110. (B) The appropriate fee must be submitted with the application for radiographer certification when filing with the department. (2) A certification ID card will be issued to each individual successfully completing the requirements of subsection (e)(2)(A)(i) - (iii) of this section. (A) Each individual's certification ID card contains the individual's photograph. The department takes the photograph at the time the examination is administered. (B) The certification ID card remains the property of the department and may be revoked or suspended under the provisions of paragraph (4) of this subsection. (C) Any individual who needs to replace a certification ID card must submit to the department a written request for a replacement certification ID card, stating the reason a replacement certification ID card is needed. A non-refundable fee of $35 must be paid to the department for each replacement of a certification ID card. The prescribed fee must be submitted with the written request for a replacement certification ID card. The individual must carry a copy of the request while performing industrial radiographic operations until a replacement certification ID card is received from the department. (D) Each certification ID card is valid for a period of five years, unless revoked or suspended as specified in paragraph (4) of this subsection. Each certification ID card expires at the end of the calendar day, in the month and year stated on the certification ID card. (3) Renewal of a radiographer certification. (A) Applications for examination to renew a radiographer certification must be filed as specified in subsection (g)(1) of this section. (B) The examination for renewal of a radiographer certification must be administered as specified in subsection (g)(2) of this section. (C) A renewal certification ID card will be issued as specified in paragraph (2) of this subsection. (4) Suspension or revocation of a radiographer certification. (A) Any radiographer violating the requirements of this chapter, or providing any material false statement in the application or any statement of fact required by this chapter, may be required to show cause at a formal hearing why the radiographer certification should not be suspended or revoked as specified in §289.205 of this chapter. (B) When a department order has been issued for an industrial radiographer to cease and desist from the use of sources of radiation or the department suspends or revokes the individual's radiographer certification, the radiographer must surrender the certification ID card to the department until the order is changed or the suspension expires. (C) An individual whose radiographer certification has been suspended or revoked by the department or another certifying entity must comply with the process and conditions of the suspension or revocation orders before certification is reinstated or the individual is permitted to apply for a new certification. (5) Reciprocity of a radiographer certification. (A) Reciprocal recognition by the department of an individual radiographer certification is granted if: (i) the individual holds a valid certification in the appropriate category and class issued by a certifying entity, as defined in subsection (c) of this section; (ii) the requirements and procedures of the certifying entity issuing the certification afford the same or comparable certification standards as those afforded by subsection (e)(2)(A)(i) - (iii) of this section; and (iii) the individual submits a legible copy of the certification to the department before conducting radiographic operations in Texas. (B) Enforcement actions with the department, another agreement state, or the NRC or sanctions by an independent certifying entity are considered when reviewing a request for reciprocal recognition from a licensee, registrant, or certified radiographer. (C) Certified radiographers granted reciprocity by the department must maintain the certification upon which the reciprocal recognition was granted, or before the expiration of such certification, must meet the requirements of paragraph (3) of this subsection. (i) Receipt, transfer, and disposal of industrial radiography sealed sources and radiography exposure devices using depleted uranium (DU) for shielding. (1) Each licensee and registrant must make and maintain records as specified in subsection (v)(1) of this section, showing the receipt, transfer, and disposal of industrial radiography sealed sources and radiography exposure devices using DU for shielding. (2) These records must include, as appropriate: (A) date of receipt, transfer, or disposal; (B) name of the individual making the record; (C) radionuclide; (D) number of curies (becquerels) or mass (for DU); (E) manufacturer, model, and serial number of each source of radiation or device; (F) for the person transferring the source of radiation, the name of the transferee, the number of the transferee's radioactive material license authorizing possession of the material, and the regulatory agency issuing the license to the transferee; and (G) for the person receiving the source of radiation, the name of the transferor, the number of the transferor's radioactive material license authorizing possession of the material, and the regulatory agency issuing the license to the transferor. (j) Radiation survey instruments. (1) Each licensee and registrant must have a sufficient number of calibrated, appropriate, and operable radiation survey instruments at each location where sources of radiation are present to perform the radiation surveys required by this section and §289.202(p)(1) and (3) of this chapter and §289.231(s)(1) and (2) of this chapter, as applicable. These radiation survey instruments must be capable of measuring a range from 2 mrem/hr (0.002 mSv/hr) through 1 rem per hour (rem/hr) (0.01 sievert per hour (Sv/hr)). (2) Each radiation survey instrument must be calibrated: (A) by a person licensed or registered by the department, another agreement state, or the NRC to perform such service; (B) at energies appropriate for the licensee's or registrant's use; (C) at intervals not to exceed six months and after each instrument servicing other than battery replacement; (D) at two points located approximately one-third and two-thirds of full-scale on each scale for linear scale instruments; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at three points between 2 and 1,000 mrem/hr (0.02 and 10 mSv/hr); and (E) to demonstrate an accuracy within plus or minus 20 percent of the true radiation level at each point checked. (3) Each radiation survey instrument must be checked with a radiation source at the beginning of each day of use and at the beginning of each work shift to ensure it is operating properly. (4) Records of the calibrations required by paragraph (2) of this subsection must be maintained as specified in subsection (v)(1) of this section. (k) Inventory. (1) Each licensee and registrant must perform a physical inventory at intervals not to exceed three months to account for all sources of radiation and for devices containing DU received or possessed except for radiation machines utilized for industrial radiography at permanent radiographic installations. Each registrant utilizing radiation machines for industrial radiography at permanent radiographic installations must perform physical inventories and maintain inventory records as required by §289.226(m)(9) of this chapter. (2) Records of the quarterly inventories required by paragraph (1) of this subsection must be made and maintained as specified in subsection (v)(1) of this section. (3) The record must include, for each source of radiation, as appropriate: (A) manufacturer, model, and serial number; (B) radionuclide; (C) number of curies (except for DU); (D) location of each source of radiation; (E) date of the inventory; and (F) name of the individual making the inventory. (l) Utilization logs. (1) Each licensee and registrant must make and maintain current logs of the use, removal, and return to storage of each source of radiation. The information must be recorded in the log when the source is removed from and returned to storage. The logs must include: (A) a unique identification, for example, make, model, and serial number, of: (i) each radiation machine; (ii) each radiographic exposure device containing a sealed source or transport and storage container in which the sealed source is located; and (iii) each sealed source; (B) the name and signature of the radiographer using the source of radiation; (C) the locations and dates where each source of radiation is used; and (D) the dates each source of radiation is removed from storage and returned to storage. (2) Utilization logs must be kept on clear legible records containing all the information required by paragraph (1) of this subsection. (3) Records of utilization logs must be made and maintained as specified in subsection (v)(1) of this section. (m) Inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments. (1) Each day before using equipment, the radiographer must: (A) perform visual and operational checks on radiation machines, survey instruments, radiographic exposure devices, transport and storage containers, associated equipment, and source changers to ensure: (i) the equipment is in good working condition; (ii) the sources are adequately shielded in radiographic exposure devices; and (iii) required labeling is present and legible; (B) determine the survey instrument is responding using check sources or other appropriate means; and (C) remove the equipment from service until repaired if equipment problems are found. (2) Each licensee and registrant must perform and must have written procedures for the following: (A) inspection and routine maintenance of radiation machines, radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three months to ensure the proper functioning of components important to safety. All appropriate components must be maintained as specified in manufacturers' specifications. Radiation machines, radiographic exposure devices, transport containers, and source changers being stored are exempted from this requirement provided each radiation machine, radiographic exposure device, transport container, or source changer is inspected and repaired before being returned to service. This inspection and maintenance program must cover, at a minimum, the items listed in subsection (x)(2) of this section; and (B) inspection and maintenance necessary to maintain the Type B packaging used to transport radioactive material. The inspection and maintenance program must include procedures to assure Type B packages are shipped and maintained as specified in the certificate of compliance or other approval. (3) Records of daily checks of equipment, equipment problems found in daily checks and quarterly inspections, and of any maintenance performed as specified in paragraph (1) of this subsection must be made and maintained as specified in subsection (v)(1) of this section. (4) The record must include: (A) date of check or inspection; (B) name of inspector; (C) equipment involved; (D) any problems found; and (E) what repairs or maintenance, if any, were done. (n) Permanent radiographic installations. (1) Permanent radiographic installations must have high radiation area entrance controls (for example, a control device that energizes a conspicuous visible and audible alarm signal or continuous direct or electronic surveillance) as described in §289.202(s)(1) - (4) of this chapter or §289.231(t)(1) - (4) of this chapter, or, if applicable, §289.229 of this chapter.(2) The entrance controls must be tested for proper operation at the beginning of each day of equipment use. (3) The alarm system must be tested for proper operation with a source of radiation each day before the installation is used for radiographic operations. The test must include a check for the visible and audible signals. (4) Entrance control devices reducing the radiation level upon entry (designated in paragraph (1) of this subsection) must be tested monthly. (5) If an entrance control device or alarm is operating improperly, it must be immediately labeled as defective and repaired within seven calendar days. The facility may continue to be used during this seven-day period, provided the licensee or registrant implements the continuous surveillance requirements of subsection (q) of this section, ensures radiographic personnel use an alarming ratemeter, and complies with the requirements of subsection (u)(8)(G) of this section. (6) Records of alarm systems and entrance control tests and repairs required by this subsection must be made and maintained as specified in subsection (v)(1) of this section. (o) Notifications. (1) The department must be notified of the loss or theft of sources of radiation, overexposures, and excessive levels as specified in §289.202(ww) - (yy) and (bbb) of this chapter or §289.231(gg) - (jj) of this chapter, as applicable. (2) In addition, whenever one of the following events occurs, each licensee or registrant must make the initial notification report by telephone to the department within 24 hours and submit a written report to the department within 30 days: (A) a source assembly cannot be returned to the fully shielded position and properly secured; (B) the source assembly becomes unintentionally disconnected from the control cable; (C) any component critical to safe operation of the radiographic exposure device fails to properly perform its intended function; (D) an indicator on a radiation machine fails to show that radiation is being produced; (E) an exposure switch on a radiation machine fails to terminate production of radiation when turned to the off position; or (F) a safety interlock fails to terminate x-ray production. (3) As specified in paragraph (2) of this subsection, the licensee or registrant must include in each report submitted: (A) a description of the equipment problem; (B) the cause of each incident, if known; (C) the manufacturer and model and serial number of equipment involved in the incident; (D) the location, time, and date of the incident; (E) the action taken to establish normal operations; (F) the corrective action taken or planned to prevent recurrence; and (G) the names of personnel involved in the incident. (4) Any licensee conducting radiographic operations or storing radioactive material at any location not listed on the license for a period more than 180 days in a calendar year must notify the department before exceeding the 180 days.(5) Any registrant conducting radiographic operations or storing radiation machines at any location not listed on the certificate of registration for a period more than 90 days in a calendar year must notify the department before exceeding the 90 days.(p) Individual monitoring. (1) The individual monitoring program must meet the applicable requirements of §289.202 of this chapter or §289.231 of this chapter. (2) During industrial radiographic operations, the following applies: (A) Licensees or registrants must not permit an individual to act as a radiographer, radiographer trainer, or radiographer trainee unless each individual wears, on the trunk of the body at all times during radiographic operations: (i) an individual monitoring device meeting the applicable requirements of §289.202(p)(4) and (5), (q), and (r) of this chapter or §289.231(s)(3) of this chapter; (ii) a direct-reading pocket dosimeter or an electronic personal dosimeter; and (iii) an operable alarming ratemeter. (B) For permanent radiographic installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required. (C) Pocket dosimeters must meet the criteria in ANSI 13.5-1972 at the time of manufacture and must have a range of zero to 200 mrem (2 mSv). Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters. (D) Pocket dosimeters must be recharged at the start of each work shift. (E) As a minimum, direct-reading pocket dosimeters must be recharged and electronic personal dosimeters reset, and "start" readings recorded: (i) immediately before checking out any source of radiation from an authorized use or storage site for the purposes of conducting industrial radiographic operations; and (ii) before beginning radiographic operations on any subsequent calendar day (if the source of radiation has not been checked back into an authorized use or storage site). (F) Whenever radiographic operations are concluded for the day, the "end" readings on pocket dosimeters or electronic personal dosimeters must be recorded and the accumulated occupational doses for that day determined and recorded. (G) If an individual's pocket dosimeter is discharged beyond its range (for example, goes "off-scale"), or if an individual's electronic personal dosimeter reads greater than 200 mrem (2 mSv) and the possibility of radiation exposure cannot be ruled out as the cause, industrial radiographic operations by that individual must cease and the individual's monitoring device requiring processing must be sent for processing immediately. The individual's monitoring device not requiring processing must be evaluated immediately. The individual must not return to work with sources of radiation until a determination of the radiation exposure has been made. This determination must be made by the RSO or the RSO's designee. The results of this determination must be included in the records maintained as specified in paragraphs (5) and (6) of this subsection and subsection (v)(1) of this section. (H) Each individual monitoring device must be assigned to and worn by only one individual. (I) Film badges must be replaced at periods not to exceed one month and all other individual monitoring devices requiring replacement must be replaced at least quarterly. After replacement, each individual monitoring device requiring processing must be returned to the supplier for processing within 14 calendar days of the exchange date specified by the supplier or as soon as practicable. All individual monitoring devices must be evaluated at least quarterly or promptly after replacement, whichever is more frequent. Circumstances preventing meeting these time limits must be documented, and those records must be available for review by the department.(J) If an individual monitoring device is lost or damaged, the worker must cease work immediately until a replacement individual monitoring device is provided and the exposure is calculated for the time period from issuance to loss or damage of the individual monitoring device. The results of the calculated exposure and the time period for which the individual monitoring device was lost or damaged must be included in the records maintained as specified in paragraph (6) of this subsection and subsection (v)(1) of this section. (3) Pocket dosimeters or electronic personal dosimeters must be checked for correct response to radiation at periods not to exceed one year. Acceptable dosimeters must read within plus or minus 20 percent of the true radiation exposure. (4) Each alarming ratemeter must: (A) be checked without being exposed to radiation before use at the start of each work shift, to ensure the audible alarm is functioning properly; (B) be set to give an alarm signal at a preset dose rate of 500 mrem/hr (5 mSv/hr) or lower with an accuracy of plus or minus 20 percent of the true radiation dose rate; (C) require special means to change the preset alarm function; (D) be calibrated for correct response to radiation at intervals not to exceed one year; and (E) have an audible alarm sufficient to be heard by the individual wearing the alarming ratemeter in a work environment or have other visual or physical notification of alarming conditions. (5) The following records required by this subsection must be made and maintained by the licensee or registrant for inspection by the department as specified in the following time requirements and subsection (v)(1) of this section. (A) Records of pocket dosimeter or electronic personal dosimeter readings and yearly operational response checks must be maintained for three years. If the dosimeter readings were used to determine external radiation dose (for example, no individual monitoring device exposure records exist), the records must be maintained for department inspection until disposal is authorized by the department. (B) Records of pocket dosimeter and electronic personal dosimeter readings of personnel exposures must be maintained for three years. (C) Records of estimates of exposures resulting from off-scale personal direct-reading dosimeters or lost or damaged individual monitoring devices must be maintained until disposal is authorized by the department. (6) The following records required by this subsection must be maintained as specified in the following time requirements and subsection (v)(1) of this section. (A) Records of alarming ratemeter calibrations must be maintained for three years. (B) Records of individual monitoring device results must be maintained until disposal is authorized by the department. (q) Access control. (1) During each industrial radiographic operation, radiographic personnel must maintain continuous visual surveillance of the operation to protect against unauthorized entry into a radiation area or high radiation area, except at permanent radiographic installations where all entryways are locked and the requirements of subsection (n) of this section are met. (2) Radiographic exposure devices must not be left unattended except when in storage or physically secured against unauthorized removal or tampering. (r) Posting. All areas where industrial radiography is being performed must be posted conspicuously as specified in §289.202 of this chapter or §289.231 of this chapter, as applicable, including the following. (1) Radiation areas. Each radiation area must be posted conspicuously with a sign or signs displaying the radiation caution symbol and the words "CAUTION, RADIATION AREA" or "DANGER, RADIATION AREA." (2) High radiation area. Each high radiation area must be posted conspicuously with a sign or signs displaying the radiation caution symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA." (3) Whenever practicable, ropes or barriers must be used in addition to appropriate signs to designate areas as specified in §289.202(n)(1) of this chapter or §289.231(o)(1) of this chapter, as applicable, and to help prevent unauthorized entry. (4) During pipeline industrial radiographic operations, sufficient radiation signs and other barriers must be posted to prevent unmonitored individuals from entering the area as specified in §289.202(n)(1) of this chapter or §289.231(o)(1) of this chapter, as applicable. (5) In lieu of the requirements of subsection (r)(1) and (2) of this section, a restricted area may be established as specified in §289.202(n)(1) of this chapter or §289.231(o)(1) of this chapter, as applicable, and be posted as specified in subsection (r)(1) and (2) of this section; for example, both signs may be posted at the same location at the boundary of the restricted area. (6) Exceptions listed in §289.202(bb) of this chapter or §289.231(y) of this chapter, as applicable, do not apply to industrial radiographic operations. (s) Specific requirements for radiographic personnel performing industrial radiography. (1) At a job site, the following must be supplied by the licensee or registrant: (A) at least one operable, calibrated survey instrument for each exposure device or radiation machine in use; (B) an individual monitoring device that meets the requirements of §289.202(p)(4) and (5), (q), and (r) of this chapter or §289.231(s)(3) of this chapter, as applicable, for each worker; (C) an operable, calibrated pocket dosimeter or electronic personal dosimeter with a range of zero to 200 mrem (2 mSv) for each worker; (D) an operable, calibrated, alarming ratemeter for each worker; and (E) the appropriate barrier ropes and signs. (2) Each radiographer at a job site must carry a valid certification ID card issued by the department or another certifying entity whose certification offers the same or comparable certification standards. (3) Each radiographer trainee at a job site must carry a trainee status card issued by the department or equivalent documentation as specified in subsection (e)(1) of this section. (4) Radiographic personnel must not perform radiographic operations if any of the items in paragraphs (1) - (3) of this subsection are not available at the job site or are inoperable. Radiographic personnel must ensure the items listed in paragraph (1) of this subsection, radiographic exposure devices, and radiation machines are used as specified in the requirements of this section. (5) During an inspection by the department, a department inspector may terminate an operation if any of the items in paragraphs (1) - (3) of this subsection are not available and operable or if the required number of radiographic personnel are not present. Operations must not resume until all required conditions are met. (t) Radiation safety and registration requirements for the use of radiation machines. (1) Registration requirements for industrial radiographic operations. (A) Radiation machines used in industrial radiographic operations must be registered as specified in §289.226 of this chapter. (B) In addition to the registration requirements in §289.226(e) and (i) of this chapter, an application for a certificate of registration must include:(i) a schedule or description of the program for training radiographic personnel that specifies: (I) initial training; (II) annual refresher training; (III) on-the-job training; (IV) procedures for administering the oral and written examination to determine the knowledge, understanding, and ability of radiographic personnel to comply with the requirements of this chapter, the conditions of the certificate of registration, and the registrant's operating, safety, and emergency procedures; and (V) procedures for administering the practical examination to demonstrate competence in the use of sources of radiation and radiation survey instruments employed in industrial radiographic assignments. (ii) written operating, safety, and emergency procedures available to each individual operating a radiation machine, including any restrictions of the operating technique required for the safe operation of the particular x-ray system; (I) The registrant must document that each individual operating a radiation machine has read the operating and safety procedures and must maintain this documentation for inspection by the department. The documentation must include: (-a-) name and signature of the individual; (-b-) date the individual read the operating and safety procedures; and (-c-) initials of the RSO; (II) The operating and safety procedures must include the items listed in subsection (x)(3) of this section; (iii) a description of the internal audit program to ensure radiographic personnel follow the requirements of this chapter, the conditions of the certificate of registration, and the registrant's operating, safety, and emergency procedures at intervals not to exceed six months; (iv) a list and description of all field stations and permanent radiographic installations (v) a description of the organization of the industrial radiographic program, including delegations of authority and responsibility for operation of the radiation safety program; and (vi) procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid. (C) A certificate of registration is issued if the requirements of this paragraph of this subsection and §289.226(e) and (i) of this chapter are met. (2) Locking of radiation machines. The control panel of each radiation machine must be equipped with a locking device preventing the unauthorized use of an x-ray system or the accidental production of radiation. The radiation machine must be kept locked and the key removed except when under the direct visual surveillance of a radiographer. (3) Permanent storage precautions for the use of radiation machines. Radiation machines must be secured while in storage to prevent tampering or removal by unauthorized individuals. (4) Requirements for radiation machines used in industrial radiographic operations. (A) Equipment used in industrial radiographic operations involving radiation machines manufactured after October 1, 1987 must be certified at the time of manufacture to meet the criteria set forth by ANSI N43.5 (relating to Radiological Safety Standards for the Design of Radiographic and Industrial X-Ray Equipment), except accelerators used in industrial radiography. (B) The registrant's name and city or town of an authorized use site listed on the certificate of registration must be prominently displayed with a durable, legible, clearly visible label on both sides of all vehicles used to transport radiation machines for temporary job site use. (5) Operating and internal audit requirements for the use of radiation machines. (A) Each registrant must conduct an internal audit program to ensure the requirements of this chapter, the conditions of the certificate of registration, and the registrant's operating, safety, and emergency procedures are followed by radiographic personnel. (B) Each radiographer's and radiographer trainee's performance during an actual radiographic operation must be audited and documented at intervals not to exceed six months. (C) If a radiographer or a radiographer trainee has not participated in a radiographic operation during the six months since the last audit, the radiographer or the radiographer trainee must demonstrate knowledge of the training requirements of subsection (f)(1) of this section by an oral or written and practical examination administered by the registrant before the individual can next participate in a radiographic operation. (D) The department may consider alternatives in those situations where the individual serves as both radiographer and RSO. (E) In those operations where a single individual serves as both radiographer and RSO and performs all radiography operations, an audit program is not required. (F) The registrant must provide annual refresher safety training, as defined in subsection (c) of this section, for each radiographer trainee, radiographer, or radiographer trainer at intervals not to exceed 12 months. (G) Individuals, other than a radiographer or a radiographer trainee, under the personal supervision of a radiographer trainer, must not manipulate controls or operate radiation machines used in industrial radiographic operations. Only one radiographer is required to operate radiation machines during industrial radiography. (H) Radiographic operations must not be conducted at storage sites unless specifically authorized by the certificate of registration. (I) Records of annual refresher training and audits of job performance specified in this subsection must be made and maintained as specified in subsection (v)(1) of this section. (J) Records of annual refresher safety training and audits of job performance made as specified in this subsection must include: (i) list of the topics discussed during the refresher safety training; (ii) dates the annual refresher safety training was conducted; (iii) names of the instructors and attendees; and (iv) for audits of job performance, records must include a list showing the items checked and any non-compliance observed by the RSO or designee. (6) Radiation surveys for the use of radiation machines. (A) Industrial radiographic operations must not be conducted unless at least one calibrated and operable radiation survey instrument, as described in subsection (j) of this section, is used for each radiation machine energized. (B) A physical radiation survey must be made after each radiographic exposure using radiation machines to determine the machine is "off." (C) All potential radiation areas where industrial radiographic operations are performed must be posted as specified in subsection (r) of this section, based on estimated dose rates, before industrial radiographic operations begin. An area survey must be performed during the first radiographic exposure to confirm the requirements of subsection (r) of this section have been met and unrestricted areas do not have radiation levels over the limits specified in §289.231(o)(1)(B) of this chapter. (D) Records of the surveys required by subparagraph (C) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. If a survey was used to determine an individual's exposure due to loss of personnel monitoring data, the records of the survey must be maintained for inspection by the department until disposal is authorized by the department. (7) Requirements for radiation machines in shielded rooms. (A) Radiation machines in shielded rooms must comply with all applicable requirements of this section. (B) Radiation machines in shielded rooms must be evaluated at intervals not to exceed one year to ensure compliance with the applicable requirements of this section and §289.231(o)(1) - (3) of this chapter. (C) Records of the annual evaluation of radiation machines in shielded rooms required by subparagraph (B) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. (8) Requirements for certified and certifiable cabinet x-ray systems. (A) Certified and certifiable cabinet x-ray systems, including those designed to allow admittance of individuals, are exempt from the requirements of this section except: (i) Registrants must not permit any individual to operate a cabinet x-ray system until the individual has received a copy of and instruction in the operating procedures for the unit. (ii) Tests for proper operation of interlocks must be conducted and recorded at intervals not to exceed 12 months. (iii) The registrant must perform an evaluation to determine compliance with §289.231(o)(1) - (3) of this chapter and 21 CFR §1020.40 at intervals not to exceed one year. (B) Records of operating instructions in cabinet x-ray systems required by subparagraph (A)(i) of this paragraph and interlock tests required by subparagraph (A)(ii) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. (C) Records of the evaluation of certified cabinet x-ray systems required by subparagraph (A)(iii) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. (9) All reciprocal recognition of certificates of registration by the department are granted as specified in §289.226(s) of this chapter. (u) Radiation safety and licensing requirements for the use of sealed sources. (1) Licensing requirements for industrial radiographic operations. (A) Sealed sources used in industrial radiographic operations must be licensed as specified in §289.252 of this subchapter. (B) In addition to the licensing requirements in §289.252 of this subchapter, an application for a license must include. (i) A schedule or description of the program for training radiographic personnel specifying: (I) initial training; (II) annual refresher training; (III) on-the-job training; (IV) procedures for administering the oral and written examinations to determine the knowledge, understanding, and ability of radiographic personnel to comply with the requirements of this chapter, the conditions of the license, and the licensee's operating, safety, and emergency procedures; and (V) procedures for administering the practical examination to demonstrate competence in the use of sources of radiation, radiographic exposure devices, related handling tools, and radiation survey instruments employed in industrial radiographic assignments. (ii) Written operating, safety, and emergency procedures are made available to each individual operating a sealed source in radiographic operations, including any restrictions of the operating technique required for the safe operation of the particular sealed source. (I) The licensee must document each individual operating a sealed source in radiographic operations has read the operating and safety procedures and must maintain this documentation for inspection by the department. The documentation must include: (-a-) name and signature of the individual; (-b-) date the individual read the operating and safety procedures; and (-c-) initials of the RSO. (II) The operating and safety procedures must include the items listed in subsection (x)(3) of this section. (iii) A description of the internal audit program to ensure radiographic personnel follow the requirements of this chapter, the conditions of the license, and the licensee's operating, safety, and emergency procedures at intervals not to exceed six months. (iv) A list and description of all field stations and permanent radiographic installations.(v) A description of the organization of the industrial radiographic program, including delegations of authority and responsibility for operation of the radiation safety program. (vi) A description of the program for inspection and maintenance of radiographic exposure devices and transport and storage containers, including items in subsection (x)(2) of this section and the applicable items in subsection (m) of this section. (vii) If a license application includes underwater radiography, as a minimum, a description of: (I) radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography; (II) radiographic equipment and radiation safety equipment unique to underwater radiography; and (III) methods for gas-tight encapsulation of equipment. (viii) If a license application includes offshore platform or lay-barge radiography, as a minimum, a description of: (I) transport procedures for radioactive material to be used in industrial radiographic operations; (II) storage areas for radioactive material; and (III) methods for restricting access to radiation areas. (ix) Procedures verifying and documenting the certification status of radiographers and ensuring that the certification of individuals acting as radiographers remains valid. (x) If the applicant intends to perform leak testing of sealed sources or exposure devices containing DU shielding, the applicant must describe the procedures for performing the leak test and the qualifications of the person authorized to do the leak test. (xi) If the applicant intends to analyze its own wipe samples, the application must include a description of the procedures to be followed. The description must include: (I) instruments to be used; (II) methods of performing the analysis; and (III) pertinent experience of the individual or individuals analyzing the wipe samples. (xii) If the applicant intends to perform "in-house" calibrations of survey instruments, the applicant must describe methods to be used and the relevant experience of the individual or individuals performing the calibrations. All calibrations must be performed as specified in subsection (j) of this section. (C) A license is issued if the requirements of this paragraph and §289.252 of this subchapter are met. (2) Limits on external radiation levels from storage containers and source changers. The maximum exposure rate limits for storage containers and source changers are 200 mrem/hr (2 mSv/hr) at any exterior surface, and 10 mrem/hr (0.1 mSv/hr) at 1 meter from any exterior surface with the sealed source in the shielded position. (3) Locking of radiographic exposure devices, storage containers, and source changers. (A) Each radiographic exposure device, storage container, and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal or exposure of a sealed source. Each exposure device and source changer must be kept locked and, if a keyed lock, the key removed except when under the direct visual surveillance of a radiographer or an individual specifically authorized by the department, except at a permanent radiographic installation. (B) Each radiographic exposure device, storage container, and source changer must be locked and the key removed from any keyed lock before being transported from one location to another and before being stored at a given location. (4) Permanent storage precautions for the use of sealed sources. (A) Radiographic exposure devices, source changers, and transport containers containing sealed sources must be secured while in storage to prevent tampering or removal by unauthorized individuals. (B) Radiographic exposure devices, source changers, or transport containers containing radioactive material must not be stored in residential locations unless specifically authorized by the department.(5) Performance requirements for industrial radiography equipment. Equipment used in industrial radiographic operations must meet the following minimum criteria. (A) Each radiographic exposure device, source assembly, sealed source, and associated equipment must meet the criteria set forth by ANSI N432-1980. This publication is available online at http://pbadupws.nrc.gov/docs/ML0508/ML050840139.pdf and may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036; Telephone (212) 642-4900. (i) All newly manufactured radiographic exposure devices and associated equipment acquired by licensees after September 1, 1993, must comply with the requirements of this section. (ii) All radiographic exposure devices and associated equipment in use after January 1, 1996, must comply with the requirements of this section. (iii) In lieu of subparagraph (A) of this paragraph, equipment used in industrial radiographic operations need not comply with §8.9.2(c) of the Endurance Test in ANSI N432-1980, if the prototype equipment has been tested using a torque value representative of the torque an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism. (B) Engineering analysis may be submitted by a licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the department may find this an acceptable alternative to actual testing of the component as specified in subparagraph (A) of this paragraph. (C) In addition to the requirements specified in subparagraph (A) of this paragraph the following requirements apply to radiographic exposure devices, source changers, source assemblies, and sealed sources. (i) Radiographic exposure devices intended for use as Type B transport containers must meet the applicable requirements of §289.257 of this subchapter. (ii) Modification of radiographic exposure devices, source changers, source assemblies, and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls, or guide tubes does not compromise the design safety features of the system. (D) In addition to the requirements specified in subparagraphs (A) - (C) of this paragraph, radiographic exposure devices, source assemblies, and associated equipment allowing the source to move outside the device must meet the following criteria. (i) The source assembly must be designed so the source does not become disconnected if cranked outside the guide tube. The source assembly cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions. (ii) The control cable must be positively connected to the source assembly before the source assembly can be driven out of the fully shielded position in a radiographic exposure device or source changer. (iii) The radiographic exposure device must automatically secure the source assembly when it is cranked back into the fully shielded position within the radiographic exposure device. This securing system may only be released by means of a deliberate operation on the radiographic exposure device. (iv) The outlet nipple, lock box, and control cable fittings of each radiographic exposure device must be equipped with safety plugs or covers installed during storage and transportation to protect the source assembly from damage and from other foreign matter, such as water, mud, or sand. (v) Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words "DANGER. RADIOACTIVE." The label may not interfere with the safe operation of the exposure device or associated equipment. (vi) Guide tubes must be used when moving the source out of the radiographic exposure device. (vii) Guide tubes must be able to withstand a crushing test closely approximating the crushing forces likely to be encountered during use, and be able to withstand a kinking resistance test closely approximating the kinking forces likely to be encountered during use. (viii) An exposure head, endcap, or similar device designed to prevent the source assembly from extending beyond the end of the guide tube must be attached to the outermost end of the guide tube during radiographic operations. (ix) The guide tube exposure head connection must be able to withstand the tensile test for control units as specified in ANSI N432-1980. (x) Source changers must provide a system for ensuring the source is not accidentally withdrawn from the changer when connecting or disconnecting the control cable to or from a source assembly. (6) Leak testing, repair, opening, and replacement of sealed sources and devices. Leak testing, repair, opening, and replacement of sealed sources and devices must be performed according to the following criteria. (A) Leak testing of sealed sources must be done as specified in §289.201(g) of this chapter, except records of leak tests must be maintained as specified in subsection (v)(1) of this section. (B) The replacement, leak testing analysis, repair, opening, or any modification of a sealed source must be performed only by persons specifically authorized to do so by the department, the NRC, or another agreement state. (C) Each exposure device using DU shielding and an "S" tube configuration must be tested for DU contamination. (i) Tests for DU contamination must be performed at intervals not to exceed 12 months. (ii) The analysis must be capable of detecting the presence of 0.005 microcuries (185 becquerels (Bq)) of radioactive material on the test sample and must be performed by a person specifically authorized by the department, the NRC, or an agreement state to perform the analysis. (iii) Should such testing reveal the presence of DU contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. (iv) Should the evaluation reveal the S-tube is worn through, the device may not be used again. (v) DU-shielded devices do not have to be tested for DU contamination while in storage and not in use. (vi) The device must be tested for DU contamination before using or transferring the device, if the interval of storage exceeds 12 months. (D) A record of the DU leak test must be made and maintained as specified in subsection (v)(1) of this section. (7) Labeling and storage. (A) Each transport container must have permanently attached to it a durable, legible, clearly visible label having, at a minimum, the standard trefoil radiation caution symbol conventional colors (for example, magenta, purple, or black on a yellow background), having a minimum diameter of 25 millimeters, and the following wording: "CAUTION. RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)" or "DANGER. RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)." In addition, transport containers must meet applicable requirements of the DOT. (B) Radiographic exposure devices, source changers, and storage containers must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee must store radioactive material in a manner that will minimize danger from explosion or fire. (C) The licensee must lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal. (D) The licensee's name and city or town of an authorized use site listed on the license must be prominently displayed with a durable, legible, and clearly visible label on both sides of all vehicles used to transport radioactive material for temporary job site use. (E) The licensee must ensure each radiographic exposure device has attached to it a durable, legible, and clearly visible label bearing: (i) the chemical symbol and mass number of the radionuclide in the device; (ii) the activity and the date on which this activity was last measured; (iii) the manufacturer, model, and serial number of the sealed source; (iv) the licensee's name, address, and telephone number; and (v) at a minimum, the standard radiation caution symbol as defined in §289.202 of this chapter, and the following wording: "CAUTION. RADIOACTIVE MATERIAL--DO NOT HANDLE. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)" or "DANGER. RADIOACTIVE MATERIAL--DO NOT HANDLE. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)." (F) Each radiographic exposure device must have a permanently stamped, legible, and clearly visible unique serial number. (8) Operating and internal audit requirements for the use of sealed sources of radiation. (A) Each licensee must conduct an internal audit program to ensure the requirements of this chapter, the conditions of the license, and the licensee's operating, safety, and emergency procedures are followed by radiographic personnel. (B) Each radiographer's and radiographer trainee's performance during an actual radiographic operation must be audited and documented at intervals not to exceed six months. (C) If a radiographer or a radiographer trainee has not participated in a radiographic operation during the six months since the last audit, the radiographer or the radiographer trainee must demonstrate knowledge of the training requirements of subsection (f)(1) of this section by an oral or written and practical examination administered by the licensee before these individuals can next participate in a radiographic operation. (D) The department may consider alternatives in those situations where the individual serves as both radiographer and RSO. (E) In those operations where a single individual serves as both radiographer and RSO, and performs all radiography operations, an audit program is not required. (F) Each licensee must provide annual refresher safety training, as defined in subsection (c) of this section, for each radiographer and radiographer trainee at intervals not to exceed 12 months. (G) Whenever radiographic operations are performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has, at minimum, met the requirements of subsection (e)(1) of this section. The additional qualified individual must observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiographic operations must not be performed if only one qualified individual is present. (H) Collimators must be used in industrial radiographic operations using crank-out devices except when physically impossible. (I) Individuals other than a radiographer or a radiographer trainee, under the personal supervision of a radiographer trainer, must not manipulate controls or operate radiographic exposure devices and associated equipment used in industrial radiographic operations. (J) All radiographic operations conducted at locations of use authorized on the license must be conducted in a permanent radiographic installation, unless specifically authorized by the department. (K) Records of annual refresher training and audits of job performance specified in this subsection must be made and maintained as specified in subsection (v)(1) of this section. (L) Records of annual refresher safety training and audits of job performance made as specified in this subsection must include: (i) list of the topics discussed during the refresher safety training; (ii) dates the annual refresher safety training was conducted; (iii) names of the instructors and attendees; and (iv) for audits of job performance, the records must also include a list showing the items checked and any non-compliance observed by the RSO or designee. (9) Radiation surveys for the use of sealed sources of radiation. (A) Industrial radiographic operations must not be conducted unless at least one calibrated and operable radiation survey instrument, as described in subsection (j) of this section, is used at each site where radiographic exposures are made. (B) A survey with a radiation survey instrument meeting the requirements of subsection (j)(1) - (3) of this section must be made after each radiographic exposure to determine the sealed source has been returned to its fully shielded position, and before exchanging films, repositioning the exposure head, or dismantling equipment. The entire circumference of the radiographic exposure device must be surveyed. If the radiographic exposure device has a source guide tube, the survey must also include the source guide tube and any collimator. (C) All potential radiation areas where industrial radiographic operations are performed must be posted as specified in subsection (r) of this section, based on calculated dose rates, before industrial radiographic operations begin. An area survey must be performed during the first radiographic exposure (for example, with the sealed source in the exposed position) to confirm the requirements of subsection (r) of this section have been met. (D) Each time re-establishment of the restricted area is required, the requirements of subparagraph (C) of this paragraph must be met. (E) The requirements of subparagraph (D) of this paragraph do not apply to pipeline industrial radiographic operations when the conditions of exposure, including the radiographic exposure device, duration of exposure, source strength, pipe size, and pipe thickness, remain constant. (F) A lock-out survey, in which all accessible surfaces of the radiographic exposure device or source changer are surveyed, must be performed. (G) Surveys must be performed in the storage area to ensure radiation levels do not exceed the limits specified in §289.202(n)(1) of this chapter. These surveys must be performed initially with the maximum amount of radioactive material present in the storage area and thereafter at the time of the quarterly inventory and whenever storage conditions change. (H) A survey meeting the requirements of subparagraph (B) of this paragraph must be performed on the radiographic exposure device and the source changer after every sealed source exchange. (I) Records of the surveys required by subparagraphs (C), (D), and (F) - (H) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. If a survey was used to determine an individual's exposure due to loss of personnel monitoring data, the records of the survey must be maintained for inspection by the department until disposal is authorized by the department. (10) Requirements for shielded rooms containing sealed sources. (A) Shielded rooms containing sealed sources must comply with all applicable requirements of this section. (B) Shielded rooms containing sealed sources must be evaluated at intervals not to exceed one year to ensure compliance with the applicable requirements of this section and §289.202(n)(1) - (3) of this chapter. (C) Tests for proper operation of interlocks must be conducted and recorded as specified in subsection (n) of this section. (D) Records of evaluations required by subparagraph (B) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. (E) Records of interlock tests required by subparagraph (C) of this paragraph must be made and maintained as specified in subsection (v)(1) of this section. (11) Underwater, offshore platform, and lay-barge radiography. (A) Underwater, offshore platform, and lay-barge radiography must not be performed unless specifically authorized in a license issued by the department as specified in paragraph (1) of this subsection. (B) In addition to the other requirements of this section, the following requirements apply to the performance of offshore platform or lay-barge radiography. (i) Cobalt-60 sources with activities more than 20 curies (Ci) (nominal) (740 gigabecquerels) and iridium-192 sources with activities more than 100 Ci (nominal) (3.7 terabecquerels) must not be used in the performance of offshore platform or lay-barge radiography. (ii) Collimators must be used for all industrial radiographic operations performed on offshore platforms or lay-barges. (12) Prohibitions. (A) Industrial radiography performed with a sealed source not fastened to or contained in a radiographic exposure device (fishpole technique) is prohibited unless specifically authorized in a license issued by the department. (B) Retrieval of disconnected sources or sources that cannot be returned by normal means to a fully shielded position or automatically secured in the radiographic exposure device must not be performed unless specifically authorized by a license condition. (13) All reciprocal recognition of licenses by the department are granted as specified in §289.252(ee) of this subchapter. (v) Record/document requirements. Each licensee and registrant must maintain the following records/documents at each site at the time intervals specified and make them available to the department for inspection. (1) Time requirements for record keeping. The following are time requirements for record keeping. Attached Graphic(2) Records and documents required at field stations . (A) Each licensee or registrant maintaining field stations where industrial radiography operations are performed must maintain copies of the following records and documents specific to that site available at each site for inspection by the department for a period of three years: (i) a copy of the appropriate license or certificate of registration authorizing the use of licensed or registered sources of radiation; (ii) operating, safety, and emergency procedures as specified in subsection (x)(3) of this section; (iii) applicable sections of this chapter as listed in the license or certificate of registration; (iv) records of receipt, transfer, and disposal of sources of radiation and devices using DU for shielding at the additional site as specified in subsection (i) of this section; (v) records of the latest survey instrument calibrations in use at the site as specified in subsection (j) of this section; (vi) records of the latest calibrations of alarming ratemeters and operational checks of pocket dosimeters and electronic personal dosimeters as specified in subsection (p) of this section; (vii) inventories as specified in subsection (k) of this section; (viii) utilization records for each radiographic exposure device and radiation machine dispatched from that location as specified in subsection (l) of this section; (ix) records of equipment problems identified in daily checks of equipment as specified in subsection (m) of this section, if applicable; (x) records of alarm systems and entrance control checks as specified in subsection (n) of this section; (xi) training records as specified in subsection (f) of this section; (xii) records of direct-reading dosimeter readings as specified in subsection (p) of this section; (xiii) audits as specified in subsections (t)(5)(A) - (C) and (u)(8)(A) - (C) of this section; (xiv) latest radiation survey records as specified in subsections (t)(6)(D) and (u)(9)(I) of this section; (xv) records of interlock testing as specified in subsections (t)(8)(A)(ii) and (u)(10)(C) of this section; (xvi) records of annual evaluation of cabinet x-ray systems as specified in subsection (t)(7)(C) of this section; (xvii) records of leak tests for specific devices and sources at the additional site as specified in subsection (u)(6) of this section; (xviii) shipping papers for the transportation of sources of radiation as specified in §289.257 of this subchapter; (xix) a copy of the NRC license, agreement state license, or state certificate of registration authorizing the use of sources of radiation, when operating under reciprocity as specified in §289.226 of this chapter and §289.252 of this subchapter; and (xx) individual monitoring records as specified in subsection (p) of this section. (B) The following records required for each field station as specified in this subsection must also be maintained at the main authorized site: (i) records of receipt, transfer, and disposal of sources of radiation and devices using DU for shielding at the additional site as specified in subsection (i) of this section; (ii) inventories as specified in subsection (k) of this section; and (iii) individual monitoring records as specified in subsection (p) of this section. (3) Records required at temporary job sites. Each licensee and registrant conducting industrial radiography at a temporary job site must have the following records available at that site for inspection by the department: (A) a copy of the appropriate license or certificate of registration or equivalent document authorizing the use of sources of radiation; (B) operating, safety, and emergency procedures as specified in subsection (x)(3) of this section; (C) applicable sections of this chapter as listed in the license or certificate of registration; (D) latest radiation survey records required as specified in subsections (t)(6)(D) and (u)(9)(I) of this section for the period of operation at the site; (E) the daily pocket dosimeter records for the period of operation at the site; (F) utilization records for each radiographic exposure device or radiation machine used at that location as specified in subsection (l) of this section; (G) the latest instrument calibration and leak test records for devices at the site. Acceptable records include tags or labels attached to the devices or survey instruments and decay charts for sources manufactured within the last six months; and (H) a copy of the NRC license, agreement state license, or state certificate of registration authorizing the use of sources of radiation, when operating under reciprocity as specified in §289.226 of this chapter or §289.252 of this subchapter. (w) Form of records. Each record required by this chapter must include all pertinent information and be stored in a legible and reproducible format throughout the specified retention period. The licensee or registrant must maintain adequate safeguards against tampering with and loss of records.(x) Appendices. (1) Subjects to be included in training courses for radiographer trainees. Training provided to qualify individuals as radiographer trainees in compliance with subsection (e)(1)(A) of this section must be presented on a formal basis. The training must include the following subjects. (A) Fundamentals of radiation safety, including: (i) characteristics of radiation; (ii) units of radiation dose in rem (sieverts) and quantity of radioactivity in curies (becquerels); (iii) significance of radiation dose, including: (I) radiation protection standards; (II) biological effects of radiation dose; (III) hazards of exposure to radiation; and (IV) case histories of radiography accidents; (iv) levels of radiation from sources of radiation; and (v) methods of controlling radiation dose, including: (I) working time; (II) working distances; and (III) shielding. (B) Radiation detection instrumentation, including: (i) use, operation, calibration, and limitations of radiation survey instruments; (ii) survey techniques; and (iii) use of individual monitoring devices. (C) Radiographic equipment to be used, including: (i) remote handling equipment; (ii) operation and control of radiographic exposure devices and sealed sources, including pictures or models of source assemblies (pigtails); (iii) storage and transport containers, source changers; (iv) operation and control of x-ray equipment; (v) collimators; (vi) storage, control, and disposal of radioactive material; and (vii) inspection and maintenance of equipment. (D) Requirements of pertinent federal and state regulations. (E) Generic written operating, safety, and emergency procedures (see subsection (x)(3) of this section). (2) General requirements for inspection of industrial radiographic equipment. (A) Radiographic exposure devices must be inspected for: (i) abnormal surface radiation levels anywhere on camera, collimator, or guide tube; (ii) condition of safety plugs; (iii) proper operation of locking mechanism; (iv) condition of pigtail connector; (v) condition of carrying device (straps, handle, etc.); and (vi) proper and legible labeling. (B) Guide tubes must be inspected for: (i) rust, dirt, or sludge buildup inside the guide tube; (ii) condition of guide tube connector; (iii) condition of source stop; and (iv) kinks or damage that could prevent proper operation. (C) Control cables and drive mechanisms must be inspected for: (i) proper drive mechanism with camera, as appropriate; (ii) changes in general operating characteristics; (iii) condition of connector on control cable; (iv) control cable flexibility, wear, and rust; (v) excessive wear or damage to crank-out devices; (vi) damage to control cable conduit that could prevent the cable from moving freely; (vii) proper connector mating between the control cable and the pigtail; and (viii) proper operation of source position indicator, if applicable. (D) Pipeliners must be inspected for: (i) abnormal surface radiation; (ii) changes in the general operating characteristics of the unit; (iii) proper operation of shutter mechanism; (iv) chafing or binding of shutter mechanism; (v) damage to the device that might impair its operation; (vi) proper operation of locking mechanism; (vii) proper drive mechanism with camera, as appropriate; (viii) condition of carrying device (strap, handle, etc.); and (ix) proper and legible labeling. (E) X-ray equipment must be inspected for: (i) change in the general operating characteristics of the unit; (ii) wear of electrical cables and connectors; (iii) proper and legible labeling of console; (iv) proper console with machine, as appropriate; (v) proper operation of locking mechanism; (vi) proper operation of timer run-down cutoff; and (vii) damage to tube head housing that might result in excessive radiation levels. (3) Operating, safety, and emergency procedures. The licensee's or registrant's operating, safety, and emergency procedures must include instructions in: (A) handling and use of sources of radiation for industrial radiography so no individual is likely to be exposed to radiation doses more than the limits established in §289.202 of this chapter; (B) methods and occasions for conducting radiation surveys, including lock-out survey requirements; (C) methods for controlling access to industrial radiography areas; (D) methods and occasions for locking and securing sources of radiation; (E) personnel monitoring and the use of personnel monitoring equipment, including steps to be taken immediately, by industrial radiographic personnel, in the event a pocket dosimeter is found to be off-scale (see subsection (p)(2)(G) of this section); (F) methods of transporting equipment to field locations, including packing of sources of radiation in the vehicles, placarding of vehicles, and controlling of sources of radiation during transportation, including applicable DOT requirements; (G) methods for minimizing exposure of individuals in the event of an accident, including procedures for a disconnect accident, a transportation accident, and loss of a sealed source; (H) notifying proper personnel in the event of an accident; (I) specific posting requirements; (J) maintenance of records (see subsection (v)(1) of this section); (K) inspection, maintenance, and operational checks of radiographic exposure devices, source changers, storage containers, transport containers, source guide tubes, crank-out devices, and radiation machines; (L) method of testing and training as specified in subsections (e) and (f) of this section; and (M) source recovery if the licensee is authorized to perform source recovery. Source Note: The provisions of this §289.255 adopted to be effective December 27, 2007, 32 TexReg 9657; amended to be effective October 1, 2011, 36 TexReg 5851; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective October 23, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.255 Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221105&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221105 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221105&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221105 03/11/2026 (a) Purpose. (1) This section establishes requirements for medical and veterinary use of radioactive material and the issuance of specific licenses authorizing medical and veterinary use of radioactive material. Unless otherwise exempted, persons must not manufacture, produce, receive, possess, use, transfer, own, or acquire radioactive material for medical or veterinary use except as authorized in a license issued as specified in this section. (2) A person who manufactures, produces, receives, possesses, uses, transfers, owns, or acquires radioactive material before receiving a license is subject to the requirements of this chapter. (3) A specific license is not needed for a person who: (A) receives, possesses, uses, or transfers radioactive material as specified in this chapter under the supervision of an authorized user as provided in subsection (s) of this section, unless prohibited by license condition; or (B) prepares unsealed radioactive material for medical or veterinary use as specified in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in subsection (s) of this section, unless prohibited by license condition. (b) Scope. (1) In addition to the requirements of this section, all licensees, unless otherwise specified, are subject to the requirements of: (A) §289.201 of this chapter (relating to General Provisions for Radioactive Material);(B) §289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials); (C) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(D) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services); (E) §289.205 of this chapter (relating to Hearing and Enforcement Procedures);(F) §289.252 of this subchapter (relating to Licensing of Radioactive Material); and(G) §289.257 of this subchapter (relating to Packaging and Transportation of Radioactive Material). (2) Veterinarians who receive, possess, use, transfer, own, or acquire radioactive material in the practice of veterinary medicine must comply with the requirements of this section except for subsections (d), (dd), and (uuu) of this section. (3) An entity that is a "covered entity" as that term is defined in HIPAA (the Health Insurance Portability and Accountability Act of 1996, 45 Code of Federal Regulations (CFR) Parts 160 and 164) may be subject to privacy standards governing how information identifying a patient can be used and disclosed. Failure to follow HIPAA requirements may result in the department making a referral of a potential violation to the United States Department of Health and Human Services. (4) In accordance with the requirements of the Texas Medical Board, 22 Texas Administrative Code (TAC) Chapter 160, medical licensees must use the services of a licensed medical physicist for activities falling within the medical physicist scope of practice as identified in 22 TAC §160.17 unless exempted under 22 TAC §160.5. (c) Definitions. The following words and terms when used in this section have the following meaning unless the context clearly indicates otherwise. (1) Address of use--The building or buildings identified on the license where radioactive material may be prepared, received, used, or stored. (2) Area of use--A portion of an address of use set aside for the purpose of preparing, receiving, using, or storing radioactive material. (3) Associate radiation safety officer (ARSO)--An individual who: (A) meets the requirements in subsections (h) and (m) of this section; and (B) is currently identified as an ARSO for the types of use of radioactive material for which the individual has been assigned duties and tasks by the radiation safety officer (RSO) on: (i) a specific medical or veterinary use license issued by the department, the United States Nuclear Regulatory Commission (NRC), or an agreement state; or (ii) a medical use permit issued by an NRC master material licensee. (4) Authorized medical physicist--An individual who: (A) meets the requirements in subsections (j) and (m) of this section; or (B) is identified as an authorized medical physicist or teletherapy physicist on: (i) a specific medical or veterinary use license issued by the department, the NRC, or an agreement state; (ii) a medical use permit issued by an NRC master material licensee; (iii) a permit issued by an NRC or agreement state broad scope medical use licensee; or (iv) a permit issued by an NRC master material license broad scope medical use permittee; and (C) holds a current Texas license under the Medical Physics Practice Act, Texas Occupations Code Chapter 602, in therapeutic radiological physics for uses in subsections (rr) and (ddd) of this section. (5) Authorized nuclear pharmacist--A pharmacist who: (A) meets the requirements in subsections (k) and (m) of this section; or (B) is identified as an authorized nuclear pharmacist on: (i) a specific license issued by the department, the NRC, or an agreement state authorizing medical use or the practice of nuclear pharmacy; (ii) a permit issued by an NRC master material licensee authorizing medical use or the practice of nuclear pharmacy; (iii) a permit issued by the department, the NRC, or an agreement state licensee of broad scope authorizing medical use or the practice of nuclear pharmacy; or (iv) a permit issued by an NRC master material license broad scope medical use permittee authorizing medical use or the practice of nuclear pharmacy; or (C) is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy authorized to identify authorized nuclear pharmacists; or (D) is designated as an authorized nuclear pharmacist as specified in §289.252(r) of this subchapter; and (E) holds a current Texas license under the Texas Pharmacy Act, Texas Occupations Code Chapters 551 - 566, 568, and 569, as amended, and who is certified as an authorized nuclear pharmacist by the Texas State Board of Pharmacy. (6) Authorized user--An authorized user is defined as follows: (A) for human use, a physician licensed by the Texas Medical Board; or a dentist licensed by the Texas State Board of Dental Examiners; or a podiatrist licensed by the Texas State Board of Podiatric Medicine who: (i) meets the requirements in subsection (m) and subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), or (ttt) of this section; or (ii) is identified as an authorized user on: (I) a department, NRC, or agreement state license authorizing the medical use of radioactive material; (II) a permit issued by an NRC master material licensee authorizing the medical use of radioactive material; (III) a permit issued by a specific licensee of broad scope issued by the department, the NRC, or an agreement state authorizing the medical use of radioactive material; or (IV) a permit issued by an NRC master material licensee of broad scope authorizing the medical use of radioactive material. (B) for veterinary use, an individual who is a veterinarian licensed by the Texas State Board of Veterinary Medical Examiners; and (i) is certified by the American College of Veterinary Radiology for the use of radioactive materials in veterinary medicine; or (ii) has received training as specified in subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), and (ttt) of this section as applicable; or (iii) is identified as an authorized user on: (I) a department, NRC, or agreement state license authorizing the veterinary use of radioactive material; (II) a permit issued by an NRC master material licensee authorizing the medical use of radioactive material; (III) a permit issued by a specific licensee of broad scope issued by the department, the NRC, or an agreement state authorizing the medical or veterinary use of radioactive material; or (IV) a permit issued by an NRC master material licensee of broad scope authorizing the medical use of radioactive material. (7) Brachytherapy--A method of radiation therapy in which plated, embedded, activated, or sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application. (8) Brachytherapy sealed source--A sealed source or a manufacturer-assembled source train or a combination of these sources designed to deliver a therapeutic dose within a distance of a few centimeters. (9) High dose-rate remote afterloader--A device remotely delivering a dose rate more than 1200 rads (12 gray (Gy)) per hour at the point or surface where the dose is prescribed. (10) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution and approved by the United States Food and Drug Administration (FDA) to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects. (11) Low dose-rate remote afterloader--A device remotely delivering a dose rate of less than or equal to 200 rads (2 Gy) per hour at the point or surface where the dose is prescribed. (12) Management--The chief executive officer or other individual delegated the authority to manage, direct, or administer the licensee's activities. (13) Manual brachytherapy--A type of brachytherapy in which the sealed sources, for example, seeds and ribbons, are manually inserted either into the body cavities in close proximity to a treatment site or directly in the tissue volume. (14) Medical event--An event meeting the criteria in subsection (uuu)(1) of this section. (15) Medical institution--An organization in which several medical disciplines are practiced. (16) Medical use--The intentional internal or external administration of radioactive material, or the radiation from radioactive material, to patients or human research subjects under the supervision of an authorized user. (17) Medium dose-rate afterloader--A device remotely delivering a dose rate greater than 200 rads (2 Gy) and less than or equal to 1200 rads (12 Gy) per hour at the point or surface where the dose is prescribed. (18) Mobile nuclear medicine service--A licensed service authorized to transport radioactive material to, and medical or veterinary use of the material at, the client's address. Services transporting calibration sources only are not considered mobile nuclear medicine licensees. (19) Ophthalmic physicist--An individual who: (A) meets the requirements in subsections (m) and (xx)(1)(B) of this section; and (B) is identified as an ophthalmic physicist on: (i) a specific medical use license issued by the department, the NRC, or an agreement state; (ii) a permit issued by a department, NRC, or agreement state broad scope medical use licensee; (iii) a medical use permit issued by an NRC master material licensee; or (iv) a permit issued by an NRC master material licensee broad scope medical use permittee. (20) Output--The exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit, a brachytherapy source, a remote afterloader unit, or a gamma stereotactic radiosurgery unit, for a specified set of exposure conditions. (21) Patient--A human or animal under medical care and treatment. (22) Patient intervention--Actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration. (23) Permanent facility--A building or buildings identified on the license within the State of Texas and where radioactive material may be prepared, received, used, or stored. This may also include an area or areas where administrative activities related to the license are performed. (24) Preceptor--An individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, an RSO, or an ARSO. (25) Prescribed dosage--The specified activity or range of activity of unsealed radioactive material as documented in a written directive or specified in the directions of the authorized user for procedures in subsections (ff) and (hh) of this section. (26) Prescribed dose--Prescribed dose means: (A) for gamma stereotactic radiosurgery, the total dose as documented in the written directive; (B) for teletherapy, the total dose and dose per fraction as documented in the written directive; (C) for brachytherapy, either the total sealed source strength and exposure time, or the total dose, as documented in the written directive; or (D) for remote afterloaders, the total dose and dose per fraction as documented in the written directive. (27) Pulsed dose-rate remote afterloader--A special type of remote afterloading device using a single sealed source capable of delivering dose rates greater than 1200 rads (12 Gy) per hour, but is approximately one-tenth of the activity of typical high dose-rate remote afterloader sealed sources and is used to simulate the radiobiology of a low dose-rate remote afterloader treatment by inserting the sealed source for a given fraction of each hour. (28) Radiation safety officer (RSO)--For purposes of this section, an individual who: (A) meets the requirements in subsections (h) and (m) of this section; or (B) is identified as an RSO on: (i) a specific license issued by the department, the NRC, or an agreement state authorizing the medical or veterinary use of radioactive material; or (ii) a permit issued by an NRC master material licensee authorizing the medical or veterinary use of radioactive material. (29) Sealed source and device registry--The national registry containing all registration certificates, generated by both the NRC and agreement states, summarizing the radiation safety information for sealed sources and devices and describing the licensing and use conditions approved for the product. (30) Stereotactic radiosurgery--The use of external radiation in conjunction with a guidance device to very precisely deliver a dose to a tissue volume using three-dimensional coordinates. (31) Technologist--A person (nuclear medicine technologist) skilled in the performance of nuclear medicine procedures under the supervision of a physician. (32) Teletherapy--Therapeutic irradiation in which the sealed source is at a distance from the patient or human or animal research subject. (33) Therapeutic dosage--The specified activity or range of activity of radioactive material intended to deliver a radiation dose to a patient or human or animal research subject for palliative or curative treatment. (34) Therapeutic dose--A radiation dose delivered from a sealed source containing radioactive material to a patient or human or animal research subject for palliative or curative treatment. (35) Treatment site--The anatomical description of tissue intended to receive a radiation dose, as described in a written directive. (36) Type of use--Use of radioactive material as specified under: (A) uptake, dilution, and excretion studies in subsection (ff) of this section; (B) imaging and localization studies in subsection (hh) of this section; (C) therapy with unsealed radioactive material in subsection (kk) of this section; (D) manual brachytherapy with sealed sources in subsection (rr) of this section; (E) sealed sources for diagnosis in subsection (bbb) of this section; (F) sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit in subsection (ddd) of this section; or (G) other medical or veterinary uses of radioactive material or a radiation source approved for medical or veterinary use in subsection (q) of this section. (37) Unit dosage--A dosage prepared for medical or veterinary use for administration as a single dosage to a patient or human or animal research subject without any further modification of the dosage after it is initially prepared. (38) Veterinary use--The intentional internal or external administration of radioactive material, or the radiation from radioactive material, to animal patients under the supervision of an authorized user. (39) Written directive--An authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in subsection (t) of this section. (d) Provisions for research involving human subjects. (1) A licensee may conduct research involving human subjects only if it uses the radioactive materials specified on its license for the uses authorized on the license. (2) The licensee may conduct research specified in paragraph (1) of this subsection provided: (A) the research is conducted, funded, supported, or regulated by a federal agency implementing the Federal Policy for the Protection of Human Subjects as required by 10 CFR §35.6 (Federal Policy); or (B) the licensee has applied for and received approval of a specific amendment to its license before conducting the research. (3) Before conducting research as specified in paragraph (1) of this subsection, the licensee must obtain: (A) "informed consent," as defined and described in the Federal Policy, from the human research subjects; and (B) review and approval of the research from an Institutional Review Board (IRB) as required by 45 CFR Part 46, and 21 CFR Part 56, and in accordance with the Federal Policy. (4) Nothing in this subsection relieves licensees from complying with the other requirements of this chapter. (e) Implementation. (1) If a license condition exempted a licensee from a provision of this section or §289.252 of this subchapter on the effective date of this rule, then the license condition continues to exempt the licensee from the requirements in the corresponding provision until there is a license amendment or license renewal modifying or removing the license condition. (2) When a requirement in this section differs from the requirement in an existing license condition, the requirement in this section governs. (3) Licensees must continue to comply with any license condition requiring implementation of procedures required by subsections (ggg) and (mmm) - (ooo) of this section until there is a license amendment or renewal modifying the license condition. (f) Specific requirements for the issuance of licenses. In addition to the requirements in §289.252(e) of this subchapter and subsections (n) - (q) of this section, as applicable, a license is issued if the department determines: (1) the applicant satisfies any applicable special requirement in this section; (2) qualifications of the designated RSO as specified in subsection (h) of this section are adequate for the purpose requested in the application; and (3) the information submitted by the applicant is approved, including: (A) an operating, safety, and emergency procedures manual to include specific information on: (i) radiation safety precautions and instructions; (ii) methodology for measurement of dosages or doses to be administered to patients or human or animal research subjects; (iii) calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and (iv) waste disposal procedures; and (B) any additional information required by this chapter requested by the department to assist in its review of the application; and (C) qualifications of the: (i) RSO as specified in subsection (c)(28) of this section; (ii) authorized users as specified in subsection (c)(6) of this section as applicable to the uses being requested; (iii) authorized medical physicist as specified in subsection (c)(4) of this section, if applicable; (iv) authorized nuclear pharmacist as specified in subsection (c)(5) of this section, if applicable; (v) ophthalmic physicist as specified in subsection (c)(19) of this section, if applicable; (vi) Radiation Safety Committee (RSC), as specified in subsection (i) of this section, if applicable; and (vii) ARSO as specified in subsection (c)(3) of this section, if applicable; and (4) the applicant's permanent facility is located in Texas. (g) Authority and responsibilities for the radiation protection program. (1) In addition to the radiation protection program requirements of §289.202(e) of this chapter, a licensee's management must approve in writing: (A) requests for a license application, renewal, or amendment before submittal to the department; and (B) any individual before being allowed to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist. (2) A licensee's management must appoint an RSO who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the RSO, must ensure radiation safety activities are being performed according to licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more ARSO to support the RSO. The RSO, with written agreement of the licensee's management, must assign the specific duties and tasks to each ARSO. These duties and tasks are restricted to the types of use for which the ARSO is listed on a license. The RSO may delegate duties and tasks to the ARSO but must not delegate the authority or responsibilities for implementing the radiation protection program. (3) Every licensee must establish in writing the authority, duties, and responsibilities of the RSO and ensure the RSO is provided sufficient authority, organizational freedom, time, resources, and management prerogative to perform the following duties: (A) establish and oversee operating, safety, emergency, and as low as reasonably achievable (ALARA) procedures, and to review them at least annually to ensure procedures are current and conform with this chapter; (B) ensure required radiation surveys and leak tests are performed and documented as specified in this chapter, including any corrective measures when levels of radiation exceed established limits; (C) ensure individual monitoring devices are used properly by occupationally exposed personnel, records are kept of the monitoring results, and timely notifications are made as specified in §289.203 of this chapter; (D) investigate and report an individual or radiation level detected over the limits established by this chapter and each theft or loss of sources of radiation, to determine the causes, and take steps to prevent a recurrence; (E) investigate and report to the department for each known or suspected case of release of radioactive material to the environment over the limits established by this chapter; (F) have a thorough knowledge of management policies and administrative procedures of the licensee; (G) identify radiation safety problems; (H) assume control and initiate, recommend, or provide corrective actions, including shutdown of operations when necessary, in emergency situations or unsafe conditions; (I) verify implementation of corrective actions; (J) ensure records are maintained as required by this chapter; (K) ensure proper storing, labeling, transport, use, and disposal of sources of radiation, storage, and transport containers; (L) ensure inventories are performed in accordance with the activities for which the license application is submitted; (M) ensure personnel are complying with this chapter, the conditions of the license, and the operating, safety, and emergency procedures of the licensee; and (N) serve as the primary contact with the department. (4) The RSO must ensure duties listed in paragraph (3)(A) - (N) of this subsection are performed. (5) The RSO must be onsite periodically, commensurate with the scope of licensed activities, to satisfy the requirements of paragraphs (3) and (4) of this subsection. (6) The RSO, or staff designated by the RSO, must be capable of physically arriving at the licensee's authorized use sites within a reasonable time of being notified of an emergency situation or unsafe condition. (7) For up to 60 days each calendar year, a licensee may permit an authorized user or an individual qualified to be an RSO, under subsections (h) and (m) of this section, to function as a temporary RSO and to perform the duties of an RSO as specified in paragraph (3) of this subsection, provided the licensee takes the actions required in paragraphs (2), (3), and (9) of this subsection, and notifies the department as specified in subsection (r)(5) of this section. Records of qualifications and dates of service must be maintained as specified in subsection (xxx) of this section for inspection by the department. (8) A licensee may simultaneously appoint more than one temporary RSO as specified in paragraph (7) of this subsection, if needed to ensure the licensee has a temporary RSO satisfying the requirements to be an RSO for each of the different types of uses of radioactive material permitted by the license. (9) The licensee must maintain records, as specified in subsection (xxx) of this section, as follows. (A) A licensee must retain a record of actions taken by the licensee's management as specified in paragraph (1) of this subsection. The record must include a summary of the actions taken and a signature of licensee management. (B) The authority, duties, and responsibilities of the RSO as required by paragraph (3) of this subsection, and a signed copy of each RSO's agreement to be responsible for implementing the radiation safety program, as required by paragraph (2) of this subsection. The records must include the signature of the RSO and licensee management. (C) A copy of the written document appointing the ARSO, for each ARSO appointed under paragraph (2) of this subsection. The record must include the signature of licensee management. (h) Training for an RSO and ARSO. Except as provided in subsection (l) of this section, the licensee must require the individual fulfilling the responsibilities of an RSO or an individual assigned duties and tasks as an ARSO as specified in subsection (g) of this section for licenses for medical or veterinary use of radioactive material, to be an individual who: (1) is certified by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state and who meets the requirements in paragraph (4) of this subsection. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page.(A) To have its certification process recognized, a specialty board must require all candidates for certification to: (i) hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science; (ii) have five or more years of professional experience in health physics (graduate training may be substituted for no more than two years of the required experience) including at least three years in applied health physics; and (iii) pass an examination, administered by diplomates of the specialty board evaluating knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or (B) to have its certification process recognized, a specialty board must require all candidates for certification to: (i) hold a master's or doctoral degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; (ii) have two years of full-time practical training or supervised experience in medical physics as follows: (I) under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the department, the NRC, or an agreement state; or (II) in clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in subsections (l), (jj), or (nn) of this section; and (iii) pass an examination, administered by diplomates of the specialty board, assessing knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or (2) has: (A) completed a structured educational program consisting of both: (i) 200 hours of classroom and laboratory training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; (IV) radiation biology; and (V) radiation dosimetry; and (ii) one year of full-time radiation safety experience under the supervision of the individual identified as the RSO on a department, NRC, or agreement state license or on a permit issued by an NRC master material licensee authorizing similar types of use of radioactive material. An ARSO may provide supervision for those areas for which the ARSO is authorized on a department, NRC, or an agreement state license or a permit issued by an NRC master material licensee. The full-time radiation safety experience must involve: (I) shipping, receiving, and performing related radiation surveys; (II) using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides; (III) securing and controlling radioactive material; (IV) using administrative controls to avoid mistakes in the administration of radioactive material; (V) using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; (VI) using emergency procedures to control radioactive material; and (VII) disposing of radioactive material; and (B) obtained written attestation, signed by a preceptor RSO or ARSO experienced with the radiation safety aspects of similar types of use of radioactive material for which the individual is seeking approval as an RSO or an ARSO. The written attestation must state the individual has satisfactorily completed the requirements in paragraphs (2)(A) and (4) of this subsection, and is able to independently fulfill the radiation safety-related duties as an RSO or as an ARSO for a medical or veterinary use license; or (3) meets one of the following: (A) is a medical physicist certified by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state as specified in subsection (j)(1) of this section, has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee is seeking approval of the individual as the RSO or ARSO, and meets the requirements in paragraph (4) of this subsection; (B) is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a department, NRC, or another agreement state's license; a permit issued by an NRC master material licensee; a permit issued by the department, the NRC, or another agreement state licensee of broad scope; or a permit issued by an NRC master material license broad scope permittee, has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee is seeking the approval of the individual as the RSO or ARSO, and who meets the requirements in paragraph (4) of this subsection; or (C) has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the RSO and the authorized user on the same new medical or veterinary use license or new medical use permit issued by an NRC master material licensee. The individual must also meet the requirements in paragraph (4) of this subsection; and (4) has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval, and this training requirement may be satisfied by completing training supervised by an RSO, an ARSO, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the types of use for which the licensee is seeking approval. (i) Radiation safety committee (RSC). Licensees of broad scope and licensees who are authorized for two or more different types of uses of radioactive material requiring a written directive under subsections (q), (kk), (rr), and (ddd) of this section, or two or more types of therapeutic units under subsections (q) and (ddd) of this section, must establish an RSC to oversee all uses of radioactive material permitted by the license. (1) The RSC must be composed of the following individuals: (A) an authorized user of each type of use permitted by the license; (B) the RSO; (C) a representative of the nursing service, if applicable; (D) a representative of management who is neither an authorized user nor the RSO; and (E) other members as the licensee deems appropriate. (2) Duties and responsibilities of the RSC. (A) For licensees without broad scope authorization, the duties and responsibilities of the RSC include: (i) meeting as often as necessary to conduct business but no less than three times a year; (ii) reviewing summaries of information presented by the RSO, including: (I) doses over the occupational or public limits; (II) significant incidents, including spills, contamination, or medical events; and (III) items of non-compliance following an inspection; (iii) reviewing the program for maintaining doses ALARA, and providing any necessary recommendations to ensure doses are ALARA; and (iv) reviewing the audit of the radiation safety program and acting upon the findings. (B) For licensees of broad scope, the duties and responsibilities of the RSC include the items in subparagraph (A) of this paragraph and: (i) reviewing the overall compliance status for authorized users; (ii) sharing responsibility with the RSO to conduct periodic audits of the radiation safety program; (iii) developing criteria to evaluate training and experience of new authorized user applicants; (iv) evaluating and approving authorized user applicants who request authorization to use radioactive material at the facility; and (v) reviewing and approving permitted program and procedural changes before implementation. (3) Records documenting the RSC meetings must be made and maintained for inspection by the department as specified in subsection (xxx) of this section. The record must include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. (j) Training for an authorized medical physicist. Except as provided in subsection (l) of this section, the licensee must require the authorized medical physicist to be: (1) an individual certified by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state and who meets the requirements in paragraph (3) of this subsection. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board must require all candidates to: (A) hold a master's or doctoral degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; (B) complete two years of full-time practical training or supervised experience in medical physics as follows: (i) under the supervision of a medical physicist who is certified in medical physics by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state; or (ii) in clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians meeting the requirements for authorized users in subsections (l), (zz), or (ttt) of this section; and (C) pass an examination, administered by diplomates of the specialty board, assessing knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or (2) an individual who: (A) holds a post graduate degree and experience, including: (i) a master's or doctoral degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and (ii) completion of one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual meeting the requirements for an authorized medical physicist for the types of use for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and must include: (I) performing sealed source leak tests and inventories; (II) performing decay corrections; (III) performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and (IV) conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and (B) has obtained written attestation the individual has satisfactorily completed the requirements in paragraphs (2)(A) and (3) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist meeting the requirements in subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and (3) an individual trained for the types of use for which authorization is sought, including hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the types of use for which the individual is seeking authorization. (k) Training for an authorized nuclear pharmacist. Except as provided in subsection (l) of this section, the licensee must require the authorized nuclear pharmacist to be a pharmacist who: (1) is certified by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board must require all candidates for certification to: (A) have graduated from a pharmacy program accredited by the Accreditation Council for Pharmacy Education or have passed the Foreign Pharmacy Graduate Examination Committee examination; (B) hold a current, active license to practice pharmacy in the State of Texas; (C) provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and (D) pass an examination in nuclear pharmacy, administered by diplomates of the specialty board, assessing knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, and research and development; or (2) has: (A) completed a 700-hour structured educational program, including both: (i) 200 hours of classroom and laboratory training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; (IV) chemistry of radioactive material for medical use; and (V) radiation biology; and (ii) supervised practical experience in a nuclear pharmacy involving: (I) shipping, receiving, and performing related radiation surveys; (II) using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides; (III) calculating, assaying, and safely preparing dosages for patients or human research subjects; (IV) using administrative controls to avoid medical events in the administration of radioactive material; and (V) using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and (B) obtained written attestation, signed by a preceptor authorized nuclear pharmacist, the individual has satisfactorily completed the requirements in paragraph (2)(A) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist. (l) Training for experienced RSO, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. (1) An individual identified on a department, NRC, or an agreement state license or a permit issued by the department, the NRC, or an agreement state broad scope licensee or master material license permit, or by a master material license permittee of broad scope as an RSO, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist, or an authorized nuclear pharmacist on or before January 14, 2019, need not comply with the training requirements of subsections (h), (j), and (k) of this section, respectively, except the RSO and authorized medical physicists identified in this paragraph must meet the training requirements in subsections (h)(4) or (j)(3) of this section, as appropriate, for any material or uses for which they were not authorized before this date. (2) Any individual certified by the American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of subsection (h) of this section to be identified as an RSO or as an ARSO on a department, NRC, or agreement state license or NRC master material license permit for those materials and uses these individuals performed on or before October 24, 2005. (3) Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in subsection (j) of this section, for those materials and uses these individuals performed on or before October 24, 2005. (4) An RSO, a medical physicist, or a nuclear pharmacist who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical or veterinary uses or in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of subsections (h), (j), or (k) of this section, respectively, when performing the same uses. A nuclear pharmacist who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist who used only accelerator-produced radioactive materials, at the locations and during the time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for the purposes of this chapter. (5) An individual identified as a physician, dentist, podiatrist, or veterinarian authorized for the medical or veterinary use of radioactive material. (A) Physicians, dentists, podiatrists, or veterinarians identified as authorized users for the medical or veterinary use of radioactive material on a license issued by the department, the NRC, or an agreement state; a permit issued by an NRC master material licensee; a permit issued by the department, the NRC, or an agreement state broad scope licensee; or a permit issued by an NRC master material license broad scope permittee on or before January 14, 2019, who perform only those medical or veterinary uses for which they were authorized on or before that date need not comply with the training requirements of subsections (gg) through (ttt) of this section. (B) Physicians, dentists, podiatrists, or veterinarians identified as authorized users for the medical or veterinary use of radioactive material on a license issued by the department, the NRC, or an agreement state; a permit issued by an NRC master material licensee; a permit issued by the department, the NRC, or an agreement state broad scope licensee; or a permit issued under an NRC master material broad scope license on or before October 24, 2005, need not comply with the training requirements of subsections (gg) through (ttt) of this section for those materials and uses these individuals performed on or before October 24, 2005, as follows: (i) for uses authorized under subsections (ff) or (hh) of this section, or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine; (ii) for uses authorized under subsection (kk) of this section, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984; (iii) for uses authorized under subsections (rr) or (ddd) of this section, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and (iv) for uses authorized under subsection (bbb) of this section, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada. (C) Physicians, dentists, podiatrists, or veterinarians who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical or veterinary uses performed at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of subsections (gg) through (ttt) of this section when performing the same medical or veterinary uses. A physician, dentist, podiatrist, or veterinarian who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical or veterinary uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for the purposes of this chapter. (6) Individuals who need not comply with training requirements in this subsection may serve as preceptors for, and supervisors of, applicants seeking authorization on a department, NRC, or agreement state license for the same uses for which these individuals are authorized. (m) Recentness of training. The training and experience specified in subsections (h), (j), and (gg) - (ttt) of this section for medical and veterinary use must have been obtained within the seven years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. (n) Licenses for medical and veterinary uses of radioactive material without broad scope authorization. In addition to the requirements of subsection (f) of this section, a license for medical and veterinary use of radioactive material as described in the applicable subsections (ff), (hh), (kk), (rr), (bbb), and (ddd) of this section is issued if the department approves documentation showing: (1) the physicians or veterinarians designated on the application as the authorized users are qualified as specified in subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), and (ttt) of this section, as applicable; (2) the radiation detection and measuring instrumentation is appropriate for performing surveys and procedures for the uses involved; (3) the radiation safety operating procedures are adequate for the handling and disposal of the radioactive material involved in the uses; and (4) an RSC has been established as specified in subsection (i) of this section, if applicable. (o) License for medical and veterinary uses of radioactive material with broad scope authorization. In addition to the requirements of subsection (f) of this section, a license for medical or veterinary use of radioactive material with broad scope authorization is issued if the department approves documentation showing: (1) the review of authorized user qualifications by the RSC is as specified in subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), and (ttt) of this section, as applicable; (2) the application is for a license authorizing unspecified forms or multiple types of radioactive material for medical research, diagnosis, and therapy; (3) the radiation detection and measuring instrumentation is appropriate for performing surveys and procedures for the uses involved; (4) the radiation safety operating procedures are adequate for the handling and disposal of the radioactive material involved in the uses; (5) staff has substantial experience in the use of a variety of radioactive material for a variety of human and animal uses; (6) the full-time RSO meets the requirements of subsection (h) of this section; and (7) an RSC has been established as specified in subsection (i)(1) of this section. (p) License for the use of remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units. In addition to the requirements of subsection (f) of this section, a license for the use of remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units is issued if the department approves documentation showing: (1) the physicians designated on the application as the authorized users are qualified as specified in subsection (ttt) of this section; (2) the radiation detection and measuring instrumentation is appropriate for performing surveys and procedures for the uses involved; (3) the radiation safety operating procedures are adequate for the handling and disposal of the radioactive material involved in the uses; (4) the radioactive isotopes to be possessed; (5) the sealed source manufacturer names and the model numbers of the sealed sources to be installed; (6) the maximum number of sealed sources of each isotope to be possessed, including the activity of each sealed source; (7) the manufacturer and model designation of the following units, as applicable: (A) remote afterloader unit; (B) teletherapy unit; or (C) gamma stereotactic radiosurgery unit; (8) the authorized medical physicist designated on the application is qualified as specified in subsection (j) of this section; (9) the safety procedures and instructions as required by subsection (ggg) of this section; (10) the spot check procedures as required by subsections (mmm) - (ooo) of this section, as applicable; and (11) an RSC has been established as specified in subsection (i) of this section, if applicable. (q) License for other medical or veterinary uses of radioactive material or a radiation source approved for medical or veterinary use not specifically addressed in this section. In addition to the requirements of subsection (f) of this section, a licensee may use radioactive material or a radiation source approved for medical or veterinary use not specifically addressed in this section if: (1) the department approves the following documentation submitted by the applicant: (A) any additional aspects of the medical or veterinary use of the material applicable to radiation safety not addressed in, or different from, requirements in this section; (B) identification of and commitment to follow the applicable radiation safety program requirements in this section appropriate for the specific medical or veterinary use; (C) any additional specific information on: (i) radiation safety precautions and instructions; (ii) methodology for measurement of dosages or doses to be administered to patients or human or animal research subjects; and (iii) calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and (D) any other information requested by the department in its review of the application; and (2) the applicant or licensee has received written approval from the department in a license or license amendment and the licensee uses the material in accordance with the regulations and specific conditions the department considers necessary for the medical or veterinary use of the material. (r) License amendments and notifications. (1) Requests for amendment of a license or deletion of an authorized use site must be filed as specified in §289.252(aa) of this subchapter. (2) A licensee must apply for and must receive a license amendment before: (A) receiving or using radioactive material for a type of use authorized by this section, but not authorized on their current license issued under this section; (B) permitting anyone to work as an authorized user, authorized nuclear pharmacist, authorized medical physicist, or ophthalmic physicist under the license except an individual who is identified as an authorized user, an authorized nuclear pharmacist, authorized medical physicist, or an ophthalmic physicist: (i) on a department, NRC, or agreement state license or other equivalent permit or license recognized by the department authorizing the use of radioactive material in medical or veterinary use or in the practice of nuclear pharmacy; (ii) on a permit issued by a department, NRC, or agreement state specific license of broad scope authorized to permit the use of radioactive material in medical or veterinary use or in the practice of nuclear pharmacy; (iii) on a permit issued by an NRC master material licensee authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy; or (iv) by a commercial nuclear pharmacy authorized to identify authorized nuclear pharmacists. (C) changing RSOs, except as provided in subsection (g)(7) of this section; (D) receiving radioactive material more than the amount or in a different form, or receiving a different radionuclide than authorized on the license; (E) adding or changing the areas where radioactive material is used or stored and identified in the application or on the license, including areas used as specified in subsection (ff) or (hh) of this section if the change includes addition or relocation of either an area where positron emission tomography (PET) radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area. Other areas of use where radioactive material is used only as specified in either subsection (ff) or (hh) of this section, are exempt; (F) changing the addresses of use identified in the application or on the license; (G) changing operating, safety, and emergency procedures; however, a licensee may revise its radiation protection program without the department's approval if the revision does not require a license amendment under the other provisions of this paragraph; and(i) the revision does not reduce the safety of an affected facility;(ii) the revision is in compliance with the rules in this chapter and the license;(iii) the revision has been reviewed and approved by the RSO and licensee management;(iv) the affected individuals are instructed on the revised program before the changes are implemented;(v) all changes to the radiation protection program are submitted to the department after the provisions of this subparagraph are completed; and(vi) the licensee retains a record of each change to the radiation protection program as specified in §289.202(mm) of this chapter.(H) before permitting anyone to work as an ARSO, or before the RSO assigns duties and tasks to an ARSO differing from those for which this individual is authorized on the license; and (I) before receiving a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license. (3) A licensee possessing a Type A specific license of broad scope for medical or veterinary use, issued under §289.252(h)(2) of this subchapter, is exempt from: (A) the provisions of subsection (q)(1) of this section regarding the need to file an amendment to the license for medical or veterinary use of radioactive material; (B) the provisions of paragraph (2)(B) of this subsection; (C) the provisions of paragraph (2)(E) of this subsection regarding additions to or changes in the areas of use at the addresses identified in the application or on the license; (D) the provisions of paragraph (4) of this subsection; (E) the provisions of paragraph (5)(A) of this subsection for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist; (F) the provisions of paragraph (5)(C) of this subsection; and (G) the provisions of subsection (u)(1) of this section. (4) A licensee must notify the department in the form of a license amendment request no later than 30 days after the date that the licensee permits an individual to work under the provisions of this subsection as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist providing the individual is authorized on a license for the same use. A licensee includes with the notification the following documentation: (A) a copy of the department, NRC, or agreement state license; (B) the permit issued by an NRC master material licensee; (C) the permit issued by the department, the NRC, or an agreement state licensee of broad scope; or (D) the permit issued by an NRC master material license broad scope permittee. (5) A licensee must notify the department in the form of a license amendment request no later than 30 days after: (A) an authorized user, an authorized nuclear pharmacist, an RSO, an ARSO, an authorized medical physicist, or an ophthalmic physicist permanently discontinues performance of duties under the license or has a name change; (B) the licensee permits an individual qualified to be an RSO under subsections (h) and (m) of this section to function as a temporary RSO and to perform the functions of an RSO as specified in subsection (g)(6) of this section; (C) the licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used as specified in either subsection (ff) or (hh) of this section, if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area; or (D) the licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in paragraph (1) of this subsection. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source. (s) Supervision. A licensee may permit the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user, unless prohibited by license condition. (1) A licensee who permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user must: (A) instruct the supervised individual in the licensee's written operating, safety, and emergency procedures, written directive procedures, requirements of this chapter, and license conditions with respect to the use of radioactive material; and (B) require the supervised individual to follow the instructions of the supervising authorized user for medical or veterinary uses of radioactive material, written operating, safety, and emergency procedures established by the licensee, written directive procedures, requirements of this chapter, and license conditions with respect to the medical or veterinary use of radioactive material. (2) A licensee who permits the preparation of radioactive material for medical or veterinary use by an individual under the supervision of an authorized nuclear pharmacist or authorized user must: (A) instruct the supervised individual in the preparation of radioactive material for medical or veterinary use, as appropriate to that individual's involvement with radioactive material; and (B) require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical or veterinary use, the written operating, safety, and emergency procedures established by the licensee, the requirements of this chapter, and license conditions. (3) A licensee who permits supervised activities as specified in paragraphs (1) and (2) of this subsection is responsible for the acts and omissions of the supervised individual. (4) Only an authorized user may authorize the medical or veterinary use of radioactive material. (t) Written directives. (1) A written directive must be dated and signed by an authorized user before any administration of sodium iodide I-131 greater than 30 microcuries (µCi) (1.11 megabequerels (MBq)), administration of any therapeutic dosage of unsealed radioactive material, or administration of any therapeutic dose of radiation from radioactive material. If, because of the emergent nature of the patient's condition, a delay to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented in writing as soon as possible in the patient's record. A written directive must be prepared and signed by the authorized user within 48 hours of the oral directive. (2) The written directive must contain the patient or human research subject's name and the following information for each application. (A) For any administration of quantities greater than 30 µCi (1.11 MBq) of sodium iodide I-131: the dosage. (B) For an administration of a therapeutic dosage of a radiopharmaceutical other than sodium iodide I-131: the radiopharmaceutical, the dosage, and the route of administration. (C) For gamma stereotactic radiosurgery: the total dose, the treatment site, and the values for the target coordinate settings per treatment for each anatomically distinct treatment site. (D) For teletherapy: the total dose, the dose per fraction, the number of fractions, and the treatment site. (E) For high-dose rate remote afterloading brachytherapy: the radionuclide, the treatment site, the dose per fraction, the number of fractions, and the total dose. (F) For permanent implant brachytherapy: (i) before implantation: the treatment site, the radionuclide, and the total source strength; and (ii) after implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date. (G) For all other brachytherapy, including low, medium, and pulsed rate afterloaders: (i) before implantation: the treatment site, the radionuclide, and the dose; (ii) after implantation but before completion of the procedure: the radionuclide, the treatment site, the number of sealed sources, the total sealed source strength, exposure time (or the total dose), and the date. (3) A written revision to an existing written directive. (A) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose. (B) If, because of the patient's condition, a delay to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within 48 hours of the oral revision. (4) The licensee must retain the written directive as specified in subsection (xxx) of this section for inspection by the department. (5) Procedures for administrations requiring a written directive. (A) For any administration requiring a written directive, the licensee must develop, implement, and maintain written procedures to provide high confidence: (i) the patient's or human research subject's identity is verified before each administration; and (ii) each administration is in accordance with the written directive. (B) The procedures required by subparagraph (A) of this paragraph must, at a minimum, address the following items applicable for the licensee's use of radioactive material: (i) verifying the identity of the patient or human research subject; (ii) verifying the administration is in accordance with the treatment plan, if applicable, and the written directive; (iii) checking both manual and computer-generated dose calculations; (iv) verifying any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by subsections (q) and (ddd) of this section; (v) determining if a medical event, as defined in subsection (uuu) of this section, has occurred; and (vi) determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented. (C) A licensee must maintain a copy of the procedures required by subparagraph (A) of this paragraph as specified in subsection (xxx) of this section. (u) Suppliers for sealed sources or devices for medical or veterinary use. A licensee may only use the following for medical or veterinary use: (1) sealed sources or devices manufactured, labeled, packaged, and distributed as specified in a license issued under §289.252(o) of this subchapter or equivalent requirements of the NRC or an agreement state; (2) sealed sources or devices non-commercially transferred from an NRC or agreement state medical or veterinary use licensee; or (3) teletherapy sources manufactured and distributed as specified in a license issued by the department, the NRC, or an agreement state. (v) Possession, use, and calibration of dose calibrators to measure the activity of unsealed radioactive material. (1) For direct measurements performed as specified in subsection (x) of this section, the licensee must possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human or animal research subject. (2) The licensee must calibrate the instrumentation specified in paragraph (1) of this subsection in accordance with nationally recognized standards or the manufacturer's instructions. (3) The calibration required by paragraph (2) of this subsection must include tests for constancy, accuracy, linearity, and geometry dependence, as appropriate to demonstrate proper operation of the instrument. The tests for constancy, accuracy, linearity, and geometry dependence must be conducted at the following intervals: (A) constancy at least once each day before assay of patient dosages; (B) linearity at installation, repair, relocation, and at least quarterly thereafter; (C) geometry dependence at installation; and (D) accuracy at installation and at least annually thereafter. (4) The licensee must maintain a record of each instrument calibration as specified in subsection (xxx) of this section. The record must include: (A) model and serial number of the instrument and calibration sources; (B) complete date of the calibration including the month, day, and year; (C) results of the calibration; and (D) name of the individual who performed the calibration. (w) Calibration of survey instruments. A licensee must calibrate the survey instruments used to show compliance with this subsection and with §289.202 of this chapter before first use, annually, and following a repair affecting the calibration. A licensee must: (1) calibrate all scales with readings up to 10 millisieverts (mSv) (1000 millirem (mrem)) per hour with a radiation source; (2) calibrate two separated readings on each scale or decade used to show compliance; (3) conspicuously note on the instrument the complete date of the calibration including the month, day, and year; (4) not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent; and (5) maintain a record of each survey instrument calibration as specified in subsection (xxx) of this section. (x) Determination of dosages of unsealed radioactive material for medical or veterinary use. (1) Before medical or veterinary use, the licensee must determine and record the activity of each dosage. (2) For a unit dosage, this determination must be made by: (A) direct measurement of radioactivity; or (B) a decay correction, based on the activity or activity concentration determined by: (i) a manufacturer or preparer licensed as specified in §289.252(r) of this subchapter, or under an equivalent NRC or agreement state license; (ii) an NRC or agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by the FDA; or (iii) a PET radioactive drug producer licensed as specified in §289.252(kk) of this subchapter or equivalent NRC or agreement state requirements. (3) For other than unit dosages, this determination must be made by: (A) direct measurement of radioactivity; (B) combination of measurement of radioactivity and mathematical calculations; or (C) combination of volumetric measurements and mathematical calculations, based on the measurement made by: (i) a manufacturer or preparer licensed as specified in §289.252(r) of this subchapter, or under an equivalent NRC or agreement state license; or (ii) a PET radioactive drug producer licensed as specified in §289.252(kk) of this subchapter or equivalent NRC or agreement state requirements. (4) Unless otherwise directed by the authorized user, a licensee must not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent. (5) A licensee restricted to only unit doses prepared as specified in §289.252(r) of this subchapter need not comply with paragraph (2) of this subsection unless the administration time of the unit dose deviates from the nuclear pharmacy's pre-calibrated time by 15 minutes or more. (6) A licensee must maintain a record of the dosage determination required by this subsection as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) the radiopharmaceutical; (B) patient's or human or animal research subject's name or identification number, if one has been assigned; (C) prescribed dosage; (D) determined dosage or a notation the total activity is less than 30 µCi (1.1 MBq); (E) the date and time of the dosage determination; and (F) the name of the individual who determined the dosage. (y) Authorization for calibration, transmission, and reference sources. (1) Any licensee authorized by subsections (n), (o), (p), or (q) of this section for medical or veterinary use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use: (A) sealed sources, not exceeding 30 millicuries (mCi) (1.11 gigabecquerel (GBq)) each, manufactured and distributed by a person licensed under §289.252(o) of this subchapter or equivalent NRC or agreement state regulations; (B) sealed sources, not exceeding 30 mCi (1.11 GBq) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under §289.252(o) of this subchapter or equivalent NRC or agreement state regulations, provided the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions; (C) any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 15 mCi (0.56 GBq); (D) any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 200 µCi (7.4 MBq) or 1000 times the quantities in §289.202(ggg)(3) of this chapter; and (E) technetium-99m in amounts as needed. (2) Radioactive material in sealed sources authorized by this subsection must not be: (A) used for medical or veterinary use as defined in subsection (c) of this section except as specified in the requirements in subsection (bbb) of this section; or (B) combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this section. (3) A licensee using calibration, transmission, and reference sources as specified in the requirements in paragraph (1) or (2) of this subsection need not list these sources on a specific medical or veterinary use license. (z) Requirements for possession of sealed sources and brachytherapy sealed sources. A licensee in possession of any sealed source or brachytherapy source must: (1) follow the radiation safety and handling instructions supplied by the manufacturer and the leakage test requirements as specified in §289.201(g) of this chapter and reporting requirements in §289.202(bbb) of this chapter; and (2) conduct a physical inventory at intervals not to exceed six months to account for all sealed sources in its possession. Records of the inventory must be made and maintained for inspection by the department as specified in subsection (xxx) of this section and must include: (A) model number of each source and serial number if one has been assigned; (B) identity of each source and its nominal activity; (C) location of each source; (D) date of the inventory; and (E) name of the individual who performed the inventory. (aa) Labeling of vials and syringes. Each syringe and vial containing a radiopharmaceutical must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded. (bb) Surveys for ambient radiation exposure rate. (1) In addition to the requirements of §289.202(p) of this chapter and except as provided in paragraph (2) of this subsection, a licensee must survey, with a radiation detection survey instrument, at the end of each day of use, all areas where radioactive material requiring a written directive was prepared for use or administered. (2) A licensee is not required to perform the surveys required by paragraph (1) of this subsection in an area where patients or human research subjects are confined when they cannot be released as specified in subsection (cc) of this section or an animal that is confined. Once the patient or human or animal research subject is released from confinement, the licensee must survey with a radiation survey instrument the area in which the patient or human or animal research subject was confined. (3) A record of each survey must be retained as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) date of the survey; (B) results of the survey; (C) manufacturer's name, model, and serial number of the instrument used to make the survey; and (D) name of the individual who performed the survey. (cc) Release of individuals containing radioactive drugs or implants containing radioactive material. (1) The licensee may authorize the release from its control, any individual administered radioactive drugs or implants containing radioactive material if the total effective dose equivalent (TEDE) to any other individual from exposure to the released individual is not likely to exceed 0.5 rem (5 mSv).(2) The licensee must provide the released individual, or the individual's parent or guardian, with written instructions on actions recommended to maintain doses to other individuals ALARA if the TEDE to any other individual is likely to exceed 0.1 rem (1 mSv). If the TEDE to a nursing infant or child could exceed 0.1 rem (1 mSv), assuming there was no interruption of breast-feeding, the instructions must include: (A) guidance on the interruption or discontinuation of breast-feeding; and (B) information on the potential consequences, if any, of failure to follow the guidance. (3) The licensee must maintain for inspection by the department, a record as specified in subsection (xxx) of this section of each patient released according to paragraph (1) of this subsection. The record must include: (A) the basis for authorizing the release of an individual; and (B) the instructions provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a TEDE exceeding 0.5 rem (5 mSv). (dd) Mobile nuclear medicine service. A license for a mobile nuclear medicine service for medical or veterinary use of radioactive material is issued if the department approves the documentation submitted by the applicant as specified in the requirements of subsections (f) and (n) of this section. The clients of the mobile nuclear medicine service must be licensed if the client receives or possesses radioactive material to be used by the mobile nuclear medicine service. (1) A licensee providing mobile nuclear medicine service must: (A) obtain a letter signed by the management of each client for which services are rendered permitting the use of radioactive material at the client's address and clearly delineating the authority and responsibility of the licensee and the client; (B) check instruments used to measure the activity of unsealed radioactive material for proper function before medical or veterinary use at each client's address or on each day of use, whichever is more frequent. As a minimum, the check for proper function required by this subparagraph must include a constancy check; (C) have at least one fixed facility where records are maintained and radioactive material is delivered by manufacturers or distributors each day before the mobile nuclear medicine licensee dispatches its vehicles to client sites; (D) agree to have an authorized physician user directly supervise each technologist at a reasonable frequency; (E) check survey instruments for proper operation with a dedicated check source before use at each client's address; and (F) before leaving a client's address, survey all areas of use to ensure compliance with the requirements of §289.202 of this chapter. (2) A mobile nuclear medicine service must not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client must be received and handled in conformance with the client's license. (3) A licensee providing mobile nuclear medicine services must maintain records, for inspection by the department, as specified in subsection (xxx) of this section including the letter required in paragraph (1)(A) of this subsection and the record of each survey required in paragraph (1)(F) of this subsection. (ee) Decay-in-storage. (1) The licensee may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage and dispose of it without regard to its radioactivity if the licensee: (A) monitors radioactive material at the surface before disposal and determines its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and (B) removes or obliterates all radiation labels, except for radiation labels on materials within containers and handled as biomedical waste after it has been released from the licensee. (2) The licensee must retain a record of each disposal as required by paragraph (1) of this subsection as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) date of the disposal; (B) manufacturer's name, model number, and serial number of the survey instrument used; (C) background radiation level; (D) radiation level measured at the surface of each waste container; and (E) name of the individual who performed the survey. (ff) Use of unsealed radioactive material for uptake, dilution, and excretion studies not requiring a written directive. Except for quantities that require a written directive as specified in subsection (t) of this section, a licensee may use any unsealed radioactive material prepared for medical or veterinary use for uptake, dilution, or excretion studies: (1) obtained from: (A) a manufacturer or preparer licensed as specified in §289.252(r) of this subchapter or equivalent NRC or agreement state requirements; or (B) a PET radioactive drug producer licensed as specified in §289.252(kk) of this subchapter or equivalent NRC or agreement state requirements; or (2) excluding production of PET radionuclides, prepared by: (A) an authorized nuclear pharmacist; or (B) a physician or veterinarian who is an authorized user and who meets the requirements specified in subsections (jj) or (nn) and (jj)(3)(A)(ii)(VII) of this section; or (C) an individual under the supervision, as specified in subsection (s) of this section, of the authorized nuclear pharmacist in subparagraph (A) of this paragraph, or the physician or veterinarian who is an authorized user in subparagraph (B) of this paragraph; or (3) obtained from and prepared by an NRC or agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by the FDA; or (4) prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by the FDA. (gg) Training for uptake, dilution, and excretion studies. Except as provided in subsection (l) of this section, the licensee must require an authorized user of unsealed radioactive material for the uses authorized in subsection (ff) of this section to be: (1) a physician certified by a medical specialty board whose certification process is recognized by the department, the NRC, or an agreement state. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification recognized, a specialty board must require all candidates for certification to: (A) complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies as described in paragraph (3)(A) of this subsection; and (B) pass an examination, administered by diplomates of the specialty board, assessing knowledge and competence in radiation safety, radionuclide handling, and quality control; or (2) an authorized user as specified in subsections (jj) or (nn) of this section or equivalent NRC or agreement state requirements; or (3) a physician or veterinarian who:(A) completes 60 hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical or veterinary use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include: (i) classroom and laboratory training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; (IV) chemistry of radioactive material for medical or veterinary use; and (V) radiation biology; and (ii) work experience, under the supervision of an authorized user meeting the requirements of this subsection, subsections (l), (jj), or (nn) of this section, or equivalent NRC or agreement state requirements involving: (I) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) calculating, measuring, and safely preparing patient or human or animal research subject dosages; (IV) using administrative controls to prevent a medical event involving the use of unsealed radioactive material; (V) using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (VI) administering dosages of radioactive drugs to patients or human or animal research subjects; and (B) obtains written attestation the individual has satisfactorily completed the requirements in subparagraph (A) of this paragraph and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical or veterinary uses authorized under subsection (ff) of this section. The attestation must be obtained from either: (i) a preceptor authorized user who meets the requirements of subsection (l) of this section, this subsection, or subsections (jj) or (nn) of this section, or equivalent NRC or agreement state requirements; or (ii) a residency program director affirming in writing the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in subsections (l), (gg), (jj), or (nn) of this section, or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subparagraph (A) of this paragraph. (hh) Use of unsealed radioactive material for imaging and localization studies not requiring a written directive. Except for quantities requiring a written directive as specified in subsection (t) of this section, a licensee may use any unsealed radioactive material prepared for medical or veterinary use for imaging and localization studies: (1) obtained from: (A) a manufacturer or preparer licensed as specified in §289.252(r) of this subchapter or equivalent NRC or agreement state requirements; or (B) a PET radioactive drug producer licensed as specified in §289.252(kk) of this subchapter or equivalent NRC or agreement state requirements; or (2) excluding production of PET radionuclides prepared by: (A) an authorized nuclear pharmacist; or (B) a physician or veterinarian who is an authorized user and who meets the requirements specified in subsections (jj) or (nn) and (jj)(3)(A)(ii)(VII) of this section; or (C) an individual under the supervision, as specified in subsection (s) of this section, of the authorized nuclear pharmacist in subparagraph (A) of this paragraph, or the physician or veterinarian who is an authorized user in subparagraph (B) of this paragraph; or (3) obtained from and prepared by an NRC or agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by the FDA; or (4) prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by the FDA. (ii) Permissible molybdenum-99, strontium-82, and strontium-85 concentrations. (1) The licensee may not administer to humans a radiopharmaceutical containing: (A) more than 0.15 µCi of molybdenum-99 per mCi of technetium-99m (0.15 kilobecquerel (kBq) of molybdenum-99 per MBq of technetium-99m); or (B) more than 0.02 µCi of strontium-82 per mCi of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82 chloride) injection; or (C) more than 0.2 µCi of strontium-85 per mCi of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride) injection. (2) The licensee using molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical must measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with paragraph (1) of this subsection. (3) The licensee using a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical must, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with paragraph (1) of this subsection. (4) If the licensee is required to measure the molybdenum-99 or strontium-82 and strontium-85 concentrations, the licensee must retain a record of each measurement as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) for each measured elution of technetium-99m: (i) the ratio of the measures expressed as µCi of molybdenum-99 per mCi of technetium-99m (kBq of molybdenum-99 per MBq of technetium-99m); (ii) time and date of the measurement; and (iii) name of the individual who made the measurement. (B) for each measured elution of rubidium-82: (i) the ratio of the measures expressed as µCi of strontium-82 per mCi of rubidium (kBq of strontium-82 per MBq of rubidium-82); (ii) the ratio of the measures expressed as µCi of strontium-85 per mCi of rubidium (kBq of strontium-85 per MBq of rubidium-82); (iii) time and date of the measurement; and (iv) name of the individual who made the measurement. (5) The licensee must report any measurement that exceeds the limits in paragraph (1) of this subsection at the time of generator elution, as specified in subsection (www) of this section. (jj) Training for imaging and localization studies. Except as provided in subsection (l) of this section, the licensee must require an authorized user of unsealed radioactive material for the uses authorized in subsection (hh) of this section to be: (1) a physician certified by a medical specialty board whose certification process is recognized by the department, the NRC, or an agreement state. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board must require all candidates for certification to: (A) complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies as described in paragraph (3) of this subsection; and (B) pass an examination, administered by diplomates of the specialty board, assessing knowledge and competence in radiation safety, radionuclide handling, and quality control; or (2) an authorized user as specified in subsection (nn) of this section and who meets the requirements of paragraph (3)(A)(ii)(VII) of this subsection or equivalent NRC or agreement state requirements; or (3) a physician or veterinarian who: (A) completes 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical or veterinary use of unsealed radioactive material for imaging and localization studies. The training and experience must include: (i) classroom and laboratory training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; (IV) chemistry of radioactive material for medical or veterinary use; and (V) radiation biology; and (ii) work experience under the supervision of an authorized user who meets the requirements in subsection (l) of this section, this subsection, or paragraph (3)(A)(ii)(VII) of this section, and subsection (nn) of this section, or equivalent NRC or agreement state requirements. An authorized nuclear pharmacist who meets the requirements in subsections (k) or (l) of this section may provide the supervised work experience for subclause (VII) of this clause. Work experience must involve: (I) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) calculating, measuring, and safely preparing patient or human or animal research subject dosages; (IV) using administrative controls to prevent a medical event involving the use of unsealed radioactive material; (V) using procedures to contain spilled radioactive material safely and using proper decontamination procedures; (VI) administering dosages of radioactive drugs to patients or human or animal research subjects; and (VII) eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and (B) obtains written attestation the individual has satisfactorily completed the requirements in this paragraph and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical or veterinary uses authorized under subsections (ff) and (hh) of this section. The attestation must be obtained from either: (i) a preceptor authorized user meeting the requirements of subsection (l) of this section, this subsection, or paragraph (3)(A)(ii)(VII) of this subsection, and subsection (nn) of this section, or equivalent NRC or agreement state requirements; or (ii) a residency program director affirming in writing the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user meeting the requirements in subsections (l), (jj), or (nn) of this section and paragraph (3)(A)(ii)(VII) of this subsection, or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in this paragraph. (kk) Use of unsealed radioactive material requiring a written directive. A licensee may use any unsealed radioactive material identified in subsection (nn)(2)(A)(ii)(VI) of this section prepared for medical or veterinary use requiring a written directive: (1) obtained from: (A) a manufacturer or preparer licensed as specified in §289.252(r) of this subchapter or equivalent NRC or agreement state requirements; (B) a PET radioactive drug producer licensed as specified in §289.252(kk) of this subchapter or equivalent NRC or agreement state requirements; or (2) excluding production of PET radionuclides prepared by: (A) an authorized nuclear pharmacist; or (B) a physician or veterinarian who is an authorized user and meets the requirements specified in subsections (jj) or (nn) of this section; or (C) an individual under the supervision, as specified in subsection (s) of this section, of the authorized nuclear pharmacist in subparagraph (A) of this paragraph, or the physician or veterinarian who is an authorized user in subparagraph (B) of this paragraph; or (3) obtained from and prepared by an NRC or agreement state licensee for use in research in accordance with an IND protocol accepted by the FDA; or (4) prepared by the licensee for use in research in accordance with an IND protocol accepted by the FDA. (ll) Safety instruction to personnel. (1) The licensee must provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human or animal research subjects who cannot be released as specified in subsection (cc) of this section. The instruction must be appropriate to the personnel's assigned duties and include: (A) patient or human or animal research subject control; and (B) visitor control, including: (i) routine visitation to hospitalized individuals or animals as specified in §289.202(n) of this chapter; (ii) contamination control; (iii) waste control; and (iv) notification of the RSO, or his or her designee, and an authorized user if the patient or the human or animal research subject has a medical emergency or dies. (2) The licensee must maintain a record for inspection by the department, as specified in subsection (xxx) of this section, of individuals receiving instruction. The record must include: (A) list of the topics covered; (B) date of the instruction or training; (C) names of the attendees; and (D) names of the personnel who provided the instruction. (mm) Safety precautions. For each human patient or human research subject who cannot be released as specified in subsection (cc) of this section, the licensee must: (1) provide a private room with a private sanitary facility; or (2) provide a room with a private sanitary facility with another individual who also has received therapy with an unsealed radioactive material and who also cannot be released as specified in subsection (cc) of this section; (3) post the patient's or the research subject's room with a "Radioactive Materials" sign and note on the door and in the patient's or research subject's chart where and how long visitors may stay in the patient's or the research subject's room; and (4) either monitor material and items removed from the patient's or the research subject's room to determine their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or, handle such material and items as radioactive waste; and (5) notify the RSO, or his or her designee, and the authorized user immediately if the patient or research subject has a medical emergency or dies. (nn) Training for use of unsealed radioactive material requiring a written directive. Except as provided in subsection (l) of this section, the licensee must require an authorized user of unsealed radioactive material for the uses authorized in subsection (kk) of this section to be: (1) a physician certified by a medical specialty board whose certification process is recognized by the department, the NRC, or an agreement state and who meets the requirements in paragraph (2)(A)(ii)(VI) of this subsection. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To be recognized, a specialty board must require all candidates for certification to: (A) successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in paragraph (2)(A)(i) - (2)(A)(ii)(V) of this subsection. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association; and (B) pass an examination, administered by diplomates of the specialty board assessing knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required; or (2) a physician or veterinarian who:(A) completes 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical or veterinary use of unsealed radioactive material requiring a written directive. The training and experience must include:(i) classroom and laboratory training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; (IV) chemistry of radioactive material for medical or veterinary use; and (V) radiation biology; and (ii) work experience, under the supervision of an authorized user meeting the requirements of subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements. A supervising authorized user meeting the requirements of this paragraph must have experience in administering dosages in the same dosage category or categories (i.e., subclause (VI) of this clause) as the individual requesting authorized user status. The work experience must involve: (I) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) calculating, measuring, and safely preparing patient or human or animal research subject dosages; (IV) using administrative controls to prevent a medical event involving the use of unsealed radioactive material; (V) using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (VI) administering dosages of radioactive drugs to patients or human or animal research subjects from the three categories in the following items. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under subsection (q) of this section. For each category in which the individual is requesting authorized user status, the work experience must involve a minimum of three cases in: (-a-) oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131, for which a written directive is required; (-b-) oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide I-131 (experience with at least three cases in this item also satisfies the requirement of item (-a-) of this subclause); and (-c-) parenteral administration of any radioactive drug that contains a radionuclide primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 kiloelectron volts (keV) for which a written directive is required; and (B) obtains written attestation the individual has satisfactorily completed the requirements of paragraph (2)(A) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical or veterinary uses authorized under subsection (kk) of this section for which the individual is requesting authorized user status. The attestation must be obtained from either: (i) a preceptor authorized user meeting the requirements of subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or (ii) a residency program director affirming in writing the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user meeting the requirements in subsections (l) or (nn) of this section, or equivalent NRC or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurring with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in this paragraph. (oo) Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 33 mCi (1.22 GBq). Except as provided in subsection (l) of this section, the licensee must require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 33 mCi (1.22 GBq) to be: (1) a physician certified by a medical specialty board whose certification process includes all the requirements of paragraph (3)(A) of this subsection and whose certification is recognized by the department, the NRC, or an agreement state (names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page); or (2) an authorized user as specified in subsection (nn) of this section for uses listed in subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-) of this section, or subsection (pp) of this section, or equivalent NRC or agreement state requirements; or (3) a physician or veterinarian who:(A) successfully completes 80 hours of classroom and laboratory training and work experience applicable to the medical or veterinary use of sodium iodide I-131 for procedures requiring a written directive. The training and experience must include:(i) classroom and laboratory training, including: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; (IV) chemistry of radioactive material for medical or veterinary use; and (V) radiation biology; and (ii) work experience, under the supervision of an authorized user meeting the requirements of subsection (l) of this section, this subsection, subsection (nn) or subsection (pp) of this section, or equivalent NRC or agreement state requirements. A supervising authorized user meeting the requirements in subsection (nn)(2) of this section must also have experience in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-) of this section. The work experience must involve: (I) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) calculating, measuring, and safely preparing patient or human or animal research subject dosages; (IV) using administrative controls to prevent a medical event involving the use of unsealed radioactive material; (V) using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (VI) administering dosages of radioactive drugs to patients or human or animal research subjects that includes at least three cases involving the oral administration of less than or equal to 33mCi (1.22 GBq) of sodium iodide I-131; and (B) obtains written attestation the individual has satisfactorily completed the requirements of paragraph (3)(A) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131 for medical or veterinary uses authorized under subsection (kk) of this section. The attestation must be obtained from either: (i) a preceptor authorized user meeting the requirements of subsection (l) of this section, this subsection, subsection (nn) or subsection (pp) of this section, or equivalent NRC or agreement state requirements and has experience in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-) of this section; or (ii) a residency program director affirming in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user meeting the requirements in subsections (l), (nn), (oo), or (pp) of this section, or equivalent NRC or agreement state requirements, has experience in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-), and concurring with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in this paragraph. (pp) Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 33 mCi (1.22 GBq). Except as provided in subsection (l) of this section, the licensee must require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 33 mCi (1.22 GBq) to be: (1) a physician certified by a medical specialty board whose certification process includes all the requirements in paragraph (3)(A) of this subsection and whose certification is recognized by the department, the NRC, or an agreement state (names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page); or (2) an authorized user as specified in subsection (nn) of this section or equivalent NRC or agreement state requirements for uses listed in subsection (nn)(2)(A)(ii)(VI)(-b-) of this section; or (3) a physician or veterinarian who:(A) successfully completes 80 hours of classroom and laboratory training applicable to the medical or veterinary use of sodium iodide I-131 for procedures requiring a written directive. The training and experience must include:(i) classroom and laboratory training, including:(I) radiation physics and instrumentation;(II) radiation protection;(III) mathematics pertaining to the use and measurement of radioactivity;(IV) chemistry of radioactive material for medical or veterinary use; and(V) radiation biology; and(ii) work experience, under the supervision of an authorized user meeting the requirements of subsection (l) of this section, subsections (nn) or (pp) of this section, or equivalent NRC or agreement state requirements. A supervising authorized user meeting the requirements of subsection (nn)(2) of this section must also have experience in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-) of this section. The work experience must involve: (I) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) calculating, measuring, and safely preparing patient or human or animal research subject dosages; (IV) using administrative controls to prevent a medical event involving the use of unsealed radioactive material; (V) using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (VI) administering dosages of radioactive drugs to patients or human or animal research subjects that includes at least three cases involving the oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide I-131; and (B) obtains written attestation the individual has satisfactorily completed the requirements of paragraph (3)(A) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide I-131 for medical or veterinary uses authorized under subsection (kk) of this section. The attestation must be obtained from either: (i) a preceptor authorized user meeting the requirements in subsections (l) or (nn) of this section, this subsection, or equivalent NRC or agreement state requirements and has experience in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-) of this section; or (ii) a residency program director affirming in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user meeting the requirements in subsections (l), (nn), or (pp) of this section, or equivalent NRC or agreement state requirements, has experience in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-) of this section, and concurring with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in this paragraph. (qq) Training for the parenteral administration of unsealed radioactive material requiring a written directive. (1) Except as provided in subsection (l) of this section, the licensee must require an authorized user for the parenteral administration of unsealed radioactive materials requiring a written directive to be: (A) an authorized user as specified in subsection (nn) of this section for uses listed in subsection (nn)(2)(A)(ii)(VI)(-c-) of this section or equivalent NRC or agreement state requirements; or (B) an authorized user under subsections (zz) or (ttt) of this section or equivalent NRC or agreement state requirements and meeting the requirements of paragraph (2) of this subsection; or (C) a physician certified by a medical specialty board whose certification process is recognized by the department, the NRC, or an agreement state as specified in subsections (zz) or (ttt) of this section, and meets the requirements of paragraph (2) of this subsection. (2) The physician or veterinarian must also: (A) successfully complete 80 hours of classroom and laboratory training applicable to parenteral administrations listed in subsection (nn)(2)(A)(ii)(VI)(-c-) of this section. (B) complete training and experience to include: (i) classroom and laboratory training, including: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; (IV) chemistry of radioactive material for medical use; and (V) radiation biology; and (ii) work experience, under the supervision of an authorized user meeting the requirements of subsection (l) of this section, this subsection, or subsection (nn) of this section, or equivalent NRC or agreement state requirements in the parenteral administration listed in subsection (nn)(2)(A)(ii)(VI)(-c-) of this section. A supervising authorized user meeting the requirements of subsection (nn) of this section, this subsection, or equivalent NRC or agreement state requirements must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience must involve: (I) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (III) calculating, measuring, and safely preparing patient or human or animal research subject dosages; (IV) using administrative controls to prevent a medical event involving the use of unsealed radioactive material; (V) using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (VI) administering dosages to patients or human or animal research subjects that include at least three cases involving the parenteral administration specified in subsection (nn)(2)(A)(ii)(VI)(-c-) of this section; and (C) obtain written attestation the individual has satisfactorily completed the requirements of paragraph (2)(A) and (B) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The attestation must be obtained from either: (i) a preceptor authorized user meeting the requirements of subsection (l) of this section, subsection (nn) of this section, or this subsection, or equivalent NRC or agreement state requirements. A preceptor authorized user meeting the requirements in subsection (nn) of this section, this section, or equivalent agreement state requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or (ii) a residency program director affirming in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user meeting the requirements in subsections (l), (nn), or (qq) of this section, or equivalent NRC or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurring with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in this paragraph. (rr) Use of sealed sources for manual brachytherapy. The licensee must use only brachytherapy sources as follows: (1) as approved in the Sealed Source and Device Registry for manual brachytherapy medical or veterinary use. The manual brachytherapy sources may be used for manual brachytherapy uses not explicitly listed in the Sealed Source and Device Registry, but must be used according to the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (2) in research to deliver therapeutic doses for medical or veterinary use in accordance with an active Investigational Device Exemption application accepted by the FDA provided the requirements of subsection (u)(1) of this section are met. (ss) Surveys after sealed source implants and removal. (1) Immediately after implanting sealed sources in a patient or a human or animal research subject, the licensee must perform a survey to locate and account for all sealed sources not implanted. (2) Immediately after removing the last temporary implant sealed source from a patient or a human or animal research subject, the licensee must perform a survey of the patient or the human or animal research subject with a radiation detection survey instrument to confirm all sealed sources are removed. (3) A record of each survey must be retained, for inspection by the department, as specified in subsection (xxx) of this section. The record must include: (A) date of the survey; (B) results of the survey; (C) manufacturer's name and model and serial number of the instrument used to make the survey; and (D) name of the individual who performed the survey. (tt) Brachytherapy sealed sources accountability. (1) The licensee must maintain accountability at all times for all brachytherapy sealed sources in storage or use. (2) Promptly after removing sealed sources from a patient or a human or animal research subject, the licensee must return brachytherapy sealed sources to a secure storage area. (3) The licensee must maintain a record of the brachytherapy sealed source accountability as specified in subsection (xxx) of this section for inspection by the department. (A) When removing temporary implants from storage, the licensee must record the number and activity of sources, time and date the sources were removed, the name of the individual who removed the sources, and the location of use. When temporary implants are returned to storage, the licensee must record the number and activity of sources, the time and date, and the name of the individual who returned them. (B) When removing permanent implants from storage, the licensee must record the number and activity of sources, the date, the name of the individual who removed the sources, and the number and activity of sources permanently implanted in the patient or human or animal research subject. The licensee must record the number and activity of sources not implanted and returned to storage, the date they were returned to storage, and the name of the individual who returned them to storage. (uu) Safety instruction to personnel. The licensee must provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human or animal research subjects receiving brachytherapy and who cannot be released as specified in subsection (cc) of this section or animals that are confined. (1) The instruction must be appropriate to the personnel's assigned duties and include: (A) size and appearance of brachytherapy sources; (B) safe handling and shielding instructions; (C) patient or human or animal research subject control; (D) visitor control, including visitation to hospitalized patients as specified in §289.202(n) of this chapter; and (E) notification of the RSO, or his or her designee, and an authorized user if the patient or the human or animal research subject has a medical emergency or dies. (2) A licensee must maintain a record, for inspection by the department, as specified in subsection (xxx) of this section, of individuals receiving instruction. The record must include: (A) list of the topics covered; (B) date of the instruction or training; (C) names of the attendees; and (D) names of the personnel who provided the instruction. (vv) Safety precautions for the use of brachytherapy. (1) For each patient or human research subject receiving brachytherapy and who cannot be released as specified in subsection (cc) of this section the licensee must: (A) provide a private room with a private sanitary facility; (B) post the patient's or the research subject's room with a "Radioactive Materials" sign and note on the door or in the patient's or research subject's chart where and how long visitors may stay in the patient's or the research subject's room; and (C) have available near each treatment room, applicable emergency response equipment to respond to a sealed source inadvertently dislodged from the patient or inadvertently lodged within the patient following removal of the sealed source applicators. (2) The RSO, or his or her designee, and the authorized user must be notified if the patient or research subject has a medical emergency, and immediately if the patient dies. (ww) Calibration measurements of brachytherapy sealed sources. (1) Before the first medical or veterinary use of a brachytherapy sealed source, the licensee must: (A) determine the sealed source output or activity using a dosimetry system meeting the requirements of subsection (iii)(1) of this section; (B) determine sealed source positioning accuracy within applicators; and (C) use published protocols accepted by nationally recognized bodies to meet the requirements of subparagraphs (A) and (B) of this paragraph. (2) Instead of the licensee making its own measurements as required in paragraph (1) of this subsection, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine made as specified in paragraph (1) of this subsection. (3) The licensee must mathematically correct the outputs or activities determined in paragraph (1) of this subsection for physical decay at intervals consistent with one percent physical decay. (4) The licensee must retain a record of each calibration as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) complete date of the calibration including the month, day, and year; (B) manufacturer's name and model and serial number for the sealed source and instruments used to calibrate the sealed source; (C) sealed source output or activity; (D) sealed source positioning accuracy within applicators; and (E) name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration. (xx) Strontium-90 sources for ophthalmic treatments. (1) A licensee using strontium-90 for ophthalmic treatments must ensure certain activities as specified in paragraph (2) of this subsection are performed by either: (A) an authorized medical physicist; or (B) an individual who: (i) is identified as an ophthalmic physicist on a specific medical use license issued by the department, the NRC, or an agreement state; permit issued by the department, the NRC, or an agreement state broad scope medical use licensee; medical use permit issued by an NRC master material licensee; or permit issued by an NRC master material licensee broad scope medical use permittee; and (ii) holds a master's or doctoral degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and (iii) has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and (iv) has documented training in: (I) the creation, modification, and completion of written directives; (II) procedures for administrations requiring a written directive; and (III) performing the calibration measurements of brachytherapy sources as detailed in subsection (ww) of this section. (2) The individual identified in paragraph (1) of this subsection must: (A) calculate the activity of each strontium-90 source used to determine the treatment times for ophthalmic treatments, and the decay must be based on the activity determined under subsection (ww) of this section; and (B) assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence the administration is in accordance with the written directive. These procedures must include the frequencies the individual meeting the requirements in paragraph (1) of this subsection will:(i) observe treatments; (ii) review the treatment methodology; (iii) calculate treatment time for the prescribed dose; and (iv) review records to verify the administrations were in accordance with the written directives. (3) A licensee must maintain a record of the activity of a strontium-90 source as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) date and initial activity of the source as determined under subsection (ww) of this section; and (B) for each decay calculation, the date and the source activity as determined under this subsection. (yy) Therapy-related computer systems for manual brachytherapy. The licensee must perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of: (1) the sealed source-specific input parameters required by the dose calculation algorithm; (2) the accuracy of dose, dwell time, and treatment time calculations at representative points; (3) the accuracy of isodose plots and graphic displays; and (4) the accuracy of the software used to determine radioactive sealed source positions from radiographic images. (zz) Training for use of manual brachytherapy sealed sources. Except as provided in subsection (l) of this section, the licensee must require an authorized user of a manual brachytherapy source for the uses authorized in subsection (rr) of this section to be a physician or veterinarian who: (1) is certified by a medical specialty board whose certification process is recognized by the department, the NRC, or an agreement state. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification recognized, a specialty board must require all candidates for certification to: (A) successfully complete a minimum of three years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association; and (B) pass an examination administered by diplomates of the specialty board assessing knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or (2) has: (A) completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources, including: (i) 200 hours of classroom and laboratory training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; and (IV) radiation biology; and (ii) 500 hours of work experience, under the supervision of an authorized user meeting the requirements of subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements at a medical facility authorized to use radioactive material under subsection (rr) of this section, involving: (I) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (II) checking survey meters for proper operation; (III) preparing, implanting, and removing brachytherapy sources; (IV) maintaining running inventories of material on hand; (V) using administrative controls to prevent a medical event involving the use of radioactive material; and (VI) using emergency procedures to control radioactive material; and (B) three years of supervised clinical experience in radiation oncology, under an authorized user meeting the requirements of subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subparagraph (A)(ii) of this paragraph; and (C) obtained written attestation the individual has satisfactorily completed the requirements in paragraph (2) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical or veterinary uses authorized under subsection (rr) of this section. The attestation must be obtained from either: (i) a preceptor authorized user meeting the requirements of subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements; or (ii) a residency program director affirming in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user meeting the requirements in subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements, and concurring with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (2) of this subsection. (aaa) Training for ophthalmic use of strontium-90. Except as provided in subsection (l) of this section, the licensee must require an authorized user of strontium-90 for ophthalmic radiotherapy to be a physician or veterinarian who: (1) is an authorized user under subsection (zz) of this section or equivalent NRC or agreement state requirements; or (2) has completed 24 hours of classroom and laboratory training applicable to the medical or veterinary use of strontium-90 for ophthalmic radiotherapy. (A) The training must include:(i) classroom training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; and (IV) radiation biology; and (ii) supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five patients. This supervised clinical training must involve: (I) examination of each patient to be treated; (II) calculation of the dose to be administered; (III) administration of the dose; and (IV) follow-up and review of each patient's case history; and (3) has obtained written attestation, signed by a preceptor authorized user meeting the requirements of subsection (l) of this section, subsection (zz) of this section, or this subsection, or equivalent NRC or agreement state requirements, that the individual has satisfactorily completed the requirements of paragraph (2)(A) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use. (bbb) Use of sealed sources and medical devices for diagnosis. (1) The licensee must use only sealed sources not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry. (2) The licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry. (3) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of subsection (u)(1) of this section are met. (4) The licensee must ensure installation or exchange of sealed sources in medical imaging equipment is performed only by the manufacturer or persons specifically authorized to perform these services by the department, the NRC, or another agreement state. The licensee must maintain a record for each installation or exchange for inspection by the department as specified in subsection (xxx) of this section. The record must include the date, the installer's radioactive material license number, and the regulatory agency that issued the license to the installer. (ccc) Training for use of sealed sources for diagnosis. Except as provided in subsection (l) of this section, the licensee must require the authorized user of a diagnostic sealed source or a device authorized as specified in subsection (bbb) of this section to be a physician, dentist, podiatrist, or veterinarian who: (1) is certified by a specialty board whose certification process includes all the requirements of paragraphs (3) and (4) of this subsection and whose certification is recognized by the department, the NRC, or an agreement state (names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page); or (2) is an authorized user for uses listed in subsection (hh) of this section or equivalent NRC or agreement state requirements; or (3) has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include: (A) radiation physics and instrumentation; (B) radiation protection; (C) mathematics pertaining to the use and measurement of radioactivity; and (D) radiation biology; and (4) has completed training in the use of the device for the uses requested. (ddd) Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit. (1) The licensee must only use sealed sources: (A) as approved and as provided for in the Sealed Source and Device Registry in photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or (B) in research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active IDE application accepted by the FDA, provided the requirements of subsection (u)(1) of this section are met. (2) A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units: (A) approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (B) in research in accordance with an active IDE application accepted by the FDA, provided the requirements of subsection (u)(1) of this section are met. (eee) Surveys of patients and human research subjects treated with a remote afterloader unit. (1) Before releasing a patient or a human research subject from licensee control, the licensee must perform a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm the sealed source or sources have been removed from the patient or human research subject and returned to the safe shielded position. (2) The licensee must maintain a record of the surveys as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) date of the survey; (B) results of the survey; (C) manufacturer's name, model, and serial number of the survey instrument used; and (D) name of the individual who made the survey. (fff) Installation, maintenance, adjustment, and repair. (1) Only a person specifically licensed by the department, the NRC, or an agreement state may install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the sealed source shielding, the sealed source driving unit, or other electronic or mechanical component that could expose the sealed source or sources, reduce the shielding around the sealed source or sources, or compromise the radiation safety of the unit or the sealed source or sources. (2) Except for low dose-rate remote afterloader units, only a person specifically licensed by the department, the NRC, or an agreement state may install, replace, relocate, or remove a sealed source or sealed source contained in other remote afterloader units, teletherapy units, or gamma stereotactic units. (3) For a low dose-rate remote afterloader unit, only a person specifically licensed by the department, the NRC, an agreement state, or an authorized medical physicist may install, replace, relocate, or remove a sealed source contained in the unit. (4) The licensee must maintain a record of the installation, maintenance, adjustment, and repair done on remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as specified in subsection (xxx) of this section for inspection by the department. For each installation, maintenance, adjustment, and repair, the record must include the date, description of the service, and names of the individuals who performed the work. (ggg) Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. (1) A licensee must: (A) secure the unit, the console, the console keys, and the treatment room when not in use or unattended; (B) permit only individuals approved by the authorized user, RSO, or authorized medical physicist to be present in the treatment room during treatment with the sealed source or sources; (C) prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and (D) develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the sealed source or sources in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. The procedures must include: (i) instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; (ii) the process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and (iii) the names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally; (2) A copy of the procedures required by paragraph (1)(D) of this subsection must be physically located at the unit console. (3) The licensee must post instructions at the unit console to inform the operator of: (A) the location of the procedures required by paragraph (1)(D) of this subsection; and (B) the names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally. (4) Before the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade affecting the operation and safety of the unit: (A) a licensee must ensure vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training. (B) a licensee must provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties, to include: (i) procedures identified in paragraph (1)(D) of this subsection; and (ii) operating procedures for the unit. (5) A licensee must ensure operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually. (6) A licensee must maintain records of the procedures required by paragraphs (1)(D) and (4)(B)(ii) of this subsection as specified in subsection (xxx) of this section for inspection by the department. (7) A licensee must maintain records of individuals receiving instruction and participating in drills required by paragraphs (4) and (5) of this subsection as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) a list of the topics covered; (B) date of the instruction or drill; (C) names of the attendees; and (D) names of the personnel who provided the instruction. (hhh) Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. The licensee must: (1) control access to the treatment room by a door at each entrance; (2) equip each entrance to the treatment room with an electrical interlock system that will: (A) prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed; (B) cause the sealed source or sources to be shielded promptly when an entrance door is opened; and (C) prevent the sealed source or sources from being exposed following an interlock interruption until all treatment room entrance doors are closed and the sealed source "on-off" control is reset at the console; (3) require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, radiation levels have returned to ambient levels; (4) except for low-dose remote afterloader units, construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation; (5) for licensed activities when sealed sources are placed within the patient's or human research subject's body, only conduct treatments allowing expeditious removal of a decoupled or jammed sealed source; (6) in addition to the requirements specified in paragraphs (1) - (5) of this subsection, require: (A) for low dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units: (i) an authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, trained in the operation and emergency response for the unit, be physically present during the initiation of all patient treatments involving the unit; and (ii) an authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, trained to remove the sealed source applicator in the event of an emergency involving the unit, be immediately available during continuation of all patient treatments involving the unit; (B) for high dose-rate remote afterloader units: (i) an authorized user and an authorized medical physicist be physically present during the initiation of all patient treatments involving the unit; and (ii) an authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, trained in the operation and emergency response for the unit, be physically present during continuation of all patient treatments involving the unit; (C) for gamma stereotactic radiosurgery units and teletherapy units, require an authorized user and an authorized medical physicist be physically present throughout all patient treatments; and (D) notify the RSO, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies; and (7) have applicable emergency response equipment available near each treatment room to respond to a sealed source that remains in the unshielded position or lodges within the patient following completion of the treatment. (iii) Dosimetry equipment. (1) Except for low dose-rate remote afterloader sealed sources where the sealed source output or activity is determined by the manufacturer, the licensee must have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions are required: (A) the system was calibrated using a system or sealed source traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration was performed within the previous two years and after any servicing that may have affected system calibration; or (B) the system was calibrated within the previous four years. Eighteen to 30 months after that calibration, the system was intercompared with another dosimetry system calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must have indicated the calibration factor of the licensee's system had not changed by more than two percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems used for calibrating sealed sources for therapeutic units, the licensee must use a comparable unit with beam attenuators or collimators, as applicable, and sealed sources of the same radionuclide as the sealed source used at the licensee's facility. (2) The licensee must have available for use a dosimetry system for spot check output measurements, if such measurements are required by this section. To satisfy this requirement, the system may be compared with a system calibrated as specified in paragraph (1) of this subsection. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot check system may be the same system used to meet the requirements of paragraph (1) of this subsection. (3) The licensee must retain a record of each calibration, intercomparison, and comparison of dosimetry equipment as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) complete date of the calibration including the month, day, and year; (B) manufacturer's model and serial numbers of the instruments that were calibrated, intercompared, or compared; (C) the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and (D) the names of the individuals who performed the calibration, intercomparison, or comparison. (jjj) Full calibration measurements on teletherapy units. (1) A licensee authorized to use a teletherapy unit for medical use must perform full calibration measurements on each teletherapy unit as follows: (A) before the first medical use of the unit; and (B) before medical use under any of the following conditions: (i) whenever spot check measurements indicate the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; (ii) following replacement of the sealed source or following reinstallation of the teletherapy unit in a new location; (iii) following any repair of the teletherapy unit that includes removal of the sealed source or major repair of the components associated with the sealed source exposure assembly; and (C) at intervals not to exceed one year. (2) Full calibration measurements must include determination of: (A) the output within plus or minus three percent for the range of field sizes and for the distance or range of distances used for medical use; (B) the coincidence of the radiation field and the field indicated by the light beam localizing device; (C) uniformity of the radiation field and its dependence on the orientation of the useful beam; (D) timer accuracy and linearity over the range of use; (E) "on-off" error; and (F) the accuracy of all distance measuring and localization devices in medical use. (3) The licensee must use the dosimetry system described in subsection (iii)(1) of this section to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (2)(A) of this subsection may be made using a dosimetry system indicating relative dose rates. (4) The licensee must make full calibration measurements required by paragraph (1) of this subsection in accordance with published protocols accepted by nationally recognized bodies. (5) The licensee must mathematically correct the outputs determined in paragraph (2)(A) of this subsection for physical decay at intervals not to exceed one month for cobalt-60, six months for cesium-137, or at intervals consistent with one percent decay for all other nuclides. (6) Full calibration measurements required by paragraph (1) of this subsection and physical decay corrections required by paragraph (5) of this subsection must be performed by an authorized medical physicist. (7) The licensee must retain a record of each calibration as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) complete date of the calibration including the month, day, and year; (B) manufacturer's name, model number, and serial number of the teletherapy unit's sealed source and the instruments used to calibrate the unit; (C) results and an assessment of the full calibrations; and (D) name and signature of the authorized medical physicist who performed the full calibration. (kkk) Full calibration measurements on remote afterloader units. (1) A licensee authorized to use a remote afterloader for medical use must perform full calibration measurements on each unit: (A) before the first medical use of the unit; (B) before medical use under any of the following conditions: (i) following replacement of the sealed source; (ii) following reinstallation of the unit in a new location outside the facility; and (iii) following any repair of the unit that includes removal of the sealed source or major repair of the components associated with the sealed source exposure assembly; (C) at intervals not to exceed three months for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sealed sources whose half-life exceeds 75 days; and (D) at intervals not to exceed one year for low dose-rate afterloader units. (2) Full calibration measurements must include, as applicable, determination of: (A) the output within plus or minus five percent; (B) sealed source positioning accuracy to within plus or minus 1 millimeter (mm); (C) sealed source retraction with backup battery upon power failure; (D) length of the sealed source transfer tubes; (E) timer accuracy and linearity over the typical range of use; (F) length of the applicators; and (G) function of the sealed source transfer tubes, applicators, and transfer tube-applicator interfaces. (3) A licensee must use the dosimetry system described in subsection (iii)(1) of this section to measure the output. (4) A licensee must make full calibration measurements required by paragraph (1) of this subsection in accordance with published protocols accepted by nationally recognized bodies. (5) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (2) of this subsection, a licensee must perform an autoradiograph of the sealed source or sources to verify inventory and sealed source arrangement at intervals not to exceed three months. (6) For low dose-rate remote afterloader units, a licensee may use measurements provided by the sealed source manufacturer that are made as specified in paragraphs (1) - (5) of this subsection. (7) The licensee must mathematically correct the outputs determined in paragraph (2)(A) of this subsection for physical decay at intervals consistent with one percent physical decay. (8) Full calibration measurements required by paragraph (1) of this subsection and physical decay corrections required by paragraph (7) of this subsection must be performed by an authorized medical physicist. (9) The licensee must retain a record of each calibration as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) complete date of the calibration including the month, day, and year; (B) manufacturer's name, model number, and serial number of the remote afterloader unit's sealed source, and the instruments used to calibrate the unit; (C) results and an assessment of the full calibrations; (D) name and signature of the authorized medical physicist who performed the full calibration; and (E) results of the autoradiograph required for low dose-rate remote afterloader unit. (lll) Full calibration measurements on gamma stereotactic radiosurgery units. (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform full calibration measurements on each gamma stereotactic radiosurgery unit: (A) before the first medical use of the unit; (B) before medical use under the following conditions: (i) whenever spot check measurements indicate the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; (ii) following replacement of the sealed sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and (iii) following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sealed sources or major repair of the components associated with the sealed source exposure assembly; and (C) at intervals not to exceed one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet. (2) Full calibration measurements must include determination of: (A) the output within plus or minus three percent; (B) relative helmet factors; (C) isocenter coincidence; (D) timer accuracy and linearity over the range of use; (E) "on-off" error; (F) trunnion centricity; (G) treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit "off"; (H) helmet microswitches; (I) emergency timing circuits; and (J) stereotactic frames and localizing devices (trunnions). (3) The licensee must use the dosimetry system described in subsection (iii)(1) of this section to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (2)(A) of this subsection may be made using a dosimetry system indicating relative dose rates. (4) The licensee must make full calibration measurements required by paragraph (1) of this subsection in accordance with published protocols accepted by nationally recognized bodies. (5) The licensee must mathematically correct the outputs determined in paragraph (2)(A) of this subsection at intervals not to exceed one month for cobalt-60 and at intervals consistent with one percent physical decay for all other radionuclides. (6) Full calibration measurements required by paragraph (1) of this subsection and physical decay corrections required by paragraph (5) of this subsection must be performed by an authorized medical physicist. (7) The licensee must retain a record of each calibration as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) complete date of the calibration including the month, day, and year; (B) manufacturer's name, model number, and serial number for the unit and the unit's sealed source and the instruments used to calibrate the unit; (C) results and an assessment of the full calibration; and (D) name and signature of the authorized medical physicist who performed the full calibration. (mmm) Periodic spot checks for teletherapy units. (1) A licensee authorized to use teletherapy units for medical use must perform output spot checks on each teletherapy unit once in each calendar month, including determination of: (A) timer constancy and linearity over the range of use; (B) "on-off" error; (C) the coincidence of the radiation field and the field indicated by the light beam localizing device; (D) the accuracy of all distance measuring and localization devices used for medical use; (E) the output for one typical set of operating conditions measured with the dosimetry system described in subsection (iii)(2) of this section; and (F) the difference between the measurement made in subparagraph (E) of this paragraph and the anticipated output, expressed as a percentage of the anticipated output, the value obtained at last full calibration corrected mathematically for physical decay. (2) The licensee must perform measurements required by paragraph (1) of this subsection in accordance with written procedures established by an authorized medical physicist. That authorized medical physicist need not actually perform the spot check measurements. The licensee must maintain a copy of the written procedures as specified in subsection (xxx) of this section for inspection by the department. (3) The licensee authorized to use a teletherapy unit for medical use must perform safety spot checks of each teletherapy facility once in each calendar month and after each sealed source installation to assure proper operation of: (A) electrical interlocks at each teletherapy room entrance; (B) electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of sealed source housing angulation or elevation, carriage or stand travel, and operation of the beam "on-off" mechanism); (C) sealed source exposure indicator lights on the teletherapy unit, on the control console, and in the facility; (D) viewing and intercom systems; (E) treatment room doors from inside and outside the treatment room; and (F) electrically assisted treatment room doors with the teletherapy unit electrical power turned "off."(4) The licensee must have an authorized medical physicist review the results of each spot check and submit a written report to the licensee within 15 days of the spot check. (5) If the results of the checks required in paragraph (3) of this subsection indicate the malfunction of any system, the licensee must lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (6) The licensee must retain a record of each spot check required by paragraphs (1) and (3) of this subsection, as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) date of the spot-check; (B) manufacturer's name and model and serial number for the teletherapy unit, and sealed source and instrument used to measure the output of the teletherapy unit; (C) assessment of timer linearity and constancy; (D) calculated "on-off" error; (E) determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; (F) the determined accuracy of each distance measuring and localization device; (G) the difference between the anticipated output and the measured output; (H) notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each sealed source exposure indicator light, and the viewing and intercom system and doors; (I) name of the individual who performed the periodic spot-check; and (J) the name and signature of the authorized medical physicist who reviewed the record of the spot check. (nnn) Periodic spot checks for remote afterloader units. (1) A licensee authorized to use a remote afterloader unit for medical use must perform spot checks of each remote afterloader facility and on each unit: (A) before the first use each day of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit; (B) before each patient treatment with a low dose-rate remote afterloader unit; and (C) after each sealed source installation. (2) The licensee must perform the measurements required by paragraph (1) of this subsection in accordance with written procedures established by an authorized medical physicist. That individual need not actually perform the spot check measurements. The licensee must maintain a copy of the written procedures as specified in subsection (xxx) of this section for inspection by the department. (3) The licensee must have an authorized medical physicist review the results of each spot check and submit a written report to the licensee within 15 days of the spot check. (4) To satisfy the requirements of paragraph (1) of this subsection, spot checks must, at a minimum, assure proper operation of: (A) electrical interlocks at each remote afterloader unit room entrance; (B) sealed source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (C) viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility; (D) emergency response equipment; (E) radiation monitors used to indicate the sealed source position; (F) timer accuracy; (G) clock (date and time) in the unit's computer; and (H) decayed sealed source activity in the unit's computer. (5) If the results of the checks required in paragraph (4) of this subsection indicate the malfunction of any system, the licensee must lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (6) The licensee must maintain a record, as specified in subsection (xxx) of this section for inspection by the department, of each check required by paragraph (4) of this subsection. The record must include, as applicable: (A) date of the spot-check; (B) manufacturer's name and model and serial number for the remote afterloader unit and sealed source; (C) an assessment of timer accuracy; (D) notations indicating the operability of each entrance door electrical interlock, radiation monitors, sealed source exposure indicator lights, viewing and intercom systems, clock, and decayed sealed source activity in the unit's computer; (E) name of the individual who performed the periodic spot-check; and (F) the signature of an authorized medical physicist who reviewed the record of the spot-check. (ooo) Periodic spot checks for gamma stereotactic radiosurgery units. (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform spot checks of each gamma stereotactic radiosurgery facility and on each unit: (A) monthly; (B) before the first use of the unit on each day of use; and (C) after each source installation. (2) The licensee must perform the measurements required by paragraph (1) of this subsection in accordance with written procedures established by an authorized medical physicist with a specialty in therapeutic radiological physics. That individual need not actually perform the spot check measurements. The licensee must maintain a copy of the written procedures as specified in subsection (xxx) of this section for inspection by the department. (3) The licensee must have an authorized medical physicist review the results of each spot check and submit a written report to the licensee within 15 days of the spot check. (4) To satisfy the requirements of paragraph (1)(A) of this subsection, spot checks must, at a minimum, achieve: (A) assurance of proper operation of these items: (i) treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit "off;" (ii) helmet microswitches; (iii) emergency timing circuits; and (iv) stereotactic frames and localizing devices (trunnions); and (B) determination of: (i) the output for one typical set of operating conditions measured with the dosimetry system described in subsection (iii)(2) of this section; (ii) the difference between the measurement made in clause (i) of this subparagraph and the anticipated output, expressed as a percentage of the anticipated output, (i.e., the value obtained at last full calibration corrected mathematically for physical decay); (iii) sealed source output against computer calculation; (iv) timer accuracy and linearity over the range of use; (v) "on-off" error; and (vi) trunnion centricity. (5) To satisfy the requirements of paragraph (1)(B) and (C) of this subsection, spot checks must assure proper operation of: (A) electrical interlocks at each gamma stereotactic radiosurgery room entrance; (B) sealed source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility; (C) viewing and intercom systems; (D) timer termination; (E) radiation monitors used to indicate room exposures; and (F) emergency "off" buttons. (6) The licensee must arrange for prompt repair of any system identified in paragraph (4) of this subsection not operating properly. (7) If the results of the checks required in paragraph (5) of this subsection indicate the malfunction of any system, the licensee must lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (8) The licensee must retain a record of each check required by paragraphs (4) and (5) of this subsection as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) date of the spot check; (B) manufacturer's name, and model and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; (C) an assessment of timer linearity and accuracy; (D) the calculated "on-off" error; (E) a determination of trunnion centricity; (F) the difference between the anticipated output and the measured output; (G) an assessment of sealed source output against computer calculations; (H) notation indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency "off" buttons, electrical interlocks, sealed source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); (I) the name of the individual who performed the periodic spot check; and (J) the name and signature of an authorized medical physicist who reviewed the record of the spot check. (ppp) Additional technical requirements for mobile remote afterloader units. (1) A licensee providing mobile remote afterloader service must: (A) check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and (B) account for all sealed sources before departure from a client's address of use. (2) In addition to the periodic spot checks required by subsection (nnn) of this section, a licensee authorized to use remote afterloaders for medical use must perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of: (A) electrical interlocks on treatment area access points; (B) sealed source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (C) viewing and intercom systems; (D) applicators, sealed source transfer tubes, and transfer tube-applicator interfaces; (E) radiation monitors used to indicate room exposures; (F) sealed source positioning (accuracy); and (G) radiation monitors used to indicate whether the sealed source has returned to a safe shielded position. (3) In addition to the requirements for checks in paragraph (2) of this subsection, the licensee must ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use. (4) If the results of the checks required in paragraph (2) of this subsection indicate the malfunction of any system, the licensee must lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (5) The licensee must maintain a record for inspection by the department, as specified in subsection (xxx) of this section, of each check required by paragraph (2) of this subsection. The record must include: (A) date of the check; (B) manufacturer's name, model number, and serial number of the remote afterloader unit; (C) notations accounting for all sealed sources before the licensee departs from a facility; (D) notations indicating the operability of each entrance door electrical interlock, radiation monitors, sealed source exposure indicator lights, viewing and intercom system, applicators and sealed source transfer tubes, and sealed source positioning accuracy; and (E) the name and signature of the individual who performed the check. (qqq) Radiation surveys. (1) In addition to the survey requirements of §289.202(p) of this chapter, a person licensed to use sealed sources in this section must make surveys to ensure the maximum radiation levels and average radiation levels, from the surface of the main sealed source safe with the sealed source or sources in the shielded position, do not exceed the levels stated in the Sealed Source and Device Registry. (2) The licensee must make the survey required by paragraph (1) of this subsection at installation of a new sealed source and following repairs to the sealed source shielding, the sealed source driving unit, or other electronic or mechanical component that could expose the sealed source or sources, reduce the shielding around the sealed source or sources, or compromise the radiation safety of the unit or the sealed source or sources. (3) The licensee must maintain a record for inspection by the department, as specified in subsection (xxx) of this section, of the radiation surveys required by paragraph (1) of this subsection. The record must include: (A) date of the measurements; (B) manufacturer's name, model number, and serial number of the treatment unit, sealed source, and instrument used to measure radiation levels; (C) each dose rate measured around the sealed source while the unit is in the "off" position and the average of all measurements; and (D) the name and signature of the individual who performed the test. (rrr) Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units. (1) The licensee must have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each sealed source replacement to ensure proper functioning of the sealed source exposure mechanism and other safety components. The interval between each full-inspection servicing must not exceed five years for each teletherapy unit and must not exceed seven years for each gamma stereotactic radiosurgery unit. (2) This inspection and servicing must only be performed by persons specifically licensed to do so by the department, the NRC, or an agreement state. (3) The licensee must maintain a record of the inspection and servicing as specified in subsection (xxx) of this section for inspection by the department. The record must include: (A) date of inspection; (B) manufacturer's name, model, and serial number of both the treatment unit and the sealed source; (C) a list of components inspected and serviced, and the type of service; (D) the inspector's radioactive material license number; and (E) the name and signature of the inspector. (sss) Therapy-related computer systems for photon-emitting remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. The licensee must perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of: (1) the sealed source-specific input parameters required by the dose calculation algorithm; (2) the accuracy of dose, dwell time, and treatment time calculations at representative points; (3) the accuracy of isodose plots and graphic displays; (4) the accuracy of the software used to determine sealed source positions from radiographic images; and (5) the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system. (ttt) Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Except as provided in subsection (l) of this section, the licensee must require an authorized user of a sealed source for a use authorized in subsection (ddd) of this section to be: (1) a physician who is certified by a medical specialty board whose certification process is recognized by the department, the NRC, or an agreement state and who meets the requirements of paragraph (3) of this subsection. The names of board certifications recognized by the department, the NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification recognized, a specialty board must require all candidates for certification to: (A) successfully complete a minimum of three years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association; and (B) pass an examination, administered by diplomates of the specialty board, assessing knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders, and external beam therapy; or (2) a physician who: (A) has completed a structured educational program in basic radionuclide handling techniques applicable to the use of a sealed source in a therapeutic medical unit, including: (i) 200 hours of classroom and laboratory training in: (I) radiation physics and instrumentation; (II) radiation protection; (III) mathematics pertaining to the use and measurement of radioactivity; and (IV) radiation biology; and (ii) 500 hours of work experience, under the supervision of an authorized user meeting the requirements of subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements at a medical facility authorized to use radioactive material in subsection (ddd) of this section involving: (I) reviewing full calibration measurements and periodic spot checks; (II) preparing treatment plans and calculating treatment times; (III) using administrative controls to prevent a medical event involving the use of radioactive material; (IV) implementing emergency procedures to be followed in the event of the abnormal operation of a medical unit or console; (V) checking and using survey meters; and (VI) selecting the proper dose and how it is to be administered; and (iii) completion of three years of supervised clinical experience in radiation therapy, under an authorized user meeting the requirements of subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by clause (ii) of this subparagraph; and (B) has obtained written attestation the individual has satisfactorily completed the requirements of paragraphs (2)(A) and (3) of this subsection and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation must be obtained from either: (i) a preceptor authorized user meeting the requirements in subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements for the types of therapeutic medical units for which the individual is requesting authorized user status; or (ii) a residency program director affirming in writing the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user meeting the requirements in subsection (l) of this section, this subsection, or equivalent NRC or agreement state requirements, for the types of therapeutic medical units for which the individual is requesting authorized user status, and concurring with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subparagraph (A) of this paragraph; and (3) a physician who has received training in device operation, safety procedures, and clinical use for the types of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, authorized for the types of use for which the individual is seeking authorization. (uuu) Report and notification of a medical event. (1) The licensee must report any event as a medical event, except for an event resulting from patient intervention, in which the administration of radioactive material, or radiation from radioactive material, except permanent implant brachytherapy, results in: (A) a dose differing from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 5 rem (0.05 sievert (Sv)) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin; and(i) the total dose delivered differs from the prescribed dose by 20 percent or more; (ii) the total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or (iii) the fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more; (B) a dose that exceeds 5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin from: (i) an administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure; (ii) an administration of a radioactive drug containing radioactive material by the wrong route of administration; (iii) an administration of a dose or dosage to the wrong individual or human research subject; (iv) an administration of a dose or dosage delivered by the wrong mode of treatment; or (v) a leaking sealed source; or (C) a dose to the skin or an organ or tissue other than the treatment site that is more than:(i) 50 rem (0.5 Sv) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and (ii) 50 percent or more of the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration. (2) For permanent implant brachytherapy, the licensee must report the administration of radioactive material or radiation from radioactive material (excluding sources that were implanted in the correct site but migrated outside the treatment site) resulting in: (A) the total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive; (B) the total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or (C) an administration, including: (i) the wrong radionuclide; (ii) the wrong individual or human research subject; (iii) sealed source or sources implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or (iv) a leaking sealed source resulting in a dose that exceeds 50 rem (0.5 Sv) to an organ or tissue. (3) The licensee must report any event resulting from patient intervention in which the administration of radioactive material, or radiation from radioactive material, results or will result in an unintended permanent functional damage to an organ or a physiological system, as determined by a physician. (4) The licensee must notify the department by telephone no later than the next calendar day after discovery of the medical event. (5) The licensee must submit a written report to the department within 15 calendar days after discovery of the medical event. The written report must include, excluding the individual's name or any other information that could lead to identification of the individual: (A) the licensee's name and radioactive material license number; (B) a description of the licensed source of radiation involved, including, for radioactive material, the kind, quantity, chemical and physical form, source and device manufacturer, model number, and serial number, if applicable; (C) the name of the prescribing physician; (D) a brief description of the medical event; (E) why the event occurred; (F) the effect, if any, on the individual who received the administration; (G) actions, if any, taken or planned to prevent recurrence; and (H) certification the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not. (6) The licensee must notify the referring physician and the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee must notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care resulting from the medical event, due to a delay in notification. To meet the requirements of this subsection, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee must inform the individual or appropriate responsible relative or guardian that a written description of the event can be obtained from the licensee upon request. The licensee must provide the written description if requested. (7) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians. (8) The licensee must annotate a copy of the report provided to the department with: (A) the name of the individual who is the subject of the event; and (B) an identification number or if no other identification number is available, the social security number of the individual who is the subject of the event. (9) The licensee must provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 calendar days after the discovery of the event. (10) The licensee must retain a copy of the annotated report of the medical event as specified in subsection (xxx) of this section for inspection by the department. (vvv) Report and notification of a dose to an embryo/fetus or nursing child. (1) The licensee must report any dose to an embryo/fetus greater than 5 rem (50 mSv) dose equivalent resulting from an administration of radioactive material or radiation from radioactive material to a woman, unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user. (2) The licensee must report any dose to a nursing child resulting from an administration of radioactive material to a breast-feeding woman: (A) greater than 5 rem (50 mSv) TEDE; or (B) resulting in unintended permanent functional damage to an organ or a physiological system, as determined by a physician. (3) The licensee must notify the department by telephone no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child requiring a report as specified in paragraphs (1) or (2) of this subsection. (4) The licensee must submit a written report to the department no later than 15 calendar days after discovery of a dose to the embryo/fetus or nursing child that requires a report as specified in paragraphs (1) or (2) of this subsection. The written report must include, excluding the individual's or child's name or any other information that could lead to identification of the individual or child: (A) the licensee's name and radioactive material license number; (B) a description of the licensed source of radiation involved, including, for radioactive material, the kind, quantity, chemical and physical form, source and device manufacturer, model number, and serial number, if applicable; (C) the name of the prescribing physician; (D) a brief description of the event; (E) why the event occurred; (F) the effect, if any, on the embryo/fetus or the nursing child; (G) actions, if any, taken or planned to prevent recurrence; and (H) certification that the licensee notified the pregnant woman (or the pregnant woman's or child's responsible relative or guardian), and if not, why not. (5) The licensee must notify the referring physician and also notify the pregnant woman, hereafter referred to as the mother, no later than 24 hours after discovery of an event requiring reporting as specified in paragraphs (1) or (2) of this subsection, unless the referring physician personally informs the licensee either that he or she will inform the mother or, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee must make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care resulting from the event, due to a delay in notification. To meet the requirements of this subsection, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother, when appropriate. If a verbal notification is made, the licensee must inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee must provide such a written description if requested. (6) The licensee must annotate a copy of the report provided to the department with: (A) the name of the individual or the nursing child who is the subject of the event; and (B) an identification number or if no other identification number is available, the social security number of the individual who is the subject of the event. (7) The licensee must provide a copy of the annotated report as described in paragraph (6) of this subsection to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event. (8) The licensee must retain a copy of the annotated report as described in paragraph (6) of this subsection of a dose to an embryo/fetus or a nursing child as specified in subsection (xxx) of this section for inspection by the department. (www) Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations. (1) The licensee must notify the department by telephone at (512) 458-7460 and the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in subsection (ii) of this section at the time of generator elution. The telephone report to the department must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects; when the distributor was notified; and the action taken. (2) The licensee must submit a written report to the department within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; the probable cause and an assessment of failure in the licensee's equipment, procedures, or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by paragraph (1) of this subsection. (xxx) Records/documents for department inspection. Each licensee must maintain copies of the following records/documents at each authorized use site and make them available to the department for inspection, upon reasonable notice. Attached Graphic Source Note: The provisions of this §289.256 adopted to be effective January 18, 2009, 34 TexReg 206; amended to be effective October 1, 2011, 36 TexReg 5851; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective September 24, 2018, 43 TexReg 6289; amended to be effective January 5, 2022, 46 TexReg 9309; amended to be effective October 23, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.256 Medical and Veterinary Use of Radioactive Material https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221106&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221106 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221106&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221106 03/11/2026 (a) Purpose. (1) This section establishes requirements for packaging, preparation for shipment, and transportation of radioactive material including radioactive waste. (2) In addition to the requirements of this section, the packaging and transport of radioactive material are subject to the requirements of: (A) §289.201 of this chapter (relating to General Provisions for Radioactive Material);(B) §289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials); (C) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(D) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services); (E) §289.205 of this chapter (relating to Hearing and Enforcement Procedures);(F) §289.251 of this subchapter (relating to Exemptions, General Licenses, and General License Acknowledgements);(G) §289.252 of this subchapter (relating to Licensing of Radioactive Material);(H) §289.256 of this subchapter (relating to Medical and Veterinary Use of Radioactive Material); and(I) the regulations of other agencies (e.g., the United States Department of Transportation (DOT) and the United States Postal Service) having jurisdiction over means of transport. (b) Scope. (1) The requirements of this section apply to any licensee authorized by a specific or general license issued by the department to receive, possess, use, or transfer radioactive material, if the licensee delivers material to a carrier for transport, transports the material outside the site of usage, as specified in the department license, or transports material on public highways. No provision of this section authorizes possession of radioactive material. (2) Exemptions from the requirements for a license in subsection (c) of this section are specified in subsection (f) of this section. The general license in subsection (i)(2), (3), and (4) of this section requires that a United States Nuclear Regulatory Commission (NRC) certificate of compliance or other package approval be issued for the package used as specified in the general license. A licensee transporting radioactive material, or delivering radioactive material to a carrier for transport, must comply with the operating control requirements of subsections (l) - (q) of this section; the quality assurance (QA) requirements of subsections (s) - (u) and (w) - (bb) of this section; and the general provisions of subsections (a) - (e) of this section, including DOT regulations referenced in subsection (e) of this section. (c) Requirement for license. Except as authorized in a general or specific license issued by the department, or as exempted as specified in this section, no licensee may transport radioactive material or deliver radioactive material to a carrier for transport. (d) Definitions. The following words and terms when used in this section have the following meaning unless the context clearly indicates otherwise. To ensure compatibility with international transportation standards, all limits in this section are given in terms of dual units: The International System of Units (SI) followed or preceded by United States (U.S.) standard or customary units. The U.S. customary units are not exact equivalents, but are rounded to a convenient value, providing a functionally equivalent unit. In this section, SI units are used. (1) A1 --The maximum activity of special form radioactive material permitted in a Type A package. This value is either listed in Table 257-3 of subsection (ee)(6) of this section, or may be derived as specified in the procedure prescribed in subsection (ee) of this section. (2) A2 --The maximum activity of radioactive material, other than special form, low specific activity (LSA), and surface contaminated object (SCO) material, permitted in a Type A package. This value is either listed in Table 257-3 of subsection (ee)(6) of this section, or may be derived as specified in the procedure prescribed in subsection (ee) of this section. (3) Carrier--A person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft. (4) Certificate holder--A person who has been issued a certificate of compliance or other package approval by the department. (5) Certificate of compliance (CoC)--The certificate issued by the NRC that approves the design of a package for the transportation of radioactive materials. (6) Chelating agent--Amine polycarboxylic acids (e.g., ethylenediaminetetraacetic acid (EDTA) and diethylenetriaminepentaacetic acid (DTPA)), hydroxy-carboxylic acids, and polycarboxylic acids (e.g., citric acid, carbolic acid, and glucinic acid). (7) Chemical description--A description of the principal chemical characteristics of low-level radioactive waste (LLRW). (8) Consignee--The designated receiver of the shipment of low-level radioactive waste. (9) Consignment--Each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport. (10) Containment system--The assembly of components of the packaging intended to retain the radioactive material during transport. (11) Contamination--The presence of a radioactive substance on a surface in quantities more than 0.4 becquerel per square centimeter (Bq/cm2 ) (10-5 microcurie per square centimeter (µCi/cm2 )) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (10-6 µCi/cm2 ) for all other alpha emitters. (A) Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport. (B) Non-fixed contamination means contamination that can be removed from a surface during normal conditions of transport. (12) Conveyance--For transport on: (A) public highway or rail by transport vehicle or large freight container; (B) water by vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and (C) aircraft. (13) Criticality Safety Index (CSI)--The dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package to designate the degree of control of accumulation of packages, overpacks, or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in subsection (i) of this section and 10 Code of Federal Regulations (CFR) §§71.22, 71.23, and 71.59. The criticality safety index for an overpack, freight container, consignment, or conveyance containing fissile material packages is the arithmetic sum of the criticality safety indices of all the fissile material packages contained within the overpack, freight container, consignment, or conveyance. (14) Decontamination facility--A facility operating under an NRC, agreement state, or department license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this section, is not considered to be a consignee for LLRW shipments. (15) Deuterium--In this section, this means deuterium and any deuterium compound, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms is greater than 1:5000. (16) Disposal container--A transport container principally used to confine LLRW during disposal operations at a land disposal facility (also see definition for high integrity container). Note that for some shipments, the disposal container may be the transport package. (17) Environmental Protection Agency (EPA) identification number--The number received by a transporter following application to the administrator of EPA as required by 40 CFR Part 263. (18) Exclusive use--The sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out as specified in the direction of the consignor or consignee. The consignor and the carrier must ensure any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor issues specific instructions, in writing, for maintenance of exclusive use shipment controls, and includes them with the shipping paper information provided to the carrier by the consignor. (19) Fissile material--The radionuclides plutonium-239, plutonium-241, uranium-233, uranium-235, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium, and natural uranium or depleted uranium irradiated in thermal reactors only, are not included in this definition. The department's jurisdiction extends only to special nuclear material in quantities not sufficient to form a "critical mass" as defined in §289.201(b) of this chapter. Certain exclusions from fissile material controls are provided in subsection (h) of this section. (20) Freight forwarder--A person or entity holding itself out to the general public to provide transportation of property for compensation and in the ordinary course of its business: (A) assembles and consolidates, or provides for assembling and consolidating, shipments and performs break-bulk and distribution operations of the shipments; (B) assumes responsibility for the transportation from the place of receipt to the place of destination; and (C) uses for any part of the transportation a rail, motor, or water carrier subject to the jurisdiction of either the Federal Motor Carrier Safety Administration or the Surface Transportation Board. (21) Generator--A licensee operating under a department, NRC, or agreement state license who: (A) is a waste generator as defined in this section; or (B) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (e.g., waste generated from decontamination or recycle activities). (22) Graphite--In this section, this means graphite with a boron equivalent content of less than 5 parts per million and density greater than 1.5 grams (g) per cubic centimeter. (23) High integrity container (HIC)--A container commonly designed to meet the structural stability requirements of 10 CFR §61.56, and to meet DOT requirements for a Type A package. (24) Indian Tribe--An Indian or Alaska Native Tribe, band, nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994, 25 United States Code (U.S.C.) §479a. (25) Low-level radioactive waste (LLRW)--Radioactive material that meets the following criteria: (A) LLRW is radioactive material: (i) discarded or unwanted and not exempt by rule adopted as specified in the Texas Radiation Control Act (Act), Texas Health and Safety Code §401.106; (ii) waste, as that term is defined in 10 CFR §61.2; and (iii) subject to: (I) concentration limits established in 10 CFR §61.55, or compatible rules adopted by the department or the Texas Commission on Environmental Quality (TCEQ), as applicable; and (II) disposal criteria established in 10 CFR or established by the department or TCEQ, as applicable. (B) LLRW does not include: (i) high-level radioactive waste as defined in 10 CFR §60.2; (ii) spent nuclear fuel as defined in 10 CFR §72.3; (iii) byproduct material defined in the Act, Texas Health and Safety Code §401.003(3)(B); (iv) naturally occurring radioactive material (NORM) waste that is not oil and gas NORM waste; (v) oil and gas NORM waste; or (vi) transuranics greater than 100 nanocuries (3.7 kilobecquerels) per gram (g). (26) Low specific activity (LSA) material--Radioactive material with limited specific activity that is non-fissile or is excepted as specified in subsection (h) of this section, and satisfies the following descriptions and limits set forth in this section. Shielding materials surrounding the LSA material is not considered in determining the estimated average specific activity of the package contents. LSA material is in one of the following three groups: (A) LSA-I. (i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radionuclides intended to be processed for the use of these radionuclides; (ii) Natural uranium, depleted uranium, natural thorium, or their compounds or mixtures, provided they are unirradiated and in solid or liquid form; (iii) Radioactive material other than fissile material for which the A2 value is unlimited; or (iv) Other radioactive material (e.g., mill tailings, contaminated earth, concrete, rubble, other debris, and activated material) in which the radioactivity is distributed throughout, and the estimated average specific activity is not more than 30 times the value for exempt material activity concentration determined in accordance with subsection (ee) of this section. (B) LSA-II. (i) Water with tritium concentration up to 0.8 terabecquerel per liter (TBq/l) (20.0 curies per liter (Ci/l)); or (ii) Other material in which the radioactivity is distributed throughout, and the average specific activity is not greater than 10-4 A2 /g for solids and gases and 10-5 A2 /g for liquids. (C) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, satisfying the requirements of 10 CFR §71.77 in which: (i) the radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.); (ii) the radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even with a loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, is not greater than 0.1 A2 ; and (iii) the estimated average specific activity of the solid, excluding any shielding material, is not greater than 2 x 10-3 A2 /g. (27) Low toxicity alpha emitters--Natural uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232, thorium-228, or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than 10 days. (28) Maximum normal operating pressure--The maximum gauge pressure that would develop in the containment system in a period of one year under the heat condition specified in 10 CFR §71.71(c)(1), in the absence of venting, external cooling by an ancillary system, or operational controls during transport. (29) Natural thorium--Thorium with the naturally occurring distribution of thorium isotopes (essentially 100 weight percent thorium-232). (30) Normal form radioactive material--Radioactive material not demonstrated to qualify as special form radioactive material. (31) NRC Forms 540, 540A, 541, 541A, 542, and 542A--Official NRC forms referenced in subsection (ff) of this section that include the information required by DOT in 49 CFR Part 172. Licensees need not use originals of these forms if any substitute forms contain the equivalent information. Licensees may include additional information deemed relevant to the licensee's shipment of low-level radioactive waste. Upon agreement between the shipper and consignee, NRC Forms 541 (and 541A) and NRC Forms 542 (and 542A) or equivalent documents may be completed, transmitted, and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest. (32) Package--The packaging together with its radioactive contents as presented for transport. (A) Fissile material package, Type AF package, Type BF package, Type B(U)F package, or Type B(M)F package--A fissile material packaging together with its fissile material contents. (B) Type A package--A Type A packaging together with its radioactive contents. A Type A package is defined and complies with DOT regulations in 49 CFR Part 173. (C) Type B package--A Type B packaging together with its radioactive contents. On approval by the NRC, a Type B package design is designated by NRC as B(U) unless the package has a maximum normal operating pressure of more than 700 kilopascals (kPa) (100 pounds per square inch (lbs/in2 )) gauge or a pressure relief device allowing the release of radioactive material to the environment under the tests specified in 10 CFR §71.73 (hypothetical accident conditions), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 CFR Part 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 CFR §71.19. (33) Packaging--The assembly of components necessary to ensure compliance with the packaging requirements of this section. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging. (34) Physical description--The items called for on NRC Form 541 to describe an LLRW. (35) Registered freight forwarder--A freight forwarder having an emergency plan approved as specified in subsection (r) of this section and issued a registration letter. (36) Registered shipper--A shipper having an emergency plan approved as specified in subsection (r) of this section and shipping containers approved as specified in subsection (cc)(8) of this section and issued a registration letter. (37) Registered transporter--A transporter having an emergency plan approved as specified in subsection (r) of this section and proof of financial responsibility submitted and approved as specified in subsection (e)(4) of this section and issued a registration letter. (38) Residual waste--LLRW resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable. (39) Shipper--The licensed entity (i.e., the waste generator, waste collector, or waste processor) offering LLRW for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator. This definition applies only to shipments of LLRW shipped to a Texas LLRW disposal facility. (40) Site of usage--The licensee's facility, including all buildings and structures between which radioactive material is transported and all roadways not within the public domain on which radioactive material can be transported. (41) Special form radioactive material--Radioactive material satisfying the following conditions: (A) either a single solid piece or contained in a sealed capsule that can be opened only by destroying the capsule; (B) the piece or capsule has at least one dimension not less than 5 millimeters (0.2 inches (in)); and (C) satisfies the requirements of 10 CFR §71.75. A special form encapsulation designed as specified in the requirements of this subsection in effect on or after June 30, 1983 (see 10 CFR Part 71, revised as of January 1, 1983), and constructed before July 1, 1985; a special form encapsulation designed as specified in the requirements of this subsection in effect on or after March 31, 1996 (see 10 CFR Part 71, revised as of January 1, 1996), and constructed before April 1, 1998; and (D) special form material successfully tested before September 10, 2015, as specified in the requirements of 10 CFR §71.75(d) in effect before September 10, 2015, may continue to be used. Any other special form encapsulation must meet the specifications of this definition. (42) Specific activity of a radionuclide--The radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material. (43) Spent nuclear fuel or spent fuel--Fuel withdrawn from a nuclear reactor following irradiation, undergone at least one year's decay since being used as a source of energy in a power reactor, and not chemically separated into its constituent elements by reprocessing. Spent fuel includes the special nuclear material, byproduct material, source material, and other radioactive materials associated with fuel assemblies. (44) Surface contaminated object (SCO)--A solid object not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. An SCO must be in one of the following two groups with surface activity not greater than the following limits: (A) SCO-I--A solid object on which: (i) the non-fixed contamination on the accessible surface averaged over 300 square centimeters (cm2 ) (or the area of the surface if less than 300 cm2 ) is not greater than 4 Bq/cm2 (10-4 µCi/cm2 ) for beta and gamma and low toxicity alpha emitters, or 4 x 10-1 Bq/cm2 (10-5 µCi/cm2 ) for all other alpha emitters; (ii) the fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2 ) is not greater than 4 x 104 Bq/cm2 (1 µCi/cm2 ) for beta and gamma and low toxicity alpha emitters, or 4 x 103 Bq/cm2 (10-1 µCi/cm2 ) for all other alpha emitters; and (iii) the non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2 ) is not greater than 4 x 104 Bq/cm2 (1 µCi/cm2 ) for beta and gamma and low toxicity alpha emitters, or 4 x 103 Bq/cm2 (10-1 µCi/cm2 ) for all other alpha emitters. (B) SCO-II--A solid object on which the limits for SCO-I are exceeded and on which the following limits are not exceeded: (i) the non-fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2 ) is not greater than 400 Bq/cm2 (10-2 µCi/cm2 ) for beta and gamma and low toxicity alpha emitters, or 40 Bq/cm2 (10-3 µCi/cm2 ) for all other alpha emitters; (ii) the fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2 ) is not greater than 8 x 105 Bq/cm2 (20 µCi/cm2 ) for beta and gamma and low toxicity alpha emitters, or 8 x 104 Bq/cm2 (2 µCi/cm2 ) for all other alpha emitters; and (iii) the non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2 ) is not greater than 8 x 105 Bq/cm2 (20 µCi/cm2 ) for beta and gamma and low toxicity alpha emitters, or 8 x 104 Bq/cm2 (2 µCi/cm2 ) for all other alpha emitters. (45) Transporter--A carrier who transports radioactive material. (46) Tribal official--The highest ranking individual representing Tribal leadership, such as the Chief, President, or Tribal Council leadership. (47) Uniform Low-Level Radioactive Waste Manifest or uniform manifest--The combination of NRC Forms 540, 541, and, if necessary, 542, and their respective continuation sheets as needed, or equivalent. (48) Unirradiated uranium--Uranium containing not more than 2 x 103 Bq (0.054 µCi) of plutonium per gram of uranium-235, not more than 9 x 106 Bq (243 µCi) of fission products per gram of uranium-235, and not more than 5 x 10-3 g of uranium-236 per gram of uranium-235. (49) Uranium--Natural, depleted, enriched: (A) Natural uranium--Uranium that may be chemically separated with the naturally occurring distribution of uranium isotopes (approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238). (B) Depleted uranium--Uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes. (C) Enriched uranium--Uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes. (50) Waste collector--An entity, operating under a department, NRC, or agreement state license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility. (51) Waste description--The physical, chemical, and radiological description of an LLRW as called for on NRC Form 541. (52) Waste generator--An entity, operating under a department, NRC, or agreement state license, who: (A) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use; and (B) transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment before disposal. A licensee performing processing or decontamination services may be a waste generator if the transfer of LLRW from its facility is defined as residual waste. (53) Waste processor--An entity, operating under an NRC or agreement state license, whose principal purpose is to process, repackage, or otherwise treat LLRW or waste generated by others before eventual transfer of waste to a licensed LLRW land disposal facility. (54) Waste type--A waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste sorbed on or solidified in a specifically defined media). (e) Transportation of radioactive material. (1) Each licensee transporting radioactive material outside the site of usage as specified in the department license, transporting on public highways, or delivering radioactive material to a carrier for transport must comply with the applicable requirements of DOT regulations in 49 CFR Part 107, Parts 171 - 180, and Parts 390 - 397 appropriate to the mode of transport. The licensee must particularly note DOT regulations in the following areas: (A) Packaging - 49 CFR Part 173: Subparts A, B, and I. (B) Marking and labeling - 49 CFR Part 172: Subpart D, and §§172.400 - 172.407 and §§172.436 - 172.441 of Subpart E. (C) Placarding - 49 CFR Part 172: Subpart F, especially §§172.500 - 172.519 and §172.556, and Appendices B and C. (D) Accident reporting - 49 CFR Part 171: §171.15 and §171.16. (E) Shipping papers and emergency information - 49 CFR Part 172: Subparts C and G. (F) Hazardous material employee training - 49 CFR Part 172: Subpart H. (G) Hazardous material shipper/carrier registration - 49 CFR Part 107: Subpart G. (H) Security Plans - 49 CFR Part 172: Subpart I. (2) The licensee must comply with DOT regulations pertaining to the following modes of transportation: (A) Rail: 49 CFR Part 174: Subparts A through D and K. (B) Air: 49 CFR Part 175. (C) Vessel: 49 CFR Part 176: Subparts A through F and M. (D) Public Highway: 49 CFR Part 177 and Parts 390 through 397. (3) If DOT regulations are not applicable to a shipment of radioactive material (i.e., DOT does not have jurisdiction), the licensee must conform to DOT standards and requirements specified in paragraph (1) of this subsection to the same extent as if the shipment or transportation were subject to DOT regulations. A request for modification, waiver, or exemption from those requirements must be filed and approved by the department. Any notification referred to in those requirements must be submitted to the department. (4) Transporter proof of financial responsibility. (A) Transporters of LLRW to a Texas LLRW disposal site must submit proof of financial responsibility required by 49 CFR §387.7 and §387.9 to the department and receive a registration letter from the department before initial shipment. (B) The transporter registration expires on the expiration date of the proof of financial responsibility or in 10 years if the proof of financial responsibility does not have an expiration date. (C) To renew a transporter's registration, the transporter must submit to the department new proof of financial responsibility. (D) The transporter must submit to the department new proof of financial responsibility any time the amount of liability coverage is reduced or a new policy is purchased. (5) The department must review and determine alternate routes for the transportation and routing of radioactive material as specified in 49 CFR §397.103. (f) Exemption for low-level radioactive materials. (1) A licensee is exempt from all requirements of this section with respect to shipment or carriage of the following low-level materials: (A) Natural material and ores containing naturally occurring radionuclides either in their natural state, or only processed for purposes other than for the extraction of the radionuclides, and not intended to be processed for use of these radionuclides, provided the activity concentration of the material is not greater than 10 times the applicable radionuclide activity concentration values specified in subsection (ee), (ee)(7), and (ee)(8) of this section. (B) Materials for which the activity concentration is not greater than the activity concentration values specified in subsection (ee), (ee)(7), and (ee)(8) of this section, or for which the consignment activity is not greater than the limit for an exempt consignment found in subsection (ee), (ee)(7), and (ee)(8) of this section. (C) Non-radioactive solid objects with radioactive substances present on any surfaces in quantities not over the levels cited in the definition of contamination in subsection (d) of this section. (2) Common and contract carriers, freight forwarders, warehousemen, and the United States Postal Service are exempt from the regulations in this subchapter to the extent they transport or store radioactive material in the regular course of their carriage for another, or storage incident thereto. (3) Persons who discard licensed material as specified in §289.202(fff) of this chapter are exempt from all requirements of this section. (g) Exemption of physicians and veterinarians. Any physician or veterinarian licensed by a state to dispense drugs in the practice of medicine or veterinary medicine is exempt from subsection (e) of this section with respect to transport by the physician or veterinarian of licensed material for use in the practice of medicine or veterinary medicine. However, any physician or veterinarian operating under this exemption must be licensed under §289.256 of this subchapter or the equivalent NRC or agreement state regulations. (h) Exemption from classification as fissile material. Fissile materials meeting the requirements of at least one of paragraphs (1) through (6) of this subsection are exempt from classification as fissile material and from the fissile material package standards of 10 CFR §71.55 and §71.59, but are subject to all other requirements of this section, except as noted. (1) An individual package containing 2 g or less fissile material. (2) Individual or bulk packaging containing 15 g or less of fissile material provided the package has at least 200 g of solid non-fissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid non-fissile material. (3) Solid fissile material commingled with solid non-fissile material. (A) Low concentrations of solid fissile material commingled with solid non-fissile material provided: (i) there is at least 2000 g of solid non-fissile material for every gram of fissile material; and (ii) there is no more than 180 g of fissile material distributed within 360 kilograms (kg) of contiguous non-fissile material. (B) Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid non-fissile material. (4) Uranium enriched in uranium-235 to a maximum of one percent by weight, and with total plutonium and uranium-233 content of up to one percent of the mass of uranium-235, provided the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than five percent of the uranium mass, and the fissile material is distributed homogeneously and does not form a lattice arrangement within the package. (5) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two percent by mass, with a total plutonium and uranium-233 content not greater than 0.002 percent of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of 2. The material must be contained in at least a DOT Type A package. (6) Packages containing, individually, a total plutonium mass of not more than 1000 g, of which not more than 20 percent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides. (i) General license. (1) NRC-approved package. (A) A general license is issued to any licensee of the department to transport, or to deliver to a carrier for transport, radioactive material in a package for which a license, CoC, or other approval has been issued by the NRC. (B) This general license applies only to a licensee who has a QA program approved by the NRC as satisfying the provisions of 10 CFR Part 71: Subpart H. (C) This general license applies only to a licensee who: (i) has a copy of the CoC or other approval by the NRC of the package, and has the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken before shipment; and (ii) complies with the terms and conditions of the specific license, certificate, or other approval by the NRC, as applicable, and the applicable requirements in 10 CFR Part 71: Subparts A, G, and H; and (iii) before the licensee's first use of the package, submits in writing to: ATTN: Document Control Desk, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 using an appropriate method listed in 10 CFR Part 71, the licensee's name and license number and the package identification number specified in the package approval. (D) This general license applies only when the package approval authorizes use of the package as specified in this general license. (E) For a Type B or fissile material package, the design of which was approved by NRC before April 1, 1996, the general license is subject to the additional restrictions of paragraph (2) of this subsection. (F) For radiography containers, a program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of §289.255(m)(2)(B) of this chapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), is deemed to satisfy the requirements of subparagraph (B) of this paragraph. (2) Use of foreign approved package. (A) A general license is issued to any licensee to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate revalidated by the DOT as meeting the applicable requirements of 49 CFR §171.23. (B) Except as otherwise provided by this section, the general license applies only to a licensee having a QA program approved by the department as satisfying the applicable provisions of subsection (s) - (u) and (w) - (bb) of this section. (C) This general license applies only to shipments made to or from locations outside the United States. (D) Each licensee issued a general license under subparagraph (A) of this paragraph must: (i) maintain a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate relating to the use and maintenance of the packaging and the actions taken before shipment; and (ii) comply with the terms and conditions of the certificate and revalidation, and with the applicable requirements of §289.205(j) and (k) of this chapter and subsections (a) - (e), (j) - (q), (s) - (u), and (w) - (bb) of this section. (3) Fissile material. (A) A general license is issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped as specified in this section. The fissile material need not be contained in a package meeting the standards of this section. The material must be contained in a Type A package. The Type A package must also meet DOT requirements in 49 CFR §173.417(a). (B) The general license applies only to a licensee having a QA program approved by the NRC as satisfying the provisions of 10 CFR Part 71. (C) The general license applies only when a package's contents: (i) contain no more than a Type A quantity of radioactive material; and (ii) contain less than 500 total grams of beryllium, graphite, or hydrogenous material enriched in deuterium. (D) The general license applies only to packages containing fissile material labeled with a CSI: (i) determined as specified in paragraph (E) of this subsection; (ii) with a value less than or equal to 10.0; and (iii) for a shipment of multiple packages containing fissile material, with a sum of the CSIs less than or equal to 50.0 for shipment on a nonexclusive use conveyance and less than or equal to 100.0 for shipment on an exclusive use conveyance. (E) The CSI must be as follows: (i) the value for the CSI is greater than or equal to the number calculated by the following equation: Attached Graphic(ii) the calculated CSI is rounded up to the first decimal place; (iii) the values of X, Y, and Z used in the CSI equation is taken from Tables 257-1 or 257-2 of this clause, as appropriate; Attached Graphic(iv) if Table 257-2 of clause (iii) of this subparagraph is used to obtain the value of X, then the values for the terms in the equation for uranium-233 and plutonium must be assumed to be zero; and (v) Table 257-1 values of clause (iii) of this subparagraph for X, Y, and Z are used to determine the CSI if: (I) uranium-233 is present in the package; (II) the mass of plutonium is greater than one percent of the mass of uranium-235; (III) the uranium is of unknown uranium-235 enrichment, or greater than 24 weight percent enrichment; or (IV) substances having a moderating effectiveness (i.e., an average hydrogen density greater than H2 O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping. (4) Plutonium-beryllium special form material. (A) A general license is issued to any licensee to transport fissile material in the form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver Pu-Be sealed sources to a carrier for transport, if the material is shipped as specified in this section. This material need not be contained in a package meeting the standards of 10 CFR Part 71; however, the material must be contained in a Type A package. The Type A package must also meet DOT requirements in 49 CFR §173.417(a). (B) The general license applies only to a licensee having a QA program approved by the NRC as satisfying the provisions of 10 CFR Part 71. (C) The general license applies only when a package's contents: (i) contain no more than a Type A quantity of material; and (ii) contain less than 1000 g of plutonium, provided plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than 240 g of the total quantity of plutonium in the package. (D) The general license applies only to packages labeled with a CSI: (i) determined as specified in subparagraph (E) of this paragraph;(ii) with a value less than or equal to 100.0; and (iii) for a shipment of multiple packages containing Pu-Be sealed sources, with a sum of the CSIs less than or equal to 50.0 for shipment on a nonexclusive use conveyance and less than or equal to 100.0 for shipment on or exclusive use conveyance. (E) The value for the CSI must: (i) be greater than or equal to the number calculated by the following equation: Attached Graphic(ii) be rounded up to the first decimal place once calculated. (j) Assumptions as to unknown properties. When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee must package the fissile material as if the unknown properties have credible values causing the maximum neutron multiplication. (k) Preliminary determinations. Before the first use of any packaging for the shipment of licensed material, the licensee must ascertain the determinations were made as specified in 10 CFR §71.85. (l) Routine determinations. Before each shipment of radioactive material, the licensee must ensure the package with its contents satisfies the applicable requirements of this section and of the license. The licensee must determine: (1) the package is proper for the contents to be shipped; (2) the package is in unimpaired physical condition except for superficial defects such as marks or dents; (3) each closure device of the packaging, including any required gasket, is properly installed, secured, and free of defects; (4) any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid; (5) any pressure relief device is operable and set as specified in written procedures; (6) the package has been loaded and closed as specified in written procedures; (7) for fissile material, any moderator or neutron absorber, if required, is present and in proper condition; (8) any structural part of the package used to lift or tie down the package during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 CFR §71.45; (9) the level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable (ALARA), and within the limits specified in DOT regulations 49 CFR §173.443; (10) external radiation levels around the package and around the vehicle, if applicable, are not greater than the following limits at any time during transportation: (A) Except as provided in subparagraph (B) of this paragraph, each package of radioactive materials offered for transportation must be designed and prepared for shipment so, under conditions normally incident to transportation, the radiation level is not greater than 2 millisieverts per hour (mSv/hr) (200 millirem per hour (mrem/hr)) at any point on the external surface of the package, and the transport index is not greater than 10. (B) A package that exceeds the radiation level limits specified in subparagraph (A) of this paragraph must be transported by exclusive use shipment only, and the radiation levels for such shipment must not be greater than the following during transportation: (i) 2 mSv/hr (200 mrem/hr) on the external surface of the package, unless the following conditions are met, in which case the limit is 10 mSv/hr (1000 mrem/hr): (I) the shipment is made in a closed transport vehicle; (II) the package is secured within the vehicle so its position remains fixed during transportation; and (III) there are no loading or unloading operations between the beginning and end of the transportation; (ii) 2 mSv/hr (200 mrem/hr) at any point on the outer surface of the vehicle, including the top and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load or enclosure, if used, and on the lower external surface of the vehicle; and (iii) 0.1 mSv/hr (10 mrem/hr) at any point 2 meters (m) (6.6 feet (ft)) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point 2 m (6.6 ft) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and (iv) 0.02 mSv/hr (2 mrem/hr) in any normally occupied space, except this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with §289.202(q) of this chapter. (C) For shipments made as specified in the provisions of subparagraph (B) of this paragraph, the shipper must provide specific written instructions to the carrier for maintenance of the exclusive use shipment controls. The instructions must be included with the shipping paper information. (D) The written instructions required for exclusive use shipments must be sufficient so, when followed, they will cause the carrier to avoid actions unnecessarily delaying delivery or unnecessarily resulting in increased radiation levels or radiation exposures to transport workers or members of the general public. (m) Air transport of plutonium. (1) Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this section or included in 49 CFR Chapter I, as may be applicable, the licensee must assure plutonium in any form, whether for import, export, or domestic shipment, is not transported by air or delivered to a carrier for air transport unless: (A) the plutonium is contained in a medical device designed for individual human application; or (B) the plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in Table 257-4 of subsection (ee)(7) of this section, and in which the radioactivity is essentially uniformly distributed; or (C) the plutonium is shipped in a single package containing no more than an A2 quantity of plutonium in any isotope or form, and is shipped as specified in subsection (e) of this section; or (D) the plutonium is shipped in a package specifically authorized for the shipment of plutonium by air in the CoC for that package issued by the NRC. (2) Nothing in paragraph (1) of this subsection is interpreted as removing or diminishing the requirements of 10 CFR §73.24. (3) For a shipment of plutonium by air subject to paragraph (1) of this subsection, the licensee must, through special arrangement with the carrier, require compliance with 49 CFR §175.704, DOT regulations applicable to the air transport of plutonium. (n) Opening instructions. Before delivery of a package to a carrier for transport, the licensee must ensure any special instructions needed to safely open the package are sent to, or otherwise made available to, the consignee for the consignee's use as specified in §289.202(ee)(5) of this chapter. (o) Records. (1) For a period of three years after shipment, each licensee must maintain, for inspection by the department, a record of each shipment of radioactive material not exempt under subsection (f) of this section, including, where applicable: (A) identification of the packaging by model number and serial number; (B) verification there are no significant defects in the packaging, as shipped; (C) volume and identification of coolant; (D) type and quantity of radioactive material in each package, and the total quantity of each shipment; (E) for each item of irradiated fissile material: (i) identification by model number and serial number; (ii) irradiation and decay history to the extent appropriate to demonstrate its nuclear and thermal characteristics comply with license conditions; and (iii) any abnormal or unusual condition relevant to radiation safety; (F) date of the shipment; (G) for fissile packages and for Type B packages, any special controls exercised; (H) name and address of the transferee; (I) address to which the shipment was made; and (J) results of the determinations required by subsection (l) of this section and by the conditions of the package approval. (2) The licensee, certificate holder, and an applicant for a CoC must make available to the department for inspection, upon reasonable notice, all records required by this section. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated. (3) The licensee, certificate holder, and an applicant for a CoC must maintain sufficient written records to furnish evidence of the quality of packaging. (A) The records maintained include: (i) results of the determinations required by subsection (k) of this section; (ii) design, fabrication, and assembly records; (iii) results of reviews, inspections, tests, and audits; (iv) results of monitoring work performance and materials analyses; and (v) results of maintenance, modification, and repair activities. (B) Inspection, test, and audit records must identify the: (i) inspector or data recorder; (ii) type of observation; (iii) results; (iv) acceptability; and (v) action taken in connection with any deficiencies noted. (C) These records must be retained for three years after the life of the packaging to which they apply. (p) Reports. The transporter and shipper must immediately report by telephone all radioactive waste transportation accidents to the department, at (512) 458-7460, and the local emergency management officials in the county where the radioactive waste accident occurs. All other accidents involving radioactive material must be reported as specified in §289.202(xx) and (yy) of this chapter. (q) Advance notification of transport of irradiated reactor fuel and certain radioactive waste. (1) As specified in paragraphs (3) - (5) of this subsection, each licensee must provide advance notification to the governor of a state or the governor's designee, of the shipment of radioactive waste within or across the boundary of the state before the transport or delivery to a carrier, for transport of radioactive waste outside the confines of the licensee's facility or other place of use or storage. (2) As specified in paragraphs (3) - (5) of this subsection, after June 11, 2013, each licensee must provide advance notification to the Tribal official of participating Tribes referenced in paragraph (4)(C)(iii) of this subsection or the official's designee, of the shipment of radioactive waste within or across the boundary of the Tribe's reservation before the transport or delivery to a carrier, for transport of radioactive waste outside the confines of the licensee's facility or other place of use or storage. (3) Advanced notification is also required under this subsection for the shipment of licensed radioactive material, other than irradiated fuel, meeting the following three conditions: (A) the radioactive waste is required by this section to be in Type B packaging for transportation; (B) the radioactive waste is being transported to or across a state boundary en route to a disposal facility or to a collection point for transport to a disposal facility; and (C) the quantity of radioactive waste in a single package is not greater than the least of: (i) 3000 times the A1 value of the radionuclides as specified in subsection (ee) of this section for special form radioactive material; (ii) 3000 times the A2 value of the radionuclides as specified in subsection (ee) of this section for normal form radioactive material; or (iii) 1000 terabecquerels (TBq) (27,000 curies (Ci)). (4) Procedures for submitting advance notification: (A) The notification must be made in writing, to: (i) the office of each appropriate governor or governor's designee and to the department; (ii) the office of each appropriate Tribal official or Tribal official's designee; and (iii) the Director, Office of Nuclear Security and Incident Response. (B) A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. (C) A notification delivered by any means other than mail must reach the office of the governor or of the governor's designee or the Tribal official or Tribal official's designee at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. (i) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating Tribes, including telephone and mailing addresses of Tribal officials and Tribal official's designees, is available on the NRC website at: https://scp.nrc.gov/special/designee.pdf. (ii) A list of the names and mailing addresses of the governors' designees and Tribal officials' designees of participating Tribes is available on request from the Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, United States Nuclear Regulatory Commission, Washington, DC 20555-0001. (D) The licensee must retain a copy of the notification for inspection by the department for three years. (5) Each advance notification of shipment of irradiated reactor fuel or radioactive waste must contain: (A) the name, address, and telephone number of the shipper, carrier, and receiver of the irradiated reactor fuel or radioactive waste shipment; (B) a description of the irradiated reactor fuel or radioactive waste contained in the shipment, as specified in the regulations of DOT in 49 CFR §172.202 and §172.203(d); (C) the point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur; (D) the seven-day period during which arrival of the shipment at state boundaries or Tribal reservation is estimated to occur; (E) the destination of the shipment, and the seven-day period during which arrival of the shipment is estimated to occur; and (F) a point of contact, with a telephone number, for current shipment information. (6) A licensee who finds schedule information previously furnished to a governor or governor's designee or a Tribal official or Tribal official's designee, as specified in this section, is not met, must telephone a responsible individual in the office of the governor of the state or of the governor's designee or the Tribal official or the Tribal official's designee and inform that individual of the extent of the delay beyond the schedule originally reported. The licensee must maintain a record of the name of the individual contacted for three years. (7) Procedures for a cancellation notice. (A) Each licensee canceling an irradiated reactor fuel or radioactive waste shipment for which advance notification was sent must send a cancellation notice to the governor of each state or to the governor's designee previously notified, to each Tribal official or to the Tribal official's designee previously notified, to the Director, Office of Nuclear Security and Incident Response, and to the department. (B) The licensee must state in the notice it is a cancellation and identify the advance notification being canceled. The licensee must retain a copy of the notice for inspection by the department for three years. (r) Emergency plan registration requirements. (1) Each shipper and transporter of radioactive waste must submit an emergency plan to the department and receive a registration letter from the department before initial shipment. (2) A freight forwarder must submit an emergency plan to become a registered freight forwarder. (3) Each shipper, transporter, or freight forwarder applying for registration must submit a Business Information Form (RC 252-1). (4) Shipper and freight forwarder registrations expire 10 years from the date of issuance. New documentation to renew the registration must be submitted at least 30 days before the expiration date. (s) QA requirements. (1) Purpose. This subsection describes QA requirements applying to the design, purchase, fabrication, handling, shipment, storage, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. (A) QA comprises all those planned and systematic actions necessary to provide adequate confidence a system or component performs satisfactorily in service. (B) QA includes quality control, which comprises those QA actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. (C) The licensee, certificate holder, and applicant for a CoC are responsible for: (i) the QA requirements as they apply to the design, fabrication, testing, and modification of packaging; and (ii) the QA provision applicable to its use of a packaging for the shipment of licensed material under subsections (s) - (bb) and (ee) of this section. (2) Establishment of program. Each licensee, certificate holder, and applicant for a CoC must: (A) establish, maintain, and execute a QA program satisfying each of the applicable criteria of this subsection, subsections (s) and (t) of this section, and 10 CFR §§71.101 - 71.137 and satisfying any specific provisions applicable to the licensee's activities including procurement of packaging; and (B) execute the applicable criteria in a graded approach to an extent commensurate with the QA requirement's importance to safety. (3) Approval of program. Before the use of any package for the shipment of licensed material subject to this subsection, each licensee must: (A) obtain department approval of its QA program; and (B) file a description of its QA program, including a discussion of which requirements of this subsection and subsections (t) and (u) are applicable and how they will be satisfied. (4) Radiography containers. A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of §289.255(m) of this subchapter, is deemed to satisfy the requirements of subsection (i)(1)(B) of this section and paragraph (2) of this subsection. (t) QA organization. The licensee, certificate holder, and applicant for a CoC must (while the term "licensee" is used in these criteria, the requirements are applicable to the design, fabrication, assembly, and testing of the package accomplished before the time a package approval is issued): (1) be responsible for establishing and executing the QA program. The licensee, certificate holder, and applicant for a CoC may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the QA program, or any part of the QA program, but must retain responsibility for the program; (2) clearly establish and delineate, in writing, the authority and duties of persons and organizations performing activities affecting the functions of structures, systems, and components important to safety. These activities include performing the functions associated with attaining quality objectives and the QA functions; and (3) establish QA functions as follows: (A) assuring an appropriate QA program is established and effectively executed; and (B) verifying, by procedures such as checking, auditing, and inspecting, activities affecting the functions important to safety are correctly performed; and (4) assure persons and organizations performing QA functions have sufficient authority and organizational freedom to: (A) identify quality problems; (B) initiate, recommend, or provide solutions; and (C) verify implementation of solutions. (u) QA program. A QA program must be maintained as follows: (1) The licensee, certificate holder, and applicant for a CoC must: (A) establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a QA program complying with the requirements of this section and 10 CFR §§71.101 - 71.137; (B) document the QA program by written procedures or instructions and carry out the program as specified in those procedures throughout the period during which the packaging is used; and (C) identify the material and components covered by the QA program, the major organizations participating in the program, and the designated functions of these organizations. (2) The licensee, certificate holder, and applicant for a CoC, through its QA program, must: (A) provide control over activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material; (B) assure activities affecting quality are accomplished under suitable controlled conditions, including: (i) the use of appropriate equipment; (ii) suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and (iii) all prerequisites for the given activity are satisfied; and (C) consider the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test. (3) The licensee, certificate holder, and applicant for a CoC must base the requirements and procedures of its QA program on considerations concerning the complexity and proposed use of the package and its components, including: (A) the impact of malfunction or failure of the item to safety; (B) the design and fabrication complexity or uniqueness of the item; (C) the need for special controls and surveillance over processes and equipment; (D) the degree to which functional compliance can be demonstrated by inspection or test; and (E) the quality history and degree of standardization of the item. (4) The licensee, certificate holder, and applicant for a CoC must provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure suitable proficiency is achieved and maintained. (5) The licensee, certificate holder, and applicant for a CoC must review the status and adequacy of the QA program at established intervals. Management of other organizations participating in the QA program must review regularly the status and adequacy of that part of the QA program they are executing. (6) Changes to QA program. (A) Each QA program approval holder must submit, as specified in §289.201(k) of this chapter, a description of a proposed change to its department-approved QA program reducing commitments in the program description as approved by the department. The QA program approval holder must not implement the change before receiving approval from the department. The description of a proposed change to the department-approved QA program must identify the change, the reason for the change, and the basis for concluding the revised program incorporating the change continues to satisfy the applicable requirements of subsections (s) - (bb) of this section. (B) Each QA program approval holder may change a previously approved QA program without prior approval from the department if the change does not reduce the commitments in the QA program previously approved by the department. Changes to the QA program that do not reduce the commitments must be submitted to the department every 24 months as specified in §289.201(k) of this chapter. In addition to QA program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment: (i) the use of a QA standard approved by the department more recent than the QA standard in the certificate holder's or applicant's current QA program at the time of the change; (ii) the use of generic organizational position titles clearly denoting the position function, supplemented as necessary by descriptive text, rather than specific titles, provided there is no substantive change to either the functions of the position or reporting responsibilities; (iii) the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided there is no substantive change to the functional relationships, authorities, or responsibilities; (iv) the elimination of QA program information duplicating language in QA regulatory guides and standards to which the QA program approval holder has committed on record; and (v) organizational revisions ensuring persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations. (C) Each QA program approval holder must maintain records of QA program changes. (v) Quality control program. Each shipper must adopt a quality control program ensuring shipping containers are suitable for shipments to a licensed disposal facility by verifying: (1) identification of appropriate containers; (2) container testing documentation is adequate; (3) appropriate container used; (4) container packaged appropriately; (5) container labeled appropriately; (6) manifest filled out appropriately; and (7) documentation maintained of each step. (w) Handling, storage, and shipping control. The licensee, certificate holder, and applicant for a CoC must establish measures to control, as specified in instructions, the handling, storing, shipping, cleaning, and preserving of materials and equipment used in packaging to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, and specific moisture content and temperature levels must be specified and provided. (x) Inspection, test, and operating status. Measures to track inspection, test, and operating status must be established. (1) The licensee, certificate holder, and applicant for a CoC must establish measures to indicate, using markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the packaging. These measures must provide for the identification of items having satisfactorily passed required inspections and tests where necessary to preclude inadvertent bypassing of the inspections and tests; and (2) The licensee must establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation. (y) Non-conforming materials, parts, or components. The licensee, certificate holder, and applicant for a CoC must establish measures to control materials, parts, or components not conforming to the licensee's requirements to prevent their inadvertent use or installation. These measures must include, as appropriate: (1) procedures for identification, documentation, segregation, disposition, and notification to affected organizations; and (2) non-conforming items must be reviewed and accepted, rejected, repaired, or reworked as specified in documented procedures. (z) Corrective action. The licensee, certificate holder, and applicant for a CoC must establish measures to assure conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and non-conformances, are promptly identified and corrected. (1) In the case of a significant condition adverse to quality, the measures must assure the cause of the condition is determined and corrective action taken prevents repetition. (2) The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken must be documented and reported to appropriate levels of management. (aa) QA records. The licensee, certificate holder, and applicant for a CoC must maintain written records sufficient to describe the activities affecting quality for inspection by the department for three years beyond the date when the licensee, certificate holder, and applicant for a CoC last engaged in the activity for which the QA program was developed. If any portion of the written procedures or instructions is superseded, the licensee, certificate holder, and applicant for a CoC must retain the superseded material for three years after it is superseded. The records must include: (1) instructions, procedures, and drawings to prescribe QA activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment; (2) instructions or procedures establishing a records retention program consistent with applicable regulations and designating factors such as duration, location, and assigned responsibility; and (3) changes to the QA program as required by subsection (u)(6) of this section. (bb) Audits. The licensee, certificate holder, and applicant for a CoC must carry out a comprehensive system of planned and periodic audits, verifying compliance with all aspects of the QA program, and determining the effectiveness of the program. The audit program must include: (1) performance as specified in written procedures or checklists by appropriately trained personnel not having direct responsibilities in the area being audited; (2) documented results reviewed by management having responsibility in the area audited; and (3) follow-up action, including reaudit of deficient areas, taken where indicated. (cc) Transfer for disposal and manifests. (1) The requirements of this section and subsection (ff) of this section are designed to: (A) control transfers of LLRW by any waste generator, waste collector, or waste processor licensee, as defined in this section, shipping LLRW either directly or indirectly through a waste collector or waste processor to a licensed LLRW land disposal facility, as defined in §289.201(b) of this chapter; (B) establish a manifest tracking system; and (C) supplement existing requirements concerning transfers and recordkeeping for those wastes. (2) Beginning March 1, 1998, all affected licensees must use subsection (ff) of this section. (3) Each shipment of LLRW intended for disposal at a licensed land disposal facility must be accompanied by a shipment manifest as specified in subsection (ff)(1) of this section. (4) Any licensee shipping LLRW intended for ultimate disposal at a licensed land disposal facility must document the information required on the uniform manifest and transfer this recorded manifest information to the intended consignee as specified in subsection (ff) of this section. (5) Each shipment manifest must include a certification by the waste generator as specified in subsection (ff)(10) of this section, as appropriate. (6) Each person involved in the transfer for disposal and disposal of LLRW, including the waste generator, waste collector, waste processor, and disposal facility operator, must comply with the requirements specified in subsection (ff) of this section, as appropriate. (7) Any licensee shipping LLRW to a licensed Texas LLRW disposal facility must comply with the waste acceptance criteria in 30 Texas Administrative Code Chapter 336. (8) Each shipper must submit a list for approval by the department of shipping containers they intend to use to ship LLRW to the Texas LLRW site. If the shipper is licensed in Texas and is the holder of a CoC, the shipper must also submit written documentation of its program for QA and control and handling, shipping, and control measures complying with the requirements of subsections (s), (t), and (v) - (bb) of this section. (dd) Fees. (1) Each shipper is assessed a fee for shipments of LLRW originating in Texas or originating out-of-state being shipped to a licensed Texas LLRW disposal facility and these fees are: (A) $10 per cubic foot of shipped LLRW; (B) collected by the department and deposited to the credit of the department's Radiation and Perpetual Care Account; (C) used by the department for emergency planning for and response to transportation accidents involving LLRW, including first responder training in counties through which transportation routes are designated as specified in this section; and (D) not collected on waste disposed of at a federal waste disposal facility. (2) Fee assessments are suspended from imposition against a party state compact waste generator when the amount in the department's Radiation and Perpetual Care Account attributable to those fees reaches $500,000. If the amount in that account attributable to those fees is reduced to $350,000 or less, the fee is reinstated until the amount reaches $500,000. (3) Money expended from the department's Radiation and Perpetual Care Account to respond to accidents involving LLRW are reimbursed to the department's Radiation and Perpetual Care Account by the responsible shipper or transporter according to this section. (4) For purposes of this subsection, "shipper" means a person who generates LLRW and ships, or arranges with others to ship, waste to a disposal site. (5) This subsection does not relieve a generator from liability for a transportation accident involving LLRW. (ee) Appendices for determination of A1 and A2 .(1) Values of A1 and A2 . Values of A1 and A2 for individual radionuclides, which are the bases for many activity limits elsewhere in these rules, are given in Table 257-3 of paragraph (6) of this subsection. The Ci values specified are obtained by converting from the TBq value. The TBq values are the regulatory standard. The Ci values are for information only and are not intended to be the regulatory standard. Where values of A1 or A2 are unlimited, it is for radiation control purposes only. For nuclear criticality safety, some materials are subject to controls placed on fissile material. (2) Values of radionuclides not listed. (A) For individual radionuclides whose identities are known but are not listed in Table 257-3 of paragraph (6) of this subsection, the A1 and A2 values contained in Table 257-5 of paragraph (8) of this subsection may be used. Otherwise, the licensee must obtain prior department or NRC approval of the A1 and A2 values for radionuclides not listed in Table 257-3 of paragraph (6) of this subsection before shipping the material. (B) For individual radionuclides whose identities are known but not listed in Table 257-4 of paragraph (7) of this subsection, the exempt material activity concentration and exempt consignment activity values contained in Table 257-5 of paragraph (8) of this subsection may be used. Otherwise, the licensee must obtain prior department or NRC approval of the exempt material activity concentration and exempt consignment activity values for radionuclides not listed in Table 257-4 of paragraph (7) of this subsection before shipping the material. (C) The licensee must submit requests for prior approval, described in subparagraphs (A) and (B) of this paragraph, to the department or the NRC. (3) Calculations of A1 and A2 for a radionuclide not in Table 257-3 of paragraph (6) of this subsection. In the calculations of A1 and A2 for a radionuclide not in Table 257-3 of paragraph (6) of this subsection, a single radioactive decay chain in which radionuclides are present in their naturally occurring proportions and in which no daughter radionuclide has a half-life either longer than 10 days or longer than the parent radionuclide, must be considered as a single radionuclide, and the activity to be taken into account and the A 1 and A2 value to be applied must be those corresponding to the parent radionuclide of that chain. In the case of radioactive decay chains in which any daughter radionuclide has a half-life either longer than 10 days, or greater than the parent radionuclide, the parent and those daughter radionuclides must be considered as mixtures of different radionuclides. (4) Determination for mixtures of radionuclides whose identities and respective activities are known. For mixtures of radionuclides whose identities and respective activities are known, the following conditions apply. (A) For special form radioactive material, the maximum quantity transported in a Type A package is as follows: Attached Graphic(B) For normal form radioactive material, the maximum quantity transported in a Type A package is as follows: Attached Graphic(C) If the package contains both special and normal form radioactive material, the activity that may be transported in a Type A package is as follows: Attached Graphic(D) Alternatively, an A1 value for mixtures of special form material may be determined as follows: Attached Graphic(E) Alternatively, an A2 value for mixtures of normal form material may be determined as follows: Attached Graphic(F) The exempt activity concentration for mixtures of nuclides may be determined as follows: Attached Graphic(G) The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows: Attached Graphic(5) Determination when individual activities of some of the radionuclides are not known. (A) When the identity of each radionuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest A1 or A2 value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph (4) of this subsection. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A1 or A2 values for the alpha emitters and beta/gamma emitters. (B) When the identity of each radionuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest (activity concentration for exempt material) or A (activity limit for exempt consignment) value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph (4) of this subsection. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest or A values for the alpha emitters and beta/gamma emitters, respectively. (6) A1 and A2 values for radionuclides. Table 257-3 contains A1 and A2 values for radionuclides. Attached Graphic(7) Exempt material activity concentrations and exempt consignment activity limits for radionuclides. Table 257-4 contains exempt material activity concentrations and exempt consignment activity limits for radionuclides: Attached Graphic(8) General values for A1 and A2 . Table 257-5 contains general values for A1 and A2 :Attached Graphic(9) Activity-mass relationships for uranium. Table 257-6 contains activity-mass relationships for uranium: Attached Graphic(ff) Appendices for the requirements for transfers of LLRW intended for disposal at licensed land disposal facilities and manifests. (1) Manifest. A waste generator, collector, or processor who transports, or offers for transportation, LLRW intended for ultimate disposal at a licensed LLRW land disposal facility must prepare a manifest reflecting information requested on applicable NRC Forms 540 (Uniform Low-Level Radioactive Waste Manifest (Shipping Paper)) and 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description)) and, if necessary, on an applicable NRC Form 542 (Uniform Low-Level Radioactive Waste Manifest (Manifest Index and Regional Compact Tabulation)) or their equivalent. NRC Forms 540 and 540A must be completed and physically accompany the pertinent LLRW shipment. Upon agreement between shipper and consignee, NRC Forms 541, 541A, 542, and 542A may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete records on the respective forms. Licensees are not required by the department to comply with the manifesting requirements of this section when they ship: (A) LLRW for processing and expect its return (i.e., for storage under their license) before disposal at a licensed land disposal facility; (B) LLRW being returned to the licensee who is the waste generator or generator, as defined in this section; or (C) radioactively contaminated material to a waste processor that becomes the processor's residual waste. (2) Form instructions. For guidance in completing these forms, refer to the instructions accompanying the forms. Copies of manifests required by this subsection may be legible carbon copies, photocopies, or computer printouts reproducing the data in the format of the uniform manifest. (3) Forms. NRC Forms 540, 540A, 541, 541A, 542, and 542A, and the accompanying instructions, in hard copy, may be obtained by writing or calling the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone (301) 415-5877; or by visiting the NRC's website at http://www.nrc.gov and selecting forms from the index found on the NRC home page or at www.nrc.gov/reading-rm/doc-collections/forms/#NRC. (4) Information requirements of the DOT. This subsection includes information requirements of the DOT, in 49 CFR Part 172. Information on hazardous, medical, or other waste required to meet EPA regulations in 40 CFR Parts 259 and 261 or elsewhere, are not addressed in this section and must be provided on the required EPA forms. The required EPA forms must accompany the uniform manifest required by this section. (5) General information. The shipper of the LLRW must include on the uniform manifest: (A) the name, facility address, and telephone number of the licensee shipping the waste; (B) an explicit declaration indicating whether the shipper is acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and (C) the name, address, and telephone number, or the name and EPA identification number, for the carrier transporting the waste. (6) Shipment information. The shipper of the LLRW must provide information regarding the waste shipment on the uniform manifest, including: (A) the date of the waste shipment; (B) the total number of packages/disposal containers; (C) the total disposal volume and disposal weight in the shipment; (D) the total radionuclide activity in the shipment; (E) the activity of each of the radionuclides hydrogen-3, carbon-14, technetium-99, and iodine-129 contained in the shipment; and (F) the total masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the total mass of uranium and thorium in source material. (7) Disposal container and waste information. The shipper of the LLRW must provide information on the uniform manifest regarding the waste and each disposal container of waste in the shipment, including: (A) an alphabetic or numeric identification uniquely identifying each disposal container in the shipment; (B) a physical description of the disposal container, including the manufacturer and model of any high integrity container; (C) the volume displaced by the disposal container; (D) the gross weight of the disposal container, including the waste; (E) for waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container; (F) a physical and chemical description of the waste; (G) the total weight percentage of chelating agent for any waste containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent; (H) the approximate volume of waste within a container; (I) the sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name; (J) the identities and activities of individual radionuclides contained in each container, the masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material. For discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides associated with or contained on these waste types within a disposal container must be reported; (K) the total radioactivity within each container; and (L) for wastes consigned to a disposal facility, the classification of the waste as specified in §289.202(ggg)(4)(A) of this chapter. Waste not meeting the structural stability requirements of §289.202(ggg)(4)(B)(ii) of this chapter must be identified. (8) Uncontainerized waste information. The shipper of the LLRW must provide information on the uniform manifest regarding a waste shipment delivered without a disposal container including: (A) the approximate volume and weight of the waste; (B) a physical and chemical description of the waste; (C) the total weight percentage of chelating agent if the chelating agent is not greater than 0.1 percent by weight, plus the identity of the principal chelating agent; (D) for waste consigned to a disposal facility, the classification of the waste as specified in §289.202(ggg)(4)(A) of this chapter. Waste not meeting the structural stability requirements of §289.202(ggg)(4)(B)(ii) of this chapter must be identified; (E) the identities and activities of individual radionuclides contained in the waste, the masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material; and (F) for wastes consigned to a disposal facility, the maximum radiation levels at the surface of the waste. (9) Multi-generator disposal container information. This paragraph applies to disposal containers enclosing mixtures of waste originating from different generators. (Note: The origin of the LLRW resulting from a processor's activities may be attributable to one or more generators (including waste generators) as defined in this section). It also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators. (A) For homogeneous mixtures of waste, such as incinerator ash, provide the waste description applicable to the mixture and the volume of the waste attributed to each generator. (B) For heterogeneous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each generator, provide: (i) the volume of waste within the disposal container; (ii) a physical and chemical description of the waste, including the solidification agent, if any; (iii) the total weight percentage of chelating agents for any disposal container containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent; (iv) the sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in §289.202(ggg)(4)(B)(ii) of this chapter; and (v) radionuclide identities and activities contained in the waste, the masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material if contained in the waste. (10) Certification. An authorized representative of the waste generator, processor, or collector must certify by signing and dating the shipment manifest the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the DOT and the department. A collector in signing the certification is certifying nothing has been done to the collected waste invalidating the waste generator's certification. (11) Control and tracking. (A) Any licensee transferring LLRW to a land disposal facility or a licensed waste collector must comply with the requirements in clauses (i) - (ix) of this subparagraph. Any licensee transferring waste to a licensed waste processor for waste treatment or repackaging must comply with the requirements of clauses (iv) - (ix) of this subparagraph. A licensee must: (i) prepare all wastes so the waste is classified according to §289.202(ggg)(4)(A) of this chapter and meets the waste characteristic requirements in §289.202(ggg)(4)(B) of this chapter; (ii) label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste to identify whether it is Class A waste, Class B waste, Class C waste, or greater than Class C waste, as specified in §289.202(ggg)(4)(A) of this chapter; (iii) conduct a QA program to assure compliance with §289.202(ggg)(4)(A) and (B) of this chapter; (iv) prepare the uniform manifest as required by this subsection; (v) forward a copy or electronically transfer the uniform manifest to the intended consignee so that either: (I) receipt of the manifest precedes the LLRW shipment; and (II) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both subclauses (I) and (II) of this clause are also acceptable; (vi) include the uniform manifest with the shipment regardless of the option chosen in clause (v) of this subparagraph; (vii) receive acknowledgement of the receipt of the shipment in the form of a signed copy of the uniform manifest; (viii) retain a copy of or electronically store the uniform manifest and documentation of acknowledgement of receipt as the record of transfer of radioactive material as required by §289.251 of this subchapter and §289.252 of this subchapter; and (ix) for any shipments or any part of a shipment for which acknowledgement of receipt is not received within the times set forth in this subsection, conduct an investigation as specified in subparagraph (D) of this paragraph. (B) Any waste collector licensee handling only prepackaged waste must: (i) acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of the uniform manifest; (ii) prepare a new uniform manifest to reflect consolidated shipments meeting the requirements of this subsection. The waste collector must ensure, for each container of waste in the shipment, the uniform manifest identifies the generator of that container of waste; (iii) forward a copy or electronically transfer the uniform manifest to the intended consignee so either: (I) receipt of the uniform manifest precedes the LLRW shipment; or (II) the uniform manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both subclauses (I) and (II) of this clause are also acceptable; (iv) include the uniform manifest with the shipment regardless of the option chosen in clause (iii) of this subparagraph; (v) receive acknowledgement of the receipt of the shipment in the form of a signed copy of the uniform manifest; (vi) retain a copy of or electronically store the uniform manifest and documentation of acknowledgement of receipt as the record of transfer of radioactive material as required by §289.251 of this subchapter and §289.252 of this subchapter; (vii) conduct an investigation as specified in subparagraph (D) of this paragraph for any shipments or any part of a shipment for which acknowledgement of receipt is not received within the times set forth as specified in this clause; and (viii) notify the shipper and the department when any shipment, or part of a shipment, does not arrive within 60 days after receipt of an advance uniform manifest, unless notified by the shipper the shipment has been cancelled. (C) Any licensed waste processor treating or repackaging waste must: (i) acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of the uniform manifest; (ii) prepare a new uniform manifest meeting the requirements of this subsection. Preparation of the new uniform manifest reflects the processor's responsibility for meeting these requirements. For each container of waste in the shipment, the manifest must identify the waste generators, the preprocessed waste volume, and the other information as required in clause (i) of this subparagraph; (iii) prepare all wastes so the waste is classified according to §289.202(ggg)(4)(A) of this chapter and meets the waste characteristics requirements in §289.202(ggg)(4)(B) of this chapter; (iv) label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, as specified in §289.202(ggg)(4)(A) and (C) of this chapter; (v) conduct a QA program to assure compliance with §289.202(ggg)(4)(A) and (B) of this subchapter; (vi) forward a copy or electronically transfer the uniform manifest to the intended consignee so either: (I) receipt of the uniform manifest precedes the LLRW shipment; or (II) the uniform manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both subclause (I) of this clause and this subclause is also acceptable; (vii) include the uniform manifest with the shipment regardless of the option chosen in clause (vi) of this subparagraph; (viii) receive acknowledgement of the receipt of the shipment in the form of a signed copy of the uniform manifest; (ix) retain a copy of or electronically store the uniform manifest and documentation of acknowledgement of receipt as the record of transfer of radioactive material as required by §289.251 of this subchapter and §289.252 of this subchapter; (x) conduct an investigation as specified in clause (v) of this subparagraph for any shipment or any part of a shipment for which acknowledgement of receipt is not received within the times set forth as specified in this clause; and (xi) notify the shipper and the department when any shipment, or part of a shipment, does not arrive within 60 days after receipt of an advance uniform manifest, unless notified by the shipper the shipment has been cancelled. (D) Any shipment or part of a shipment for which acknowledgement is not received within the times set forth as specified in this section must be: (i) investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and (ii) traced and reported. The investigation must include tracing the shipment and filing a report with the department. Each licensee who conducts a trace investigation must file a written report with the department within two weeks of completion of the investigation. Source Note: The provisions of this §289.257 adopted to be effective December 27, 2007, 32 TexReg 9633; amended to be effective October 1, 2011, 36 TexReg 5851; amended to be effective March 22, 2015, 40 TexReg 1386; amended to be effective March 1, 2016, 41 TexReg 1444; amended to be effective September 24, 2018, 43 TexReg 6289; amended to be effective January 5, 2022, 46 TexReg 9309; amended to be effective October 23, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.257 Packaging and Transportation of Radioactive Material https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221107&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221107 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221107&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221107 03/11/2026 (a) Purpose. This section contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive material used in irradiating objects or materials using gamma radiation. This section also contains radiation safety requirements for operating irradiators. (b) Scope. (1) In addition to the requirements of this section, all licensees, unless otherwise specified, are subject to the requirements of: (A) §289.201 of this chapter (relating to General Provisions for Radioactive Material);(B) §289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials); (C) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(D) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services); (E) §289.205 of this chapter (relating to Hearing and Enforcement Procedures);(F) §289.252 of this subchapter (relating to Licensing of Radioactive Material); and(G) §289.257 of this subchapter (relating to Packaging and Transportation of Radioactive Material). (2) Nothing in this section relieves the licensee from complying with other applicable federal, state, and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.(3) The requirements in this section apply to panoramic irradiators having either dry or wet storage of radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates are greater than 500 rads (5 grays) per hour at 1 meter (m) from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this section. (4) The requirements in this section do not apply to self-contained, dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for non-destructive testing purposes), gauging, or open-field (agricultural) irradiations. (c) Definitions. The following words and terms when used in this section have the following meanings unless the context clearly indicates otherwise. (1) Annually--At intervals not greater than 390 days. (2) Doubly encapsulated sealed source--A sealed source in which the radioactive material is sealed within a capsule and that capsule is sealed within another capsule. (3) Category I self-contained, dry-source irradiator--An irradiator in which the sealed source is completely contained in a dry container constructed of solid materials and shielded at all times, and in which human access to the sealed source and the volume undergoing irradiation is not physically possible in its designed configuration. (4) Irradiator--A facility using radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates are greater than 500 rads (5 grays) per hour exist at 1 m from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and not accessible to personnel. (5) Irradiator operator--An individual who successfully completed the training and testing described in subsection (s) of this section and is authorized by the terms of the license to operate the irradiator without the presence of a supervisor who completed the requirements of subsection (s)(1) - (3) of this section. (6) Onsite--A physical presence within the building housing the irradiator or on property controlled by the licensee contiguous with the building housing the irradiator. (7) Panoramic dry-source-storage irradiator--An irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations. (8) Panoramic irradiator--An irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators. (9) Panoramic wet-source-storage irradiator--An irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool. (10) Pool irradiator--Any irradiator in which the sources are stored or used in a pool of water, including panoramic wet-source-storage irradiators and underwater irradiators. (11) Product conveyor system--A system for moving the product to be irradiated to, from, and within the area where irradiation takes place. (12) Radiation room--A shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms. (13) Seismic area--Any area where the probability of horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10 percent, as designated by the United States Geological Survey. (14) Underwater irradiator--An irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool. (d) Application for a specific license. Applications for specific licenses must be filed as specified in §289.252(d) of this subchapter. (e) Specific licenses for irradiators. (1) The department approves an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section. (2) The applicant must satisfy the general requirements specified in §289.252 of this subchapter and the requirements contained in this section. (3) The application must describe the training provided to irradiator operators including: (A) classroom training; (B) on-the-job or simulator training; (C) safety reviews; (D) means employed by the applicant to test each operator's understanding of the department's rules and licensing requirements and the irradiator operating, safety, and emergency procedures; and (E) minimum training and experience of personnel providing training. (4) The application must include a copy of the written operating, safety, and emergency procedures as outlined in subsection (t) of this section describing the radiation safety aspects of the procedures. (5) The application must describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer (RSO) and those management personnel having radiation safety responsibilities or authorities. In particular, the application must specify who, within the management structure, has the authority to stop unsafe operations. The application must also describe the training and experience required for the position of RSO. (6) The application must include a description of the access control systems required by subsection (i) of this section, the radiation monitors required by subsection (l) of this section, the method of detecting leaking sources required by subsection (w) of this section, including the sensitivity of the method, and a diagram of the facility showing the locations of all required interlocks and radiation monitors. (7) If the applicant intends to perform and analyze leak tests of dry-source-storage sealed sources, the applicant must establish procedures for leak testing and submit a description of these procedures to the department. The description must include at least: (A) the instruments to be used; (B) the methods of performing the analysis; and (C) the pertinent experience of the individual analyzing the samples. (8) If licensee personnel are to load or unload sources, the applicant must describe the qualifications and training of the personnel and the procedures used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading must be done by a person specifically authorized by the department, the United States Nuclear Regulatory Commission (NRC), or an agreement state to load or unload irradiator sources. (9) The applicant must describe the inspection and maintenance checks, including the frequency of the checks required by subsection (x) of this section. (f) Start of construction. The applicant must not begin construction of a new irradiator before the submission to the department of both an application for a license for the irradiator and the fee required by §289.204 of this chapter. As used in this section, the term "construction" includes the construction of any portion of the permanent irradiator structure on the site but does not include engineering and design work; purchase of a site; site surveys or soil testing; site preparation; site excavation; construction of warehouse or auxiliary structures; and other similar tasks. Any construction activities undertaken before the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the Texas Radiation Control Act (Act), rules, and orders issued as specified in the Act. (g) Applications for exemptions. Any applications for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this section. The department approves the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates they are likely to provide an adequate level of safety for workers and the public. (h) Performance criteria for sealed sources. (1) Cesium-137 must not be used in any irradiator other than a Category I self-contained, dry-source irradiator as defined in subsection (c) of this section. (2) Sealed sources. Sealed sources installed after August 1, 1996, must: (A) be evaluated as specified in §289.252(v) of this subchapter; (B) be doubly encapsulated; (C) use radioactive material as non-dispersible as practical and as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator; (D) be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools; and (E) be leak tested and found leak-free in prototype testing of the sealed source after each of the tests described in paragraphs (3) - (8) of this subsection. (3) Temperature. The test source must be held at negative 40 degrees Celsius for 20 minutes, 600 degrees Celsius for one hour, and then subjected to thermal shock test with a temperature drop from 600 degrees Celsius to 20 degrees Celsius within 15 seconds. (4) Pressure. The test source must be subjected twice, for at least five minutes, to an external pressure (absolute) of 2 million newtons per square meter. (5) Impact. A 2-kilogram steel weight, 2.5 centimeters (cm) in diameter, must be dropped from a height of 1 m onto the test source. (6) Vibration. The test source must be subjected three times for ten minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of five times the acceleration of gravity. In addition, each test source must be vibrated for 30 minutes at each resonant frequency found. (7) Puncture. A 50-gram weight and pin, 0.3-centimeter pin diameter, must be dropped from a height of 1 m onto the test source. (8) Bend. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source must be subjected to a force of 2,000 newtons at its center equidistant from two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source. (i) Access control requirements in addition to the requirements of §289.202(u) of this chapter. (1) Each entrance to a radiation room at a panoramic irradiator must have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers if they reliably and consistently function as a barrier. It must not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed must cause the sources to return promptly to the shielded position. The personnel entrance door or barrier must have a lock operated by the same key used to move the sources. The doors and barriers must not prevent any individual in the radiation room from leaving. (2) In addition, each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make the individual entering the room aware of the hazard. The alarm must also make at least one other individual onsite aware of the entry. That individual must be trained on how to respond to the alarm and be prepared to promptly render or summon assistance. (3) A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels must activate the alarm described in paragraph (2) of this subsection. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam. (4) Before the sources move from their shielded position in a panoramic irradiator, the source control must automatically activate conspicuous visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position. The alarms must give individuals enough time to leave the room and to operate the control described in paragraph (5) of this subsection before the sources leave the shielded position. (5) Each radiation room at a panoramic irradiator must have a clearly visible and readily accessible control allowing an individual in the room to return the sources to their fully shielded position. (6) Each radiation room of a panoramic irradiator must contain a control preventing the sources from moving from the shielded position unless the control is activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control. (7) Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator must have a sign bearing the radiation symbol and the words, "CAUTION (or DANGER), RADIOACTIVE MATERIAL." Panoramic irradiators must also have a sign stating "CAUTION (or DANGER), HIGH RADIATION AREA," as defined in §289.201(b) of this chapter, or "GRAVE DANGER, VERY HIGH RADIATION AREA," as defined in §289.201(b) of this chapter, whichever is applicable, but the sign may be removed, covered, or otherwise made inoperative when the sources are fully shielded. (8) If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. The requirement may be met by interlocks preventing operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating. (9) Underwater irradiators must have a personnel access barrier around the pool locked to prevent access when the irradiator is not attended. Only operators and facility management may have access keys to the personnel access barrier. There must be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) prepared to respond or summon assistance. (j) Shielding. (1) The radiation dose rate in areas normally occupied during operation of a panoramic irradiator must not be greater than 2 millirem (mrem) (0.02 millisievert (mSv)) per hour at any location 30 cm or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not greater than 100 square centimeters (cm2 ) having no linear dimension greater than 20 cm. Areas where the radiation dose rate is greater than 2 mrem (0.02 mSv) per hour must be locked, roped off, or posted. (2) The radiation dose at 30 cm over the edge of the pool of a pool irradiator may not be greater than 2 mrem (0.02 mSv) per hour when the sources are in the fully shielded position. (3) The radiation dose rate at 1 m from the shield of a dry-source-storage panoramic irradiator when the source is shielded must not be greater than 2 mrem (0.02 mSv) per hour and at 5 cm from the shield, not greater than 20 mrem (0.2 mSv) per hour. (k) Fire protection. (1) The radiation room at a panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected. (2) The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. If water is used, the system for the radiation room must have a shut-off valve to control flooding into unrestricted areas. (l) Radiation monitors. (1) Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of this paragraph. (2) Underwater irradiators not in a shielded radiation room must have a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual prepared to respond promptly. (m) Control of source movement. (1) The mechanism moving the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate the sources are leaving the shielded position. Only one key may be in use at any time and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key. (2) The console of a panoramic irradiator must have a source position indicator indicating when the sources are in the fully shielded position, when they are in transit, and when the sources are in the fully exposed position. (3) The control console of a panoramic irradiator must have a control that, when activated, must return the source to its fully shielded position within its normal transit time. (4) Each control for a panoramic irradiator must be clearly marked as to its function. (n) Irradiator pools. (1) For licenses initially issued after August 1, 1996, irradiator pools must either: (A) have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool; or (B) be constructed so there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination. In either case, the licensee must have a method to safely store the sources during repairs of the pool. (2) For licenses initially issued after August 1, 1996, irradiator pools must have no outlets more than 0.5 m below the normal low water level that could allow water to drain out of the pool. Pipes having openings more than 0.5 m below the normal low water level and that could act as siphons must have siphon breakers to prevent the siphoning of pool water. (3) A means must be provided to replenish water losses from the pool. (4) A visible indicator must be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level. (5) Irradiator pools must be equipped with a purification system designed to maintain the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so the sources can be seen clearly. (6) A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation preventing personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations. (7) If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not be greater than 2 mrem (0.02 mSv) per hour. (o) Source rack protection. If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism moving the rack must be protected by a carrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism. (p) Power failures. (1) If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically return to the shielded position. (2) The lock on the door of the radiation room of a panoramic irradiator must not be deactivated by a power failure. (3) During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter. (q) Design requirements for irradiators. The following are design requirements for irradiators beginning construction after August 1, 1996. (1) Shielding. For panoramic irradiators, the licensee must design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entrance ways to meet the radiation shielding requirements of subsection (j) of this section. If the irradiator will use more than 5 million curies (2 x 1017 becquerels) of activity, the licensee must evaluate the effects of heating of the shielding walls by the irradiator sources. (2) Foundations. For panoramic irradiators, the licensee must design the foundation, with consideration given to soil characteristics, ensuring it is adequate to support the weight of the facility shield walls. (3) Pool integrity. For pool irradiators, the licensee must design the pool to assure it is leak resistant, strong enough to bear the weight of the pool water and shipping casks, a dropped cask would not fall on sealed sources, all outlets or pipes meet the requirements of subsection (n)(2) of this section, and metal components are metallurgically compatible with other components in the pool. (4) Water handling system. For pool irradiators, the licensee must verify the design of the water purification system is adequate to meet the requirements of subsection (n)(5) of this section. The system must be designed so water leaking from the system does not drain to unrestricted areas without being monitored. (5) Radiation monitors. For all irradiators, the licensee must evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by subsection (l)(1) of this section. The licensee must verify the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person. For pool irradiators, if the licensee uses radiation monitors to detect contamination as specified in subsection (w)(2) of this section, the licensee must verify the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate. (6) Source rack. For pool irradiators, the licensee must verify there are no crevices on the source or between the source and source holder that would promote corrosion on a critical area of the source. For panoramic irradiators, the licensee must determine source rack drops due to loss of power will not damage the source rack and source rack drops due to failure of cables (or alternate means of support) do not cause loss of integrity of sealed sources. For panoramic irradiators, the licensee must review the design of the mechanism that moves the sources to assure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel. (7) Access control. For panoramic irradiators, the licensee must verify from the design and logic diagram the access control system meets the requirements of subsection (i) of this section. (8) Fire protection. For panoramic irradiators, the licensee must verify the number, locations, and spacing of the smoke and heat detectors are appropriate to detect fires and the detectors are protected from mechanical and radiation damage. The licensee must verify the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and the system is protected from mechanical and radiation damage. (9) Source return. For panoramic irradiators, the licensee must verify the source rack will automatically return to the fully shielded position if power is lost for more than 10 seconds. (10) Seismic. For panoramic irradiators to be built in seismic areas, the licensee must design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source such as American Concrete Institute Standard ACI 318-89, "Building Code Requirements for Reinforced Concrete," Chapter 21, "Special Provisions for Seismic Design," or local building codes, if current. (11) Wiring. For panoramic irradiators, the licensee must verify electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation. (r) Construction monitoring and acceptance testing requirements. The requirements for construction monitoring and acceptance testing must be met before loading sources in irradiators that began construction after August 1, 1996. (1) Shielding. For panoramic irradiators, the licensee must monitor the construction of the shielding to verify its construction meets design specifications and generally accepted building code requirements for reinforced concrete. (2) Foundations. For panoramic irradiators, the licensee must monitor the construction of the foundations to verify the foundation construction meets design specifications. (3) Pool integrity. For pool irradiators, the licensee must verify the pool meets design specifications and must test the integrity of the pool. The licensee must verify outlets and pipes meet the requirements of subsection (n)(2) of this section. (4) Water handling system. For pool irradiators, the licensee must verify the water purification system, the conductivity meter, and the water level indicators operate properly. (5) Radiation monitors. For all irradiators, the licensee must verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by subsection (l)(1) of this section. For pool irradiators, the licensee must verify the proper operation of the radiation monitors and the related alarm if used to meet subsection (w)(2) of this section. For underwater irradiators, the licensee must verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by subsection (l)(2) of this section. (6) Source rack. For panoramic irradiators, the licensee must test the movement of the source racks for proper operation before source loading. Testing must include source rack lowering due to simulated loss of power. For all irradiators with product conveyor systems, the licensee must observe and test the operation of the conveyor system to assure the requirements in subsection (o) of this section are met for protection of the source rack and the mechanism moving the rack. Testing must include tests of any limit switches and interlocks protecting the source rack and mechanism moving that rack from moving product carriers. (7) Access control. For panoramic irradiators, the licensee must test the completed access control system to assure it functions as designed and all alarms, controls, and interlocks work properly. (8) Fire protection. For panoramic irradiators, the licensee must test the ability of the heat and smoke detectors to detect a fire, activate alarms, and cause the source rack to automatically become fully shielded. The licensee must test the operability of the fire extinguishing system. (9) Source return. For panoramic irradiators, the licensee must demonstrate the source racks can be returned to their fully shielded positions without power. (10) Computer systems. For panoramic irradiators using a computer system to control the access control system, the licensee must verify the access control system operates properly if power is lost and must verify the computer has security features preventing an irradiator operator from commanding the computer to override the access control system when it is required to be operable. (11) Wiring. For panoramic irradiators, the licensee must verify the electrical wiring and electrical equipment installed meet the design specifications. (s) Training. (1) Before an individual is permitted to operate an irradiator without a supervisor present who has completed the requirements of this paragraph and paragraphs (2) and (3) of this subsection, the individual must be instructed in: (A) the fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination, units of radiation dose, dose limits, why large radiation doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and individual monitoring devices, other radiation safety features of an irradiator, and the basic function of the irradiator); (B) the requirements of this section and §289.203 of this chapter relevant to the irradiator; (C) the operation of the irradiator; (D) those operating, safety, and emergency procedures listed in subsection (t) of this section the individual is responsible for performing; and (E) case histories of accidents or problems involving irradiators. (2) Before an individual is permitted to operate an irradiator without a supervisor present who has completed the requirements of this paragraph and paragraphs (1) and (3) of this subsection, the individual must pass a written test on the instruction received consisting primarily of questions based on the licensee's operating, safety, and emergency procedures the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision. (3) Before an individual is permitted to operate an irradiator without a supervisor present who has completed the requirements of this paragraph and paragraphs (1) and (2) of this subsection, the individual must have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual must also demonstrate the ability to perform those portions of the operating, safety, and emergency procedures he or she is to perform. (4) The licensee must conduct safety reviews for irradiator operators at least annually. The licensee must give each operator a brief written test on the information. Each safety review must include, to the extent appropriate: (A) changes in operating, safety, and emergency procedures since the last review, if any; (B) changes in rules and license conditions since the last review, if any; (C) reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any; (D) relevant results of inspections of operator safety performance; (E) relevant results of the facility's inspection and maintenance checks; and (F) a drill to practice an emergency or abnormal event procedure. (5) The licensee must evaluate the safety performance of each irradiator operator at least annually ensuring the department's rules, license conditions, and operating, safety, and emergency procedures are followed. The licensee must discuss the results of the evaluation with the operator and must instruct the operator how to correct any mistakes or deficiencies observed. (6) Individuals permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators and the RSO, must be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in subsection (t) of this section they are expected to comply with or perform, and their proper response to alarms required in this section. Tests may be oral. (7) Individuals required to respond to alarms by subsections (i)(2) and (9), (k), (l), and (w)(2) of this section must be trained and tested on how to respond. Each individual must be retested at least once a year. Tests may be oral. (t) Operating, safety, and emergency procedures. (1) The licensee must have and follow written operating, safety, and emergency procedures for: (A) operation of the irradiator, including entering and leaving the radiation room; (B) use of individual monitoring devices; (C) surveying the shielding of panoramic irradiators; (D) monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas; (E) leak testing of sources; (F) inspection and maintenance checks required by subsection (x) of this section; (G) loading, unloading, and repositioning sources, if the operations are performed by the licensee; and (H) inspection of movable shielding required by subsection (i)(8) of this section, if applicable. (2) The licensee must have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for: (A) sources stuck in the unshielded position; (B) personnel overexposures; (C) a radiation alarm from the product exit portal monitor or pool monitor; (D) detection of leaking source, pool contamination, or alarm caused by contamination of pool water; (E) a low or high water level indicator, an abnormal water loss, or leakage from the source storage pool; (F) a prolonged loss of electrical power; (G) a fire alarm or explosion in the radiation room; (H) an alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area; (I) natural phenomena, including an earthquake, a tornado, flooding, or other phenomena appropriate for the geographical location of the facility; and (J) the jamming of automatic conveyor systems. (3) The licensee may revise operating, safety, and emergency procedures without approval from the department only if all these conditions are met: (A) the revisions do not reduce the safety of the facility; (B) the revisions are consistent with the outline or summary of procedures including procedures for changes to operating, safety, and emergency procedures submitted with the license application; (C) the revisions are reviewed and approved by the radiation safety officer (RSO); and (D) the users or operators are instructed and tested on the revised procedures before they are put into use. (4) Changes to operating, safety, and emergency procedures must be submitted to the department after the provisions of paragraph (3) of this subsection are completed. (u) Personnel monitoring. (1) Irradiator operators must wear an individual monitoring device while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The individual monitoring device must be capable of detecting high-energy photons in the normal and accident dose ranges. Each individual monitoring device must be assigned to and worn by only one individual. Film badges must be replaced at least monthly, and all other individual monitoring devices requiring replacement must be replaced at least quarterly. After replacement, individual monitoring devices requiring processing must be returned to the supplier for processing within 14 calendar days of the exchange date specified by the supplier, or as soon as practicable. All individual monitoring devices must be evaluated at least quarterly or promptly after replacement, whichever is more frequent. Circumstances preventing meeting these time limits must be documented, and those records must be available for review by the department.(2) Other individuals entering the radiation room of a panoramic irradiator must wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people entering the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within plus or minus 30 percent of the true radiation dose. (v) Radiation surveys. (1) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts operations. A radiation survey of the area above the pool of pool irradiators must be conducted after the sources are loaded but before the facility starts operations. Additional radiation surveys of the shielding must be performed at intervals not greater than three years and before resuming operations after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates. (2) If the radiation levels specified in subsection (j) of this section are exceeded, the facility must be modified to comply with the requirements in subsection (j) of this section. (3) Portable radiation survey meters must be calibrated at least annually to an accuracy of plus or minus 20 percent for the gamma energy of the sources in use. The calibration must be done at two points on each scale or, for digital instruments, at one point per decade over the range used. Portable radiation survey meters must be of a type that does not saturate and read zero at high radiation dose rates. (4) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not be greater than those specified in Table 2, Column 2, or Table 3 of §289.202(ggg)(2) of this chapter. (5) Before releasing resins for unrestricted use, the resins must be monitored in an area with a background level less than 0.05 mrem (0.5 microsieverts (µSv)) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.05 mrem (0.5 µSv) per hour. (w) Detection of leaking sources. (1) Each dry-source-storage sealed source must be tested for leakage at intervals not greater than six months using a leak test kit or method approved by the department, the NRC, or an agreement state. In the absence of a certificate from a transferor that a test was made within the six months before the transfer, the sealed source must not be used until tested. The test must be capable of detecting the presence of 0.005 microcurie (200 becquerels) of radioactive material and must be performed by a person approved by the department, the NRC, or an agreement state. (2) For pool irradiators, sources must not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test was done within the six months before the transfer. Water from the pool must be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis must be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clear up contamination in the pool if specifically provided for in written emergency procedures. (3) If a leaking source is detected, the licensee must arrange to remove the leaking source from service and decontaminate, repair, or dispose of it by a department, NRC, or agreement state licensee authorized to perform these functions. The licensee must promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product is checked and found free of contamination. If a product is shipped and may have been inadvertently contaminated, the licensee must arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee must arrange to have them decontaminated or disposed of by a department, NRC, or agreement state licensee authorized to perform these functions. If a pool is contaminated, the licensee must arrange to clean the pool until the contamination levels are not greater than the appropriate concentration in Table 2, Column 2 of §289.202(ggg)(2) of this chapter. (See §289.202(xx) and (yy) of this chapter for reporting requirements.) (x) Inspection and maintenance. (1) The licensee must perform inspection and maintenance checks, including, at a minimum, each of the following, at the frequency specified in the license or license application: (A) operability of each aspect of the access control system required by subsection (i) of this section; (B) functionality of the source position indicator required by subsection (m) (2) of this section; (C) operability of the radiation monitor for radioactive contamination in pool water required by subsection (w)(2) of this section using a radiation check source, if applicable; (D) operability of the over-pool radiation monitor at underwater irradiators as required by subsection (l)(2) of this section; (E) operability of the product exit monitor required by subsection (l)(1) of this section; (F) operability of the emergency source return control required by subsection (m)(3) of this section; (G) leak-tightness of systems through which pool water circulates (visual inspection); (H) operability of the heat and smoke detectors and extinguisher system required by subsection (k) of this section (but without turning extinguishers on); (I) operability of the means of pool water replenishment required by subsection (n)(3) of this section; (J) operability of the indicators of high and low pool water levels required by subsection (n)(4) of this section; (K) operability of the intrusion alarm required by subsection (i)(8) of this section, if applicable; (L) functionality and wear of the system, mechanisms, and cables used to raise and lower sources; (M) condition of the barrier to prevent products from hitting the sources or source mechanism as required by subsection (o) of this section; (N) amount of water added to the pool to determine if the pool is leaking; (O) electrical wiring on required safety systems for radiation damage; (P) pool water conductivity measurements and analysis as required by subsection (y)(2) of this section; and (Q) operability of automatic communications systems used to alert individuals to alarms, emergencies, or abnormal event conditions if required by subsection (z)(2)(A) of this section. (2) Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay. If repairs are required, the irradiator must not be operated unless alternative methods are utilized to provide an equivalent level of safety until repairs are completed. (y) Pool water purity. (1) Pool water purification system must be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, the licensee must take prompt actions to lower the pool water conductivity and must take corrective actions to prevent future recurrences. (2) The licensee must measure the pool water conductivity no less than weekly to assure the conductivity remains below 20 microsiemens per centimeter. Conductivity meters must be calibrated at least annually. (z) Attendance during operation. (1) Both an irradiator operator and at least one other individual, trained to respond to alarms as specified in subsection (s)(7) of this section and prepared to promptly render or summon assistance, must be present onsite whenever it is necessary to enter the radiation room. (2) At least one individual trained to respond to alarms described in subsection (s)(7) of this section must be available and prepared to promptly respond to alarms, emergencies, or abnormal event conditions at any time a panoramic irradiator is operating. If the individual is not onsite, the following requirements must be met. (A) Automatic means of communications must be provided from the irradiator control system to alert the individual to alarms, emergencies, or abnormal event conditions. As a minimum, the automatic communication system must alert the individual to those emergency or abnormal events listed in subsection (t)(2) of this section. (B) The irradiator control system must be secured from unauthorized access at any time an irradiator operator is not onsite. This security must include physically securing the key described in subsection (m)(1) of this section to ensure the key is not removed from the control console. (3) At an underwater irradiator, an irradiator operator must be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they must have received the training described in subsection (s)(6) and (7) of this section. Static irradiations may be performed without a person present at the facility. (aa) Entering and leaving the radiation room. (1) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator must use a survey meter to determine the source has returned to its fully shielded position. The operator must check the functioning of the survey meter with a radiation check source before entry. (2) Before exiting from and locking the door to the radiation room of a panoramic irradiator before a planned irradiation, the irradiator operator must: (A) visually inspect the entire radiation room to verify no one else is in it; and (B) activate a control in the radiation room permitting the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control. (3) During a power failure, the area around the pool of an underwater irradiator must not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by subsection (l)(2) of this section is operating with backup power. (bb) Irradiation of explosive or flammable materials. (1) Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the department. Authorization is not granted unless the licensee can demonstrate detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel. (2) Irradiation of more than small quantities of flammable material (flash point below 140 degrees Fahrenheit) is prohibited in panoramic irradiators unless the licensee receives prior written authorization from the department. Authorization is not granted unless the licensee can demonstrate a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures of personnel. (cc) Records/documents. The licensee must maintain records/documents at the irradiator for the time intervals indicated for inspection by the department, including: (1) a copy of the license, license conditions, documents incorporated into a license by reference, and amendments to the license until superseded by new documents or until the department terminates the license; (2) records of each individual's training, tests, and safety reviews provided meeting the requirements of subsection (s)(1) - (4), (6), and (7) of this section until three years after the individual terminates work; (3) records of the annual evaluations of the safety performance of irradiator operators required by subsection (s)(5) of this section for three years after the evaluation; (4) a copy of the current operating, safety, and emergency procedures required by subsection (t) of this section until superseded or the department terminates the license. Records of the RSO review and approval of changes in procedures as required by subsection (t)(3)(C) of this section, retained for three years from the date of the change; (5) individual monitoring device results required by subsection (u) of this section until the department terminates the license; (6) records of radiation surveys required by subsection (v) of this section for three years from the date of the survey; (7) records of radiation survey meter calibrations required by subsection (v) of this section and pool water conductivity meter calibrations required by subsection (y)(2) of this section until three years from the date of calibration; (8) records of the results of leak tests required by subsection (w)(1) of this section and the results of contamination checks required by subsection (w)(2) of this section for three years from the date of each test; (9) records of inspection and maintenance checks required by subsection (x) of this section for three years; (10) records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems involving required radiation safety equipment for three years after repairs are completed; (11) records of the receipt, transfer, and disposal of all licensed sealed sources as required by §289.201(d) and §289.252(x) and (cc) of this chapter; (12) records on the design checks required by subsection (q) of this section and the construction control checks required by subsection (r) of this section until the license is terminated. The records must be signed and dated. The title or qualification of the person signing must be included; and (13) records related to decommissioning of the irradiator required by §289.252(gg)(7) of this subchapter. (dd) Reports. (1) In addition to the reporting requirements in other sections of this chapter, the licensee must report the following events if not reported as specified in other sections of this chapter: (A) source stuck in an unshielded position; (B) any fire or explosion in a radiation room; (C) damage to the source racks; (D) failure of the cable or drive mechanism used to move the source racks; (E) inoperability of the access control system; (F) detection of radiation source by the product exit monitor; (G) detection of radioactive contamination attributable to licensed radioactive material; (H) structural damage to the pool liner or walls; (I) abnormal water loss or leakage from the source storage pool; and (J) pool water conductivity greater than 100 microsiemens per centimeter during normal operations. (2) The report must include a telephone report within 24 hours as described in §289.202(xx)(8)(A) of this chapter, and a written report within 30 days as described in §289.202(xx)(8)(B) of this chapter. Source Note: The provisions of this §289.258 adopted to be effective August 1, 1996, 21 TexReg 6628; amended to be effective October 1, 2000, 25 TexReg 9618; amended to be effective May 1, 2008, 33 TexReg 3417; amended to be effective October 23, 2024, 49 TexReg 8090. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.258 Licensing and Radiation Safety Requirements for Irradiators https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125298 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125298 03/11/2026 (a) Purpose. This section establishes radiation protection standards for the possession, use, transfer, transport, and/or storage of naturally occurring radioactive material (NORM) or the recycling of NORM-contaminated materials not subject to regulation under the Atomic Energy Act of 1954, as amended (AEA). This section is not intended to regulate the disposal of radioactive substances. The Texas Natural Resource Conservation Commission (TNRCC) has the jurisdiction to regulate disposal of NORM, other than oil and gas NORM, which is under the jurisdiction of the Railroad Commission of Texas (RCT). (b) Scope. (1) This section applies to any person who engages in the extraction, mining, beneficiating, processing, use, transfer, transport, or storage of NORM or the recycling of NORM-contaminated materials. (2) This section addresses the introduction of NORM into products in which neither the NORM nor the radiation emitted from the NORM is considered to be beneficial to the products. The manufacture and commercial distribution of products containing NORM in which the NORM or its associated radiation(s) are considered to be a beneficial attribute are licensed in accordance with the provisions of §289.252 of this title (relating to Licensing of Radioactive Material). (3) The requirements of this section are in addition to and not in substitution for other applicable requirements of §289.201 of this title (relating to General Provisions), §289.202 of this title (relating to Standards for Protection Against Radiation), §289.203 of this title (relating to Notices, Instructions and Reports to Workers; Inspections), §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.251 of this title (relating to Exemptions, General Licenses, and General License Acknowledgments), §289.252 of this title, and §289.257 of this title (relating to Packaging and Transportation of Radioactive Material). (c) Definition. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Beneficial attribute or beneficial to the product--The radioactivity of the product is necessary to the use of the product. (2) Beneficiating--The processing of materials for the purpose of altering chemical or physical properties to improve the quality, purity, or assay grade. (3) Decontamination--The cleaning process of removing or reducing residual radioactivity from equipment, buildings, structures, and land owned, possessed, or controlled by other persons to a level that permits release of equipment, buildings, structures and land for unrestricted use or termination of license. (4) Naturally occurring radioactive material (NORM)--Naturally occurring materials not regulated under the AEA whose radionuclide concentrations have been increased by or as a result of human practices. NORM does not include the natural radioactivity of rocks or soils, or background radiation, but instead refers to materials whose radioactivity is concentrated by controllable practices (or by past human practices). NORM does not include source, byproduct, or special nuclear material. (5) Other media--Any volumetric material other than soils or liquids (for example: sludge, scale, slag, etcetera). (6) Person--As defined in §289.201(b)(68) of this title. (7) Product--Something produced, made, manufactured, refined, or beneficiated. (8) Recycling--A process by which materials that have served their intended use are collected, separated, or processed and returned to use in the form of raw materials in the production of new products. Recycling shall not include the use of a material in a manner that constitutes disposal. (d) Exemptions. (1) Persons who receive, possess, use, process, transfer, transport, store, or commercially distribute: (A) Oil and gas NORM waste are exempt from the requirements of this chapter if the material contains, or is contaminated at, concentrations of: (i) 30 picocuries per gram (pCi/gm) or less of radium-226 or radium-228 in: (I) soil, averaged over any 100 square meters (m 2 ) and averaged over the first 15 centimeters (cm) of soil below the surface; or (II) other media; or (ii) 150 pCi or less per gram of any other NORM radionuclide in: (I) soil, averaged over any 100 m2 and averaged over the first 15 cm of soil below the surface, provided that these concentrations are not exceeded; or (II) other media, provided that these concentrations are not exceeded. (B) Other than oil and gas NORM waste, NORM is exempt from the requirements of this chapter if the materials contain, or are contaminated at, concentrations of: (i) 30 pCi/gm or less of radium-226 or radium-228 in: (I) soil, averaged over any 100 m2 and averaged over the first 15 cm of soil below the surface, provided the radon emanation rate is less than 20 picocuries per square meter per second (pCi/m2 /sec); or (II) other media, provided the radon emanation rate is less than 20 pCi/m2 /sec; (ii) 5 pCi/gm or less of radium-226 or radium-228 in: (I) soil, averaged over any 100 m2 and averaged over the first 15 cm of soil below the surface, in which the radon emanation rate is equal to or greater than 20 pCi/m 2 /sec; or (II) other media, in which the radon emanation rate is equal to or greater than 20 pCi/m2 /sec; or (iii) 150 pCi or less per gram of any other NORM radionuclide in: (I) soil, averaged over any 100 m2 and averaged over the first 15 cm of soil below the surface, provided that the radon emanation rate is less than 20 pCi/m2 /sec; or (II) other media, provided that these concentrations are not exceeded. (2) Materials and equipment in the recycling process contaminated with NORM scale or residue not otherwise exempted are exempt from the requirements of this section if the maximum radiation exposure level does not exceed 50 microroentgens per hour (µR/hr) including the background radiation level at any accessible point. (3) Pipe (tubulars) and other downhole or surface equipment used in oil production contaminated with NORM scale or residue not otherwise exempted is exempt from the requirements of this section if the maximum radiation exposure level does not exceed 50 µR/hr including the background radiation level at any accessible point. (4) Products or materials containing NORM distributed in accordance with a specific license issued by the agency in accordance with subsection (k)(4) of this section or an equivalent license issued by another licensing state are exempt from the requirements of this section. (5) The manufacture, commercial distribution, use, or storage of the following products/materials or the recycling of equipment or containers used to produce, contain, or transport these products are exempt from the requirements of this section: (A) potassium and potassium compounds that have not been isotopically enriched in the radionuclide K-40; (B) byproducts from fossil fuel combustion (bottom ash, fly ash, and flue-gas emission control byproducts); and (C) material used for building construction, industrial processing, sand blasting, metal casings, or other NORM in which the radionuclide content has not been concentrated to higher levels than found in its natural state. (6) The wholesale and retail commercial distribution (including custom blending), possession, and use of the following products/materials or the recycling of equipment or containers used to produce, contain, or transport these products, are exempt from the requirements of this section. The manufacture of phosphate and potash fertilizer is subject to the general license requirements in subsections (f)-(h) of this section: (A) phosphate and potash fertilizer; (B) phosphogypsum for agricultural uses if such commercial distribution and uses meet the requirements of 40 Code of Federal Regulations (CFR) 61.204; and (C) materials used for building construction if the materials contain NORM that has not been concentrated to higher levels than found in its natural state. (7) The possession, storage, use, transportation, and commercial distribution of natural gas and natural gas products and of crude oil and crude oil products containing NORM are exempt from the requirements of this section. The processing of natural gas and crude oil and the manufacture of natural gas products and crude oil products containing NORM are subject to the general license requirements in subsections (f)-(h) of this section. (8) Possession of produced waters from crude oil and natural gas production is exempt from the requirements of this section if the produced waters are reinjected in a well approved by the agency having jurisdiction to regulate such reinjection or if the produced waters are discharged under the authority of the agency having jurisdiction to regulate such discharge. (e) Radiation survey instruments. (1) Radiation survey instruments used to determine exemptions in accordance with subsection (d)(2) and (3) of this section and radiation survey instruments used to make surveys in accordance with subsection (f) of this section shall be able to measure from 1 µR/hr through at least 500 µR/hr. (2) Radiation survey instruments used to make surveys required by this section and §289.202(p)(1) of this title shall be calibrated, appropriate, and operable. (3) Each radiation survey instrument shall be calibrated: (A) by a person licensed or registered by the agency, another agreement state or licensing state, or the United States Nuclear Regulatory Commission (NRC) to perform such service; (B) at energies appropriate for the licensee's use; (C) at intervals not to exceed 12 months, and after each instrument servicing other than battery replacement; and (D) to demonstrate an accuracy within plus or minus 20% using a reference source provided by a person authorized in accordance with subparagraph (A) of this paragraph. (4) Records of these calibrations shall be maintained for agency inspection for five years after the calibration date. (f) General license. (1) A general license is hereby issued to mine, extract, receive, possess, own, use, process, transport, store, and transfer for disposal NORM or to recycle NORM-contaminated materials not exempted in subsection (d) of this section without regard to quantity. This general license does not authorize the manufacture or commercial distribution of products containing NORM in concentrations greater than those specified in subsection (d)(1)(B) of this section, or of NORM in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being. The melting of scrap metal is authorized by the general license if the dilution of the NORM in the end-products or melt byproducts is sufficient to reduce any expected average concentration of NORM to levels not to exceed the concentration specified in subsection (d)(1)(B) of this section. (2) Equipment, buildings, and structures contaminated with NORM in excess of the levels set forth in subsection (w) of this section and equipment not otherwise exempted under the provisions of subsection (d)(2) and (3) of this section shall not be released for unrestricted use. The decontamination of equipment, buildings, and structures as described in subsection (i)(2) of this section shall be performed only by persons specifically licensed by the agency or another licensing state to conduct such work, including contractors of a general licensee, except that a general licensee or a contractor under the control and supervision of a general licensee can perform routine maintenance on equipment, buildings, and structures owned or controlled by the general licensee. (Maintenance that provides a different pathway for exposure than is found in daily operations and that increases the potential for additional exposure is not considered routine.) Persons conducting activities specified in subsection (i)(2) of this section and working as a contractor under the control and supervision of a general licensee must possess a specific license issued by the agency in accordance with subsection (k) of this section. (3) The handling or processing by a general licensee of NORM-contaminated materials not otherwise exempted from the requirements of this section for the purpose of recycling is authorized by the agency if the radiation level 18 inches from the NORM-contaminated material does not exceed 2 millirem per hour (mrem/hr). (4) The transfer of NORM not exempt from the requirements of this section from one general licensee to another general licensee is authorized by the agency if the: (A) equipment, buildings, and structures contaminated with NORM are to be used by the recipient for the same purpose or at the same site; (B) materials being transferred are ores or raw materials for processing or refinement; or (C) materials being transferred are in the recycling process. (g) Protection of workers and the general population. Each person subject to the general license in subsection (f) of this section shall conduct operations in compliance with the standards for radiation protection established in §289.202(f)-(o), (ww)-(zz) of this title, and §289.203 of this title, except for transfer for disposal, which shall be governed by subsection (h) of this section.(h) Transfer of waste for disposal. (1) Each person subject to the general license in subsection (f) of this section shall manage and dispose of wastes containing NORM: (A) in accordance with the United States Environmental Protection Agency's (EPA) applicable requirements for disposal of such wastes; (B) by transfer of the wastes for disposal to a person specifically licensed to receive waste containing NORM; or (C) in accordance with alternate methods authorized by the agency having jurisdiction to regulate disposal of such waste. (2) Records of transfers for disposal shall be maintained for inspection by the agency. (i) Specific license. (1) Unless otherwise exempted under the provisions of subsection (d) of this section or licensed under the provisions of §289.252 of this title, the manufacture and commercial distribution of any material or product containing NORM shall be specifically licensed in accordance with this section or in accordance with the equivalent requirements of another licensing state. (2) Persons conducting deliberate operations to decontaminate the following shall be specifically licensed in accordance with the requirements of this section: (A) buildings and structures owned, possessed, or controlled by other persons and contaminated with NORM in excess of the levels set forth in subsection (w) of this section; or (B) equipment or land owned, possessed, or controlled by other persons and not otherwise exempted under the provisions of subsection (d) of this section. (3) Unless otherwise exempted in accordance with subsection (d) of this section, persons receiving NORM waste from other persons for storage or processing or persons who process NORM for other persons at temporary job sites shall be specifically licensed in accordance with the requirements of this section. (4) Spinning pipe gauge licensees performing reclamation activities shall obtain specific authorization to perform NORM decontamination on pipe. Alternatively, spinning pipe gauge licensees may survey tubing before reclamation activities are performed. If the exposure rate on the outside of a pipe, measured at any accessible point, is greater than 50 µR/hr, then the spinning pipe gauge licensee shall obtain a NORM decontamination license. If the exposure rate of the pipe measures less than 50 µR/hr, a spinning pipe gauge licensee may perform the scale removal activity without additional authorization on their license. (j) Filing application for specific licenses. (1) Applications for specific licenses shall be filed in duplicate on a form prescribed by the agency. (2) The agency may at any time after the filing of the original application, and before the expiration of the license, require further information in order to determine whether the application should be granted or denied, or whether a license should be modified or revoked. (3) Each application shall be signed by the applicant or licensee, or a person duly authorized to act for and on the licensee's behalf. (4) A license application may include a request for a license authorizing one or more activities. (5) Applications and documents submitted to the agency may be made available for public inspection. The agency may, however, withhold any document or part thereof from public inspection in accordance with §289.201(n) of this title. (6) Each application for a specific license shall be accompanied by the fee prescribed in §289.204 of this title. (k) Requirements for the issuance of specific licenses. (1) A license application will be approved if the agency determines that: (A) the applicant is qualified by reason of training and experience to use the material in question for the purpose requested, according to this section, and in a manner that minimizes danger to public health and safety, property, or the environment; (B) the applicant's proposed buildings, structures, and procedures are adequate to minimize danger to public health and safety, property, or the environment; (C) the issuance of the license will not adversely affect the health and safety of the public; (D) the applicant satisfies any applicable special requirements in this section; and (E) the applicant has met the financial security requirements of subsection (v) of this section. (2) An application for a specific license to decontaminate equipment or land not otherwise exempted under the provisions of subsection (d) of this section or buildings and structures contaminated with NORM in excess of the levels set forth in subsection (w) of this section, as applicable, will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; and (B) the applicant has adequately addressed the following items in the application: (i) procedures and equipment for monitoring and protection of workers; (ii) an evaluation of the radiation levels and concentrations of contamination expected during normal operations; (iii) operating and emergency procedures, and quality assurance of items released for unrestricted use; and (iv) a method of managing the NORM waste removed from contaminated equipment, buildings, structures, and land for disposal or storage. (3) An application for a specific license to perform NORM decontamination for spinning pipe gauges not otherwise exempted from the requirements of this section in accordance with subsection (d)(3) of this section will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; and (B) the applicant has adequately addressed the following items in the application: (i) procedures and equipment for monitoring and protection of workers; (ii) an evaluation of the radiation levels and concentrations of contamination expected during normal operations; (iii) operating and emergency procedures, and quality assurance of items released for unrestricted use; and (iv) a method of managing the NORM waste removed from contaminated pipes for disposal or storage. (4) An application for a specific license to manufacture and/or commercially distribute products or materials containing NORM to persons exempted from the requirements of this section in accordance with subsection (d)(4) of this section will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; (B) the NORM is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being; and (C) the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the NORM material or product to demonstrate that the material or product will meet the safety criteria set forth in subsection (l) of this section. The information shall include: (i) a description of the material or product and its intended use or uses; (ii) the type, quantity, and concentration of NORM in each material or product; (iii) the chemical and physical form of the NORM in the material or product, and changes in chemical and physical form that may occur during the useful life of the material or product; (iv) an analysis of the solubility in water and human body fluids of the NORM in the material or product; (v) the details of manufacture and design of the material or product relating to containment and shielding of the NORM and other safety features under normal and severe conditions of handling, storage, use, reuse, and disposal of the material or product; (vi) the type and extent of human access to the material or product during normal handling, use, and disposal; (vii) the total quantity of NORM expected to be distributed annually in the material or product; (viii) the expected useful life of the material or product; (ix) the proposed method for labeling or marking each unit of the material or product to identify the manufacturer and/or commercial distributor of the product and the radionuclide(s) and quantity of NORM in the material or product; (x) procedures for prototype testing of the material or product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, reuse, and disposal; (xi) results of the prototype testing of the material or product, including any change in the form of the NORM contained in it, the extent that the NORM may be released to the environment, any change in radiation levels, and any other changes in safety features; (xii) the estimated external radiation doses and dose commitments relevant to the safety criteria in subsection (l) of this section and the basis for such estimates; (xiii) a determination that the probabilities with respect to doses referred to in subsection (l) of this section meet the criteria; (xiv) quality control procedures to be followed in assuring each production lot meets agency-approved quality control standards; and (xv) any additional information, including experimental studies and tests, required by the agency to facilitate a determination of the safety of the material or product. (5) An application for a specific license for persons who receive NORM waste from other persons for processing or persons who process NORM for other persons at temporary job sites in accordance with subsection (i)(3) of this section will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; and (B) the applicant has adequately addressed the following items in the application: (i) procedures and equipment for monitoring and protection of workers; (ii) an evaluation of the radiation levels and concentrations of contamination expected during normal operations; and (iii) operating and emergency procedures, including quality assurance of items released for unrestricted use. (6) Notwithstanding the provisions of paragraph (4) of this subsection, the agency may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen through complete technical documentation. (l) Safety criteria. An applicant for a license under subsection (k)(4) of this section shall demonstrate that the product is designed and will be manufactured so that: (1) during routine use and disposal, it is unlikely that the external radiation dose in any one year, or the dose equivalent resulting from the intake of radioactive material, excluding radon and radon decay products, in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the consumer end-use material or product, will exceed the doses in column I of subsection (m) of this section; (2) during routine handling and storage of the quantities of the industrial material or product likely to accumulate in one location during marketing, commercial distribution, installation, and servicing of the material or product, it is unlikely that the external radiation dose in any one year, or the dose equivalent resulting from the intake of radioactive material, excluding radon and radon decay products, in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the industrial material or product, will exceed the doses in column II of subsection (m) of this section; (3) during routine use, disposal, handling, and storage, it is unlikely that the radon released from the material or product will result in an increase in the average radon concentration in air of more than 0.4 picocurie per liter (pCi/l); and (4) it is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the material or product from wear and abuse likely to occur in normal handling and use of the material or product during its useful life. (m) Table of allowable organ doses. The following table describes the doses allowed per specific organ.Attached Graphic(n) Issuance of specific licenses. (1) When an application meets the requirements of the Act and rules of the agency, the agency will issue a specific license authorizing the proposed activity in such form and containing appropriate or necessary conditions and limitations. (2) The agency may incorporate in a license at the time of issuance, or thereafter by amendment, any additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of NORM subject to this section as it considers appropriate or necessary in order to: (A) minimize danger to public health and safety, property, or the environment; (B) require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and (C) prevent loss or theft of material subject to this section. (o) Conditions of licenses issued under subsection (k) of this section. (1) General terms and conditions. (A) Each license issued in accordance with this section shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules and orders of the agency. (B) No license issued or granted under this section and no right to possess or utilize NORM granted by any license issued in accordance with this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the agency, after securing full information, finds that the transfer is in accordance with the provisions of the Act, and gives its consent in writing. (C) Each person licensed by the agency in accordance with this section shall use and possess the licensed material at the locations and for purposes authorized in the license. (D) Each person licensed by the agency in accordance with this section is subject to the general license provisions of subsection (g) of this section. (E) Each person licensed by the agency in accordance with this section shall manage and dispose of wastes containing NORM: (i) in accordance with EPA applicable requirements for disposal of such wastes; (ii) by transfer of the wastes for disposal to a person specifically licensed to receive waste containing NORM and that is licensed under requirements equivalent to those for uranium and thorium byproduct materials in §289.260 of this title; (iii) by transfer of the wastes for disposal to a facility licensed in accordance with the requirements equivalent to those in the 10 CFR Part 61 by NRC, an agreement state, or a licensing state; or (iv) in accordance with alternate methods authorized by the agency having jurisdiction to regulate such wastes. (F) Notification to the agency. (i) Each licensee shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by or against: (I) a licensee; (II) an entity controlling a licensee or listing the license of the licensee as property of the estate; or (III) an affiliate of the licensee. (ii) This notification shall include: (I) the bankruptcy court in which the petition for bankruptcy was filed; (II) the name of the entity in bankruptcy; and (III) the date of the filing of the petition. (2) Quality control, labeling, and reports of transfer. Each person licensed under subsection (k)(4) of this section shall: (A) carry out adequate control procedures in manufacturing the material or product to assure that each production lot meets the quality control standards approved by the agency; (B) label or mark each unit to identify the manufacturer, processor, producer, or commercial distributor of the material or product and the NORM in the material or product; and (C) maintain records identifying, by name and address, each person to whom NORM is transferred for use under subsection (d)(4) of this section or the equivalent requirements of another licensing state, and stating the kinds, quantities, and uses of NORM transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the agency. Each report shall cover the year ending December 31, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made in accordance with (k)(4) of this section during the reporting period, the report shall so indicate. (p) Expiration and termination of licenses. (1) Except as provided in paragraph (6) of this subsection and subsection (q)(2) of this section, each specific license shall expire at the end of the specified day in the month and year stated in the license. (2) Each licensee shall notify the agency immediately, in writing, and request termination of the license when the licensee decides to terminate all activities involving materials authorized under the license or when the licensee decides to terminate a licensed location. This notification and request for termination of the license or a licensed location must include the reports and information specified in paragraph (4)(D) of this subsection. The licensee is subject to the provisions of paragraphs (3)-(5) of this subsection, as applicable. (3) No less than 30 days before the expiration date specified in a specific license, the licensee shall either: (A) submit an application for license renewal under subsection (q) of this section; or (B) notify the agency in writing, under paragraph (2) of this subsection, if the licensee decides to discontinue all activities involving NORM. (4) If a licensee terminates a licensed location or if a licensee does not submit an application for license renewal under subsection (q) of this section, the licensee shall, before a licensed location can be removed from the license, or on or before the expiration date specified in the license: (A) terminate use of NORM; (B) properly dispose of NORM; and (C) submit a record of NORM disposal and radiation survey(s) to confirm the absence of NORM or to establish the levels of residual radioactive contamination. The licensee shall, as appropriate: (i) submit a record of disposal of radioactive material and radiation survey(s) of the licensee's permanent location of use or storage. Levels of radiation shall be reported in units as required by subsection (w) of this section; and (ii) specify the instruments(s) used and certify that each instrument is properly calibrated and tested. (5) If no radioactivity attributable to activities conducted under the license is detected, the licensee shall submit a certification that no detectable radioactive contamination exceeding the levels listed in subsections (d)(1) and (w) of this section was found. If the agency determines that the information submitted under this paragraph and paragraph (4)(D) of this subsection is adequate and surveys conducted by the agency confirm the findings, the agency will notify the licensee in writing that the license is terminated. (6) If detectable levels of residual radioactivity attributable to activities conducted under the license are found, the requirements of the license continue in effect beyond the expiration date, if necessary, with respect to possession of residual NORM until the agency notifies the licensee in writing that the requirements of the license have been completed. During this time, the licensee is subject to the provisions of paragraph (7) of this subsection. In addition to the information submitted under paragraph (4)(D) of this subsection, the licensee shall submit a plan, if appropriate, for decontaminating the location(s) and disposing of the residual NORM. (7) Each licensee who possesses residual radioactive material under paragraph (6) of this subsection, following the expiration date specified in the license, shall:(A) be limited to actions involving NORM related to preparing the location(s) for release for unrestricted use; and (B) continue to control entry to restricted areas until the location(s) is suitable for release for unrestricted use and the release is approved by the agency in writing. (q) Renewal of licenses. (1) Applications for renewal of specific licenses shall be filed in accordance with subsection (j) of this section. (2) If a licensee has filed the appropriate application form for renewal (or for a new license authorizing the same activities) at least 30 days prior to the expiration date of the existing license, that license shall not expire until final action by the agency. (r) Amendment of licenses at request of licensee. Applications for amendment of a license shall be filed in writing and in accordance with subsection (j)(2)-(6) of this section and shall specify how the licensee desires the license to be amended and the grounds for such amendment. (s) Agency action on applications to renew and amend. In considering an application by a licensee to renew, amend, or transfer the license, the agency will apply the criteria set forth in subsection (k) of this section. (t) Modification and revocation of licenses. Modification, suspension, and revocation of licenses shall be in accordance with §289.205 of this title. (u) Reciprocal recognition of licenses. Subject to this section, any person who holds a specific license from any licensing state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within the state of Texas provided that: (1) the requirements in §289.252(s) of this title are met; and (2) the out-of-state licensee shall not transfer or dispose of NORM possessed or used under the general license provided in paragraph (1) of this subsection except by transfer to a person: (A) specifically licensed by the agency, the Texas agency authorized to regulate disposal of NORM waste, or by another licensing state to receive such material; or (B) exempt from the requirements for a license for such material under subsection (d) of this section. (v) Financial security requirements. (1) Each person specifically licensed in accordance with this section for possession of NORM shall comply with the financial security requirements of §289.252(u) of this title. (2) On April 11, 1999, current licenses in effect may continue provided that the required security arrangements be submitted to the agency by October 11, 1999. (3) No later than 90 days after the licensee notifies the agency that decontamination and decommissioning have been completed, the agency shall determine if these have been conducted in accordance with the requirements of this section and the conditions of the license. If the agency finds that the requirements have been met, the Director of the Radiation Control Program shall direct the return or release of the licensee's security in full plus any accumulated interest. If the agency finds that the requirements have not been met, the agency will notify the licensee of the steps necessary for compliance. (w) Acceptable surface contamination levels for NORM. The following table is to be used in determining compliance with subsections (f)(2) and (p) of this section.Attached Graphic Source Note: The provisions of this §289.259 adopted to be effective April 11, 1999, 24 TexReg 2701. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL F LICENSE REGULATIONS §289.259 Licensing of Naturally Occurring Radioactive Material (NORM) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222649&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222649 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=222649&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 222649 03/11/2026 (a) Purpose.(1) This section establishes requirements for protection against all classes of laser radiation and intense-pulsed light (IPL) device hazards. This section includes the responsibilities of the registrant and the laser safety officer (LSO), laser and IPL device hazard control methods, training requirements, and notification of injuries.(2) For the purpose of this section, any reference to a class of laser includes both International Electrotechnical Commission (IEC) and United States Food and Drug Administration (FDA) classifications, as appropriate.(3) This section establishes requirements for the registration of a person who receives, possesses, acquires, uses, or transfers Class IIIb (3B), or Class IV (4) lasers in the healing arts, veterinary medicine, and industrial, academic, research and development institutions, and of a person in the business of providing laser services.(A) A person must not use a Class 3B or Class 4 laser or perform laser services except as authorized in a certificate of registration issued by the Texas Department of State Health Services (department) as specified in this section.(B) A person who receives, possesses, uses, owns, or acquires a Class 3B or Class 4 laser before receiving a certificate of registration is subject to the requirements of this chapter. (4) Class I (1) lasers, Class II (2) lasers, FDA Class IIIa (3a) lasers, IEC Class 3R lasers, and IPL devices are not required to be registered. However, the use of Class 1, Class 2, Class 3a, Class 3R lasers, and IPL devices is subject to applicable requirements in this section.(b) Scope.(1) Except as otherwise provided, this section applies to a person who receives, possesses, acquires, transfers, or uses lasers that emit or may emit laser radiation. Lasers or IPL devices must not be used on humans or animals unless under the supervision of a licensed practitioner of the healing arts (practitioner) or veterinary medicine and unless the use of lasers or IPL devices is within the scope of their professional license. This section does not limit the intentional exposure of patients to laser or IPL device radiation for the purpose of diagnosis, therapy, or treatment by a practitioner of the healing arts or veterinary medicine within the scope of their professional license. This section does not apply to the manufacture of lasers or IPL devices.(2) This section applies to lasers operating at wavelengths between 180 nanometers (nm) and 1 millimeter (mm).(3) This section applies to IPL devices. These devices must be Class 2 or Class 3 surgical devices certified as complying with the designing, labeling, and manufacturing standards of the FDA.(4) This section applies to lasers meeting the requirements of IEC standards 60825-1 and 60601-2-22 as allowed by the FDA Centers for Devices and Radiological Health in the current Laser Notice guidance document.(5) In addition to the requirements of this section, all registrants authorized to use Class 3B and Class 4 lasers are subject to the following requirements:(A) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections) except for subsection (d), "Notifications and reports to individuals," and information relating to ionizing radiation or exposure history contained in subsection (i), "Notice to employees."(B) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);(C) §289.205 (a), (b), and (h) - (n) of this chapter (relating to Hearing and Enforcement Procedures); and(D) §289.231 (d), (f) - (j), (aa), (bb), (ff), (kk), and (ll)(1), (2), and (5) of this chapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation) and the applicable definitions in §289.231(c) of this chapter.(c) Prohibitions.(1) The department prohibits the use of lasers and IPL devices posing a significant threat or endangering occupational or public health and safety as specified in §289.205 and §289.231 of this chapter.(2) An individual must not be intentionally exposed to laser or IPL radiation above the maximum permissible exposure (MPE) unless a practitioner has authorized such exposure.(A) Exposure of an individual for training, demonstration, or other non-healing arts purposes is prohibited unless authorized by a practitioner.(B) Exposure of an individual for the purpose of healing arts screening is prohibited, except as specifically authorized by the department.(C) Research and development using radiation machines on humans is prohibited except for the following. (i) Any research using radiation machines on humans must be approved by an Institutional Review Board (IRB) as required by 45 Code of Federal Regulations (CFR) Part 46, and 21 CFR Part 56. The IRB must include at least one physician to direct any laser radiation or IPL device use as specified in subsection (b)(1) of this section.(ii) Facilities with radiation machines, with investigational device exemptions, involved in clinical studies must follow regulations governing the conduct of clinical studies and applying to the manufacturers, sponsors, clinical investigators, IRBs, and the medical device. These regulations include:(I) 21 CFR Part 812, Investigational Device Exemptions;(II) 21 CFR Part 50, Protection of Human Subjects;(III) 21 CFR Part 56, Institutional Review Boards;(IV) 21 CFR Part 54, Financial Disclosure by Clinical Investigators; and(V) 21 CFR Part 820, Subpart C, Design Controls of the Quality System Regulation.(d) Definitions. The following words and terms, when used in this section, have the following meanings, unless the context indicates otherwise.(1) Access to laser radiation--Proximity to radiation not blocked by an intervening barrier or filter.(2) Accessible emission limit (AEL)--The maximum accessible emission level permitted within a particular class.(3) Accessible laser radiation--Proximity to radiation not blocked by an intervening barrier or filter.(4) American National Standards Institute (ANSI) standards--Specific standards for lasers and IPL devices published by the American National Standards Institute.(5) Aperture--An opening through which radiation can pass.(6) Beam--A collection of rays characterized by direction, diameter (or dimensions), and divergence (or convergence).(7) Class 1 laser--Any laser not permitting human exposure during operation to levels of visible laser radiation more than the accessible emission limits contained in ANSI.(8) Class 2 laser--Any laser permitting human exposure during operation to levels of visible laser radiation more than the accessible emission limits of Class 1 lasers contained in ANSI but does not permit human exposure during operation to levels of visible laser radiation more than the accessible emission limits of Class 2 lasers contained in ANSI.(9) Class 3a laser, IEC Class 3R--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 2 lasers contained in ANSI but does not permit human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 3a lasers contained in ANSI.(10) Class 3B laser--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of FDA Class 3a lasers in ANSI but does not permit human exposure during operation to levels of laser radiation in excess of the emission limits of Class 3B lasers contained in ANSI.(11) Class 4 laser--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 3B lasers contained in ANSI.(12) Coherent--A light beam is coherent when the electric vector at any point in it is related to any other point by a definite, continuous function.(13) Collateral radiation--Any electromagnetic radiation, except laser radiation, emitted by a laser that is physically necessary for its operation. The applicable, accessible emission limits for collateral radiation are found in 21 CFR §1040.10.(14) Continuous wave--A laser operating with a continuous output for greater than or equal to 0.25 seconds is regarded as a continuous wave laser.(15) Controlled area--An area where the occupancy and activity of those within are subject to control and supervision by the registrant for the purpose of protection from radiation hazards.(16) Divergence--The increase in the diameter of the laser beam with propagation distance from the exit aperture. This is also referred to as beam spread The value of the divergence is expressed in radians or milliradians.(17) Electromagnetic radiation--Radiation consisting of electromagnetic waves, including x-ray, ultraviolet, visible, infrared, and radio waves occupying various portions of the electromagnetic spectrum and differing only in frequency, wavelength, or photon energy.(18) Electronic product--Any product or article defined as follows:(A) any manufactured or assembled product, when in operation:(i) contains or acts as part of an electronic circuit; and(ii) emits, or in the absence of effective shielding or other controls would emit electronic product radiation; or(B) any manufactured or assembled article intended for use as a component, part, or accessory of a product described in subparagraph (A) of this paragraph and when in operation emits, or in the absence of effective shielding or other controls would emit radiation.(19) Energy--The capacity for doing work. Energy content is commonly used to characterize the output from pulsed lasers and is expressed in joules (J).(20) Engineering controls--Control measures designed or incorporated into the laser or laser system (e.g., interlocks, shutters, watchdog timer) or its application.(21) Healing arts--Any system, treatment, operation, diagnosis, prescription, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.(22) Infrared radiation--The region of the electromagnetic spectrum between the long-wavelength extreme of the visible spectrum (about 0.7 micrometer (µm)) and the shortest microwaves (about 1 mm).(23) Inoperable--Incapable of operation because of damage, disassembly, removal, or inactivation of key components that cannot be restored without significant repair or renovation.(24) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct a periodic review of biomedical research involving human subjects.(25) Intense-pulsed light (IPL) device--A device that emits radiation to energy density levels that could cause bodily harm and used for photothermolysis. This device is a Class 2 or Class 3 surgical device certified as complying with FDA designing, labeling, and manufacturing standards.(26) Invisible radiation--Laser or collateral radiation having wavelengths greater than or equal to 180 nm but less than or equal to 400 nm or greater than 710 nm but less than or equal to 1.0 x 106 nm (1 millimeter).(27) Irradiance--Radiant power incident per unit area upon a surface, expressed in watts-per-square-centimeter (W-cm-2 ).(28) Joule (J)--A unit of energy. One joule is equal to one watt • second.(29) Laser--An electronic device that emits stimulated radiation to energy density levels that could cause bodily harm. A laser may also produce an intense, coherent, directional beam of light by stimulating electronic or molecular transitions to lower energy levels. The term "laser" includes the assembly of electrical, mechanical, and optical components associated with the laser. A laser can be a component of a product or system.(30) Laser light show--Use of lasers for entertainment, advertising display, or artistic composition.(31) Laser product--Any manufactured product or assemblage of components constituting, incorporating, or intending to incorporate a laser and is classified as a Class 1, Class 2, Class 3a, Class 3B, or Class 4 laser product according to the performance standards set by the FDA. A laser intended for use as a component of an electronic product must be considered a laser product. A laser product can contain an enclosed laser with an assigned class number higher than the inherent capability of the laser product in which it is incorporated and where the product's lower classification is appropriate due to the engineering features limiting accessible emission.(32) Laser safety officer (LSO)--An individual with knowledge of and the authority and responsibility to apply appropriate laser radiation protection rules, standards, and practices, and is specifically authorized on a certificate of laser registration.(33) Manufacturer--Any person who designs, manufactures, assembles, fabricates, or processes a finished laser device.(34) Maximum permissible exposure (MPE)--The level of laser radiation a person may be exposed to without hazardous effects or adverse biological changes in the eye or skin. Maximum permissible exposures to laser radiation may be found in ANSI.(35) Medical event--Any adverse patient health effect directly resulting from the use of laser equipment on an individual.(36) Mobile service operation--The provision of lasers and personnel at temporary sites for limited time periods. The lasers may be fixed inside a motorized vehicle or a portable laser that can be removed from the vehicle and taken into a facility for use.(37) Nominal hazard zone (NHZ)--The space where the level of direct, reflected, or scattered radiation during operation exceeds the applicable MPE. Exposure levels beyond the boundary of the NHZ are below the applicable MPE level.(38) Optical density (D&lgr )--The logarithm to the base ten of the reciprocal of the transmittance. D&lgr = -log10 &tgr&lgr , where &tgr&lgr is transmittance.(39) Personal protective equipment (PPE)--Device used to mitigate hazards associated with laser use, including laser eye protection (LEP), protective clothing, and gloves.(40) Practitioner--A person licensed under Texas Occupations Code Title 3 Health Professions. A practitioner's use of a laser is limited to the person's scope of professional practice as determined by the appropriate licensing agency.(41) Protective housing--An enclosure surrounding the laser preventing access to laser radiation above the applicable MPE level. The aperture through which the useful beam is emitted is not part of the protective housing. The protective housing may enclose associated optics and a workstation and must limit access to other associated radiant energy emissions and to electrical hazards associated with components and terminals.(42) Provider of lasers--A person providing lasers on a routine basis to a facility for limited time periods.(43) Pulse duration--The duration of a laser pulse. This is measured as the time interval between the half-power points on the leading and trailing edges of the laser pulse.(44) Pulsed laser--A laser delivering its energy in the form of a single pulse or a train of pulses. In this section, the duration of a pulse is less than 0.25 seconds.(45) Reflection--The deviation of laser radiation following incidence on a surface.(46) Source--A laser or a laser-illuminated reflecting surface.(47) Supervision--Delegating to a person under the practitioner's authority, the task of applying laser radiation to persons or animals under this section. The practitioner assumes full responsibility for these tasks and must ensure the tasks are administered correctly.(48) Transmission--Passage of laser radiation through a medium.(49) Ultraviolet radiation--Electromagnetic radiation with wavelengths shorter than those of visible radiation; for this section, 0.18 to 0.4 µm.(50) Veterinarian--A person licensed as a veterinarian by the Texas Board of Veterinary Medical Examiners.(51) Veterinary medicine--When used in this chapter, has the same meaning as found in Texas Occupations Code Chapter 801.(52) Visible radiation (light)--Electromagnetic radiation that can be detected by the human eye. This term is commonly used to describe wavelengths in the range of 0.4 to 0.7 µm.(53) Watt--The unit of power or radiant flux. 1 watt equals 1 joule per second.(54) Wavelength (&lgr)--The distance between two successive points on a periodic wave having the same phase.(e) Exemptions.(1) Lasers in storage or transit are exempt from the requirements of this section. This exemption does not apply to the providers of lasers.(2) Inoperable lasers are exempt from the requirements of this section.(3) Class 1, Class 2, and Class 3a lasers, IEC Class 3R lasers, or products and IPL devices are exempt from the registration requirements of subsections (f) and (g) of this section.(4) Facilities, including academic institutions and research or development facilities, registered for the use of lasers are exempt from the registration requirements of subsection (f) of this section, regarding laser services, and the applicable paragraphs of subsection (g) of this section, to the extent their personnel perform laser services only for the registrant by whom they are employed.(f) Registration for the use of Class 3B and Class 4 lasers and laser services.(1) For purposes of this section, use of Class 3B or Class 4 lasers and laser services includes:(A) possession and use of lasers in the healing arts, veterinary medicine, industry, academics, and research and development institutions;(B) demonstration or sale of lasers requiring the person to operate or cause a laser to be operated to demonstrate or sell;(C) provision of lasers on a routine basis to a facility for limited time periods by a provider of lasers. For healing arts facilities, the use of lasers must be directed by a practitioner employed by the contracting facility;(D) alignment, calibration, installation, or repair; or(E) laser light shows.(2) A person who applies for registration as specified in this section and uses a Class 3B or Class 4 laser before receiving a certificate of laser registration is subject to the requirements of this chapter.(g) Application requirements.(1) General application requirements.(A) Application for certificate of laser registration must be completed on forms prescribed by the department and must contain all the information required by the form and accompanying instructions.(B) An LSO must be designated on each application form. The qualifications of that individual must be submitted to the department with the application. The LSO must meet the applicable requirements of subsection (o) of this section and carry out the responsibilities of subsection (p) of this section.(C) Each application must be accompanied by a completed RC Form 226-01 (Business Information Form), which must contain the legal name of the entity or business. Unless exempt under Texas Business and Commerce Code Chapter 71, the applicant must:(i) be authorized to conduct business in the State of Texas as listed on the Texas Secretary of State (SOS) website; and(ii) file an assumed name certificate with the Texas SOS if using an assumed name in their application.(D) Each application for a certificate of laser registration must be accompanied by the appropriate fee prescribed in §289.204 of this chapter.(E) An application for a certificate of laser registration may include a request for authorization of one or more activities.(F) At any time after filing the original application, the department may require further information to determine whether the certificate of laser registration will be issued or denied.(G) Applications and documents submitted to the department may be made available for public inspection, except the department may withhold any document or part of a document from public inspection as specified in §289.231(aa) of this chapter.(2) Application for the use of Class 3B or Class 4 lasers on humans or animals.(A) In addition to the requirements of subsection (g)(1) of this section, each person having a Class 3B or Class 4 laser for use in the healing arts or for use on animals must submit an application to the department within 30 days after beginning operation of the laser.(B) Application signatures.(i) An application for healing arts use must be signed by a practitioner.(ii) An application for veterinary medicine use must be signed by a licensed veterinarian.(iii) The signature of the administrator, president, or chief executive officer will be accepted instead of the practitioner's signature if the facility is a licensed hospital or a medical facility.(iv) A signature by the administrator, president, or chief executive officer does not relieve the practitioner or veterinarian from following the requirements of this section. The LSO must also sign the application.(C) If a person is furnished a Class 3B or Class 4 laser by a provider of lasers, that person is responsible for ensuring a practitioner authorizes intentional exposure of laser radiation to humans.(D) The applicant must ensure a laser machine is operated by a person qualified by training and experience to use the laser machine for the purpose requested, and in a manner minimizing danger to occupational and public health and safety.(3) Application for the use of Class 3B or Class 4 lasers in industrial, academic, and research and development institutions. (A) In addition to the requirements of subsection (g)(1) of this section, each person having a laser for use in industrial, academic, and research and development institutions must apply to the department within 30 days after beginning operation of the laser.(B) An application for the use of Class 3B or Class 4 lasers in industrial, academic, and research and development institutions must be signed by the applicant or registrant or a person duly authorized to act on behalf of the applicant or registrant. The LSO must also sign the application.(4) Application for registration of laser services.(A) In addition to the requirements of subsection (g)(1) of this section, an applicant who intends to provide laser services described in subsection (f)(1) of this section must apply and receive a certificate of registration from the department before providing the services.(B) An application for laser services must be signed by the applicant, registrant, or a person duly authorized to act on behalf of the applicant or registrant. The LSO must also sign the application.(C) Providing services specified in subsection (f)(1) of this section, not specifically authorized by the department, is prohibited.(D) A service provider must not provide laser machine services for a person who cannot produce evidence of a completed registration application or a valid certificate of registration issued by the department, except for the initial installation of the first machine for a new certificate of registration.(5) Application for laser light show.(A) Each applicant must receive a certificate of laser registration for a laser light show before beginning any show.(B) An application to use Class 3B or Class 4 lasers in a laser light show must be signed by the applicant, registrant, or a person duly authorized to act on behalf of the applicant or registrant. The LSO must also sign the application.(C) According to subparagraph (A) of this paragraph and in addition to the requirements of subsection (g)(1) of this section, each applicant must submit:(i) a valid variance issued by the FDA, or evidence of an Annual Report on Radiation Safety Testing of Laser and Laser Light Show Products meeting FDA variance requirements, for the laser intended to be used, with all applicable documents required by the variance; and(ii) a written notice of the laser light show to be performed in Texas. The information contained in RC Form 301-05 must be provided at least seven days before each show. If, in a specific case, the seven-day period would impose an undue hardship on the applicant, the applicant may, upon written request to the department, obtain permission to proceed sooner.(6) Application for mobile service operation for Class 3B or Class 4 lasers used in the healing arts and veterinary medicine.(A) Each applicant must apply for and receive a certificate of laser registration for mobile service operation involving Class 3B or Class 4 lasers before beginning mobile service operation.(B) In addition to the requirements of subsection (g)(1) of this section, each applicant must submit the address of the established main location where the laser and records will be maintained for inspection. This must be a physical street address, not a post office box number.(C) An application for mobile service operation for the healing arts must be signed by a practitioner and an application for mobile services for veterinary medicine must be signed by a licensed veterinarian. The LSO must also sign the application.(h) Issuance of certificate of laser registration.(1) A certificate of registration application will be approved if the department determines an application meets the Texas Radiation Control Act (Act) requirements and the requirements of this chapter. The certificate of registration authorizes the proposed activity and contains the conditions and limitations the department requires. The certificate of laser registration must be maintained as specified in subsection (cc) of this section.(2) The department may incorporate in the certificate of laser registration at the time of issuance, or by amendment, additional requirements and conditions concerning the registrant's receipt, possession, acquisition, use, and transfer of lasers subject to this section, as it deems appropriate or necessary to:(A) minimize danger to occupational and public health and safety;(B) prevent loss or theft of lasers; or(C) require additional reports and maintenance records as may be appropriate or necessary.(3) At the request of the department the registrant must provide additional information after the certificate of laser registration has been issued for the department to determine whether the certificate of laser registration will be modified in accordance with subsection (n) of this section.(i) Specific terms and conditions of certificates of laser registration.(1) Each certificate of laser registration issued as specified in this section is subject to the applicable provisions of the Act and the applicable rules in this chapter and orders issued by the department.(2) Each person registered by the department for laser use as specified in this section must confine use and possession of the laser registered to the locations and purposes authorized in the certificate.(3) A certificate of laser registration issued under this section must not be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the department authorizes the transfer, in writing.(4) In determining whether to issue, deny, amend, renew, revoke, suspend, or restrict a certificate of laser registration, the department may consider the technical competence and compliance history of an applicant or holder of a certificate of laser registration. (5) After an opportunity for a hearing, the department will deny an application, amendment, or renewal of a certificate of laser registration if the applicant's compliance history reveals, within the previous six years, three or more actions have been issued against the applicant assessing administrative or civil penalties, or revoking or suspending a certificate of laser registration.(j) Registrant responsibilities.(1) The registrant is responsible for complying with this section and the conditions listed on the certificate of registration. (2) The registrant must designate a qualified individual as the LSO as specified in subsection (o) of this section and ensure the individual continually performs the responsibilities of the LSO as identified in subsection (p) of this section.(3) A person must not make, sell, lease, transfer, or lend lasers unless the machine and equipment, when properly placed in operation and used, meet the applicable requirements of this section.(4) The registrant must notify the department in writing within 30 days of a change in any of the following:(A) name and mailing address;(B) street address where laser will be used;(C) LSO; or(D) additional use location.(5) Each registrant must inventory all Class 3B and Class 4 lasers in their possession at an interval not to exceed 12 months. The inventory record must be maintained for inspection by the department as specified in subsection (cc) of this section and must include:(A) the manufacturer's name;(B) the model and serial number of the laser;(C) a description of the laser (for example, yag, silicon, CO2 , neon);(D) the location of the laser (for example, room number); and(E) a complete inventory of equipment supplied by a provider of lasers as defined in subsection (d)(42) of this section.(6) Notification to the department is required within 30 days of:(A) any increase in the number of lasers above those authorized by the certificate of laser registration; or(B) any change in the category of the machine type or type of use as specified in §289.231(ll) or as authorized on the certificate of registration.(7) The registrant, or the parent company, must notify the department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy. The notification must include:(A) the name of the bankruptcy court; and(B) the case name, and number, when known, and the date the petition was filed.(8) A registrant must not engage a person for services described in subsection (f)(1) of this section until the service provider demonstrates current registration with the department.(9) Registrants with certificates of laser registration as specified in subsection (g)(5) of this section must have the following documents on site at each laser light show:(A) certificate of laser registration;(B) FDA variance, or evidence of Annual Report on Radiation Safety Testing of Laser and Laser Light Show Products meeting FDA variance requirements, with all applicable documents required by the variance; and(C) instructions for the safe use of lasers as specified in subsection (q)(2) of this section.(10) Each registrant must maintain records of receipt, transfer, and disposal of Class 3B or Class 4 lasers for inspection by the department. The records must include the following information and be maintained as specified in subsection (cc) of this section:(A) manufacturer's name;(B) model and serial number of the laser;(C) date of the receipt, transfer, and disposal;(D) name and address of the person the laser was received from, transferred to, or disposed by; and(E) name of the person recording the information.(11) A laser must not be used unless an application for registration is filed with the department, as specified in subsection (g) of this section, within the first 30 days of use. This section does not apply to operation of a laser for installation and calibration.(12) A service provider must not provide laser services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the department, except for:(A) the initial installation of the first machine for a new certificate of registration; and(B) the registrant authorized for demonstration and sale, demonstrates a laser machine as specified in paragraph (15) of this subsection.(13) A person authorized to perform alignment, calibration, installation, and repair of lasers in Texas must maintain:(A) a daily log including:(i) date of service;(ii) name and address of the customer; and(iii) customer's certificate of registration number, unless the service provided is an initial installation as described in paragraph (12)(A) of this subsection; and(B) records of all services for inspection by the department as specified in subsection (cc) of this section.(14) A person authorized to provide lasers must comply with the following.(A) Providers of equipment must:(i) ensure all lasers used on humans meet the requirements of this chapter;(ii) provide lasers only to facilities holding a valid certificate of registration; and(iii) keep a log of lasers provided in Texas, and record the following information:(I) date machine provided;(II) name of customer; and(III) customer's certificate of registration number.(B) Records of machines provided must be made and maintained for inspection by the department as specified in subsection (cc) of this section.(15) A person authorized to demonstrate and sell lasers in Texas must comply with the following.(A) Maintain a log including:(i) date of all demonstrations and sales of lasers performed in Texas;(ii) name and address of the customer; and(iii) customer's certificate of registration number unless the service provided is an initial demonstration as described in paragraph (12)(B) of this subsection.(B) Prevent exposure of individuals to a laser except for healing arts purposes and unless a licensed practitioner of the healing arts has authorized such exposure. This provision specifically prohibits the deliberate exposure of an individual for training, demonstrating, or other non-healing arts purposes.(C) Demonstrate lasers on phantoms only.(D) Document all tests required by this section when a demonstration of a laser involves exposure specifically and individually ordered by a practitioner.(E) Records of demonstrations and sales must be made and maintained for inspection by the department as specified in subsection (cc) of this section.(16) A person using loaner laser machines must comply with the following.(A) For a person having a valid certificate of registration, loaner radiation machines may be used for up to 30 days. Within 30 days, the registrant must:(i) notify the department of a change in the category of the machine type or type of use as specified in §289.231(ll) of this title and as authorized in the certificate of registration; or(ii) notify the department of any increase in the number of machines beyond those authorized by the certificate of registration in any machine type or type of use category.(B) For a person who does not hold a valid certificate of registration, a loaner laser may be used for human use for up to 30 days, by or under the direction of a practitioner, before applying for a certificate of registration as specified in subsection (g) of this section. This does not include mobile services.(k) Expiration of certificates of laser registration.(1) Except as provided by subsection (m) of this section, a certificate of laser registration expires at 11:59 p.m. Central Time in the month and year stated in the certificate of laser registration. (2) If a registrant does not submit an application for renewal of the certificate of laser registration as specified in subsection (m) of this section, as applicable, the registrant must, before the expiration date specified in the certificate of laser registration, terminate use of all lasers and laser services as specified in subsection (l) of this section.(3) The expiration of the certificate of laser registration does not relieve the registrant of the requirements of this chapter.(l) Termination of certificates of laser registration.(1) When a registrant decides to terminate all activities involving laser or laser services authorized under the certificate of laser registration, the registrant must immediately:(A) request termination of the certificate of laser registration in writing, signed by the LSO, owner, or a person authorized to act on behalf of the registrant; and(B) submit to the department a record of the disposition of the laser, and, if applicable, include if the laser was transferred and to whom it was transferred.(2) The registrant must pay any outstanding fees as specified in §289.204 of this chapter.(m) Renewal of certificate of laser registration.(1) An application for renewal of a certificate of laser registration must be filed as specified in subsection (g)(1)(A) - (G) and (g)(2) of this section.(2) If a registrant applies for a renewal before the existing certificate of laser registration expires, the existing certificate of laser registration does not expire until the application status has been determined by the department.(n) Modification, suspension, and revocation of certificates of laser registration.(1) The terms and conditions of all certificates of laser registration are subject to revision or modification.(2) Any certificate of laser registration may be revoked, suspended, or modified, in whole or in part for:(A) any materially false statement in the application or any false statement of fact required by the Act;(B) information received by the department indicating a certificate of laser registration should not be issued;(C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or of the certificate of laser registration, or order of the department or a court; or(D) existing conditions threatening occupational safety, public health and safety, or the environment.(3) Except in cases in which occupational and public health or safety requires otherwise, a registrant will be notified, in writing, of the department's intent to suspend or revoke a certificate of registration and be provided an opportunity to demonstrate compliance before proceedings to suspend or revoke begin.(o) LSO qualifications. LSO qualifications must be submitted to the department and include:(1) education related to laser radiation safety or a laser safety officer course; or(2) experience in the use and familiarity of the type of equipment or services registered; and(3) knowledge of potential laser radiation hazards, laser emergency situations, and the appropriate response to an injury.(p) LSO duties. The LSO must:(1) ensure users of lasers are trained in laser safety, as applicable for the class and type of lasers used;(2) assume control and have the authority to institute corrective actions to include the shutdown of operations, when necessary, in emergencies or unsafe conditions;(3) specify whether any changes in control measures are required after:(A) any service and maintenance of lasers affecting the output power or operating characteristics; or(B) a deliberate modification is made that could change the laser class and affect the output power or operating characteristics; (4) ensure maintenance and other practices required for the safe operation of the laser are performed;(5) ensure the proper use of protective eyewear and other safety measures; and(6) ensure compliance with the requirements in this section, the conditions of the certificate of laser registration, and any engineering or operational controls specified by the registrant.(q) Requirements for protection against Class 3B or Class 4 lasers and IPL device radiation. These requirements are for Class 3B or Class 4 lasers and IPL devices in their intended mode of operation and include special requirements for service, testing, maintenance, and modification. During some operations, certain engineering controls may be inappropriate. When an engineering control may be inappropriate, for example, during medical procedures or surgery, the LSO must specify alternate controls to obtain equivalent safety protection.(1) MPE. A registrant or user of any laser may not permit any individual to be exposed to levels of laser or collateral radiation higher than are specified in ANSI and 21 CFR §1040.10, respectively.(2) Instructions to personnel. Personnel using a laser must be provided with written instructions for safe use, including clear warnings and precautions to avoid possible exposure to laser and collateral radiation more than the MPE, as specified in ANSI and the collateral limits listed in 21 CFR §1040.10. The instructions to personnel must be maintained as specified in subsection (cc) of this section for inspection by the department.(3) Engineering controls.(A) Protective housing.(i) Each laser must have a protective housing preventing human exposure during the operation to laser and collateral radiation that exceeds the limits of Class 1 lasers as specified in ANSI and 21 CFR §1040.10, if human exposure is not necessary for the laser to perform its intended function.(ii) If human exposure to laser radiation levels more than the limits of Class 1 is necessary, these levels must not exceed the limits of the lowest laser class required to perform the intended function.(B) Safety interlocks.(i) A safety interlock ensuring radiation is not accessible above MPE limits as specified in ANSI must be provided for any portion of the protective housing that, by design, can be removed or displaced during normal operation or maintenance, and thereby allows exposure to radiation above the MPE limits.(ii) Adjustment during operation, service, testing, or maintenance of a laser containing interlocks must not cause the interlocks to become inoperative or the radiation to exceed MPE limits outside protective housing except where a laser controlled area as specified in subparagraph (E) of this paragraph is established.(iii) For pulsed lasers, interlocks must be designed to prevent the firing of the laser; for example, by dumping the stored energy into a dummy load.(iv) For continuous wave lasers, the interlocks must turn off the power supply or interrupt the beam; for example, by using shutters.(v) An interlock must not allow automatic accessibility of radiation emission above MPE limits when the interlock is closed.(vi) Either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing upon interlock failure must be provided if failure of a single interlock would allow the following:(I) human exposure to levels of laser radiation more than the accessible emission limit of FDA Class 3a laser radiation; or(II) laser radiation more than the accessible emission limits of Class 2 emitted directly through the opening created by removing or displacing that portion of the protective housing.(C) Viewing optics and windows.(i) All viewing ports, viewing optics, or display screens included as an integral part of an enclosed laser or laser product must incorporate suitable means such as interlocks, filters, or attenuators to maintain the laser radiation at the viewing position at or below the applicable MPE as specified in ANSI and the collateral limits listed in 21 CFR §1040.10, under any conditions of operation or use of the laser.(ii) All collecting optics, such as lenses, telescopes, microscopes, or endoscopes, intended for viewing use with a laser must incorporate suitable means such as interlocks, filters, or attenuators to maintain the laser radiation transmitted through the collecting optics to levels at or below the appropriate MPE, as specified in ANSI. Normal or prescription eyewear is not considered collecting optics.(D) Warning systems. Each Class 3B or Class 4 laser or laser product must provide visual or audible indication during the emission of accessible laser radiation. In the case of Class 3B lasers, except those only allowing access to less than 5 milliwatt (mW) peak visible laser radiation, and Class 4 lasers, the indication must be sufficient before emission of such radiation to allow appropriate action to avoid exposure. Any visual indicator must be visible through protective eyewear designed specifically for the wavelength of the emitted laser radiation. If the laser and laser energy source are housed separately and can be operated at a separation distance of greater than two meters, both laser and laser energy source must incorporate visual or audible indicators. The visual indicators must be positioned so viewing does not require human exposure to laser radiation more than the MPE, as specified in ANSI.(E) Controlled area. With a Class 3B laser, except those only allowing access to less than 5 mW visible peak power, or Class 4 laser, a controlled area must be established when exposure to the laser radiation more than the MPE, as specified in ANSI or the collateral limits listed in 21 CFR §1040.10, is possible. The controlled area must meet the following requirements, as applicable.(i) The area is posted with hazard signs as required by subsection (u) of this section.(ii) Access to the controlled area is restricted.(iii) For Class 4 indoor controlled areas, latches, interlocks, or other appropriate means are used to prevent unauthorized entry into controlled areas.(I) Such measures are designed to allow rapid exit by laser personnel and allow admittance to the controlled area for emergency personnel. For such emergency conditions, a control-disconnect switch or equivalent device (panic button) must be available for deactivating the laser.(II) Where safety latches or interlocks are not feasible or are inappropriate, for example, during medical procedures, such as surgery, the following applies.(-a-) All authorized personnel are trained in laser safety, and appropriate PPE is provided upon entry.(-b-) A door, blocking barrier, screen, or curtains is used to block, screen, or attenuate the laser radiation at the entryway. The level at the exterior of these devices cannot be more than the applicable MPE, as specified in ANSI.(-c-) Within the laser controlled area, there is a visible or audible signal indicating the laser is energized and operating at Class 4 levels. A lighted laser warning sign, flashing light (visible through laser protective eyewear), and other appropriate signage are methods to accomplish this requirement.(iv) For Class 4 indoor controlled areas, during tests requiring continuous operation, the person in charge of the controlled area is permitted to momentarily override the safety interlocks to allow access by other authorized personnel if it is evident there is no optical radiation hazard at the point of entry, and if the necessary protective devices are being worn by the entering personnel.(v) For Class 4 indoor controlled areas, optical paths (for example, windows) from an indoor facility must be controlled to reduce the transmitted values of the laser radiation to levels at or below the appropriate ocular MPE, as specified in ANSI and the collateral limits listed in 21 CFR §1040.10. When the laser beam must exit the indoor controlled area (as in the case of exterior atmospheric beam paths), the operator is responsible for ensuring air traffic is protected from any laser projecting into navigable air space (contact Federal Aviation Administration (FAA) or other appropriate agencies, as necessary) or controlled ground space when the beam irradiance or radiant exposure is above the appropriate MPE, as specified in ANSI.(vi) When the removal of panels or protective covers or overriding of interlocks becomes necessary, such as for servicing, testing, or maintenance, and accessible laser radiation exceeds the MPE, as specified in ANSI and the collateral limits listed in 21 CFR §1040.10, a temporary controlled area must be established and posted.(4) Key control. Each Class 3B or Class 4 laser and IPL device must incorporate a key-actuated or computer-actuated primary control. The key must be removable, and the Class 3B or Class 4 laser or IPL device must not be operable when the key is removed. When the device is not being prepared for operation or is unattended, the key must be removed from the device and stored in a location away from the machine.(r) Additional requirements for special lasers and applications.(1) Infrared laser. The beam from a laser must be terminated in fire-resistant material, where necessary. Inspection intervals of absorbent material and actions to be taken in the event of degradation must be specified in the operating and safety procedures.(2) Laser optical fiber transmission system.(A) Laser transmission systems employing optical cables are considered enclosed systems with the optical cable forming part of the protective housing.(B) Disconnection of a connector resulting in exposure to radiation more than the applicable MPE limits, as specified in ANSI and the collateral limits listed in 21 CFR §1040.10, must take place in a controlled area. Except for medical lasers whose manufacture has been approved by the FDA, the use of a tool is required for the disconnection of a connector for service and maintenance purposes when the connector is not within a secured enclosure. All connectors must bear the appropriate label or tag as specified in subsection (u)(3) of this section.(s) Additional requirements for safe operation.(1) Eye protection. Protective eyewear must be worn by each individual exposed to laser radiation from IPL, Class 3B, or Class 4 levels of laser radiation. Protective eyewear devices must meet the following requirements:(A) provide a comfortable and appropriate fit all around the area of the eye;(B) be in proper condition to ensure the optical filter and holder provide the required optical density or greater at the desired wavelengths, and retain all protective properties during its use;(C) be suitable for the specific wavelength of the laser and be of optical density adequate for the energy involved;(D) have the optical density or densities and associated wavelength permanently labeled on the filters or eyewear; and(E) be examined, at intervals not to exceed 12 months, to ensure the reliability of the protective filters and integrity of the protective filter frames. Unreliable eyewear must be discarded. Documentation of the examination is required to be maintained as specified in subsection (cc) of this section for inspection by the department.(2) Skin protection. When there is a possibility of exposure to laser radiation more than the MPE limits for skin as specified in ANSI the registrant must require the use of appropriate PPE.(t) NHZ. Where applicable, in the presence of unenclosed Class 3B and Class 4 laser beam paths, an NHZ must be established. If the beam of an unenclosed Class 3B and Class 4 laser is contained within a region by adequate control measures to protect personnel from exposure to levels of radiation more than the MPE, as specified in ANSI, that region is the NHZ. The NHZ may be determined by information supplied by the laser manufacturer, by measurement, or by using the appropriate laser range equation or other equivalent assessment.(u) Hazard signs, labels, and posting for lasers and IPL devices.(1) General requirements. Except as otherwise authorized by the department, signs, symbols, and labels prescribed by this section must use the design and colors as specified in paragraph (3) of this subsection.(2) Posting. The laser controlled area must be conspicuously posted with a sign or signs as specified in paragraph (3) of this subsection.(3) Labeling lasers and posting laser facilities. All signs and labels associated with Class 2, 3a, 3B, and 4 lasers must contain the following wording or sign posting requirements found in ANSI.(A) Danger sign.(i) The signal word "DANGER" indicating death or serious injury will occur if required control measures are not implemented to mitigate the hazards within the laser controlled area. This signal word is restricted to those Class 4 lasers with high (e.g., multi-kilowatt) output power or pulse energies with exposed beams.(ii) The danger sign must include:(I) The signal word "DANGER" in white letters on a rectangular safety red background placed at the top of the sign.(II) "Class 4 Laser Controlled Area."(III) "Avoid eye or skin exposure to direct or scattered radiation."(IV) "Laser eye protection required," and include:(-a-) optical density;(-b-) laser type;(-c-) wavelength; and (-d-) wattage.(iii) The safety alert symbol must precede the signal word.(I) The base of the symbol must be on the same horizontal line as the base of the letter of the signal word.(II) The height of the safety alert symbol must be equal to or exceed the signal word letter height.(III) The words "Avoid eye or skin exposure to direct or scattered radiation" must appear to the right of the safety alert symbol.(iv) The following sign meets the requirements of this subparagraph.Attached Graphic(B) Warning sign.(i) The signal word "WARNING" must be used with all signs and labels associated with lasers and laser systems whose output is more than the applicable MPE for irradiance, including all Class 3B and most Class 4 lasers and laser systems.(ii) The warning sign must include:(I) The signal word "WARNING" in black letters on a rectangular orange background placed at the top of the sign.(II) "Class 4 Laser Controlled Area."(III) "Avoid eye or skin exposure to direct or scattered radiation."(IV) "Do not enter when light is illuminated."(V) "Laser eye protection required," and include:(-a-) optical density;(-b-) laser type;(-c-) wavelength; and(-d-) wattage.(iii) The safety alert symbol must precede the signal word.(I) The base of the symbol must be the same horizontal line as the base of the letter of the signal word.(II) The height of the safety alert symbol must be equal to or exceed the signal word letter height.(III) The words "Avoid eye or skin exposure to direct or scattered radiation" must appear to the right of the safety alert symbol.(iv) The following sign meets the requirements of this subparagraph.Attached Graphic(C) Caution sign.(i) The signal word "CAUTION" must be used with all signs and labels associated with Class 2 and Class 2M lasers and laser systems not more than the applicable MPE for irradiance.(ii) The caution sign must include:(I) The signal word "CAUTION" in black letters on a rectangular yellow background placed at the top of the sign.(II) "Class 2M Laser In Use."(III) "Do not stare into beam or view directly with optical instruments," and include:(-a-) optical density, if provided by the manufacturer;(-b-) laser type;(-c-) wavelength; and(-d-) wattage.(iii) The safety alert symbol must precede the signal word.(I) The base of the symbol must be on the same horizontal line as the base of the letters of the signal word.(II) The height of the safety alert symbol must be equal to or exceed the signal word letter height.(III) The words "Do not stare into beam or view directly with optical instruments" must appear to the right of the safety alert symbol.(iv) The following sign meets the requirements of this subparagraph.Attached Graphic(D) Lasers, except a laser used in the practice of medicine or veterinary medicine, must have a label in close proximity to each aperture emitting accessible laser or collateral radiation in excess of the limits specified in ANSI and the collateral limits listed in 21 CFR §1040.10, labeled with the following as applicable: (i) "AVOID EXPOSURE - Laser radiation is emitted from this aperture," if the radiation emitted through the aperture is laser radiation;(ii) "AVOID EXPOSURE - Hazardous electromagnetic radiation is emitted from this aperture," if the radiation emitted through the aperture is collateral radiation; or(iii) "AVOID EXPOSURE - Hazardous x-rays are emitted from this aperture," if the radiation emitted through the aperture is collateral x-ray radiation.(E) Each defeatable or non-interlocked portion of the protective housing or enclosure designed to be displaced or removed during normal operation or servicing that permits human exposure to laser or collateral radiation must have the following label:(i) for Class 3B accessible laser radiation, the wording, "DANGER - LASER RADIATION WHEN OPEN. AVOID DIRECT EXPOSURE TO BEAM";(ii) for Class 4 accessible laser radiation, the wording, "DANGER - LASER RADIATION WHEN OPEN. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION"; or(iii) for collateral radiation more than the emission limits as specified in 21 CFR §1040.10, "CAUTION - HAZARDOUS ELECTROMAGNETIC RADIATION WHEN OPEN" and "CAUTION - HAZARDOUS X-RAY RADIATION" as applicable.(F) For protective housing or enclosures providing a defeatable interlock, the words "and interlock defeated" must be included in the labels as specified in subparagraph (E)(i) and (ii) of this paragraph.(G) Other required information.(i) The word "invisible" must immediately precede the word "radiation" on labels and signs required by this subparagraph for wavelengths of laser and collateral radiation outside of the range of 400 to 700 nm.(ii) The words "visible and invisible" must immediately precede the word "radiation" on labels and signs required by this subparagraph for wavelengths of laser and collateral radiation both within and outside the range of 400 to 700 nm.(H) Labels and signs required by this subparagraph must be clearly visible, legible, and permanently attached to the laser or facility.(4) In lieu of the requirements in paragraphs (1) - (3) of this subsection, the department will accept labeling and signage as specified by:(A) 21 CFR §1040.10;(B) ANSI; and(C) IEC standards 60825-1 and 60601-2-22.(v) Surveys. Each registrant must conduct surveys necessary to comply with this section and maintain records of the surveys as specified in subsection (cc) of this section for inspection by the department. Surveys must be performed at intervals not to exceed 12 months, and include:(1) a determination if all laser and IPL protective devices are labeled correctly, functioning within the design specifications, and properly chosen for lasers and IPL devices in use;(2) a determination if all warning devices are functioning within their design specifications;(3) a determination if the controlled area is properly controlled and posted with accurate warning signs as specified in subsection (u) of this section;(4) a re-evaluation of potential hazards from surfaces associated with beam paths; and(5) additional surveys to evaluate the primary and collateral radiation hazard incident to the use of lasers and IPL devices.(w) Records or documents. Each registrant must maintain current records or documents required by this subsection as specified in subsection (cc) of this section for inspection by the department.(x) Measurements and instrumentation. Each determination requiring a measurement for compliance with this section must use instrumentation calibrated and designed for use with the laser or IPL device to be tested. Records of measurements and instrumentation must be maintained as specified in subsection (cc) of this section.(y) Notification of injury other than a medical event.(1) Each registrant of Class 3B or Class 4 lasers or user of an IPL device must immediately seek appropriate medical attention for the injured individual and notify the department by telephone of any injury involving a laser possessed by the registrant or an IPL device, other than intentional exposure of patients for medical purposes, that has or may have caused:(A) an injury to an individual involving the partial or total loss of sight in either eye; or(B) an injury to an individual involving intentional perforation of the skin or other serious injury excluding eye injury.(2) Each registrant of Class 3B or Class 4 lasers or user of an IPL device must, within 24 hours of the discovery of an injury, notify the department of any injury involving a laser possessed by the registrant or IPL device possessed by a user, as applicable, other than intentional exposure of patients for medical purposes, that has or may have caused, or threatens to cause, exposure to an individual with second or third-degree burns to the skin or potential injury and partial loss of sight. Record of a notification of injury must be documented and maintained as specified in subsection (cc) of this section.(z) Reports of injuries.(1) Each registrant of Class 3B or Class 4 lasers or user of an IPL device must make a report, in writing, or by electronic transmittal, within 30 days to the department of any injury required to be reported as specified in subsection (y) of this section.(2) Each report must describe:(A) the extent of injury to each individual from radiation caused by lasers or IPL devices;(B) power output of laser or IPL device involved;(C) the cause of the injury; and(D) corrective steps taken or planned to prevent a recurrence.(3) A report filed with the department as specified in this subsection must include the full name of each individual injured and a description of the injury. The report must include personally identifying information in a separate part of the report.(4) When a registrant or user of an IPL device is required, as specified in paragraphs (1) - (3) of this subsection, to report to the department any injury of an individual caused by radiation from a laser or IPL device, the registrant or user of an IPL device must notify the individual. The notice must be sent to the individual at the same time the report is sent to the department. Record of a report of injury must be documented and maintained as specified in subsection (cc) of this section.(aa) Medical event.(1) The registrant of a Class 3B or Class 4 laser or user of an IPL device must notify the department, by telephone or electronic transmittal, within 24 hours of the discovery of a medical event involving a Class 3B or Class 4 laser resulting in injury or death of a patient. Within 30 days after a 24-hour notification is made, the registrant of a Class 3B or Class 4 laser or the user of an IPL device must submit a written report to the department of the event. Record of a medical event must be documented and maintained as specified in subsection (cc) of this section.(2) The written report must include:(A) the registrant's or user's name;(B) a brief description of the event;(C) the effect on the patient;(D) the action taken to prevent recurrence; and(E) whether the registrant or user informed the patient or the patient's responsible relative or legal guardian.(3) When a medical event occurs, the registrant or user must promptly investigate its cause, make a record for department review, and retain the records as specified in subsection (cc) of this section.(bb) Reports of stolen, lost, or missing Class 3B or Class 4 lasers and IPL devices.(1) Each registrant of Class 3B or Class 4 lasers or user of an IPL device must report to the department by telephone at (512) 458-7460, or email at RAMAssist@dshs.texas.gov, a stolen, lost, or missing laser or IPL device within 24 hours after its occurrence becomes known to the registrant or IPL device user.(2) Each person required to make a report as specified in paragraph (1) of this subsection must, within 30 days after making the telephone or email report, make a written report to the department including:(A) a description of the laser or IPL device involved, including the manufacturer, model, serial number, and class;(B) a description of the circumstances under which the loss or theft occurred;(C) a statement of disposition, or probable disposition, of the laser or IPL device involved;(D) actions taken, or to be taken, to recover the laser or IPL device; and(E) procedures or measures taken to prevent a recurrence of the loss or theft of lasers or IPL devices.(3) Report of a stolen, lost, or missing Class 3B or Class 4 laser and IPL device must be maintained as specified in subsection (cc) of this section.(cc) Record or document retention requirements for registration of a radiation machine. Each registrant must maintain the following records or documents at each site, including authorized records sites for mobile services at the time intervals specified for inspection by the department.Attached Graphic Source Note: The provisions of this §289.301 adopted to be effective September 1, 2004, 29 TexReg 7427; amended to be effective October 12, 2008, 33 TexReg 8326; amended to be effective December 17, 2024, 49 TexReg 10104. 1 DEPARTMENT OF STATE HEALTH SERVICES 289 RADIATION CONTROL G REGISTRATION REGULATIONS §289.301 Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103056&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103056 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103056&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103056 03/11/2026 The purpose of these sections is to provide employers and employees with guidance needed to comply with the Texas Hazard Communication Act. Source Note: The provisions of this §295.1 adopted to be effective February 28, 1986, 11 TexReg 852; amended to be effective January 3, 1989, 13 TexReg 6270; amended to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.1 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103057&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103057 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103057&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103057 03/11/2026 The following words and terms, when used in these sections, shall have the following meanings unless the context clearly indicates otherwise.(1) Act--The Hazard Communication Act, the Health and Safety Code, Chapter 502.(2) Appropriate hazard warning--Any words, pictures, symbols, or combination thereof appearing on a label or other appropriate form of warning which convey the health and physical hazards, including the target organ effects of the chemical(s) in the container(s).(3) Appropriate personal protective equipment (PPE) or protective equipment -Equipment that is provided to an employee by the employer and provides a level of protection to chemicals to which the employee may be exposed that will be adequate to ensure their health and safety based on current industry standards. In determining the selection of PPE, the employer shall consider all routes of entry, permeability of PPE materials, the duties being performed by the employee, the hazardous chemicals present, and such other factors as may affect the performance of the equipment. The employer must ensure that the provided equipment fits the individual employee and is functional for its intended use as described by the manufacturer's specifications.(4) Asphyxiation--A death or injury from suffocation that is caused by a chemical and which is due to interference with the oxygen supply of the blood, other than drowning.(5) Categories of hazardous chemicals--A grouping of hazardous chemicals with similar hazard properties.(6) Commissioner of Health--the director of the Texas Department of Health, as referenced in the Health and Safety Code, §502.003(8).(7) Container--Any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical or contains multiple smaller containers of an identical hazardous chemical. The term "container" does not mean pipes or piping systems, nor does it mean engines, fuel tanks, or other operating systems in a vehicle. A primary container is the one in which the hazardous chemical is received from the supplier. A secondary container is one to which the hazardous chemical is transferred after receipt from the supplier.(8) Department--The Texas Department of Health.(9) Emergency service organization--Any organization established to provide the following services for the general public: fire prevention and suppression, hazardous materials response operations, or emergency medical services. An emergency service organization may consist of volunteer members or be a unit of a political subdivision of the state with compensated employees.(10) Employee education and training program--Actual instruction, regardless of the technology or method used to deliver it, provided by the employer to employees as required by the Act, §502.009. This program is the instruction of employees and records of training, as opposed to a written plan for training.(11) Employer--The overall organizational public entity rather than individual facilities or workplaces. Examples of public employers are an entire state agency, a county, a city, a public school district, a public university, a public college or community college, a river authority, a public hospital, or a volunteer emergency service organization. Each university, college, or community college in a university or college system shall be considered as a separate employer under the Act.(12) Handle--To touch, move, or manipulate hazardous chemicals.(13) Health hazard--A chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes.(14) Label--Any written, printed, or graphic material displayed on or affixed to containers of hazardous chemicals.(15) OSHA Standard--The Hazard Communication Standard of the United States Department of Labor, Occupational Safety and Health Administration (OSHA), Title 29 Code of Federal Regulations, 1910.1200.(16) Stationary process container--A tank, vat, or other such container which holds different hazardous chemicals at different times.(17) Workplace--A contiguous facility that is staffed 20 hours or more per week, unless such a facility is subdivided by the employer. Normally this subdivision would be a building, cluster of buildings or other structures, or complex of buildings, but could be for a portion of a building if the employer chooses. Noncontiguous properties are always separate workplaces unless they are temporary workplaces, in which case they can be either work areas of a headquarters workplace or separate workplaces, at the discretion of the employer.(18) Written hazard communication program--A document which describes an employer's program for compliance with those requirements of the Act imposed on the employer. Source Note: The provisions of this §295.2 adopted to be effective February 28, 1986, 11 TexReg 852; amended to be effective October 16, 1987, 12 TexReg 335; amended to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103058&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103058 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103058&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103058 03/11/2026 The commissioner's responsibilities under the Act are carried out through the Texas Department of Health, Product Safety Division, Hazard Communication Branch. Routine inquiries regarding this Act shall be addressed to: Texas Department of Health, Product Safety Division, Hazard Communication Branch, 1100 West 49th Street, Austin, Texas 78756, at toll free telephone number 1-800-452-2791. Source Note: The provisions of this §295.3 adopted to be effective February 28, 1986, 11 TexReg 852; amended to be effective January 3, 1989, 13 TexReg 6270; amended to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.3 Responsibility for Implementation of Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103059&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103059 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103059&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103059 03/11/2026 (a) An employer may choose to develop workplace chemical lists by work areas, pursuant to the Act, §502.005(c). However, the workplace chemical list threshold of 55 gallons or 500 pounds must be applied to the aggregate amount of the hazardous chemical in the workplace, even though such chemicals may be present below these thresholds in each work area.(b) If an employer chooses to subdivide a contiguous facility into separate workplaces, a workplace chemical list must be prepared for each separate workplace.(c) Employers may use the department's model form in developing workplace chemical lists. This form will provide a recommended format for the workplace chemical list, but is not mandatory. Source Note: The provisions of this §295.4 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.4 Workplace Chemical List https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103060&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103060 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103060&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103060 03/11/2026 (a) The employer shall maintain a current and appropriate MSDS, as defined by the Act, §502.003(17), for each hazardous chemical purchased. Except as described in subsection (b) of this section, MSDSs, whether in printed or electronic form, are considered "readily available" if they can be accessed for review at the workplace during the same workshift in which they are requested. For purposes of this section, a current MSDS shall be one which contains the most recent significant hazard information for the hazardous chemical as determined by the chemical's manufacturer.(b) An employer shall provide MSDSs to emergency responders as soon as practicable upon request.(c) An employer shall request or obtain a missing MSDS within 30 business days of receipt of the hazardous chemical. An employer shall not permit the use of any hazardous chemical for which a current MSDS is not available.(d) A chemical manufacturer or distributor must provide an appropriate MSDS to an employer within three business days of receipt of the employer's written request.(e) If the hazardous chemical was last received prior to the original effective date of the Act, January 1, 1986, an MSDS is not required. Source Note: The provisions of this §295.5 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.5 Material Safety Data Sheets https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103061&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103061 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103061&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103061 03/11/2026 (a) Employers shall rely on the manufacturers or distributors of their hazardous chemicals to provide container labels which meet the requirements of the OSHA Standard at 29 CFR, 1910.1200(f) and shall be responsible for re-labeling a container only:(1) when the label is missing or illegible; or(2) when it comes to the attention of the employer that the labeling does not meet the labeling requirements of the OSHA Standard.(b) An employer who receives an unlabeled or mislabeled primary container of a hazardous chemical from a supplier or a container which requires re-labeling according to subsection (a) of this section shall ensure that such containers are re-labeled to conform to the OSHA Standard prior to use by any employee. Employers may contact their suppliers to request such replacement labels or may prepare their own replacement labels.(c) In cases where an employer receives a primary container of a hazardous chemical that requires re-labeling according to subsection (a) of this section, except as provided in the Act, §502.007(b), the employer shall ensure that the replacement label contains the following information:(1) the identity of the chemical appearing on the MSDS;(2) the appropriate hazard warnings, or alternatively, words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the employer's education and training program, will reasonably provide employees with the specific information regarding the physical and health hazards, including the target organ effects of the hazardous chemical; and(3) the chemical manufacturer's name and address.(d) Except as provided in the Act, §§502.004(f) and 502.007(b), each secondary container label must include:(1) the identity of the chemical appearing on the MSDS; and(2) the appropriate hazard warnings, or alternatively, words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the employer's education and training program, will reasonably provide employees with the specific information regarding the physical and health hazards including the target organ effects of the hazardous chemical.(e) The employer shall ensure that labels or other forms of warning are legible, in English, and prominently displayed on the container in the workplace, work area, or temporary workplace throughout each work shift. The employer may add label information in another language to hazardous chemical containers.(f) Signs, placards, process sheets, batch tickets, operating procedures, or other such written materials may be used in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys the label information required by the Act.(g) Alternative labeling systems may be used by employers, as specified in subsections (c)(2) and (d)(2) of this section. Examples of such labeling systems are the National Fire Protection Association (NFPA) 704m Standard; the Hazardous Materials Information Systems (HMIS) Standard; and the U.S. Department of Transportation shipping label system.(h) Except as provided in the Act, §502.004(f), containers of hazardous chemicals which were received prior to the original effective date of the Act, January 1, 1986, and which do not meet the requirements of this section, must be re-labeled in accordance with the current labeling requirements of the Act. Source Note: The provisions of this §295.6 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.6 Labeling of Containers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103062&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103062 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103062&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103062 03/11/2026 (a) An employer is required to develop a written hazard communication program which will describe how the employer will comply with those requirements of the Act imposed on the employer. The written hazard communication program must include a description of the procedures that the employer will follow to achieve compliance with each applicable requirement of the Act. Employers may develop written hazard communication programs that are specific to each separate workplace or may develop a standard written program that could be used or modified for each workplace. Employers may use the department's model program in developing written hazard communication programs for each of their workplaces. This model program will provide a recommended format for the written hazard communication program, but is not mandatory.(b) An employer shall maintain either a printed or electronic copy of the written hazard communication program at the workplace to which the program applies.(c) The elements that shall be considered in an employer's written hazard communication program, if applicable, include:(1) workplace chemical lists;(2) material safety data sheets;(3) labels;(4) employee education and training programs, including the following subjects:(A) the use of the information provided in material safety data sheets and labels, and how they are related; and(B) the following subjects which relate to hazardous chemicals known to be present in the employee's work area:(i) locations;(ii) the physical effects and short-term and long-term health effects of exposure;(iii) safe handling;(iv) the proper use of personal protective equipment;(v) first aid treatment for exposures; and(vi) safety instructions on handling, cleanup, and disposal;(5) reporting employee deaths and injuries;(6) posting employee notice(s);(7) providing personal protective equipment; and(8) maintaining employee rights.(d) The employee education and training program shall include training sessions for employees and the record of each training session. The training subjects listed in subsection (c)(4) of this section shall be conducted in the following manner:(1) the instruction may be provided by categories of chemicals under the Act, §502.009(d); or(2) the instruction may be provided for specific chemicals known to be present and to which the employee may be exposed.(e) Training records may be maintained by the employer in either printed or electronic form, must be developed for each session which is necessary to demonstrate compliance, and shall contain all of the following information:(1) the date of the training session;(2) a legible list of names of all the employees who attended the training session;(3) any of the subjects listed in subsection (c)(4) of this section which were included in the training session, and the names of the categories of chemicals that were covered in the training session, if training is conducted by such categories; and(4) a legible list of names of all instructors who provided the training for that session.(f) When training is conducted by categories of hazardous chemicals under the Act, §502.009(d), the employer shall ensure that all the categories used are adequate to cover all hazardous chemicals to which the employees may be exposed. Such training need only cover those categories of chemicals which are appropriate, based on the hazards presented by the chemicals to which the employees may be exposed.(g) Training for new or newly assigned employees must be completed prior to assigning any duties that may result in exposure to hazardous chemicals.(h) Emergency service organizations shall provide to their members or employees the following information:(1) for any hazardous chemicals which the members or employees use or handle, the emergency service organization shall provide the training required by the Act, §502.009(c);(2) for any hazardous chemicals to which the members or employees may be exposed during emergency responses, the emergency service organization shall provide information on the recognition, evaluation, and control of exposures to such chemicals.(i) The information referenced in subsection (h)(2) of this section may be in the form of training sessions, written materials, or any other form of communication which provides this information. Training which meets the requirements of the Hazardous Waste Operations and Emergency Response Rule which was promulgated by the U.S. Environmental Protection Agency in Title 40 CFR, Part 311 shall meet the requirements for the Act, §502.009(h), and subsection (h)(2) of this section. Source Note: The provisions of this §295.7 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.7 Written Hazard Communication Program and Employee Education and Training Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103063&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103063 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103063&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103063 03/11/2026 (a) The commissioner or his representative shall investigate in a timely manner any complaint relating to an alleged violation of the Act. Such complaints do not have to be submitted to the department in writing and may be anonymous. An inspection based on a complaint is not limited to the specific allegations of the complaint. An employer who refuses to allow such an investigation shall be in violation of the Act.(b) The commissioner or his designated representatives may enter a workplace at all reasonable times to conduct random compliance inspections. An employer who refuses to allow such an inspection is in violation of the Act and these rules.(c) The department may find multiple violations by an employer during an inspection.(d) Upon request from a representative of the commissioner, an employer shall make or allow photocopies of documents to be made and permit the representative to take photographs required to verify the compliance status of the employer. Such requests may be made during a compliance inspection or in a written Notice of Violation issued by the department. Source Note: The provisions of this §295.8 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.8 Complaints and Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103064&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103064 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103064&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103064 03/11/2026 (a) Employers are required to report to the department the occurrence of any employee accident, including asphyxiation, resulting from a chemical exposure and that is fatal to one or more employees or that results in the hospitalization of five or more employees.(b) Such employee accidents may be reported to the Texas Department of Health, Product Safety Division, Hazard Communication Branch, at toll free telephone number 1-800-452-2791. Reports shall be submitted either orally or in writing no later than 48 hours after the occurrence of the accident. Written reports may be transmitted via facsimile or electronic means. Source Note: The provisions of this §295.9 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.9 Reporting Fatalities and Injuries https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103595&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103595 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103595&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103595 03/11/2026 (a) Inspections may be conducted by the commissioner or his representative to determine if an employer is in violation of the Act or the rules. An employer will be notified in writing of any alleged violations. The employer shall send a written response to the department within 15 business days of receipt of the notification. The employer's response must conform to at least one of the options listed in the notification from the department. (b) Employers who do not respond to the written notice from the department in accordance with subsection (a) of this section shall be subject to administrative penalties. Each violation of the Act may be cited separately in the written notice and a separate penalty may be proposed for each citation. Each day a violation continues may be considered a separate violation. (c) Penalties shall be due after an order is issued by the commissioner. An order may be issued on or after the 16th business day following the date that a written notification of violations is received by the employer, unless the department receives a written response which documents that each violation has been corrected or that an informal conference or a formal hearing has been requested. If an informal settlement conference is requested, the employer must respond that each violation has been corrected within 11 business days after the employer receives a summary letter following the informal conference. (d) The written response from the employer must address each violation separately and must provide the documentation requested by the department or an alternative agreed to by the department. An inappropriate or unacceptable response may result in a penalty being assessed for the underlying violations. (e) Violations will be classified in one of four severity levels: (1) a minor violation is related to a minor records keeping deficiency; (2) a serious violation is related to failure to take an action that poses a threat of harm to any employee or a substantial records keeping deficiency; (3) a severe violation is related to failure to take an action that poses a substantial threat of harm to any employee or a major records keeping deficiency; or (4) a critical violation is related to failure to take an action that has caused harm or is likely to cause significant harm to any employee. (f) Penalty amounts will be assessed based on the following schedule: Attached Graphic(g) Proposed penalties for individual violations may be reduced or enhanced by the department based on consideration of the history of previous violations, good faith efforts made to correct violations, duration of the violation, or any other considerations that justice may require. A maximum reduction or enhancement of 50% per individual proposed penalty may be considered, based on the facts presented to the department. (h) Follow-up inspections may be made to confirm the status of violations. In cases where the department determines that one or more specific violations of the Act are ongoing, the department may issue a written notice to the employer proposing a per day penalty for each violation. (i) Examples of violations for the various severity levels include, but are not limited to: (1) Minor violation: (A) failure to update the workplace chemical list as needed; failure to maintain previous workplace chemical lists for 30 years; or failure to develop the current workplace chemical list; (B) failure to include one to five required elements in employee training records for one or more training sessions. Each employee name, training subject, instructor's name, and the date of the training session is a separate element; (C) having a written hazard communication program which fails to describe how one to three of the criteria specified in §295.7(c) of this title (relating to Written Hazard Communication Program and Employee Education and Training) will be met; (D) failure to post the workplace notice specified in §295.12 of this title (relating to Employee Notice; Rights of Employees) in up to 25% of the locations where notices are normally posted in the workplaces covered by an inspection; (E) failure to maintain consistent names for hazardous chemicals on MSDSs, labels, and the workplace chemical list; or (F) failure to maintain a current MSDS for one hazardous chemical in one workplace. (2) Serious violation: (A) failure to provide the proper identity or required hazard information on replacement or secondary labels for up to three containers of hazardous chemicals in a workplace; (B) failure to provide a replacement or secondary label on a hazardous chemical container; (C) failure to maintain five or more required elements in employee training records for one or more training sessions. Each employee name, training subject, instructor's name, and the date of the training session is considered a separate element; (D) failure to post the workplace notice specified in §295.12 of this title in 26% to 99% of the locations where notices are normally posted in the workplaces covered by an inspection; (E) failure to provide up to 10% of employees in the workplaces covered during an inspection the training required under the Act, §502.009(c); (F) having a written hazard communication program which fails to describe how four to six of the criteria specified in §295.7(c) of this title will be met; (G) failure to maintain current MSDSs for more than one and less than 6.0% of the hazardous chemicals in one workplace which are surveyed during an inspection; or (3) Severe violation: (A) failure to post the notice to employees specified in §295.12 of this title in any of the locations where employee notices are normally posted in any workplace; (B) failure to provide the proper identity or required hazard information on replacement or secondary labels of four to ten containers of hazardous chemicals in a workplace; (C) failure to provide replacement or secondary labels on up to five hazardous chemical containers; (D) failure to provide 11% to 25% of employees in the workplaces covered during an inspection the training required under the Act, §502.009(c); (E) having a written hazard communication program which fails to describe how more than six of the criteria specified in §295.7(c) of this title will be met; (F) failure to maintain current MSDSs for 6.0% to 10% of the hazardous chemicals in one workplace which are surveyed during an inspection; (G) failure by a chemical manufacturer or distributor to provide an MSDS to an employer within three business days of receipt of the employer's written request; or (H) failure to report an incident to the department as required under the Act, §502.012. (4) Critical violation: (A) intentionally removing or defacing a label on a primary container of a hazardous chemical or maintaining another product's label on a hazardous chemical container; (B) failure to provide the proper identity or required hazard information on replacement or secondary labels of more than ten containers of hazardous chemicals in the workplace; (C) failure to provide replacement or secondary labels on more than five hazardous chemical containers; (D) failure to provide more than 25% of employees in the workplaces covered during an inspection the training required under the Act, §502.009(c); (E) denial by an employer to allow a representative of the department to conduct a compliance inspection; (F) failure to maintain current MSDSs for greater than 10% of the hazardous chemicals in one workplace which are surveyed during an inspection; (G) failure to provide, at the request of an employee, a copy of an MSDS for a hazardous chemical to a physician or emergency responder for purposes of treating any employee who may have suffered a chemical exposure; or (H) a request or a requirement for an employee to waive any rights provided by the Act, §502.107. Source Note: The provisions of this §295.11 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.11 Administrative Penalties https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103066&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103066 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103066&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103066 03/11/2026 (a) Employers covered by the Act must post and maintain workplace notices specified in this section. The wording of the required workplace notice may be changed by the commissioner as needed.Attached Graphic(b) The workplace notice shall measure at least 8-1/2 by 11 inches and be typed, typeset, or mechanically produced with lettering that is clearly legible. The letters shall not be smaller than 12 characters per inch. The words "NOTICE TO EMPLOYEES" shall be in bold capital letters at least 1/2 inch high. Other words spelled in capital letters in the sample notice shall be reproduced in capital letters. (c) A current version of the workplace notice shall be clearly posted and unobstructed at all locations in the workplace where notices are normally posted, and at least one location in each workplace. (d) An employer may add information to the workplace notice as long as the wording required by this section is included. Employers may add the name and telephone number of the employer's safety or environmental health officer to the bottom of the workplace notice in order to facilitate communication within the workplace. (e) To assist employers in providing the workplace notice information, the department shall make original copies of the workplace notice available for photocopying by employers. The department shall also make an electronic version of the workplace notice available to employers. A Spanish translation of the workplace notice is available from the department. (f) Employees have guaranteed rights to accessing the workplace chemical list and MSDSs and to receive training under the Act. (g) Employees have a guaranteed right to receive appropriate personal protective equipment (PPE) from their employer. Employers shall provide appropriate PPE to employees who may be exposed to hazardous chemicals in their workplace. The employer shall provide training to employees regarding how to maintain and store PPE appropriately to ensure that contamination does not occur. (h) An employee shall not be disciplined, harassed, or discriminated against by an employer for filing complaints, assisting inspectors of the department, participating in proceedings related to the Act, or exercising any rights under the Act. (i) Employees cannot waive their rights under the Act. A request or requirement for such a waiver by an employer violates the Act. Source Note: The provisions of this §295.12 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.12 Employee Notice; Rights of Employees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103067&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103067 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=103067&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 103067 03/11/2026 The citation of the OSHA Standard for physicians treating employees that is provided in the Act, §502.018, is in error. The correct citation for this standard is 29 CFR, §1910.1200(i)(2). This standard allows nurses, as well as physicians, to obtain the chemical identity of a trade secret hazardous chemical when that information is needed for medical treatment during an emergency. Source Note: The provisions of this §295.13 adopted to be effective September 1, 1999, 24 TexReg 3711; amended to be effective July 3, 2003, 28 TexReg 4914. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH A HAZARD COMMUNICATION §295.13 Standard for Physician Treatment https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13781&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13781 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13781&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13781 03/11/2026 (a) General provisions.(1) Purpose. The purpose of this section is to provide a means of reimbursement for services performed, so as to acquire or maintain certification status, supplies, equipment, personnel, and assistance necessary relative to state and federal regulations of asbestos, reflecting a greatly increased demand for these services.(2) Scope. This section covers fees for the non-mandatory review and approval of asbestos management plans, as submitted.(3) Statutory authority. The Texas Board of Health (board) is granted authority under the Health and Safety Code, §12.031 and §12.032, to charge fees to persons who receive public health services from the Texas Department of Health (department), which includes environmental and consumer health services.(4) Waiver. The commissioner of health of the State of Texas may waive any of the fee requirements in this section if the commissioner determines that a public emergency requires such action.(5) Review. The board shall review and approve all changes of the amounts of fees assessed, or any additions to fees for the services set forth in this section.(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.(1) Asbestos--Fibrous mineral forms (chrysotile, amosite, crocidolite, tremolite, anthophyllite, and actinolite).(2) Board--The Texas Board of Health.(3) Department--The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.(c) Fees for plans review.(1) The department may collect a reasonable fee for the review and approval of plans affecting the control and abatement of asbestos or asbestos containing materials (ACM). The fee determined for the review process for each asbestos plan, or partial plan, submitted under the provisions of this subsection shall be the greater of $75 or one-tenth of a cent ($0.001) per square foot of the total building area under review.(2) Parts of an entire asbestos plan may be submitted separately for facilities in separate locations. Each partial submission shall be subject to the fees set forth in paragraph (1) of this subsection.(3) The department may refuse or return asbestos plans that are found to be incomplete or not correctly prepared. The department may, at its election, hold documents pending notification to the sender of the required corrections or completions by mail. If the department has not received the required corrections or completions, or any necessary explanation thereof, within 30 days of the date of mailing the letter of requirements to the sender, the department may return or discard the plans or specifications.(4) The department shall complete the review process within 90 days of the date of acceptance by the department of an asbestos plan in an essentially complete and correct form.(5) The department shall refuse to accept or review plans submitted without proper provisions for payment. Fees for plans accepted by the department for the review process are not refundable. Source Note: The provision of this §295.21 adopted to be effective April 15, 1988, 13 TexReg 1338; amended to be effective October 20, 1992, 17 TexReg 6901. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH B FEES FOR ASBESTOS SERVICES §295.21 Fees for Management Plans https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107285&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107285 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107285&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107285 03/11/2026 (a) Purpose. The authority for these rules is granted to the Texas Department of Health (department) in the Health and Safety Code, §341.002. The purpose of this section is to provide the public with information on recommended allowable concentrations of toxic gases, as specified in the Health and Safety Code (HSC), §341.016(c)(1). Since HSC, §341.016, only provides the department with authority for developing occupational and sanitation standards for industrial establishments, and since the department's authority over industrial establishments is preempted by the U.S. Occupational Safety and Health Administration (OSHA), the department is issuing the List of Toxic Gases and Recommended Allowable Concentrations only as a guideline. (b) Information sources. In developing the List of Toxic Gases and Recommended Allowable Concentrations (RACs) for this section, the department used the following information and criteria. (1) The List of Toxic Gases was derived from those gases appearing in Table Z-1, "Limits for Air Contaminants," published by the U.S. Occupational Safety and Health Administration (OSHA) in 29 Code of Federal Regulations (CFR), §1910.1000. Only those gases that had a Median Lethal Concentration (LC(50)) in air of more than 200 parts per million (ppm) were selected for inclusion on the List of Toxic Gases. The department used the LC(50) criterion to ensure that only those gases that met the definition of "highly toxic" or "toxic," as those terms are defined in OSHA's Hazard Communication Standard, 29 CFR, §1910.1200, Appendix A, would be included on the List of Toxic Gases. (2) In order to ensure a unique identity for each toxic gas and provide the public with information that could be used to match chemical name synonyms to a specific listed gas, both the chemical name and the corresponding Chemical Abstract Service Number (CAS#) are referenced in the List of Toxic Gases. (3) The Recommended Allowable Concentration (RAC) for each toxic gas was derived from its corresponding Table Z-1 Permissible Exposure Limit (PEL) concentration established by OSHA. As appropriate, the RAC is provided in both ppm in air and milligrams per cubic meter (mg/M 3 ). (c) Adopted List of Toxic Gases and Recommended Allowable Concentrations. Attached Graphic(d) Responsibility for implementation of program. The department's responsibilities under this section are carried out through its General Sanitation Division. Routine inquiries regarding this section and requests for additional guidance related to occupational health and safety should be addressed to: Texas Department of Health, General Sanitation Division, 1100 West 49th Street, Austin, Texas 78756, or telephone number (512) 834-6635. Source Note: The provisions of this §295.101 adopted to be effective February 5, 2004, 29 TexReg 996. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH D OCCUPATIONAL HEALTH GUIDELINES §295.101 Recommended Allowable Concentrations of Toxic Gases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107286&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107286 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107286&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107286 03/11/2026 (a) Purpose. The authority for these guidelines is granted to the Texas Department of Health (department) in the Health and Safety Code, §341.002. The purpose of this section is to provide governing boards and administrators of Texas school districts with recommended guidelines on the selection and use of face and eye protection necessary to protect the health of employees, students, and visitors when such individuals are exposed to certain hazardous environments in schools.(b) Scope. The guidelines in these sections are applicable to all staff members, students, and visitors within Texas public schools participating in educational activities and programs that involve:(1) the use of hazardous chemicals;(2) the use of hot liquids or solids;(3) the use of molten materials;(4) performing grinding, chipping, or other hazardous activities where there is danger of flying particles;(5) milling, sawing, turning, shaping, cutting, or stamping of any solid materials;(6) heat treatment, tempering, or kiln firing of any metal or other materials;(7) cutting, welding, or brazing operations;(8) the use of hazardous radiation, including the use of infrared and ultraviolet light or lasers;(9) repair or servicing of any vehicle; or(10) any process or activity in a vocational, art, industrial arts or science course or laboratory that might have a tendency to cause damage to the eyes. Source Note: The provisions of this §295.141 adopted to be effective February 5, 2004, 29 TexReg 998. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH F GUIDELINES FOR SELECTION AND USE OF FACE AND EYE PROTECTION IN PUBLIC SCHOOLS §295.141 Purpose and Scope https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107287&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107287 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107287&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107287 03/11/2026 (a) The following section in the Code of Federal Regulations (CFR) is adopted by reference by the Texas Department of Health (department) as a recommended guideline for selection and use of face and eye protection in public schools: 29 CFR, Part 1910, Subpart I, §1910.133, titled "Eye and Face Protection," effective May 2, 1996, as amended.(b) The following section in the CFR is adopted by reference by the department as a recommended guideline for hazard assessment and face and eye protective equipment selection in public schools: 29 CFR, Part 1910, Subpart I, Appendix B, titled, "Non-mandatory Compliance Guidelines for Hazard Assessment and Personal Protective Equipment Selection," effective April 6, 1994, as amended. Source Note: The provisions of this §295.142 adopted to be effective February 5, 2004, 29 TexReg 998. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH F GUIDELINES FOR SELECTION AND USE OF FACE AND EYE PROTECTION IN PUBLIC SCHOOLS §295.142 Guidelines for Selection and Use of Eye and Face Protective Devices https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107288&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107288 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=107288&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 107288 03/11/2026 The responsibilities under this section are carried out through the Texas Department of Health, General Sanitation Division. Printed or electronic copies of the documents referenced in §295.142 of this title (relating to Guidelines for Selection and Use of Eye and Face Protective Devices) may be obtained free of charge by contacting the division. Routine inquiries regarding §§295.141-295.142 of this title, and requests for additional guidance related to face and eye safety should be addressed to: Texas Department of Health, General Sanitation Division, 1100 West 49th Street, Austin, Texas 78756, telephone number (512) 834-6635. Source Note: The provisions of this §295.143 adopted to be effective February 5, 2004, 29 TexReg 998. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH F GUIDELINES FOR SELECTION AND USE OF FACE AND EYE PROTECTION IN PUBLIC SCHOOLS §295.143 Responsibility for Implementation of Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=9558&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 9558 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=9558&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 9558 03/11/2026 (a) Scope. These sections of this undesignated head apply to temporary places of employment. This includes locations or situations where one or more persons are directly or indirectly employed by others in:(1) work of a mobile nature or at a series of locations involving movement from one location to another;(2) work of a transitory or seasonal nature performed for a limited period of time or at a temporary job site, or both;(3) work on railroad facilities, i.e., maintenance of way; or(4) work in any agricultural operation or activity performed in the field or outside of any permanent structure or facility.(b) Exclusion. Places of employment or numbers of employees to which specific federal sanitation standards apply, as adopted under the Occupational Safety and Health Act of 1970, Public Law 91-596, are excluded (29 United States Code Annotated §§651-678). This section does not apply to the operation of railroad rolling stock.(c) Purpose. The purpose of these sections is to prescribe minimum standards for the protection of the individual employee and the public welfare at temporary places of employment.(d) Employer responsibility.(1) Each person, association, or organization acting as employer shall have the responsibility to provide and maintain, or cause to be provided and maintained, sanitary facilities at any temporary place of employment according to the minimum standards set forth in these sections for the total number of persons employed during each workday or part thereof, except as otherwise provided, whether the mode of employment is direct or by means of an intermediary.(2) Where labor is performed under a contractual arrangement, that person, association, or organization for whose benefit such labor is performed shall have primary responsibility, and each labor contractor thereto shall have joint responsibility, for compliance with the provisions of these sections.(3) Where employees of more than one employer perform work at a temporary place of employment, it shall be the responsibility of each employer to provide or arrange for sanitary facilities meeting minimum standards for the total number of his own employees.(4) Employers shall permit the use of the required sanitary facilities by their employees without fee or other charge, nor shall any charge be made to employees if transportation is provided to or from such facilities. The pay of employees shall not be subject to deduction as a consequence of providing or using such facilities.(5) Employers shall inform their employees of their rights and obligations as set forth in these sections. They shall notify their employees of the location(s) of all sanitary facilities designated for their use and of any means of travel to these facilities, if provided, or of any subsequent changes in location or other arrangement.(6) An employer who employs no more than six persons performing work at a temporary place of employment on any work day may, on such days, be exempt from the requirement to provide toilet and handwashing facilities so long as he has provided or arranged for immediate transportation for these persons to travel to and from nearby facilities that meet minimum sanitary standards and are accessible to their use.(e) Employee responsibility. Each employee shall make proper use of the sanitary facilities provided, as is reasonable and necessary, so as not to adversely affect his own health or that of others.(f) Travel-distance limitation concerning all sanitary facilities.(1) An unimpeded walking distance of no more than 440 yards, which may also be measured as 400 meters or 1/4 mile, is the maximum distance that shall be required of employees to walk to the sanitary facilities provided for their use, as required by these sections. Impeded distances or those requiring climbing shall be shorter, so that in no case does walking to these facilities require more than five minutes.(2) Where sanitary facilities are required but it is not possible to comply with this travel-distance limitation, the employer must provide such facilities at the nearest possible location, and shall provide or arrange for transportation during both work and rest periods for immediate travel to and from these facilities, which must meet minimum sanitary standards. Transportation to the facilities so located shall not require more than five minutes travel time.(3) The travel-distance limitation shall not apply to employment as mounted riders nor when operating moving power equipment or vehicles on the job.(g) Penalty and enforcement. The statutory penalty and enforcement provisions covering violations of Health and Safety Code, Chapter 341, and these sections are contained in the Health and Safety Code, Chapter 341, §341.091 and §341.092. Source Note: The provisions of this §295.161 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.161 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13813&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13813 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13813&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13813 03/11/2026 The following words and terms, when used in these sections of this undesignated head, shall have the following meanings, unless the context clearly indicates otherwise.(1) Approved--Approved by the Texas Department of Health or the local health authority, whichever shall maintain jurisdiction.(2) Chemical toilets--A toilet facility in which human waste is collected in a container charged with a chemical, for the purpose of disinfecting and deodorizing prior to disposal.(3) Drinking water (potable water)--All water which may be distributed by any organization or individual, public or private, for all purposes of human consumption, washing of the person, the preparation of foods or beverages, or for the cleansing of any utensil or article used in the course of preparation or consumption of food or beverages.(4) Hand-washing facility--A plumbing device for washing the hands, arms, face and head, including lavatories, basins and sinks, both for cleanliness and for safety purposes.(5) Hygiene--Conditions or practices conducive to the establishment and maintenance of health.(6) Limited period of time--Not to exceed 12 months.(7) May--Used to denote authorized alternatives to mandatory provisions of these sections.(8) Nuisance--Any object, place, or condition which constitutes a possible or probable medium of transmission of disease to or between human beings or any other object, place, or condition which may be specifically declared to be a nuisance.(9) Number of employees--The maximum number of employees present at any one time during a regular work day at a temporary place of employment.(10) Putrescible--Organic waste subject to rotting or undergoing anaerobic decomposition, becoming foul and malodorous.(11) Sanitary condition--That condition of good order and cleanliness which precludes the probability of disease transmission.(12) Sanitary facility--Equipment built or installed to serve as a means of:(A) dispensing drinking water;(B) washing the hands;(C) eliminating body wastes; or(D) collecting refuse.(13) Shall (or must)--Used to denote mandatory provisions of these sections.(14) Should--Indicates provisions which are not mandatory, but which are recommended as good practice.(15) Standards--Methods, practices, processes, or operations necessary or appropriate to establish healthful employment conditions.(16) Toilet facility--A plumbing device for the purpose of defecation or urination, or both, including water closets and biological or chemical toilets, and urinals.(17) Toilet room--An enclosed area containing one or more toilet facilities and offering personal privacy. Toilet rooms may be either permanently located (fixed) or portable. Source Note: The provisions of this §295.162 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.162 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13814&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13814 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13814&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13814 03/11/2026 (a) Hygiene.(1) Employers shall require that work areas be kept clean to the extent that the nature of the work allows.(2) Job sites shall be kept free from obstructions that may cause or contribute to the injury of an employee, cause an unsafe act to be committed, or impede sanitation.(b) Waste collection and disposal.(1) Any receptacle used for the collection and storage of putrescible wastes shall be sturdily constructed so that it does not leak and may be conveniently and thoroughly cleaned. Such a receptacle shall be equipped with a tight-fitting cover, and shall be maintained in a sanitary condition. Disposable plastic bags of suitable size and strength are recommended for use as liners for such containers.(2) All solid or liquid wastes, debris, refuse, and garbage, shall be removed from work and rest areas in such a manner as to avoid creating a nuisance or menace to health. Removal shall be repeated as often as necessary to maintain sanitary conditions.(3) All wastes, including human waste, that are collected as a consequence of temporary employment shall be disposed of according to the applicable statutes covering the disposal of wastes.(c) Inspection. Every temporary place of employment shall be maintained in a sanitary condition. To this purpose, inspections of job sites and related sanitary facilities shall be made by the employer or his designated representative(s) as often as necessary to insure compliance with all sanitary requirements of these sections. Source Note: The provisions of this §295.163 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.163 Standards for General Sanitation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13815&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13815 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13815&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13815 03/11/2026 (a) Lighting. Where artificial lighting is necessary, employers shall provide lighting levels in such work areas that shall be not less than the levels of illumination summarized in Bulletin RP-15, titled "Recommended Levels of Illumination," and further described in the "IES Lighting Handbook," 5th Edition, both published by the Illumination Engineering Society of North America (IES).(b) Ventilation.(1) Employers shall provide proper ventilation for enclosed spaces which people may occupy in the course of temporary employment. This requires outside fresh air of acceptable quality. Whenever local building codes do not specify either ventilation rates or amounts, the provisions of paragraphs (2) and (3) of this subsection shall constitute the minimum ventilation standard.(2) Ventilating systems shall provide outside fresh air by natural or mechanical means. When mechanical ventilation is used, provision for air-flow measurement should be included. When natural ventilation and infiltration are used the ventilation rate shall be measurable. When infiltration rates are not sufficient to meet ventilation air requirements, mechanical ventilation shall be provided.(3) The minimum rate of ventilation, supplying outside fresh air of acceptable quality for any indoor or enclosed space, shall not be less than five cubic feet per minute per occupant, not less than 20 cubic feet per minute per occupant where smoking, or cooking, or open flames are permitted. Such ventilation shall be continuous during all working hours and any other periods of occupancy. Source Note: The provisions of this §295.164 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.164 Standards for Lighting and Ventilation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13808&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13808 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13808&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13808 03/11/2026 (a) Drinking water (potable water).(1) Every temporary place of employment shall be provided with an adequate supply of potable water for drinking. Employers shall make drinking water readily accessible to all employees during all working hours and rest periods in sufficient amounts to meet their needs. All drinking water shall be obtained from a water system complying with 31 TAC §§290.38-290.49 concerning Rules and Regulations for Public Water Systems. Drinking water may also be supplied in sealed glass or plastic containers from producers inspected by the Food and Drug Division of the Texas Department of Health according to the provisions of the Health and Safety Code, Chapter 431. All water supplies must be protected from contamination to the point of consumption.(2) Sanitary drinking fountains, where installed, shall be in accordance with American National Standard Specifications for Drinking Fountains and Self-Contained Mechanically-Refrigerated Drinking Water Coolers, ANSI/ARI 1010-73, published by the American National Standards Institute.(3) Where no supply system of drinking water meeting minimum standards is available, the requirement for providing drinking water may be met by the use of individual, disposable, or portable containers filled with water from a source in compliance with minimum standards for water hygiene, as set forth in paragraph (1) of this subsection.(4) All kinds of portable containers used to dispense water for drinking shall be clearly marked as to the nature of their contents, maintained in a sanitary condition, and not used for any other purpose. They must be capable of being tightly closed. All portable containers except those used for individual consumption must be equipped with a suitable tap. Containers such as barrels, pails, or tanks from which water must be poured or dipped shall be prohibited. The common drinking cup is prohibited.(5) Portable containers shall supply a total minimum capacity of not less than two quarts for each of the maximum number of employees present for each work day. Drinking water contained therein, during the period of dispensing to employees, shall not exceed a temperature of 80 degrees Fahrenheit.(6) Where drinking water is dispensed from portable containers other than individual containers it shall be dispensed either through the use of a drinking fountain or a gravity water tap. Except where drinking water is supplied exclusively by fountain, disposable single-service cups shall be supplied to all persons at a job site for drinking purposes. A container for storage of a sufficient number of cups and a receptacle for the disposal of used cups shall be provided adjacent to each water dispenser.(7) Where drinking water is cooled by ice, the construction of the container shall be such that the ice does not come in contact with the water unless the ice is manufactured from potable water and is protected from contamination between the point of manufacture and the point of use.(b) Non-potable water.(1) Outlets for non-potable water, such as water for industrial, irrigation, or fire-fighting purposes only, shall be clearly identified by employers, who must inform all employees and all others at the job site that the water is unsafe for drinking, washing, or cooking purposes.(2) Under no circumstances shall non-potable water be supplied or used for any drinking water purpose. Source Note: The provisions of this §295.165 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.165 Standards for Water Supply https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2431&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2431 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2431&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2431 03/11/2026 (a) General.(1) Employers shall provide toilet facilities, in separate toilet rooms for both sexes, according to these sections, for all temporary places of employment. They shall be readily accessible to all employees during all working hours and rest periods. These facilities may be either fixed (permanently located) or portable.(2) Toilet facilities shall be either water-actuated, chemical, or biological toilets. Other systems, such as privies, combustion toilets, sealed-bag toilets, and vault toilets, may be used only upon specific permission of the health authority having local jurisdiction.(3) Except as provided as follows, a minimum of one toilet, either fixed or portable, shall be provided per 30 employees of each sex, or fraction thereof, as determined on a daily basis at each temporary place of employment. However, when chemical toilets are furnished, a minimum of one toilet per 20 employees of each sex, or fraction thereof, shall be specified unless cleanout service is provided more often than once per week. When toilet facilities are not used by women, urinals may be substituted for as many as one-third of the minimum number of toilets specified for men.(4) Whenever other persons in addition to employees will use the same facilities, a reasonable additional allowance shall be included for them when determining the total number of toilets.(5) In those instances where the total number of employees to be provided for at a job site is 15 or less, as determined on a daily basis, a single toilet in a toilet room that offers complete privacy and can be locked from the inside may be provided for both men and women.(6) Toilet rooms and facilities shall be maintained in a sanitary condition, free of objectionable toilet odors, during all work hours and rest periods. The floors, walls, ceilings, partitions, and doors of all toilet rooms shall be of a finish that can be easily cleaned. An adequate supply of toilet paper in a suitable holder shall be maintained for each toilet. Covered waste receptacles shall be provided in all toilet rooms used by women.(b) Specifications: toilet facilities and rooms at fixed locations.(1) Each toilet facility (water closet, chemical, or biological toilet) at a fixed (permanent) location shall occupy a separate compartment equipped with a door and latch. Walls or partitions between fixtures shall be sufficiently high to assure privacy.(2) Each toilet facility shall be so installed that the space around it can be easily cleaned. This provision does not prohibit the use of wall-hung toilet stools or urinals.(3) Each toilet shall have a seat made of substantial material having a nonabsorbent finish.(4) Toilet rooms at fixed locations that are not ventilated by mechanical means shall be provided with a screened ventilation opening sufficiently large to permit adequate ventilation.(c) Specifications: portable toilet facilities and rooms.(1) Portable toilet facilities shall be so constructed as to be readily accessible. Privacy must be assured. Steps, handrails, and other installations shall be provided, as necessary, to allow convenient and safe access and usage by every person.(2) Portable combination arrangements combining toilet facilities with drinking water, hand-washing, and waste-disposal facilities, together with recommended first aid and emergency equipment, and which are capable of being towed or otherwise moved from one job site to another while maintaining a sanitary condition, are specifically authorized so long as their sanitary components meet minimum standards.(3) Buildings housing portable toilet rooms may be mobile trailers or prefabricated, skid-mounted, or otherwise portable structures. If they contain more than one facility, each shall occupy a separate compartment with a door and latch. Walls or partitions between toilets shall be sufficiently high to assure privacy. Urinals need not occupy separate compartments.(4) If the structure contains a tank in which waste is stored, the tank shall be vented to the outside of the structure.(5) Portable toilet rooms that are not ventilated by mechanical means shall be provided with an adequate screened ventilation opening. Source Note: The provisions of this §295.166 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.166 Standards for Toilet Facilities and Toilet Rooms https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13818&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13818 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=13818&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 13818 03/11/2026 (a) General.(1) Employers shall provide hand-washing facilities for maintaining personal cleanliness at every temporary place of employment. These shall be convenient for employee use and shall be maintained in a sanitary condition.(2) Hand-washing facilities shall be supplied with running water, which may be gravity flow. It is required that this be potable water. See §295.165(a) of this title (relating to Standards for Water Supply).(3) At least one hand-washing facility shall be located in or adjacent to any toilet room provided for employees' use, whether these are portable or at fixed (permanent) locations. A minimum of one hand-washing facility shall be provided for each two toilet facilities, as determined from the requirements of §295.166(a)(3) of this title (relating to Standards for Toilet Facilities and Toilet Rooms).(4) A dispenser containing a suitable cleansing agent shall be provided for each hand-washing facility. Individual hand towels and proper receptacles for their disposal shall be located conveniently.(5) Wherever a sufficient supply of potable water for hand-washing cannot be provided at a particular temporary job site, compliance with the hand-washing standards may be accomplished by providing an ample supply of disposable, pre-moistened cleaning towels and emulsifiable skin cleaners. This alternative shall not be employed as a permanent substitute for hand-washing facilities, however.(b) Specifications: portable hand-washing facilities.(1) Portable hand-washing facilities shall be supplied with potable water for washing purposes to the extent of at least one-half gallon for each of the maximum number of employees present for regular work day. Storage tanks for such water must be kept in a sanitary condition.(2) "Grey water" (wash water after being used) shall be disposed of in a holding tank, seepage pit, or by other means so as not to create a nuisance or menace to health. Source Note: The provisions of this §295.167 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.167 Standards for Hand-washing Facilities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=30528&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 30528 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=30528&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 30528 03/11/2026 (a) At all temporary places of employment where employees or others are required or permitted to eat or take rest periods at the job site, employers shall provide or designate one or more areas suitable for that purpose for the maximum number of persons who may use them at one time. In outdoor areas where insufficient shade is available, a tarpaulin fly or similar means should be provided for shade during eating and rest periods.(b) All required sanitary facilities shall be furnished during eating and rest periods. See travel distance limitations in §295.161(f) of this title (relating to General Provisions) for more information.(c) An adequate number of covered receptacles shall be provided for disposal of all waste food. Such receptacles shall be emptied at least once daily and shall be maintained free of residues. See waste collection and disposal standards in §295.163(b) of this title (relating to Standards for General Sanitation) for more information.(d) No food shall be stored, prepared, or eaten in any area where there are any materials or substances present in quantities or concentrations which may contaminate food or be injurious to health.(e) No food shall be stored or eaten in any toilet room. Source Note: The provisions of this §295.168 adopted to be effective February 22, 1993, 18 TexReg 848. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.168 Standards for Lunch or Rest Areas https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187570 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=187570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 187570 03/11/2026 The preparation, storage, and dispensing of food at any temporary place of employment shall be accomplished according to Chapter 228 of this title (relating to Retail Food) as administered by the health authority having local jurisdiction. Source Note: The provisions of this §295.169 adopted to be effective February 22, 1993, 18 TexReg 848; amended to be effective February 18, 2018, 43 TexReg 580. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH G SANITATION AT TEMPORARY PLACES OF EMPLOYMENT §295.169 Standards for Food Service https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101117&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101117 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101117&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101117 03/11/2026 (a) Purpose. The purpose of these sections is to establish the means to control and minimize public exposure to lead by regulating lead-based paint activities in target housing and child-occupied facilities.(b) Scope (for the purposes of certification and accreditation).(1) Rules application. These sections contain procedures and requirements for the accreditation of lead training providers, procedures and requirements for the certification of individuals and firms engaged in lead-based paint activities and standards for performing such activities in target housing and child-occupied facilities. These sections also require that all lead-based paint activities in target housing and child-occupied facilities be performed by certified individuals.(2) Exclusions. These sections do not apply to housing for the elderly or persons with disabilities, unless a child who is six years of age or younger resides or is expected to reside in that housing, nor do these sections apply to target housing with zero bedrooms. These sections also do not apply to persons who perform lead-based paint activities within residences which they own, unless the residence is occupied by a person or persons other than the owner or the owner's immediate family while the activities are being conducted or a child residing in the building has been identified as having an elevated blood lead level.(c) Severability. Should any section or subsection in this chapter be found to be void for any reason, such finding shall not affect any other sections. Source Note: The provisions of this §295.201 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.201 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206694&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206694 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206694&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206694 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. (1) Accessible surface--An interior or exterior surface painted with lead-based paint that is accessible to a young child to mouth or chew. (2) Accredited training program--A training program that has been accredited by the Department of State Health Services (department) to provide training for persons engaged in lead-based paint activities. (3) Act--The Texas Occupations Code, Chapter 1955. (4) Adequate quality control--A plan or design to ensure the authenticity, integrity, and accuracy of lead-based paint samples, including dust, soil, and paint chip or paint film samples. Adequate quality control also includes provisions for representative sampling. (5) Approved documented methodologies--Methods or protocols used to sample for the presence of lead in paint, dust, and soil. Approved documented methodologies may be found in the United States Department of Housing and Urban Development (HUD) Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (2012 edition); Standard Specification for Wipe Sampling Materials for Lead in Surface Dust (ASTM Designation E1792); Standard Practice for Field Collection of Settled Dust Samples Using Wipe Sampling Methods for Lead Determination by Atomic Spectrometry Techniques (ASTM Designation E1728); Standard Practice for Field Collection of Soil Samples for Lead Determination by Atomic Spectrometry Techniques or equivalent method (ASTM Designation E1727); and other equivalent methods recognized by EPA, HUD, or the department. (6) Arithmetic mean--The algebraic sum of data values divided by the number of data values (e.g., the sum of the concentration of lead in several soil samples divided by the number of samples). (7) ASTM--American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Pennsylvania, 19428. (8) Bare soil--Soil not covered with grass, sod, or some other similar vegetation. Bare soil includes sand. (9) Certified lead abatement project designer--A person who has been certified by the department to prepare lead abatement project designs, occupant protection plans, and abatement reports. (10) Certified lead abatement supervisor--A person who has been certified by the department to supervise and conduct lead abatements, and to prepare occupant protection plans and abatement reports. (11) Certified lead abatement worker--A person who has been certified by the department to perform abatements. (12) Certified lead firm--A company, contractor, partnership, corporation, sole proprietorship, association, or other business entity that performs or offers to perform lead-based paint activities, and that has been certified by the department. (13) Certified lead inspector--A person who has been certified by the department to conduct lead inspections. Inspectors may also sample dust and soil for the purposes of abatement cleanup and clearance testing. (14) Certified lead risk assessor--A person who has been certified by the department to conduct lead risk assessments, lead inspections and lead hazard screens. Risk assessors may also sample dust and soil for the purposes of lead abatement cleanup and clearance testing. (15) Chewable surface--An interior or exterior surface painted with lead-based paint that a young child can mouth or chew. A chewable surface is the same as an "accessible surface" as defined in 42 U.S.C. 4851b(2). Hard metal substrates and other materials that cannot be dented by the bite of a young child are not considered chewable. (16) Child-occupied facility--A building or part of a building constructed before 1978, including, but not limited to, a day-care center, preschool, or kindergarten classroom, that is visited regularly by the same child, six years of age or younger, at least two days in any calendar week if the visits are for at least: (A) three hours each day; and (B) 60 hours each year. (17) Clearance levels--Values that indicate the maximum amount of lead permitted in dust on a surface following completion of an abatement activity. To achieve clearance when dust sampling is required, values below these levels must be achieved. Clearance levels that are appropriate when dust sampling is required may be found in §295.212(d)(13) of this title (relating to Standards for Conducting Lead Based Paint Activities). (18) Commissioner--The Commissioner of the Department of State Health Services. (19) Common area--A portion of target housing or a child-occupied facility that is generally accessible to all occupants. Such an area may include, but is not limited to, hallways, stairways, laundry and recreational rooms, playgrounds, community centers, garages, and boundary fences. (20) Common area group--A group of common areas that are similar in design, construction, and function. Common area groups include, but are not limited to, hallways, stairwells, and laundry rooms. (21) Complete certification application--An application that contains, at a minimum: (A) an original signature not photocopied, facsimiled, or electronically reproduced; (B) a legible printed name and mailing address; (C) any business or organization affiliation and mailing address; (D) copies of any applicable required training course completion certificates issued by a department-accredited training provider within the specified time frames; (E) documentation of any applicable required formal education in the form of a diploma, degree, or transcript; (F) documentation of any applicable required work experience detailing job duties that includes verification contacts covering the minimum time frames required; (G) documentation of any specified professional certification, professional engineer, or professional registration, if required; (H) the appropriate certification fee; and (I) for lead firms, documentation of items required in §295.211(b)(1) - (3) of this title (relating to Lead Firm Certification Requirements), as applicable. (22) Component or building component--Specific design or structural elements or fixtures of target housing or a child-occupied facility that are distinguished from each other by form, function, and location. These include, but are not limited to, interior components, such as ceilings, crown molding, walls, chair rails, doors, door trim, floors, fireplaces, radiators and other heating units, shelves, shelf supports, stair treads, stair risers, stair stringers, newel posts, railing caps, balustrades, windows and trim (including sashes, window heads, jambs, sills or stools and troughs), built-in cabinets, columns, beams, bathroom vanities, counter tops, and air conditioners; and exterior components, such as painted roofing, chimneys, flashing, gutters and downspouts, ceilings, soffits, fascias, rake boards, cornerboards, bulkheads, doors and door trim, fences, floors, joists, lattice work, railings and railing caps, siding, handrails, stair risers and treads, stair stringers, columns, balustrades, window sills or stools and troughs, casings, sashes and wells, and air conditioners. (23) Concentration--The relative content of a specific substance contained within a larger mass, such as the amount of the lead (in micrograms per gram or parts per million by weight) in a sample of dust or soil. (24) Containment--A regulated area that has been sealed and designed to prevent the release of lead-containing dust or materials into surrounding areas. (25) Course agenda--An outline of the key topics to be covered during a training course, including the time allotted to teaching each topic. (26) Course test--An evaluation of the overall effectiveness of the training which shall test the trainees' knowledge and retention of the topics covered during the course. (27) Course test blue print--Written documentation of the proportion of course test questions devoted to each major topic in the course curriculum. (28) Department--The Department of State Health Services. (29) Deteriorated paint--Any interior or exterior paint or other coating that is peeling, chipping, chalking or cracking, or any paint or coating located on an interior or exterior surface or fixture that is otherwise damaged or separated from the substrate. (30) Discipline--One of the specific types or categories of lead-based paint activities for which individuals may receive training from accredited programs and become certified by the department. For example, "lead worker" is a discipline. (31) Distinct painting history--The application history, as indicated by its visual appearance or a record of application, over time, of paint or other surface coatings to a component, room, or unit of a building structure. (32) Dripline--The area within three feet surrounding the perimeter of a building. (33) Elevated blood lead level (EBL)--An absorption of lead that is a confirmed concentration of lead in whole blood of 20 µg/dl (micrograms of lead per deciliter of whole blood) for a single venous test or of 15-19 µg/dl in two consecutive tests taken three to four months apart. (34) EHNG--Environmental Health Notifications Group within the Inspection Unit, Environmental and Consumer Safety Section, Department of State Health Services. (35) Encapsulant--A substance that forms a barrier between lead-based paint and the environment using a liquid-applied coating (with or without reinforcement materials) or an adhesively bonded covering material. Only encapsulant products that meet the performance standards developed by ASTM (E1796, E1795) shall be used for lead hazard reduction. (36) Encapsulation--The application of an encapsulant. (37) Enclosure--A process that makes lead-based paint inaccessible by providing a physical barrier that is mechanically attached to a surface. (38) EPA--The United States Environmental Protection Agency. (39) Federal laws and rules--Applicable federal laws and regulations adopted in this paragraph: (A) Toxic Substances Control Act (15 United States Code §2681 et seq.) Title IV, and the rules adopted by the EPA under that law for authorization of state programs; (B) Title X, Residential Lead-Based Paint Hazard Reduction Act of 1992, and any regulations or requirements adopted by the HUD regarding eligibility for grants to states and local governments; and (C) any other requirements adopted by a federal agency with jurisdiction over lead hazards. (40) Friction surface--An interior or exterior surface that is subject to abrasion or friction, including, but not limited to, certain window, floor, and stair surfaces. (41) Guest instructor--An individual designated by the training program manager to provide instruction specific to the lecture, hands-on activities, or work practice components of a course. (42) Hands-on skills assessment--An evaluation which tests the trainees' ability to perform satisfactorily the work practices and procedures used by a discipline, as well as any other skills covered in a training course. (43) HEPA filter--A high-efficiency particulate air filter, capable of trapping and retaining 99.97% of mono-dispersed airborne particles 0.3 microns or larger in diameter. (44) Historical records--Documentation which identifies the material makeup (including brand, color type, and lead content) and dates of application of paint and other surface coatings. (45) HUD--The United States Department of Housing and Urban Development. (46) HVAC--Heating, ventilation, and air conditioning systems. (47) Impact surface--An interior or exterior surface that is subject to damage by repeated sudden force such as certain parts of door frames. (48) Inspection--A surface-by-surface investigation by a certified lead inspector or a certified lead risk assessor to determine the presence of lead-based paint including a written report explaining the results of the investigation. (49) Interim controls--A set of measures designed to temporarily reduce human exposure or likely exposure to lead-based paint hazards, including specialized cleaning, repairs, maintenance, painting, temporary containment, ongoing monitoring of lead-based paint hazards or potential hazards, and the establishment and operation of management and resident education programs. (50) Interior window sill--The portion of the horizontal window ledge that protrudes into the interior of the room. (51) Lead Abatement-- (A) Includes any measure or set of measures designed to permanently eliminate lead-based paint hazards. Abatement includes, but is not limited to: (i) the removal of paint and dust, the permanent enclosure or encapsulation of lead-based paint, the replacement of painted surfaces or fixtures, or the removal or permanent covering of soil, when lead-based paint hazards are present in such paint, dust or soil; and (ii) all preparation, cleanup, disposal, and post-abatement clearance testing activities associated with such measures; and (iii) abatement projects, which specifically include, but are not limited to: (I) projects for which there is a written contract or other documentation, which provides that an individual or firm will be conducting activities in or to target housing or child-occupied facilities that: (-a-) shall result in the permanent elimination of lead-based paint, lead-contaminated dust or soil, and other lead-based paint hazards; or (-b-) are described in clauses (i) and (ii) of this subparagraph. (II) projects resulting in the permanent elimination of a lead-based paint hazard, lead-based paint, and lead-contaminated dust or soil, conducted by persons certified in accordance with §§295.206 - 295.211 of this title relating to the certification requirements unless such projects are covered by subparagraph (B) of this paragraph; (III) projects resulting in the permanent elimination of a lead-based paint hazard, lead-based paint, and lead-contaminated dust or soil, conducted by persons who, through their company name or promotional literature, represent, advertise, or hold themselves to be in the business of performing lead-based paint activities as identified and defined by this section, unless such projects are covered by subparagraph (B) of this paragraph; or (IV) projects involving the permanent elimination of lead-based paint hazards, lead-based paint, or lead-contaminated dust or soil, that are conducted in response to state or local abatement orders. (B) Excludes: (i) renovation, remodeling, or landscaping activities, which are not designed to permanently eliminate lead-based paint hazards, but, instead, are designed to repair, restore, or remodel a given structure or dwelling, even though these activities may incidentally result in a reduction or elimination of lead-based paint hazards; (ii) interim controls, operations and maintenance activities, or other measures and activities designed to temporarily, but not permanently, reduce lead-based paint hazards; and (iii) demolition of target housing buildings and child-occupied facilities. (52) Lead-based paint--Paint or other surface coatings that contain lead equal to or in excess of 1.0 milligrams per square centimeter or more than 0.5% by weight. (53) Lead-based paint activity--Inspection, testing, risk assessment, risk reduction, lead abatement project design or planning, abatement or removal, or creation of lead-based paint hazards. (54) Lead-based paint hazard--Hazardous lead-based paint, dust-lead hazard or soil-lead hazard as identified in this paragraph. (A) Paint-lead hazard. A paint-lead hazard is any of the following: (i) any lead-based paint on a friction surface that is subject to abrasion and where the lead dust levels on the nearest horizontal surface underneath the friction surface (e.g., the window sill, or floor) are equal to or greater than the dust-lead hazard levels identified in subparagraph (B) of this paragraph; (ii) any damaged or otherwise deteriorated lead-based paint on an impact surface that is caused by impact from a related building component (such as a door knob that knocks into a wall or a door that knocks against its door frame); (iii) any chewable lead-based painted surface on which there is evidence of teeth marks; and (iv) any other deteriorated lead-based paint in any residential building or child-occupied facility or on the exterior of any residential building or child-occupied facility. (B) Dust-lead hazard. A dust-lead hazard is surface dust in a residential building or child-occupied facility that contains mass-per-area concentration of lead equal to or exceeding 10 micrograms per square foot (µg/ft2 ) on floors or 100 µg/ft2 on interior window sills based on wipe samples. (C) Soil-lead hazard. A soil-lead hazard is bare soil on residential real property or on the property of a child-occupied facility that contains total lead equal to or exceeding 400 parts per million (ppm) in a play area or average of 1,200 ppm of bare soil in the rest of the yard based on soil samples. (55) Lead-hazard screen--An activity conducted by a certified risk assessor that involves limited paint and dust sampling to determine the presence of a lead-based paint hazard. (56) Living area--Areas of a target housing unit or a child-occupied facility used by one or more children six years of age or younger, including, but not limited to, living rooms, kitchen areas, dens, play rooms, and children's bedrooms. (57) Loading--The quantity of a specific substance present per unit of surface area, such as the amount of lead in micrograms contained in the dust collected from a certain surface area divided by the surface area in square feet or square meters. (58) Mid-yard--An area of a residential yard approximately midway between the dripline of a residential building and the nearest property boundary or between the driplines of a residential building and another building on the same property. (59) Multi-family dwelling--A structure that contains more than one separate residential dwelling unit, which is used or occupied, or intended to be used or occupied, in whole or in part, as the home or residence of one or more persons. (60) Non-profit--An entity which has demonstrated to any branch of the Federal Government or to a State, municipal, tribal or territorial government, that no part of its net earnings inure to the benefit of any private shareholder or individual. (61) OSHA--The Occupational Safety and Health Administration of the United States Department of Labor. (62) Permanently covered soil--Soil which has been separated from human contact by the placement of a barrier consisting of solid, relatively impermeable materials, such as pavement or concrete. Grass, mulch, and other landscaping materials are not considered permanent covering. (63) Person--An individual, corporation, company, contractor, subcontractor, association, firm, partnership, joint stock company, foundation, institution, trust, society, union, governmental entity, or any other association of individuals. (64) Play area--An area of frequent soil contact by children six years of age or less as indicated by, but not limited to, such factors, including the following the presence of play equipment (e.g., sandboxes, swing sets, and sliding boards), toys, or other children's possessions, observations of play patterns, or information provided by parents, residents, care givers, or property owners. (65) Principal instructor--The individual who has the primary responsibility for organizing and teaching a particular course. (66) Recognized laboratory--An environmental laboratory recognized by EPA, pursuant to the Toxic Substances Control Act (TSCA) §405(b), as being capable of performing an analysis for lead content in materials, including paint, soil, and dust. (67) Reduction--Any measures designed to reduce or eliminate human exposure to lead-based paint hazards through methods, including, but not limited to, interim controls and abatement. (68) Residential building--A building containing one or more residential dwellings. (69) Residential dwelling--A dwelling that is: (A) a detached single family dwelling unit, including attached structures such as porches and stoops; or (B) a single family dwelling unit in a structure that contains more than one separate residential dwelling unit, which is used or occupied, or intended to be used or occupied, in whole or in part, as the home or residence of one or more persons. (70) Risk assessment--An assessment consists of: (A) an on-site investigation conducted by a certified risk assessor to determine the existence, nature, severity, and location of lead-based paint hazards; and (B) a written report by the person or the firm conducting the risk assessment, explaining the results of the investigation and options for reducing lead-based paint hazards. (71) Room--A separate part of the inside of a building, such as a bedroom, living room, dining room, kitchen, bathroom, laundry room, or utility room. To be considered a separate room, the room must be separated from adjoining rooms by built-in walls or archways that extend at least six inches from an intersecting wall. Half walls or bookcases count as room separators if built-in. Movable or collapsible partitions or partitions consisting solely of shelves or cabinets are not considered built-in walls. A screened in porch that is used as a living area is a room. (72) Soil Sample--A sample collected in a representative location using ASTM E1727, "Standard Practice for Field Collection of Soil Samples for Lead Determination by Atomic Spectrometry Techniques," or equivalent method. (73) Start-date--The date that the lead abatement begins. (74) Stop-date--The date that all dust-wipe clearance levels are achieved and reported to the lead firm conducting the abatement for interior abatement, or for exterior abatement, the date that visual clearance levels are all achieved. (75) Target housing--Any housing constructed prior to 1978, except housing for the elderly or persons with disabilities (unless any child who is six years of age or younger resides or is expected to reside in such housing) or any zero-bedroom dwelling. As defined in this section, target housing includes the terms residential dwelling, multi-family dwelling, and unit. (76) Testing--The collection of paint, soil, or dust-wipe samples for determining the presence of lead in paint or lead-based paint hazards by an EPA recognized laboratory or the use of an XRF. (77) Training curriculum--An established set of course topics for instruction in an accredited training program for a particular discipline designed to provide specialized knowledge and skills. (78) Training hour--At least 50 minutes of actual teaching, including, but not limited to, time devoted to lecture, learning activities, small group activities, demonstrations, evaluations, and hands-on experience. (79) Training manager--The individual responsible for administering a training program and monitoring the performance of principal instructors and guest instructors. (80) TSCA--Toxic Substances Control Act (15 United States Code §2681 et seq) Title IV. (81) Unit--A room or connected group of rooms used or intended to be used by a single tenant or owner. (82) Visual inspection for clearance testing--The visual examination of a residential dwelling or a child-occupied facility following an abatement to determine whether or not the abatement has been successfully completed, as indicated by the absence of visible residue, dust, and debris. (83) Visual inspection for risk assessment--The visual examination of a residential dwelling or a child-occupied facility to determine the existence of deteriorated lead-based paint or other potential sources of lead-based paint hazards. (84) Weighted arithmetic mean--The arithmetic mean of sample results weighted by the number of subsamples in each sample. Its purpose is to give influence to a sample relative to the surface area it represents. A single surface sample is comprised of a single subsample. A composite sample may contain from two to four subsamples of the same area as each other and of each single surface sample in the composite. The weighted arithmetic mean is obtained by summing, for all samples, the product of the sample's result multiplied by the number of subsamples in the sample, and dividing the sum by the total number of subsamples contained in all samples. For example, the weighted arithmetic mean of a single surface sample containing 60 µg/ft2 , a composite sample (three subsamples) containing 100 µg/ft2 , and a composite sample (four subsamples) containing 110 µg/ft2 is 100 µg/ft2 . This result is based on the equation [60 + (3*100) + (4*110)]/(1+3+4). (85) Window trough--For a typical double-hung window, the portion of the exterior window sill between the interior window sill (or stool) and the frame of the storm window. If there is no storm window, the window trough is the area that receives both the upper and lower window sashes when they are both lowered. The trough is sometimes referred to as the window "well." (86) Wipe sample--A sample collected by wiping a representative surface of known area, as determined by ASTM E1728, "Standard Practice for Field Collection of Settled Dust Samples Using Wipe Sampling Methods for Lead Determinations by Atomic Spectrometry Techniques," or equivalent method, with an acceptable wipe material as defined in ASTM E1792, "Standard Specification for Wipe Sampling Materials for Lead in Surface Dust." (87) Working days--Monday through Friday including holidays that fall on those days. (88) Worksite--An interior or exterior area at a target housing or child-occupied facility where lead-based paint abatement activity is taking place or is scheduled to take place. (89) X-Ray Fluorescence Analyzer (XRF)--An instrument used to determine the concentration of lead in a sample; readings are in milligrams per square centimeter (mg/cm2 ). (90) Zero-bedroom dwelling--Any residential dwelling in which the living area is not separated from the sleeping area. The term includes, but is not limited to, efficiencies, studio apartments, dormitory housing, military barracks, and rental of individual rooms in residential dwellings. Source Note: The provisions of this §295.202 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987; amended to be effective November 9, 2021, 46 TexReg 7608. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.202 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101119&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101119 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101119&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101119 03/11/2026 (a) The following approved federal documented methodologies provide information for conducting lead-based paint activities:(1) "Guidelines for the Evaluation and Control of Lead-based Paint Hazards in Housing," United States Department of Housing and Urban Development (HUD), June 1995 (and 1997 Chapter 7 revision), issued pursuant to §1017 of the Residential Lead-Based Paint Hazard Reduction Act of 1992;(2) "Standard Specification for Wipe Sampling Materials for Lead in Surface Dust." American Society for Testing and Materials (ASTM) Designation E1792;(3) "Standard Practice for Field Collection of Settled Dust Samples Using Wipe Sampling Methods for Lead Determination by Atomic Spectrometry Techniques." ASTM Designation E1728; and(4) "Standard Practice for Field Collection of Soil Samples for Lead Determination by Atomic Spectrometry Techniques or equivalent methods." ASTM Designation E1727.(b) Copies of the documents in subsection (a) of this section are available for review at any department-accredited training provider or the Texas Department of Health, Toxic Substances Control Division, Austin, Texas, or any Texas Department of Health regional office and may be reviewed during normal business hours or may be purchased through ASTM. Source Note: The provisions of this §295.203 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.203 Approved Federal Documented Methodologies https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118566&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118566 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118566&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118566 03/11/2026 (a) Accreditation requirement.(1) A training program provider may seek accreditation from the department to offer courses in any of the following disciplines:(A) lead inspector;(B) lead risk assessor;(C) lead abatement supervisor;(D) lead abatement project designer; and(E) lead abatement worker.(2) A training program provider may also seek accreditation to offer refresher courses for each of the disciplines listed in paragraph (1) of this subsection.(3) A training program provider shall not provide, offer, or claim to provide department-accredited training courses for certification purposes without accreditation from the department as required under subsection (c) of this section.(b) Fees.(1) Two-year accreditations. Effective January 1, 2005, the fee for a two-year lead training program provider accreditation shall be $1,000. The fee payment must accompany the application. After initial accreditation, an application and a fee of $100 shall be submitted for each additional course discipline the training provider wishes to teach. Applicants seeking a replacement accreditation certificate shall submit such a request in writing on a department-issued form along with the reissuance fee of $20.(2) Three-year accreditations. Three-year accreditations, which were issued prior to January 1, 2005, shall remain valid for the remainder of their three-year term provided that the annual fee of $500 is paid on time to the department. Upon expiration of this three-year accreditation, a fee of $1,000 for a two-year renewal accreditation shall be paid upon submission of a complete application. Trainers who possess a three-year accreditation on January 1, 2005, must submit an annual fee when due accompanied by a payment coupon issued by the department. In order to retain a three-year accreditation for the remainder of its term, all annual fees must be paid on time as required. Failure to make a timely annual fee payment may result in the suspension of the accreditation. After initial accreditation, an application and a fee of $100 shall be submitted for each additional course discipline the training provider wishes to teach. Applicants seeking a replacement accreditation certificate shall submit such a request in writing on a department-issued form along with the reissuance fee of $20.(3) TexasOnline. The department is authorized to collect subscription and convenience fees, in amounts determined by the TexasOnline Authority, to recover costs associated with processing accreditation applications through TexasOnline, in accordance with the Texas Government Code, §2054.111 (relating to Use of TexasOnline Project).(c) Application process. The following are procedures a training program provider shall follow to receive department accreditation to offer lead-based paint activities courses.(1) A training program provider seeking accreditation shall submit a written application to the department containing the following information:(A) the training program provider's name, address, and telephone number;(B) a list of courses for which the training provider is applying; and(C) a statement signed by the training program manager certifying that the training program meets the minimum requirements established in subsection (d) of this section. If a training program provider uses EPA-developed model training materials, a statement certifying the use of these materials shall be submitted. If a training program provider does not use EPA-developed training materials, its application for accreditation shall include:(i) a copy of the student and instructor manuals to be used for each course; and(ii) a copy of the course agenda for each course, which must include the time allotted for teaching each course topic.(2) All training program providers shall include in their application for accreditation the following:(A) a description of the facilities and equipment available for lecture and hands-on training;(B) a copy of the course test blueprint for each course;(C) a description of the activities and procedures that will be used for conducting the assessment of hands-on skills for each course;(D) a copy of the quality control plan as described in subsection (d)(9) of this section;(E) a statement certifying that copies of the approved documented methodologies listed in compliance with §295.203(a) of this title (relating to Approved Documented Methodologies) are on-site and available for review;(F) documentation that the training manager and principal instructor(s) meet the requirements of subsection (d) of this section; and(G) a specimen of the training certificate which will be given to students upon successful course completion and test passage.(3) The department shall approve or disapprove an application for accreditation no more than 90 days after receiving a complete application from a training program provider. Upon approval, a certificate of accreditation shall be sent to the applicant within 30 days. Prior to disapproval, the department may, at its discretion, work with training program providers to address inadequacies in the application for accreditation. If necessary to determine compliance with this subsection the department may also request additional materials retained by the training program provider under subsections (c) and (d) of this section. If a training program provider's application is disapproved, the program may reapply for accreditation at any time by following the procedures in subsections (b) and (c) of this section.(4) A training program provider may apply for accreditation to offer courses or refresher courses in as many training disciplines as it chooses. A training program provider may seek accreditation for additional courses at any time as long as the program can demonstrate that it meets the requirements and submits the additional fees cited in subsection (b) of this section.(d) Minimum requirements for the accreditation of training program providers. For a training program provider to obtain and maintain accreditation from the department to offer courses in lead-based paint activities, the program shall meet the following minimum requirements for each discipline for which the program is seeking accreditation.(1) The training program provider shall employ a training manager who has:(A) at least two years of experience, education, or training in teaching workers or adults; or(B) a bachelor's or graduate degree in building construction technology, engineering, industrial hygiene, safety, public health, education, or business administration or program management; or(C) two years of experience in managing an occupational health and safety training program specializing in environmental hazards; and(D) demonstrated experience, education, or training in the construction industry including lead or asbestos abatement, painting, carpentry, renovation, remodeling, occupational safety and health, or industrial hygiene.(2) The training program manager shall designate a qualified principal instructor for each course who has:(A) demonstrated experience, education, or training in teaching workers or adults;(B) successfully completed at least 16 hours of instruction from a trainer utilizing a lead-specific EPA model course curriculum; or at least 16 hours of lead-specific training from a department-accredited training provider; and(C) at least one year of experience in a lead discipline.(3) The principal instructor shall be responsible for the organization of the course and oversight of the teaching of all course material. The training program manager may designate guest instructors as needed to provide instruction specific to the lecture, hands-on activities, or work practice components of a course. One individual may be employed as both the training manager and principal instructor if the individual possesses the qualifications listed in paragraphs (1) and (2) of this subsection.(4) The following documents shall be recognized by the department as proof that training managers and principal instructors meet the relevant education, work experience, and/or training requirements specifically listed in paragraphs (1) and (2) of this subsection. This documentation must be submitted with the accreditation application and shall be retained and verified by the training program provider as required by the recordkeeping requirements contained at subsection (j) of this section. Those documents include the following:(A) official academic transcripts or diploma, as proof of meeting the education requirements;(B) resumes, letters of reference, or documentation of work experience, as records of meeting the work experience requirements; and(C) certificates from train-the-trainer courses and lead-specific training courses, as proof of meeting the training requirements.(5) The training program provider shall ensure the availability of and provide adequate facilities for the delivery of the lecture, course test, hands-on training, and assessment activities. This includes providing training equipment that reflects current work practices and maintaining or updating the equipment and facilities as needed.(6) To become accredited in the following disciplines, the training program provider shall provide training courses that meet the following training hour requirements:(A) The lead inspector course shall last a minimum of 24 training hours, with a minimum of eight hours devoted to hands-on training. The curriculum for the inspector course is contained in subsection (e)(1) of this section.(B) The lead risk assessor course shall last a minimum of 16 training hours. The curriculum for the risk assessor course is contained in subsection (e)(2) of this section, and must include at least four hours of hands-on training activities.(C) The lead abatement supervisor course shall last a minimum of 32 training hours, with a minimum of eight hours devoted to hands-on training activities. The curriculum for the supervisor course is contained in subsection (e)(3) of this section.(D) The lead abatement project designer course shall last a minimum of eight training hours. The curriculum for the project designer course is contained in subsection (e)(4) of this section.(E) The lead abatement worker course shall last a minimum of 16 training hours, with a minimum of eight hours devoted to hands-on training activities. The curriculum for the worker course is contained in subsection (e)(5) of this section.(7) For each course offered, the training program provider shall conduct a course test, and if applicable, a hands-on skills assessment at the completion of the course. Each individual must successfully complete the hands-on skills assessment and receive a passing score of 70% or above correct on the course test to pass any course.(A) The training manager is responsible for maintaining the validity and integrity of the hands-on skills assessment to ensure that it accurately evaluates the trainees' performance of the work practices and procedures associated with the course topics contained in subsection (e) of this section.(B) The training manager is responsible for maintaining the validity and integrity of the course test to ensure that it accurately evaluates the trainees' knowledge and retention of the course topics.(C) The course test shall be developed in accordance with the test blueprint submitted with the training accreditation application.(8) Training program providers shall issue unique course completion certificates approved by the department to each individual who passes the training course. The course completion certificate shall include:(A) the name and a unique identification number or social security number of the individual;(B) the name of the particular course that the individual completed;(C) the date of course completion or test passage date (no other dates shall be listed);(D) the name, address, and telephone number of the training program provider;(E) a signed statement by the training program manager or principal instructor that the course meets the requirements of §295.204 of this title (relating to Accreditation of Training Program Providers); and(F) the training program provider accreditation number.(9) The training manager shall develop and implement a quality control plan. The plan shall be used to maintain and improve the quality of the training program over time. This plan shall contain at least the following elements:(A) procedures for periodic revision of training materials and the course test to reflect innovations in the field; and(B) procedures for the training manager's annual review of instructor competency.(10) Training program providers must offer courses which teach the standards for conducting lead-based paint activities contained in §295.212 of this title (relating to Standards for Conducting Lead-Based Paint Activities), and other such standards developed by EPA and HUD. These standards shall be taught in the appropriate courses to provide trainees with the knowledge needed to perform the lead-based paint activities they are responsible for conducting.(11) The training manager shall be responsible for ensuring that the training program complies at all times with all of the requirements in subsection (e) of this section.(12) The training program manager shall allow the department to audit the training program at any reasonable time to verify the contents of the application for accreditation as described in subsection (c) of this section and to verify that the requirements of subsection (e) of this section are being met.(13) The training program manager shall furnish the department with a copy of all scheduled courses and shall notify the department at least 24 hours in advance of any course cancellations or changes. Course schedules shall be postmarked or faxed to the department at least seven working days prior to conducting any course on the schedule. In the event that a training course must be scheduled immediately due to an emergency, notification to the department must be made as soon as possible, but no less than 48 hours prior to commencement of the course. Written justification for not notifying the department seven working days in advance must be provided with the emergency training request.(14) The training program manager shall submit to the department a list of those individuals successfully completing a course including the name, social security number (optional) or other identifying information, and the date of course completion postmarked or faxed to the department within ten working days of the completion of the course.(e) Minimum training curriculum requirements. To become accredited to offer lead-based paint activities instruction in the specific disciplines listed in paragraphs (1) - (5) of this subsection, training program providers must ensure that their courses of study include the following course topics. Requirements beginning with an asterisk (*) indicate areas that require hands-on activities as an integral component of the course.(1) Lead inspector instruction:(A) role and responsibilities of the inspector;(B) background information on lead and its adverse health effects;(C) background information regarding federal, state, and local regulations and guidance that pertain to lead-based paint and lead-based paint activities including the Texas Environmental Lead Reduction Rules;(D) * lead-based paint inspection methods, including selection of rooms and components for sampling or testing;(E) * paint, dust, and soil sampling methodologies;(F) * clearance standards and testing, including random sampling;(G) * preparation of the written final inspection report; and(H) recordkeeping.(2) Lead risk assessor instruction:(A) role and responsibilities of the risk assessor;(B) collection of background information to perform a risk assessment;(C) sources of environmental lead contamination such as paint, surface dust and soil, water, air, packaging, and food;(D) * visual inspection for the purposes of identifying potential sources of lead-based paint hazards;(E) lead hazard screen protocol;(F) * sampling for other sources of lead exposure;(G) * interpretation of lead-based paint and other lead sampling results, including all applicable state and federal guidance or regulations pertaining to lead-based paint hazards;(H) development of hazard control options, the role of interim controls, and operations and maintenance activities to reduce lead-based paint hazards; and(I) preparation of a final risk assessment report.(3) Lead abatement supervisor instruction:(A) role and responsibilities of the supervisor;(B) background information on lead and its adverse health effects;(C) background information regarding federal, state, and local regulations and guidance that pertain to lead-based paint abatement including the Texas Environmental Lead Reduction Rules;(D) liability and insurance issues relating to lead-based paint abatement;(E) contract specifications and cost estimation;(F) community relations;(G) project management and supervisory techniques;(H) * risk assessment and inspection report interpretation;(I) development and implementation of an occupant protection plan and abatement report;(J) * lead-based paint hazard recognition and control;(K) * lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices;(L) * interior dust abatement/cleanup or lead-based paint hazard control and reduction methods;(M) * soil and exterior dust abatement or lead-based paint hazard control and reduction methods;(N) clearance standards and testing;(O) cleanup and waste disposal; and(P) recordkeeping.(4) Lead abatement project designer instruction:(A) role and responsibilities of the project designer;(B) contract specifications and cost estimation for abatement projects;(C) development and implementation of an occupant protection plan for abatement projects;(D) lead-based paint abatement and lead hazard reduction methods, including restricted practices for abatement projects;(E) interior dust abatement/cleanup or lead hazard control and reduction methods for abatement projects;(F) clearance standards and testing for abatement projects; and(G) integration of lead-based paint abatement methods with modernization and rehabilitation projects for abatement projects.(5) Lead abatement worker instruction:(A) role and responsibilities of the lead abatement worker;(B) background information regarding lead and its adverse health effects;(C) background information regarding federal, state, and local regulations and guidance that pertain to lead-based paint abatement including the Texas Environmental Lead Reduction Rules;(D) * lead-based paint hazard recognition and control;(E) * lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices;(F) * interior dust abatement methods/cleanup or lead-based paint hazard reduction; and(G) * soil and exterior dust abatement methods or lead-based paint hazard reduction.(f) Minimum requirements for the accreditation of refresher training program providers. A training program provider may apply for accreditation to teach as many different refresher training courses as it chooses. To teach an accredited refresher course, a training program provider must be accredited, or concurrently applying for accreditation, to provide instruction in the corresponding full course (e.g., lead-based paint inspector, abatement supervisor). To obtain department accreditation to offer refresher training, a training program provider must meet the following minimum requirements.(1) Each refresher course shall review the curriculum topics of the full-length courses listed under subsection (e) of this section, as appropriate. In addition, to become accredited to offer refresher training courses, training programs shall ensure that their courses of study include, at a minimum, the following:(A) an overview of current safety practices relating to lead-based paint activities in general as well as discipline-specific information;(B) current laws and regulations relating to lead-based paint activities in general as well as discipline-specific information; and(C) current technologies relating to lead-based paint activities in general as well as discipline-specific information.(2) Each refresher course, except for the project designer course, shall last a minimum of eight training hours and shall include a hands-on skills assessment if required in the original course. The project designer refresher course shall last a minimum of four training hours and does not require a hands-on skills assessment.(3) Each student shall be required to pass a course test that covers all of the topics contained in the course. Passing students shall be provided with a refresher course completion certificate.(4) A training program provider seeking refresher course accreditation shall submit to the department a written application containing the following:(A) the training program provider's name, address, and telephone number;(B) a list of the refresher courses for which it is applying for accreditation;(C) a copy of the table of contents and course-identifying cover sheet of the student and instructor manuals for each course;(D) a statement signed by the training program manager certifying that the program complies at all times with all requirements of subsection (f) of this section; and(E) the course test blueprint for each refresher course.(5) If a training program provider applies for accreditation of a refresher course concurrently with its application for accreditation of the corresponding training course, the department shall use the approval procedure described in subsection (c) of this section.(6) If an application for refresher training accreditation is received apart from an application for accreditation as described in subsection (c) of this section, the department shall approve or disapprove a request for refresher training accreditation within 90 days of receiving a complete application. Upon approval, a certificate of refresher training accreditation shall be sent to the applicant within 30 days. In the case of disapproval, a letter describing the reasons for disapproval shall be sent to the applicant. The department may, at its discretion, work with training program providers to address inadequacies in the application for refresher accreditation. If a training program provider's application is disapproved, the training program provider may reapply at any time after the reason for disapproval has been corrected.(g) Re-accreditation of training programs.(1) A training program provider's accreditation that was issued prior to January 1, 2005, shall expire three years after the date of issuance. A training program provider's accreditation that was issued on or after January 1, 2005, shall expire two years after the date of issuance. If a training program meets the requirements of this section, the training program provider shall be re-accredited.(2) A training program provider seeking re-accreditation shall submit an application to the department no later than 30 days before its accreditation expires. At least 60 days before the date an accreditation expires, the department, as a service to the accredited trainer, shall send a reminder notice to the accredited trainer, by first class mail to the last known address of the accredited trainer. Failure of the department to send the reminder notice creates no liability to the department and does not relieve the accredited trainer from paying the accreditation renewal fee in a timely manner. Training accreditations which have expired may be renewed under the following conditions:(A) a training program whose accreditation has been expired for 90 days or less may renew the accreditation by paying to the department a renewal fee that is equal to 1-1/2 times the normally required fee;(B) a training program whose accreditation has been expired for more than 90 days but less than one year may renew the accreditation by paying to the department a renewal fee that is equal to two times the normally required renewal fee; and(C) a training program whose accreditation has been expired for one year or more may not renew the accreditation by paying a renewal fee only. To become re-accredited the training program must comply with the current requirements placed on a new applicant.(3) The training program provider's application for re-accreditation shall contain:(A) the training program provider's name, address, and telephone number;(B) a list of courses for which it is applying for re-accreditation;(C) a description of any changes or updates to the training facility or equipment since its last application was approved; and(D) a certified statement signed by the program manager stating:(i) the training program provider will at all times comply with all requirements in subsections (d) and (f) of this section; and(ii) the recordkeeping and reporting requirements of subsection (j) of this section will be followed.(4) The department may audit the training program provider at any reasonable time to verify the contents of the application for re-accreditation as described in paragraph (3) of this subsection.(h) Suspension, deaccreditation, and modification of accredited training programs.(1) The department may, after notice and an opportunity for hearing, suspend, deaccredit, or modify a training program provider's accreditation if a training program, training manager, or other person with supervisory authority over the training program has:(A) misrepresented the contents of a training course to the department and/or the student population;(B) failed to submit required information or notifications in a timely manner;(C) failed to maintain required records;(D) falsified accreditation records, instructor qualifications, or other accreditation information;(E) failed to comply with the training standards and requirements in this section;(F) failed to comply with federal, state, or local lead-based paint statutes or regulations;(G) made false or misleading statements to the department in its application for accreditation or re-accreditation which the department relied upon in approving the application; or(H) failed to pay the annual fee.(2) In addition to an administrative or judicial finding of violation, execution of a consent agreement in settlement of an enforcement action constitutes, for purposes of this subsection, evidence of a failure to comply with relevant statutes or regulations.(i) Procedures for suspension, deaccreditation or modification of training program accreditation.(1) When the department decides to suspend, deaccredit, or modify the accreditation of a training program, it shall notify the affected entity in writing of the following:(A) the assertion of laws and facts upon which the suspension, deaccreditation, or modification is based;(B) the commencement date and duration of the suspension, deaccreditation, or modification;(C) actions, if any, which the affected entity may take to avoid suspension, deaccreditation, or modification, or to receive accreditation in the future;(D) the opportunity and method for requesting a hearing prior to final departmental action to deaccredit, suspend, or modify accreditation; and(E) any additional information, as appropriate, which the department may provide.(2) If a hearing is requested by the accredited training program pursuant to subsection (h)(1) of this section, the person charged shall be given the opportunity for a hearing conducted in accordance with the department's Fair Hearing Procedures found at 25 TAC, §§1.51 - 1.55.(j) Training program recordkeeping requirements.(1) Accredited training program providers shall maintain and make available to the department, upon request, the following records:(A) all documents specified in subsection (d)(4) of this section that demonstrate the qualifications listed in subsection (d)(1) - (3) of this section of the training manager and principal instructors;(B) current curriculum/course materials and documents reflecting any changes made to these materials;(C) the course test blueprint;(D) information on how the hands-on assessment is conducted including, but not limited to, who conducts the assessment, how the skills are graded, what facilities are used, types of equipment used, and the pass/fail rate;(E) the quality control plan as described in subsection (d)(9) of this section;(F) results of each student's hands-on skills assessments and course tests, and a record of each student's course completion certificate and test passage date; and(G) any other material not listed in subparagraphs (A) - (F) of this paragraph that was submitted to the department as part of the program's application for accreditation.(2) The training program shall retain the records required by paragraph (1) of this subsection at the location (i.e., address) specified on the training program accreditation application (or as modified in accordance with paragraph (3) of this subsection) for a minimum of three years and six months.(3) The training program shall notify the department in writing within 30 days of relocating its business or transferring the records. Source Note: The provisions of this §295.204 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.204 Accreditation of Training Program Providers https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118567&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118567 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118567&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118567 03/11/2026 (a) General requirements. Applications for initial or renewal certification under these sections must be made on the appropriate forms provided by the Texas Department of Health (department). The application shall be signed by the applicant and must be accompanied by a check or money order, made payable to the Texas Department of Health, for the amount of the initial or renewal certification fee. Only applications that are complete shall be considered by the department; the duty to meet all requirements for certification rests with the applicant. For specific requirements for the various certification disciplines, refer to the sections applicable to that discipline relating to certification requirements.(b) Inquiries. Potential applicants who wish to discuss or obtain information concerning qualification requirements may do so by calling the department's Environmental Lead Program at (512) 834-6612 or (888) 778-9440 (toll-free in Texas). The applicant may also visit the program's website at http://www.tdh.state.tx.us/beh/lead to obtain information and to download forms.(c) Denials. The department may deny an application for initial or renewal certification if the applicant fails to meet the standards established by these sections. If a time period is specified, applicants may not reapply for that period.(1) past history of assessed penalties from violations of these sections by the applicant and/or the applicant's employees or agents--three years;(2) evidence that the applicant cannot be legally employed in the United States;(3) fraud, misrepresentation, or deception in obtaining, attempting to obtain, or renewing a certificate--three years;(4) failure to submit the required appropriate documentation within 60 days of a written request by the department for consideration toward granting certification;(5) failure to submit the required fee for initial certification or when renewing a certification, including any additionally required late fees within 60 days of a written request;(6) failure to maintain or to permit inspection of the records required of all certified persons--one year;(7) employing or permitting an unauthorized person or individual to work on any lead project or operation--one year;(8) engaging in or attempting to engage in a lead-related activity without a valid certification--three years;(9) failure to comply with any rule adopted by the board or order issued by the department--one year;(10) failure to meet the terms of reciprocity as described in §295.215(a) of this title (relating to Reciprocity);(11) conviction within the past five years of a felony or a misdemeanor related to conditions for which a person engaged in lead activities--three years;(12) failure of a certified person to complete their responsibilities during a lead project or operation due to insufficient financial resources--three years;(13) failure to prevent lead contamination of areas adjacent to the abatement area--three years;(14) failure to pass the state certification examination with a score of at least 70% correct in no more than three attempts within six months of completing the appropriate training course(s);(15) engaging in cheating practices on any state certification examination--three years;(16) failure to provide a certification application with an original signature of the applicant (not photocopied, facsimiled, or electronically reproduced);(17) failure to successfully complete the required appropriate training course(s) from a department-accredited training program provider for consideration toward granting certification;(18) failure to successfully complete the required appropriate refresher training course(s) from a department-accredited training program provider for consideration toward granting renewal certification;(19) failure to successfully complete the required appropriate refresher training course(s) from a department-accredited training program provider no sooner than 180 days prior to the certification's expiration date or within one year beyond the certification expiration date;(20) failure to submit a complete renewal certification application within one year beyond the three-year certification expiration date of the previous certification;(21) failure to submit a complete initial certification application within six months after passing the state certification examination with a score of at least 70% correct;(22) failure to submit a complete initial certification application, including documentation of any additionally required refresher training course(s), within one year after completing the additionally required refresher training course, and within three years of passing the state certification examination with a score of at least 70% correct; or(23) failure to submit a complete initial certification application, including documentation of any additionally required refresher training course(s), within one year after completing the additionally required refresher training course(s), and within three years of completing the original training course.(d) Administrative penalty. In accordance with §295.220 of this title (relating to Compliance: Administrative Penalty) an administrative penalty may be assessed, for fraud or misrepresentation in obtaining, attempting to obtain, or renewing a certification.(e) Appeal of certification denial. A denial of an initial or renewal certification application may be appealed by the applicant. The hearing will be conducted as outlined in subsection (f)(5) of this section. The details for requesting a hearing will be included in each letter of denial.(f) Processing initial or renewal certification applications.(1) Time periods. Applications for initial or renewal certification will be processed within 60 days of receipt by issuing a certification or by providing a written notice to the applicant outlining the reasons why the application is deficient. In cases of a deficient application, the certification will be issued within 60 days of the applicant meeting all the certification requirements including receipt of all acceptable documents at the department.(2) Reimbursement of fees. Initial or renewal certification application fees will be refunded only when the department does not process a completed application in the time period specified, or an applicant is not able to meet the certification requirements. If fee amounts paid to the department are in excess of the correct fee amount, the excess payment will be reimbursed. Reimbursement of fees paid for a certification application not meeting the requirements will be made, minus a $25 administrative fee.(3) Denial of an initial or renewal certification application due to abandonment of the application does not constitute grounds for reimbursement. Abandonment is defined as failure to respond to a written request of the department by the applicant for a period of 90 days.(4) Appeal of reimbursement denial. If a request for reimbursement authorized by this subsection is denied, the applicant may then appeal to the commissioner of health for a resolution of the dispute. The applicant shall give written notice to the commissioner by writing to the chief, Environmental Lead Branch, the designated representative of the commissioner, requesting reimbursement of all filing fees paid because his/her initial or renewal certification application was not processed within the prescribed time period or the applicant can prove that he/she did respond to a written request of the department within 90 days of that request. The branch chief shall submit a written report of the facts related to the processing of the application and good cause for exceeding the established time periods or evidence that the application was abandoned. The commissioner will determine the final action and provide written notification of his/her decision to the applicant and the branch chief.(5) Contested case hearing. If at any time during the processing of the initial or renewal certification application, a contested case proceeding arises, the applicant may request a hearing in accordance with the department's Fair Hearing Procedures found at 25 TAC, §§1.51 - 1.55.(g) Reminder notices. Not later than the 60th day before the date a person's or firm's certification is scheduled to expire, the department, as a service to the certified person or firm, shall send written notice of the impending expiration to the person or firm at the person's or firm's last known address according to the records of the department. For those individuals or firms issued a three-year certification prior to January 1, 2005, at least 60 days before the end of years one and two of the three-year certification period, the department, as a service to the certified person or firm, shall send a reminder notice of the impending due-date of their annual fee, including an annual fee payment coupon, to the certified person's or firm's last known address according to the records of the department. It is the responsibility of the certified person or firm to keep the department informed of their current address, or change of address for all certification categories, and to take action to keep their certification current or renew their certification whether or not they have received the notification from the department. Failure by the department to send the timely notice, including any annual fee payment coupon, creates no liability to the department and does not relieve the applicant of the obligation to file a timely renewal application or making a timely annual fee payment. The reminder notice will state:(1) the type of certification requiring payment of the annual fee or certification renewal fee;(2) the time period allowed for payment of the annual fee or certification renewal fee; and(3) the amount of the annual fee or certification renewal fee.(h) Certification renewal requirements.(1) A certification may be renewed for an additional two-year term provided that the person:(A) is qualified to be certified;(B) pays to the department the proper certification renewal fee;(C) submits to the department a complete certification renewal application on the prescribed form along with all required documentation;(D) successfully completes the requirements for certification renewal;(E) has complied with all final orders resulting from any violations of these sections; and(F) submits a copy of the refresher training course certificate(s), if required.(2) Expired certifications. A person whose certification has been expired for:(A) 90 days or less may renew the certification by paying to the department a renewal fee that is equal to 1-1/2 times the normally required renewal fee;(B) more than 90 days but less than one year may renew the certification by paying to the department a renewal fee that is two times the normally required renewal fee;(C) one year or more may not renew their certification. The person may become re-certified by complying with the current requirements and procedures, including any examination requirements, for an original certification.(3) Renewal by out-of-state practitioner. A person who was certified in this state, moved to another state, and is currently certified and has been in practice in the other state for the two years preceding the date of application, may obtain a new certification without any applicable reexamination. The person must pay to the department a fee that is equal to two times the normally required renewal fee for the certification.(i) Prohibition. Practicing with an expired certification is prohibited. If a certification holder makes a timely and sufficient application for the renewal of the certification by the expiration date, the current certification in his/her possession does not expire until the application has been finally approved or denied by the department. Certifications which have been expired for a period of one year or more beyond the expiration date cannot be renewed. The person or firm whose certification has been expired for one year or more may become re-certified by complying with the current requirements and procedures, including any examination requirements, for an original certification.(j) Replacements. A certified person or firm may obtain a replacement certificate and/or identification (ID) card by submitting such request in writing on a department-issued form along with the reissuance fee of $20 for each official document requested.(k) Retention of control. The department may, at any time after the filing of any application and before the expiration of any certification, require:(1) additional written information and assurances; and(2) cooperation with any inspections initiated by the department, or the production of any documentary or other evidence that the department considers necessary to determine whether the certification should be granted, delayed, denied, modified, suspended or revoked.(l) Change of name, address, telephone number, business name, organization affiliation, and/or firm's owner or authorized agent. The Texas Department of Health (department) must be notified in writing by the certified person or firm of these changes from that person's or firm's original application for certification on file at the department no later than 60 days after that change. Failure to maintain current information on file with the department may result in the suspension of the certification.(m) TexasOnline. The department is authorized to collect subscription and convenience fees, in amounts determined by the TexasOnline Authority, to recover costs associated with processing certification applications, examination registrations, and replacement applications through TexasOnline, in accordance with the Texas Government Code, §2054.111 (relating to Use of TexasOnline Project). Source Note: The provisions of this §295.205 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.205 Certification: Applications, Denials, and Renewals https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118568&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118568 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118568&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118568 03/11/2026 (a) Certification requirements. A person must be certified by the department as a lead inspector to engage in lead inspection of target housing and child-occupied facilities. Certifications issued by the department prior to January 1, 2005, are valid for a period of three years from the date of issue, provided that the appropriate fee is paid on time each year. Certifications issued by the department on or after January 1, 2005, are valid for a period of two years from the date of issue.(b) Specific requirements of applicants for certification as lead inspectors:(1) successfully complete a lead inspector training course and receive a course completion certificate from a department-accredited training program provider;(2) pass the state certification examination for lead inspectors; and(3) submit a complete application for lead inspector certification to the department on a department-issued form and pay the appropriate certification fee within six months of passing the state certification examination.(c) State certification examination.(1) In order to take the certification examination for lead inspectors, an individual must first successfully complete a lead inspector course and receive a course completion certificate from a department-accredited training provider.(2) The individual shall then register for the examination on a department-issued form prior to taking the examination, provide a copy of the lead inspector course completion certificate with the registration form, and receive confirmation from the department that the individual is registered for that particular examination and examination date prior to taking the examination.(3) A score of at least 70% correct must be achieved to pass the examination.(4) An individual must achieve a passing score on the certification examination in no more than three attempts within six months of completing the appropriate course.(5) If an individual does not pass the certification examination within six months of receiving a course completion certificate, the individual must retake the original lead inspector course from a department-accredited training provider and receive a course completion certificate prior to retaking the certification examination.(6) An examination fee of $50 for each examination attempt shall be submitted to the department with the department-issued examination registration form. The required fee must be in the form of a check or money order made payable to the Texas Department of Health. The required fee must be received by the department prior to taking the examination. If the required fee is not received by the department prior to taking the examination, the examination results will not be released and become official until payment is received.(7) Not later than the 30th day after the date a person takes a certification examination, the department shall notify the person of the results of the examination.(8) A person who fails the examination shall be allowed an opportunity immediately following their notification of the results to analyze their performance on the examination. Further analysis of the examination results may be provided by the department upon written request by the examinee.(9) A complete lead inspector certification application must be received by the department within six months of passing the lead inspector state examination in order for the examination results to be eligible for consideration toward granting certification.(A) A person who fails to submit a complete certification application within 6 months of passing the lead inspector state examination, will be required to additionally complete a lead inspector refresher training course from a department-accredited training program provider and receive a course completion certificate. The individual must then submit a complete certification application, including a course completion certificate of the additionally required lead inspector refresher training course, within six months of completing this refresher course.(B) If the applicant has not submitted a complete lead inspector certification application within three years of passing the state lead inspector examination, including documentation of any additionally required refresher training course, the person will again be subject to the certification requirements of subsection (b) of this section in order to be granted certification.(d) Responsibilities. The certified lead inspector shall be responsible for the following:(1) conduct soil and dust abatement clearance sampling following procedures in §295.212 of this title (relating to Standards for Conducting Lead-Based Paint Activities);(2) conduct lead-based paint inspections of target housing and child-occupied facilities that measure the concentration of lead in paint on a surface-by-surface basis; and(3) complete a written inspection report as described in §295.212(a)(4) of this title (relating to Standards for Conducting Lead-Based Paint Activities).(e) Application for certification renewal. To become re-certified, the certified inspector must successfully complete an inspector refresher training course from a department-accredited training program provider no sooner than 180 days prior to the inspector's certification expiration date and follow the procedures contained in §295.205 of this title (relating to Certification: Applications, Denials, and Renewals).(1) If a certification holder makes a timely and sufficient application for the renewal of the certification by their current certification's expiration date, the current certification in his/her possession does not expire until the application has been finally approved or denied by the department. The person whose certification has been expired for less than one year may renew their certification by complying with the requirements of §295.205(h) of this title. Certifications that have been expired for a period of one year or more beyond the expiration date cannot be renewed. The person whose certification has been expired for a period of one year or more may become re-certified by complying with the current requirements and procedures, including any examination requirements, for an original certification, subject to the certification requirements of subsection (b) of this section.(2) To maintain certification, the certified lead inspector must seek re-certification by submitting a complete certification renewal application to the department no later than 30 days before the certification expires. If the certified lead inspector does not submit an application for re-certification by that date, the application will not be deemed timely filed and the department cannot guarantee that the application will be reviewed and acted upon before the end of the lead inspector's certification period.(f) Fees.(1) Two-year certifications. Effective January 1, 2005, the fee for a two-year lead inspector certification shall be $300. The fee must accompany the initial or renewal certification application.(2) Three-year certifications. Three-year certifications, which were issued prior to January 1, 2005, shall remain valid for the remainder of their three-year term provided that the annual fee of $150 is paid on time to the department. Upon expiration of this three-year certification, a fee of $300 for a two-year renewal certification shall be paid upon submission of a complete application. Persons who possess a three-year certification that was issued prior to January 1, 2005, must submit an annual fee when due accompanied by a payment coupon issued by the department. In order to retain a three-year certification for the remainder of its term, all annual fees must be paid on time as required. Upon payment of each annual fee, a new photo identification (ID) card will be issued and shall be valid for the time period for which the annual fee was paid. Failure to make a timely annual fee payment may result in the suspension of the certification. Source Note: The provisions of this §295.206 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.206 Lead Inspector: Certification Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118569&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118569 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118569&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118569 03/11/2026 (a) Certification requirements. A person must be certified by the department as a lead risk assessor to engage in lead risk assessment or lead hazard screens of target housing and child-occupied facilities. Certifications issued by the department prior to January 1, 2005, are valid for a period of three years from the date of issue, provided that the appropriate fee is paid on time each year. Certifications issued by the department on or after January 1, 2005, are valid for a period of two years from the date of issue.(b) Specific requirements of applicants for certification as lead risk assessors:(1) successfully complete a lead inspector and a lead risk assessor training course, and receive course completion certificates from a department-accredited training program provider;(2) pass the state certification examination for lead risk assessors; and(3) meet or exceed the following additional education and/or experience requirements:(A) a bachelor's degree and one year of experience in a related field (e.g. lead, asbestos, public health, environmental remediation work, or building construction trades); or(B) an associate's degree and two years of experience in a related field (e.g. lead, asbestos, public health, environmental remediation work, or building construction trades); or(C) a high school diploma (or equivalent), plus at least three years of experience in a related field (e.g. lead, asbestos, public health, environmental remediation work, or building construction trades); or(D) certification as an industrial hygienist, a professional engineer, a public health nurse, a professional registered sanitarian, a certified safety professional, a registered architect, or an environmental scientist.(4) submit a complete application for lead risk assessor certification to the department on a department-issued form and pay the appropriate certification fee within six months of passing the state certification examination.(c) State certification examination.(1) In order to take the certification examination for risk assessors, an individual must first successfully complete lead inspector and lead risk assessor courses and receive course completion certificates from a department-accredited training provider and meet or exceed the education and experience requirements in subsection (b)(3) of this section.(2) The individual shall then register for the examination on a department-issued form prior to taking the examination, provide copies of the lead inspector and lead risk assessor course completion certificates with the registration form, and receive confirmation from the department that the individual is registered for that particular examination and examination date prior to taking the examination.(3) A score of at least 70% correct must be achieved to pass the examination.(4) An individual must achieve a passing score on the certification examination in no more than three attempts within six months of completing the appropriate courses.(5) If an individual does not pass the certification examination within six months of receiving course completion certificates, the individual must retake the original lead inspector and lead risk assessor courses from a department-accredited training provider and receive course completion certificates prior to retaking the certification examination.(6) An examination fee of $50 for each examination attempt shall be submitted to the department with the department-issued examination registration form. The required fee must be in the form of a check or money order made payable to the Texas Department of Health. The required fee must be received by the department prior to taking the examination. If the required fee is not received by the department prior to taking the examination, the examination results will not be released and become official until payment is received.(7) Not later than the 30th day after the date a person takes a certification examination, the department shall notify the person of the results of the examination.(8) A person who fails the examination shall be allowed an opportunity immediately following their notification of the results to analyze their performance on the examination. Further analysis of the examination results may be provided by the department upon written request by the examinee.(9) A complete lead risk assessor certification application must be received by the department within six months of passing the lead risk assessor state examination in order for the examination results to be eligible for consideration toward granting certification.(A) A person who fails to submit a complete certification application within 6 months of passing the lead risk assessor state examination, will be required to additionally complete lead inspector and lead risk assessor refresher training courses from a department-accredited training program provider and receive course completion certificates. The individual must then submit a complete certification application, including course completion certificates of the additionally required lead inspector and lead risk assessor refresher training courses, within six months of completing these refresher courses.(B) If the applicant has not submitted a complete lead risk assessor certification application within three years of passing the state lead risk assessor examination, including documentation of any additionally required refresher training courses, the person will again be subject to the certification requirements of subsection (b) of this section in order to be granted certification.(d) Responsibilities. The certified lead risk assessor shall be responsible for the following:(1) conduct a risk assessment and other lead hazard assessment activities (such as screening a residence for lead hazard) in target housing and child-occupied facilities;(2) complete a written risk assessment report as described in §295.212(c)(11) of this title (relating to Standards for Conducting Lead-Based Paint Activities);(3) interpret the results of assessments;(4) identify hazard control strategies to reduce or eliminate lead exposures;(5) conduct post-abatement soil and dust clearance sampling and evaluate the results; and(6) perform the same duties of a certified lead inspector as specified in §295.206(d) of this title (relating to Lead Inspector: Certification Requirements).(e) Application for certification renewal. To become re-certified, the certified risk assessor must successfully complete lead inspector and lead risk assessor refresher training courses from a department-accredited training program provider no sooner than 180 days prior to the risk assessor's certification expiration date and follow the procedures contained in §295.205 of this title (relating to Certification: Applications, Denials, and Renewals).(1) If a certification holder makes a timely and sufficient application for the renewal of the certification by their current certification's expiration date, the current certification in his/her possession does not expire until the application has been finally approved or denied by the department. The person whose certification has been expired for less than one year may renew their certification by complying with the requirements of §295.205(h) of this title. Certifications that have been expired for a period of one year or more beyond the three-year expiration date cannot be renewed. The person whose certification has been expired for a period of one year or more may become re-certified by complying with the current requirements and procedures, including any examination requirements, for an original certification, subject to the certification requirements of subsection (b) of this section.(2) To maintain certification, the certified lead risk assessor must seek re-certification by submitting a complete certification renewal application to the department no later than 30 days before the certification expires. If the certified lead risk assessor does not submit an application for re-certification by that date, the application will not be deemed timely filed and the department cannot guarantee that the application will be reviewed and acted upon before the end of the lead risk assessor's certification period.(f) Fees.(1) Two-year certifications. Effective January 1, 2005, the fee for a two-year lead risk assessor certification shall be $600. The fee must accompany the initial or renewal certification application.(2) Three-year certifications. Three-year certifications, which were issued prior to January 1, 2005, shall remain valid for the remainder of their three-year term provided that the annual fee of $300 is paid on time to the department. Upon expiration of this three-year certification, a fee of $600 for a two-year renewal certification shall be paid upon submission of a complete application. Persons who possess a three-year certification that was issued prior to January 1, 2005, must submit an annual fee when due accompanied by a payment coupon issued by the department. In order to retain a three-year certification for the remainder of its term, all annual fees must be paid on time as required. Upon payment of each annual fee, a new photo identification (ID) card will be issued and shall be valid for the time period for which the annual fee was paid. Failure to make a timely annual fee payment may result in the suspension of the certification. Source Note: The provisions of this §295.207 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.207 Lead Risk Assessor: Certification Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118570 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118570 03/11/2026 (a) Certification requirements. A person must be certified by the department as a lead abatement supervisor to engage in such activity in target housing and child-occupied facilities. Certifications issued by the department prior to January 1, 2005, are valid for a period of three years from the date of issue, provided that the appropriate fee is paid on time each year. Certifications issued by the department on or after January 1, 2005, are valid for a period of two years from the date of issue.(b) Specific requirements of applicants for certification as lead abatement supervisors:(1) successfully complete a lead abatement supervisor training course and receive a course completion certificate from a department-accredited training program provider;(2) pass the state certification examination for lead abatement supervisors;(3) meet or exceed the following additional experience requirements:(A) one year of experience as a certified lead abatement worker; or(B) at least two years experience in a related field (e.g. lead, asbestos, or environmental remediation work), or in the building construction trades; and(4) submit a complete application for lead abatement supervisor certification to the department on a department-issued form and pay the appropriate certification fee within six months of passing the state certification examination.(c) State certification examination.(1) In order to take the certification examination for lead abatement supervisors, an individual must first successfully complete a lead abatement supervisor course and receive a course completion certificate from a department-accredited training provider and meet or exceed the experience requirement of subsection (b)(3) of this section.(2) The individual shall then register for the examination on a department-issued form prior to taking the examination, provide a copy of the lead abatement supervisor course completion certificate with the registration form, and receive confirmation from the department that the individual is registered for that particular examination and examination date prior to taking the examination.(3) A score of at least 70% correct must be achieved to pass the examination.(4) An individual must achieve a passing score on the certification examination in no more than three attempts within six months of completing the appropriate course.(5) If an individual does not pass the certification examination within six months of receiving a course completion certificate, the individual must retake the original lead abatement supervisor course from a department-accredited training provider and receive a course completion certificate prior to taking the certification examination.(6) An examination fee of $50 for each examination attempt shall be submitted to the department with the department-issued examination registration form. The required fee must be in the form of a check or money order made payable to the Texas Department of Health. The required fee must be received by the department prior to taking the examination. If the required fee is not received by the department prior to taking the examination, the examination results will not be released and become official until payment is received.(7) Not later than the 30th day after the date a person takes a certification examination, the department shall notify the person of the results of the examination.(8) A person who fails the examination shall be allowed an opportunity immediately following their notification of the results to analyze their performance on the examination. Further analysis of the examination results may be provided by the department upon written request by the examinee.(9) A complete lead abatement supervisor certification application must be received by the department within six months of passing the lead inspector state examination in order for the examination results to be eligible for consideration toward granting certification.(A) A person who fails to submit a complete certification application within six months of passing the lead abatement supervisor state examination, will be required to additionally complete a lead abatement supervisor refresher training course from a department-accredited training program provider and receive a course completion certificate. The individual must then submit a complete certification application, including a course completion certificate of the additionally required lead abatement supervisor refresher training course, within six months of completing this refresher course.(B) If the applicant has not submitted a complete lead abatement supervisor certification application within three years of passing the state lead abatement supervisor examination, including documentation of any additionally required refresher training course, the person will again be subject to the certification requirements of subsection (b) of this section in order to be granted certification.(d) Responsibilities. The certified lead abatement supervisor shall be responsible for the following:(1) identify the most appropriate course(s) of action to eliminate identified lead hazards;(2) ensure that all abatement activities in target housing and child-occupied facilities are completed according to the standards outlined in §295.212 of this title (relating to Standards for Conducting Lead-Based Paint Activities);(3) supply personal protection equipment to employees, train employees who perform lead-related activities in the use of equipment, and supervise their compliance;(4) ensure that abatement activities are conducted in accordance with regulatory requirements;(5) prepare a written abatement report as described in §295.212(d)(11) of this title;(6) develop an occupant protection plan as described in §295.212(d)(5) of this title;(7) be available at all times as described in §295.212(d)(2) of this title when abatement activities are being conducted;(8) ensure completion of all abatement activities according to these sections;(9) assume the duties of lead abatement workers or perform activities affecting lead materials;(10) cooperate with department personnel in the discharge of their official duties to conduct inspections and investigations, as described in §295.218 of this title (relating to Compliance: Inspections and Investigations);(11) maintain standards of operation, including Environmental Protection Agency (EPA) and Occupational Safety and Health Administration of the United States Department of Labor (OSHA) regulations; and(12) ensure that each lead abatement worker under their supervision has a department-issued certification identification (ID) card and one form of government-issued photo ID at the worksite.(e) Application for certification renewal. To become re-certified, the certified lead abatement supervisor must successfully complete a lead abatement supervisor refresher training course from a department-accredited training provider no sooner than 180 days prior to the supervisor's certification expiration date and follow the procedures contained in §295.205 of this title.(1) If a certification holder makes a timely and sufficient application for the renewal of the certification by their current certification's expiration date, the current certification in his/her possession does not expire until the application has been finally approved or denied by the department. The person whose certification has been expired for less than one year may renew their certification by complying with the requirements of §295.205(h) of this title. Certifications that have been expired for a period of one year or more beyond the three-year expiration date cannot be renewed. The person whose certification has been expired for a period of one year or more may become re-certified by complying with the current requirements and procedures, including any examination requirements, for an original certification, subject to the certification requirements of subsection (b) of this section.(2) To maintain certification, the certified lead abatement supervisor must seek re-certification by submitting a complete certification renewal application to the department no later than 30 days before the certification expires. If the certified lead abatement supervisor does not submit an application for re-certification by that date, the application will not be deemed timely filed and the department cannot guarantee that the application will be reviewed and acted upon before the end of the lead abatement supervisor's certification period.(f) Fees.(1) Two-year certifications. Effective January 1, 2005, the fee for a two-year lead abatement supervisor certification shall be $300. The fee must accompany the initial or renewal certification application.(2) Three-year certifications. Three-year certifications, which were issued prior to January 1, 2005, shall remain valid for the remainder of their three-year term provided that the annual fee of $150 is paid on time to the department. Upon expiration of this three-year certification, a fee of $300 for a two-year renewal certification shall be paid upon submission of a complete application. Persons who possess a three-year certification that was issued prior to January 1, 2005, must submit an annual fee when due accompanied by a payment coupon issued by the department. In order to retain a three-year certification for the remainder of its term, all annual fees must be paid on time as required. Upon payment of each annual fee, a new photo identification (ID) card will be issued and shall be valid for the time period for which the annual fee was paid. Failure to make a timely annual fee payment may result in the suspension of the certification. Source Note: The provisions of this §295.208 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280 ; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.208 Lead Abatement Supervisor: Certification Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118571&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118571 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118571&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118571 03/11/2026 (a) Certification requirements. A person must be certified by the department as a lead abatement project designer to engage in such activity in target housing and child-occupied facilities. Certifications issued by the department prior to January 1, 2005, are valid for a period of three years from the date of issue, provided that the appropriate fee is paid on time each year. Certifications issued by the department on or after January 1, 2005, are valid for a period of two years from the date of issue.(b) Specific requirements of applicants for certification as lead abatement project designers:(1) successfully complete a lead abatement supervisor training course, unless currently certified as a lead abatement supervisor in Texas, and receive a course completion certificate from a department-accredited training program provider;(2) successfully complete a lead abatement project designer training course and receive a course completion certificate from a department-accredited training program provider; and(3) meet or exceed the following additional education and/or experience requirements:(A) a bachelor's degree in engineering, architecture, or a related profession, and one year of experience in building construction and design or a related field; or(B) four years of experience in building construction and design or a related field.(4) submit a complete application for lead abatement project designer certification to the department on a department-issued form and pay the appropriate certification fee within one year of successfully completing the original lead abatement supervisor and lead abatement project designer training courses.(A) A person who fails to submit a complete lead abatement project designer certification application within one year of completing the required courses will be required to additionally complete lead abatement supervisor and lead abatement project designer refresher training courses from a department-accredited training program provider and receive course completion certificates. The individual must then submit a complete certification application, including course completion certificates of the additionally required lead abatement supervisor and lead abatement project designer refresher training courses, within one year of completing these refresher courses.(B) If the applicant has not submitted a complete lead abatement project designer certification application within three years of completing the original lead abatement supervisor and lead abatement project designer training courses, including documentation of any additionally required refresher training courses as per subsection (b)(4)(A) of this section, the person will again be subject to the certification requirements of subsection (b) of this section in order to be granted certification.(c) Responsibilities. The certified lead abatement project designer shall be responsible for the following:(1) comply with standards of operation, including EPA and OSHA regulations;(2) prepare a written abatement project design(s);(3) develop a written occupant protection plan as described in §295.212(d)(5) of this title;(4) prepare a written abatement report as described in §295.212(d)(11) of this title; and(5) cooperate with department personnel in the discharge of their official duties to conduct inspections and investigations, as described in §295.218 of this title (relating to Compliance: Inspections and Investigations).(d) Application for certification renewal. To become re-certified, the certified lead abatement project designer must successfully complete lead abatement supervisor and lead abatement project designer refresher training courses from a department-accredited training provider no sooner than 180 days prior to the project designer's certification expiration date and follow the procedures contained in §295.205 of this title (relating to Certification: Applications, Denials, and Renewals).(1) If the certified lead abatement project designer currently possesses department-certification as a lead abatement supervisor, the 180-day limitation does not apply to taking the lead abatement supervisor refresher course. However, the 180-day limitation must still be met for renewing a lead abatement supervisor certification as required in §295.208(e) of this title (relating to Lead Abatement Supervisor: Certification Requirements).(2) If a certification holder makes a timely and sufficient application for the renewal of the certification by their current certification's expiration date, the current certification in his/her possession does not expire until the application has been finally approved or denied by the department. The person whose certification has been expired for less than one year may renew their certification by complying with the requirements of §295.205(h) of this title. Certifications that have been expired for a period of one year or more beyond the three-year expiration date cannot be renewed. The person whose certification has been expired for a period of one year or more may become re-certified by complying with the current requirements and procedures, including any examination requirements, for an original certification, subject to the certification requirements of subsection (b) of this section.(3) To maintain certification, the certified lead abatement project designer must seek re-certification by submitting a complete certification renewal application to the department no later than 30 days before the certification expires. If the certified lead abatement project designer does not submit an application for re-certification by that date, the application will not be deemed timely filed and the department cannot guarantee that the application will be reviewed and acted upon before the end of the lead abatement project designer's certification period.(e) Fees.(1) Two-year certifications. Effective January 1, 2005, the fee for a two-year lead abatement project designer certification shall be $600. The fee must accompany the initial or renewal certification application.(2) Three-year certifications. Three-year certifications, which were issued prior to January 1, 2005, shall remain valid for the remainder of their three-year term provided that the annual fee of $300 is paid on time to the department. Upon expiration of this three-year certification, a fee of $600 for a two-year renewal certification shall be paid upon submission of a complete application. Persons who possess a three-year certification that was issued prior to January 1, 2005, must submit an annual fee when due accompanied by a payment coupon issued by the department. In order to retain a three-year certification for the remainder of its term, all annual fees must be paid on time as required. Upon payment of each annual fee, a new photo identification (ID) card will be issued and shall be valid for the time period for which the annual fee was paid. Failure to make a timely annual fee payment may result in the suspension of the certification. Source Note: The provisions of this §295.209 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.209 Lead Abatement Project Designer: Certification Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118572&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118572 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118572&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118572 03/11/2026 (a) Certification requirements. A person must be certified by the department as a lead abatement worker to engage in such activity in target housing and child-occupied facilities. Certifications issued by the department prior to January 1, 2005, are valid for a period of three years from the date of issue, provided that the appropriate fee is paid on time each year. Certifications issued by the department on or after January 1, 2005, are valid for a period of two years from the date of issue.(b) Specific requirements of applicants for certification as lead abatement workers:(1) successfully complete a lead abatement worker training course and receive a course completion certificate from a department-accredited training program provider; and(2) submit a complete application for lead abatement worker certification to the department on a department-issued form and pay the appropriate certification fee within one year of successfully completing the original lead abatement worker course.(A) A person who fails to submit a complete lead abatement worker certification application within one year of completing the required course will be required to additionally complete a lead abatement worker refresher training course from a department-accredited training program provider and receive a course completion certificate. The individual must then submit a complete certification application, including a course completion certificate of the additionally required lead abatement worker refresher training course, within one year of completing the refresher course.(B) If the applicant has not submitted a complete lead abatement worker certification application within three years of completing the original lead abatement worker training course, including documentation of any additionally required refresher training course, the person will again be subject to the certification requirements of subsection (b) of this section in order to be granted certification.(c) Application for certification renewal. To become re-certified, the certified lead abatement worker must successfully complete a lead abatement worker refresher training course from a department-accredited training provider no sooner than 180 days prior to the worker's certification expiration date and follow the procedures contained in §295.205 of this title (relating to Certification: Applications, Denials, and Renewals).(1) If a certification holder makes a timely and sufficient application for the renewal of the certification by their current certification's expiration date, the current certification in his/her possession does not expire until the application has been finally approved or denied by the department. The person whose certification has been expired for less than one year may renew their certification by complying with the requirements of §295.205(h) of this title. Certifications that have been expired for a period of one year or more beyond the three-year expiration date cannot be renewed. The person whose certification has been expired for a period of one year or more may become re-certified by complying with the current requirements and procedures, including any examination requirements, for an original certification, subject to the certification requirements of subsection (b) of this section.(2) To maintain certification, the certified lead abatement worker must seek re-certification by submitting a complete certification renewal application to the department no later than 30 days before the certification expires. If the certified lead abatement worker does not submit an application for re-certification by that date, the application will not be deemed timely filed and the department cannot guarantee that the application will be reviewed and acted upon before the end of the lead abatement worker's certification period.(d) Fees.(1) Two-year certifications. Effective January 1, 2005, the fee for a two-year lead abatement worker certification shall be $100. The fee must accompany the initial or renewal certification application.(2) Three-year certifications. Three-year certifications, which were issued prior to January 1, 2005, shall remain valid for the remainder of their three-year term provided that the annual fee of $50 is paid on time to the department. Upon expiration of this three-year certification, a fee of $100 for a two-year renewal certification shall be paid upon submission of a complete application. Persons who possess a three-year certification that was issued prior to January 1, 2005, must submit an annual fee when due accompanied by a payment coupon issued by the department. In order to retain a three-year certification for the remainder of its term, all annual fees must be paid on time as required. Upon payment of each annual fee, a new photo identification (ID) card will be issued and shall be valid for the time period for which the annual fee was paid. Failure to make a timely annual fee payment may result in the suspension of the certification. Source Note: The provisions of this §295.210 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.210 Lead Abatement Worker: Certification Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118573&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118573 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118573&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118573 03/11/2026 (a) Certification requirements. All firms engaged in or offering to perform lead-based paint activities in target housing and child-occupied facilities must be certified by the department. Certifications issued by the department prior to January 1, 2005, are valid for a period of three years from the date of issue, provided that the appropriate fee is paid on time each year. Certifications issued by the department on or after January 1, 2005, are valid for a period of two years from the date of issue.(b) Specific requirements of applicants for certification as lead firms:(1) A firm seeking certification shall submit to the department a letter signed by the firm's owner or an authorized agent of the firm certifying that the firm will:(A) only employ certified employees to conduct lead-based paint activities; and(B) follow the standards for conducting lead-based paint activities set out in §295.212 of this title (relating to Standards for Conducting Lead-Based Paint Activities).(2) A firm shall submit a statement indicating whether the firm is a corporation, giving the state of incorporation and charter number; or, if not a corporation, provide a list of all owners (including their titles) employed by the unincorporated firm.(3) If the firm operates under an assumed name, the owner or authorized agent of the firm shall provide to the department with their Lead Firm certification application a copy of the firm's Certificate of Assumed Name that lists the firm's Assumed Name of Business, the address of the firm, and the name of the person registering the firm as an assumed name.(4) The firm shall maintain all records pursuant to the requirements in §295.212 of the title.(5) A firm shall submit a complete application form for lead firm certification to the department on a department-issued form and pay the appropriate certification fee.(c) Responsibilities. The certified firm shall be responsible for the following:(1) comply with the standards of operation, including EPA and the Occupational Safety and Health Administration of the United States Department of Labor (OSHA) regulations;(2) provide required notification to the department about impending abatement projects, changes requiring re-notification, and emergency notifications, as described in §295.214 of this title (relating to Notifications);(3) supply and train employees who perform lead-based paint abatement activities in the use of personal protection equipment, and to supervise their compliance;(4) assist department personnel in the discharge of their official duties to conduct inspections and investigations, as described in §295.218 of this title (relating to Compliance: Inspections and Investigations); and(5) ensure that each employee engaged in lead-based paint activities is properly certified, and has a department-issued identification (ID) card and one form of a government-issued photo ID present at the worksite.(d) Application for certification renewal. To become re-certified, the certified lead firm must follow the procedures contained in §295.205 of this title (relating to Certification: Applications, Denials, and Renewals).(1) If a certification holder makes a timely and sufficient application for the renewal of the certification by their current certification's expiration date, the current certification in the firm's possession does not expire until the application has been finally approved or denied by the department. The firm whose certification has been expired for less than one year may renew their certification by complying with the requirements of §295.205(h) of this title. Certifications that have been expired for a period of one year or more beyond the three-year expiration date cannot be renewed. The firm whose certification has been expired for a period of one year or more may become re-certified by complying with the current requirements and procedures for an original certification, subject to the certification requirements of subsection (b) of this section.(2) To maintain certification, the certified firm must seek re-certification by submitting a complete certification renewal application to the department no later than 30 days before its certification expires. If the certified firm does not submit its application for re-certification by that date, the application will not be deemed timely filed and the department cannot guarantee that the application will be reviewed and acted upon before the end of the firm's certification period.(e) Fees.(1) Two-year certifications. Effective January 1, 2005, the fee for a two-year lead firm certification shall be $1000. The fee must accompany the initial or renewal certification application.(2) Three-year certifications. Three-year certifications, which were issued prior to January 1, 2005, shall remain valid for the remainder of their three-year term provided that the annual fee of $500 is paid on time to the department. Upon expiration of this three-year certification, a fee of $1000 for a two-year renewal certification shall be paid upon submission of a complete application. Lead firms that possess a three-year certification that was issued prior to January 1, 2005, must submit an annual fee when due accompanied by a payment coupon issued by the department. In order to retain a three-year certification for the remainder of its term, all annual fees must be paid on time as required. Failure to make a timely annual fee payment may result in the suspension of the certification. Source Note: The provisions of this §295.211 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.211 Lead Firm: Certification Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206695&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206695 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=206695&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 206695 03/11/2026 (a) Inspection. (1) Lead-based paint inspections shall be conducted only by persons certified by the department as an inspector or risk assessor and must be conducted according to the procedures in this section. (2) When conducting an inspection, the following locations shall be selected according to approved documented methodologies and tested for the presence of lead-based paint. (A) For every residential dwelling and child-occupied facility, each interior component with a distinct painting history, and each exterior component with a distinct painting history shall be tested for lead-based paint, except those components that the inspector or risk assessor determines to have been replaced after 1978, or to not contain lead-based paint. (B) If conducting an inspection in a multi-family dwelling or child-occupied facility, all components with a distinct painting history in every common area shall be tested for lead-based paint, except those components that the inspector or risk assessor determines to have been replaced after 1978, or to not contain lead-based paint. (3) The collection and analysis of paint samples to determine the presence of lead-based paint shall be conducted using approved documented methodologies which incorporate adequate quality control procedures and analyzed according to subsection (e) of this section. (4) The certified inspector or risk assessor shall prepare a written inspection report, which shall include the following information: (A) date of inspection; (B) address of buildings and units; (C) date of construction of buildings and units; (D) unit numbers (if applicable); (E) name, address, and telephone number of the owner of buildings and units; (F) name, signature, and certification number of each certified inspector, risk assessor, or both conducting testing; (G) name, address, and telephone number of the certified firm employing or contracting with each inspector, risk assessor, or both; (H) name, address, and telephone number of each recognized laboratory conducting an analysis of collected samples; (I) each testing method, device, and sampling procedure employed for paint analysis, including quality control data, copy of laboratory reports, and, if used, the brand name, model, and serial number of any XRF device, including downloaded XRF data; (J) specific locations of each painted component tested for the presence of lead-based paint; and (K) the results of the inspection expressed according to the sampling method used. (5) All inspection reports shall be retained for a minimum of three years. (b) Lead hazard screen. (1) A lead hazard screen shall be conducted only by persons certified by the department as risk assessors. (2) A lead hazard screen shall be conducted as follows. (A) Collect background information regarding the physical characteristics of the residential dwelling or child-occupied facility and occupant use patterns that may cause lead-based paint exposure to one or more children six years of age or younger. (B) A visual inspection of the residential dwelling or child-occupied facility and common area shall be conducted to: (i) determine if any deteriorated paint is present; and (ii) locate at least two dust sampling locations. (C) If deteriorated paint is present, each surface with deteriorated paint and having a distinct painting history shall be tested, using approved documented methodologies, for the presence of lead-based paint. (D) In residential dwellings, two composite dust samples shall be collected, one from the floors and the other from the windows, in rooms, hallways, or stairwells where one or more children, age six or younger, are most likely to come in contact with dust. (E) In multi-family dwellings and child-occupied facilities, in addition to the floor and window samples required in subparagraph (D) of this paragraph, the risk assessor shall also collect composite dust samples from any common areas where one or more children six years of age or younger are likely to come into contact with dust. (3) Any paint and dust samples shall be taken using approved documented methodologies that incorporate adequate quality control procedures. (4) Any collected paint chip or dust samples shall be analyzed according to subsection (e) of this section to determine if they contain detectable levels of lead that can be quantified numerically. (5) The risk assessor shall prepare a written lead hazard screen report, which shall include the following: (A) the information required in a risk assessment report as specified in subsection (c) of this section, excluding paragraphs (11)(P) - (R); and (B) recommendations concerning the desirability for follow-up risk assessments. (6) All lead hazard screen reports shall be retained for a minimum of three years. (c) Risk assessment. (1) A lead risk assessment shall be conducted only by persons certified by the department as risk assessors and must be conducted according to the procedures in this subsection. (2) A visual inspection for risk assessment of the residential dwelling or child-occupied facility shall be undertaken to locate the existence of deteriorated paint, assess the extent and causes of the deterioration, and other potential sources of lead-based paint hazards. If deteriorated paint or other potential sources of lead-based paint hazards are present, each surface with deteriorated paint or each painted surface which is a potential lead-based paint hazard shall be tested using approved documented methodologies for the presence of lead. (3) Background information shall be collected regarding the physical characteristics of the residential dwelling or child-occupied facility and occupant use patterns that may result in lead-based paint exposure to one or more children six years of age or younger. (4) The following surfaces which are determined, using approved documented methodologies to have a distinct painting history, shall be tested for the presence of lead: (A) each friction surface or impact surface with visibly deteriorated paint; and (B) all other surfaces with visibly deteriorated paint. (5) In residential dwellings, dust samples (either composite or single-surface samples) from the interior window sill(s) and floor shall be collected and analyzed for lead concentration in all living areas where one or more children six years of age or younger are most likely to come into contact with dust. (6) For multi-family dwellings and child-occupied facilities, the samples required in paragraph (4) of this subsection shall be taken. In addition, interior window sill and floor dust samples (either composite or single-surface samples) shall be collected and analyzed for lead concentration in the following locations: (A) common areas adjacent to the sampled residential dwelling or child-occupied facility; and (B) dripline/foundation areas where bare soil is present. (7) For child-occupied facilities, interior window sill and floor dust samples (either composite or single-surface samples) shall be collected and analyzed for lead concentration in each room, hallway or stairwell utilized by one or more children, age six and under, and in other common areas in the child-occupied facility where one or more children, age six and under, are likely to come into contact with dust. (8) Soil samples shall be collected and analyzed for lead concentrations in the following locations: (A) exterior play areas where bare soil is present; (B) the rest of the yard (i.e., non-play areas) where bare soil is present; and (C) dripline/foundation areas where bare soil is present. (9) Any paint, dust, or soil sampling or testing shall be conducted using approved documented methodologies that incorporate adequate quality control procedures. (10) Any collected paint chip, dust, or soil samples shall be analyzed according to subsection (e) of this section to determine if they contain detectable levels of lead that can be quantified numerically. (11) A written risk assessment report shall be completed by a certified risk assessor and the report shall include the following information: (A) date of assessment; (B) physical address of building; (C) date of construction of building; (D) unit numbers (if applicable); (E) name, address, and telephone number of the owner of each building or unit; (F) name, signature, and certification number of the certified risk assessor conducting the assessment; (G) name, address, and telephone number of the certified firm employing each risk assessor; (H) name, address, and telephone number of each recognized laboratory conducting analysis of collected samples; (I) results of the visual inspection; (J) testing method and sampling procedure for paint analysis employed; (K) specific locations of each painted component tested for the presence of lead-based paint; (L) all data collected from on-site testing including quality control data and, if used, the brand name, model, and serial number of any XRF device (including downloaded XRF data); (M) copies of all laboratory analysis on collected paint, soil, and dust samples; (N) any other sampling results; (O) any background information collected pursuant to paragraph (3) of this subsection; (P) to the extent that they are used as part of the lead-based paint hazard determination, an evaluation of the adequacy of any previous inspections or analyses for the presence of lead-based paint, or other assessments of lead-related hazards; (Q) a description of the location, type, and severity of identified lead-based paint hazards and any other potential lead hazards; and (R) a description of recommended interim controls and abatement options for each identified lead-based paint hazard, and a suggested prioritization for taking each action based on the immediacy and severity of the hazard. If the use of an encapsulant or enclosure is recommended, the report shall include a maintenance and monitoring schedule for the encapsulant or enclosure. (12) All risk assessment reports shall be retained for a minimum of three years. (d) Abatement. (1) A lead abatement shall be conducted only by an individual certified by the department as a worker or supervisor, and if conducted, shall be conducted according to the procedures in this subsection. (2) A certified supervisor is required for each abatement project and shall be onsite during all work site preparation and during the post-abatement cleanup of work areas. At all other times when abatement activities are being conducted, the certified supervisor shall be available either directly or by phone or answering service, and able to be present at the work site in no more than two hours. (3) The certified supervisor and the certified firm employing that supervisor shall ensure that all abatement activities are conducted according to the requirements of this subsection and all other federal, state, and local requirements. (4) Notification of the commencement of lead-based paint abatement activities in target housing or child-occupied facilities or as a result of a federal, state, or local order shall be given to the department, according to the procedures established in §295.214 of this title (relating to Notifications), prior to the commencement of abatement activities. (5) A written occupant protection plan shall be developed and implemented for all abatement projects and shall be prepared according to the following procedures. (A) The occupant protection plan shall be unique to each residential dwelling or child-occupied facility and be developed prior to the abatement. The occupant protection plan shall describe the measures and management procedures that will be taken during the abatement to protect any individual with access to the abatement area from exposure to any lead-based paint hazards. (B) A certified supervisor or project designer shall prepare and sign the occupant protection plan. (C) The occupant protection plan must be kept at the worksite by the certified lead abatement firm at all times during any abatement activity. (6) Unless presumed lead, a copy of the lead inspection or lead risk assessment report prepared for the lead abatement project shall be kept at the worksite by the certified lead abatement firm and be available for department inspection. (7) The following work practices shall be followed during a lead abatement. (A) Open-flame burning or torching of lead-based paint is prohibited. (B) Machine sanding or grinding or abrasive blasting or sandblasting of lead-based paint is prohibited unless used with High Efficiency Particulate Air (HEPA) exhaust control capable of removing particles of 0.3 microns or larger from the air at 99.97% or greater efficiency. (C) Dry scraping of lead-based paint is permitted only in conjunction with heat guns or around electrical outlets or when treating defective paint spots totaling no more than two square feet in any one room, hallway, or stairwell or totaling no more than 20 square feet on exterior surfaces. (D) Operating a heat gun on lead-based paint is permitted only at a temperature below 1,100 degrees Fahrenheit. (8) If conducted, soil abatement shall be conducted in one of the following ways. (A) If soil is removed: (i) the soil shall be replaced by soil with a lead concentration as close to local background as practicable, but less than 400 ppm; and (ii) the soil that is removed shall not be used as top soil at another residential property or child-occupied facility. (B) If soil is not removed, the soil shall be permanently covered, as defined in §295.202 of this title (relating to Definitions). (9) The following post-abatement clearance procedures shall be performed by a certified inspector or risk assessor. (A) Following an abatement, a visual inspection shall be performed to determine if deteriorated painted surfaces or visible amounts of dust, debris, or residue are still present. If deteriorated painted surfaces or visible amounts of dust, debris, or residue are present, these conditions must be eliminated prior to the continuation of the clearance procedures. (B) Following the visual inspection and any post-abatement cleanup required by subparagraph (A) of this paragraph, clearance sampling for lead in dust shall be conducted. Clearance sampling may be conducted by employing single-surface sampling or composite sampling techniques. (C) Dust samples for clearance purposes shall be taken using approved documented methodologies that incorporate adequate quality control procedures. (D) Dust samples for clearance purposes shall be taken a minimum of one hour after completion of final post-abatement cleanup activities. (E) The following post-abatement clearance activities shall be conducted as appropriate based upon the extent or manner of abatement activities conducted in or to the residential dwelling or child-occupied facility. (i) After conducting an abatement with containment between abated and unabated areas, one dust sample shall be taken from one interior window sill and from one window trough (if present) and one dust sample shall be taken from the floors of each of no less than four rooms, hallways or stairwells within the containment area. In addition, one dust sample shall be taken from the floor outside the containment area. If there are less than four rooms, hallways or stairwells within the containment area, then all rooms, hallways or stairwells shall be sampled. (ii) After conducting an abatement with no containment, two dust samples shall be taken from each of no less than four rooms, hallways or stairwells in the residential dwelling or child-occupied facility. One dust sample shall be taken from one interior window sill and window trough (if present) and one dust sample shall be taken from the floor of each room, hallway or stairwell selected. If there are less than four rooms, hallways or stairwells within the residential dwelling or child-occupied facility then all rooms, hallways or stairwells shall be sampled. (iii) Following an exterior paint abatement, a visual inspection shall be conducted to determine and ensure that all horizontal surfaces in the outdoor living area closest to the abated surface shall be cleaned of visible dust and debris. In addition, a visual inspection shall be conducted to determine the presence of paint chips in bare soil in common areas, on the dripline or next to the foundation below any abated exterior surface. If paint chips are present, they must be removed from the site and properly disposed, according to all applicable federal, state, and local requirements. (F) The rooms, hallways or stairwells selected for sampling shall be selected according to approved documented methodologies. (G) The certified inspector or risk assessor shall compare the residual lead dust level (as determined by the laboratory analysis) from each single surface dust sample with clearance levels in paragraph (13) of this subsection for lead in dust on floors, interior window sills, and window troughs or from each composite dust sample with the applicable clearance levels for lead in dust on floors, interior window sills, and window troughs divided by half the number of subsamples in the composite sample. If the residual lead level in a single surface dust sample equals or exceeds the applicable clearance level or if the residual lead level in a composite dust sample equals or exceeds the applicable clearance level divided by half the number of subsamples in the composite sample, the components represented by the failed sample shall be recleaned and retested. (10) In a multi-family dwelling with similarly constructed and maintained units, random sampling for the purposes of clearance may be conducted, provided: (A) the individuals who abate or clean the units do not know which units will be selected in the sample; (B) a sufficient number of units are selected for sampling to provide a 95% level of confidence that no more than 5.0% or 50 of the units (whichever is smaller) in the sampled population exceed the appropriate clearance levels; and (C) the selected units are sampled and evaluated for clearance according to the procedures found in paragraph (9) of this subsection. (11) All lead-based paint waste materials from the abatement project must be disposed of in accordance with applicable federal, state, and local requirements. (12) A written abatement report shall be prepared by a certified supervisor or project designer as required in this section. This report shall be completed within sixty days of the stop-date on each abatement notification. The abatement report shall include the following information: (A) start and completion dates of abatement; (B) the name and address of each certified firm conducting the abatement and the name of each supervisor assigned to the abatement project; (C) the occupant protection plan prepared pursuant to paragraph (5) of this subsection; (D) the name, address, and signature of each certified risk assessor or inspector conducting clearance sampling and the date of clearance testing; (E) a copy of all laboratory reports of clearance testing and all soil analyses (if applicable) and the name of each recognized laboratory that conducted the analyses; (F) a detailed written description of the abatement, including abatement methods used, locations of rooms or components, or both where abatement occurred, reason for selecting particular abatement methods for each component, and any suggested monitoring of encapsulants or enclosures; (G) the name, address, and telephone number of the waste disposal site; and (H) the name, signature, and the department certification number of the person completing the post-abatement report and the completion date of the report. (13) Clearance levels for lead in dust that are appropriate for the purposes of this section are: (A) dust wipes for floors: <10 micrograms per square foot (µg/ft2 ); (B) dust wipes for interior window sills: <100 µg/ft2 ; and (C) dust wipes for window troughs: <400 µg/ft2 . (e) Collection and laboratory analysis of samples. Any paint chip, dust, or soil samples collected pursuant to the standards contained in this section shall be: (1) collected by persons certified by the department as a lead inspector or risk assessor; and (2) ensured by the lead inspector or risk assessor to be analyzed by a laboratory recognized by the Environmental Protection Agency pursuant to §405(b) of the Toxic Substances Control Act (TSCA) as being capable of performing analyses for lead in paint chip, dust, and soil samples. (f) Composite dust sampling. Composite dust sampling may only be conducted in the situations specified in subsections (b) - (d) of this section. If such sampling is conducted, the following conditions shall apply: (1) composite dust samples shall consist of at least two subsamples; (2) every component that is being tested shall be included in the sampling; and (3) composite dust samples shall not consist of subsamples from more than one type of component. (g) Determinations of presence of lead-based paint and lead hazards. (1) Lead-based paint is present: (A) on any surface that is tested and found to contain lead equal to or in excess of 1.0 milligrams per square centimeter or equal to or in excess of 0.5% by weight; and (B) on any surface like a surface tested in the same room equivalent that has a similar painting history and that is found to be lead-based paint. (2) A paint-lead hazard is present: (A) on any friction surface that is subject to abrasion and where the lead dust levels on the nearest horizontal surface underneath the friction surface (e.g., the window sill or floor) are equal to or greater than the dust hazard levels identified in paragraph (3)(A) of this subsection; (B) on any chewable lead-based paint surface on which there is evidence of teeth marks; (C) where there is any damaged or otherwise deteriorated lead-based paint on an impact surface that is caused by impact from a related building component, such as a door knob that knocks into a wall or a door that knocks against its door frame; or (D) if there is any other deteriorated lead-based paint in any residential building or child-occupied facility or on the exterior of any residential building or child-occupied facility. (3) A dust-lead hazard is present in a residential dwelling or child-occupied facility: (A) in a residential dwelling on floors and interior window sills when the weighted arithmetic mean lead loading for all single surface or composite samples of floors and interior window sills are equal to or greater than 10 µg/ft2 for floors and 100 µg/ft2 for interior window sills, respectively; (B) on floors or interior window sills in an unsampled residential dwelling in a multi family dwelling, if a dust-lead hazard is present on floors or interior window sills, respectively, in at least one sampled residential unit on the property; or (C) on floors or interior window sills in an unsampled common area in a multi-family dwelling, if a dust-lead hazard is present on floors or interior window sills, respectively, in at least one sampled common area in the same common area group on the property. (4) A soil-lead hazard is present: (A) in a play area when the soil-lead concentration from a composite play area sample of bare soil is equal to or greater than 400 parts per million (ppm); or (B) in the rest of the yard when the arithmetic mean lead concentration from a composite sample (or arithmetic mean of composite samples) of bare soil from the rest of the yard (i.e., non-play areas) for each residential building on a property is equal to or greater than 1,200 ppm. (h) Recordkeeping. All reports or plans required in this section shall be maintained by the certified firm or individual contractor, who prepared the report, for no less than three years. The certified firm or individual contractor also shall provide copies of these reports to the building owner who contracted for its services and these reports shall be made available to the department upon request. Building owners are subject to the requirements mandated under §1018 of the Residential Lead-Based Paint Hazard Reduction Act of 1992 and 40 Code of Federal Regulations, §745, Subpart F, "Disclosure of Known Lead-based Paint and/or Lead-based Paint Hazards Upon Sale or Lease of Residential Property." Source Note: The provisions of this §295.212 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987; amended to be effective November 9, 2021, 46 TexReg 7608. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.212 Standards for Conducting Lead-Based Paint Activities https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101127&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101127 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101127&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101127 03/11/2026 (a) Lead-based paint activities, as defined in §295.202 of this title (relating to Definitions) shall only be conducted according to the procedures and standards contained in §295.212 of this title (relating to Standards for Conducting Lead-Based Paint Activities). However, the standards contained in §295.212 of this title do not apply when treating paint-lead hazards less than:(1) two square feet of deteriorated lead-based paint per room or equivalent;(2) 20 square feet of deteriorated paint on the exterior building; or(3) 10% of the total surface area of deteriorated paint on an interior or exterior type of component with a small surface area.(b) No persons may offer to perform or perform any lead-based paint activity in target housing or in a child-occupied facility, unless certified to perform that activity according to the procedures in §§295.205 - 295.211 of this title (relating to Texas Environmental Lead Reduction).(c) All firms performing lead-based paint activities shall employ only appropriately certified individuals to conduct those lead-based paint activities.(d) All persons engaged in lead-based paint activities must have the department-issued certification ID card and one form of photo identification present at the worksite. Source Note: The provisions of this §295.213 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.213 Lead-Based Paint Activities Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118575&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118575 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118575&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118575 03/11/2026 (a) Notification requirement. The Texas Department of Health's (department) Environmental Lead Notification Section (ELNS) and the appropriate department regional office shall be notified by the certified lead firm in writing on a form specified by the department of any lead-based paint abatement activity in target housing (each individual and separate residential dwelling or each building within a multifamily dwelling complex) or child-occupied facilities. The department notification form must be filled out completely and properly including an accurate description of the work to be performed. Blanks which do not apply shall be marked "N/A." The designation of "N/A" will not be accepted for references requiring identification of the work site, building description, building owner, certified lead abatement firm, and individuals required to be identified on the notification form. Any changes to the original notification will require that an amended notification be submitted.(b) Responsibility. It is the responsibility of the certified lead firm to notify the ELNS and regional office of any initial notifications, amendments, cancellations, or emergency notifications. Each notification made to the ELNS shall contain the original signature of the certified firm's owner or an authorized agent of the firm.(c) Timeliness of notification.(1) ELNS notification. Written notifications of lead abatement activity must be hand delivered, express mailed, or postmarked at least seven working days (not calendar days) before the start of lead-based paint abatement. Notifications must be delivered by United States Postal Service, commercial delivery service, or by hand delivery. Telephone facsimile (FAX) of notifications to the ELNS is not permitted. The start date is considered to be the date when lead-based paint abatement begins.(2) Regional office notification. In addition to the notification requirement in paragraph (1) of this subsection, a copy of the notification must be received by the regional office on the same date that the notification is mailed to the ELNS, which shall be at least seven working days prior to the start of the lead-based paint abatement. The copy of the notification may be hand-delivered, express-mailed, sent by electronic mail (E-mail), or faxed to the regional office.(d) Start/Stop-date amendments. For any changes to the start and/or stop-date(s), the EHNG and the appropriate regional office shall be notified by telephone during the hours of 8:00 a.m. to 5:00 p.m. Central Time (CT) prior to the original or amended start and/or stop-date(s) as previously specified on the notification form. If the amended stop-date is earlier than the original scheduled or previously amended stop-date, then it must be reported prior to the new or amended stop-date. A written amended notification must be postmarked to the EHNG and delivered to the regional office within 24 hours following the telephone communication with the EHNG and the regional office.(e) Cancellations. When a lead abatement project is to be cancelled, the EHNG and the regional office shall be notified by telephone during the hours of 8:00 a.m. to 5:00 p.m. CT at least 24 hours prior to the scheduled start date, and a notification of cancellation must be submitted to the EHNG and postmarked no later than 24 hours following the telephone communication with the EHNG and regional office. The copy of the notification shall also be hand-delivered, express-mailed, sent by E-mail, or faxed to the regional office no later than 24 hours following the telephone communication with the EHNG and regional office.(f) Emergency notification. In the event of lead abatement made necessary by an unexpected or unplanned lead incident, notification will be made as soon as practicable, but not later than the following work day after the occurrence of the incident. Initial notification shall be made by telephone to the ELNS and regional office followed by formal notification on the department's notification form. Emergencies shall be documented to the extent that the need for the emergency is evident. An emergency lead abatement operation means a lead abatement operation that was not planned, but results from a sudden, unexpected event. This event, if not immediately attended to, presents a public health or safety hazard. Emergencies do not include immediate abatement work resulting solely from a lack of adequate planning for foreseeable lead abatement activity.(g) Lead abatement notification fees.(1) Applicability. The certified firm's owner or an authorized agent of the firm shall remit to the department a fee that is based on each child-occupied facility, individual and separate residential dwelling, or each building within a multi-family dwelling complex to be abated.(2) Payment. An invoice for the required fee will be sent to the person submitting the notice after the notification has been received by the department. Fee amounts, address, and fund numbers are included on the form. Payment must be received no later than 60 days following the invoice date.(3) Fees. The fee for each original notification is $100.(4) Nonpayment of fees. Failure to pay the required fee after an invoice has been sent shall be considered a violation and may subject the certified firm or authorized agent of the firm to administrative penalties as listed in §295.220 of this title (relating to Compliance: Administrative Penalty). The certified firm or authorized agent of the firm may also be subject to civil or criminal penalties if applicable. Governmental organizations may submit a copy of the interagency transfer document or a statement that a check has been requested and is in processing. Source Note: The provisions of this §295.214 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.214 Notifications https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118576&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118576 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118576&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118576 03/11/2026 (a) Terms of reciprocity. A person who is certified or licensed in good standing to perform lead-based paint activities in target housing and child-occupied facilities in another state may obtain reciprocal certification in the same discipline provided they are certified according to the terms of these sections prior to commencing such activities.(1) An applicant seeking reciprocal certification shall submit a complete reciprocal application on a department-issued form with the appropriate fee.(2) An applicant seeking reciprocal certification shall sign a statement that the applicant has read and understands the Texas Environmental Lead Reduction Rules (§§295.201 - 295.220 of this title) and agrees to follow the standards for conducting lead-based paint activities set out in §§295.212 and 295.213 of this title (relating to Standards for Conducting Lead-Based Paint Activities and Lead-Based Paint Activities Requirements).(b) Applicant status. All persons residing in other states, applying for any category of certification, must comply with all certification requirements which would be imposed on a Texas resident.(c) Acceptance of qualifying documents. Out-of-state certifications or licenses can be accepted for the purpose of qualifying for Texas certification provided that they are valid and are verifiable by the department. The certification or license from another state must be from a state which has received United States Environmental Protection Agency (EPA) authorization to administer and enforce a state certification and training program under Title IV of the Toxic Substances Control Act (TSCA) or be from a state whose certification and training program is operated by EPA. The burden of proof in such matters is the responsibility of the applicant; the department must reject unverifiable documentation. Source Note: The provisions of this §295.215 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.215 Reciprocity https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118577&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118577 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118577&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118577 03/11/2026 (a) Accreditation. Accreditation fees for training programs operated by any federal, state, or local government, or nonprofit entities shall be waived.(b) Certification.(1) Government employees who currently possess a fee-exempt certification which was issued prior to September 1, 2003, for the sole purpose of executing governmental duties in the course of their employment shall continue to remain exempt from annual fees until their certification expires, provided that the certified individual remains employed by the government and the governmental nature of the duties performed remain unchanged. Except as specified in paragraph (2) of this subsection, upon expiration of this fee-exempt certification, the appropriate fee shall be paid upon submission of a complete certification application for renewal.(2) Employees of the Department of State Health Services, who engage in a lead-based paint activity as a condition of their employment, shall be exempt from certification fees and examination fees. Fee-exempted certifications shall be restricted for use only in required departmental duties and the credentials will indicate the restriction. If the department employee is no longer required to possess certification as a condition of employment or the individual terminates employment from the department, all unexpired fee-exempt certification credentials shall immediately be returned to the Environmental Lead Program and closed. If fee-exempt certifications are used to perform non-department related lead-based paint activities, penalties may be assessed against the individual. Source Note: The provisions of this §295.216 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.216 Accreditation and Certification Fee Exemption https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101123&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101123 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101123&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101123 03/11/2026 (a) The Texas Department of Health (department) shall maintain the right to inspect or investigate the practices of any person involved in lead-based paint activities in target housing or child-occupied facilities as defined in this subchapter of this title (relating to Texas Environmental Lead Reduction).(b) A department representative, upon presenting appropriate credentials, shall have the right to enter at all reasonable times any area or environment, including but not limited to any containment work area, building, construction site, storage, vehicle, training facility, or office area to inspect and investigate for compliance with these sections of this title (relating to Texas Environmental Lead Reduction), to review records, to question any person, or to locate, identify, sample, and assess the condition of lead-based paint-containing material.(c) Advance notice of inspections or investigations by the department is not required.(d) Authority and responsibility for the qualifications, health status, and personal protection of department representatives reside with the department. A department representative shall not be impeded or refused entry in the course of his official duties in accordance with these regulations by reason of any regulatory or contractual specification. A person who refuses to allow a compliance inspection shall be in violation in these sections of this title (relating to Texas Environmental Lead Reduction). Source Note: The provisions of this §295.218 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.218 Compliance: Inspections and Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101124&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101124 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=101124&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 101124 03/11/2026 (a) After notice to the certified or accredited person of an opportunity for a hearing in accordance with subsection (c) of this section, the Texas Department of Health (department) may reprimand the person or modify, suspend, suspend on an emergency basis, or decertify a certification or deaccredit an accreditation.(b) The department may reprimand any certified or accredited person, or may suspend or decertify a certification or deaccredit an accreditation for:(1) failure to comply with any provision of the Act, any rule adopted by the Texas Board of Health, or any order issued by the department or a court;(2) failure to comply with applicable federal or state standards for lead-based paint activities;(3) failure to maintain records as required by these sections;(4) failure to meet the qualifications for which one holds a certification or accreditation;(5) fraudulently, by misrepresentation, or deceptively obtaining or attempting to obtain a certification or contract for a lead-based paint activity;(6) falsifying records that are required to be maintained by this section; or(7) failure to pay required annual certification or accreditation fees.(c) The contested-case hearing provisions of the Administrative Procedure Act, Texas Government Code, Chapter 2001, shall not apply to any enforcement action proposed to be taken under this section. The department's Fair Hearing Procedures found at 25 TAC, §§1.51-1.55, shall apply.(d) If a certification or accreditation issued under these sections has been suspended, the person(s) named in the suspension are not eligible to reapply for certification or accreditation under these sections of this title (relating to Texas Environmental Lead Reduction) for one year.(e) If a certification issued under these sections of this title (relating to Texas Environmental Lead Reduction) has been decertified, the person(s) named in the decertification are not eligible to reapply for certification under these sections for three years.(f) The board may place on probation a person whose certification or accreditation is suspended.(g) The board may require a person whose certification or accreditation suspension is probated to:(1) report regularly to the department on matters that are the basis of the probation;(2) limit practice to the areas prescribed by the board; or(3) continue or review professional education until the person attains a degree of skill satisfactory to the board in those areas that are the basis of the probation. Source Note: The provisions of this §295.219 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.219 Compliance: Reprimand, Suspension, Decertification, Deaccreditation, and Probation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118578&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118578 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=118578&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 118578 03/11/2026 (a) If a person violates the Act, or a rule adopted or order issued under the Act, the Texas Department of Health (department) may assess an administrative penalty.(b) The penalty shall not exceed $5,000 a day per violation. Each day a violation continues will be considered a separate violation. The total penalty will be the sum of all individual violation penalties.(c) In assessing administrative penalties, the department shall consider the:(1) history of previous violation(s);(2) seriousness of the violation(s);(3) hazard to the health and safety of the public; and(4) demonstrated good faith, and any other matter which justice may require.(d) Individual violations may be reduced or enhanced based on the considerations listed in subsection (c) of this section, or other matters that justice may require. A reduction or enhancement may be considered, based on the facts presented to the department.(e) A person is subject to double the initial penalty on second finding of violation of any provision of the Act or rules. Third and subsequent violations of a provision are subject to five times the initial penalty. In any case, the penalty shall not exceed $5,000 a day per violation.(f) Violations shall be placed in one of the following severity levels.(1) Severity Level I. The base penalty for a Level I violation, first occurrence will not exceed $5,000 per day, per violation. Examples of Level I violations include, but are not limited to:(A) working without certification from the department or working with improper (forged, altered, etc,) certification;(B) working with a suspended or decertified certification;(C) failing to develop and implement a written occupant protection plan;(D) providing training certificates to persons who have not attended the required training course as specified by the department;(E) using prohibited lead abatement methods such as open-flame burning or torching, machine sanding or grinding without a high-efficiency particulate air (HEPA) vacuum tool, uncontained hydroblasting or high pressure washing, abrasive blasting or sand blasting without HEPA vacuum exhaust tools, or heat guns that operate at 1100 degrees Fahrenheit or above; or(F) training for certification purposes without obtaining accreditation from the department.(2) Severity Level II. The base penalty for Level II violations on a first occurrence will not exceed $2,000 per day, per violation. Examples of Level II violations include, but are not limited to:(A) failing to submit a notification to the department;(B) failing to conduct a training course for the specified time period;(C) certified supervisor not onsite or available directly through a pager or answering service;(D) refusing or impeding entry to department representatives in order to conduct compliance inspections;(E) working with an expired certification;(F) training with an expired training provider accreditation; or(G) working with a fee-exempt certification, issued to a department employee, on non-department related lead-based paint activities.(3) Severity Level III. The base penalty for Level III violations on first occurrence will not exceed $1,000 per day, per violation. Examples of Level III violations include, but are not limited to:(A) failing to pay the required notification fee to the department;(B) submitting an improper notification to the department;(C) failing to have the department-issued certification ID card and one form of photo identification present at the worksite ;(D) training provider fails to submit information to the department regarding training course schedules, or to notify the department of cancellations within the specified time periods;(E) inspection/risk assessment report not prepared; or(F) failure to have a written occupant protection plan at the worksite.(g) The person charged with the violation will be given the opportunity for a hearing conducted in accordance with the department's fair hearing procedures in Chapter 1 of this title (relating to the Board of Health).(h) The hearing regarding a proposed administrative penalty may be consolidated with another hearing on an administrative penalty.(i) If the person charged with the violation fails to request a hearing within 30 days following receipt of a notice of violation, an administrative penalty may be assessed after the Commissioner of Health has determined that a violation did occur and the amount of the penalty is warranted. Source Note: The provisions of this §295.220 adopted to be effective February 19, 1996, 21 TexReg 968; amended to be effective May 10, 1998, 23 TexReg 4280; amended to be effective March 23, 2003, 28 TexReg 2347; amended to be effective January 1, 2005, 29 TexReg 11987. 1 DEPARTMENT OF STATE HEALTH SERVICES 295 OCCUPATIONAL HEALTH I TEXAS ENVIRONMENTAL LEAD REDUCTION §295.220 Compliance: Administrative Penalty https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205392&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205392 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205392&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205392 03/11/2026 (a) Purpose. Asbestos is a known carcinogen and health hazard. Preventing asbestos disease depends on limiting exposure of an individual to asbestos fibers. The purpose of this chapter is to control and minimize public exposure to airborne asbestos by regulating asbestos-related activities in public buildings, commercial buildings, and facilities, as defined in §296.21 of this chapter (relating to Definitions). This chapter implements Texas Occupations Code, Chapter 1954 (relating to Asbestos Health Protection); Texas Health and Safety Code, Chapter 161, Subchapter Q (relating to Installation of Asbestos); and federal regulations of the Environmental Protection Agency (EPA), as adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards). Any federal regulations of the Occupational Safety and Health Administration with which a person is required to comply is not limited by the applicability or effect of the provisions of this chapter.(b) Scope.(1) This chapter applies to a person disturbing, removing, encapsulating, or enclosing any amount of asbestos within a public building for any purpose, including repair, renovation, dismantling, demolition, installation, or maintenance operations, or any other activity that may involve the disturbance, encapsulation, enclosure, or removal of any amount of asbestos-containing building material, whether intentional or unintentional. This chapter establishes:(A) licensing requirements;(B) building owner and licensee responsibilities;(C) applicable requirements for the performance of asbestos-related activities in public buildings; and(D) notification requirements.(2) For purposes of enforcing the EPA National Emission Standards for Hazardous Air Pollutants (NESHAP) specific to asbestos, as defined in §296.21(61) of this chapter, this chapter applies to facilities as defined in §296.21(41) of this chapter and facility owners or operators as defined in §296.21(42) of this chapter.(3) For purposes of enforcing the EPA Asbestos Model Accreditation Plan (MAP), as defined in §296.21(56) of this chapter, this chapter applies to commercial buildings as defined in §296.21(25) of this chapter.(4) For purposes of enforcing the federal regulations adopted to implement the Asbestos Hazard Emergency Response Act (AHERA), this chapter applies to local education agencies (LEAs) as defined in §296.21(51) of this chapter.(c) Exclusions. This chapter does not apply to a single private residence or a single apartment building with no more than four dwelling units, except for a residential building subject to NESHAP as described in §296.191(g)(4)(A) - (C) of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility).(d) Severability. Should any section or provision in this chapter be adjudged invalid by a court of competent jurisdiction, such finding will not affect any other section or provision.(e) License possession requirements. Anyone engaged in asbestos-related activities that require a license must provide proof of a current license, upon request, to any representative from the Department of State Health Services (DSHS), to an employer, or to a prospective employer if licensure is required for employment. All licensees must have the identification card issued by DSHS on-site at all times while engaged in any asbestos-related activity.(f) Days. A day means calendar day unless working day, as defined in §296.21(96) of this chapter, is specified. Source Note: The provisions of this §296.1 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION A GENERAL PROVISIONS §296.1 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205393&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205393 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205393&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205393 03/11/2026 (a) Adoption by reference. The Executive Commissioner of the Health and Human Services Commission (executive commissioner) adopts by reference and enforces the following asbestos-related federal regulations as part of this chapter:(1) the asbestos-specific provisions of the National Emission Standards of Hazardous Air Pollutants specific to asbestos, 40 CFR Part 61, Subpart M, regarding demolition and renovation activities: §61.140, adopted effective November 20, 1990; §61.141, amended effective June 19, 1995; §61.145, amended effective January 16, 1991; §61.146, amended effective June 19, 1995; §61.148, adopted effective November 20, 1990; §61.150, amended effective November 17, 2003; §61.152, amended effective November 20, 1990; §61.156, amended effective August 19, 2004; §61.157, adopted effective November 20, 1990; and Appendix A, amended effective June 19, 1995; and(2) except as otherwise provided in this paragraph, 40 CFR Part 763, Subpart E, (relating to Asbestos-Containing Materials in Schools) adopted under the Asbestos Hazard Emergency Response Act: §§763.80-763.86, adopted effective October 30, 1987; §763.87, amended effective June 19, 1995; §763.88, adopted effective October 30, 1987; §763.90, amended effective August 3, 2012; §763.91 and §763.92, amended effective November 15, 2000; §§763.93-763.97, adopted effective October 30, 1987; §763.98, amended effective October 13, 2005; §763.99, adopted effective October 30, 1987; Appendix A, adopted effective October 30, 1987; Appendix C and Appendix D, amended effective August 23, 2019; and Appendix E, amended effective June 19, 1995. The executive commissioner does not adopt from Appendix C (relating to Asbestos Model Accreditation Plan), the Environmental Protection Agency's (EPA) recommended project monitor accreditation category in its Asbestos Model Accreditation Plan.(b) References to federal standards, guidance, and analytical methods. The executive commissioner references the following asbestos-related federal regulations, guidance documents, and analytical methods in this chapter:(1) the provisions of the National Institute of Standards and Technology, 15 CFR Part 285, §§285.1-285.3, §§285.5-285.14, effective May 30, 2001, §285.4, amended effective December 20, 2011, and §285.15 amended effective July 3, 2007 (relating to National Voluntary Laboratory Accreditation Program);(2) the provisions of OSHA, 29 CFR Part 1910, Subpart H, §1910.120, amended effective July 15, 2019 (relating to Hazardous waste operations and emergency response);(3) the provisions of OSHA, 29 CFR Part 1910, Subpart I, §1910.132, amended effective January 17, 2017 (relating to General requirements);(4) the provisions of OSHA, 29 CFR Part 1910, Subpart I, §1910.134, amended effective July 8, 2011 (relating to Respiratory protection);(5) the provisions of OSHA, 29 CFR Part 1910, Subpart Z, §1910.1001, amended effective July 15, 2019, Appendix A, amended effective October 11, 1994, and Appendix B, amended effective June 29, 1995 (relating to Asbestos);(6) the provisions of OSHA, 29 CFR Part 1910, Subpart Z, §1910.1200, amended effective February 8, 2013 (relating to Hazard Communication);(7) the provisions of OSHA, 29 CFR Part 1926, Subpart C, §1926.32, amended effective June 30, 1993 (relating to Definitions);(8) the provisions of OSHA, 29 CFR Part 1926, Subpart Z, §1926.1101, amended effective July 15, 2019 (relating to Asbestos);(9) the provisions of EPA, 40 CFR Part 763, Subpart G, effective December 15, 2000 (relating to Asbestos Worker Protection);(10) the provisions of Pipeline and Hazardous Materials Safety Administration, 49 CFR Part 172, Subpart H, §172.700 and §172.701, effective May 15, 1992, §172.702, amended effective, May 30, 1996, and §172.704, amended effective December 23, 2015 (relating to Hazardous materials table, special provisions, hazardous materials communications, emergency response and information, training requirements, and security plans);(11) the NIOSH 7400 analytical method, entitled, "Asbestos and Other Fibers by PCM," published in the NIOSH Manual of Analytical Methods, Fifth Edition, Third Issue, June 14, 2019;(12) the EPA/600/R-93/116 analytical method, entitled, "Method for the Determination of Asbestos in Bulk Building Materials," July 1993; and(13) the EPA Publication for O&M activities entitled, "Managing Asbestos in Place: A Building Owner's Guide to Operations and Maintenance Programs," (also known as the EPA Green Book), July 1990.(c) Availability. Links to the documents in subsection (a) and (b) of this section are available on the DSHS's Asbestos Program website, http://www.dshs.texas.gov/asbestos/. Copies of the documents listed in subsection (a) of this section are available for review during normal business hours at DSHS's Consumer Protection Division office in Austin, Texas, and at DSHS regional offices.(d) State and federal standards. A requirement otherwise stated in applicable state statute or this chapter that is more stringent than a federal standard adopted by reference in subsection (a) of this section must be met. Source Note: The provisions of this §296.2 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION A GENERAL PROVISIONS §296.2 Reference of Federal Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205394&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205394 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205394&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205394 03/11/2026 (a) An owner or operator of a demolition or renovation activity, as defined in §296.21(69) of this chapter (relating to Definitions), must comply with NESHAP for all covered activities.(b) A DSHS representative may enter any facility to inspect and investigate conditions to determine compliance with this chapter in accordance with Texas Occupations Code §1954.060(b), Texas Health and Safety Code §12.018, and §296.271(c) of this chapter (relating to Inspections and Investigations).(c) The Executive Commissioner of the Health and Human Services Commission adopts by reference a memorandum of understanding between the predecessor agencies for DSHS and the Texas Commission on Environmental Quality, adopted by rule, effective September 5, 1999, in 30 TAC §7.122 (relating to Adoption of Memorandum of Understanding between the Texas Natural Resource Conservation Commission (commission) and the Texas Department of Health (TDH) Regarding Emissions Related to Asbestos Demolition and Renovation Activities) concerning the inspection of solid waste facilities that receive asbestos waste.(d) DSHS may take enforcement action as described in Subchapter Q of this chapter (relating to Compliance) for violations of NESHAP. Source Note: The provisions of this §296.3 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION A GENERAL PROVISIONS §296.3 Compliance with National Emission Standards for Hazardous Air Pollutants (NESHAP) and Memorandum of Understanding between the Texas Commission on Environmental Quality and the Texas Department of State Health Services for the Regulation of the NESHAP for Asbestos https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205395&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205395 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205395&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205395 03/11/2026 (a) A local education agency must ensure compliance with AHERA for all schools under its administrative control.(b) A DSHS representative may enter any regulated school building to inspect and investigate conditions to determine compliance in accordance with Texas Occupations Code §1954.060(b), Texas Health and Safety Code §12.018, and §296.271(c) of this chapter (relating to Inspections and Investigations).(c) DSHS may take enforcement action as described in Subchapter Q of this chapter (relating to Compliance) for violations of AHERA. Source Note: The provisions of this §296.4 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION A GENERAL PROVISIONS §296.4 Compliance with Federal Regulations Implementing the Asbestos Hazard Emergency Response Act (AHERA) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205396&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205396 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205396&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205396 03/11/2026 The following words and terms, when used in this chapter, have the following meaning, unless the context clearly indicates otherwise.(1) Abatement preparation--Preparation before asbestos abatement begins, which includes the following activities:(A) removing any movable objects from the interior space of a public building once an asbestos abatement contractor takes control of that space for the purpose of asbestos abatement;(B) pre-cleaning, wet wiping, HEPA vacuuming, and sealing a penetration or opening;(C) installing plastic sheeting, such as a critical barrier, any part of a decontamination system, or any part of the water line connections to a shower, drain, or filtration;(D) setting-up or using a load-out or bag-out system;(E) selecting, installing, or maintaining a respiratory system or fiber reduction system (such as misting or spraying);(F) posting warning signs;(G) installing engineering controls, including local exhaust ventilation equipped with a HEPA filter dust collection system, construction of a containment or isolation mechanism to control processes producing asbestos dust, and ventilation of the regulated area to move contaminated air away from the breathing zone of persons in containment and toward a filtration or collection device equipped with a HEPA filter;(H) installing scaffolding in an area in which asbestos may be disturbed during the installation; and(I) installing, setting-up, and calibrating monitoring devices, including sampling systems and manometers.(2) ACBM--Asbestos-containing building material. Surfacing, TSI, or miscellaneous ACM that is found in, or on interior structural members or other parts of, a public or commercial building.(3) Accredited person--A person who has attended and passed, within the last year, the appropriate asbestos course, as described in the MAP, that:(A) has been approved by DSHS and offered by a DSHS-licensed asbestos training provider;(B) has been approved by another state that has the authority from EPA to approve courses; or(C) has been approved directly by EPA.(4) ACM--Asbestos-containing material. Materials or products, including any single material component of a structure or any layer of a material sample that, when analyzed for asbestos using the method specified in 40 CFR Part 763, Subpart E, Appendix E, Section 1 (relating to Polarized Light Microscopy), by a laboratory accredited by the NVLAP for polarized light microscopy, or by using the EPA-recommended method listed in EPA/600/R-93/116 for transmission electron microscopy, are found to contain:(A) for purposes of complying with this chapter's provisions relating to a public building, 1.0% or more asbestos;(B) for purposes of complying with AHERA provisions relating to a school building, greater than 1.0% asbestos;(C) for purposes of complying with NESHAP provisions relating to commercial buildings and facilities, greater than 1.0% asbestos; or(D) for purposes of complying with OSHA provisions relating to occupational asbestos exposure, greater than 1.0% asbestos.(5) Act--The Texas Asbestos Health Protection Act, Texas Occupations Code, Chapter 1954.(6) ACWM--Asbestos-containing waste material. This term includes mill tailings or any waste material that contains asbestos and is generated by a source subject to the provisions of NESHAP or this chapter. This term includes filters from control devices, friable asbestos waste material, and bags or other similar packaging contaminated with asbestos. As applied to demolition and renovation operations, this term also includes RACM and materials contaminated with asbestos, including disposable equipment and clothing.(7) Adequately wet--Sufficiently mixed or penetrated with liquid to prevent the release of particulates. If visible emissions are observed coming from ACM, then that material is not adequately wet. However, the absence of visible emissions is not sufficient evidence of being adequately wet.(8) Aggressive air sampling--Collecting air samples after walls, ceilings, and floors are swept with the exhaust of an unaltered leaf blower that is operated per the manufacturer's instructions and is directed at all surfaces to cause loose asbestos fibers to become airborne.(9) AHERA--For purposes of this chapter, the Asbestos Hazard Emergency Response Act of 1986, 15 USC §2641, et seq., and EPA's implementing regulations under 40 CFR Part 763, Subpart E (relating to Asbestos-Containing Materials in Schools), adopted by reference as part of this chapter.(10) Airlock--A system for permitting movement into and out of the containment that controls air-flow patterns such that the air flows only towards the inside of the enclosure to which the decontamination system is attached. An airlock may consist of overlapping curtains, partitions to a separate chamber, or both.(11) Air monitoring--The collection of air samples for the analysis of fibers.(12) Amended water--Water to which a surfactant (wetting agent) has been added to increase the ability of the liquid to penetrate ACM.(13) Asbestos--The asbestiform varieties of chrysotile, amosite, crocidolite, tremolite, anthophyllite, and actinolite.(14) Asbestos abatement--Asbestos removal, encapsulation, or enclosure to reduce or eliminate, or that has the effect of reducing or eliminating, a concentration of asbestos fibers or an ACM.(15) Asbestos abatement activity--Asbestos abatement, or any on-site abatement preparations or cleanup related to the abatement.(16) Asbestos abatement project design--The design for an asbestos abatement project that includes, at minimum:(A) the review of the survey report of a public building for ACBM;(B) the evaluation and selection of appropriate asbestos abatement methods;(C) the preparation of the project layout;(D) the preparation of specifications and plans; and(E) the determination of environmental controls, abatement procedures, and personal protection equipment to be employed every day of the asbestos abatement activity, from the start through the completion date of the project.(17) Asbestos-related activity--Activities including:(A) the removal, encapsulation, or enclosure of asbestos, whether intentional or unintentional;(B) the preparations for final clearance;(C) the performance of an asbestos survey;(D) the development of an asbestos survey report, management plan, or response action;(E) the design of an asbestos abatement project;(F) the collection or analysis of a bulk asbestos sample;(G) the monitoring for airborne asbestos; or(H) any other activity for which a license is required under the Act.(18) Asbestos removal--Any action that disturbs, dislodges, strips, or otherwise takes away asbestos fibers or ACM.(19) ASTM E1494-18--The 2018 edition of the Standard Practice for Testing Physical Properties of Friable Surfacing Materials developed by ASTM International, www.astm.org.(20) Bag-out area--An area distinct from the decontamination area that is used to decontaminate asbestos waste bags before placing them into outer bags.(21) Building owner--The owner of record of a building.(22) Category I nonfriable ACM--Asbestos-containing packings, gaskets, resilient floor-covering material, and asphalt roofing products determined to be ACM.(23) Category II nonfriable ACM--Any material determined to be ACM, excluding Category I nonfriable ACM, that when dry, cannot be crumbled, pulverized, or reduced to powder by hand pressure.(24) CFR--The Code of Federal Regulations.(25) Commercial building--The interior space of any building that does not otherwise fall within the definition of a public building. Interior space includes exterior hallways connecting buildings, porticos, and mechanical systems used to condition interior space. This term includes industrial buildings, federal government-owned buildings, warehouses, and factories. This term does not include a detached single private residence or single apartment building with four or fewer dwelling units.(26) Commissioner--The commissioner of the Department of State Health Services.(27) Containment--A portion of the regulated area that has been sealed and placed under negative air pressure using negative air machines with HEPA filters.(28) Critical barrier--An impermeable barrier, such as plastic sheeting or dividing wall, sealing any opening between the containment and adjacent areas.(29) Decontamination area--An enclosed area consisting of an equipment room, shower room, and clean room that is used for the decontamination of persons, materials, and equipment that are contaminated with asbestos. This area is adjacent to, and where feasible, connected to, the containment.(30) Demolition--The wrecking or removal of any load-supporting structural member of a public building or facility for the purpose of razing the building or portion of the building to the ground, or the intentional burning of any public building or facility. The removal of load-supporting structural members followed by resupport of the structure is considered renovation, not demolition. Moving a building from its foundation is considered demolition.(31) Designated person--The individual designated by an LEA in accordance with, and to ensure compliance with, AHERA.(32) Disturbance--Activities that disrupt the matrix of ACM, render ACM friable, or generate visible debris from ACM.(33) DSHS--The Department of State Health Services.(34) Emergency renovation operation--A renovation operation that was not planned but results from a sudden, unexpected event that, if not immediately attended to, presents a safety or public health hazard, is necessary to protect equipment from damage, or is necessary to avoid imposing an unreasonable financial burden. This term includes operations necessitated by nonroutine failures of equipment or systems, such as water, steam, and electrical systems.(35) Emergency responder--Any person responsible for mitigation activities in a medical emergency, fire emergency, hazardous material emergency, or natural disaster.(36) Employee--A person who works in expectation of compensation in the service of an employer and whose work performance is subject to the direction and control of the employer.(37) Encapsulation--A method of control of asbestos fibers in which the surface of ACM is penetrated by or covered with a coating prepared for that purpose. Painting with a non-encapsulant that does not disturb asbestos is not an asbestos-related activity.(38) Enclosure--The construction of an airtight, impermeable, permanent wall and ceiling or comparable barrier around ACM to prevent the release of asbestos fibers into the air.(39) EPA--The United States Environmental Protection Agency.(40) Exposure assessment--A determination by an employer in accordance with 29 CFR §1926.1101(f) of the level of employee exposure to asbestos fibers by analyzing breathing zone air samples that are representative of an 8-hour time-weighted average and a 30-minute representative short-term exposure of each employee.(41) Facility--Any institutional, commercial, public, industrial, or residential structure, installation, or building (including any structure, installation, or building containing condominiums or individual dwelling units operated as a residential cooperative, but excluding a single residential building having four or fewer dwelling units); any ship; and any active or inactive waste disposal site. For purposes of this chapter, any building, structure, or installation that contains a loft used as a dwelling is not considered a residential structure, installation, or building.(42) Facility owner or operator--Any person who owns, leases, operates, controls, or supervises the facility being demolished or renovated or any person who owns, leases, operates, controls, or supervises the demolition or renovation operation, or both.(43) Federal government-owned building--Any building owned by the United States Federal Government. This term does not include space leased by the United States Federal Government.(44) Friable asbestos material--Any ACM that, when dry, can be crumbled, pulverized, or reduced to powder by hand pressure.(45) HEPA--A high-efficiency particulate air filtration, capable of trapping and retaining 99.97% of mono-dispersed airborne particles that are 0.3 micron or larger in diameter.(46) HVAC--Heating, ventilation, and air conditioning.(47) Independent third-party air monitor--A person retained to collect area air samples to be analyzed for the owner of the building or facility being abated.(48) Installation--A building or structure, or group of buildings or structures, at a single demolition or renovation site controlled by the same owner or operator. A project involving a single private residence or a single apartment building with no more than four dwelling units is not considered an installation. When there are two or more residential buildings on the same site that are controlled by the same owner or operator, the buildings are considered an installation under NESHAP.(49) Intact--As defined in 29 CFR §1926.1101(b), ACM that has not crumbled, been pulverized, or otherwise deteriorated so that the asbestos is no longer likely to be bound with its matrix.(50) Layer--Any constituent of an asbestos bulk sample that exhibits different physical properties, such as color or composition, and can be separated from the rest of the sample with an instrument, such as a modeler's knife.(51) LEA--Local education agency. An LEA includes:(A) a public board of education or other public authority legally constituted within a state for either administrative control or direction of, or to perform a service function for, public elementary or secondary schools in a city, county, township, school district, or other political subdivision of a state, or such combination of school districts or counties as are recognized in a state as an administrative agency for its public elementary or secondary schools;(B) any other public institution or agency having administrative control and direction of a public elementary or secondary school; and(C) the owner of any nonpublic, nonprofit elementary or secondary school building.(52) License--Any license or registration issued under this chapter.(53) Licensee--A person who has been issued a license or registration by DSHS under this chapter.(54) Major fiber release episode--Any uncontrolled or unintentional disturbance of ACBM, resulting in a visible emission, which involves the falling or dislodging of more than three square feet or three linear feet of friable ACBM.(55) Management plan--A written plan for a public building that describes appropriate actions for surveillance and management of ACM in the building.(56) MAP--Asbestos Model Accreditation Plan. As described in Appendix C (relating to Asbestos Model Accreditation Plan) of AHERA and adopted by reference into this chapter, EPA's model accreditation plan that provides standards for initial training, examinations, refresher training courses, applicant qualifications, decertification, and reciprocity.(57) Mini-containment--A small walk-in containment that accommodates no more than two people and conforms to its localized work area. A mini-containment is constructed of 6-mil thick plastic sheeting or the equivalent and is kept under negative pressure by means of a HEPA vacuum or similar ventilation unit as described for a mini-enclosure in 29 CFR §1926.1101(g)(5)(vi).(58) MSDS--Material safety data sheet. (See also the definition of SDS.)(59) Municipality--A general-law, home-rule, or special-law municipality as defined in the Texas Local Government Code §1.005 (relating to Definitions).(60) Negative exposure assessment--A demonstration by an employer in accordance with 29 CFR §1926.1101(f) that employee exposure during an operation is expected to remain below the PELS for the duration of the applicable asbestos-related activity.(61) NESHAP--The EPA National Emission Standards for Hazardous Air Pollutants specific to asbestos, in 40 CFR Part 61, Subpart M (relating to National Emission Standard for Asbestos), as adopted by reference in this chapter.(62) NIOSH--The National Institute for Occupational Safety and Health.(63) Nonfriable ACM--ACM that, when dry, cannot be crumbled, pulverized, or reduced to powder by hand pressure.(64) Nonscheduled renovation operation--A renovation operation necessitated by the routine failure of equipment, which is expected to occur within a given period based on past operating experience, but for which an exact date cannot be predicted.(65) NVLAP--National Voluntary Laboratory Accreditation Program. NVLAP is a federal program administered by the National Institute of Standards and Technology, an office of the U.S. Department of Commerce. NVLAP provides third-party accreditation to testing and calibration laboratories based on evaluation of their technical qualifications and competence to carry out specific calibrations or tests. Accreditation procedures and requirements are described in 15 CFR Part 285 (relating to National Voluntary Laboratory Accreditation Program), which references clauses 4 and 5 of the international standard, ISO/IEC 17025, as the criteria for accreditation.(66) O&M activity--Operations and maintenance activity that includes repairs, maintenance, renovation, installation, replacement, or cleanup of building materials or equipment.(67) OSHA--The Occupational Safety and Health Administration, part of the U.S. Department of Labor.(68) OSHA regulations--Regulations found in 29 CFR (relating to Labor), including 29 CFR §1926.1101 and portions of 29 CFR Parts 1926 (relating to Safety and Health Regulations for Construction) and 1910 (relating to Occupational Safety and Health Standards), as referenced in this chapter or otherwise applicable to a person subject to this chapter.(69) Owner or operator of a demolition or renovation activity--Any person who owns, leases, operates, controls, or supervises a facility being demolished or renovated, or any person who owns, leases, operates, controls, or supervises the demolition or renovation operation, or both.(70) PELS--Permissible exposure limits, as described in 29 CFR §1926.1101(c).(71) Permit--A license, certificate, approval, registration, consent, or other form of authorization that a person is required by law, rule, regulation, order, or ordinance to obtain to perform an action, or initiate, continue, or complete a project.(72) Person--A person is:(A) an individual, including a sole proprietorship; or(B) a corporation, partnership, governmental subdivision or agency, association, or any other legal entity.(73) Planned renovation operation--A renovation operation, or a number of renovation operations, in which some RACM will be removed or stripped within a given period of time and that can be predicted. Individual nonscheduled renovation operations are included if a number of renovation operations can be predicted to occur during a given period of time based on operating experience.(74) Public building--The interior space of a building used, either in the past or at present, or to be used, for a purpose that involves public access or occupancy, such as a school, hospital, or prison. Interior space includes exterior hallways connecting buildings, porticos, and mechanical systems used to condition interior space. The term includes any such interior space during a period of vacancy, including the period during preparations before demolition. The term does not include:(A) an industrial facility to which access is limited principally to employees of the facility because of processes or functions that are hazardous to human safety or health;(B) a federal government-owned building or installation (civilian or military);(C) a private residence;(D) an apartment building with no more than four dwelling units;(E) a manufacturing facility or building that is part of a manufacturing facility, to which access is limited to workers and invited guests under controlled conditions;(F) a building, facility, or any portion of which, before demolition, has been determined to be structurally unsound and in danger of imminent collapse by a professional engineer or a city, county, or state government official; or(G) the portion of a building that has become structurally unsound due to demolition.(75) Public school--An elementary or secondary school operated by publicly elected or appointed school officials in which the program and activities are under the control of these officials and that is supported primarily by public funds.(76) RACM--Regulated asbestos-containing material. RACM means:(A) friable asbestos material;(B) Category I nonfriable ACM that has become friable;(C) Category I nonfriable ACM that will be or has been subjected to sanding, grinding, cutting, or abrading; or(D) Category II nonfriable ACM that has a high probability of becoming or has become crumbled, pulverized, or reduced to powder by the forces expected to act on the material in the course of demolition or renovation operations.(77) Regulated area--An area where on-site asbestos-related activity is performed, and any adjoining area where debris and waste accumulate from such asbestos-related activity, including any area within which airborne concentrations of asbestos exceed or there is a reasonable possibility they may exceed the PELS, in accordance with 29 CFR §1926.1101 (relating to Asbestos).(78) Renovation--Additions to or alterations of a building, including by removal, repairing, or rebuilding.(79) Resilient floor-covering material--For purposes of this chapter, this term includes adhesives, sheet vinyl flooring, and resilient tile, such as vinyl composition tile, asphalt tile, and rubber tile.(80) Response action--A method, including removal, encapsulation, enclosure, repair, and operations and maintenance that protects human health and the environment from friable ACBM.(81) Responsible person--The individual that is appointed by the licensed asbestos abatement contractor, asbestos operations and maintenance contractor, asbestos laboratory, asbestos consultant agency, asbestos management planner agency, or asbestos training provider as responsible for compliance with the requirements for the licensee under this chapter.(82) RFCI--Resilient Floor Covering Institute.(83) School--Any day or residential public or private non-profit elementary or secondary school, kindergarten through grade 12.(84) School building--Any structure suitable for use as a classroom, including:(A) a school facility, such as a laboratory, library, eating facility, or facility used for the preparation of food;(B) a gymnasium or other facility that is specially designed for athletic or recreational activities for an academic course in physical education;(C) a facility used for the instruction or housing of students or for the administration of educational or research programs;(D) a maintenance, storage, or utility facility, including any hallway, essential to the operation of any of the preceding facilities described in this definition;(E) a portico or covered exterior hallway or walkway; or(F) an exterior portion of a mechanical system used to condition interior space.(85) SDS--Safety data sheet. A written or printed material concerning a hazardous chemical that is prepared in compliance with OSHA regulations in 29 CFR §1910.1200(g) (relating to Hazard communication). This term reflects a change in terminology from MSDS and updated format requirements, based upon the adoption of the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals.(86) Specifications and plans--Site-specific asbestos abatement description, consisting of:(A) a clear and understandable written description of the determinations made during the asbestos abatement project design, including the work to be performed, such as asbestos abatement methods and air clearance procedures to be used, abatement preparations to be made, and equipment to be used; and(B) drawings, floor plans, or the equivalent, that distinctly display the location of asbestos abatement activities and equipment to be used with a level of detail and in a size sufficient to make each location visually discernable.(87) SSSD activities--Small-scale, short-duration activities are work operations where a negative-pressure containment cannot be constructed because of the configuration of the work environment. SSSD activities include tasks, such as removal of asbestos-containing insulation on pipes, removal of small quantities of asbestos-containing insulation on beams or above ceilings, replacement of an asbestos-containing gasket on a valve, installation or removal of a small section of drywall, or installation of electrical conduits through or proximate to ACM. SSSD activities can be further defined as the following:(A) removal of small quantities of ACM only if required in the performance of another maintenance activity not intended as asbestos abatement;(B) removal of asbestos-containing TSI, not to exceed amounts greater than those that can be contained in a single, standard (60 inches by 60 inches) glove bag and not intended as asbestos abatement;(C) minor repairs to damaged TSI that do not require removal;(D) repairs to a piece of asbestos-containing wallboard; and(E) repairs, involving encapsulation, enclosure, or removal, to small amounts of ACM only if required in the performance of emergency or routine maintenance activity and not intended solely as asbestos abatement. Such work may not exceed amounts greater than those which can be contained in a single prefabricated mini-containment.(88) SSSD O&M activity--An O&M activity that is limited to SSSD activities.(89) Start date--The date defined as:(A) Asbestos abatement start date. For the purpose of notification to DSHS as required in §296.251 of this chapter (relating to Notifications), the date that the actual disturbance of asbestos begins. Abatement preparation that does not disturb asbestos is not the asbestos abatement start date.(B) Demolition start date. The date that the demolition begins. Asbestos preparation that does not wreck or remove a load-bearing structural member or move a building from its foundation is not the demolition start date.(90) Stop date--The date defined as:(A) Asbestos abatement stop date (completion date).(i) For the purpose of notification to DSHS as required in §296.251 of this chapter, the date that clearance is achieved as described in §296.211(h)(C)(iii) of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building).(ii) For removal of resilient floor-covering material in accordance with §296.171 of this chapter (relating to Removal of Resilient Floor-Covering Material), the asbestos abatement stop date is the date that the ACBM is removed from the substrate and properly containerized as required in the RFCI work practices.(iii) For NESHAP projects, the asbestos abatement stop date is the date that all RACM is removed from the substrate and properly containerized.(B) Demolition stop date (completion date). In public buildings, commercial buildings, or facilities that do not contain RACM, the date that the wrecking or removal operations of load-bearing structural components or both are completed. In structurally unsound buildings or facilities that contain RACM, the demolition stop date is the date that load-bearing structural components are removed and RACM is containerized or removed from the site in accordance with 40 CFR §61.150 (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations).(91) Surfacing material--Material that is sprayed on, troweled on, or otherwise applied to surfaces, such as acoustical plaster on ceilings and fireproofing materials on structural members, or other materials on surfaces for acoustical, fireproofing, or other purposes.(92) Survey--An inspection activity undertaken in a public building, commercial building, or facility to determine the quantities and locations of homogeneous areas of ACBM by assuming suspect material or collecting samples of such material and assessing its condition, whether by visual or physical examination.(A) This term includes reinspections of friable and nonfriable known or assumed ACBM previously identified, as described in 40 CFR §763.85(b) (relating to Inspection and reinspections).(B) This term does not include:(i) a periodic surveillance as described in 40 CFR §763.92(b) (relating to Training and periodic surveillance) performed solely for the purpose of recording or reporting a change in the condition of known or assumed ACBM;(ii) an inspection performed by an employee or agent of federal, state, or local government solely for the purpose of determining compliance with applicable statutes or regulations; or(iii) a visual inspection of the type described in 40 CFR §763.90(i) (relating to Response actions) solely for the purpose of determining proper completion of a response action.(93) Survey report--A report that contains:(A) for a public building:(i) a written description, diagram, or both that clearly and accurately identifies and reflects the location of each homogeneous area of suspected ACBM that is assumed to be ACM or was sampled for ACM, including the sampling location for each bulk sample and the dates that each sample was collected;(ii) a written description of:(I) the manner used to determine sampling locations;(II) the estimated amount of ACBM in each homogeneous area in square feet or, for ACBM on piping, in linear feet;(III) the type of material sampled; and(IV) the condition and friability of the ACBM, and the assessment of ACBM must conform to generally accepted industry standards, such as the AHERA requirements specified in 40 CFR Part 763, Subpart E (relating to Asbestos-Containing Materials in Schools), §§763.85 - 763.88, which is the required method for schools;(iii) the name, signature, and, as applicable, accreditation and state of accreditation or license number of the inspector performing each activity;(iv) the name, signature, and as applicable, accreditation and state of accreditation or license number of the licensed management planner or consultant employing the licensed asbestos inspector performing each activity; and(v) a copy of the analyses of any bulk samples, the dates of analyses, and a copy of any other laboratory reports pertaining to the analyses; or(B) for a NESHAP facility, a record of the thorough inspection of the affected facility or part of the facility where the demolition or renovation operation will occur for the presence of asbestos, including Category I and Category II nonfriable ACM that identifies:(i) the location of ACM; and(ii) the inspector that performed the survey.(94) TSI--Thermal system insulation. TSI is ACM applied to pipes, fittings, boilers, breeching, tanks, ducts, or other interior structural components to prevent heat loss or gain, water condensation, or for other similar purposes.(95) USC--The United States Code.(96) Working days--Monday through Friday, including a holiday that falls on one of those days. Source Note: The provisions of this §296.21 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION B DEFINITIONS §296.21 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205397&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205397 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205397&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205397 03/11/2026 (a) Independent third-party air monitoring. The public building owner or authorized representative must provide for an appropriately licensed third party to perform area monitoring and project clearance monitoring for airborne concentrations of asbestos fibers during an abatement project, as required in §296.211(h)(1) of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building). The third party who analyzes an area sample collected during the abatement project must not be employed or subcontracted for that purpose by an asbestos abatement contractor hired to conduct the asbestos abatement project by or for the owner except that an O&M contractor who owns or manages the building may hire a licensed air monitoring technician, licensed air monitoring technician project monitor, or a licensed asbestos consultant to perform air clearance monitoring for that building as required in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building).(b) Licensee conflict of interest.(1) Without limiting the restrictions of §1954.254 and §1954.255 of the Act, for a project in a public building:(A) a licensed asbestos consultant or licensed asbestos consultant agency for the project must not hire a licensed asbestos abatement contractor for the same project;(B) a licensed asbestos abatement contractor for the project must not hire a licensed asbestos consultant or a licensed asbestos consultant agency for the same project, except that a licensed asbestos consultant or licensed consultant agency may be hired to collect and analyze personal samples to evaluate worker exposure, in accordance with 29 CFR §1926.1101 (relating to Asbestos);(C) a person that is a licensed asbestos abatement contractor and licensed asbestos consultant must not act in both capacities on the same project; and(D) a licensed asbestos management planner, licensed asbestos management planner agency, or licensed asbestos inspector that is also a licensed asbestos abatement contractor must not act as the asbestos abatement contractor on a project for which the licensee also performed a survey or, if otherwise authorized by the person's license, developed the management plan.(2) A person must not be the responsible person for two companies that hold the same type of license.(c) Municipality exemption. Notwithstanding subsection (b) of this section, a municipality may hire a licensed person to perform asbestos surveys, write management plans, design abatement projects, and abate asbestos in the same building or facility, consistent with the scope of the individual's licensure. This exemption does not relieve a municipality from the requirements of subsection (a) of this section. Area and project clearance monitoring activities must be performed by an independent third party who is not an employee of the municipality. Source Note: The provisions of this §296.31 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION C STANDARDS OF CONDUCT §296.31 Conflict of Interest https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205398&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205398 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205398&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205398 03/11/2026 (a) License and registration requirements. A person must be licensed or registered in compliance with the Act and this chapter to perform any asbestos abatement or asbestos-related activity that requires a license or registration under the Act or this chapter.(b) Qualifying work experience.(1) A licensee who performs supervision for any form of pre-licensure work experience required to obtain a license under any of the following provisions must provide direct, in-person supervision in the immediate proximity of the trainee and is the responsible licensee for such supervised acts.(2) For the purpose of determining the work experience required under this chapter for an initial license, eight hours of qualifying on-the-job work experience equals one day of the required work experience.(3) Work experience gained from performing removal of resilient floor-covering material under this section does not apply toward the training or work experience requirements for a registration or license to perform other asbestos-related activities.(c) Age requirement. An individual applying for a license or registration under this chapter must be at least 18 years old.(d) Term and expiration. The term of a new license or registration is two years and expires on the second anniversary of the issue date. The term of a renewal license or registration is two years after the date the previous license or registration expires.(e) License or registration card. A license or registration identification card issued by DSHS is valid for the person named on the card until the license or registration expires or is revoked.(f) Responsibility to report violations. A licensee who becomes aware of a violation of this chapter must report the violation to DSHS within 24 hours after becoming aware of the violation if the violation is not immediately corrected by the responsible party. The phone number to report a violation is on the Violation Notification Procedure poster that must be posted at the entrance to the regulated area as required in §296.211(i) of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building).(g) Prohibition. A licensee is subject to disciplinary action, in addition to a violation of the Act or this chapter, if the licensee engages in the following activities:(1) alters, sells, assigns, or transfers a license or registration issued in accordance with this chapter;(2) makes any false, misleading, or deceptive claim in any asbestos-related advertising, announcement, presentation, or competitive bidding; or(3) engages in activities prohibited in §296.271 of this chapter relating to (Inspections and Investigations) or §296.313 of this chapter (relating to Denial, Suspension, or Revocation of License or Reprimand of Licensee).(h) Penalties. A licensee is subject to applicable administrative, civil, and criminal sanctions for any violation as described in Subchapter Q of this chapter (relating to Compliance). State and federal violations and citations become a part of a licensee's DSHS record. Source Note: The provisions of this §296.41 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.41 License and Registration Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205399&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205399 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205399&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205399 03/11/2026 (a) General requirements. To apply for a license or registration as required in this chapter, an applicant must submit a complete and signed application on the form provided by DSHS. DSHS will not accept an altered application form. A complete application includes all required documentation and payment of the application fee by check, money order, or proof of online payment. An applicant who applies for more than one license or registration must submit all required documentation with each application.(b) Processing applications.(1) Upon receipt of a complete application, DSHS will issue the following documents within the time periods set forth below, as applicable:(A) license or identification (ID) card, or letter of acceptance:(i) for a training provider license--90 days; and(ii) for any other license or registration--45 days;(B) letter of approval for examination--30 days;(C) approval of additional training course--90 days; and(D) duplicate license or ID card--30 days.(2) If an application is incomplete, DSHS will issue a deficiency notice within the time periods set forth below:(A) for a training provider license--90 days;(B) for any other license or registration--45 days;(C) for an examination request--30 days.(3) If an application remains incomplete after the deadline provided in the deficiency notice issued under subsection (b)(2) of this section, DSHS will issue a notice of proposed denial of license, registration, or examination, as applicable.(c) Denial. DSHS may deny an application for license or registration of a person for fraud or misrepresentation or for failure to meet the standards established by this chapter, as described in Subchapter Q of this chapter (relating to Compliance). This includes §296.313 of this chapter (relating to Denial, Suspension, or Revocation of License or Reprimand of Licensee), and as required in §296.315 of this chapter (relating to Suspension of License under Texas Family Code Chapter 232), or for any reason allowed by law.(d) Renewal notices. DSHS sends a renewal notice to the licensee before the license expires. However, a licensee must renew a license before the license expiration date, even if the licensee does not receive a renewal notice. The renewal notice includes the following:(1) the license type;(2) the time period allowed for renewal; and(3) the applicable renewal fee.(e) Renewal requirements.(1) A license may not be renewed more than 60 days before or more than one year after the license expires. An applicant may renew a license if the applicant:(A) meets the requirements to renew the license;(B) pays the required fee;(C) submits a renewal application along with all required documentation; and(D) has complied with all final orders resulting from any violation of this chapter.(2) If a licensee submits an incomplete application, including an application resubmitted in response to a deficiency letter, and the application is not complete, or the deficiency resolved before the license expiration date, the license expires on the expiration date and engaging in activities for which a license is required is a violation of this chapter. If a licensee submits a complete renewal application with the required fee and documentation before the license expires, the current license does not expire until DSHS approves or denies the application.(f) Re-application for license. A person whose license has expired must not engage in activities for which the license is required. If a license has been expired for more than one year, the person may not renew the license. The person may obtain a new license by complying with the requirements and procedures at the time of application for obtaining an initial license, including the examination requirements.(g) Application for duplicate license. A licensee may obtain a duplicate or replacement license by submitting:(1) an application for a duplicate license;(2) an unaltered, 2-inch by 2-inch, color photograph of the face (without tinted glasses, hats, bandanas, or other articles that may obscure the head or any part of the face) with a white background taken within the past 12 months and submitted either on photo quality paper or in digital format; and(3) the required fee.(h) Name change. A licensee must submit a name change application and required fee to change the name currently on record. DSHS does not charge a separate name change fee if the applicant submits the name change application with the renewal application. The name change application must be submitted with a copy of a divorce decree, marriage certificate, legal name change document, driver's license, or social security card showing the new name. If the tax identification number for a company has changed, a new license must be obtained.(i) Physician's written statement. A copy of DSHS's Physician's Written Statement form must be submitted with all individual applications to document that the applicant has received a medical examination within the past 12 months, in accordance with 29 CFR §1926.1101(m) (relating to Asbestos) or 40 CFR §763.122 (relating to What does this subpart require me to do?), whichever is applicable. A current copy of the individual's Physician's Written Statement form must be on-site while performing asbestos-related activities. Source Note: The provisions of this §296.42 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.42 Initial and Renewal Applications https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205400&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205400 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205400&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205400 03/11/2026 (a) Any degrees or academic credit earned in the United States must be from a college or university that has a program accredited by a national accrediting organization that is also recognized by the United States Secretary of Education under the Higher Education Act of 1965 (20 USC §1001, et seq.).(b) Any degrees and academic credit received from a university outside the United States may apply toward the education requirement for a license only if the course work and degrees could be counted as transfer credits by universities described in subsection (a) of this section. An applicant must furnish, at the applicant's own expense, an original or certified copy of an evaluation of each foreign degree from a credential evaluation service that is acceptable to DSHS. An applicant must show proof of each degree and the date it was awarded by submitting an original or certified copy of each applicable transcript. Documents written in a language other than English must also be accompanied by a certified English translation.(c) A high school diploma or equivalency diploma received from a school outside the United States may apply toward the education requirement for a license only if the education is equivalent to a diploma or equivalency diploma issued in the United States. An applicant must furnish, at the applicant's own expense, an original or certified copy of an evaluation of each foreign diploma from a credential evaluation service that is acceptable to DSHS. An applicant must show proof of each diploma and the date it was awarded by submitting an original or certified copy of the diploma. A document written in a language other than English must also be accompanied by a certified English translation. Source Note: The provisions of this §296.43 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.43 Acceptable Academic Credit https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205401&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205401 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205401&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205401 03/11/2026 (a) Qualifications. Out-of-state applicants must comply with all licensing qualifications that are required for Texas residents.(b) Documentation of education, experience, training, and medical examinations acquired out of state must be verifiable. DSHS may approve applications with out-of-state documentation on a case-by-case basis. If DSHS is unable to verify the documentation, the applicant is responsible for verifying the documentation.(c) Texas Asbestos Law and Rules course. A person applying for an initial or renewal license or registration who did not receive any of the required training for that license or registration from a DSHS-licensed training provider must complete a three-hour Texas Asbestos Law and Rules course. The Texas Asbestos Law and Rules course must be completed within one year before DSHS receives the license or registration application. A training course taken from a DSHS-licensed training provider in an asbestos licensure or accreditation category other than the one for which license or registration is sought may substitute for the Texas Asbestos Law and Rules course.(d) Interstate commerce. A foreign entity, as defined in Texas Business Organizations Code §1.002, that transacts business only in interstate commerce may qualify as not transacting business in Texas if the entity submits a statement with its license application that the entity engages only in interstate commerce, does not transact business in Texas, and is not a foreign entity that is required under Texas law to register with the Secretary of State. The statement must be in the form of a sworn affidavit from an individual authorized to make the statement on behalf of the entity.(e) Formerly licensed in Texas. A person who was licensed by DSHS, moved to another state, and is currently licensed in the other state and has been in practice there for the two years preceding the date of application, may obtain a new DSHS license without reexamination. The person must pay to DSHS a fee that is equal to two times the normally required renewal fee for the license term. The person must meet all other qualifications applicable to the new license.(f) Provisional license or registration. A person who is currently licensed or registered as an asbestos abatement worker, asbestos abatement supervisor, asbestos inspector, or asbestos management planner in another state, including a foreign country, may request a provisional license or registration in the same discipline.(1) A person may receive a provisional license or registration issued by DSHS if:(A) the person has been licensed or registered in good standing for at least two years in another state, including a foreign country, that has licensing or registration requirements substantially equivalent to the requirements in this chapter;(B) the person has passed a national or other examination recognized by DSHS relating to the provisional license requested;(C) the person pays the nonrefundable provisional license or registration fee set forth in §296.91 of this chapter (relating to Fees); and(D) the person is sponsored by a company that meets the insurance requirements of §296.45 of this chapter (relating to Insurance Requirements) with whom the person will practice during the time the person holds a provisional license or registration. DSHS may waive the requirement of sponsorship for an applicant if DSHS determines that compliance with §296.45 would be a hardship to the applicant.(2) A provisional license or registration is valid until the date DSHS approves or denies the provisional license or registration holder's application for licensing or registration, or 180 days after the date the provisional license or registration is issued, whichever comes first.(3) A person who holds a provisional license or registration issued in accordance with this section may apply for a license or registration if the applicant provides documentation showing successful completion of the Texas Asbestos Law and Rules course described in §296.73 of this chapter (relating to Asbestos Training Courses), pays the required licensing fee in addition to the provisional license or registration fee as outlined in §296.91 of this chapter, and meets the requirements in §296.46 of this chapter (relating to Initial and Renewal Licensure Requirements for an Individual), as applicable. Source Note: The provisions of this §296.44 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.44 Out-of-State Applicants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205402&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205402 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205402&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205402 03/11/2026 (a) Liability insurance. Without limiting any other applicable requirement of law, for purposes of this chapter:(1) Each applicant and licensee who performs asbestos-related activities and who is required under §1954.105(c) of the Act or this subchapter to maintain specified liability insurance as a condition of licensure must meet the insurance and proof requirements of:(A) this section;(B) the sections of this subchapter applicable to each license they hold; and(C) §1954.105(c) of the Act.(2) The required liability insurance for each applicant and licensee must include coverage in the amount of at least $1 million per occurrence.(3) Each applicant and licensee required to have specified liability coverage for work performed for hire must obtain individual coverage, unless covered as required under the insurance of the individual's licensed employer. An applicant or licensee may satisfy applicable liability insurance requirements through coverage under the policy of that person's licensed employer only to the extent that the activities of the applicant or licensee requiring a license are performed on behalf of that employer.(4) Each applicant and licensee must obtain, and submit with any license application, a certificate of insurance issued for the purpose of licensing in accordance with §1954.105(c) of the Act and this subchapter that verifies the liability coverage required under the Act and this subchapter for each license the applicant or licensee holds.(A) A policy for the required liability coverage must be issued by a company or other person that is specifically authorized in Texas, for all relevant purposes, to issue the applicable policy. The applicant or licensee must provide any information requested by DSHS to demonstrate such authority.(B) A governmental or other authorized applicant or licensee that is authorized by law to do so may provide proof of required liability coverage through a form other than a certificate of insurance for purchased insurance if it otherwise meets the requirements of this paragraph.(i) An applicant or licensee that provides proof of required liability coverage under this subparagraph must identify the form of required liability coverage and provide any information requested by DSHS concerning that form and the authority for that form.(ii) An applicant or licensee that is otherwise subject to specific requirements for liability coverage under this subchapter may request a variance from a requirement of this subchapter based upon a demonstrated legal limitation to meeting that requirement, and a demonstrated alternative method for assessing and addressing the risks otherwise addressed by the required liability coverage.(b) Pollution liability insurance. In addition to the liability insurance required by subsection (a)(2) of this section, each asbestos abatement contractor and asbestos transporter applicant and licensee must obtain liability insurance that includes pollution liability coverage for asbestos exposure in the amount of at least $1 million per occurrence.(c) Workers' compensation.(1) An applicant or licensee who is an employer, as defined for purposes of the Texas Labor Code, Title 5, Subtitle A (relating to Texas Workers' Compensation Act) and who is not otherwise required by law to have workers' compensation insurance must, for purposes of this chapter, have and provide proof with the license application of workers' compensation insurance, except as otherwise provided under this paragraph. If an applicant is otherwise required by law to have workers' compensation insurance, the applicant must verify such insurance at the time of license application, as required under paragraph (2) of this subsection.(A) Proof of workers' compensation insurance is not required if an applicant or licensee who certifies that the individual or entity will not use the applicable license for any activity for which workers' compensation insurance is required by the owner of a public building, or by the specifications and plans for the asbestos-related activity. Such certification may be utilized when a person applies for a license or renews it for a term during which the person will not utilize the license.(B) If, during the license term of a licensee who has made a certification under subparagraph (A) of this paragraph, the licensee engages in asbestos-related activity with respect to a public building for which its owner requires workers' compensation insurance, or for which the specifications and plans for the asbestos-related activity require workers' compensation insurance, the licensee must submit the proof of workers' compensation insurance required under this subsection.(2) Verification of workers' compensation required under paragraph (1) of this subsection must be provided to DSHS with an applicant or licensee's application in the following form:(A) proof of workers' compensation insurance for asbestos-related activities performed in Texas and issued in compliance with Texas law on the appropriate form; or(B) proof of self-insurance authorized in accordance with the Texas Workers' Compensation Act or Texas Labor Code, Title 5, Subtitle C (relating to Workers' Compensation Insurance Coverage for Certain Government Employees);(i) an applicant or licensee other than a governmental entity must submit proof of self-insurance approval from the applicable authority; or(ii) a governmental entity that self-insures must submit any documentation requested by DSHS to verify its self-insurance status in accordance with applicable authority.(d) Policy cancellation notification. The licensee must notify DSHS at least 10 days before the effective date of a policy cancellation by the licensee or the insurance company. The licensee must promptly replace the policy without lapse in coverage and submit the proof required under this section for the applicable coverage.(e) Policy expiration. Before a policy expires, the licensee must promptly replace or renew the policy without lapse in coverage and must submit the proof required under this section for the applicable coverage.(f) A licensee must not engage in an asbestos abatement activity or asbestos-related activity in a public building if not insured in accordance with §1954.105(c) of the Act and this section. Source Note: The provisions of this §296.45 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.45 Insurance Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205403&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205403 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205403&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205403 03/11/2026 (a) Initial and renewal licensure and registration requirements. To receive or renew a license or registration for an asbestos abatement worker, asbestos abatement supervisor, asbestos operations and maintenance (O&M) supervisor, asbestos inspector, asbestos air monitoring technician, asbestos air monitoring technician project monitor (AMT/PM), asbestos management planner, asbestos consultant, or asbestos project manager, an applicant must submit a complete application as required under §296.42 of this chapter (relating to Initial and Renewal Applications) and the documentation required in this section. An out-of-state applicant must comply with §296.44 of this chapter (relating to Out-of-State Applicants).(b) Initial requirements. An applicant for an initial license or registration must submit the following:(1) A copy of DSHS's Physician's Written Statement form that documents a medical examination performed within the past 12 months, as required in §296.42(i) of this chapter.(2) Copies of the initial training certificates and any refresher training courses to show current accreditation under §296.73 of this chapter (relating to Asbestos Training Courses) for the following licenses, as applicable:(A) an asbestos abatement worker--the initial Asbestos Abatement Worker course, and the Asbestos Contractor/Supervisor course may be substituted for the Asbestos Abatement Worker course and all subsequent refresher training courses must be for the same course taken as the initial training;(B) an asbestos abatement supervisor or asbestos O&M supervisor--the initial Contractor/Supervisor course;(C) an asbestos inspector--the initial Asbestos Inspector course;(D) an asbestos air monitoring technician--the initial Asbestos Air Monitoring Technician course;(E) an AMT/PM--the initial Asbestos Air Monitoring Technician and Asbestos Contractor/Supervisor courses;(F) an asbestos management planner--the initial Asbestos Inspector and initial Asbestos Management Planner courses;(G) an asbestos consultant--the initial Asbestos Project Designer, Asbestos Inspector, Asbestos Management Planner, and Asbestos Air Monitoring Technician courses; and(H) an asbestos project manager--the initial Asbestos Contractor/Supervisor course.(3) A copy of the current photo-identification card issued by the training provider.(4) An unaltered, 2-inch by 2-inch, color photograph of the face (without tinted glasses, hats, bandanas, or other articles that may obscure the head or any part of the face) with a white background taken within the past 12 months and submitted either on photo quality paper or in digital format.(5) Proof of passing the DSHS examination as required in Subchapter G of this chapter (relating to State Licensing Examination), as applicable, for:(A) an asbestos abatement supervisor or asbestos O&M supervisor--DSHS's Asbestos Contractor/Supervisor examination;(B) an asbestos inspector--DSHS's Asbestos Inspector examination;(C) an asbestos air monitoring technician--DSHS's Air Monitoring Technician examination;(D) an AMT/PM--DSHS's Air Monitoring Technician and Asbestos Contractor/Supervisor examinations;(E) an asbestos management planner--DSHS's Asbestos Management Planner examination;(F) an asbestos consultant--DSHS's Asbestos Consultant examination; and(G) an asbestos project manager--DSHS's Asbestos Contractor/Supervisor examination.(6) Written documentation of qualifying work experience as described in §296.41(b)(2) of this chapter (relating to License and Registration Requirements) for the following licensees, including contact information for the person who supervised the applicant and can verify the work experience for:(A) an asbestos abatement supervisor--at least 90 days of verifiable qualifying work experience gained within the past 24 months from one or more of the following categories, as needed to fulfill the requirements:(i) work experience as a licensed asbestos worker, asbestos abatement supervisor (during previous Texas or out-of-state licensure), AMT/PM, asbestos consultant, or asbestos project manager;(ii) work experience as a MAP-accredited asbestos abatement worker, asbestos abatement supervisor, or asbestos project designer in Texas or another state, or as a MAP-accredited asbestos project monitor in another state conducting activities for which either a Texas license or a license in another state was not required, or for which the applicant held the required license; or(iii) work experience performing air monitoring as a licensed or trained asbestos air monitoring technician or AMT/PM on at least five asbestos abatement projects; and(I) work experience must have been gained while the license was current or after completion of training required under this chapter;(II) if an applicant is relying on work experience as a trained air monitoring technician or AMT/PM, the applicant must have been authorized to perform the activity in the state where the work experience occurred, or must have performed the air monitoring within the immediate proximity and under the in-person and direct supervision of a licensed air monitoring technician, licensed AMT/PM, or licensed consultant; and(III) no more than 30 days of air monitoring work experience as a licensed or trained asbestos air monitoring technician or AMT/PM may be counted towards the work experience requirements;(B) an asbestos inspector--participation in at least five asbestos surveys performed within immediate proximity and under the in-person and direct supervision of a licensed asbestos inspector, licensed management planner, or licensed asbestos consultant, and work experience must have been gained after completion of training required for licensure as an asbestos inspector under this chapter;(C) an air monitoring technician--performing air monitoring on at least three asbestos abatement projects for a total of at least 15 days, within the immediate proximity and under the in-person and direct supervision of a licensed air monitoring technician, licensed AMT/PM, or licensed asbestos consultant working for a licensed asbestos laboratory or licensed asbestos consultant agency, and work experience must be gained after completion of the Asbestos Air Monitoring Technician course as described in §296.73 of this chapter;(D) an AMT/PM--at least 30 days of verifiable qualifying work experience gained within the past 24 months that includes:(i) performing air monitoring on at least three asbestos abatement projects for a total of at least 15 days, within the immediate proximity and under the in-person and direct supervision of a licensed air monitoring technician, licensed AMT/PM, or licensed asbestos consultant working for a licensed asbestos laboratory or licensed asbestos consultant agency, and work experience must be gained after completion of the Asbestos Air Monitoring Technician course as described in §296.73 of this chapter; and(ii) any combination of qualifying work experiences from one or more of the following categories, as needed to fulfill the requirements:(I) work experience as a licensed asbestos abatement worker, licensed asbestos abatement supervisor, licensed air monitoring technician, or licensed asbestos consultant during previous Texas or out-of-state licensure, or a licensed AMT/PM or licensed project manager during previous Texas licensure;(II) work experience as a MAP-accredited asbestos abatement worker, asbestos abatement supervisor, asbestos project monitor, or asbestos project designer, in Texas or another state; and(-a-) work experience must consist of activities for which either no Texas license or license in another state was required, or for which the applicant held the required license; and(-b-) work experience must have been gained while accreditation was current in accordance with the MAP; or(III) performing project monitoring within immediate proximity and under the in-person and direct supervision of a licensed asbestos consultant, AMT/PM, or asbestos project manager working for a licensed laboratory or asbestos consultant agency, and work experience must have been gained after completion of the Asbestos Contractor/Supervisor course as described in §296.73 of this chapter; and(iii) to meet the work experience requirements under clauses (i) and (ii) of this subparagraph, work experience performing project monitoring and air monitoring during the same project may be used to satisfy the project monitoring and air monitoring work experience requirement;(E) an asbestos management planner:(i) participation in the development of at least five management plans as a licensed asbestos management planner (during previous Texas of out-of-state licensure), or a licensed asbestos consultant or within immediate proximity and under the in-person and direct supervision of a licensed asbestos management planner or a licensed asbestos consultant, and work experience must have been gained after completion of the Asbestos Management Planner course as described in §296.73 of this chapter;(ii) participation in conducting five asbestos surveys, including development of asbestos survey reports, as a licensed inspector or licensed asbestos consultant or within the immediate proximity and under the in-person and direct supervision of a licensed inspector, licensed management planner, or licensed asbestos consultant, and work experience must have been gained after completion of the Asbestos Inspector course as described in §296.73 of this chapter; and(iii) to meet the work experience requirements under clauses (i) and (ii) of this subparagraph, work experience participating in an asbestos survey and then participating in the development of the management plan using that asbestos survey during the same project may be used to satisfy one management plan and one asbestos survey requirement;(F) an asbestos consultant--one of the following combinations of professional or educational achievement and work experience gained after completion of any training that is required to perform the applicable asbestos-related activity and performed while the training is current:(i) current status as a Texas-registered architect or a Texas-licensed professional engineer combined with at least 180 days of work experience performing asbestos-related activities in public buildings, in accordance with applicable law in effect at the time of the work experience and gained within the past four years; the asbestos-related work experience:(I) must include the following:(-a-) developing at least six specifications and plans within the immediate proximity and under the in-person and direct supervision of a licensed asbestos consultant;(-b-) conducting at least three asbestos surveys that include collecting bulk samples as a licensed asbestos inspector or licensed asbestos management planner or within the immediate proximity and under the in-person and direct supervision of a licensed asbestos inspector, licensed asbestos management planner, or licensed asbestos consultant;(-c-) performing project monitoring for at least 10 days within the immediate proximity and under the in-person and direct supervision of a licensed asbestos project manager, licensed AMT/PM, or consultant;(-d-) performing air monitoring for at least 10 days within the immediate proximity and under the in-person and direct supervision of a licensed air monitoring technician, licensed AMT/PM, or a licensed asbestos consultant; and(-e-) to meet the work experience requirements under items (-c-) and (-d-) of this subclause, work experience performing project monitoring and air monitoring during the same project may be used to satisfy the project monitoring and air monitoring work experience requirement;(II) may include any of the following:(-a-) developing one or more management plans as a licensed management planner or within the immediate proximity and under the in-person and direct supervision of a licensed asbestos management planner or licensed asbestos consultant;(-b-) working as a licensed asbestos abatement supervisor; or(-c-) working as a registered asbestos abatement worker, that may qualify for no more than 30 days of the required work experience; or(ii) a bachelor's degree in architecture, engineering, or a physical or natural science from an accredited college or university combined with the following work experience:(I) two years of work experience in an environmental field or in occupational health; and(II) at least 180 days of work experience performing asbestos-related activities in public buildings, in accordance with applicable law in effect at the time of the work experience and gained within the past four years; the asbestos-related experience must meet the requirements of clause (i)(I) and (II) of this subparagraph; or(iii) completion of 60 college credit hours from an accredited college or university, including 30 credit hours in engineering or natural or physical science and 9 credit hours in mathematics, combined with the following work experience:(I) three years of work experience in an environmental field or in occupational health, and(II) at least 250 days of work experience performing asbestos-related activities in public buildings, in accordance with applicable law in effect at the time of the work experience and gained within the past four years, and the asbestos-related work experience must meet the requirements of clause (i)(I) and (II) of this subparagraph and in addition, the applicant must provide a letter of recommendation from a supervising licensed asbestos consultant; and(G) an asbestos project manager--at least 15 days of verifiable qualifying work experience on at least three asbestos abatement projects gained within the past 24 months that includes any combination of qualifying work experience from one or more of the following categories, as needed to fulfill the requirements:(i) work experience as a licensed asbestos abatement worker, licensed asbestos abatement supervisor, licensed asbestos consultant, or licensed air monitoring technician during previous Texas or out-of-state licensure, or as a licensed AMT/PM, or licensed project manager during previous Texas licensure;(ii) work experience as a MAP-accredited asbestos abatement worker, asbestos abatement supervisor, asbestos project monitor, or asbestos project designer, in Texas or another state; and(I) work experience must consist of activities for which either no Texas license or license in another state was required, or for which the applicant held the required license; and(II) work experience must have been gained while accreditation was current in accordance with the MAP; or(iii) work experience performing project monitoring within immediate proximity and under the in-person and direct supervision of a licensed AMT/PM, asbestos consultant, or asbestos project manager working for a licensed laboratory or asbestos consultant agency, and work experience must have been gained after completion of training required for licensure as an asbestos project manager under this chapter.(7) Proof of the following education requirements for:(A) an asbestos inspector, asbestos air monitoring technician, AMT/PM, or asbestos project manager--a high school diploma or equivalent;(B) an asbestos management planner--an associate's degree or successful completion of a minimum of 60 credit hours from an accredited college or university; or(C) an asbestos consultant--the education requirements set forth in subparagraph (6)(F) of this subsection.(8) Proof of insurance coverage requirements for an asbestos inspector, asbestos management planner, and asbestos consultant--professional liability insurance coverage for errors and omissions individually or under the licensee's employer policy if performing work for hire, in accordance with §1954.105(c) of the Act and as required in §296.45 of this chapter (relating to Insurance Requirements).(c) Renewal requirements. An applicant renewing a license must submit the documentation as required for the initial application in subsection (b)(1)-(4) of this section and, if applicable, subsection (b)(8) of this section.(d) Qualification renewal requirements. Licensees must not allow required qualifications (such as accreditation, DSHS's Physician's Written Statement form, or insurance requirements) to expire and continue to work as a licensee.(e) Examination not required.(1) A licensed consultant is not required to take a state examination to obtain an asbestos inspector, asbestos air monitoring technician, AMT/PM, or asbestos management planner licenses.(2) A licensed management planner is not required to take a state examination to obtain an inspector license.(3) A licensed AMT/PM is not required to take a state examination to obtain an asbestos air monitoring license. Source Note: The provisions of this §296.46 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.46 Initial and Renewal Licensing Requirements for an Individual https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205404&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205404 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205404&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205404 03/11/2026 (a) Initial and renewal licensure requirements. To receive or renew a license as an asbestos abatement contractor, asbestos operations and maintenance (O&M) contractor, asbestos management planner agency, asbestos consultant agency, asbestos transporter, or asbestos laboratory, an applicant must submit a complete application as required under §296.42 of this chapter (Initial and Renewal Applications) and the documentation required in this section. An out-of-state applicant must comply with §296.44 of this chapter (relating to Out-of-State Applicants).(b) Initial requirements. An applicant for an initial license must submit the following:(1) the name and license number of the appointed responsible person for an asbestos abatement contractor, an asbestos O&M contractor, a management planner agency, or an asbestos consultant agency;(2) a copy of the current training certificate for the appointed responsible person documenting that training was completed as required in §296.73 of this chapter (relating to Asbestos Training Courses) for:(A) an asbestos abatement contractor or asbestos O&M contractor--the Asbestos Contractor/Supervisor course;(B) a management planner agency--the Asbestos Management Planner course; or(C) a consultant agency--the Asbestos Inspector, Asbestos Management Planner, Asbestos Air Monitoring Technician, and Asbestos Project Designer courses;(3) in relation to the applicant's franchise tax account status, whichever applies:(A) a certificate of account status from the Texas Comptroller of Public Accounts regarding the applicant's franchise tax account status, if the applicant is a taxable entity, as defined in Texas Tax Code §171.0002; or(B) documentation that the applicant is not a taxable entity or is otherwise not subject to or exempt from franchise tax; and(C) any verification relating to subparagraph (A) or (B) of this paragraph requested by DSHS;(4) a copy of the applicant's assumed name certificate, with proof of required filing, if the applicant conducts business or renders professional services under an assumed name (commonly referred to as a DBA or "doing business as");(5) if the applicant is an entity, as defined in Texas Business Organizations Code §1.002:(A) documentation issued by the Secretary of State that verifies:(i) a domestic entity's existence; or(ii) a foreign entity's registration and authorization to conduct business in Texas; or(B) if the applicant is a foreign entity to which §296.44(d) of this chapter applies, the applicant must submit a sworn affidavit that meets the requirements of that subsection;(6) if the applicant is a nonfiling entity or a foreign nonfiling entity, as those terms are defined in Texas Business Organizations Code §1.002, documentation of that status on the application and any verification of that status requested by DSHS;(7) a taxpayer identification number;(8) the applicant's Texas sales tax permit number from the Texas Comptroller of Public Accounts, if applicable;(9) the physical address of the central location where asbestos records are maintained, as required by §296.291 of this chapter (relating to Recordkeeping);(10) proof of required insurance in accordance with §1954.105(c) of the Act and as required in §296.45 of this chapter (relating to Insurance Requirements) for:(A) an asbestos abatement contractor or an asbestos O&M contractor--asbestos abatement liability coverage, including pollution liability coverage, if performing work for hire, and workers' compensation insurance, where required;(B) an asbestos management planner agency, asbestos consultant agency, or an asbestos laboratory--professional liability insurance for errors and omissions, if performing work for hire and workers' compensation insurance, where required;(C) an asbestos transporter--liability insurance coverage, including pollution liability coverage to transport for hire ACM for purposes of disposal and workers' compensation coverage insurance, where required;(11) a copy of the applicant's standard operating procedures for an asbestos abatement contractor relating to activities involving ACBM or an asbestos O&M contractor relating to SSSD O&M activities involving ACBM in accordance with 29 CFR §1926.1101(g)(9), that must include the following:(A) a written respiratory protection plan to be maintained and adhered to during periods of abatement activity;(B) a description of on-site personnel decontamination procedures;(C) a description of the procedures for handling and disposal of ACWM;(D) a description of the engineering controls and work practices for asbestos abatement;(E) a description of personal air monitoring procedures;(F) a description of final cleanup procedures; and(G) a description of the provisions for recordkeeping;(12) for an asbestos transporter applicant, a copy of the applicant's emergency response plan prepared in compliance with 29 CFR §1910.120(q), unless exempt under the requirements of that section, which must include, without limitation:(A) pre-emergency planning and coordination with outside parties;(B) personnel roles, lines of authority, training, and communication;(C) emergency recognition and prevention;(D) safe distances and places of refuge;(E) site security and control;(F) evacuation routes and procedures;(G) decontamination;(H) emergency medical treatment and first aid;(I) emergency alerting and response procedures;(J) critique of response and follow-up; and(K) personal protection equipment and emergency equipment; and(13) the following proof applicable to each type of analysis for which an asbestos laboratory applicant is applying for a license to perform:(A) accreditation by the NVLAP for analysis of bulk samples by polarized light microscopy (PLM), if the laboratory is applying to perform PLM bulk analysis;(B) accreditation by the NVLAP for analysis of air samples by transmission electron microscopy (TEM), if the laboratory is applying to perform TEM air analysis; or(C) if the laboratory is applying to perform phase contrast microscopy (PCM) air analysis, proof of at least one of the following:(i) accreditation by the American Industrial Hygiene Association (AIHA) Industrial Hygiene Laboratory Accreditation Program and AIHA's most recent PCM proficiency testing results for the laboratory;(ii) proficiency according to the standards of the AIHA proficiency analytical testing (PAT) Program, including quarterly proficiency testing for airborne fibers by PCM and a quality assurance/quality control program, in accordance with the NIOSH 7400 method; or(iii) proficiency of the individual laboratory analysts through the AIHA asbestos analyst registry (AAR) and the most recent proficiency testing results.(c) Renewal requirements. An applicant renewing a license must submit the documentation as required for the initial application in subsection (b)(1)-(10) of this section.(d) Qualification renewal requirements. Licensees must not allow required qualifications (such as accreditation, DSHS's Physician's Written Statement form for the responsible person, or insurance requirements) to expire and continue to work as a licensee. Source Note: The provisions of this §296.47 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.47 Initial and Renewal License Requirements for a Company https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205405&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205405 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205405&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205405 03/11/2026 (a) Registration required. A person must be registered as an asbestos abatement worker to perform asbestos abatement activities or loading or unloading of asbestos in a public building, including performing any maintenance, repair, installation, renovation, or cleaning that may dislodge, break, cut, abrade, or impinge on ACM.(b) Registrant scope of practice. An asbestos abatement worker may perform asbestos abatement activities or O&M activities only while employed by a licensed asbestos abatement contractor or licensed asbestos operations and maintenance (O&M) contractor and supervised by a licensed asbestos abatement supervisor or licensed asbestos O&M supervisor.(c) Registrant responsibilities. An asbestos abatement worker must:(1) comply with standards of operation, including the applicable EPA and OSHA regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards);(2) comply with applicable OSHA requirements, including the requirements for the use of personal protective equipment;(3) comply with the requirements of §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(4) comply with the work practices required under §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building);(5) comply with the restrictions and required work practices described in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building) for SSSD O&M activities conducted under that section;(6) comply with the restrictions and required work practices described in:(A) §296.232 of this chapter (relating to Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building);(B) §296.233 of this chapter (relating to Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building); and(C) §296.234 of this chapter (relating to Alternative Practices and Procedures for Removal of Whole Components of Intact Asbestos-Containing Material (ACM) in a Public Building) for activities conducted under these sections; and(7) cooperate with DSHS personnel during inspections and investigations, as required in §296.271 of this chapter (relating to Inspections and Investigations). Source Note: The provisions of this §296.48 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.48 Asbestos Abatement Worker https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205406&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205406 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205406&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205406 03/11/2026 (a) License required. A person must be licensed as an asbestos abatement supervisor to directly oversee personnel and work practices and procedures during an asbestos abatement activity or project conducted in a public building.(b) Licensee scope of practice.(1) Licensee practice and limitations.(A) An asbestos abatement supervisor must be employed by a licensed asbestos abatement contractor or asbestos operations and maintenance (O&M) contractor to supervise or perform asbestos abatement activities in a public building. An asbestos abatement supervisor employed by an O&M contractor is limited to supervising the work practices and procedures described in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building) for SSSD O&M activities, as permitted under that section.(B) An asbestos abatement supervisor may perform the duties of a registered asbestos abatement worker on any project.(C) An asbestos abatement supervisor must not supervise or perform asbestos abatement activities in a public building when the asbestos project manager or asbestos consultant is not on-site, except during activities performed in accordance with:(i) §296.213 of this chapter;(ii) §296.232 of this chapter (relating to Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building);(iii) §296.233 of this chapter (relating to Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building); and(iv) §296.234 of this chapter (relating to Alternative Practices and Procedures for Removal of Whole Components of Intact Asbestos-Containing Material (ACM) in a Public Building).(2) Licensee responsibilities. An asbestos abatement supervisor must:(A) comply with standards of operation, including the EPA regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards);(B) comply with applicable OSHA regulations, including, as applicable, the work practices and controls in 29 CFR §1926.1101(g) (relating to Asbestos);(C) comply with the requirements of §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(D) comply with the work practices required under §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building);(E) comply with the restrictions and required work practices described in §296.213 of this chapter for SSSD O&M activities conducted under that section;(F) comply with the restrictions and required work practices described in §296.232 of this chapter, §296.233 of this chapter, and §296.234 of this chapter for activities conducted under those sections;(G) comply with personal protective equipment (PPE) requirements for employees who perform asbestos-related activities to ensure that PPE is worn in compliance with 29 CFR §1926.1101 or 40 CFR §763.122 (relating to What does this subpart require me to do?), whichever is applicable;(H) be on the project site at all times when asbestos abatement activities are being performed;(I) control access to the regulated area and entrance into containment as required in §§296.212, 296.213, and 296.232 - 296.234 of this chapter;(J) immediately correct any issue of noncompliance with asbestos abatement activity and if such an issue is related to the removal of ACBM, the asbestos abatement supervisor must stop the removal and must not resume removal until each identified issue has been corrected;(K) cooperate with DSHS personnel during inspections and investigations, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(L) maintain records at the work site location, as required in §296.291 of this chapter (relating to Recordkeeping). Source Note: The provisions of this §296.49 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.49 Asbestos Abatement Supervisor https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205407&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205407 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205407&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205407 03/11/2026 (a) License required. A person must be licensed as an asbestos abatement contractor to engage in asbestos abatement in a public building for others under contract or other agreement or otherwise be designated to perform that function.(b) Licensee scope of practice.(1) Licensee practice and limitations.(A) An asbestos abatement contractor must employ licensed asbestos abatement supervisors and registered asbestos abatement workers to perform asbestos abatement activities.(B) An asbestos abatement contractor must employ a responsible person who has completed the Asbestos Contractor/Supervisor training as required in §296.46 of this chapter (relating to Initial and Renewal Licensure Requirements for an Individual) to engage in asbestos abatement activities.(C) An asbestos abatement contractor must employ a licensed asbestos operations and maintenance (O&M) supervisor or a licensed asbestos abatement supervisor to supervise an SSSD O&M activity performed as described in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building).(D) An asbestos abatement contractor may employ a licensed O&M supervisor or a licensed asbestos abatement supervisor to perform the duties of an asbestos abatement worker.(E) An asbestos abatement contractor must not engage in an asbestos abatement activity in a public building unless the asbestos project manager or asbestos consultant and an asbestos abatement supervisor is on-site.(2) Licensee responsibilities. An asbestos abatement contractor may be held responsible for a violation under this chapter by its employees or the responsible person. An asbestos abatement contractor must:(A) require the responsible person to:(i) oversee the operations for the asbestos abatement activities; and(ii) comply with the applicable requirements of this chapter;(B) require that its responsible person and any employee who performs an activity on behalf of the asbestos abatement contractor comply with all applicable:(i) responsibilities for:(I) licensed asbestos abatement supervisors, as required in §296.49 of this chapter (relating to Asbestos Abatement Supervisor);(II) licensed asbestos air monitoring technicians, as required in §296.54 of this chapter (relating to Asbestos Air Monitoring Technician);(III) licensed asbestos air monitoring technician project monitors, as required in §296.55 of this chapter (relating to Asbestos Air Monitoring Technician Project Monitor); and(IV) licensed asbestos abatement workers, as required in §296.48 of this chapter (relating to Asbestos Abatement Worker); and(ii) requirements of this chapter;(C) employ at least one licensed asbestos abatement supervisor to oversee asbestos abatement activity for each project where asbestos abatement activity is occurring in a public building;(D) comply with standards of operation, including the EPA regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards);(E) comply with applicable OSHA regulations, including, as applicable, the work practices and controls in 29 CFR §1926.1101(g) (relating to Asbestos);(F) comply with the requirements of §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(G) comply with the work practices required under §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building);(H) comply with the restrictions and required work practices for SSSD O&M activities described in §296.213 of this chapter for SSSD O&M activities conducted under that section;(I) comply with the restrictions and required work practices described in:(i) §296.232 of this chapter (relating to Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building);(ii) §296.233 of this chapter (relating to Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building); and(iii) §296.234 of this chapter (relating to Alternative Practices and Procedures for Removal of Whole Components of Intact Asbestos-Containing Material (ACM) in a Public Building) for activities conducted under those sections;(J) at no cost to the employee, comply with personal protective equipment (PPE) requirements in 29 CFR §1910.132(h) (relating to General requirements), §1926.1101(h) and (i), and 40 CFR §763.122 (relating to What does this subpart require me to do?), as applicable, for employees who perform asbestos-related activities. This includes:(i) providing and maintaining PPE for employees;(ii) training employees on the proper use, care, and inspection of PPE;(iii) documenting training in the proper use, care, and inspection of PPE;(iv) documenting respirator inspections; and(v) ensuring compliance with the use of PPE;(K) provide at no cost to the employee, an annual medical examination, as required in §296.42(i) of this chapter (relating to Initial and Renewal Applications) for each employee who performs an asbestos-related activity;(L) ensure that each employee who performs asbestos-related activities has a current DSHS's Physician's Written Statement, as required in §296.42(i) of this chapter;(M) ensure that each employee who performs asbestos-related activities is familiar with federal, state, and local standards for asbestos removal, encapsulation, and enclosure;(N) obtain and keep on-site a copy of the current training certificate, as required in §296.73 of this chapter (relating to Asbestos Training Courses) for each employee who performs an asbestos-related activity;(O) control asbestos exposure in all work, in compliance with 29 CFR §1926.1101 (relating to Asbestos) and 40 CFR §763.122, as applicable;(P) provide and maintain in good working condition the necessary equipment for performing asbestos abatement activities;(Q) if delegated by the owner, comply with the notification requirements, as required in §296.251 of this chapter (relating to Notifications);(R) provide for temporary storage of ACWM, as required in §296.212(c)(8) of this chapter;(S) provide for disposal of ACWM in accordance with 40 CFR §61.150 (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations):(i) complete and provide a waste shipment record (manifest) for the asbestos transporter before the transporter departs with the waste on a form as described for the waste generator in 40 CFR §61.150(d);(ii) contact the waste site if a copy of the manifest signed by the owner or operator of the designated waste disposal site has not been received within 35 calendar days after the date the waste was accepted by the transporter;(iii) report in writing to DSHS in accordance with 40 CFR §61.150(d)(4) if a copy of the manifest signed by the owner or operator of the designated waste disposal site is not received within 45 calendar days after the date the waste was accepted by the transporter;(iv) provide a copy of the manifest signed by the owner or operator of the designated waste disposal site to the building owner or the building owner's authorized representative; and(v) maintain records in accordance with 40 CFR §61.150(d)(5) and §296.291 of this chapter (relating to Recordkeeping);(T) report a change of the responsible person in writing to DSHS within 10 working days after the change;(U) cooperate with DSHS personnel during inspections and investigations, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(V) comply with recordkeeping requirements, as required in §296.291 of this chapter. Source Note: The provisions of this §296.50 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.50 Asbestos Abatement Contractor https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205408&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205408 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205408&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205408 03/11/2026 (a) License required. A person must be licensed as an asbestos operations and maintenance (O&M) supervisor to directly oversee the practices and procedures described in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building), and to supervise any registered asbestos abatement workers performing such work, unless licensed as an asbestos abatement supervisor.(b) Licensee scope of practice.(1) An asbestos O&M supervisor must be employed by a building owner or manager who is a licensed asbestos O&M contractor or a licensed asbestos abatement contractor to perform or supervise the activities for which a license is required under subsection (a) of this section.(2) An asbestos O&M supervisor may perform the duties of a licensed asbestos abatement worker on any project.(3) An asbestos O&M supervisor must not supervise any asbestos-related activity in a public building that is outside the scope of §296.213 of this chapter.(c) Licensee responsibilities. An asbestos O&M supervisor must:(1) comply with standards of operation, including the EPA regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards);(2) comply with applicable OSHA regulations, including, as applicable, the work practices and controls in 29 CFR §1926.1101(g)(relating to Asbestos);(3) comply with the requirements of §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(4) comply with the restrictions and required work practices described in §296.213 of this chapter for SSSD O&M activities conducted under that section;(5) comply with personal protective equipment (PPE) requirements for employees who perform asbestos-related activities to ensure that PPE is worn in compliance with 29 CFR §1926.1101 or 40 CFR §763.122 (relating to What does this subpart require me to do?), whichever is applicable;(6) immediately correct any issue of noncompliance with asbestos abatement activity and if such an issue is related to removal of ACBM, the asbestos O&M supervisor must stop the removal and must not resume removal until each identified issue has been corrected.(7) cooperate with DSHS personnel during inspections and investigations, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(8) maintain records at work site locations, as required in §296.291 of this chapter (relating to Recordkeeping). Source Note: The provisions of this §296.51 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.51 Asbestos Operations and Maintenance Supervisor https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205409&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205409 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205409&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205409 03/11/2026 (a) License required. A person must be licensed as an asbestos operations and maintenance (O&M) contractor to employ an asbestos O&M supervisor to supervise or perform asbestos SSSD O&M activities in a public building owned or managed by the O&M contractor.(b) Licensee scope of practice.(1) An asbestos O&M contractor is restricted to carrying out SSSD O&M activities as described in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building).(2) The asbestos O&M contractor's employees who perform asbestos SSSD O&M activities must be registered asbestos abatement workers, licensed O&M supervisors, or licensed asbestos abatement supervisors.(3) An asbestos O&M contractor must employ a responsible person who has completed the Asbestos Contractor/Supervisor training as required in §296.46 of this chapter (relating to Initial and Renewal Licensure Requirements for an Individual) to carry out asbestos SSSD O&M activities.(c) Licensee responsibilities. An O&M contractor may be held responsible for a violation under this chapter by its employees or the responsible person. An asbestos O&M contractor must:(1) require the responsible person to:(A) oversee the operations for the asbestos SSSD O&M activities; and(B) comply with the applicable requirements of this chapter;(2) require that its responsible person and any employee who performs an activity on behalf of the asbestos O&M contractor comply with all applicable:(A) responsibilities for:(i) licensed asbestos O&M supervisors, as required in §296.51 of this chapter (relating to Asbestos Operations and Maintenance Supervisor);(ii) licensed asbestos abatement supervisors, as required in §296.49 of this chapter (relating to Asbestos Abatement Supervisor);(iii) licensed asbestos air monitoring technicians, as required in §296.54 of this chapter (relating to Asbestos Air Monitoring Technician);(iv) licensed asbestos air monitoring technician project monitor, as required in §296.55 of this chapter (relating to Asbestos Air Monitoring Technician Project Monitor); and(v) registered asbestos abatement workers, as required in §296.48 of this chapter (relating to Asbestos Abatement Worker); and(B) requirements of this chapter;(3) employ at least one licensed asbestos O&M supervisor or licensed asbestos abatement supervisor to oversee or perform SSSD O&M activities involving asbestos abatement;(4) comply with standards of operation, including the EPA regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards);(5) comply with applicable OSHA regulations, including, as applicable, the work practices and controls in 29 CFR §1926.1101(g) (relating to Asbestos);(6) comply with the requirements of §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building) and §296.213 of this chapter, as applicable, for the asbestos-related activity being performed;(7) at no cost to the employee, follow personal protective equipment (PPE) requirements in 29 CFR §1910.132(h), §1926.1101(h) and (i), and 40 CFR §763.122 (relating to What does this subpart require me to do?), as applicable, for employees who perform asbestos-related activities. This includes:(A) providing and maintaining PPE for employees;(B) training employees in the proper use, care, and inspection of PPE;(C) documenting training in the proper use, care, and inspection of PPE;(D) documenting respirator inspections; and(E) ensuring compliance with the use of PPE;(8) provide at no cost to the employee, an annual medical examination, as required in §296.42(i) of this chapter (relating to Initial and Renewal Applications) for each employee who performs an asbestos-related activity;(9) ensure that each employee who performs asbestos-related activities has a current DSHS's Physician's Written Statement, as required in §296.42(i) of this chapter;(10) ensure that each employee who performs asbestos-related activities is familiar with federal, state, and local standards for asbestos removal, encapsulation, and enclosure;(11) obtain and keep on-site a copy of the current training certificate, as required in §296.73 of this chapter (relating to Asbestos Training Courses) for each employee who performs an asbestos-related activity;(12) control asbestos exposure in all work, in compliance with 29 CFR §1926.1101 and 40 CFR §763.122, as applicable;(13) provide and maintain in good working condition and free of asbestos contamination the necessary equipment for employees to perform asbestos SSSD O&M activities;(14) if delegated by the owner, comply with the notification requirements, as required in §296.251 of this chapter (relating to Notifications);(15) provide for temporary storage of ACWM, as required in §296.213(b)(15) of this chapter;(16) provide for disposal of ACWM in accordance with 40 CFR §61.150 (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations):(A) complete and provide a waste shipment record (manifest) for the asbestos transporter before the transporter departs with the waste on a form as described for the waste generator in 40 CFR §61.150(d);(B) contact the waste site if a copy of the manifest signed by the owner or operator of the designated waste disposal site has not been received within 35 calendar days after the date the waste was accepted by the transporter;(C) report in writing to DSHS in accordance with 40 CFR §61.150(d)(4) if a copy of the manifest signed by the owner or operator of the designated waste disposal site is not received within 45 calendar days after the date the waste was accepted by the transporter; and(D) provide a copy of the manifest signed by the owner or operator of the designated waste disposal site to the building owner or the building owner's authorized representative; and(E) maintain records in accordance with 40 CFR §61.150(d)(5) and §296.291 of this chapter (relating to Recordkeeping);(17) report a change of the responsible person in writing to DSHS within 10 working days after the change;(18) cooperate with DSHS personnel during inspections and investigations, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(19) comply with recordkeeping requirements, as required in §296.291 of this chapter. Source Note: The provisions of this §296.52 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.52 Asbestos Operations and Maintenance Contractor https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205410&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205410 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205410&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205410 03/11/2026 (a) License required. A person must be licensed as an asbestos inspector to conduct an asbestos survey in a public building.(b) Licensee scope of practice.(1) An asbestos inspector may:(A) determine the location and assess the condition of suspect ACBM in a public building;(B) determine that ACBM is present in a public building by collecting bulk samples of suspected ACBM or assuming the suspected ACBM is ACM; and(C) develop an asbestos survey report.(2) An asbestos inspector must be employed by a licensed asbestos consultant agency or a licensed asbestos management planner agency to perform an asbestos survey in a public building.(c) Licensee responsibilities. An asbestos inspector must:(1) comply with standards of operation and sampling schemes, as required in §296.191 of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility);(2) prepare an asbestos survey report that includes, at a minimum:(A) for a public building:(i) a written description, diagram, or both that clearly and accurately identifies and reflects:(I) the location and boundaries of each homogeneous area of suspected ACBM that is assumed to be ACM or was sampled for ACM;(II) the sampling location for each bulk sample; and(III) the dates that each sample was collected;(ii) a written description of:(I) the manner used to determine sampling locations;(II) the estimated amount of ACBM in each homogeneous area in square feet or, for ACBM on piping, in linear feet;(III) the type of material sampled; and(IV) the condition and friability of the ACBM, and the assessment of ACBM must conform to generally accepted industry standards, such as the AHERA requirements specified in 40 CFR Part 763, Subpart E (relating to Asbestos-Containing Materials in Schools), §763.88(b), which is the required method for schools;(iii) the name, signature, and, as applicable, based upon the building type, accreditation and state of accreditation or license number of the inspector performing each activity; and(iv) a copy of the analyses of any bulk samples, the dates of analyses, and a copy of any other laboratory reports pertaining to the analyses; and(B) for a NESHAP facility, a record of the thorough inspection of the affected facility or part of the facility where the demolition or renovation operation will occur for the presence of asbestos, including Category I and Category II nonfriable ACM that identifies:(i) the location of ACM; and(ii) the inspector that performed the survey;(3) sign, date, and print the inspector's name and license number on the cover page of each asbestos survey report; and(4) cooperate with DSHS personnel during any inspection or investigation, as required in §296.271 of this chapter (relating to Inspections and Investigations). Source Note: The provisions of this §296.53 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.53 Asbestos Inspector https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205411&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205411 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205411&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205411 03/11/2026 (a) License required. A person must be licensed as an asbestos air monitoring technician (AMT) to perform air monitoring services for an asbestos abatement project or asbestos-related activity in a public building. A licensed AMT must have written delegated authority, as required in §296.58(b)(1)(K) of this chapter (relating to Asbestos Consultant) to perform project air monitoring in a public building. Unless otherwise prohibited in §296.31 of this chapter relating to (Conflict of Interest), a licensed asbestos consultant may also perform the duties of a licensed AMT and is subject to the same conditions, restrictions, and requirements applicable to an AMT under this section.(b) Licensee scope of practice. An AMT may:(1) collect baseline, area, and clearance samples, if employed by an asbestos consultant agency or an asbestos laboratory;(2) collect personal samples in accordance with 29 CFR §1926.1101 (relating to Asbestos), if employed by a licensed asbestos consultant or licensed consultant agency that is hired by an asbestos abatement contractor or asbestos operations and maintenance (O&M) contractor, as described in §296.31(b)(1)(B); and(3) analyze airborne fibers in the field, if the AMT is employed by a licensed asbestos laboratory and:(A) is listed on the American Industrial Hygiene Association (AIHA) Asbestos Analyst Registry, as required in §296.61 of this chapter (relating to Asbestos Laboratory); or(B) has received the NIOSH 582 or NIOSH 582 Equivalent training and participates in the AIHA Proficiency Analytical Testing Program.(c) Licensee responsibilities. An AMT must:(1) collect area, baseline, and clearance air samples either:(A) as described in the asbestos abatement project specifications and plans; or(B) as required in §296.211(h) of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building) when specifications and plans are not required;(2) collect personal air samples in accordance with 40 CFR Part 763, Subpart G (relating to Asbestos Worker Protection) or 29 CFR §1926.1101 (relating to Asbestos), whichever is applicable, when hired to collect personal samples;(3) if analyzing air samples in the field, demonstrate, upon request by a DSHS inspector, competency in phase contrast microscopy analysis using the NIOSH 7400 method, including:(A) calibrating microscopes;(B) reading test slides provided by the DSHS inspector;(C) preparing sampling logs;(D) preparing sample slides;(E) performing calculations to determine sample time, flow rate, volume, sample count, fiber concentration, and time weighted average; and(F) providing documentation of AMT's NIOSH 582 or NIOSH 582 Equivalent training certificate and documentation of current participation in the AIHA Proficiency Analytical Testing Program or current registration with the AIHA Asbestos Analyst Registry;(4) record in writing the results of area, baseline, clearance, and personal air samples that are analyzed, and document that area, baseline, and clearance air sample results are provided verbally, and personal air sample results are provided in writing, to the asbestos abatement contractor by the following time frames unless the consultant has designed a sampling strategy that deviates from these time frames:(A) the next working day after the date of sampling for any air sample analyzed on-site; or(B) the third working day after the date of initial sampling of friable ACBM for any air sample analyzed in an asbestos laboratory off-site;(5) cooperate with DSHS personnel during inspections and investigations, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(6) comply with recordkeeping requirements, as required in §296.291 of this chapter (relating to Recordkeeping). Source Note: The provisions of this §296.54 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.54 Asbestos Air Monitoring Technician https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205412&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205412 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205412&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205412 03/11/2026 (a) License required. A person must be licensed as an asbestos air monitoring technician project monitor (AMT/PM) and have written delegated authority, as required in §296.58(b)(1)(J) and (K) of this chapter (related to Asbestos Consultant) to perform air monitoring services and asbestos project monitoring for an asbestos abatement project or related activity in a public building. Unless otherwise prohibited in §296.31 of this chapter (relating to Conflict of Interest), a licensed asbestos consultant may also perform the duties of a licensed AMT/PM and is subject to the same conditions, restrictions, and requirements applicable to an AMT/PM under this section.(b) Licensee scope of practice.(1) An AMT/PM must be employed by a licensed asbestos consultant agency to monitor compliance with this chapter and the specifications and plans, on behalf of the building owner, during an asbestos abatement project.(2) An AMT/PM may:(A) provide personal air monitoring as required in §296.54 of this chapter (relating to Asbestos Air Monitoring Technician) and project air monitoring as required in §296.54 of this chapter and §296.58(c)(12) of this chapter;(B) provide project monitoring as required in §296.58(c)(11) of this chapter;(C) recommend to the asbestos consultant changes to the asbestos abatement specifications and plans; and(D) assist the asbestos consultant in the development of an asbestos exposure assessment.(c) Licensee responsibilities. An AMT/PM must, consistent with the scope of the AMT/PMs delegated authority in accordance with section (a) of this section and §296.58(b)(1)(J) and (K) of this chapter, as applicable;(1) perform project air monitoring, as required in §296.54(b) and §296.58(c)(12) of this chapter, or project monitoring, as required in §296.58(c)(11) of this chapter, or both, and provide the consultant with all project documents after completion of the project;(2) cooperate with DSHS personnel during inspections and investigations, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(3) comply with recordkeeping requirements and maintain records on-site, as required in §296.291 of this chapter (relating to Recordkeeping).(d) Asbestos air monitoring technician and asbestos project manager licensed before the effective date of this section. An individual holding both the asbestos air monitoring technician and project manager licenses issued before the effective date of this section may apply for the AMT/PM license and continue to perform work under and renew this license based upon the eligibility and renewal requirements of the Texas Asbestos Health Protection rules that were in effect when the individual licenses were issued. If an AMT/PM fails to timely renew the license and the license remains expired for one year or more, the license may not be renewed. The former AMT/PM may re-apply for an initial license by meeting all education, work experience, and other application requirements for initial licensure under §296.46 of this chapter (relating to Initial and Renewal Licensure Requirements for an Individual). Source Note: The provisions of this §296.55 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.55 Asbestos Air Monitoring Technician Project Monitor https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205413&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205413 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205413&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205413 03/11/2026 (a) License required. A person must be licensed as an asbestos management planner to develop a plan to manage asbestos in a public building.(b) Licensee scope of practice.(1) An asbestos management planner may develop a management plan and perform the duties of a licensed asbestos inspector.(2) An asbestos management planner must not be employed as a management planner at a company that employs another asbestos management planner, asbestos consultant, or an asbestos inspector, unless the company is licensed as an asbestos management planner agency, as required in §296.57 of this chapter (relating to Asbestos Management Planner Agency), or an asbestos consultant agency, as required in §296.59 of this chapter (relating to Asbestos Consultant Agency).(c) Licensee responsibilities. An asbestos management planner must:(1) comply with standards of operation and sampling schemes, as required in §296.191 of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility);(2) prepare asbestos survey reports, as required in §296.53(c)(2) of this chapter (relating to Asbestos Inspector);(3) prepare a management plan for a school in accordance with AHERA;(4) include the following, at a minimum, for any other management plan that is not subject to AHERA:(A) the date of the asbestos survey;(B) a copy of the asbestos survey report, prepared as required in §296.53(c)(2) of this chapter;(C) a description of assessments of all ACBM within the scope of the management plan;(D) for each person making the assessment:(i) the person's name and signature; and(ii) Texas license number;(E) a description of any recommended response action or preventative measures needed to reduce asbestos exposure or address potential hazards related to asbestos; and(F) a recommendation to address ACBM that is in poor condition (damaged or separating from building material or equipment) and the requirement to address ACBM that will be disturbed as part of any renovation, demolition, or O&M activity;(5) sign, date, and print the asbestos management planner's name and license number on the asbestos survey report and management plan, including on all drawings;(6) cooperate with DSHS personnel during any inspection or investigation, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(7) comply with recordkeeping requirements, as required in §296.291 of this chapter (relating to Recordkeeping). Source Note: The provisions of this §296.56 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.56 Asbestos Management Planner https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205414&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205414 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205414&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205414 03/11/2026 (a) License required. A person employing an asbestos management planner and one or more additional asbestos management planners, asbestos consultants, or asbestos inspectors to conduct asbestos management planning activity must be licensed as an asbestos management planner agency. This license is not required if the person is already licensed as an asbestos consultant agency.(b) Licensee scope of practice.(1) An asbestos management planner agency may employ:(A) an asbestos management planner or asbestos consultant who is licensed, as required in this chapter and working in the capacity of that individual's license to conduct surveys, develop asbestos survey reports, and develop asbestos management plans; the duties of a licensed asbestos consultant employed by an asbestos management planner agency must be limited to those of a management planner; and(B) a licensed asbestos inspector to conduct surveys and develop asbestos survey reports.(2) An asbestos management planner agency must employ a responsible person who has completed the Asbestos Inspector and Asbestos Management Planner training referenced in §296.46 of this chapter (relating to Initial and Renewal Licensing Requirements for an Individual) to conduct surveys, develop asbestos survey reports, and develop asbestos management plans.(c) Licensee responsibilities. An asbestos management planner agency may be held responsible for a violation under this chapter by its employees or the responsible person. An asbestos management planner agency must:(1) require the responsible person to:(A) oversee the operations for the asbestos management planner agency activities; and(B) comply with the applicable requirements of this chapter;(2) require that its responsible person and any employee who performs an activity on behalf of the asbestos management planner agency comply with all applicable:(A) responsibilities for licensed asbestos inspectors, as required in §296.53 of this chapter (relating to Asbestos Inspector) and licensed asbestos management planners, as required in §296.56 of this chapter (relating to Asbestos Management Planner); and(B) requirements of this chapter;(3) comply with standards of operation, including the EPA regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards);(4) comply with the applicable OSHA regulations, including, as applicable, the work practices and controls in 29 CFR §1926.1101(g) (relating to Asbestos);(5) comply with the requirements of §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(6) use generally accepted principles and practices in performing asbestos surveys and producing management plans, as required in §296.191 of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility);(7) at no cost to the employee, comply with personal protective equipment (PPE) requirements in 29 CFR §1910.132(h) (relating to General requirements), 29 CFR §1926.1101(h) and (i), and 40 CFR §763.122 (relating to What does this subpart require me to do?), as applicable, for employees who perform asbestos-related activities. This includes:(A) providing and maintaining PPE for employees;(B) training employees in the proper use, care, and inspection of PPE;(C) documenting training in the proper use, care, and inspection of PPE;(D) documenting respirator inspections; and(E) ensuring compliance with the use of PPE;(8) provide at no cost to the employee, an annual medical examination, as required in §296.42(i) of this chapter (relating to Initial and Renewal Applications) for each employee who performs an asbestos-related activity;(9) ensure that each employee who performs asbestos-related activities has a current DSHS's Physician's Written Statement, as required in §296.42(i) of this chapter;(10) ensure that each employee who performs asbestos-related activities is familiar with federal, state, and local standards for asbestos removal, encapsulation, and enclosure;(11) ensure that each employee who performs asbestos-related activities receives annual training, as required in §296.73 of this chapter (relating to Asbestos Training Courses);(12) provide and maintain in good working condition the necessary equipment for performing asbestos-related activities;(13) report a change of the responsible person in writing to DSHS within 10 working days after the change;(14) cooperate with DSHS personnel during any inspection or investigation, as required in §296.271 of this chapter (relating to Inspections and Investigations);(15) comply with recordkeeping requirements, as required in §296.291 of this chapter (relating to Recordkeeping). Source Note: The provisions of this §296.57 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.57 Asbestos Management Planner Agency https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205415&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205415 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205415&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205415 03/11/2026 (a) License required. A person must be licensed as an asbestos consultant to provide asbestos consulting services relating to a public building.(b) Licensee scope of practice.(1) An asbestos consultant may:(A) design an asbestos abatement project;(B) specify work practices that vary from the minimum requirements, as described in §296.212(a)(1)(A) of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building);(C) collect bulk material samples and plan sampling strategies;(D) develop a management plan;(E) perform an asbestos survey and develop an asbestos survey report;(F) provide consultation regarding compliance with asbestos regulations and standards;(G) recommend abatement options, prepare contract documents for an asbestos abatement project, and provide technical specifications and plans;(H) provide the building owner with asbestos project monitoring services, asbestos air monitoring services, or sampling strategies, alone or in combination, to be used during an asbestos abatement project;(I) recommend appropriate personal protective equipment for an asbestos abatement activity;(J) designate a project manager or an asbestos air monitoring technician project monitor (AMT/PM) to provide project monitoring and delegate specific responsibilities and authority to the project manager or AMT/PM in writing, for which the consultant, as well as the project manager or AMT/PM performing the delegated responsibility, are responsible;(K) designate an asbestos air monitoring technician or AMT/PM to provide project air monitoring and delegate specific responsibilities and authority to the AMT or AMT/PM in writing, for which the consultant, as well as the AMT or AMT/PM performing the delegated responsibility, are responsible; and(L) design, supervise, and direct an exposure assessment for purposes of §296.233(c) of this chapter (relating to Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building) that meet the requirements of that subsection.(2) An asbestos consultant must not:(A) design an asbestos abatement project that includes alterations to a building's structure, or its electrical, mechanical, or safety systems, or their components, unless the consultant is or works together with a licensed professional engineer in Texas and the specifications and plans are prepared in accordance with all applicable requirements of Texas Occupations Code, Chapter 1001 (relating to Engineers) and 22 TAC Part 6 (relating to Texas Board of Professional Engineers); or(B) employ an asbestos inspector, asbestos project manager, asbestos air monitoring technician, AMT/PM, asbestos management planner, or any additional asbestos consultant to work in the capacity of that individual's license unless the asbestos consultant is licensed as an asbestos consultant agency, as required in §296.59 of this chapter (relating to Asbestos Consultant Agency).(c) Licensee responsibilities. When providing the following professional services to the building owner or the building owner's authorized representative, an asbestos consultant must:(1) provide the building owner or the building owner's authorized representative with a signed written asbestos survey report after completion of an asbestos survey or assessment, as described in §296.53(b) of this chapter (relating to Asbestos Inspector), which must advise the building owner of the recommendation to address ACBM or assumed ACBM that is damaged or separating and the requirement to address ACBM that will be disturbed as part of any renovation, demolition, or O&M activity;(2) provide a management plan, as required in §296.56(c) of this chapter (relating to Asbestos Management Planner);(3) design an asbestos abatement project, as described in §296.21(16) of this chapter related to (Definitions);(4) design and supervise any clearance-level assessment that is performed under §296.233 of this chapter;(5) prepare site-specific specifications and plans consisting of:(A) a clear and understandable written description of the determinations made during the asbestos abatement project design including the work to be performed and:(i) the location and total quantities of homogeneous areas of ACBM to be removed;(ii) the asbestos abatement methods and air clearance procedures to be used;(iii) the abatement preparations to be made;(iv) the equipment to be used; and(v) the appropriate selection of personal protective equipment to be used; and(B) drawings, floor plans, or the equivalent, that distinctly display the location of asbestos abatement activities and equipment to be used with a level of detail and in a size sufficient to make each location visually discernable, including the approximate locations of:(i) the negative air machines;(ii) the decontamination unit;(iii) the bag-out area, if used; and(iv) the boundaries of the containment;(C) a clear and understandable written description of ACWM disposal methods, including:(i) labeling of ACWM containers, in accordance with 40 CFR §61.150(a)(1)(iv) and (v) (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations); and(ii) marking ACWM transport vehicles, in accordance with 40 CFR §61.150(c);(D) the consultant's signature on every page that addresses the scope of work or contains drawings related to the abatement work; and(E) a cover page with the consultant's signature, date, license number, and license expiration date;(6) if required under §296.212(a)(1)(A) of this chapter, receive written approval from DSHS for specifications and plans prepared for an asbestos abatement project design that includes dry removal or no negative air before releasing specifications and plans to the asbestos abatement contractor;(7) review specifications and plans developed by another asbestos consultant or asbestos consultant agency, for which the consultant must:(A) review every page that addresses the scope of work or contains drawings related to the asbestos abatement project for which the consultant is preparing documents, as required under this subparagraph;(i) amend each page, as needed; and(ii) sign every reviewed page; and(B) prepare a separate cover page that indicates the adequacy of the specifications and plans, references any amendments, and includes the consultant's signature, date, license number, and license expiration date; the consultant assumes responsibility for the content by signing the cover page;(8) provide the site-specific specifications and plans used for asbestos abatement and prepared by the consultant, developed by another asbestos consultant or asbestos consultant agency, or both to the building owner before the asbestos abatement begins;(9) advise on the selection and use of appropriate personal protective equipment for each asbestos abatement activity;(10) review suggested changes to the asbestos abatement specifications and plans recommended by the consultant's designated project manager or AMT/PM and, if amending specifications and plans:(A) amend each relevant page of the specifications and plans in writing;(B) sign every amended page; and(C) provide the amended specifications and plans to the designated project manager or AMT/PM, building owner, and asbestos abatement supervisor for the project;(11) provide project monitoring, either personally or through a project manager or AMT/PM to whom the consultant has specifically delegated authority and responsibility as required in subsection (b)(1)(J) of this section, as follows:(A) enter and inspect the regulated area, containment, or both, as necessary to monitor that asbestos abatement activities are conducted, as required by regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards), in Subchapter L of this chapter (relating to General Requirements, and Practices and Procedures for Asbestos Abatement in a Public Building), and Subchapter M of this chapter (relating to Alternative Asbestos Practices and Procedures in a Public Building), as applicable, for the duration of the project, every day of asbestos abatement activity, before the start of the asbestos abatement activity for the day, and routinely throughout the day, from the beginning of containment abatement preparation through completion of the removal of containment, final visual inspection of the project site, and loading of ACWM for transport, as applicable, to:(i) monitor the asbestos abatement activity by observing, reporting, and documenting that the regulated area, containment, or both is in compliance with this chapter and with the specifications and plans, as applicable;(ii) identify and document any issue of noncompliance and corrections needed;(iii) document correction of any identified issue of noncompliance with asbestos abatement activity in a regulated area, containment, or both, as applicable, before work proceeds;(iv) report any identified issue of noncompliance that was not corrected to DSHS, as required in §296.41(f) of this chapter (relating to License and Registration Requirements);(B) consult with and notify the asbestos abatement supervisor of:(i) any issue of noncompliance with the provisions of this chapter and the specifications and plans; and(ii) corrections that must be made;(C) remain on-site and in immediate proximity of the regulated area, or the regulated area and containment, as applicable, at all times when an asbestos abatement activity is being conducted and when ACWM is being loaded for transport into a dumpster or other transport container or vehicle;(12) provide project air monitoring, as required in §296.54(b) of this chapter (relating to Asbestos Air Monitoring Technician), either personally or through an air monitoring technician or AMT/PM to whom the consultant has specifically delegated authority and responsibility as required in subsection (b)(1)(J) of this section;(13) provide progress records and, when necessary, photographs relating to any professional services undertaken for the building owner;(14) provide final close-out documents for each asbestos abatement project to the building owner or the building owner's authorized representative, including:(A) baseline and area air monitoring results;(B) clearance documentation, including visual inspection and clearance air monitoring results, as required in §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(C) copies of each required license ID card and certification for the consultant's personnel involved in the asbestos abatement project; and(D) the asbestos abatement consultant's daily logs;(15) cooperate with DSHS personnel during any inspection or investigation, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(16) comply with recordkeeping requirements, as required in §296.291 of this chapter (relating to Recordkeeping).(d) Consultant licensed before the effective date of this section. An asbestos consultant who is issued a license before the effective date of this section and qualified for licensure with full-qualification membership in a national professional organization may continue to perform work with and renew that license under the eligibility and renewal requirements of the Texas Asbestos Health Protection rules that were in effect when the license was issued. If the asbestos consultant fails to timely renew the license and the license remains expired for one year or more, the license may not be renewed. The asbestos consultant may re-apply for an initial license by meeting all education, work experience, and other application requirements for initial licensure under this section. Source Note: The provisions of this §296.58 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.58 Asbestos Consultant https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205416&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205416 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205416&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205416 03/11/2026 (a) License required. A person employing an asbestos consultant and one or more asbestos inspectors, asbestos project managers, asbestos air monitoring technicians, asbestos air monitoring technician project monitors (AMT/PM), asbestos management planners, or additional asbestos consultants working in the capacity of their licenses must be licensed as an asbestos consultant agency.(b) Licensee scope of practice.(1) An asbestos consultant agency may:(A) employ an asbestos consultant, asbestos inspector, asbestos project manager, asbestos air monitoring technician, AMT/PM, or asbestos management planner licensed as required in this chapter and working in the capacity of that individual's license; and(B) represent a building owner by providing asbestos project monitoring services and asbestos air monitoring services during an asbestos abatement project.(2) An asbestos consultant agency must employ a responsible person who has completed the training as referenced in §§296.46(b)(2)(G) and (c) of this chapter (relating to Initial and Renewal Licensure Requirements for an Individual) to engage in asbestos abatement activities.(c) Licensee responsibilities. An asbestos consultant agency may be held responsible for a violation under this chapter by its employees or the responsible person. An asbestos consultant agency must:(1) require the responsible person to:(A) oversee the operations for the asbestos consultant agency activities; and(B) comply with the applicable requirements of this chapter;(2) require that its responsible person and any employee who performs an activity on behalf of the asbestos consultant agency comply with all applicable:(A) responsibilities for licensed asbestos project managers, as required in §296.62 of this chapter (relating to Asbestos Project Manager), licensed asbestos air monitoring technicians, as required in §296.54 of this chapter (relating to Asbestos Air Monitoring Technician), licensed asbestos air monitoring technician project monitors, as required in §296.55 of this chapter (relating to Asbestos Air Monitoring Technician Project Monitor), and licensed asbestos consultants, as required in §296.58 of this chapter (relating to Asbestos Consultant); and(B) requirements of this chapter;(3) comply with standards of operation, including the EPA regulations adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards);(4) comply with applicable OSHA regulations, including, as applicable, the work practices and controls in 29 CFR §1926.1101(g) (relating to Asbestos);(5) comply with the relevant requirements in §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(6) comply with the abatement practices and procedures in §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building), as applicable;(7) comply with the restrictions and required work practices described in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building) for SSSD O&M activities conducted under that section, as applicable;(8) comply with the restrictions and required work practices described in §296.232 of this chapter (relating to Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building) for activities conducted under that section, as applicable;(9) comply with the restrictions and required work practices described in §296.233 of this chapter (relating to Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building) for activities conducted under that section, as applicable;(10) comply with the restrictions and required work practices described in §296.234 of this chapter (relating to Alternative Practices and Procedures for Removal of Whole Components of Intact Asbestos-Containing Material (ACM) in a Public Building) for activities conducted under that section, as applicable;(11) at no cost to the employee, comply with personal protective equipment (PPE) requirements in 29 CFR §1910.132(h) (relating to General requirements), 29 CFR §1926.1101(h) and (i) and 40 CFR §763.122 (relating to What does this subpart require me to do?), as applicable, for employees who perform asbestos-related activities, including:(A) providing and maintaining PPE for employees;(B) training employees in the proper use, care, and inspection of PPE;(C) documenting training in the proper use, care, and inspection of PPE;(D) documenting respirator inspections; and(E) ensuring compliance with the use of PPE;(12) provide at no cost to the employee, an annual medical examination, as required in §296.42(i) of this chapter (relating to Initial and Renewal Applications), for each employee who performs an asbestos-related activity;(13) ensure that each employee who performs asbestos-related activities has a current DSHS's Physician's Written Statement, as required in §296.42(i) of this chapter;(14) ensure that each employee who performs asbestos-related activities is familiar with federal, state, and local standards for asbestos removal, encapsulation, and enclosure;(15) ensure that each employee who performs an asbestos-related activity complies with the applicable training, as required in §296.73 of this chapter (relating to Asbestos Training Courses);(16) provide and maintain in good working condition the necessary equipment for performing asbestos-related activities;(17) report a change of the responsible person in writing to DSHS within 10 working days after the change;(18) cooperate with DSHS personnel during any inspection or investigation, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(19) comply with recordkeeping requirements, in accordance with §296.291 of this chapter (relating to Recordkeeping). Source Note: The provisions of this §296.59 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.59 Asbestos Consultant Agency https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205417&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205417 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205417&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205417 03/11/2026 (a) License required. A person must be licensed as an asbestos transporter to transport ACWM removed from a public building.(b) Licensee scope of practice.(1) An asbestos transporter may transport ACWM to a permitted waste disposal facility that accepts ACWM or to temporary storage off-site.(2) An asbestos transporter must not transport ACWM that is not properly labeled or without a waste shipment record (manifest).(c) Licensee responsibilities. An asbestos transporter must:(1) comply with applicable requirements in 49 CFR, Subtitle B, Chapter I (relating to Pipeline and Hazardous Materials Safety Administration, Department of Transportation); NESHAP, specifically the provisions concerning asbestos transport; and, where applicable, Appendix D, (relating to Transport and Disposal of Asbestos Waste) of AHERA;(2) provide and maintain in good working condition the necessary equipment for performing asbestos-related activity;(3) at no cost to the employee, comply with personal protective equipment (PPE) requirements in 29 CFR §1910.132(h) (relating to General requirements) and 29 CFR §1926.1101(h) and (i) (relating to Asbestos) and 40 CFR §763.122 (relating to What does this subpart require me to do?), as applicable, for employees who will handle asbestos, including:(A) providing and maintaining PPE for employees;(B) training employees on the proper use, care, and inspection of PPE;(C) documenting training in the proper use, care, and inspection of PPE;(D) documenting respirator inspections; and(E) ensuring employees use PPE properly;(4) ensure that all employees who will be transporting, loading, or unloading asbestos are fully trained in accordance with 49 CFR, Subtitle B, Chapter I, Subchapter C (relating to Hazardous Materials Regulations);(5) in anticipation of possible spills of ACWM, train employees on hazardous materials and emergency response operations in compliance with 29 CFR §1910.120 (relating to Hazardous waste operations and emergency response) and 49 CFR Part 172, Subpart H (relating to Training), as applicable;(6) verify ACWM is properly labeled with warning labels, in compliance with 29 CFR §1926.1101(k) and generator labels, in accordance with 40 CFR §61.150(a)(1)(v) (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations) before accepting ACWM for transport, and if ACWM is unlabeled, the asbestos transporter must notify the asbestos abatement contractor;(7) obtain a manifest from the asbestos abatement contractor on a form as described for the waste generator in 40 CFR §61.150(d) before transporting ACWM and deliver the ACWM with the manifest to a waste disposal facility on the approved list provided by the Texas Commission on Environmental Quality, and if transporting out of state, the asbestos transporter must follow the regulations of the receiving state applicable to delivery of the ACWM to an out-of-state disposal facility;(8) provide a copy of the manifest signed by the owner or operator of the designated disposal site to the asbestos abatement contractor or the building owner or the building owner's authorized representative within 14 calendar days after the date the ACWM was accepted for disposal; and(9) cooperate with DSHS personnel during any inspection or investigation, in accordance with §296.271 of this chapter (relating to Inspections and Investigations). Source Note: The provisions of this §296.60 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.60 Asbestos Transporter https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205418&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205418 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205418&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205418 03/11/2026 (a) License required. A laboratory must be licensed as an asbestos laboratory before providing polarized light microscopy (PLM), phase contrast microscopy (PCM), or transmission electron microscopy (TEM) analysis of a bulk or air sample collected in a public building.(b) Licensee scope of practice.(1) Each branch office of a licensed asbestos laboratory must be separately licensed and accredited for each type of analysis it will perform.(2) An asbestos laboratory must be appropriately accredited by the NVLAP to perform the following types of analysis:(A) PLM analysis of a bulk sample; or(B) TEM analysis of an air sample.(3) An asbestos laboratory may analyze air samples by PCM:(A) in the laboratory, if accredited by the American Industrial Hygiene Association (AIHA), the laboratory's individual analysts performing the analysis are listed on the AIHA Asbestos Analyst Registry (AAR), or the laboratory is enrolled and proficient in the AIHA Proficiency Analytical Testing (PAT) Program, as required in §296.47(b)(13)(C) of this chapter (relating to Initial and Renewal Licensure Requirements for a Company); and(B) in the field only if the laboratory's individual analysts performing the analysis are licensed asbestos air monitoring technicians or AMT/PMs; and:(i) listed on the AIHA AAR; or(ii) the laboratory is enrolled in the AIHA PAT Program and performs quality control analysis on at least 10% of the samples analyzed.(4) An asbestos laboratory or a laboratory's individual analyst must not perform asbestos analysis if the laboratory or analyst loses accreditation or proficiency, as applicable.(c) Licensee responsibilities. An asbestos laboratory may be held responsible for a violation under this chapter by its employees or the responsible person. An asbestos laboratory must:(1) maintain the proficiency and accreditation requirements, as required for licensure in §296.47(b)(13) of this chapter for each analytical method performed; any change in accreditation or proficiency must be reported in writing to DSHS within 10 working days after the change;(2) employ one individual as the responsible person who is responsible for the asbestos laboratory's operations and compliance with this chapter; any change of the responsible person must be reported in writing to DSHS within 10 working days after the change;(3) cooperate with DSHS personnel during any inspection or investigation, in accordance with §296.271 of this chapter (relating to Inspections and Investigations); and(4) comply with recordkeeping requirements, as required in §296.291 of this chapter (relating to Recordkeeping). Source Note: The provisions of this §296.61 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.61 Asbestos Laboratory https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205419&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205419 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205419&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205419 03/11/2026 (a) License required. A person must be licensed as an asbestos project manager and have written delegated authority, as required in §296.58(b)(1)(J) of this chapter (relating to Asbestos Consultant) to perform asbestos project monitoring in a public building.(b) Licensee scope of practice.(1) An asbestos project manager must be employed by a licensed asbestos consultant agency to monitor compliance with this chapter and the specifications and plans, on behalf of the building owner, during an asbestos abatement project.(2) An asbestos project manager may:(A) perform project monitoring as required in §296.58(c)(11) of this chapter;(B) recommend to the asbestos consultant changes to the asbestos abatement specifications and plans; and(C) assist the asbestos consultant in the development of an asbestos exposure assessment.(c) Licensee responsibilities. An asbestos project manager must, consistent with the scope of the project manager's delegated authority in accordance with subsection (a) of this section and §296.58(b)(1)(J) of this chapter, as applicable;(1) provide project monitoring as required in §296.58(c)(11) of this chapter and provide the consultant with all project documents after completion of the project;(2) cooperate with DSHS personnel during any inspection or investigation, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(3) maintain records on-site, as required in §296.291 of this chapter (relating to Recordkeeping).(d) Project manager licensed before the effective date of this section. A project manager who is issued a license before the effective date of this section may continue to perform work with and renew that license based upon the eligibility and renewal requirements of the Texas Asbestos Health Protection rule that was in effect when the license was issued. If an asbestos project manager fails to timely renew the license and the license remains expired for one year or more, the license may not be renewed. The former asbestos project manager may re-apply for an initial license by meeting all education, work experience, and other application requirements for initial licensure under §296.46 of this chapter (relating to Initial and Renewal Licensure Requirements for an Individual). Source Note: The provisions of this §296.62 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION D LICENSE AND REGISTRATION §296.62 Asbestos Project Manager https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205420&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205420 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205420&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205420 03/11/2026 (a) License required. A person must be licensed as an asbestos training provider to offer training to an individual who seeks MAP accreditation or a DSHS license.(b) Licensee scope of practice.(1) Licensee practice and limitations.(A) A licensed asbestos training provider may offer, schedule, and conduct any of the following courses for which the provider has received DSHS approval:(i) one or more asbestos training courses designed to meet accreditation requirements in accordance with the MAP;(ii) the Asbestos Air Monitoring Technician course, as required in §296.73 of this chapter (relating to Asbestos Training Courses); and(iii) the Texas Asbestos Law and Rules course, as required in §296.73 of this chapter.(B) An asbestos training provider must not:(i) allow instructors to self-train in order to qualify for approval under subsection (f) of this section or accreditation;(ii) combine course disciplines, hands-on training sessions, or other aspects of two courses, such as the Asbestos Abatement Worker course and the Asbestos Contractor/Supervisor course, that must not be taught in a combined course;(iii) combine an initial training course with a refresher training course;(iv) combine an Asbestos Abatement Worker course taught in one language with an Asbestos Abatement Worker course taught in another language;(v) allow an instructor to teach the Asbestos Abatement Worker course in a language other than English unless the instructor can speak, read, and write effectively in that language;(vi) allow a guest speaker to present more than 15% of a course; or(vii) allow an unapproved instructor to teach an asbestos training course.(2) Licensee responsibilities. An asbestos training provider may be held responsible for a violation under this chapter by its employees or the responsible person. An asbestos training provider must:(A) require the responsible person to:(i) oversee the operations for the asbestos training provider activities; and(ii) comply with the applicable requirements of this chapter;(B) require that its responsible person and any employee who performs an activity on behalf of the asbestos training provider comply with all applicable:(i) responsibilities for approved asbestos training instructors, as required in subsection (f) of this section; and(ii) requirements of this chapter;(C) provide for the course training equipment to be on-site and in proper working order;(D) provide for training in an environment that is conducive to learning and without excessive or avoidable external distractions and must:(i) not utilize a classroom for other purposes while training is being conducted; and(ii) only use facilities that have the following:(I) adequate lighting;(II) adequate seating and workspace for each trainee;(III) a climate-controlled environment in all areas used for training; and(IV) clean restrooms that are readily accessible and in proper working order;(E) provide training taught by only asbestos training instructors who:(i) are approved by DSHS to teach the course; and(ii) possess current accreditation or training for the course being taught;(F) ensure that each approved asbestos training instructor employed by the asbestos training provider:(i) presents all course materials as outlined in the syllabus and as presented to DSHS for approval;(ii) provides a course review to improve comprehension before administering the course examination; and(iii) administers a closed-book examination at the conclusion of each initial training course;(G) comply with course notification requirements in subsection (c) of this section;(H) specify in promotional materials the course prerequisites for admission, the content of the course and requirements for successful completion;(I) comply with requirements for each asbestos training course for which the asbestos training provider is licensed, as required in §296.73 of this chapter, including requiring and verifying that:(i) the number of trainees does not exceed the applicable trainee-to-instructor ratio; and(ii) a trainee who has not met attendance standards or who has not passed the required final examination is not issued a training certificate;(J) confirm that each trainee possesses current accreditation or is within the 12-month grace period before granting the trainee admission to a refresher training course;(K) inform each prospective trainee, in the language of the course being taught, of the following:(i) that requirements and qualifications apply to each category of license being sought under this chapter and that more information can be found on the DSHS website;(ii) that, to maintain accreditation, refresher training must be taken before the accreditation expiration date, including:(I) a 12-month grace period after the accreditation expiration date to take the refresher training course to renew the accreditation during which time an individual must not perform any activity for which accreditation is required until the refresher training course is successfully completed and the accreditation is renewed; and(II) that if the accreditation is not timely renewed within the 12-month grace period, the initial training must be completed again in order to obtain accreditation; and(iii) that a trainee may not complete the course if the trainee misses more than 10% of a training course;(L) provide instructions for locating the registration form for the state licensing examination and the examination schedule on DSHS's website;(M) record each trainee's examination score;(N) maintain security of all training certificates to ensure that trainees do not have access to the certificates until successful completion of the course;(O) at the conclusion of each training course, issue a training certificate that meets the requirements in subsection (d)(1)(Q) of this section to each trainee who has completed the course and passed the required final examination;(P) at the conclusion of each training course, issue a wallet-size photograph identification (ID) card that meets the requirements in subsection (d)(1)(R) of this section to each trainee who has completed the course and passed the required examination;(Q) submit a training course roster to DSHS within 10 working days after the completion date of each course, including:(i) the name of each trainee;(ii) the unique identifier of each trainee that is determined by the asbestos training provider;(iii) specification of successful or unsuccessful course completion for each trainee; and(iv) an attached color group photograph of all trainees who successfully completed the course that is:(I) taken at the end of the training course; and(II) of sufficient size and clarity to identify each trainee;(R) report a change of the responsible person in writing to DSHS within 10 working days after the change;(S) permit DSHS representatives to observe, evaluate, and monitor any training course;(T) cooperate with DSHS personnel during any inspection or investigation, as required in §296.271 of this chapter (relating to Inspections and Investigations); and(U) comply with recordkeeping requirements, as required in §296.291 of this chapter (relating to Recordkeeping).(c) Course notification requirements.(1) Course notifications. An asbestos training provider must notify DSHS of each scheduled course. DSHS must receive the notification at least 10 working days before the start date of the course. A notification may include multiple courses. The notification must include:(A) the name, license number, and contact phone number of the asbestos training provider;(B) the name, and contact phone number of the asbestos training instructor;(C) the name of the course, and for the Asbestos Abatement Worker course, the language that the course is conducted in specified in the course name;(D) the physical location (address and room number or name of the conference room) where the training will be held, including all off-site field trip locations;(E) the start and end dates for the training course; and(F) the start and end times for each day of training.(2) Amendments.(A) Notified courses must be amended by notifying DSHS by email or fax at least two working days before the start date of the course of the following course changes:(i) instructor, unless an alternate approved instructor that meets the qualifications to teach the course is provided with the course notification as required in paragraph (1)(A) of this subsection;(ii) location;(iii) time;(iv) date; and(v) language of the asbestos abatement worker course.(B) Amendments are not accepted for changes in course discipline.(C) Notified courses must not be amended fewer than two working days before the start date of the course and must be cancelled if not timely amended as soon as possible, but no later than two hours after the scheduled start time.(3) Emergency notifications. A training provider may request emergency approval of a course if unforeseen circumstances prevent the asbestos training provider from meeting the 10-working-day notification requirement. The emergency notification must be submitted to DSHS by email or fax and must include a justification of why the 10-working-day notification requirement could not be met and must contain the information required in subsection (c)(1)(A) - (F) of this section. The emergency notification must be submitted at least three working days before the start date of the course. The training provider must receive written approval from DSHS before conducting the course.(4) Cancellation notifications. A training provider must notify DSHS of a course cancellation by email or fax as soon as possible, but no later than two hours after the scheduled start time of the course.(d) Initial and renewal license requirements. To receive or renew a license as required in this section, an applicant must submit a completed application, as required in §296.42 of this chapter (relating to Initial and Renewal Applications) and the documentation required in this section. An out-of-state applicant must comply with §296.44 of this chapter (relating to Out-of-State Applicants).(1) Initial requirements. An applicant for an initial license must submit the following:(A) in relation to the applicant's franchise tax account status, whichever applies:(i) a certificate of account status from the Texas Comptroller of Public Accounts regarding the applicant's franchise tax account status, if the applicant is a taxable entity, as defined in Texas Tax Code §171.0002; or(ii) documentation that the applicant is not a taxable entity or is otherwise not subject to or exempt from franchise tax; and(iii) any verification relating to clause (i) or (ii) of this subparagraph that is requested by DSHS;(B) a copy of the applicant's assumed name certificate, with proof of required filing, if the applicant transacts business or renders professional services under an assumed name (commonly referred to as a DBA or "doing business as");(C) if the applicant is an entity, as defined in Texas Business Organizations Code §1.002:(i) documentation issued by the Secretary of State that verifies:(I) a domestic entity's existence; or(II) a foreign entity's registration and authorization to conduct business in Texas; or(ii) if the applicant is a foreign entity to which §296.44(d) of this chapter applies, the applicant must submit a sworn affidavit that meets the requirements of that subsection;(D) if the applicant is a nonfiling entity or a foreign nonfiling entity, as those terms are defined in Texas Business Organizations Code §1.002, documentation of that status on the application and any verification of that status that is requested by DSHS;(E) a taxpayer identification number;(F) the applicant's Texas sales tax permit number from the Texas Comptroller of Public Accounts, if applicable;(G) the name and mailing address of each principal owner;(H) a list of each course to be offered that includes the name of each asbestos instructor that will teach each course;(I) the name of any guest speaker and the speaker's topics along with the completed asbestos guest speaker approval application form, as required in subsection (g) of this section;(J) the name of the appointed responsible person;(K) a description of any equipment and accessories that will be used for course instruction, such as hands-on items, audiovisual aids, and brochures;(L) the applicant's refund and cancellation policies and if the applicant will provide the Asbestos Abatement Worker course in a language other than English, the refund and cancellation policies must be submitted in each language that the course will be offered;(M) a detailed course outline for each day that includes start and end times for each topic covered, scheduled break times, and specific hands-on training activities for each course;(N) student training manuals, instructor notebooks, handouts, and related course materials, including all required elements listed in §296.73 of this chapter for each initial and refresher training course to be offered; and(i) if the applicant will provide the Asbestos Abatement Worker course in a language other than English, the training manuals and all related course materials must be submitted in each language in which the course will be offered; and(ii) if the applicant will use an EPA-developed manual, the applicant may submit a statement attesting to its use in place of submitting the manual;(O) the applicant's policy regarding the administration of the multiple-choice examination to be given at the conclusion of training, in accordance with §296.73 of this chapter, which at minimum, must state the following:(i) each trainee must obtain a passing score of at least 70% on the multiple-choice examination before receiving a training certificate;(ii) one multiple-choice re-examination is allowed per trainee for each course;(iii) questions from the original examination that are randomly reordered or questions randomized from course to course may be used for the re-examination;(iv) if a trainee fails the re-examination, the trainee must repeat the course and pass a new examination before issuance of the training certificate; and(v) a trainee must read the examination and mark the answers on a score sheet unless the trainee requests a reasonable testing accommodation under the Americans with Disabilities Act of 1990, 42 USC 12101 et seq. and is a qualified individual with a disability;(P) a copy of each examination and re-examination that will be administered at the end of each course and if the applicant will provide the Asbestos Abatement Worker course in a language other than English, examinations must be submitted in each language that the course is offered;(Q) a sample of the training certificate that will be issued to each trainee who completes the course and passes the final course examination, including:(i) a unique certificate number;(ii) the asbestos training provider's name, a field for the asbestos training provider's license number, phone number, and address;(iii) the printed name of the accredited person;(iv) the discipline (name) of the training course completed;(v) the printed name and signature of the asbestos instructor;(vi) the start and end dates of the training course;(vii) the expiration date of one year after the date upon which the person successfully completed the training course;(viii) the printed name and signature of the responsible person, principal officer, owner, or chief executive officer of the asbestos training provider; and(ix) a statement, as applicable, that the trainee:(I) "has successfully completed the requisite training for asbestos accreditation under Title II of the Toxic Substances Control Act, 15 USC, Chapter 53, Subchapter II that meets the requirements of the Texas Asbestos Health Protection rules" (applicable to a MAP training course for which accreditation is issued); or(II) "has successfully completed training that meets the requirements of the Texas Asbestos Health Protection rules" (applicable to the Asbestos Air Monitoring Technician course or the Texas Asbestos Law and Rules course);(R) a sample of the training ID card that must be issued to each trainee who completes the course and passes the final course examination; the training ID card must include:(i) the name of the asbestos training provider;(ii) a color photo of the trainee's face (without tinted glasses, hats, bandanas, or other articles that may obscure the head or any part of the face) taken on a white background;(iii) the name of the accredited person;(iv) the discipline of the training course completed;(v) the effective date of the accreditation; and(vi) the unique certificate number shown on the training certificate for the accredited person; and(S) verifiable documentation that each asbestos training instructor that will teach an asbestos training course and is employed by the applicant meets the qualifications listed in subsection (h)(1)(B) of this section.(2) Renewal requirements. An applicant renewing a license must submit the following:(A) documentation as required for the initial application in subsection (d)(1)(A) - (F) of this section;(B) a copy of all policies, training resources, training certificates, or training manuals that the applicant seeks approval to amend with a detailed description of the specific changes that must be approved by DSHS before the training provider may implement the changes; and(C) a list of all approved asbestos instructors and guest speakers the training provider intends to use in the asbestos training courses, including the courses that each instructor will teach, proof that the accreditation of each instructor is current and valid for each course the instructor will teach, and the topics that each guest speaker will present.(e) Online asbestos refresher training course. An online asbestos refresher training course presented to a student by a licensed asbestos training provider may be conducted if the course meets the requirements of this subsection.(1) Scope.(A) For purposes of this subsection:(i) an asynchronous online course means a course type that can be taken at any time;(ii) a synchronous online course means an online course type that is taken live;(iii) conducting an initial asbestos training course online is prohibited; and(iv) an online course under this section will only be approved if it is a synchronous online course; an asynchronous online course will not be approved.(B) A training provider must not provide, offer, or claim to provide an online refresher course without applying for and receiving approval from DSHS as required under this subsection.(C) An application for an online course must be submitted separately from an application for approval for an in-person refresher course.(D) A licensed training provider may apply for approval to conduct an online asbestos refresher course that the training provider is approved to teach in-person.(2) Online refresher course requirements. A training provider that offers an online course must have a system in place that:(A) authenticates the identity of the student taking the training and their eligibility to enroll in the course to deter fraud and falsification of student identity;(B) uses encryption technology to protect sensitive user information;(C) ensures that the student is focusing on the training material throughout the entire training period, such as a strong interactive component to ensure continued student focus through discussion between the student and approved instructor or approved guest speaker, or interactive video clips, or both;(D) monitors and records a student's actual time spent online, including applicable breaks;(E) allows the student to ask questions of an approved instructor or approved guest speaker and allows the instructor or guest speaker to provide a response to the student's question during the course;(F) provides technical support to the student during the course to address any technical issue as soon as possible but no later than the end of the course day, and if a student is inadvertently logged out of an online session due to a technical issue, the student must be given credit for the portion of the course completed and be required to make-up the portion of the course missed;(G) reduces the opportunity for document fraud by providing a distinct course certificate that contains all the requirements of subsection (d)(1)(Q) of this section and specifies the course type and that the course is online; and(H) provides DSHS unrestricted access to an online course for auditing purposes at no charge at any time the course is being given.(3) Approval requirements.(A) A licensed training provider must submit an application for approval of an online course to DSHS that includes, in addition to the requirements of subsection (d)(2) of this section and §296.73 of this chapter, the following:(i) that the application is for an online asbestos refresher course;(ii) the type and discipline of the course;(iii) documentation of the systems in place required by paragraph (2) of this subsection;(iv) a technical support plan that describes potential technical issues that may occur and how the issues will be immediately handled; and(v) a description of the method used to verify student's attendance as required in paragraph (4)(B) of this subsection.(B) Upon receipt of a complete application and the required application fee, DSHS will issue the training provider contingent course approval. DSHS will conduct an audit of the online course. If DSHS finds that the course:(i) meets the requirements of this chapter, DSHS will remove the contingent course approval status within 45 days of the course audit.(ii) does not meet the requirements of this chapter, DSHS will issue a deficiency notice within 45 days of the course audit.(I) If the training provider does not submit the corrections identified in the deficiency notice, if applicable, and request a second audit by the deadline provided in the deficiency notice, DSHS will issue a notice of withdrawal of contingent approval of the training course.(II) A training provider may request two audits to remove the contingent course status.(III) If the training provider fails to meet the requirements of this chapter after the third audit, DSHS will issue a notice of withdrawal of contingent approval of the training course and the training provider must reapply for approval of the course.(C) If approved by DSHS to conduct online training, the training provider must clearly identify that the course is approved by DSHS when advertising or registering a student for the course.(4) Additional notification, course, and roster requirements.(A) The course type must be submitted with the course notification.(B) Training instructors must:(i) view each student during the course to ensure student focus;(ii) validate student identity during registration and after each break and lunch period; and(iii) have at least one support staff member assist the instructor to monitor online students during an in-person course that is also being presented online.(C) The group photograph may include multiple frames or photographs, if a single group photograph is not feasible, to meet the requirement of subsection (b)(2)(Q)(iv) of this section.(5) Recordkeeping requirements. A licensed training provider that is approved to administer an online course is subject to the following additional recordkeeping requirements.(A) Student identity authentication and verification data.(B) Student online time tracking data.(C) Training instructor, guest speaker, and technical support contact data.(6) Disciplinary action.(A) For purposes of license or registration renewal, DSHS will not accept certificates from an online course that was not approved by DSHS.(B) Failure to obtain approval before conducting an online course and failure to meet the requirements of this subsection may result in disciplinary action against the licensed training provider.(C) DSHS will withdraw course approval if the training provider fails to meet the requirements of this subsection.(f) Approval of additional training courses.(1) A licensed training provider must request approval to provide any additional training course that was not submitted as part of the initial application for the training provider's license. To apply for approval, the training provider must submit:(A) an Asbestos Course Approval Application for each course;(B) the fee as outlined in §296.91 of this chapter (relating to Fees);(C) student training manuals, instructor notebooks, handouts, and related course materials, including all required elements listed in §296.73 of this chapter for each initial and refresher training course to be offered; and(i) if the applicant will provide the Asbestos Abatement Worker course in a language other than English, the training manuals and all related course materials must be submitted in each language in which the course will be offered; and(ii) if the applicant will use an EPA-developed manual, the applicant may submit a statement attesting to its use in place of submitting the manual;(D) a detailed course outline for each day that includes start and end times for each topic covered, scheduled break times, and specific hands-on training activities for each course;(E) a copy of each required examination that will be administered at the end of each course and if the applicant will provide the Asbestos Abatement Worker course in a language other than English, examinations must be submitted in each language in which the course will be offered;(F) the name of the approved asbestos instructor who will teach each additional course; and(G) the name of any guest speaker and the speaker's topics along with the completed asbestos guest speaker approval application form, as required in subsection (i) of this section.(2) DSHS will provide written notice to the licensed training provider whether DSHS grants approval of the additional course. Training providers must not add the additional training course to their schedule, advertise, accept payment for, or conduct the course without approval by DSHS.(g) Training providers licensed before the effective date of this section. A training provider that is licensed before the effective date of this section must submit any updated training material to DSHS and receive approval six months after the effective date of this section or with the license renewal application, whichever is later, in order to continue teaching the course.(h) Asbestos training instructor approval, qualifications, responsibilities, and withdrawal of approval.(1) Asbestos training instructor approval and qualifications.(A) DSHS must approve an asbestos training instructor to teach an asbestos training course.(B) An asbestos training instructor must meet the following qualifications to teach an asbestos training course.(i) An asbestos training instructor must have one of the following combinations of education and work experience, as described in §296.41(b)(2) of this chapter (relating to License and Registration Requirements):(I) a bachelor's degree in a natural or physical science;(II) a bachelor's degree with at least six months of experience performing asbestos-related activities with any required license or accreditation;(III) an associate's degree or successful completion of 60 college credit hours with at least one year of experience performing asbestos-related activities; or(IV) a high school diploma or equivalent with at least two years of experience performing asbestos-related activities with any required licensure or accreditation.(ii) An asbestos training instructor must have the following teaching experience:(I) at least three months of teaching experience at the secondary or post-secondary education level;(II) at least three months of teaching adult learners at a vocational school, trade school, or equivalent formal educational or professional setting as approved by DSHS; or(III) successful completion of a train-the-trainer course approved by DSHS.(C) Acceptable documentation of the relevant education, work, and teaching experience, as described in subparagraph (B)(i) and (ii) of this paragraph must include each of the following or an equivalent alternative approved by DSHS:(i) an official academic transcript or diploma that verifies the major;(ii) a description of experience performing asbestos-related activities including:(I) the project name and location;(II) the start and end date;(III) a description of duties performed; and(IV) the name and contact information of the individual or office that can verify the experience;(iii) a description of the applicant's teaching experience including:(I) the course title and description;(II) the start and end date;(III) the location or institution; and(IV) the name and contact information of the individual or office that can verify the teaching experience; and(iv) proof of licensure or accreditation or both; and(D) training certificates for the initial asbestos training courses and all subsequent refresher training courses to show current accreditation under §296.73 of this chapter for each course the instructor will teach, if applicable.(2) Approved training instructor scope of practice.(A) Approved training instructor practice and limitations.(i) An asbestos training instructor must:(I) teach only DSHS-approved asbestos training courses for which the instructor holds current MAP accreditation, for an Asbestos Air Monitoring Technician (AMT) course, holds a Texas AMT training certificate, or if only teaching the Texas Asbestos Law and Rules course, holds a Texas Asbestos Law and Rules training certificate;(II) teach each DSHS-approved asbestos training course in accordance with the MAP and as required in this subchapter;(III) be able to read, write, and communicate in the language that the course is taught; and(IV) be employed by a licensed training provider.(ii) An approved asbestos training instructor must not:(I) teach a course for accreditation under the MAP or a course required for a license from DSHS if notification has not been submitted to DSHS, in accordance with subsection (c) of this section; or(II) self-train in order to qualify to teach a training course or qualify for a license or accreditation.(B) Approved asbestos training instructor responsibilities. An asbestos training instructor must:(i) coordinate with the responsible person to verify that there is documented confirmation that:(I) each trainee possesses current accreditation, or is within the 12-month grace period for accreditation renewal, before granting admission to a refresher training course;(II) necessary training equipment is on-site and in good working order; and(III) the number of trainees does not exceed the applicable trainee-to-instructor ratio, as required in §296.73(a)(8) of this chapter;(ii) confirm with each trainee that the training provider has informed the trainee of each required information item, as required in subsection (b)(2)(K) of this section;(iii) inform each trainee of the following:(I) for an initial training course, each trainee must achieve a score of at least 70% on the course examination to receive a training certificate;(II) if a trainee fails the course examination, a second examination will be administered; and(III) a trainee must retake the initial training course if the trainee does not achieve a score of at least 70% on the second examination;(iv) comply with requirements for training courses, as required in §296.73 of this chapter;(v) present all course materials as outlined in the syllabus and as presented to DSHS for approval;(vi) implement and enforce attendance and course completion requirements;(vii) take an attendance record at the beginning of each four-hour segment of course instruction;(viii) document a trainee's absence from the course on the attendance record;(ix) provide instructions for locating the registration form for the state licensing examination and examination schedule on DSHS's website;(x) provide a course review to improve and reinforce comprehension before administering the examination;(xi) administer a closed-book examination at the conclusion of each initial training course;(xii) administer one re-examination to each trainee who fails the first examination, as required under the policy and practices required under subsection (d)(1)(O) of this section;(xiii) record each trainee's examination score;(xiv) provide attendance records to the training provider upon completion of each course; and(xv) cooperate with DSHS personnel during inspections, audits, and investigations, as required in §296.271 of this chapter.(3) Withdrawal of instructor approval. DSHS may withdraw instructor approval if the instructor does not meet the requirements in this subsection, does not provide training that meets the requirements of the MAP or this chapter, or no longer possesses valid or current qualifications.(4) Instructors approved before the effective date of this section. An instructor who is approved to teach before the effective date of this section does not need to meet additional education, work experience, and teaching experience required under subsection (h)(1)(B) of this section that was not required when the instructor was approved and does not need to resubmit documents for approval. A certificate for the Texas Law and Rules course is not required to teach that course until six months after the effective date of this section. If, within six months after the effective date of this section, the instructor has not received a certificate for the Texas Law and Rules course, the instructor may not continue teaching under the instructor's prior approval. Any future instructor approval will be subject to the education, work experience, and teaching experience otherwise required under this section.(i) Guest speaker approval and withdrawal of approval.(1) Approval. Prior approval of a guest speaker is required. A guest speaker may be used to supplement and enhance learning objectives but must not present more than 15% of any course. A guest speaker must have knowledge based on education, research, or experience in a particular area of study related to the course content being taught. Training providers seeking approval for a guest speaker must submit a completed Asbestos Guest Speaker Approval Application Form and sufficient documentation to show the person's knowledge, experience, and expertise. Acceptable documentation may include:(A) official copies of any applicable academic transcript or diploma specifying the guest speaker's major;(B) technical experience;(C) a verifiable resume; and(D) relevant, verifiable work experience, as described in §296.41(b)(2) of this chapter (relating to License and Registration Requirements).(2) Withdrawal of guest speaker approval. DSHS may withdraw guest speaker approval if the guest speaker is not providing training that meets the requirements of the MAP or this chapter or if the guest speaker's qualifications are no longer valid or current. Source Note: The provisions of this §296.71 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION E TRAINING PROVIDER LICENSE AND TRAINING COURSES §296.71 Asbestos Training Provider https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205421&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205421 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205421&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205421 03/11/2026 (a) General training requirements.(1) The MAP requires that each of the approved training disciplines be separate and distinct from the others. Training courses for all disciplines must be in accordance with the MAP, except the Asbestos Air Monitoring Technician and Texas Asbestos Law and Rules courses, which are specific to Texas.(2) Each initial and refresher training course, including hands-on-training, must be specific to a single discipline and not combined with other training.(3) The Asbestos Air Monitoring Technician and Texas Asbestos Law and Rules courses are DSHS-approved courses and not MAP courses. To be applied toward DSHS license requirements, each course must be conducted by a DSHS-licensed asbestos training provider.(4) A training certificate expires one year after the date upon which the person successfully completed the course. A person whose training certificate has expired must not engage in an activity for which a current training certificate is required under the MAP or this chapter until the training certificate is renewed. Training must be renewed annually by completing the appropriate refresher training course. The initial training course must be repeated if the refresher training course is not completed within one year after the expiration date of the training certificate.(5) Initial and refresher training courses must be conducted as follows:(A) one day of training must equal eight hours and include:(i) at least 6 hours and 40 minutes of classroom instruction, hands-on training, and field trips (excluding field trip travel time); and(ii) a maximum of 80 minutes for breaks and lunch; no more than four hours of instruction may be given without at least a 30-minute break;(B) one-half day of training must be a minimum of four hours and include:(i) at least 3 hours and 40 minutes of classroom instruction; and(ii) a maximum of 20 minutes for breaks;(C) trainees must not attend more than eight hours of classroom instruction, hands-on training, and field trips in a 24-hour period;(D) evening instruction must not exceed 4 hours in any single session; and(E) the course must be completed within 14 calendar days after the first class.(6) A trainee may not complete the course if the trainee misses more than 10% of a training course.(7) During hands-on training, each trainee must physically perform simulated activities specific to the asbestos training discipline. The simulated activities must not be asbestos-related activities for which licensure is required. Demonstrations and audiovisuals are not substitutes for required hands-on training.(8) The student to instructor ratio during each course must be as follows:(A) for initial courses:(i) hands-on training activities must not exceed 15 to 1;(ii) worker training course sessions must not exceed 25 to 1; and(iii) all other training course sessions must not exceed 40 to 1;(B) for refresher courses, sessions must not exceed 40 to 1.(9) Methods of instruction.(A) At least 50% of the classroom instruction must be presented by the instructor. Instructors must direct and oversee 100% of the hands-on training.(B) Audiovisual materials are not substitutes for the instructor-led portion of the class.(10) All training courses must be taught in English, except the Asbestos Abatement Worker course. The Asbestos Abatement Worker course may be taught in another language, provided the instructor is able to speak, read, and write effectively in that language, and training materials and examinations are in that same language.(b) Initial training course requirements.(1) Asbestos Abatement Worker course. The Asbestos Abatement Worker course must be at least four training days. This course must include lectures, demonstrations, at least 14 hours of hands-on training, individual respirator fit-testing, course review, and a written examination of 50 multiple-choice questions. Successful completion of the course will require passing the examination with a score of at least 70%. The course must adequately address the following in accordance with the MAP:(A) the physical characteristics of asbestos, ACBM, and other ACM;(B) potential health effects related to asbestos exposure;(C) employee personal protective equipment;(D) state-of-the-art work practices;(E) personal hygiene;(F) additional safety hazards;(G) medical monitoring;(H) air monitoring;(I) relevant federal, Texas, and local regulatory requirements, procedures and standards;(J) establishment of respiratory protection programs and medical surveillance programs;(K) hands-on training that includes work area abatement preparation, decontamination chamber construction, cleaning and disposal, and respirator fit-testing and maintenance; and(L) course review.(2) Asbestos Contractor/Supervisor course. The Asbestos Contractor/Supervisor course must be at least five training days. The course must include lectures, demonstrations, at least 14 hours of hands-on training, individual respirator fit-testing, course review, and a written examination of 100 multiple-choice questions. Successful completion of the course will require passing the examination with a score of at least 70%. The course must adequately address the following in accordance with the MAP:(A) the physical characteristics of asbestos, ACBM, and other ACM;(B) potential health effects related to asbestos exposure;(C) employee personal protective equipment;(D) state-of-the-art work practices;(E) personal hygiene;(F) additional safety hazards;(G) medical monitoring;(H) air monitoring;(I) relevant federal, Texas, and local regulatory requirements and standards;(J) establishment of respiratory protection programs and medical surveillance programs;(K) hands-on training that includes work area abatement preparation, decontamination chamber construction, cleaning and disposal, and respirator fit-testing and maintenance;(L) insurance and liability issues;(M) recordkeeping for asbestos abatement projects;(N) supervisory techniques for asbestos abatement activities;(O) contract specifications; and(P) course review.(3) Asbestos Air Monitoring Technician course. The Asbestos Air Monitoring Technician course must be at least three training days. The course must include lectures, demonstrations, hands-on individual respirator fit-testing, course review, and a written examination consisting of 50 multiple-choice questions. Successful completion of the course will require passing the examination with a score of at least 70%. The course must adequately address the following:(A) the health effects of asbestos exposure including:(i) the nature of asbestos-related diseases;(ii) routes of exposure;(iii) no known safe exposure level;(iv) the synergistic effect between cigarette smoking and asbestos exposure;(v) the latency periods for asbestos-related diseases; and(vi) a discussion of the relationship of asbestos exposure to asbestosis, lung cancer, mesothelioma, and cancers of other organs;(B) the following OSHA regulations:(i) 29 CFR §1910.134 (relating to Respiratory protection);(ii) 29 CFR §1910.1001, Appendix A (relating to OSHA Reference Method--Mandatory);(iii) 29 CFR §1910.1001, Appendix B (relating to Detailed Procedure for Asbestos Sampling and Analysis--Non-mandatory);(iv) 29 CFR §1910.1200 (relating to Hazard communication); and(v) 29 CFR §1926.1101 (relating to Asbestos), OSHA's asbestos standard for the construction industry;(C) the following sections of this chapter:(i) §296.21 of this chapter (relating to Definitions);(ii) §296.54 of this chapter (relating to Asbestos Air Monitoring Technician);(iii) §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(iv) §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building);(v) §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building); and(vi) §296.291 of this chapter (relating to Recordkeeping);(D) 40 CFR Part 763, Subpart E, Appendix A (relating to Interim Transmission Electron Microscopy Analytical Methods--Mandatory and Nonmandatory--and Mandatory Section To Determine Completion of Response Actions), overview of AHERA air monitoring requirements and AHERA sampling;(E) asbestos air sampling methods, including:(i) calibration of air sampling pumps;(ii) air sample volume calculations;(iii) sampling strategies for clearance monitoring;(iv) types of air samples (personal breathing zone versus fixed-station area);(v) sampling location and objectives (pre-abatement, during abatement, and clearance monitoring);(vi) number of samples to collect;(vii) minimum and maximum air volumes in accordance with the NIOSH 7400 method;(viii) period of sampling;(ix) aggressive clearance sampling;(x) interpretations of sampling results;(xi) quality assurance methods (for example, Z-test); and(xii) special sampling problems (crawl spaces, unacceptable samples for laboratory analysis, sampling in occupied buildings);(F) evaluation methods, including:(i) transmission electron microscopy (analysis feedback affecting flow rates, EPA's recommended technique for analysis of final air clearance samples);(ii) phase contrast microscopy;(iii) AHERA's limits on the use of phase contrast microscopy;(iv) what each technique measures (phase contrast microscopy versus transmission electron microscopy);(v) analytical methodologies;(vi) AHERA transmission electron microscopy protocol;(vii) NIOSH 7400 method;(viii) OSHA reference method (non-clearance); and(ix) EPA recommendation for clearance (transmission electron microscopy);(G) sampling equipment, including:(i) sampling pumps (low volume versus high volume, battery versus plug-in);(ii) flow regulating devices;(iii) sampling media;(iv) types of filters;(v) types of cassettes and how to prepare for each type of analysis;(vi) filter orientation;(vii) storage and shipment of filters;(viii) calibration techniques;(ix) primary and secondary calibration standards;(x) temperature and pressure effects;(xi) environmental conditions that prohibit analysis; and(xii) frequency of calibration;(H) calculating sampling times, including:(i) documenting start time and end time; and(ii) calculating total time;(I) time weighted average (TWA) calculation including 8-hour TWA and TWA formula;(J) calibration of air sampling pumps, including:(i) primary versus secondary calibration standards;(ii) soap film flowmeter;(iii) in-line and inlet rotameter positioning;(iv) rotameter calibration worksheet;(v) electronic calibrators;(vi) temperature and pressure correction and effects on sample integrity;(vii) high volume air sampling pumps and calibration; and(viii) critical orifices;(K) air sampling logs and records, including:(i) data elements;(ii) air sample labeling;(iii) chain of custody forms;(iv) shipping and handling methods;(v) cassette labeling; and(vi) recordkeeping and field work documentation;(L) types of air sampling, including:(i) baseline;(ii) area;(iii) personal;(iv) clearance;(v) area sampling during glove bag operations; and(vi) upwind and downwind; and(M) course review.(4) Asbestos Inspector course. The Asbestos Inspector course must be at least three training days. The course must include lectures, demonstrations, 4 hours of hands-on training, individual respirator fit-testing, course review, and a written examination consisting of 50 multiple choice questions. Successful completion of the course will require passing the examination with a score of at least 70%. The course must adequately address the following in accordance with the MAP:(A) background information on asbestos;(B) potential health effects related to asbestos exposure;(C) functions/qualifications and role of inspectors;(D) legal liabilities and defenses;(E) understanding building systems;(F) public/employee/building occupant relations;(G) pre-survey planning, and review of previous survey records;(H) inspecting for friable and nonfriable ACM;(I) assessing the condition of friable ACM;(J) bulk sampling/documentation of asbestos;(K) respiratory protection;(L) personal protective equipment;(M) hands-on training that includes a pre-field-trip simulated asbestos survey with bulk sampling of non-ACBM, and respirator fit-testing and maintenance;(N) recordkeeping and writing the asbestos survey report;(O) federal, state, and local regulations;(P) field trip that includes a building walk-through at a suitable location outside of the classroom; and(Q) course review.(5) Asbestos Management Planner course. The Asbestos Management Planner course must be two training days. The prerequisite for admission to the course is to provide a copy of a current asbestos inspector training certificate. The course must include lectures, demonstration, course review, and a written examination consisting of 50 multiple choice questions. Successful completion of the course will require passing the examination with a score of at least 70%. The course must adequately address the following in accordance with the MAP:(A) course overview;(B) evaluation and interpretation of survey results;(C) hazard assessment;(D) legal implications;(E) evaluation and selection of control options;(F) role of other professionals;(G) developing an operations and maintenance (O&M) plan;(H) regulatory review;(I) recordkeeping for the management planner;(J) assembling and submitting the management plan;(K) financing abatement actions; and(L) course review.(6) Asbestos Project Designer course. The Asbestos Project Designer course must be at least three training days. This course must include lectures, demonstrations, a field trip, course review, and a written examination of 100 multiple-choice questions. Successful completion of the course will require passing the examination with a score of at least 70%. The course must adequately address the following, in accordance with the MAP:(A) background information on asbestos;(B) potential health effects related to asbestos exposure;(C) overview of abatement construction projects to include clearance of the project area;(D) safety system design specifications, including written sampling rationale for air clearance;(E) field trip;(F) employee personal protective equipment;(G) additional safety hazards;(H) fiber aerodynamics and control;(I) designing abatement solutions, including discussion of removal, encapsulation, and enclosure methods and asbestos waste disposal;(J) final clearance process, including discussion of the need for a written sampling rationale for aggressive final air clearance; requirements of a complete visual inspection; and the relationship of the visual inspection to final air clearance;(K) budgeting and cost estimating;(L) writing abatement specifications and plans;(M) preparing abatement drawings;(N) contract preparation and administration;(O) legal/liabilities/defenses;(P) replacement of asbestos with asbestos-free substitutes;(Q) role of other consultants;(R) occupied buildings, special design procedures required in occupied buildings, education of occupants, extra monitoring recommendations, staging of work to minimize occupant exposure, and scheduling of renovation to minimize exposure;(S) how to accomplish a complete visual inspection;(T) relevant federal, Texas, and local regulatory requirements; and(U) course review.(7) Texas Asbestos Law and Rules course. The Texas Asbestos Law and Rules course must be three hours. The course must adequately address the law and rules for the following:(A) asbestos management in public buildings;(B) notification requirements for public buildings;(C) operations and maintenance (O&M) requirements for public buildings;(D) abatement practices and procedures for public buildings;(E) asbestos licensing requirements;(F) recordkeeping requirements;(G) exemptions; and(H) conflicts of interest.(c) Refresher training course requirements.(1) An annual refresher training course is required for each discipline to maintain accreditation or licensure. Each refresher training course must adequately address the following:(A) federal, state, and local regulations;(B) developments in state-of-the-art procedures; and(C) key aspects of the initial training course.(2) A refresher training course must consist of at least the following amount of training, as specified for the applicable refresher training course:(A) asbestos abatement worker--one day of training;(B) asbestos contractor/supervisor--one day of training;(C) asbestos inspector--one half-day of training;(D) asbestos management planner--one half-day of training;(E) asbestos project designer--one day of training; and(F) asbestos air monitoring technician--one half-day of training. Source Note: The provisions of this §296.73 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION E TRAINING PROVIDER LICENSE AND TRAINING COURSES §296.73 Asbestos Training Courses https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205422&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205422 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205422&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205422 03/11/2026 (a) All applicable fees must be paid to DSHS before DSHS issues a registration or license.(b) For all initial and renewal applications, DSHS is authorized to collect subscription and convenience fees, in amounts determined by the Texas Department of Information Resources pursuant to Texas Government Code §2054.252 (relating to State Electronic Internet Portal Project), to recover costs associated with electronic application and renewal application processing.(c) The fees, not including subscription and convenience fees, are as follows:(1) asbestos abatement contractor initial or renewal--$1,070;(2) asbestos abatement supervisor initial or renewal--$400;(3) asbestos abatement worker initial or renewal--$65;(4) asbestos air monitoring technician initial or renewal--$99;(5) asbestos air monitoring technician project monitor initial or renewal--$400;(6) asbestos consultant initial or renewal--$645;(7) asbestos consultant agency initial or renewal--$430;(8) asbestos inspector initial or renewal--$130;(9) asbestos laboratory initial or renewal--$430;(10) asbestos management planner initial or renewal--$260;(11) asbestos management planner agency initial or renewal--$430;(12) asbestos operations and maintenance contractor initial or renewal--$260;(13) asbestos operations and maintenance supervisor initial or renewal--$225;(14) asbestos project manager initial or renewal--$320;(15) asbestos training provider initial or renewal--$963;(16) asbestos transporter initial or renewal--$430;(17) reimbursement processing for fee overpayment--$50;(18) approval of additional training course--$100;(19) examination--$25;(20) identification card replacement--$20;(21) license replacement--$20;(22) name change--$20;(23) returned check--$30;(24) special examination request--$50;(25) provisional asbestos abatement supervisor--$185;(26) provisional asbestos abatement worker--$30;(27) provisional asbestos inspector--$60; and(28) provisional asbestos management planner--$120. Source Note: The provisions of this §296.91 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION F LICENSE AND REGISTRATION FEES §296.91 Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205423&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205423 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205423&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205423 03/11/2026 A person who does not submit a timely renewal application must pay the late fee, as required under paragraph (1) or (2) of this section, as applicable, if the person is eligible to renew the license under §296.42(e) of this chapter (relating to Initial and Renewal Applications). A renewal application is considered timely if the application, fee, and all required documents are received by DSHS or postmarked before the license expires. If the application, fee, or required documents are deficient and the deficiency is not resolved before the license expires, the renewal application is not timely and is subject to the following late fees:(1) If a person's license has been expired for one to 90 days, the person's renewal application must be accompanied by a renewal fee that is equal to 1.5 times the normally required renewal fee.(2) If a person's license has been expired for more than 90 days, but less than a year, the person's renewal application must be accompanied by a renewal fee that is equal to two times the normally required renewal fee. Source Note: The provisions of this §296.92 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION F LICENSE AND REGISTRATION FEES §296.92 Late Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205424&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205424 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205424&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205424 03/11/2026 (a) An application is incomplete if an applicant submits the application fee by a payment device that is not honored by the issuing financial institution. No later than 30 days after the date of DSHS's notice of the dishonored payment, the applicant must submit to DSHS a money order or cashier's check in the amount of the dishonored payment device, plus the fee of $30 for each dishonored payment device.(b) If DSHS has issued a license obtained with a dishonored payment device and the person does not pay the full amount due by the 30-day payment deadline specified in DSHS's notice, the person is in violation of this chapter and subject to enforcement action, including license revocation and administrative penalties, as described in Subchapter Q of this chapter (relating to Compliance).(c) If an applicant has taken an examination, DSHS must receive full payment of all applicable fees before releasing the examination score or approving the initial license. Source Note: The provisions of this §296.93 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION F LICENSE AND REGISTRATION FEES §296.93 Dishonored Payment Device https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205425&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205425 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205425&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205425 03/11/2026 (a) Application fees paid to DSHS are not transferable and may be reimbursed only if:(1) fee amounts are paid in excess of the required fee, including as a result of an error in the online payment system, and DSHS deducts an administrative fee, as specified in §296.91(c)(17) of this chapter (relating to Fees) and subscription and convenience fees, as specified in §296.91(b) of this chapter from an excess payment before issuing a refund; or(2) an application is not processed within the time periods described in §296.42(b) of this chapter (relating to Initial and Renewal Applications).(A) In that event, the applicant has the right to request reimbursement of the application fee in writing.(B) A request for reimbursement may be denied if DSHS does not determine that the applicable time period has been exceeded or finds that there was good cause for exceeding the time period.(C) Good cause for exceeding the time period exists if:(i) the number of license applications to be processed exceeds the number of applications processed in the same calendar quarter of the preceding year by 15% or more;(ii) DSHS relies on another public or private entity to process all or part of the application process and that entity causes the delay; or(iii) any other condition exists that gives DSHS good cause for exceeding the time period.(b) If DSHS denies a request for reimbursement under subsection (a)(2) of this section, the applicant may appeal in writing to the commissioner. If the commissioner determines that DSHS exceeded the applicable processing time period without good cause, the applicant is entitled to reimbursement of all application fees paid after being notified in writing of the decision. Source Note: The provisions of this §296.94 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION F LICENSE AND REGISTRATION FEES §296.94 Reimbursement of Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205426&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205426 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205426&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205426 03/11/2026 (a) Each license applicant, except an asbestos abatement worker applicant, must pass the examination for the license type for which the applicant is applying to qualify for a license as required in §296.46(b)(5) of this chapter (relating to Initial and Renewal Licensure Requirements for an Individual). The examination is provided in the English language and translation of the examination to another language is not allowed.(b) A passing examination score may not be used to obtain more than one license, except as provided in §296.46(e) of this chapter.(c) An applicant must submit all documents and fees necessary to complete the licensing process within three years after passing the required examination. If the applicant does not complete the licensing process within three years, the applicant must prepare and submit a new application with the application fee and retake the examination.(d) DSHS approval to take an examination lapses and is no longer valid if an applicant:(1) fails to take a scheduled examination; or(2) does not take an examination within six months after submitting the application.(e) An applicant who is a qualified person with a disability may request a reasonable testing accommodation under the Americans with Disabilities Act of 1990, 42 USC §12101 et seq. by submitting to the Asbestos program a "Reasonable Modification Request for Licensing or Certification Examinations" form and other required documentation, in accordance with the Health and Human Services System's Circular C-039, "Reasonable Modifications in the Licensing and Certification Examination Process". Applicants may contact DSHS for additional information. Source Note: The provisions of this §296.111 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.111 General Examination Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205427&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205427 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205427&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205427 03/11/2026 DSHS publishes all scheduled examination dates and locations on its website. DSHS may cancel or reschedule examinations when necessary. A request to take an examination on a date not listed on the schedule must be submitted to DSHS in writing with the applicable fee for a special examination request, as required in §296.91 of this chapter (relating to Fees). DSHS may approve or deny the request at its discretion. Source Note: The provisions of this §296.112 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.112 Examination Schedule https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205428&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205428 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205428&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205428 03/11/2026 (a) An individual must complete all required training courses from a DSHS-licensed training provider or a training provider approved by another state that administers training in accordance with the MAP, before applying to take an examination.(b) An individual who has completed all required training in another state must meet the requirements in §296.44 of this chapter (relating to Out-of-State Applicants).(c) A copy of all required initial and refresher training certificates proving current accreditation must be submitted with the examination application. Source Note: The provisions of this §296.113 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.113 Examination Qualifications https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205429&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205429 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205429&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205429 03/11/2026 (a) To apply to take an examination, an applicant must submit a completed examination application, the examination fee outlined in §296.91 of this chapter (relating to Fees), and documentation of all required training courses at least 15 calendar days before the desired examination date.(b) Submission of an application does not guarantee approval or admission for a specific examination. If the applicant meets all requirements to take the applicable examination, DSHS will attempt to schedule the applicant for the requested date and location, but space limitations may require DSHS to offer an examination date and location other than the requested selection.(c) Upon approval of an examination request, DSHS will email, fax, or mail an examination confirmation letter to the applicant with the date, location, and time of the examination. Source Note: The provisions of this §296.114 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.114 Examination Registration and Confirmation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205430&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205430 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205430&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205430 03/11/2026 (a) To enter the test site, the examinee must present the examination confirmation letter from DSHS and a government-issued photo identification.(b) If an examinee fails to follow the proctor's instructions regarding conduct, the proctor may terminate that individual's examination by collecting the examination materials and asking the individual to leave. The examination fee is not refundable. An examination that has been terminated as a result of an examinee's conduct counts as a failed examination attempt.(c) If an examinee's conduct involves an act of dishonesty, DSHS may withdraw the examination confirmation letter, impose administrative penalties, revoke any license the examinee holds under this chapter, or deny the license application that applies to the examination. Source Note: The provisions of this §296.115 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.115 Examination Admittance and Conduct https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205431&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205431 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205431&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205431 03/11/2026 (a) A grade of 70% must be achieved for an examinee to pass the examination.(b) DSHS notification to the examinee of the examination result of an examination graded or reviewed by DSHS is sent to the examinee no later than 30 working days after the examination is administered.(c) DSHS notification to the examinee of the examination result of an examination graded or reviewed by a testing service is sent to the examinee no later than 14 days after DSHS receives the result. If DSHS does not receive notice of the examination result from the testing service within 30 working days after the examination is administered, DSHS notification of the reason for the delay is sent to the examinee no later than 90 days after the examination is administered. DSHS may require a testing service to notify an examinee of the results directly.(d) Instructions regarding re-examination accompany DSHS notice to the examinee of a failing grade. Source Note: The provisions of this §296.116 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.116 Grading Examinations and Reporting Scores https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205432&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205432 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205432&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205432 03/11/2026 An individual applying for re-examination must submit a new examination application and pay the required fee. An applicant may take a maximum of two re-examinations after failing the initial examination. Re-examination must occur within one year after the previous examination. An applicant who fails the state examination three times per license category must repeat the initial training course or courses, as applicable, for the intended license and submit a new examination application. Source Note: The provisions of this §296.117 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.117 Re-examination https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205433&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205433 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205433&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205433 03/11/2026 An examinee may obtain an analysis of the examinee's performance on a failed examination upon written request to DSHS. The request must be made within one year after the examination date. Source Note: The provisions of this §296.118 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION G STATE LICENSING EXAMINATION §296.118 Analysis of Examination Performance https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205435&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205435 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205435&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205435 03/11/2026 (a) Activities. In a commercial building, a person must be appropriately accredited as an asbestos abatement worker, asbestos contractor/supervisor, asbestos project designer, asbestos project monitor, or asbestos inspector, in accordance with the MAP to engage in the activities for that accredited discipline, including:(1) work, supervision, or design to carry out any of the following activities:(A) a response action other than an SSSD activity;(B) a maintenance activity that disturbs friable ACBM, other than an SSSD activity; or(C) a response action for a major fiber release episode;(2) conducting an asbestos survey; or(3) project monitoring:(A) to observe, on behalf of the commercial building owner, an abatement activity performed by an accredited asbestos contractor/supervisor; and(B) to observe, evaluate, report, and document that abatement work is completed according to specifications and plans and in compliance with all relevant statutes and regulations.(b) Accreditation course. A person receives accreditation by successfully completing the appropriate asbestos training course in accordance with the MAP. The applicable asbestos training course must:(1) be approved by DSHS and offered by a DSHS-licensed asbestos training provider;(2) be approved by another state that has the authority from EPA to approve courses; or(3) be approved directly by EPA.(c) Proof of accreditation. A person performing an asbestos-related activity must provide proof of current accreditation at the work site by having one of the following:(1) a government-issued photo identification (ID) with either a Texas training course certificate from a Texas-licensed asbestos training provider or an accreditation certificate from another state; or(2) a training ID card from a Texas-licensed asbestos training provider or an accreditation photo ID card from another state.(d) Reaccreditation. Annual refresher training is required for reaccreditation. A person whose accreditation certificate has expired must not engage in an activity for which a current accreditation certificate is required under the MAP or this chapter unless the person has been reaccredited. An accredited person has a 12-month grace period after the expiration date of the accreditation certificate in which to complete a refresher training course for reaccreditation. After that grace period, initial training must be repeated to become reaccredited.(e) Standards. Work practices and accreditation for any asbestos-related activity described in this section must meet or exceed applicable federal laws and regulations relating to the MAP and NESHAP. Source Note: The provisions of this §296.151 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION I ACCREDITATION §296.151 Accreditation for Asbestos-Related Activities in a Commercial Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205436&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205436 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205436&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205436 03/11/2026 The license and registration requirements in this chapter do not apply to a person who is performing or supervising resilient floor-covering material removal in a public building using work practices for that activity published by the Resilient Floor Covering Institute (RFCI work practices) or other methods determined by the commissioner to provide public health protection from asbestos exposure and who otherwise complies with §1954.104 of the Act and §296.231 of this chapter (relating to Alternative Practices and Procedures for Removal of Asbestos-Containing Resilient Floor-Covering Material in a Public Building). This includes the removal of an asbestos-containing mastic that is adhered to non-asbestos-containing flooring material. Source Note: The provisions of this §296.171 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION J EXEMPTIONS §296.171 Removal of Resilient Floor-Covering Material https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205437&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205437 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205437&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205437 03/11/2026 In a catastrophic emergency affecting public health or safety that results from a sudden, unexpected event that requires unplanned emergency asbestos abatement, DSHS, upon receipt of oral or written notification of the emergency, as required in §296.251 of this chapter (relating to Notifications), may waive the requirement for a license for that emergency abatement. Source Note: The provisions of this §296.172 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION J EXEMPTIONS §296.172 Emergency Abatement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205438&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205438 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205438&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205438 03/11/2026 (a) Public building owner responsibilities.(1) The public building owner is responsible for compliance with this chapter in relation to the presence, condition, disturbance, renovation, demolition, and disposal of any ACBM and ACWM that is encountered in the construction, operations, maintenance, or furnishing of that public building, including when the building is under management by others.(2) Before operations and maintenance, renovation, or demolition, the public building owner is required to have an asbestos survey performed, identify the presence of asbestos, and have ACBM that may be disturbed by the operations and maintenance, renovation, or demolition activity abated, as required in this chapter.(3) The public building owner must fulfill the following obligations, either personally or through the building owner's authorized representative, including when the building is under management by others:(A) inform anyone who performs any type of construction, maintenance, installation, repairs, custodial services, renovation, or demolition work in the owner's building of:(i) the presence and location of ACBM before the start of any asbestos-related activity;(ii) that the ACBM could be disturbed or dislodged by those activities; and(iii) that the person conducting those activities must arrange for proper handling of ACBM and ACWM;(B) hire or otherwise permit only a person holding the required license to perform asbestos-related activity in the building;(C) require each person described under subparagraph (B) of this paragraph to comply with all applicable requirements of this chapter;(D) ensure compliance with this chapter during periods of vacancy; and(E) confirm that the regulated area meets the clearance level of 0.01 f/cc before reoccupancy of that area.(4) The building owner or the building owner's authorized representative may provide the information described in paragraph (3) of this subsection in writing or through documented oral communication.(b) Commercial building owner responsibilities. The commercial building owner is responsible for compliance with this chapter in relation to the presence, condition, disturbance, renovation, demolition, and disposal of any asbestos that is encountered in the construction, operations, maintenance, or furnishing of that commercial building, including when the building is under management by others. Before operations and maintenance, renovation, or demolition, the commercial building owner is required to have a thorough inspection performed, identify the presence of asbestos, and have the RACM that may be disturbed by the operations and maintenance, renovation, or demolition activity abated in accordance with NESHAP. The commercial building owner must also ensure compliance with this chapter during periods of building vacancy.(c) Facility owner responsibilities. The facility owner is responsible for compliance with this chapter in relation to the presence, condition, disturbance, renovation, demolition, and disposal of any asbestos that is encountered in the construction, operations, maintenance, or furnishing of that facility, including when the facility is under management by others. Before operations and maintenance, renovation, or demolition, the facility owner is required to have a thorough inspection performed, identify the presence of asbestos, and have the RACM that may be disturbed by the operations and maintenance, renovation, or demolition activity abated in accordance with NESHAP. The facility owner must also ensure compliance with NESHAP during periods of vacancy.(d) Mandatory survey for ACBM before renovation or demolition.(1) Before any renovation or dismantling outside of or within a public building, commercial building, or facility, including preparations for partial or complete demolition, the owner must have an asbestos survey performed.(2) The work area and all immediately surrounding areas that could foreseeably be disturbed by the actions necessary to perform the project must be thoroughly surveyed and, as applicable, sampled before renovation or demolition.(3) A copy of the asbestos survey report that includes the contents described in §296.21(93) of this chapter (relating to Definitions), as applicable, must be produced upon request by DSHS within 10 working days after the request.(4) A building may be demolished with RACM in place if a state or local government orders the demolition because the building is structurally unsound and in danger of imminent collapse, as determined by a professional engineer or a city, county, or state government official who is qualified to make that decision.(A) The owner must maintain documentation of such order.(B) If an owner is unable to obtain a survey because the building is structurally unsound and unsafe to enter, and the owner is unable to obtain an order for demolition and has a letter from a professional engineer stating the building is structurally unsound and in danger of imminent collapse, the owner may contact DSHS to request a waiver from the survey requirement. Documentation supporting the inability to obtain an order must be submitted with the request.(C) If a survey cannot be performed before demolition starts due to the building being structurally unsound and unsafe to enter, all suspect material must be treated as RACM, in accordance with NESHAP requirements in 40 CFR §61.141 (relating to Definitions), §61.145(a)(3) and (c)(4) - (9) (relating to Standards for demolition and renovation), and §61.150(a)(3) (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations).(5) Without otherwise limiting the scope of an asbestos survey, each survey for a public building must treat any building material listed in subsection (o)(2) of this section as suspect ACBM and include all such materials in the asbestos survey if the materials could foreseeably be disturbed during the renovation or demolition activities.(6) In a public building, the mandatory survey requirement must be met in one of the following two ways.(A) A person appropriately licensed as required in this chapter and the Act performs a survey which conforms to generally accepted industry standards, such as the AHERA requirements specified in 40 CFR Part 763, Subpart E (relating to Asbestos-Containing Materials in Schools), §§763.85 - 763.88, the required method for schools. The licensee must prepare a survey report that includes the contents described in §296.21(93) of this chapter. To demonstrate that there is no ACBM, the licensed individual must collect a minimum of three samples from each suspect homogeneous area.(B) A Texas-registered architect or a Texas-licensed professional engineer certifies that the architect or engineer has compiled and reviewed the information from MSDSs and SDSs of the materials used in the original construction of the building and the renovations or alterations of all parts of the building affected by the planned renovation or demolition, matches the MSDSs and SDSs to materials on-site, reviews any asbestos survey reports of the building previously conducted as required at the time of the survey, and certifies that in the architect's or engineer's professional opinion, no part of the building, including the building materials, affected by the planned renovation or demolition contain asbestos. This certification must also clearly identify the name of the building, the street address and specific area of the building that applies to the certification, the survey report date of each previous asbestos survey report reviewed, whether the relevant work was new construction or renovation, and the specific dates of completion of all original construction and renovations or alterations that apply to the certification. A Texas-registered architect must prepare this certification in accordance with the rules of professional conduct in 22 TAC Chapter 1. A Texas-licensed professional engineer must prepare this certification in accordance with the rules of professional conduct in 22 TAC Chapter 137. A complaint that a certification was not performed as required in this paragraph will be referred to the Texas licensing boards or another government agency with jurisdiction over the complaint as needed. A building owner that meets the mandatory survey requirement, as described in this subparagraph, must keep the certification, copies of the MSDSs or SDSs or both, and any previous asbestos surveys as required in §296.291(j) of this chapter (relating to Recordkeeping) that were reviewed by the architect or engineer. A certification prepared as described in this paragraph does not meet the OSHA or NESHAP requirement for an asbestos survey.(7) In a commercial building, an accredited inspector who has completed the MAP inspector training may perform the asbestos survey.(8) In a facility that is not a public or commercial building, the survey must conform to 40 CFR §61.145. OSHA regulations or other EPA regulations may apply.(e) Asbestos survey.(1) A limited asbestos survey may be performed to address a specific area of a building, such as an area identified for renovation. A limited asbestos survey may not be substituted for a thorough asbestos survey of the entire building.(2) A comprehensive asbestos survey covering the entire building is required before demolition of a building.(3) An asbestos survey report remains acceptable if the asbestos survey is done in compliance with the applicable law, including the Texas Asbestos Health Protection rules in effect at the time the asbestos survey is completed and the asbestos survey addresses and accurately represents ACM and ACBM, as applicable, for the building affected by the planned renovation, demolition, or O&M activity, including its location, type, and condition.(4) An environmental assessment report may not be used as an asbestos survey report unless it is conducted by an appropriately accredited or licensed person and contains all of the required elements of an asbestos survey report, as applicable.(f) Sampling for asbestos in a public building. A licensed asbestos inspector must perform an asbestos survey in accordance with generally accepted standards, such as the methods described in 40 CFR §§763.85 - 763.88. The survey and survey report must identify, including its location, type, and condition, all ACBM that is found to be ACM. To assess the presence of ACBM and determine the need for any O&M activity or abatement, the licensed asbestos inspector must collect a minimum of three samples from each homogeneous area. The samples must be evaluated by a licensed asbestos laboratory. If one sample from a homogeneous area is found to be ACM, the remaining samples from that homogeneous area do not have to be analyzed. Building materials that have not been surveyed as required in this subsection and are suspected of containing asbestos must be treated as ACBM.(1) When conducting core sample analysis, each layer must be analyzed and reported separately. Core sample analysis in a public building must not be reported as an average or a composite result.(2) A result of visual estimation by polarized light microscopy (PLM) analysis of 0% asbestos or no asbestos detected does not require further analysis for the detection of asbestos in friable or nonfriable suspect materials.(3) Point counting may be used to analyze either a friable or nonfriable material. Nonfriable materials, such as mastics and floor tile where fibers are occluded by a binding matrix must be processed using a technique that renders the material friable, such as acid washing and ashing outlined in EPA/600/R-93/116.(4) A result of visual estimation by PLM analysis of greater than 0% and less than 10% asbestos may be demonstrated to be material that is not ACBM only if the material is further analyzed using other analysis based upon the hierarchy and terms of the following:(A) The result of point counting by PLM analysis of a sample supersedes and replaces the initial result of visual estimation by PLM.(B) The result of gravimetric preparation, followed by point counting or transmission electron microscopy (TEM) visual estimation analysis of a sample, supersedes and replaces the result of visual estimation by PLM and the result of point counting by PLM.(g) Conditions requiring mandatory abatement. Before any renovation or dismantling of a public building, commercial building, or facility, including preparations for partial or complete demolition, the building owner must have ACBM abated, as required in this section.(1) Demolition or renovation of a public building. Before performing any demolition in a public building, the building owner must ensure that all suspect ACBM is surveyed and RACM is abated in accordance with NESHAP and as required in this chapter. Before performing any renovation in a public building, the building owner must ensure that all suspect ACBM that could foreseeably be disturbed in the area to be renovated is surveyed and ACBM is abated, as required in this chapter.(2) Demolition or renovation of a commercial building. Before performing any demolition, renovation, or O&M activity in a commercial building, the owner or operator must ensure that all suspect ACBM is surveyed and RACM is abated in accordance with NESHAP by a person accredited, as required §296.151 of this chapter (relating to Accreditation for Asbestos-Related Activities in a Commercial Building) and in accordance with the MAP.(3) Demolition or renovation of a facility. Before performing any demolition, renovation, or O&M activity in a facility, the owner or operator must ensure that all suspect ACM is surveyed and RACM is abated in accordance with NESHAP. Any structure, installation, or building that was previously subject to NESHAP is not excluded, regardless of its current use or function.(4) Demolition or renovation of a residential building that contains four or fewer dwelling units.(A) Two or more residential buildings that contain four or fewer dwelling units are considered an installation and are subject to NESHAP if they are on the same site and under the control of the same owner or operator or owner or operator under common control as part of the same renovation or demolition project. Residential buildings are considered to be on the same site if they are within 660 feet of each other. Demolitions planned at the same time or as part of the same planning or scheduling period, that is often a calendar year, fiscal year, or the term of a contract, are considered to be part of the same project. Each owner or operator of the residential buildings must ensure that all suspect ACM is surveyed and RACM is abated in accordance with NESHAP.(B) A residential building that is being demolished together with any other type of building as part of a larger private or public project, such as an urban renewal, shopping mall, or highway construction project is subject to NESHAP and each owner or operator must ensure that all suspect ACM in the residential building, as well as in the other building types, is surveyed and RACM is abated in accordance with NESHAP. If one residential building that contains four or fewer dwelling units is the only building being demolished, NESHAP regulations do not apply.(C) Any renovation or demolition of a residential building is subject to NESHAP if the residence contains greater than four dwelling units or if it meets the conditions described in subparagraphs (A) or (B) of this paragraph.(h) Demolition with ACM left in place.(1) Category I nonfriable ACM may be left in place if it is not in poor condition, has not become friable, and will not become RACM during demolition.(2) Category II nonfriable ACM may be left in place if the probability is low that the material will become RACM, or be crumbled, pulverized, or reduced to a powder during demolition.(3) RACM on a facility component that is encased in concrete or other similarly hard material and is adequately wet whenever exposed during demolition may be left in place.(4) RACM that is not accessible for testing and is, therefore, not discovered until after demolition begins and, because of the demolition the material, cannot be safely removed may be left in place. If not removed for safety reasons, the exposed RACM and any asbestos-contaminated debris must be treated as ACWM and adequately wet at all times until disposed of.(i) Mandatory asbestos abatement project design for friable ACBM in a public building. An asbestos abatement project design is required and must be conducted by a licensed asbestos consultant for a project that involves any of the following activities:(1) a response action other than an SSSD activity;(2) a maintenance activity that disturbs friable ACBM other than an SSSD activity or a small project or repetitive task described in §296.233 of this chapter (relating to Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building); or(3) a response action for a major fiber release episode.(j) Asbestos abatement project design for friable ACM in a commercial building. An asbestos abatement project design for a response action in a commercial building must be conducted by a person appropriately accredited to conduct a project design in accordance with AHERA.(k) Mandatory asbestos abatement project design for nonfriable ACBM in a public building.(1) An asbestos abatement project design is required and must be conducted by a licensed asbestos consultant for an abatement project in a public building that has a combined amount of nonfriable ACBM to be removed in excess of 160 square feet of surface area, 260 linear feet of pipe length, or 35 cubic feet of material.(2) Only individual amounts of nonfriable ACBM to be removed that are in the same unit of measurement require combination for purposes of determining whether a project design is required.(3) An asbestos abatement project that has a combined amount of nonfriable ACBM to be removed equal to or less than 160 square feet of surface area, 260 linear feet of pipe length, or 35 cubic feet of material; and a project conducted as described in §296.231 of this chapter (relating to Alternative Practices and Procedures for Removal of Asbestos-Containing Resilient Floor-Covering Material in a Public Building); §296.232 of this chapter (relating to Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building); §296.233 of this chapter; and §296.234 of this chapter (relating to Alternative Practices and Procedures for Removal of Whole Components of Intact Asbestos-Containing Material (ACM) in a Public Building) does not require an asbestos abatement project design.(4) In a commercial building, nonfriable material does not require a project design, but must be treated in accordance with NESHAP.(l) Asbestos control and abatement in a public building. The public building owner must manage the asbestos found in the owner's building in accordance with the following requirements.(1) The building owner must hire a licensed asbestos consultant, licensed asbestos consultant agency, licensed asbestos management planner, or licensed asbestos management planner agency to perform an asbestos survey that may be used for O&M activities, renovation, or demolition.(2) The building owner must hire a licensed asbestos abatement contractor to conduct:(A) asbestos abatement in accordance with §296.212 of this chapter (Standard Asbestos Abatement Practices and Procedures in a Public Building);(B) asbestos abatement of nonfriable ACBM using the work practices described in §296.232 of this chapter, where applicable;(C) small projects or repetitive tasks involving the disturbance of friable ACBM, under the conditions and using the work practices described in §296.233 of this chapter; and(D) an activity described and conducted in accordance with §296.234 of this chapter.(3) The building owner must hire or retain a licensed asbestos abatement contractor or a licensed asbestos O&M contractor to conduct an SSSD O&M activity or cleanup affecting asbestos, in accordance with in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building). When utility work is to be performed, the building owner must either have the affected ACM removed before the work of a utility contractor or require the utility contractor to be licensed to handle ACM.(4) A building owner licensed as an asbestos abatement contractor, as required in §296.50 of this chapter (relating to Asbestos Abatement Contractor) or as an asbestos O&M contractor, as required in §296.52 of this chapter (relating to Asbestos Operations and Maintenance Contractor) may conduct the activities described in paragraphs (2) and (3) of this subsection, as applicable.(5) The building owner must hire a licensed asbestos management planner, licensed asbestos management planner agency, licensed asbestos consultant, or licensed asbestos consultant agency to develop a management plan to control ACM during O&M, renovation, and demolition, if applicable.(m) Mandatory notification. Notification is required under §296.251 of this chapter (relating to Notifications) under the following conditions.(1) Notification is required for any demolition of a facility or public building, whether or not asbestos has been identified.(2) In a public building, a notification to abate any amount of ACBM must be submitted to DSHS by the public building owner or operator or delegated agent.(3) In a facility, a notification to abate an amount of RACM described in NESHAP must be submitted to DSHS by the facility owner or operator.(n) Requirement for survey and management plan. A building owner or the building owner's authorized representative, if required by certified letter from DSHS, must immediately obtain an asbestos survey report and asbestos management plan completed by a licensed asbestos inspector, licensed asbestos management planner, or licensed asbestos consultant, if, in the opinion of DSHS following a site inspection of a public building, there appears to be a danger or potential danger from ACBM in poor condition to the workers or occupants of the building or to the general public. A copy of the management plan must be submitted for review and approval to DSHS within 90 days after receipt of the certified letter. A copy of the plan must be on file with the owner or management agency and in the possession of the supervisor in charge of building operations and maintenance.(o) Installation of new materials in a public building. Texas Health and Safety Code, Chapter 161, Subchapter Q (relating to Installation of Asbestos), requires the following:(1) A person who installs a building material or replacement part designated in paragraph (2) of this subsection in a public building must obtain an MSDS or SDS before the installation. A person must not install a material or part designated in paragraph (2) of this subsection that requires an MSDS or SDS under this paragraph unless:(A) the person obtains an MSDS or SDS for the material proposed to be installed showing that the material or replacement part is not ACM; or(B) the material or replacement part, according to the MSDS or SDS, is ACM, but the building owner or contractor can demonstrate that there is no alternative material or part.(2) A person must obtain an MSDS or SDS before installing the following building materials or replacement parts:(A) surfacing materials:(i) acoustical plaster;(ii) decorative plaster/stucco;(iii) textured paint/coating;(iv) spray applied insulation;(v) blown-in insulation;(vi) fireproofing insulation;(vii) joint compound; and(viii) spackling compounds;(B) TSI:(i) taping compounds (thermal);(ii) HVAC duct insulation;(iii) boiler insulation;(iv) breaching insulation;(v) pipe insulation; and(vi) thermal paper products;(C) miscellaneous material:(i) cement pipes;(ii) cement wallboard/siding;(iii) asphalt/vinyl floor tile;(iv) vinyl sheet flooring/vinyl wall coverings;(v) floor backing;(vi) construction mastic;(vii) ceiling tiles/lay-in ceiling panels;(viii) packing materials;(ix) high temperature gaskets;(x) laboratory hoods/table tops;(xi) fire blankets/curtains;(xii) elevator equipment panels;(xiii) elevator brake shoes;(xiv) ductwork flexible fabric connections;(xv) cooling towers;(xvi) heating and electrical ducts;(xvii) electrical panel partitions;(xviii) electrical cloth/electrical wiring insulation;(xix) chalkboards;(xx) roofing shingles/tiles;(xxi) roofing felt;(xxii) base flashing;(xxiii) fire doors;(xxiv) caulking/putties;(xxv) adhesives/mastics;(xxvi) wallboard; and(xxvii) vermiculite.(p) Application for exemption. An owner or licensee may apply to DSHS for an exemption of a demolition or renovation project from any rule under this chapter relating to demolition and renovation activities, that DSHS, in its sole discretion, may grant if the rule exemption is not inconsistent with the Act and it meets one of the following conditions:(1) the EPA has exempted the project from federal regulations; or(2) DSHS determines that:(A) the project will use a method for the abatement or removal of asbestos that provides protection for the public health and safety at least equivalent to the protection provided by the procedure required in this chapter for the abatement or removal of asbestos; and(B) the project does not violate federal law.(q) Survey or certification required for municipal permit. A municipality that requires a person to obtain a permit before renovating or demolishing a public or commercial building must not issue the permit unless the applicant provides one of the following types of documentation:(1) written evidence acceptable to the municipality that an asbestos survey of all parts of the building affected by the planned renovation or demolition has been completed by a person licensed in accordance with the Act and this chapter (for a public building) or accredited under the MAP (for a nonpublic building) to perform a survey; or(2) written certification from a Texas-registered architect or Texas-licensed professional engineer that:(A) identifies the name of the building, the street address, and the specific area of the building that applies to the certification;(B) certifies that the Texas-registered architect or Texas-licensed professional engineer has compiled and reviewed the information from:(i) MSDSs and SDSs of the materials used in the original construction of the building and any renovations or alterations of all parts of the building affected by the planned renovation or demolition, has matched them by manufacturer to materials on-site in the construction; and(ii) any previous asbestos survey report of the building that is conducted as required at the time of the survey;(C) certifies based upon review of the information in subparagraph (B) of this paragraph that in the architect's or engineer's professional opinion, no part of the building, including the building materials, affected by the planned renovation or demolition contain asbestos;(D) specifies the dates of each asbestos survey report reviewed;(E) specifies whether the relevant work was new construction or renovation; and(F) specifies the dates of completion of all original construction and renovations or alterations that apply to the certification. Source Note: The provisions of this §296.191 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION K ASBESTOS MANAGEMENT IN A PUBLIC BUILDING, COMMERCIAL BUILDING, OR FACILITY §296.191 Asbestos Management in a Public Building, Commercial Building, or Facility https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205439&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205439 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205439&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205439 03/11/2026 (a) Responsibility. The public building owner or the owner's delegated agent must engage persons licensed as required in this chapter to perform any asbestos-related activity.(b) Project supervision and monitoring.(1) Every asbestos abatement project undertaken by a licensed asbestos abatement contractor in a public building under this section must be supervised by at least one licensed asbestos abatement supervisor and monitored by a licensed asbestos consultant or the consultant's designated licensed project manager or licensed asbestos air monitoring technician project monitor (AMT/PM). Except as described in the following subparagraphs, these supervisory and monitoring requirements extend to all projects performed in a public building under Subchapter K of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility), Subchapter L of this chapter (relating to General Requirements, and Practices and Procedures for Asbestos Abatement in a Public Building), and Subchapter M of this chapter (relating to Alternative Asbestos Practices and Procedures in a Public Building).(A) A licensed asbestos consultant or a licensed project manager or licensed AMT/PM designated by the consultant is not required to monitor or assess an SSSD O&M activity conducted under §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building), except that, for a project involving the use of a mini-containment, visual clearance must be performed by a licensed asbestos consultant or a licensed project manager or licensed AMT/PM designated by the consultant and third-party air clearance monitoring must be performed by a licensed air monitoring technician (AMT), licensed AMT/PM, or a licensed asbestos consultant before the mini-containment is removed.(B) An asbestos abatement supervisor, consultant, or designated project manager or AMT/PM licensed under this chapter is not required to supervise, monitor, or assess, as applicable, a project conducted in accordance with §296.231 of this chapter (relating to Alternative Practices and Procedures for Removal of Asbestos-Containing Resilient Floor-Covering Material in a Public Building).(2) Except as otherwise provided under paragraph (1) of this subsection:(A) A licensed asbestos abatement supervisor and a licensed asbestos consultant or the consultant's designated licensed asbestos project manager or licensed AMT/PM must remain on-site and in immediate proximity to the abatement activity during all periods of that activity.(B) A licensed asbestos abatement supervisor must supervise the asbestos abatement activity from inside the containment area during at least 25% of each day on which asbestos abatement activity occurs in a containment.(C) A licensed asbestos consultant or the consultant's designated licensed asbestos project manager or licensed AMT/PM must enter and inspect the containment and monitor asbestos abatement activities, conducted as required in Subchapter L of this chapter and Subchapter M of this chapter, as applicable, every day of the asbestos abatement activity, before the start of asbestos abatement activity for the day, routinely throughout the day, for the duration of the project from the beginning of containment to the final visual inspection of the project site and loading of ACWM for transport, as applicable, to:(i) monitor the asbestos abatement activity by observing, reporting, and documenting that the regulated area, containment, or both is in compliance with this chapter and the specifications and plans, as applicable;(ii) identify and document any correction needed;(iii) document correction of any identified issue of noncompliance with asbestos abatement activity in a regulated area, containment, or both, as applicable, before work proceeds; and(iv) report any identified issue of noncompliance that was not corrected to DSHS, as required in §296.41(f) of this chapter (relating to License and Registration Requirements).(D) At least one licensed asbestos O&M supervisor or licensed asbestos abatement supervisor must supervise every SSSD O&M activity performed as described in §296.213 of this chapter during all periods of asbestos abatement activity.(c) Employees. If an employee or delegated agent of any licensee who is an employer must intentionally disturb, handle, or otherwise work with ACBM, or engage in an asbestos abatement project, asbestos SSSD O&M activity, or other asbestos-related activity, the employee must have an annual medical examination and respirator fit-test that meets the requirements stated in the asbestos regulations of the EPA or OSHA, as applicable, and be properly equipped, trained, and licensed as required in this chapter.(d) Records. Project records for each asbestos-related activity in a public building must be kept for 30 years from the date of project completion and made available for inspection and review upon request from DSHS. Project records include all findings of violation and disciplinary action issued against a licensee by the EPA, OSHA, or a state agency. The recordkeeping responsibilities for licensees are described in §296.291 of this chapter (relating to Recordkeeping).(e) Inspections and investigations. Each licensee, RFCI contractor, and building owner must assist and cooperate with all properly identified representatives of DSHS in the conduct of an asbestos inspection or investigation, as described in §296.271 (relating to Inspections and Investigations) of this chapter at any reasonable time, with or without prior notice or permission.(f) Respiratory protection program. Each employer with one or more employees who perform any asbestos-related activity must comply with the requirements in 29 CFR §1910.134 (relating to Respiratory protection) for establishing and following a written respiratory protection program, with worksite-specific procedures, and in accordance with 29 CFR §1926.1101(h)(2) (relating to Asbestos), 29 CFR §1910.1001(g)(2) (relating to Asbestos), and 40 CFR Part 763, Subpart G (relating to Asbestos Worker Protection), whichever is applicable. Each employer must maintain a current copy of the respiratory protection program at all project locations. Required respirators must be properly worn at all times in containment and as otherwise required during asbestos abatement activity.(1) The employer must provide for personal air monitoring to determine airborne concentrations of asbestos exposure to its employees in compliance with 40 CFR Part 763, Subpart G (relating to Asbestos Worker Protection), or 29 CFR §1926.1101, whichever is applicable, unless the employer has obtained a negative exposure assessment in compliance with 29 CFR §1926.1101.(2) The employer must maintain, in a safe working condition, a sufficient number of respirators of the types and styles approved by NIOSH to meet all requirements for the employees. The employer and any representative of the employer must not permit any person whose facial characteristics, hair, mustache, or beard preclude the tight fit of a negative-pressure respirator to enter the containment during any asbestos abatement activity. The employer must select and provide an appropriate respirator that correctly fits the employee, such as a positive pressure or supplied-air respirator designed for usage with facial hair.(g) Suspect ACBM found during the asbestos abatement project. A suspect building material found during an asbestos abatement project that has not been surveyed must be treated as ACBM. The material may be proven to be non-asbestos-containing by laboratory analysis, as required in §296.191(f) of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility).(h) Project air monitoring, personal air monitoring, and project work practice monitoring. The licensed asbestos consultant for an abatement project in a public building must specify in writing the duties, responsibilities, and authority of the licensed project manager, air monitoring technician, and AMT/PM. When asbestos is abated under an alternative work practice established in Subchapter M of this chapter, the project monitoring requirements for the chosen work practice apply and air sampling and analysis must comply with the NIOSH 7400 requirements outlined in paragraph (1) of this subsection, as applicable.(1) Ambient air sampling. Air samples must be collected by a licensed asbestos air monitoring technician, AMT/PM, or asbestos consultant. The sample pumps must be monitored throughout the day during the sampling period by the person collecting the samples. For all projects, samples must be collected and analyzed using the NIOSH 7400 method, counting rules A, Phase-contrast Microscopy (PCM). Samples must be collected at a flow rate between 0.5 to 16 liters per minute on 0.8 micron mixed cellulose ester (MCE) filters in cassettes with electrically conductive extension cowls. Only one cassette may be placed on a pump at a time. PCM must be used in accordance with the NIOSH 7400 method to determine the fiber concentration present. Alternatively, the AHERA protocol may be used to determine volume and flow rate needed for transmission electron microscopy (TEM) analysis in accordance with the mandatory provisions of Appendix A (relating to Interim Transmission Electron Microscopy Analytical Methods--Mandatory and Nonmandatory--and Mandatory Section to Determine Completion of Response Actions) of AHERA.(A) Baseline.(i) Baseline air samples must be collected before the start of any asbestos abatement project that requires a design as described in §296.191(i) and (j) of this chapter. The samples must be collected from inside the space that will become the regulated area for the project before any asbestos abatement activity that disturbs ACBM begins. A minimum of three samples must be collected on 0.8 micron (MCE) filters loaded in cassettes with electrically conductive extension cowls. The locations from which baseline air samples are collected must provide suitable data for comparison with indoor air monitoring samples collected after asbestos abatement activities begin. Sampling and, if any, analysis must conform to the NIOSH 7400 method, counting rules A. For each sample, a sample volume of at least 1,250 liters must be drawn. Only one cassette may be placed on a pump at a time.(ii) Baseline air samples must be kept for no fewer than 30 days after clearance is achieved.(B) Air sampling during the project.(i) Ambient air samples must be collected continually during disturbance of ACM or when asbestos abatement is being conducted in a containment. Air samples must be analyzed in accordance with the NIOSH 7400 method, counting rules A and only one cassette may be placed on a pump at a time.(ii) Ambient air samples must be collected:(I) inside containment adjacent to the abatement activities;(II) outside containment but inside the building, if applicable;(III) within 10 feet of the unobstructed exhaust from the negative air unit discharge, but not directly in the airstream, where feasible;(IV) immediately outside the entrance to the decontamination area used to enter the containment (representative of the air being drawn into the containment area) or in the case of a remote decontamination area, immediately outside the entrance to the containment;(V) immediately outside the entrance of the bag-out area, if applicable; and(VI) at any other location required by the specifications and plans.(C) Clearance.(i) Project clearance must consist of an initial visual inspection, followed by air clearance sampling, removal of containment, and a final visual inspection.(ii) Clearance air samples must be collected inside the containment, as specified by a licensed asbestos consultant, with a minimum of two samples per containment or in accordance with AHERA and OSHA regulations, as applicable. Only one cassette may be placed on a pump at a time.(iii) All project activities, except an SSSD O&M activity performed as described in §296.213 of this chapter, must be cleared by using aggressive air sampling. For each sample, a sample volume of at least 1,250 liters must be drawn. All air sampling and analysis must comply with the NIOSH 7400 requirements. Clearance is achieved if no sample is reported greater than 0.01 f/cc by the analysis report from the licensed laboratory.(D) Air sample results. The licensed air monitoring technician, AMT/PM, or licensed asbestos consultant must record in writing the results of area, baseline, and clearance air samples that are analyzed and document that the results are provided to the asbestos abatement contractor verbally by the following time frames, unless the consultant designs a sampling strategy that deviates from these time frames, as described in paragraph (4) of this subsection:(i) the next working day after the date of sampling, for any air sample analyzed on-site; or(ii) for asbestos abatement of friable ACBM, the third working day after the date of initial sampling, for any air sample analyzed in an asbestos laboratory off-site.(2) Personal air monitoring.(A) Unless a negative exposure assessment is made in compliance with 29 CFR §1926.1101(f)(2)(iii) (relating to Asbestos), personal air samples must be collected, monitoring conducted, and employees informed of results, in compliance with 40 CFR Part 763, Subpart G (related to Asbestos Worker Protection) or 29 CFR §1926.1101 (relating to Asbestos), as applicable, and subsection (f) of this section.(B) Without limiting the requirements of 40 CFR Part 763, Subpart G or 29 CFR §1926.1101, as applicable, a licensed air monitoring technician, AMT/PM, or asbestos consultant must record in writing the results of personal air samples that are analyzed and document that the results are provided to the asbestos abatement contractor in writing by the following time frames, unless the asbestos consultant designs a sampling strategy that deviates from these time frames, as described in paragraph (4) of this subsection:(i) the next working day after the date of sampling, for any air sample analyzed on-site; or(ii) for asbestos abatement of friable ACBM, the third working day after the date of initial sampling for any air sample analyzed in an asbestos laboratory off-site.(3) Other monitoring requirements.(A) Initial visual inspection. The licensed asbestos abatement supervisor must perform an initial visual inspection of the abatement area to confirm that all specified ACM was removed, encapsulated, or enclosed. The asbestos abatement supervisor must ensure that all abatement-related items are removed from the containment, excluding negative air machines and equipment essential to maintain the containment and to perform the visual inspection. Once the asbestos abatement supervisor confirms that all specified ACM is addressed, a licensed asbestos consultant, or a licensed asbestos project manager or licensed AMT/PM whom the asbestos consultant has given written authorization to perform the visual inspection, must perform a visual inspection to determine that all specified ACM was removed, encapsulated, or enclosed. The initial visual inspection must be performed to ensure compliance with this chapter, the site-specific specifications and plans, AHERA, and NESHAP.(B) Final visual inspection. A final visual inspection must be performed after the removal of containment and the initial visual inspection to determine if any ACM escaped the containment or any ACWM remains. This visual inspection must be conducted by a licensed asbestos consultant or the consultant's designated licensed asbestos project manager or licensed AMT/PM and as required in subsection (b)(1) of this section. The licensed asbestos abatement contractor must abate all ACM and remove any ACWM discovered by the final visual inspection, as required in this chapter.(4) Deviations. A licensed asbestos consultant must design the air monitoring strategies and may deviate from this subsection or from the time frames required under §296.54(c)(4) of this chapter (relating to Asbestos Air Monitoring Technician) and paragraphs (1)(D) and (2)(B) of this subsection for reporting air sampling results only if the consultant demonstrates in writing in the specifications and plans that the engineering controls are at least as protective of public health as the requirements of this subsection, or for deviations from the time frames, why the deviation is necessary and any additional controls put in place as a result of the deviation. The deviation must be documented on the notification form and described in the project specifications and plans. The asbestos consultant must, upon request by DSHS, provide documentation and justification to support any deviation and must be able to demonstrate that the design is as protective of public health as the requirements of this subsection, paragraphs (1)(D) and (2)(B) of this subsection, or §296.54(c)(4) of this chapter, as applicable.(i) Posting documents. Each licensed asbestos abatement contractor, licensed O&M contractor, and RFCI contractor must post the following documents visible to the public at the entrance to the regulated area:(1) the Violation Notification Procedure poster issued by DSHS; and(2) a copy of any asbestos-related order issued by DSHS or any other order from a federal or state asbestos-regulating authority; each order must be posted for a period of 12 months after the effective date of the order or for a federal asbestos-related order, the period required by the federal asbestos-regulating authority. Source Note: The provisions of this §296.211 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION L GENERAL REQUIREMENTS, AND PRACTICES AND PROCEDURES FOR ASBESTOS ABATEMENT IN A PUBLIC BUILDING §296.211 General Requirements for Asbestos Abatement in a Public Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205440&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205440 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205440&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205440 03/11/2026 (a) General provisions. The general work practices in this section are minimum requirements for protection of public health for standard projects using full containment in a public building and do not constitute complete or sufficient specifications and plans for an asbestos abatement project. An asbestos abatement project may have specifications and plans for an asbestos abatement activity that are specific to the project and are more detailed or stringent than the requirements of this section so long as the work practices specified are as protective of the public health as the general requirements in this section. These specifications and plans, to the extent they do not conflict with other applicable federal and state law must be followed as a requirement of this chapter. Otherwise, the general work practices described in this section must be used for asbestos removal that does not meet the conditions required to use alternative methods described in Subchapter M (relating to Alternative Asbestos Practices and Procedures in a Public Building).(1) Subject to the following conditions, and if otherwise consistent with other applicable federal and state law, a licensed asbestos consultant may specify work practices that vary from the requirements of this section as long as the work practices specified are as protective of public health.(A) A licensed asbestos consultant who designs a project that includes dry removal or no negative air must submit a written request for approval to DSHS, including the project specifications and plans or a written description of the design. The request must include the licensed asbestos consultant's certification that the design is as protective of public health as the work practices described in this section and the consultant's basis for that conclusion. The request must include documentation that a certified industrial hygienist or a professional engineer licensed in Texas approved the design. The consultant must not begin the project without written approval from DSHS. The licensee must clearly describe the approved variance on the notification form.(B) A licensed asbestos consultant who designs a project with work practices other than dry removal or no negative air that differ from this section must document the variance on DSHS's notification form. The licensee must clearly describe on the notification form the work practices and demonstrate how the specific work practices are as protective of public health as the work practices in this section. DSHS may disapprove the proposed variation after receiving notice or documentation under this subparagraph or any other information related to the variation if DSHS does not or cannot determine that the work practice variance is as protective of public health as the work practices in this section.(C) The asbestos consultant must, upon request by DSHS, provide additional documentation and justification to support any variance.(2) A licensed asbestos contractor must follow the specifications and plans for a design that varies from the general work practices in compliance with this section.(3) In addition to the requirements of this section, abatement practices must be carried out in accordance with federal standards for asbestos abatement and waste disposal in 40 CFR §61.145 (relating to Standard for demolition and renovation) and §61.150 (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations).(4) ACBM must be removed, encapsulated, or enclosed within a regulated area that is demarcated. Except as provided in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building), §296.231 of this chapter (relating to Alternative Practices and Procedures for Removal of Asbestos-Containing Resilient Floor-Covering Material in a Public Building), §296.232 of this chapter (relating to Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building), and §296.234 of this chapter (relating to Alternative Practices and Procedures for Removal of Whole Components of Intact Asbestos-Containing Material (ACM) in a Public Building), or, after a clearance-level assessment is completed as required in §296.233 of this chapter (relating to Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building), removal of ACBM must take place within a containment.(5) Except as otherwise provided in this paragraph or by other applicable law, access to the regulated area must be limited to:(A) licensees;(B) emergency responders;(C) licensed, registered, or accredited building professionals required for emergency situations, as determined by a licensed asbestos consultant;(D) appropriate governmental inspectors;(E) authorized personnel, in accordance with 29 CFR §1926.1101(e) (relating to Asbestos); and(F) a building owner or building owner's authorized representative, if authorized by the licensed asbestos abatement contractor, and may enter a containment if accompanied by the contractor, licensed asbestos abatement supervisor, licensed asbestos consultant, or the consultant's designated licensed asbestos project manager or licensed AMT/PM. A building owner or building owner's authorized representative who enters containment must wear at a minimum the personal protective equipment required for workers performing the asbestos-related activity, must follow the specified decontamination procedures when exiting the containment, and must comply with all other applicable health and safety procedures.(b) Containment construction.(1) Plastic sheeting. When specified by a licensed asbestos consultant that fire retardant plastic sheeting must be used, it must be certified by the Underwriters Laboratory (UL) as being fire retardant.(2) Objects within containment. All uncontaminated movable objects must be removed from the containment before the start of asbestos abatement. Contaminated non-porous items that are to be salvaged or reused must be decontaminated. Porous items that are contaminated must be disposed of as ACWM. All non-movable objects that remain in the containment must be decontaminated and covered with a minimum of 4-mil thick plastic sheeting attached securely in place.(3) Critical barriers. A regulated area within which asbestos abatement is to be conducted must be separated from adjacent areas by a minimum of one impermeable barrier, such as plastic sheeting attached securely in place. Any opening between a containment and adjacent areas must be sealed, including a window, doorway, elevator opening, corridor entrance, ventilation opening, drain, duct, grill, grate, diffuser, skylight, and lay-in suspended ceiling grid system where the space above the grid is open to other rooms. The HVAC system must be isolated from the regulated area, as required in paragraph (9) of this subsection. A penetration of the sheeting that could permit air infiltration or an air leak through the barrier must be sealed, except the make-up air provision and the means of entry and exit. When a critical barrier is placed over a large opening, such as a corridor entrance or when isolating a portion of a hallway or a room, the critical barrier becomes the containment wall and the plastic sheeting requirements in paragraphs (4) and (5) of this subsection apply in addition to the requirements of this paragraph.(4) Floor abatement preparation. Floors must be sealed to prevent water leakage by performing the following floor abatement preparation. All floor surfaces must be completely covered by a minimum of two layers of 6-mil thick plastic sheeting. Floor sheeting must extend up sidewalls at least 12 inches and be sized to minimize the number of seams. Seams must not be located at wall-to-floor joints. When asbestos abatement includes wall removal, the asbestos consultant must specify how removal will occur and how the practice will be at least as protective of public health as the minimum requirements of this section.(5) Wall abatement preparation. All wall surfaces must be completely covered by a minimum of two layers of 4-mil thick plastic sheeting. Wall sheeting must be installed so as to minimize seams and must extend beyond wall-to-floor joints at least 12 inches. The wall sheeting must overlap the floor sheeting. Seams must not be located at wall-to-wall joints. Where feasible, a viewing window must be included in the wall for each 260 linear feet or fraction of that distance that permits the viewing of at least 51% of the abatement work area. At least one viewing window must be included in the wall, unless a licensed asbestos consultant specifies that a viewing window is not feasible. The window must be constructed of a transparent, shatter-resistant panel, also called acrylic or acrylic glass, which measures approximately 18 inches by 18 inches. The window must be at a reasonable height for viewing.(6) Bag-out area. A licensed asbestos consultant must specify when a bag-out area is required as part of containment. At a minimum, a bag-out area is a two-stage area connected to the containment, separated by airlocks, with a rinse station separated from the bagging-room. A bag-out area must not be used to decontaminate personnel.(7) Prohibited activities in a regulated area. The asbestos abatement contractor and asbestos consultant must ensure that their employees do not eat, drink, smoke, chew tobacco or gum, or apply cosmetics in the regulated area. Food or drink containers, coolers, tobacco products, gum, and cosmetics are not permitted in the regulated area.(8) Decontamination area. The containment must include an attached personnel decontamination area. The area must consist of a clean room, shower room, and equipment room. Each room must be at least 30 inches by 30 inches wide and 75 inches tall. Each room must be separated from the other and from the containment by airlocks so that air does not escape outside the containment and that air flows from the outside to the inside of containment through the decontamination area. The shower room must be provided with soap and water and, where feasible, hot and cold water where the temperature can be adjusted by the user. A licensed asbestos consultant must specify a remote decontamination area when it is not feasible to attach the decontamination area to the containment. The consultant must specify procedures for minimizing the migration of fibers from the containment to the remote decontamination area. Except where remote decontamination area is specified, all persons must exit the containment through the shower before entering the clean room. An asbestos-contaminated individual or item must not enter the clean room. A licensed asbestos abatement supervisor must ensure that the decontamination area is fully operational before and during any asbestos abatement activity. Any person exiting containment must:(A) remove all gross contamination and debris from protective clothing before entering the equipment room;(B) remove protective clothing in the equipment room and deposit the clothing in impermeable plastic bags or containers labeled as required in subsection (c)(4) of this section;(C) not remove respirators in the equipment room;(D) shower before entering the clean room; and(E) enter the clean room before changing into street clothes.(9) HVAC equipment. The HVAC system must be isolated from the regulated area. Any supply and return opening and any seam in system components must be sealed with either impermeable plastic sheeting, tape, or both. An old filter must be disposed of as asbestos waste.(10) Warning signs. A warning sign that complies with 29 CFR §1926.1101, must be displayed at all entrances to regulated area, including an area requiring a critical barrier that can be used to gain entrance to the containment, such as a door, window, or hallway. To protect the public from accidental entry, a warning sign must be displayed, at minimum, in both Spanish and English at the same location. Asbestos caution tape must not be substituted for a warning sign.(11) Cleaning. Cleaning procedures must include wet methods and HEPA vacuuming. A HEPA vacuum designed and equipped with a HEPA filter must remain on-site during any asbestos abatement activity. HEPA vacuums must be operated and maintained in accordance with the manufacturer's instructions. A HEPA vacuum that meets the standard of ASTM F1977-04 and is operated according to manufacturer's specifications will meet the requirement of this section.(12) Containment-area ventilation. HEPA filtration units must be operated continuously from the time containment is established through the time acceptable final air clearance is achieved, maintaining negative pressure with a manometric reading of at least -0.02 inches inside the containment. There must be HEPA units in sufficient number to provide negative pressure within the containment relative to the non-containment area, as indicated by a water column differential that produces a manometric instrument reading of at least -0.02 inches. HEPA units must, in combination, provide a minimum of four containment air changes per hour. Units must be operated with unrestricted exhaust, unless it is not feasible, and must be in a location that draws air across the containment area so that asbestos fibers are captured and minimizes areas without air movement. These units must exhaust filtered air to the outside of the building wherever feasible.(c) Removal of ACBM.(1) All ACBM must be adequately wetted using amended water before removal or other handling. A consultant may specify the use of water without surfactant if it is as protective of public health. The ACBM must then be placed in bags (or other suitable containers) that must be marked in accordance with applicable NESHAP and OSHA regulations and paragraph (4) of this subsection. All ACWM must be double-bagged into 6-mil thick plastic bags or placed into a leak-tight drum.(2) A bag must not be filled to a level that tears or breaks the bag. Excess air in a bag must be removed before entering the bag-out area. The top of the bag must be twisted closed, folded over, and sealed with duct tape. The bag must be rinsed off or HEPA-vacuumed in the bag-out area to remove asbestos contamination and placed inside another bag or leak-tight drum. If an outer bag is used, excess air must be removed, and the bag must be closed and sealed in the same manner as the inner bag.(3) If a bag leaks, the bag must be placed into a third bag and sealed as required in paragraphs (1) and (2) of this subsection. If a drum leaks, the drum must be wrapped in a minimum of one layer of 6-mil thick plastic sheeting and sealed.(4) The exterior bag, wrapping, or leak-tight drum must have warning and generator labels applied as specified in 40 CFR §61.150(a)(1)(iv) and (v) (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations). Generator labels must be printed in letters of sufficient size and contrast to be readily visible and legible. All required labeling of ACWM containers must be done before removal from the regulated area. Any container or wrapped component labeled as asbestos must be containerized and labeled as ACWM before removal from the regulated area.(5) A component covered with, coated with, or containing ACM that is going to be removed from the building may either, after being adequately wetted, be stripped in place, cleaned, and pass a visual inspection by the asbestos consultant, or the ACBM may be adequately wetted and the entire component wrapped in two layers of 6-mil thick plastic sheeting or equivalent, labeled, and sealed, provided that:(A) any component, such as a section of metal lath, that cannot be safely lowered to the floor must, after being adequately wetted, be stripped in place;(B) any component that cannot be lowered or handled without presenting an excessive fiber release or safety hazard must be stripped in place; and(C) a sharp edge of any component must be protected to preclude tearing the plastic wrapping and causing injury.(6) ACBM must be removed as a wrapped unit or in small sections and containerized while wet. Material must not be allowed to accumulate on the floor or become dry. Any structural component or piping must be adequately wetted before wrapping it in plastic sheeting for disposal.(7) At the conclusion of the removal, the licensed asbestos abatement contractor must perform a visual inspection to confirm that all ACBM required to be removed was removed and containerized, in accordance with this section, and that the containment is free of all residual dust and debris.(8) Temporary storage of ACWM must be provided (for example, a dedicated roll-off box, dumpster, or storage room lined with 6-mil thick plastic sheeting). All temporary storage must be sealed to prevent unauthorized access and safeguarded to keep the storage container sealed and leak tight. Final disposal of ACWM must be within 30 days after project completion, or when the receiving container is full, whichever is sooner.(9) A vehicle used to transport ACWM must be marked in accordance with 40 CFR §61.149(d)(1)(i) - (iii), (relating to Standard for waste disposal for asbestos mills) and §61.150(c) during the loading and unloading of ACWM so that the signs are visible.(10) ACWM transported by a licensed asbestos transporter off the asbestos abatement project site must be disposed of in accordance with 40 CFR §61.150(d).(d) Requirements for the encapsulation of ACBM.(1) Any product used for encapsulation must be clearly labeled or described in writing by the manufacturer as being designed for the particular asbestos-related activity. A product that is not clearly labeled or described as an asbestos encapsulant must be tested before use, and found to conform to ASTM E1494-12, if the intended use is to encapsulate ACBM.(2) Any encapsulation must be performed within a containment.(3) Loose and hanging ACBM must be removed before encapsulation. Filler material applied to any gap in existing material must contain no asbestos, adhere well to the substrate, and provide an adequate base for the encapsulating agent.(4) Encapsulant must be applied using only airless spray equipment with the nozzle pressure and tip size set according to the manufacturer's recommendations.(5) Any encapsulated material must be specifically designated by sign, label, color coding, or other mechanism to warn any individual who may in the future be required to disturb the material.(e) Requirements for the enclosure of ACBM.(1) Acceptable enclosure must be airtight and of permanent construction so that the material enclosed is inaccessible.(2) Any area of ACBM that can be reasonably anticipated to be disturbed during the installation of a hanger, bracket, or any other portion of the enclosure must be wetted within containment before such activity.(3) Before building the enclosure, loose and hanging ACBM that may be disturbed must be removed.(4) Any enclosure for ACBM must be specifically designated by sign, label, color coding, or other mechanism to warn any individual who may in the future be required to disturb the material.(f) Safety requirements and prohibitions. The following safety requirements must be in effect for an abatement project:(1) Fire safety. A minimum of one fire extinguisher with a minimum National Fire Protection Association rating of 10BC (dry chemical) must be placed within each abatement project containment for every 3,000 square feet, or fraction thereof, of containment. One fire extinguisher must be placed at each entrance inside of the containment. Each fire extinguisher must be maintained in a fully charged and operable condition with a current annual inspection tag securely attached reflecting that maintenance was performed by an appropriately licensed individual. Where more than one fire extinguisher is required, they must be distributed proportionately throughout the containment and their locations clearly marked.(2) Electrical safety. An active electrical service line within a regulated area and containment must be connected through ground-fault circuit interrupter devices (GFCI). An electrical appliance must not be plugged into an outlet unless equipped with a GFCI.(3) Prohibitions. Use of any solvent with a flash point of 140 degrees Fahrenheit or below is prohibited. Source Note: The provisions of this §296.212 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION L GENERAL REQUIREMENTS, AND PRACTICES AND PROCEDURES FOR ASBESTOS ABATEMENT IN A PUBLIC BUILDING §296.212 Standard Asbestos Abatement Practices and Procedures in a Public Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205441&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205441 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205441&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205441 03/11/2026 (a) Restrictions. An O&M licensee is limited to performing the practices and procedures described in this section for O&M activities in a public building that involve friable and nonfriable ACBM and are SSSD activities. These activities are subject to the following conditions:(1) the practices and procedures must be performed by individuals licensed or registered to perform the applicable activity and supervised by a licensed O&M supervisor or a licensed asbestos abatement supervisor;(2) an asbestos O&M licensee may perform or supervise, as applicable, an SSSD O&M activity following the practices and procedures described in this section;(3) if the practices and procedures are supervised by an O&M supervisor, the public building must be under the control of the O&M supervisor's employer who is a licensed asbestos O&M contractor or a licensed asbestos abatement contractor;(4) a larger project must not be broken down into smaller projects or tasks in order to qualify under this section as an SSSD O&M project to circumvent the restricted applicability of this section or other applicable requirements of this chapter;(5) an activity conducted under, or a licensee or public building owner acting under, this section remains subject to all applicable requirements of §296.191 of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility), including, without limitation, the requirement of an asbestos survey performed by an individual licensed to conduct it and the requirement to provide DSHS with written notification, as required in §296.251 of this chapter (relating to Notifications) and §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building); and(6) the practices and procedures described in this section do not limit and must be used only to the extent that they are consistent with the requirements of any other applicable law, including 29 CFR §1926.1101 (relating to Asbestos).(b) Work practices. Work practices under this section must comply with the following requirements.(1) An employer must furnish and require the use of a respirator, protective clothing, HEPA vacuum machines, glove bags, and other necessary equipment for an employee who performs an SSSD O&M activity.(2) A regulated area must be established where an SSSD O&M activity will be conducted and at minimum, asbestos caution tape must be used to demarcate the regulated area. Except as otherwise provided by other applicable law, access to the regulated area must be limited to:(A) licensees;(B) emergency responders;(C) licensed, registered, or accredited building professionals required for emergency situations;(D) appropriate governmental inspectors;(E) authorized personnel, in accordance with 29 CFR §1926.1101(e) (relating to Asbestos); and(F) a building owner or building owner's authorized representative, if authorized by the O&M contractor and accompanied by a licensed O&M contractor, licensed asbestos abatement contractor, licensed O&M supervisor, licensed asbestos abatement supervisor, licensed asbestos consultant, or the consultant's designated licensed asbestos project manager or licensed asbestos air monitoring technician project monitor. A building owner or building owner's authorized representative who enters the regulated area must have at a minimum the personal protective equipment required for workers performing the SSSD O&M activity and must comply with all other applicable health and safety procedures.(3) A warning sign that complies with 29 CFR §1926.1101, must be displayed at all entrances to regulated area. To protect the public from accidental entry, a warning sign must be displayed, at minimum, in both Spanish and English at the same location. Asbestos caution tape must not be substituted for a warning sign.(4) Before beginning the SSSD O&M activity, all uncontaminated movable objects must be removed from the regulated area or covered with 4-mil thick plastic sheeting. Any object that is already contaminated must:(A) be cleaned with a HEPA-filtered vacuum or wet-wiped before removal; or(B) be completely encased in two layers of 6-mil thick plastic sheeting and treated as ACWM.(5) Asbestos material must be wetted with amended water or another wetting agent and remain wet throughout the work operation and until final disposal, unless wet methods are not feasible because the asbestos work is being performed on live electrical equipment or in other areas where water will seriously damage materials or equipment.(6) A small amount of ACM may be removed by using a glove bag, removing the entire asbestos-covered pipe or structure, or constructing a mini-containment, as appropriate, in accordance with the following procedures for the method utilized.(A) Glove bags.(i) A glove bag made of transparent 6-mil thick plastic, and seamless at the bottom, must be installed so that it completely covers the pipe or other structure where asbestos work is to be done. The open edges must be folded together and securely sealed with tape. All openings in the glove bag must be sealed with duct tape or equivalent material and the integrity of the bag must be maintained at all times.(ii) Respirator use and selection must comply with 29 CFR §1910.134 (relating to Respiratory protection) and it's required written respiratory protection program, in accordance with 29 CFR §1926.1101(h)(2), 29 CFR §1910.1001(g)(2) (relating to Asbestos), and 40 CFR Part 763, Subpart G (relating to Asbestos Worker Protection), whichever is applicable. An employee who performs asbestos removal with a glove bag or in close contact with the glove bag must properly wear required respirators at all times during SSSD O&M activity.(iii) The ACM must be thoroughly wetted with amended water before it is removed from the pipe (applied with a sprayer through the precut port provided in most glove bags or applied through a small hole in the bag). A razor knife must be used to cut any painted canvas covering ACM and peel it away from the ACM. Nips, tin snips, or other appropriate tool must be used to cut and remove any wire mesh covering the ACM. If the ACM beneath the canvas or wire mesh is dry, it must be resprayed with a wetting agent, including any layer of dry material that is exposed beneath the mesh, the surface of the stripped underlying structure, and the inside of the glove bag.(iv) Once the ACM is removed from the pipe it must be thoroughly wetted with amended water.(v) After removal of the layer of ACM, the surface from which asbestos was removed must be thoroughly cleaned with a wire brush and wet-wiped with a wetting agent until no traces of the ACM are visible.(vi) An asbestos-containing insulation edge that was exposed as a result of the removal or maintenance activity must be encapsulated with a bridging encapsulant that creates a membrane over the surface before the glove bag is removed.(vii) When the asbestos removal and encapsulation is complete, the glove bag must be vacuumed with a HEPA-filtered vacuum by inserting the vacuum's hose into the glove bag through the port. Once the air has been removed from the bag, the bag, after being squeezed tightly as close to the top as possible and twisted, must be sealed with tape. Once the HEPA vacuum is then removed from the bag, the glove bag itself must be removed from the work area for proper disposal. A glove bag must only be used once and must not be moved.(B) Mini-containments.(i) A mini-containment must completely contain any disturbance or removal of ACM and must be constructed of 6-mil thick plastic sheeting by:(I) affixing the plastic sheeting to the walls with spray adhesive and tape;(II) covering the floor with plastic, and sealing that plastic floor covering to the plastic on the walls; and(III) sealing any penetration, such as pipes or electrical conduit, with tape; or(IV) using equivalent methods that effectively establish a leak-proof and puncture-resistant mini-containment; and(V) constructing a change room, contiguous to the mini-containment, made of 6-mil thick plastic sheeting, supported by 2-inch by 4-inch lumber, or equivalent, to which the plastic is attached with staples or spray adhesive and tape, or which otherwise complies with 29 CFR §1926.1101(j) and 40 CFR Part 763, Subpart G, whichever is applicable.(ii) Before use, the mini-containment must be checked for leaks and any leaks sealed.(iii) The mini-containment must be placed under negative pressure by means of a HEPA-filtered vacuum or similar ventilation unit.(iv) Appropriate protective clothing and respiratory protection must be worn within the mini-containment.(v) A visual inspection must be performed by a licensed O&M supervisor before removing a mini-containment.(vi) If the mini-containment will be reused, the interior must be completely washed with amended water and HEPA-vacuumed. Air clearance must be performed by a licensed asbestos consultant or the consultant's designated licensed AMT.(vii) If the mini-containment will not be reused, it must be removed by sealing the door, collapsing the containment using a HEPA-equipped vacuum and disposal as ACWM.(C) Removal of entire structures.(i) Before removing an asbestos-insulated pipe or an asbestos-containing or covered structure in its entirety, the structure must be wrapped with 6-mil thick plastic sheeting and securely sealed with duct tape or wrapped and sealed in a manner that provides equivalent protection.(ii) If the entire structure cannot be removed without disturbing ACM, but a small section can be stripped of the ACM to allow for cutting and removal of the entire structure at the stripped sections, the glove-bag method described in subparagraph (A) of this paragraph must be used to strip the small section of ACM to allow for removal of the entire structure.(7) Enclosure of ACM must be performed in accordance with the following requirements.(A) To enclose a structure with ACM, rather than removing the ACM, a solid structure with airtight walls and ceiling must be built around the asbestos-covered structure. A suspended ceiling with laid-in panels does not constitute an airtight ceiling for purposes of this paragraph.(B) If enclosure is the control method used, electrical conduits, telephone lines, recessed lights, and pipes in the area to be enclosed must be moved before construction of the enclosure to ensure that the enclosure will not have to be re-opened.(C) The enclosure must:(i) be permanent;(ii) be built of new construction materials;(iii) be impact resistant; and(iv) be airtight.(D) Enclosure walls must be made of tongue-and-groove boards, boards with spine joints, or gypsum boards having taped seams. The underlying structure must be able to support the weight of the enclosure.(E) All joints adjoining the walls and ceiling of the enclosure must be caulked.(F) Tools used during the installation of the enclosure must be equipped with a HEPA-filtered vacuum.(8) Asbestos exposed as a result of any spot repair must be properly enclosed or encapsulated.(9) HEPA vacuuming, wet cleaning, or both must be used to decontaminate regulated areas and equipment until there is no visible debris.(10) ACWM must be double-bagged into 6-mil thick plastic bags or sealed in leak-tight drums that must be marked in accordance with applicable NESHAP and OSHA regulations and paragraph (13) of this subsection and disposed of in accordance with NESHAP and as required in paragraphs (15) - (17) of this subsection.(11) A bag must not be filled to a level that tears or breaks the bag. Excess air in a bag must be removed before exiting a mini-containment or removing a glove bag. The top of the bag must be twisted closed, folded over, and sealed with duct tape. The bag must be rinsed off or HEPA-vacuumed in the regulated area to remove asbestos contamination and placed inside another bag or leak-tight drum. If an outer bag is used, excess air must be removed, and the bag must be closed and sealed in the same manner as the inner bag.(12) If a bag leaks, the bag must be placed into a third bag and sealed as required in paragraphs (10) and (11) of this subsection. If a drum leaks, the drum must be wrapped in a minimum of one layer of 6-mil thick plastic sheeting and sealed.(13) The exterior bag, wrapping, or leak-tight drum must have warning and generator labels applied as specified in 40 CFR §61.150(a)(1)(iv) and (v) (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations). Generator labels must be printed in letters of sufficient size and contrast to be readily visible and legible. All required labeling of ACWM containers must be done before removal from the regulated area. Any container or wrapped component labeled as asbestos must be containerized and labeled as ACWM before removal from the regulated area.(14) ACBM must be removed as a wrapped unit or in small sections and containerized while wet. Material must not be allowed to accumulate on the floor or become dry. Any structural component or piping must be adequately wetted before wrapping it in plastic sheeting for disposal.(15) Temporary storage of ACWM must be provided (for example, a dedicated roll-off box, dumpster, or storage room lined with 6-mil thick plastic sheeting). All temporary storage must be sealed to prevent unauthorized access and safeguarded to keep the storage container sealed and leak tight. Final disposal of ACWM must be within 30 days after project completion, or when the receiving container is full, whichever is sooner.(16) A vehicle used to transport ACWM must be marked in accordance with 40 CFR §61.149(d)(1)(i) - (iii), (relating to Standard for waste disposal for asbestos mills) and §61.150(c) during the loading and unloading of ACWM so that the signs are visible.(17) ACWM transported by a licensed asbestos transporter off the asbestos operations and maintenance abatement project site must be disposed of in accordance with 40 CFR §61.150(d). Source Note: The provisions of this §296.213 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION L GENERAL REQUIREMENTS, AND PRACTICES AND PROCEDURES FOR ASBESTOS ABATEMENT IN A PUBLIC BUILDING §296.213 Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205442&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205442 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205442&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205442 03/11/2026 (a) General provisions. As specified in §296.171 of this chapter (relating to Removal of Resilient Floor-Covering Material), the licensing and registration requirements of this chapter do not apply to a person who is performing or supervising the removal of resilient floor-covering material in a public building as required in this section. Such removal must:(1) be performed using work practices for that activity published by the Resilient Floor Covering Institute (RFCI work practices) at the time of the activity and supervised by an individual (RFCI supervisor) who meets the requirements of subsection (c) of this section who is responsible for ensuring that RFCI work practices and the requirements of this section are followed; or(2) be performed using other methods determined by the commissioner to provide public health protection from asbestos exposure, in accordance with §1954.104 of the Act.(b) Scope and limitations.(1) The removal activity allowed under this exemption is strictly limited to intact resilient floor-covering material that is nonfriable; remains intact; and has not been sanded, ground, mechanically chipped, drilled, abraded, cut, or sawed. Shearing, slicing, or punching the flooring does not, by itself, make this section inapplicable to the flooring material. Asbestos-containing resilient floor-covering material that does not meet the limitations of this paragraph is subject to paragraph (3) of this subsection.(2) The removal activity must not become a response action.(3) If, either before or during the removal, any of the resilient floor-covering material does not meet the limitations of paragraph (1) of this subsection, then:(A) removal under RFCI work practices is prohibited and, if already begun, must immediately cease; and(B) the area must be prepared and abated as required in §296.191 of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility) and §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building).(4) An RFCI contractor or RFCI supervisor who fails to stop the project under the circumstances referenced in paragraph (3) of this subsection and to abate as required in paragraph (3)(B) of this subsection violates this section, applicable licensing requirements, and the provisions of this chapter that are applicable to the continuing activity. Any such person, as well as the building owner, is subject to penalties as described in §296.318 of this chapter (relating to Administrative Penalty).(5) A person who performs removal using RFCI work practices must:(A) establish and maintain a regulated area with appropriate signage and demarcation to inform and protect the public from exposure as described in the RFCI work practices and in compliance with OSHA in 29 CFR §1926.1101(e) and (k)(7) (relating to Asbestos);(B) keep a copy of the current RFCI work practices and other records applicable to the removal activity on-site for the duration of the project, as required in §296.291 of this chapter (relating to Recordkeeping);(C) double bag and label ACWM, as required in §296.212(c) of this chapter;(D) upon completion of the project, have an RFCI supervisor confirm that all ACBM required to be removed was removed and containerized as required in this chapter and the abatement work area is free of all residual dust and debris;(E) provide proper temporary storage of ACWM (for example, a dedicated roll-off box, dumpster, or storage room lined with 6-mil thick plastic sheeting). All temporary storage must be sealed to prevent unauthorized access and safeguarded to keep the storage container sealed and leak tight. Final disposal of ACWM must be within 30 days after project completion or when the receiving container is full, whichever is sooner, as required in §296.212(c)(9) and (10) of this chapter; and(F) provide DSHS with written notification, as required in §296.251 of this chapter (relating to Notifications).(c) Training.(1) An individual engaged in removal of resilient floor-covering material using the RFCI work practices must successfully complete an eight-hour RFCI training course and any required refresher course, in compliance with 29 CFR §1926.1101(k)(9), that covers the elements described in the RFCI work practices. The removal of resilient floor-covering material must be supervised by an RFCI supervisor who is a competent person, as defined under 29 CFR 1926.32(f) (relating to Definitions), and, except as provided in paragraph (3) of this subsection, has successfully completed an additional minimum four-hour training course, review and examination required to supervise the removal of resilient floor-covering material, that addresses the following topics:(A) prework activities and considerations, including determination of asbestos-containing materials, methods of identification, walk through survey and bulk sampling, common building materials containing asbestos, and review of OSHA, EPA, Department of Transportation, and state and local regulations;(B) assessment of the work area, including site preparation considerations, conducting a negative exposure assessment, isolating the work area, adjacent areas, regulated areas, and safety hazards;(C) notification, recordkeeping, and waste disposal, including recordkeeping requirements, notification requirements, warning signs, special equipment, and transport and disposal of asbestos waste; and(D) supervising workers, including establishing goals, providing clear instructions, establishing expectations, use of supervisory authority, and motivating workers.(2) An individual employed by a school who elects to use the RFCI work practices must first complete the 16-hour custodial training required by AHERA, unless the individual is a registered asbestos abatement worker, licensed asbestos O&M supervisor, or licensed asbestos abatement supervisor.(3) An individual licensed as an asbestos abatement supervisor or accredited as an asbestos contractor/supervisor under the MAP is not required to complete the additional four-hour training required under paragraph (1) of this subsection to supervise the removal of resilient floor-covering material. Source Note: The provisions of this §296.231 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION M ALTERNATIVE ASBESTOS PRACTICES AND PROCEDURES IN A PUBLIC BUILDING §296.231 Alternative Practices and Procedures for Removal of Asbestos-Containing Resilient Floor-Covering Material in a Public Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205443&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205443 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205443&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205443 03/11/2026 (a) Scope and limitations.(1) The alternative work practices under subsection (b) of this section may be used for the removal of the following intact, nonfriable ACBM:(A) any packing;(B) any gaskets; and(C) any cements and mastics.(2) The work practices described in subsection (b) of this section do not limit, and must be followed in their entirety to the extent that they are consistent with, the requirements of any other applicable law, including 29 CFR §1926.1101 (relating to Asbestos) and must not be used if the ACBM listed in paragraph (1) of this subsection becomes friable during the removal project. Unless those work practices are followed, or if the ACBM becomes friable or becomes RACM, all abatement activity must stop, and the area prepared and abated in accordance with §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building), if applicable, or §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building).(3) Only a person who is a licensed asbestos abatement contractor, licensed asbestos abatement supervisor, or registered asbestos abatement worker may conduct asbestos abatement of nonfriable ACBM using the work practices outlined in subsection (b) of this section. A licensed asbestos abatement supervisor must supervise any registered asbestos abatement worker. A licensed asbestos consultant or the consultant's designated licensed asbestos project manager or licensed asbestos air monitoring technician project monitor (AMT/PM) must monitor the project for compliance with the requirements of this section. A project design is not required for a project using this alternative method.(4) Written notification must be provided, as required in §296.251 of this chapter (relating to Notifications).(b) Work practices.(1) A regulated area must be established where asbestos abatement will be conducted, and at minimum, asbestos caution tape must be used to demarcate the regulated area. Except as otherwise provided by other applicable law, access to the regulated area must be limited to:(A) licensees;(B) emergency responders;(C) licensed, registered, or accredited building professionals required for emergency situations;(D) appropriate governmental inspectors;(E) authorized personnel, in accordance with 29 CFR §1926.1101(e) (relating to Asbestos); and(F) a building owner or building owner's authorized representative, if authorized by the licensed asbestos abatement contractor and accompanied by the contractor, licensed asbestos abatement supervisor, licensed asbestos consultant, or the consultant's designated licensed asbestos project manager or licensed AMT/PM. A building owner or building owner's authorized representative who enters the regulated area must have at a minimum the personal protective equipment required for workers performing the asbestos-related activity and must comply with all other applicable health and safety procedures.(2) A warning sign that complies with 29 CFR §1926.1101, must be displayed at all entrances to regulated area. To protect the public from accidental entry, the warning sign must be displayed, at minimum, in both Spanish and English at the same location. Asbestos caution tape must not be substituted for a warning sign.(3) All HVAC equipment in or passing through the regulated area must be shut down, and preventative measures taken to prevent accidental start-ups. Supply and return openings and seams in system components must be sealed with at least 6-mil thick plastic sheeting, tape, or both.(4) All active electrical service lines within the regulated area must be connected through ground-fault circuit interrupter devices (GFCI). An electrical appliance must not be plugged into an outlet unless equipped with a GFCI.(5) ACBM must be wetted with amended water and remain wet throughout the abatement activity.(6) Work practices must not include grinding, abrading, sanding, or pulverizing ACBM.(7) HEPA vacuuming, wet cleaning, or both must be used to decontaminate the regulated area and equipment until there is no visible debris.(8) ACWM must be double-bagged into 6-mil thick plastic bags or sealed in leak-tight drums as required in §296.212(c) of this chapter and disposed of as required in §296.212(c)(8) - (10) of this chapter.(9) Ambient air must be monitored and analyzed on-site by a licensed asbestos consultant or the consultant's designated licensed asbestos air monitoring technician (AMT) or AMT/PM employed by a licensed asbestos laboratory and as required in §296.211(h)(1) of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building). Samples must be taken throughout the regulated area and adjacent to any active asbestos abatement activity and the asbestos consultant or the asbestos consultant's designated AMT or AMT/PM must provide the result of any ambient air analysis that exceeds a concentration of 0.01 f/cc (fibers per cubic centimeter) to the asbestos abatement supervisor. All asbestos abatement activity must be stopped and cleanup conducted as described in subsection (a)(2) of this section if at any time the result of ambient air analysis exceeds a concentration of 0.01 f/cc (fibers per cubic centimeter) for any sample, when measured by phase contrast microscopy using the NIOSH 7400 method.(10) A licensed asbestos abatement supervisor must perform an initial visual inspection upon completion of the project to confirm that all ACBM required to be removed was removed and containerized as required in this chapter and that the abatement work area is free of all residual dust and debris. This paragraph does not affect otherwise applicable requirements for personal air monitoring.(11) A licensed asbestos consultant or the consultant's designated licensed asbestos project manager or licensed AMT/PM must:(A) monitor the project for compliance with the requirements of this section; and(B) perform a final visual inspection upon completion of the project and the asbestos abatement contractor's initial visual inspection to observe and determine if all ACBM required to be removed was removed and containerized as required in this chapter and the abatement work area is free of all residual dust and debris.(12) The licensed asbestos abatement contractor must abate all ACM and remove any ACWM discovered by the final visual inspection as required in this chapter.(13) Work practices must be performed in accordance with 29 CFR §1926.1101 (relating to Asbestos), as applicable. Source Note: The provisions of this §296.232 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION M ALTERNATIVE ASBESTOS PRACTICES AND PROCEDURES IN A PUBLIC BUILDING §296.232 Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205444&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205444 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205444&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205444 03/11/2026 (a) Purpose. The purpose of this section is to describe the requirements that must be met to permit a small project or repetitive task described under this section to be performed without containment in a public building.(b) Scope and limitations.(1) This section applies only to a maintenance or installation project or task:(A) that is incident to another activity that has a primary purpose other than asbestos abatement;(B) that disturbs 10 square feet or less of ACBM for each small project or task; and(C) that is the same task performed by licensees without deviation from a documented procedure as described in subsection (c) of this section, and with material containing the same type and similar content of asbestos.(2) A small project or repetitive task, as described, and limited under this section, may be performed without using a negative pressure glove bag, glove box, or mini-containment only if all requirements of this section are met and a clearance-level assessment has been conducted as required in subsection (c) of this section showing that the work practices will not result in a concentration of asbestos fibers in excess of 0.01 f/cc at any time during the duration of the project.(3) A larger project must not be broken down into smaller projects or tasks in order to fall within the scope of this section or to circumvent the restricted applicability of this section or other applicable requirements of this chapter.(4) A registered asbestos abatement worker may perform a small project or repetitive task that disturbs ACBM, as described in paragraph (2) of this subsection, using the work practices outlined in subsection (d) of this section only when supervised by a licensed asbestos abatement supervisor who is employed by a licensed asbestos abatement contractor and a clearance-level assessment was done, as required in subsection (c) of this section showing that the work practices do not result in a concentration of fibers in excess of 0.01 f/cc at any time during the duration of the project.(5) A licensed asbestos abatement supervisor employed by an asbestos abatement contractor may perform and supervise a small project or repetitive task that disturbs ACBM as described in paragraph (2) of this subsection using the work practices outlined in subsection (d) of this section.(6) If a clearance-level assessment was done, as required in subsection (c) of this section, and the requirements and limitations of this section are otherwise met in performing a small project or repetitive task described in this section, a licensed consultant is not required to design the small project or repetitive task.(7) Written notification must be provided, as required in §296.251 of this chapter (relating to Notifications).(c) Clearance-level assessment. A project or task may be performed under this section only if, within the previous 12-month period, an assessment has been conducted on-site using a method permitted under paragraph (3) of this subsection, that demonstrates that the work practices used to perform the project or task do not result in a concentration of asbestos fibers in excess of 0.01 f/cc at any time during the duration of the project. The assessment method and results must be documented and clearly indicated on, and submitted with, the notification for the small project or repetitive task planned to be performed as described in this section.(1) The clearance-level assessment must be conducted as required §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building) and by performing the project or task as it would be performed under this section.(2) A person must hold the required license to conduct the components of the assessment.(A) A licensed asbestos consultant must design the clearance-level assessment and directly observe the performance of the project or task being assessed and the assessment methods and activities conducted under this subsection.(B) During an assessment under this subsection, a licensed consultant or a licensed air monitoring technician or licensed AMT/PM must conduct air monitoring in accordance with §296.211 of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building).(3) To establish, for purposes of this subsection, that clearance-level concentrations will be maintained throughout the project, the assessment method and results must be documented and submitted with the notification for the small project or repetitive task planned to be performed as described in this section. The documented assessment methods and results submitted must:(A) be consistent with procedures described:(i) for exposure assessments described under 29 CFR §1926.1101(f) (relating to Asbestos), including the engineering controls, work practices, and other safeguards described in connection with exposure assessments conducted under that subsection; or(ii) in ASTM D7886-14 Standard Practice for Asbestos Exposure Assessments for Repetitive Maintenance and Installation Tasks - ASTM International, www.astm.org; or(B) be equivalent to a procedure described in subparagraph (A)(i) and (ii) of this paragraph and capable of reliably determining whether clearance levels will be maintained throughout the project.(4) A licensed asbestos abatement supervisor must be in the containment directly performing the task or monitoring the registered asbestos abatement worker for purposes of the clearance-level assessment.(d) Work practices. Without limiting the restrictions of 29 CFR §1926.1101, work practices must include the following:(1) A regulated area must be established where asbestos abatement will be conducted and at minimum, asbestos caution tape must be used to demarcate the regulated area. Except as otherwise provided by other applicable law, access to the regulated area must be limited to:(A) licensees;(B) emergency responders;(C) licensed, registered, or accredited building professionals required for emergency situations;(D) appropriate governmental inspectors;(E) authorized personnel, in accordance with 29 CFR §1926.1101(e); and(F) a building owner or building owner's authorized representative, if authorized by the licensed asbestos abatement contractor and accompanied by the contractor, licensed asbestos abatement supervisor, licensed asbestos consultant, or the consultant's designated project manager or AMT/PM. A building owner or building owner's authorized representative who enters the regulated area must have at a minimum the personal protective equipment required for workers performing the asbestos-related activity and must comply with all other applicable health and safety procedures.(2) A warning sign that complies with 29 CFR §1926.1101, must be displayed at all entrances to regulated area. To protect the public from accidental entry, a warning sign must be displayed, at minimum, in both Spanish and English at the same location. Asbestos caution tape must not be substituted for a warning sign.(3) All HVAC equipment in or passing through the regulated area must be shut down and preventative measures taken to prevent accidental start-ups. Supply and return openings and any seam in system components must be sealed with at least 6-mil thick plastic sheeting, tape, or both.(4) An active electrical service line within the regulated area must be connected through ground-fault circuit interrupter devices (GFCI). An electrical appliance must not be plugged into an outlet unless equipped with a GFCI.(5) ACBM must be wetted with amended water or foam agents intended to control airborne fiber release and must remain wet throughout project.(6) HEPA vacuuming, wet cleaning, or both must be used to decontaminate the regulated area and equipment until there is no visible debris.(7) ACWM must be double-bagged into 6-mil thick plastic bags or sealed in leak-tight drums as required in §296.212(c) of this chapter and disposed of as required in §296.212(c)(8) - (10) of this chapter and NESHAP. Final disposal of ACWM must be within 30 days after project completion or when the receiving container is full, whichever is sooner.(8) A licensed asbestos abatement supervisor must monitor the project or task and perform an initial visual inspection upon completion of the project or task to confirm that all ACBM required to be removed was removed and containerized as required in this chapter and AHERA, if applicable, and the regulated area is free of all residual dust and debris. This paragraph does not affect otherwise applicable requirements for personal air monitoring.(9) A licensed asbestos consultant or the consultant's designated licensed asbestos project manager or licensed AMT/PM must:(A) monitor the project or task for compliance with the requirements of this section and AHERA, if applicable; and(B) perform a final visual inspection upon completion of the project or task and the asbestos abatement supervisor's initial visual inspection to:(i) observe and determine if all ACBM required to be removed was removed and containerized as required in this chapter and AHERA, if applicable; and(ii) the regulated area is free of all residual dust and debris.(10) The licensed asbestos abatement contractor must abate ACM and remove ACWM discovered by the final visual inspection, as required in this chapter. Source Note: The provisions of this §296.233 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION M ALTERNATIVE ASBESTOS PRACTICES AND PROCEDURES IN A PUBLIC BUILDING §296.233 Alternative Asbestos Practices and Procedures for Small Projects and Repetitive Tasks in a Public Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205445&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205445 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205445&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205445 03/11/2026 (a) Scope and limitations.(1) Eligible activities. The alternative work practices described in the following subparagraphs may be used for the removal of the following intact ACM if the conditions of paragraph (2) of this subsection are met and the work practices required under subsection (b) of this section are followed. Other requirements of §296.212 of this chapter (relating to Standard Asbestos Abatement Practices and Procedures in a Public Building) are not mandatory for the following activities:(A) removal of an asbestos cement sheet or wall panel by unbolting or unscrewing and removing the whole sheet or panel intact;(B) removal of a lab-type asbestos cement desktop by either unbolting or unscrewing and removing the whole desktop intact;(C) removal of a nonfriable countertop or backsplash by completely removing the whole unit intact;(D) removal of a window unit with window glazing, if the window glazing is secured with tape or a similar material before removal, and the whole window unit with window glazing is removed intact;(E) picking up one or more loose floor tiles that have become completely disassociated from the floor and are either whole or slightly broken, but which are still intact and not RACM;(F) picking up a loose miscellaneous nonfriable item, such as a roll of linoleum, a loose gasket, or a loose shingle;(G) removal of a fire door with asbestos-containing insulation from its hinges by removing the whole door, including its hardware, intact;(H) removal of any other nonfriable building component by removing it as a whole component and keeping it intact; and(I) removal of any packings, gaskets and mastics by removing them whole and intact, if not otherwise removed using the alternate method described in §296.232 of this chapter (relating to Alternative Asbestos Abatement Practices and Procedures for Certain Nonfriable Asbestos-Containing Building Material (ACBM) in a Public Building).(2) Restrictions. If the following conditions are met and the work practices required under subsection (b) of this section are followed, other requirements of §296.212 of this chapter are not mandatory for an activity described in paragraph (1) of this subsection.(A) ACM must be in good condition and removed as a whole component, keeping the component intact with no breakage or generation of dust during the removal or collection.(B) ACM must not be RACM.(C) If the ACM becomes RACM or cannot be removed as a whole component and kept intact, all abatement activities must be stopped, and the area must be prepared and abated as required in §296.213 of this chapter (relating to Asbestos Operations and Maintenance (O&M) Practices and Procedures for O&M Licensees in a Public Building) or §296.212 of this chapter, as applicable.(D) Only a licensed asbestos abatement contractor or licensed asbestos abatement supervisor employed by a licensed asbestos abatement contractor may perform an activity under this section. A registered asbestos abatement worker may perform an activity under this section only when supervised by a licensed asbestos abatement supervisor. A licensed consultant is not required to design a project that uses this alternative method and is conducted in accordance with the requirements and restrictions of this section.(E) Written notification must be provided, as required in §296.251 of this chapter (relating to Notifications).(b) Work practices. Work practices must include the following:(1) A regulated area must be established where asbestos abatement will be conducted and, at minimum, asbestos caution tape must be used to demarcate the regulated area. Except as otherwise provided by other applicable law, access to the regulated area must be limited to:(A) licensees;(B) emergency responders;(C) licensed, registered, or accredited building professionals required for emergency situations;(D) appropriate governmental inspectors;(E) authorized personnel, in accordance with 29 CFR §1926.1101(e) (relating to Asbestos); and(F) a building owner or building owner's authorized representative, if authorized by the licensed asbestos abatement contractor and accompanied by the contractor, licensed asbestos abatement supervisor, licensed asbestos consultant, or the consultant's designated licensed asbestos project manager or licensed air monitoring technician project monitor (AMT/PM). A building owner or building owner's authorized representative who enters the regulated area must have at a minimum the personal protective equipment required for workers performing the asbestos-related activity and must comply with all other applicable health and safety procedures.(2) A warning sign that complies with 29 CFR §1926.1101, must be displayed at all entrances to the regulated area. To protect the public from accidental entry, a warning sign must be displayed, at minimum, in both Spanish and English at the same location. Asbestos caution tape must not be substituted for a warning sign.(3) Asbestos material must be kept wet during removal and disposal.(4) Ambient air monitoring is not required.(5) A licensed asbestos abatement supervisor must perform an initial visual inspection upon completion of the project to confirm that all ACBM required to be removed was removed and containerized as required in this chapter and AHERA, if applicable, and the regulated area is free of all residual dust and debris. This paragraph does not affect otherwise applicable requirements for personal air monitoring.(6) A licensed asbestos consultant or the consultant's designated licensed asbestos project manager or AMT/PM must:(A) monitor the project for compliance with the requirements of this section; and(B) perform a final visual inspection upon completion of the project and the asbestos abatement supervisor's initial visual inspection to:(i) observe and determine if all ACBM required to be removed was removed and containerized as required in this chapter and AHERA, if applicable; and(ii) the regulated area is free of all residual dust and debris.(7) The licensed asbestos abatement contractor must abate all ACM and remove any ACWM discovered by the final visual inspection as required in this chapter.(8) ACWM must be double-wrapped in 6-mil thick plastic sheeting, double-bagged into 6-mil thick plastic bags, or sealed in leak-tight drums as required in §296.212(c) of this chapter and disposed of as required in §296.212(c)(8) - (10) of this chapter and in accordance with NESHAP. Source Note: The provisions of this §296.234 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION M ALTERNATIVE ASBESTOS PRACTICES AND PROCEDURES IN A PUBLIC BUILDING §296.234 Alternative Practices and Procedures for Removal of Whole Components of Intact Asbestos-Containing Material (ACM) in a Public Building https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205446&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205446 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205446&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205446 03/11/2026 (a) General provisions. DSHS must be notified using DSHS's online asbestos notification system on its website or on a form specified by DSHS of any asbestos abatement or demolition, as required in paragraphs (1) and (2) of this subsection. Notification must be made to DSHS no fewer than 10 working days before commencement of the activity. Submitting the notification form online on DSHS's website or by hard copy meets the requirements for notification to DSHS under both NESHAP and this chapter. The notification form must be properly completed and submitted as required in this section.(1) Public buildings. DSHS must be notified of any demolition of a public building whether or not asbestos has been identified. DSHS must be notified of any asbestos abatement within a public building. Notification must be submitted as required in this section.(2) Facilities. For all facilities, including commercial buildings that are not otherwise subject to this chapter as public buildings, DSHS must be notified of any demolition of a facility, whether or not asbestos has been identified. DSHS must be notified of any renovation operation if the combined amount of RACM to be stripped, removed, dislodged, cut, drilled, or similarly disturbed meets or exceeds the NESHAP threshold, in accordance with 40 CFR §61.145 (relating to Standard for demolition and renovation) of 160 square feet of surface area, 260 linear feet of pipe length, or 35 cubic feet off facility components where the length or area could not be measured. Notification must be submitted in accordance with NESHAP.(b) Responsibility for proper notification.(1) Public buildings. It is the responsibility of the public building owner and delegated agent (such as a licensed asbestos abatement contractor, asbestos consultant, or demolition contractor) to submit a notification to DSHS for each project. When the task to notify is delegated, the building owner's delegation and the name of the delegated agent must be specified on the notification form. The building owner and the delegated agent are responsible for the accuracy and timeliness of the notification and one or both may be found in violation for failing to accurately and timely notify DSHS of a project.(2) Facilities. It is the responsibility of the facility owner or operator to submit a notification to DSHS for each project. The facility owner and operator are responsible for the accuracy and timeliness of the notification and one or both may be found in violation for failing to accurately and timely notify DSHS of a project.(c) Completion of the notification form. The DSHS notification form must be fully and properly completed.(1) No applicable form field as specified on the notification form and notification instructions may be left blank and form fields must contain accurate information. Form fields that are not applicable must be marked "NA." The fields on the form for the work site, building description, building owner, abatement and waste transportation companies, and start and stop dates and times must be filled in. Use of the designation "NA" for any of these fields does not comply with the requirements of this section or 40 CFR §61.145 (relating to Standard for demolition and renovation).(2) The building owner or the delegated agent must submit an amendment to the notification for any changes. This includes changes to the start and stop dates, phased schedule form, amounts of asbestos to be removed, and cancellations. An amendment is not required if the amount of asbestos to be removed changes by less than 20%.(3) A hard copy notification form must contain an original signature. DSHS does not accept a copied signature.(d) Submission of the notification form and an amendment to the notification.(1) The notification form and an amendment to the notification must:(A) be submitted online on DSHS's website;(B) be postmarked and delivered by the United States Postal Service (USPS);(C) be date-stamped and delivered by commercial delivery service; or(D) be delivered by hand during normal business hours.(2) Printed notification forms must not be submitted by fax or email.(e) Timeliness of an initial notification and an amendment to the notification.(1) The initial notification of asbestos abatement or demolition must be submitted to DSHS at least 10 working days before the asbestos abatement or demolition start date. If the initial notification is for both asbestos abatement and demolition, the initial notification must be submitted 10 working days before either the asbestos abatement or demolition start date, whichever is earliest.(2) If a project start date, stop date, phased project schedule, scheduled work day, or time changes from the current notified date, schedule, scheduled work day, or time, an amended notification must be submitted to DSHS, as required in subsections (f) - (j) and (q)(2) of this section.(f) Start date change to an earlier date. When asbestos abatement or demolition will begin on a date earlier than the date in the notification:(1) an amended notification must be submitted to DSHS at least 10 working days before the new start date, as required in subsection (d) of this section;(2) the appropriate DSHS regional office must be provided with a fax or email copy of the amended notification at least 10 working days before the new start date; and(3) for notifications not submitted online, the appropriate DSHS regional office must also be contacted by phone at least 10 working days before the new start date.(g) Stop date change to an earlier date. An amendment is required for a stop date that changes to an earlier date unless the stop date changes by one working day for every seven calendar days of scheduled work in the notification but does not change by more than seven working days from the notified stop date. This provision does not grant an extension of time to amend the notification. When asbestos abatement or demolition ends on a date earlier than the date in the notification:(1) an amended notification of the new stop date must be submitted as required in subsection (d) of this section to DSHS as soon as possible, but no later than the new stop date;(2) the appropriate DSHS regional office must be provided with a fax or email copy of the amended notification as soon as possible, but no later than the new stop date; and(3) for notification not submitted online, the appropriate DSHS regional office must also be contacted by phone of the new stop date as soon possible, but no later than the new stop date.(h) Start date change to a later date. When asbestos abatement or demolition will begin later than the date in the notification:(1) an amended notification with the new start date must be submitted as required in subsection (d) of this section to DSHS as soon as possible, but no later than the current notified start date;(2) the appropriate DSHS regional office must be provided with a fax or email copy of the amended notice as soon as possible, but no later than the current notified start date; and(3) for notification not submitted online, the appropriate DSHS regional office must also be contacted by phone of the new start date as soon as possible, but no later than the current notified start date.(i) Stop date change to a later date. An amendment is required for a stop date that changes to a later date unless the stop date changes by one working day for every seven calendar days of scheduled work in the notification but does not change by more than seven working days from the notified stop date. This provision does not grant an extension of time to amend the notification. When asbestos abatement or demolition will end on a date later than the current notified stop date:(1) an amended notification of the new stop date must be submitted as required in subsection (d) of this section to DSHS as soon as possible, but no later than the current notified stop date;(2) the appropriate DSHS regional office must be provided with a fax or email copy of the amended notice as soon as possible, but no later than the current notified stop date; and(3) for notification not submitted online, the appropriate DSHS regional office must also be contacted by phone of the new stop date as soon as possible, but no later than the current notified stop date.(j) Cancellation.(1) When asbestos abatement or demolition is cancelled, the building owner or the delegated agent must:(A) submit a notice of the cancellation as required in subsection (d) of this section to DSHS as soon as possible, but no later than the current notified start date;(B) the appropriate DSHS regional office must be provided with a fax or email copy of the notice of cancellation as soon as possible, but no later than the current notified start date; and(C) the appropriate DSHS regional office must also be contacted by phone of the cancellation as soon as possible, but no later than the current notified start date.(2) When asbestos abatement and demolition are both notified on the same notification, and either the abatement or demolition will not occur, an amendment must be submitted to remove the abatement or demolition activity that will not occur on or before the notified start date for that activity.(k) Consolidated notification of nonscheduled asbestos O&M activities in a public building.(1) Notification of a series of nonscheduled, separate O&M activities involving ACBM, each of which does not meet or exceed a threshold of 160 square feet of surface area, 260 linear feet of pipe length, or 35 cubic feet volume off facility components where the length or area could not be measured previously, may be made annually. An individual project that meets or exceeds this threshold must be notified separately and must not be notified as part of the consolidated notification. The consolidated notification must include a prediction of the cumulative amount of asbestos to be removed, enclosed, or encapsulated from January 1 through December 31 of the calendar year for which consolidated notification is being given. Consolidated notifications must be submitted at least 10 working days before the calendar year for which notification is being given for a single building, or for a group of public buildings at one site under the control of one owner or operator. Consolidated notification must be submitted as required in subsection (d) of this section.(2) The building owner or delegated agent must notify the appropriate DSHS regional office by fax or email before each O&M activity for which notification is given in a consolidated notification under this subsection.(3) The building owner must keep records of the individual O&M activities. If, at any point during the calendar year for which consolidated notification was given, the amount of asbestos removed, enclosed, or encapsulated changes from the notified amount by 20% or more, an amendment must be submitted within 10 working days thereafter.(l) Consolidated notification of nonscheduled renovation operations in a facility that is not a public building.(1) A notification is required when the combined amount of RACM for planned renovation operations involving individual nonscheduled renovation operations, such as renovations resulting from equipment failure, meets or exceeds the NESHAP threshold of 160 square feet of surface area, 260 linear feet of pipe length, or 35 cubic feet off facility components where the length or area could not be measured. To determine whether notification is required, the facility owner or operator must predict the combined additive amount of RACM to be removed from January 1 to December 31 of the calendar year for which consolidated notification is being given. These operations may be notified on a single consolidated notification form for each facility for which a consolidated notification is required under this paragraph. Consolidated notifications must be submitted at least 10 working days before the calendar year for which notice is being given. Consolidated notification must be submitted as required in subsection (d) of this section.(2) Upon request by DSHS, the facility owner or operator must be able to demonstrate that the amount of RACM stripped or removed did not change from the notified amount by 20% or more. If, at any point during the calendar year for which consolidated notification was given, the amount of RACM stripped or removed changes from the notified amount by 20% or more, an amendment must be submitted within 10 working days thereafter.(3) If the facility owner or operator determines that the NESHAP threshold amount will be exceeded and a consolidated notification was not previously submitted under this subsection, a notification must be submitted at least 10 working days before the start date of the activity that will exceed the threshold.(m) Notification of emergency renovation operations.(1) An emergency notification must be submitted when the need for an emergency renovation operation arises. A description of the sudden, unexpected event precipitating the emergency renovation operation must be documented on the form. Notification of an emergency renovation operation must be submitted as soon as possible, but no later than the first working day after the date of the incident that precipitates the emergency operation. Initial notification can be made by phone followed by written notification, as required in subsection (d) of this section.(2) The building owner or the delegated agent or the facility owner or operator, as applicable, must also notify the appropriate DSHS regional office by phone and fax or email as soon as possible, but no later than the first working day after the date of the incident that precipitates the emergency renovation operation. The fax or email must include a description of the emergency and a copy of the notification form.(n) Addition of asbestos abatement or demolition to an existing notification. If asbestos abatement or demolition is to be added to a notification and the notified abatement or demolition stop date has not passed, a notification amendment must be submitted to DSHS, as required in subsection (d) of this section to add the asbestos abatement or demolition no fewer than 10 working days before the start date of the added abatement or demolition.(o) Notification of ordered demolitions for structurally unsound buildings.(1) If the facility is being demolished under an order of a state or local government agency or a court-issued order because the facility is structurally unsound and in danger of imminent collapse, the DSHS notification must be submitted as soon as possible, but no later than the first working day after the start date of the demolition. The determination that a structure is in danger of imminent collapse or that it is unsafe for anyone to enter must be made by a professional engineer or government official reasonably qualified to make the decision. A copy of the order must be attached to the notification form. Notification must be made as required in subsection (d) of this section. If an owner is unable to obtain a demolition order from a city, county, or state government official and has a letter from a professional engineer stating that the building is structurally unsound and in danger of imminent collapse, the owner may contact DSHS to request a waiver from the 10 working day notification deadline. Documentation supporting the inability to obtain an order must be submitted with the waiver request.(2) For structurally unsound buildings that are in danger of imminent collapse, the building owner or the delegated agent or the facility owner or operator must also notify the appropriate DSHS regional office by phone and fax or email as soon as possible, but no later than the first working day after the start date of the demolition. The email must include a copy of the demolition order or letter from a professional engineer, as applicable, and the notification form.(p) Notification of asbestos abatement and demolition. In a public building or a facility, including a commercial building, when asbestos abatement and demolition are notified on the same notification form and all asbestos abatement included in the notification concludes early, the demolition may start as early as the next calendar day when an amended notification is submitted, as required in the following paragraphs. It is the responsibility of the person that submits the notification to amend the abatement stop date and demolition start date.(1) A statement must be included on the initial notification submitted that demolition will start early if abatement concludes early.(2) An amended notification must be submitted, as required in subsection (d) of this section to DSHS as soon as possible, but no later than the new abatement stop date.(3) The appropriate DSHS regional office must be provided with a fax or email copy of the amended notice as soon as possible, but no later than the new abatement stop date.(4) The appropriate DSHS regional office must also be contacted by phone of the amended notice as soon as possible, but no later than the new abatement stop date and demolition start date.(q) Notification of a phased project for asbestos abatement, demolition, or abatement and demolition in a public building or facility.(1) To qualify as a phased project, the project must have planned periods of inactivity and all of the abatement and demolition work must be performed at one site. The site may contain more than one building, such as an office complex or university, if the buildings are under the control of one owner or operator. Notification of a phased project must not cover a period that exceeds 12 calendar months from the project start date. A completed Phased Project Schedule form must be submitted with each notification. The notification form must be submitted at least 10 working days before the start date of the first phase. The notification form must be submitted, as required in subsection (d) of this section.(2) When there is a change to the phased project schedule, the building owner or the delegated agent or the facility owner or operator, as applicable, must:(A) submit a notification amendment along with the revised Phased Project Schedule form to DSHS as soon as possible, but no later than the new proposed start date, stop date, or both of the phased project, whichever is earlier; and(B) also fax or email a revised Phased Project Schedule form to the appropriate DSHS regional inspector as soon as possible, but no later than the new proposed start date, stop date, or both of the phased project, whichever is earlier.(r) Asbestos notification fees.(1) Applicability. The building owner or the delegated agent or the facility owner or operator, as applicable, must pay to DSHS an asbestos notification fee, as required in this subsection. The fee is based upon the amount of asbestos removed and includes a subscription fee in an amount determined by the Texas Department of Information Resources to recover costs associated with the development and maintenance of Texas.gov services. The subscription fee is 3% of the total notification fee. The minimum fee for notification or the cancellation of a notification is $55.(2) Payment.(A) When a notification is submitted online, the user has the option to pay the notification fee at the time of submission or request to have an invoice mailed. DSHS mails an invoice to the building owner or the delegated agent or the facility owner or operator, as applicable, within 30 working days after the completion of the notified project. Payment must be received by DSHS within 60 calendar days after the invoice date.(B) When a notification is submitted by mail, DSHS mails an invoice to the building owner or the delegated agent, or the facility owner or operator, as applicable, within 30 working days after the completion of the notified project. Payment must be received by DSHS within 60 calendar days after the invoice date.(3) Notification fees.(A) Fees for asbestos abatement projects.(i) Notification fees for asbestos abatement are based on the total amount of the RACM or ACBM reported on the notification form to be abated, as required in §296.191 of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility) and this section. Fees for abatement are required to be paid based upon a $30 fee for each asbestos reporting unit (ARU).(ii) The minimum asbestos abatement notification fee per notification is $55 and the maximum fee per notification is $3,210 for abatement projects of 107 ARUs or more, except that the maximum fee per notification for a school building is $320.(iii) Notification fees are calculated by measuring the amount of RACM or ACBM to be abated in square feet, linear feet, or cubic feet.(I) ARU calculation for square feet. The number of ARUs is determined by measuring the total amount of RACM or ACBM to be abated in square feet, dividing that number by 160, and, if applicable, rounding that total down to a whole number.(II) ARU calculation for linear feet. The number of ARUs is determined by measuring the total amount of RACM or ACBM to be abated from pipes in linear feet, dividing that number by 260, and, if applicable, rounding that number down to a whole number.(III) ARU calculation for cubic feet. The number of ARUs is determined by measuring the total amount of RACM or ACBM to be abated from off facility components where the length or area could not be measured previously, dividing that number by 35, and, if applicable, rounding that number down to a whole number.(IV) Notification fee calculation. The notification fee is calculated by adding the total number of ARUs for each category (square feet, linear feet, and cubic feet) and multiplying the total number of ARUs by $30.(B) Fees for demolition only projects. The fee per notification for demolition for which RACM or ACBM will not be abated or will be left in place is $55.(C) Fees for abatement and demolition projects. The fee per notification for abatement with demolition is based solely on the amount of RACM and ACBM removed during the abatement. If an abatement notification is amended to add demolition, no additional fee is required for adding the demolition to the notification.(4) Reimbursement of notification fees. The building owner or the delegated agent or the facility owner or operator, as applicable, may submit a request for reimbursement based upon cancellation of the abatement or demolition or overestimation in calculating the number of ARUs of the amount of RACM or ACBM to be abated. If less than the reported amount will be removed, a notification amendment must be provided to DSHS with the reimbursement request. The written request must be received by DSHS within 10 working days after the notified project end date or its timely cancellation. DSHS deducts an administrative fee of $57 from any reimbursement for an excess payment of a notification fee. The requestor is not entitled to reimbursement of a notification fee for $62 or less.(5) Nonpayment of fees. Failure to pay the required fee by the invoice due date is a violation under this chapter and may subject the building owner or the delegated agent or the facility owner or operator, as applicable, to an administrative penalty under §296.318 of this chapter (relating to Administrative Penalty). Source Note: The provisions of this §296.251 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION N NOTIFICATIONS §296.251 Notifications https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205447&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205447 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205447&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205447 03/11/2026 (a) DSHS has the right to inspect or investigate the practices of any person involved with asbestos abatement or asbestos-related activity in a public building, commercial building, or facility.(b) A DSHS representative is not required to provide advance notice of, or seek permission to conduct, any asbestos-related inspection or investigation.(c) In order to inspect and investigate for compliance with this chapter, a DSHS representative, upon presenting a DSHS identification (ID) card, has the right to:(1) enter at all reasonable times:(A) any notified, actual, or former site of an asbestos-related activity;(B) if used to store records, the premises of a licensee under this chapter or the central location where asbestos records are maintained as required in §296.291 of this chapter (relating to Recordkeeping); or(C) any containment, facility or building, construction site, storage area, storage area of a transport vehicle, or office area;(2) review records and make copies;(3) interview any person;(4) locate, identify, and assess the condition of ACM;(5) take photographs; and(6) collect bulk samples, air samples, or both.(d) A person must not interfere with, refuse, or delay an inspection or investigation conducted by a DSHS representative.(e) DSHS is authorized to conduct any inspection or investigation to evaluate compliance under the Act and this chapter. A DSHS representative must not be impeded or denied entry to conduct official duties. A person must not threaten or attempt to bribe or intimidate a DSHS representative during the course of an inspection or investigation and is subject to applicable administrative, civil, and criminal sanctions for any violation. Source Note: The provisions of this §296.271 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION O INSPECTIONS AND INVESTIGATIONS §296.271 Inspections and Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205656 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205656 03/11/2026 (a) Recordkeeping requirements. Without limiting any federal or state requirement to which a licensee or record may otherwise be subject, a person regulated by this chapter must maintain, retain, and make available to DSHS for inspection or produce, upon request, including for copying on or off-site, records and documents as required by this section and each applicable subsection. For purposes of this chapter, records that are required to be maintained at a central location are not required to be maintained at the licensee's principal place of business and may be located off-site if the records are readily accessible. A person that ceases to do business must notify DSHS in writing within 30 days after such event and must make appropriate arrangements for retention and maintenance of records, as required under this section. The person must provide DSHS with the details of such arrangement or comply with DSHS's alternative instructions within 60 days after ceasing to do business or receiving instructions from DSHS, whichever is later.(b) Asbestos abatement contractors, asbestos O&M contractors, and RFCI contractors.(1) Central location. A contractor described in this subsection must maintain the following records and documents for any project performed in a public building at a central location for a period of at least 30 years after the date of project completion:(A) records and documents which comply with applicable recordkeeping requirements under 29 CFR Part 1910 (relating to Occupational Safety and Health Standards), 29 CFR §1926.1101 (relating to Asbestos), NESHAP, and AHERA;(B) the name, address, and asbestos training certificate number of each employee, past and present, including dates of employment and a description of each employee's involvement in each asbestos project while employed by the contractor; records must include the name, physical address, and duration of each project;(C) a copy of all regulatory agency correspondence, including each required asbestos abatement/demolition notification form, inspection form, letter, notice, and order;(D) a copy of each waste shipment record (manifest), including a copy of the manifest, signed in accordance with 40 CFR §61.150(d)(5) (relating to Standard for waste disposal for manufacturing, fabricating, demolition, renovation, and spraying operations) by the owner or operator of the designated waste disposal site and each receipt and documentation of disposal of asbestos waste showing the date, location, and amount of asbestos waste disposed and identifying each source of the asbestos waste and each transporter of the waste, including the company name or driver name, if the driver is an employee of the contractor;(E) a copy of each laboratory report and sample analysis documenting required air monitoring for the project, including a copy of each consultant report provided to the contractor regarding project monitoring; and(F) a copy of all contracts and project specifications and plans for each asbestos abatement project.(2) On-site. Without limiting the retention requirements of paragraph (1) of this subsection, the records and documents described under this paragraph must be maintained on-site at the asbestos project location for the duration of the project. RFCI contractors and DSHS-licensed asbestos abatement and O&M contractors are responsible for their employees' documents to be on-site. The following records and documents, at a minimum, must be maintained on-site as required in this paragraph:(A) each current applicable state-issued license or registration for every person conducting an asbestos-related activity for the contractor on the project site and a full-sized copy of each applicable training certificate, that must be current, for each person;(B) a copy of the current license for the licensed asbestos abatement contractor or O&M contractor;(C) a current copy of the contractor's standard operating procedures;(D) a copy of the asbestos project specifications and plans, or if project specifications and plans are not required, a scope of work that outlines the location and describes operations and abatement procedures for the project;(E) a listing of each employee working on the project by name and all applicable asbestos license or registration numbers and training certificate numbers for each employee;(F) name and address of each contractor, project supervisor, consultant, project manager, air monitoring technician project monitor (AMT/PM), waste transporter, waste disposal site, and building owner for the asbestos project;(G) a daily sign-in/sign-out log for the containment or the regulated area if no containment is present; sign-in/sign-out logs must identify each person by name and the length of time each spent in the containment or regulated area;(H) results of personal air monitoring samples, as required in §296.211(h) of this chapter (relating to General Requirements for Asbestos Abatement in a Public Building);(I) a written respiratory protection program that complies with 29 CFR §1910.134(c) (relating to Respiratory protection);(J) a description of personal safety practices;(K) a current copy of DSHS's Physician's Written Statement form and each respirator fit-test performed within the past 12 months for any individual who enters a regulated area;(L) a copy of the current asbestos abatement/demolition notification;(M) a copy of this chapter;(N) a copy of any federal regulation adopted by reference in §296.2 of this chapter (relating to Reference of Federal Standards) that applies to the asbestos-related activity that is being performed;(O) the EPA Publication for O&M activities entitled, "Managing Asbestos in Place: A Building Owner's Guide to Operations and Maintenance Programs" (also known as the EPA Green Book) if such activities are being performed;(P) a copy of the recommended work practices for resilient floor-covering removal published by the Resilient Floor Covering Institute if the project involves removal of resilient floor-covering materials using that method;(Q) the Violation Notification Procedure poster issued by DSHS, that must be posted and visible to the public at the entrance to the regulated area, as required in §296.211(i) of this chapter; and(R) a copy of any asbestos-related order issued by DSHS, EPA, or OSHA, that must be posted for 12 months or for a federal asbestos-related order, the period of time required by the federal asbestos-regulating authority from the date the order becomes effective and visible to the public at the entrance to the regulated area, as required in §296.211(i) of this chapter.(c) Asbestos management planners. A licensed asbestos management planner who undertakes and performs an activity independent of an agency, must maintain each of the licensee's asbestos survey reports, bulk sampling results, and management plans for that activity for 30 years after the date of project completion. These records and documents must be maintained at a central location.(d) Asbestos management planner agencies. A licensed asbestos management planner agency must maintain each of its asbestos survey reports, bulk sampling results, and management plans for 30 years from the date of project completion. These records and documents must be maintained at a central location.(e) Asbestos consultants. A licensed asbestos consultant who undertakes and performs an activity independent of an agency, must maintain for that activity each of the licensee's asbestos survey reports, assessments, bulk sampling results, asbestos management plans, O&M plans, specifications and plans, air monitoring records, each written designation of a project manager or AMT/PM and the project manager's or AMT/PM's responsibilities and authority, and a copy of every other asbestos abatement project document for 30 years after the date of project completion. These records and documents must be maintained at a central location. While a project is in process and until final visual inspection has been completed, all asbestos abatement project documents for the project must be kept at the asbestos project site.(f) Asbestos consultant agencies. A licensed asbestos consultant agency must maintain each of its asbestos survey reports, assessments, bulk sampling results, asbestos management plans, O&M plans, specifications and plans, air monitoring records, each written designation of a project manager or AMT/PM and the project manager's or AMT/PM's responsibilities and authority, and a copy of every other asbestos abatement project document for 30 years after the date of project completion. These records and documents must be maintained at a central location. While a project is in process and until final visual inspection has been completed, all asbestos abatement project documents for the project must be kept at the asbestos project site.(g) Asbestos air monitoring technicians and asbestos air monitoring technician project monitors. A licensed air monitoring technician (AMT) or asbestos air monitoring technician project monitors (AMT/PM) who performs phase contrast microscopy (PCM) analysis in the field as an employee of a licensed asbestos laboratory must maintain on-site for the duration of the project:(1) all analyzed slides, each labeled so that the AMT or AMT/PM can provide the project name, date, and time of sample collection and analysis, and sample location;(2) documentation of the AMT's or AMT/PM's relative standard of deviation, in accordance with the NIOSH 7400 method; and(3) a copy of:(A) the AMT's or AMT/PM's NIOSH 582 or NIOSH 582 Equivalent training certificate and documentation of current participation in the American Industrial Hygiene Association (AIHA) Proficiency Analytical Testing Program; or(B) documentation of current registration with the AIHA Asbestos Analyst Registry (AAR).(h) Asbestos laboratories. A licensed asbestos laboratory must maintain a copy of all analyses performed and all other records and documents required by this chapter for 30 years after the date of analysis, including the sample identification number and analytical results.(1) An analyzing laboratory must keep all samples from a public building received for analysis for 30 days following completion of the analysis. Sample grids must be maintained for one year after the date of the analysis.(2) An analyzing laboratory must maintain a copy of individual records for each analyst to document the individual analyst's relative standard of deviation in accordance with the NIOSH 7400 method for three years after the date the calculation was made. Records must be kept in the laboratory indicating which samples were used to meet the 10% quality-control analysis requirement.(i) Asbestos training providers.(1) Central location. The following records and documents must be maintained at a central location for a period of three years after the date of the course:(A) Training course materials. A licensed training provider must retain a copy of each instructional material used in the delivery of a classroom training, such as student training manuals, instructor notebooks, and handouts. Each instructional material must be kept for three years after the last date of the most recent training for which it was used.(B) Training courses. Records must indicate the name of the course, date of the course, each instructor who taught the course, and list the students who attended the course.(C) Instructor qualifications. A licensed training provider must retain a copy of each instructor's resume and the documents approving each instructor issued by DSHS or EPA for three years after the conclusion of their last classroom training.(D) Examinations. A licensed training provider must document that each person who receives an accreditation certificate for an initial training course has achieved a minimum passing score of 70% correct on the written examination, as required in §296.73(b) of this chapter (relating to Asbestos Training Courses). These records must include a copy of the exam and clearly indicate the date on which the exam was administered, the training course and discipline for which the exam was given, the name of the person who proctored the exam, and the name, examination answer sheet, and test score of each person taking the exam. All information from the training course and examination, including the topic and dates of the training course, must correspond to the information listed on each person's accreditation certificate. All records required to be maintained in accordance with this section must be maintained for three years after the date of the examination and immediately upon conclusion of the course and administration of the examination, must be made available for DSHS inspection.(E) Accreditation certificates. A licensed training provider must maintain records that document the names of each individual who has been awarded one or more training certificate, the certificate number applicable to each certificate awarded to an individual, each discipline for which accreditation was conferred, each applicable training and expiration date, and the training location.(2) Records access. A licensed training provider must allow DSHS reasonable access to all of the records required by the MAP and any other records required by DSHS for the approval of an asbestos training provider or the accreditation of an asbestos training course.(j) Public building owners. A building owner that meets the mandatory survey requirement using the method described in §296.191(d)(6)(B) of this chapter (relating to Asbestos Management in a Public Building, Commercial Building, or Facility) and uses the certification in lieu of an asbestos survey must maintain the following records;(1) the Texas-registered architect's or Texas-licensed professional engineer's certification; and(2) copies of the MSDSs or SDSs or both and any previous asbestos surveys reviewed by the Texas-registered architect or Texas-licensed professional engineer to prepare the certification. Source Note: The provisions of this §296.291 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION P RECORDKEEPING §296.291 Recordkeeping https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205449&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205449 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205449&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205449 03/11/2026 DSHS has the authority to enforce this chapter, the Act, and an order issued under the Act. DSHS may:(1) suspend or revoke an accreditation;(2) suspend an accreditation on an emergency basis;(3) deny an application for license or registration;(4) suspend or revoke a license or registration;(5) reprimand a licensee or registrant;(6) modify or refuse to renew a license or registration;(7) suspend a license or registration on an emergency basis;(8) place on probation a person whose license or registration is suspended;(9) impose an administrative penalty on a person regulated under the Act;(10) revoke or suspend approval of a training course;(11) suspend approval of a training course; or(12) suspend approval of a training course on an emergency basis. Source Note: The provisions of this §296.311 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.311 Disciplinary Action https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205450&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205450 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205450&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205450 03/11/2026 (a) DSHS must revoke an accredited person or suspend or revoke an accreditation for:(1) performing work requiring accreditation on an asbestos project without being in physical possession of current accreditation certificates;(2) possessing another person's duplicate accreditation certificate, permitting the duplication or use of one's own accreditation certificate by another, or failing to prevent duplication or unauthorized use of an accreditation certificate;(3) performing work without the required accreditation;(4) obtaining accreditation from a training provider that does not have approval to offer training for the particular accreditation type from EPA or from a state that has a contractor accreditation plan at least as stringent as the MAP; or(5) failing to pay a required or assessed fee, as required in this chapter.(b) DSHS must revoke an accreditation if DSHS finds, after notice and an opportunity for a hearing, as required in §296.320 of this chapter (relating to Notice and Violation), that a person:(1) has obtained the accreditation through fraudulent representation of training or examination documents;(2) has obtained training documentation through fraudulent means;(3) has gained admission to and completed refresher training through fraudulent representation of initial or previous refresher training documentation; or(4) has obtained accreditation through fraudulent representation of accreditation requirements, such as education, training, professional registration, or experience.(c) DSHS may suspend or revoke an accreditation certificate, or suspend an accreditation certificate on an emergency basis if the accredited person violates this chapter, the Act, or an order issued under the Act.(d) If an accreditation has been suspended, the person whose accreditation has been suspended is not eligible for reaccreditation to be granted before one year after the date of the order imposing the suspension.(e) If an accreditation has been revoked, the person whose accreditation is revoked is not eligible for reaccreditation to be granted before three years after the date of the order imposing the revocation. Source Note: The provisions of this §296.312 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.312 Action Against an Accreditation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205451&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205451 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205451&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205451 03/11/2026 (a) DSHS may deny an application for a license or registration, modify a license or registration, reprimand a licensee or registrant, suspend or revoke a licensee or registration, or suspend a license or registration on an emergency basis if it finds that a person regulated under the Act:(1) has obtained or attempted to obtain a license, registration, or contract to perform an asbestos-related activity by fraud, deception, submission of a false statement or material misrepresentation, or submission of invalid documentation;(2) has falsified a record or submitted or allowed to be submitted, a falsified record required by a federal agency or by DSHS in connection with an asbestos-related activity or licensure, registration, or accreditation for such an activity;(3) has refused to provide information requested by DSHS; or(4) has been convicted within the past five years of a felony or misdemeanor arising from an asbestos-related activity;(5) has violated a federal or state law, rule, standard or order regarding asbestos-related activities, including any violation of this chapter, the Act, or an order issued under the Act;(6) has failed to maintain any record required by DSHS in connection with an asbestos-related activity;(7) has failed at any time to meet the qualifications for a license or registration;(8) has failed to comply with the requirements of a probation period imposed under this subchapter; or(9) has failed to pay a required or assessed fee, as required in this chapter.(b) A person whose license or registration application was denied or whose license or registration was suspended or revoked may reapply for a license or registration subject to the following conditions.(1) A person who has had an application for a license or registration denied, or has had a license or registration suspended or revoked under subsection (a)(1) - (5), (8), or (9) of this section is ineligible to reapply for a license or registration before three years after the date of the denial, suspension, or revocation order.(2) A person who has had an application for a license or registration denied or has had a license or registration suspended or revoked under subsection (a)(6) of this section may reapply for a license one year after the date of the denial, suspension, or revocation order.(3) A person who has had an application for a license or registration denied or has had a license or registration suspended or revoked under subsection (a)(7) of this section may reapply for a license or registration after the person meets all qualifications for a license. Source Note: The provisions of this §296.313 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.313 Denial, Suspension, or Revocation of License or Reprimand of Licensee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205452&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205452 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205452&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205452 03/11/2026 (a) DSHS may suspend a license, registration, accreditation, or approval of an asbestos training course on an emergency basis if DSHS determines that the public health, interest, or welfare warrants immediate action.(b) An emergency suspension is effective immediately.(c) The person whose license, registration, accreditation, or approval of an asbestos training course is suspended under subsection (a) of this section is entitled to an opportunity for a hearing no later than the 20th day after the date of the emergency suspension order and in accordance with the Administrative Procedure Act, Texas Government Code, Chapter 2001. Source Note: The provisions of this §296.314 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.314 Emergency Suspension https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205453&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205453 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205453&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205453 03/11/2026 (a) Every license or registration of a person who is a licensee or registrant under this chapter is subject to suspension based upon a final order of a court or the Office of the Attorney General, Child Support Division under Texas Family Code, Chapter 232 (relating to Suspension of License) directing DSHS to suspend the person's license or registration.(b) If DSHS receives an order described in subsection (a) of this section, DSHS immediately determines if a license has been issued to the individual named on the order. If a license has been issued, DSHS:(1) records the suspension of the license in its records; and(2) reports and provides notice of the suspension, as applicable and appropriate, to:(A) the Office of the Attorney General, Child Support Division, or court from which it received the order suspending license;(B) the licensee; and(C) any current employer of the licensee or registrant, if known.(c) DSHS implements any final order described in subsection (a) of this section without additional review or hearing. DSHS is without authority to modify, remand, reverse, vacate, or stay an order issued under Texas Family Code, Chapter 232, and may not review, vacate, or reconsider the terms of such a final order suspending license.(d) A licensee or registrant whose license is suspended based upon a final order suspending license described in subsection (a) of this section:(1) is prohibited from engaging in any activity requiring a license and is subject to disciplinary action for violation of this prohibition;(2) must comply with normal renewal procedures to keep the license current; a renewed license remains subject to the suspension until the suspension is lifted under subsection (e) of this section; and(3) is not entitled to a refund for any fee paid to DSHS.(e) Upon DSHS's receipt of an order vacating or staying an order suspending the license, DSHS will promptly issue the affected license to the individual if the individual is otherwise qualified for and has met the prerequisites for the license under this chapter.(f) DSHS may not grant any license or registration application or any renewal application if it receives notice from a child support agency, as defined in Family Code §101.004, concerning an applicant, licensee, or registrant who has failed to pay child support under a support order for six months or more, requesting that DSHS deny approval of any such application. DSHS may not grant any application with respect to which it has received such notice until the authority is notified by the child support agency that the applicable applicant has:(1) paid all child support arrearages;(2) made an immediate payment of not less than $200 toward child support arrearages owed and established with the agency a satisfactory repayment schedule for the remainder or is in compliance with a court order for payment of the arrearages;(3) been granted an exemption from this subsection as part of a court-supervised plan to improve the obligor's earnings and child support payments; or(4) successfully contested the denial of issuance or renewal of license under Texas Family Code, Chapter 232.(g) DSHS may charge a fee to an individual who is the subject of an order described under subsection (a) of this section or who is refused approval of an application under subsection (f) of this section in an amount sufficient to recover the administrative costs incurred by DSHS under Texas Family Code, Chapter 232. Source Note: The provisions of this §296.315 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.315 Suspension of License under Texas Family Code Chapter 232 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205454&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205454 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205454&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205454 03/11/2026 DSHS may place on probation a person whose license or registration is suspended. If a suspension is probated, DSHS may require the person to:(1) report regularly to DSHS on any matter that is the basis of the probation;(2) limit practice to one or more areas prescribed by DSHS; or(3) continue or review professional education until the person demonstrates that the person has attained a degree of skill satisfactory to DSHS in those areas that are the basis of the probation. Source Note: The provisions of this §296.316 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.316 Probation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205455&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205455 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205455&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205455 03/11/2026 DSHS may deny, revoke, or suspend approval for a training course offered or taught by a DSHS-licensed training provider or instructor if the training course does not meet the requirements of the MAP or this chapter, or if a training provider or instructor:(1) makes a false statement, material misrepresentation, or is otherwise deceptive in connection with an application for course approval;(2) makes a false statement or material misrepresentation of the extent of a training course's approval by DSHS, another state, or EPA;(3) refuses to provide information requested by DSHS in connection with training or a training course;(4) fails to submit required information or a required course notification in a timely manner;(5) fails to maintain required records;(6) falsifies any accreditation record, instructor qualification, or other accreditation information, or otherwise submits invalid documentation;(7) fails to adhere to any training standard or requirement of the MAP or an applicable State Accreditation Program;(8) fails to pay a required or assessed fee, as required under this chapter; or(9) violates any provision of the Act or this chapter related to training or any training course, including any training duty or responsibility. Source Note: The provisions of this §296.317 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.317 Denial, Revocation, or Suspension of Approval of a Training Course https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205456&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205456 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205456&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205456 03/11/2026 (a) DSHS may impose an administrative penalty against a person who violates this chapter, the Act, or an order issued under the Act or this chapter.(b) The maximum administrative penalty is $10,000 per day, per violation. DSHS may consider each day that a violation continues as a separate violation for purposes of imposing a penalty.(c) To determine the amount of the administrative penalty, DSHS considers:(1) the person's history of previous violations;(2) the seriousness of the violation;(3) any hazard to the health and safety of the public;(4) demonstrated good faith efforts to correct the violation and maintain compliance; and(5) any other matter that justice may require for the violation.(d) DSHS classifies a violation according to its level of severity.(1) Severity Level I, critical violation. A critical violation has a direct negative impact on public health and safety.(2) Severity Level II, serious violation. A serious violation could threaten public health and safety.(3) Severity Level III, significant violation. A significant violation could lead to more serious consequences for public health and safety if uncorrected. Source Note: The provisions of this §296.318 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.318 Administrative Penalty https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205457&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205457 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205457&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205457 03/11/2026 (a) This section applies to an asbestos abatement supervisor against whom DSHS has issued one or more final orders containing findings arising from three complaints that the supervisor has violated the Act or this chapter.(b) The license of an asbestos abatement supervisor described in subsection (a) of this section is subject to revocation, as required in the Act and this chapter.(c) When DSHS revokes a license as described in this section, DSHS issues a worker registration to the person that expires six months after the date of issuance.(d) After the registration expires, the person may reapply for a license. Source Note: The provisions of this §296.319 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.319 Revocation of Asbestos Abatement Supervisor's License https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205458&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205458 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205458&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205458 03/11/2026 (a) Before DSHS takes final disciplinary action under §296.312 of this chapter (relating to Action against an Accreditation), §296.313 of this chapter (relating to Denial, Suspension, or Revocation of License or Reprimand of Licensee), §296.316 of this chapter (relating to Probation), §296.317 of the chapter (relating to Denial, Revocation, or Suspension of Approval of a Training Course), or assesses an administrative penalty under §296.318 of this chapter (relating to Administrative Penalty), DSHS will issue a notice of violation proposing a disciplinary action.(b) A person may accept DSHS's proposal in writing or may request a hearing in writing no later than 30 days after the date the person receives the notice. If the person accepts DSHS's proposal, DSHS issues a final order imposing the disciplinary action or administrative penalty, or both. If the person requests a hearing, DSHS refers the matter to the State Office of Administrative Hearings for a contested case hearing.(c) If the person named in a notice does not timely request a hearing on a notice assessing an administrative penalty, DSHS may find that the alleged conduct and violation occurred and issue a final order assessing an administrative penalty.(d) A hearing held under this chapter is governed by and conducted under:(1) the Administrative Procedure Act, Texas Government Code, Chapter 2001;(2) the procedural rules of the State Office of Administrative Hearings in 1 TAC Chapter 155 (relating to Rules of Procedure); and(3) Chapter 1, Subchapter B of this title (relating to Formal Hearing Procedures). Source Note: The provisions of this §296.320 adopted to be effective July 8, 2021, 46 TexReg 3880. 1 DEPARTMENT OF STATE HEALTH SERVICES 296 TEXAS ASBESTOS HEALTH PROTECTION Q COMPLIANCE §296.320 Notice and Violation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200569&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200569 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200569&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200569 03/11/2026 This chapter implements Texas Health and Safety Code, Chapter 443, regulating the manufacture, distribution, and retail sale of consumable hemp and consumable hemp products in the State of Texas. Source Note: The provisions of this §300.100 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS A GENERAL PROVISIONS §300.100 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200570 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200570&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200570 03/11/2026 The following words and terms, when used in this chapter, have the following meanings unless context clearly indicates otherwise:(1) Acceptable hemp THC level--A delta-9 tetrahydrocannabinol content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3 percent or less.(2) Accredited laboratory--A laboratory, including at an institution of higher education, accredited in accordance with the International Organization for Standardization ISO/IEC 17025 or a comparable or successor standard.(3) Act--House Bill 1325, 86th Legislature, Regular Session, 2019, relating to the production and regulation of hemp in Texas, codified in Texas Health and Safety Code, Chapter 443.(4) Analyte--A chemical, compound, element, bacteria, yeast, fungus, mold, or toxin identified and measured by accredited laboratory analysis.(5) Approved hemp source--Hemp and hemp products grown for human use and consumption produced under a state or a compatible federal, foreign, or Tribal plan, approved by the United States Department of Agriculture under 7 United States Code (U.S.C.) Chapter 38, Subchapter VII, or Texas Agriculture Code, Chapter 121, or in a manner that is consistent with federal law and the laws of respective foreign jurisdictions.(6) Cannabidiol (CBD)--A phytocannabinoid identified as an extract from cannabis plants.(7) Certificate of Analysis (COA)--An official document released by the accredited laboratory to the manufacturer, processor, distributor, or retailer of consumable hemp products, the public, or department, which contains the concentrations of cannabinoid analytes and other measures approved by the department, to also include data on levels of THC and state whether a sample passed or failed any limits of content analysis.(8) Consumable hemp product (CHP)--Any product processed or manufactured for consumption that contains hemp, including food, a drug, a device, and a cosmetic, as those terms are defined by Texas Health and Safety Code, §431.002, but does not include any consumable hemp product containing a hemp seed, or hemp seed-derived ingredient being used in a manner that has been generally recognized as safe (GRAS) by the FDA.(9) Consumable hemp products license--A license issued to a person or facility engaged in the act of manufacturing, extracting, processing, or distributing consumable hemp products for human consumption or use.(10) Delta-9 tetrahydrocannabinol (THC)--The primary psychoactive component of cannabis. For the purposes of this chapter, the terms delta-9 tetrahydrocannabinol and THC are interchangeable.(11) Department--Department of State Health Services.(12) Distributor--A person who distributes consumable hemp products for resale, either through a retail outlet owned by that person or through sales to another retailer. A distributor is required to hold a consumable hemp products license.(13) Facility--A place of business engaged in manufacturing, processing, or distributing consumable hemp products subject to the requirements of this chapter and Texas Health and Safety Code, Chapter 431. A facility includes a domestic or foreign facility that is required to register under the Federal Food, Drug, and Cosmetic Act, Section 415 in accordance with the requirements of 21 Code of Federal Regulations Part 1, Subpart H.(14) FDA--The United States Food and Drug Administration or its successor agency.(15) Federal Act--Federal Food, Drug, and Cosmetic Act (Title 21 U.S.C. 301 et seq.).(16) Hemp--The plant, Cannabis sativa L. and any part of that plant, including the seeds of the plant and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3 percent or less.(17) Independent contractor--A person or entity contracted to perform work or sales for a registrant.(18) License holder--The person who is legally responsible for the operation as a consumable hemp manufacturer, processor, or distributor, and possesses a valid license.(19) Lot number--A specific quantity of raw or processed hemp product that is uniform and intended to meet specifications for identity, strength, purity, and composition that shall contain the manufacturer's, processor's, or distributor's, number and a sequence to allow for inventory, traceability, and identification of the plant batches used in the production of consumable hemp products.(20) Manufacturer--A person who makes, extracts, processes, or distributes consumable hemp product from one or more ingredients, including synthesizing, preparing, treating, modifying or manipulating hemp or hemp crops or ingredients to create a consumable hemp product. For farmers and persons with farm mixed-type facilities, manufacturing and processing does not include activities related to growing, harvesting, packing, or holding raw hemp product.(21) Measurement of uncertainty--The parameter, associated with the results of an analytical measurement that characterizes the dispersion of the values that could reasonably be attributed to the quantity subjected to testing measurement. For example, if the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis is 0.35% and the measurement of uncertainty is +/- 0.06%, the measured delta-9 tetrahydrocannabinol content concentration level on a dry weight basis for this sample ranges from 0.29% to 0.41%. Because 0.3% is within the distribution or range, the sample is within the acceptable hemp THC level for the purpose of plan compliance.(22) Non-consumable hemp processor--A person who intends to process hemp products not for human consumption and is registered with the Texas Department of Agriculture.(23) Non-consumable hemp product--As defined by Texas Agriculture Code, §122.001(8), means a product that contains hemp, other than a consumable hemp product as defined by Texas Health and Safety Code, §443.001. The term includes cloth, cordage, fiber, fuel, paint, paper, particleboard, construction materials, and plastics derived from hemp.(24) Pathogen--A microorganism of public health significance, including molds, yeasts, Listeria monocytogenes, Campylobacter, Salmonella, E. coli, Yersinia, or Staphylococcus.(25) Person--An individual, business, partnership, corporation, or association.(26) Process--Extraction of a component of hemp, including CBD or another cannabinoid, that is:(A) sold as a consumable hemp product;(B) offered for sale as a consumable hemp product;(C) incorporated into a consumable hemp product; or(D) intended to be incorporated into a consumable hemp product.(27) Processor--A person who operates a facility which processes raw agriculture hemp into consumable hemp products for manufacture, distribution, and sale. A hemp processor is required to hold a consumable hemp products license. A person issued a consumable hemp products license, which only engages in the manufacturing, processing, and distribution of consumable hemp products, is not required to hold a license under Texas Health and Safety Code, Chapter 431, Subchapter J.(28) QR code--A quick response machine-readable code that can be read by a camera, consisting of an array of black and white squares used for storing information or directing or leading a user to product information regarding manufacturer data and accredited laboratory certificates of analysis.(29) Raw hemp--An unprocessed hemp plant, or any part of that plant, in its natural state.(30) Registrant--A person, on the person's own behalf or on behalf of others, who sells consumable hemp products directly to consumers, and who submits a complete registration form to the department for purposes of registering their place of business to sell consumable hemp products at retail to the public.(31) Reverse distributor--A person registered with the federal Drug Enforcement Agency as a reverse distributor that receives controlled substances from another person or entity for return of the products to the registered manufacturer or to destroy adulterated or impermissible THC products.(32) Smoking--Burning or igniting a consumable hemp product and inhaling the resultant smoke, vapor, or aerosol.(33) Tetrahydrocannabinol (THC)--The primary psychoactive component of the cannabis plant.(34) Texas Department of Agriculture--The state agency responsible for regulation of planting, growing, harvesting, and testing of hemp as a raw agricultural product.(35) Texas.gov--The online registration system for the State of Texas found at https://www.texas.gov. Source Note: The provisions of this §300.101 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS A GENERAL PROVISIONS §300.101 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200571&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200571 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200571&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200571 03/11/2026 Hemp manufacturers, processors, distributors, and retailers must comply with all relevant laws and rules applicable to the manufacture, processing, distribution and sale of consumable products, including:(1) Chapter 217, Subchapter C of this title (relating to Rules for the Manufacture of Frozen Desserts);(2) Chapter 229, Subchapter D of this title (relating to Regulation of Cosmetics);(3) Chapter 229, Subchapter F of this title (relating to Production, Processing, and Distribution of Bottled and Vended Drinking Water);(4) Chapter 229, Subchapter G of this title (relating to Manufacture, Storage, and Distribution of Ice Sold for Human Consumption, Including Ice Produced at Point of Use);(5) Chapter 229, Subchapter L of this title (relating to Licensure of Food Manufacturers, Food Wholesalers, and Warehouse Operators);(6) Chapter 229, Subchapter N of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice In Manufacturing, Packing, Or Holding Human Food);(7) Chapter 229, Subchapter W of this title (relating to Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices);(8) Chapter 229, Subchapter X of this title (relating to Licensing of Device Distributors and Manufacturers); and(9) Chapter 229, Subchapter GG of this title (relating to Sanitary Transportation of Human Foods). Source Note: The provisions of this §300.102 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS A GENERAL PROVISIONS §300.102 Applicability of Other Rules and Regulations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200567&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200567 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200567&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200567 03/11/2026 (a) Authorized employees of the department may, upon presenting appropriate credentials to the owner, operator, or person in charge:(1) enter at reasonable times the premises, conduct inspections, collect samples, and take photographs to determine compliance with this chapter and Texas Health and Safety Code, Chapters 431 and 443;(2) enter a vehicle being used to transport or hold the consumable hemp product in commerce; or(3) inspect at reasonable times, within reasonable limits, and in a reasonable manner, the facility or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of this chapter.(b) The inspection of a facility where consumable hemp products are manufactured, processed, distributed, packed, held or sold, for introduction into commerce shall be for the purpose of determining if the consumable hemp product is:(1) adulterated or misbranded; or(2) otherwise manufactured, processed, held, distributed or sold in violation of this chapter or Texas Health and Safety Code, Chapters 431 and 443.(c) An inspection of a facility in which a prescription drug or restricted device is being manufactured, processed, packed, or held for introduction into commerce under subsection (b) of this section shall not extend to:(1) financial data;(2) sales data other than shipment data;(3) pricing data;(4) personnel data other than data relating to the qualifications of technical and professional personnel performing functions under this chapter; or(5) research data other than data:(A) relating to new consumable hemp products; and(B) subject to reporting and inspection under regulations issued under §505(i) or (j), §519, or §520(g) of the Federal Act.(d) An inspection under subsection (b) of this section shall be started and completed with reasonable promptness. Source Note: The provisions of this §300.103 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS A GENERAL PROVISIONS §300.103 Inspections https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214074&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214074 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214074&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214074 03/11/2026 The manufacturing and processing of consumable hemp products for smoking is prohibited. Source Note: The provisions of this §300.104 adopted to be effective August 2, 2020, 45 TexReg 5195; amended to be effective July 5, 2023, 48 TexReg 3504. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS A GENERAL PROVISIONS §300.104 Manufacturing and Processing of Hemp Products for Smoking https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200564&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200564 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200564&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200564 03/11/2026 (a) A person must hold a consumable hemp products license issued by the department before engaging in the manufacture, processing, or distribution of consumable hemp products.(b) A person shall apply for a consumable hemp products license under this subchapter by submitting an application to the department in the manner prescribed by the department for each location engaged in the manufacture, processing, or distribution of consumable hemp products. The application must be accompanied by:(1) a legal description of each location to include the global positioning system coordinates for the perimeter of each location:(A) where the applicant intends to manufacture or process consumable hemp products; and(B) where the applicant intends to store consumable hemp products to include the global positioning system coordinates for the perimeter of each location;(2) written consent from the applicant or the property owner, if the applicant is not the property owner, for the department, the Department of Public Safety, and any other state or local law enforcement agency, to enter all premises where consumable hemp is manufactured, processed, or delivered, to conduct a physical inspection or to ensure compliance with this chapter; and(3) a fingerprint-based criminal background check from each applicant at the applicant's expense.(c) If the applicant or person has been convicted of a felony relating to a controlled substance under federal law or the law of any state within ten years before the date of application, the department shall not issue a consumable hemp products license under this subchapter.(d) If the department receives information that a license holder under this subchapter has been convicted of a felony relating to a controlled substance under federal law or the law of any state within ten years before the issue date of the license, the department shall revoke the consumable hemp products license.(e) A person who holds a consumable hemp products license under this subchapter shall undergo a fingerprint-based criminal background check at his own expense.(f) Applications must contain the following information:(1) the name of the license applicant;(2) the business name, if different than applicant name;(3) the mailing address of the business;(4) the street address of the facility;(5) the primary business contact telephone number;(6) the personal email address of the applicant; and(7) the email address of the business, if different than the applicant's email address.(g) If a person owns or operates two or more facilities, each facility shall be licensed separately by listing the name and address of each facility on separate application forms.(h) Applicants must submit an application for a consumable hemp products license request under this subchapter electronically through www.Texas.gov. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through www.Texas.gov.(i) All fees required by the department must be submitted with the application.(j) Applicants must submit any other information required by the department, as evidenced and provided upon application forms.(k) A consumable hemp products license issued by the department should be displayed in an obvious and conspicuous public location within the facility to which the license applies. Source Note: The provisions of this §300.201 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS B MANUFACTURE, PROCESSING, AND DISTRIBUTION OF CONSUMABLE HEMP PRODUCTS §300.201 Application for License or Renewal https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200565&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200565 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200565&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200565 03/11/2026 (a) A consumable hemp product license is valid for one year from the date displayed on the license.(b) The department shall issue and renew a license if the license holder:(1) is eligible to obtain a license under §300.201 of this subchapter (relating to Application for License or Renewal);(2) submits a license fee to the department;(3) does not owe outstanding fees to the department;(4) possesses testing results of consumable hemp products before their manufacture, distribution, or sale into commerce, and provides those testing results upon department request; and(5) has not been convicted of a felony relating to a controlled substance under federal law or the law of any state in the ten years before the date of renewal of the license.(c) Fees.(1) Before the manufacture, processing, or distribution of consumable hemp products, a license holder must pay a fee of $250 per facility.(2) For each facility a license holder must pay:(A) a $250.00 fee for amendment to a new license due to a change of ownership of the licensed facility; or(B) a $125.00 fee for any amendment during the licensure period due to minor changes, such as change of location, change of name, or change of address.(3) Fees are not prorated.(4) A person who files a renewal application after the expiration date of the current license must pay an additional delinquency fee of $100.(d) An application for an amendment of a consumable hemp product license is complete when the department has received, reviewed, and found acceptable the application information and fee required by the subsection (c) of this section.(e) An initial and renewal application for a consumable hemp product license must be processed in accordance with the following time periods:(1) the first time period of 45 business days begins on the date the department receives a completed application. If an incomplete application is received, the period ends on the date the facility is issued a written notice that the application is incomplete. The written notice shall be issued within 45 business days after receipt of the incomplete application and describe the specific information or fee that is required before the application is considered complete;(2) the second time period of 45 business days begins on the date the department receives a completed application and ends on the date the license is issued or the facility is issued a written notice that the application is being proposed for denial; and(3) if the applicant fails to submit the requested information or fee within 135 calendar days after the date the department issued the written notice to the applicant as described in paragraph (1) of this subsection, the application is considered withdrawn.(f) Reimbursement of fees:(1) in the event the application is not processed within the time periods stated in subsection (g) of this section, the applicant has the right to make a written request within 30 business days after the end of the second time period that the department shall reimburse in full the fee paid in that application process; and(2) if the department finds that good cause does not exist for exceeding the established periods, the request shall be denied, and the department shall notify the applicant in writing of the denial of the reimbursement within 30 business days after the department's decision. Source Note: The provisions of this §300.202 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS B MANUFACTURE, PROCESSING, AND DISTRIBUTION OF CONSUMABLE HEMP PRODUCTS §300.202 License Term and Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200566&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200566 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200566&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200566 03/11/2026 (a) A person who is required to maintain records under this chapter or §519 or §520(g) of the Federal Act must maintain records on site for immediate inspection, and at the request of the department, provide access to records for review or copying to verify consumable hemp products are being produced in accordance with United States Department of Agriculture under 7 United States Code (U.S.C.) Chapter 38, Subchapter VII, or Texas Agriculture Code, Chapter 121.(b) A person licensed under Texas Agriculture Code, Chapter 122, shall make available to the department upon request the results of tests conducted on samples of hemp or hemp products as evidence that the delta-9 tetrahydrocannabinol content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3 percent or less delta-9 tetrahydrocannabinol concentration of the hemp or hemp products does not exceed 0.3 percent.(c) Records described in subsection (b) of this section must be maintained for a period of no less than three years after the date the records are created. Source Note: The provisions of this §300.203 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS B MANUFACTURE, PROCESSING, AND DISTRIBUTION OF CONSUMABLE HEMP PRODUCTS §300.203 Access to Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200572&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200572 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200572&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200572 03/11/2026 (a) All hemp or hemp derivatives used in the manufacture of a consumable hemp product must be tested as appropriate for the product and process by an accredited laboratory to determine:(1) the presence and concentration of cannabinoids;(2) the presence and concentration of THC; and(3) the presence or quantity of residual solvents, heavy metals, pesticides, and harmful pathogens.(b) A Certificate of Analysis documenting tests conducted under this subchapter shall:(1) be made available to the department upon request in an electronic format before manufacture, processing, or distribution into commerce; and(2) include measurement of uncertainty analysis parameters. Source Note: The provisions of this §300.301 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS C TESTING OF CONSUMABLE HEMP PRODUCTS §300.301 Testing Required https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200573&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200573 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200573&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200573 03/11/2026 (a) This section does not apply to low-THC cannabis regulated under Texas Health and Safety Code, Chapter 487.(b) Notwithstanding any other law, a person shall not sell, offer for sale, possess, distribute, or transport a consumable hemp product in this state, including CBD oil, if the consumable hemp product contains any material extracted or derived from the plant Cannabis sativa L., other than from hemp produced in compliance with 7 United States Code (U.S.C.) Chapter 38, Subchapter VII, unless:(1) a representative sample of the oil has been tested by an accredited laboratory and found to have a delta-9 tetrahydrocannabinol content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3 percent or less; and(2) testing results are provided to the department upon request.(c) The department shall conduct random testing of consumable hemp products at various retail and other facilities that sell or distribute products to ensure the products:(1) do not contain harmful ingredients;(2) are produced in compliance with 7 U.S.C. Chapter 38, Subchapter VII; and(3) have a delta-9 tetrahydrocannabinol content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3 percent or less.(d) Upon request by the department, the manufacturer, processor, distributor, or retailer of consumable hemp products shall provide representative raw or finished consumable hemp product samples to the department.(e) Representative raw or finished consumable hemp product samples shall be provided to the department at owner, license holder, or registrant expense. Source Note: The provisions of this §300.302 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS C TESTING OF CONSUMABLE HEMP PRODUCTS §300.302 Sample Analysis of Consumable Hemp and Certain Cannabinoid Oils https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200574&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200574 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200574&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200574 03/11/2026 (a) A consumable hemp product that exceeds the acceptable hemp THC level or is adulterated in a manner harmful to human consumption shall not be sold at retail or otherwise introduced into commerce in this state.(b) A hemp manufacturer, processor, or distributor shall provide the results of testing required by §300.301 of this subchapter (relating to Testing Required) to the department upon request.(c) The registrant shall provide the testing results required under §300.301 of this subchapter to a consumer or the department upon request.(d) A license holder shall not use an independent testing accredited laboratory unless the license holder has:(1) no ownership interest in the accredited laboratory; or(2) holds less than a ten percent ownership interest in the accredited laboratory if the accredited laboratory is a publicly-traded company.(e) A license holder must pay the costs of raw and finished hemp product testing in an amount prescribed by the accredited laboratory selected by the license holder.(f) The department shall recognize and accept the results of a test performed by an accredited laboratory, including at an institution of higher education.(g) The department may require that a copy of the test results be sent directly to the department and the license holder.(h) The department shall notify the license holder of the results of the test not later than the 14th day after the date testing results are made available to the department.(i) A license holder shall retain results from samples for a period of no less than three years from the date that testing results are made available to the license holder.(j) A manufacturer or processor of consumable hemp products shall conduct sampling and testing using acceptance criteria that are protective of public health. (k) A consumable hemp product is not required to be tested under §300.301 of this subchapter if each hemp-derived ingredient of the product:(1) has been tested;(2) includes the results that are available upon request from the department before distribution or sale; and(3) contains an acceptable hemp THC level.(l) The department may utilize Table 1 to test raw or finished consumable hemp products as appropriate for the product and the process:Attached Graphic Source Note: The provisions of this §300.303 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS C TESTING OF CONSUMABLE HEMP PRODUCTS §300.303 Provisions Related to Testing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200575&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200575 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200575&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200575 03/11/2026 A person licensed or registered by the department under this chapter may possess, transport, distribute, or sell a consumable hemp product processed or manufactured in compliance with this chapter. Source Note: The provisions of this §300.401 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS D RETAIL SALE OF CONSUMABLE HEMP PRODUCTS §300.401 Possession, Distribution, and Sale of Consumable Hemp Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200576&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200576 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200576&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200576 03/11/2026 (a) All consumable hemp products marketed as containing more than trace amounts of cannabinoids must, in addition to the requirements of §300.102 of this chapter (relating to Applicability of Other Rules and Regulations), be labeled in the manner provided by this section with the following information:(1) lot number;(2) lot date;(3) product name;(4) the name of the product's manufacturer;(5) telephone number and email address of manufacturer; and(6) a Certificate of Analysis that the delta-9 tetrahydrocannabinol content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3 percent or less.(b) The label required by this section must appear on each product intended for individual retail sale.(c) The label required by this section may be in the form of:(1) a uniform resource locator (URL) for the manufacturer's Internet website that provides or links to the information required by this section; and(2) a QR code or other bar code that may be scanned and that leads to the information required on the label. Source Note: The provisions of this §300.402 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS D RETAIL SALE OF CONSUMABLE HEMP PRODUCTS §300.402 Packaging and Labeling Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200577&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200577 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200577&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200577 03/11/2026 A registrant selling consumable hemp products processed or manufactured outside of this state must, upon request, submit to the department evidence that the products were processed or manufactured in another state or a foreign jurisdiction in compliance with:(1) a state or tribal or jurisdiction's plan approved by the United States Department of Agriculture under 7 United States Code (U.S.C.) §1639p;(2) a plan established under 7 U.S.C. §1639q if that plan applies to the state or jurisdiction; or(3) the laws of a foreign jurisdiction if the products are tested in accordance with §300.301 of this chapter (relating to Testing Required) and comply with federal regulations. Source Note: The provisions of this §300.403 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS D RETAIL SALE OF CONSUMABLE HEMP PRODUCTS §300.403 Retail Sale of Out-Of-State Consumable Hemp Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200578&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200578 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200578&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200578 03/11/2026 Consumable hemp products may be legally transported across state lines and exported to foreign jurisdictions in a manner that is consistent with federal law and the laws of respective foreign jurisdictions. Source Note: The provisions of this §300.404 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS D RETAIL SALE OF CONSUMABLE HEMP PRODUCTS §300.404 Transportation and Exportation of Consumable Hemp Products Out of State https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200579&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200579 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200579&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200579 03/11/2026 (a) This section does not apply to:(1) low-THC cannabis regulated under Texas Health and Safety Code, Chapter 487; or(2) products recognized by the FDA under 21 CFR Part 182, Substances Generally Recognized as Safe (GRAS).(b) A person shall not sell consumable hemp products containing CBD at retail in this state unless the person registers with the department each location owned, operated, or controlled by the person at which those products are sold.(c) A person is not required to register with the department under subsection (b) of this section if the person is:(1) an employee of a registrant; or(2) an independent contractor of a registrant who sells the registrant's products at retail. Source Note: The provisions of this §300.501 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS E REGISTRATION FOR RETAILERS OF CONSUMABLE HEMP PRODUCTS §300.501 Registration Required for Retailers of Certain Products https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200580&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200580 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200580&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200580 03/11/2026 (a) A person shall register under this subchapter by submitting an application in the manner prescribed by the department.(b) Applications must be submitted by the owner, operator, or owner designee and shall contain the following information:(1) the name under which the business is operated;(2) the mailing address of the facility;(3) the street address of each location;(4) the primary business contact telephone number;(5) the phone number for each location; and(6) the primary business email address.(c) A registration is valid for one year and may be renewed annually, provided the registrant remains in good standing.(d) Proof of registration from the department must be prominently displayed in a conspicuous location visible to the public.(e) Applicants must submit an application for registration request electronically through www.Texas.gov.(f) The department shall collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through www.Texas.gov.(g) All fees required by the department must be submitted with the application.(1) A retail hemp registration or renewal fee of $150.00 for each location is required before the sale of consumable hemp product.(2) A person who holds a registration issued by the department under Texas Health and Safety Code, Chapter 443, shall renew the registration by filing an application for renewal on a form authorized by the department accompanied by the appropriate registration fee. A registrant must file for renewal before the expiration date of the current registration. A person who files a renewal application after the expiration date must pay an additional $100 delinquency fee.(3) Fees are non-refundable. Source Note: The provisions of this §300.502 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS E REGISTRATION FOR RETAILERS OF CONSUMABLE HEMP PRODUCTS §300.502 Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200581&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200581 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200581&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200581 03/11/2026 (a) A person commits a violation if the person manufactures, processes, distributes, or sells a consumable hemp product into commerce without a license or registration required by the department under:(1) §300.201 of this chapter (relating to Application for License or Renewal) for the manufacture, processing, or distributing of consumable hemp products; or(2) §300.502 of this chapter (relating to Application) for the retail sale of consumable hemp products.(b) Each day a violation continues or occurs is a separate violation for purposes of imposing an administrative penalty. Source Note: The provisions of this §300.601 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS F ENFORCEMENT §300.601 Violation of Department License or Registration Requirement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200582&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200582 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200582&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200582 03/11/2026 The following acts, and the causing of the following acts, within this state are unlawful and prohibited:(1) the distribution in commerce of a packaged consumable hemp product, if there is affixed to that consumable hemp product a label that does not conform to the provisions of this chapter; and(2) engaging in the packaging or labeling of packaged consumable hemp products if there is affixed to the consumable hemp product a label that does not conform to the provisions of this chapter. Source Note: The provisions of this §300.602 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS F ENFORCEMENT §300.602 Prohibited Acts https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200583&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200583 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200583&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200583 03/11/2026 The department shall affix to an article that is a food, drug, device, cosmetic, or consumer commodity a tag or other appropriate marking that gives notice that the article is, or is suspected of being, adulterated or misbranded and that the article has been detained or embargoed if the department finds or has probable cause to believe that the article:(1) is adulterated;(2) is misbranded so that the article is dangerous or fraudulent under this chapter; or(3) is in violation of Texas Health and Safety Code, §431.084, §431.114, or §431.115. Source Note: The provisions of this §300.603 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS F ENFORCEMENT §300.603 Detained or Embargoed Article https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200584&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200584 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200584&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200584 03/11/2026 (a) The department shall request court-ordered destruction of a sampled, detained, or embargoed consumable hemp product if the court finds the article is misbranded or adulterated.(b) After entry of the court's order, an authorized agent shall supervise the destruction of the article.(c) The claimant of the article shall pay the cost of the destruction of the article.(d) If the article is being destroyed in whole or in part due to a THC content that meets the definition of a schedule I drug, the article must be destroyed by a reverse distributor authorized by the United States Drug Enforcement Agency. Source Note: The provisions of this §300.604 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS F ENFORCEMENT §300.604 Destruction of Article https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200585&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200585 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200585&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200585 03/11/2026 (a) A court may order the delivery of a sampled article or a detained or embargoed article that is adulterated or misbranded to the claimant of the article for labeling or processing under the supervision of the department if:(1) the decree has been entered in the suit;(2) the costs, fees, and expenses of the suit have been paid;(3) the adulteration or misbranding can be corrected by proper labeling or processing; and(4) a good and sufficient bond, conditioned on the correction of the adulteration or misbranding by proper labeling or processing, has been executed.(b) The claimant shall pay the costs of department supervision. Source Note: The provisions of this §300.605 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS F ENFORCEMENT §300.605 Correction By Proper Labeling or Processing https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200586&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200586 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=200586&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 200586 03/11/2026 (a) The department may impose an administrative penalty against a person who holds a license or is registered under this chapter and who violates this chapter.(b) The department shall notify a retailer of consumable hemp products of a potential violation concerning consumable hemp products sold by the registrant and provide the registrant an opportunity to resolve such violations made unintentionally or negligently within ten business days after the department notifies the registrant.(c) The department shall assess administrative penalties based upon one or more of the following criteria:(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of any prohibited acts, and the hazard or potential hazard created to the health, safety, or economic welfare of the public;(2) the history of previous violations;(3) the amount necessary to deter future violations;(4) efforts to correct the violation; and(5) any other matter that justice may require in relation to the violation.(d) If the department determines that a violation has occurred, the department shall issue a notice of violation that states the facts on which the determination is based, including an assessment of the penalty.(e) The notice of violation shall be in writing and sent to the license holder by certified mail. The notice must include a summary of the alleged violation and a statement of the amount of the recommended penalty and must inform the person that the person has a right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.(f) Within 20 business days after the date the person receives the notice of violation, the person in writing may accept the determination and recommended penalty of the department or may make a written request for a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.(g) If the person accepts the determination and recommended penalty, the department by order shall impose the recommended penalty.(h) If the person charged with the violation does not respond in writing within 20 business days after the date the person receives the notice of violation, the department shall assess the penalty after determining that a violation occurred and the amount of penalty. The department shall issue an order requiring that the person pay the penalty.(i) If the person requests a hearing, the department shall refer the matter to the State Office of Administrative Hearings. Source Note: The provisions of this §300.606 adopted to be effective August 2, 2020, 45 TexReg 5195. 1 DEPARTMENT OF STATE HEALTH SERVICES 300 MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS F ENFORCEMENT §300.606 Administrative Penalty https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152168&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152168 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152168&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152168 03/11/2026 The purpose of this subchapter:(1) establishes the two types of review boards that conduct hearings to determine whether an individual is manifestly dangerous;(2) defines the elements to be considered in the determination of manifest dangerousness by review boards;(3) describes which persons may and may not be subject to a hearing to determine manifest dangerousness;(4) enumerates the rights of an individual who is subject to a hearing to determine manifest dangerousness;(5) provides due process for individuals who have been determined manifestly dangerous; and(6) provides procedures governing the transfer of an individual to the maximum security unit/secure adolescent unit (MSU/SAU) and from the MSU/SAU. Source Note: The provisions of this §415.301 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.301 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152169&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152169 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152169&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152169 03/11/2026 This subchapter applies to facilities, as defined in §415.303(8) of this title (relating to Definitions). Source Note: The provisions of this §415.302 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.302 Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152170&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152170 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152170&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152170 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:(1) Adolescent--A person who is 13, 14, 15, 16, or 17 years of age.(2) Adult--A person who is 18 years of age or older.(3) Assessment of risk for manifest dangerousness--An age and developmentally appropriate comprehensive evaluation of the commonly accepted risk factors for violence and the results of evidence based tools that assess and/or measure risk of violence.(4) Child--A person who is 12 years of age or younger.(5) Commissioner--The commissioner of the Texas Department of State Health Services or designee.(6) DSHS--The Texas Department of State Health Services.(7) DSHS Dangerousness Review Board (DRB)--Five mental health professionals impaneled in accordance with §415.305(e) of this title (relating to Procedures and Requirements for All Review Boards) to conduct a hearing to determine whether or not an individual served in the MSU/SAU is manifestly dangerous.(8) Facility--Any state hospital, or a state center with an inpatient component, that is operated by DSHS, excluding Waco Center for Youth.(9) Facility CEO (chief executive officer)--The superintendent or director of a facility or his/her designee.(10) Facility review board--Five mental health professionals impaneled in accordance with §415.305(e) of this title to conduct a hearing to determine whether or not an individual served in a facility is manifestly dangerous.(11) Hearing--An oral proceeding conducted by a review board in accordance with §415.305(g) of this title in which evidence relating to an individual's possible manifest dangerousness is heard.(12) Independent evaluator--A licensed physician or mental health professional (as defined) retained by an individual or LAR who conducts an evaluation or examination of the individual.(13) Individual--An adult or adolescent committed to a facility (as defined) who is to be the subject of a hearing to determine manifest dangerousness or who has been determined manifestly dangerousness in accordance with this subchapter.(14) LAR or legally authorized representative--A person authorized by law to act on behalf of an individual with regard to a matter described in this subchapter, and who may include a parent, guardian, or managing conservator of a minor individual, or a guardian of an adult individual.(15) Local authority--An entity designated by the commissioner in accordance with the Texas Health and Safety Code, §533.035(a).(16) Manifestly dangerous--The term used to describe an individual who, despite receiving appropriate treatment, including treatment targeted to the individual's dangerousness, remains likely to endanger others and requires a maximum security environment in order to continue treatment and protect public safety.(17) Mental health professional--A person, licensed in the State of Texas, who has at least one year of experience as a provider of mental health services within the past five years and who is:(A) a licensed physician who has successfully completed a psychiatric residency;(B) a licensed psychologist or licensed psychological associate;(C) a licensed master social worker (LMSW);(D) a licensed registered nurse with a bachelor's degree in nursing with American Nurses Credentialing Center (ANCC) certification in psychiatric/mental health nursing;(E) an advanced practice registered nurse licensed to practice in the area of psychiatric/mental health nursing; or(F) a licensed registered nurse with a master's degree in psychiatric/mental health nursing.(18) Maximum security unit--A facility unit designated by the commissioner to treat adults who are determined manifestly dangerous in accordance with this subchapter and persons who have been committed pursuant to the Texas Code of Criminal Procedure, Article 46B or 46C.(19) MSU/SAU (maximum security unit/secure adolescent unit)--Either the maximum security unit or the secure adolescent unit, as appropriate to the individual.(20) MSU/SAU CEO (chief executive officer)--The superintendent or director, or his/her designee, of the facility at which the MSU/SAU is located.(21) Receiving facility--(A) For an individual who was transferred to the MSU/SAU--The receiving facility is the facility that transferred the individual to the MSU/SAU unless another facility is identified as the receiving facility.(B) For an individual who was committed to the MSU/SAU pursuant to the Texas Code of Criminal Procedure--The receiving facility is the facility in the service area of the local authority that serves the individual's county of residence unless another facility or state mental retardation facility is identified as the receiving facility.(22) Risk management plan--A plan for managing the factors contributing to an individual's potential for dangerousness that is implemented following transfer from the MSU/SAU and which includes a description of the level of external controls needed to ensure the safety of others and effective treatment for the individual, the type of commitment needed to support these controls, and recommendations for continuing care.(23) Secure adolescent unit--A facility unit designated by the commissioner to treat adolescents who are determined manifestly dangerous in accordance with this subchapter.(24) Spokesperson--A person appointed by an individual or LAR to represent the individual or LAR at a hearing. A spokesperson may be an attorney, a relative, a friend, or advocate. Source Note: The provisions of this §415.303 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.303 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152164&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152164 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152164&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152164 03/11/2026 (a) Only an adult or adolescent who is committed by a court of law to a facility (as defined) may be subject to a hearing to determine manifest dangerousness.(b) The following persons may not be subject to a hearing to determine manifest dangerousness:(1) an adult, adolescent, or child who is voluntarily admitted to a facility (as defined) or who is under an order of protective custody in accordance with the Texas Health and Safety Code, §574.022; and(2) a child who is committed by a court of law to a facility (as defined). Source Note: The provisions of this §415.304 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.304 Persons Who May and May Not Be Subject to a Hearing to Determine Manifest Dangerousness https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152165&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152165 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152165&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152165 03/11/2026 (a) Pool of mental health professionals.(1) Facility review board. Each facility CEO is responsible for having access to a pool of mental health professionals who will be available to be impaneled as members on the facility review board. A CEO may appoint a pool of professionals or may arrange to have access to a pool of professionals appointed by another facility CEO.(2) DSHS Dangerousness Review Board. The commissioner will appoint a pool of at least 16 mental health professionals who will be available to be impaneled as members on the DSHS Dangerousness Review Board.(b) Chair.(1) Facility review board. The facility CEO will appoint the chair of the facility review board from the pool of mental health professionals described in subsection (a)(1) of this section. If the chair is unable to serve on the review board for a particular hearing, then the chair will appoint another review board member to act as chair for the hearing. If the chair is unable to appoint an acting chair, then the facility CEO will make the appointment.(2) DSHS Dangerousness Review Board. The commissioner will appoint the chair of the DSHS Dangerousness Review Board from the pool of mental health professionals described in subsection (a)(2) of this section. If the chair is unable to serve on the review board during a convening date of the board or for a particular hearing, then the chair will appoint another review board member to act as chair for the convening date or the particular hearing, as appropriate. If the chair is unable to appoint an acting chair, then the commissioner will make the appointment.(c) Qualification of certain members impaneled for a hearing.(1) If the individual who is the subject of the hearing is an adolescent, then:(A) at least one member must be a psychiatrist with training and experience in the care of adolescents; and(B) at least two members must have training and experience in the care of adolescents as a provider of mental health services.(2) If the individual who is the subject of the hearing is an adult, then:(A) at least one member must be a psychiatrist with training and experience in the care of adults; and(B) at least two members must have training and experience in the care of adults as a provider of mental health services.(3) If the individual who is the subject of the hearing has mental retardation, then at least one member must have training and experience in the care of persons with mental retardation.(d) Disqualification from being impaneled as a review board member for a hearing.(1) A mental health professional in a pool may not be impaneled as a facility review board member or as a DSHS Dangerousness Review Board member for the hearing of an individual if:(A) the professional has been a staff member on the individual's unit or a member of the individual's treatment team within the past 12 months or during the individual's current admission, whichever is longer; or(B) the review board chair and the individual or LAR agree that the participation of the professional would constitute a conflict of interest.(2) A mental health professional in a pool may not be impaneled as a facility review board member for the hearing of an individual if the professional has had personal or professional involvement with the individual's behavior or incident that precipitated the hearing.(3) A mental health professional in a pool may not be impaneled as a DSHS Dangerousness Review Board member for the hearing of an individual if the professional served on the facility review board that determined the individual to be manifestly dangerous and which resulted in the individual's transfer to the MSU/SAU.(e) Impaneling review board members for a hearing. For each hearing, the chair will select five mental health professionals from the pool to be impaneled as review board members.(1) For each hearing, at least three of the five review board members must meet the qualifications described in subsection (c) of this section.(2) For each hearing, none of the five review board members may be disqualified as described in subsection (d) of this section.(f) Legal assistance. An attorney from the DSHS Office of General Counsel will provide legal assistance to a review board as needed.(g) Conduct of hearings.(1) Each hearing must be tape-recorded or transcribed, with the recording or transcription made a part of the individual's medical record.(2) The review board must consider all pertinent and relevant information including the hearing documentation submitted in accordance with §415.307(3)(A) of this title (relating to Procedures and Requirements Specific to a Facility Review Board) or §415.310(4)(A) of this title (relating to Procedures and Requirements Specific to the DSHS Dangerousness Review Board) and the source documents that correspond to the hearing documentation.(3) Only review board members, the individual, LAR, and spokesperson(s) may participate in the hearing, except that other persons may provide testimony as permitted under this subchapter.(4) If requested by the individual or LAR, or at the chair's discretion, the chair will require each witness to provide his/her testimony without other witnesses being present. The chair is not required to exclude any person whose presence is determined by the chair to be essential to the hearing. The individual and LAR are not subject to being excluded from the hearing room under this paragraph.(5) The review board will assure that, prior to providing testimony to the review board, each witness will swear or affirm that his/her testimony will be the truth, the whole truth, and nothing but the truth.(6) The chair or the facility CEO may permit persons to attend the hearing to provide technical assistance or for professional training purposes.(7) All persons attending and participating in a hearing must conduct themselves with proper dignity, courtesy, and respect for the hearing. Disorderly conduct will not be tolerated. Attorneys must observe and practice the standards of ethical behavior prescribed for attorneys at law by the State Bar of Texas.(8) The chair must provide the individual with an opportunity to be interviewed by the review board. The individual may decline to be interviewed.(9) The chair is responsible for ensuring that hearings are conducted according to the provisions in this subchapter and that a safe environment is maintained during the hearing.(h) Deliberations.(1) After all evidence has been heard, the review board chair will adjourn the hearing and the review board members will begin deliberations.(2) Only review board members may be present and participate in deliberations.(3) The review board may cease deliberating in order to reopen the hearing if the board decides that additional information is necessary. If the board reopens the hearing, then the board must allow all persons who participated in the hearing before it was adjourned to attend and participate in the reopened hearing.(4) A review board may not view the mere fact that an individual chooses not to participate in the hearing as evidence that the individual is manifestly dangerous.(i) Review board determination.(1) A review board may determine that an individual is manifestly dangerous only if there is sufficient clinical justification that the individual is manifestly dangerous (as defined).(2) A facility review board may determine that an individual is manifestly dangerous only if the vote by review board members is unanimous.(3) The DSHS Dangerousness Review Board may determine that an individual is not manifestly dangerous only if the vote by review board members is unanimous.(4) If the vote by review board members is not unanimous, then any member may prepare a written dissent, stating the reason for such dissent.(j) Written report.(1) Within 14 days after the review board's determination, the chair of the review board or designee shall prepare a written report and submit it to the facility CEO or MSU/SAU CEO (as appropriate), along with copies to the individual, LAR, and spokesperson(s). The report must include:(A) findings of fact;(B) the determination of whether or not the individual is manifestly dangerous;(C) the rationale for the determination; and(D) written dissents, if any.(2) The facility CEO shall ensure a copy of the report is filed in the individual's medical record. Source Note: The provisions of this §415.305 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective February 4, 2004, 29 TexReg 999; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.305 Procedures and Requirements for All Review Boards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152166&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152166 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152166&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152166 03/11/2026 (a) The individual and LAR have the right to represent themselves at the hearing or to be represented by a spokesperson of their choice.(b) The individual and LAR and their spokesperson(s) have the right to:(1) be present at the hearing; and(2) examine before the date of the hearing:(A) the hearing documentation referenced as §415.307(3)(A) of this title (relating to Procedures and Requirements Specific to a Facility Review Board) unless an exception exists as provided by §415.307(3)(B) of this title; or(B) the hearing documentation referenced as §415.310(4)(A) of this title (relating to Procedures and Requirements Specific to the DSHS Dangerousness Review Board).(c) The individual and LAR or their spokesperson(s) have the right to:(1) present witnesses on the individual's behalf;(2) present evidence and establish all pertinent facts and circumstances;(3) present an argument on any issue involved;(4) cross-examine witnesses; and(5) respond to or refute any testimony or evidence.(d) The individual and LAR have the right to have each witness provide his/her testimony without other witnesses being present as described in §415.305(g)(4) of this title (relating to Procedures and Requirements for All Review Boards). Source Note: The provisions of this §415.306 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.306 Rights of the Individual https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152167&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152167 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152167&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152167 03/11/2026 If the facility CEO has reason to believe that a person receiving services in the facility may be manifestly dangerous and in need of transfer to the MSU/SAU, then the facility CEO may convene the facility review board to conduct a hearing to determine whether the person is manifestly dangerous in accordance with this section.(1) Convening the board. The facility CEO will inform the chair of the facility review board of the need to convene the board. The chair will impanel a review board in accordance with §415.305(e) of this title (relating to Procedures and Requirements for All Review Boards) and identify the time and location of the hearing. The chair will serve as one of the five members unless the chair is disqualified as described in §415.305(d) of this title. If the chair is disqualified, then the chair will appoint one of the five impaneled members to act as chair for the hearing.(2) Notice and statement(s). The facility CEO will provide notice of the hearing and receive statement(s) in accordance with this paragraph.(A) Notice. At least three days before the hearing, the facility CEO will complete the Notice of Hearing by Facility Review Board, referenced in §415.314 of this title (relating to Notice of Hearing Forms), and deliver it to the individual and LAR, if any, for signature.(i) The facility CEO must ensure that the content of the notice is communicated in a language and format likely to be understandable to the recipient(s) and initiating a discussion with the individual and LAR regarding the right to be represented by a spokesperson. If the individual or LAR requests a spokesperson, then the CEO will assist him/her with identifying and securing a spokesperson. If an individual who lacks capacity does not request a spokesperson, then the CEO will make a reasonable effort to identify and secure a spokesperson. If the CEO is unable to secure a spokesperson, then the facility rights protection officer will serve as the individual's spokesperson to ensure the individual's rights are protected during the hearing.(ii) The facility CEO will provide a copy of the signed notice to the individual, LAR, and spokesperson(s) and will file a copy of the signed notice in the individual's medical record.(B) Statement(s). At least three days before the hearing, the facility CEO will provide the individual and LAR with an opportunity to submit a statement concerning the possible manifest dangerousness of the individual. The CEO will offer assistance to the individual or LAR in preparing a statement, and will provide assistance if requested. The individual or LAR may decline to submit a statement.(3) Hearing documentation.(A) At least one day before the hearing the facility CEO will ensure the following documentation is distributed to each impaneled review board member, the individual, LAR, and spokesperson(s):(i) a written summary, prepared by the individual's treatment team, of all pertinent background information, including:(I) a legal history, including current legal status;(II) a clinical history and assessments, including identified strengths that may contribute to success in treatment;(III) a chronology of aggressive behaviors with emphasis upon those that have occurred since the last admission;(IV) the treatment interventions used to address the aggressive behaviors and behavioral responses of the individual to the interventions;(V) an assessment of risk for manifest dangerousness, including the results of any applicable standardized assessment tools; and(VI) a description of the alleged behavior or incident believed to indicate manifest dangerousness and the rationale for making the individual the subject of a hearing;(ii) statement(s) from the individual and LAR, as described in paragraph (2)(B) of this section, if submitted; and(iii) any other pertinent information considered appropriate by the individual's treatment team.(B) The hearing will not be delayed solely as a result of the hearing documentation not being received by the LAR or spokesperson(s) if a reasonable effort was made to deliver the documentation and the facility CEO determines that the safety of the individual and others will be compromised by delaying the hearing.(4) Hearing, deliberations, and determination. The chair will ensure the hearing, deliberations, and determination are conducted in accordance with §415.305(g) - (i) of this title.(5) Action taken upon determination.(A) Notification. Within 24 hours after the facility review board's determination, the facility CEO will provide written notification to the individual, LAR, and spokesperson(s) of:(i) the facility review board's determination; and(ii) if the review board determines that the individual is manifestly dangerous, the right of the individual or LAR to appeal the determination and the procedures for requesting an appeal as described in §415.309 of this title (relating to Appealing a Facility Review Board's Determination of Manifest Dangerousness).(B) Determined manifestly dangerous.(i) If the facility review board determines that an individual is manifestly dangerous, then the facility CEO will ensure compliance with §415.308 of this title (relating to Transfer of an Individual to the MSU/SAU).(ii) If, prior to being transferred to the MSU/SAU, the facility CEO believes that the individual is no longer manifestly dangerous, then the CEO must reconvene the facility review board to conduct another hearing in accordance with paragraphs (1) - (4) of this section. Transfer of the individual to the MSU/SAU is stayed pending the hearing.(C) Determined not manifestly dangerous. If the facility review board determines that an individual is not manifestly dangerous, then the individual will remain at the facility. The facility CEO may not convene the facility review board to conduct another hearing to determine whether the individual is manifestly dangerous unless the CEO has reason to believe that there has been sufficient change in the individual's condition to indicate that the individual may be manifestly dangerous. Source Note: The provisions of this §415.307 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.307 Procedures and Requirements Specific to a Facility Review Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152171&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152171 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152171&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152171 03/11/2026 (a) Prior to the transfer of an individual who has been determined manifestly dangerous by a facility review board, the facility CEO will ensure:(1) the hearing documentation described in §415.307(3)(A) of this title (relating to Procedures and Requirements Specific to a Facility Review Board) is submitted to the MSU/SAU CEO; and(2) the individual's treating physician communicates with the MSU/SAU physician who will treat the individual regarding the characteristics of the individual. The individual's treating physician may communicate with another physician at the MSU/SAU if the other physician at the MSU/SAU is the designee of MSU/SAU physician who will treat the individual.(b) The facility is responsible for the individual's transportation to the MSU/SAU, which will occur as soon as clinically and practicably feasible.(c) The facility CEO will ensure the following are informed of the individual's transfer to the MSU/SAU when it occurs:(1) the committing court;(2) the individual's LAR, if any; and(3) the local authority that serves the individual's county of residence. Source Note: The provisions of this §415.308 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.308 Transfer of an Individual to the MSU/SAU https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152172&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152172 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152172&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152172 03/11/2026 The individual, LAR, or facility CEO may appeal a facility review board's determination that the individual is manifestly dangerous on the grounds that the determination was substantively flawed or on the grounds that the determination was affected by an error in a procedure specified in this subchapter. Transfer of the individual to the MSU/SAU is not stayed pending appeal.(1) A request for an appeal from the individual or LAR must be in writing and received by the facility CEO within 10 days after receipt of the written report as described in §415.305(j) of this title (relating to Procedures and Requirements for All Review Boards). The request must include:(A) the reason(s) why the requestor believes the review board's determination was substantively flawed; or(B) the reason(s) why the requestor believes the review board's determination was affected by an alleged procedural error, including a description of the procedure specified in this subchapter and the alleged error.(2) If the facility CEO believes that the determination was substantively flawed or that a procedural error may have affected the determination or if the CEO agrees with the person who requested an appeal that the determination was substantively flawed or that a procedural error may have affected the determination, then the facility CEO will convene the facility review board to conduct a new hearing in accordance with §415.307(1) - (4) of this title (relating to Procedures and Requirements Specific to a Facility Review Board), except that the facility review board members who were impaneled for the original hearing may not be impaneled on the facility review board that convenes for the new hearing. If the individual has already been transferred to the MSU/SAU, then the facility is responsible for returning the individual to the facility for the new hearing. A determination that the individual is manifestly dangerous by the facility review board in accordance with this paragraph may not be appealed.(3) If the facility CEO does not agree with the person who requested an appeal that the determination was substantively flawed or that a procedural error may have affected the determination, then the facility CEO will notify the person in writing that the appeal has been denied. Source Note: The provisions of this §415.309 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.309 Appealing a Facility Review Board's Determination of Manifest Dangerousness https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152173&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152173 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152173&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152173 03/11/2026 The DSHS Dangerousness Review Board must convene at least once every month in accordance with this section.(1) Schedule of hearings. The DSHS Dangerousness Review Board chair, in consultation with the MSU/SAU CEO, is responsible for scheduling hearings in accordance with this paragraph.(A) Initial hearing.(i) A hearing for an individual committed to the MSU/SAU under the Texas Code of Criminal Procedure must be scheduled to occur on such a date so as to ensure the individual, if determined not manifestly dangerous, will be transferred from the MSU/SAU within 60 days after arrival at the MSU/SAU, as required by the Texas Code of Criminal Procedure, Article 46B.105 or 46C.260.(ii) A hearing for an individual transferred to the MSU/SAU from a facility must be scheduled within 60 days after transfer.(B) Regularly scheduled hearing(s). If an individual is determined manifestly dangerous at the initial hearing, then another hearing must be scheduled no later than six months after the initial hearing. If the individual continues to be determined manifestly dangerous, then another hearing must be scheduled no later than every six months after the previous hearing for as long as the individual remains at the MSU/SAU.(C) Hearings scheduled upon request.(i) If, between regularly scheduled hearings, an individual's treating physician or treatment team determines that there has been sufficient change in the individual's condition to indicate that the individual may no longer be manifestly dangerous, then the physician or team will request that a hearing be scheduled. The request must be in writing, submitted to the MSU/SAU CEO, and include the individual's name, the reason(s) for the request, and supporting documentation.(I) If the MSU/SAU CEO concurs with the request, then a hearing must be scheduled for the next convening date of the board that will enable adequate notice as described in paragraph (3) of this section.(II) If the MSU/SAU CEO does not concur with the request, then the CEO will notify the physician or team that the request has been denied.(ii) If, between regularly scheduled hearings, an independent evaluator (as defined) determines that there is sufficient evidence that the individual may no longer be manifestly dangerous, then the individual or LAR may request that a hearing be scheduled. The request must be in writing, submitted to the MSU/SAU CEO, and include the individual's name, the reason(s) for the request, and supporting documentation.(I) If the MSU/SAU CEO concurs with the request, then a hearing must be scheduled for the next convening date of the board that will enable adequate notice as described in paragraph (3) of this section.(II) If the MSU/SAU CEO does not concur with the request, then the CEO will notify the individual or LAR that the request has been denied.(2) Convening the board. The chair will convene the review board by impaneling review board members for each hearing that is scheduled for the convening date in accordance with §415.305(e) of this title (relating to Procedures and Requirements for All Review Boards). If the chair does not select him/herself to serve as one of the five members for a hearing, then the chair will appoint one of the five impaneled members to act as chair for the hearing.(3) Notice and statement(s). The MSU/SAU CEO will provide notice of a hearing and receive statement(s) in accordance with this paragraph.(A) Notice. At least 10 days before the hearing, the MSU/SAU CEO will complete the Notice of Hearing by DSHS Dangerousness Review Board, referenced in §415.314 of this title (relating to Notice of Hearing Forms), and deliver it to the individual and LAR, if any, for signature.(i) The MSU/SAU CEO must ensure that the content of the notice is communicated in a language and format likely to be understandable to the recipient(s) and initiating a discussion with the individual and LAR regarding the right to be represented by a spokesperson. If the individual or LAR requests a spokesperson, then the CEO will assist him/her with identifying and securing a spokesperson. If an individual who lacks capacity does not request a spokesperson, then the CEO will make a reasonable effort to identify and secure a spokesperson. If the CEO is unable to secure a spokesperson, then the facility rights protection officer will serve as the individual's spokesperson to ensure the individual's rights are protected during the hearing.(ii) The MSU/SAU CEO will provide a copy of the signed notice to the individual, LAR, and spokesperson(s) and will file a copy of the signed notice in the individual's medical record.(B) Statement(s). At least 10 days before the hearing, the MSU/SAU CEO will provide the individual and LAR with an opportunity to submit a statement concerning the possible manifest dangerousness of the individual. The CEO will offer assistance to the individual or LAR in preparing a statement, and will provide assistance if requested. The individual or LAR may decline to submit a statement.(4) Hearing documentation.(A) At least seven days before the hearing the MSU/SAU CEO will ensure the following documentation is distributed to each review board member impaneled for the hearing, the individual, LAR, and spokesperson(s):(i) a written summary, prepared by the individual's MSU/SAU treatment team, of all pertinent background information, including:(I) a legal history, including current legal status;(II) a clinical history and assessments, including identified strengths that may contribute to success in treatment;(III) a chronology of aggressive behaviors with emphasis upon those that have occurred since the last admission;(IV) the treatment interventions used to address the aggressive behaviors and behavioral responses of the individual to the interventions;(V) an assessment of risk for manifest dangerousness, including the results of any applicable standardized assessment tools; and(VI) a description of the behavior or incident that resulted in the individual's transfer or commitment to the MSU/SAU;(ii) statement(s) from the individual and LAR, as described in paragraph (3)(B) of this section, if submitted;(iii) if an independent evaluator requested the hearing, the request, including the reason(s) for the request and the supporting documentation; and(iv) any other pertinent information considered appropriate by the individual's MSU/SAU treatment team.(B) Any additional relevant documentation that becomes available after the hearing documentation has been distributed shall be submitted to the MSU/SAU CEO. The CEO will ensure the chair receives a copy of the additional documentation as soon as possible before the hearing.(C) With the approval of the chair, the individual or LAR may agree to receive the hearing documentation less than seven days before the hearing.(5) Preparing for possible transfer from the MSU/SAU. At least seven days prior to the hearing, the MSU/SAU CEO must ensure:(A) that a copy of the hearing documentation (referenced in paragraph (4)(A) of this section), is sent to the receiving facility CEO; and(B) that the individual's MSU/SAU treating physician consults with a physician at the identified receiving facility regarding the individual's characteristics, including those with implications for risk management, to facilitate the development of an appropriate risk management plan by the receiving facility.(6) Hearing, deliberations, and determination. The chair will ensure the hearing, deliberations, and determination are conducted in accordance with §415.305(g) - (i) of this title (relating to Procedures and Requirements for All Review Boards).(7) Action taken upon determination.(A) Notification. Within 24 hours after the DSHS Dangerousness Review Board's determination, the MSU/SAU CEO will provide written notification to the individual, LAR, and spokesperson(s) of:(i) the review board's determination; and(ii) the right of the individual or LAR to request that the MSU/SAU CEO refer the matter to the commissioner and the procedures for requesting a referral as described in §415.311 of this title (relating to Disagreement with DSHS Dangerousness Review Board Determination and Referral to Commissioner) if the individual or LAR disagrees with the determination.(B) Determined manifestly dangerous. If the DSHS Dangerousness Review Board determines that an individual is manifestly dangerous, then the individual will remain at the MSU/SAU. A subsequent hearing will be scheduled for the individual in accordance with paragraph (1) of this section.(C) Determined not manifestly dangerous. If the DSHS Dangerousness Review Board determines that an individual is not manifestly dangerous, then the MSU/SAU CEO will:(i) notify the receiving facility CEO of the determination; and(ii) ensure compliance with §415.312 of this title (relating to Transferring an Individual from the MSU/SAU).(D) New hearing. The DSHS Dangerousness Review Board may conduct a new hearing at any time upon request by the MSU/SAU CEO or upon its own motion. The new hearing must be conducted in accordance with paragraphs (2) - (6) of this section. Source Note: The provisions of this §415.310 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.310 Procedures and Requirements Specific to the DSHS Dangerousness Review Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152174&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152174 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152174&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152174 03/11/2026 (a) If the MSU/SAU CEO disagrees with the DSHS Dangerousness Review Board's determination, then the CEO will refer the matter to the commissioner for resolution. The referral must be in writing and include the CEO's reason(s) for disagreeing with the determination and documentation supporting the reason(s). Transfer of the individual from the MSU/SAU is stayed pending resolution.(b) The commissioner will resolve the disagreement by deciding whether or not the individual is manifestly dangerous. The commissioner will inform the MSU/SAU CEO of the decision within 21 days after receipt of the referral.(c) If the individual, LAR, or treatment team member disagrees with the DSHS Dangerousness Review Board's determination, then he/she may request that the MSU/SAU CEO refer the matter to the commissioner for resolution. The request must be in writing and received by the CEO within five days after receipt of the written report as described in §415.305(j) of this title (relating to Procedures and Requirements for All Review Boards). The request must include the reason(s) for disagreeing with the determination and documentation supporting the reason(s). Upon receipt, the CEO will review the request and decide whether to refer the matter to the commissioner in accordance with subsection (a) of this section. Source Note: The provisions of this §415.311 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.311 Disagreement with DSHS Dangerousness Review Board Determination and Referral to Commissioner https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152175&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152175 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152175&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152175 03/11/2026 (a) An individual committed to the MSU/SAU pursuant to the Texas Code of Criminal Procedure, Article 46B or 46C, who has been determined not manifestly dangerous by the DSHS Dangerousness Review Board or the commissioner at the initial hearing (described in §415.310(1)(A)(i) of this title (relating to Procedures and Requirements Specific to the DSHS Dangerousness Review Board)) must be transferred from the MSU/SAU within 60 days following his/her arrival at the MSU/SAU.(b) In addition to the timeframe for transfer described in subsection (a) of this section, an individual must be transferred from the MSU/SAU within 14 days after being determined not manifestly dangerous by the DSHS Dangerousness Review Board or the commissioner.(c) As soon as possible after an individual has been determined not manifestly dangerous by the DSHS Dangerousness Review Board or the commissioner, the MSU/SAU staff will notify the committing court of the pending transfer.(d) Prior to the individual's transfer from the MSU/SAU, the MSU/SAU CEO will ensure that the hearing documentation described in §415.310(4)(A) of this title (relating to Procedures and Requirements Specific to the DSHS Dangerousness Review Board) becomes a part of the individual's medical record.(e) The MSU/SAU is responsible for the individual's transportation from the MSU/SAU to the receiving facility.(f) Upon completion of the transfer, the receiving facility must contact the committing court to establish communication between the receiving facility and the court (e.g., inform court of new contact concerning the individual).(g) The receiving facility CEO may not convene the facility review board to conduct a hearing to determine whether the individual is manifestly dangerous unless the CEO has reason to believe that there has been sufficient change in the individual's condition to indicate that the individual may be manifestly dangerous.(h) A continuing care plan for an individual who has received treatment at the MSU/SAU must include an assessment of risk for manifest dangerousness. Source Note: The provisions of this §415.312 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.312 Transferring an Individual from the MSU/SAU https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152176&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152176 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152176&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152176 03/11/2026 (a) Using a DSHS-approved orientation and training program:(1) the chair of each review board is responsible for providing initial orientation to each mental health professional appointed in the pool from which the chair selects review board members; and(2) the MSU/SAU CEO and the chair of the DSHS Dangerousness Review Board are responsible for conducting annual training for all mental health professionals appointed in all pools.(b) Each mental health professional appointed in a pool is responsible for:(1) maintaining a current professional license;(2) preparing for and attending each review board hearing for which the professional is impaneled;(3) immediately informing the chair of the review board of any disqualifying factor as described in §415.305(d) of this title (relating to Procedures and Requirements for All Review Boards);(4) attending initial orientation and annual training;(5) being knowledgeable about current clinical and scientific information relevant to the assessment, management, and treatment of risk for manifest dangerousness and determination of manifest dangerousness; and(6) complying with this subchapter.(c) On an annual basis, each facility CEO will evaluate the performance of the mental health professionals employed at the facility who are appointed to a pool. In order to remain in a pool, a professional must achieve a rating of at least competent in his/her performance of the work behaviors described in subsection (b) of this section.(d) The commissioner may waive for emergent or special circumstances, as minimally necessary to assure the efficient operation of a review board, the responsibility for a mental health professional appointed to a pool to annual training. There is no waiver of the requirement to attend initial orientation. Source Note: The provisions of this §415.313 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.313 Competency of Review Board Members https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152177&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152177 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152177&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152177 03/11/2026 The following forms are referenced in this subchapter.(1) Notice of Hearing by Facility Review Board; andAttached Graphic(2) Notice of Hearing by DSHS Dangerousness Review Board.Attached Graphic Source Note: The provisions of this §415.314 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.314 Notice of Hearing Forms https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152178&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152178 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=152178&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 152178 03/11/2026 Reference is made to the following statutes:(1) Texas Health and Safety Code, §533.035(a) and §574.022; and(2) Texas Code of Criminal Procedure, Articles 46B and 46C. Source Note: The provisions of this §415.315 adopted to be effective July 17, 2002, 27 TexReg 6297; amended to be effective July 19, 2011, 36 TexReg 4567. 1 DEPARTMENT OF STATE HEALTH SERVICES 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES G DETERMINATION OF MANIFEST DANGEROUSNESS §415.315 References https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194012 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194012 03/11/2026 The purpose of this subchapter is to establish standards for volunteer programs associated with facilities and for donations made by private individuals to facilities and persons served. Source Note: The provisions of this §417.301 adopted to be effective April 24, 2008, 33 TexReg 3292; amended to be effective February 6, 2019, 44 TexReg 478. 1 DEPARTMENT OF STATE HEALTH SERVICES 417 AGENCY AND FACILITY RESPONSIBILITIES G VOLUNTEER AND COMMUNITY ENGAGEMENT §417.301 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194013&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194013 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194013&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194013 03/11/2026 This subchapter applies to an individual or group volunteering at or donating to a facility, other than an individual employed by the department. Employees who wish to volunteer with a facility should consult department policy and guidelines. Source Note: The provisions of this §417.302 adopted to be effective February 6, 2019, 44 TexReg 478. 1 DEPARTMENT OF STATE HEALTH SERVICES 417 AGENCY AND FACILITY RESPONSIBILITIES G VOLUNTEER AND COMMUNITY ENGAGEMENT §417.302 Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194014 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194014 03/11/2026 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.(1) 501(c)(3) organization--An organization exempt from taxation under §501(c)(3) of the Internal Revenue Code.(2) Community relations director--The employee responsible for coordinating community relations functions, volunteer programs, fund-raising, and donations at a facility.(3) Department--The Department of State Health Services.(4) Donation--A contribution of anything of value (for example, funds or in-kind goods and services) freely given to a facility, an individual served, or a private organization. The term does not include funding under a federal, state, private, or non-profit organization grant for which a facility has submitted a formal written application and is subject to an agreement between the recipient and the donor relating to the use of the grant.(5) Employee--An individual who is legally employed or contracted to perform work for the department.(6) Facility--A public health facility operated by the Department of State Health Services.(7) Person served--A person receiving services from a facility.(8) Private donor--A person or private organization that makes a donation to a facility directly or through a volunteer services council.(9) Volunteer and Community Relations Unit--Facility employees responsible for promoting individual and community awareness, volunteerism, community collaborations, and partnerships.(10) Volunteer Services Council (VSC)--A 501(c)(3) volunteer organization formed to generate resources for the benefit of a facility and persons served. Source Note: The provisions of this §417.303 adopted to be effective April 24, 2008, 33 TexReg 3292; amended to be effective February 6, 2019, 44 TexReg 478. 1 DEPARTMENT OF STATE HEALTH SERVICES 417 AGENCY AND FACILITY RESPONSIBILITIES G VOLUNTEER AND COMMUNITY ENGAGEMENT §417.303 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194015 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194015 03/11/2026 (a) A facility may not accept a donation from a person who is a party to a contested case before the department or the Texas Health and Human Services Commission until the 30th day after the date the decision in the case becomes final. "Contested case" has the meaning assigned by Texas Government Code, §2001.003.(b) A private donor must not use an employee of the department or department property except under a contract with the department or with approval of the head of the facility. Source Note: The provisions of this §417.305 adopted to be effective April 24, 2008, 33 TexReg 3292; amended to be effective February 6, 2019, 44 TexReg 478. 1 DEPARTMENT OF STATE HEALTH SERVICES 417 AGENCY AND FACILITY RESPONSIBILITIES G VOLUNTEER AND COMMUNITY ENGAGEMENT §417.305 Limitations on Private Donations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194016 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194016 03/11/2026 (a) A VSC may generate resources to enhance the lives of the persons served at a facility.(b) The community relations director and volunteer and community relations unit may work with the VSC to enhance fund-raising activities.(c) The head of the facility and community relations director are nonvoting members of the VSC board and executive committee.(d) The community relations unit may process and issue receipts for donations to the VSC.(e) No employee may sign a VSC check or use a VSC debit or credit card.(f) The volunteer and community relations unit may maintain a VSC petty cash fund of up to $300.00 to be used for the benefit of persons served by a facility.(1) The community relations director may make expenditures of up to $300.00 from the petty cash fund on behalf of the VSC for the benefit of persons served.(2) The community relations director must appoint a primary and alternate custodian for the VSC petty cash fund.(3) The primary custodian of the petty cash fund is responsible for maintaining receipts and accurate documentation of all funds disbursed and for furnishing this documentation to the treasurer of the VSC.(4) An officer of the VSC, or an employee outside of the community relations unit, must reconcile the petty cash fund at least once every two months.(g) A facility may provide items of support for the VSC, such as:(1) office space;(2) fund-raising assistance;(3) clerical and administrative services;(4) assistance in the coordination of activities; or(5) other items or services requested by the VSC upon approval by the head of the facility.(h) Funds generated by a VSC may only be used for:(1) the needs of persons served by the facility;(2) the enhancement of existing facility operations;(3) recognition and education projects;(4) new initiatives to improve the quality of life for persons served by the facility; and(5) other expenses specifically authorized by the VSC board of directors.(i) The VSC must not use funds or reference the facility's name or branding for:(1) recognition events, receptions, or gifts for a legislator;(2) political contributions, political advertisements, or lobbying efforts;(3) alcoholic beverages, unless used at an off-campus fund-raising event;(4) loans, including travel advances;(5) operating programs, or contracting for programs on behalf of the facility;(6) cash awards or salary supplementation for employees; and(7) other purposes determined by the department to be unethical, unlawful, or inappropriate.(j) All funds and goods donated to the VSC remain the property of the VSC until the facility accepts them.(k) The department has the right to review and approve all VSC donations of real property and any permanent improvements to existing real property that may be donated to the facility by the VSC. Source Note: The provisions of this §417.306 adopted to be effective April 24, 2008, 33 TexReg 3292; amended to be effective February 6, 2019, 44 TexReg 478. 1 DEPARTMENT OF STATE HEALTH SERVICES 417 AGENCY AND FACILITY RESPONSIBILITIES G VOLUNTEER AND COMMUNITY ENGAGEMENT §417.306 Volunteer Services Council https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193963&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193963 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193963&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193963 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Accurate and Consistent data--Data that has been edited by DSHS and subjected to provider validation and certification.(2) ANSI 837 Institutional Guide--American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Institutional Claim Implementation Guide.(3) Attending Physician--The individual licensed under the Medical Practice Act (Occupations Code, Chapter 151) who would normally be expected to certify and recertify the medical necessity of the services rendered or the licensed health professional primarily responsible for the care of the patient during the hospital episode. For Skilled Nursing Facility (SNF) services, the attending physician is the individual who certifies the SNF plan of care.(4) Certification Process--The process by which a provider confirms the accuracy and completeness of the encounter data set required to produce the public use data file as specified in §421.7 of this title (relating to Certification of Discharge Reports).(5) Charge--The amount billed by a provider for specific procedures or services provided to a patient before any adjustment for contractual allowances, government mandated fee schedules or write-offs for charity care, bad debt or administrative courtesy. The term does not include co-payments charged to health maintenance organization enrollees by providers paid by capitation or salary in a health maintenance organization.(6) Comments--The notes or explanations submitted by the hospitals, physicians or other health professionals concerning the provider quality reports or the encounter data for public use as described in the Texas Health and Safety Code, §108.010(c) and (e) and §108.011(g) respectively.(7) Data format--The sequence or location of data elements in an electronic record according to prescribed specifications.(8) DSHS--Department of State Health Services.(9) Discharge--The formal release of a patient by a hospital; that is, the termination of a period of hospitalization by death or by disposition to a residence or another health care provider.(10) Discharge claim--A set of computer records as specified in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) relating to a specific patient. "Discharge claim" corresponds to the ANSI 837 Institutional Guide term, "Transaction set."(11) Discharge report--A computer file as defined in §421.9 of this title periodically submitted on or on behalf of a Hospital in compliance with the provisions of this chapter. "Discharge report" corresponds to the ANSI 837 Institutional Guide terms, "Communication Envelope" or "Interchange Envelope."(12) DRG--Diagnosis Related Group.(13) EDI--Electronic Data Interchange--A method of sending data electronically from one computer to another. EDI helps providers and payers maintain a flow of vital information by enabling the transmission of claims and managed care transactions.(14) Edit--An electronic standardized process developed and implemented by DSHS to identify potential errors and mistakes in data elements by reviewing data fields for the presence or absence of data and the accuracy and appropriateness of data.(15) Electronic filing--The submission of computer records in machine readable form by modem transfer from one computer to another (EDI) or by recording the records on a nine track magnetic tape, computer diskette or other portable data storage media acceptable to the executive director.(16) Error--Data submitted on a discharge report which are not consistent with the format and data standards contained in this section or with editing criteria established by the executive director, or the failure to submit required data.(17) Ethnicity--The status of patients relative to Hispanic background. Hospitals shall report this data element according to the following ethnic types: Hispanic or Non-Hispanic.(18) Facility Type Indicators--An indicator that provides information to the data user as to the type of facility or the primary health services delivered at that facility (e.g., Teaching, Acute Care, Rehabilitation, Psychiatric, Pediatric, Cancer, Skilled Nursing, Long Term Acute Care or other Long Term Care Facility). A facility may have more than one indicator. Hospitals may request updates to this field.(19) Geographic identifiers--A set of codes indicating the public health region and county in which the patient resides.(20) HCPCS--HCFA's Common Procedure Coding System (HCFA - Health Care Finance Administrations (Now called Centers for Medicare and Medicaid Services)).(21) Health care facility--A hospital, an ambulatory surgery center licensed under Chapter 243 of the Health and Safety Code, a chemical dependency treatment facility licensed under Chapter 464 of the Health and Safety Code, a renal dialysis center, a birthing center, a rural health clinic or a federally qualified health center as defined by 42 United States Code, §1396(1)(2)(B).(22) HIPPS--Health Insurance Prospective Payment System.(23) Hospital--A public, for-profit, or nonprofit institution licensed or owned by this state that is a general or special hospital, private mental hospital, chronic disease hospital or other type of hospital.(24) ICD--International Classification of Disease.(25) Inpatient--A patient, including a newborn infant, who is formally admitted to the inpatient service of a hospital and who is subsequently discharged, regardless of status or disposition. Inpatients include patients admitted to medical/surgical, intensive care, nursery, subacute, skilled nursing, long-term, psychiatric, substance abuse, physical rehabilitation and all other types of hospital units.(26) Institutional Review Board--DSHS' appointees or agent who have experience and expertise in ethics, patient confidentiality, and health care data who review and approve or disapprove requests for data or information other than the public use data as described in §421.46 of this title (relating to Institutional Review Board).(27) Operating or Other Physician--The "physician" licensed by the Texas Medical Board, or "other health professional" licensed by the State of Texas who performed the principal procedure or performed the surgical procedure most closely related to the principal diagnosis.(28) Other exempted provider--A hospital exempt from state franchise, sales, ad valorem, or other state and local taxes that does not seek or receive reimbursement for providing health care services to patients from any source, including the patient or any person legally obligated to support the patient; a third party payer; or Medicaid, Medicare, or any other federal, state or local program for indigent health care.(29) Other health professional--A person licensed to provide health care services other than a physician. An individual other than a physician who admits patients to hospitals or who provides diagnostic or therapeutic procedures to inpatients. The term encompasses persons licensed under various Texas practice statutes, such as psychologists, chiropractors, dentists, nurse practitioners, nurse midwives, and podiatrists who are authorized by the hospital to admit or treat patients.(30) Patient account number--A number assigned to each patient by the hospital, which appears on each computer record in a patient discharge claim. This number is not consistent for a given patient from one hospital to the next, or from one admission to the next in the same hospital. DSHS deletes or encrypts this number to protect patient confidentiality prior to release of data.(31) Physician--An individual licensed under the laws of this state to practice medicine under the Medical Practice Act, Occupations Code, Chapter 151.(32) Present on admission (POA)--Diagnosis present on admission.(33) Provider--A physician or health care facility.(34) Provider quality data--A report or reports authored by DSHS on provider quality or outcomes of care, as defined in Health and Safety Code, Chapter 108, created from data collected by DSHS or obtained from other sources.(35) Public use data file--A data file composed of discharge claims with risk and severity adjustment scores which have been altered by the deletion, encryption or other modification of data fields to protect patient and physician confidentiality and to satisfy other restrictions on the release of hospital discharge data imposed by statute.(36) Race--A division of patients according to traits that are transmissible by descent and sufficient to characterize them as distinctly human types. Hospitals shall report this data element according to the following racial types: American Indian, Eskimo, or Aleut; Asian or Pacific Islander; Black; White; or Other.(37) Required minimum data set--The list of data elements which hospitals are required to submit in a discharge claim for each inpatient stay in the hospital. The required minimum data set is specified in §421.9(d) of this title. This list does not include the data elements that are required by the ANSI 837 Institutional Guide to submit an acceptable discharge report. For example: Interchange Control Headers and Trailers, Functional Group Headers and Trailers, Transaction Set Headers and Trailers and Qualifying Codes (which identify which qualify as subsequent data elements).(38) Research data file--A customized data file, which includes the data elements in the public use file and may include data elements other than the required minimum data set submitted to DSHS, except those data elements that could reasonably identify a patient or physician. The data elements may be released to a requestor when the requirements specified in §421.8 of this title (relating to Hospital Discharge Data Creation) are completed.(39) Risk adjustment--A statistical method to account for a patient's severity of illness at the time of admission and the likelihood of development of a disease or outcome, prior to any medical intervention.(40) Service Unit Indicator--An indicator derived from submitted data (based on Bill type or Revenue Codes) and represents the type of service unit or units (e.g., Coronary Care Unit, Detoxification Unit, Intensive Care Unit, Hospice Unit, Nursery, Obstetric Unit, Oncology Unit, Pediatric Unit, Psychiatric Unit, Rehabilitation Unit, Sub acute Care Unit or Skilled Nursing Unit) where the patient received treatment.(41) Severity adjustment--A method to stratify patient groups by degrees of illness and mortality.(42) Submission--The transfer of a set of computer records as specified in §421.9 of this title that constitutes the discharge report for one or more hospitals.(43) Submitter--The person or organization, which physically prepares discharge reports for one or more hospitals and submits them to DSHS. A submitter may be a hospital or an agent designated by a hospital or its owner.(44) THCIC Identification Number--A string of six characters assigned by DSHS to identify health care facilities for reporting and tracking purposes.(45) Uniform facility identifier--A unique number assigned by DSHS to each health care facility licensed in the state. For hospitals, this will include the hospital's state license number. For hospitals operating multiple facilities under one license number and duplicating services, DSHS will assign a distinguishable uniform facility identifier for each separate facility. The relationship between facility identifier and the name and license number of the facility is public information.(46) Uniform patient identifier--A unique identifier assigned by DSHS to an individual patient and composed of numeric, alpha, or alphanumeric characters, which remains constant across hospitals and inpatient admissions. The relationship of the identifier to the patient-specific data elements used to assign it is confidential.(47) Uniform physician identifier--A unique identifier assigned by DSHS to a physician or other health professional who is reported as attending or treating a hospital inpatient and which remains constant across hospitals. The relationship of the identifier to the physician-specific data elements used to assign it is confidential. The uniform physician identifier shall consist of alphanumeric characters.(48) Validation--The process by which a provider verifies the accuracy and completeness of data and corrects any errors identified before certification. Source Note: The provisions of this §421.1 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective December 29, 1997, 22 TexReg 12494; amended to be effective December 24, 2000, 25 TexReg 12430; amended to be effective July 29, 2001, 26 TexReg 5408; amended to be effective April 21, 2002, 27 TexReg 3183; amended to be effective July 6, 2003, 28 TexReg 4915; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effective January 9, 2011, 35 TexReg 9743; amended to be effective December 18,2014,39TexReg 7582; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.1 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193964&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193964 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193964&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193964 03/11/2026 (a) All hospitals in operation for all or any of the reporting periods described in §421.3 of this title (relating to Schedule for Filing Discharge Reports) shall submit discharge claims as specified in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) on all discharged inpatients to DSHS. To the extent the admission, treatment, or discharge is made by a health professional, other than a physician, data elements specified in §421.9(d)(36) - (41) of this title shall be filled accordingly or data elements (38) or (41) shall be marked with one of DSHS approved temporary "Physician" or "Other health professional" code numbers and data elements (36)(A) - (C) or (39)(A) - (C) may be left blank. Hospitals owned by the federal government and hospitals exempted may submit hospital discharge claim. (b) All inpatient discharges shall be reported. Except as noted in paragraphs (1) - (4) of this subsection, one or more discharge claims shall be submitted for each patient for each discharge covering all services and charges from admission through discharge. (1) Separate discharge claims shall be submitted for mothers and newborns. (2) Hospitals shall either submit separate discharge claims corresponding to each interim, revised, or final discharge claims or submit a single consolidated final discharge claim for each discharged patient. (3) For all patients for which the hospital prepares one or more bills for inpatient services, the hospital shall submit a discharge claim corresponding to each bill containing the data elements required by §421.9 of this title. For all patients for which the hospital does not prepare a bill for inpatient services, the hospital shall submit a discharge claim containing the required minimum data set.(4) For all patients that are covered by 42 USC §290dd-2 and 42 CFR Part 2.1, a hospital shall submit a discharge claim containing the required data elements specified by §421.9 of this title. The hospital shall replace the patient identifying information with the default values specified in §421.9(f) of this title or submit the patient identifying information if release of patient identifying information is authorized in writing by the patient or patient's guardian. (c) All hospitals shall file discharge reports by electronic filing unless the hospital receives an exemption letter from DSHS. (d) All hospitals shall submit discharge claims and discharge reports in the format specified in §421.9 of this title.(e) Hospitals shall submit discharge reports, data certifications, exemption requests and other required information to DSHS or its contractors at physical or telephonic addresses specified by DSHS. DSHS shall notify all hospitals and submitters in writing and by publication in the Texas Register at least 30 calendar days before any change in the addresses. (f) Hospitals may submit discharge reports, or may designate an agent to submit the reports. If a hospital designates an agent, it shall inform DSHS of the designation in writing at least 30 calendar days prior to the agent's submission of any discharge report. The hospital shall inform DSHS in writing at least 30 calendar days prior to changing agents or making the submissions itself. Designation of an agent does not relieve the hospital of responsibility for compliance with this chapter or other related law. (g) If requested by DSHS, a hospital shall provide DSHS access to, copies of and/or information from the hospital documents and records underlying and documenting the discharge reports submitted, as well as other patient related documentation deemed necessary to audit hospital data to verify its accuracy and reliability. Each request from DSHS shall detail the reasons for such request, provide the hospital with at least 14 calendar days advance notice, and ensure that confidentiality of patient records is maintained. Source Note: The provisions of this §421.2 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective December 29, 1997, 22 TexReg 12494; amended to be effective July 26, 1998, 23 TexReg 7365; amended to be effective February 21, 1999, 24 TexReg 948; amended to be effective July 29, 2001, 26 TexReg 5408; amended to be effective July 6, 2003, 28 TexReg 4915; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effective December 18, 2014, 39 TexReg 7582; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.2 Collection of Hospital Discharge Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193965&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193965 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193965&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193965 03/11/2026 (a) Hospitals shall file discharge reports according to the following schedule as shown in paragraphs (1) - (4) of this subsection unless a hospital has received an exemption letter from DSHS.(1) Each discharge report covering inpatient discharges occurring between January 1 and March 31, inclusive, shall be submitted no later than June 1 of the calendar year in which the discharge occurred.(2) Each discharge report covering inpatient discharges occurring between April 1 and June 30, inclusive, shall be submitted no later than September 1, of the calendar year in which the discharge occurred.(3) Each discharge report covering inpatient discharges occurring between July 1 and September 30, inclusive, shall be submitted no later than December 1 of the calendar year in which the discharge occurred.(4) Each discharge report covering inpatient discharges occurring between October 1 and December 31, inclusive, shall be submitted no later than March 1 of the year following the year in which the discharge occurred.(b) Extensions to processing due dates may be granted by DSHS for a maximum of ten working days in response to a written request signed by the hospital's chief executive officer. Requests must be in writing, must be received at least five working days prior to the due date and must be accompanied by adequate justification for the delay. Source Note: The provisions of this §421.3 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective July 29, 2001, 26 TexReg 5408; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.3 Schedule for Filing Discharge Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193966&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193966 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193966&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193966 03/11/2026 (a) Portable Data Storage Media. A discharge report may be filed on computer diskettes, USB flash drive, or other portable data storage media approved by DSHS. All discharges shall be reported using the same file and record formats specified in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) regardless of medium.(1) Media specifications are:(A) Optical Media: Devices or disc that uses digital optical disc data storage format, for example Compact Disc (CD) or Digital Video Disc (DVD): MS-DOS formatted; PC Text file (ASCII).(B) Universal Serial Bus (USB) flash drive: portable data memory device using flash memory with a USB interface.(C) Other electronic, magnetic or other portable data storage media: Discharge reports may be filed on other data storage media only with the prior written approval of DSHS. DSHS will not normally approve any medium which DSHS is not currently equipped to read.(2) Hospitals shall submit no more than one tape or two diskettes per submission, with the following external identification affixed as listed in subparagraphs (A) - (G) of this paragraph:(A) hospital name;(B) facility identifier (THCIC 6 digit identifier);(C) reporting period for discharges;(D) number of transaction sets;(E) tape density: 1600/6250 BPI (if applicable);(F) collating sequence for tapes (if applicable);(G) the description: "DISCHARGE DATA."(3) Data for more than one hospital may be submitted on a single tape if the submitter provides external identification items in subparagraphs (A) - (D) of this paragraph for each hospital.(4) In addition to the provisions of this section, DSHS shall document instructions for filing discharge reports on data storage media and shall make this documentation available to hospitals at no charge and to the public for the cost of reproduction. DSHS shall notify hospitals or their designated agents directly in writing at least 90 days in advance of any change in instructions for filing discharge reports on data storage media.(b) Electronic Data Interchange. Discharge reports may be filed by modem using electronic data interchange (EDI). All discharges shall be reported using the same file and record formats specified in §421.9 of this title regardless of the medium of transmission, unless the hospital has obtained an exemption authorized by §421.81 of this title (relating to Health Care Facilities Exemptions from Filing Requirements). DSHS shall document instructions for filing discharge reports by EDI and shall make this documentation available to hospitals at no charge and to the public for the cost of reproduction. DSHS shall notify hospitals and their designated agents directly in writing at least 90 days in advance of any change in instructions for filing discharge reports by EDI. DSHS' instructions shall follow Department of Information Resources standards for EDI. Source Note: The provisions of this §421.4 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective December 29, 1997, 22 TexReg 12494; amended to be effective July 6, 2003, 28 TexReg 4915; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.4 Instructions for Filing Discharge Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193967&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193967 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193967&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193967 03/11/2026 (a) To verify the accuracy of all discharge claims prior to public release, DSHS shall establish procedures for the review of all discharge reports to determine whether the report is acceptable, as required by Health and Safety Code, §108.011.(b) Upon receipt of a discharge report, DSHS shall determine if it satisfies minimum criteria for processing. If it does not, DSHS shall return the discharge report in the same submission format and media that is approved for that provider and state the deficiencies in writing within ten calendar days of receipt. The hospital shall resubmit the report within ten calendar days of notification by DSHS. A discharge report does not meet minimum standards for processing under the following circumstances as shown in paragraphs (1) - (3) of this subsection.(1) The physical media and labeling do not conform to the specifications in §421.4 of this title (relating to Instructions for Filing Discharge Reports).(2) The physical media are unreadable due to physical damage.(3) The file structure does not conform to the specifications in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes), unless the hospital has received a letter from DSHS authorizing filing in another format.(c) Correction of Errors.(1) DSHS shall review all discharge reports accepted for processing and will process all discharge claims against the editing criteria established by this section and by DSHS. Within 10 calendar days of receipt of an accepted discharge report, DSHS shall notify the hospital in detail of all errors detected in the discharge report.(2) Within 30 calendar days of receiving initial notice of errors in a discharge report, the hospital shall correct all discharge claims containing errors, add any discharge claims determined to be missing from the initial discharge report and resubmit the corrected and/or previously missing discharge claims. If the hospital disagrees with any identified error, the hospital may indicate that the discharge claim is as accurate as it can be or cannot be corrected. Each hospital shall submit such modified and/or additional discharge claims as may be required to allow the chief executive officer or the chief executive officer's designated agent to certify the quarterly discharge report as required by §421.7 of this title (relating to Certification of Discharge Reports). Corrections to a discharge report shall be submitted on approved media and formats as specified in §421.4 of this title and §421.9 of this title unless DSHS approves another medium or format.(3) Within ten calendar days of receiving corrections to a discharge report from a hospital, DSHS shall notify the hospital of any remaining errors. The hospital shall have ten calendar days from receipt of this notice to correct the errors noted or indicate why the data should be deemed acceptable and complete. This process may be repeated until the data is substantially accurate and the hospital is able to certify the discharge report as required by §421.7 of this title or the deadline for submitting corrections prior to certification is reached. Corrected data is required to be submitted on or before the following dates for the respective quarter's discharges; Quarter 1 - August 1, Quarter 2 - November 1, Quarter 3 - February 1, Quarter 4 - May 1. No individual hospitals will be granted extensions to the dates. DSHS may grant an extension to all hospitals when deemed necessary.(4) Discharge claims that have not been previously submitted shall be submitted prior to the deadline for the following quarter's data. Correction and certification of these previously missing or additional discharge claims for the prior calendar quarter shall be made according to the deadlines established for following quarter in which the data that is scheduled to be processed as specified in §421.3(a)(1) of this title (relating to the Schedule for Filing Discharge Reports), paragraph (3) of this subsection (relating to the Acceptance of Discharge Reports and Correction of Errors) and §421.7(b) and (d) of this title. Corrections to discharge claims previously submitted or that have a discharge date prior to calendar quarter immediately before the calendar quarter being processed scheduled will not be processed.(d) DSHS will document and DSHS will approve all acceptance and editing criteria utilized in reviewing discharge reports. If acceptance and editing criteria are incorporated into computer software, and if the software is the property of DSHS, DSHS will make copies of the portions of the software containing the criteria available on paper, magnetic, or other portable data storage media. DSHS shall make this information available to submitters without charge and to others for the cost of reproduction.(e) Failure to correct or comment on a discharge report which has been filed but contains errors or omissions, known to the hospital, within the due dates in §421.3 of this title is punishable by a civil penalty pursuant to Health and Safety Code, §108.014. Source Note: The provisions of this §421.6 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective December 29, 1997, 22 TexReg 12494; amended to be effective July 29, 2001, 26 TexReg 5408; amended to be effective April 21, 2002, 27 TexReg 3183; amended to be effective July 6, 2003, 28 TexReg 4915; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.6 Acceptance of Discharge Reports and Correction of Errors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193968&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193968 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193968&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193968 03/11/2026 (a) Within five months after the end of each reporting quarter, DSHS shall compile one or more electronic data files for each reporting hospital using all discharge claims received from each hospital. The file shall have one record for each patient discharged during the reporting quarter and one record for any patient discharged during one prior reporting quarter for whom additional discharge claims have been received. This file will include all data submitted by the hospital, which DSHS intends to use in the creation of the public use data file. The data files, including reports and any additional information returned to the hospital, allows the hospital to provide physicians and other health professionals the opportunity to review, request correction of, and comment on records of discharged patients for whom they are shown as "attending" or "operating or other." DSHS shall determine the format and medium in which the quarterly file will be delivered to hospitals.(b) The chief executive officer or chief executive officer's designated agent of each hospital shall indicate whether the hospital is certifying or not certifying the discharge encounter data specified in subsection (a) of this section, sign and return the form corresponding to the discharge report for each quarter using forms supplied by DSHS. The certification form may be signed by a person designated by the chief executive officer and acting as the officer's agent. Designation of an agent does not relieve the chief executive officer of personal responsibility for the certification. If the chief executive officer or chief executive officer's designated agent does not believe the quarterly file is accurate, the officer shall provide DSHS with detailed comments regarding the errors or submit a written request (on a form supplied by DSHS) and provide the data necessary to correct any inaccuracy and certify the file subject to those corrections being made prior to the deadlines specified in this subsection. Corrections to certification discharge data shall be submitted on or prior to the following schedule: Quarter 1- October 1; Quarter 2- January 1; Quarter 3- April 1; and Quarter 4- July 1. Chief Executive Officers or designees that elect not to certify shall submit a reasoned justification explaining their decision to not certify their discharge encounter data and attach the justification to the certification form. Election to not certify data does not prevent data from appearing in the public use data file. Data that is not corrected and submitted by the deadline may appear in the public use data file.(c) The signed certification form shall represent that:(1) policies and procedures are in place within the hospital's processes to validate and assure the accuracy of the discharge encounter data and any corrections submitted; and(2) all errors and omissions known to the hospital have been corrected or the hospital has submitted comments describing the errors and the reasons why they could not be corrected; and(3) to the best of their knowledge and belief, the data submitted accurately represents the hospital's administrative status of discharged inpatients for the reporting quarter; and(4) the hospital has provided physicians and other health professionals a reasonable opportunity to review and comment on the discharge data of patients for which they were reported in one of the available physician number and name fields provided on the acceptable formats specified in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) (for example, "attending physician" or "operating or other physician" as applicable). The physicians or other health professionals may write comments and have errors brought to the attention of the chief executive officer or the chief executive officer's designated agent and the chief executive officer or the chief executive officer's designated agent, shall address any comments by the physicians or other health professionals.(5) if the chief executive officer or the officer's designee elects not to certify the discharge encounter data for a specific quarter, a written justification of any unresolved data issues concerning the accuracy and completeness of the data at the time of the certification shall be included on the certification form. Discharge data that has been edited, returned to hospital and is not certified may be released and published in the public use data file.(d) Each hospital shall submit its certification form for each quarter's data to DSHS by the fifteenth day of the seventh month (Quarter 1- October 15; Quarter 2- January 15; Quarter 3- April 15; and Quarter 4- July 15) following the last day of the reporting quarter as specified in §421.3(a)(1) - (4) of this title (relating to Schedule for Filing Discharge Reports). Individual hospital requests for an extension to these deadlines will not be granted. DSHS may extend the deadline for all hospitals when deemed necessary.(e) Hospitals, physicians or other health professionals may submit concise written comments regarding any data submitted by them or relating to services, they have delivered which may be released as public use data. Comments shall be submitted to DSHS on or before the dates specified in subsection (d) of this section, regarding the submission of the certification form. Commenters are responsible for assuring that the comments contain no patient or physician identifying information. Comments shall be submitted electronically using the method described in §421.4(a) and (b) of this title (relating to Instructions for Filing Discharge Reports).(f) Failure to either correct a discharge report which has been submitted and contains errors or omissions known to the hospital on or prior to the dates specified in subsection (b) of this section or to address in the comments the errors known to the hospital contained in the data and return the comments on or prior to the dates specified in subsection (d) of this section is punishable by a civil penalty pursuant to Health and Safety Code, §108.014(b). Source Note: The provisions of this §421.7 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective December 29, 1997, 22 TexReg 12494; amended to be effective July 26, 1998, 23 TexReg 7365; amended to be effective July 29, 2001, 26 TexReg 5408; amended to be effective April 21, 2002, 27 TexReg 3183; amended to be effective July 6, 2003, 28 TexReg 4915; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effectiveJanuary 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.7 Certification of Discharge Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193969&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193969 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193969&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193969 03/11/2026 (a) DSHS records are public records under Government Code, Chapter 552, except as specifically exempted by Health and Safety Code, §108.010 and §108.013. Copies of such records may be obtained upon request and upon payment of user fees established by DSHS. The public use data files shall be available for public inspection during normal business hours within ten business days of a written or oral request. Discharge claims in the original format as submitted to DSHS are not available to the public, are not stored at DSHS' office and are exempt from disclosure pursuant to Health and Safety Code, §108.010 and §108.013, and shall not be released. Likewise, patient and physician identifying data collected by DSHS through editing of hospital data shall not be released.(b) Creation of codes and identifiers. DSHS shall develop the following codes and identifiers, as listed in paragraphs (1) - (2) of this subsection, required for creation of the public use data file and for other purposes.(1) The executive director shall create a process for assigning uniform patient identifiers, uniform physician identifiers and uniform other health professional identifiers using data elements collected. This process is confidential and not subject to public disclosure. Any documents or records produced describing the process or disclosing the person associated with an identifier are confidential and not subject to public disclosure.(2) The executive director shall create a process for assigning geographic identifiers to each discharge record.(c) Creation of public use data file. DSHS will create a public use data file by creating a single record for each inpatient discharge and adding, modifying or deleting data elements in the following manner as listed in paragraphs (1) - (11) of this subsection:(1) delete patient, and insured name, Social Security Number, address and certificate data elements and any patient identifying information, if submitted; delete patient control and medical record numbers.(2) convert patient birth date to age group;(3) convert admission and discharge dates to a length of stay measured in days and a code for the day of the week of the admission;(4) convert procedure and occurrence dates to day of stay values;(5) delete physician and other health professional names and numbers and assign an alphanumeric uniform physician identifier for the physicians and other health professionals who were reported as "attending" or "operating or other" on discharged patients;(6) assign codes indicating the primary and secondary sources of payment;(7) suppress the record level data elements in a way that the aggregate numbers for a facility or geographic region for that data element is below the number five. Five is the established minimum cell size required by §108.011(i) of the Health and Safety Code, unless DSHS determines that a higher cell size is required to protect the confidentiality of an individual patient or physician;(8) convert all procedure codes to ICD codes (in the version that is current for the date the data was due to be submitted or the version in effect at the date of service);(9) add risk and severity adjustment scores utilizing an algorithm approved by DSHS;(10) suppress admission source data at patient level when the admission type code represents "Newborn;"(11) include the following data elements in the public use data file, unless the data element needs to be suppressed for patient or physician confidentiality as noted under paragraphs (7), (10), or (12) of this subsection:(A) Discharge Year and Quarter;(B) Provider Name (Facility Name);(C) THCIC Identification Number;(D) Facility Type Indicators;(E) Patient Sex/Gender;(F) Type of Admission;(G) Source of Admission;(H) Patient ZIP Code;(I) County Code;(J) Public Health Region Code;(K) Patient State;(L) Patient Status;(M) Patient Race;(N) Patient Ethnicity;(O) Claim Type Indicator Code;(P) Type of Bill;(Q) Encounter Indicator: This indicates whether more than one claim was used to create the encounter;(R) Principal Diagnosis Code (Current version of ICD codes at the time data is submitted);(S) Other Diagnosis Codes (Up to 24 diagnosis codes can be submitted and reported. Current version of ICD codes at the time data is submitted);(T) Principal Procedure code (if applicable) (Current version of ICD codes at the time data is submitted);(U) Other Procedure codes (Up to 24 procedure codes can be submitted and report Current version of ICD codes at the time data is submitted);(V) Admitting Diagnosis (Current version of ICD codes at the time data is submitted);(W) External Cause of Injury (E-codes), (if applicable) (Current version of ICD codes at the time data is submitted) up to 9 E-codes can be submitted and reported;(X) Day of Week Patient is admitted code (Sun. = 1, Mon. = 2, Tues. = 3, Wed. = 4, Thur. = 5, Fri. = 6, Sat. = 7);(Y) Length of Stay;(Z) Age group of the patient;(AA) Day number of Principal Procedure (Calculated: Principal Procedure Date minus Admission/Start of Care Date);(BB) Day number of Procedure (1) (Calculated: Procedure Date (1) minus Admission/Start of Care Date);(CC) Day number of Procedure (2) (Calculated: Procedure Date (2) minus Admission/Start of Care Date);(DD) Day number of Procedure (3) (Calculated: Procedure Date (3) minus Admission/Start of Care Date);(EE) Day number of Procedure (4) (Calculated: Procedure Date (4) minus Admission/Start of Care Date);(FF) Day number of Procedure (5) (Calculated: Procedure Date (5) minus Admission/Start of Care Date);(GG) Major Diagnostic Category (MDC);(HH) HCFA-DRG Code (Obtained from the 3M HCFA-DRG Grouper);(II) APR-DRG Code (Obtained from 3M APR-DRG Grouper);(JJ) Risk of Mortality Score (Obtained from 3M APR-DRG Grouper);(KK) Severity of Illness Score (Obtained from 3M APR-DRG Grouper);(LL) Uniform Physician Identifier assigned to Attending Physician;(MM) Uniform Physician Identifier assigned to Operating or Other Physician;(NN) Service unit indicator from which the patient received services;(OO) Accommodations Private Room Charges;(PP) Accommodations Semi-Private Charges;(QQ) Accommodations Ward Charges;(RR) Accommodations Intensive Care Charges;(SS) Accommodations Coronary Care Charges;(TT) Ancillary Service - Other Charges;(UU) Ancillary Service - Pharmacy Charges;(VV) Ancillary Service - Medical/Surgical Supply Charges;(WW) Ancillary Service - Durable Medical Equipment Charges;(XX) Ancillary Service - Used Durable Medical Equipment Charges;(YY) Ancillary Service - Physical Therapy Charges;(ZZ) Ancillary Service - Occupational Therapy Charges;(AAA) Ancillary Service - Speech Pathology Charges;(BBB) Ancillary Service - Inhalation Therapy Charges;(CCC) Ancillary Service - Blood Charges;(DDD) Ancillary Service - Blood Administration Charges;(EEE) Ancillary Service - Operating Room Charges;(FFF) Ancillary Service - Lithotripsy Charges;(GGG) Ancillary Service - Cardiology Charges;(HHH) Ancillary Service - Anesthesia Charges;(III) Ancillary Service - Laboratory Charges;(JJJ) Ancillary Service - Radiology Charges;(KKK) Ancillary Service - MRI Charges;(LLL) Ancillary Service - Outpatient Services Charges;(MMM) Ancillary Service - Emergency Service Charges;(NNN) Ancillary Service - Ambulance Charges;(OOO) Ancillary Service - Professional Fees Charges;(PPP) Ancillary Service - Organ Acquisition Charges;(QQQ) Ancillary Service - ESRD Revenue Setting Charges;(RRR) Ancillary Service - Clinic Visit Charges;(SSS) Total Charges - Accommodations;(TTT) Total Charges - Ancillary;(UUU) Total Non-Covered Accommodation Charges;(VVV) Total Non-Covered Ancillary Charges;(WWW) Total Charges;(XXX) Total Non-Covered Charges;(YYY) Encounter Identifier - a unique number for each encounter for the quarter;(ZZZ) Service Line Revenue Code;(AAAA) Service Line Procedure Code;(BBBB) HCPCS/HIPPS Procedure Code;(CCCC) HCPCS/HIPPS Procedure Modifiers (Up to 4 may be submitted and reported);(DDDD) Service Line Charge Amount;(EEEE) Service Line Unit Code;(FFFF) Service Line Unit Count;(GGGG) Service Line Non-Covered Charge Amount;(HHHH) Patient Country (when address is not in the United States of America and confidentiality can be maintained);(IIII) POA indicator (if applicable).(JJJJ) Hospital Emergency Department Indicator.(12) The following data elements for records submitted with diagnosis codes that are associated with alcohol or drug use will be modified to protect those patients that may be covered by 42 USC §290dd-2 and 42 CFR Part 2:(A) Patient ZIP Code shall be reported as "`" (back quote);(B) Patient Country shall be reported as "`" (back quote); and(C) Patient Sex shall be reported as "U" (Unknown). Source Note: The provisions of this §421.8 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective December 29, 1997, 22 TexReg 12494; amended to be effective July 26, 1998, 23 TexReg 7365; amended to be effective December 24, 2000, 25 TexReg 12430; amended to be effective July 29, 2001, 26 TexReg 5408; amended to be effective April 21, 2002, 27 TexReg 3183; amended to be effective July 6, 2003, 28 TexReg 4915; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effectiveJanuary 9, 2011, 35 TexReg 9743; amended to be effective December 18, 2014, 39 TexReg 7582; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.8 Hospital Discharge Data Creation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193970&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193970 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193970&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193970 03/11/2026 (a) Hospitals that have not obtained an exemption letter authorized by §421.81 of this title (relating to Health Care Facilities Exemptions from Filing Requirements) shall submit discharge reports, electronically in the file format for inpatient hospital bills defined by the American National Standards Institute (ANSI), commonly known as the ANSI ASC X12N form 837 Health Care Claims (ANSI 837 Institutional Guide) transaction for institutional claims and/or encounters. ANSI updates this format from time to time by issuing new versions.(b) DSHS will make detailed specifications for these data elements available to submitters and to the public.(c) In addition to the data elements contained in the ANSI 837 Institutional Guide, DSHS has defined the following data elements shown in this subsection and as defined the location in the ANSI 837 Institutional Guide where each element is to be reported. Data element content, format and locations may change as federal and state legislative requirements change in regards to Public Law 104-191, Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, is implemented.(1) Patient race - This data element shall be reported at Loop 2300 in the K3 segment as the second numeric value in this data segment. Acceptable codes are 1 = American Indian/Eskimo/Aleut, 2 = Asian or, Pacific Islander, 3 = Black, 4 = White and 5 = Other Race. In order to obtain this data, the hospital staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient to classify the patient. If the patient, or person speaking for the patient, declines to answer, the hospital staff is to use its best judgment to make the correct classification based on available data.(2) Patient ethnicity - This data element shall be reported at Loop 2300 in the K3 segment as the first numeric value. Acceptable codes are 1 = Hispanic or Latino Origin and 2 = Not of Hispanic or Latino Origin. In order to obtain this data, the hospital staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient to classify the patient. If the patient, or person speaking for the patient, declines to answer, the hospital staff is to use its best judgment to make the correct classification based on available data.(3) Other E-codes - These additional E-codes (maximum of nine (9)) shall be reported in the following ANSI X12N Form 837 locations: Loop 2300, segments, HI05-2, HI06-2, HI07-2, HI08-2, HI09-2, HI10-2, HI11-2 and HI12-2. (The first E-code is reported in Loop 2300 segment HI04-2).(4) THCIC Identification Number - This data element shall be submitted in data segment REF02 of Loop 2010AA or Loop 2010AB (in the Pay-to provider reported provided the services), or Loop 2310E (if the Service Facility Provider is submitted).(d) Hospitals shall submit the required minimum data set for all patients for which a discharge claim is required by this title. The required minimum data set includes the following data elements as listed in this subsection:(1) Patient Name:(A) Patient Last Name;(B) Patient First Name;(C) Patient Middle Initial;(2) Patient Address:(A) Patient Address Line 1;(B) Patient Address Line 2 (if applicable);(C) Patient City;(D) Patient State;(E) Patient ZIP;(F) Patient Country (if address is not in the United States of America, or one of its territories);(3) Patient Birth Date;(4) Patient Sex;(5) Patient Race;(6) Patient Ethnicity;(7) Patient Social Security Number;(8) Patient Account Number;(9) Patient Medical Record Number;(10) Claim Filing Indicator Code (Payer Source - primary and secondary (if applicable for secondary payer source);(11) Payer Name - Primary and secondary (if applicable, for both);(12) National Plan Identifier - for primary and secondary (if applicable) payers (National Health Plan Identification number, if applicable and when assigned by the Federal Government);(13) Type of Bill;(14) Statement Dates (replaces Statement From and Statement Thru dates);(15) Admission / Start of Care:(A) Admission / Start of Care Date;(B) Admission / Start of Care Hour;(16) Admission Type;(17) Admission Source;(18) Patient (Discharge) Status;(19) Patient Discharge Hour;(20) Principal Diagnosis;(21) Admitting Diagnosis;(22) Principle External Cause of Injury (E-Code);(23) Other Diagnosis Codes - up to 24 occurrences (all applicable);(24) External Cause Of Injury (E-Code) - up to 9 occurrences (if applicable);(25) Principal Procedure Code (if applicable);(26) Principal Procedure Date (if applicable);(27) Other Procedure Codes - up to 24 occurrences (if applicable);(28) Other Procedure Dates - up to 24 occurrences (if applicable);(29) Occurrence Span Code - up to 24 occurrences (if applicable);(30) Occurrence Span Code Associated Date - up to 24 occurrences (if applicable);(31) Occurrence Code - up to 24 occurrences (if applicable);(32) Occurrence Code Associated Date - up to 24 occurrences (if applicable);(33) Value Code - up to 24 occurrences (if applicable);(34) Value Code Associated Amount - up to 24 occurrences (if applicable);(35) Condition Code - up to 24 occurrences (if applicable);(36) Attending Physician or Attending Practitioner Name:(A) Attending Practitioner Last Name;(B) Attending Practitioner First Name;(C) Attending Practitioner Middle Initial;(37) Attending Practitioner Primary Identifier (National Provider Identifier, when HIPAA rule is implemented);(38) Attending Practitioner Secondary Identifier (Texas state license number or UPIN);(39) Operating Physician or Other Practitioner Name (if applicable):(A) Operating Physician or Other Practitioner Last Name;(B) Operating Physician or Other Practitioner First Name;(C) Operating Physician or Other Practitioner Middle Initial;(40) Operating Physician or Other Practitioner Primary Identifier (National Provider Identifier, when HIPAA rule is implemented);(41) Operating Physician or Other Practitioner Secondary Identifier (Texas state license number or UPIN);(42) Total Claim Charges;(43) Revenue Service Line Details (up to 999 service lines) (all applicable):(A) Revenue Code;(B) Procedure Code;(C) HCPCS/HIPPS Procedure Modifier 1;(D) HCPCS/HIPPS Procedure Modifier 2;(E) HCPCS/HIPPS Procedure Modifier 3;(F) HCPCS/HIPPS Procedure Modifier 4;(G) Charge Amount;(H) Unit Code;(I) Unit Quantity;(J) Unit Rate;(K) Non-covered Charge Amount;(44) Service Provider Name;(45) Service Provider Primary Identifier - Provider Federal Tax ID (EIN) or National Provider Identifier (when HIPAA rule is implemented);(46) Service Provider Address:(A) Service Provider Address Line 1;(B) Service Provider Address Line 2 (if applicable);(C) Service Provider City;(D) Service Provider State;(E) Service Provider ZIP;(47) Service Provider Secondary Identifier - THCIC 6-digit Hospital ID assigned to each facility.(e) A hospital shall submit the "POA indicator" for all diagnosis codes on inpatient claims filed, unless exempted by this subsection. Exempted hospitals may, but are not required to, submit POA indicators to DSHS The following hospital types are exempted from reporting POA indicators to DSHS for the purposes of this subsection:(1) Critical Access Hospitals (certified by the Secretary of the United States Department of Health and Human Services as a critical access hospital under Title 42 United States Code, §1395i-4).(2) Inpatient Rehabilitation Hospitals (a majority of the patients are inpatients being rehabilitated).(3) Inpatient Psychiatric Hospitals (a majority of the patients are inpatients being treated for psychiatric diseases or associated conditions).(4) Cancer Hospitals (a majority of the patients are inpatients being treated for cancer or associated cancerous conditions).(5) Children's or Pediatric Hospitals (a majority of the patients are under the age of 18 and admitted as inpatients).(6) Long Term Care Hospitals (a majority of the patients are inpatients being treated for chronic conditions or associated diseases that require extended stays in a hospital).(f) For patients which are covered by 42 USC §290dd-2 and 42 CFR Part 2, the hospital shall submit the following patient identifying information or default values in the specified Record and Field locations as required by subsection (a) of this section:(1) Patient Account Number - This alphanumeric patient control number shall be reported. This number is unique to the institution and episode of care and will be used by the hospital to review and certify data.(2) Last Name - The patient's last name shall be removed and replaced with "Doe."(3) First Name - The patient's first name shall be removed and replaced with "Jane" if female, or "John" if male, and can include a sequential number (e.g., John1, John2, John3... etc.).(4) Middle Initial - The patient's middle initial shall be removed and left blank (space filled).(5) Date of Birth - "January 1" and the patient's year of birth shall be reported.(6) Address - The patient's residence address shall be removed and replaced with the hospital's street address.(7) City - The patient's city of residence shall be removed and replaced with the name of the city where the hospital is located.(8) State - The patient's state of residence shall be reported.(9) ZIP Code - The patient's ZIP code of residence shall be removed and replaced with the hospital's ZIP code.(10) Medical Record Number - The patient's medical record number shall be reported. This number is unique to the institution and episode of care and will be used by DSHS to process the claim data and for the hospital to review and certify the patient's data.(11) Social Security Number - The patient's Social Security Number shall be removed and replaced with "999999999."(12) Statement Dates - The month, day, and year of the statement from and statement through dates shall be reported as required. Only the year of service will be retained with the record after transfer to the DSHS program administering and completing the processing of the data for the health care data collection system under Health and Safety Code, Chapter 108. Source Note: The provisions of this §421.9 adopted to be effective August 19, 1997, 22 TexReg 7490; amended to be effective December 29, 1997, 22 TexReg 12494; amended to be effective July 26, 1998, 23 TexReg 7365; amended to be effective February 21, 1999, 24 TexReg 948; amended to be effective July 29, 2001, 26 TexReg 5408; amended to be effective July 6, 2003, 28 TexReg 4915; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective December 27, 2007, 32 TexReg 9683; amended to be effective January 9, 2011, 35 TexReg 9743; amendedto be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION A COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA §421.9 Discharge Reports--Records, Data Fields and Codes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115039 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115039&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115039 03/11/2026 The purpose of these sections is to establish a data collection and reporting system for health maintenance organizations (HMOs) in the State of Texas. Source Note: The provisions of this §421.21 adopted to be effective July 15, 1997, 22 TexReg 6442; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION B COLLECTION AND REPORTING OF HEALTH PLAN EMPLOYER DATA AND INFORMATION SET (HEDIS) FROM HEALTH MAINTENANCE ORGANIZATIONS (HMOS) §421.21 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115040&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115040 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115040&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115040 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Council--The Texas Health Care Information Council.(2) Executive director--The chief administrative officer of the Council, or, in the event the Council is without an executive director, the person designated by the chairperson of the Council to perform the functions and exercise the authority of the executive director.(3) HEDIS--An acronym for the Health Plan Employer Data and Information Set, published by the National Committee for Quality Assurance. HEDIS is a set of standardized performance measures, designed to allow for the reliable comparison of the performance of managed care health plans. HEDIS covers a broad range of areas: effectiveness of care, accessibility/availability of care, satisfaction with the experience of care, cost of care, stability of the health plan, informed health care choices, use of services, and plan descriptive information. HEDIS is a registered trademark of NCQA.(4) HEDIS data--The information the health maintenance organization collects and reports to the Council in accordance with the provisions of this chapter. Data are collected from January 1st through December 31st annually.(5) HEDIS Guidelines - The version of the HEDIS reporting guidelines as specified by the Council.(6) HMO--A health maintenance organization as defined in Texas Health Maintenance Organization Act, Texas Insurance Code, Article 20A.02(j), Texas Civil Statutes.(7) NCQA--The National Committee for Quality Assurance, 2000 L Street, N.W., Suite 500, Washington, D.C. 20036.(8) Reporting set measures--Those measures specified as "Reporting Set Measures" in the HEDIS Guidelines.(9) Service area- as defined in 28 TAC, Part 1, Chapter 11 Subchapter A §11.2(b)(10) Service area division - An operation of a HMO corporation that meets one of the following conditions:(A) a distinct and separate operation of a HMO corporation as opposed to other operations of the corporation serving other distinct and separate geographical service areas;(B) a separate geographical area whereby the geographical location of an enrollee or a group contract holder is used in determining charges or rates; or(C) a service area that crosses state lines or international boundaries is considered to have a separate divisional operation in each state or country and requires separate cost centers and reports.(11) Single Service HMO--An HMO offering a single health care service as defined in Texas Health Maintenance Organization Act, Texas Insurance Code, Article 20A.02(r), Texas Civil Statutes.(12) Testing set measures--Those measures specified as "Testing Set Measures" in the HEDIS Guidelines. Source Note: The provisions of this §421.22 adopted to be effective July 15, 1997, 22 TexReg 6442; amended to be effective April 21, 1999, 24 TexReg 3090; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION B COLLECTION AND REPORTING OF HEALTH PLAN EMPLOYER DATA AND INFORMATION SET (HEDIS) FROM HEALTH MAINTENANCE ORGANIZATIONS (HMOS) §421.22 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115041&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115041 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115041&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115041 03/11/2026 (a) Any health maintenance organization (HMO) operating in the State of Texas on December 1, 1996, and on that date each year thereafter, shall have a system in place to collect the full HEDIS data set, and shall be required to report HEDIS data, collected during the next calendar year. Single service HMOs which contract as secondary providers with other HMOs to provide services to covered lives which are the same lives covered by the primary HMO, shall report data as necessary to fulfill data reporting requirements under this rule to the primary HMO, which will report HEDIS data to the Council. Single service HMOs, which contract directly with employers to provide specific services, shall report HEDIS data directly to the Council. Basic HMOs which contract as secondary providers with other basic HMOs to provide a range of health care services normally considered to be full health coverage on a specified group of covered lives, e.g., ages 0 to 18 year olds, shall report complete HEDIS data to primary HMOs, with which the secondary HMOs have contracted to provide services, which, in turn, shall report directly to the Council.(b) HMOs shall report HEDIS data, by Service area division. Data to be reported shall be a subset of the "Reporting Set Measures" (i.e., this excludes data specified as "Testing Set Measures"), as specified by the Council by November 15th of the year for which the data are collected. Reporting by any specific subpopulation (e.g., Medicare, Medicaid) will be specified by the Council by November 15th of the year for which the data are collected.(c) The HMO shall report HEDIS data to the Council by the reporting deadline as specified by NCQA or as specified by the executive director (should the date be incompatible with the Council's goals) in the current year.(d) HEDIS data shall be reported to the Council or its agents at physical or telephonic addresses specified by the executive director. The executive director shall notify all HMOs in writing and by publication in the Texas Register at least 30 days before any change in the address.(e) Any HMO which judges that it cannot meet required performance measure specifications due to either low enrollment (such that sample size requirements are not met) or short time of existence (such that length of time requirements are not met) shall provide the Council with a narrative that documents the reason for not reporting the data for that performance measure. Single service HMOs shall notify the Council to address which measures are applicable to the services they provide. All requests for exemptions from reporting data for any performance area(s) required by this chapter shall be submitted by the HMO on an annual basis, prior to November 15th of the year for which the data are collected, and processed by the executive director using the following procedures.(1) An HMO requesting an exemption from reporting any required performance measure prescribed by this chapter shall submit to the executive director a letter requesting the exemption and provide all information necessary to establish the HMO's entitlement to the exemption. The exemption request shall be signed by the chief executive officer of the HMO who shall certify that all information contained in the request is true and correct.(2) The executive director shall review the request for exemption. The executive director may request additional information from the HMO relevant to the exemption request. Within 30 days of receipt of a request for exemption, the executive director shall issue a letter granting or denying the exemption. If denied, the letter shall state in detail the reasons for the denial. The executive director shall notify Council members of exemptions requested and the disposition of these requests for information purposes only.(3) If the executive director denies an exemption request, the HMO may resubmit the request along with any additional information or analysis the HMO deems relevant to the executive director. The resubmission shall be considered in the same manner as the initial submission.(4) If the executive director denies the resubmitted exemption request, the HMO may appeal the executive director's decision to the Council. In making its determination, the Council will consider only those facts and issues which have been previously presented to the executive director. The Council will decide exemption appeals by majority vote of members present. Source Note: The provisions of this §421.23 adopted to be effective July 15, 1997, 22 TexReg 6442; amended to be effective April 21, 1999, 24 TexReg 3090; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION B COLLECTION AND REPORTING OF HEALTH PLAN EMPLOYER DATA AND INFORMATION SET (HEDIS) FROM HEALTH MAINTENANCE ORGANIZATIONS (HMOS) §421.23 Collection and Reporting of Health Plan Employer Data and Information Set (HEDIS) Data by Health Maintenance Organizations (HMOs) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115042&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115042 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115042&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115042 03/11/2026 (a) The entire subset of HEDIS data specified by the Council on November 15th of the year for which the data are collected, and reported by the HMO to the Council shall be verified.(b) HEDIS data shall be verified by HMOs at their own expense.(c) Verification of HEDIS data shall be by an independent auditor using guidelines as developed by the National Committee for Quality Assurance (NCQA) in effect on November 15th of the year for which the data are collected. If no guidelines have been released by NCQA, the data will be verified in accordance with auditing procedures as specified by the Council. These auditing procedures shall be specified by the Council by November 15th of the year for which the data are collected. Source Note: The provisions of this §421.24 adopted to be effective July 15, 1997, 22 TexReg 6442; amended to be effective April 21, 1999, 24 TexReg 3090; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION B COLLECTION AND REPORTING OF HEALTH PLAN EMPLOYER DATA AND INFORMATION SET (HEDIS) FROM HEALTH MAINTENANCE ORGANIZATIONS (HMOS) §421.24 Verification of Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115043&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115043 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=115043&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 115043 03/11/2026 Failure to timely report verified HEDIS data is punishable by a civil penalty of not less than $1,000 nor more than $10,000 for each violation as set forth in Health and Safety Code, §108.014. Source Note: The provisions of this §421.25 adopted to be effective July 15, 1997, 22 TexReg 6442; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION B COLLECTION AND REPORTING OF HEALTH PLAN EMPLOYER DATA AND INFORMATION SET (HEDIS) FROM HEALTH MAINTENANCE ORGANIZATIONS (HMOS) §421.25 Civil Penalty https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199767&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199767 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199767&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199767 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) DSHS--Department of State Health Services.(2) Director--Director of the Center for Health Statistics.(3) Executive Leaders--Executive leaders with the classification of Assistant Deputy Commissioner or above.(4) Health care facility--(A) A hospital;(B) An ambulatory surgical center licensed under Chapter 243;(C) A chemical dependency treatment facility licensed under Chapter 464;(D) A renal dialysis facility;(E) A birthing center;(F) A rural health clinic;(G) A federally qualified health center as defined by 42 U.S.C. §1396d(l)(2)(B); or(H) A freestanding emergency medical care facility, as defined by Texas Health and Safety Code, Section 108.002(10)(I).(5) Provider--Physician or health care facility.(6) Provider Level--Data or information that identifies specific providers by name or uniform identifier.(7) Public Information Report--A report created for providing information related to health care quality or effectiveness or access to health care that will be shared with the public. For example: A provider level public information report provides data or information at the provider level and includes provider (health care facility) identifiers and a statewide or geographic level public information report provides data at the prescribed geographic level and does not include provider identifiers. Query results generated from public use data which are available on the DSHS website are not considered as a public information report.(8) Request for information--A request made by an individual or organization for summarized or analyzed responses from publicly available data. DSHS does not consider a request for information and responses as a public information report. Source Note: The provisions of this §421.41 adopted to be effective April 21, 2002, 27 TexReg 3186; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective January 30, 2019, 44 TexReg 429; amended to be effective June 17, 2020, 45 TexReg 4041. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION C RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES §421.41 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193976&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193976 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193976&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193976 03/11/2026 (a) One or more executive leaders of DSHS shall issue a charge to DSHS' staff to produce a provider level public information report.(b) DSHS staff shall provide a written description of the charge to the executive leader assigning the charge. Clarification of the charge shall be made at this time, if required.(c) DSHS staff shall submit the written description of the charge to the affected staff member.(d) DSHS staff shall research, investigate, deliberate or reconcile the charge and generate the outcome or draft of the product requested in the charge.(e) Upon completion of subsection (d) of this section DSHS staff shall submit this to any additional DSHS staff for recommendations as required by the charge or Chapter 108, Health and Safety Code.(f) DSHS staff shall submit a report or arrange for a presentation to the executive leader or director, after DSHS staff have made their recommendations or produced the report.(g) The executive leader may review, discuss, deliberate, or take action on the report or presentation. If the executive leader approves the report or presentation, a recommendation to the director for approval shall be made. If further modifications are required for the report or presentation, the executive leader shall issue a new charge and subsections (a) - (g) of this section shall be followed until a recommendation is approved or is disapproved. Source Note: The provisions of this §421.42 adopted to be effective April 21, 2002, 27 TexReg 3186; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION C RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES §421.42 Procedures for Provider Level Public Information Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193977&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193977 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193977&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193977 03/11/2026 (a) The provider level public information report shall provide contact and website information to obtain the technical documentation regarding the provider level public information report.(b) The provider level public information report technical documentation shall be available to providers reviewing the provider level public information report as required by Health and Safety Code, §108.010(e) or §108.011(f) and (g). Source Note: The provisions of this §421.43 adopted to be effective April 21, 2002, 27 TexReg 3186; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION C RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES §421.43 Technical Documentation regarding Provider Level Public Information Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193971&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193971 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193971&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193971 03/11/2026 (a) DSHS will make available the technical documentation regarding the provider level public information report no less than 7 days prior to the masked provider level public information report being made available to providers for review and comment.(b) DSHS shall provide access to a paper copy or an electronic copy of the provider level public information report to each hospital named in the report. In providing a copy of the provider level public information report to each named provider, DSHS shall mask the identities of the other providers in the report.(c) Providers may submit comments regarding the provider level public information report to DSHS.(1) Any comments shall be submitted to and received by DSHS, on or prior to the date specified by DSHS, which shall not be less than 60 calendar days after notification is sent from DSHS.(2) Comments shall be submitted on a form created by DSHS.(3) Comments shall be returned to DSHS in an electronic format specified by DSHS.(4) Comments received by DSHS shall be posted on DSHS' website with each release of the provider level public information reports. Source Note: The provisions of this §421.44 adopted to be effective April 21, 2002, 27 TexReg 3186; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION C RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES §421.44 Timeline Requirements for Release of Technical Documentation and Provider Level Public Information Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193972&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193972 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193972&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193972 03/11/2026 (a) Data Requests - General Information.(1) DSHS shall establish procedures for screening all data and information requests to assure that filling the request will not violate the provisions of Health and Safety Code, §108.013(c).(2) Requests for data files including data on one or more providers are matters of public record and copies of all requests shall be maintained by DSHS for two years from the date of receipt. DSHS shall make available on DSHS' website summary of all requests received for public use data.(3) Texas State agencies that request data solely for internal use in accordance with Health and Safety Code, §108.012(b) shall abide by the data users' agreement.(4) The data elements specified for discharge reports in §421.9 of this title (relating to Discharge Reports--Records, Data Fields and Codes) or event files in §421.67 of this title (Event Files--Records, Data Fields and Codes) or §421.77 of this title (Event Files--Records, Data Fields and Codes) do not constitute "Provider Quality Data" as discussed in Health and Safety Code, §108.010.(b) Public Use Data File Requests and Releases.(1) Release of public use data files. DSHS shall release public use data that has the identities masked relating to health care facilities that are low volume providers to protect the confidentiality and privacy of the patients, physicians and other health professionals.(2) DSHS will make available a public use data file on electronic, magnetic or portable data storage media for each quarter as authorized by Health and Safety Code, Chapter 108 and by this section.(3) DSHS shall release public use data from health care facilities that have certified the data as required by §421.7 of this title (relating to Certification of Discharge Reports), or §421.66 (relating to Certification of Compiled Event Data) or §421.76 of this title (relating to Certification of Compiled Event Data) of this title. A health care facility's failure to execute the certification form by the dates specified in §421.7(d) or §421.66(d) or §421.76 of this title, or elects to not certify the discharge encounter data shall not prevent DSHS from releasing the hospital's data if DSHS believes the data submitted is reasonably accurate and complete. DSHS may suppress for any quarter's data one or more data elements if deemed necessary to comply with provisions of the statutes. If an element is ordered suppressed by a judicial authority, DSHS may suppress the element.(4) If additional discharge claims (not previously submitted as specified in §421.6(c)(4) of this title (relating to Acceptance of Discharge Reports and Correction of Errors) or §421.65(b)(4) of this title (relating to Acceptance of Event Files and Correction of Data Content Errors) or §421.75 of this title (relating to Acceptance of Event Files and Correction of Data Content Errors) of this title, excluding replacement, adjustments and void/cancel discharge claims become available after the initial release of the public use data file for any quarter, DSHS will add the discharge claims, that are received on or prior to the date specified in §421.3(a)(1) of this title (relating to Schedule for Filing Discharge Reports) or §421.63(a)(1) - (4) of this title (relating to Schedule for Filing Event Files) or §421.73 of this title (relating to Schedule for Filing Event Files) of this title of the following quarter, to the public use data file and make the additional records available to the public.(5) A public use data file which is disseminated to a requestor shall not be considered a report issued by DSHS as referenced in Health and Safety Code, §108.011(f), and requires no additional opportunity for the facility to review or comment on the data.(6) With any public use data file prepared by DSHS, DSHS shall attach all comments submitted by providers, which relate to any data included in the file. DSHS shall make these comments available at DSHS offices and on DSHS' website.(c) Research Data File Requests and Releases - A research data file may be released provided the following criteria are met:(1) DSHS' Hospital Discharge Data Research Data File Request Form, or Outpatient Research Data File Request Form, or Emergency Department Research Data File Request Form is completed and submitted to DSHS;(2) DSHS' Institutional Review Board reviews the research request and has determined the proposed research outcome can be achieved with the requested data;(3) the Institutional Review Board and DSHS' Executive Steering Committee grant authorization to the request or restrict access to specified data elements determined to be inappropriate for the research proposal in accordance with §421.46 of this title (relating to Institutional Review Board);(4) the requestor agrees to dispose of the research data using authorized methods by the established end date stated on the written data release agreement;(5) the requestor has signed a written data release agreement; and(6) the requestor has made payment according to §421.47 of this title (relating to Data Fees). Source Note: The provisions of this §421.45 adopted to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION C RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES §421.45 Data Requests and Releases https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193973&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193973 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193973&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193973 03/11/2026 (a) DSHS shall use the Institutional Review Board for the purposes of:(1) evaluating applications for various measures or variables that are found in DSHS' hospital discharge data "research" file or outpatient surgical and radiological procedures at hospitals and ambulatory surgical centers "research" file or hospital outpatient emergency department data "research" file; and(2) deciding whether the data requests should be granted.(b) The Institutional Review Board functions relating to §421.45 of this title (relating to Data Requests and Release) and this section are abolished at such time as DSHS ceases to maintain a hospital discharge data "research" file or outpatient surgical and radiological procedures at hospitals and ambulatory surgical centers "research" file or hospital outpatient emergency department data "research" file.(c) Decision-Making Guidelines.(1) Requests should reasonably identify and justify the requested data elements. Requesters who have detailed information that would assist in justifying the records request are urged to provide such information in order to expedite the handling of the request. Envelopes in which written requests are submitted should be clearly identified as Open Records requests. Requests should include the fee or request determination of the fee.(2) Fee structures for the public use data file and the research file shall be set by the executive commissioner.(3) Waiver or reduction of the fees charged for the public use data file or the research file may be made upon a determination by DSHS in consultation with the executive commissioner when such waiver or reduction is in DSHS' interest.(4) All requests for data must be submitted in writing, either on the form provided by DSHS or on a similar form containing all of the same information. Denials of written requests will be in writing and will contain the reasons for the denial including, as appropriate, a statement that a document or data element requested is nonexistent or is not reasonably described, or is subject to one or more clearly described exemption or exemptions.(5) Only data elements requested by the requestor and approved for release by the Institutional Review Board, shall be included in the research file for release to the requestor in accordance with this chapter.(d) Reports to DSHS. The Chair of the Institutional Review Board shall file with the Program Director a written report of all action taken relating to requests under this section at any meeting of the Institutional Review Board or of a Subcommittee within three working days of such meeting, including a detailed list of how each participating member voted. Source Note: The provisions of this §421.46 adopted to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION C RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES §421.46 Institutional Review Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193974&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193974 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193974&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193974 03/11/2026 (a) Public Use Data File Fees. Fees shall be charged for hospital inpatient data, outpatient data, and hospital emergency department data collected and created under Health and Safety Code, Chapter 108 and §421.8 of this title (relating to Hospital Discharge Data Creation), §421.67 of this title (relating to Event Files--Records, Data Fields and Codes) and §421.77 of this title (relating to Event Files--Records, Data Fields and Codes), respectively:(1) State Agencies (including State owned universities) - $0.00.(2) Texas City/County/Local Government Health Departments - $0.00.(3) Texas Reporting Hospitals, Texas In-State Media, and Out of State Health Departments:(A) Three most recent calendar years of data - $3,000.00;(B) Calendar quarters for the three most recent calendar years - $875.00; or(C) Calendar quarters that are four or more years than the current date - $312.50.(4) Texas private universities/colleges, out of state universities, out of state media, out of state agencies, out of state hospitals and all other businesses or consumers, including hospital or ambulatory surgery center affiliates, organizations, institutions and corporate offices:(A) Three most recent calendar years of data - $6,000.00;(B) Calendar quarters for the three most recent calendar years - $1,750.00; or(C) Calendar quarters that are four or more years than the current date - $625.00.(5) Multiple site location organizations:(A) Two to four license locations:(i) Three most recent calendar years of data - $9,000.00;(ii) Calendar quarters for the three most recent calendar years - $2,750.00; or(iii) Calendar quarters that are four or more years than the current date - $982.00.(B) Five to nine license locations:(i) Three most recent calendar years of data - $12,000.00;(ii) Calendar quarters for the three most recent calendar years - $4,000.00; or(iii) Calendar quarters that are four or more years than the current date - $1429.00.(C) Ten or more license locations:(i) Three most recent calendar years of data - $15,000.00;(ii) Calendar quarters for the three most recent calendar years - $5,250.00; or(iii) Calendar quarters that are four or more years than the current date - $1875.00.(b) Research Data File Fees. Research data file requests require Institutional Review Board approval in §421.46 of this title (relating to Institutional Review Board).(1) State Agencies:(A) Health and Human Services Agencies - $0.00.(B) Texas State Agencies (other than Health and Human Services Agencies) and Texas State universities - Refer to paragraph (3) of this subsection.(2) All other requestors - Refer to paragraph (3) of this subsection.(3) Research Data File Fee Structure - All Institutional Review Board approved Research Data Files are custom built and may incur one or more of the following charges dependent on the approved request.(A) Base fee - Approved Institutional Review Board research data file requests that require no additional work to prepare the data (For example, filtering or linking) the fee shall be $30 per data element per calendar quarter;(B) Fee for identifying and extracting Institutional Review Board approved data according to the specific criteria noted on the Institutional Review Board documentation and in consultation with the requestor. The data shall be extracted from the complete dataset of requested data noted in the Institutional Review Board documentation. The fee will be dependent on the number of hours of labor determined by DSHS program staff performing the service to prepare, process, and verify the Institutional Review Board approved data for the requestor, multiplied by the hourly midpoint range rate of the Salary Group for Class Title "Research Specialist IV" determined by the State Auditor's Office. This fee shall be added to the fee noted in subparagraph (A) of this paragraph and if applicable, subparagraph (C) of this paragraph;(C) Fee for linking of approved research data file requests with other datasets. The fee will be dependent on the number of hours of labor determined by DSHS staff performing the service to prepare, process, and verify the Institutional Review Board approved data for the requestor, multiplied by the hourly midpoint range rate of the Salary Group for Class Title "Research Specialist IV" determined by the State Auditor's Office; or(D) Fee for additional processing and reviews for requests for data which are not currently available, but DSHS is anticipated to receive and process in the future. The fee will be dependent on the number of hours of labor determined by DSHS staff performing the service to prepare, process, and verify the Institutional Review Board approved data for the requestor, multiplied by the hourly midpoint range rate of the Salary Group for Class Title "Research Specialist IV" determined by the State Auditor's Office. Source Note: The provisions of this §421.47 adopted to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION C RULES RELATING TO REPORTS, DATA REQUESTS AND DATA FEES §421.47 Data Fees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199768&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199768 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199768&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199768 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Accurate and Consistent Data--Data that has been edited by DSHS and subjected to provider validation and certification.(2) Ambulatory Surgical Care Data--Data for events associated with facility services, which require surgery to be performed in an operating room on an anesthetized patient.(3) Ambulatory surgical center--An establishment licensed as an ambulatory surgical center under the Texas Health and Safety Code, Chapter 243.(4) Anesthetized patient--For the purposes of this subchapter, an outpatient who receives an anesthetic (a substance that reduces sensitivity, feeling, or awareness to pain or bodily sensations or renders the patient unconscious) prior to surgical services from a hospital or ambulatory surgical center.(5) ANSI 837 Institutional Guide--American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Institutional Claim Implementation Guide.(6) ANSI 837 Professional Guide--American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Professional Claim Implementation Guide.(7) APC--Ambulatory Payment Classification.(8) APG--Enhanced Ambulatory Patient Grouper --A prospective payment system (PPS) for ambulatory patient care developed by 3M™. The APGs provide information regarding the kinds and amounts of resources utilized in an outpatient visit and classify patients with similar clinical characteristics.(9) Audit--An electronic standardized process developed and implemented by DSHS to identify potential errors and mistakes in file structure format or data element content by reviewing data fields for the presence or absence of data and the accuracy and appropriateness of data.(10) Certification File--One or more electronic files (may include reports concerning the data and its compilation process) compiled by DSHS that contain one record for each patient event which has at least one procedure covered in the revenue codes or surgical and radiological categories specified in §421.67(f) or §421.67(g) of this title (relating to Event Files--Records, Data Fields and Codes) submitted for each facility under this subchapter during the reporting quarter and may contain one record for any patient event occurring during one prior reporting quarter for whom additional event claims have been received.(11) Certification Process--The process by which a provider confirms the accuracy and completeness of the certification file required to produce the public use data file as specified in §421.66 of this title (relating to Certification of Compiled Event Data).(12) Charge--The amount billed by a provider for specific procedures or services provided to a patient before any adjustment for contractual allowances, government mandated fee schedules or write offs for charity care, bad debt or administrative courtesy. The term does not include co-payments charged to health maintenance organization enrollees by providers paid by capitation or salary in a health maintenance organization.(13) Clinical Classifications Software--A classification system that groups diagnoses and procedures into a limited number of clinically meaningful categories developed at the United States Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ).(14) Comments--The notes or explanations submitted by the facilities, physicians or other health professionals concerning the provider quality reports or the encounter data for public use as described in the Texas Health and Safety Code, §108.010(c) and (e) and §108.011(g) respectively.(15) Data format--The sequence or location of data elements in an electronic record according to prescribed specifications.(16) DSHS--Department of State Health Services.(17) EDI--Electronic Data Interchange--A method of sending data electronically from one computer to another. EDI helps providers and payers maintain a flow of vital information by enabling the transmission of claims and managed care transactions.(18) Electronic Filing--The submission of computer records in machine readable form by modem transfer from one computer to another (EDI) or by recording the records on a nine-track magnetic tape, computer diskette, magnetic, or portable data storage media acceptable to DSHS.(19) Emergency Department--Department or room within a hospital as determined by federal or state law for the provision of emergency health care.(20) Emergency Department Data--Events associated with hospital services in an emergency department or emergency room.(21) Error--Data submitted on a event file which are not consistent with the format and data standards contained in this subchapter or with auditing criteria established by DSHS.(22) Ethnicity--The status of patients relative to Hispanic background. Facilities shall report this data element according to the following ethnic types: Hispanic or Non-Hispanic.(23) Event--The medical screening examination, triage, observation, diagnosis or treatment of a patient within the authority of a facility.(24) Event claim--A set of computer records as specified in §421.67 of this title relating to a specific patient. "Event claim" corresponds to the ANSI 837 Institutional Guide and ANSI 837 Professional Guide term, "Transaction set."(25) Event file--A computer file as defined in §421.67 of this title periodically submitted on or on behalf of a facility in compliance with the provisions of this subchapter. "Event File" corresponds to the ANSI 837 Institutional Guide and ANSI 837 Professional Guide terms, "Communication Envelope" or "Interchange Envelope."(26) Facility--For the purposes of this subchapter, a facility is a hospital or ambulatory surgical center, required to report under the Texas Health and Safety Code, Chapter 108 and this subchapter.(27) Facility Type Indicators--An indicator that provides information to the data user as to the type of facility or the primary health services delivered at that hospital (e.g., Hospital based ambulatory surgical unit and hospitals with an emergency department or emergency room) and ambulatory surgical centers. A facility may have more than one indicator.(28) Geographic identifiers--A set of codes indicating the health service region and county in which the patient resides.(29) HCPCS--Healthcare Common Procedure Coding System of the Centers for Medicare and Medicaid Services. This includes the "Current Procedural Terminology" (CPT) codes (maintained by the "American Medical Association" (AMA)), which are "Level 1" HCPCS codes.(30) HIPPS--Health Insurance Prospective Payment System.(31) Hospital--A public, for-profit or nonprofit institution licensed as a general or special hospital (25 TAC §133.2(21)) of this title, or a hospital owned by the state.(32) ICD--International Classification of Disease.(33) IRB--Institutional Review Board composed of DSHS' appointees or agents who have experience and expertise in ethics, patient confidentiality, and health care data who review and approve or disapprove requests for data or information other than the outpatient event public use data.(34) Operating or Other Physician--The "physician" licensed by the Texas Medical Board or "other health professional" licensed by the State of Texas who performed the surgical or radiological procedure most closely related to the principal diagnosis.(35) Other health professional--A person licensed to provide health care services other than a physician. An individual other than a physician who provides diagnostic or therapeutic procedures to patients. The term encompasses persons licensed under various Texas practice statutes, such as psychologists, chiropractors, dentists, nurse practitioners, nurse midwives, and podiatrists who are authorized by the facilities to examine, observe or treat patients.(36) Other Provider--For the purposes of reporting on the modified ANSI 837 Institutional Guide, the physician, other health professional or facility as reported on a claim, who performed a secondary surgical or a primary or secondary radiological procedure on the patient for the event if they are not reported as the operating or other physician or the facility. In the case where a substitute provider (locum tenens) is used, that physician or other health professional shall be submitted as specified in this subchapter.(37) Outpatient or patient--For the purposes of this subchapter, a patient who receives surgical or radiological services from an ambulatory surgical center, or a patient who receives surgical or radiological services from a hospital and is not admitted to a hospital for inpatient services. Outpatients include patients who receive one or more services covered by the revenue codes or surgical and radiological categories that are specified in §421.67(f) or §421.67(g) of this title, which may occur in the emergency department, ambulatory care, radiological, imaging or other types of hospital units. Outpatient includes a patient who is transferred from an ambulatory surgical center to another facility or a hospital patient who is under observation and not admitted to the hospital.(38) Patient account number--A number assigned to each patient by the facility which appears on each computer record in a patient event claim. This number is not consistent for a given patient from one facility to the next, or from one admission to the next in the same facility. DSHS will delete or encrypt this number to protect patient confidentiality prior to release of data.(39) Physician--An individual licensed under the laws of this state to practice medicine under the Medical Practice Act, Occupations Code, Chapter 151 et seq.(40) Provider--For the purposes of this subchapter, a physician or facility.(41) Public use data file--For the purposes of this subchapter, a data file composed of event claims which have been altered by the deletion, encryption or other modification of data fields to protect patient and physician confidentiality and to satisfy other restrictions on the release of data imposed by statute.(42) Race--A division of patients according to traits that are transmissible by descent and sufficient to characterize them as distinctly human types. Facilities shall report this data element according to the following racial types: American Indian, Eskimo, or Aleut; Asian or Pacific Islander; Black; White; or Other.(43) Radiological procedures--For the purposes of this subchapter, diagnostic procedures performed on a patient using radiant energy devices (Projection Radiology (for example - X-ray), Computed Tomography, or other ionizing radiation) or diagnostic radioactive material or other non-ionizing imaging devices (e.g., Magnetic Resonance Imaging, Nuclear Medicine devices (for example Positron Emission Tomography), Sound Imaging devices (for example Ultrasound or Echocardiography), Thermal imaging devices, Diagnostic Light imaging devices (for example - diagnostic photography, endoscopy, and fundoscopy) and other diagnostic imaging devices.(44) Rendering provider or rendering other health professional--For the purposes of reporting on the modified ANSI 837 Professional Guide, the physician or other health professional who performed the surgical or radiological procedure on the patient for the event. In the case where a substitute provider (locum tenans) is used, that physician or other health professional shall be submitted as specified in this subchapter. For purposes of this definition, the term "provider" is not limited to only a physician or facility as defined in paragraphs (26), (36), and (40) of this subsection.(45) Required minimum data set--The list of data elements for which facilities may submit an event claim for each patient event occurring in the facility. The required minimum data sets are specified in §421.67(d) and (e) of this title. This list does not include all the data elements that are required by the modified ANSI 837 Institutional Guide or modified ANSI 837 Professional Guide to submit an acceptable event file. For example: Interchange Control Headers and Trailers, Functional Group Headers and Trailers, Transaction Set Headers and Trailers and Qualifying Codes (which identify or qualify subsequent data elements).(46) Research data file--A customized data file, which may include the data elements in the public use file and may include data elements other than the required minimum data set submitted to DSHS, except those data elements that could reasonably identify a patient or physician.(47) Submission--The transfer of a set of computer records as specified in §421.67 of this title that constitutes the event file for one or more reporting hospitals under this subchapter.(48) Submitter--The person or organization which physically prepares an event file for one or more facilities and submits them under this subchapter. A submitter may be a facility or an agent designated by a facility or its owner.(49) Surgical procedure--For the purposes of this subchapter, an invasive procedure that penetrates or breaks the skin or other patient tissue (in vivo) for the purpose diagnosing, evaluating, analyzing, monitoring or treating a patient.(50) THCIC Identification Number--A string of 6 characters assigned by DSHS to identify facilities for reporting and tracking purposes. For a facility operating multiple facility locations under one license number and duplicating services at those locations, DSHS will assign a distinguishable identifier for each separate facility location under one license number. The relationship of the identifier to the name and license number of the facility is public information.(51) Uniform patient identifier--A unique identifier assigned by DSHS to an individual patient and composed of numeric, alpha, or alphanumeric characters, which remains constant across facilities and patient events. The relationship of the identifier to the patient-specific data elements used to assign it is confidential.(52) Uniform physician identifier--A unique identifier assigned by DSHS to a physician or other health professional who is reported as operating, rendering or other provider providing health care services or treating a patient in a facility and which remains constant across facilities. The relationship of the identifier to the physician-specific data elements used to assign it is confidential. The uniform physician identifier shall consist of alphanumeric characters.(53) Validation--The process by which a provider verifies the accuracy and completeness of data and corrects any errors identified before certification. Source Note: The provisions of this §421.61 adopted to be effective August 29, 2004, 29 TexReg 8123; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective February 26, 2009, 33 TexReg 9694; amended to be effective October 31, 2011, 36 TexReg 5214; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429; amended to be effective June 17, 2020, 45 TexReg 4041. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.61 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193979&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193979 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193979&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193979 03/11/2026 (a) Each facility in operation for all or any of the reporting periods described in §421.63 of this title (relating to Schedule for Filing Event Files) shall submit to DSHS event claims as specified in §421.67 of this title (relating to Event Files--Records, Data Fields and Codes) on all patient events in which the patient received one or more of the surgical procedures or radiological services covered by the revenue codes or surgical and radiological categories specified in §421.67(f) or (g) of this title. All facilities that are exempt under the Health and Safety Code, Chapter 108, but choose to participate in reporting under this subchapter, shall comply with the requirements in this subchapter. To the extent the medical screening examination, triage, observation, diagnosis or treatment is made by a health professional, other than a physician, data elements specified in §421.67(d)(25) - (30) or (e)(19) of this title shall be filled accordingly or data elements in §421.67(d)(26) or (29) in the modified ANSI 837 Institutional Guide or §421.67(e)(20) in the modified ANSI 837 Professional Guide shall be marked with one of DSHS approved temporary "Physician" or "Other health professional" code numbers and data elements in §421.67(d)(25)(A) - (C) or (28)(A) - (C) in the ANSI 837 Institutional Guide format or §421.67(e)(19)(A) - (C) in the ANSI 837 Professional Guide format may be left blank. (b) All patient events in which the patient received one or more of the surgical procedures or radiological services covered by the revenue codes or surgical and radiological categories specified in §421.67(f) or §421.67(g) of this title shall be reported by the facility that prepares one or more bills for patient services. (1) The facility shall submit an event claim corresponding to each bill containing the data elements required by §421.67 of this title. For all patients who received one or more of the surgical procedures or radiological services covered by the revenue codes or surgical and radiological categories specified in §421.67(f) or §421.67(g) of this title for which the facility does not prepare a bill for patient services, the facility shall submit an event claim containing the required minimum data set. (2) For all patients that are covered by 42 USC §290dd-2 and 42 CFR Part 2.1, a hospital or ambulatory surgical center shall submit a discharge claim containing the required data elements specified by §421.67 of this title. The hospital or ambulatory surgical center shall replace the patient identifying information with the default values specified in §421.67(h) of this title or submit the patient identifying information if release of patient identifying information is authorized in writing by the patient or patient's guardian. (c) Each facility shall submit event files by electronic filing unless the facility receives an exemption letter from DSHS. (d) Each facility shall submit event claims and event files in the format specified in §421.67 of this title. (e) Each facility shall submit event files, data certifications and other required information to DSHS or its agents at physical or telephonic addresses specified by DSHS. DSHS shall notify all facilities and submitters in writing and by publication in the Texas Register at least 30 calendar days before any change in the addresses. (f) Each facility may submit event files, or may designate an agent to submit the event files. If a facility designates an agent, it shall inform DSHS of the designation in writing at least 30 calendar days prior to the agent's submission of any discharge report. The facility shall inform DSHS in writing at least 30 calendar days prior to changing agents or making the submissions itself. Source Note: The provisions of this §421.62 adopted to be effective August 29, 2004, 29 TexReg 8123; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective February 26, 2009, 33 TexReg 9694; amended to be effective October 31, 2011, 36 TexReg 5214; amended to be effective December 18, 2014, 39 TexReg 7582; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.62 Collection of Hospital Outpatient and Ambulatory Surgical Center Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193980&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193980 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193980&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193980 03/11/2026 (a) For patient events occurring on or after January 1, 2009, as specified by DSHS, facilities shall file event files according to the following schedule as shown in paragraphs (1) - (4) of this subsection:(1) Each event claim covering patient events occurring between January 1 and March 31, inclusive, shall be submitted no later than June 1 of the calendar year in which the discharge occurred.(2) Each event file covering patient events occurring between April 1 and June 30, inclusive, shall be submitted no later than September 1 of the calendar year in which the discharge occurred.(3) Each event file covering patient events occurring between July 1 and September 30, inclusive, shall be submitted no later than December 1 of the calendar year in which the discharge occurred.(4) Each event file covering patient events occurring between October 1 and December 31, inclusive, shall be submitted no later than March 1 of the year following the year in which the discharge occurred.(b) Extensions to processing due dates may be granted by DSHS in response to a written request signed by the facility's chief executive officer. Requests must be in writing, must be received at least 5 working days prior to the due date and must be accompanied by adequate justification for the delay. A timely written request shall constitute a stay (delay) of the due date until a decision is issued by DSHS. Source Note: The provisions of this §421.63 adopted to be effective August 29, 2004, 29 TexReg 8123; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective February 26, 2009, 33 TexReg 9694; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.63 Schedule for Filing Event Files https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193981&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193981 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193981&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193981 03/11/2026 (a) Electronic Data Interchange. Event files may be filed electronically using electronic data interchange (EDI). All event files and event claims shall be reported using the same file and record formats specified in §421.67 of this title (relating to Event Files--Records, Data Fields and Codes) regardless of the medium of transmission. DSHS shall document instructions for filing event files by EDI and shall make this documentation available to facilities at no charge and to the public for the cost of reproduction. DSHS shall notify facilities reporting under this subchapter and their designated agents directly in writing at least 90 calendar days in advance of any change in instructions for filing event files by EDI. DSHS' instructions shall follow Department of Information Resources standards for EDI.(b) File Transfer Protocol (FTP). Event files may be filed by FTP using a Transmission Control Protocol over Internet Protocol (TCP/IP) Network connection. DSHS shall document instructions for filing event files by FTP and shall make this documentation available to facilities at no charge and to the public for the cost of reproduction or on DSHS' website. DSHS shall notify facilities reporting under this subchapter and their designated agents directly in writing at least 90 calendar days in advance of any change in instructions for filing event files by FTP. DSHS' instructions shall follow Department of Information Resources standards for FTP.(c) Other Electronic, Magnetic, or other Portable Data Storage Media. An event report may be filed on other electronic, magnetic, or portable data storage media with prior written approval by DSHS. All events shall be reported using the same file and record formats specified in §421.67 of this title regardless of medium. DSHS will not normally approve any medium which DSHS or the DSHS contract vendor is not currently equipped to read at the time of the request for approval.(1) Media specifications are:(A) Optical Media: Devices or disc that uses digital optical disc data storage format, for example Compact Disc (CD) or Digital Video Disc (DVD). Compact disk (CD): MS-DOS formatted; PC Text file (ASCII);(B) Universal Serial Bus (USB) flash drive: portable data memory device using flash memory with a USB interface; or(C) other electronic, magnetic, or other portable data storage media only with the prior written approval from DSHS. DSHS will not normally approve any medium which DSHS is not currently equipped to read.(2) Facilities shall submit to DSHS only pre-approved media with the following external identification affixed:(A) hospital name;(B) facility identifier;(C) reporting period for discharges;(D) number of records by record type; and(E) the description: "OUTPATIENT DATA."(3) In addition to the provisions of this section, DSHS shall document instructions for filing discharge reports on electronic, magnetic, or portable data storage media and shall make this documentation available to facilities at no charge and to the public for the cost of reproduction. DSHS shall notify facilities or their designated agents directly in writing at least 90 calendar days in advance of any change in instructions for filing event reports on electronic, magnetic, or portable data storage media. Source Note: The provisions of this §421.64 adopted to be effective August 29, 2004, 29 TexReg 8123; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective February 26, 2009, 33 TexReg 9694; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.64 Instructions for Filing Event Files https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193982&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193982 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193982&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193982 03/11/2026 (a) Upon receipt of an event file, DSHS shall establish a process to determine if it satisfies minimum criteria for processing. If it does not, DSHS shall establish a process to provide a report to be returned to the submitter regarding the invalid event file in a format and media that is approved for that provider and states the deficiencies. The facility shall submit a corrected event file within 10 calendar days of notification by DSHS or DSHS' agent. An event file does not meet minimum standards for processing if the file structure does not conform to the specifications in §421.67 of this title (relating to Event Files--Records, Data Fields and Codes).(b) Correction of Data Content Errors.(1) DSHS shall establish an audit process for all event files accepted for processing. DSHS shall notify the facility identified from the event file in detail of all errors detected in an event file which was received in an acceptable format as provided in §421.67 of this title.(2) Within 30 calendar days of receiving initial notice of errors in an event file, the facility shall correct all event claims containing errors, add any event claims determined to be missing from the initial event file and resubmit the corrected and/or previously missing event claims. If the facility disagrees with any identified error, the facility may indicate that the event claim is as accurate as it can be or cannot be corrected. Each facility shall submit such modified and/or additional event claims as may be required to allow the chief executive officer or the chief executive officer's designated agent to certify the quarterly event file as required by §421.66 of this title (relating to Certification of Compiled Event Data). Corrections to an event file shall be submitted on approved media and formats as specified in §421.64 of this title (relating to Instructions for Filing Event Files) and §421.67 of this title unless DSHS approves another medium or format.(3) Within 10 calendar days of receiving corrections to an event file from a facility, DSHS shall notify the facility of any remaining errors. The facility shall have 10 calendar days from receipt of this notice to correct the errors noted or indicate why the data should be deemed acceptable and complete. This process may be repeated until the data is substantially accurate and the facility is able to certify the event file as required by §421.66 of this title or the deadline for submitting corrections prior to certification is reached. Corrected data is required to be submitted on or before the following dates for the respective quarter's discharges: Quarter 1 - August 1; Quarter 2 - November 1; Quarter 3 - February 1; Quarter 4 - May 1. DSHS may grant an extension to all facilities when deemed necessary.(4) Event claims that have not been previously submitted shall be submitted prior to the deadline for the following quarter's data. Correction and certification of these previously missing or additional event claims for the prior calendar quarter shall be made according to the deadlines established for following quarter in which the data that is scheduled to be processed as specified in §421.63(a) of this title (relating to the Schedule for Filing Event Files), paragraph (3) of this subsection concerning the acceptance of event files and correction of data content errors), and §421.66(b) and (d) of this title. Corrections to event claims previously submitted or that have a statement date prior to calendar quarter immediately before the calendar quarter being processed scheduled will not be processed.(c) DSHS will document format acceptance criteria for event files. DSHS shall make this information available to submitters and facilities. Source Note: The provisions of this §421.65 adopted to be effective August 29, 2004, 29 TexReg 8123; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective February 26, 2009, 33 TexReg 9694; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.65 Acceptance of Event Files and Correction of Data Content Errors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184769&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184769 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184769&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184769 03/11/2026 (a) Within 5 months after the end of each reporting quarter, DSHS shall establish a process to compile one or more electronic data files for each facility using the event claims received from each facility. The certification file shall have one record for each patient event during the reporting quarter and one record for any patient event occurring during one prior reporting quarter for which additional event claims have been received. The data files, including reports returned to the facilities, allow the facility to provide physicians and other health professionals the opportunity to review, request correction of, and comment on patients for whom an event occurred under the jurisdiction of the facilities and they are indicated as "attending" or "operating or other." DSHS shall determine the format and medium in which the quarterly file will be delivered to facilities.(b) The chief executive officer or chief executive officer's designated agent of each facility shall mark the appropriate box on the form provided indicating whether the facility is certifying or not certifying the event data and reports in the certification file specified in subsection (a) of this section. The chief executive officer or chief executive officer's designated agent shall sign and return the form to DSHS by fax or mail. A person designated by the chief executive officer and acting as the officer's agent may sign the certification form. Designation of an agent does not relieve the chief executive officer of personal responsibility for the certification. If the chief executive officer or chief executive officer's designated agent does not believe the quarterly file is accurate, the officer shall provide DSHS with detailed comments regarding the errors or submit a written request (on a form supplied by DSHS) and provide the data, processes and resources necessary to correct any inaccuracy and certify the certification file subject to those corrections being made prior to the deadlines specified in this subsection. Corrections to certification event data shall be submitted on or prior to the following schedule: Quarter 1- October 1; Quarter 2- January 1; Quarter 3- April 1; and Quarter 4- July 1. Chief Executive Officers or designees that elect not to certify shall submit a reasoned justification explaining their decision to not certify their discharge encounter data and attach the justification to the certification form. Election to not certify data does not prevent certification file data from appearing in the public use data file. Data that is not corrected and submitted by the deadline may appear in the public use data file.(c) The signed certification form shall represent that:(1) policies and procedures are in place within the facility's processes to validate and assure the accuracy of the event data and any corrections submitted; and(2) all errors and omissions known to the facility have been corrected or the facility has submitted comments describing the errors and the reasons why they could not be corrected; and(3) to the best of their knowledge and belief, the data submitted accurately represents the facility's administrative status of patients for which the services covered by the revenue codes or surgical and radiological categories identified in §421.67(f) or §421.67(g) of this title (relating to Event File--Records, Data Fields and Codes) were provided for the reporting quarter; and(4) the facility has provided physicians and other health professionals a reasonable opportunity to review and comment on the event data of patients for which they were reported in one of the available physician number and name fields provided on the acceptable formats specified in §421.67 of this title (for example, "attending physician" or "operating or other physician" as applicable). The physicians or other health professionals may write comments and have errors brought to the attention of the chief executive officer or the chief executive officer's designated agent who shall address any comments by the physicians or other health professionals; or(5) if the chief executive officer or the officer's designee elects not to certify the event data file for a specific quarter, a written justification of any unresolved data issues concerning the accuracy and completeness of the data at the time of the certification shall be included on the certification form. Event claim data that has been audited, returned to the facility and is not certified, may be released and published in the public use data file and used by DSHS for analysis.(d) Each facility shall submit its certification form for each quarter's data to DSHS by the fifteenth day of the seventh month (Quarter 1- October 15; Quarter 2- January 15; Quarter 3- April 15; and Quarter 4- July 15) following the last day of the reporting quarter as specified in §421.63(a)(1) - (4) of this title (relating to Schedule for Filing Event Files). DSHS may extend the deadline for any or all facilities when deemed necessary.(e) Facilities, physicians or other health professionals may submit concise written comments regarding any data submitted by the associated facilities or relating to services they have delivered which may be released as public use data. Comments shall be submitted to DSHS on or before the dates specified in subsection (d) of this section, regarding the submission of the certification form. Commenters are responsible for assuring that the comments contain no patient or physician identifying information. Comments shall be submitted electronically using the method described in §421.64(a) and (b) of this title (relating to Instructions for Filing Event Files).(f) Failure to submit a signed certification form that is supplied by DSHS on or before the dates specified in subsection (d) of this section corresponding to event data previously submitted shall be considered as not certified. Source Note: The provisions of this §421.66 adopted to be effective August 29, 2004, 29 TexReg 8123; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective February 26, 2009, 33 TexReg 9694; amended to be effective October 31, 2011, 36 TexReg 5214; amended to be effective July 5, 2017, 42 TexReg 3373. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.66 Certification of Compiled Event Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193983 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193983 03/11/2026 (a) Facilities shall submit event files, electronically in the file format for outpatient bills defined by the American National Standards Institute (ANSI), commonly known as the ANSI ASC X12N form 837 Health Care Claims transaction for institutional claims or ANSI ASC X12N form 837 Health Care Claims transaction for professional claims. ANSI updates these formats from time to time by issuing new versions and the United States Department of Health and Human Services adopts regulations regarding HIPAA that update the version allowed for claim submissions. (b) DSHS will make detailed specifications for these data elements available to submitters and to the public. (c) In addition to the data elements contained in the ANSI 837 Institutional Guide and the ANSI 837 Professional Guide, DSHS has specified the location where each of the following data elements in this subsection shall be reported in the ANSI 837 Institutional Guide format and the ANSI 837 Professional Guide format. Data element content, format and locations may change as state legislative requirements, or federal legislative or regulation requirements change (i.e., HIPAA). (1) Patient race - This data element shall be reported at Loop 2300 in the K3 segment as the second numeric value in this data segment. Acceptable codes are 1 = American Indian/Eskimo/Aleut, 2 = Asian or, Pacific Islander, 3 = Black, 4 = White and 5 = Other Race. In order to obtain this data, the facility staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient, to classify the patient. If the patient, or person speaking for the patient, declines to answer, the facility staff is to use its best judgment to make the correct classification based on available data. (2) Patient ethnicity - This data element shall be reported at Loop 2300 in the segment K3 as the first numeric value. Acceptable codes are 1 = Hispanic or Latino Origin and 2 = Not of Hispanic or Latino Origin. In order to obtain this data, the facility staff retrieves the patient's response from a written form or asks the patient, or the person speaking for the patient, to classify the patient. If the patient, or person speaking for the patient, declines to answer, the facility staff is to use its best judgment to make the correct classification based on available data. (3) Other E-codes - These additional E-codes (maximum of 9 other E-codes, a total of 10 E-codes may be submitted) shall be reported (if applicable) in the following ANSI 837 Institutional Guide locations: Loop 2300, segments, HI05-2, HI06-2, HI07-2, HI08-2, HI09-2, HI10-2, HI11-2 and HI12-2. (The first E-code is generally reported in Loop 2300 segment HI04-2). E-codes may be submitted in the ANSI 837 Professional Guide in the following locations Loop 2300, data fields: HI02-2, HI03-2, HI04-2, HI05-2, HI06-2, HI07-2 or HI08-2 if applicable preceded by "BN" qualifying code in the respective data field HI02-1, HI03-1, HI04-1, HI05-1, HI06-1, HI07-1 or HI08-1. (4) THCIC Identification Number - This data element shall be submitted in data segment REF02 (Secondary Identification Number) of one of the following Loops where the patient received the event services:(A) Loop 2010AA associated with the "Billing Provider"; or (B) Loop 2010AB associated with the "Pay-to provider"; or (C) Loop 2310E (ANSI 837 Institutional Guide) or Loop 2310D (ANSI 837 Professional Guide) associated with the "Service Facility Provider". (d) Facilities shall submit the required minimum data set in the following modified ANSI 837 Institutional Guide format for all patients that are uninsured or considered self-pay or covered by third party payers in which the payer requires the claim be submitted in an ANSI 837 Institutional Guide format or CMS-1450 format for which an event claim is required by this subchapter. The required minimum data set for the modified (as specified in subsection (c) of this section) ANSI 837 Institutional Guide format includes the following data elements as listed in this subsection: (1) Patient Name: (A) Patient Last Name; (B) Patient First Name; and (C) Patient Middle Initial. (2) Patient Address: (A) Patient Address Line 1; (B) Patient Address Line 2 (if applicable); (C) Patient City; (D) Patient State; (E) Patient ZIP; and (A)(F) Patient Country (if address is not in the United States of America, or one of its territories). (3) Patient Birth Date; (4) Patient Sex; (5) Patient Race; (6) Patient Ethnicity; (7) Patient Social Security Number; (8) Patient Account Number; (9) Patient Medical Record Number; (10) Claim Filing Indicator Code (primary and secondary); (11) Payer Name - Primary and secondary (if applicable, for both); (12) National Plan Identifier - for primary and secondary (if applicable) payers (National Health Plan Identification number, if applicable and when assigned by the Federal Government); (13) Type of Bill (Facility Type Code plus Claim Frequency Code);(14) Statement Dates; (15) Principal Diagnosis; (16) Patient's Reason for Visit; (17) External Cause of Injury (E-Code) up to 10 occurrences (if applicable); (18) Other Diagnosis Codes - up to 24 occurrences (all applicable); (19) Occurrence Code - up to 24 occurrences (if applicable); (20) Occurrence Code Associated Date - up to 24 occurrences (if applicable); (21) Value Code - up to 24 occurrences (if applicable); (22) Value Code Associated Amount - up to 24 occurrences (if applicable); (23) Condition Code - up to 24 occurrences (if applicable); (24) Related Cause Code - up to 3 occurrences (if applicable); (25) Other Provider or Other Health Professional Name (if applicable): (A) Other Provider or Other Health Professional Last Name; (B) Other Provider or Other Health Professional First Name; and (C) Other Provider or Other Health Professional Middle Initial.(26) Other Provider or Other Health Professional Primary Identifier (National Provider Identifier) (if applicable); (27) Other Provider or Other Health Professional Secondary Identifier (Texas state license number) (if applicable); (28) Operating Physician or Other Health Professional Name (if applicable): (A) Operating Physician or Other Health Professional Last Name; (B) Operating Physician or Other Health Professional First Name; and (C) Operating Physician or Other Health Professional Middle Initial. (29) Operating Physician or Other Health Professional Primary Identifier (National Provider Identifier) (if applicable); (30) Operating Physician or Other Health Professional Secondary Identifier (Texas state license number) (if applicable); (31) Total Claim Charges; (32) Revenue Service Line Details (up to 999 service lines) (all applicable); (A) Revenue Code; (B) Procedure Code; (C) HCPCS Procedure Modifier 1 (applicable to each submitted Procedure code); (D) HCPCS Procedure Modifier 2 (applicable to each submitted Procedure code); (E) HCPCS Procedure Modifier 3 (applicable to each submitted Procedure code); (F) HCPCS Procedure Modifier 4 (applicable to each submitted Procedure code);(G) Charge Amount; (H) Unit Code; (I) Unit Quantity; (J) Unit Rate; and (K) Non-covered Charge Amount. (33) Service Line Date (effective 90 calendar days after being published in the Texas Register ); (34) Service Provider Name; (35) Service Provider Primary Identifier - Provider Federal Tax ID (EIN) or National Provider Identifier; (36) Service Provider Address: (A) Service Provider Address Line 1; (B) Service Provider Address Line 2 (if applicable); (C) Service Provider City; (D) Service Provider State; and (E) Service Provider ZIP; and (37) Service Provider Secondary Identifier - THCIC 6-digit facility ID assigned to each facility;(38) Point of Origin (Source of Admission) (Hospital Emergency Department Visits only); and (39) Patient Status (Hospital Emergency Department Visits only).(e) Facilities shall submit the following required minimum data set in the following modified ANSI 837 Professional Guide format for all patients for which an event claim is required by a third party payer to be in the ANSI 837 Professional Guide format or CMS-1500 format and required to be submitted under this subchapter. At a facility's option, a facility may choose to submit the required data set listed in subsection (d) of this section. The required minimum data set for the modified (as specified in subsection (c) of this section) ANSI 837 Professional Guide format includes the following data elements as listed in this subsection. (1) Patient Name. (A) Patient Last Name; (B) Patient First Name; and (C) Patient Middle Initial; (2) Patient Address. (A) Patient Address Line 1; (B) Patient Address Line 2 (if applicable); (C) Patient City; (D) Patient State; (E) Patient ZIP; and (F) Patient Country (if address is not in the United States of America or one of its territories); (3) Patient Birth Date; (4) Patient Sex;(5) Patient Race; (6) Patient Ethnicity; (7) Patient Social Security Number; (8) Patient Account Number; (9) Patient Medical Record Number (if applicable); (10) Claim Filing Indicator Code (Payer Source - primary and secondary (if applicable for secondary payer source); (11) Payer Name - Primary and secondary (if applicable, for both); (12) National Plan Identifier - for primary and secondary (if applicable) payers (National Health Plan Identification number, if applicable and when assigned by the federal government); (13) Type of Bill (Facility Type Code plus Claim Frequency Code); (14) Service Date; (15) Principal Diagnosis; (16) Other Diagnosis Codes - up to 7 occurrences (all applicable); (17) Related Cause Code - up to 3 occurrences (if applicable); (18) Procedure Codes - up to 50 occurrences (all applicable): (A) HCPCS Procedure Modifier 1 (applicable to each submitted Procedure code); (B) HCPCS Procedure Modifier 2 (applicable to each submitted Procedure code); (C) HCPCS Procedure Modifier 3 (applicable to each submitted Procedure code); (D) HCPCS Procedure Modifier 4 (applicable to each submitted Procedure code); (E) Charge Amount; (F) Unit Code; and (G) Unit Quantity; (19) Rendering Provider or Rendering Other Health Professional Name (Up to 2 occurrences): (A) Rendering Provider or Rendering Other Health Professional Last Name; (B) Rendering Provider or Rendering Other Health Professional First Name; and (C) Rendering Provider or Rendering Other Health Professional Middle Initial; (20) Rendering Provider or Rendering Other Health Professional Primary Identifier (National Provider Identifier) (Up to 2 occurrences); (21) Rendering Provider or Rendering Other Health Professional Secondary Identifier (Texas state license number) (if primary identifier not available) (Up to 2 occurrences); (22) Total Claim Charges; (23) Service Provider Name;(24) Service Provider Primary Identifier--Provider Federal Tax ID (EIN) or National Provider Identifier; (25) Service Provider Address: (A) Service Provider Address Line 1; (B) Service Provider Address Line 2 (if applicable); (C) Service Provider City; (D) Service Provider State; and(E) Service Provider ZIP; (26) Service Provider Secondary Identifier--THCIC 6-digit Hospital ID assigned to each facility.(f) Facilities shall submit the required minimum data set to DSHS for each patient who has one or more of the following revenue codes in this subsection or one or more of the outpatient surgical or radiological procedures (which are covered by the service and procedure categories listed in subsection (g) of this section) for services rendered to the patient in the facility. Facilities operating in the State of Texas shall submit the required data elements as specified in subsection (d) or (e) of this section relating to the revenue codes in this subsection or the procedure codes covered in the service and procedure categories listed in subsection (g) of this section. (1) 0320 Radiology--Diagnostic General Classification. (effective 90 calendar days after being published in the Texas Register ); (2) 0321 Radiology--Diagnostic Angiocardiology; (3) 0322 Radiology--Diagnostic Arthrography; (4) 0323 Radiology--Diagnostic Arteriography; (5) 0329 Radiology--Diagnostic Other Radiology - Diagnostic; (6) 0330 Radiology--Therapeutic General Classification; (7) 0333 Radiology--Therapeutic Radiation Therapy; (8) 0339 Radiology--Therapeutic Other Radiology - Therapeutic; (9) 0340 Nuclear Medicine General Classification; (10) 0341 Nuclear Medicine Diagnostic; (11) 0342 Nuclear Medicine Therapeutic;(12) 0343 Nuclear Medicine Diagnostic Pharmaceuticals; (13) 0344 Nuclear Medicine Therapeutic Pharmaceuticals; (14) 0349 Nuclear Medicine Other Nuclear Medicine; (15) 0350 Computed Tomography (CT) Scan General Classification; (16) 0351 Computed Tomography (CT)--Head Scan; (17) 0352 Computed Tomography (CT)--Body Scan; (18) 0359 Computed Tomography (CT)--Other; (19) 0360 Operating Room Services General Classification; (20) 0361 Operating Room Services Minor Surgery; (21) 0369 Operating Room Services Other Operating Room Services; (22) 0400 Other Imaging Services General Classification; (23) 0401 Other Imaging Services Diagnostic Mammography; (24) 0403 Other Imaging Services Screening Mammography; (25) 0404 Other Imaging Services Positron Emission Tomography (PET); (26) 0409 Other Imaging Services Other Imaging Services;(27) 0481 Cardiology Cardiac Catheterization Lab; (28) 0483 Cardiology Echocardiology; (29) 0489 Cardiology Other Cardiology Services; (30) 0490 Ambulatory Surgical Care General Classification; (31) 0499 Ambulatory Surgical Care Other Ambulatory Surgical; (32) 0500 Outpatient Services General Classification; (33) 0509 Outpatient Services Other Outpatient; (34) 0610 Magnetic Resonance Technology General Classification; (35) 0611 Magnetic Resonance Technology Magnetic Resonance Imaging (MRI)--Brain/Brainstem; (36) 0612 Magnetic Resonance Technology Magnetic Resonance Imaging (MRI)--Spinal Cord/Spine; (37) 0614 Magnetic Resonance Technology Magnetic Resonance Imaging (MRI)--Other; (38) 0615 Magnetic Resonance Technology Magnetic Resonance Angiography (MRA)--Head and Neck; (39) 0616 Magnetic Resonance Technology Magnetic Resonance Angiography (MRA)--Lower Extremities; (40) 0618 Magnetic Resonance Technology Magnetic Resonance Angiography (MRA)--Other;(41) 0619 Magnetic Resonance Technology Other Magnetic Resonance Technology; (42) 0760 Specialty Room--Treatment/Observation Room General Classification; (43) 0761 Specialty Room--Treatment Room; (44) 0762 Specialty Room--Observation Room; and (45) 0769 Specialty Room--Other Specialty Room.(g) Service and Procedure Categories. The HCPCS code ranges relating to the surgical and radiological or imaging categories to be reported shall be specified by DSHS and published on DSHS' website by November 1st of the year prior to the date on which the services are performed. (1) Incision or excision of Central Nervous System (CNS); (2) Insertion, replacement, or removal of extracranial ventricular shunt; (3) Laminectomy, excision intervertebral disc; (4) Diagnostic spinal tap; (5) Insertion of catheter or spinal stimulator and injection into spinal canal; (6) Decompression of peripheral nerves; (7) Other diagnostic nervous system procedures (requiring surgical or radiological procedures); (8) Other operating room therapeutic nervous system surgical procedures; (9) Thyroidectomy, partial or complete; (10) Diagnostic endocrine procedures (requiring surgical or radiological procedures); (11) Other therapeutic endocrine procedures (requiring surgical or radiological procedures); (12) Corneal transplant; (13) Glaucoma procedures (requiring surgical or radiological procedures); (14) Lens and cataract procedures (requiring surgical or radiological procedures);(15) Repair of retinal tear, detachment (requiring surgical or radiological procedures); (16) Destruction of lesion of retina and choroid (requiring surgical or radiological procedures); (17) Diagnostic procedures on eye (requiring surgical or radiological procedures); (18) Other therapeutic procedures on eyelids, conjunctiva, cornea (requiring surgical or radiological procedures); (19) Other intraocular therapeutic procedures (requiring surgical or radiological procedures); (20) Other extraocular muscle and orbit therapeutic procedures (requiring surgical or radiological procedures); (21) Tympanoplasty; (22) Myringotomy; (23) Mastoidectomy; (24) Diagnostic procedures on ear (requiring surgical or radiological procedures); (25) Other therapeutic ear procedures (requiring surgical or radiological procedures); (26) Control of epistaxis (requiring surgical or radiological procedures); (27) Plastic procedures on nose (requiring surgical or radiological procedures); (28) Oral and Dental Services (requiring surgical or radiological procedures);(29) Tonsillectomy or adenoidectomy; (30) Diagnostic procedures on nose, mouth and pharynx (requiring surgical or radiological procedures); (31) Other non-operating room therapeutic procedures on nose, mouth and pharynx (requiring surgical procedures); (32) Other operating room therapeutic procedures on nose, mouth and pharynx (requiring surgical or radiological procedures); (33) Tracheostomy, temporary and permanent; (34) Tracheoscopy and laryngoscopy with biopsy; (35) Lobectomy or pneumonectomy; (36) Diagnostic bronchoscopy and biopsy of bronchus (requiring surgical or radiological procedures); (37) Other diagnostic procedures on lung and bronchus (requiring surgical or radiological procedures); (38) Incision of pleura, thoracentesis, chest drainage; (39) Other diagnostic procedures of respiratory tract and mediastinum (requiring surgical or radiological procedures); (40) Other non-operating room therapeutic procedures on respiratory system (requiring surgical procedures); (41) Other operating room therapeutic procedures on respiratory system (requiring surgical or radiological procedures); (42) Heart valve procedures; (43) Coronary artery bypass graft (CABG); (44) Percutaneous transluminal coronary angioplasty (PTCA); (45) Coronary thrombolysis (requiring surgical or radiological procedures); (46) Diagnostic Cardiovascular (Cardiac) catheterization, coronary arteriography; (47) Insertion, revision, replacement, removal of Cardiovascular (Cardiac) pacemaker or cardioverter/defibrillator (requiring surgical or radiological procedures); (48) Other operating room heart procedures (requiring surgical or radiological procedures); (49) Extracorporeal circulation auxiliary to open heart procedures (requiring surgical or radiological procedures); (50) Endarterectomy, vessel of head and neck; (51) Aortic resection, replacement or anastomosis; (52) Varicose vein stripping, lower limb; (53) Other vascular catheterization, not heart; (54) Peripheral vascular bypass; (55) Other vascular bypass and shunt, not heart; (56) Creation, revision and removal of arteriovenous fistula or vessel-to-vessel cannula for dialysis; (57) Hemodialysis; (58) Other operating room procedures on vessels of head and neck (requiring surgical or radiological procedures); (59) Embolectomy and endarterectomy of lower limbs (requiring surgical or radiological procedures); (60) Other operating room procedures on vessels other than head and neck (requiring surgical or radiological procedures); (61) Other diagnostic cardiovascular procedures (requiring surgical or radiological procedures); (62) Other non-operating room therapeutic cardiovascular procedures (requiring surgical or radiological procedures); (63) Bone marrow transplant;(64) Bone marrow biopsy; (65) Procedures on spleen (requiring surgical or radiological procedures); (66) Other therapeutic procedures, hemic or lymphatic system (requiring surgical or radiological procedures); (67) Ligation of esophageal varices; (68) Esophageal dilatation (requiring surgical or radiological procedures); (69) Upper gastrointestinal endoscopy, biopsy; (70) Gastrostomy, temporary or permanent; (71) Colostomy, temporary or permanent; (72) Ileostomy and other enterostomy; (73) Gastrectomy, partial or total; (74) Small bowel resection; (75) Colonoscopy or biopsy; (76) Proctoscopy or anorectal biopsy; (77) Colorectal resection; (78) Local excision of large intestine lesion (not endoscopic);(79) Appendectomy; (80) Hemorrhoid procedures (requiring surgical or radiological procedures); (81) Endoscopic retrograde cannulation of pancreas (ERCP); (82) Biopsy of liver; (83) Cholecystectomy or common duct exploration (requiring surgical or radiological procedures); (84) Inguinal or femoral hernia repair (requiring surgical or radiological procedures); (85) Other hernia repair (requiring surgical or radiological procedures); (86) Laparoscopy; (87) Abdominal paracentesis; (88) Exploratory laparotomy; (89) Excision, lysis peritoneal adhesions (requiring surgical or radiological procedures); (90) Other bowel diagnostic procedures (requiring surgical or radiological procedures); (91) Other non-operating room upper GI therapeutic procedures (requiring surgical or radiological procedures); (92) Other operating room upper GI therapeutic procedures (requiring surgical or radiological procedures); (93) Other non-operating room lower GI therapeutic procedures (requiring surgical or radiological procedures);(94) Other operating room lower GI therapeutic procedures (requiring surgical or radiological procedures); (95) Other gastrointestinal diagnostic procedures (requiring surgical or radiological procedures); (96) Other non-operating room gastrointestinal therapeutic procedures (requiring surgical or radiological procedures); (97) Other operating room gastrointestinal therapeutic procedures (requiring surgical or radiological procedures); (98) Endoscopy or endoscopic biopsy of the urinary tract;(99) Transurethral excision, drainage, or removal urinary obstruction (requiring surgical or radiological procedures); (100) Ureteral catheterization; (101) Nephrotomy or nephrostomy; (102) Nephrectomy, partial or complete; (103) Kidney transplant; (104) Genitourinary incontinence procedures (requiring surgical or radiological procedures); (105) Extracorporeal lithotripsy, urinary (requiring surgical or radiological procedures); (106) Indwelling catheter; (107) Procedures on the urethra (requiring surgical or radiological procedures); (108) Other diagnostic procedures of urinary tract (requiring surgical or radiological procedures); (109) Other non-operating room therapeutic procedures of urinary tract (requiring surgical or radiological procedures); (110) Other operating room therapeutic procedures of urinary tract (requiring surgical or radiological procedures); (111) Transurethral resection of prostate (TURP); (112) Open prostatectomy; (113) Circumcision; (114) Diagnostic procedures, male genital (requiring surgical or radiological procedures);(115) Other non-operating room therapeutic procedures, male genital (requiring surgical or radiological procedures); (116) Other operating room therapeutic procedures, male genital (requiring surgical or radiological procedures); (117) Oophorectomy, unilateral or bilateral; (118) Other operations on ovary (requiring surgical or radiological procedures); (119) Ligation of fallopian tubes (requiring surgical or radiological procedures); (120) Removal of ectopic pregnancy (requiring surgical or radiological procedures); (121) Other operations on fallopian tubes (requiring surgical or radiological procedures); (122) Hysterectomy, abdominal or vaginal (requiring surgical or radiological procedures); (123) Other excision of cervix or uterus; (124) Abortion (termination of pregnancy); (125) Dilatation and curettage (D&C), aspiration after delivery or abortion (requiring surgical or radiological procedures); (126) Diagnostic dilatation and curettage (D&C); (127) Repair of cystocele or rectocele, obliteration of vaginal vault (requiring surgical or radiological procedures); (128) Other diagnostic procedures, female organs (requiring surgical or radiological procedures);(129) Other non-operating room therapeutic procedures, female organs (requiring surgical or radiological procedures); (130) Other operating room therapeutic procedures, female organs (requiring surgical or radiological procedures); (131) Episiotomy; (132) Cesarean section; (133) Forceps, vacuum, or breech delivery (requiring surgical or radiological procedures); (134) Artificial Rupture of membranes to assist delivery (requiring surgical procedures); (135) Other procedures to assist delivery (requiring surgical or radiological procedures); (136) Diagnostic amniocentesis; (137) Fetal monitoring (requiring surgical or radiological procedures); (138) Repair of current obstetric laceration; (139) Other therapeutic obstetrical procedures (requiring surgical or radiological procedures); (140) Partial excision bone; (141) Bunionectomy or repair of toe deformities (requiring surgical or radiological procedures); (142) Treatment, facial fracture or dislocation (requiring surgical or radiological procedures); (143) Treatment, fracture or dislocation of radius and ulna (requiring surgical or radiological procedures); (144) Treatment, fracture or dislocation of hip and femur (requiring surgical or radiological procedures); (145) Treatment, fracture or dislocation of lower extremity (other than hip or femur) (requiring surgical or radiological procedures); (146) Other fracture and dislocation procedure (requiring surgical or radiological procedures);(147) Arthroscopy; (148) Division of joint capsule, ligament or cartilage; (149) Excision of semilunar cartilage of knee; (150) Arthroplasty knee; (151) Hip replacement, total or partial; (152) Arthroplasty other than hip or knee; (153) Arthrocentesis; (154) Injections and aspirations of muscles, tendons, bursa, joints and soft tissue (requiring surgical or radiological procedures); (155) Amputation of lower extremity; (156) Spinal fusion (requiring surgical or radiological procedures); (157) Other diagnostic procedures on musculoskeletal system (requiring surgical or radiological procedures); (158) Other therapeutic procedures on muscles and tendons (requiring surgical or radiological procedures); (159) Other operating room therapeutic procedures on bone (requiring surgical or radiological procedures); (160) Other operating room therapeutic procedures on joints (requiring surgical or radiological procedures); (161) Other non-operating room therapeutic procedures on musculoskeletal system (requiring surgical or radiological procedures); (162) Other operating room therapeutic procedures on musculoskeletal system (requiring surgical or radiological procedures); (163) Breast biopsy or other diagnostic procedures on breast (requiring surgical or radiological procedures); (164) Lumpectomy, quadrantectomy of breast; (165) Mastectomy; (166) Incision and drainage, skin and subcutaneous tissue (requiring surgical or radiological procedures); (167) Excision of skin lesion; (168) Suture of skin or subcutaneous tissue; (169) Skin graft; (170) Other diagnostic procedures on skin or subcutaneous tissue; (171) Other non-operating room therapeutic procedures on skin or breast (requiring surgical or radiological procedures); (172) Other operating room therapeutic procedures on skin or breast (requiring surgical or radiological procedures); (173) Other organ transplantation; (174) Computerized axial tomography (CT) scan head; (175) Computerized axial tomography (CT) scan chest; (176) Computerized axial tomography (CT) scan abdomen;(177) Other Computerized axial tomography (CT) scan; (178) Myelogram; (179) Mammography; (180) Routine chest X-ray; (181) Intraoperative cholangiogram; (182) Upper gastrointestinal X-ray; (183) Lower gastrointestinal X-ray; (184) Intravenous pyelogram; (185) Cerebral arteriogram; (186) Contrast aortogram; (187) Contrast arteriogram of femoral or lower extremity arteries; (188) Arteriogram or venogram (not heart or head); (189) Diagnostic ultrasound of head or neck; (190) Diagnostic ultrasound of heart (echocardiogram);(191) Diagnostic ultrasound of gastrointestinal tract; (192) Diagnostic ultrasound of urinary tract; (193) Diagnostic ultrasound of abdomen or retroperitoneum; (194) Other diagnostic ultrasound; (195) Magnetic resonance imaging; (196) Electroencephalogram (EEG) (requiring surgical or radiological procedures); (197) Swan-Ganz catheterization for monitoring; (198) Radioisotope bone scan; (199) Radioisotope pulmonary scan; (200) Radioisotope scan or function studies; (201) Other radioisotope scan; (202) Therapeutic Radiology; (203) Traction, splints, or other wound care (requiring surgical or radiological procedures); (204) Ophthalmologic or otologic diagnosis and treatment (requiring surgical or radiological procedures); (205) Nasogastric tube (requiring radiological procedures); (206) Blood transfusion; (207) Parenteral nutrition (via intravenous methods); (208) Cancer chemotherapy (requiring surgical or radiological procedures); (209) Conversion of Cardiovascular (Cardiac) rhythm; (210) Other diagnostic radiology and related (requiring surgical or radiological procedures); (211) Other therapeutic procedures (requiring surgical or radiological procedures); (212) Infertility Services (requiring surgical or radiological procedures); (213) Medications (Infusions and other forms requiring surgical or radiological procedures); and (214) Gastric bypass and volume reduction (requiring surgical or radiological procedures).(h) For patients that are covered by 42 USC §290dd-2 and 42 CFR Part 2, the hospital shall submit the following patient identifying information or default values in the specified record and field locations as required by subsection (a) of this section: (1) Patient Account Number - This alphanumeric patient control number shall be reported. This number is unique to the institution and episode of care and will be used by the health care facility to review and certify data. (2) Last Name--The patient's last name shall be removed and replaced with "Doe." (3) First Name--The patient's first name shall be removed and replaced with "Jane" if female, or "John" if male, and can include a sequential number (e.g., John1, John2, John3... etc.). (4) Middle Initial--The patient's middle initial shall be removed and left blank (space filled). (5) Date of Birth--"January 1" and the patient's year of birth shall be reported. (6) Address--The patient's residence address shall be removed and replaced with the health care facility's street address. (7) City--The patient's city of residence shall be removed and replaced with the hospital's city. (8) State--The patient's state of residence shall be reported. (9) ZIP Code--The patient's ZIP code of residence shall be removed and replaced with the health care facility's ZIP code. (10) Medical Record Number--The patient's medical record number shall be reported. This number is unique to the institution and episode of care and will be used by DSHS to process the claim data and for the health care facility to review and certify the patient's data. (11) Social Security Number--The Patient's Social Security Number shall be removed and replaced with "999999999." (12) Statement Dates--The month, day, and year of the statement from and statement through dates shall be reported as required. Only the year of service will be retained with record after transfer to the DSHS program administering and completing the processing of the data for the health care data collection system under Health and Safety Code, Chapter 108. Source Note: The provisions of this §421.67 adopted to be effective August 29, 2004, 29 TexReg 8123; transferred effective September 1, 2004, as published in the Texas Register September 10, 2004, 29 TexReg 8842; amended to be effective February 26, 2009, 33 TexReg 9694; amended to be effective October 31, 2011, 36 TexReg 5214; amended to be effective December 18, 2014, 39 TexReg 7582; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.67 Event Files--Records, Data Fields and Codes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193984 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193984 03/11/2026 (a) DSHS records are public records under Government Code, Chapter 552, except as specifically exempted by Health and Safety Code, §§108.010, 108.011 and 108.013 or other state or federal law. Copies of such records may be obtained upon request and upon payment of user fees established by DSHS. The public use data files shall be available for public inspection during normal business hours within ten business days of a written or oral request. Event claims in any format as submitted to DSHS are not available to the public and are exempt from disclosure pursuant to Health and Safety Code, §§108.010, 108.011 and 108.013, and shall not be released. Likewise, patient and physician identifying data collected by the DSHS through editing of facility data shall not be released.(b) Creation of codes and identifiers. DSHS shall develop the following codes and identifiers, as listed in paragraphs (1) - (2) of this subsection, required for creation of the public use data file and for other purposes.(1) DSHS shall create a process for assigning uniform patient identifiers, uniform physician identifiers and uniform other health professional identifiers using data elements collected. This process is confidential and not subject to public disclosure. Any documents or records produced describing the process or disclosing the person associated with an identifier are confidential and not subject to public disclosure.(2) DSHS shall create a process for assigning geographic identifiers to each event record.(c) The data elements specified for outpatient event reports in this section do not constitute "Provider Quality Data" as discussed in Health and Safety Code, §108.010.(d) Creation of public use data file. DSHS will create a public use data file by creating a single record for each reportable outpatient event and adding, modifying, or deleting data elements in the following manner as listed in this subsection:(1) delete patient and insured name, Social Security number, address and certificate data elements, any patient identifying information, and patient control and medical record numbers;(2) convert patient birth date to age;(3) convert procedure dates to a code for the day of the week;(4) convert occurrence dates to day values;(5) delete physician and other health professional names and numbers and assign an alphanumeric uniform physician identifier for the physicians and other health professionals who were reported as "rendering," "operating or other," or "other provider" on patients;(6) assign codes indicating the primary and secondary sources of payment;(7) suppress the record level data elements in a way that the aggregate numbers for a facility or geographic region for that data element is below the number five. Five is the established minimum cell size required by Health and Safety Code, §108.011(i), unless DSHS determines that a higher cell size is required to protect the confidentiality of an individual patient or physician;(8) convert all procedure codes to HCPCS codes (in the version that is current for the date the data was due to be submitted or the version in effect at the date of service);(9) add nationally accepted risk and severity adjustment scores utilizing an algorithm approved by DSHS, when available and applicable;(10) include the following data elements in the public use data file, unless the data element needs to be suppressed for patient or physician confidentiality as noted under paragraphs (7) or (11) of this subsection:(A) Event Year and Quarter;(B) Provider Name (Facility Name);(C) THCIC Identification Number;(D) Facility Type Indicators;(E) Patient Sex/Gender;(F) Patient ZIP Code;(G) County Code;(H) Health Service Region Code;(I) Patient State;(J) Patient Race;(K) Patient Ethnicity;(L) Claim Type Indicator;(M) Type of Bill;(N) Principal Diagnosis Code (Current version of ICD codes at the time data is submitted);(O) Other Diagnosis Codes (Up to 24 diagnosis codes can be submitted and reported. Current version of ICD codes at the time data is submitted);(P) Procedure codes (Up to 24 procedure codes can be submitted and reported. Current version of HCPCS codes at the time data is submitted);(Q) Reason For Visit (Current version of ICD or HCPCS codes at the time data is submitted);(R) External Cause of Injury (E-codes), (if applicable) (Current version of ICD codes at the time data is submitted. Up to nine (9) E-codes can be submitted and reported);(S) Related Cause Code, (if applicable) (Up to three (3) codes can be submitted and reported);(T) Day of Week Patient is provided services code (Sunday = 1, Monday = 2, Tuesday = 3, Wednesday = 4, Thursday = 5, Friday = 6, Saturday = 7);(U) Age group of the patient;(V) APG Code (Obtained from 3M APG Grouper) if applicable (Up to 10);(W) APG Category Code (Obtained from 3M APG Grouper) if applicable (Up to 10);(X) APG Type Code (Obtained from 3M APG Grouper) if applicable (Up to 10);(Y) Final APG Assignment Code (Obtained from 3M APG Grouper) if applicable (Up to 10);(Z) Final APG Category Code (Obtained from 3M APG Grouper) if applicable (Up to 10);(AA) APC Procedure Code (if applicable) (Up to 10);(BB) APC Procedure Status Indicator Code (if applicable) (Up to 10);(CC) APC Diagnosis Edits (if applicable) (Up to 10);(DD) APC Procedure Code Edits (if applicable) (Up to 10);(EE) APC Weight (if applicable) (Up to 10);(FF) APC Base Procedure (if applicable) (Up to 10);(GG) Clinical Classification Software Category Codes and associated codes, if applicable;(HH) Uniform Physician Identifier assigned to Rendering Physician or Rendering Other Health Professional;(II) Uniform Physician Identifier assigned to Operating Physician or Other Physician or Other Health Professional;(JJ) Uniform Physician Identifier assigned to Other Provider or Other Health Professional;(KK) Ancillary Service--Other Charges;(LL) Ancillary Service--Pharmacy Charges;(MM) Ancillary Service--Medical/Surgical Supply Charges;(NN) Ancillary Service--Durable Medical Equipment Charges;(OO) Ancillary Service--Used Durable Medical Equipment Charges;(PP) Ancillary Service--Physical Therapy Charges;(QQ) Ancillary Service--Occupational Therapy Charges;(RR) Ancillary Service--Speech Pathology Charges;(SS) Ancillary Service--Inhalation Therapy Charges;(TT) Ancillary Service--Blood Charges;(UU) Ancillary Service--Blood Administration Charges;(VV) Ancillary Service--Operating Room Charges;(WW) Ancillary Service--Lithotripsy Charges;(XX) Ancillary Service--Cardiology Charges;(YY) Ancillary Service--Anesthesia Charges;(ZZ) Ancillary Service--Laboratory Charges;(AAA) Ancillary Service--Radiology Charges;(BBB) Ancillary Service--MRI Charges;(CCC) Ancillary Service--Outpatient Services Charges;(DDD) Ancillary Service--Emergency Service Charges;(EEE) Ancillary Service--Ambulance Charges;(FFF) Ancillary Service--Professional Fees Charges;(GGG) Ancillary Service--Organ Acquisition Charges;(HHH) Ancillary Service--ESRD Revenue Setting Charges;(III) Ancillary Service--Clinic Visit Charges;(JJJ) Total Charges--Ancillary;(KKK) Total Non-Covered Ancillary Charges;(LLL) Total Charges;(MMM) Total Non-Covered Charges;(NNN) Encounter Identifier--a unique number for each encounter for the quarter;(OOO) Service Line Revenue Code;(PPP) Service Line Procedure Code;(QQQ) HCPCS/HIPPS Procedure Code;(RRR) HCPCS/HIPPS Procedure Modifiers (Up to 4 may be submitted and reported);(SSS) Service Line Charge Amount;(TTT) Service Line Unit Code;(UUU) Service Line Unit Count;(VVV) Service Line Non-Covered Charge Amount;(WWW) Patient Country (when the address is not in the United States of America and confidentiality can be maintained);(XXX) Point of Origin (Source of Admission) (Hospital Emergency Department Visits only);(YYY) Patient Status (Hospital Emergency Department Visits only); and(ZZZ) Hospital Emergency Department Indicator.(11) The following data elements for records submitted with diagnosis codes that are associated with alcohol or drug use will be modified to protect those patients that maybe covered by 42 USC §290dd-2 and 42 CFR Part 2:(A) Patient ZIP Code shall be reported as "`" (back quote);(B) Patient Country shall be reported as "`" (back quote); and(C) Patient Sex shall be reported as "U" (Unknown). Source Note: The provisions of this §421.68 adopted to be effective February 26, 2009, 33 TexReg 9694; amended to be effective October 31, 2011, 36 TexReg 5214; amended to be effective December 18, 2014, 39 TexReg 7582; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.68 Event Data Release https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184772&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184772 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184772&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184772 03/11/2026 Refer to §421.81 of this title (relating to Health Care Facilities Exemptions from Filing Requirements) for exemptions from filing discharge reports. Source Note: The provisions of this §421.69 adopted to be effective July 5, 2017, 42 TexReg 3373. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION D COLLECTION AND RELEASE OF OUTPATIENT SURGICAL AND RADIOLOGICAL PROCEDURES AT HOSPITALS AND AMBULATORY SURGICAL CENTERS §421.69 Exemptions from Filing Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199769&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199769 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199769&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199769 03/11/2026 The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Accurate and Consistent Data--Data that has been edited by DSHS and subjected to provider validation and certification.(2) ANSI--American National Standards Institute.(3) ANSI 837 Institutional Guide--American National Standards Institute, Accredited Standards Committee X12N, 837 Health Care Institutional Claim Implementation Guide.(4) APC--Ambulatory Payment Classification.(5) APG--Enhanced Ambulatory Patient Grouper--A prospective payment system (PPS) for ambulatory patient care developed by 3M™. The APGs provide information regarding the kinds and amounts of resources utilized in an outpatient emergency visit and classify patients with similar clinical characteristics.(6) Audit--An electronic standardized process developed and implemented by DSHS to identify potential errors and mistakes in file structure format or data element content by reviewing data fields for the presence or absence of data and the accuracy and appropriateness of data.(7) Certification File--One or more electronic files (may include reports concerning the data and its compilation process) compiled by DSHS that contain one record for each patient event which has at least one procedure covered in the revenue codes specified in §421.77(e) of this title (relating to Event Files--Records, Data Fields and Codes) submitted for each facility under this subchapter during the reporting quarter and may contain one record for any patient event occurring during one prior reporting quarter for whom additional event claims have been received.(8) Certification Process--The process by which a provider confirms the accuracy and completeness of the certification file required to produce the public use data file as specified in §421.76 of this title (relating to Certification of Compiled Event Data).(9) Charge--The amount billed by a provider for specific procedures or services provided to a patient before any adjustment for contractual allowances, government mandated fee schedules or write-offs for charity care, bad debt or administrative courtesy. The term does not include co-payments charged to health maintenance organization enrollees by providers paid by capitation or salary in a health maintenance organization.(10) Clinical Classifications Software--A classification system that groups diagnoses and procedures into a limited number of clinically meaningful categories developed at the United States Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ).(11) Comments--The notes or explanations submitted by the facilities, physicians or other health professionals concerning the provider quality reports or the encounter data for public use as described in the Texas Health and Safety Code, §108.010(c) and (e) and §108.011(g), respectively.(12) Data format--The sequence or location of data elements in an electronic record according to prescribed specifications.(13) DSHS--Department of State Health Services.(14) EDI--Electronic Data Interchange--A method of sending data electronically from one computer to another. EDI helps providers and payers maintain a flow of vital information by enabling the transmission of claims and managed care transactions.(15) Electronic Filing--The submission of computer records in machine readable form by modem transfer from one computer to another (EDI) or by recording the records on a nine-track magnetic tape, computer diskette, magnetic, or other portable data storage media acceptable to DSHS.(16) Emergency Department--Department or room within a hospital or freestanding emergency medical care facility as determined by federal or state law for the provision of emergency health care services.(17) Emergency Visit Patient or patient--For the purposes of this subchapter a patient who receives services in the emergency department or emergency room of the health care facility. Emergency Visit Patients include patients who receive one or more services, which occur in the emergency department or emergency room of the healthcare facility.(18) ESRD--End Stage Renal Disease.(19) Error--Data submitted on an event file which are not consistent with the format and data standards contained in this subchapter or with auditing criteria established by DSHS.(20) Ethnicity--The status of patients relative to Hispanic background. Facilities shall report this data element according to the following ethnic types: Hispanic or Non-Hispanic.(21) Event--The medical screening examination, triage, observation, diagnosis or treatment of a patient within the authority of a facility that occurs as result of an outpatient emergency visit.(22) Event claim--A set of computer records as specified in §421.77 of this title relating to a specific patient. "Event claim" corresponds to the ANSI 837 Institutional Guide term, "Transaction set."(23) Event file--A computer file as defined in §421.77 of this title periodically submitted on or on behalf of a facility in compliance with the provisions of this subchapter. "Event File" that corresponds to the ANSI 837 Institutional Guide terms, "Communication Envelope" or "Interchange Envelope."(24) Facility--For the purposes of this subchapter, a facility is a hospital or freestanding emergency medical care facility required to report under the Texas Health and Safety Code, Chapter 108 and this subchapter.(25) Facility Type Indicators--An indicator that provides information to the data user as to the type of facility or the primary health services delivered at that hospital (e.g., Acute Care Hospital, Children's Hospital, Cancer Hospital, or Freestanding Emergency Medical Care Facility. A facility may have more than one indicator.(26) Geographic identifiers--A set of codes indicating the health service region and county in which the patient resides.(27) HCPCS--Healthcare Common Procedure Coding System of the Centers for Medicare and Medicaid Services. This includes the "Current Procedural Terminology" (CPT) codes (maintained by the "American Medical Association" (AMA)), which are "Level 1" HCPCS codes.(28) Hospital--A public, for-profit, or nonprofit institution licensed as a general or special hospital as defined in §133.2(21) of this title (relating to Definitions), or a hospital owned by the state.(29) ICD--International Classification of Disease.(30) Inpatient--A patient, including a newborn infant, who is formally admitted to the inpatient service of a hospital and who is subsequently discharged, regardless of status or disposition. Inpatients include patients admitted to medical/surgical, intensive care, nursery, subacute, skilled nursing, long-term, psychiatric, substance abuse, physical rehabilitation and all other types of hospital units.(31) IRB--Institutional Review Board--composed of DSHS' appointees or agents who have experience and expertise in ethics, patient confidentiality, and health care data who review and approve or disapprove requests for data or information other than the emergency visit public use data.(32) Operating or Other Physician--The "physician" licensed by the Texas Medical Board or "other health professional" licensed by the State of Texas who performed the surgical or radiological procedure most closely related to the principal diagnosis.(33) Other health professional--A person licensed to provide health care services other than a physician. "Other health professional" is an individual other than a physician who provides diagnostic or therapeutic procedures to patients. The term encompasses persons licensed under various Texas practice statutes, such as psychologists, chiropractors, dentists, nurse practitioners, nurse midwives, physicians assistants and podiatrists who are authorized by the facilities to examine, observe or treat patients.(34) Other Provider--For the purposes of reporting on the modified ANSI 837 Institutional Guide, the physician, other health professional or facility as reported on a claim, who performed a secondary surgical or a primary or secondary radiological procedure on the patient for the event, if they are not reported as the operating or other physician or the facility. In the case where a substitute provider (locum tenens) is used, that physician or other health professional shall be submitted as specified in this subchapter.(35) Outpatient Emergency Visit--For the purposes of this subchapter, events associated with services in an emergency department, emergency room, or a freestanding emergency medical care facility.(36) Patient account number--A number assigned to each patient by the facility, which appears on each computer record in a patient event claim. This number is not consistent for a given patient from one facility to the next, or from one admission to the next in the same facility. DSHS will delete or encrypt this number to protect patient confidentiality prior to release of data.(37) Physician--An individual licensed under the laws of this state to practice medicine under the Medical Practice Act, Occupations Code, Chapter 151 et seq.(38) Provider--For the purposes of this subchapter, a physician or facility.(39) Public use data file--For the purposes of this subchapter, a data file composed of encounter or event claims which have been altered by the deletion, encryption or other modification of data fields to protect patient and physician confidentiality and to satisfy other restrictions on the release of data imposed by statute.(40) Race--A division of patients according to traits that are transmissible by descent and sufficient to characterize them as distinctly human types. Facilities shall report this data element according to the following racial types: American Indian, Eskimo, or Aleut; Asian or Pacific Islander; Black; White; or Other.(41) Required minimum data set--The list of data elements for which facilities may submit an event claim for each patient event occurring in the facility. The required minimum data sets are specified in §421.77(d) of this title. This list does not include all the data elements that are required by the modified ANSI 837 Institutional Guide to submit an acceptable event file. For example: Interchange Control Headers and Trailers, Functional Group Headers and Trailers, Transaction Set Headers and Trailers and Qualifying Codes (which identify or qualify subsequent data elements).(42) Research data file--A customized data file, which may include the data elements in the public use file and may include data elements other than the required minimum data set submitted to DSHS, except those data elements that could reasonably identify a patient or physician, except as authorized by law.(43) Submission--The transfer of a set of computer records as specified in §421.77 of this title that constitutes the event file for one or more reporting hospitals under this subchapter.(44) Submitter--The person or organization, which physically prepares an event file for one or more facilities and submits them under this subchapter. A submitter may be a facility or an agent designated by a facility or its owner.(45) THCIC Identification Number--A string of six characters assigned by DSHS to identify facilities for reporting and tracking purposes. For a facility operating multiple facility locations under one license number and duplicating services at those locations, DSHS will assign a distinguishable identifier for each separate facility location under one license number. The relationship of the identifier to the name and license number of the facility is public information.(46) Uniform patient identifier--A unique identifier assigned by DSHS to an individual patient and composed of numeric, alpha, or alphanumeric characters, which remains constant across facilities and patient events. The relationship of the identifier to the patient-specific data elements used to assign it is confidential.(47) Uniform physician identifier--A unique identifier assigned by DSHS to a physician or other health professional who is reported as attending, operating or other provider providing health care services or treating a patient in a facility and which remains constant across facilities. The relationship of the identifier to the physician-specific data elements used to assign it is confidential. The uniform physician identifier shall consist of alphanumeric characters.(48) Universal Resource Locator (URL)--A specific set of ordered characters to identify a unique resource location (address) on the Internet or World Wide Web.(49) Validation--The process by which a provider verifies the accuracy and completeness of data and corrects any errors identified before certification. Source Note: The provisions of this §421.71 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429; amended to be effective June 17, 2020, 45 TexReg 4041. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.71 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199770&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199770 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199770&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199770 03/11/2026 (a) Each facility in operation for all or any of the reporting periods described in §421.73 of this title (relating to Schedule for Filing Event Files) shall submit to DSHS emergency visit claims as specified in §421.77 of this title (relating to Event Files--Records, Data Fields and Codes) on all emergency visit patients. All facilities that are exempt under Texas Health and Safety Code, Chapter 108, which choose to participate in reporting under this subchapter, shall comply with the requirements in this subchapter. To the extent the medical screening examination, triage, observation, diagnosis or treatment is made by a health professional other than a physician, data elements specified in §421.77(d)(25) - (30) of this title shall be filed accordingly or data elements in §421.77(d)(26) or (29) of this title in the modified ANSI 837 Institutional Guide shall be marked with one of DSHS approved temporary "Physician" or "Other health professional" code numbers and data elements in §421.77(d)(28)(A) - (C) of this title in the ANSI 837 Institutional Guide format may be left blank.(b) All emergency visit events shall be reported by the facility that prepares one or more bills for patient services. The facility shall submit an event claim corresponding to each bill containing the data elements required by §421.77 of this title. For all patients who received one or more emergency services for which the facility does not prepare a bill for patient services, the facility shall submit an event claim containing the required minimum data set.(c) Each facility shall submit event files by electronic filing unless the facility receives an exemption letter from DSHS.(d) Each facility shall submit event claims and event files in the format specified in §421.77 of this title.(e) Each facility shall submit event files, data certifications and other required information to DSHS or its agents at physical, universal resource locator (URL) addresses or telephonic addresses specified by DSHS. DSHS shall notify all facilities and submitters in writing and by publication in the Texas Register at least 30 calendar days before any change in the addresses.(f) Each facility may submit event files, or may designate an agent to submit the event files. If a facility designates an agent, it shall inform DSHS of the designation in writing at least 30 calendar days prior to the agent's submission of any discharge report. The facility shall inform DSHS in writing at least 30 calendar days prior to changing agents or making the submissions itself. Source Note: The provisions of this §421.72 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective June 17, 2020, 45 TexReg 4041. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.72 Collection of Emergency Visit Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193986&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193986 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193986&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193986 03/11/2026 For patient events occurring on or after January 1, 2015, as specified by DSHS, facilities shall file event files according to the schedule listed in §421.63(a)(1) - (4) of this title (relating to Schedule for Filing Event Files). Source Note: The provisions of this §421.73 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.73 Schedule for Filing Event Files https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193987&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193987 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193987&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193987 03/11/2026 Electronic Data Interchange. Event files may be filed electronically using methods and media as specified in §421.64(a) and (b) of this title (relating to Instructions for Filing Event Files). Source Note: The provisions of this §421.74 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.74 Instructions for Filing Event Files https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193988&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193988 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193988&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193988 03/11/2026 Upon receipt of an event file, DSHS shall use the established process specified in §421.65(a) - (c) of this title (relating to Acceptance of Event Files and Correction of Data Content Errors). Source Note: The provisions of this §421.75 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.75 Acceptance of Event Files and Correction of Data Content Errors https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193989&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193989 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=193989&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 193989 03/11/2026 The chief executive officer or chief executive officer's designated agent of each facility shall certify the compiled event data as specified in §421.66(a) - (f) of this title (relating to Certification of Compiled Event Data). Source Note: The provisions of this §421.76 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective January 30, 2019, 44 TexReg 429. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.76 Certification of Compiled Event Data https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199771&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199771 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199771&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199771 03/11/2026 (a) Facilities shall submit event files electronically in the file format for emergency visit bills defined by ANSI, commonly known as the ANSI ASC X12N form 837 Health Care Claims transaction for institutional claims. ANSI updates these formats from time to time by issuing new versions and the United States Department of Health and Human Services adopts regulations regarding HIPAA that update the version allowed for claim submissions.(b) DSHS will make detailed specifications for these data elements available to submitters and to the public. (c) In addition to the data elements contained in the ANSI 837 Institutional Guide, DSHS has specified the location where additional data elements shall be reported in the ANSI 837 Institutional Guide format. These are specified in §421.67(c) of this title (relating to Event Files--Records, Data Fields and Codes.) (d) Facilities shall submit the required minimum data set in the following modified ANSI 837 Institutional Guide format for all patients that are uninsured or considered self-pay or covered by third party payers in which the payer requires the claim be submitted in an ANSI 837 Institutional Guide format for which an event claim is required by this subchapter. The required minimum data set for the modified (as specified in subsection (c) of this section) ANSI 837 Institutional Guide format includes the following data elements as listed in this subsection: (1) Patient Name: (A) Patient Last Name; (B) Patient First Name; and (C) Patient Middle Initial. (2) Patient Address: (A) Patient Address Line 1; (B) Patient Address Line 2 (if applicable); (C) Patient City; (D) Patient State; (E) Patient ZIP; and (F) Patient Country (if address is not in United States of America, or one of its territories). (3) Patient Birth Date; (4) Patient Sex; (5) Patient Race; (6) Patient Ethnicity; (7) Patient Social Security Number; (8) Patient Account Number; (9) Patient Medical Record Number; (10) Claim Filing Indicator Code (primary and secondary); (11) Payer Name - Primary and secondary (if applicable, for both); (12) National Plan Identifier - for primary and secondary (if applicable) payers (National Health Plan Identification number, if applicable and when assigned by the Federal Government); (13) Type of Bill (Facility Type Code plus Claim Frequency Code); (14) Statement Dates; (15) Principal Diagnosis; (16) Patient's Reason for Visit; (17) External Cause of Injury (E-Code) up to 10 occurrences (if applicable); (18) Other Diagnosis Codes - up to 24 occurrences (all applicable); (19) Occurrence Code - up to 24 occurrences (if applicable); (20) Occurrence Code Associated Date - up to 24 occurrences (if applicable); (21) Value Code - up to 24 occurrences (if applicable); (22) Value Code Associated Amount - up to 24 occurrences (if applicable); (23) Condition Code - up to 24 occurrences (if applicable); (24) Related Cause Code - up to 3 occurrences (if applicable); (25) Attending Physician or Attending Practitioner Name (if applicable): (A) Attending Practitioner Last Name; (B) Attending Practitioner First Name; and (C) Attending Practitioner Middle Initial. (26) Attending Practitioner Primary Identifier (National Provider Identifier) (if applicable); (27) Attending Practitioner Secondary Identifier (Texas state license number) (if applicable); (28) Operating Physician or Other Health Professional Name (if applicable): (A) Operating Physician or Other Health Professional Last Name; (B) Operating Physician or Other Health Professional First Name; and (C) Operating Physician or Other Health Professional Middle Initial. (29) Operating Physician or Other Health Professional Primary Identifier (National Provider Identifier) (if applicable); (30) Operating Physician or Other Health Professional Secondary Identifier (Texas state license number) (if applicable); (31) Total Claim Charges; (32) Revenue Service Line Details (up to 999 service lines) (all applicable); (A) Revenue Code; (B) Procedure Code; (C) HCPCS Procedure Modifier 1 (applicable to each submitted Procedure code); (D) HCPCS Procedure Modifier 2 (applicable to each submitted Procedure code); (E) HCPCS Procedure Modifier 3 (applicable to each submitted Procedure code); (F) HCPCS Procedure Modifier 4 (applicable to each submitted Procedure code); (G) Charge Amount; (H) Unit Code; (I) Unit Quantity; (J) Unit Rate; and (K) Non-covered Charge Amount. (33) Service Line Date; (34) Service Provider Name; (35) Service Provider Primary Identifier - Provider Federal Tax ID (EIN) or National Provider Identifier; (36) Service Provider Address: (A) Service Provider Address Line 1; (B) Service Provider Address Line 2 (if applicable); (C) Service Provider City; (D) Service Provider State; and (E) Service Provider ZIP; and (37) Service Provider Secondary Identifier - THCIC 6-digit facility ID assigned to each facility; (38) Point of Origin (Source of Admission); and (39) Patient Status. (e) Facilities shall submit the required minimum data set to DSHS for each patient who has one or more of the following revenue codes in this subsection. Facilities operating in the State of Texas shall submit the required data elements as specified in subsection (d) of this section relating to the revenue codes in this subsection. (1) 0450 Emergency Room--General Classification; (2) 0451 Emergency Room--EMTALA Emergency Medical Screening; (3) 0452 Emergency Room--Emergency Room beyond EMTALA; (4) 0456 Emergency Room--Urgent Care; and (5) 0459 Emergency Room--Other Emergency Room; (f) This section is effective 90 calendar days after being published in the Texas Register. Source Note: The provisions of this §421.77 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective June 17, 2020, 45 TexReg 4041. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.77 Event Files--Records, Data Fields and Codes https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199772&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199772 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=199772&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 199772 03/11/2026 (a) DSHS records are public records under Government Code, Chapter 552, except as specifically exempted by Texas Health and Safety Code, §§108.010, 108.011 and 108.013 or other state or federal law. Copies of such records may be obtained upon request and upon payment of user fees established by DSHS. Event claims in any format as submitted to DSHS are not available to the public and are exempt from disclosure pursuant to Texas Health and Safety Code, §§108.010, 108.011 and 108.013, and shall not be released. Likewise, patient and physician identifying data collected by the DSHS through editing of facility data shall not be released.(b) Creation of codes and identifiers. DSHS shall develop the following codes and identifiers, as listed in paragraphs (1) - (2) of this subsection, required for creation of the public use data file and for other purposes.(1) DSHS shall create a process for assigning uniform patient identifiers, uniform physician identifiers and uniform other health professional identifiers using data elements collected. This process is confidential and not subject to public disclosure. Any documents or records produced describing the process or disclosing the person associated with an identifier are confidential and not subject to public disclosure.(2) DSHS shall create a process for assigning geographic identifiers to each event record.(c) The data elements specified for emergency visit reports in this section do not constitute "Provider Quality Data" as discussed in Texas Health and Safety Code, §108.010.(d) Creation of public use data file. DSHS will create a public use data file by creating a single record for each reportable emergency visit and adding, modifying, or deleting data elements in the following manner as listed in this subsection:(1) delete patient and insured name, Social Security number, address and certificate data elements, any patient identifying information, and patient control and medical record numbers;(2) convert patient birth date to age;(3) convert procedure dates to a code for the day of the week;(4) convert occurrence dates to day values;(5) delete physician and other health professional names and numbers and assign an alphanumeric uniform physician identifier for the physicians and other health professionals who were reported as "Attending," or "operating or other" on patients;(6) assign codes indicating the primary and secondary sources of payment;(7) suppress the record level data elements in a way that the aggregate numbers for a facility or geographic region for that data element is below the number five. Five is the established minimum cell size required by Texas Health and Safety Code, §108.011(i), unless DSHS determines that a higher cell size is required to protect the confidentiality of an individual patient or physician;(8) convert all procedure codes to HCPCS codes (in the version that is current for the date the data was due to be submitted or the version in effect at the date of service);(9) add nationally accepted risk and severity adjustment scores utilizing an algorithm approved by DSHS, when available and applicable;(10) include the following data elements in the public use data file, unless the data element needs to be suppressed for patient or physician confidentiality as noted under paragraph (7) of this subsection:(A) Event Year and Quarter;(B) Provider Name (Facility Name);(C) THCIC Identification Number;(D) Facility Type Indicators;(E) Patient Sex/Gender;(F) Patient ZIP Code;(G) County Code;(H) Health Service Region Code;(I) Patient State;(J) Patient Race;(K) Patient Ethnicity;(L) Claim Type Indicator;(M) Type of Bill;(N) Principal Diagnosis Code (Current version of ICD codes at the time data is submitted);(O) Other Diagnosis Codes (Up to 24 diagnosis codes can be submitted and reported. Current version of ICD codes at the time data is submitted);(P) Procedure codes (Up to 24 procedure codes can be submitted and reported. Current version of HCPCS codes at the time data is submitted);(Q) Reason For Visit (Current version of ICD or HCPCS codes at the time data is submitted);(R) External Cause of Injury (E-codes), (if applicable) (Current version of ICD codes at the time data is submitted. Up to nine (9) E-codes can be submitted and reported);(S) Related Cause Code, (if applicable) (Up to three (3) codes can be submitted and reported);(T) Day of Week Patient is provided services code (Sunday = 1, Monday = 2, Tuesday = 3, Wednesday = 4, Thursday = 5, Friday = 6, Saturday = 7);(U) Age group of the patient;(V) APG Code (Obtained from 3M™ APG Grouper) if applicable (Up to 10);(W) APG Category Code (Obtained from 3M™ APG Grouper) if applicable (Up to 10);(X) APG Type Code (Obtained from 3M™ APG Grouper) if applicable (Up to 10);(Y) Final APG Assignment Code (Obtained from 3M™ APG Grouper) if applicable (Up to 10);(Z) Final APG Category Code (Obtained from 3M™ APG Grouper) if applicable (Up to 10);(AA) APC Procedure Code (if applicable) (Up to 10);(BB) APC Procedure Status Indicator Code (if applicable) (Up to 10);(CC) APC Diagnosis Edits (if applicable) (Up to 10);(DD) APC Procedure Code Edits (if applicable) (Up to 10);(EE) APC Weight (if applicable) (Up to 10);(FF) APC Base Procedure (if applicable) (Up to 10);(GG) Clinical Classification Software Category Codes and associated codes, if applicable;(HH) Uniform Physician Identifier assigned to Rendering Physician or Rendering Other Health Professional;(II) Uniform Physician Identifier assigned to Operating Physician or Other Physician or Other Health Professional;(JJ) Uniform Physician Identifier assigned to Other Provider or Other Health Professional;(KK) Ancillary Service--Other Charges;(LL) Ancillary Service--Pharmacy Charges;(MM) Ancillary Service--Medical/Surgical Supply Charges;(NN) Ancillary Service--Durable Medical Equipment Charges;(OO) Ancillary Service--Used Durable Medical Equipment Charges;(PP) Ancillary Service--Physical Therapy Charges;(QQ) Ancillary Service--Occupational Therapy Charges;(RR) Ancillary Service--Speech Pathology Charges;(SS) Ancillary Service--Inhalation Therapy Charges;(TT) Ancillary Service--Blood Charges;(UU) Ancillary Service--Blood Administration Charges;(VV) Ancillary Service--Operating Room Charges;(WW) Ancillary Service--Lithotripsy Charges;(XX) Ancillary Service--Cardiology Charges;(YY) Ancillary Service--Anesthesia Charges;(ZZ) Ancillary Service--Laboratory Charges;(AAA) Ancillary Service--Radiology Charges;(BBB) Ancillary Service--MRI Charges;(CCC) Ancillary Service--Outpatient Services Charges;(DDD) Ancillary Service--Emergency Service Charges;(EEE) Ancillary Service--Ambulance Charges;(FFF) Ancillary Service--Professional Fees Charges;(GGG) Ancillary Service--Organ Acquisition Charges;(HHH) Ancillary Service--ESRD Revenue Setting Charges;(III) Ancillary Service--Clinic Visit Charges;(JJJ) Total Charges--Ancillary;(KKK) Total Non-Covered Ancillary Charges;(LLL) Total Charges;(MMM) Total Non-Covered Charges;(NNN) Encounter Identifier--a unique number for each encounter for the quarter;(OOO) Service Line Revenue Code;(PPP) Service Line Procedure Code;(QQQ) HCPCS Procedure Code;(RRR) HCPCS Procedure Modifiers (Up to 4 may be submitted and reported);(SSS) Service Line Charge Amount;(TTT) Service Line Unit Code;(UUU) Service Line Unit Count;(VVV) Service Line Non-Covered Charge Amount; and(WWW) Patient Country (when the address is not in the United States of America and confidentiality can be maintained). Source Note: The provisions of this §421.78 adopted to be effective December 18, 2014, 39 TexReg 7582; amended to be effective July 5, 2017, 42 TexReg 3373; amended to be effective January 30, 2019, 44 TexReg 429; amended to be effective June 17, 2020, 45 TexReg 4041. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.78 Emergency Visit Data Release https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184775&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184775 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184775&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184775 03/11/2026 Refer to §421.81 of this title (relating to Health Care Facilities Exemptions from Filing Requirements) for exemptions from filing discharge reports. Source Note: The provisions of this §421.79 adopted to be effective July 5, 2017, 42 TexReg 3373. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION E COLLECTION AND RELEASE OF HOSPITAL OUTPATIENT EMERGENCY ROOM DATA §421.79 Exemptions from Filing Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184776&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184776 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184776&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184776 03/11/2026 (a) Types of Exemptions.(1) Exemption as an exempted provider. All health care facilities except those owned by the federal government shall submit discharge reports to the department unless the department determines that the hospital shall be considered an exempted provider. The department shall make a determination of which health care facilities are entitled to this exemption and shall notify hospitals by email or by regular United States mail. This exemption, if granted, may be revoked by the department should the hospital cease to meet the criteria for exemption. Health care facilities that cease to be exempted as an exempted provider shall be responsible for submitting discharge claims on all discharges that occur 30 days after loss of the exemption. The initial discharge report shall not be due until 90 days after notice is given. Subsequent discharge reports are due as specified in §421.3(a) of this title (relating to Schedule for Filing Discharge Reports).(2) Exemptions from Quarterly Filing of Discharge Reports. Health care facilities that wish to submit discharge reports to the department more often than quarterly may do so by requesting an exemption to the standard submission schedule. The department may also issue general exemptions based on the processing arrangements for data collection. Exemption requests meeting the following criteria as shown in subparagraphs (A) - (D) of this paragraph will normally be approved.(A) The exemption request includes the specific schedule on which the health care facility will make its discharge reports, which will usually be daily, weekly or monthly.(B) The exemption request states the medium in which submissions will be made.(C) The exemption request will not result in data on any discharge being submitted to the department at a later date than it would have been if the standard schedule had been followed.(D) The health care facility agrees to adhere to the schedule specified in the exemption request until the health care facility notifies the department in writing that it wishes to end the exemption and report according to the standard schedule, or until a new exemption letter is issued.(b) Requests for exemptions shall be submitted and processed using the following procedures as shown in paragraphs (1) - (4) of this subsection.(1) A health care facility requesting an exemption shall submit to the department a letter requesting the exemption and providing all information necessary to establish the hospital's entitlement to the exemption. The exemption request shall be signed by the chief executive officer of the hospital who shall certify that all information contained in the request is true and correct.(2) The department shall review the request for exemption. The department may request additional information from the health care facility relevant to the exemption request. Within 30 days of receipt of a request, the department shall issue a letter granting or denying the exemption. If denied, the letter shall state in detail the reasons for the denial.(3) If the department denies an exemption request the health care facility may:(A) resubmit the request along with any additional information or analysis the health care facility deems relevant to the department. The resubmission shall be considered in the same manner as an initial submission; or(B) appeal the department's decision to the commissioner of the department. The health care facility may make an appeal directly to the commissioner of the department. In making its determination, the department will consider only those facts and issues which have been previously presented to the department.(4) The department may revoke any type of exemption if facts indicate that a health care facility no longer meets the criteria required for an exemption. The department shall give the health care facility written notice of the revocation at least 30 days prior to the effective date of the revocation. The notice shall include a detailed statement of the facts on which the revocation is based. A health care facility may challenge the revocation of its exemption by:(A) requesting the department to reconsider the revocation by submitting any information or analysis the health care facility deems relevant to the department in writing at least ten days prior to the effective date of the revocation; and(B) by appealing to the commissioner of the department if the department does not grant the request for reconsideration. In making its determination, the commissioner of the department will consider only those facts and issues which have been previously presented to the department.(c) Reporting loss of exemptions. Health care facilities shall notify the department in writing within 30 days of their loss of an exemption authorized by subsection (a) of this section. Source Note: The provisions of this §421.81 adopted to be effective July 5, 2017, 42 TexReg 3373. 1 DEPARTMENT OF STATE HEALTH SERVICES 421 HEALTH CARE INFORMATION F HEALTH CARE FACILITY EXEMPTIONS §421.81 Health Care Facilities Exemptions from Filing Requirements https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108800&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108800 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108800&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108800 03/11/2026 (a) Term of office. The chair shall be elected from among the members of the board at the annual meeting in odd-numbered years for a term of two years.(b) Duties. The chair of the board shall be the chief executive officer of the board and preside over all meetings of the board and of its executive committee. The chair shall represent the board before legislative bodies, official boards, and in the business of the board concerning public relations. Expenditures other than those related to the ordinary conduct of the business of the board shall require the approval of the chair.(c) Vacancy. In the event that the chairmanship is vacated, the vice chair shall succeed to that office for the remainder of the unexpired term, and if required, the executive committee may appoint a successor for the remainder of the unexpired term. Source Note: The provisions of this §471.1 adopted to be effective October 6, 1980, 5 TexReg 3803; amended to be effective May 14, 1979, 4 TexReg 1532; amended to be effective October 6, 1980; amended to be effective August 11, 1986, 11 TexReg 3404; amended to be effective January 7, 2001, 26 TexReg 199; amended to be effective March 29, 2004, 29 TexReg 3229. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 471 OFFICERS §471.1 Chair of the Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108801&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108801 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108801&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108801 03/11/2026 (a) Term of office. The vice chairman shall be elected from among the members of the board at the annual meeting in odd numbered years for a term of two years.(b) Vacancy. In the event that the vice chairmanship is vacated, the executive committee may appoint a successor for the remainder of the unexpired term, unless a regular meeting is imminent and no business is required.(c) Duties. The vice chairman shall have such duties as are assigned to him by the chairman. Source Note: The provisions of this §471.2 adopted to be effective May 14, 1979, 4 TexReg 1532; amended to be effective October 6, 1980, 5 TexReg 3803; amended to be effective August 11, 1986, 11 TexReg 3404; amended to be effective March 29, 2004, 29 TexReg 3229. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 471 OFFICERS §471.2 Vice Chairman of the Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83993&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83993 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83993&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83993 03/11/2026 (a) Term of office. The secretary-treasurer shall be elected from among the members of the board at the annual meeting in odd numbered years for a term of two years.(b) Duties. The secretary-treasurer shall(1) keep minutes of all meetings of the board and a record of other actions of the board and of its executive committee;(2) give notice of meetings and conduct the correspondence of the board;(3) prepare annually a report of the number of cadavers procured and used and of the number of students in courses in anatomy that required use of cadavers;(4) conduct all routine business of the board that does not require formal action of the board or of its executive committee;(5) receive and disburse all monies belonging to the board;(6) maintain both a checking and a savings account in an insured bank in the name of the Anatomical Board of the State of Texas;(7) withdraw monies from savings only with the approval of the board as attested by the signature of the chair;(8) prepare an annual financial report and send copies to all members of the board; and perform such other duties as may be directed by the board or its executive committee.(c) Bonding and audit. The secretary-treasurer shall be bonded as an individual in an amount not less than $10,000, costs of said bond to be paid by the board. If so directed by the board or its executive committee, the accounts of the board shall be audited by an expert accountant employed by the board.(d) Vacancy. In the event that the office of secretary-treasurer is vacated, the executive committee shall appoint an individual to perform the duties of the secretary-treasurer for the remainder of the unexpired term. Source Note: The provisions of this §471.3 adopted to be effective May 14, 1979, 4 TexReg 1532; amended to be effective October 6, 1980, 5 TexReg 3803; amended to be effective August 11, 1986, 11 TexReg 3404; amended to be effective January 7, 2001, 26 TexReg 199. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 471 OFFICERS §471.3 Secretary-Treasurer of the Board https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83994&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83994 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83994&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83994 03/11/2026 Officers of the board are eligible for re-election to the office without limitations. Source Note: The provisions of this §471.4 adopted to be effective August 11, 1986, 11 TexReg 3404; amended to be effective January 7, 2001, 26 TexReg 199. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 471 OFFICERS §471.4 Eligibility for Re-Election https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83991&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83991 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=83991&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 83991 03/11/2026 The executive committee shall be composed of the chair, the vice chair, and the secretary-treasurer. It shall be authorized to transact all necessary business of the board between meetings. Actions taken by the executive committee shall be reported to the full board at its next meeting. Source Note: The provisions of this §473.1 adopted to be effective May 14, 1979, 4 TexReg 1532; amended to be effective August 11, 1986, 11 TexReg 3404; amended to be effective January 7, 2001, 26 TexReg 199. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 473 EXECUTIVE COMMITTEE §473.1 Executive Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108804&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108804 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108804&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108804 03/11/2026 Regular meetings shall be held at least annually, at a place and a time designated by the secretary-treasurer as best suited to the convenience of the board. Thirty days written notice of the meeting shall be given to all members by the secretary-treasurer. Source Note: The provisions of this §475.1 adopted to be effective January 1, 1976; amended to be effective January 7, 2001, 26 TexReg 200; amended to be effective March 29, 2004, 29 TexReg 3230. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 475 MEETINGS §475.1 Regular Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108805&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108805 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108805&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108805 03/11/2026 Special meetings may be called from time to time by the chair, the secretary-treasurer, the executive committee, or upon written request of representatives of four member institutions. In such situations, the secretary-treasurer shall set a time and a place for such a special meeting and shall give each member of the board 10 days written notice. Source Note: The provisions of this §475.2 adopted to be effective January 1, 1976; amended to be effective August 11, 1986, 11 TexReg 3405; amended to be effective January 7, 2001, 26 TexReg 200; amended to be effective March 29, 2004, 29 TexReg 3230. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 475 MEETINGS §475.2 Special Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108806&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108806 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108806&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108806 03/11/2026 The executive committee shall meet from time to time at the pleasure of the chair or the secretary-treasurer. Source Note: The provisions of this §475.3 adopted to be effective January 1, 1976; amended to be effective August 11, 1986, 11 TexReg 3405; amended to be effective January 7, 2001, 26 TexReg 200; amended to be effective March 29, 2004, 29 TexReg 3230. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 475 MEETINGS §475.3 Meetings of the Executive Committee https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108807&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108807 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108807&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108807 03/11/2026 (a) All meetings of the board and its committees are subject to the Open Meetings Act, Government Code, Chapter 551.(b) A quorum for the transactions of business of the board and of its committees shall be a majority representation of the institutions comprising the board, or of the committee. Source Note: The provisions of this §475.4 adopted to be effective January 1, 1976; amended to be effective March 29, 2004, 29 TexReg 3230. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 475 MEETINGS §475.4 Meeting Requirements and Quorum https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197072&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197072 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197072&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197072 03/11/2026 The secretary-treasurer is authorized to reimburse members of the board and any additional necessary staff members for expenses incurred by members of the board and necessary staff members in attending any meeting of the board or of its committees. Requests for reimbursement shall conform in format and amounts claimed to similar requests of the parent institution of the member of the board or the parent institution of the necessary staff member. Source Note: The provisions of this §475.5 adopted to be effective January 1, 1976; amended to be effective January 7, 2001, 26 TexReg 200; amended to be effective November 19, 2019, 44 TexReg 7056. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 475 MEETINGS §475.5 Reimbursement for Travel to Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108827&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108827 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=108827&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 108827 03/11/2026 A person or institution is entitled to a hearing before the board refuses, suspends, or revokes authorization to receive and dissect bodies under Health and Safety Code, Section 691.034. Hearings shall be conducted by the State Office of Administrative Hearings (SOAH) in accordance with SOAH's procedural rules at Title 1, Texas Administrative Code, Section 155, et. seq. The board's decision shall be in writing and shall contain findings of fact and conclusions of law. The board's order is final. Source Note: The provisions of this §483.1 adopted to be effective March 29, 2004, 29 TexReg 3232. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 483 HEARING PROCEDURES §483.1 Hearing Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154740&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154740 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=154740&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 154740 03/11/2026 Each member institution shall conduct an audit of its procedures and methods for receiving, storing, using, and transporting bodies or anatomical specimens and disposing of remains. This audit must be conducted at an interval of 5 years, coincidental with regularly scheduled Board inspections. The audit shall be performed by the institution's audit department or a professional audit firm according to an audit template prescribed by the Board. The template shall be reviewed by the Board at each Annual Meeting. The results of the audit shall be filed with the secretary-treasurer within 30 days of its completion. A follow-up report shall be filed with the secretary-treasurer no more than 1 year later. Source Note: The provisions of this §485.1 adopted to be effective March 29, 2004, 29 TexReg 3232; amended to be effective January 23, 2012, 37 TexReg 198. 4 ANATOMICAL BOARD OF THE STATE OF TEXAS 485 AUDIT PROCEDURES §485.1 Audit Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179167&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179167 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=179167&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 179167 03/11/2026 (a) Purpose. The purpose of the Statewide Health Coordinating Council (council) is to review and assess major statewide health concerns and the availability and use of the state's health resources, including higher education resources, for addressing these issues in order to provide direction for the state's legislative and executive policy making processes.(b) Conflict of interest. A member who has a personal or private interest in a measure, proposal, or decision pending before the council shall publicly disclose the fact to the council in a meeting. The member may not vote or otherwise participate in the decision or discussion. The disclosure shall be entered in the minutes of the meeting. An individual does not have a "personal or private interest" in a measure, proposal, or decision if the individual is engaged in a profession, trade, or occupation and the individual's interest is the same as all others similarly engaged in the profession, trade, or occupation.(c) Assistance. The Texas Department of State Health Services (department) shall assist the council in performing the council's duties and functions as described in a memorandum of understanding between the council and the department. Source Note: The provisions of this §571.1 adopted to be effective November 8, 1995, 20 TexReg 8799; amended to be effective October 1, 2003, 28 TexReg 7710; amended to be effective August 1, 2016, 41 TexReg 5556. 6 STATEWIDE HEALTH COORDINATING COUNCIL 571 HEALTH PLANNING AND RESOURCE DEVELOPMENT A STATEWIDE HEALTH COORDINATING COUNCIL §571.1 General Provisions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131466&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131466 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=131466&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 131466 03/11/2026 (a) Proposed state health plan. The department, in accordance with rules adopted by the statewide health coordinating council, shall prepare and review a proposed state health plan every six years and shall revise and update the plan biennially. The council approves the state health plan for submission to the governor for adoption.(b) Periodic issue papers. The council may direct the department to prepare periodic issue papers analyzing important issues within the scope of the Health and Safety Code, §104.022, for the purpose of informing other governmental entities and the public regarding health concerns facing the state and options for addressing them.(c) Recommendations. On the basis of periodic issue papers and other information gathered by the council, the council shall prepare recommendations that will be part of the state health plan.(d) Public comment. The council shall give priority to soliciting public comment from throughout the state on the proposed plan and shall direct the department to prepare and make such revisions to the plan as it considers appropriate.(e) Plan presentation. The council shall develop and direct strategies for presentation of appropriate sections of the state health plan to the legislature.(f) Plan implementation. The legislative committee shall develop and submit to the council proposals and strategies for presentation of the state health plan to the legislature and for implementation of the plan. Source Note: The provisions of this §571.2 adopted to be effective October 1, 2003, 28 TexReg 7710. 6 STATEWIDE HEALTH COORDINATING COUNCIL 571 HEALTH PLANNING AND RESOURCE DEVELOPMENT A STATEWIDE HEALTH COORDINATING COUNCIL §571.2 State Health Plan and Plan Implementation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215970&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215970 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215970&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215970 03/11/2026 (a) The purpose of Chapters 601 - 604 of this title is to implement the duties of the Texas Medical Disclosure Panel under Texas Civil Practice and Remedies Code, Chapter 74 (relating to Medical Liability), Subchapter C (relating to Informed Consent), §§74.101-74.107.(b) The treatments and procedures requiring full disclosure of related risks and hazards by a physician or health care provider to a patient or person authorized to consent for the patient are found in Chapter 602 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A).(c) The treatments and procedures requiring no disclosure of related risks and hazards by a physician or health care provider to a patient or person authorized to consent for the patient are found in Chapter 603 of this title (relating to Procedures Requiring No Disclosure of Specific Risks and Hazards--List B).(d) The disclosure and consent forms adopted by the Panel are found in Chapter 604 of this title (relating to Disclosure Forms). Source Note: The provisions of this §601.1 adopted to be effective December 26, 2023, 48 TexReg 7984. 7 TEXAS MEDICAL DISCLOSURE PANEL 601 GENERAL §601.1 Purpose https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215971&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215971 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215971&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215971 03/11/2026 (a) The procedures requiring full disclosure--List A, the procedures requiring no disclosure--List B and the disclosure and consent form were first published in the December 15, 1981, issue of the Texas Register as §601.1 of this title (relating to Procedures Requiring Full Disclosure (List A)), §601.2 of this title (relating to Procedures Requiring No Disclosure (List B)), and §601.3 of this title (relating to Disclosure and Consent Form) and initially became effective on June 1, 1982.(b) The first amendments to §601.1 of this title and §601.2 of this title were published in the December 3, 1982, issue of the Texas Register and became effective on January 1, 1983.(c) The second amendments to §601.1 of this title and §601.2 of this title were published in the November 23, 1984, issue of the Texas Register and became effective on January 1, 1985.(d) The third amendments to §601.1 of this title and §601.2 of this title were published in the April 19, 1988, issue of the Texas Register and became effective on May 2, 1988.(e) The fourth amendment to §601.1 of this title was published in the July 21, 1989, issue of the Texas Register and became effective on August 3, 1989.(f) Further amendments to §601.1 of this title and §602.2 of this title and new §601.4 of this title (relating to Radiation Therapy Disclosure and Consent Form) were published in the February 2, 1990, issue of the Texas Register and became effective on May 3, 1990.(g) Effective October 3, 1995, §§601.1 - 601.4 of this title were repealed and replaced with new §601.1 of this title (relating to General), §601.2 of this title (relating to Procedures Requiring Full Disclosure (List A)), §601.3 of this title (relating to Procedures Requiring No Disclosure (List B)), and §601.4 of this title (relating to Disclosure and Consent Form), §601.5 of this title (relating to Radiation Therapy Disclosure and Consent Form), this section, and §601.7 of this title (relating to Informed Consent for Electroconvulsive Therapy). The sections were repealed to incorporate List A and List B into Texas Register format. In addition, sections were added to include general provisions; to provide a history of the rules of the panel; and to adopt a section which addresses informed consent for electroconvulsive therapy.(h) Effective October 23, 1997, §601.2 of this title was amended to update risks and hazards requiring full disclosure prior to performing abdominal endoscopic/laparoscopy procedures and endoscopic surgery of the thorax.(i) Effective February 18, 1998, §601.4 of this title and this section were amended and new §601.8 of this title (relating to Hysterectomy Disclosure and Consent Form) were added to address legislative requirements relating to informed consent for hysterectomies. Section 601.8 of this title adopts a form to be used in providing informed consent prior to performing a hysterectomy and applies to hysterectomies performed at least 90 days after the date of publication of adopted §601.8 of this title in the Texas Register .(j) Effective September 1, 2003, by Acts 2003, 78th Texas Legislature, Regular Session, Chapter 204, §10.01, Texas Civil Statutes, Article 4590i, Subchapter F, relating to informed consent was recodified to the Texas Civil Practice and Remedies Code, Chapter 74, Medical Liability, Subchapter C, §74.102 (relating to Texas Medical Disclosure Panel).(k) Effective March 18, 2004, §601.2 of this title (relating to Procedures Requiring Full Disclosure--List A) was amended to include the addition of clarifying and new language to subsection (g) concerning female genital system treatments and procedures. Risks were identified for dilation and curettage of uterus (diagnostic/therapeutic); surgical abortion/dilation and curettage/dilation and curettage/dilation and evacuation; and medical abortion/non-surgical procedures.(l) Effective October 16, 2005, §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A) was amended to include the addition of clarifying and new language concerning the cardiovascular system and nervous system treatments and procedures. Section 601.3 of this title (relating to Procedures Requiring No Disclosure of Specific Risks and Hazards--List B) was amended to remove procedures relating to the nervous system and radiology. Sections 601.4 and 601.5 were amended to include a Spanish language version of the disclosure and consent form for medical and surgical procedures, and the disclosure and consent form for radiation therapy. Section 601.8 was amended to make editorial corrections to the disclosure and consent for hysterectomy form and correct a difference between the English and Spanish language versions of the form.(m) Effective March 4, 2007, §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A) was amended to include procedures and risks and hazards for anesthesia, the digestive system treatments and procedures, the endocrine system treatments and procedures, and the hematic and lymphatic system. Section 601.3 of this title (relating to Procedures Requiring No Disclosure of Specific Risks and Hazards--List B) was amended to add and rename procedures relating to the digestive system.(n) Effective January 16, 2012, §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A) was amended to revise and include procedures and risks and hazards for the cardiovascular system, digestive system treatments and procedures, eye treatments and procedures, female genital system treatments and procedures, male genital system, maternity and related cases, musculoskeletal system treatments and procedures, radiology, respiratory system treatments and procedures, urinary system and pain management procedures. Section 601.3 of this title (relating to Procedures Requiring No Disclosure of Specific Risks and Hazards--List B) was amended to revise and include procedures relating to maternity and related cases, musculoskeletal system, respiratory system, urinary system, and pain management procedures. Section 601.9 of this title (relating to Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia)) was added to include a disclosure and consent form for anesthesia and/or perioperative pain management (analgesia). (o) Effective December 5, 2012, §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A) was amended to revise and include procedures and risks and hazards for the following systems: anesthesia, cardiovascular, musculoskeletal, and radiology. Section 601.3 of this title (relating to Procedures Requiring No Disclosure of Specific Risks and Hazards--List B) was amended to revise and include procedures for the following systems: cardiovascular, musculoskeletal, and radiology. A Spanish language version of the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) was added to §601.9 of this title (relating to Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia)).(p) Effective January 15, 2015, §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A) was amended to revise procedures and risks and hazards for the Hematic and Lymphatic System. Additionally, a new subsection (u) was added for Dental Surgery Procedures. Section 601.3 of this title (relating to Procedures Requiring No Disclosure of Specific Risks and Hazards--List B) was amended to revise procedures for anesthesia. Section 601.9 of this title (relating to Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) was amended to add Deep Sedation and Moderate Sedation to the anesthesia consent form. Both the English and Spanish language versions of the forms were amended.(q) Effective January 7, 2016, §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A) was amended to revise procedures and risks and hazards for female genital system treatments and procedures and laparoscopic/thoracoscopic surgery, and adds a new subsection (v) plastic surgery. Section 601.4 of this title (relating to Disclosure and Consent Form) for medical and surgical procedures, and §601.8 of this title (relating to Disclosure and Consent Form for Hysterectomy) were amended to add risks and hazards related to the use of blood and blood products, risks and hazards related to the use of a power morcellator in laparoscopic surgery, and deletion of references to anesthesia.(r) Effective December 24, 2017, §601.2 of this title was amended to revise procedures and risks and hazards for Anesthesia. Section 601.9 of this title (relating to Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia)) was amended to remove "Monitored Anesthesia Care" and to add risks and hazards related to potential long-term negative effects with the use of prolonged (greater than 3 hours) or repeated exposure to anesthesia on the fetus of a woman in her 3rd trimester of pregnancy and on a child up to 3 years of age. Source Note: The provisions of this §601.2 adopted to be effective December 26, 2023, 48 TexReg 7984. 7 TEXAS MEDICAL DISCLOSURE PANEL 601 GENERAL §601.2 History https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215972&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215972 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215972&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215972 03/11/2026 (a) Epidural.(1) Nerve damage.(2) Persistent back pain.(3) Headache.(4) Bleeding/epidural hematoma.(5) Infection.(6) Medical necessity to convert to general anesthesia.(7) Brain damage.(8) Chronic pain.(b) General.(1) Permanent organ damage.(2) Memory dysfunction/memory loss.(3) Injury to vocal cords, teeth, lips, eyes.(4) Awareness during the procedure.(5) Brain damage.(c) Spinal.(1) Nerve damage.(2) Persistent back pain.(3) Bleeding/epidural hematoma.(4) Infection.(5) Medical necessity to convert to general anesthesia.(6) Brain damage.(7) Headache.(8) Chronic pain.(d) Regional block.(1) Nerve damage.(2) Persistent pain.(3) Bleeding/hematoma.(4) Infection.(5) Medical necessity to convert to general anesthesia.(6) Brain damage.(e) Deep sedation.(1) Memory dysfunction/memory loss.(2) Medical necessity to convert to general anesthesia.(3) Permanent organ damage.(4) Brain damage.(f) Moderate sedation.(1) Memory dysfunction/memory loss.(2) Medical necessity to convert to general anesthesia.(3) Permanent organ damage.(4) Brain damage.(g) Prenatal/Early Childhood Anesthesia. Potential long-term negative effects on memory, behavior, and learning with prolonged or repeated exposure to general anesthesia/moderate sedation/deep sedation during pregnancy and in early childhood. Source Note: The provisions of this §602.1 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.1 Anesthesia Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215973&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215973 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215973&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215973 03/11/2026 (a) Cardiac.(1) Coronary artery bypass.(A) Acute myocardial infarction (heart attack).(B) Hemorrhage (severe bleeding).(C) Kidney failure.(D) Stroke.(E) Sudden death.(F) Infection of chest wall/chest cavity.(2) Heart valve replacement by open surgery, structural heart surgery.(A) Acute myocardial infarction (heart attack).(B) Hemorrhage (severe bleeding).(C) Kidney failure.(D) Stroke.(E) Sudden death.(F) Infection of chest wall/chest cavity.(G) Valve related delayed onset infection.(H) Malfunction of new valve.(I) Persistence of problem for which surgery was performed, including need for repeat surgery.(3) Heart transplant.(A) Infection.(B) Rejection.(C) Death.(4) Coronary angiography (Injection of contrast material into arteries of the heart), coronary angioplasty (opening narrowing in heart vessel), and coronary stent insertion (placement of permanent tube into heart blood vessel to open it).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(5) Percutaneous (through the skin) or minimally invasive heart valve insertion/replacement.(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Malfunction of new valve.(K) Need for permanent pacemaker implantation.(6) Left atrial appendage closure (closing of small pouch on left side of heart) - percutaneous (through the skin) or minimally invasive.(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Device embolization (device moves from intended location).(K) Pericardial effusion (development of fluid in the sack around the heart) and cardiac tamponade (fluid around heart causing too much pressure for heart to pump properly).(7) Patent foramen ovale/atrial septal defect/ventricular septal defect closure by percutaneous (through the skin) or minimally invasive procedure (closing of abnormal hole between the chambers of the heart).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Atrial fibrillation (irregular heart rhythm).(K) Pulmonary embolus (development of blood clot that travels to blood vessels in lungs).(L) Device embolization (device moves from where it is placed).(M) Cardiac perforation (creation of hole in wall of heart).(8) Electrophysiology studies (exams of heart rhythm), arrhythmia ablation (procedure to control or stop abnormal heart rhythms).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Rupture of myocardium/cardiac perforation (hole in wall of heart).(K) Cause or worsening of arrhythmia (damage to heart electrical system causing abnormal heart rhythm), possibly requiring permanent pacemaker implantation, possibly life threatening.(L) Pulmonary vein stenosis (narrowing of blood vessel going from lung to heart.(9) Pacemaker insertion, AICD insertion (implanted device to shock the heart out of an abnormal rhythm).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Rupture of myocardium/cardiac perforation (hole in wall of heart).(K) Cause or worsening of arrhythmia (damage to heart electrical system causing abnormal heart rhythm), possibly requiring permanent pacemaker implantation, possibly life threatening.(L) Device related delayed onset infection (infection related to the device that happens at some time after surgery).(10) Electrical cardioversion (shocking the heart out of an abnormal rhythm).(A) Heart arrhythmias (abnormal heart rhythm), possibly life threatening.(B) Skin burns on chest.(11) Stress testing.(A) Acute myocardial infarction (heart attack).(B) Heart arrhythmias (abnormal heart rhythm), possibly life threatening.(12) Transesophageal echocardiography (ultrasound exam of the heart from inside the throat).(A) Sore throat.(B) Vocal cord damage.(C) Esophageal perforation (hole or tear in tube from mouth to stomach).(13) Circulatory assist devices (devices to help heart pump blood).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy or other kidney injury (kidney damage due to the contrast agent used during the procedure or procedure itself).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Hemorrhage (severe bleeding) possibly leading to sudden death.(K) Hemolysis (blood cells get broken apart).(L) Right heart failure (poor functioning of the side of heart not assisted by device).(M) Acquired von Willebrand syndrome (platelets do not work).(N) Arrhythmia (irregular or abnormal heart rhythm).(O) Cardiac or vascular injury or perforation (hole in heart or blood vessel).(P) Limb ischemia (lack of blood flow or oxygen to limb that device placed through).(Q) Device migration or malfunction.(R) Exposure of device/wound break down with need for surgery to cover/reimplant.(14) Extracorporeal Membrane Oxygenation (ECMO).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.(B) Arrhythmia (abnormal heart rhythm), possibly life threatening.(C) Hemorrhage (severe bleeding).(D) Myocardial infarction (heart attack).(E) Worsening of the condition for which the procedure is being done.(F) Sudden death.(G) Stroke.(H) Contrast nephropathy or other kidney injury (kidney damage due to the contrast agent used during the procedure or procedure itself).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Thrombocytopenia (low platelets) or other coagulopathy (blood thinning).(K) Vascular or cardiac perforation (hole in blood vessel or heart).(L) Seizure.(M) Device migration or malfunction.(N) Ischemia to limb (lack of blood flow or oxygen to limb that device placed through).(O) Thromboembolism (blood clots in blood vessels or heart and possibly traveling to blood vessels in lungs).(b) Vascular.(1) Open surgical repair of aortic, subclavian, iliac, or other artery aneurysms or occlusions, arterial or venous bypass or other vascular surgery.(A) Hemorrhage (severe bleeding).(B) Paraplegia (unable to move limbs) (for surgery involving the aorta or other blood vessels to the spine).(C) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).(D) Worsening of the condition for which the procedure is being done.(E) Stroke (for surgery involving blood vessels supplying the neck or head).(F) Kidney damage.(G) Myocardial infarction (heart attack).(H) Infection of graft (material used to repair blood vessel).(2) Angiography (inclusive of aortography, arteriography, venography) - Injection of contrast material into blood vessels.(A) Injury to or occlusion (blocking) of artery which may require immediate surgery or other intervention.(B) Hemorrhage (severe bleeding).(C) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).(D) Worsening of the condition for which the procedure is being done.(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(3) Angioplasty (intravascular dilatation technique).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.(B) Hemorrhage (severe bleeding).(C) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).(D) Worsening of the condition for which the procedure is being done.(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Failure of procedure or injury to blood vessel requiring stent (small, permanent tube placed in blood vessel to keep it open) placement or open surgery.(4) Endovascular stenting (placement of permanent tube into blood vessel to open it) of any portion of the aorta, iliac or carotid artery or other (peripheral) arteries or veins.(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.(B) Hemorrhage (severe bleeding).(C) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).(D) Worsening of the condition for which the procedure is being done.(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(I) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(J) Failure of procedure or injury to blood vessel requiring stent (small, permanent tube placed in blood vessel to keep it open) placement or open surgery.(K) Change in procedure to open surgical procedure.(L) Failure to place stent/endoluminal graft (stent with fabric covering it).(M) Stent migration (stent moves from location in which it was placed).(N) Impotence (difficulty with or inability to obtain penile erection) (for abdominal aorta and iliac artery procedures).(5) Vascular thrombolysis (removal or dissolving of blood clots) - percutaneous (through the skin) (mechanical or chemical).(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.(B) Hemorrhage (severe bleeding).(C) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).(D) Worsening of the condition for which the procedure is being done.(E) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).(F) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).(G) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).(H) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(I) Kidney injury or failure which may be temporary or permanent (for procedures using certain mechanical thrombectomy devices).(J) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(K) Increased risk of bleeding at or away from site of treatment (when using medications to dissolve clots).(L) For arterial procedures: distal embolus (fragments of blood clot may travel and block other blood vessels with possible injury to the supplied tissue).(M) For venous procedures: pulmonary embolus (fragments of blood clot may travel to the blood vessels in the lungs and cause breathing problems or if severe could be life threatening).(N) Need for emergency surgery.(6) Angiography with occlusion techniques (including embolization and sclerosis) - therapeutic.(A) For all embolizations/sclerosis:(i) Injury to or occlusion (blocking) of blood vessel other than the one intended which may require immediate surgery or other intervention.(ii) Hemorrhage (severe bleeding).(iii) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).(iv) Worsening of the condition for which the procedure is being done.(v) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(vi) Unintended thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(vii) Loss or injury to body parts with potential need for surgery, including death of overlying skin for sclerotherapy/treatment of superficial lesions/vessels and nerve injury with associated pain, numbness or tingling or paralysis (inability to move).(viii) Infection in the form of abscess (infected fluid collection) or septicemia (infection of blood stream).(ix) Nontarget embolization (blocking of blood vessels other than those intended) which can result in injury to tissues supplied by those vessels.(B) For procedures involving the thoracic aorta and/or vessels supplying the brain, spinal cord, head, neck or arms, these risks in addition to those under subparagraph (A) of this paragraph:(i) Stroke.(ii) Seizure.(iii) Paralysis (inability to move).(iv) Inflammation or other injury of nerves (for procedures involving blood vessels supplying the spine).(v) For studies of the blood vessels of the brain: contrast-related, temporary blindness or memory loss.(C) For female pelvic arterial embolizations including uterine fibroid embolization, these risks in addition to those under subparagraph(A) of this paragraph:(i) Premature menopause with resulting sterility.(ii) Injury to or infection involving the uterus which might necessitate hysterectomy (removal of the uterus) with resulting sterility.(iii) After fibroid embolization: prolonged vaginal discharge.(iv) After fibroid embolization: expulsion/delayed expulsion of fibroid tissue possibly requiring a procedure to deliver/remove the tissue.(D) For male pelvic arterial embolizations, in addition to the risks under subparagraph (A) of this paragraph: impotence (difficulty with or inability to obtain penile erection).(E) For embolizations of pulmonary arteriovenous fistulae/malformations, these risks in addition to those under subparagraph (A) of this paragraph:(i) New or worsening pulmonary hypertension (high blood pressure in the lung blood vessels).(ii) Paradoxical embolization (passage of air or an occluding device beyond the fistula/malformation and into the arterial circulation) causing blockage of blood flow to tissues supplied by the receiving artery and damage to tissues served (for example the blood vessels supplying the heart (which could cause chest pain and/or heart attack) or brain (which could cause stroke, paralysis (inability to move) or other neurological injury)).(F) For varicocele embolization, these risks in addition to those under subparagraph (A) of this paragraph:(i) Phlebitis/inflammation of veins draining the testicles leading to decreased size and possibly decreased function of affected testis and sterility (if both sides performed).(ii) Nerve injury (thigh numbness or tingling).(G) For ovarian vein embolization/pelvic congestion syndrome embolization: general angiography and embolization risks as listed in subparagraph (A) of this paragraph.(H) For cases utilizing ethanol (alcohol) injection, in addition to the risks under subparagraph (A) of this paragraph: shock or severe lowering of blood pressure (when more than small volumes are utilized).(I) For varicose vein treatments (with angiography) see paragraph (12) of this subsection.(7) Mesenteric angiography with infusional therapy (Vasopressin) for gastrointestinal bleeding.(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.(B) Hemorrhage (severe bleeding).(C) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).(D) Worsening of the condition for which the procedure is being done.(E) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(F) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(G) Ischemia/infarction of supplied or distant vascular beds (reduction in blood flow causing lack of oxygen with injury or death of tissues supplied by the treated vessel or tissues supplied by blood vessels away from the treated site including heart, brain, bowel, extremities).(H) Antidiuretic hormone side effects of vasopressin (reduced urine output with disturbance of fluid balance in the body, rarely leading to swelling of the brain).(8) Inferior vena caval filter insertion and removal.(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.(B) Hemorrhage (severe bleeding).(C) Worsening of the condition for which the procedure is being done.(D) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(E) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere including caval thrombosis (clotting of main vein in abdomen and episodes of swelling of legs).(F) Injury to the inferior vena cava (main vein in abdomen).(G) Filter migration or fracture (filter could break and/or move from where it was placed).(H) Risk of recurrent pulmonary embolus (continued risk of blood clots going to blood vessels in lungs despite filter).(I) Inability to remove filter (for "optional"/retrievable filters).(9) Pulmonary angiography.(A) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.(B) Hemorrhage (severe bleeding).(C) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).(D) Worsening of the condition for which the procedure is being done.(E) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).(F) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.(G) Cardiac arrhythmia (irregular heart rhythm) or cardiac arrest (heart stops beating).(H) Cardiac injury/perforation (heart injury).(I) Death.(10) Percutaneous treatment of pseudoaneurysm (percutaneous thrombin injection through the skin versus compression).(A) Thrombosis (clotting) of supplying vessel or branches in its territory.(B) Allergic reaction to thrombin (agent used for direct injection).(11) Vascular access - nontunneled catheters, tunneled catheters, implanted access.(A) Pneumothorax (collapsed lung).(B) Injury to blood vessel.(C) Hemothorax/hemomediastinum (bleeding into the chest around the lungs or around the heart).(D) Air embolism (passage of air into blood vessel and possibly to the heart and/or blood vessels entering the lungs).(E) Vessel thrombosis (clotting of blood vessel).(12) Varicose vein treatment (percutaneous (through the skin), via laser, radiofrequency ablation (RFA), chemical or other method) without angiography.(A) Burns.(B) Deep vein thrombosis (blood clots in deep veins).(C) Hyperpigmentation (darkening of skin).(D) Skin wound (ulcer).(E) Telangiectatic matting (appearance of tiny blood vessels in treated area).(F) Paresthesia and dysesthesia (numbness or tingling in the area or limb treated).(G) Injury to blood vessel requiring additional procedure to treat. Source Note: The provisions of this §602.2 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.2 Cardiovascular System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225041&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225041 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225041&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225041 03/11/2026 (a) Cholecystectomy with or without common bile duct exploration.(1) Pancreatitis (inflammation of the pancreas).(2) Bile duct injury (Injury to the tube between the liver and the bowel).(3) Retained bile duct stones (stones remaining in the tube between the liver and the bowel).(4) Bile duct stenosis or occlusion (narrowing or obstruction of the tube between the liver and the bowel).(5) Injury to the bowel and/or intestinal obstruction.(6) Bile leak (leak of bile from end of gallbladder duct or variant duct from the liver).(b) Bariatric surgery (including gastric bypass (Roux-en-Y), biliopancreatic diversion with duodenal switch, sleeve gastrectomy, gastric banding).(1) Failure of wound to heal or wound dehiscence (separation of wound).(2) Injury to organs.(3) Failure of device, including slippage or erosion requiring additional surgical procedure (for surgeries with implanted devices such as gastric banding).(4) Obstructive symptoms requiring additional surgical procedure.(5) Development of gallstones (Roux-En-Y).(6) Development of metabolic and vitamin disorders (Roux-En-Y, biliopancreatic diversion with duodenal switch).(7) Dumping syndrome causing nausea, vomiting, diarrhea, dizziness, sweating (Roux-En-Y, biliopancreatic diversion with duodenal switch).(c) Pancreatectomy (subtotal or total and including Whipple Procedure (pancreaticoduodenectomy)).(1) Pancreatitis (inflammation of the pancreas) (subtotal). (2) Diabetes (total).(3) Lifelong requirement of enzyme and digestive medication. (4) Anastomotic leaks (leak of bile or intestinal fluids at surgical site where ducts and intestines are joined).(d) Colectomy - total or subtotal.(1) Permanent ileostomy.(2) Injury to organs.(3) Infection.(4) Anastomotic leaks (leak of bowel contents at site where intestines reattached).(5) Need for colostomy, permanent or temporary (subtotal colectomy).(6) Incontinence (if ileoanal anastomosis)(unable to control bowel if small bowel attached directly to anus).(e) Hepatobiliary drainage/intervention including percutaneous transhepatic cholangiography, percutaneous biliary drainage, percutaneous cholecystostomy, biliary stent placement (temporary or permanent), biliary stone removal/therapy (bile duct, gallbladder, and gallstone related procedures).(1) Leakage of bile at the skin site or into the abdomen with possible peritonitis (inflammation of the abdominal lining and pain or if severe can be life threatening).(2) Pancreatitis (inflammation of the pancreas).(3) Hemobilia (bleeding into the bile ducts).(4) Cholangitis, cholecystitis, sepsis (inflammation/infection of the bile ducts, gallbladder or blood).(5) Pneumothorax (collapsed lung) or other pleural complications (complication involving chest cavity).(f) Gastrointestinal tract stenting.(1) Stent migration (stent moves from location in which it was placed).(2) Esophageal/bowel perforation (creation of a hole or tear in the tube from the throat to the stomach or in the intestines). (3) Tumor ingrowth or other obstruction of stent.(4) For stent placement in the esophagus (tube from the throat to the stomach).(A) Tracheal compression (narrowing of windpipe) with resulting or worsening of shortness of breath.(B) Reflux (stomach contents passing up into esophagus or higher).(C) Aspiration pneumonia (pneumonia from fluid getting in lungs) (if stent in lower part of the esophagus).(D) Foreign body sensation (feeling like there is something in throat) (for stent placement in the upper esophagus).(E) Tracheoesophageal fistula (formation of hole and connection between the windpipe and tube between mouth and stomach).(g) Anti reflux procedures (surgical, endoscopic, including hiatal hernia repair).(1) Dysphagia (difficulty swallowing).(2) Stomach bloating, difficulty belching or vomiting.(3) Esophageal perforation (hole in tube from mouth to stomach).(4) Mediastinal abscess (infected collection in central portion of chest).(5) Pneumothorax (collapsed lung).(6) Device erosion into esophagus/surrounding tissues (procedures with implanted devices).(h) Endoscopy simple (diagnostic endoscopy).(1) Perforation (hole) of the esophagus (tube from mouth to stomach), stomach, small intestine (with leakage of contents into chest or abdomen), possibly requiring additional procedures including open surgery.(2) Need for inclusion of or conversion to advanced endoscopy procedures with those risks (see subsection (i) of this section).(i) Advanced upper endoscopic procedures (anything more than simple, diagnostic endoscopy) (ERCP, POEM, ESD, pancreatic fluid collection drainage/necrosectomy).(1) Perforation (hole) of the esophagus, stomach, small intestine (with leakage of contents into chest or abdomen).(2) Pancreatitis (inflammation of the pancreas) (for any procedures involving pancreas/pancreatic duct).(3) Hemorrhage (Severe bleeding).(4) Adjacent organ injury for transluminal procedures (e.g. liver biopsy, fluid drainage).(5) Biliary peritonitis (bile leakage causing inflammation of the abdominal cavity).(6) Sepsis (severe infection).(j) Appendectomy.(1) Injury to nearby organs.(2) Infectious collection of fluid (abscess) requiring additional procedure(s).(3) Normal appendix.(k) Hemorrhoidectomy with/without fistulectomy or fissurectomy. (1) Fecal incontinence (unable to control bowel).(2) Anal stenosis (narrowing of the anus).(3) Damage to bowel.(4) Recurrent or new hemorrhoid(s).(l) Repair and plastic operations on anus and rectum (anal fistula repair, rectovaginal fistula repair, rectal prolapse repair, anal sphincter repair, perineal reconstruction).(1) Fecal incontinence (unable to control bowel).(2) Anal stenosis (narrowing of the anus).(3) Damage to bowel.(m) Hernia repair (for example inguinal or ventral) (for hiatal hernia repair see subsection (g) of this section).(1) Injury to adjacent structures (bowel, bladder, blood vessels, nerves).(2) Seroma (fluid) or hematoma (blood) collection at surgical site.(3) Chronic pain.(4) Testicular injury (for those of male sex).(5) If mesh used, infection, failure, migration, or rejection of the mesh.(6) Recurrence.(n) Esophageal dilatation (opening a narrowing of the tube between the mouth and the stomach).(1) Perforation of the esophagus (creation of hole in tube from mouth to stomach), with possible need for additional procedures including open surgery.(2) Recurrent stenosis (return of narrowing of the tube from the mouth to the stomach).(o) Gastrostomy/gastrojejunostomy open, percutaneous, or endoscopic (placement of tube directly between the skin and the stomach with surgical incision, puncture from the skin into the stomach, or puncture from the stomach out towards the skin with endoscopy (camera)). (1) Damage to surrounding organs.(2) Hemorrhage (severe bleeding).(3) Peritonitis (irritation of the abdominal compartment). (p) Pyloromyotomy (cutting of the muscle at the end of the stomach to treat blockage of the stomach outlet).(1) Perforation (creation of a hole from the mucosa (inside of the stomach) to the outside of the stomach) possible requiring additional procedures or surgeries.(2) Incomplete myotomy (incomplete cutting of the muscle) possibly requiring repeat procedure/surgery.(3) Delayed gastric emptying (food takes longer to leave the stomach than normal).(q) Colonoscopy. Perforation (creation of a hole in the intestine) possibly requiring additional procedures or open surgery. Source Note: The provisions of this §602.3 adopted to be effective December 26, 2023, 48 TexReg 7985; amended to be effective May 25, 2025, 50 TexReg 2968. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.3 Digestive System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215975&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215975 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215975&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215975 03/11/2026 (a) Stapedectomy.(1) Facial paralysis.(2) Diminished or bad taste.(3) Total or partial loss of hearing in the operated ear.(4) Brief or long-standing dizziness.(5) Eardrum hole requiring more surgery.(6) Ringing in the ear.(b) Reconstruction of auricle of ear for congenital deformity or trauma.(1) Less satisfactory appearance compared to possible alternative artificial ear.(2) Exposure of implanted material with possible need for removal of material.(c) Tympanoplasty with mastoidectomy.(1) Facial paralysis.(2) Altered or loss of taste.(3) Recurrence of original disease process.(4) Total loss of hearing in operated ear.(5) Dizziness.(6) Ringing in the ear. Source Note: The provisions of this §602.4 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.4 Ear Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225042&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225042 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225042&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225042 03/11/2026 (a) Thyroidectomy.(1) Acute airway obstruction requiring temporary tracheostomy (creation of hole in neck to breathe).(2) Injury to nerves resulting in hoarseness or impairment of speech.(3) Injury to parathyroid glands resulting in low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness and muscle irritability.(4) Lifelong requirement of thyroid medication.(b) For scarless/minimally invasive thyroidectomy.(1) All risks of standard thyroidectomy.(2) For axillary approach.(A) Injury to brachial plexus (nerves in shoulder/neck) which can affect function of muscles and sensation in the affected extremity.(B) Tract seeding of thyroid tissue (thyroid tissue can deposit and grow along the surgical tract).(C) Postoperative seroma (fluid collection in the area of the surgery).(D) Great vessel injury (injury to large blood vessels of the upper chest and neck).(3) Transoral/transoral vestibular approach (TOETVA)).(A) CO2 embolism (gas bubbles enter bloodstream) (Transoral/transoral vestibular approach (TOETVA)).(B) Mental nerve injury (nerve injury causing paresthesias (pins and needles sensation) of the lower lip and/or chin) (Transoral/transoral vestibular approach (TOETVA)).(C) Skin perforation (hole in skin) (Transoral/transoral vestibular approach (TOETVA)).(D) Burns (Transoral/transoral vestibular approach (TOETVA)).(E) Surgical space infection (Transoral/transoral vestibular approach (TOETVA)).(c) Parathyroidectomy.(1) Acute airway obstruction requiring temporary tracheostomy (creation of hole in neck to breathe).(2) Injury to nerves resulting in hoarseness or impairment of speech.(3) Low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness, and muscle irritability.(4) Persistent high calcium level with need for additional treatment/surgery.(d) Adrenalectomy.(1) Loss of endocrine functions (lifelong requirement for hormone replacement therapy and steroid medication).(2) Damage to kidneys.(e) For pituitary surgery, see §602.13 of this chapter (relating to Nervous System Treatments and Procedures).(f) For pancreatic surgery, see §602.3 of this chapter (relating to Digestive System Treatments and Procedures). Source Note: The provisions of this §602.5 adopted to be effective December 26, 2023, 48 TexReg 7985; amended to be effective May 25, 2025, 50 TexReg 2968. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.5 Endocrine System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215976&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215976 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215976&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215976 03/11/2026 (a) Eye muscle surgery.(1) Additional treatment and/or surgery.(2) Double vision.(3) Partial or total blindness.(b) Surgery for cataract with or without implantation of intraocular lens.(1) Complications requiring additional treatment and/or surgery.(2) Need for glasses or contact lenses.(3) Complications requiring the removal of implanted lens.(4) Partial or total blindness.(c) Retinal or vitreous surgery.(1) Complications requiring additional treatment and/or surgery.(2) Recurrence or spread of disease.(3) Partial or total blindness.(d) Reconstructive and/or plastic surgical procedures of the eye and eye region, such as blepharoplasty, tumor, fracture, lacrimal surgery, foreign body, abscess, or trauma.(1) Blindness.(2) Nerve damage with loss of use and/or feeling to eye or other areas of face.(3) Painful or unattractive scarring.(4) Worsening or unsatisfactory appearance.(5) Dry eye.(e) Photocoagulation and/or cryotherapy.(1) Complications requiring additional treatment and/or surgery.(2) Pain.(3) Partial or total blindness.(f) Corneal surgery, such as corneal transplant, refractive surgery and pterygium.(1) Complications requiring additional treatment and/or surgery.(2) Pain.(3) Need for glasses or contact lenses.(4) Partial or total blindness.(g) Glaucoma surgery by any method.(1) Complications requiring additional treatment and/or surgery.(2) Worsening of the glaucoma.(3) Pain.(4) Partial or total blindness.(h) Removal of the eye or its contents (enucleation or evisceration).(1) Complications requiring additional treatment and/or surgery.(2) Worsening or unsatisfactory appearance.(3) Recurrence or spread of disease.(i) Surgery for penetrating ocular injury, including intraocular foreign body.(1) Complications requiring additional treatment and/or surgery.(2) Possible removal of eye.(3) Pain.(4) Partial or total blindness. Source Note: The provisions of this §602.6 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.6 Eye Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215977&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215977 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215977&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215977 03/11/2026 (a) Hysterectomy (abdominal and vaginal).(1) Uncontrollable leakage of urine.(2) Injury to bladder.(3) Injury to the tube (ureter) between the kidney and the bladder.(4) Injury to the bowel and/or intestinal obstruction.(5) Need to covert to abdominal incision.(6) If laparoscopic surgery is utilized, include the following risks:(A) Damage during introduction of trocar to adjacent intra-abdominal structures and organs (e.g., bowel, bladder, blood vessels, or nerves) and potential need for additional surgery.(B) Trocar site complications (e.g., hematoma, bleeding, leakage of fluid, or hernia formation).(C) Air embolus (bubble causing heart failure or stroke).(D) Change during the procedure to an open procedure.(E) If cancer is present, may increase the risk of the spread of cancer.(b) All fallopian tube and ovarian surgery with or without hysterectomy, including removal and lysis of adhesions.(1) Injury to the bowel and/or bladder.(2) Sterility.(3) Failure to obtain fertility (if applicable).(4) Failure to obtain sterility (if applicable).(5) Loss of ovarian functions or hormone production from ovary(ies).(6) If performed with hysterectomy, all associated risks under subsection (a) of this section.(7) For fallopian tube occlusion (for sterilization with or without hysterectomy), see subsection (n) of this section.(c) Removing fibroids (uterine myomectomy).(1) Injury to bladder.(2) Sterility.(3) Injury to the tube (ureter) between the kidney and the bladder.(4) Injury to the bowel and/or intestinal obstruction.(5) May need to convert to hysterectomy.(6) If laparoscopic surgery is utilized, include the following risks:(A) Damage during introduction of trocar to adjacent intra-abdominal structures and organs (e.g., bowel, bladder, blood vessels, or nerves) and potential need for additional surgery.(B) Trocar site complications (e.g., hematoma, bleeding, leakage of fluid, or hernia formation).(C) Air embolus (bubble causing heart failure or stroke).(D) Change during the procedure to an open procedure.(E) If cancer is present, may increase the risk of the spread of cancer.(d) Uterine suspension.(1) Uncontrollable leakage of urine.(2) Injury to bladder.(3) Injury to the tube (ureter) between the kidney and the bladder.(4) Injury to the bowel and/or intestinal obstruction.(e) Removal of the nerves to the uterus (presacral neurectomy).(1) Uncontrollable leakage of urine.(2) Injury to bladder.(3) Injury to the tube (ureter) between the kidney and the bladder.(4) Injury to the bowel and/or intestinal obstruction.(5) Hemorrhage (severe bleeding).(f) Removal of the cervix.(1) Uncontrollable leakage of urine.(2) Injury to bladder.(3) Sterility.(4) Injury to the tube (ureter) between the kidney and the bladder.(5) Injury to the bowel and/or intestinal obstruction.(6) Need to convert to abdominal incision.(g) Repair of vaginal hernia (anterior and/or posterior colporrhaphy and/or enterocele repair).(1) Uncontrollable leakage of urine.(2) Injury to bladder.(3) Sterility.(4) Injury to the tube (ureter) between the kidney and the bladder.(5) Injury to the bowel and/or intestinal obstruction.(6) Mesh erosion (with damage to vagina and adjacent tissue).(h) Abdominal suspension of the bladder (retropubic urethropexy).(1) Uncontrollable leakage of urine.(2) Injury to bladder.(3) Injury to the tube (ureter) between the kidney and the bladder.(4) Injury to the bowel and/or intestinal obstruction.(i) Conization of cervix.(1) Hemorrhage (severe bleeding) which may result in hysterectomy.(2) Sterility.(3) Injury to bladder.(4) Injury to rectum.(j) Dilation and curettage of uterus (diagnostic/therapeutic).(1) Possible hysterectomy.(2) Perforation (hole) created in the uterus.(3) Sterility.(4) Injury to bowel and/or bladder.(5) Abdominal incision and operation to correct injury.(k) Surgical abortion/dilation and curettage/dilation and evacuation.(1) Possible hysterectomy.(2) Perforation (hole) created in the uterus.(3) Sterility.(4) Injury to the bowel and/or bladder.(5) Abdominal incision and operation to correct injury.(6) Failure to remove all products of conception.(l) Medical abortion/non-surgical.(1) Hemorrhage with possible need for surgical intervention.(2) Failure to remove all products of conception.(3) Sterility.(m) Selective salpingography and tubal reconstruction.(1) Perforation (hole) created in the uterus or Fallopian tube.(2) Future ectopic pregnancy (pregnancy outside of the uterus).(3) Pelvic infection.(n) Fallopian tube occlusion (for sterilization with or without hysterectomy).(1) Perforation (hole) created in the uterus or Fallopian tube.(2) Future ectopic pregnancy (pregnancy outside of the uterus).(3) Pelvic infection.(4) Failure to obtain sterility.(o) Hysteroscopy.(1) Perforation (hole) created in the uterus.(2) Fluid overload/electrolyte imbalance.(3) Possible hysterectomy.(4) Abdominal incision to correct injury. Source Note: The provisions of this §602.7 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.7 Female Genital System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215979&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215979 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215979&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215979 03/11/2026 (a) Transfusion of blood and blood components.(1) Serious infection including but not limited to Hepatitis and HIV which can lead to organ damage and permanent impairment.(2) Transfusion related injury resulting in impairment of lungs, heart, liver, kidneys, and immune system.(3) Severe allergic reaction, potentially fatal.(b) Splenectomy.(1) Susceptibility to infections and increased severity of infections.(2) Increased immunization requirements. Source Note: The provisions of this §602.8 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.8 Hematic and Lymphatic System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225043&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225043 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225043&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225043 03/11/2026 (a) Radical or modified radical mastectomy (removal of the breast, possible removal of other chest wall tissues, and possible removal of lymph nodes in the chest and/or under the arm).(1) Limitation of movement of shoulder and arm.(2) Permanent swelling of the arm.(3) Loss of the skin of the chest requiring skin graft.(4) Residual or recurrent malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).(5) Decreased sensation or numbness of the inner aspect of the arm and chest wall.(b) Simple mastectomy (removal of the breast).(1) Loss of skin of the chest requiring skin graft.(2) Residual or recurrent malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).(3) Decreased sensation or numbness of the nipple.(c) Lumpectomy (removal of a portion of the breast).(1) Loss of skin of the chest requiring skin graft.(2) Residual or recurrent malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).(3) Decreased sensation or numbness of the nipple.(d) Open biopsy of the breast.(1) Loss of skin of the chest requiring skin graft.(2) Residual or recurrent malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).(3) Decreased sensation or numbness of the nipple. Source Note: The provisions of this §602.9 adopted to be effective December 26, 2023, 48 TexReg 7985; amended to be effective May 25, 2025, 50 TexReg 2968. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.9 Breast Surgery (non-cosmetic) Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215980&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215980 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215980&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215980 03/11/2026 (a) Orchidopexy (reposition of testis(es)).(1) Removal of testicle.(2) Atrophy (shriveling) of the testicle with loss of function.(b) Orchiectomy (removal of the testis(es)).(1) Decreased sexual desire.(2) Difficulties with penile erection.(3) Permanent sterility (inability to father children) if both testes are removed.(c) Vasectomy.(1) Loss of testicle.(2) Failure to produce permanent sterility (inability to father children).(d) Circumcision.(1) Injury to penis.(2) Need for further surgery. Source Note: The provisions of this §602.10 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.10 Male Genital System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215982&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215982 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215982&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215982 03/11/2026 (a) Delivery (vaginal).(1) Injury to bladder and/or rectum, including a fistula (hole) between bladder and vagina and/or rectum and vagina.(2) Hemorrhage (severe bleeding) possibly requiring blood administration and/or hysterectomy (removal of uterus) and/or artery ligation (tying off) to control.(3) Sterility (inability to get pregnant).(4) Brain damage, injury or even death occurring to the fetus before or during labor and/or vaginal delivery whether or not the cause is known.(b) Delivery (cesarean section).(1) Injury to bowel and/or bladder.(2) Sterility (inability to get pregnant).(3) Injury to ureter (tube between kidney and bladder).(4) Brain damage, injury or even death occurring to the fetus before or during labor and/or cesarean delivery whether or not the cause is known.(5) Uterine disease or injury requiring hysterectomy (removal of uterus).(c) Cerclage.(1) Premature labor.(2) Injury to bowel and/or bladder.(3) Rupture to membranes and possible infection. Source Note: The provisions of this §602.11 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.11 Maternity and Related Cases Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215983 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215983&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215983 03/11/2026 (a) Arthroplasty of any joints with mechanical device.(1) Impaired function such as stiffness, limp, or change in limb length.(2) Blood vessel or nerve injury.(3) Pain.(4) Blood clot in limb or lung.(5) Failure of bone to heal.(6) Infection.(7) Removal or replacement of any implanted device or material.(8) Dislocation or loosening requiring additional surgery.(9) If performed on a child age 12 or under, include the following additional risks: problems with appearance, use, or growth requiring additional surgery.(b) Arthroscopy of any joint.(1) Blood vessel or nerve injury.(2) Continued pain.(3) Stiffness of joint.(4) Blood clot in limb or lung.(5) Joint infection.(6) If performed on a child age 12 or under, include the following additional risks: problems with appearance, use, or growth requiring additional surgery.(c) Open reduction with internal fixation.(1) Impaired function such as stiffness, limp, or change in limb length.(2) Blood vessel or nerve injury.(3) Pain.(4) Blood clot in limb or lung.(5) Failure of bone to heal.(6) Infection.(7) Removal or replacement of any implanted device or material.(8) If performed on a child age 12 or under, include the following additional risks: problems with appearance, use, or growth requiring additional surgery.(d) Osteotomy.(1) Impaired function such as stiffness, limp, or change in limb length.(2) Blood vessel or nerve injury.(3) Pain.(4) Blood clot in limb or lung.(5) Failure of bone to heal.(6) Infection.(7) Removal or replacement of any implanted device or material.(8) If performed on a child age 12 or under, include the following additional risks: problems with appearance, use, or growth requiring additional surgery.(e) Ligamentous reconstruction of joints.(1) Continued instability of the joint.(2) Arthritis.(3) Continued pain.(4) Stiffness of joint.(5) Blood vessel or nerve injury.(6) Impaired function and/or scarring.(7) Blood clot in limb or lung.(8) If performed on a child age 12 or under, include the following additional risks: problems with appearance, use, or growth requiring additional surgery.(f) Vertebroplasty/kyphoplasty.(1) Nerve/spinal cord injury.(2) Need for emergency surgery.(3) Embolization of cement (cement passes into blood vessels and possibly all the way to the lungs).(4) Collapse of adjacent vertebrae (bones in spine).(5) Leak of cerebrospinal fluid (fluid around the brain and spinal cord).(6) Pneumothorax (collapsed lung).(7) Failure to relieve pain.(8) Rib fracture.(g) If the following procedures are performed on a child age 12 or under, problems with appearance, use, or growth requiring additional surgery should be disclosed.(1) Arthrotomy (opening of joint).(2) Closed reduction with or without pin or external fixation.(3) Surgical management of open wound.(4) Partial excision or removal of bone.(5) Removal of external fixation device.(6) Traction or casting with or without manipulation for reduction.(h) Amputation of limb.(1) Pain and/or phantom sensation in removed limb.(2) Need for further surgery.(3) Infection.(4) Hemorrhage (severe bleeding).(5) Difficulty with prosthesis fitting. Source Note: The provisions of this §602.12 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.12 Musculoskeletal System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215984 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215984&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215984 03/11/2026 (a) Craniotomy, craniectomy or cranioplasty.(1) Loss of brain function such as memory and/or ability to speak.(2) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).(3) Stroke (damage to brain resulting in loss of one or more functions).(4) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).(5) Weakness, paralysis, loss of coordination.(6) Cerebrospinal fluid leak with potential for severe headaches.(7) Meningitis (infection of coverings of brain and spinal cord).(8) Brain abscess.(9) Persistent vegetative state (not able to communicate or interact with others).(10) Hydrocephalus (abnormal fluid buildup causing pressure in the brain).(11) Seizures (uncontrolled nerve activity).(12) Need for permanent breathing tube and/or permanent feeding tube.(b) Cranial nerve operations.(1) Weakness, numbness, impaired muscle function or paralysis.(2) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).(3) Seizures (uncontrolled nerve activity).(4) New or different pain.(5) Stroke (damage to brain resulting in loss of one or more functions).(6) Persistent vegetative state (not able to communicate or interact with others).(7) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).(8) Cerebrospinal fluid leak with potential for severe headaches.(9) Meningitis (infection of coverings of brain and spinal cord).(10) Need for prolonged nursing care.(11) Need for permanent breathing tube and/or permanent feeding tube.(c) Spine operation, including laminectomy, decompression, fusion, internal fixation or procedures for nerve root or spinal cord compression; diagnosis; pain; deformity; mechanical instability; injury; removal of tumor, abscess or hematoma (excluding coccygeal operations).(1) Weakness, pain, numbness or clumsiness.(2) Impaired muscle function or paralysis.(3) Incontinence, impotence or impaired bowel function (loss of bowel/bladder control and/or sexual function).(4) Migration of implants (movement of implanted devices).(5) Failure of implants (breaking of implanted devices).(6) Adjacent level degeneration (breakdown of spine above and/or below the level treated).(7) Cerebrospinal fluid leak with potential for severe headaches.(8) Meningitis (infection of coverings of brain and spinal cord).(9) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).(10) Unstable spine (abnormal movement between bones and/or soft tissues of the spine).(d) Peripheral nerve operation; nerve grafts, decompression, transposition or tumor removal; neurorrhaphy, neurectomy or neurolysis.(1) Numbness.(2) Impaired muscle function.(3) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).(4) Continued, increased or different pain.(5) Weakness.(e) Transphenoidal hypophysectomy or other pituitary gland operation.(1) Cerebrospinal fluid leak with potential for severe headaches.(2) Necessity for hormone replacement.(3) Recurrence or continuation of the condition that required this operation.(4) Deformity or perforation of nasal septum (hole in wall between the right and left halves of the nose).(5) Facial nerve injury resulting in disfigurement (loss of nerve function controlling muscles in face).(6) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).(7) Stroke (damage to brain resulting in loss of one or more functions).(8) Persistent vegetative state (not able to communicate or interact with others).(9) Headaches.(f) Cerebrospinal fluid shunting procedure or revision.(1) Shunt obstruction (blockage of shunt/tubing causing it to stop draining adequately).(2) Malposition or migration of shunt/tubing (improper positioning or later movement of shunt/tubing causing it to stop draining adequately).(3) Seizures (uncontrolled nerve activity).(4) Recurrence or continuation of brain dysfunction.(5) Injury to internal organs of the chest or abdomen.(6) Brain injury.(7) Stroke (damage to brain resulting in loss of one or more functions).(8) Persistent vegetative state (not able to communicate or interact with others).(9) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).(10) Cerebrospinal fluid leak with potential for severe headaches.(11) Meningitis (infection of coverings of brain and spinal cord).(12) Need for prolonged nursing care.(13) Need for permanent breathing tube and/or permanent feeding tube.(g) Elevation of depressed skull fracture.(1) Loss of brain function such as memory and/or ability to speak.(2) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse).(3) Loss of senses (blindness, double vision, deafness, smell, numbness, taste).(4) Weakness, paralysis, loss of coordination.(5) Cerebrospinal fluid leak with potential for severe headaches.(6) Meningitis (infection of coverings of brain and spinal cord).(7) Brain abscess.(8) Persistent vegetative state (not able to communicate or interact with others).(9) Seizures (uncontrolled nerve activity).(10) Need for permanent breathing tube and/or permanent feeding tube. Source Note: The provisions of this §602.13 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.13 Nervous System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215985&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215985 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215985&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215985 03/11/2026 (a) Splenoportography (needle injection of contrast media into the spleen).(1) All associated risks as listed under §602.2(b)(2) of this chapter (relating to Cardiovascular System Treatments and Procedures).(2) Injury to the spleen requiring blood transfusion and/or removal of the spleen.(b) Chemoembolization.(1) All associated risks as listed under §602.2(b)(2) of this chapter.(2) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).(3) Injury to or failure of liver (or other organ in which tumor is located).(4) Risks of the chemotherapeutic agent(s) utilized.(5) Cholecystitis (inflammation of the gallbladder) (for liver or other upper GI embolizations).(6) Abscess (infected fluid collection) in the liver or other embolized organ requiring further intervention.(7) Biloma (collection of bile in or near the liver requiring drainage) (for liver embolizations).(c) Radioembolization.(1) All associated risks as listed under §602.2(b)(2) of this chapter.(2) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).(3) Injury to or failure of liver (or other organ in which tumor is located).(4) Radiation complications: pneumonitis (inflammation of lung) which is potentially fatal; inflammation of stomach, intestines, gallbladder, pancreas; stomach or intestinal ulcer; scarring of liver.(d) Thermal and other ablative techniques for treatment of tumors (for curative intent or palliation) including radiofrequency ablation, microwave ablation, cryoablation, and high intensity focused ultrasound (HIFU).(1) Injury to tumor-containing organ or adjacent organs/structures.(2) Injury to nearby nerves potentially resulting in temporary or chronic (continuing) pain and/or loss of use and/or feeling.(3) Failure to completely treat tumor.(e) TIPS (Transjugular Intrahepatic Portosystemic Shunt) and its variants such as DIPS (Direct Intrahepatic Portocaval Shunt).(1) All associated risks as listed under §602.2(b)(2)-(4) of this chapter.(2) Hepatic encephalopathy (confusion/decreased ability to think).(3) Liver failure or injury.(4) Gallbladder injury.(5) Hemorrhage (severe bleeding).(6) Recurrent ascites (fluid building up in abdomen) and/or bleeding.(7) Kidney failure.(8) Heart failure.(9) Death.(f) Myelography.(1) Chronic (continuing) pain.(2) Nerve injury with loss of use and/or feeling.(3) Transient (temporary) headache, nausea, and/or vomiting.(4) Numbness.(5) Seizure.(g) Percutaneous abscess/fluid collection drainage (percutaneous abscess/seroma/lymphocele drainage and/or sclerosis (inclusive of percutaneous, transgluteal, transrectal and transvaginal routes)).(1) Sepsis (infection in the blood stream), possibly resulting in shock (severe decrease in blood pressure).(2) Injury to nearby organs.(3) Hemorrhage (severe bleeding).(4) Infection of collection which was not previously infected, or additional infection of abscess.(h) Procedures utilizing prolonged fluoroscopy.(1) Skin injury (such as epilation (hair loss), burns, or ulcers).(2) Cataracts (for procedures in the region of the head). Source Note: The provisions of this §602.14 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.14 Radiology Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215986&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215986 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215986&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215986 03/11/2026 (a) Biopsy and/or excision (removal) of lesion of larynx, vocal cords, trachea.(1) Loss or change of voice.(2) Swallowing or breathing difficulties.(3) Perforation (hole) or fistula (connection) in esophagus (tube from throat to stomach).(b) Rhinoplasty (surgery to change the shape of the nose) or nasal reconstruction with or without nasal septoplasty (surgical procedure to remove blockage in or straighten the bone and cartilage dividing the space between the two nostrils).(1) Deformity of skin, bone or cartilage.(2) Creation of new problems, such as perforation of the nasal septum (hole in wall between the right and left halves of the nose) or breathing difficulty.(c) Submucous resection of nasal septum or nasal septoplasty (surgery to remove blockage in or straighten the bone and cartilage dividing the space between the two nostrils).(1) Persistence, recurrence or worsening of the obstruction.(2) Perforation of nasal septum (hole in the bone and/or cartilage dividing the space between the right and left halves of the nose) with dryness and crusting.(3) External deformity of the nose.(d) Sinus surgery/endoscopic sinus surgery.(1) Spinal fluid leak.(2) Visual loss or other eye injury.(3) Numbness in front teeth and palate (top of mouth).(4) Loss or reduction in sense of taste or smell.(5) Recurrence of disease.(6) Empty Nose Syndrome (sensation of nasal congestion, sensation of not being able to take in adequate air through nose).(7) Injury to tear duct causing drainage of tears down the cheek.(8) Brain injury and/or infection.(9) Injury to nasal septum (the bone and cartilage dividing the space between the two nostrils).(10) Nasal obstruction.(e) Lung biopsy (removal of small piece of tissue from inside of lung).(1) Air leak with pneumothorax (leak of air from lung to inside of chest causing the lung to collapse) with need for insertion of chest tube or repeat surgery.(2) Hemothorax (blood in the chest around the lung) possibly requiring additional procedures.(3) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).(f) Segmental resection of lung (removal of a portion of a lung).(1) Hemothorax (blood in the chest around the lung).(2) Abscess (infected fluid collection) in chest.(3) Air leak with pneumothorax (leak of air from lung inside of chest causing the lung to collapse) with need for insertion of chest drainage tube into space between lung and chest wall or repeat surgery.(4) Need for additional surgery.(g) Thoracotomy (surgery to reach the inside of the chest).(1) Hemothorax (blood in the chest around the lung).(2) Abscess (infected fluid collection) in chest.(3) Air leak with pneumothorax (leak of air from lung inside of chest causing the lung to collapse) with need for insertion of chest drainage tube into space between lung and chest wall or repeat surgery.(4) Need for additional surgery.(h) VATS - video-assisted thoracoscopic surgery (camera-assisted surgery to reach the inside of the chest through small incisions).(1) Hemothorax (blood in the chest around the lung).(2) Abscess (infected fluid collection) in chest.(3) Air leak with pneumothorax (leak of air from lung inside of chest causing the lung to collapse) with need for insertion of chest drainage tube into space between lung and chest wall or repeat surgery.(4) Need for additional surgery.(5) Need to convert to open surgery.(i) Percutaneous (puncture through the skin instead of incision) or Open (surgical incision) tracheostomy.(1) Loss of voice.(2) Breathing difficulties.(3) Pneumothorax (collapsed lung) with need for insertion of chest tube.(4) Hemothorax (blood in the chest around the lung).(5) Scarring in trachea (windpipe).(6) Fistula (connection) between trachea into esophagus (tube from throat to stomach) or great vessels.(7) Bronchospasm (constriction of the airways leading to trouble breathing).(8) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).(j) Bronchoscopy (insertion of a camera into the airways of the neck and chest).(1) Mucosal injury (damage to lining of airways) including perforation (hole in the airway).(2) Pneumothorax (collapsed lung) with need for insertion of chest tube.(3) Pneumomediastinum (air enters the space around the airways including the space around the heart).(4) Injury to vocal cords, laryngospasm (irritation/spasm of the vocal cords) or laryngeal edema (swelling of the vocal cords).(5) Bronchospasm (constriction of the airways leading to trouble breathing).(6) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).(k) Endobronchial valve placement (device inserted into airways in the lung that controls air movement into and out of abnormal portions of a lung).(1) Mucosal injury (damage to lining of airways) including perforation (hole in the airway).(2) Pneumothorax (collapsed lung) with need for insertion of chest tube.(3) Pneumomediastinum (air enters the space around the airways including the space around the heart).(4) Injury to vocal cords, laryngospasm (irritation/spasm of the vocal cords) or laryngeal edema (swelling of the vocal cords).(5) Migration (movement) of the stent from its original position.(6) Airway blockage, potentially life threatening.(7) Stent blockage.(8) Worsening of chronic obstructive pulmonary disease (worsening of emphysema).(9) Respiratory failure (need for breathing tube placement with ventilator support).(10) Bronchospasm (constriction of the airways leading to trouble breathing).(11) Hemoptysis (coughing up blood which can result in trouble breathing and the need to be placed on a ventilator or breathing machine and oxygen).(12) Recurrent infections.(l) Endobronchial balloon dilatation with or without stent placement (placement of tube to keep airway open).(1) Bronchial rupture (tearing of the airway) with need for additional surgery.(2) Pneumothorax (collapsed lung) with need for insertion of chest tube.(3) Pneumomediastinum (air enters the space around the airways including the space around the heart).(4) Injury to vocal cords, laryngospasm (irritation/spasm of the vocal cords) or laryngeal edema (swelling of the vocal cords).(5) Migration (movement) of the stent from its original position.(6) Airway blockage, potentially life threatening.(7) Stent blockage.(8) Stent fracture (broken stent).(9) Recurrent infections.(10) Stent erosion into adjacent structures (stent wears a hole through the airway and injures nearby tissues).(11) Hemoptysis (coughing up blood which can result in respiratory distress and the need to be placed on a ventilator or breathing machine and oxygen).(m) Mediastinoscopy (insertion of a camera into the space behind the breastbone and between the lungs) with or without biopsy (removal of tissue).(1) Hemorrhage (severe bleeding) requiring open surgery.(2) Nerve injury causing vocal cord paralysis or poor function.(3) Pneumothorax (collapsed lung).(4) Tracheal injury (damage to the airway/windpipe).(n) Pleurodesis (procedure to prevent fluid build-up in space between the lung and chest wall).(1) Respiratory failure (need for breathing tube placement).(2) Empyema (infection/pus in the space around the lung). Source Note: The provisions of this §602.15 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.15 Respiratory System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225044&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225044 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225044&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225044 03/11/2026 (a) Nephrectomy (removal of part or all of the kidney).(1) Incomplete removal of stone(s) or tumor, if present.(2) Blockage of urine (risk of partial nephrectomy).(3) Leakage of urine at surgical site.(4) Injury to or loss of the entire kidney (risk of partial nephrectomy, intentional for total or radical nephrectomy)(5) Loss of the adrenal gland (gland on top of the kidney that makes certain hormones/chemicals the body needs) - intentional in the case of radical nephrectomy.(6) Damage to organs next to kidney.(b) Nephrolithotomy and pyelolithotomy (removal of kidney stone(s)).(1) Incomplete removal of stone(s).(2) Blockage of urine.(3) Leakage of urine at surgical site.(4) Injury or loss of the kidney.(5) Damage to organs next to kidney.(c) Pyeloureteroplasty (pyeloplasty or reconstruction of the kidney drainage system), Ureteroplasty (reconstruction of ureter (tube between kidney and bladder)).(1) Blockage of urine.(2) Leakage of urine at surgical site.(3) Injury to or loss of the kidney (pyeloureteroplasty) or ureter (ureterolithotomy).(4) Damage to organs next to kidney.(5) Incomplete removal of the stone or tumor (when applicable).(d) Ureterolithotomy (surgical removal of stone(s) from ureter (tube between kidney and bladder)).(1) Leakage of urine at surgical site.(2) Incomplete removal of stone.(3) Blockage of urine.(4) Damage to organs next to ureter (tube that carries urine from kidney to bladder).(5) Damage to or loss of ureter (tube that carries urine from kidney to bladder).(e) Ureterectomy (partial/complete removal of ureter tube that carries urine from kidney to bladder), Ureterolysis (partial/complete removal of ureter (tube that carries urine from kidney to bladder) from adjacent tissue).(1) Leakage of urine at surgical site.(2) Incomplete removal of stone (if stone present).(3) Blockage of urine.(4) Damage to organs next to ureter.(5) Damage to or loss of ureter (ureterolysis).(f) Ureteral reimplantation (reinserting ureter (tube between kidney and bladder) into the bladder).(1) Leakage of urine at surgical site.(2) Blockage of urine.(3) Damage to or loss of ureter.(4) Backward flow of urine from bladder into ureter.(5) Damage to organs next to ureter.(g) Prostatectomy (partial or total removal of prostate).(1) Leakage of urine at surgical site.(2) Blockage of urine.(3) Incontinence (difficulty with control of urine flow).(4) Semen passing backward into bladder.(5) Difficulty with penile erection (possible with partial and probable with total prostatectomy).(h) Total cystectomy (removal of bladder).(1) Probable loss of penile erection and ejaculation in the male.(2) Damage to organs next to bladder.(3) This procedure will require an alternate method of urinary drainage (urine will need a new place to collect or empty from the body).(i) Radical cystectomy.(1) Probable loss of penile erection and ejaculation in the male.(2) Damage to organs next to bladder.(3) This procedure will require an alternate method of urinary drainage (urine will need a new place to collect or empty from the body).(4) Chronic (continuing) swelling of thighs, legs and feet.(5) Recurrence or spread of cancer if present.(j) Partial cystectomy (removal of a portion of the bladder).(1) Leakage of urine at surgical site.(2) Incontinence (difficulty with control of urine flow).(3) Backward flow of urine from bladder into ureter (tube between kidney and bladder).(4) Blockage of urine.(5) Damage to organs next to bladder.(k) Cystolithotomy (surgical removal of stone(s) from the bladder).(1) Injury to bladder or surrounding organs.(2) Urinary incontinence (inability to control release of urine from bladder).(l) Cystolitholapaxy (cystoscopic crushing and removal of bladder stone(s)).(1) Injury to bladder.(2) Scarring/injury of urethra (tube from bladder to outside).(m) Cystostomy (placement of tube into the bladder). Injury to bladder or surrounding organs.(n) Diverticulectomy of the bladder (removal of outpouching of the bladder).(1) Injury to bladder or surrounding organs.(2) Urinary incontinence (inability to control release of urine from bladder).(o) Urinary diversion (ileal conduit, colon conduit).(1) Blood chemistry abnormalities requiring medication.(2) Development of stones, strictures (scars or narrowings) or infection in the kidneys, ureter or bowel (intestine).(3) Leakage of urine at surgical site.(4) This procedure will require an alternate method of urinary drainage (urine will need a new place to collect or empty from the body).(p) Ureterosigmoidostomy attachment of ureters (tubes between kidney and bladder to the colon (large intestine)).(1) Blood chemistry abnormalities requiring medication.(2) Development of stones, strictures or infection in the kidneys, ureter or bowel (intestine).(3) Leakage of urine at surgical site.(4) Difficulty in holding urine in the rectum.(q) Urethroplasty (construction/reconstruction/dilation of drainage tube from bladder to the outside).(1) Leakage of urine at surgical site.(2) Stricture formation (narrowing of urethra (tube from bladder to outside)).(3) Need for additional surgery.(r) Diverticulectomy or diverticulotomy of the urethra (repair or drainage of outpouching of the urethra).(1) Injury to urethra (tube from bladder to outside) with leak of urine or narrowing of urethra.(2) Fistula formation (connection between urethra and other pelvic structure).(3) Sexual dysfunction (pain with sexual intercourse, change in sensation with sex).(s) Percutaneous nephrostomy/stenting/stone removal.(1) Pneumothorax or other pleural complications (collapsed lung or filling of the chest cavity on the same side with fluid).(2) Septic shock/bacteremia (infection of the blood stream with possible shock/severe lowering of blood pressure) when pyonephrosis (infected urine in the kidney) present.(3) Bowel (intestinal) injury.(4) Blood vessel injury with or without significant bleeding.(t) Lithotripsy ("Shockwave Lithotripsy") (sound wave removal of stones from kidney and ureter).(1) Injury to kidney, ureter (tube between kidney and bladder), or other nearby organs.(2) Stone fragments blocking ureter.(3) Bleeding in or around kidney or ureter.(u) Dialysis (technique to replace functions of kidney and clean blood of toxins).(1) Hemodialysis.(A) Hypotension (low blood pressure).(B) Hypertension (high blood pressure).(C) Air embolism (air bubble in blood vessel) resulting in possible death or paralysis.(D) Cardiac arrhythmias (irregular heart rhythms).(E) Infections of blood stream, access site, or blood borne (for example: Hepatitis B, C, or HIV).(F) Hemorrhage (severe bleeding as a result of clotting problems or due to disconnection of the bloodline).(G) Nausea, vomiting, cramps, headaches, and mild confusion during and/or temporarily after dialysis.(H) Allergic reactions.(I) Chemical imbalances and metabolic disorders (unintended change in blood minerals).(J) Pyrogenic reactions (fever).(K) Hemolysis (rupture of red blood cells).(L) Graft/fistula damage including bleeding, aneurysm, formation (ballooning of vessel), clotting (closure) of graft/fistula.(2) Peritoneal dialysis.(A) Infections, including peritonitis (inflammation or irritation of the tissue lining the inside wall of abdomen and covering organs), catheter infection and catheter exit site infection.(B) Development of hernias of umbilicus (weakening of abdominal wall or muscle).(C) Hypertension (high blood pressure).(D) Hypotension (low blood pressure).(E) Hydrothorax (fluid in chest cavity).(F) Arrhythmia (irregular heart rhythm).(G) Perforation of the bowel (hole in intestine).(H) Sclerosis or scarring of the peritoneum (lining of the abdomen) with loss of dialysis function.(I) Weight gain leading to obesity.(J) Abdominal discomfort/distension.(K) Heartburn or reflux.(L) Increase in need for anti-diabetic medication.(M) Muscle weakness.(N) Dehydration (extreme loss of body fluid).(O) Chemical imbalances and metabolic disorders (unintended change in blood minerals).(P) Allergic reactions.(Q) Nausea, vomiting, cramps, headaches, and mild confusion during and/or temporarily after dialysis. Source Note: The provisions of this §602.16 adopted to be effective December 26, 2023, 48 TexReg 7985; amended to be effective May 25, 2025, 50 TexReg 2968. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.16 Urinary System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215988&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215988 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215988&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215988 03/11/2026 (a) Electroconvulsive therapy with modification by intravenous muscle relaxants and sedatives.(1) Memory changes of events prior to, during, and immediately following the treatment.(2) Fractures or dislocations of bones.(3) Significant temporary confusion requiring special care.(b) Other Procedures. No other procedures are assigned at this time. Source Note: The provisions of this §602.17 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.17 Psychiatric Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215989&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215989 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215989&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215989 03/11/2026 (a) A child is defined for the purpose of this section as an individual who is not physiologically mature as determined by the physician using the appropriate medical parameters.(b) Head and neck.(1) Early reactions.(A) Reduced and sticky saliva, loss of taste and appetite, altered sense of smell, nausea.(B) Sore throat, difficulty swallowing, weight loss, fatigue.(C) Skin changes: redness, irritation, scaliness, blistering or ulceration, color change, thickening, hair loss.(D) Hoarseness, cough, loss of voice, and swelling of airway.(E) Blockage and crusting of nasal passages.(F) Inflammation of ear canal, feeling of "stopped up" ear, hearing loss, dizziness.(G) Dry and irritable eye(s).(H) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.(I) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Dry mouth and altered sense, or loss, of taste.(B) Tooth decay and gum changes.(C) Bone damage, especially in jaws.(D) Stiffness and limitation of jaw movement.(E) Changes in skin texture and/or coloration, permanent hair loss, and scarring of skin.(F) Swelling of tissues, particularly under the chin.(G) Throat damage causing hoarseness, pain or difficulty breathing or swallowing.(H) Eye damage causing dry eye(s), cataract, loss of vision, or loss of eye(s).(I) Ear damage causing dryness of ear canal, fluid collection in middle ear, hearing loss.(J) Brain, spinal cord or nerve damage causing alteration of thinking ability or memory, and/or loss of strength, feeling or coordination in any part of the body.(K) Pituitary or thyroid gland damage requiring long-term hormone replacement therapy.(L) In children, there may be additional late reactions.(i) Disturbance of bone and tissue growth.(ii) Bone damage to face causing abnormal development.(iii) Brain damage causing a loss of intellectual ability, learning capacity, and reduced intelligence quotient (IQ).(iv) Second cancers developing in the irradiated area.(c) Central nervous system.(1) Early reactions.(A) Skin and scalp reaction with redness, irritation, scaliness, blistering, ulceration, change in color, thickening, hair loss.(B) Nausea, vomiting, headaches.(C) Fatigue, drowsiness.(D) Altered sense of taste or smell.(E) Inflammation of ear canal, feeling of "stopped-up" ear, hearing loss, dizziness.(F) Depression of blood count leading to increased risk of infection and/or bleeding.(G) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.(H) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Permanent hair loss of variable degrees, altered regrowth, texture and color of hair.(B) Persistent drowsiness and tiredness.(C) Brain damage causing a loss of some degree of thinking ability or memory, or personality changes.(D) Scarring of skin.(E) Spinal cord or nerve damage causing loss of strength, feeling or coordination in any part of the body.(F) Damage to eye(s), or optic nerve(s) causing loss of vision.(G) Ear damage causing dryness of ear canal, fluid collection in middle ear, hearing loss.(H) Pituitary gland damage requiring long-term hormone replacement therapy.(I) In children, there may be additional late reactions.(i) Disturbances of bone and tissue growth.(ii) Bone damage to spine, causing stunting of growth, curvature and/or reduction in height.(iii) Bone damage to face, or pelvis causing stunting of bone growth and/or abnormal development.(iv) Brain damage causing a loss of intellectual ability, learning capacity, and reduced intelligence quotient (IQ).(v) Second cancers developing in the irradiated area.(d) Thorax.(1) Early reactions.(A) Skin changes: redness, irritation, scaliness, ulceration, change in color, thickening, hair loss.(B) Inflammation of esophagus causing pain on swallowing, heartburn, or sense of obstruction.(C) Loss of appetite, nausea, vomiting.(D) Weight loss, weakness, vomiting.(E) Inflammation of the lung with pain, fever and cough.(F) Inflammation of the heart sac with chest pain and palpitations.(G) Bleeding or creation of a fistula resulting from tumor destruction.(H) Depression of blood count leading to increased risk of infection and/or bleeding.(I) Intermittent electric shock-like feelings in the lower spine or legs on bending the neck.(J) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.(K) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Changes in skin texture and/or coloration, permanent hair loss and scarring of skin.(B) Lung scarring or shrinkage causing shortness of breath.(C) Narrowing of esophagus causing swallowing problems.(D) Constriction of heart sac which may require surgical correction.(E) Damage to heart muscle or arteries leading to heart failure.(F) Fracture of ribs.(G) Nerve damage causing pain, loss of strength or feeling in arms.(H) Spinal cord damage causing loss of strength or feeling in arms and legs, and/or loss of control of bladder and rectum.(I) In children, there may be additional late reactions.(i) Disturbances of bone and tissue growth.(ii) Bone damage to spine, causing stunting of growth, curvature and/or reduction in height.(iii) Underdevelopment or absence of development of female breast.(iv) Second cancers developing in the irradiated area.(e) Breast.(1) Early reactions.(A) Skin changes: redness, irritation, scaliness, blistering, ulceration, coloration, thickening, and hair loss.(B) Breast changes including swelling, tightness, or tenderness.(C) Inflammation of the esophagus causing pain or swallowing, heartburn, or sense of obstruction.(D) Lung inflammation with cough.(E) Inflammation of heart sac with chest pain and palpitations.(2) Late reactions.(A) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.(B) Breast changes including thickening, firmness, tenderness, shrinkage.(C) Swelling of arm.(D) Stiffness and discomfort in shoulder joint.(E) Rib or lung damage causing pain, fracture, cough, shortness of breath.(F) Nerve damage causing pain, loss of strength or feeling in arm.(G) Damage to heart muscle or arteries or heart sac leading to heart failure.(f) Abdomen.(1) Early reactions.(A) Skin changes: redness, irritation, scaliness, ulceration, coloration, thickening, hair loss.(B) Loss of appetite, nausea, vomiting.(C) Weight loss, weakness, fatigue.(D) Inflammation of stomach causing indigestion, heartburn, and ulcers.(E) Inflammation of bowel causing cramping and diarrhea.(F) Depression of blood count leading to increased risk of infections and/or bleeding.(G) In children, these reactions are likely to be intensified by chemotherapy before, during and after radiation therapy.(H) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.(B) Stomach damage causing persistent indigestion, pain, and bleeding.(C) Bowel damage causing narrowing or adhesions of bowel with obstruction, ulceration, or bleeding which may require surgical correction, chronic diarrhea, or poor absorption of food elements.(D) Kidney damage leading to kidney failure and/or high blood pressure.(E) Liver damage leading to liver failure.(F) Spinal cord or nerve damage causing loss of strength or feeling in legs and/or loss of control of bladder and/or rectum.(G) In children, there may be additional late reactions.(i) Disturbances of bone and tissue growth.(ii) Bone damage to spine causing stunting of growth, curvature and/or reduction in height.(iii) Bone damage to pelvis causing stunting of bone growth and/or abnormal development.(iv) Second cancers developing in the irradiated area.(g) Female pelvis.(1) Early reactions.(A) Inflammation of bowel causing cramping and diarrhea.(B) Inflammation of rectum and anus causing pain, spasm, discharge, bleeding.(C) Bladder inflammation causing burning, frequency, spasm, pain, bleeding.(D) Skin changes: redness, irritation, scaliness, blistering or ulceration, coloration, thickening, hair loss.(E) Disturbance of menstrual cycle.(F) Vaginal discharge, pain, irritation, bleeding.(G) Depression of blood count leading to increased risk of infection and/or bleeding.(H) In children, these reactions are likely to be intensified by chemotherapy before, during, or after radiation therapy.(I) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Bowel damage causing narrowing or adhesions of the bowel with obstruction, ulceration, bleeding, chronic diarrhea, or poor absorption of food elements and may require surgical correction or colostomy.(B) Bladder damage with loss of capacity, frequency of urination, blood in urine, recurrent urinary infections, pain, or spasm which may require urinary diversion and/or removal of bladder.(C) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.(D) Bone damage leading to fractures.(E) Ovarian damage causing infertility, sterility, or premature menopause.(F) Vaginal damage leading to dryness, shrinkage, pain, bleeding, or sexual dysfunction.(G) Swelling of the genitalia or legs.(H) Nerve damage causing pain, loss of strength or feeling in legs, and/or loss of control of bladder or rectum.(I) Fistula between the bladder and/or bowel and/or vagina.(J) In children, there may be additional late reactions.(i) Disturbances of bone and tissue growth.(ii) Bone damage to pelvis and hips causing stunting of bone growth and/or abnormal development.(iii) Second cancers developing in the irradiated area.(h) Male pelvis.(1) Early reactions.(A) Inflammation of bowel causing cramping and diarrhea.(B) Inflammation of rectum and anus causing pain, spasm, discharge, bleeding.(C) Bladder inflammation causing burning, frequency, spasm, pain, and/or bleeding.(D) Skin changes: redness, irritation, scaliness, blistering or ulceration, coloration, thickening, hair loss.(E) Depression of blood count leading to increased risk of infection and/or bleeding.(F) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.(G) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Bowel damage causing narrowing or adhesions of the bowel with obstruction, ulceration, bleeding, chronic diarrhea, or poor absorption of food elements and may require surgical correction or colostomy.(B) Bladder damage with loss of capacity, frequency of urination, blood in urine, recurrent urinary infections, pain, or spasm which may require urinary diversion and/or removal of bladder.(C) Changes in skin texture and/or coloration, permanent hair loss, scarring of skin.(D) Bone damage leading to fractures.(E) Testicular damage causing reduced sperm counts, infertility, sterility, or risk of birth defects.(F) Impotence (loss of erection) or sexual dysfunction.(G) Swelling of the genitalia or legs.(H) Nerve damage causing pain, loss of strength or feeling in legs, and/or loss of control of bladder or rectum.(I) Fistula between the bowel and other organs.(J) In children, there may be additional late reactions.(i) Disturbances of bone and tissue growth.(ii) Bone damage to pelvis and hips causing stunting of bone growth and/or abnormal development.(iii) Second cancers developing in the irradiated area.(i) Skin.(1) Early reactions.(A) Redness, irritation, or soreness.(B) Scaliness, ulceration, crusting, oozing, discharge.(C) Hair loss.(D) These reactions are likely to be intensified by chemotherapy.(2) Late reactions.(A) Changes in skin texture causing scaly or shiny smooth skin, thickening with contracture, puckering, scarring of skin.(B) Changes in skin color.(C) Prominent dilated small blood vessels.(D) Permanent hair loss.(E) Chronic or recurrent ulcerations.(F) Damage to adjacent tissues including underlying bone or cartilage.(G) In children, second cancers may develop in the irradiated area.(j) Extremities.(1) Early reactions.(A) Skin changes: redness, irritation, scaliness, ulceration, coloration, thickening, hair loss.(B) Inflammation of soft tissues causing tenderness, swelling, and interference with movement.(C) Inflammation of joints causing pain, swelling and limitation of joint motion.(D) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.(E) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Changes in skin reaction and/or coloration, permanent hair loss and scarring of the skin.(B) Scarring or shrinkage of soft tissues and muscle causing loss of flexibility and movement, swelling of the limb.(C) Nerve damage causing loss of strength, feeling or coordination.(D) Bone damage causing fracture.(E) Joint damage causing permanent stiffness, pains and arthritis.(F) Swelling of limb below the area treated.(G) In children, there may be additional late reactions.(i) Disturbances of bone and tissue growth.(ii) Bone damage to limbs causing stunting of bone growth and/or abnormal development.(iii) Second cancers developing in the irradiated area.(k) Total body irradiation.(1) Early reactions.(A) Loss of appetite, nausea, vomiting.(B) Diarrhea.(C) Reduced and sticky saliva, swelling of the salivary gland(s), loss of taste.(D) Hair loss.(E) Sore mouth and throat, difficulty swallowing.(F) Permanent destruction of bone marrow leading to infection, bleeding, and possible death.(G) Inflammation of the lung with fever, dry cough and difficulty breathing with possible fatal lung failure.(H) Damage to liver with possible fatal liver failure.(I) In children, these reactions are likely to be intensified by chemotherapy before, during or after radiation therapy.(J) In children, depression of blood count leading to increased risk of infection and/or bleeding is more common.(2) Late reactions.(A) Lung scarring causing shortness of breath, infection, and fatal lung failure.(B) Cataract formation in the eyes, possible loss of vision.(C) Testicular damage in males causing sterility.(D) Ovarian damage in females causing premature menopause and sterility.(E) Increased risk of second cancer. Source Note: The provisions of this §602.18 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.18 Radiation Therapy Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215990&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215990 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215990&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215990 03/11/2026 The following shall be in addition to risks and hazards of the same surgery when done as an open procedure.(1) Damage during introduction of trocar to adjacent intra-abdominal structures (e.g., organs, blood vessels, or other vital tissues) and potential need for additional surgery.(2) Trocar site complications (e.g., hematoma/bleeding, leakage of fluid, or hernia formation).(3) Air embolus (bubble causing heart failure or stroke).(4) Postoperative pneumothorax (collapsed lung).(5) Subcutaneous emphysema (air in between skin layers).(6) Change during the procedure to an open procedure.(7) If cancer is present, may increase the risk of the spread of cancer. Source Note: The provisions of this §602.19 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.19 Laparoscopic, Thoracoscopic and Robotic Surgery Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215991&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215991 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215991&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215991 03/11/2026 (a) Neuroaxial procedures (injections into or around spine).(1) Failure to reduce pain or worsening of pain.(2) Nerve damage including paralysis (inability to move).(3) Epidural hematoma (bleeding in or around spinal canal).(4) Infection.(5) Seizure.(6) Persistent leak of spinal fluid which may require surgery.(7) Breathing and/or heart problems including cardiac arrest (heart stops beating).(8) Loss of vision.(9) Stroke.(b) Peripheral and visceral nerve blocks and/or ablations.(1) Failure to reduce pain or worsening of pain.(2) Bleeding.(3) Nerve damage including paralysis (inability to move).(4) Infection.(5) Damage to nearby organ or structure.(6) Seizure.(c) Implantation of pain control devices.(1) Failure to reduce pain or worsening of pain.(2) Nerve damage including paralysis (inability to move).(3) Epidural hematoma (bleeding in or around spinal canal).(4) Infection.(5) Persistent leak of spinal fluid which may require surgery. Source Note: The provisions of this §602.20 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.20 Pain Management Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215992&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215992 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215992&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215992 03/11/2026 (a) Oral surgery.(1) Extraction (removing teeth).(A) Dry socket (inflammation in the socket of a tooth).(B) Permanent or temporary numbness or altered sensation.(C) Sinus communication (opening from tooth socket into the sinus cavity).(D) Fracture of alveolus and/or mandible (upper and/or lower jaw).(2) Surgical exposure of tooth in order to facilitate orthodontics.(A) Injury to tooth or to adjacent teeth and structures.(B) Failure to get proper attachment to tooth requiring additional procedure.(b) Endodontics (deals with diseases of the dental pulp).(1) Apicoectomy (surgical removal of root tip or end of the tooth, with or without sealing it).(A) Shrinkage of the gums and crown margin exposure.(B) Sinus communication (opening from tooth socket into the sinus cavity).(C) Displacement of teeth or foreign bodies into nearby tissues, spaces, and cavities.(2) Root amputation (surgical removal of portion of one root of a multi-rooted tooth).(A) Shrinkage of the gums and crown margin exposure.(B) Sinus communication (opening from tooth socket into the sinus cavity).(C) Displacement of teeth or foreign bodies into nearby tissues, spaces, and cavities.(3) Root canal therapy (from an occlusal access in order to clean and fill the canal system).(A) Instrument separation (tiny files which break within the tooth canal system).(B) Fenestration (penetration of walls of tooth into adjacent tissue).(C) Failure to find and/or adequately fill all canals.(D) Expression of irrigants or filling material past the apex of the tooth (chemicals used to clean or materials used to fill a root may go out the end of the root and cause pain or swelling).(E) Damage to adjacent tissues from irrigants or clamps.(F) Fracture or loss of tooth.(c) Periodontal surgery (surgery of the gums).(1) Gingivectomy and gingivoplasty (involves the removal of soft tissue).(A) Tooth sensitivity to hot, cold, sweet, or acid foods.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(2) Anatomical crown exposure (removal of enlarged gingival tissue and supporting bone to provide an anatomically correct gingival relationship).(A) Tooth sensitivity to hot, cold, sweet, or acid foods.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(3) Gingival flap procedure, including root planing (soft tissue flap is laid back or removed to allow debridement (cleaning) of the root surface and the removal of granulation tissue (unhealthy soft tissue)).(A) Permanent or temporary numbness or altered sensation.(B) Tooth sensitivity to hot, cold, sweet, or acid foods.(C) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(4) Apically positioned flap (used to preserve keratinized gingival (attached gum tissue) in conjunction with osseous resection (removal) and second stage implant procedure).(A) Permanent or temporary numbness or altered sensation.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(5) Clinical crown lengthening (removal of gum tissue and/or bone from around tooth).(A) Permanent or temporary numbness or altered sensation.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(6) Osseous surgery-including flap entry and closure (modification of the bony support of the teeth).(A) Permanent or temporary numbness or altered sensation.(B) Tooth sensitivity to hot, cold, sweet, or acid foods.(C) Loss of tooth.(D) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(7) Guided tissue regeneration-resorbable barrier.(A) Permanent or temporary numbness or altered sensation.(B) Accidental aspiration (into the lungs) of foreign matter.(C) Rejection of donor materials.(8) Guided tissue regeneration-nonresorbable barrier (includes membrane removal).(A) Permanent or temporary numbness or altered sensation.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(C) Accidental aspiration (into the lungs) of foreign matter.(D) Rejection of donor materials.(9) Pedicle soft tissue graft procedure.(A) Permanent or temporary numbness or altered sensation.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(C) Rejection of donor materials.(10) Free soft tissue graft protection-including donor site surgery.(A) Permanent or temporary numbness or altered sensation.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(C) Rejection of graft.(11) Sub epithelial connective tissue graft procedures.(A) Permanent or temporary numbness or altered sensation.(B) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(C) Rejection of graft.(12) Distal or proximal wedge procedure (taking off gum tissue from the very back of the last tooth or between teeth). Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(13) Soft tissue allograft and connective tissue double pedicle graft from below (creates or augments gum tissue).(A) Permanent or temporary numbness or altered sensation.(B) Tooth sensitivity to hot, cold, sweet, or acid foods.(C) Shrinkage of the gums upon healing resulting in teeth appearing longer and greater spaces between some teeth.(d) Implant procedures.(1) Bone grafting (replacing missing bone).(A) Permanent or temporary numbness or altered sensation.(B) Rejection of bone particles or graft from donor or recipient sites.(C) Damage to adjacent teeth or bone.(2) Surgical placement of implant body.(A) Blood vessel or nerve injury.(B) Damage to adjacent teeth or bone fracture.(C) Sinus communication (opening from tooth socket into the sinus cavity).(D) Failure of implant requiring corrective surgery.(E) Cyst formation, bone loss, or gum disease around the implant. Source Note: The provisions of this §602.21 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.21 Dental Surgery Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215993&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215993 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215993&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215993 03/11/2026 (a) Augmentation mammoplasty (breast enlargement with implant).(1) Bleeding around implant.(2) Sensory changes or loss of nipple sensitivity.(3) Failure, deflation, or leaking of implant requiring replacement.(4) Worsening or unsatisfactory appearance including asymmetry (unequal size or shape).(5) Problems with or the inability to breastfeed.(6) Capsular contracture (hardening of breast).(b) Bilateral breast reduction.(1) Skin flap or fat necrosis (injury or death of skin and fat).(2) Loss of nipple or areola.(3) Sensory changes or loss of nipple sensitivity.(4) Problems with or the inability to breastfeed.(5) Worsening or unsatisfactory appearance including asymmetry (unequal size or shape or not desired size).(c) Rhinoplasty or nasal reconstruction with or without septoplasty (repairing the middle wall of the nose).(1) Development of new problems, such as perforation of the nasal septum (hole in wall between the right and left halves of the nose) or breathing difficulty.(2) Spinal fluid leak.(3) Worsening or unsatisfactory appearance.(d) Reconstruction and/or plastic surgery operations of the face and neck.(1) Impairment of regional organs, such as eye or lip function.(2) Recurrence of the original condition.(3) Worsening or unsatisfactory appearance.(e) Liposuction (removal of fat by suction).(1) Shock.(2) Pulmonary fat embolism (fat escaping with possible damage to vital organs).(3) Damage to skin with possible skin loss.(4) Loose skin.(5) Worsening or unsatisfactory appearance.(f) Breast reconstruction with other flaps and/or implants.(1) Bleeding around implant.(2) Sensory changes or loss of nipple sensitivity.(3) Failure, deflation, or leaking of implant requiring replacement.(4) Damage to internal organs.(5) Worsening or unsatisfactory appearance including asymmetry (unequal size or shape).(g) Nipple Areolar Reconstruction.(1) Loss of graft.(2) Unsatisfactory appearance.(h) Panniculecotomy (removal of skin and fat).(1) Persistent swelling in the legs.(2) Nerve damage.(3) Worsening or unsatisfactory appearance.(i) Tendonitis, tendon release, and trigger releases.(1) Recurrence of symptoms.(2) Damage to blood vessels, nerves, tendons, or muscles.(3) Worsening function.(j) Breast reconstruction with flaps.(1) Damage to blood vessels, nerves, or muscles.(2) Loss of flap possibly requiring additional surgery.(3) Damage to internal organs.(4) Increased risk of abdominal wall complications with pregnancy.(5) Abdominal hernias with abdominal flaps.(6) Chronic abdominal pain with abdominal flaps.(7) Worsening or unsatisfactory appearance including asymmetry (unequal size or shape).(k) Flap or graft surgery.(1) Damage to blood vessels, nerves, or muscles.(2) Deep vein thrombosis (blood clot in legs or arms).(3) Loss of flap possibly requiring additional surgery.(4) Worsening or unsatisfactory appearance.(l) Tendons, nerves, or blood vessel repair.(1) Damage to nerves.(2) Deep vein thrombosis (blood clot in legs or arms).(3) Rupture of repair.(4) Worsening of function.(m) Reconstructive and/or plastic surgical procedures of the eye and eye region, such as blepharoplasty, tumor, fracture, lacrimal surgery, foreign body, abscess, or trauma. See §602.6(d) of this chapter (relating to Eye Treatments and Procedures). Source Note: The provisions of this §602.22 adopted to be effective December 26, 2023, 48 TexReg 7985. 7 TEXAS MEDICAL DISCLOSURE PANEL 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A §602.22 Plastic Surgery and Surgery of the Integumentary System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215994&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215994 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215994&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215994 03/11/2026 Local. Source Note: The provisions of this §603.1 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.1 Anesthesia Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215995&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215995 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215995&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215995 03/11/2026 (a) Excision and ligation of varicose veins of the leg.(b) Arterial line for monitoring purposes. Source Note: The provisions of this §603.2 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.2 Cardiovascular System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225045&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225045 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225045&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225045 03/11/2026 (a) Incision (cutting into) or excision (removal) of perirectal tissue.(b) Local excision (removal) and/or destruction of a lesion of anus and/or rectum.(c) Tonsillectomy without adenoidectomy. Source Note: The provisions of this §603.3 adopted to be effective December 26, 2023, 48 TexReg 7995; amended to be effective May 25, 2025, 50 TexReg 2969. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.3 Digestive System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215997&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215997 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215997&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215997 03/11/2026 (a) Myringotomy.(b) Reconstruction of auricle of ear for skin cancer.(c) Tympanoplasty without mastoidectomy. Source Note: The provisions of this §603.4 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.4 Ear Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215998&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215998 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215998&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215998 03/11/2026 No procedures assigned at this time. Source Note: The provisions of this §603.5 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.5 Endocrine System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215999&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215999 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215999&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215999 03/11/2026 (a) Administration of topical, parenteral (such as IV), or oral drugs or pharmaceuticals, including, but not limited to, fluorescein angiography, orbital injection or periocular injections.(b) Removal of extraocular foreign bodies.(c) Chalazion excision. Source Note: The provisions of this §603.6 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.6 Eye Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216000&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216000 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216000&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216000 03/11/2026 No procedures assigned at this time. Source Note: The provisions of this §603.7 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.7 Female Genital System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216001&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216001 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216001&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216001 03/11/2026 (a) Biopsy of lymph nodes.(b) Other procedures. No other procedures are assigned at this time. Source Note: The provisions of this §603.8 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.8 Hematic and Lymphatic System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216002&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216002 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216002&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216002 03/11/2026 (a) Needle biopsy.(b) Incision and drainage of skin lesion. Source Note: The provisions of this §603.9 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.9 Breast Surgery (non-cosmetic) Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216003&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216003 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216003&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216003 03/11/2026 (a) Biopsy of testicle.(b) Placement of testicular prosthesis.(c) Hydrocelectomy (removal/drainage of cyst in scrotum).(d) Cystoscopy. Source Note: The provisions of this §603.10 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.10 Male Genital System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216004&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216004 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216004&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216004 03/11/2026 Intrauterine Devices (IUD). Source Note: The provisions of this §603.11 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.11 Maternity and Related Cases Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216005&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216005 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216005&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216005 03/11/2026 (a) Arthrotomy, arthrocentesis, or joint injection (unless performed on a child age 12 or under, see §602.12(g) of this title (relating to Musculoskeletal System Treatments and Procedures.)).(b) Closed reduction without internal fixation (unless performed on a child age 12 or under, see §602.12(g) of this title).(c) Wound debridement (unless performed on a child age 12 or under, see §602.12(g) of this title).(d) Needle biopsy or aspiration, bone marrow (unless performed on a child age 12 or under, see §602.12(g) of this title).(e) Partial excision of bone (unless performed on a child age 12 or under, see §602.12(g) of this title).(f) Removal of external fixation device (unless performed on a child age 12 or under, see §602.12(g) of this title).(g) Traction or fixation without manipulation for reduction (unless performed on a child age 12 or under, see §602.12(g) of this title). Source Note: The provisions of this §603.12 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.12 Musculoskeletal System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216006&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216006 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216006&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216006 03/11/2026 (a) Lumbar puncture.(b) Closure of meningomyelocele.(c) Ventriculostomy with or without air ventriculogram.(d) Cisternal puncture (diagnostic).(e) Stereotactic surgery for dystonia.(f) Insertion of skeletal tongs.(g) Intravenous cut-down.(h) Cervical 1-2 puncture (diagnostic). Source Note: The provisions of this §603.13 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.13 Nervous System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216007&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216007 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216007&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216007 03/11/2026 (a) Lymphangiography.(b) Discography.(c) Lumbar puncture with/without injection of medication.(d) Nerve root injection, epidural injection, nerve blocks, and radiofrequency treatments for pain control.(e) Venography (Venogram) with contrast media by peripheral IV.(f) Cholangiography with contrast media through existing drain; T-tube cholangiography.(g) Urography (IVP) with contrast media.(h) Radionuclide scans and/or blood flow studies.(i) Gastrointestinal (GI) tract radiography and fluoroscopy.(j) Nasogastric/nasojejunal tube placement with fluoroscopy.(k) Percutaneous gastrostomy/gastrojejunostomy.(l) Fistula or sinus tract injection.(m) Sialography.(n) Dacryocystography, stenting.(o) Cystography, cystourethrography.(p) Retrograde and antegrade urography.(q) Larynogography, bronchography.(r) Hysterosalpingography.(s) ERCP (Endoscopic retrograde cholangio pancreatography).(t) Galactography.(u) Skeletal radiography and/or fluoroscopy (skull, mastoids, sinuses and facial bones; spine, ribs, pelvis; extremities).(v) Foreign body radiography and/or fluoroscopy and foreign body retrieval.(w) Chest and abdomen radiography and fluoroscopy.(x) Portable radiography/fluoroscopy.(y) Pelvimetry, fetogram.(z) Magnetic Resonance Imaging/Magnetic Resonance Angiography without and with contrast.(aa) Computed tomography scan/computed tomography angiogram without and with contrast media.(bb) Ultrasound and Doppler studies.(cc) Laminography, polytomography.(dd) Soft-tissue radiography including xeroradiography and xeromammography.(ee) Arthrography, arthrocentesis, tenography.(ff) Ureteral or urethral balloon dilatation/stent.(gg) Percutaneous suprapubic cystostomy.(hh) Cyst aspiration/drainage/sclerosis.(ii) Percutaneous or transvascular biopsy.(jj) Paracentesis.(kk) Thoracentesis. Source Note: The provisions of this §603.14 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.14 Radiology Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216008&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216008 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216008&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216008 03/11/2026 (a) Aspiration of bronchus.(b) Reduction of nasal fracture. Source Note: The provisions of this §603.15 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.15 Respiratory System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225046&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225046 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=225046&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 225046 03/11/2026 (a) Biopsy of prostrate, bladder or urethra.(b) Urethrotomy (incision of the urethra). Source Note: The provisions of this §603.16 adopted to be effective December 26, 2023, 48 TexReg 7995; amended to be effective May 25, 2025, 50 TexReg 2969. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.16 Urinary System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216010&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216010 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216010&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216010 03/11/2026 No procedures assigned at this time. Source Note: The provisions of this §603.17 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.17 Psychiatric Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216011&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216011 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216011&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216011 03/11/2026 No procedures assigned at this time. Source Note: The provisions of this §603.18 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.18 Radiation Therapy Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216012 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216012&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216012 03/11/2026 No procedures assigned at this time. Source Note: The provisions of this §603.19 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.19 Laparoscopic/Thoracoscopic Surgery (including robotic surgery) Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216013&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216013 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216013&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216013 03/11/2026 (a) Trigger point injection (injection into tendon or muscle).(b) Scar injection. Source Note: The provisions of this §603.20 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.20 Pain Management Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216014 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216014&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216014 03/11/2026 (a) Cutting and preparation of skin grafts or small pedicle flaps.(b) Removal or treatment of local skin or subcutaneous lesion.(c) Excision of pilonidal sinus or cyst.(d) Suture of skin.(e) Wide or radical excision of skin lesion with or without graft.(f) Z plasty with or without excision.(g) Biopsy of skin or mucus membrane.(h) Debridement of ulceration of the skin. Source Note: The provisions of this §603.21 adopted to be effective December 26, 2023, 48 TexReg 7995. 7 TEXAS MEDICAL DISCLOSURE PANEL 603 PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B §603.21 Plastic Surgery and Surgery of the Integumentary System Treatments and Procedures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216015 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216015&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216015 03/11/2026 (a) The Texas Medical Disclosure Panel adopts the following form which shall be used by a physician or health care provider to inform a patient or person authorized to consent for the patient of the possible risks and hazards involved in the medical treatments and surgical procedures named in the form. Except for the procedures shown in subsection (b) of this section, the following form shall be used for the medical treatments and surgical procedures described in Chapter 602 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A). Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Health and Human Services Commission. (1) English form.Attached Graphic(2) Spanish form.Attached Graphic(b) Informed consent for:(1) radiation therapy shall be provided in accordance with §604.2 of this chapter (relating to Disclosure and Consent Form for Radiation Therapy);(2) electroconvulsive therapy shall be provided in accordance with §604.3 of this chapter (relating to Informed Consent for Electroconvulsive Therapy);(3) hysterectomy procedures shall be provided in accordance with §604.4 of this chapter (relating to Disclosure and Consent Form for Hysterectomy); and(4) anesthesia and/or perioperative pain management (analgesia) procedures shall be in accordance with §604.5 of this chapter (relating to Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia)). Source Note: The provisions of this §604.1 adopted to be effective December 26, 2023, 48 TexReg 7997. 7 TEXAS MEDICAL DISCLOSURE PANEL 604 DISCLOSURE FORMS §604.1 Disclosure and Consent Form https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216016 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216016&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216016 03/11/2026 The Texas Medical Disclosure Panel adopts the following form to be used by a physician or health care provider to inform a patient or person authorized to consent for a patient of the possible risks and hazards involved in the radiation therapy named in the form. This form is to be used in lieu of the general disclosure and consent form adopted in §604.1(a) of this chapter (relating to Disclosure and Consent Form) for disclosure and consent relating to only radiation therapy procedures. If a surgical or anesthetic procedure is required in combination with a radiation therapy procedure, the general disclosure and consent form as adopted in §604.1(a) of this chapter and the form adopted in this section shall be used. The general disclosure and consent form shall be used for the surgical or anesthetic procedure and the radiation therapy disclosure and consent form shall be used for the radiation therapy procedure. Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Health and Human Services Commission.(1) English form.Attached Graphic(2) Spanish form.Attached Graphic Source Note: The provisions of this §604.2 adopted to be effective December 26, 2023, 48 TexReg 7997. 7 TEXAS MEDICAL DISCLOSURE PANEL 604 DISCLOSURE FORMS §604.2 Disclosure and Consent Form for Radiation Therapy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216017 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216017&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216017 03/11/2026 (a) Health and Safety Code (HSC) §578.003, relating to Consent to Therapy, requires the Texas Department of State Health Services (DSHS) to adopt a standard written consent form to be used when electroconvulsive therapy is considered. HSC §578.003 requires that the form include the minimum information which is also required by the Texas Medical Disclosure Panel (panel) for electroconvulsive therapy. HSC §578.003 states that use of the consent form prescribed by DSHS in the manner described by HSC §578.003 creates a rebuttable presumption that the disclosure requirements of Texas Civil Practice and Remedies Code §74.102 have been met.(b) The panel recognizes that DSHS has adopted a written consent form for electroconvulsive therapy in §405.108 of this title (relating to Informed Consent to ECT).(c) If the DSHS consent form is in compliance with HSC §578.003, and contains the minimum information required by the panel for electroconvulsive therapy, specifically the risks and hazards identified by the panel, a physician or health care provider using the DSHS consent form for electroconvulsive therapy is not required to use both the DSHS form and the panel's Disclosure and Consent - Medical Care and Surgical Procedures form to document consent for the electroconvulsive therapy. This section does not constitute approval of DSHS's current consent form or of DSHS's assessment of the risks and hazards associated with electroconvulsive therapy.(d) If the physician or healthcare provider will be administering List A anesthesia or analgesia in conjunction with electroconvulsive therapy, the panel recommends utilization of the panel's Disclosure and Consent - Anesthesia and /or Perioperative Pain Management (Analgesia) form set out at §604.5(1) or (2) of this chapter (relating to Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia)) to document disclosure and consent for the anesthesia and analgesia. The panel's form includes the risks and hazards identified by the panel for List A anesthesia and analgesia. Source Note: The provisions of this §604.3 adopted to be effective December 26, 2023, 48 TexReg 7997. 7 TEXAS MEDICAL DISCLOSURE PANEL 604 DISCLOSURE FORMS §604.3 Informed Consent for Electroconvulsive Therapy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216018&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216018 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216018&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216018 03/11/2026 The Texas Medical Disclosure Panel adopts the following form which shall be used to provide informed consent to a patient or person authorized to consent for the patient of the possible risks and hazards involved in the hysterectomy surgical procedure named in the form. This form is to be used in lieu of the general disclosure and consent form adopted in §604.1(a) of this chapter (relating to Disclosure and Consent Form) for disclosure and consent relating to only hysterectomy procedures. Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Health and Human Services Commission.(1) English form.Attached Graphic(2) Spanish form.Attached Graphic Source Note: The provisions of this §604.4 adopted to be effective December 26, 2023, 48 TexReg 7997. 7 TEXAS MEDICAL DISCLOSURE PANEL 604 DISCLOSURE FORMS §604.4 Disclosure and Consent Form for Hysterectomy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216019 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=216019&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 216019 03/11/2026 The Texas Medical Disclosure Panel adopts the following form which shall be used to provide informed consent to a patient or person authorized to consent for the patient of the possible risks and hazards involved in anesthesia and/or perioperative pain management (analgesia). Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Health and Human Services Commission.(1) English form.Attached Graphic(2) Spanish form.Attached Graphic Source Note: The provisions of this §604.5 adopted to be effective December 26, 2023, 48 TexReg 7997. 7 TEXAS MEDICAL DISCLOSURE PANEL 604 DISCLOSURE FORMS §604.5 Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2649&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2649 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2649&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2649 03/11/2026 These rules outline the procedures the council will follow in the conduct of its meetings. Source Note: The provisions of this §651.1 adopted to be effective May 22, 1984, 9 TexReg 2563. 9 TEXAS DIABETES COUNCIL 651 CONDUCT OF COUNCIL MEETINGS §651.1 Introduction https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2650&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2650 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2650&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2650 03/11/2026 The council in all its meetings is subject to the requirements of the Texas Open Meetings Act, Texas Civil Statute 6252-17. Source Note: The provisions of this §651.2 adopted to be effective May 22, 1984, 9 TexReg 2563. 9 TEXAS DIABETES COUNCIL 651 CONDUCT OF COUNCIL MEETINGS §651.2 Applicability of Texas Open Meetings Law https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14604 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14604&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14604 03/11/2026 (a) Written notice giving the date, time, place, and subject of each meeting shall be prepared as required by the Texas Open Meetings Law.(b) A copy of the notice shall be sent to each council member at least seven days prior to the meeting except in emergency cases as determined by the chairperson.(c) The meetings will be held at least quarterly and generally will be located in Austin, Texas. Source Note: The provisions of this §651.3 adopted to be effective May 22, 1984, 9 TexReg 2563. 9 TEXAS DIABETES COUNCIL 651 CONDUCT OF COUNCIL MEETINGS §651.3 Notice of Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14608&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14608 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14608&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14608 03/11/2026 (a) All meetings will be conducted according to Robert Rules of Order, except as provided otherwise in these rules.(b) All council actions taken must be approved by a majority vote of the members present. The chairperson may vote on any item of business as any other council member; however, in the case of a tie vote, the chairperson's vote shall be the tie breaker. Source Note: The provisions of this §651.4 adopted to be effective May 22, 1984, 9 TexReg 2563. 9 TEXAS DIABETES COUNCIL 651 CONDUCT OF COUNCIL MEETINGS §651.4 Transaction of Business https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2651&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2651 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2651&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2651 03/11/2026 Requests from members of the public to participate in council meetings shall be submitted to the chairperson prior to the beginning of the meeting. The chairperson has the discretion to allow or disallow participation. If the chairperson allows participation, he/she determines the manner and time limits of the participation. Source Note: The provisions of this §651.5 adopted to be effective May 22, 1984, 9 TexReg 2563. 9 TEXAS DIABETES COUNCIL 651 CONDUCT OF COUNCIL MEETINGS §651.5 Public Participation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166291&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166291 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166291&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166291 03/11/2026 The Institute shall:(1) Create and expedite innovation in the area of cancer research and enhance the potential for medical or scientific breakthrough in the prevention of cancer and cures for cancer;(2) Attract, create, or expand research capabilities of public or private institutions of higher education and other public or private entities that will promote a substantial increase in cancer research and in the creation of high-quality new jobs in Texas; and(3) Develop and implement the Texas Cancer Plan. Source Note: The provisions of this §701.1 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.1 Intent https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218579&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218579 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218579&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218579 03/11/2026 The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.(1) Advisory Committee--a committee of experts, including practitioners and patient advocates, created by the Oversight Committee to advise the Oversight Committee on issues related to cancer.(2) Allowable Cost--a cost that is reasonable, necessary for the proper and efficient performance and administration of the project, and allocable to the project.(3) Annual Public Report--the report issued by the Institute pursuant to Texas Health and Safety Code §102.052 outlining Institute activities, including Grant Awards, research accomplishments, future Program directions, compliance, and Conflicts of Interest actions.(4) Approved Budget--the financial expenditure plan for the Grant Award, including revisions approved by the Institute and permissible revisions made by the Grant Recipient. The Approved Budget may be shown by Project Year and detailed budget categories.(5) Authorized Expense--cost items including honoraria, salaries and benefits, consumable supplies, other operating expenses, contracted research and development, capital equipment, construction or renovation of state or private facilities, travel, and conference fees and expenses.(6) Authorized Signing Official (ASO)--the individual, including designated alternates, named by the Grant Applicant, who is authorized to act for the Grant Applicant or Grant Recipient in submitting the Grant Application and executing the Grant Contract and associated documents or requests.(7) Bylaws--the rules established by the Oversight Committee to provide a framework for its operation, management, and governance.(8) Cancer Prevention--a reduction in the risk of developing cancer, including early detection, control and/or mitigation of the incidence, disability, mortality, or post-diagnosis effects of cancer.(9) Cancer Prevention and Control Program--effective strategies and interventions for preventing and controlling cancer designed to reduce the incidence and mortality of cancer and to enhance the quality of life of those affected by cancer.(10) Cancer Prevention and Research Fund--the dedicated account in the general revenue fund consisting of legislative appropriations, gifts, grants, other donations, and earned interest.(11) Cancer Research--research into the prevention, causes, detection, treatments, and cures for all types of cancer in humans, including basic mechanistic studies, pre-clinical studies, animal model studies, translational research, and clinical research to develop preventative measures, therapies, protocols, medical pharmaceuticals, medical devices or procedures for the detection, treatment, cure or substantial mitigation of all types of cancer and its effects in humans.(12) Chief Compliance Officer--the individual employed by the Institute to monitor and report to the Oversight Committee regarding compliance with the Institute's statute and administrative rules. The term may also apply to an individual designated by the Chief Compliance Officer to fulfill the duty or duties described herein, unless the context clearly indicates otherwise.(13) Chief Executive Officer--the individual hired by the Oversight Committee to perform duties required by the Institute's Statute or designated by the Oversight Committee. The term may apply to an individual designated by the Chief Executive Officer to fulfill the duty or duties described herein, unless the context clearly indicates otherwise.(14) Chief Prevention Officer--the individual hired by the Chief Executive Officer to oversee the Institute's Cancer Prevention program, including the Grant Review Process, and to assist the Chief Executive Officer in collaborative outreach to further Cancer Research and Cancer Prevention. The term may also apply to an individual designated by the Chief Prevention Officer to fulfill the duty or duties described herein, unless the context clearly indicates otherwise.(15) Chief Product Development Officer--the individual hired by Chief Executive Officer to oversee the Institute's Product Development program for drugs, biologicals, diagnostics, or devices arising from Cancer Research, including the Grant Review Process, and to assist the Chief Executive Officer in collaborative outreach to further Cancer Research and Cancer Prevention. The term may apply to an individual designated by the Chief Product Development Officer to fulfill the duty or duties described herein, unless the context clearly indicates otherwise.(16) Chief Scientific Officer--the individual hired by the Chief Executive Officer to oversee the Institute's Cancer Research program, including the Grant Review Process, and to assist the Chief Executive Officer in collaborative outreach to further Cancer Research and Cancer Prevention. The term may apply to an individual designated by the Chief Scientific Officer to fulfill the duty or duties described herein, unless the context clearly indicates otherwise.(17) Code of Conduct and Ethics--the code adopted by the Oversight Committee pursuant to Texas Health and Safety Code §102.109 to provide guidance related to the ethical conduct expected of Oversight Committee Members, Program Integration Committee Members, and Institute Employees.(18) Compliance Program--a process to assess and ensure compliance by the Oversight Committee Members and Institute Employees with applicable laws, rules, and policies, including matters of ethics and standards of conduct, financial reporting, internal accounting controls, and auditing.(19) Conflict(s) of Interest--a financial, professional, or personal interest held by the individual or the individual's Relative that is contrary to the individual's obligation and duty to act for the benefit of the Institute.(20) Encumbered Funds--funds that are designated by a Grant Recipient for a specific purpose.(21) Financial Status Report--form used to report all Grant Award related financial expenditures incurred in implementation of the Grant Award. This form may also be referred to as "FSR" or "Form 269-A."(22) Grant Applicant--the public or private institution of higher education, as defined by §61.003, Texas Education Code, research institution, government organization, non-governmental organization, non-profit organization, other public entity, private company, individual, or consortia, including any combination of the aforementioned, that submits a Grant Application to the Institute. Unless otherwise indicated, this term includes the Principal Investigator or Program Director.(23) Grant Application--the written proposal submitted by a Grant Applicant to the Institute in the form required by the Institute that, if successful, will result in a Grant Award.(24) Grant Award--funding, including a direct company investment, awarded by the Institute pursuant to a Grant Contract providing money to the Grant Recipient to carry out the Cancer Research or Cancer Prevention project in accordance with rules, regulations, and guidance provided by the Institute.(25) Grant Contract--the legal agreement executed by the Grant Recipient and the Institute setting forth the terms and conditions for the Cancer Research or Cancer Prevention Grant Award approved by the Oversight Committee.(26) Grant Management System--the electronic interactive system used by the Institute to exchange, record, and store Grant Application and Grant Award information.(27) Grant Mechanism--the specific Grant Award type.(28) Grant Program--the functional area in which the Institute makes Grant Awards, including research, prevention and product development.(29) Grant Progress Report--the required report submitted by the Grant Recipient at least annually and at the close of the grant award describing the activities undertaken to achieve the Scope of Work of the funded project and including information, data and program metrics. Unless the context clearly indicates otherwise, the Grant Progress Report also includes other required reports such as a Historically Underutilized Business and Texas Supplier form, a single audit determination form, an inventory report, a single audit determination form, a revenue sharing form, and any other reports or forms designated by the Institute.(30) Grant Recipient--the entire legal entity responsible for the performance or administration of the Grant Award pursuant to the Grant Contract. Unless otherwise indicated, this term includes the Principal Investigator, Program Director, or Company Representative.(31) Grant Review Cycle--the period that begins on the day that the Request for Applications is released for a particular Grant Mechanism and ends on the day that the Oversight Committee takes action on the Grant Award recommendations.(32) Grant Review Process--the Institute's processes for Peer Review, Program Review and Oversight Committee approval of Grant Applications.(33) Indirect Costs--the expenses of doing business that are not readily identified with a particular Grant Award, Grant Contract, project, function, or activity, but are necessary for the general operation of the Grant Recipient or the performance of the Grant Recipient's activities.(34) Institute--the Cancer Prevention and Research Institute of Texas or CPRIT.(35) Institute Employee--any individual employed by the Institute, including any individual performing duties for the Institute pursuant to a contract of employment. Unless otherwise indicated, the term does not include an individual providing services to the Institute pursuant to a services contract.(36) Intellectual Property Rights--any and all of the following and all rights in, arising out of, or associated therewith, but only to the extent resulting from the Grant Award:(A) The United States and foreign patents and utility models and applications therefore and all reissues, divisions, re-examinations, renewals, extensions, provisionals, continuations and such claims of continuations-in-part as are entitled to claim priority to the aforesaid patents or patent applications, and equivalent or similar rights anywhere in the world in Inventions and discoveries;(B) All trade secrets and rights in know-how and proprietary information;(C) All copyrights, whether registered or unregistered, and applications therefore, and all other rights corresponding thereto throughout the world excluding scholarly and academic works such as professional articles and presentations, lab notebooks, and original medical records; and(D) All mask works, mask work registrations and applications therefore, and any equivalent or similar rights in semiconductor masks, layouts, architectures or topography.(37) Invention--any method, device, process or discovery that is conceived and/or reduced to practice, whether patentable or not, by the Grant Recipient in the performance of work funded by the Grant Award.(38) License Agreement--an understanding by which an owner of Technology and associated Intellectual Property Rights grants any right to make, use, develop, sell, offer to sell, import, or otherwise exploit the Technology or Intellectual Property Rights in exchange for consideration.(39) Matching Funds--the Grant Recipient's Encumbered Funds equal to one-half of the Grant Award available and not yet expended that are dedicated to the research that is the subject of the Grant Award. For public and private institutions of higher education, this includes the dollar amount equivalent to the difference between the indirect cost rate authorized by the federal government for research grants awarded to the Grant Recipient and the five percent (5%) Indirect Cost limit imposed by §102.203(c), Texas Health and Safety Code.(40) Numerical Ranking Score--the score given to a Grant Application by the Review Council that is substantially based on the final Overall Evaluation Score submitted by the Peer Review Panel, but also signifies the Review Council's view related to how well the Grant Application achieves program priorities set by the Oversight Committee, the overall Program portfolio balance, and any other criteria described in the Request for Applications.(41) Overall Evaluation Score--the score given to a Grant Application during the Peer Review Panel review that signifies the reviewers' overall impression of the Grant Application. Typically, it is the average of the scores assigned by two or more Peer Review Panel members.(42) Oversight Committee--the Institute's governing body, composed of the nine individuals appointed by the Governor, Lieutenant Governor, and the Speaker of the House of Representatives.(43) Oversight Committee Member--any person appointed to and serving on the Oversight Committee.(44) Patient Advocate--a trained individual who meets the qualifications set by the Institute and is appointed to a Scientific Research and Prevention Programs Committee to specifically represent the interests of cancer patients as part of the Peer Review of Grant Applications assigned to the individual's committee.(45) Peer Review--the review process performed by Scientific Research and Prevention Programs Committee members and used by the Institute to provide guidance and recommendations to the Program Integration Committee and the Oversight Committee in making decisions for Grant Awards. The process involves the consistent application of standards and procedures to produce a fair, equitable, and objective evaluation of scientific and technical merit, as well as other relevant aspects of the Grant Application. When used herein, the term applies individually or collectively, as the context may indicate, to the following review process(es): Preliminary Evaluation, Individual Evaluation by Primary Reviewers, Peer Review Panel discussion and Review Council prioritization.(46) Peer Review Panel--a group of Scientific Research and Prevention Programs Committee members conducting Peer Review of assigned Grant Applications.(47) Prevention Review Council--the group of Scientific Research and Prevention Programs Committee members designated as the chairpersons of the Peer Review Panels that review Cancer Prevention program Grant Applications. This group includes the Review Council chairperson.(48) Primary Reviewer--a Scientific Research and Prevention Programs Committee member responsible for individually evaluating all components of the Grant Application, critiquing the merits according to explicit criteria published in the Request for Applications, and providing an individual Overall Evaluation Score that conveys the general impression of the Grant Application's merit.(49) Principal Investigator, Program Director, or Company Representative--the single individual designated by the Grant Applicant or Grant Recipient to have the appropriate level of authority and responsibility to direct the project to be supported by the Grant Award.(50) Product Development Prospects--the potential for development of products, services, or infrastructure to support Cancer Research efforts, including but not limited to pre-clinical, clinical, manufacturing, and scale up activities.(51) Product Development Review Council--the group of Scientific Research and Prevention Programs Committee Members designated as the chairpersons of the Peer Review Panels that review Grant Applications for the development of drugs, drugs, biologicals, diagnostics, or devices arising from earlier-stage Cancer Research. This group includes the Review Council chairperson.(52) Program Income--income from fees for services performed, from the use or rental of real or personal property acquired with Grant Award funds, and from the sale of commodities or items fabricated under the Grant Contract. Except as otherwise provided, Program Income does not include rebates, credits, discounts, refunds, etc. or the interest earned on any of these items. Interest otherwise earned in excess of $250 on Grant Award funds is considered Program Income.(53) Program Integration Committee--the group composed of the Chief Executive Officer, the Chief Scientific Officer, the Chief Product Development Officer, the Commissioner of State Health Services, and the Chief Prevention Officer that is responsible for submitting to the Oversight Committee the list of Grant Applications the Program Integration Committee recommends for Grant Awards.(54) Project Results--all outcomes of a Grant Award, including publications, knowledge gained, additional funding generated, and any and all Technology and associated Intellectual Property Rights.(55) Project Year--the intervals of time (usually 12 months each) into which a Grant Award is divided for budgetary, funding, and reporting purposes. The effective date of the Grant Contract is the first day of the first Project Year.(56) Real Property--land, including land improvements, structures and appurtenances thereto, excluding movable machinery and equipment.(57) Relative--a person related within the second degree by consanguinity or affinity determined in accordance with §§573.021 - 573.025, Texas Government Code. For purposes of this definition:(A) examples of an individual within the second degree by consanguinity are a child, grandchild, parent, grandparent, brother, sister;(B) a husband and wife are related to each other in the first degree of affinity. For other relationship by affinity, the degree of relationship is the same as the degree of the underlying relationship by consanguinity;(C) an individual adopted into a family is considered a Relative on the same basis as a natural born family member; and(D) an individual is considered a spouse even if the marriage has been dissolved by death or divorce if there are surviving children of that marriage.(58) Request for Applications--the invitation released by the Institute seeking the submission of Grant Applications for a particular Grant Mechanism. It provides information relevant to the Grant Award to be funded, including funding amount, Grant Review Process information, evaluation criteria, and required Grant Application components. The Request for Applications includes any associated written instructions provided by the Institute and available to all Grant Applicants.(59) Review Council--the term used to generally refer to one or more of the Prevention Review Council, the Product Development Review Council, or Scientific Review Council.(60) Scientific Research and Prevention Programs Committee--a group of experts in the field of Cancer Research, Cancer Prevention or Product Development, including trained Patient Advocates, appointed by the Chief Executive Officer and approved by the Oversight Committee for the purpose of conducting Peer Review of Grants Applications and recommending Grant Awards. A Peer Review Panel is a Scientific Research and Prevention Programs Committee, as is a Review Council.(61) Scientific Research and Prevention Programs Committee Member--an individual appointed by the Chief Executive Officer and approved by the Oversight Committee to serve on a Scientific Research and Prevention Programs Committee. Peer Review Panel Members are Scientific Research and Prevention Programs Committee Members, as are Review Council Members.(62) Scientific Review Council--the group of Scientific Research and Prevention Programs Committee Members designated as the chairpersons of the Peer Review Panels that review Cancer Research Grant Applications. This group includes the Review Council chairperson.(63) Scope of Work--the goals and objectives or specific aims and subaims, if appropriate, of the Cancer Research or Cancer Prevention project, including the timeline and milestones to be achieved.(64) Senior Member or Key Personnel--the Principal Investigator, Project Director or Company Representative and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not the individuals receive salary or compensation under the Grant Award.(65) Technology--any and all of the following resulting or arising from work funded by the Grant Award:(A) Inventions;(B) Third-Party Information, including but not limited to data, trade secrets and know-how;(C) databases, compilations and collections of data;(D) tools, methods and processes; and(E) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all instantiations of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug formulations, devices, diagnostics, biomarkers, reagents and research tools.(66) Texas Cancer Plan--a coordinated, prioritized, and actionable framework that helps to guide statewide efforts to fight the human and economic burden of cancer in Texas.(67) Third-Party Information--generally, all trade secrets, proprietary information, know-how and non-public business information disclosed to the Institute by Grant Applicant, Grant Recipient, or other individual external to the Institute.(68) Tobacco--all forms of tobacco products, including but not limited to cigarettes, cigars, pipes, water pipes (hookah), bidis, kreteks, electronic cigarettes, smokeless tobacco, snuff and chewing tobacco.(69) Tranche--the portion of the Grant Award disbursed to the Grant Recipient in a sequential and conditional manner based upon the successful completion of predefined milestones as specified in the Grant Contract. Source Note: The provisions of this §701.3 adopted to be effective March 2, 2014, 39 TexReg 1380; amended to be effective December 7, 2016, 41 TexReg 9526; amended to be effective June 8, 2017, 42 TexReg 2937; amended to be effective September 13, 2018, 43 TexReg 5806; amended to be effective September 7, 2023, 48 TexReg 4859; amended to be effective June 9, 2024, 49 TexReg 3926. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.3 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166289&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166289 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166289&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166289 03/11/2026 The Oversight Committee shall adopt Bylaws to govern the conduct of its meetings and its management of the Institute, consistent with applicable law.(1) The Bylaws shall include:(A) A process to elect a presiding officer, assistant presiding officer, and any other officer positions that may be created by the Oversight Committee and to set terms of service for such positions;(B) A meeting schedule that permits a public meeting to be held no less than once each calendar quarter, with appropriate notice and opportunity for a formal public comment period;(C) Duties and responsibilities for the presiding officer and assistant presiding officer, as well as other additional officer positions that may be created by the Oversight Committee;(D) Responsibilities of the Oversight Committee and the Committee's officers that are distinguished from responsibilities of the Chief Executive Officer and Institute employees;(E) A process for the Oversight Committee to review the financial practices of the Institute, including a review of the annual financial audit of the Institute's activities and the Comptroller of Public Accounts' report and evaluation of the Institute's annual financial audit;(F) A prohibition against an interlocking directorate between the Oversight Committee and any foundation established to benefit the Institute;(G) A process for hiring a Chief Executive Officer and evaluating the Chief Executive Officer's job performance; and(H) A designation of grounds for removal from the Oversight Committee based on illness, absence, or ineligibility and provide process for removal.(2) The Bylaws must be posted on the Institute's Internet website. Source Note: The provisions of this §701.5 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.5 Oversight Committee Bylaws https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181376&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181376 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181376&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181376 03/11/2026 (a) Oversight Committee Members, Institute Employees, Scientific Research and Prevention Program Committee Members, Program Integration Committee Members, Grant Applicants, Grant Recipients, and contract service providers are expected to comply with applicable laws, rules, regulations, and policies in conduct of their official duties and responsibilities as well as professional standards of business and personal ethics.(b) The Institute's Compliance Program shall ensure that agency operations conform to federal and state regulations, and that such operations are undertaken consistent with the Institute's administrative rules, policies, and procedures.(1) The Compliance Program shall specifically address at least the following agency operations: Grant Review Process, Grant Award financial reporting and performance monitoring, Institute financial reporting, internal accounting controls, and auditing.(2) The Compliance Program shall implement and oversee systems and activities to detect and report instances of conduct that do not conform to applicable law or policy, as well as the timely response to non-conforming conduct and to prevent future similar conduct.(3) The Compliance Program shall implement and enforce the Code of Conduct and Ethics as well as the consistent enforcement of other compliance standards and procedures adopted by the Oversight Committee.(c) The Compliance Program shall operate under the direction of the Chief Compliance Officer.(1) In performing the duties under this program, the Chief Compliance Officer shall have direct access to the Oversight Committee.(2) The Chief Compliance Officer is responsible and will be held accountable for apprising the Oversight Committee and the Chief Executive Officer of the institutional compliance functions and activities.(A) The Chief Compliance Officer shall report at least quarterly to the Oversight Committee on the Institute's compliance with the applicable laws, rules and Institute policies. The Chief Compliance Officer may report more frequently to the Audit Subcommittee of the Oversight Committee.(B) The Chief Compliance Officer shall report at least annually on the Institute's compliance program activities, including any proposed legislation or other recommendations identified through the activities. The compliance report shall be included in the Institute's Annual Public Report.(C) The Chief Compliance Officer shall report to the Oversight Committee on the Grant Recipients' compliance with the terms and conditions of the Grant Contracts. This report shall be presented at each quarterly Oversight Committee meeting.(D) The Chief Compliance Officer shall inquire into and monitor the timely submission status of required Grant Recipient reports and notify the Oversight Committee and General Counsel of a Grant Recipient's failure to meaningfully comply with reporting deadlines.(d) Oversight Committee Members and Institute Employees shall participate in periodic Compliance Program training. Source Note: The provisions of this §701.7 adopted to be effective March 2, 2014, 39 TexReg 1380; amended to be effective December 7, 2016, 41 TexReg 9526. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.7 Compliance Program https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181377&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181377 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181377&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181377 03/11/2026 (a) The Chief Compliance Officer oversees the Institute's activities related to the report and investigation of suspected compliance violations, including fraud, waste, and abuse.(b) To encourage good faith reporting of suspected noncompliance, the Institute shall establish a system to receive confidential reports of suspected instances or events that failed to comply with the Institute's applicable laws, rules and policies, including allegations of fraud, waste, and abuse. The Institute may use a telephonic and/or electronic mailbox system, such as an "ethics hotline" to preserve confidentiality of communications regarding suspected compliance violations and the anonymity of a person making a compliance report or participating in a compliance investigation.(1) Information describing how to report a suspected compliance violation, including a designated telephone number and electronic mail address for confidentially reporting suspected compliance violations, shall be displayed on the Institute's Internet website and included in all Institute contracts and agreements.(2) Information describing how to report a suspected compliance violation shall be included in the Institute's employee policies manual, and discussed internally with Institute Employees and included in ethics training sessions.(3) Only good faith reports made to the designated telephone number or electronic mailbox shall be investigated.(c) The Institute shall implement procedures to investigate a good faith report of a suspected violation, including:(1) The prompt initiation of an investigation by the Chief Compliance Officer;(2) Assignment to an appropriate individual or individuals to conduct the investigation, including the Audit Subcommittee, the Compliance Office, General Counsel, the Internal Auditor, or outside experts or advisors; and(3) A recommendation for appropriate corrective actions, if any are warranted by the investigation, made to the Oversight Committee.(d) To the extent allowed by law, the Institute will preserve the confidential nature of the good faith report of a suspected violation, including the identity of the individual submitting the report.(e) The Chief Compliance Officer shall maintain a log that tracks the receipt, investigation, and resolution of reports made regarding compliance violations.(f) In performing duties under this rule, the Chief Compliance Officer has direct access to the Oversight Committee. The Chief Compliance Officer shall report to the Oversight Committee at least quarterly on compliance activity.(g) The following information is confidential and not subject to disclosure under Chapter 552, Texas Government Code, unless the information relates to an individual who consents to the disclosure:(1) information that directly or indirectly reveals the identity of an individual who made a report to the Institute's Compliance Program office, sought guidance from the office, or participated in an investigation conducted under the Compliance Program;(2) information that directly or indirectly reveals the identity of an individual who is alleged to have or may have planned, initiated, or participated in activities that are the subject of a report made to the Compliance Program if, after completing an investigation, the Compliance Program determines the report to be unsubstantiated or without merit; and(3) other information that is collected or produced in a Compliance Program investigation if releasing the information would interfere with an ongoing compliance investigation.(h) The Oversight Committee may meet in a closed session under Chapter 551, Texas Government Code, to discuss an on-going compliance investigation into issues related to fraud, waste or abuse of state resources. Source Note: The provisions of this §701.9 adopted to be effective March 2, 2014, 39 TexReg 1380; amended to be effective December 7, 2016, 41 TexReg 9526. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.9 Report and Investigation of Compliance Violations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220458&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220458 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=220458&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 220458 03/11/2026 The Institute shall develop, implement, continually monitor, and revise the Texas Cancer Plan as necessary.(1) The intent of the Texas Cancer Plan is to reduce the cancer burden across the state and improve the lives of Texans by providing a coordinated, prioritized, and actionable framework that will help guide statewide efforts to fight the human and economic burden of cancer in Texas.(2) Activities undertaken by the Institute to monitor the Texas Cancer Plan will be described in the Annual Public Report required by Texas Health and Safety Code §102.052.(3) The Institute will periodically update the Texas Cancer Plan by issuing a revised version of the Texas Cancer Plan every seven (7) years, unless a different timeline for a revised version of the Texas Cancer Plan is approved by a simple majority of the Oversight Committee.(4) The Institute may solicit input from public or private institutions, government organizations, non-profit organizations, other public entities, private companies, and individuals affected by cancer to assist the Institute in monitoring, implementing, and revising the Texas Cancer Plan.(5) The most recent version of the Texas Cancer Plan shall be posted on the Institute's Internet website. Source Note: The provisions of this §701.11 adopted to be effective March 2, 2014, 39 TexReg 1380; amended to be effective September 12, 2024, 49 TexReg 7044. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.11 Texas Cancer Plan https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166294&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166294 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166294&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166294 03/11/2026 The Oversight Committee may rely upon Advisory Committees of experts to advise the Oversight Committee on issues related to cancer and to inform Institute policies and procedures.(1) The University Advisory Committee shall advise the Oversight Committee and Review Councils regarding the role of higher education in Cancer Research. The committee's membership is composed of the members specified by §102.154, Texas Health and Safety Code.(2) The Oversight Committee shall create an ad hoc Advisory Committee to address childhood cancers.(3) The Oversight Committee may create additional ad hoc Advisory Committees to advise the Oversight Committee on issues related to cancer.(4) The presiding officer of the Oversight Committee appoints experts, including practitioners and patient advocates, to serve as ad hoc Advisory Committee members, subject to approval by the Oversight Committee, for terms of service determined by the Oversight Committee.(A) When used in this section, the term "patient advocates" is not intended to and does not have the meaning ascribed to the same term defined by §701.3 of this chapter (relating to Definitions). The term, when used herein, applies more generally to the broad category of individuals that advocate, either personally or professionally, on behalf of a group of individuals affected by cancer. A patient advocate serving on an ad hoc Advisory Committee does not undergo the selection process or receive science-based training required by Patient Advocates under Chapter 703, §703.5 of this title (relating to Scientific Research and Prevention Programs Committees).(B) An Institute Employee, Oversight Committee Member, or Scientific Research and Prevention Programs Committee Member may not be a member of any Advisory Committee of the Institute.(C) Grant Applicants and Grant Recipients may be Advisory Committee members.(5) The Institute may reimburse Advisory Committee members for reasonable and necessary expenses incurred to attend meetings or perform other official duties authorized by the presiding officer of the Oversight Committee.(6) Each Advisory Committee shall create a committee charter for approval by the Oversight Committee that delineates the role of the Advisory Committee and expected activities.(7) The Oversight Committee shall establish a process for each Advisory Committee to report no less than annually to the Oversight Committee regarding the activities of the Advisory Committee.(8) A list of the Institute's Advisory Committees and the reports presented to the Oversight Committee by each Advisory Committee shall be maintained on the Institute's Internet website. Source Note: The provisions of this §701.13 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.13 Advisory Committees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166295 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166295&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166295 03/11/2026 The Institute recruits high level, highly respected, well established members of the Cancer Research, Product Development, or Cancer Prevention communities for appointments to Scientific Research and Prevention Programs Committees to conduct Peer Review of Grant Applications. The Institute may pay an honorarium to a Scientific Research and Prevention Programs Committee Member, pursuant to the Institute's honoraria policy.(1) The honoraria policy shall be set by the Chief Executive Officer in consultation with the Oversight Committee and updated from time to time as necessary upon written notification to the Oversight Committee. Changes made to the honoraria policy must be supported by written justification.(2) Honoraria rates paid by the Institute must be based upon the responsibilities, hours committed, and hourly rate commensurate with the expertise and professional background of the Scientific Research and Prevention Programs Committee Members.(3) The honoraria policy may provide a comparison to honoraria and related compensation paid by other similar grant-making organizations to ensure that honoraria payment rates are reasonable and competitive for the value the Institute receives.(4) Minimum documentation requirements for honoraria payments shall be set forth in the honoraria policy.(5) The Institute's honoraria policy shall be publicly available. Source Note: The provisions of this §701.15 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.15 Scientific Research and Prevention Programs Committee Honoraria Policy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166296&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166296 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166296&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166296 03/11/2026 (a) To minimize the potential for Conflicts of Interest in the Peer Review of Grant Applications, the Institute recruits individuals who live and work outside of the State to serve as Scientific Research and Prevention Programs Committee Members, including Patient Advocates, unless a special need justifies using one or more individuals living or working in Texas.(b) If an individual who lives or works in Texas is appointed to serve as a Scientific Research and Prevention Programs Committee Member, an explanation of the special need must be provided at the time the Chief Executive Officer's appointment is approved by the Oversight Committee and recorded in the minutes of the Oversight Committee meeting. Source Note: The provisions of this §701.17 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.17 Scientific Research and Prevention Programs Committee Member Residency Policy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181378&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181378 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181378&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181378 03/11/2026 (a) Except as addressed by the Request for Applications or this rule, only Texas-based entities are eligible to receive Grant Awards.(b) Grant Applicants responding to a Request for Applications may be located outside the state of Texas when the Grant application is submitted and reviewed. However, the Institute requires the Grant Applicant to demonstrate that it will relocate to Texas as a condition of the Grant Award.(c) A Grant Applicant for a Product Development Grant Award may demonstrate compliance with subsection (b) by fulfilling a majority of the following requirements:(1) The U.S. headquarters is physically located in Texas;(2) The Chief Executive Officer resides in Texas;(3) A majority of the company's personnel, including at least two other C-level employees (or equivalent) reside in Texas;(4) Manufacturing activities take place in Texas;(5) At least 90% of Grant Award funds are paid to individuals and entities in Texas, including salaries and personnel costs for employees and contractors;(6) At least one clinical trial site in Texas; and(7) Collaboration with a medical research organization in Texas, including a public or private institution of higher education.(d) The location criteria to be fulfilled by the Grant Recipient are reflected in the Grant Contract.(e) Unless otherwise specified by the Grant Contract, the Grant Recipient must fulfill the requirements within one year of receiving the disbursement of Grant Award funds.(f) The Grant Recipient will report on the location criteria at least annually.(g) The Institute will monitor compliance with this policy. Failure to meet and maintain the Texas location requirements may result in suspension of the Grant Award, termination of the Grant Contract, repayment of Grant Award funds; or other appropriate action as determined by the Chief Executive Officer and reported to the Oversight Committee.(h) Nothing herein prohibits the Grant Recipient from proposing and the Institute from approving one or more alternative or additional location requirements. The Chief Executive Officer shall notify the Oversight Committee of the alternative criteria at an open meeting. The proposed alternative location requirement is approved unless a simple majority of the Oversight Committee votes to reject the Chief Executive Officer's recommendation. Source Note: The provisions of this §701.19 adopted to be effective March 2, 2014, 39 TexReg 1380; amended to be effective December 7, 2016, 41 TexReg 9526. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.19 Texas Location for Grant Awards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166298 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166298&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166298 03/11/2026 It is the policy of the Institute to encourage the purchase of goods and services required for the Grant Award from suppliers in the State to the extent reasonably possible. A Grant Recipient shall undertake good faith efforts to purchase from suppliers in the State at least fifty percent (50%) of the goods and services purchased with Grant Award funds.(1) A Grant Recipient must use good faith efforts to purchase goods and services from suppliers in the State when available at a price and time comparable to products and materials purchased outside of the State.(2) A Grant Recipient that expends more than forty percent (40%) of the Grant Award funds budgeted for a Project Year on goods and services purchased outside of the State must notify the Institute in writing and provide an explanation of the good faith efforts undertaken to purchase the goods or services from suppliers in the State, including a statement that products and materials were not available in the State at a comparable price and time. Such notification and explanation may be accomplished by completing the Historically Underutilized Business and Texas Supplier form submitted as part of the annual Grant Progress Report.(3) The Institute may deny reimbursement or require repayment of Grant Award funds already expended if the Grant Recipient fails to provide a statement as required by paragraph (2) of this section with a reasonable explanation of the good faith efforts undertaken to purchase the goods or services from suppliers in the State of Texas. Source Note: The provisions of this §701.21 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.21 Preference for Texas Suppliers for Purchases Made by Grant Recipients https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166299&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166299 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166299&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166299 03/11/2026 It is the policy of the Institute to encourage the use of historically underutilized businesses (HUBs) by Grant Recipients to promote full and equal business opportunities for all businesses.(1) A Grant Recipient is expected to undertake good faith efforts to utilize HUBs in subcontracts for construction, commodities purchases, and other services, including professional and consulting services, paid for with Grant Award funds.(2) A Grant Recipient must report to the Institute at least annually regarding efforts undertaken by the Grant Recipient to utilize HUBs in the performance of the Grant Contract by completing the Historically Underutilized Business and Texas Supplier form submitted as part of the annual Grant Progress Report. Source Note: The provisions of this §701.23 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.23 Historically Underutilized Businesses Policy for Grant Recipients https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215703&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215703 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=215703&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 215703 03/11/2026 A Grant Recipient's use of the Institute's electronic Grant Management System or a Grant Applicant's use of the Institute's electronic Application Receipt System to create, exchange, execute, submit, and verify legally binding Grant Contract documents and Grant Award reports or a Grant Application shall be pursuant to an agreement between the Institute and the Grant Recipient or Grant Applicant regarding the use of binding electronic signatures. Such agreement shall include at least the following minimum standards:(1) The Grant Recipient or Grant Applicant agrees that by entering the Authorized Signing Official's password in the electronic Grant Management System or Application Receipt System at certain specified points, the Grant Recipient or Grant Applicant electronically signs the Grant Contract document or related form or Grant Application . The Grant Recipient or Grant Applicant further agrees that the electronic signature is the legal equivalent of the Authorized Signing Official's manual signature.(2) The Institute may rely upon the electronic signature rendered by entering the Authorized Signing Official's password as evidence that the Grant Recipient or Grant Applicant consents to be legally bound by the terms and conditions of the Grant Contract or related form or Grant Application as if the document was manually signed.(3) The Grant Recipient or Grant Applicant shall provide prompt written notification to the Institute of any changes regarding the status or authority of the individual(s) designated by the Grant Recipient or Grant Applicant to be the Grant Recipient's or Grant Applicant's Authorized Signing Official. The notice must be provided to an individual designated by the Institute. Source Note: The provisions of this §701.25 adopted to be effective March 2, 2014, 39 TexReg 1380; amended to be effective December 7, 2023, 48 TexReg 7063. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.25 Electronic Signature Policy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=192146&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 192146 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=192146&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 192146 03/11/2026 To promote transparency in its activities, the Institute maintains the information described in this section and makes such information publicly available through the Institute's Internet website or upon request.(1) The Texas Cancer Plan;(2) The Institute's Annual Public Report;(3) The Conflict of Interest information described in this paragraph for the previous 12 months:(A) A list of disclosed Conflicts of Interest requiring recusal.(B) Any unreported Conflicts of Interest confirmed by an Institute investigation and actions taken by the Institute regarding same.(C) Any Conflict of Interest waivers granted.(4) The annual Grant Program priorities set by the Oversight Committee;(5) Oversight Committee Bylaws;(6) Code of Conduct and Ethics;(7) A list, separated by Grant Program and Peer Review Panel, of the Scientific Research and Prevention Programs Committee Members provisionally appointed or approved by the Oversight Committee;(8) The Institute's honoraria policy for Scientific Research and Prevention Programs Committee Members;(9) The supporting documentation regarding the Institute's implementation of its Conflict of Interest policy and actions taken to exclude a conflicted Oversight Committee Member, Program Integration Committee Member, Scientific Research and Prevention Programs Committee Member or Institute Employee from participating in the review, discussion, deliberation and vote on the Grant Application;(10) The Chief Executive Officer's annual report to the Oversight Committee on the progress and continued merit of each research Program funded by the Institute;(11) Grant Applicant information:(A) Name and address;(B) Amount of funding applied for;(C) Type of cancer addressed by the Grant Application; and(D) A high-level summary of work proposed to be funded by the Grant Award;(12) Information related to Grant Awards, including the name of the Grant Recipient, the amount of the Grant Award approved by the Oversight Committee, the type of cancer addressed, and a high-level summary of the work funded by the Grant Award;(13) Records of a nonprofit organization established to provide support to the Institute;(14) Except as excluded by 702.7(f) of this Title, information related to any gift, grant, or other consideration provided to the Institute, Institute Employee, or a member of an Institute committee. Such information shall state:(A) Donor's name;(B) Amount of donation; and(C) Date of donation;(15) A list of the Institute's Advisory Committees and the reports presented to the Oversight Committee by each Advisory Committee;(16) The Institute's approved internal audit annual report and the internal audit plan posted no later than thirty (30) days after approval by the Oversight Committee, or the Chief Executive Officer if the Oversight Committee is unable to meet;(17) A detailed summary of the weaknesses, deficiencies, wrongdoings, or other concerns raised by the audit plan or annual report and a summary of the action taken by the Institute to the address concerns, if any, that are raised by the audit plan or annual report; and(18) Information regarding staff compensation in compliance with §659.026, Texas Government Code. Source Note: The provisions of this §701.27 adopted to be effective March 2, 2014, 39 TexReg 1380; amended to be effective December 7, 2016, 41 TexReg 9526; amended to be effective September 13, 2018, 43 TexReg 5806. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.27 Publicly Available Institute Reports and Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166302&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166302 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166302&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166302 03/11/2026 (a) In order to protect the actual or potential value of information submitted to the Institute by a Grant Applicant or a Grant Recipient, the Institute shall undertake reasonable efforts to protect Third-Party Information as described herein from unauthorized public disclosure, consistent with the requirements of Chapter 552, Texas Government Code.(b) With the exception of information set forth in subsection (g) of this section, the Institute shall consider the following material confidential:(1) Information that relates to a Grant Applicant's or Grant Recipient's product, device, or process that has the potential for being sold, traded, or licensed for a fee, including the application or use of such product, device, or process;(2) All technological or scientific information developed in whole or in part by the Grant Applicant or Grant Recipient that has the potential for being sold, traded, or licensed for a fee;(3) All information that relates to the plans, specifications, blueprints, and designs, including related proprietary information, of a scientific research and development facility;(4) Written comments made by one or more Scientific Research and Prevention Programs Committee Members that reveals, directly or indirectly, information relating to the Grant Applicant's or Grant Recipient's product, device, or process that has the potential for being sold, traded, or licensed for a fee, including the application or use of such product, device, or process; and(5) Information included in the business operations and management due diligence and intellectual property reviews conducted for the Grant Review Process that reveals, directly or indirectly, information relating to the Grant Applicant's or Grant Recipient's product, device, or process that has the potential for being sold, traded, or licensed for a fee.(c) The Institute shall consider that a product, device, or process and the technological or scientific information described in the Grant Application submitted to the Institute has the potential for being sold, traded, or licensed for a fee unless the Grant Applicant informs the Institute that no economic potential exists.(d) The confidential nature of the information submitted by the Grant Applicant or Grant Recipient is not dependent upon whether the information is patentable or capable of being registered under copyright or trademark laws.(e) Oversight Committee Members, Institute Employees, Program Integration Committee Members, and Scientific Research and Prevention Programs Committee Members may access Third-Party Information solely for Institute purposes. All Third-Party Information in the individual's possession must be returned to the Institute or destroyed immediately upon the Institute's request or upon the termination of individual's employment with or service to the Institute, whichever comes first. An individual given access to Third-Party Information described herein shall not:(1) Publicly disclose Third-Party Information for any reason unless the Institute's General Counsel determines that the disclosure is either permitted or required by law;(2) Use non-public Third-Party Information for the individual's own personal gain or for the gain of other parties; or(3) Copy Third-Party Information, for any reason, except as required to fulfill their duties for the Institute.(f) The Institute may establish procedures to protect non-public Third-Party Information from unauthorized disclosure such as the use of non-disclosure agreements.(g) Notwithstanding the foregoing, the following Third-Party Information is public information and shall be disclosed under Chapter 552, Texas Government Code:(1) The Grant Applicant's name and address;(2) The amount of Grant Award funding applied for;(3) The type of cancer to be addressed under the Grant Application;(4) The high-level summary of the Grant Application specifically created to be publicly disclosed;(5) Any other Third-Party Information submitted to the Institute by a Grant Applicant or Grant Recipient if the third-party consents to the disclosure of the information; and(6) The records of a nonprofit organization established to provide support to the Institute. Source Note: The provisions of this §701.29 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.29 Third-Party Information Held by the Institute https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166303&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166303 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166303&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166303 03/11/2026 (a) The charge to any person requesting copies of any public record of the Institute will be:(1) Standard paper copy--$.10 per page.(2) Nonstandard-size copy:(A) Diskette: $1.00;(B) Magnetic tape: actual cost;(C) Data cartridge: actual cost;(D) Tape cartridge: actual cost;(E) Rewritable CD (CD-RW)--$1.00;(F) Non-rewritable CD (CD-R)--$1.00;(G) Digital video disc (DVD)--$3.00;(H) JAZ drive--actual cost;(I) Other electronic media--actual cost;(J) VHS video cassette--$2.50;(K) Audio cassette--$1.00;(L) Oversize paper copy (e.g.: 11 inches by 17 inches, greenbar, bluebar, not including maps and photographs using specialty paper)--$.50 per page;(M) Specialty paper (e.g.: Mylar, blueprint, blueline, map, photographic)--actual cost.(3) Labor charge:(A) For programming--$28.50 per hour;(B) For locating, compiling, and reproducing--$15 per hour.(4) Overhead charge--20% of labor charge.(5) Microfiche or microfilm charge:(A) Paper copy--$.10 per page;(B) Fiche or film copy--Actual cost.(6) Remote document retrieval charge--Actual cost.(7) Computer resource charge:(A) Mainframe--$10 per CPU minute;(B) Midsize--$1.50 per CPU minute;(C) Client/Server system--$2.20 per clock hour;(D) PC or LAN--$1.00 per clock hour.(8) Miscellaneous supplies--Actual cost.(9) Postage and shipping charge--Actual cost.(10) Photographs--Actual cost.(11) Maps--Actual cost.(12) Other costs--Actual cost.(13) Outsourced/Contracted Services--Actual cost for the copy.(b) The Institute may reduce or waive these charges at the discretion of the Chief Executive Officer if there is a public benefit.(c) No Sales Tax shall be applied to copies of public information. Source Note: The provisions of this §701.31 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.31 Charges for Copies of Public Records https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166304&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166304 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166304&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166304 03/11/2026 (a) In accordance with Texas Government Code §2260.052(c), the Institute adopts herein by reference the model rules provided by the Office of the Attorney General relating to procedures for the negotiation and mediation of certain contract claims asserted by contractors against the Institute.(b) The procedures, as adopted, are exclusive and required prerequisites to suit against the Institute under the Texas Civil Practice and Remedies Code, Chapter 107, and the Texas Government Code, Chapter 2260.(c) Nothing herein waives the Institute's sovereign immunity to suit or liability.(d) Unless specifically provided for by the Grant Contract, this rule does not apply to Grant Contracts. The Grant Contract shall specify the process and procedures for terminating a Grant Award, as well as any associated remedy. Source Note: The provisions of this §701.33 adopted to be effective March 2, 2014, 39 TexReg 1380. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.33 Negotiation and Mediation of Certain Breach of Contract Claims https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=170517&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 170517 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=170517&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 170517 03/11/2026 (a) An interested party may petition the Institute to adopt a rule by submitting a proposed rule in writing either by electronic or regular mail to the Chief Executive Officer and the General Counsel of the Institute. Each proposed rule must be submitted to the Institute in a separate petition for adoption.(b) The petition must include the following information:(1) the full name, mailing address, email address, and phone number of the petitioner;(2) the complete text of the new proposed rule, if the proposed rule alters text of a current Institute rule then changes shall be shown in the following manner, deletion of current text shall be marked by striking through the text, addition of new text shall be marked by underlining the text;(3) an explanation of how the proposed rule benefits the public, including supporting information or data demonstrating the need for the proposed rule;(4) a statement of the legal authority for the proposed rule; and(5) any other information required by the Institute.(c) The General Counsel of the agency shall review the petition for adoption and confirm it complies with subsection (b) of this section, if not in compliance the petition for adoption may be denied. On or before the 60th day after receipt of the proposed rule, the Chief Executive Officer shall either deny the petition for adoption in writing stating reasons for denial or direct the General Counsel to initiate a rulemaking procedure pursuant to Chapter 2001, Texas Government Code. Source Note: The provisions of this §701.35 adopted to be effective December 10, 2014, 39 TexReg 9565. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.35 Petition for Adoption of Rules https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=190070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 190070 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=190070&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 190070 03/11/2026 (a) Travel costs for Grant Recipients are allowable based on the State of Texas travel policy, administered by the Texas Comptroller of Public Accounts, provided that costs are deemed by the Institute to be reasonable and necessary. The Institute will not reimburse a Grant Recipient for travel expenses in an amount that exceeds the standards in the State of Texas travel policy.(b) Grant Recipients must provide adequate supporting documentation when requesting reimbursement for travel expenses on a Financial Status Report pursuant to §703.24.(1) A separate travel expense report should be submitted for each trip taken.(2) Meal costs may be charged on an actual cost basis or on a per diem, provided that one method is used uniformly on an entire trip.(3) Lodging expenses must be supported with either a receipt or, if a receipt is unavailable, the canceled check or credit card slip used to pay the lodging expense, the credit card billing on which the lodging charges appear, or a copy of the check, slip or billing.(4) Mileage must be supported with a detailed record of actual point-to-point mileage with odometer readings or copies of mapping website mileage. Mileage should not be rounded to the nearest decimal point.(5) Transportation expenses must be supported with a receipt or itinerary. If neither is available then a Grant recipient should provide the canceled check or credit card slip used to pay for the transportation, the credit card billing on which the transportation charges appear, or a copy of the receipt, check, slip or billing.(6) Rental of motor vehicles must be supported by a receipt and/or rental contract.(7) Incidental expenses must be supported by an itemization of the expenses incurred.(c) International travel must either be part of the Grant Recipient's approved budget in the Grant Contract, or the Grant Recipient must receive prior approval from CPRIT for the international travel if the international travel is added to the budget subsequently.(1) International travel costs may be reimbursed according to the United States Department of State rates, if the costs are deemed by CPRIT to be reasonable and necessary.(2) Grant Recipients should submit requests for reimbursement in United States dollar amounts. If the original cost is in a foreign currency, the Grant Recipient must convert the cost to a dollar amount and provide documentation of the exchange rate used for the conversion.(d) Nothing herein prohibits a Grant Recipient from having more restrictive internal travel policy requirements. Source Note: The provisions of this §701.37 adopted to be effective March 15, 2018, 43 TexReg 1441. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 701 POLICIES AND PROCEDURES §701.37 Grant Recipient Travel Policy https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=141266&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 141266 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=141266&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 141266 03/11/2026 This chapter is adopted pursuant to and in satisfaction of the provisions of Texas Government Code Annotated, Chapters 572 and 2255, Texas Health and Safety Code, Chapter 102, and other relevant statutes. Source Note: The provisions of this §702.1 adopted to be effective July 13, 2009, 34 TexReg 4640. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.1 Authority https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166305&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166305 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166305&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166305 03/11/2026 The words and terms used in this chapter shall have the meanings provided in Chapter 701, §701.3 of this title (relating to Definitions), unless the context clearly indicates otherwise. Source Note: The provisions of this §702.3 adopted to be effective July 13, 2009, 34 TexReg 4640; amended to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.3 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166306&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166306 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166306&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166306 03/11/2026 It is the intent of the Institute that the Institute's Grant Review process provide Grant Applicants a fair and unbiased merit-based assessment free from conflicts of interest, impropriety and self-dealing. To implement this policy, this chapter provides standards of conduct and conflict of interest disclosure requirements to be observed by those individuals that are a part of the Grant Review Process and the execution of Grant Contracts. Individuals subject to this chapter include Oversight Committee Members, Program Integration Committee Members, Scientific Research and Prevention Programs Committee Members, and Institute Employees. Independent contractors, such as outside legal counsel, grant management system contractors, and subject matter experts, shall be subject to applicable provisions of this chapter to the extent that the individuals are performing duties associated with Grant Applications under consideration for Grant Awards. Source Note: The provisions of this §702.5 adopted to be effective July 13, 2009, 34 TexReg 4640; amended to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.5 Intent https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181380&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181380 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181380&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181380 03/11/2026 (a) As authorized by Texas Health and Safety Code §102.054, the Institute may solicit and accept gifts from any source to support the operations of the Institute and to further its purposes; except that the Institute may not supplement the salary of any Institute Employee with a gift or grant received by the Institute.(b) An Oversight Committee Member or an Institute Employee shall not authorize a donor to use the property of the Institute unless the property is used in accordance with a contract between the Institute and the donor, the contract is found by the Institute to serve a public purpose, the contract contains provisions to ensure the public purpose continues, and the Institute is reasonably compensated for the use of the property.(c) Procedure for acceptance of gifts.(1) Gifts to the Institute may be designated for one of the following categories:(A) Unrestricted General Support;(B) Restricted Programmatic Support;(C) Endowed and Restricted Funds; or(D) Other (includes gifts of real or personal property).(2) Gifts of ten thousand dollars ($10,000) or less may be accepted on behalf of the Institute by the Chief Executive Officer.(3) The Oversight Committee by a majority vote may accept gifts of cash, stock, bonds, or personal property with a value in excess of ten thousand dollars ($10,000), gifts of real property regardless of value, and all other gifts not herein described on behalf of the Institute.(4) For gifts made to the Institute of cash, stock, bonds, or personal property with a value in excess of one million dollars, gifts of real property regardless of value, and all other gifts not herein described, a report shall be created by the Chief Executive Officer for the Oversight Committee that includes the following information:(A) Name and biographical data regarding the individual or organization making the gift;(B) A description of the gift;(C) A list of conditions or requirements to be imposed on the Institute as a result of accepting the gift;(D) If one of the conditions is naming, then include a description of the object to be named and whether there is a time limit on continuing the name;(E) If the gift is real property, an evaluation of the gift by the General Land Office;(F) If the gift is stock or other investments, a description of how they will be sold and the expected net proceeds; and(G) A description of how the gift will be used.(5) All funds received from donations to the Institute will be deposited to the state treasury and used for the purpose specified by the donor or for general Institute programs when no purpose is specified.(d) The Institute encourages the offer of gifts of additional revenue and real and personal property through naming.(1) Naming can be given to both real objects and inanimate objects, such as Grant Awards.(2) The Oversight Committee will consider a request for naming in connection with a gift of real or personal property of substantial value to the Institute and its programs. In determining whether a gift has substantial value, the Oversight Committee will evaluate the following factors:(A) The size of the real or personal property in relation to other fund sources--including bonds--available at the same time and consideration of whether the donation will make a material contribution to the Institute's goals and programs that otherwise would not be made;(B) Availability of the real or personal property; and(C) The degree of flexibility and discretion the Institute will have in the use of the real or personal property.(3) The Oversight Committee must approve the recommendation to name an object or program by a majority vote of its members.(e) The Oversight Committee may refuse a gift to the Institute for any reason, including:(1) The gift requires an initial and/or on-going expenditure that will likely equal or exceed the value of the gift.(2) The gift is from an institution, entity, or organization, or a director, officer, or an executive of an institution, entity or organization that has applied for funding from the Institute, or currently receives funding from the Institute, or the gift is from a Senior Member or Key Personnel of the research or prevention program team listed on a Grant Application or Grant Award.(3) The Institute may return a gift made by an institution, entity, organization, or individual that was otherwise eligible to make the donation at the time that the gift was accepted by the Institute in the event that the donor subsequently submits a Grant Application for funding from the Institute within the fiscal year of the donation.(4) For purposes of this section, the limitation on gifts does not apply to a donation made as the result of the final bequeathal.(f) The Institute shall report information pertaining to gifts, grants, or other consideration provided to the Institute, an Institute Employee, or a member of an Institute committee, subject to the requirements in this subsection.(1) The information shall be posted on the Institute's Internet website.(2) The information to be posted shall include the donor's name, the date of the donor's donation, and the amount of the donor's donation.(3) The reporting requirement applies to all gifts, grants, or other consideration provided to the Institute except that individual conference registration fees for a conference hosted by the Institute and paid to the Institute by conference attendees shall not be treated as consideration for purposes of the reporting requirement. The total amount received for conference registration fees may be reported.(4) The reporting requirement applies to all gifts, grants, or other consideration given to a Oversight Committee Member, Institute Employee, or Program Integration Committee Member except that the following items are not considered gifts, grants or consideration subject to the reporting requirement:(A) Books, pamphlets, articles, or other similar materials that contain information directly related to the job duties of an Oversight Committee Member, Institute Employee, or Program Integration Committee Member and that are accepted by the individual on behalf of Institute for use in performing the individual's job duties.(B) A gift or other benefit conferred on account of kinship or a personal, professional, or business relationship independent of the official status of the recipient so long as:(i) The personal friend or a Relative of the personal friend is not an employee of an entity receiving or applying to receive money from the Institute; and(ii) The individual subject to this provision has no reason to believe that the item or consideration is being offered through an intermediary in an attempt to evade reporting requirements.(C) Items with a value of less than $50, excluding cash or a negotiable instrument described by §3.104, Business and Commerce Code.(5) The reporting requirement applies only to the gifts, grants, or other consideration given to a Scientific Research and Prevention Programs Committee Member by a Grant Applicant or Grant Recipient during the period that the Member is appointed except that the following items are not considered gifts, grants or consideration subject to the reporting requirement:(A) Books, pamphlets, articles, or other similar materials that contain information directly related to the job duties of the Scientific Research and Prevention Programs Committee Member and that are accepted by the individual for use in performing the individual's job duties.(B) Items with a value of less than $50, excluding cash or a negotiable instrument as described by §3.104, Business and Commerce Code.(6) The reporting requirement applies to a member of an Advisory Committee of the Institute only to the extent that the individual participates in the Grant Review Process.(A) A gift or other benefit conferred on account of kinship or personal, professional, or business relationship independent of the official status of the recipient so long as:(i) The personal friend or a Relative of the personal friend is not an employee of an entity receiving or applying to receive money from the Institute; and(ii) The individual subject to this provision has no reason to believe that the item or consideration is being offered through an intermediary in an attempt to evade reporting requirements.(B) If the individual participates in the Grant Review Process, then the individual must report gifts, grants, or other consideration given to the Advisory Committee member by a Grant Applicant or Grant Recipient during the period that the Advisory Committee member participates in the Grant Review Process except that the following items are not considered gifts, grants or consideration subject to the reporting requirement:(i) Books, pamphlets, articles, or other similar materials that contain information directly related to the job duties of the Advisory Committee member and that are accepted by the individual for use in performing the individual's job duties.(ii) Items with a value of less than $50, excluding cash or a negotiable instrument as described by §3.104, Business and Commerce Code.(C) For purposes of this subsection, participation in the Grant Review Process by an Advisory Committee member does not include submitting a Grant Application or receiving a Grant Award. Source Note: The provisions of this §702.7 adopted to be effective July 13, 2009, 34 TexReg 4640; amended to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385; amended to be effective September 17, 2014, 39 TexReg 7341; amended to be effective December 7, 2016, 41 TexReg 9527. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.7 Acceptance of Gifts and Donations by the Institute https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181381&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181381 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181381&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181381 03/11/2026 (a) All Oversight Committee Members, Program Integration Committee Members, and Institute Employees shall avoid acts which are improper or give the appearance of impropriety in the disposition of state funds.(b) The Oversight Committee shall adopt a Code of Conduct and Ethics to provide guidance related to the ethical conduct required of Oversight Committee Members, Program Integration Committee Members, and Institute Employees. The Code of Conduct and Ethics shall be distributed to each new Oversight Committee Member, Program Integration Committee Member, and Institute Employee not later than the third business day after the date that the person begins employment with or service to the Institute.(c) The Code of Conduct and Ethics shall include at least the following requirements and prohibitions. Nothing herein prevents the Oversight Committee from adopting stricter standards:(1) A member of the Oversight Committee, Institute Employee, or Program Integration Committee Member, or the spouse of an individual governed by this provision shall not accept or solicit any gift, favor, or service that could reasonably influence him or her in the discharge of official duties or that he or she knows or should know is being offered with the intent to influence him or her or with the intent to influence the member or employee's official conduct.(2) A member of the Oversight Committee, Institute Employee, or Program Integration Committee Member, or the spouse of an individual governed by this provision shall not accept employment or engage in any business or professional activity that would reasonably require or induce that person to disclose confidential information acquired by reason of the member or employee's official position.(3) A member of the Oversight Committee, Institute Employee, or Program Integration Committee Member, or the spouse of an individual governed by this provision shall not accept other employment or compensation that could reasonably impair his or her independent judgment in the performance of the member or employee's official duties.(4) A member of the Oversight Committee, Institute Employee, or Program Integration Committee Member, or the spouse of an individual governed by this provision shall not make personal investments or have a financial interest that could reasonably create a substantial conflict between his or her private interest and the member or employee's official duties.(5) A member of the Oversight Committee, Institute Employee, or Program Integration Committee Member, or the spouse of an individual governed by this provision shall not intentionally or knowingly solicit, accept, or agree to accept any benefit for exercising his or her official powers or performing the member or employee's official duties in favor of another.(6) A member of the Oversight Committee, Institute Employee, or Program Integration Committee Member, or the spouse of an individual governed by this provision shall not lease, directly or indirectly, any property, capital equipment, employee or service to a Grant Recipient.(7) A member of the Oversight Committee, Institute Employee, or Program Integration Committee Member, or the spouse of an individual governed by this provision shall not submit a Grant Application to the Institute.(8) A member of the Oversight Committee, the member's spouse, or an Institute Employee shall not be employed by or participate in the management of a business entity or other organization receiving money from the Institute.(9) A member of the Oversight Committee or the member's spouse shall not own or control, directly or indirectly, an interest in a business or entity or other organization receiving money from the Institute.(10) A member of the Oversight Committee or the member's spouse shall not use or receive a substantial amount of tangible goods, services, or money from the Institute other than reimbursement authorized for Oversight Committee Members attendance or expenses.(11) A member of the Oversight Committee, Institute Employee, Program Integration Committee Member, or the spouse of an individual governed by this provision shall not serve on the Grant Recipient's board of directors or similar committee that exercises governing powers over the Grant Recipient. This prohibition also applies to serving on the board of directors or similar committee of a non-profit foundation established to benefit the Grant Recipient.(12) A member of the Oversight Committee, Institute Employee, Program Integration Committee Member, or the spouse of an individual governed by this provision shall not use non-public Third-Party Information, or knowledge of non-public decisions related to Grant Applicants, received by virtue of the individual's employment or official duties associated with the Institute to make an investment or take some other action to realize a personal financial benefit.(13) A member of the Oversight Committee, Institute Employee, or a Program Integration Committee Member who is a member of a professional organization shall comply with any standards of conduct adopted by the organizations of which he or she is a member.(14) A member of the Oversight Committee, Institute Employee, or a Program Integration Committee Member shall be honest in the exercise of all duties and may not take actions that will discredit the Institute.(15) A member of the Oversight Committee or an Institute Employee shall not have an office in a facility owned by an entity receiving or applying to receive money from the Institute.(16) An Oversight Committee Member, Institute Employee, or Program Integration Committee Member shall report to the Institute's Chief Compliance Officer any gift, grant, or consideration received by the individual as soon as possible, but no later than thirty (30) days after receipt of the gift, grant or consideration. The individual shall provide the name of the donor, the date of receipt, and amount of the gift, grant, or consideration.(17) An Oversight Committee Member or Institute Employee may not solicit, agree to accept, or accept an honorarium in consideration for services the Oversight Committee Member or Institute Employee would not have been asked to provide but for the person's official position.(18) An Oversight Committee Member and the Chief Executive Officer shall not make any communication to or appearance before an Institute officer or employee before the second anniversary of the date the Oversight Committee Member or Chief Executive Officer ceased to be a Oversight Committee Member or Chief Executive Officer if the communication or appearance is made:(A) with the intent to influence; and(B) on behalf of any person in connection with any matter on which the person seeks official action.(19) An Oversight Committee Member or Institute Employee who ceases service or employment with the Institute may not represent any person or receive compensation for services rendered on behalf of any person regarding a particular matter in which the former Oversight Committee Member or Institute Employee participated during the period of state service or employment, either through personal involvement or because the issue was a matter within the Oversight Committee Member's or Institute Employee's official responsibility.(A) This paragraph applies to an Institute Employee who is compensated, as of the last date of state employment, at or above the amount prescribed by the General Appropriations Act for step 1, salary group 17, of the position classification salary schedule, including an employee who is exempt from the state's position classification plan.(B) This paragraph does not apply to a rulemaking proceeding that was concluded before the Oversight Committee Member's or Institute Employee's service or employment ceased.(C) For purposes of this paragraph, "participated" means to have taken action as an Oversight Committee member or Institute Employee through decision, approval, disapproval, recommendation, giving advice, investigation or similar matter.(D) For purposes of this paragraph, "particular matter" means a specific investigation, application, request for ruling or determination, rulemaking proceeding, contract, claim, charge, accusation, or judicial or other proceeding.(d) The Code of Conduct and Ethics shall include information about reporting an actual or potential violation of the standards adopted by the Oversight Committee.(e) Any reports due under Texas Government Code §572.021 shall be simultaneously filed with the Institute Source Note: The provisions of this §702.9 adopted to be effective July 13, 2009, 34 TexReg 4640; amended to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385; amended to be effective December 7, 2016, 41 TexReg 9527. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.9 Code of Conduct and Ethics for Oversight Committee Members, Institute Employees, and Program Integration Committee Members https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178061&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178061 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=178061&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 178061 03/11/2026 (a) For purposes of this chapter, a Conflict of Interest exists when an individual subject to this rule has an interest in the outcome of a Grant Application submitted by an entity receiving or applying to receive money from the Institute such that the individual is in a position to gain financially, professionally, or personally from either a positive or negative evaluation of the Grant Application. Individuals subject to this rule are:(1) Oversight Committee Members;(2) Institute employees;(3) Scientific Research and Prevention Programs Committee Members;(4) Program Integration Committee Members; and(5) Independent Contractors that perform services associated with the Grant Review Process on behalf of the Institute, such as facilitating grant review activities, evaluating the intellectual property held by or licensed to a Grant Applicant, or performing a business management due diligence review.(b) Except under exceptional circumstances as provided in §702.17 of this chapter (relating to Exceptional Circumstances Requiring Participation), an individual who has a financial, professional, or personal interest, as set forth herein, in an entity receiving or applying to receive money from the Institute shall recuse himself or herself and may not participate in the review, discussion, deliberation, or vote related to the entity.(c) A financial Conflict of Interest exists if the individual subject to this rule or a Relative of the individual subject to this rule:(1) Owns or controls, directly or indirectly, an ownership interest in an entity receiving or applying to receive money from the Institute or in a foundation or similar organization affiliated with the entity;(A) Interests subject to this provision include sharing in profits, proceeds, or capital gains. Examples of ownership or control, include but are not limited to owning shares, stock, or otherwise, and are not dependent on whether voting rights are included;(B) It is not a financial Conflict of Interest if the ownership interest is limited to shares owned via an investment in a publicly traded mutual fund or similar investment vehicle so long as the individual subject to this rule does not exercise any discretion or control regarding the investment of the assets of the fund or other investment vehicle;(2) Could reasonably foresee that an action taken by the Scientific Research and Prevention Programs Committee, the Program Integration Committee, the Institute, or its Oversight Committee related to an entity receiving or applying to receive money from the Institute could result in a financial benefit to the individual; or(3) Has received a financial benefit from the Grant Applicant unrelated to the Grant Application of more than $5,000 within the past twelve months. This total includes fees, stock and other benefits. It also includes current stock holdings, equity interest, intellectual property or real property interest, but does not include diversified mutual funds or similar investment vehicle in which the person does not exercise any discretion or control regarding the investment of the assets of the fund or other investment vehicle.(d) For purposes of this rule, a professional Conflict of Interest exists if the individual subject to this rule or a Relative of the individual subject to this rule:(1) Is a member of the board of directors, other governing board or any committee of an entity or of a foundation or similar organization affiliated with an entity receiving or applying to receive money from the Institute during the same Grant Review Cycle;(2) Serves as an elected or appointed officer of an entity receiving or applying to receive money from the Institute or of a foundation or similar organization affiliated with the entity;(3) Is an employee of or is negotiating future employment with an entity receiving or applying to receive money from the Institute or a foundation or similar organization affiliated with the entity;(4) Represents in business or law, including actively seeking to represent, an entity receiving or applying to receive money from the Institute or a foundation or similar organization affiliated with the entity;(A) Representation that constitutes a professional Conflict of Interest includes providing services as a consultant or contractor;(B) "Actively seeking to represent" includes activities such as responding to a request for proposals or qualifications issued by the entity applying to receive money from the Institute, providing a solicited or unsolicited proposal for work to the entity applying to receive money from the Institute, and negotiating terms of service for representation even if a final agreement has not yet been executed;(C) For the purposes of this rule, an individual is no longer considered to be actively seeking to represent an entity if that entity has selected another provider or has notified the individual that the individual's services are not needed;(5) Is a colleague, scientific mentor, or student of a Senior Member or Key Personnel of the research or prevention program team listed on the Grant Application, or is conducting or has conducted research or other significant professional activities with a Senior Member or Key Personnel of the research or prevention program team listed on the Grant Application within three years of the date of the review;(6) Is a student, postdoctoral associate, or part of a laboratory research group for a Senior Member or Key Personnel of the research or prevention program team listed on the Grant Application or has been within the past six years;(7) Is engaged or is actively planning to be engaged in collaboration with a Senior Member or Key Personnel of the research or prevention program team listed on the Grant Application; or(8) Has long-standing scientific differences or disagreements with a Senior Member or Key Personnel of the research or prevention program team listed on the Grant Application that are known to the professional community and could be perceived as affecting objectivity.(e) For purposes of this rule, a personal Conflict of Interest exists if a Senior Member or Key Personnel of the research or prevention program team listed on the Grant Application or an applicant is a Relative or close personal friend of an individual subject to this rule.(f) Nothing herein shall prevent the Oversight Committee from adopting more stringent standards with regard to prohibited conflicts of interest.(g) The General Counsel and Chief Compliance Officer may provide guidance to individuals subject to this section on what interests would constitute a Conflict of Interest or an appearance of a Conflict of Interest. Source Note: The provisions of this §702.11 adopted to be effective July 13, 2009, 34 TexReg 4640; amended to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385; amended to be effective June 12, 2016, 41 TexReg 4027. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.11 Conflicts of Interest Requiring Recusal https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181382&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181382 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181382&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181382 03/11/2026 (a) If an Oversight Committee Member or a Program Integration Committee Member has a Conflict of Interest as described in this chapter with respect to an entity or Grant Application that comes before the individual for review or other action, the Member shall:(1) Provide written notice of the Conflict of Interest to the Chief Executive Officer and the presiding officer of the Oversight Committee (or the next ranking member of the Oversight Committee if the presiding officer has the Conflict of Interest). For purposes of this requirement, an Oversight Committee member or Program Integration Committee member who designates the Conflict of Interest on the secure website provided to review the recommended Grant Awards is deemed to have provided written notice;(2) Disclose the Conflict of Interest in an open meeting of the Oversight Committee; and(3) Recuse himself or herself from participation in the review, discussion, deliberation and vote on the entity or Grant Application, including access to information regarding the matter to be decided, unless a waiver has been granted pursuant to §702.15 of this chapter (relating to Investigation of Unreported Conflicts of Interest Affecting the Grant Review Process).(b) If a Scientific Research and Prevention Programs Committee Member has a Conflict of Interest as described in this chapter with respect to a Grant Application that comes before the individual for review or other action, the member shall:(1) Provide written notice of the Conflict of Interest to the Chief Executive Officer. For purposes of this requirement, a Scientific Research and Prevention Program Committee Member who designates the Conflict of Interest on the secure website provided to review the Grant Applications is deemed to have provided written notice; and(2) Recuse himself or herself from any participation in the review, discussion, scoring, deliberation and vote on the Grant Application, including access to information regarding the matter to be decided unless a waiver has been granted pursuant to §702.15 of this chapter.(c) Some Conflicts of Interest are such that the existence of a conflict with a Grant Applicant applying for a Grant Mechanism raises the presumption that the conflict may affect the individual's impartial review of other Grant Applications pursuant to the same Grant Mechanism in the Grant Review Cycle. The Institute has determined that the existence of one or more of the following Conflicts of Interest for an Oversight Committee Member, Scientific Research and Prevention Programs Committee Member, Program Integration Committee Member, Institute employee, Independent Contractor or a Relative of an individual subject to this rule shall require recusal of the individual from participating in the review, discussion, scoring, deliberation and vote on all Grant Applications competing for the same Grant Mechanism in the entire Grant Review Cycle, unless a waiver has been granted pursuant to §702.15 of this chapter:(1) The individual subject to this provision is an employee of a Grant Applicant;(2) The individual subject to this provision is actively seeking employment with a Grant Applicant. For the purposes of this paragraph, "actively seeking employment" includes activities such as submission of an employment application, resume, curriculum vitae, or similar document and/or interviewing with one or more representatives from the organization with no final action taken by the organization regarding consideration of such employment;(3) The individual subject to this provision serves on the board of directors or as an elected or appointed officer of a Grant Applicant or a foundation or similar organization affiliated with the Grant Applicant; or(4) The individual subject to this provision owns or controls, directly or indirectly, an ownership interest in a Grant Applicant or a foundation or similar organization affiliated with the Grant Applicant. Interests subject to this provision include sharing in profits, proceeds, or capital gains. Examples of ownership or control, include but are not limited to owning shares, stock, or otherwise, and are not dependent on whether voting rights are included.(d) If an Institute Employee or independent contractor involved in the Grant Review Process has a Conflict of Interest as described in this chapter with respect to a Grant Application that comes before the individual for review or other action, the Institute Employee or independent contractor shall:(1) Provide written notice to the Chief Executive Officer of the Conflict of Interest; and(2) Recuse himself or herself from participation in the review of the Grant Application and be prevented from accessing information regarding the matter to be decided, unless a waiver has been granted pursuant to §702.15 of this chapter.(e) The Institute shall retain supporting documentation regarding the implementation of its Conflict of Interest policy and actions taken to exclude a conflicted Oversight Committee Member, Program Integration Committee Member, Scientific Research and Prevention Programs Committee Member or Institute Employee from participating in the review, discussion, deliberation and vote on the Grant Application.(1) The supporting documentation retained by the Institute may be stored by the Institute's electronic Grant Management System.(2) For purposes of this rule, "supporting documentation" may include Conflict of Interest agreements, Conflict of Interest disclosure forms, action taken to address a previously unreported Conflict of Interest after its existence is determined, approved waivers, sign-out sheets, independent third party observation reports, post-review certifications and Oversight Committee meeting minutes.(3) All supporting documentation shall be publicly available, except that information included in the supporting documentation that is otherwise protected by Chapter 552, Texas Government Code may be redacted.(f) Individuals subject to this chapter are encouraged to self-report. Any individual who self-reports a potential Conflict of Interest or any impropriety or self-dealing, and who fully complies with any recommendations of the General Counsel and recusal from any discussion, voting, deliberation or access to information regarding the matter, shall be considered by the Institute to be in compliance with this chapter. The individual is still subject to the operation of other laws, rules, requirements or prohibitions. Substantial compliance with the procedures provided herein constitutes compliance.(g) Intentional violations of this rule may result in the removal of the individual from further participation in the Institute's Grant Review Process Source Note: The provisions of this §702.13 adopted to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385; amended to be effective December 7, 2016, 41 TexReg 9527. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.13 Disclosure of Conflict of Interest and Recusal from Review https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166311&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166311 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166311&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166311 03/11/2026 (a) An Oversight Committee Member, a Program Integration Committee Member, a Scientific Research and Prevention Programs Committee Member, or an Institute Employee who becomes aware of a potential Conflict of Interest described by §702.11 of this chapter (relating to Conflicts of Interest Requiring Recusal) that has not been reported shall immediately notify the Chief Executive Officer of the potential Conflict of Interest. If the potential Conflict of Interest is held by the Chief Executive Officer, then the report shall be made directly to the presiding officer of the Oversight Committee. Upon notification, the Chief Executive Officer must notify the presiding officer of the Oversight Committee and the General Counsel of the unreported conflict.(b) A Grant Applicant seeking an investigation regarding whether an individual subject to this chapter failed to report a Conflict of Interest described by §702.11 of this chapter shall file a written request with the Institute's Chief Executive Officer. The Grant Applicant shall:(1) Provide all facts regarding the alleged Conflict of Interest known to the Grant Applicant requesting the investigation; and(2) Submit the request for investigation not later than the 30th day after the Chief Executive Officer presents final funding recommendations for the affected Grant Review Cycle to the Oversight Committee. Nothing herein prohibits the Chief Executive Officer from initiating an investigation if the Grant Applicant fails to submit the request by the deadline set herein, so long as the Grant Applicant shows good cause for failing to meet the deadline.(c) On notification of an alleged Conflict of Interest under subsection (a) or (b) of this section, the General Counsel shall:(1) Investigate the matter; and(2) Provide an opinion to the Chief Executive Officer and presiding officer of the Oversight Committee. If the alleged conflict is held by the presiding officer, then the opinion shall be provided to the next ranking member of the Oversight Committee who has no conflict. The opinion shall include:(A) A statement of the facts giving rise to the alleged conflict;(B) A determination of whether a Conflict of Interest, another impropriety, or self-dealing exists; and(C) If the opinion finds that a Conflict of Interest or another impropriety or self-dealing exists, then recommendations for any appropriate course of action.(d) After receiving the General Counsel's opinion and consulting with the presiding officer (or, if appropriate, the next highest ranking Oversight Committee Member), the Chief Executive Officer shall take immediate actions regarding the recusal of the individual from any discussion of or access to information regarding the matter at issue. If the alleged Conflict of Interest is held by the Chief Executive Officer, the presiding officer of Oversight Committee shall take actions regarding recusal.(e) A determination regarding the existence of a Conflict of Interest involving an individual subject to this chapter shall be made by the Chief Executive Officer, or by the presiding officer of the Oversight Committee if the alleged Conflict of Interest is held by the Chief Executive Officer, and reported to the Oversight Committee. The determination will be considered final unless three or more Oversight Committee Members request that the issue be added to the agenda of the Oversight Committee. The determination must include actions to be taken, if any, to address the Conflict of Interest, impropriety, or self-dealing, including:(1) Reconsideration of the Grant Application; or(2) Referral of the Grant Application to a different Scientific Research and Prevention Programs Committee for review.(f) The Chief Executive Officer or, if applicable, the presiding officer of the Oversight Committee must provide written notice of the final determination to the person requesting the investigation, including a description of further actions to be taken, if any.(g) Unless specifically stated in the final determination, the validity of an action taken with regard to a Grant Application is not affected by the fact that an individual that failed to report a Conflict of Interest participated in the action. Source Note: The provisions of this §702.15 adopted to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.15 Investigation of Unreported Conflicts of Interest Affecting the Grant Review Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166312&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166312 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166312&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166312 03/11/2026 In exceptional cases, as determined by a vote of the simple majority of the Oversight Committee present and voting, the participation of an Oversight Committee Member, Institute Employee, Program Integration Committee Member, independent contractor, or Scientific Research and Prevention Programs Committee Member in the Grant Review Process, the Grant Contract process, or the monitoring of the Grant Award outweighs the potential bias posed by a Conflict of Interest held by the individual and a waiver from recusal required by §702.13 of this chapter (relating to Disclosure of Conflict of Interest and Recusal from Review) may be granted by the Oversight Committee, unless otherwise prohibited by state or federal law.(1) The Chief Executive Officer or an Oversight Committee Member may propose granting a waiver on behalf of the Oversight Committee Member, the Institute Employee, the Program Integration Committee Member, independent contractor, or the Scientific Research and Prevention Programs Committee Member by submitting a written statement to the presiding officer of the Oversight Committee. The statement must include:(A) information about the Conflict of Interest, including the name and position of the person with the conflict to be waived;(B) the exceptional circumstances justifying a waiver of one or more of the Institute's Conflict of Interest provisions;(C) that the integrity of the Grant Review Process, the Grant Contract process, the monitoring of Grant Awards, or committee action would not be impaired by the individual's participation; and(D) any proposed limits on certain activities to be taken by the individual.(2) The written proposal for a waiver must be submitted to the Oversight Committee and publicly reported at the Oversight Committee meeting. The waiver is granted if a majority of the Oversight Committee Members present and voting approve the waiver. The vote on a proposed waiver may take place prior to the Oversight Committee's decision regarding the Grant Application recommended for funding.(3) If the Conflict of Interest is one that is reasonably expected to affect more than one Grant Review Cycle or grant monitoring activities in a fiscal year, the waiver proposal may request that the waiver apply for all activities associated with the Grant Review Process, Grant Contract process, or grant monitoring process during the fiscal year.(4) The Institute shall report annually to the Governor, the Lieutenant Governor, and the Speaker of the House of Representatives, and the standing committee of each house of the legislature with primary jurisdiction over Institute matters on all waivers granted for the past twelve months. The reporting obligation is fulfilled by including the information in the Institute's Annual Public Report required by Texas Health and Safety Code §102.052. Source Note: The provisions of this §702.17 adopted to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.17 Exceptional Circumstances Requiring Participation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205226&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205226 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=205226&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 205226 03/11/2026 (a) Communication regarding the substance of a pending Grant Application between the Grant Applicant and an Oversight Committee Member, a Program Integration Committee Member, or a Scientific Research and Prevention Programs Committee Member is prohibited.(b) The prohibition on communication begins on the first day that Grant Applications for the Grant Mechanism are accepted by the Institute and extends until the Grant Applicant receives notice regarding a final decision on the Grant Application.(1) The prohibition on communication does not apply to the time period when pre-applications or letters of interest are accepted.(2) In special circumstances, an Oversight Committee Member or a Program Integration Committee Member may respond to a question or request for more information from a Grant Applicant so long as the response is made available to all Grant Applicants.(3) The prohibition does not apply to a Scientific Research and Prevention Programs Committee Member who is assigned by the Product Development Review Council chairperson to participate in the business operations and management due diligence review and intellectual property review as described in Chapter 703 of this title (relating to Grants for Cancer Prevention and Research). A Scientific Research and Prevention Programs Committee Member, on behalf of the Product Development Review Council, may participate in the due diligence review process and ask clarifying questions of a Grant Applicant to gain substantive knowledge, which the Product Development Review Council will use in the review of the Grant Application.(A) Each Grant Application recommended to the due diligence stage of review will be subject to the same review and participation by a Scientific Research and Prevention Programs Committee Member as described in paragraph (3) of this subsection.(B) The Institute will maintain documentation of the Scientific Research and Prevention Programs Committee Members assigned to participate in due diligence review.(c) Intentional, serious, or frequent violations of this rule may result in the disqualification of the Grant Applicant from further consideration for a Grant Award.(d) This rule is not intended to prohibit open dialogue between the public and the Chief Executive Officer, a Program Integration Committee Member or a member of the Oversight Committee regarding the general status or nature of pending Grant Applications.(e) The Chief Executive Officer may grant a waiver from the general prohibition on communication upon finding that the waiver is in the interest of promoting the objectives of the Institute and is not intended to give one or more Grant Applicants an unfair advantage. The waiver shall be provided to the Oversight Committee in writing at the time it is granted and state the reasons for the granting the waiver. The waiver shall be included as part of the public information supporting the Chief Executive Officer's affidavit(s) for Grant Award recommendations in the Grant Review Cycle(s) corresponding to the waiver.(f) A Program Integration Committee Member shall not communicate individually with one or more Oversight Committee Members about a Grant Award recommendation for a Grant Application in a pending Grant Review Cycle until such time that the Program Integration Committee has submitted the list of Grant Award Recommendations to the Oversight Committee and the Chief Executive Officer has submitted the written affidavit required by Chapter 703, §703.7 of this title (relating to Program Integration Committee Funding Recommendation). Nothing herein shall prohibit the Chief Executive Officer or a Program Integration Committee Member from responding to an individual Oversight Committee Member's question or request for more information so long as the response is made available to all Oversight Committee Members. Source Note: The provisions of this §702.19 adopted to be effective February 11, 2010, 35 TexReg 872; amended to be effective March 2, 2014, 39 TexReg 1385; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 10, 2021, 46 TexReg 3522. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.19 Restriction on Communication Regarding Pending Grant Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=144269&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 144269 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=144269&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 144269 03/11/2026 The members of the Oversight Committee shall receive training on the Texas Public Information Act and the Texas Open Meetings Act after the conclusion of each regular session of the Texas Legislature. This requirement is in addition to any statutorily required training and may be met by attending a training session during a meeting of the Oversight Committee, or via other form of in-person, video, or on-line training approved by the Attorney General. Source Note: The provisions of this §702.21 adopted to be effective February 11, 2010, 35 TexReg 872. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 702 INSTITUTE STANDARDS ON ETHICS AND CONFLICTS, INCLUDING THE ACCEPTANCE OF GIFTS AND DONATIONS TO THE INSTITUTE §702.21 Availability of Information https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166326&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166326 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166326&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166326 03/11/2026 (a) Grant Awards from the Institute shall fund:(1) Research into the causes of and cures for all types of cancer in humans;(2) Facilities for use in research into the causes and cures for cancer;(3) Research, including translational research, to develop therapies, protocols, medical pharmaceuticals, or procedures for the cure or substantial mitigation of all types of cancer in humans;(4) Cancer Prevention and Control Programs in this state to mitigate the incidence of all types of cancer in humans;(5) Support for institutions of learning and advanced medical research facilities and collaborations in this state in all stages in the process of finding the causes of all types of cancer in humans and developing cures, from laboratory research to clinical trials and including programs to address the problem of access to advanced cancer treatment; and(6) Implementation of the Texas Cancer Plan.(b) The Oversight Committee shall annually set priorities for each of the Institute's Grant Programs to be considered during the Institute's Grant Review Process.(1) The presiding officer of the Oversight Committee is responsible for establishing a process to develop annual Grant Program priorities.(2) The annual Grant Program priorities shall be approved by a simple majority of the Oversight Committee and posted on the Institute's Internet website. Source Note: The provisions of this §703.1 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.1 Purpose and Application https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166327&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166327 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166327&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166327 03/11/2026 The words and terms, when used in this chapter, shall have the meanings provided in Chapter 701, §701.3 of this title (relating to Definitions), unless the context clearly indicates otherwise. Source Note: The provisions of this §703.2 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective August 1, 2010, 35 TexReg 6656; amended to be effective March 2, 2014, 39 TexReg 1386. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.2 Definitions https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=204085&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 204085 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=204085&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 204085 03/11/2026 (a) The Institute shall accept Grant Applications for Cancer Research and Cancer Prevention programs to be funded by the Cancer Prevention and Research Fund or the proceeds of general obligation bonds issued on behalf of the Institute in response to standard format Requests for Applications issued by the Institute.(b) Each Request for Applications shall be publicly available through the Institute's Internet website. The Institute reserves the right to modify the format and content requirements for the Requests for Applications from time to time. Any modifications will be available through the Institute's Internet website. The Request for Applications shall:(1) Include guidelines for the proposed projects and may be accompanied by instructions provided by the Institute.(2) State the criteria to be used during the Grant Review Process to evaluate the merit of the Grant Application, including guidance regarding the range of possible scores.(A) The specific criteria and scoring guidance shall be developed by the Chief Program Officer in consultation with the Review Council.(B) When the Institute will use a preliminary evaluation process as described in §703.6 of this chapter (relating to Grant Review Process) for the Grant Applications submitted pursuant to a particular Grant Mechanism, the Request for Applications shall state the criteria and Grant Application components to be included in the preliminary evaluation.(3) Specify limits, if any, on the number of Grant Applications that may be submitted by an entity for a particular Grant Mechanism to ensure timely and high-quality review when a large number of Grant Applications are anticipated.(4) Specify the minimum level of effort, if any, for the Principal Investigator, co-Principal Investigator, and other specified key personnel of an entity approved for a Grant Award.(c) Requests for Applications for Cancer Research and Cancer Prevention projects issued by the Institute may address, but are not limited to, the following areas:(1) Basic research;(2) Translational research, including proof of concept, preclinical, and Product Development activities;(3) Clinical research;(4) Population based research;(5) Training;(6) Recruitment to the state of researchers and clinicians with innovative Cancer Research approaches;(7) Infrastructure, including centers, core facilities, and shared instrumentation;(8) Implementation of the Texas Cancer Plan; and(9) Evidence based Cancer Prevention education, outreach, and training, and clinical programs and services.(d) An otherwise qualified applicant is eligible solely for the Grant Mechanism specified by the Request for Applications under which the Grant Application was submitted.(e) The Institute may limit the number of times a Grant Application not recommended for a Grant Award during a previous Grant Review Cycle may be resubmitted in a subsequent Grant Review Cycle. The Request for Applications will state the resubmission guidelines, including specific instructions for resubmissions.(f) Failure to comply with the material and substantive requirements set forth in the Request for Applications may serve as grounds for disqualification from further consideration of the Grant Application by the Institute. A Grant Application determined by the Institute to be incomplete or otherwise noncompliant with the terms or instructions set forth by the Request for Applications shall not be eligible for consideration of a Grant Award.(g) Only those Grant Applications submitted via the designated electronic portal designated by the Institute by the deadline, if any, stated in the Request for Applications shall be eligible for consideration of a Grant Award.(1) Nothing herein shall prohibit the Institute from extending the submission deadline for one or more Grant Applications upon a showing of good cause, as determined by the Chief Program Officer.(2) A request to extend the Grant Application submission deadline must be in writing and sent to the CPRIT Helpdesk via electronic mail, within 24 hours of the submission deadline.(3) The Institute shall document any deadline extension granted, including the good cause for extending the deadline and will cause the documentation to be maintained as part of the Grant Review Process records.(h) The Grant Applicant shall certify that it has not made and will not make a donation to the Institute or any foundation created to benefit the Institute.(1) Grant Applicants that make a donation to the Institute or any foundation created to benefit the Institute on or after June 14, 2013, are ineligible to be considered for a Grant Award.(2) For purposes of the required certification, the Grant Applicant includes the following individuals or the spouse or dependent child(ren) of the following individuals:(A) the Principal Investigator, Program Director, or Company Representative;(B) a Senior Member or Key Personnel listed on the Grant Application; and(C) an officer or director of the Grant Applicant.(3) Notwithstanding the foregoing, one or more donations exceeding $500 by an employee of a Grant Applicant not described by paragraph (2) of this subsection shall be considered to be made on behalf of the Grant Applicant for purposes of the certification.(4) The certification shall be made at the time the Grant Application is submitted.(5) The Chief Compliance Officer shall compare the list of Grant Applicants to a current list of donors to the Institute and any foundation created to benefit the Institute.(6) To the extent that the Chief Compliance Officer has reason to believe that a Grant Applicant has made a donation to the Institute or any foundation created to benefit the Institute, the Chief Compliance Officer shall seek information from the Grant Applicant to resolve any issue. The Grant Application may continue in the Grant Review Process during the time the additional information is sought and under review by the Institute.(7) If the Chief Compliance Officer determines that the Grant Applicant has made a donation to the Institute or any foundation created to benefit the Institute, then the Institute shall take appropriate action. Appropriate action may entail:(A) Withdrawal of the Grant Application from further consideration; or(B) Return of the donation, if the return of the donation is possible without impairing Institute operations.(8) If the donation is returned to the Applicant, then the Grant Application is eligible to be considered for a Grant Award.(i) Grant Applicants shall identify by name all sources of funding contributing to the project proposed for a Grant Award. A Grant Applicant for a Product Development Research Grant Award must provide a capitalization table that includes those individuals or entities that have an investment, stock or rights in the company. The Institute shall make the information provided by the Grant Applicant available to Scientific Research and Prevention Programs Committee members, Institute employees, independent contractors participating in the Grant Review Process, Program Integration Committee Members and Oversight Committee Members for purposes of identifying potential Conflicts of Interest prior to reviewing or taking action on the Grant Application. The information shall be maintained in the Institute's Grant Review Process records.(j) A Grant Applicant shall indicate if the Grant Applicant is currently ineligible to receive Federal or State grant funds due to debarment or suspension or if the Grant Applicant has had a grant terminated for cause within five years prior to the submission date of the Grant Application. For purposes of the provision, the term Grant Applicant includes the personnel, including collaborators or contractors, who will be working on the Grant Award. A Grant Applicant is not eligible to receive a Grant Award if the Grant Applicant is debarred, suspended, ineligible or otherwise excluded from participation in a federal or state grant award.(k) The Institute may require each Grant Applicant for a Cancer Research Grant Award for Product Development to submit an application fee.(1) The Chief Executive Officer shall adopt a policy regarding the application fee amount.(2) The Institute shall use the application fee amounts to defray the Institute's costs associated with the Product Development review processes, including due diligence and intellectual property reviews, as specified in the Request for Application.(3) Unless a request to submit the fee after the deadline has been approved by the Institute, the Institute may administratively withdraw a Grant Application if the application review fee is not received by the Institute within seven business days of the Grant Application submission deadline.(4) Upon a written request from the Grant Applicant, the Institute may refund the application fee to the Grant Applicant if the Grant Applicant withdraws the Grant Application or the Grant Application is otherwise removed from the Grant Review Process prior to the review of the Grant Application by the Scientific Research and Prevention Programs Committees. The Institute's decision regarding return of the application fee is final.(l) During the course of administrative review of the Grant Application, the Institute may contact the Grant Applicant to seek clarification on information provided in the Grant Application or to request additional information if such information clarifies the Grant Application. The Institute shall keep a record of requests made under this subsection for review by the Chief Compliance Officer. Source Note: The provisions of this §703.3 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective August 1, 2010, 35 TexReg 6656; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective March 9, 2016, 41 TexReg 1694; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective March 14, 2019, 44 TexReg 1346; amended to be effective September 11, 2019, 44 TexReg 4873; amended to be effective March 11, 2021, 46 TexReg 1472. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.3 Grant Applications https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166329&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166329 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166329&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166329 03/11/2026 The Institute may engage third-party grants management services. Such services may include the deployment and maintenance of an electronic Grants Management System to facilitate the Institute's receipt and review of Grant Applications, execution of Grant Contracts, and the ongoing monitoring and management of Grant Awards, including required Grant Recipient reports and submissions.(1) The Institute may use the electronic Grants Management System to:(A) Facilitate the Institute's receipt and review of Grant Applications;(B) Maintain complete Grant Review Process records for Grant Applications undergoing Peer Review, including the final Overall Evaluation Score and Numerical Ranking Score assigned to Grant Applications during the Peer Review Process;(C) Maintain supporting documentation regarding the implementation of the Institute's Conflict of Interest process for each Grant Review Cycle, including a list of any Conflicts of Interest requiring recusal, any unreported Conflicts of Interest confirmed by an investigation and the actions taken, any waivers, the identity of the Primary Investigator, Program Director or Company Representative and the funding sources for the Grant Award project;(D) Expedite execution of Grant Contracts and the electronic submission of Grant Contract change requests and required Grant Award reports;(E) Maintain complete Grant Award records, including the Grant Contract and Matching Funds certification, required Grant Award financial reports and Grant Progress Reports, and the Institute's review of those reports;(F) Support the Institute's Grant Award compliance monitoring by tracking the due dates and submission status for required Grant Award reports; and(G) Monitor the status of past-due required Grant Award financial reports and Grant Progress Reports.(2) The Institute may require, as a condition of receiving a Grant Award, that the Grant Recipient use the Institute's electronic Grant Management System to exchange, execute, and verify legally binding Grant Contract documents and Grant Award reports. Such use shall be in accordance with the Institute's electronic signature policy as set forth in Chapter 701, §701.25 of this title (relating to Electronic Signature Policy).(3) The Institute shall require periodic audits of any electronic Grant Management System. Weaknesses identified by system audits must be timely addressed pursuant to a specified timeline. Source Note: The provisions of this §703.4 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.4 Grants Management System https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184642&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184642 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=184642&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 184642 03/11/2026 (a) The Oversight Committee shall establish Scientific Research and Prevention Programs Committees for the purpose of conducting Peer Review of Grant Applications submitted to the Institute. Such Peer Review activities may include post award evaluation of Grant Progress Reports. The Chief Executive Officer, with approval by simple majority of the Oversight Committee, is responsible for appointing experts in the fields of Cancer Research, Prevention life science Product Development, and patient advocacy to serve as Scientific Research and Prevention Programs Committee members for terms designated by the Chief Executive Officer.(b) The Chief Executive Officer may provisionally appoint an individual as a Scientific Research and Prevention Programs Committee Member until such time that the individual can be considered for approval by the Oversight Committee. The provisional appointee may participate in the Peer Review Process prior to a vote of the Oversight Committee on the appointment so long as the appointment is considered at the next regular Oversight Committee meeting.(c) A Scientific Research and Prevention Programs Committee Member is responsible for conducting Peer Review of the Grant Applications assigned to the individual member's Peer Review Panel.(d) A Scientific Research and Prevention Programs Committee Member may receive an honorarium in accordance with the policy described in Chapter 701, §701.15 of this title (relating to the Scientific Research and Prevention Programs Committee Honoraria Policy).(e) A member of a Scientific Research and Prevention Programs Committee is prohibited from attempting to use the committee member's official position to influence a decision to approve or award a grant or contract to the committee member's employer.(f) A member of a Scientific Research and Prevention Programs Committee must comply with the requirements set forth in Chapter 702 of this title (relating to Institute Standards on Ethics and Conflicts, Including the Acceptance of Gifts and Donations to the Institute) and Chapter 102, Texas Health and Safety Code.(g) The Scientific Research and Prevention Programs Committee Member shall not provide professional services for compensation exceeding $5,000 to any Grant Applicant that was reviewed by the Scientific Research and Prevention Programs Committee Member's Peer Review Panel.(1) The term of this restriction is for a period of one year from the due date of the Grant Application or the effective date of the Grant Award, whichever is later, unless waived by a vote of the Oversight Committee.(2) For purposes of this restriction, "professional services" do not include those services for which an honorarium is paid; however, honoraria exceeding $5,000 paid to a Scientific Research and Prevention Programs Committee Member by a Grant Applicant while the individual is serving as a Committee Member shall be reported within 30 days to the Institute's Chief Executive Officer.(3) Even if a payment to a Scientific Research and Prevention Programs Committee Member is not otherwise prohibited, a Grant Recipient shall not pay a Scientific Research and Prevention Programs Committee Member with Grant Award funds.(h) An individual that serves as a Scientific Research and Prevention Programs Committee Member may not concurrently serve on the Board of Directors or other governing board of a Grant Recipient or of a foundation or similar organization affiliated with the entity. This prohibition lasts so long as the Grant Recipient receives Grant Award funds or the Scientific Research and Prevention Programs Committee Member receives an honorarium from the Institute, whichever ends first.(i) The Scientific Research and Prevention Programs Committee Member shall not use non-public Third-Party Information or knowledge of non-public decisions related to Grant Applicants, gained by virtue of the individual's participation in the Institute's Peer Review Process, to make an investment or take some other action resulting in a financial benefit to the individual or the individual's employer.(j) A violation of any requirement of this section may result in the removal of the Scientific Research and Prevention Programs Committee Member from further participation in the Institute's Peer Review Process.(k) The Institute shall provide on the Institute's Internet website a register of the individuals appointed as Scientific Research and Prevention Programs Committee Members, including provisional members. The register may list the Scientific Research and Prevention Programs Committee members by Peer Review Panel. For the purpose of identifying undisclosed Conflicts of Interest, a Grant Applicant may be notified of the Peer Review Panel to which the Grant Application has been assigned.(l) The Chief Executive Officer shall ensure that at least one Patient Advocate is appointed to each Peer Review Panel. To be considered for a Patient Advocate appointment by the Chief Executive Officer as a Scientific Research and Prevention Programs Committee Member, an applicant must:(1) Represent an organization or other community of people;(2) Demonstrate prior community involvement or other work on behalf of cancer patients;(3) Possess good communication and writing skills, including the ability to analyze information and make judgments with consideration of patient impact;(4) Express interest in and fundamental knowledge of the medical research process, including basic and translational scientific research and prevention concepts;(5) Reside outside of the state of Texas;(6) Have science-based training. This training requirement shall be considered fulfilled if the Patient Advocate has:(A) attended a science-based training program from the American Association for Cancer Research Survivor-Scientist Program, American Society of Clinical Oncology Research Review Sessions for Patient Advocates, Research Advocacy Network Advocate Institute or National Breast Cancer Coalition Project LEAD no more than three years prior to appointment to the Institute's Scientific Research and Prevention Programs Committee; or(B) participated in at least one full cycle of grant review conducted by the Institute, National Institutes of Health, Department of Defense Congressionally Directed Medical Research Programs, Federal Drug Administration or Patient-Centered Outcomes Research Institute no more than three years prior to appointment to the Institute's Scientific Research and Prevention Programs Committee.(m) An individual interested in a Patient Advocate appointment shall submit an application, in a format specified by the Institute that includes at least the following information:(1) Dates of service on a peer review panel within the past three years, or dates of attendance at advocate training programs within the past three years as documentation of the fulfillment of the science-based training program requirement;(2) Current resume or curriculum vitae;(3) A letter of recommendation from a community-based organization and a personal statement on advocacy and education if the applicant has attended a training program but not yet served on a peer review panel Source Note: The provisions of this §703.5 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 8, 2017, 42 TexReg 2937. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.5 Scientific Research and Prevention Programs Committees https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214991&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214991 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214991&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214991 03/11/2026 (a) For all Grant Applications that are not administratively withdrawn by the Institute for noncompliance or otherwise withdrawn by the Grant Applicant, the Institute shall use a two-stage Peer Review process.(1) The Peer Review process, as described herein, is used to identify and recommend meritorious Cancer Research projects, including those projects with Cancer Research Product Development prospects, and evidence-based Cancer Prevention and Control projects for Grant Award consideration by the Program Integration Committee and the Oversight Committee.(2) Peer Review will be conducted pursuant to the requirements set forth in Chapter 702 of this title (relating to Institute Standards on Ethics and Conflicts, Including the Acceptance of Gifts and Donations to the Institute) and Chapter 102, Texas Health and Safety Code.(b) The two stages of the Peer Review Process used by the Institute are:(1) Evaluation of Grant Applications by Peer Review Panels; and(2) Prioritization of Grant Applications by the Prevention Review Council, the Product Development Review Council, or the Scientific Review Council, as may be appropriate for the Grant Program.(c) Except as described in subsection (e) of this section, the Peer Review Panel evaluation process encompasses the following actions, which will be consistently applied:(1) The Institute distributes all Grant Applications submitted for a particular Grant Mechanism to one or more Peer Review Panels.(2) The Peer Review Panel chairperson assigns each Grant Application to no less than two panel members that serve as the Primary Reviewers for the Grant Application. Assignments are made based upon the expertise and background of the Primary Reviewer in relation to the Grant Application.(3) The Primary Reviewer is responsible for individually evaluating all components of the Grant Application, critiquing the merits according to explicit criteria published in the Request for Applications, and providing an individual Overall Evaluation Score that conveys the Primary Reviewer's general impression of the Grant Application's merit. The Primary Reviewers' individual Overall Evaluation Scores are averaged together to produce a single initial Overall Evaluation Score for the Grant Application.(4) The Peer Review Panel meets to discuss the Grant Applications assigned to the Peer Review Panel. If there is insufficient time to discuss all Grant Applications, the Peer Review Panel chairperson determines the Grant Applications to be discussed by the panel. The chairperson's decision is based largely on the Grant Application's initial Overall Evaluation Score; however, a Peer Review Panel member may request that a Grant Application be discussed by the Peer Review Panel.(A) If a Grant Application is not discussed by the Peer Review Panel, then the initial Overall Evaluation Score serves as the final Overall Evaluation Score for the Grant Application. The Grant Application is not considered further during the Grant Review Cycle.(B) If a Grant Application is discussed by the Peer Review Panel, each Peer Review Panel member submits a score for the Grant Application based on the panel member's general impression of the Grant Application's merit and accounting for the explicit criteria published in the Request for Applications. The submitted scores are averaged together to produce the final Overall Evaluation Score for the Grant Application.(i) The panel chairperson participates in the discussion but does not score Grant Applications.(ii) A Primary Reviewer has the option to revise his or her score for the Grant Application after panel discussion or to keep the same score submitted during the initial review.(C) If the Peer Review Panel recommends changes to the Grant Award funds amount requested by the Grant Applicant or to the Scope of Work for the proposed project, then the recommended changes and explanation shall be recorded at the time the final Overall Evaluation Score is set.(5) At the conclusion of the Peer Review Panel evaluation, the Peer Review Panel chairperson submits to the appropriate Review Council a list of Grant Applications discussed by the panel ranked in order by the final Overall Evaluation Score. Any changes to the Grant Award funding amount or to the Scope of Work recommended by the Peer Review Panel shall be provided to the Review Council at that time.(d) The Review Council's prioritization process for Grant Award recommendations encompasses the following actions, which will be consistently applied:(1) The Review Council prioritizes the Grant Application recommendations across all the Peer Review Panels by assigning a Numerical Ranking Score to each Grant Application that was discussed by a Peer Review Panel. The Numerical Ranking Score is substantially based on the final Overall Evaluation Score submitted by the Peer Review Panel, but also takes into consideration how well the Grant Application achieves program priorities set by the Oversight Committee, the overall Program portfolio balance, and any other criteria described in the Request for Applications.(2) The Review Council's recommendations are submitted simultaneously to the presiding officers of the Program Integration Committee and Oversight Committee. The recommendations, listed in order by Numerical Ranking Score, shall include:(A) An explanation describing how the Grant Application meets the Review Council's standards for Grant Award funding;(B) The final Overall Evaluation Score assigned to the Grant Application by the Peer Review Panel, including an explanation for ranking one or more Grant Applications ahead of another Grant Application with a more favorable final Overall Evaluation Score; and(C) The specified amount of the Grant Award funding for each Grant Application, including an explanation for recommended changes to the Grant Award funding amount or to the Scope of Work.(3) A Grant Award recommendation is not final until the Review Council formally submits the recommendation to the presiding officers of the Program Integration Committee and the Oversight Committee. The Program Integration Committee, and, if appropriate, the Oversight Committee must make a final decision on the Grant Award recommendation in the same state fiscal year that the Review Council submits its final recommendation.(e) Circumstances relevant to a particular Grant Mechanism or to a Grant Review Cycle may justify changes to the dual-stage Peer Review process described in subsections (c) and (d) of this section. Peer Review process changes the Institute may implement are described in this subsection. The list is not intended to be exhaustive. Any material changes to the Peer Review process, including those listed in this subsection, shall be described in the Request for Applications or communicated to all Grant Applicants.(1) The Institute may use a preliminary evaluation process if the volume of Grant Applications submitted pursuant to a specific Request for Applications is such that timely review may be impeded. The preliminary evaluation will be conducted after Grant Applications are assigned to Peer Review Panels but prior to the initial review described in subsection (c) of this section. The preliminary evaluation encompasses the following actions:(A) The criteria and the specific Grant Application components used for the preliminary evaluation shall be stated in the Request for Applications;(B) No less than two Peer Review Panel members are assigned to conduct the preliminary evaluation for a Grant Application and provide a preliminary score that conveys the general impression of the Grant Application's merit pursuant to the specified criteria; and(C) The Peer Review Panel chairperson is responsible for determining the Grant Applications that move forward to initial review as described in subsection (c) of this section. The decision will be based upon preliminary evaluation scores. A Grant Application that does not move forward to initial review will not be considered further, and the average of the preliminary evaluation scores received becomes the final Overall Evaluation Score for the Grant Application.(2) The Institute shall assign all Grant Applications submitted for recruitment of researchers and clinicians to the Scientific Review Council.(A) The Scientific Review Council members review all components of the Grant Application, evaluate the merits according to explicit criteria published in the Request for Applications, and, after discussion by the Review Council members, provide an individual Overall Evaluation Score that conveys the Review Council member's recommendation related to the proposed recruitment.(B) The individual Overall Evaluation Scores are averaged together for a final Overall Evaluation Score for the Application.(C) If more than one recruitment Grant Application is reviewed by the Scientific Review Council during the Grant Review Cycle, then the Scientific Review Council shall assign a Numerical Ranking Score to each Grant Application to convey its prioritization ranking.(D) If the Scientific Review Council recommends a change to the Grant Award funds requested by the Grant Application, then the recommended change and explanation shall be recorded at the time the final Overall Evaluation Score is set.(E) The Scientific Review Council's recommendations shall be provided to the presiding officer of the Program Integration Committee and to the Oversight Committee pursuant to the process described in subsection (d) of this section.(3) The Institute may assign continuation Grant Applications to the appropriate Review Council.(A) The Review Council members review all components of the Grant Application, evaluate the merits according to explicit criteria published in the Request for Applications, and, after discussion by the Review Council members, provide an individual Overall Evaluation Score that conveys the Review Council member's recommendation related to the progress and continued funding.(B) The individual Overall Evaluation Scores are averaged together for a final Overall Evaluation Score for the Application.(C) If more than one continuation Grant Application is reviewed by the Review Council during the Grant Review Cycle, then the Review Council shall assign a Numerical Ranking Score to each continuation Grant Application to convey its prioritization ranking.(D) If the Review Council recommends a change to the Grant Award funds or to the Scope of Work requested by the continuation Grant Application, then the recommended change and explanation shall be recorded at the time the final Overall Evaluation Score is set.(E) The Review Council's recommendations shall be provided to the presiding officer of the Program Integration Committee and to the Oversight Committee pursuant to the process described in subsection (d) of this section.(4) The Institute's Peer Review process described in subsections (c) and (d) of this section may include the following additional process steps for Product Development of Cancer Research Grant Applications:(A) A Grant Applicant may be invited to deliver an in-person presentation to the Peer Review Panel. The Product Development Review Council chairperson is responsible for deciding which Grant Applicants will make in-person presentations. The decision is based upon the initial Overall Evaluation Scores of the primary reviewers following a discussion with Peer Review Panel members, as well as explicit criteria published in the Request for Applications.(i) Peer Review Panel members may submit questions to be addressed by the Grant Applicant at the in-person presentation.(ii) A Grant Application that is not presented in-person will not be considered further. The average of the primary reviewers' initial Overall Evaluation Scores will be the final Overall Evaluation Score for the Grant Application.(iii) Following the in-person presentation, each Peer Review Panel member submits a score for the Grant Application based on the panel member's general impression of the Grant Application's merit and accounting for the explicit criteria published in the Request for Applications. The submitted scores are averaged together to produce the final Overall Evaluation Score for the Grant Application.(B) A Grant Application may undergo business operations and management due diligence review and an intellectual property review. The Peer Review Panel submits a list of applications recommended for due diligence review to the Product Development Review Council. The Product Development Review Council decides which Grant Applications submitted by the Peer Review Panel will undergo business operations and management due diligence and intellectual property review. The decision is based upon the Grant Application's final Overall Evaluation Score, but also takes into consideration how well the Grant Application achieves program priorities set by the Oversight Committee, the overall Program portfolio balance, and any other criteria described in the Request for Applications. A Grant Application that is not recommended for due diligence and intellectual property review will not be considered further.(i) Business operations and management due diligence may be conducted by an outside vendor, contracted by the Institute or by members of the Product Development Review Council.(ii) It will be at the Institute's discretion as to who to use to perform business operations and management due diligence; factors may include volume of work and expertise required.(C) After receipt of the business operations and management due diligence and intellectual property reviews for a Grant Application, the Product Development Review Council and the Primary Reviewers meet to determine whether to recommend the Grant Application for a Grant Award based upon the information set forth in the due diligence and intellectual property reviews. The Product Development Review Council may recommend changes to the Grant Award budget and Scope of Work.(D) The Product Development Review Council assigns a Numerical Ranking Score to each Grant Application recommended for a Grant Award.(f) Institute Employees and Oversight Committee members may attend Peer Review Panel and Review Council meetings. If an Institute Employee or an Oversight Committee member attends a Peer Review Panel meeting or a Review Council meeting, the attendance shall be recorded and the Institute Employee or Oversight Committee member shall certify in writing compliance with the Institute's Conflict of Interest rules. The Institute Employee's and Oversight Committee member's attendance at the Peer Review Panel meeting or Review Council meeting is subject to the following restrictions:(1) Unless waived pursuant to the process described in Chapter 702, §702.17 of this title (relating to Exceptional Circumstances Requiring Participation), Institute Employees and Oversight Committee members shall not be present for any discussion, vote, or other action taken related to a Grant Applicant if the Institute Employee or Oversight Committee member has a Conflict of Interest with that Grant Applicant; and(2) The Institute Employee or Oversight Committee member shall not participate in a discussion of the merits, vote, or other action taken related to a Grant Application, except to answer technical or administrative questions unrelated to the merits of the Grant Application and to provide input on the Institute's Grant Review Process.(g) The Institute's Chief Compliance Officer shall observe meetings of the Peer Review Panel and Review Council where Grant Applications are discussed.(1) The Chief Compliance Officer shall document that the Institute's Grant Review Process is consistently followed, including observance of the Institute's established Conflict of Interest rules, and that participation by Institute employees, if any, is limited to providing input on the Institute's Grant Review Process and responding to committee questions unrelated to the merits of the Grant Application. Institute Program staff shall not participate in a discussion of the merits, vote, or any other action taken related to a Grant Application.(2) The Chief Compliance Officer shall report to the Oversight Committee prior to a vote on the award recommendations specifying issues, if any, that are inconsistent with the Institute's established Grant Review Process.(3) Nothing herein shall prevent the Institute from contracting with an independent third party to serve as a neutral observer of meetings of the Peer Review Panel and/or the Review Council where Grant Applications are discussed and to assume the reporting responsibilities of the Chief Compliance Officer described in this subsection. In the event that the independent third party observes the meeting of the Peer Review Panel and/or the Review Council, then the independent third party reviewer shall issue a report to the Chief Compliance Officer specifying issues, if any, that are inconsistent with the Institute's established Grant Review Process.(h) Excepting a finding of an undisclosed Conflict of Interest as set forth in §703.9 of this chapter (relating to Limitation on Review of Grant Process), the Review Council's decision to not include a Grant Application on the prioritized list of Grant Applications submitted to the Program Integration Committee and the Oversight Committee is final. A Grant Application not included on the prioritized list created by the Review Council shall not be considered further during the Grant Review Cycle.(i) At the time that the Peer Review Panel or the Review Council concludes its tasks for the Grant Review Cycle, each member shall certify in writing that the member complied with the Institute's Conflict of Interest rules. An Institute Employee or an Oversight Committee member attending one or more Peer Review Panel meetings during the Grant Review Cycle shall certify compliance with the Institute's Conflict of Interest rules.(j) The Institute shall retain a review record for a Grant Application submitted to the Institute, even if the Grant Application did not receive a Grant Award. Such records will be retained by the Institute's electronic Grant Management System. The records retained by the Institute must include the following information:(1) The final Overall Evaluation Score and Numerical Ranking Score, if applicable, assigned to the Grant Application;(2) The specified amount of the Grant Award funding for the Grant Application, including an explanation for recommended changes to the Grant Award funding amount or to the Scope of Work;(3) The Scientific Research and Prevention Programs Committee that reviewed the Grant Application;(4) Conflicts of Interest, if any, with the Grant Application identified by a member of the Scientific Research and Prevention Programs Committee, the Review Council, the Program Integration Committee, or the Oversight Committee; and(5) Documentation of steps taken to recuse any member or members from the Grant Review Process because of disclosed Conflicts of Interest.(k) For purposes of this rule, a Peer Review Panel chairperson or a Review Council chairperson that is unable to carry out his or her assigned duties due to a Conflict of Interest with regard to one or more Grant Applications or for any other reason may designate a co-chairperson from among the appointed Scientific Research and Prevention Programs committee members to fulfill the chairperson role. Such designation shall be recorded in writing and include the specific time and extent of the designation. Source Note: The provisions of this §703.6 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective March 11, 2015, 40 TexReg 1092; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 8, 2017, 42 TexReg 2937; amended to be effective June 5, 2019, 44 TexReg 2723; amended to be effective September 7, 2023, 48 TexReg 4863. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.6 Grant Review Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214992&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214992 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214992&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214992 03/11/2026 (a) The Institute uses a Program Review process undertaken by the Institute's Program Integration Committee to identify and recommend for funding a final list of meritorious Cancer Research projects, including those projects with Cancer Research Product Development prospects, and evidence-based Cancer Prevention and Control Program projects that are in the best overall interest of the State.(b) Program Review shall be conducted pursuant to the requirements set forth in Chapter 702 of this title (relating to Institute Standards on Ethics and Conflicts, Including the Acceptance of Gifts and Donations to the Institute) and Chapter 102, Texas Health and Safety Code.(c) The Program Integration Committee shall meet pursuant to a schedule established by the Chief Executive Officer, who serves as the Committee's presiding officer, to consider the prioritized list of Grant Applications submitted by the Prevention Review Council, the Product Development Review Council, or the Scientific Review Council.(d) The Program Integration Committee shall approve by a majority vote a final list of Grant Applications recommended for Grant Awards to be provided to the Oversight Committee, including a list of Grant Applications, if any, that have been deferred until a future meeting of the Program Integration Committee. In composing the final list of Grant Applications recommended for Grant Award funding, the Program Integration Committee shall:(1) Substantially base the list upon the Grant Award recommendations submitted by the Review Council.(2) To the extent possible, give priority for funding to Grant Applications that:(A) Could lead to immediate or long-term medical and scientific breakthroughs in the area of Cancer Prevention or cures for cancer;(B) Strengthen and enhance fundamental science in Cancer Research;(C) Ensure a comprehensive coordinated approach to Cancer Research and Cancer Prevention;(D) Are interdisciplinary or interinstitutional;(E) Address federal or other major research sponsors' priorities in emerging scientific or Technology fields in the area of Cancer Prevention, or cures for cancer;(F) Are matched with funds available by a private or nonprofit entity and institution or institutions of higher education;(G) Are collaborative between any combination of private and nonprofit entities, public or private agencies or institutions in this state, and public or private institutions outside this state;(H) Have a demonstrable economic development benefit to this state;(I) Enhance research superiority at institutions of higher education in this state by creating new research superiority, attracting existing research superiority from institutions not located in this state and other research entities, or enhancing existing research superiority by attracting from outside this state additional researchers and resources;(J) Expedite innovation and commercialization, attract, create, or expand private sector entities that will drive a substantial increase in high-quality jobs, and increase higher education applied science or Technology research capabilities; and(K) Address the goals of the Texas Cancer Plan.(3) Document the factors considered in making the Grant Award recommendations, including any factors not listed in paragraph (2) of this subsection;(4) Explain in writing the reasons for not recommending a Grant Application that was recommended for a Grant Award by the Review Council or for deferring a Grant Application recommendation until a future meeting date;(5) Specify the amount of Grant Award funding for each Grant Application.(A) Unless otherwise specifically stated, the Program Integration Committee adopts the changes to the Grant Award amount recommended by the Review Council.(B) If the Program Integration Committee approves a change in the Grant Award amount that was not recommended by the Review Council, then the Grant Award amount and a written explanation for the change shall be provided.(6) Specify changes, if any, to the Grant Application's Scope of Work recommended for a Grant Award and provide an explanation for the changes made;(7) Address how the funding recommendations meet the annual priorities for Cancer Prevention, Cancer Research and Product Development programs and affect the Institute's overall Grant Award portfolio established by the Oversight Committee; and(8) Provide a list of deferred Grant Applications, if any.(e) In the event that the Program Integration Committee's vote on the final list of Grant Award recommendations or deferrals is not unanimous, then the Program Integration Committee Member or Members not voting with the majority may submit a written explanation to the Oversight Committee for the vote against the final list of Grant Award recommendations or deferrals. The explanation may include the Program Integration Committee Member or Members' recommended prioritized list of Grant Award recommendations or deferrals.(f) The Program Integration Committee's decision to not include a Grant Application on the prioritized list of Grant Applications submitted to the Oversight Committee is final. A Grant Application not included on the prioritized list created by the Program Integration Committee shall not be considered further during the Grant Review Cycle, except for the following:(1) In the event that the Program Integration Committee's vote on the final list of Grant Award recommendations is not unanimous, then, upon a motion of an Oversight Committee Member, the Oversight Committee may also consider the Grant Award recommendations submitted by the non-majority Program Integration Committee Member or Members;(2) A finding of an undisclosed Conflict of Interest as set forth in §703.9 of this chapter (relating to Limitation on Review of Grant Process); or(3) A decision by the Program Integration Committee to defer a decision to include a Grant Application on the prioritized list of Grant Applications submitted to the Oversight Committee until a future meeting of the Program Integration Committee, subject to subsection (k) of this section.(g) The Chief Compliance Officer shall attend and observe Program Integration Committee meetings to document compliance with Chapter 102, Texas Health and Safety Code and the Institute's administrative rules.(h) At the time that the Program Integration Committee's final Grant Award recommendations are formally submitted to the Oversight Committee, the Chief Executive Officer shall prepare a written affidavit for each Grant Application recommended by the Program Integration Committee containing relevant information related to the Grant Application recommendation.(1) Information to be provided in the Chief Executive Officer's affidavit may include:(A) The Peer Review process for the recommended Grant Application, including:(i) The Request for Applications applicable to the Grant Application;(ii) The number of Grant Applications submitted in response to the Request for Applications;(iii) The name of the Peer Review Panel reviewing the Grant Application;(iv) Whether a preliminary review process was used by the Peer Review Panel for the Grant Mechanism in the Grant Review Cycle;(v) An overview of the Conflict of Interest process applicable to the Grant Review Cycle noting any waivers granted; and(vi) A list of all final Overall Evaluation Scores for all Grant Applications submitted pursuant to the same Grant Mechanism, de-identified by Grant Applicant;(B) The final Overall Evaluation Score and Numerical Ranking Score assigned for the Grant Applications recommended during the Peer Review process; and(C) A high-level summary of the business operations and management due diligence and intellectual property reviews, if applicable, conducted for a Cancer Research Product Development Grant Application.(2) In the event that the Program Integration Committee's final Grant Award recommendations are not unanimous and the Program Integration Committee Member or Members in the non-majority recommend Grant Applications not included on the final list of Grant Award recommendations, then the Chief Executive Officer shall also prepare a written affidavit for each Grant Application recommended by the non-majority Program Integration Committee Member or Members.(i) To the extent that the information or documentation for one Grant Application is the same for all Grant Applications recommended for Grant Award funding pursuant to the same Grant Mechanism, it shall be sufficient for the Chief Executive Officer to provide the information or documentation once and incorporate by reference in each subsequent affidavit.(j) At least three business days prior to the Oversight Committee meeting held to consider the Grant Applications for Grant Award funding, the Chief Executive Officer shall provide a list of Grant Applications, if any, recommended for an advance of Grant Award funds upon execution of the Grant Contract. The list shall include the reasons supporting the recommendation to advance funds.(k) The Program Integration Committee's decision to defer the final Grant Award recommendation for a Grant Application is only effective for the state fiscal year in which the Program Integration Committee's deferral decision is made.(1) A Grant Application that is deferred by the Program Integration Committee and is pending a final Grant Award recommendation at the end of the state fiscal year shall be considered not recommended for a Grant Award without further action from the Program Integration Committee.(2) A Grant Application that is deferred and pending a final Grant Award recommendation at the end of the state fiscal year may be resubmitted by the Grant Applicant in a subsequent review cycle. Such resubmission will not count against the resubmission limit, if any, stated in the Request for Applications. Source Note: The provisions of this §703.7 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 9, 2015, 40 TexReg 5792; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective September 7, 2023, 48 TexReg 4863. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.7 Program Integration Committee Funding Recommendation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181388&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181388 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181388&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181388 03/11/2026 The Oversight Committee must vote to approve each Grant Award recommendation submitted by the Program Integration Committee.(1) Prior to the Oversight Committee's consideration and approval of the Program Integration Committee's Grant Award recommendations, the Chief Compliance Officer must review the process documentation for each Grant Application recommended for a Grant Award by the Program Integration Committee and report the findings to the Chief Executive Officer and to the Oversight Committee. The Chief Compliance Officer's report shall:(A) Publicly certify that the Grant Review Process complied with the Institute's administrative rules and procedures, including those procedures stated in the Request for Applications.(B) Indicate variances, if any, from the Institute's administrative rules and procedures with a Grant Application or the Grant Review Process.(C) Compare the list of Grant Applicants recommended for a Grant Award to a list of donors from any nonprofit organization established to provide support to the Institute.(2) The Chief Executive Officer may recommend good cause for considering variances, if any, identified by the Chief Compliance Officer. The Oversight Committee shall consider and may approve the recommendation, which may include corrective actions at that time that the Grant Award recommendations are approved by a vote of a simple majority of Oversight Committee members present and voting.(3) Two-thirds of the Oversight Committee Members present and voting must approve each Grant Award recommendation. The Oversight Committee may take up more than one Grant Award recommendation at a time unless an Oversight Committee member requests taking up a recommendation individually. At the time that the Oversight Committee approves the Grant Award recommendation:(A) The total amount of money approved to fund a multiyear project must be specified.(B) The Chief Executive Officer's recommendation, if any, regarding an advance of Grant Award funds must be approved by a majority vote of the Oversight Committee.(4) If the Oversight Committee does not approve a Grant Award recommendation made by the Program Integration Committee, the minutes of the meeting shall record the explanation for not approving the Grant Award recommendation.(5) The Oversight Committee may not award more than $300 million in Grant Awards in a fiscal year.(6) No Oversight Committee action is necessary related to the Program Integration Committee's decision made pursuant to §703.7 to defer a final Grant Award recommendation for one or more Grant Applications.(7) Nothing herein prevents the Oversight Committee from voting to defer a final decision on a Grant Award recommendation made by the Program Integration Committee until a future meeting date pursuant to the following process:(A) The motion to defer a final decision on a Grant Award recommendation must be made by an Oversight Committee member that is not recused from taking action on the Grant Application;(B) The motion must be approved by two-thirds of the Oversight Committee Members present and voting;(C) The reason for deferring a final decision on one or more Grant Award recommendations must be recorded in the minutes of the Oversight Committee meeting;(D) Applications that have been deferred shall be considered by the Program Integration Committee at a future meeting date pursuant to §703.7;(E) The decision to defer the final Grant Award recommendation is only effective for the state fiscal year in which the deferral decision is made;(F) A Grant Application that is deferred and pending a final Grant Award recommendation at the end of the state fiscal year shall be considered not recommended for a Grant Award without further action from the Program Integration Committee or the Oversight Committee; and(G) A Grant Application that is deferred and pending a final Grant Award recommendation at the end of the state fiscal year may be resubmitted by the Grant Applicant in a subsequent review cycle. Such resubmission will not count against the resubmission limit, if any, stated in the Request for Applications. Source Note: The provisions of this §703.8 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective September 9, 2015, 40 TexReg 5792; amended to be effective December 7, 2016, 41 TexReg 9527. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.8 Oversight Committee Consideration of the Program Integration Committee's Funding Recommendation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166334&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166334 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166334&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166334 03/11/2026 (a) The decision to recommend a Grant Application for funding is based upon the sufficiency, merit, and, if applicable, Product Development prospects of the Grant Application, as determined by the Institute's Peer Review and Program Review processes as described in this chapter.(b) By submitting a Grant Application, the Grant Applicant understands and accepts that grounds for reconsideration of the Institute's final decision regarding a Grant Application are limited to an undisclosed Conflict of Interest as set forth in Chapter 702 of this title (relating to Institute Standards on Ethics and Conflicts, Including the Acceptance of Gifts and Donations to the Institute).(c) The Grant Applicant shall file a request with the Chief Executive Officer for a review of the Grant Review Process based on the undisclosed Conflict of Interest pursuant to the process and timeline set forth in Chapter 702 of this title. Source Note: The provisions of this §703.9 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.9 Limitation on Review of Grant Process https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218580&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218580 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218580&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218580 03/11/2026 (a) The Oversight Committee shall negotiate on behalf of the state regarding the awarding of grant funds and enter into a written contract with the Grant Recipient.(b) The Oversight Committee may delegate Grant Contract negotiation duties to the Chief Executive Officer and the General Counsel for the Institute. The Chief Executive Officer may enter into a written contract with the Grant Recipient on behalf of the Oversight Committee.(c) The Grant Contract shall include the following provisions:(1) If any portion of the Grant Contract has been approved by the Oversight Committee to be used to build a capital improvement, the Grant Contract shall specify that:(A) The state retains a lien or other interest in the capital improvement in proportion to the percentage of the Grant Award amount used to pay for the capital improvement; and(B) If the capital improvement is sold, then the Grant Recipient agrees to repay to the state the Grant Award used to pay for the capital improvement, with interest, and share with the state a proportionate amount of any profit realized from the sale;(2) Terms relating to Intellectual Property Rights and the sharing with the Institute of revenues generated by the sale, license, or other conveyance of such Project Results consistent with the standards established by this chapter;(3) Terms relating to publication of materials created with Grant Award funds or related to the Cancer Research or Cancer Prevention project that is the subject of the Grant Award, including an acknowledgement of Institute funding and copyright ownership, if applicable:(A) Acknowledgment of Institute funding must include the grant number of every Institute-funded grant contributing to the work memorialized in the publication; and(B) Subparagraph (A) of this paragraph is effective beginning September 1, 2021;(4) Repayment terms, including interest rates, to be enforced if the Grant Recipient has not used Grant Award funds for the purposes for which the Grant Award was intended;(5) A statement that the Institute does not assume responsibility for the conduct of the Cancer Research or Cancer Prevention project, and that the conduct of the project and activities of all investigators are under the scope and direction of the Grant Recipient;(6) A statement that the Cancer Research or Cancer Prevention project is conducted with full consideration for the ethical and medical implications of the project and that the project will comply with all federal and state laws regarding the conduct of the Cancer Research or Prevention project;(7) Terms related to the Standards established by the Oversight Committee in Chapter 701 of this title (relating to Policies and Procedures) to ensure that Grant Recipients, to the extent reasonably possible, demonstrate good faith effort to purchase goods and services for the Grant Award project from suppliers in this state and from historically underutilized businesses as defined by Chapter 2161, Texas Government Code, and any other state law;(8) An agreement by the Grant Recipient to submit to regular inspection reviews of the Grant Award project by Institute staff during normal business hours and upon reasonable notice to ensure compliance with the terms of the Grant Contract and continued merit of the project;(9) An agreement by the Grant Recipient to submit Grant Progress Reports to the Institute on a schedule specified by the Grant Contract that includes information on a grant-by-grant basis quantifying the amount of additional research funding, if any, secured as a result of Institute funding;(10) An agreement that, to the extent possible, the Grant Recipient will evaluate whether any new or expanded preclinical testing, clinical trials, Product Development, or manufacturing of any real or intellectual property resulting from the award can be conducted in this state, including the establishment of facilities to meet this purpose;(11) An agreement that the Grant Recipient will abide by the Texas Grant Management Standards (TxGMS) published by the Comptroller of Public Accounts Statewide Procurement Division, if applicable, unless one or more standards conflicts with a provision of the Grant Contract, Chapter 102, Texas Health and Safety Code, or the Institute's administrative rules. Such interpretation of the Institute rules and TxGMS shall be made by the Institute;(12) An agreement that the Grant Recipient is under a continuing obligation to notify the Institute of any adverse conditions that materially impact the Scope of Work in the Grant Contract;(13) An agreement that the design, conduct, and reporting of the Cancer Research or Prevention project will not be biased by conflicting financial interest of the Grant Recipient or any individuals associated with the Grant Award. This duty is fulfilled by certifying that an appropriate written, enforced Conflict of Interest policy governs the Grant Recipient;(14) An agreement regarding the amount, schedule, and requirements for payment of Grant Award funds, if such advance payments are approved by the Oversight Committee in accordance with this chapter. Notwithstanding the foregoing, the Institute may require that up to ten percent of the final Tranche of funds approved for the Grant Award must be expended on a reimbursement basis. Such reimbursement payment shall not be made until close out documents described in this section and required by the Grant Contract have been submitted and approved by the Institute;(15) An agreement to provide quarterly Financial Status Reports and supporting documentation for expenses submitted for reimbursement or, if appropriate, to demonstrate how advanced funds were expended;(16) A statement certifying that, as of June 14, 2013, the Grant Recipient has not made and will not make a contribution, during the term of the Grant Contract, to the Institute or to any foundation established specifically to support the Institute;(17) A statement specifying the agreed effective date of the Grant Contract and the period in which the Grant Award funds must be spent. If the effective date specified in the Grant Contract is different from the date the Grant Contract is signed by both parties, then the effective date shall control;(18) A statement providing for reimbursement with Grant Award funds of expenses made prior to the effective date of the Grant Contract at the discretion of the Institute. Pre-contract reimbursement shall be made only in the event that:(A) The expenses are allowable pursuant to the terms of the Grant Contract;(B) The request is made in writing by the Grant Recipient and approved by the Chief Executive Officer; and(C) The expenses to be reimbursed were incurred on or after the date the Grant Award recommendation was approved by the Oversight Committee;(19) Requirements for closing out the Grant Contract at the termination date, including the submission of a Financial Status Report, a final Grant Progress Report, an equipment inventory, a HUB and Texas Business report, a revenue sharing form, a single audit determination report form and a list of contractual terms that extend beyond the termination date;(20) A certification of dedicated Matching Funds equal to one-half of the amount of the Research Grant Award that includes the name of the Research Grant Award to which the matching funds are to be dedicated, as specified in Section §703.11 of this chapter (relating to Requirement to Demonstrate Available Funds for Cancer Research Grants);(21) The project deliverables as described by the Grant Application and stated in the Scope of Work for the Grant Contract reflecting modifications, if any, approved during the Peer Review process or during Grant Contract negotiation;(22) An agreement that the Grant Recipient shall notify the Institute and seek approval for a change in effort for any of the Senior Members or Key Personnel of the research or prevention team listed on the Grant Application, including any proposed temporary leave of absence of a Principal Investigator, Program Director, or Company Representative;(23) An agreement that the Grant Recipient is legally responsible for the integrity of the fiscal and programmatic management of the organization; and(24) An agreement that the Grant Recipient is responsible for the actions of its employees and other research collaborators, including third parties, involved in the project. The Grant Recipient is responsible for enforcing its standards of conduct, taking appropriate action on individual infractions, and, in the case of financial conflict of interest, informing the Institute if the infraction is related to a Grant Award.(d) The Grant Recipient's failure to comply with the terms and conditions of the Grant Contract may result in termination of the Grant Contract, pursuant to the process prescribed in the Grant Contract, and trigger repayment of the Grant Award funds. Source Note: The provisions of this §703.10 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective August 1, 2010, 35 TexReg 6656; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective September 11, 2019, 44 TexReg 4873; amended to be effective June 10, 2021, 46 TexReg 3522; amended to be effective December 8, 2022, 47 TexReg 8042; amended to be effective September 7, 2023, 48 TexReg 4863; amended to be effective June 9, 2024, 49 TexReg 3926. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.10 Awarding Grants by Contract https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211230&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211230 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211230&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211230 03/11/2026 (a) Prior to the disbursement of Grant Award funds, the Grant Recipient of a Cancer Research Grant Award shall demonstrate that the Grant Recipient has an amount of Encumbered Funds equal to at least one-half of the Grant Award available and not yet expended that are dedicated to the research that is the subject of the Grant Award.(1) The Grant Recipient's written certification of Matching Funds, as described in this section, shall be included in the Grant Contract.(2) A Grant Recipient of a multiyear Grant Award may certify Matching Funds on a year-by-year basis for the amount of Award Funds to be distributed for the Project Year based upon the Approved Budget.(3) A Grant Recipient receiving multiple Grant Awards may provide certification at the institutional level.(4) Nothing herein restricts the Institute from requiring the Grant Recipient to demonstrate an amount of Encumbered Funds greater than one-half of the Grant Award available and not yet expended that are dedicated to the research that is the subject of the Grant Award. To the extent that a greater Matching Funds amount will be required, the Institute shall include the requirement in the Request for Applications and in the Grant Contract.(b) For purposes of the certification required by subsection (a) of this section, a Grant Recipient that is a public or private institution of higher education, as defined by §61.003, Texas Education Code, may credit toward the Grant Recipient's Matching Funds obligation the dollar amount equivalent to the difference between the indirect cost rate authorized by the federal government for research grants awarded to the Grant Recipient and the five percent (5%) Indirect Cost limit imposed by §102.203(c), Texas Health and Safety Code, subject to the following requirements:(1) The Grant Recipient shall file certification with the Institute documenting the federal indirect cost rate authorized for research grants awarded to the Grant Recipient;(2) To the extent that the Grant Recipient's Matching Funds credit does not equal or exceed one-half of the Grant Award funds to be distributed for the Project Year, then the Grant Recipient's Matching Funds certification shall demonstrate that a combination of the dollar amount equivalent credit and the funds to be dedicated to the Grant Award project as described in subsection (c) of this section is available and sufficient to meet or exceed the Matching Fund requirement;(3) Calculation of the portion of federal indirect cost rate credit associated with subcontracted work performed for the Grant Recipient shall be in accordance with the Grant Recipient's established internal policy; and(4) If the Grant Recipient's federal indirect cost rate changes six months or less following the anniversary of the Effective Date of the Grant Contract, then the Grant Recipient may use the new federal indirect cost rate for the purpose of calculating the Grant Recipient's Matching Funds credit for the entirety of the Project Year.(c) For purposes of the certification required by subsection (a) of this section, Encumbered Funds must be spent directly on the Grant Project or spent on closely related work that supports, extends, or facilitates the Grant Project and may include:(1) Federal funds, including, but not limited to, American Recovery and Reinvestment Act of 2009 funds, and the fair market value of drug development support provided to the recipient by the National Cancer Institute or other similar programs;(2) State of Texas funds;(3) funds of other states;(4) Non-governmental funds, including private funds, foundation grants, gifts and donations;(5) Unrecovered Indirect Costs not to exceed ten percent (10%) of the Grant Award amount, subject to the following conditions:(A) These costs are not otherwise charged against the Grant Award as the five percent (5%) indirect funds amount allowed under §703.12(c) of this chapter (relating to Limitation on Use of Funds);(B) The Grant Recipient must have a documented federal indirect cost rate or an indirect cost rate certified by an independent accounting firm; and(C) The Grant Recipient is not a public or private institution of higher education as defined by §61.003 of the Texas Education Code.(6) Funds contributed by a subcontractor or subawardee and spent on the Grant Project, so long as the subcontractor's or subawardee's portion of otherwise allowable Matching Funds for a Project Year may not exceed the percentage of the total Grant Funds paid to the subcontractor or subawardee for the same Project Year.(7) Costs incurred by the Grant Recipient to relocate the Grant Recipient's operations and/or personnel to Texas.(d) For purposes of the certification required by subsection (a) of this section, the following items do not qualify as Encumbered Funds:(1) In-kind costs;(2) Volunteer services furnished to the Grant Recipient;(3) Noncash contributions;(4) Income earned by the Grant Recipient that is not available at the time of Grant Award;(5) Pre-existing real estate of the Grant Recipient including building, facilities and land;(6) Deferred giving such as a charitable remainder annuity trust, a charitable remainder unitrust, or a pooled income fund; or(7) Other items as may be determined by the Oversight Committee.(e) To the extent that a Grant Recipient of a multiyear Grant Award elects to certify Matching Funds on a Project Year basis, the failure to provide certification of Encumbered Funds at the appropriate time for each Project Year may serve as grounds for suspending reimbursement or advancement of Grant Funds for project costs or terminating the Grant Contract.(f) In no event shall Grant Award funds for a Project Year be advanced or reimbursed, as may be appropriate for the Grant Award and specified in the Grant Contract, until the certification required by subsection (a) of this section is filed and approved by the Institute.(g) No later than thirty (30) days following the due date of the FSR reflecting expenses incurred during the last quarter of the Grant Recipient's Project Year, the Grant Recipient shall file a form with the Institute reporting the amount of Matching Funds spent for the preceding Project Year.(1) The Grant Recipient must provide all documentation, including proof of payment, showing that the Grant Recipient expended the required amount of Matching Funds on the CPRIT project for the preceding Project Year. The Institute will accept a general ledger from public or private institutions of higher education as proof of payment.(2) The Institute will not review or approve the Grant Recipient's Matching Funds form until the Grant Recipient submits the form and all required documentation.(h) If the Grant Recipient failed to expend Matching Funds equal to one-half of the actual amount of Grant Award funds distributed to the Grant Recipient for the same Project Year the Institute shall:(1) Carry forward and add to the Matching Fund requirement for the next Project Year the dollar amount equal to the deficiency between the actual amount of Grant Award funds distributed and the actual Matching Funds expended, so long as the deficiency is equal to or less than twenty percent (20%) of the total Matching Funds required for the same period and the Grant Recipient has not previously had a Matching Funds deficiency for the project;(2) Suspend distributing Grant Award funds for the project to the Grant Recipient if the deficiency between the actual amount of Grant Funds distributed and the Matching Funds expended is greater than twenty percent (20%) but less than fifty percent (50%) of the total Matching Funds required for the period;(A) The Grant Recipient will have no less than eight months from the anniversary of the Grant Contract's effective date to demonstrate that it has expended Encumbered Funds sufficient to fulfill the Matching Funds deficiency for the project.(B) If the Grant Recipient fails to fulfill the Matching Funds deficiency within the specified period, then the Grant Contract shall be considered in default and the Institute may proceed with terminating the Grant Award pursuant to the process established in the Grant Contract.(3) Declare the Grant Contract in default if the deficiency between the actual amount of Grant Award funds distributed and the Matching Funds expended is greater than fifty percent (50%) of the total Matching Funds required for the period. The Institute may proceed with terminating the Grant Award pursuant to the process established in the Grant Contract; or(4) Take appropriate action, including withholding reimbursement, requiring repayment of the deficiency, or terminating the Grant Contract if a deficiency exists between the actual amount of Grant Award funds distributed and the Matching Funds expended and it is the last year of the Grant Contract.(i) Nothing herein shall preclude the Institute from taking action other than described in subsection (h) of this section based upon the specific reasons for the deficiency. To the extent that other action not described herein is taken by the Institute, such action shall be documented in writing and included in Grant Contract records. The options described in subsection (h)(1) and (2) of this section may be used by the Grant Recipient only one time for the particular project. A second deficiency of any amount shall be considered an event of default and the Institute may proceed with terminating the Grant Award pursuant to the process established in the Grant Contract.(j) The Grant Recipient shall maintain adequate documentation supporting the source and use of the Matching Funds reported in the certification required by subsection (a) of this section. The Institute shall conduct an annual review of the documentation supporting the source and use of Matching Funds reported in the required certification for a risk-identified sample of Grant Recipients. Based upon the results of the sample, the Institute may elect to expand the review of supporting documentation to other Grant Recipients. Nothing herein restricts the authority of the Institute to review supporting documentation for one or more Grant Recipients or to conduct a review of Matching Funds documentation more frequently.(k) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection. Source Note: The provisions of this §703.11 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective December 10, 2014, 39 TexReg 9565; amended to be effective March 11, 2015, 40 TexReg 1092; amended to be effective June 10, 2015, 40 TexReg 3569; amended to be effective March 9, 2016, 41 TexReg 1694; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 8, 2017, 42 TexReg 2937; amended to be effective September 13, 2018, 43 TexReg5807;amended to be effective December 18, 2018, 43 TexReg 8123; amended to be effective June 10, 2020, 45 TexReg 3773; amended to be effective December 8, 2022, 47 TexReg 8042. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.11 Requirement to Demonstrate Available Funds for Cancer Research Grants https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181391&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181391 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181391&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181391 03/11/2026 (a) A Grant Recipient may use Grant Award funds only for Cancer Research and Cancer Prevention projects consistent with the purpose of the Act, and in accordance with the Grant Contract. Grant Award funds may not be used for purposes other than those purposes for which the grant was awarded. The Institute may require a Grant Recipient to repay Grant Award funds if the Grant Recipient fails to expend the Grant Award funds in accordance with the terms and conditions of the Grant Contract and the provisions of this chapter.(b) A Grant Recipient of Grant Award funds for a Cancer Research or Cancer Prevention project may not spend more than five percent (5%) of the Grant Award funds for Indirect Costs.(c) The Institute may not award more than five percent (5%) of the total Grant Award funds for each fiscal year to be used for facility purchase, construction, remodel, or renovation purposes during any year. Any Grant Award funds that are to be expended by a Grant Recipient for facility purchase, construction, remodel, or renovations are subject to the following conditions:(1) The use of Grant Award funds must be specifically approved by the Chief Executive Officer with notification to the Oversight Committee;(2) Grant Award funds spent on facility purchase, construction, remodel, or renovation projects must benefit Cancer Prevention and Research;(3) If Grant Award funds are used to build a capital improvement, then the state retains a lien or other interest in the capital improvement in proportion to the percentage of the Grant Award funds used to pay for the capital improvement. If the capital improvement is sold, then the Grant Recipient agrees to repay to the state the Grant Award funds used to pay for the capital improvement, with interest, and share with the state a proportionate amount of any profit realized from the sale.(d) The Institute may not award more than ten percent (10%) of the money awarded from the Cancer Prevention and Research Fund or from the proceeds of bonds issued on behalf of the Institute to be used for Cancer Prevention and Control programs during any year. Grant Awards for Cancer Prevention research projects shall not be counted toward the Grant Award amount limit for Cancer Prevention and Control Programs. For purposes of this subsection, the Institute is presumed to award the full amount of funds available. At the first regular Oversight Committee meeting of the fiscal year, the Chief Executive Officer shall report that full amount of Grant Award funds available to be awarded for the fiscal year subject to periodic updates announced at regular meetings of the Oversight Committee. Source Note: The provisions of this §703.12 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective December 9, 2015, 40 TexReg 8793; amended to be effective March 9, 2016, 41 TexReg 1694; amended to be effective June 12, 2016, 41 TexReg 4027; amended to be effective December 7, 2016, 41 TexReg 9527. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.12 Limitation on Use of Funds https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224397&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224397 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224397&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224397 03/11/2026 (a) Upon request and with reasonable notice, an entity receiving Grant Award funds directly under the Grant Contract or indirectly through a subcontract under the Grant Contract shall allow, or shall cause the entity that is maintaining such items to allow the Institute, or auditors or investigators working on behalf of the Institute, including the State Auditor and/or the Comptroller of Public Accounts for the State of Texas, to review, inspect, audit, copy or abstract its records pertaining to the specific Grant Contract during the term of the Grant Contract and for the three year period following the date the last disbursement of funds is made by the Institute or all reports required pursuant to the Grant Contract are submitted and approved, whichever date is later.(1) A Grant Recipient shall maintain its records pertaining to the specific Grant Contract for a period of three years following the date the last disbursement of funds is made by the Institute or all reports required pursuant to the Grant Contract are submitted and approved, whichever date is later.(2) The Grant Recipient may maintain its records in either electronic or paper format.(b) Notwithstanding the foregoing, the Grant Recipient shall submit a single audit determination form no later than 60 days following the close of the Grant Recipient's fiscal year. The Grant Recipient shall report whether the Grant Recipient has expended $1 million or more in state awards during the Grant Recipient's fiscal year. If the Grant Recipient has expended $1 million or more in state awards in its fiscal year, the Grant Recipient shall obtain either an annual single independent audit, a program specific independent audit, or an agreed upon procedures engagement as defined by the American Institute of Certified Public Accountants and pursuant to guidance provided in subsection (e) of this section.(1) The audited time period is the Grant Recipient's fiscal year.(2) The audit must be submitted to the Institute within thirty (30) days of receipt by the Grant Recipient but no later than nine (9) months following the close of the Grant Recipient's fiscal year and shall include a corrective action plan that addresses any weaknesses, deficiencies, wrongdoings, or other concerns raised by the audit report and a summary of the action taken by the Grant Recipient to address the concerns, if any, raised by the audit report.(A) The Grant Recipient may seek additional time to submit the required audit and corrective action plan by providing a written explanation for its failure to timely comply and providing an expected time for the submission.(B) The Grant Recipient's request for additional time must be submitted on or before the due date of the required audit and corrective action plan. For purposes of this rule, the "due date of the required audit" is no later than nine (9) months following the close of the Grant Recipient's fiscal year.(C) Approval of the Grant Recipient's request for additional time is at the discretion of the Institute. Such approval must be granted by the Chief Executive Officer.(c) No reimbursements or advances of Grant Award funds shall be made to the Grant Recipient if the Grant Recipient is delinquent in filing the required audit and corrective action plan. A Grant Recipient that has received approval from the Institute for additional time to file the required audit and corrective action plan may receive reimbursements or advances of Grant Award funds during the pendency of the delinquency unless the Institute's approval declines to permit reimbursements or advances of Grant Award funds until the delinquency is addressed.(d) A Grant Recipient that is delinquent in submitting to the Institute the audit and corrective action plan required by this section is not eligible to be awarded a new Grant Award or a continuation Grant Award until the required audit and corrective action plan are submitted. A Grant Recipient that has received approval from the Institute for additional time to file the required audit and corrective action plan may remain eligible to be awarded a new Grant Award or a continuation Grant Award unless the Institute's approval declines to continue eligibility during the pendency of the delinquency.(e) For purposes of this rule, an agreed upon procedures engagement is one in which an independent certified public accountant is hired by the Grant Recipient to issue a report of findings based on specific procedures to be performed on a subject matter.(1) The option to perform an agreed upon procedures engagement is intended for a non-profit or for-profit Grant Recipient that is not subject to Generally Accepted Government Audit Standards (also known as the Yellow Book) published by the U.S. Government Accountability Office.(2) The agreed upon procedures engagement will be conducted in accordance with attestation standards established by the American Institute of Certified Public Accountants.(3) The certified public accountant is to perform procedures prescribed by the Institute and to report his or her findings attesting to whether the Grant Recipient records are in agreement with stated criteria.(4) The agreed upon procedures apply to all current year expenditures for Grant Awards received by the Grant Recipient. Nothing herein prohibits the use of a statistical sample consistent with the American Institute of Certified Public Accountants' guidance regarding government auditing standards and 2 CFR Part 200, Subpart F, "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards."(5) At a minimum, the agreed upon procedures report should address:(A) Processes and controls;(B) The Grant Contract;(C) Indirect Costs;(D) Matching Funds, if appropriate;(E) Grant Award expenditures (payroll and non-payroll related transactions);(F) Equipment;(G) Revenue Sharing and Program Income;(H) Reporting; and(I) Grant Award closeout.(6) The certified public accountant should consider the specific Grant Mechanism and update or modify the procedures accordingly to meet the requirements of each Grant Award and the Grant Contract reviewed.(f) For purposes of this rule, a program specific audit should address:(1) Sample of awards;(2) Reporting;(3) Indirect costs;(4) Matching funds, if appropriate;(5) Expenditures;(6) Expenditure Reporting;(7) Personnel Level of Effort Reporting;(8) Grant Closeout;(9) Performance Measures;(10) Publications and Acknowledgements;(11) Title to equipment;(12) Contract certifications;(13) Changes in Principal Investigator or Program Director; (14) Intellectual Property and revenue sharing;(15) Early termination and event of default; and(16) Any other issue identified by the Institute, the Grant Recipient, or the person performing the program specific audit.(g) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection. Source Note: The provisions of this §703.13 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective December 10, 2014, 39 TexReg 9565; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective March 8, 2017, 42 TexReg 1029; amended to be effective December 21, 2017, 42 TexReg 7167; amended to be effective June 7, 2018, 43 TexReg 3595; amended to be effective December 18, 2018, 43 TexReg 8123; amended to be effective March 14, 2019, 44 TexReg 1346; amended to be effective June 5, 2019, 44TexReg 2723; amended to be effective March 12, 2025, 50 TexReg 1824. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.13 Audits and Investigations https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197286&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197286 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=197286&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 197286 03/11/2026 (a) The termination date of a Grant Contract shall be the date stated in the Grant Contract, except:(1) The Chief Executive Officer may elect to terminate the Grant Contract earlier because the Grant Recipient has failed to fulfill contractual obligations, including timely submission of required reports or certifications;(2) The Institute terminates the Grant Contract because funds allocated to the Grant Award are reduced, depleted, or unavailable during the award period, and the Institute is unable to obtain additional funds for such purposes; or(3) The Institute and the Grant Recipient mutually agree to terminate the Grant Contract earlier.(b) If the Institute elects to terminate the Grant Contract pursuant to subsection (a)(1) or (2) of this section, then the Chief Executive Officer shall notify the Grant Recipient in writing of the intent to terminate funding at least thirty (30) days before the intended termination date. The notice shall state the reasons for termination, and the procedure and time period for seeking reconsideration of the decision to terminate. Nothing herein restricts the Institute's ability to terminate the Grant Contract immediately or to seek additional remedies if justified by the circumstances of the event leading to early termination.(c) The Institute may approve the Grant Recipient's written request to extend the termination date of the Grant Contract to permit the Grant Recipient additional time to complete the work of the project.(1) A no cost extension may be granted if the Grant Recipient is in good fiscal and programmatic standing.(A) If a Grant Recipient is not in good fiscal and programmatic standing, the Grant Recipient may petition the Chief Executive Officer in writing to consider the no cost extension. The Grant Recipient's petition must show good cause for failing to be in good fiscal and programmatic standing.(B) Upon a finding of good cause, the Chief Executive Officer may consider the request. If a no cost extension is approved under this subsection, the Chief Executive Officer must notify the Oversight Committee in writing and provide justification for the approval.(2) The Grant Recipient may request a no cost extension no earlier than 180 days and no later than thirty (30) days prior to the termination date of the Grant Contract.(A) If a Grant Recipient fails to request a no cost extension within the required timeframe, the Grant Recipient may petition the Chief Executive Officer in writing to consider the no cost extension. The Grant Recipient's petition must show good cause for failing to submit the request within the timeframe specified in subsection (c) of this section.(B) Upon a finding of good cause, the Chief Executive Officer may consider the request. If a no cost extension request is approved under this subsection, the Chief Executive Officer must notify the Oversight Committee in writing and provide justification for the approval.(3) The Institute may approve one or more no cost extensions. The duration of each no cost extension may be no longer than six months from the termination date of the Grant Contract, unless the Institute finds that special circumstances justify authorizing additional time to complete the work of the project. If a grant recipient requests a second no cost extension or requests a no cost extension greater than six months, the grantee must provide good cause for approving the request.(4) If the Institute approves the request to extend the termination date of the Grant Contract, then the termination date shall be amended to reflect the change.(5) Nothing herein prohibits the Institute and the Grant Recipient from taking action more than 180 days prior to the termination date of the Grant contract to extend the termination date of the Grant Contract. Approval of an extension must be supported by a finding of good cause and the Grant Contract shall be amended to reflect the change.(6) The Institute's decision to approve or deny a no cost extension request is final.(d) The Grant Recipient must submit a final Financial Status Report and final Grant Progress Report as well as any other required reports as specified in the Grant Contract. For purposes of this rule, the final Grant Progress Report and other required reports shall be collectively referred to as "close out documents."(1) The final Financial Status Report shall be submitted to the Institute within ninety (90) days of the end of the state fiscal quarter that includes the termination date of the Grant Contract. The Grant Recipient's failure to submit the Financial Status report within thirty (30) days following the due date specified in this subsection will waive reimbursement of project costs incurred during the reporting period. The Institute may approve additional time to submit the final Financial Status Report if the Grant Recipient can show good cause for failing to timely submit the final Financial Status Report.(2) Close out documents must be submitted within ninety (90) days of the termination date of the Grant Contract. The final reimbursement payment shall not be made until all close out documents have been submitted and approved by the Institute. Failure to submit one or more close out documents within 180 days of the Grant Contract termination date shall result in the Grant Recipient being ineligible to receive new Grant Awards or continuation Grant Awards until such time that the close out documents are submitted unless the Institute waives the final submission of close out documents by the Grant Recipient.(A) Approval of the Grant Recipient's request to waive the submission of close out documents is at the discretion of the Institute. Such approval must be granted by the Chief Executive Officer.(B) The Oversight Committee shall be notified in writing of the Grant Recipient's waiver request and the Chief Executive Officer's decision to approve or reject the waiver request.(C) Unless the Oversight Committee votes by a simple majority of members present and able to vote to overturn the Chief Executive Officer's decision regarding the waiver, the Chief Executive Officer's decision shall be considered final.(e) The Institute may make upward or downward adjustments to the Allowable Costs requested by the Grant Recipient within ninety (90) days following the approval of the close out reports or the final Financial Status Report, whichever is later.(f) Nothing herein shall affect the Institute's right to disallow costs and recover Grant Award funds on the basis of a later audit or other review or the Grant Recipient's obligation to return Grant Award funds owed as a result of a later refund, correction, or other transaction.(g) Any Grant Award funds paid to the Grant Recipient in excess of the amount to which the Grant Recipient is finally determined to be entitled under the terms of the Grant Contract constitute a debt to the state. If not paid within a reasonable period after demand, the Institute may reduce the debt owed by:(1) Making an administrative offset against other requests for reimbursements;(2) Withholding advance payments otherwise due to the Grant Recipient; or(3) Other action permitted by law.(h) Grant Award funds approved by the Oversight Committee and specified in the Grant Contract but not spent by the Grant Recipient at the time that the Grant Contract is terminated are considered de-obligated for the purposes of calculating the maximum amount of annual Grant Awards and the total amount authorized by Section 67, Article III, Texas Constitution. Such de-obligated funds are available for all purposes authorized by the statute.(i) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection. Source Note: The provisions of this §703.14 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective March 9, 2016, 41 TexReg 1694; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective December 18, 2018, 43 TexReg 8123; amended to be effective September 11, 2019, 44 TexReg 4873; amended to be effective December 11, 2019, 44 TexReg 7549. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.14 Termination, Extension, Close Out of Grant Contracts, and De-Obligation of Grant Award Funds https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211231&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211231 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211231&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211231 03/11/2026 (a) The Grant Recipient is responsible for managing the day-to-day operations of the activities supported by the Grant Award and is accountable to Institute for the performance of the Grant Award, including the appropriate expenditure of Grant Award funds by all parties and all other obligations of the Grant Recipient.(b) The Grant Recipient must maintain a sound financial management system that provides appropriate fiscal controls and accounting procedures to ensure accurate preparation of reports by the Grant Contract and adequate identification of the source and application of Grant Award funds.(1) The Grant Recipient may use its established controls and policies, as long as the controls and policies are consistent with requirements described in the Institute's administrative rules, the Grant Contract, and other applicable standards.(2) The Grant Recipient's system of internal controls should encompass segregation of functions, proper authorization of transactions, proper recording of transactions, limited access to assets, and monitoring of internal controls. The extent to which internal controls are established is dependent upon the nature and size of the organization involved.(3) The Grant Recipient's accounting system must conform to Generally Accepted Accounting Principles applicable to state and federal grant funds and conform to the standards for financial management set forth in the Texas Grant Management Standards (TxGMS).(4) The Institute may review the adequacy of the financial management system of any Grant Recipient to ensure that the system is appropriate to fulfill the Institute's administrative rules, the Grant Contract, and other applicable standards.(c) The Grant Recipient shall use cash basis accounting when reporting expenses to be reimbursed with Grant Award funds.(1) A Grant Recipient utilizing an accrual basis of accounting in its normal operations must present expenses on a cash basis and reflect actual costs incurred during the payment period.(2) A subcontractor is not required to record the adjustment in the general ledger; the adjustment should be documented by memo entries along with a reconciliation of the expense reported to the Institute and the expense recorded to the general ledger. Source Note: The provisions of this §703.15 adopted to be effective December 21, 2009, 34 TexReg 9213; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective December 8, 2022, 47 TexReg 8042. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.15 Financial Policies Applicable to Grant Awards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181395&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181395 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=181395&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 181395 03/11/2026 (a) To the extent that there is a conflict between this chapter and the Grant Contract between the Institute and the Grant Recipient, the Grant Contract terms will control.(b) The Grant Recipient may retain, assign or transfer all or a portion of any of the Intellectual Property Rights relating to the project results. Any such assignment or transfer to a third party is subject to the following requirements:(1) The Grant Recipient shall notify the Institute of the proposed transfer or assignment;(2) The Grant Recipient shall ensure that the assignment or transfer is subject to the licenses, interests and other rights provided to the Institute pursuant to the Grant Contract and any applicable law or regulation; and(3) Unless the transfer is taking place pursuant to an exercise of the United States government's rights under 35 U.S.C. §203, the Institute may provide comments to the Grant Recipient related to the proposed transfer or assignment of rights, which the Grant Recipient shall consider in good faith and use reasonable efforts to account for and incorporate such comments into the actual transfer or assignment of such rights.(c) Unless specifically authorized by the Institute, Grant Award proceeds shall not be used to pay the costs or expenses associated with the efforts to protect the Intellectual Property Rights.(d) As a condition of accepting Grant Award funding from the Institute, the Grant Recipient agrees to the following required commitments as defined in the Grant Contract with regard to any project results:(1) To use commercially reasonable efforts to protect, develop, commercialize, or otherwise bring Project Results to practical application to the fullest extent feasible as determined by the Grant Recipient. The Grant Recipient is relieved of its obligations pursuant to this section so long as the Grant Recipient complies with paragraph (3) of this subsection and §703.19 of this chapter (relating to Opt-Out and Default).(2) To share with the Institute a portion of the benefit derived from the commercial development of the Project Results, as set forth in the Grant Contract.(3) To notify the Institute in writing prior to declining to pursue, abandoning, waiving or disclaiming some or all Intellectual Property Rights related to the Project Results. Such notification shall be made with sufficient time to provide the Institute an opportunity to license or pursue the appropriate applications and other protections for such Intellectual Property Rights to the fullest extent permitted by law.(4) To keep the Institute promptly and reasonably informed regarding the activities undertaken by the Grant Recipient to protect and/or commercialize the Project Results and to consider in good faith Institute input, if any, regarding same. Such activities may include, but are not limited to, the following:(A) Filing of an invention disclosure forms (including updates and revisions);(B) Creation of commercial development plans;(C) Application, issuance, prosecution and maintenance of patents; and(D) Negotiation of final term sheets and License Agreements.(5) To allow access to the books and records of the Grant Recipient for the purpose of conducting an audit during normal business hours with reasonable notice to verify amounts paid to the Institute pursuant to this chapter. Notwithstanding the time limitation provided in §703.13 of this chapter (relating to Audits and Investigations), the right to audit the books and records of the Grant Recipient to verify amounts required to be paid to the Institute shall continue for so long as the payments shall be made. Source Note: The provisions of this §703.16 adopted to be effective August 1, 2010, 35 TexReg 6656; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective December 7, 2016, 41 TexReg 9527. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.16 Intellectual Property Agreement https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=209176&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 209176 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=209176&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 209176 03/11/2026 (a) The Institute shall share in the financial benefit received by the Grant Recipient resulting from the patents, royalties, assignments, sales, conveyances, licenses and/or other benefits associated with the Project Results, including interest or proceeds resulting from securities and equity ownership. Such payment may include royalties, income, milestone payments, or other financial interest in an existing company or other entity.(b) The Institute's election as to form of payment and the calculation of such payment shall be specified in the Grant Contract.(c) Unless otherwise provided by the Grant Contract between the Institute and the Grant Recipient, payments to the Institute required by this section shall be made no less than annually pursuant to a schedule set forth in the Grant Contract and shall be accompanied by an appropriate financial statement supporting the calculation of the payment.(d) Nothing herein shall affect or otherwise impair the application of federal laws for projects receiving some portion of funding from the U.S. Government.(e) Unless the Grant Contract specifically states otherwise, the obligation to share revenues with the Institute is continuous so long as the product resulting from the Institute supported project enjoys government exclusivity.(f) If the Institute elects to take equity ownership in a Grant Recipient, the Grant Contract shall specify:(1) Any additional requirements associated with the equity ownership, including a specified schedule for the Grant Recipient to certify and verify the Grant Recipient's Matching Funds obligation.(2) The Grant Contract shall also specify the Institute's recourse in the event that the Grant Recipient fails to fulfill reporting requirement deadlines. Source Note: The provisions of this §703.17 adopted to be effective August 1, 2010, 35 TexReg 6656; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 9, 2022, 47 TexReg 3266. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.17 Revenue Sharing Standards https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166323&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166323 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166323&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166323 03/11/2026 (a) The Grant Recipient bears the responsibility for licensing activities including identification of potential licensees, negotiation of License Agreements, documentation of the progress and development under a License Agreement, monitoring the performance of the licensee, and taking commercially reasonable actions to enforce the terms of the License Agreements.(b) Each License Agreement for Project Results entered into by the Grant Recipient shall include an acknowledgement by the licensee that such License Agreement is subject to the Institute's licenses, interests and other rights, if any.(c) Nothing herein prohibits the Grant Recipient from negotiating an exclusive License Agreement for Project Results if exclusivity is reasonably believed by the Grant Recipient to provide an economic incentive necessary for achieving commercial development and availability of the Project Results. The Grant Recipient shall take reasonable action to enforce the terms of the exclusive license and report any default notice to the Institute.(d) A not-for-profit Grant Recipient negotiating exclusive or non-exclusive License Agreements shall seek to retain the right to exploit the use of its Project Results and utilize the same for its non-commercial purposes. Source Note: The provisions of this §703.18 adopted to be effective August 1, 2010, 35 TexReg 6656; amended to be effective March 2, 2014, 39 TexReg 1386. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.18 Licensing and Assignment of Intellectual Property Rights https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166324&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166324 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=166324&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 166324 03/11/2026 (a) The Institute shall have the option, but not the obligation, to pursue protection of the applicable Intellectual Property Rights and/or to commercialize or otherwise bring to practical application the applicable Project Results either directly or through one or more licensees, in the event of the following:(1) Upon receipt of Grant Recipient's notice of its election to abandon, waive or disclaim any Intellectual Property Rights or to cease its efforts to commercialize or otherwise bring to practical application any particular Project Results; or(2) Grant Recipient's failure to materially comply with its obligations to protect the Intellectual Property Rights or to use diligent and commercially reasonable efforts to commercialize or otherwise bring to practical application the Project Results in accordance with the Grant Recipient's commercial development plan(s), and Grant Recipient fails to cure such non-compliance within a reasonable period of time following written notice from the Institute specifically describing the events of non-compliance.(b) If the Institute elects to exercise its options pursuant to this section, it shall notify the Grant Recipient in writing of such election. Upon receipt of notification, the Grant Recipient shall:(1) Fully cooperate with the Institute's efforts to protect, commercialize or otherwise bring to practical application the applicable Project Results at the Institute's cost, including but not limited to the transfer to the Institute or the Institute's designee of the Grant Recipient's rights, title and interest in and to the applicable Project Results, to the maximum extent allowed by law;(2) Not take any action that would materially impede the Institute's ability to protect, commercialize or otherwise bring to practical application the applicable Project Results.(c) If the Institute exercises its option under this section, the Grant Recipient shall have no further claim to or interest in to the applicable Project Results and shall not be entitled to any share of the revenue or other compensation with respect to such Project Results, except to the minimum extent required by law, if any.(d) The Institute's exercise of rights pursuant to this section is subject to any applicable rights of the United States government. Source Note: The provisions of this §703.19 adopted to be effective August 1, 2010, 35 TexReg 6656; amended to be effective March 2, 2014, 39 TexReg 1386. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.19 Opt-Out and Default https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=176784&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 176784 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=176784&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 176784 03/11/2026 To be eligible to receive a Grant Award, a Grant Recipient shall certify that the entity has adopted and enforces a Tobacco-free workplace policy.(1) A Tobacco-free workplace policy will comply with the certification required by this section if the policy is adopted by the Grant Recipient's board of directors, governing body, or similar and, at a minimum, includes provisions:(A) Prohibiting the use of all Tobacco products by all employees and visitors to the property owned, operated, leased, occupied, or controlled by the Grant Recipient. For purposes of the Tobacco-free workplace policy, the Grant Recipient may designate the property to which the policy applies, so long as the workplace policy encompasses all buildings and structures where the Grant Award project is taking place as well as the sidewalks, parking lots, walkways, and attached parking structures immediately adjacent, but only to the extent the Grant Recipient owns, leases or controls the building, sidewalks, parking lots and parking structures.(B) Providing for and/or referring to Tobacco use cessation services for employees.(2) Upon request by a Grant Recipient and a showing of good cause, the Chief Executive Officer may authorize a waiver of compliance with this section. In the event that the requested waiver is necessary because Tobacco use is a required component of one or more research studies conducted at the entity, the Grant Recipient must specify the research project and location of the project. If approved, the waiver is effective only for the State fiscal year during which it was approved. CPRIT reserves the right to limit the waiver to a specific location or time period.(3) The certification and waiver requests addressed herein shall be submitted by the Grant Recipient via the Institute's electronic Grant Management System. Source Note: The provisions of this §703.20 adopted to be effective February 8, 2012, 37 TexReg 498; amended to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective March 9, 2016, 41 TexReg 1694. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.20 Certification of Tobacco-Free Policy for Grant Recipients https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218581&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218581 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218581&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218581 03/11/2026 (a) The Institute, under the direction of the Chief Compliance Officer, shall monitor Grant Awards to ensure that Grant Recipients comply with applicable financial, administrative, and programmatic terms and conditions and exercise proper stewardship over Grant Award funds. Such terms and conditions include requirements set forth in statute, administrative rules, and the Grant Contract.(b) Methods used by the Institute to monitor a Grant Recipient's performance and expenditures may include:(1) Financial Status Reports Review--The Institute shall review Grant Award expenditures reported by Grant Recipients on the quarterly Financial Status Reports and supporting documents to determine whether expenses charged to the Grant Award are:(A) Allowable, allocable, reasonable, necessary, and consistently applied regardless of the source of funds; and(B) Adequately supported with documentation such as cost reports, receipts, third party invoices for expenses, or payroll information.(2) Timely submission of Grant Award Reports--The Institute shall monitor the submission of all required reports and implement a process to ensure that Grant Award funds are not disbursed to a Grant Recipient with one or more delinquent reports.(3) Grant Progress Reports--The Institute shall review Grant Progress Reports to determine whether sufficient progress is made consistent with the Scope of Work set forth in the Grant Contract.(A) The Grant Progress Reports shall be submitted at least annually but may be required more frequently pursuant to Grant Contract terms or upon request and reasonable notice of the Institute.(B) Unless specifically stated otherwise herein, the annual Grant Progress Report shall be submitted within sixty (60) days after the anniversary of the effective date of the Grant Contract. The annual Grant Progress Report shall include at least the following information:(i) An affirmative verification by the Grant Recipient of compliance with the terms and conditions of the Grant Contract;(ii) A description of the Grant Recipient's progress made toward completing the Scope of Work specified by the Grant Contract, including information, data, and program metrics regarding the achievement of the Scope of Work;(iii) The number of new jobs created and the number of jobs maintained for the preceding twelve-month period as a result of Grant Award funds awarded to the Grant Recipient for the project;(iv) An inventory of the equipment purchased for the project in the preceding twelve-month period using Grant Award funds;(v) A verification of the Grant Recipient's efforts to purchase from suppliers in this state more than 50 percent goods and services purchased for the project with grant funds;(vi) A Historically Underutilized Businesses report;(vii) Scholarly articles, presentations, and educational materials produced for the public addressing the project funded by the Institute;(viii) The number of patents applied for or issued addressing discoveries resulting from the research project funded by the Institute;(ix) A statement of the identities of the funding sources, including amounts and dates for all funding sources supporting the project;(x) A verification of the amounts of Matching Funds dedicated to the research that is the subject of the Grant Award for the period covered by the annual report, which shall be submitted pursuant to the timeline in §703.11 of this title (relating to Requirement to Demonstrate Available Funds for Cancer Research Grants). In order to receive disbursement of grant funds, the most recently due verification of the amount of Matching Funds must be approved by CPRIT;(xi) All financial information necessary to support the calculation of the Institute's share of revenues, if any, received by the Grant Recipient resulting from the project; and(xii) A single audit determination form, which shall be submitted pursuant to the timeline in §703.13 of this title (relating to Audits and Investigations).(C) Notwithstanding subparagraph (B) of this paragraph, in the event that the Grant Recipient and Institute execute the Grant Contract after the effective date of the Grant Contract, the Chief Program Officer may approve additional time for the Grant Recipient to prepare and submit the outstanding reports. The approval shall be in writing and maintained in the Institute's electronic Grants Management System. The Chief Program Officer's approval may cover more than one report and more than one fiscal quarter.(D) In addition to annual Grant Progress Reports, a final Grant Progress Report shall be filed no more than ninety (90) days after the termination date of the Grant Contract. The final Grant Progress Report shall include a comprehensive description of the Grant Recipient's progress made toward completing the Scope of Work specified by the Grant Contract, as well as other information specified by the Institute.(E) The Grant Progress Report will be evaluated pursuant to criteria established by the Institute. The evaluation shall be conducted under the direction of the Chief Prevention Officer, the Chief Product Development Officer, or the Chief Scientific Officer, as may be appropriate. Required financial reports associated with the Grant Progress Report will be reviewed by the Institute's financial staff. In order to receive disbursement of grant funds, the final progress report must be approved by CPRIT.(F) If the Grant Progress Report evaluation indicates that the Grant Recipient has not demonstrated progress in accordance with the Grant Contract, then the Chief Program Officer shall notify the Chief Executive Officer and the General Counsel for further action.(i) The Chief Program Officer shall submit written recommendations to the Chief Executive Officer and General Counsel for actions to be taken, if any, to address the issue.(ii) The recommended action may include termination of the Grant Award pursuant to the process described in §703.14 of this chapter (relating to Termination, Extension, and Close Out of Grant Contracts, and De-Obligation of Grant Award Funds).(G) If the Grant Recipient fails to submit required financial reports associated with the Grant Progress Report, then the Institute financial staff shall notify the Chief Executive Officer and the General Counsel for further action.(H) In order to receive disbursement of grant funds, the most recently due progress report must be approved by CPRIT.(I) If a Grant Recipient fails to submit the Grant Progress Report within 60 days of the anniversary of the effective date of the Grant Contract, then the Institute shall not disburse any Grant Award funds as reimbursement or advancement of Grant Award funds until such time that the delinquent Grant Progress Report is approved.(J) In addition to annual Grant Progress Reports, Product Development Grant Recipients shall submit a Grant Progress Report at the completion of specific Tranches of funding specified in the Award Contract. For the purpose of this subsection, a Grant Progress Report submitted at the completion of a Tranche of funding shall be known as "Tranche Grant Progress Report."(i) The Institute may specify other required reports, if any, that are required to be submitted at the time of the Tranche Grant Progress Report.(ii) Grant Funds for the next Tranche of funding specified in the Grant Contract shall not be disbursed until the Tranche Grant Progress Report has been reviewed and approved pursuant to the process described in this section.(K) A Grant Award in the prevention program with a Grant Contract effective date within the last quarter of a state fiscal year (June 1-August 31) will have an initial reporting period beginning September 1 of the following state fiscal year.(4) Desk Reviews--The Institute may conduct a desk review for a Grant Award to review and compare individual source documentation and materials to summary data provided during the Financial Status Report review for compliance with financial requirements set forth in the statute, administrative rules, and the Grant Contract.(5) Site Visits and Inspection Reviews--The Institute may conduct a scheduled site visit to a Grant Recipient's place of business to review Grant Contract compliance and Grant Award performance issues. Such site visits may be comprehensive or limited in scope.(6) Audit Reports--The Institute shall review audit reports submitted pursuant to §703.13 of this chapter (relating to Audits and Investigations).(A) If the audit report findings indicate action to be taken related to the Grant Award funds expended by the Grant Recipient or for the Grant Recipient's fiscal processes that may impact Grant Award expenditures, the Institute and the Grant Recipient shall develop a written plan and timeline to address identified deficiencies, including any necessary Grant Contract amendments.(B) The written plan shall be retained by the Institute as part of the Grant Contract record.(c) All required Grant Recipient reports and submissions described in this section shall be made via an electronic grant portal designated by the Institute, unless specifically directed to the contrary in writing by the Institute.(d) The Institute shall document the actions taken to monitor Grant Award performance and expenditures, including the review, approvals, and necessary remedial steps, if any.(1) To the extent that the methods described in subsection (b) of this section are applied to a sample of the Grant Recipients or Grant Awards, then the Institute shall document the Grant Contracts reviewed and the selection criteria for the sample reviewed.(2) Records will be maintained in the electronic Grant Management System as described in §703.4 of this chapter (relating to Grants Management System).(e) The Chief Compliance Officer shall be engaged in the Institute's Grant Award monitoring activities and shall notify the General Counsel and Oversight Committee if a Grant Recipient fails to meaningfully comply with the Grant Contract reporting requirements and deadlines, including Matching Funds requirements.(f) The Chief Executive Officer shall report to the Oversight Committee at least annually on the progress and continued merit of each Grant Program funded by the Institute. The written report shall also be included in the Annual Public Report. The report should be presented to the Oversight Committee at the first meeting following the publication of the Annual Public Report.(g) The Institute may rely upon third parties to conduct Grant Award monitoring services independently or in conjunction with Institute staff.(h) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection. Source Note: The provisions of this §703.21 adopted to be effective March 2, 2014, 39 TexReg 1386; amended to be effective September 17, 2014, 39 TexReg 7342; amended to be effective March 9, 2016, 41 TexReg 1694; amended to be effective June 12, 2016, 41 TexReg 4027; amended to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 7, 2018, 43 TexReg 3595; amended to be effective December 18, 2018, 43 TexReg 8123; amended to be effective March 14, 2019, 44 TexReg 1346; amended to be effective September 7, 2023, 48 TexReg 4863; amended to be effective June 9, 2024, 49 TexReg 3926. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.21 Monitoring Grant Award Performance and Expenditures https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194424&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194424 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=194424&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 194424 03/11/2026 (a) The Institute, under the direction of the Chief Compliance Officer, shall create a compliance training program for Grant Recipients addressing applicable financial, administrative, and programmatic requirements related to proper stewardship over Grant Award funds, including grant reporting.(b) Initial Grant Recipient training program - A Grant Recipient that is approved for a Grant Award for the first time on or after September 1, 2015, shall complete an initial compliance training program. For purposes of this subsection, a Grant Recipient that has received at least one Grant Award prior to September 1, 2015, is not required to complete the initial compliance training program.(1) The Chief Compliance Officer shall design the initial compliance training program.(2) The Grant Recipient must complete the initial compliance training program prior to receiving disbursement of Grant Award funds, unless the Chief Compliance Officer finds good cause to disburse grant funds in advance of completing the initial compliance training program.(3) Nothing herein prohibits the Chief Compliance Officer from requiring a Grant Recipient to complete the initial compliance training program.(c) Annual Grant Recipient training program - All Grant Recipients shall complete an annual compliance training program by November 1, 2016, and then by December 31 of each year thereafter that the Grant Recipient has at least one active Grant Award.(1) The Chief Compliance Officer shall design the annual compliance training program.(2) The Institute shall withhold disbursement of Grant Award funds if the Grant Recipient fails to complete the annual compliance training program by November 1, unless the Chief Compliance Officer finds good cause to disburse grant funds in advance of completing the annual compliance training program.(d) Grant Recipient personnel required to attend training - The Grant Recipient's Authorized Signing Official and at least one other individual employed by the Grant Recipient must attend the trainings required by this rule.(1) Upon a finding of good cause, the Chief Compliance Officer may allow the Grant Recipient to substitute another employee to attend a required training in place of the Authorized Signing Official.(2) In the event that the Authorized Signing Official designated by the Grant Recipient changes on or after November 1, 2016, and the new Authorized Signing Official has not completed the annual compliance training program, the new Authorized Signing Official shall complete the annual compliance training program within 60 days of change. Failure to do so may result in the withholding of Grant Award funds until the training is completed. Source Note: The provisions of this §703.22 adopted to be effective December 9, 2015, 40 TexReg 8793; amended to be effective March 14, 2019, 44 TexReg 1346. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.22 Required Training for Grant Recipients https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218582&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218582 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=218582&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 218582 03/11/2026 (a) The Institute disburses Grant Award funds by reimbursing the Grant Recipient for allowable costs already expended; however, the nature and circumstances of the Grant Mechanism or a particular Grant Award may justify advance payment of funds by the Institute pursuant to the Grant Contract.(1) The Chief Executive Officer shall seek authorization from the Oversight Committee to disburse Grant Award funds by advance payment.(A) A simple majority of Oversight Committee Members present and voting must approve the Chief Executive Officer's advance payment recommendation for the Grant Award.(B) Unless specifically stated at the time of the Oversight Committee's vote, the Oversight Committee's approval to disburse Grant Award funds by advance payment is effective for the term of the Grant Award.(2) Unless otherwise specified in the Grant Contract, the amount of Grant Award funds advanced in any particular Tranche may not exceed the budget amount for the corresponding Project Year.(3) The Grant Recipient receiving advance payment of Grant Award funds must maintain or demonstrate the willingness and ability to maintain procedures to minimize the time elapsing between the transfer of the Grant Award funds and disbursement by the Grant Recipient.(4) The Grant Recipient must comply with all financial reporting requirements regarding use of Grant Award funds, including timely submission of quarterly Financial Status Reports.(5) The Grant Recipient must expend at least 90% of the Grant Award funds in a Tranche before Institute will advance additional grant funds or reimburse additional costs. To the extent possible, the Institute will work with the Grant Recipient to coordinate the advancement of Grant Award fund Tranches in such a way as to avoid affecting work in progress or project planning.(6) Nothing herein creates an entitlement to advance payment of Grant Award funds; the Institute may determine in its sole discretion that circumstances justify limiting the amount of Grant Award funds eligible for advance payment, may restrict the period for the advance payment of Grant Award funds, or may revert to payment on a reimbursement-basis. Unless specifically stated in the Grant Contract, the Institute will disburse the last ten percent (10%) of the total Grant Award funds using the reimbursement method of funding, and will withhold payment until the Grant Recipient has closed its Grant Contract and the Institute has approved the Grant Recipient's final reports pursuant to §703.14 of this chapter relating to Termination, Extension, Close Out of Grant Contracts, and De-Obligation of Grant Award funds.(A) A Grant Recipient receiving advance payment may request in writing that the Institute withhold less than ten percent (10%) of the total Grant Award funds. The Grant Recipient must submit the request and reasonable justification to the Institute no sooner than the start of the final year and no later than the start of the final financial status reporting period of the grant project.(B) The Chief Executive Officer may approve or deny the request. If approved, the Chief Executive Officer will provide written notification to the Oversight Committee. The Chief Executive Officer's decision to approve or deny a request is final.(b) The Institute will disburse Grant Award funds for actual cash expenditures reported on the Grant Recipient's quarterly Financial Status Report.(1) Only expenses that are allowable and supported by adequate documentation are eligible to be paid with Grant Award funds.(2) A Grant Recipient must pay their vendors and subcontractors prior to requesting reimbursement from CPRIT.(c) The Institute may withhold disbursing Grant Award funds if the Grant Recipient has not submitted required reports, including quarterly Financial Status Reports, Grant Progress Reports, Matching Fund Reports, audits and other financial reports. Unless otherwise specified for the particular Grant Award, Institute approval of the required report(s) is necessary for disbursement of Grant Award funds.(d) All Grant Award funds are disbursed pursuant to a fully executed Grant Contract. Grant Award funds shall not be disbursed prior to the effective date of the Grant Contract. Source Note: The provisions of this §703.23 adopted to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 10, 2020, 45 TexReg 3773; amended to be effective June 9, 2024, 49 TexReg 3926. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.23 Disbursement of Grant Award Funds https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211361&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211361 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=211361&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 211361 03/11/2026 (a) The Grant Recipient shall report expenditures to be reimbursed with Grant Award funds on the quarterly Financial Status Report form. The Grant Recipient must report all expenses for which it seeks reimbursement that the Grant Recipient paid during the fiscal quarter indicated on the quarterly Financial Status Report form.(1) Expenditures shall be reported by budget category consistent with the Grant Recipient's Approved Budget.(2) If the Grant Recipient seeks reimbursement for an expense it paid prior to the period covered by the current quarterly Financial Status Report but did not previously report to the Institute, the Grant Recipient must provide a written explanation for failing to claim the prior payment in the appropriate period.(A) The Grant Recipient must submit the written explanation with any supporting documentation at the time that the Grant Recipient files its current Financial Status Report.(B) The Institute shall consider the explanation and may approve reimbursement for the otherwise eligible expense. The Institute's decision whether to reimburse the expense is final.(3) All expenditures must be supported with appropriate documentation showing that the costs were incurred and paid. A Grant Recipient that is a public or private institution of higher education as defined by §61.003, Texas Education Code is not required to submit supporting documentation for an individual expense totaling less than $750 in the "supplies" or "other" budget categories.(4) The Financial Status Report and supporting documentation must be submitted via the Grant Management System, unless the Grant Recipient is specifically directed in writing by the Institute to submit or provide it in another manner.(5) The Institute may request in writing that a Grant Recipient provide more information or correct a deficiency in the supporting documentation for a Financial Status Report. If a Grant Recipient does not submit the requested information within five (5) business days after the request is submitted, the Financial Status Report may be disapproved by the Institute.(A) Nothing herein restricts the Institute from disapproving the FSR without asking for additional information or prior to the submission of additional information.(B) Nothing herein extends the FSR due date.(6) The requirement to report and timely submit quarterly Financial Status Reports applies to all Grant Recipients, regardless of whether Grant Award funds are disbursed by reimbursement or in advance of incurring costs.(b) Quarterly Financial Status Reports shall be submitted to the Institute within ninety (90) days of the end of the state fiscal quarter (based upon a September 1 - August 31 fiscal year). The Institute shall review expenditures and supporting documents to determine whether expenses charged to the Grant Award are:(1) Allowable, allocable, reasonable, necessary, and consistently applied regardless of the source of funds; and(2) Adequately supported with documentation such as cost reports, receipts, third party invoices for expenses, or payroll information.(c) A Grant Award with a Grant Contract effective date within the last quarter of a state fiscal year (June 1 - August 31) will have an initial financial reporting period beginning September 1 of the following state fiscal year.(1) A Grant Recipient that incurs Authorized Expenses after the Grant Contract effective date but before the beginning of the next state fiscal year may request reimbursement for those Authorized Expenses.(2) The Authorized Expenses described in paragraph (1) of this subsection must be reported in the Financial Status Report reflecting Authorized Expenses for the initial financial reporting period beginning September 1.(d) Except as provided herein, the Grant Recipient waives the right to reimbursement of project costs incurred during the reporting period if the Financial Status Report for that quarter is not submitted to the Institute within thirty (30) days of the Financial Status Report due date. Waiver of reimbursement of project costs incurred during the reporting period also applies to Grant Recipients that have received advancement of Grant Award funds.(1) For purposes of this rule, the "Financial Status Report due date" is ninety (90) days following the end of the state fiscal quarter.(2) The Chief Executive Officer may approve a Grant Recipient's request to defer submission of the reimbursement request for the current fiscal quarter until the next fiscal quarter if, on or before the original Financial Status Report due date, the Grant Recipient submits a written explanation for the Grant Recipient's inability to complete a timely submission of the Financial Status Report.(3) A Grant Recipient may appeal the waiver of its right to reimbursement of project costs.(A) The appeal shall be in writing, provide good cause for failing to submit the Financial Status Report within thirty (30) days of the Financial Status Report due date, and be submitted via the Grant Management System.(B) The Chief Executive Officer may approve the appeal for good cause. The decision by the Chief Executive Officer to approve or deny the grant recipient's appeal shall be in writing and available to the Grant Recipient via the Grant Management System.(C) The Chief Executive Officer's decision to approve or deny the Grant Recipient's appeal is final, unless the Grant Recipient timely seeks reconsideration of the Chief Executive Officer's decision by the Oversight Committee.(D) The Grant Recipient may request that the Oversight Committee reconsider the Chief Executive Officer's decision regarding the Grant Recipient's appeal. The request for reconsideration shall be in writing and submitted to the Chief Executive Officer within 10 days of the date that the Chief Executive Officer notifies the Grant Recipient of the decision regarding the appeal as noted in subparagraph (C) of this paragraph.(E) The Chief Executive Officer shall notify the Oversight Committee in writing of the decision to approve or deny the Grant Recipient's appeal. The notice should provide justification for the Chief Executive Officer's decision. In the event that the Grant Recipient timely seeks reconsideration of the Chief Executive Officer's decision, the Chief Executive Officer shall provide the Grant Recipient's written request to the Oversight Committee at the same time.(F) The Grant Recipient's request for reconsideration is deemed denied unless three or more Oversight Committee members request that the Chief Executive Officer add the Grant Recipient's request for reconsideration to the agenda for action at the next regular Oversight Committee meeting. The decision made by the Oversight Committee is final.(G) If the Grant Recipient's appeal is approved by the Chief Executive Officer or the Oversight Committee, the Grant Recipient shall report the project costs and provide supporting documentation for the costs incurred during the reporting period covered by the appeal on the next available financial status report to be filed by the Grant Recipient.(H) Approval of the waiver appeal does not connote approval of the expenditures; the expenditures and supporting documentation shall be reviewed according to subsection (b) of this section.(I) This subsection applies to any waivers of the Grant Recipient's reimbursement decided by the Institute on or after September 1, 2015.(4) Notwithstanding subsection (c) of this section, in the event that the Grant Recipient and Institute execute the Grant Contract after the effective date of the Grant Contract, the Chief Program Officer may approve additional time for the Grant Recipient to prepare and submit the outstanding Financial Status Report(s). The approval shall be in writing and maintained in the Grants Management System. The Chief Program Officer's approval may cover more than one Financial Status Report and more than one fiscal quarter.(5) In order to receive disbursement of grant funds, the most recently due Financial Status Report must be approved by the Institute.(e) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection. Source Note: The provisions of this §703.24 adopted to be effective December 7, 2016, 41 TexReg 9527; amended to be effective June 8, 2017, 42 TexReg 2937; amended to be effective September 6, 2017, 42 TexReg 4467; amended to be effective December 18, 2018, 43 TexReg 8123; amended to be effective December 11, 2019, 44 TexReg 7549; amended to be effective December 8, 2022, 47 TexReg 8042. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.24 Financial Status Reports https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214995&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214995 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=214995&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 214995 03/11/2026 (a) The Grant Contract shall include an Approved Budget that reflects the amount of the Grant Award funds to be spent for each Project Year.(b) All expenses charged to a Grant Award must be budgeted and reported in the appropriate budget category.(c) Actual expenditures under each category should not exceed budgeted amounts authorized by the Grant Contract as reflected on the Approved Budget for each Grant Award.(d) Recipients may make transfers between or among lines within budget categories listed on the Approved Budget so long as the transfer fits within the Scope of Work and the total Approved Budget; is beneficial to the achievement of the Scope of Work; and is an efficient, effective use of Grant Award funds.(e) Except as provided herein, all budget changes or transfers require Institute approval.(1) The Grant Recipient may make budget changes or transfers without prior approval from the Institute for expenses not specified in the equipment category if:(A) The total dollar amount of all changes of any single line item (individually and in the aggregate) within budget categories other than equipment is 10% or less of the total budget for the applicant grant year;(B) The transfer will not increase or decrease the total grant budget; and(C) The transfer will not materially change the nature, performance level, or Scope of Work.(2) The Institute may reverse one or more budget changes or transfers under paragraph (1) of this subsection if the Institute determines that the Grant Recipient made multiple individual budget changes or transfers within the same category that, if considered together, would require Institute approval.(f) A Grant Recipient awarded a Grant Award for a multiyear project that fails to expend the total Project Year budget may carry forward the unexpended budget balance to the next Project Year.(1) If the amount of the unexpended balance for a budget line item in a Project Year exceeds twenty-five percent (25%) or more of the total budget line item amount for that year, Institute approval is required before the Grant Recipient may carry forward the unexpended balance to the next Project Year.(2) For a budget carry forward requiring Institute approval, the Grant Recipient must provide justification for why the total Grant Award amount should not be reduced by the unexpended balance. Source Note: The provisions of this §703.25 adopted to be effective December 7, 2016, 41 TexReg 9527; amended to be effective March 8, 2017, 42 TexReg 1029; amended to be effective September 11, 2019, 44 TexReg 4873; amended to be effective September 7, 2023, 48 TexReg 4863. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.25 Grant Award Budget https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224398&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224398 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=224398&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 224398 03/11/2026 (a) A cost is an Allowable Cost and may be charged to the Grant Award if it is reasonable, allocable, and adequately documented.(1) A cost is reasonable if the cost does not exceed that which would be incurred by a prudent individual or organization under the circumstances prevailing at the time the decision was made to incur the cost; and is necessary for the performance of the Grant Award defined in the Scope of Work in the Grant Contract.(2) A cost is allocable if the cost:(A) Benefits the Grant Award either directly or indirectly, subject to Indirect Cost limits stated in the Grant Contract;(B) Is assigned the Grant Award in accordance with the relative benefit received;(C) Is allowed or not prohibited by state laws, administrative rules, contractual terms, or applicable regulations;(D) Is not included as a cost or used to meet Matching Fund requirements for any other Grant Award in either the current or a prior period; and(E) Conforms to any limitations or exclusions set forth in the applicable cost principles, administrative rules, state laws, and terms of the Grant Contract.(3) A cost is adequately documented if the cost is supported by the organization's accounting records and documented consistent with §703.24 of this title (relating to Financial Status Reports).(b) Grant Award funds must be used for Allowable Costs as provided by the terms of the Grant Contract, Chapter 102, Texas Health and Safety Code, the Institute's administrative rules, and the Texas Grant Management Standards (TxGMS) adopted by the Comptroller's Office. If guidance from TxGMS on a particular issue conflicts with a specific provision of the Grant Contract, Chapter 102, Texas Health and Safety Code or the Institute's administrative rules, then the Grant Contract, statute, or Institute administrative rule shall prevail.(c) An otherwise Allowable Cost will not be eligible for reimbursement if the Grant Recipient incurred the expense outside of the Grant Contract term, unless the Grant Recipient has received written approval from the Institute's Chief Executive Officer to receive reimbursement for expenses incurred prior to the effective date of the Grant Contract.(d) An otherwise Allowable Cost will not be eligible for reimbursement if the benefit from the cost of goods or services charged to the Grant Award is not realized within the applicable term of the Grant Award. The Grant Award should not be charged for the cost of goods or services that benefit another Grant Award or benefit a period prior to the Grant Contract effective date or after the termination of the Grant Contract.(e) Grant Award funds shall not be used to reimburse unallowable expenses, including, but not limited to:(1) Bad debt, such as losses arising from uncollectible accounts and other claims and related costs.(2) Contributions to a contingency reserve or any similar provision for unforeseen events.(3) Contributions and donations made to any individual or organization.(4) Costs of entertainment, amusements, social activities, and incidental costs relating thereto, including tickets to shows or sports events, meals, alcoholic beverages, lodging, rentals, transportation and gratuities.(5) Costs relating to food and beverage items, unless the food item is related to the issue studied by the project that is the subject of the Grant Award.(6) Fines, penalties, or other costs resulting from violations of or failure to comply with federal, state, local or Indian tribal laws and regulations.(7) An honorary gift or a gratuitous payment.(8) Interest and other financial costs related to borrowing and the cost of financing.(9) Legislative expenses such as salaries and other expenses associated with lobbying the state or federal legislature or similar local governmental bodies, whether incurred for purposes of legislation or executive direction.(10) Liability insurance coverage.(11) Benefit replacement pay or legislatively-mandated pay increases for eligible general revenue-funded state employees at Grant Recipient state agencies or universities.(12) Professional association fees or dues for an individual employed by the Grant Recipient. Professional association fees or dues for the Grant Recipient's membership in business, technical, and professional organizations may be allowed, with prior approval from the Institute, if:(A) the professional association is not involved in lobbying efforts; and(B) the Grant Recipient demonstrates how membership in the professional association benefits the Grant Award project(s).(13) Promotional items and costs relating to items such as T-shirts, coffee mugs, buttons, pencils, and candy that advertise or promote the project or Grant Recipient.(14) Fees for visa services.(15) Payments to a subcontractor if the subcontractor working on a Grant Award project employs an individual who is a Relative of the Principal Investigator, Program Director, Company Representative, Authorized Signing Official, or any person designated as Key Personnel for the same Grant Award project (collectively referred to as "affected Relative"), and the Grant Recipient will be paying the subcontractor with Grant Award funds for any portion of the affected Relative's salary or the Relative submits payment requests on behalf of the subcontractor to the Grant Recipient for payment with Grant Award funds.(A) For exceptional circumstances, the Institute's Chief Executive Office may grant an exception to allow payment of Grant Award funds if the Grant Recipient notifies the Institute prior to finalizing the subcontract. The Chief Executive Officer must notify the Oversight Committee in writing of the decision to allow reimbursement for the otherwise unallowable expense.(B) Nothing herein is intended to supersede a Grant Recipient's internal policies, to the extent that such policies are stricter.(16) Fundraising.(17) Tips or gratuities.(18) Reimbursements to employees for their out-of-pocket health insurance premium or other health care expenses which are not made through an employer-sponsored plan established under Section 105 of the Internal Revenue Code.(f) Pursuant to Texas Health and Safety Code Section 102.203(b) the Institute may authorize reimbursement for one or more of the following expenses incurred by a cancer clinical trial participant that are associated with participating in a clinical trial and included in the Grant Recipient's Approved Budget:(1) transportation, including car mileage, parking, bus fare, taxi or ride hailing fare exclusive of tips, and commercial economy class airfare within the borders of the State of Texas;(2) lodging; and(3) any cost reimbursed under a cancer clinical trial participation program established pursuant to Texas Health and Safety Code Chapter 51 (relating to Cancer Clinical Trial Participation Program). (g) The Institute is responsible for making the final determination regarding whether an expense shall be considered an Allowable Cost. Source Note: The provisions of this §703.26 adopted to be effective December 7, 2016, 41 TexReg 9527; amended to be effective March 15, 2018, 43 TexReg 1442; amended to be effective June 5, 2019, 44 TexReg 2723; amended to be effective March 11, 2021, 46 TexReg 1472; amended to be effective September 9, 2021, 46 TexReg 5570; amended to be effective March 10, 2022, 47 TexReg 1093; amended to be effective December 8, 2022, 47 TexReg 8042; amended to be effective March 12, 2025, 50 TexReg 1824. 11 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS 703 GRANTS FOR CANCER PREVENTION AND RESEARCH §703.26 Allowable Costs https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125087&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125087 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=125087&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 125087 03/11/2026 (a) Applicable law. The Texas Council on Alzheimer's Disease and Related Disorders is created by the Health and Safety Code, Subtitle E., Chapter 101 by the 70th Legislature, Regular Session, 1987.(b) Officers and their duties.(1) The governor shall designate a member of the council who is not an agency representative as the chairman of the council to serve in that capacity at the will of the governor.(2) The chairman shall preside at all council meetings at which he or she is in attendance, call meetings in accordance with this section, assist in the preparation of the agenda, appoint committees, task forces or workgroups of the council with council consensus, cause proper reports to be made to the governor, lieutenant governor and speaker of the house and serve as spokesperson for the council. The chairman may serve as an ex-officio member of any subcommittee or workgroup of the council. The chairman may invite guests or speakers.(3) The members of the council shall elect a vice-chairman each year.(4) The vice-chairman shall perform the duties of the chairman in the absence or disability of the chairman. Should the office of the chairman become vacant, the vice-chairman shall serve until a successor is appointed.(c) Meetings.(1) The council shall meet at least two times in each calendar year and may meet at other times, as the chairman deems necessary.(2) Each meeting of the council shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551.(3) A simple majority of the members of the council shall constitute a quorum for the purpose of transacting official business.(4) The council is authorized to transact official business only when in a legally constituted meeting with a quorum present.(5) Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.(6) Any action taken by the council must be approved by a majority of the voting members present once a quorum is established. Each member appointed by the Governor, Lieutenant Governor and Speaker of the House shall have one vote. A member may not authorize another individual to represent the member by proxy. Source Note: The provisions of this §801.1 adopted to be effective June 25, 2006, 31 TexReg 4865. 12 TEXAS COUNCIL ON ALZHEIMER'S DISEASE AND RELATED DISORDERS 801 PROCEDURES §801.1 Conduct of Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2656 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2656&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2656 03/11/2026 These sections outline the procedures the Toxic Substances Coordinating Committee will follow in the conduct of its meetings. Source Note: The provisions of this §1001.1 adopted to be effective August 19, 1988, 13 TexReg 3824. 14 TOXIC SUBSTANCES COORDINATING COMMITTEE 1001 MEETINGS §1001.1 Introduction https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2657&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2657 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=2657&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 2657 03/11/2026 The committee is subject to the requirements of the Texas Open Meetings Act, Texas Civil Statutes, Article 6252-17, except as modified by §1001.3(a) of this title (relating to Notice of Meetings). Source Note: The provisions of this §1001.2 adopted to be effective August 19, 1988, 13 TexReg 3824. 14 TOXIC SUBSTANCES COORDINATING COMMITTEE 1001 MEETINGS §1001.2 Applicability of Texas Open Meetings Law https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14635&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14635 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14635&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14635 03/11/2026 (a) Written notice giving the date, time, place, and subject of each meeting shall be prepared as required by the Open Meetings Act and posted with the secretary of state at least 15 days prior to the meeting.(b) A copy of the notice shall be sent to each committee member at least seven days prior to the date of the meeting except in emergency cases as determined by the chairperson. Source Note: The provisions of this §1001.3 adopted to be effective August 19, 1988, 13 TexReg 3824. 14 TOXIC SUBSTANCES COORDINATING COMMITTEE 1001 MEETINGS §1001.3 Notice of Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14629 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14629&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14629 03/11/2026 The committee shall meet at the call of the chief administrative officer of any member agency or, at a minimum, once each quarter on a meeting date set by the committee. Source Note: The provisions of this §1001.4 adopted to be effective August 19, 1988, 13 TexReg 3824. 14 TOXIC SUBSTANCES COORDINATING COMMITTEE 1001 MEETINGS §1001.4 Time of Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=30610&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 30610 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=30610&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 30610 03/11/2026 (a) All meetings will be conducted according to Roberts Rules of Order.(b) All committee actions taken must be approved by a majority vote of the members present. The chairperson may vote on any item of business as any other committee member; however, in the case of a tie vote, the chairperson's vote shall be the tie breaker. Source Note: The provisions of this §1001.5 adopted to be effective August 19, 1988, 13 TexReg 3824. 14 TOXIC SUBSTANCES COORDINATING COMMITTEE 1001 MEETINGS §1001.5 Transaction of Business https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14636&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14636 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=14636&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 14636 03/11/2026 Requests from members of the public to participate in committee meetings should be submitted to the chairperson prior to the beginning of the meeting. The chairperson has the discretion to allow or disallow participation. If the chairperson allows participation, he/she determines the manner and time limits of the participation. Source Note: The provisions of this §1001.6 adopted to be effective August 19, 1988, 13 TexReg 3824. 14 TOXIC SUBSTANCES COORDINATING COMMITTEE 1001 MEETINGS §1001.6 Public Participation https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=132557&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 132557 03/11/2026 https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=132557&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 132557 03/11/2026 (a) Applicable law. The Texas Council on Cardiovascular Disease and Stroke is created by Health and Safety Code, Chapter 93.(b) Officers and their duties.(1) The governor shall designate a member of the council as the presiding officer of the council to serve in that capacity at the will of the governor.(2) The presiding officer shall preside at all council meetings at which he or she is in attendance, call meetings in accordance with this section, assist in the preparation of the agenda, appoint subcommittees or workgroups of the council as necessary and with council consensus, cause proper reports to be made to the governor, lieutenant governor and speaker of the house and serve as spokesperson for the council. The presiding officer may serve as an ex-officio member of any subcommittee or workgroup of the council. The presiding officer may invite guests or speakers.(3) The members of the council shall elect a vice-chairman each year.(4) The vice-chairman shall perform the duties of the presiding officer in the absence or disability of the presiding officer. Should the office of the presiding officer become vacant, the vice-chairman shall serve until a successor is appointed.(c) Meetings.(1) The council shall meet at least quarterly. A meeting may be called with the agreement of Department of State Health Services staff and the presiding officer.(2) Each meeting of the council shall be announced and conducted in accordance with the Open Meetings Act, Government Code, Chapter 551.(3) A simple majority of the members of the council shall constitute a quorum for the purpose of transacting official business.(4) The council is authorized to transact official business only when in a legally constituted meeting with a quorum present.(5) Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.(6) Any action taken by the council must be approved by a majority vote of the public members present once quorum is established. Each public member shall have one vote. A public member may not authorize another individual to represent the member by proxy. Source Note: The provisions of this §1051.1 adopted to be effective October 14, 2007, 32 TexReg 7065. 15 COUNCIL ON CARDIOVASCULAR DISEASE AND STROKE 1051 RULES §1051.1 Conduct of Meetings https://texas-sos.appianportalsgov.com/rules-and-meetings?recordId=221963&queryAsDate=03%2F11%2F2026&interface=VIEW_TAC_SUMMARY&$locale=en_US 221963 03/11/2026